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2021-10-08
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Pfizer Asks FDA to Authorize Covid-19 Vaccine in Young Children<blockquote>辉瑞要求 FDA 授权幼儿接种 Covid-19 疫苗</blockquote>
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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":823783209,"tweetId":"823783209","gmtCreate":1633661942582,"gmtModify":1633661942920,"author":{"id":3577328076842122,"idStr":"3577328076842122","authorId":3577328076842122,"authorIdStr":"3577328076842122","name":"KenYH","avatar":"https://static.tigerbbs.com/d66ef119b8f92fe120002147d2397bdd","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":11,"crmLevelSwitch":0,"individualDisplayBadges":[],"wearingBadges":[],"fanSize":15,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"title":"","extraTitle":"","html":"<html><head></head><body><p>Like and comment</p></body></html>","htmlText":"<html><head></head><body><p>Like and comment</p></body></html>","text":"Like and comment","highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":1,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/823783209","repostId":1152262514,"repostType":4,"repost":{"id":"1152262514","kind":"news","pubTimestamp":1633649428,"share":"https://www.laohunote.com/m/news/1152262514?lang=zh_CN&edition=full","pubTime":"2021-10-08 07:30","market":"us","language":"en","title":"Pfizer Asks FDA to Authorize Covid-19 Vaccine in Young Children<blockquote>辉瑞要求 FDA 授权幼儿接种 Covid-19 疫苗</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1152262514","media":"The Wall Street Journal","summary":"Children ages 5 to 11 may be able to start getting immunized by November if health regulators author","content":"<p>Children ages 5 to 11 may be able to start getting immunized by November if health regulators authorize the shots</p><p><blockquote>如果卫生监管机构批准注射，5 至 11 岁的儿童可能能够在 11 月之前开始接种疫苗</blockquote></p><p> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/67355adb6edb0e8646555bf98ce5a2a3\" tg-width=\"1050\" tg-height=\"700\" referrerpolicy=\"no-referrer\"><span>A team at a pharmacy in Ohio in August prepared the Pfizer vaccine as part of a trial in children under the age of 12.</span></p><p><blockquote><p class=\"t-img-caption\"><span>8 月份，俄亥俄州一家药房的一个团队准备了辉瑞疫苗，作为 12 岁以下儿童试验的一部分。</span></p></blockquote></p><p> Pfizer Inc. and BioNTech SE have asked U.S. health regulators to green light their Covid-19 vaccine for children 5 to 11 years old, setting up the shot to potentially be available to millions of youngsters in a matter of weeks.</p><p><blockquote>辉瑞公司 (Pfizer Inc.) 和 BioNTech SE 已要求美国卫生监管机构为 5 至 11 岁儿童接种 Covid-19 疫苗开绿灯，预计数百万年轻人可能会在几周内接种该疫苗。</blockquote></p><p> The companies said Thursday that they submitted the application for authorization with the U.S. Food and Drug Administration.</p><p><blockquote>两家公司周四表示，他们已向美国提交了授权申请。食品药品监督管理局。</blockquote></p><p> The FDA may clear the shot for use in the youths before November, which would mean pediatrician offices, schools and other locations could get doses to give as early as Halloween.</p><p><blockquote>美国食品和药物管理局可能会在11月之前批准在年轻人中使用这种疫苗，这意味着儿科医生办公室、学校和其他地方最早可以在万圣节获得剂量。</blockquote></p><p> There are more than 28 million children ages 5 to 11 in the U.S., according to the American Academy of Pediatrics.</p><p><blockquote>根据美国儿科学会的数据，美国有超过2800万5至11岁的儿童。</blockquote></p><p> The FDA has already scheduled for a panel of outside experts to review the data Oct. 26. The agency doesn’t have to follow the panel’s recommendation, but normally does.</p><p><blockquote>FDA 已安排外部专家小组于 10 月 26 日审查这些数据。该机构不必遵循小组的建议，但通常会遵循。</blockquote></p><p> If authorized, young children would get two injections of the Pfizer-BioNTech, three weeks apart, just like adolescents and adults do but at a lower dosage.</p><p><blockquote>如果获得授权，幼儿将像青少年和成年人一样，间隔三周注射两次辉瑞-BioNTech，但剂量较低。