Desmondong
2021-10-20
Wow 😮
Novavax plunged over 20% in premarket trading<blockquote>Novavax 在盘前交易中暴跌超过 20%</blockquote>
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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><p><blockquote>美国政府在 2020 年向 Novavax 投资了 16 亿美元，这是当时向疫苗制造商投入的最多的一笔，希望它能为世界提供另一种安全有效疫苗的选择，以帮助预防 Covid-19。但该公司一直遇到生产问题。据多位熟悉 Novavax 困难的人士称，该公司用于测试疫苗纯度的方法没有达到监管机构的标准，而且该公司也未能证明自己能够生产出始终如一的疫苗。所有人都不愿透露姓名，讨论敏感的公司谈话。</blockquote></p><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><p><blockquote>据两位直接了解此事的人士称，尽管 Novavax 最近在向美国证券交易委员会提交的季度文件中证明了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><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><p><blockquote>美国食品和药物管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每批疫苗应至少达到90%。该公司一直在努力实现接近这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>一位直接了解情况的人士说。另一位熟悉该公司生产工艺的人士说，Novavax 最近的纯度水平徘徊在 70% 左右。低纯度水平增加了最终产品中污染物或不必要物质的机会，降低了疫苗的有效性，或者增加了患者对未知成分产生反应的机会。</blockquote></p><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><p><blockquote>COVAX 最近将 2021 年目标从 20 亿剂下调至 14.25 亿剂，该公司已经估计，在为发展中国家接种疫苗的过程中，其面临多达 10 亿剂的供应短缺。如果 Novavax 步履蹒跚，到 2022 年，赤字可能会增加一倍，导致数亿人失去对 Covid-19 的免疫力，并延长疫情。</blockquote></p><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><p><blockquote>“COVAX 继续面临充足供应的挑战.在这种情况下，Novavax 的制造挑战和延误造成了巨大的破坏性，”COVAX 主任克里希纳-乌达亚库马尔（Krishna Udayakumar）说。<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><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><p><blockquote>全球联盟本月已经落后了数亿剂计划剂量，仅运送了 10 月份 7 亿剂目标中的 3.71 亿剂。它现在还面临无法实现已经下调的 2021 年目标的风险。</blockquote></p><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><p><blockquote>在 Novavax 和其他制造商的障碍之间，“COVAX 不得不争先恐后地实时大幅修改其供应战略，”Udayakumar 说。他补充说，因此，全球卫生组织正在强调更多的捐款来满足眼前的需求。</blockquote></p><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><p><blockquote>Novavax 投资者关系和企业事务高级副总裁西尔维娅-泰勒（Silvia Taylor）在一份声明中告诉 POLITICO，该公司的分析测试方法已经过 “验证”，但没有回答有关 FDA 是否已签署这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><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><p><blockquote>“疫苗开发和监管提交过程非常复杂，往往需要数年时间才能达到现在的水平。我们将在美国和全球范围内履行所有承诺的剂量，”泰勒说。</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><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><p><blockquote>但三位知情人士表示，他们不确定该公司是否拥有持续生产高质量疫苗所需的资源——这是 Novavax 在此之前必须达到的基准。这些人士表示，Novavax 有可能解决其制造问题，并在 2022 年底前获得全面许可。</blockquote></p><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><p><blockquote>诺瓦瓦克斯公司（Novavax）以前从未生产过疫苗，它拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><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><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速生产的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，用昆虫细胞制造关键成分。虽然科学家们熟悉这个过程，包括感染细胞以产生刺突蛋白，但它很难扩大规模。</blockquote></p><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><p><blockquote>有关 Novavax 持续生产问题的披露正值全球只有 36% 的人接种疫苗之际，发展中国家的领导人继续向美国施压，要求其提供更多疫苗。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><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><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这两个国家约有 1% 的公民完全接种了疫苗。</blockquote></p><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><p><blockquote>Novavax 只是最新一家在承诺成为发展中国家主要疫苗贡献者后遇到核心生产问题的疫苗制造商。4 月，强生公司停止了由合同制造商运营的巴尔的摩工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现 1500 万剂疫苗意外被另一种 Covid-19 疫苗的成分污染后。