Key decisions on Pfizer Covid-19 vaccine boosters for all adults could come this week
Key decisions on whether all adults will be eligible for a Covid-19 vaccine booster could come soon.
The US Food and Drug Administration is currently considering Pfizer and BioNTech's request to amend the emergency use authorization for their Covid-19 vaccine so that all adults would be eligible for a booster shot; Dr. Peter Marks, director of the FDA'S Center for Biologics Evaluation and Research, told CNN the request was the center's "highest priority."
On Tuesday, the agency confirmed its vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, will not be convened to consider the booster EUA decision -- which means the FDA's authorization decision could come any time.
"While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible," FDA spokesperson Alison Hunt told CNN.
Also on Tuesday, CDC spokesperson Jason McDonald said the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet Friday to discuss expanding booster eligibility for Pfizer's Covid-19 vaccine. CDC's vaccine advisers typically meet only once a vaccine has received authorization from the FDA.
If the FDA authorizes the boosters for all adults and CDC's vaccine advisers support recommending them, CDC Director Dr. Rochelle Walensky must sign off on the recommendation before they can be officially administered.
However, the majority of adults are already eligible to receive boosters.The FDA had already authorized boosters for anyone 65 and older who was vaccinated at least six months ago and for certain adults at high risk of infection or of severe disease. Recent studies suggest that while vaccination still provides strong protection against severe disease and death months later, immunity may begin to wane and protection against milder and asymptomatic disease may drop. Studies also show that booster doses restore that immunity.
And with Covid-19 cases on the rise, some states and cities are choosing not to wait for official signoff from FDA or CDC, and have already opened up boosters to all adults.
Need for transparency
FDA's vaccine advisers typically meet to discuss a requested EUA amendment and make a recommendation on how the agency should proceed. This time, the FDA has concluded that Pfizer/BioNTech's request does not raise questions that would require additional discussion by the advisory committee, which is made up of experts who do not work for the agency.
Dr. Arnold Monto, the acting chairman of FDA's advisory committee, told CNN last week there is a precedent for FDA opting not to consult its vaccine advisory committee on certain decisions, noting that members of the committee meet "at the discretion of the FDA," and that it can be "cumbersome" to convene members, which makes it difficult to respond quickly to changing circumstances.
But Dr. Paul Offit, a member of the FDA vaccine advisory committee, told CNN last week that he thought meetings of both FDA's and CDC's vaccine advisers were "the best way for us to be transparent" about Covid-19 vaccine boosters.
"I think we need to show why a booster dose is clearly of benefit to 18-29 year-olds, because if it's not clearly of benefit, we have to consider the fact that myocarditis was a second dose phenomenon and may also be a third dose phenomenon. Do the benefits clearly and definitively outweigh risks for 18-29 year old?" Offit said.
Dr. Grace Lee, a member of the CDC's vaccine advisory committee, noted that the ACIP meeting will give the public a view of the vaccine booster data once it has been authorized by FDA.
"We know Pfizer submitted a request to FDA and I anticipate as soon as FDA has made their decision, ACIP will be discussing this in an open meeting where the public can see all the data in hand," said Lee, a pediatrician at the Stanford University School of Medicine.
本周可能会做出针对所有成年人的辉瑞 Covid-19 疫苗助推器的关键决定
关于是否所有成年人都有资格获得 Covid-19 疫苗加强剂的关键决定可能很快就会做出。
美国食品和药物管理局目前正在考虑辉瑞和 BioNTech 的要求，修改其 Covid-19 疫苗的紧急使用授权，以便所有成年人都有资格接受加强注射； FDA 生物制品评估和研究中心主任彼得·马克斯博士告诉 CNN，该请求是该中心的“最高优先事项”。
周二，该机构确认其疫苗顾问、疫苗和相关生物产品咨询委员会将不会召开会议来考虑加强 EUA 决定——这意味着 FDA 的授权决定可能随时出现。
“虽然 FDA 无法预测对数据和信息的评估需要多长时间，但该机构将尽快审查请求，”FDA 发言人艾莉森亨特告诉 CNN。
同样在周二，CDC 发言人杰森·麦克唐纳 (Jason McDonald) 表示，美国疾病控制与预防中心的免疫实践咨询委员会将于周五开会，讨论扩大辉瑞 Covid-19 疫苗的加强接种资格。 CDC 的疫苗顾问通常只在疫苗获得 FDA 的授权后才会开会。
如果 FDA 授权所有成年人使用加强剂并且 CDC 的疫苗顾问支持推荐它们，则 CDC 主任 Rochelle Walensky 博士必须在推荐上签字，然后才能正式使用。
然而，大多数成年人已经有资格接受加强接种。 FDA 已经批准对至少六个月前接种过疫苗的 65 岁及以上的任何人以及某些感染或患有严重疾病的高风险成年人进行加强接种。最近的研究表明，虽然接种疫苗仍能在数月后对严重疾病和死亡提供强有力的保护，但免疫力可能开始减弱，对较轻和无症状疾病的保护可能会下降。研究还表明，加强剂量可以恢复这种免疫力。
随着 Covid-19 病例的增加，一些州和城市选择不等待 FDA 或 CDC 的正式批准，并且已经向所有成年人开放了助推器。
需要透明度
FDA 的疫苗顾问通常会开会讨论所请求的 EUA 修正案，并就该机构应如何开展工作提出建议。这一次，FDA 得出结论，辉瑞 / BioNTech 的请求不会引起需要由不为该机构工作的专家组成的咨询委员会进行额外讨论的问题。
FDA 咨询委员会代理主席 Arnold Monto 博士上周告诉 CNN，FDA 选择不就某些决定咨询其疫苗咨询委员会是有先例的，并指出委员会成员会“由 FDA 酌情决定， "而且召集成员可能很“麻烦”，这使得很难对不断变化的情况做出快速反应。
但 FDA 疫苗咨询委员会成员 Paul Offit 博士上周告诉 CNN，他认为 FDA 和 CDC 疫苗顾问的会议是“让我们对 Covid-19 疫苗助推器保持透明的最佳方式”。
“我认为我们需要说明为什么加强剂量对 18-29 岁的人明显有益，因为如果它没有明显的益处，我们必须考虑这样一个事实，即心肌炎是第二剂现象，也可能是第三剂现象。剂量现象。对于 18-29 岁的人来说，这些好处是否明确而明确地超过了风险？”奥菲特说。
CDC 疫苗咨询委员会成员 Grace Lee 博士指出，一旦获得 FDA 的授权，ACIP 会议将让公众了解疫苗加强数据。
“我们知道辉瑞向 FDA 提交了请求，我预计一旦 FDA 做出决定，ACIP 将在公开会议上讨论这个问题，公众可以在那里看到手头的所有数据，”斯坦福大学的儿科医生 Lee 说。大学医学院。