</blockquote></p><p> School districts and public-health officials have begun preparations for vaccinations, though the work remains in early stages. Health and vaccine experts expect the vaccines to be administered at certain schools, pediatrician offices and some pharmacies.</p><p><blockquote>学区和公共卫生官员已经开始准备接种疫苗，尽管这项工作仍处于早期阶段。健康和疫苗专家预计疫苗将在某些学校、儿科医生办公室和一些药店接种。</blockquote></p><p> Schools and public-health departments are experienced with childhood vaccines unrelated to Covid-19 because they routinely administer them, although the cold-storage requirements of the Pfizer-BioNTech vaccine may pose some challenges, according to the experts.</p><p><blockquote>专家表示，学校和公共卫生部门在与新冠肺炎无关的儿童疫苗方面经验丰富，因为他们经常接种这些疫苗，尽管辉瑞-BioNTech疫苗的冷藏要求可能会带来一些挑战。</blockquote></p><p> Pediatrician offices and other administration sites won’t be able to vaccinate the children with existing supply on hand because doses for children are smaller and prepared differently than for adults. Pfizer said it would start shipping the pediatric doses, if authorized, as soon as it is cleared to do so by U.S. health authorities.</p><p><blockquote>儿科医生办公室和其他管理点将无法用现有的疫苗为儿童接种疫苗，因为儿童的疫苗剂量较小，而且准备方式与成人不同。辉瑞公司表示，如果获得授权，一旦获得美国卫生当局的批准，它将立即开始运输儿科剂量。</blockquote></p><p> The filing comes after the vaccine appeared to safely generate a strong immune response in young subjects in a late-stage trial, according to the companies.</p><p><blockquote>据两家公司称，该疫苗似乎在后期试验中安全地在年轻受试者中产生了强烈的免疫反应。</blockquote></p><p> Antibody levels in the child volunteers who received the vaccine were similar to those observed in younger adults, the companies said.</p><p><blockquote>两家公司表示，接种疫苗的儿童志愿者的抗体水平与年轻人的抗体水平相似。</blockquote></p><p> The FDA has already been reviewing the Pfizer-BioNTech study data, after the companies began providing it to the agency in September. The companies still needed to submit other information, however, and the adjusted timeline could stretch authorization into November,The Wall Street Journal has reported.</p><p><blockquote>在辉瑞-BioNTech公司于9月份开始向该机构提供该研究数据后，FDA已经在审查辉瑞-BioNTech公司的研究数据。然而，据《华尔街日报》报道，这些公司仍需提交其他信息，调整后的时间表可能会将授权延长至 11 月。</blockquote></p><p> Young children are among the last groups in the U.S. waiting for vaccines against the coronavirus authorized by the FDA.</p><p><blockquote>幼儿是美国最后一批等待 FDA 批准的冠状病毒疫苗的群体之一。</blockquote></p><p> They are at lower risk of severe disease and hospitalization than adults, according to health experts, but more children have been going to the hospital than earlier in the pandemic because of the highly contagious Delta variant’s spread primarily among unvaccinated people.</p><p><blockquote>卫生专家表示，与成年人相比，他们患重病和住院的风险较低，但由于高传染性德尔塔变异毒株病毒主要在未接种疫苗的人群中传播，因此前往医院就诊的儿童人数比大流行早期要多。</blockquote></p><p> Many parents have been anxious to get their young children vaccinated, hoping to protect them as the school year gets under way.</p><p><blockquote>许多父母一直急于让他们的孩子接种疫苗，希望在新学年开始时保护他们。</blockquote></p><p> Some parents with younger children have been so eager to get their young children vaccinated they enrolled them in clinical trials hoping the youngsters would get the real shots, rather than a placebo.</p><p><blockquote>一些有年幼孩子的父母非常渴望让他们的年幼孩子接种疫苗，他们让他们参加临床试验，希望年轻人能接种真正的疫苗，而不是安慰剂。</blockquote></p><p> Doctors and health authorities have said it will be important to immunize the children, not only to protect them from the virus but also to help protect children around them and family members.</p><p><blockquote>医生和卫生当局表示，给儿童接种疫苗非常重要，这不仅是为了保护他们免受病毒的侵害，也是为了帮助保护他们周围的儿童和家庭成员。</blockquote></p><p> Pediatricians and public health experts say that much work will need to be done to address parents’ concerns about vaccinating young children, including parents who received Covid-19 vaccines themselves.</p><p><blockquote>儿科医生和公共卫生专家表示，需要做大量工作来解决家长对给幼儿接种疫苗的担忧，包括那些自己接种了 Covid-19 疫苗的家长。</blockquote></p><p> About one-third of parents of children 5 to 11 years old plan to “wait and see” how the shot performs before vaccinating their children, while about one-quarter of parents said they had no plans to inoculate their children, according to a survey published in September by the Kaiser Family Foundation.