+关注
boredsilly5
暂无个人介绍
IP属地:未知
37
关注
5
粉丝
0
主题
0
勋章
主贴
热门
boredsilly5
2021-12-24
$Tesla Motors(TSLA)$
arggh regret not adding more when it was 900 ish but well
boredsilly5
2021-12-14
$Tesla Motors(TSLA)$
tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.
boredsilly5
2021-12-02
Yay tesla
抱歉,原内容已删除
boredsilly5
2021-11-29
$Novavax(NVAX)$
let's go. Will go up with the cases increasing
boredsilly5
2021-11-16
$Razer(01337)$
ehat is happening! Woah
boredsilly5
2021-11-15
$Tiger Brokers(TIGR)$
cmon cmon let's go up like a helicopter
boredsilly5
2021-10-23
$Digital World Acquisition Corp(DWAC)$
anyone considering keeping till next week?
boredsilly5
2021-10-20
Sigh
Novavax plunged over 20% in premarket trading
boredsilly5
2021-10-20
Sigh
Novavax plunged over 20% in premarket trading
boredsilly5
2021-07-27
Sigh
抱歉,原内容已删除
boredsilly5
2021-07-16
Damn I sold it! But profit is profit!
Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.
boredsilly5
2021-07-07
$Novavax(NVAX)$
what is happening?
boredsilly5
2021-02-01
$Palantir Technologies Inc.(PLTR)$
should have sold some around 40. Oh well
boredsilly5
2021-01-28
$GameStop(GME)$
am not in this but good luck to those in it!
boredsilly5
2021-01-27
$Nokia Oyj(NOK)$
have a feeling this will be the next yolo share.
boredsilly5
2021-01-26
$Palantir Technologies Inc.(PLTR)$
wow that was a spetacular drop. And I'm now in the red. 🤷♀️
boredsilly5
2021-01-25
$Hims & Hers Health Inc.(HIMS)$
no reason why it should be falling this much.
boredsilly5
2021-01-11
$Beyond Meat, Inc.(BYND)$
it's a good price to buy in now me thinks.
boredsilly5
2020-12-15
$Bridgetown Holdings Limited(BTWN)$
The best time to buy is now and hold. Hold hold hold for the long term.
boredsilly5
2020-12-05
$Luminar Technologies, Inc.(LAZR)$
wonder how long this rally will last.
去老虎APP查看更多动态
{"i18n":{"language":"zh_CN"},"userPageInfo":{"id":"3566466633436913","uuid":"3566466633436913","gmtCreate":1603374511552,"gmtModify":1603852007217,"name":"boredsilly5","pinyin":"boredsilly5","introduction":"","introductionEn":"","signature":"","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","hat":null,"hatId":null,"hatName":null,"vip":1,"status":2,"fanSize":5,"headSize":37,"tweetSize":28,"questionSize":0,"limitLevel":999,"accountStatus":4,"level":{"id":3,"name":"书生虎","nameTw":"書生虎","represent":"努力向上","factor":"发布10条非转发主帖,其中5条获得他人回复或点赞","iconColor":"3C9E83","bgColor":"A2F1D9"},"themeCounts":0,"badgeCounts":0,"badges":[],"moderator":false,"superModerator":false,"manageSymbols":null,"badgeLevel":null,"boolIsFan":false,"boolIsHead":false,"favoriteSize":0,"symbols":null,"coverImage":null,"realNameVerified":null,"userBadges":[{"badgeId":"e50ce593bb40487ebfb542ca54f6a561-1","templateUuid":"e50ce593bb40487ebfb542ca54f6a561","name":"出道虎友","description":"加入老虎社区500天","bigImgUrl":"https://static.tigerbbs.com/0e4d0ca1da0456dc7894c946d44bf9ab","smallImgUrl":"https://static.tigerbbs.com/0f2f65e8ce4cfaae8db2bea9b127f58b","grayImgUrl":"https://static.tigerbbs.com/c5948a31b6edf154422335b265235809","redirectLinkEnabled":0,"redirectLink":null,"hasAllocated":1,"isWearing":0,"stamp":null,"stampPosition":0,"hasStamp":0,"allocationCount":1,"allocatedDate":"2022.03.07","exceedPercentage":null,"individualDisplayEnabled":0,"backgroundColor":null,"fontColor":null,"individualDisplaySort":0,"categoryType":1001},{"badgeId":"228c86a078844d74991fff2b7ab2428d-2","templateUuid":"228c86a078844d74991fff2b7ab2428d","name":"投资总监虎","description":"证券账户累计交易金额达到30万美元","bigImgUrl":"https://static.tigerbbs.com/9d20b23f1b6335407f882bc5c2ad12c0","smallImgUrl":"https://static.tigerbbs.com/ada3b4533518ace8404a3f6dd192bd29","grayImgUrl":"https://static.tigerbbs.com/177f283ba21d1c077054dac07f88f3bd","redirectLinkEnabled":0,"redirectLink":null,"hasAllocated":1,"isWearing":0,"stamp":null,"stampPosition":0,"hasStamp":0,"allocationCount":1,"allocatedDate":"2021.12.28","exceedPercentage":"80.31%","individualDisplayEnabled":0,"backgroundColor":null,"fontColor":null,"individualDisplaySort":0,"categoryType":1101},{"badgeId":"976c19eed35f4cd78f17501c2e99ef37-1","templateUuid":"976c19eed35f4cd78f17501c2e99ef37","name":"博闻投资者","description":"累计交易超过10只正股","bigImgUrl":"https://static.tigerbbs.com/e74cc24115c4fbae6154ec1b1041bf47","smallImgUrl":"https://