</blockquote></p><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><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产过程恢复缓慢，迄今为止，强生公司仅生产了最初承诺在年底前向 COVAX 提供的 2 亿支疫苗的一小部分。</blockquote></p><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><p><blockquote>“国际倡导组织 Health GAP 的执行董事 Asia Russell 说：”对这些制造商来说，过度承诺和交付不足是游戏的名称。“这就是全球应对措施的基础设施，这太可怕了”。</blockquote></p><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><p><blockquote>与强生公司不同，Novavax 是疫苗领域的新手。它从未成功推出疫苗，并且在疫情之前一直在财务上陷入困境。在经历了一系列药物开发失败后，该公司于 2019 年出售了生产设施，这笔交易还包括裁员 100 名员工。当年 5 月，Novavax 的股价跌至每股 36 美分。</blockquote></p><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><p><blockquote>然而，随着 Covid-19 的出现，该公司的命运发生了变化。在疫情早期争相开发一系列候选疫苗的过程中，特朗普执政授予 Novavax 16 亿美元，以帮助其 Covid-19 疫苗的研发工作——这是当时授予任何 Covid-19 疫苗制造商的最大一笔交易。</blockquote></p><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><p><blockquote>这份合同代表了对 Novavax 能力的重大信任票--在后期试验显示疫苗对病毒有 90% 的有效率后，这一赌注似乎得到了回报。</blockquote></p><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><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普执政高级官员也一再警告该公司，在扩大疫苗生产规模方面可能会遇到问题。</blockquote></p><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><p><blockquote>他们尤其担心，一旦疫苗投入批量生产，Novavax 将很难确保疫苗始终符合 FDA 的严格质量标准--这正是困扰该公司数月之久的问题。</blockquote></p><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><p><blockquote>“一位知情人士说：”他们加快了进程。“这很难做到。他们也做不到。”</blockquote></p><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><p><blockquote>Novavax 发言人泰勒在一份声明中说，该公司已经采纳了监管机构的反馈意见，并 “在扩大商业生产流程方面取得了巨大进展”。她说，到今年年底，该公司仍有望每月生产 1.5 亿剂疫苗，并在美国和国际上提交监管文件之前储备了数千万剂疫苗。</blockquote></p><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><p><blockquote>公司高管在最近向投资者发表的演讲中也表达了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准开始分发剂量。在aSept期间。在 29 投资者活动上，首席商务官约翰-特里齐诺（John Trizzino）表示，公司已经 “解决 ”了问题，并即将提交最终的监管申请。</blockquote></p><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><p><blockquote>“Novavax 研发总裁格雷戈里-格伦（Gregory Glenn）补充说：”我们现在真的在测试我们的批次疫苗。“我们认为这很快就会结束”。</blockquote></p><p></p><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><p><blockquote>据三位知情人士透露，与该公司合作的美国官员并不那么有信心。这些人士说，Novavax 的生产问题被认为比今年早些时候导致强生疫苗在紧急工厂生产的卫生和设计问题更难解决。</blockquote></p><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><p><blockquote>尽管该公司开始寻求其他国家的监管批准，但美国仍然怀疑它是否已经解决了根本的疫苗纯度缺陷，知情人士表示，这些缺陷影响了其在世界各地工厂生产疫苗的能力。</blockquote></p><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><p><blockquote>几批疫苗已经被丢弃，四位知情人士表示，美国官员现在不再指望该公司最早要到明年才能获得 FDA 对该疫苗的批准。</blockquote></p><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><p><blockquote>“一位知情人士说：”在某种程度上，我认为疗效永远不会超过与其中杂质相关的风险。“我对我们的处境并不感到惊讶”。</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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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: 12.5px; color: #7E829C; margin: 0;}\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<blockquote>Novavax 在盘前交易中暴跌超过 20%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\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 smaller\">2021-10-20 16:14</p>\n</div>\n</a>\n</h4>\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><p><blockquote>（10月20日）<a href=\"https://laohu8.com/S/NVAX\">诺瓦瓦克斯</a>可能因生产问题推迟10亿剂冠状病毒疫苗的交付。