</p><p><blockquote>凯撒家庭基金会（Kaiser Family Foundation）9 月份公布的一项调查显示，约三分之一有 5 至 11 岁儿童的家长计划在给孩子接种疫苗之前 “观望 ”疫苗的效果，而约四分之一的家长表示他们没有给孩子接种疫苗的计划。</blockquote></p><p> About 34% of parents of children ages 5 to 11 years would vaccinate their children right away after regulators clear vaccines for that age group, according to the survey.</p><p><blockquote>调查显示，在监管机构批准针对 5 至 11 岁儿童的疫苗后，约 34% 的 5 至 11 岁儿童的父母会立即为孩子接种疫苗。</blockquote></p><p> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/f6cbf9d4fb7f80be2243e6f18a234ee9\" tg-width=\"1050\" tg-height=\"701\" width=\"100%\" height=\"auto\"><span>A vaccination clinic in Carson, Calif.</span></p><p><blockquote><p class=\"t-img-caption\"><span>加州卡森的一家疫苗接种诊所。</span></p></blockquote></p><p> After the authorization in 5- to 11-year-olds, the only group left awaiting vaccines will be children as young as six months.</p><p><blockquote>在5至11岁儿童获得授权后，唯一等待疫苗的群体将是6个月大的儿童。</blockquote></p><p></p><p> Pfizer has said that results from a study in the younger children, ages 6 months to under 5 years, could come by the fourth quarter this year.</p><p><blockquote>辉瑞公司表示，一项针对 6 个月至 5 岁以下儿童的研究结果可能会在今年第四季度得出。</blockquote></p><p> For 5- to 11-year-olds, the companies are seeking what is known as an emergency-use authorization, which the FDA grants during public-health emergencies based on the best available evidence at the time.</p><p><blockquote>对于 5 至 11 岁的儿童，这些公司正在寻求所谓的紧急使用授权，FDA 根据当时现有的最佳证据在公共卫生紧急情况下授予该授权。</blockquote></p><p> To speed the availability of Covid-19 vaccines because of the urgency of the pandemic, the FDA has been authorizing shots including Pfizer-BioNTech’s for emergency use.</p><p><blockquote>由于大流行病的紧迫性，为了加快 Covid-19 疫苗的供应，美国食品和药物管理局一直在授权包括辉瑞-BioNTech 疫苗在内的疫苗用于紧急使用。</blockquote></p><p> Children as young as 12 are permitted to take the Pfizer-BioNTech shot under an emergency-use authorization. The vaccine is now fully approved for people 16 years and older.</p><p><blockquote>根据紧急使用授权，12岁的儿童可以注射辉瑞-BioNTech疫苗。该疫苗现已完全批准用于16岁及以上的人群。</blockquote></p><p> In their key study, Pfizer and BioNTech enrolled about 2,268 subjects 5 to 11 years. Two-thirds of the subjects got two doses of the vaccine, three weeks apart, with the rest getting a placebo. Children received a smaller, 10 microgram dosage, compared with the 30 microgram dose than adults take.</p><p><blockquote>在他们的关键研究中，辉瑞和BioNTech招募了大约2268名5至11岁的受试者。三分之二的受试者间隔三周接种两剂疫苗，其余受试者接种安慰剂。与成人服用的30微克剂量相比，儿童接受的10微克剂量较小。</blockquote></p><p> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/6b596ccbc070386938764cd6817f695f\" tg-width=\"1050\" tg-height=\"700\" width=\"100%\" height=\"auto\"><span>A health-care worker met with a volunteer in Ohio in August as part of a vaccine trial for children under 12.</span></p><p><blockquote><p class=\"t-img-caption\"><span>8 月，一名卫生保健工作者在俄亥俄州会见了一名志愿者，作为针对 12 岁以下儿童的疫苗试验的一部分。</span></p></blockquote></p><p> Pfizer hasn’t provided detailed results yet but did say an analysis of data of children taking the vaccine had neutralizing antibody levels one month after the second dose similar to those found in people ages 16 to 25 years who received 30-microgram doses in a separate Pfizer study.</p><p><blockquote>辉瑞公司尚未提供详细结果，但确实表示，对接种疫苗的儿童的数据分析显示，第二剂疫苗一个月后的中和抗体水平与辉瑞公司在另一项研究中发现的 16 至 25 岁接种 30 微克剂量疫苗的人群相似。</blockquote></p><p> Neutralizing antibodies, which prevent the virus from entering cells and replicating, play a key role in the body’s immune response against Covid-19.</p><p><blockquote>中和抗体可以阻止病毒进入细胞和复制，在人体对 Covid-19 的免疫反应中起着关键作用。</blockquote></p><p> The companies haven’t been able to say yet how well the shot protects against Covid-19 because too few young subjects in the study have become sick to compare rates between children who got a vaccine and those who got a placebo.