Brandon Guerrero, 34, of Compton, receives both a flu and COVID-19 vaccine at CVS in Huntington Park on August 28, 2024.

2024年8月28日，34岁的布兰登·格雷罗在亨廷顿公园的CVS同时接种了流感和新冠疫苗。

Christina House | Los Angeles Times | Getty Images

克里斯蒂娜·豪斯 | 洛杉矶时报 | 盖蒂图片社

The Food and Drug Administration on Tuesday outlined new regulatory guidance for future Covid-19 vaccine boosters, setting stricter approval standards for healthy Americans.

美国食品和药物管理局周二概述了对未来新冠疫苗加强针的新监管指南，为健康的美国人设定了更严格的审批标准。

The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid, according to a paper published Tuesday in the New England Journal of Medicine. The paper's authors are FDA Commissioner Marty Makary and Vinay Prasad, an outspoken critic of the pharmaceutical industry who was appointed to lead the agency's division that oversees vaccines..

根据周二发表在《新英格兰医学杂志》上的一篇论文，FDA建议根据患者因新冠导致严重疾病的风险制定不同的证据标准以批准药物。该论文的作者是FDA专员马蒂·马卡里和曾被任命领导监督疫苗部门的直言不讳的制药行业批评者维奈·普拉萨德。

The new guidance comes as Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, overhauls the nation's health agencies.

新的指导方针出台之际，卫生与公众服务部部长、著名的疫苗怀疑论者小罗伯特·肯尼迪正在对美国的卫生机构进行彻底改革。

For adults 65 and older, and for people as young as 6 months who have certain underlying health conditions, the FDA said it will accept immunogenicity data – which shows a vaccine triggers a strong enough antibody response – as enough to determine that a shot's benefits outweigh its risks.

对于 65 岁及以上的成年人，以及低至 6 个月且患有某些基础健康状况的人群，FDA 表示将接受免疫原性数据（即显示疫苗能引发足够强的抗体反应的数据），作为判断疫苗益处大于风险的充分依据。

But for healthy people between 6 months and 64 years old who don't have risk factors, the agency plans to require stronger evidence for vaccines from randomized, controlled trials. These studies must show actual clinical outcomes, such as fewer infections or hospitalizations, before the FDA grants full approval of a shot. .

但对于年龄在6个月至64岁之间且没有风险因素的健康人群，该机构计划要求通过随机对照试验提供更有力的疫苗证据。这些研究必须展示出实际的临床结果，例如减少感染或住院人数，FDA才会给予完全批准。

When approving a Covid vaccine for high-risk people, the FDA will encourage manufacturers to conduct randomized, controlled clinical trials in healthy adults as part of their post-marketing commitment for the shot.

当批准高风险人群使用新冠疫苗时，FDA将鼓励制造商在健康成年人中开展随机对照临床试验，作为该疫苗上市后承诺的一部分。

Previously, the FDA relied more heavily on immunogenicity data when evaluating Covid booster shots – which are tailored to new circulating strains of the virus – for approval for all Americans each year. That approach mirrored the flu vaccine model, where annual strain updates are approved based on immune response data, not full clinical trials..

此前，FDA 在评估新冠加强针（针对新流行病毒株的疫苗）是否适合所有美国人每年接种时，更依赖于免疫原性数据。这种方法类似于流感疫苗模式，即每年的毒株更新是基于免疫反应数据批准的，而非完整的临床试验。

'The FDA's new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science,' the agency said in the paper.  'The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.'

“FDA 的新 Covid-19 方针体现了监管灵活性与对金标准科学承诺之间的平衡，”该机构在文件中表示。“FDA 将批准高风险人群使用疫苗，同时要求提供关于低风险人群的强有力、符合金标准的数据。”

Makary and Prasad will address the new framework during a virtual town hall on Tuesday at 1 p.m. ET.

马卡里和普拉萨德将在东部时间周二下午1点的虚拟市政厅会议上讨论这一新框架。