</blockquote></p><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><p><blockquote>全球疫苗分销商一直指望美国公司在 2022 年底前向中低收入国家提供 20 多亿剂疫苗--这是结束 Covid-19 大流行的关键一步。</blockquote></p><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><p><blockquote>但据三位直接了解该公司问题的人士称，由名为 COVAX 的国际财团开展的活动由于生产滞后而被严重推迟，现在可能会缺少 10 亿剂以上的疫苗，因为一家主要供应商在证明自己能够生产出符合监管机构质量标准的疫苗方面面临重大障碍。</blockquote></p><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><p><blockquote>其他三名熟悉马里兰州 Novavax 和拜登政府之间讨论的人士证实了这一延迟，这标志着在新的、更具传播性的变种出现后，为世界接种疫苗的努力遭遇了重大挫折。</blockquote></p><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><p><blockquote>美国政府在 2020 年向 Novavax 投资了 16 亿美元，这是当时向疫苗制造商投入的最多的一笔，希望它能为世界提供另一种安全有效疫苗的选择，以帮助预防 Covid-19。但该公司一直遇到生产问题。据多位熟悉 Novavax 困难的人士称，该公司用于测试疫苗纯度的方法没有达到监管机构的标准，而且该公司也未能证明自己能够生产出始终如一的疫苗。所有人都不愿透露姓名，讨论敏感的公司谈话。</blockquote></p><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><p><blockquote>据两位直接了解此事的人士称，尽管 Novavax 最近在向美国证券交易委员会提交的季度文件中证明了其一些分析和测试问题，但该公司的问题比之前理解的更令人担忧。</blockquote></p><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><p><blockquote>美国食品和药物管理局根据2020年6月的冠状病毒疫苗指南，与每个制造商一起制定纯度水平，但普遍认为每批疫苗应至少达到90%。该公司一直在努力实现接近这一目标，<a href=\"https://laohu8.com/S/AONE.U\">一</a>一位直接了解情况的人士说。另一位熟悉该公司生产工艺的人士说，Novavax 最近的纯度水平徘徊在 70% 左右。低纯度水平增加了最终产品中污染物或不必要物质的机会，降低了疫苗的有效性，或者增加了患者对未知成分产生反应的机会。</blockquote></p><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><p><blockquote>COVAX 最近将 2021 年目标从 20 亿剂下调至 14.25 亿剂，该公司已经估计，在为发展中国家接种疫苗的过程中，其面临多达 10 亿剂的供应短缺。如果 Novavax 步履蹒跚，到 2022 年，赤字可能会增加一倍，导致数亿人失去对 Covid-19 的免疫力，并延长疫情。</blockquote></p><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><p><blockquote>“COVAX 继续面临充足供应的挑战.在这种情况下，Novavax 的制造挑战和延误造成了巨大的破坏性，”COVAX 主任克里希纳-乌达亚库马尔（Krishna Udayakumar）说。<a href=\"https://laohu8.com/S/DRE\">公爵</a>全球健康创新中心。</blockquote></p><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><p><blockquote>全球联盟本月已经落后了数亿剂计划剂量，仅运送了 10 月份 7 亿剂目标中的 3.71 亿剂。它现在还面临无法实现已经下调的 2021 年目标的风险。</blockquote></p><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><p><blockquote>在 Novavax 和其他制造商的障碍之间，“COVAX 不得不争先恐后地实时大幅修改其供应战略，”Udayakumar 说。他补充说，因此，全球卫生组织正在强调更多的捐款来满足眼前的需求。</blockquote></p><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><p><blockquote>Novavax 投资者关系和企业事务高级副总裁西尔维娅-泰勒（Silvia Taylor）在一份声明中告诉 POLITICO，该公司的分析测试方法已经过 “验证”，但没有回答有关 FDA 是否已签署这些方法的问题。泰勒说，该公司仍计划在今年年底前提交紧急使用授权。</blockquote></p><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><p><blockquote>“疫苗开发和监管提交过程非常复杂，往往需要数年时间才能达到现在的水平。我们将在美国和全球范围内履行所有承诺的剂量，”泰勒说。</blockquote></p><p> The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p><p><blockquote>白宫和卫生与公众服务部没有回应多次置评请求。</blockquote></p><p></p><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><p><blockquote>但三位知情人士表示，他们不确定该公司是否拥有持续生产高质量疫苗所需的资源——这是 Novavax 在此之前必须达到的基准。这些人士表示，Novavax 有可能解决其制造问题，并在 2022 年底前获得全面许可。</blockquote></p><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><p><blockquote>诺瓦瓦克斯公司（Novavax）以前从未生产过疫苗，它拒绝回答有关其产品纯度水平以及是否成功解决了长期存在的生产问题的具体问题。</blockquote></p><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><p><blockquote>不像<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>Moderna是第一家使用快速生产的信使RNA推出疫苗的制造商，Novavax正在采用以前使用但复杂的方法，用昆虫细胞制造关键成分。虽然科学家们熟悉这个过程，包括感染细胞以产生刺突蛋白，但它很难扩大规模。</blockquote></p><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><p><blockquote>有关 Novavax 持续生产问题的披露正值全球只有 36% 的人接种疫苗之际，发展中国家的领导人继续向美国施压，要求其提供更多疫苗。