</p><p><blockquote>由于研究中患病的年轻受试者太少，无法比较接种疫苗和接种安慰剂的儿童之间的发病率，因此两家公司还不能透露这种疫苗对 Covid-19 的保护效果如何。</blockquote></p><p> Yet the FDA commonly clears vaccines based on data indicating a vaccine already shown to be protective in older people generates similar antibody levels in young children as in adults.</p><p><blockquote>然而，FDA 通常会根据数据批准疫苗，这些数据表明已经被证明对老年人具有保护作用的疫苗在幼儿中产生的抗体水平与成人相似。</blockquote></p><p> There appeared to be fewer side effects such as fever and chills among younger children who got the vaccine compared with 16- to 25-year-olds, Pfizer has said.</p><p><blockquote>辉瑞公司表示，与 16 至 25 岁的儿童相比，接种疫苗的年龄较小的儿童出现发烧和发冷等副作用似乎较少。</blockquote></p><p> There also were no cases of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect primarily in young men, Pfizer said.</p><p><blockquote>辉瑞公司表示，也没有心肌炎病例，心肌炎是一种炎症性心脏病，迄今为止被发现是一种罕见的副作用，主要发生在年轻男性身上。</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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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: 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\">\nPfizer Asks FDA to Authorize Covid-19 Vaccine in Young Children<blockquote>辉瑞要求 FDA 授权幼儿接种 Covid-19 疫苗</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">The Wall Street Journal</strong><span class=\"h-time small\">2021-10-08 07:30</span>\n</p>\n</h4>\n</header>\n<article>\n<p>Children ages 5 to 11 may be able to start getting immunized by November if health regulators authorize the shots</p><p><blockquote>如果卫生监管机构批准注射，5 至 11 岁的儿童可能能够在 11 月之前开始接种疫苗</blockquote></p><p> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/67355adb6edb0e8646555bf98ce5a2a3\" tg-width=\"1050\" tg-height=\"700\" referrerpolicy=\"no-referrer\"><span>A team at a pharmacy in Ohio in August prepared the Pfizer vaccine as part of a trial in children under the age of 12.</span></p><p><blockquote><p class=\"t-img-caption\"><span>8 月份，俄亥俄州一家药房的一个团队准备了辉瑞疫苗，作为 12 岁以下儿童试验的一部分。</span></p></blockquote></p><p> Pfizer Inc. and BioNTech SE have asked U.S. health regulators to green light their Covid-19 vaccine for children 5 to 11 years old, setting up the shot to potentially be available to millions of youngsters in a matter of weeks.</p><p><blockquote>辉瑞公司 (Pfizer Inc.) 和 BioNTech SE 已要求美国卫生监管机构为 5 至 11 岁儿童接种 Covid-19 疫苗开绿灯，预计数百万年轻人可能会在几周内接种该疫苗。</blockquote></p><p> The companies said Thursday that they submitted the application for authorization with the U.S. Food and Drug Administration.</p><p><blockquote>两家公司周四表示，他们已向美国提交了授权申请。食品药品监督管理局。</blockquote></p><p> The FDA may clear the shot for use in the youths before November, which would mean pediatrician offices, schools and other locations could get doses to give as early as Halloween.</p><p><blockquote>美国食品和药物管理局可能会在11月之前批准在年轻人中使用这种疫苗，这意味着儿科医生办公室、学校和其他地方最早可以在万圣节获得剂量。</blockquote></p><p> There are more than 28 million children ages 5 to 11 in the U.S., according to the American Academy of Pediatrics.</p><p><blockquote>根据美国儿科学会的数据，美国有超过2800万5至11岁的儿童。</blockquote></p><p> The FDA has already scheduled for a panel of outside experts to review the data Oct. 26. The agency doesn’t have to follow the panel’s recommendation, but normally does.</p><p><blockquote>FDA 已安排外部专家小组于 10 月 26 日审查这些数据。该机构不必遵循小组的建议，但通常会遵循。</blockquote></p><p> If authorized, young children would get two injections of the Pfizer-BioNTech, three weeks apart, just like adolescents and adults do but at a lower dosage.</p><p><blockquote>如果获得授权，幼儿将像青少年和成年人一样，间隔三周注射两次辉瑞-BioNTech，但剂量较低。</blockquote></p><p> School districts and public-health officials have begun preparations for vaccinations, though the work remains in early stages. Health and vaccine experts expect the vaccines to be administered at certain schools, pediatrician offices and some pharmacies.</p><p><blockquote>学区和公共卫生官员已经开始准备接种疫苗，尽管这项工作仍处于早期阶段。健康和疫苗专家预计疫苗将在某些学校、儿科医生办公室和一些药店接种。