美国食品药品监督管理局不再建议为健康的婴儿接种新冠疫苗。
FDA No Longer Recommends COVID Vaccine For Healthy Babies

原始链接: https://www.zerohedge.com/covid-19/fda-no-longer-recommends-covid-vaccine-healthy-babies

根据特朗普政府的新指导方针,美国政府正在限制新冠疫苗的推荐接种范围,主要集中在老年人和高危人群。美国食品药品监督管理局(FDA)在《新英格兰医学杂志》上概述的新框架强调,要简化针对65岁以上人群和患有健康风险的年轻人的更新版疫苗的审批流程。但是,它敦促在批准针对更健康人群的改良疫苗之前进行广泛的研究。这标志着与之前建议所有六个月以上美国人都应每年接种新冠疫苗的政策相比发生了转变。FDA官员维奈·普拉萨德博士称这是一种“合理的妥协”,既允许继续为高危人群接种疫苗,又可以收集有关疫苗对更健康人群益处的更多数据。对于那些不完全符合既定风险类别的人群的疫苗接种途径问题依然存在。虽然2023年新冠肺炎相关死亡人数超过4.7万,但专家们仍在争论每年为所有人接种疫苗的必要性与有针对性的推荐之间的关系。美国疾病控制和预防中心(CDC)的咨询小组将于6月份讨论针对不同人群的疫苗接种建议。


原文

Via Headline USA,

The U.S. government no longer recommends the COVID-19 vaccine for healthy babies thanks to new guidelines from the Trump administration, which said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else.

Top officials for the Food and Drug Administration laid out new standards for updated COVID shots, saying they’d continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.

But the FDA framework, published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. 

Previously, federal policy recommended an annual COVID shot for all Americans six months and older. 

In the paper and a subsequent online webcast, the FDA’s top vaccine official said more than 100 million Americans still should qualify for what he termed a booster under the new guidance.

Dr. Vinay Prasad described the new approach as a “reasonable compromise” that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.

“For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster,” said Prasad, who joined the FDA earlier this month. He previously spent more than a decade in academia, frequently criticizing the FDA’s handling of drug and vaccine approvals.

It’s unclear what the upcoming changes mean for people who may still want a fall COVID-19 shot but don’t clearly fit into one of the categories.

Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year. The virus was the underlying cause for two-thirds of those and it was a contributing factor for the rest.

Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended only for people at increased risk.

In June, an influential panel of advisers to the CDC is set to debate which vaccines should be recommended to which groups.

Loading...

联系我们 contact @ memedata.com