static.tigerbbs.com/d48265cbfd97c57f9048db29f22227b0","grayImgUrl":"https://static.tigerbbs.com/76c6d6898b073c77e1c537ebe9ac1c57","redirectLinkEnabled":0,"redirectLink":null,"hasAllocated":1,"isWearing":0,"stamp":null,"stampPosition":0,"hasStamp":0,"allocationCount":1,"allocatedDate":"2021.12.21","exceedPercentage":null,"individualDisplayEnabled":0,"backgroundColor":null,"fontColor":null,"individualDisplaySort":0,"categoryType":1102},{"badgeId":"518b5610c3e8410da5cfad115e4b0f5a-1","templateUuid":"518b5610c3e8410da5cfad115e4b0f5a","name":"实盘交易者","description":"完成一笔实盘交易","bigImgUrl":"https://static.tigerbbs.com/2e08a1cc2087a1de93402c2c290fa65b","smallImgUrl":"https://static.tigerbbs.com/4504a6397ce1137932d56e5f4ce27166","grayImgUrl":"https://static.tigerbbs.com/4b22c79415b4cd6e3d8ebc4a0fa32604","redirectLinkEnabled":0,"redirectLink":null,"hasAllocated":1,"isWearing":0,"stamp":null,"stampPosition":0,"hasStamp":0,"allocationCount":1,"allocatedDate":"2021.12.21","exceedPercentage":null,"individualDisplayEnabled":0,"backgroundColor":null,"fontColor":null,"individualDisplaySort":0,"categoryType":1100},{"badgeId":"35ec162348d5460f88c959321e554969-2","templateUuid":"35ec162348d5460f88c959321e554969","name":"宗师交易员","description":"证券或期货账户累计交易次数达到100次","bigImgUrl":"https://static.tigerbbs.com/ad22cfbe2d05aa393b18e9226e4b0307","smallImgUrl":"https://static.tigerbbs.com/36702e6ff3ffe46acafee66cc85273ca","grayImgUrl":"https://static.tigerbbs.com/d52eb88fa385cf5abe2616ed63781765","redirectLinkEnabled":0,"redirectLink":null,"hasAllocated":1,"isWearing":0,"stamp":null,"stampPosition":0,"hasStamp":0,"allocationCount":1,"allocatedDate":"2021.12.21","exceedPercentage":"80.66%","individualDisplayEnabled":0,"backgroundColor":null,"fontColor":null,"individualDisplaySort":0,"categoryType":1100}],"userBadgeCount":5,"currentWearingBadge":null,"individualDisplayBadges":null,"crmLevel":5,"crmLevelSwitch":0,"location":"未知","starInvestorFollowerNum":0,"starInvestorFlag":false,"starInvestorOrderShareNum":0,"subscribeStarInvestorNum":0,"ror":null,"winRationPercentage":null,"showRor":false,"investmentPhilosophy":null,"starInvestorSubscribeFlag":false},"baikeInfo":{},"tab":"post","tweets":[{"id":698921927,"gmtCreate":1640279658930,"gmtModify":1640279659074,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a> arggh regret not adding more when it was 900 ish but well","listText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a> arggh regret not adding more when it was 900 ish but well","text":"$Tesla Motors(TSLA)$ arggh regret not adding more when it was 900 ish but well","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/698921927","isVote":1,"tweetType":1,"viewCount":2595,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":607985689,"gmtCreate":1639474734030,"gmtModify":1639474734131,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a> tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate. ","listText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a> tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate. ","text":"$Tesla Motors(TSLA)$ tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/607985689","isVote":1,"tweetType":1,"viewCount":2010,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":603164518,"gmtCreate":1638375354339,"gmtModify":1638375354511,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Yay tesla ","listText":"Yay tesla ","text":"Yay tesla","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/603164518","repostId":"1121479816","repostType":2,"isVote":1,"tweetType":1,"viewCount":2120,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":600731859,"gmtCreate":1638196931721,"gmtModify":1638196931880,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing ","listText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing ","text":"$Novavax(NVAX)$let's go. Will go up with the cases increasing","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/600731859","isVote":1,"tweetType":1,"viewCount":1982,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":871128610,"gmtCreate":1637038902795,"gmtModify":1637038924098,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a> ehat is happening! Woah","listText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a> ehat is