</blockquote></p><p> Schools and public-health departments are experienced with childhood vaccines unrelated to Covid-19 because they routinely administer them, although the cold-storage requirements of the Pfizer-BioNTech vaccine may pose some challenges, according to the experts.</p><p><blockquote>专家表示，学校和公共卫生部门在与新冠肺炎无关的儿童疫苗方面经验丰富，因为他们经常接种这些疫苗，尽管辉瑞-BioNTech疫苗的冷藏要求可能会带来一些挑战。</blockquote></p><p> Pediatrician offices and other administration sites won’t be able to vaccinate the children with existing supply on hand because doses for children are smaller and prepared differently than for adults. Pfizer said it would start shipping the pediatric doses, if authorized, as soon as it is cleared to do so by U.S. health authorities.</p><p><blockquote>儿科医生办公室和其他管理点将无法用现有的疫苗为儿童接种疫苗，因为儿童的疫苗剂量较小，而且准备方式与成人不同。辉瑞公司表示，如果获得授权，一旦获得美国卫生当局的批准，它将立即开始运输儿科剂量。</blockquote></p><p> The filing comes after the vaccine appeared to safely generate a strong immune response in young subjects in a late-stage trial, according to the companies.</p><p><blockquote>据两家公司称，该疫苗似乎在后期试验中安全地在年轻受试者中产生了强烈的免疫反应。</blockquote></p><p> Antibody levels in the child volunteers who received the vaccine were similar to those observed in younger adults, the companies said.</p><p><blockquote>两家公司表示，接种疫苗的儿童志愿者的抗体水平与年轻人的抗体水平相似。</blockquote></p><p> The FDA has already been reviewing the Pfizer-BioNTech study data, after the companies began providing it to the agency in September. The companies still needed to submit other information, however, and the adjusted timeline could stretch authorization into November,The Wall Street Journal has reported.</p><p><blockquote>在辉瑞-BioNTech公司于9月份开始向该机构提供该研究数据后，FDA已经在审查辉瑞-BioNTech公司的研究数据。然而，据《华尔街日报》报道，这些公司仍需提交其他信息，调整后的时间表可能会将授权延长至 11 月。</blockquote></p><p> Young children are among the last groups in the U.S. waiting for vaccines against the coronavirus authorized by the FDA.</p><p><blockquote>幼儿是美国最后一批等待 FDA 批准的冠状病毒疫苗的群体之一。</blockquote></p><p> They are at lower risk of severe disease and hospitalization than adults, according to health experts, but more children have been going to the hospital than earlier in the pandemic because of the highly contagious Delta variant’s spread primarily among unvaccinated people.</p><p><blockquote>卫生专家表示，与成年人相比，他们患重病和住院的风险较低，但由于高传染性德尔塔变异毒株病毒主要在未接种疫苗的人群中传播，因此前往医院就诊的儿童人数比大流行早期要多。</blockquote></p><p> Many parents have been anxious to get their young children vaccinated, hoping to protect them as the school year gets under way.</p><p><blockquote>许多父母一直急于让他们的孩子接种疫苗，希望在新学年开始时保护他们。</blockquote></p><p> Some parents with younger children have been so eager to get their young children vaccinated they enrolled them in clinical trials hoping the youngsters would get the real shots, rather than a placebo.</p><p><blockquote>一些有年幼孩子的父母非常渴望让他们的年幼孩子接种疫苗，他们让他们参加临床试验，希望年轻人能接种真正的疫苗，而不是安慰剂。</blockquote></p><p> Doctors and health authorities have said it will be important to immunize the children, not only to protect them from the virus but also to help protect children around them and family members.</p><p><blockquote>医生和卫生当局表示，给儿童接种疫苗非常重要，这不仅是为了保护他们免受病毒的侵害，也是为了帮助保护他们周围的儿童和家庭成员。</blockquote></p><p> Pediatricians and public health experts say that much work will need to be done to address parents’ concerns about vaccinating young children, including parents who received Covid-19 vaccines themselves.</p><p><blockquote>儿科医生和公共卫生专家表示，需要做大量工作来解决家长对给幼儿接种疫苗的担忧，包括那些自己接种了 Covid-19 疫苗的家长。</blockquote></p><p> About one-third of parents of children 5 to 11 years old plan to “wait and see” how the shot performs before vaccinating their children, while about one-quarter of parents said they had no plans to inoculate their children, according to a survey published in September by the Kaiser Family Foundation.</p><p><blockquote>凯撒家庭基金会（Kaiser Family Foundation）9 月份公布的一项调查显示，约三分之一有 5 至 11 岁儿童的家长计划在给孩子接种疫苗之前 “观望 ”疫苗的效果，而约四分之一的家长表示他们没有给孩子接种疫苗的计划。</blockquote></p><p> About 34% of parents of children ages 5 to 11 years would vaccinate their children right away after regulators clear vaccines for that age group, according to the survey.