仅在非洲，只有4.4%的人口接种了疫苗。</blockquote></p><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><p><blockquote>这包括非洲大陆一些人口最多的国家，如尼日利亚和乌干达，这两个国家约有 1% 的公民完全接种了疫苗。</blockquote></p><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><p><blockquote>Novavax 只是最新一家在承诺成为发展中国家主要疫苗贡献者后遇到核心生产问题的疫苗制造商。4 月，强生公司停止了由合同制造商运营的巴尔的摩工厂的工作<a href=\"https://laohu8.com/S/EBS\">新兴生物解决方案</a>在发现 1500 万剂疫苗意外被另一种 Covid-19 疫苗的成分污染后。</blockquote></p><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><p><blockquote>根据联合国儿童基金会保存的记录，强生公司的生产过程恢复缓慢，迄今为止，强生公司仅生产了最初承诺在年底前向 COVAX 提供的 2 亿支疫苗的一小部分。</blockquote></p><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><p><blockquote>“国际倡导组织 Health GAP 的执行董事 Asia Russell 说：”对这些制造商来说，过度承诺和交付不足是游戏的名称。“这就是全球应对措施的基础设施，这太可怕了”。</blockquote></p><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><p><blockquote>与强生公司不同，Novavax 是疫苗领域的新手。它从未成功推出疫苗，并且在疫情之前一直在财务上陷入困境。在经历了一系列药物开发失败后，该公司于 2019 年出售了生产设施，这笔交易还包括裁员 100 名员工。当年 5 月，Novavax 的股价跌至每股 36 美分。</blockquote></p><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><p><blockquote>然而，随着 Covid-19 的出现，该公司的命运发生了变化。在疫情早期争相开发一系列候选疫苗的过程中，特朗普执政授予 Novavax 16 亿美元，以帮助其 Covid-19 疫苗的研发工作——这是当时授予任何 Covid-19 疫苗制造商的最大一笔交易。</blockquote></p><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><p><blockquote>这份合同代表了对 Novavax 能力的重大信任票--在后期试验显示疫苗对病毒有 90% 的有效率后，这一赌注似乎得到了回报。</blockquote></p><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><p><blockquote>但两名直接了解这些讨论的人士表示，即便如此，负责加速疫苗开发的“曲速行动”（Operation Warp Speed）的特朗普执政高级官员也一再警告该公司，在扩大疫苗生产规模方面可能会遇到问题。</blockquote></p><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><p><blockquote>他们尤其担心，一旦疫苗投入批量生产，Novavax 将很难确保疫苗始终符合 FDA 的严格质量标准--这正是困扰该公司数月之久的问题。</blockquote></p><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><p><blockquote>“一位知情人士说：”他们加快了进程。“这很难做到。他们也做不到。”</blockquote></p><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><p><blockquote>Novavax 发言人泰勒在一份声明中说，该公司已经采纳了监管机构的反馈意见，并 “在扩大商业生产流程方面取得了巨大进展”。她说，到今年年底，该公司仍有望每月生产 1.5 亿剂疫苗，并在美国和国际上提交监管文件之前储备了数千万剂疫苗。</blockquote></p><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><p><blockquote>公司高管在最近向投资者发表的演讲中也表达了类似的乐观语气，淡化了制造障碍，并预测很快就会获得批准开始分发剂量。在aSept期间。在 29 投资者活动上，首席商务官约翰-特里齐诺（John Trizzino）表示，公司已经 “解决 ”了问题，并即将提交最终的监管申请。</blockquote></p><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><p><blockquote>“Novavax 研发总裁格雷戈里-格伦（Gregory Glenn）补充说：”我们现在真的在测试我们的批次疫苗。“我们认为这很快就会结束”。</blockquote></p><p></p><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><p><blockquote>据三位知情人士透露，与该公司合作的美国官员并不那么有信心。这些人士说，Novavax 的生产问题被认为比今年早些时候导致强生疫苗在紧急工厂生产的卫生和设计问题更难解决。</blockquote></p><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><p><blockquote>尽管该公司开始寻求其他国家的监管批准，但美国仍然怀疑它是否已经解决了根本的疫苗纯度缺陷，知情人士表示，这些缺陷影响了其在世界各地工厂生产疫苗的能力。</blockquote></p><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><p><blockquote>几批疫苗已经被丢弃，四位知情人士表示，美国官员现在不再指望该公司最早要到明年才能获得 FDA 对该疫苗的批准。</blockquote></p><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><p><blockquote>“一位知情人士说：”在某种程度上，我认为疗效永远不会超过与其中杂质相关的风险。“我对我们的处境并不感到惊讶”。</blockquote></p><p></p>\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":933,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":5,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/859445713"}
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