happening! Woah","text":"$Razer(01337)$ ehat is happening! Woah","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/871128610","isVote":1,"tweetType":1,"viewCount":2118,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":873765705,"gmtCreate":1636988033557,"gmtModify":1636988033688,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","listText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","text":"$Tiger Brokers(TIGR)$cmon cmon let's go up like a helicopter","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/873765705","isVote":1,"tweetType":1,"viewCount":1262,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":851460065,"gmtCreate":1634922504270,"gmtModify":1634922504396,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a> anyone considering keeping till next week? ","listText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a> anyone considering keeping till next week? ","text":"$Digital World Acquisition Corp(DWAC)$ anyone considering keeping till next week?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":4,"repostSize":0,"link":"https://laohu8.com/post/851460065","isVote":1,"tweetType":1,"viewCount":4393,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859498208,"gmtCreate":1634719138359,"gmtModify":1634719138493,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Sigh ","listText":"Sigh ","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498208","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":1637,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859498813,"gmtCreate":1634719131861,"gmtModify":1634719132032,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Sigh ","listText":"Sigh ","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498813","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":1505,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":809205787,"gmtCreate":1627370360449,"gmtModify":1631892985724,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Sigh ","listText":"Sigh ","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/809205787","repostId":"2153137486","repostType":2,"isVote":1,"tweetType":1,"viewCount":732,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":170618044,"gmtCreate":1626426043188,"gmtModify":1631892985727,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Damn I sold it! But profit is profit! ","listText":"Damn I sold it! But profit is profit! ","text":"Damn I sold it! But profit is profit!","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/170618044","repostId":"1166310062","repostType":4,"repost":{"id":"1166310062","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1626425479,"share":"https://www.laohu8.com/m/news/1166310062?lang=&edition=full","pubTime":"2021-07-16 16:51","market":"us","language":"en","title":"Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.","url":"https://stock-news.laohu8.com/highlight/detail?id=1166310062","media":"Tiger Newspress","summary":"Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.\nModerna Inc. will replace ","content":"<p>Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.</p>\n<p><img src=\"https://static.tigerbbs.com/67fe1c018d8b5dfd6c9ed79f6402e3f0\" tg-width=\"1290\" tg-height=\"612\" referrerpolicy=\"no-referrer\">Moderna Inc. will replace Alexion Pharmaceuticals Inc. in the S&P 500 effective prior to the opening of trading on Wednesday, July 21. AstraZeneca Plc is acquiring Alexion Pharmaceuticals in a deal expected to be completed soon pending final closing conditions.</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nModerna shares jumps 6.85% in premarket trading,as to be joining S&P 500.\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-07-16 16:51</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.</p>\n<p><img src=\"https://static.tigerbbs.com/67fe1c018d8b5dfd6c9ed79f6402e3f0\" tg-width=\"1290\" tg-height=\"612\" referrerpolicy=\"no-referrer\">Moderna Inc. will replace Alexion Pharmaceuticals Inc. in the S&P 500 effective prior to the opening of trading on Wednesday, July 21. AstraZeneca Plc is acquiring Alexion Pharmaceuticals in a deal expected to be completed soon pending final closing conditions.