</p><p><blockquote>调查显示，在监管机构批准针对 5 至 11 岁儿童的疫苗后，约 34% 的 5 至 11 岁儿童的父母会立即为孩子接种疫苗。</blockquote></p><p> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/f6cbf9d4fb7f80be2243e6f18a234ee9\" tg-width=\"1050\" tg-height=\"701\" width=\"100%\" height=\"auto\"><span>A vaccination clinic in Carson, Calif.</span></p><p><blockquote><p class=\"t-img-caption\"><span>加州卡森的一家疫苗接种诊所。</span></p></blockquote></p><p> After the authorization in 5- to 11-year-olds, the only group left awaiting vaccines will be children as young as six months.</p><p><blockquote>在5至11岁儿童获得授权后，唯一等待疫苗的群体将是6个月大的儿童。</blockquote></p><p></p><p> Pfizer has said that results from a study in the younger children, ages 6 months to under 5 years, could come by the fourth quarter this year.</p><p><blockquote>辉瑞公司表示，一项针对 6 个月至 5 岁以下儿童的研究结果可能会在今年第四季度得出。</blockquote></p><p> For 5- to 11-year-olds, the companies are seeking what is known as an emergency-use authorization, which the FDA grants during public-health emergencies based on the best available evidence at the time.</p><p><blockquote>对于 5 至 11 岁的儿童，这些公司正在寻求所谓的紧急使用授权，FDA 根据当时现有的最佳证据在公共卫生紧急情况下授予该授权。</blockquote></p><p> To speed the availability of Covid-19 vaccines because of the urgency of the pandemic, the FDA has been authorizing shots including Pfizer-BioNTech’s for emergency use.</p><p><blockquote>由于大流行病的紧迫性，为了加快 Covid-19 疫苗的供应，美国食品和药物管理局一直在授权包括辉瑞-BioNTech 疫苗在内的疫苗用于紧急使用。</blockquote></p><p> Children as young as 12 are permitted to take the Pfizer-BioNTech shot under an emergency-use authorization. The vaccine is now fully approved for people 16 years and older.</p><p><blockquote>根据紧急使用授权，12岁的儿童可以注射辉瑞-BioNTech疫苗。该疫苗现已完全批准用于16岁及以上的人群。</blockquote></p><p> In their key study, Pfizer and BioNTech enrolled about 2,268 subjects 5 to 11 years. Two-thirds of the subjects got two doses of the vaccine, three weeks apart, with the rest getting a placebo. Children received a smaller, 10 microgram dosage, compared with the 30 microgram dose than adults take.</p><p><blockquote>在他们的关键研究中，辉瑞和BioNTech招募了大约2268名5至11岁的受试者。三分之二的受试者间隔三周接种两剂疫苗，其余受试者接种安慰剂。与成人服用的30微克剂量相比，儿童接受的10微克剂量较小。</blockquote></p><p> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/6b596ccbc070386938764cd6817f695f\" tg-width=\"1050\" tg-height=\"700\" width=\"100%\" height=\"auto\"><span>A health-care worker met with a volunteer in Ohio in August as part of a vaccine trial for children under 12.</span></p><p><blockquote><p class=\"t-img-caption\"><span>8 月，一名卫生保健工作者在俄亥俄州会见了一名志愿者，作为针对 12 岁以下儿童的疫苗试验的一部分。</span></p></blockquote></p><p> Pfizer hasn’t provided detailed results yet but did say an analysis of data of children taking the vaccine had neutralizing antibody levels one month after the second dose similar to those found in people ages 16 to 25 years who received 30-microgram doses in a separate Pfizer study.</p><p><blockquote>辉瑞公司尚未提供详细结果，但确实表示，对接种疫苗的儿童的数据分析显示，第二剂疫苗一个月后的中和抗体水平与辉瑞公司在另一项研究中发现的 16 至 25 岁接种 30 微克剂量疫苗的人群相似。</blockquote></p><p> Neutralizing antibodies, which prevent the virus from entering cells and replicating, play a key role in the body’s immune response against Covid-19.</p><p><blockquote>中和抗体可以阻止病毒进入细胞和复制，在人体对 Covid-19 的免疫反应中起着关键作用。</blockquote></p><p> The companies haven’t been able to say yet how well the shot protects against Covid-19 because too few young subjects in the study have become sick to compare rates between children who got a vaccine and those who got a placebo.</p><p><blockquote>由于研究中患病的年轻受试者太少，无法比较接种疫苗和接种安慰剂的儿童之间的发病率，因此两家公司还不能透露这种疫苗对 Covid-19 的保护效果如何。</blockquote></p><p> Yet the FDA commonly clears vaccines based on data indicating a vaccine already shown to be protective in older people generates similar antibody levels in young children as in adults.</p><p><blockquote>然而，FDA 通常会根据数据批准疫苗，这些数据表明已经被证明对老年人具有保护作用的疫苗在幼儿中产生的抗体水平与成人相似。