华盛顿-华盛顿(美联社)年度新冠肺炎摄影对于健康的年轻人和儿童来说例行批准根据周二公布的一项新的重大政策转变特朗普政府。
最高官员食品与药物管理局提出了获得年度冠状病毒肺炎疫苗注射的新要求，称他们将继续使用简化的方法，继续向65岁及以上的成年人以及至少有一种健康问题使他们处于更高风险的儿童和年轻人提供疫苗。
但是FDA的框架敦促公司在调整疫苗被批准用于更健康的人之前进行大规模的长期研究。在框架中周二发表在《新英格兰医学杂志》上该机构官员说，这种方法仍然可以保证每年有1亿到2亿人接种疫苗。
即将到来的变化给那些可能仍然想在秋季新冠肺炎拍摄，但显然不符合其中一个类别的人带来了问题。
“药剂师会确定你是否属于高危人群吗?”费城儿童医院的疫苗专家保罗·奥菲特博士问道。“唯一可能的结果是，疫苗的可保性和可获得性将会下降。”
该框架是一个最近采取的一系列措施仔细检查冠状病毒肺炎疫苗的使用，并对唐纳德·特朗普总统执政期间疫苗的更广泛可用性提出了重大质疑。它是在特朗普政府下FDA外部疫苗专家首次会议前两天发布的。
上周食品和药物管理局获得Novavax新冠肺炎疫苗的完全批准但是对谁能得到它有很大的限制——周二的指导反映了这些限制。在特朗普任命的人否决了FDA科学家早些时候批准无限制注射的计划后，该批准获得了批准。
生产最广泛使用的新冠肺炎疫苗的辉瑞和Moderna没有立即置评。
多年来，联邦卫生官员一直告诉大多数美国人，预计新冠肺炎疫苗每年都会更新，类似于每年的流感疫苗注射。就像流感疫苗一样，直到现在，当制造商提供证据证明它们与前一年版本一样具有免疫保护作用时，FDA才批准更新的冠状病毒肺炎疫苗。
但是FDA的新指南似乎是这种方法的终结卫生部长小罗伯特·F·肯尼迪世卫组织向FDA和其他卫生机构提出了对政府处理冠状病毒肺炎疫苗的直言不讳的批评，特别是他们对年轻、健康的成人和儿童的建议。根据联邦程序，FDA以草案形式发布新的指南，并允许公众在最终确定其计划之前发表意见。据FDA专家称，在医学杂志上发表周二的政策是非常不寻常的，可能会与联邦程序相冲突。
周二的更新，作者食品和药物管理局局长马蒂·马卡里和FDA疫苗主管Vinay Prasad批评了美国“一刀切”的做法，并表示，与欧洲国家相比，美国在推荐冠状病毒肺炎助推器方面是“最积极的”。
他们写道:“我们只是不知道，一名健康的52岁女性，患有正常的身体质量指数，曾三次感染新冠肺炎，并接受过六剂新冠肺炎疫苗，是否会从第七剂中受益。”
Makary和Prasad建议公司对不被视为高风险的人进行六个月的研究，随机分配他们接种疫苗或安慰剂，并跟踪结果，特别关注严重疾病、住院或死亡。
专家表示，每年接种冠状病毒肺炎疫苗对每个人都有多少益处，或者是否应该推荐给高危人群，这些都是合理的问题。
疾病控制和预防中心的一个有影响力的顾问小组将讨论应该向哪些群体推荐哪些疫苗。
Offit说，FDA的声明似乎篡夺了顾问小组的工作。他补充说，疾病预防控制中心的研究表明，加强剂量确实可以在注射后的4到6个月内保护健康人免受轻度至中度疾病的影响。
FDA sets new requirements for COVID vaccines in healthy adults and children
WASHINGTON --WASHINGTON (AP) —Annual COVID-19 shotsfor healthy younger adults and children will no longer beroutinely approvedunder a major new policy shift unveiled Tuesday bythe Trump administration.
Top officials for theFood and Drug Administrationlaid out new requirements for access to yearly COVID shots, saying they'd continue to use a streamlined approach that would continue offering them to adults 65 and older as well as children and younger adults with at least one health problem that puts them at higher risk.
But the FDA framework urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. In a frameworkpublished Tuesday in the New England Journal of Medicine, agency officials said the approach still could keep annual vaccinations available for between 100 million and 200 million people.
The upcoming changes raise questions for people who may still want a fall COVID-19 shot but don't clearly fit into one of the categories.
“Is the pharmacist going to determine if you're in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”
The framework is the culmination of aseries of recent stepsscrutinizingthe use of COVID shots and raising major questions about the broader availability of vaccines under President Donald Trump. It was released two days ahead of the first meeting of FDA’s outside vaccine experts under the Trump administration.
Last week the FDAgranted full approval of Novavax's COVID-19 vaccinebut with major restrictions on who can get it — and Tuesday's guidance mirrors those restrictions. The approval came after Trump appointees overruled FDA scientists' earlier plans to approve the shot without restrictions.
Pfizer and Moderna, which make the most widely used COVID-19 vaccines, didn't immediately comment.
For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots when manufacturers provide evidence that they spark just as much immune protection as the previous year's version.
But FDA's new guidance appears to be the end of that approach underHealth Secretary Robert F. Kennedy Jr., who has filled the FDA and other health agencies with outspoken critics of the government’s handling of COVID shots, particularly their recommendation for young, healthy adults and children. Under federal procedures, the FDA releases new guidance in draft form and allows the public to comment before finalizing its plans. The publication of Tuesday's policy in a medical journal is highly unusual and could run afoul of federal procedures, according to FDA experts.
Tuesday’s update, written byFDA Commissioner Marty MakaryandFDA vaccine chief Vinay Prasad, criticized the U.S.’s “one-size-fits-all” approach and states that the U.S. has been “the most aggressive” in recommending COVID boosters, when compared with European countries.
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” they wrote.
Makary and Prasad recommended that companies study people not deemed at high risk for six months, randomly assigning them to get a vaccine or a placebo and tracking outcomes with special attention to severe disease, hospitalization or death.
Experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended for people at increased risk.
An influential panel of advisers to the Centers for Disease Control and Prevention is set to debate which vaccines should be recommended to which groups.
The FDA's announcement appears to usurp that advisory panel's job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people.