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"MRNA":"Moderna, Inc.","ALXN":"亚力兄制药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1166310062","content_text":"Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.\nModerna Inc. will replace Alexion Pharmaceuticals Inc. in the S&P 500 effective prior to the opening of trading on Wednesday, July 21. AstraZeneca Plc is acquiring Alexion Pharmaceuticals in a deal expected to be completed soon pending final closing conditions.","news_type":1,"symbols_score_info":{"ALXN":0.9,"MRNA":0.9}},"isVote":1,"tweetType":1,"viewCount":247,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":140490099,"gmtCreate":1625667872711,"gmtModify":1631885336944,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a> what is happening? ","listText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a> what is happening? ","text":"$Novavax(NVAX)$ what is happening?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/140490099","isVote":1,"tweetType":1,"viewCount":1101,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":315022642,"gmtCreate":1612190908986,"gmtModify":1703758575060,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/PLTR\">$Palantir Technologies Inc.(PLTR)$</a> should have sold some around 40. Oh well","listText":"<a href=\"https://laohu8.com/S/PLTR\">$Palantir Technologies Inc.(PLTR)$</a> should have sold some around 40. Oh well","text":"$Palantir Technologies Inc.(PLTR)$ should have sold some around 40. Oh well","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/315022642","isVote":1,"tweetType":1,"viewCount":194,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":311174240,"gmtCreate":1611770616280,"gmtModify":1703753690523,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/GME\">$GameStop(GME)$</a> am not in this but good luck to those in it! ","listText":"<a href=\"https://laohu8.com/S/GME\">$GameStop(GME)$</a> am not in this but good luck to those in it! ","text":"$GameStop(GME)$ am not in this but good luck to those in it!","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/311174240","isVote":1,"tweetType":1,"viewCount":286,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":311907358,"gmtCreate":1611758814274,"gmtModify":1703753294088,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NOK\">$Nokia Oyj(NOK)$</a> have a feeling this will be the next yolo share. ","listText":"<a href=\"https://laohu8.com/S/NOK\">$Nokia Oyj(NOK)$</a> have a feeling this will be the next yolo share. ","text":"$Nokia Oyj(NOK)$ have a feeling this will be the next yolo share.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/311907358","isVote":1,"tweetType":1,"viewCount":201,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":319551260,"gmtCreate":1611590932650,"gmtModify":1703751444149,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/PLTR\">$Palantir Technologies Inc.(PLTR)$</a> wow that was a spetacular drop. And I'm now in the red. 🤷♀️","listText":"<a href=\"https://laohu8.com/S/PLTR\">$Palantir Technologies Inc.(PLTR)$</a> wow that was a spetacular drop. And I'm now in the red. 🤷♀️","text":"$Palantir Technologies Inc.(PLTR)$ wow that was a spetacular drop. And I'm now in the red. 🤷♀️","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/319551260","isVote":1,"tweetType":1,"viewCount":310,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":319229095,"gmtCreate":1611586742917,"gmtModify":1703751285785,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/HIMS\">$Hims & Hers Health Inc.(HIMS)$</a> no reason why it should be falling this much. ","listText":"<a href=\"https://laohu8.com/S/HIMS\">$Hims & Hers Health Inc.(HIMS)$</a> no reason why it should be falling this much. ","text":"$Hims & Hers Health Inc.(HIMS)$ no reason why it should be falling this much.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":3,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/319229095","isVote":1,"tweetType":1,"viewCount":304,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":332634431,"gmtCreate":1610377907624,"gmtModify":1703743956467,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BYND\">$Beyond Meat, Inc.(BYND)$</a>it's a good price to buy in now me thinks. ","listText":"<a href=\"https://laohu8.com/S/BYND\">$Beyond Meat, Inc.(BYND)$</a>it's a good price to buy in now me thinks. ","text":"$Beyond Meat, Inc.