</blockquote></p><p> There appeared to be fewer side effects such as fever and chills among younger children who got the vaccine compared with 16- to 25-year-olds, Pfizer has said.</p><p><blockquote>辉瑞公司表示，与 16 至 25 岁的儿童相比，接种疫苗的年龄较小的儿童出现发烧和发冷等副作用似乎较少。</blockquote></p><p> There also were no cases of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect primarily in young men, Pfizer said.</p><p><blockquote>辉瑞公司表示，也没有心肌炎病例，心肌炎是一种炎症性心脏病，迄今为止被发现是一种罕见的副作用，主要发生在年轻男性身上。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://www.wsj.com/articles/pfizer-asks-fda-to-approve-covid-19-vaccine-in-young-children-11633610319?mod=hp_lead_pos7\">The Wall Street Journal</a></p>\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"PFE":"辉瑞"},"source_url":"https://www.wsj.com/articles/pfizer-asks-fda-to-approve-covid-19-vaccine-in-young-children-11633610319?mod=hp_lead_pos7","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1152262514","content_text":"Children ages 5 to 11 may be able to start getting immunized by November if health regulators authorize the shots\nA team at a pharmacy in Ohio in August prepared the Pfizer vaccine as part of a trial in children under the age of 12.\nPfizer Inc. and BioNTech SE have asked U.S. health regulators to green light their Covid-19 vaccine for children 5 to 11 years old, setting up the shot to potentially be available to millions of youngsters in a matter of weeks.\nThe companies said Thursday that they submitted the application for authorization with the U.S. Food and Drug Administration.\nThe FDA may clear the shot for use in the youths before November, which would mean pediatrician offices, schools and other locations could get doses to give as early as Halloween.\nThere are more than 28 million children ages 5 to 11 in the U.S., according to the American Academy of Pediatrics.\nThe FDA has already scheduled for a panel of outside experts to review the data Oct. 26. The agency doesn’t have to follow the panel’s recommendation, but normally does.\nIf authorized, young children would get two injections of the Pfizer-BioNTech, three weeks apart, just like adolescents and adults do but at a lower dosage.\nSchool districts and public-health officials have begun preparations for vaccinations, though the work remains in early stages. Health and vaccine experts expect the vaccines to be administered at certain schools, pediatrician offices and some pharmacies.\nSchools and public-health departments are experienced with childhood vaccines unrelated to Covid-19 because they routinely administer them, although the cold-storage requirements of the Pfizer-BioNTech vaccine may pose some challenges, according to the experts.\nPediatrician offices and other administration sites won’t be able to vaccinate the children with existing supply on hand because doses for children are smaller and prepared differently than for adults. Pfizer said it would start shipping the pediatric doses, if authorized, as soon as it is cleared to do so by U.S. health authorities.\nThe filing comes after the vaccine appeared to safely generate a strong immune response in young subjects in a late-stage trial, according to the companies.\nAntibody levels in the child volunteers who received the vaccine were similar to those observed in younger adults, the companies said.\nThe FDA has already been reviewing the Pfizer-BioNTech study data, after the companies began providing it to the agency in September. The companies still needed to submit other information, however, and the adjusted timeline could stretch authorization into November,The Wall Street Journal has reported.\nYoung children are among the last groups in the U.S. waiting for vaccines against the coronavirus authorized by the FDA.\nThey are at lower risk of severe disease and hospitalization than adults, according to health experts, but more children have been going to the hospital than earlier in the pandemic because of the highly contagious Delta variant’s spread primarily among unvaccinated people.