华盛顿-特朗普政府的强加的努力对...的新要求诺瓦瓦克斯新冠肺炎疫苗—全国唯一的传统的基于蛋白质的选择对于冠状病毒来说，这也为其他疫苗的更新埋下了不确定性的种子。
Novavax周一表示，食品药品监督管理局要求该公司对其产品进行新的临床试验疫苗在机构完全批准后。该公司表示，它已经做出回应，并认为它的拍摄仍然是“可批准的”
但是一个周末邮政在社交媒体上食品和药物管理局局长马蒂·马卡里建议在注射年度菌株更新之前需要一个新的试验——这在秋天之前是不可能的。这就提出了一个问题其他疫苗会陷入混乱。
“我不认为因为有一个菌株的变化，这是一个新产品，”乔治敦大学的杰西·古德曼博士说，他是前FDA疫苗主管。如果这是新的政策，“你将总是做临床试验，你永远不会有最新的疫苗。”
FDA不寻常的举动发生在该机构长期的疫苗主管被逼出来的因为分歧马克里的老板，卫生部长小罗伯特·F·肯尼迪
肯尼迪赢得了参议院对他工作的确认，部分原因是他承诺不会改变国家的疫苗接种计划。自从上任以来，他承诺“调查”儿童镜头，取消了的会议疫苗专家顾问并指示官员们再次寻找疫苗和自闭症之间的联系很久以前被揭穿了.
Novavax疫苗最初在近30，000人的临床试验中显示出有效性，但仍在美国根据紧急使用授权销售。美国的其他两种选择，即辉瑞和Moderna制造的mRNA疫苗，已获得FDA对特定年龄组的完全批准。
因为冠状病毒不断变异，制造商遵循说明就像流感疫苗一样，每年对他们的配方做一次改变——针对哪种菌株。
据两名对情况有直接了解的人士透露，FDA有望在4月1日的目标日期前授予Novavax完全批准，这两名人士要求匿名讨论该机构的机密事宜。但据其中一名知情人士透露，特朗普任命的人指示FDA的科学家暂停他们的决定。自从这一极不寻常的举动后，Novavax和该机构一直在讨论额外的批准要求。
在他周末的推文中，FDA的Makary将Novavax疫苗称为“新产品”，可能是因为它已经更新，以匹配去年常见的冠状病毒株。
“新产品需要新的临床研究，”Makary补充说。
政府发言人没有回应关于辉瑞和Moderna的具体问题，但暗示所有新冠肺炎疫苗可能面临更严格的要求。
美国卫生与公众服务部发言人Andrew Nixon在一份声明中说:“冠状病毒肺炎带来的威胁已经过去多年了，在没有正常监督的情况下匆忙批准助推器的紧迫性已经不复存在。”。
费城儿童医院(Children ' s Hospital of Philadelphia)的疫苗专家保罗·奥菲特(Paul Offit)博士说，几十年来，美国食品和药物管理局一直像对待流感疫苗一样，对待每年的新冠肺炎病毒株更新——不是新产品，而是现有的产品，它们只是经过调整，以抵御最新的病毒株。
奥菲特说，这些公司仍然必须在少数人身上进行测试，表明这些更新的疫苗产生已知具有保护作用的抗病毒抗体水平，并且它们的安全性受到密切监测。
HHS发言人Nixon暗示，该政策可能不适用于流感疫苗，“这种疫苗已经被反复试验了80多年”
根据联邦法律，FDA在向制药商发布审批要求时，必须遵循既定的程序。专家说，如果该机构跳过某些步骤或出于政治原因强加额外要求，它可能会被制药商起诉，甚至被患者起诉，例如那些因为过敏或其他原因而喜欢Novavax疫苗的人。
除了在所有三种新冠肺炎疫苗获准使用之前进行的大型临床试验，还有真实世界使用的数据，前卫生部长泽维尔·韦塞拉说，他在拜登政府期间负责监督新冠肺炎疫苗政策。
“在我离开的时候，我们已经把大约7亿支冠状病毒肺炎疫苗送到了美国人的手中，”他说。“这是一个相当大规模的临床试验。”
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
WASHINGTON --The Trump administration'seffort to imposenew requirements onNovavax's COVID-19 vaccine— the nation's onlytraditional protein-based optionfor the coronavirus — is sowing uncertainty about updates to other vaccines, too.
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of itsvaccineafter the agency grants full approval. The company said it had responded and that it believed its shot remains “approvable.”
But a weekendposton social media byFDA Commissioner Marty Makarysuggested the prospect of needing a new trial before the shots' yearly strain update — something unlikely to be possible before fall. That's raised questions about whetherother vaccineswill be caught in the turmoil.
“I don’t think because there’s a strain change that this is a new product,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. If that’s the new policy, “you’d always be doing clinical trials and you’d never have a vaccine that was up to date.”
The unusual move at FDA come shortly after the agency'slongtime vaccine chiefwas forced outover disagreementswith Makary's boss, Health SecretaryRobert F. Kennedy Jr.
Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking office, he’spromised to “investigate” children’s shots, canceled meetings ofexpert vaccine advisersand directed officials to look again for connections between vaccines and autism, a linklong-ago debunked.
The Novavax vaccine, which originally showed effectiveness in a nearly 30,000-person clinical trial, is still being sold under emergency use authorization in the U.S. The nation's other two options, mRNA vaccines made by Pfizer and Moderna, have earned full FDA approval for certain age groups.
Because the coronavirus continually mutates,manufacturers follow instructionsfrom FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.
The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters. But Trump appointees directed FDA scientists to pause their decision, according to one of the people. Since that highly unusual move, Novavax and the agency have been discussing additional requirements for approval.
In his weekend tweet, FDA's Makary referred to the Novavax vaccine as “a new product,” presumably because it had been updated to match last year's common coronavirus strain.
“New products require new clinical studies,” Makary added.
An administration spokesman didn't respond to specific questions about Pfizer and Moderna but suggested all COVID-19 vaccines could face stricter requirements.
“It’s now been years since COVID has presented the threat it once did, and the urgency to rush approval of boosters without normal oversight no longer exists,” said Andrew Nixon, a Health and Human Services spokesman, in a statement.
The FDA had been treating the annual COVID-19 strain updates exactly as it's done for decades with flu vaccines — not as new products, but existing ones that are merely adjusted to protect against the latest strains, said Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia.
Offit said the companies still must perform tests in small numbers of people that show these updated vaccines produce levels of virus-fighting antibodies known to be protective, and they're closely monitored for safety.
Nixon, the HHS spokesman, suggested the policy might not apply to the flu shot, “which has been tried and tested for more than 80 years.”
Under federal law, the FDA is required to follow established procedures when issuing requirements to drugmakers for approval. If the agency skips certain steps or imposes additional requirements for political reasons, experts say, it could be sued by drugmakers — or even patients, such as those who prefer the Novavax vaccine over its competitors because of an allergy or some other reason.
In addition to large clinical trials conducted before all three COVID-19 vaccines were cleared for use, there's data on real-world use, said former Health Secretary Xavier Becerra, who oversaw COVID-19 vaccine policy during the Biden administration.
“At the point where I had left, we had put some 700 million COVID vaccines into the arms of Americans,” he said. "That’s a pretty good size clinical trial."