(BYND)$it's a good price to buy in now me thinks.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":4,"repostSize":0,"link":"https://laohu8.com/post/332634431","isVote":1,"tweetType":1,"viewCount":2221,"authorTweetTopStatus":1,"verified":2,"comments":[{"author":{"id":"224317250819766","authorId":"224317250819766","name":"平凡的我mz","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":1,"crmLevelSwitch":0,"idStr":"224317250819766","authorIdStr":"224317250819766"},"content":"拄着拐杖的英语","text":"拄着拐杖的英语","html":"拄着拐杖的英语"}],"imageCount":0,"langContent":"EN","totalScore":0},{"id":394213394,"gmtCreate":1608037507618,"gmtModify":1703850771409,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BTWN\">$Bridgetown Holdings Limited(BTWN)$</a> The best time to buy is now and hold. Hold hold hold for the long term. ","listText":"<a href=\"https://laohu8.com/S/BTWN\">$Bridgetown Holdings Limited(BTWN)$</a> The best time to buy is now and hold. Hold hold hold for the long term. ","text":"$Bridgetown Holdings Limited(BTWN)$ The best time to buy is now and hold. Hold hold hold for the long term.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":2,"link":"https://laohu8.com/post/394213394","isVote":1,"tweetType":1,"viewCount":483,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":396645516,"gmtCreate":1607101746235,"gmtModify":1703846554289,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/LAZR\">$Luminar Technologies, Inc.(LAZR)$</a> wonder how long this rally will last. ","listText":"<a href=\"https://laohu8.com/S/LAZR\">$Luminar Technologies, Inc.(LAZR)$</a> wonder how long this rally will last. ","text":"$Luminar Technologies, Inc.(LAZR)$ wonder how long this rally will last.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/396645516","isVote":1,"tweetType":1,"viewCount":103,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"hots":[{"id":332634431,"gmtCreate":1610377907624,"gmtModify":1703743956467,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BYND\">$Beyond Meat, Inc.(BYND)$</a>it's a good price to buy in now me thinks. ","listText":"<a href=\"https://laohu8.com/S/BYND\">$Beyond Meat, Inc.(BYND)$</a>it's a good price to buy in now me thinks. ","text":"$Beyond Meat, Inc.(BYND)$it's a good price to buy in now me thinks.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":4,"repostSize":0,"link":"https://laohu8.com/post/332634431","isVote":1,"tweetType":1,"viewCount":2221,"authorTweetTopStatus":1,"verified":2,"comments":[{"author":{"id":"224317250819766","authorId":"224317250819766","name":"平凡的我mz","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":1,"crmLevelSwitch":0,"idStr":"224317250819766","authorIdStr":"224317250819766"},"content":"拄着拐杖的英语","text":"拄着拐杖的英语","html":"拄着拐杖的英语"}],"imageCount":0,"langContent":"EN","totalScore":0},{"id":851460065,"gmtCreate":1634922504270,"gmtModify":1634922504396,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a> anyone considering keeping till next week? ","listText":"<a href=\"https://laohu8.com/S/DWAC\">$Digital World Acquisition Corp(DWAC)$</a> anyone considering keeping till next week? ","text":"$Digital World Acquisition Corp(DWAC)$ anyone considering keeping till next week?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":4,"repostSize":0,"link":"https://laohu8.com/post/851460065","isVote":1,"tweetType":1,"viewCount":4393,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":873765705,"gmtCreate":1636988033557,"gmtModify":1636988033688,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","listText":"<a href=\"https://laohu8.com/S/TIGR\">$Tiger Brokers(TIGR)$</a>cmon cmon let's go up like a helicopter","text":"$Tiger Brokers(TIGR)$cmon cmon let's go up like a helicopter","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/873765705","isVote":1,"tweetType":1,"viewCount":1262,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":394213394,"gmtCreate":1608037507618,"gmtModify":1703850771409,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BTWN\">$Bridgetown Holdings Limited(BTWN)$</a> The best time to buy is now and hold. Hold hold hold for the long term. ","listText":"<a href=\"https://laohu8.com/S/BTWN\">$Bridgetown Holdings Limited(BTWN)$</a> The best time to buy is now and hold. Hold hold hold for the long term. ","text":"$Bridgetown Holdings Limited(BTWN)$ The best time to buy is now and hold. Hold hold hold for the long term.