\nMany parents have been anxious to get their young children vaccinated, hoping to protect them as the school year gets under way.\nSome parents with younger children have been so eager to get their young children vaccinated they enrolled them in clinical trials hoping the youngsters would get the real shots, rather than a placebo.\nDoctors and health authorities have said it will be important to immunize the children, not only to protect them from the virus but also to help protect children around them and family members.\nPediatricians and public health experts say that much work will need to be done to address parents’ concerns about vaccinating young children, including parents who received Covid-19 vaccines themselves.\nAbout one-third of parents of children 5 to 11 years old plan to “wait and see” how the shot performs before vaccinating their children, while about one-quarter of parents said they had no plans to inoculate their children, according to a survey published in September by the Kaiser Family Foundation.\nAbout 34% of parents of children ages 5 to 11 years would vaccinate their children right away after regulators clear vaccines for that age group, according to the survey.\nA vaccination clinic in Carson, Calif.\nAfter the authorization in 5- to 11-year-olds, the only group left awaiting vaccines will be children as young as six months.\nPfizer has said that results from a study in the younger children, ages 6 months to under 5 years, could come by the fourth quarter this year.\nFor 5- to 11-year-olds, the companies are seeking what is known as an emergency-use authorization, which the FDA grants during public-health emergencies based on the best available evidence at the time.\nTo speed the availability of Covid-19 vaccines because of the urgency of the pandemic, the FDA has been authorizing shots including Pfizer-BioNTech’s for emergency use.\nChildren as young as 12 are permitted to take the Pfizer-BioNTech shot under an emergency-use authorization. The vaccine is now fully approved for people 16 years and older.\nIn their key study, Pfizer and BioNTech enrolled about 2,268 subjects 5 to 11 years. Two-thirds of the subjects got two doses of the vaccine, three weeks apart, with the rest getting a placebo. Children received a smaller, 10 microgram dosage, compared with the 30 microgram dose than adults take.\nA health-care worker met with a volunteer in Ohio in August as part of a vaccine trial for children under 12.\nPfizer hasn’t provided detailed results yet but did say an analysis of data of children taking the vaccine had neutralizing antibody levels one month after the second dose similar to those found in people ages 16 to 25 years who received 30-microgram doses in a separate Pfizer study.\nNeutralizing antibodies, which prevent the virus from entering cells and replicating, play a key role in the body’s immune response against Covid-19.\nThe companies haven’t been able to say yet how well the shot protects against Covid-19 because too few young subjects in the study have become sick to compare rates between children who got a vaccine and those who got a placebo.\nYet the FDA commonly clears vaccines based on data indicating a vaccine already shown to be protective in older people generates similar antibody levels in young children as in adults.\nThere appeared to be fewer side effects such as fever and chills among younger children who got the vaccine compared with 16- to 25-year-olds, Pfizer has said.\nThere also were no cases of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect primarily in young men, Pfizer said.","news_type":1,"symbols_score_info":{"PFE":0.9}},"isVote":1,"tweetType":1,"viewCount":4668,"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":14,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/823783209"}
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