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":2,"link":"https://laohu8.com/post/394213394","isVote":1,"tweetType":1,"viewCount":483,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":302130025,"gmtCreate":1604569864667,"gmtModify":1703833817799,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/ZM\">$Zoom(ZM)$</a> It's literally zooming to the top. Let's go! ","listText":"<a href=\"https://laohu8.com/S/ZM\">$Zoom(ZM)$</a> It's literally zooming to the top. Let's go! ","text":"$Zoom(ZM)$ It's literally zooming to the top. Let's go!","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":7,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/302130025","isVote":1,"tweetType":1,"viewCount":389,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":170618044,"gmtCreate":1626426043188,"gmtModify":1631892985727,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Damn I sold it! But profit is profit! ","listText":"Damn I sold it! But profit is profit! ","text":"Damn I sold it! But profit is profit!","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/170618044","repostId":"1166310062","repostType":4,"repost":{"id":"1166310062","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1626425479,"share":"https://www.laohu8.com/m/news/1166310062?lang=&edition=full","pubTime":"2021-07-16 16:51","market":"us","language":"en","title":"Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.","url":"https://stock-news.laohu8.com/highlight/detail?id=1166310062","media":"Tiger Newspress","summary":"Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.\nModerna Inc. will replace ","content":"<p>Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.</p>\n<p><img src=\"https://static.tigerbbs.com/67fe1c018d8b5dfd6c9ed79f6402e3f0\" tg-width=\"1290\" tg-height=\"612\" referrerpolicy=\"no-referrer\">Moderna Inc. will replace Alexion Pharmaceuticals Inc. in the S&P 500 effective prior to the opening of trading on Wednesday, July 21. AstraZeneca Plc is acquiring Alexion Pharmaceuticals in a deal expected to be completed soon pending final closing conditions.</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nModerna shares jumps 6.85% in premarket trading,as to be joining S&P 500.\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-07-16 16:51</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.</p>\n<p><img src=\"https://static.tigerbbs.com/67fe1c018d8b5dfd6c9ed79f6402e3f0\" tg-width=\"1290\" tg-height=\"612\" referrerpolicy=\"no-referrer\">Moderna Inc. will replace Alexion Pharmaceuticals Inc. in the S&P 500 effective prior to the opening of trading on Wednesday, July 21. AstraZeneca Plc is acquiring Alexion Pharmaceuticals in a deal expected to be completed soon pending final closing conditions.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"MRNA":"Moderna, Inc.","ALXN":"亚力兄制药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1166310062","content_text":"Moderna shares jumps 6.85% in premarket trading,as to be joining S&P 500.\nModerna Inc. will replace Alexion Pharmaceuticals Inc. in the S&P 500 effective prior to the opening of trading on Wednesday, July 21. AstraZeneca Plc is acquiring Alexion Pharmaceuticals in a deal expected to be completed soon pending final closing conditions.","news_type":1,"symbols_score_info":{"ALXN":0.9,"MRNA":0.9}},"isVote":1,"tweetType":1,"viewCount":247,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":308906471,"gmtCreate":1603812346893,"gmtModify":1703830843827,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/LMT\">$Lockheed Martin(LMT)$</a> may drop more over short term but will reinforce over mid to longer term imo. ","listText":"<a href=\"https://laohu8.com/S/LMT\">$Lockheed Martin(LMT)$</a> may drop more over short term but will reinforce over mid to longer term imo. ","text":"$Lockheed Martin(LMT)$ may drop more over short term but will reinforce over mid to longer term imo.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/308906471","isVote":1,"tweetType":1,"viewCount":468,"authorTweetTopStatus":1,"verified":2,"comments":[{"author":{"id":"3527667803686145","authorId":"3527667803686145","name":"社区成长助手","avatar":"https://static.tigerbbs.com/2b7c7106b5c0c8b0037faa67439d898f","crmLevel":1,"crmLevelSwitch":0,"idStr":"3527667803686145","authorIdStr":"3527667803686145"},"content":"终于等到了您的初发帖[比心][比心]希望您能在老虎社区玩得愉快、赚得开心!如果您想创作优质文章,请查看老虎社区创作指引","text":"终于等到了您的初发帖[比心][比心]希望您能在老虎社区玩得愉快、赚得开心!如果您想创作优质文章,请查看老虎社区创作指引","html":"终于等到了您的初发帖[比心][比心]希望您能在老虎社区玩得愉快、赚得开心!如果您想创作优质文章,请查看老虎社区创作指引"}],"imageCount":0,"langContent":"EN","totalScore":0},{"id":600731859,"gmtCreate":1638196931721,"gmtModify":1638196931880,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing ","listText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>let's go. Will go up with the cases increasing ","text":"$Novavax(NVAX)$let's go. Will go up with the cases increasing","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/600731859","isVote":1,"tweetType":1,"viewCount":1982,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":871128610,"gmtCreate":1637038902795,"gmtModify":1637038924098,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a> ehat is happening! Woah","listText":"<a href=\"https://laohu8.com/S/01337\">$Razer(01337)$</a> ehat is happening! Woah","text":"$Razer(01337)$ ehat is happening! Woah","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/871128610","isVote":1,"tweetType":1,"viewCount":2118,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859498208,"gmtCreate":1634719138359,"gmtModify":1634719138493,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Sigh ","listText":"Sigh ","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498208","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":1637,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":140490099,"gmtCreate":1625667872711,"gmtModify":1631885336944,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a> what is happening? ","listText":"<a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a> what is happening? ","text":"$Novavax(NVAX)$ what is happening?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/140490099","isVote":1,"tweetType":1,"viewCount":1101,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":859498813,"gmtCreate":1634719131861,"gmtModify":1634719132032,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"Sigh ","listText":"Sigh ","text":"Sigh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/859498813","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax plunged over 20% in premarket trading</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20) <a href=\"https://laohu8.com/S/NVAX\">Novavax</a> may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":1505,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":399979339,"gmtCreate":1605918470421,"gmtModify":1703840475652,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/CARR\">$Carrier Global Corporation(CARR)$</a> im thinking of going into this. Looks like it has mid term to lt potential. ","listText":"<a href=\"https://laohu8.com/S/CARR\">$Carrier Global Corporation(CARR)$</a> im thinking of going into this. Looks like it has mid term to lt potential. ","text":"$Carrier Global Corporation(CARR)$ im thinking of going into this. Looks like it has mid term to lt potential.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/399979339","isVote":1,"tweetType":1,"viewCount":761,"authorTweetTopStatus":1,"verified":2,"comments":[{"author":{"id":"3565059053379605","authorId":"3565059053379605","name":"Blakezzd","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":4,"crmLevelSwitch":0,"idStr":"3565059053379605","authorIdStr":"3565059053379605"},"content":"Bro!!It is related to vaccine logistics right ?How do we transport huge amount of vaccine without it?","text":"Bro!!It is related to vaccine logistics right ?How do we transport huge amount of vaccine without it?","html":"Bro!!It is related to vaccine logistics right ?How do we transport huge amount of vaccine without it?"}],"imageCount":0,"langContent":"EN","totalScore":0},{"id":304886341,"gmtCreate":1605193826583,"gmtModify":1703836704295,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/BYND\">$Beyond Meat, Inc.(BYND)$</a> i see this going up in the mid term. ","listText":"<a href=\"https://laohu8.com/S/BYND\">$Beyond Meat, Inc.(BYND)$</a> i see this going up in the mid term. ","text":"$Beyond Meat, Inc.(BYND)$ i see this going up in the mid term.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/304886341","isVote":1,"tweetType":1,"viewCount":475,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":302480893,"gmtCreate":1604679777912,"gmtModify":1703834527226,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/ACB\">$Aurora Cannabis Inc(ACB)$</a> painful lesson - reminder to self - don't be greedy! ","listText":"<a href=\"https://laohu8.com/S/ACB\">$Aurora Cannabis Inc(ACB)$</a> painful lesson - reminder to self - don't be greedy! ","text":"$Aurora Cannabis Inc(ACB)$ painful lesson - reminder to self - don't be greedy!","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":2,"repostSize":0,"link":"https://laohu8.com/post/302480893","isVote":1,"tweetType":1,"viewCount":1351,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":308203733,"gmtCreate":1603979582222,"gmtModify":1703831507275,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/SPCE\">$Virgin Galactic(SPCE)$</a> will buy in around 16 plus. It has longer term potential but am not willing to play er. ","listText":"<a href=\"https://laohu8.com/S/SPCE\">$Virgin Galactic(SPCE)$</a> will buy in around 16 plus. It has longer term potential but am not willing to play er. ","text":"$Virgin Galactic(SPCE)$ will buy in around 16 plus. It has longer term potential but am not willing to play er.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/308203733","isVote":1,"tweetType":1,"viewCount":879,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":311174240,"gmtCreate":1611770616280,"gmtModify":1703753690523,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/GME\">$GameStop(GME)$</a> am not in this but good luck to those in it! ","listText":"<a href=\"https://laohu8.com/S/GME\">$GameStop(GME)$</a> am not in this but good luck to those in it! ","text":"$GameStop(GME)$ am not in this but good luck to those in it!","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/311174240","isVote":1,"tweetType":1,"viewCount":286,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":319229095,"gmtCreate":1611586742917,"gmtModify":1703751285785,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/HIMS\">$Hims & Hers Health Inc.(HIMS)$</a> no reason why it should be falling this much. ","listText":"<a href=\"https://laohu8.com/S/HIMS\">$Hims & Hers Health Inc.(HIMS)$</a> no reason why it should be falling this much. ","text":"$Hims & Hers Health Inc.(HIMS)$ no reason why it should be falling this much.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":3,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/319229095","isVote":1,"tweetType":1,"viewCount":304,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":607985689,"gmtCreate":1639474734030,"gmtModify":1639474734131,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a> tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate. ","listText":"<a href=\"https://laohu8.com/S/TSLA\">$Tesla Motors(TSLA)$</a> tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate. ","text":"$Tesla Motors(TSLA)$ tsla has been panned over the years but if you look at the price movement over the years it's always recovered. I see it as a chance to accumulate.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/607985689","isVote":1,"tweetType":1,"viewCount":2010,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":315022642,"gmtCreate":1612190908986,"gmtModify":1703758575060,"author":{"id":"3566466633436913","authorId":"3566466633436913","name":"boredsilly5","avatar":"https://static.tigerbbs.com/345db003c8aa9af9cf97265420b598ec","crmLevel":5,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3566466633436913","authorIdStr":"3566466633436913"},"themes":[],"htmlText":"<a href=\"https://laohu8.com/S/PLTR\">$Palantir Technologies Inc.(PLTR)$</a> should have sold some around 40. Oh well","listText":"<a href=\"https://laohu8.com/S/PLTR\">$Palantir Technologies Inc.(PLTR)$</a> should have sold some around 40. Oh well","text":"$Palantir Technologies Inc.(PLTR)$ should have sold some around 40. Oh well","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/315022642","isVote":1,"tweetType":1,"viewCount":194,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"lives":[]}