FDA will require a covid-19 vaccine be at least 50 percent more effective than a placebo [View all]
The Food and Drug Administration said Tuesday that to win regulatory approval, any covid-19 vaccine will have to prevent disease, or decrease its severity, in at least 50 percent of the people who receive it.
The agency also said it would require drug companies to monitor the vaccine’s performance after approval for any emerging safety problems.
The agency issued guidance to vaccine developers in conjunction with testimony by FDA Commissioner Stephen Hahn and other health officials before the Senate Health, Education, Labor and Pensions Committee on how schools and businesses can safely reopen amid the pandemic.
The standards spelled out apply to full approvals. But many people believe a vaccine initially would be made available through a much lower standard for temporary approvals, through what’s called an emergency use authorization. The guidance said any decision on an emergency authorization would be made “on a case-by-case basis considering the target population, the characteristics of the product” and the available evidence, including clinical trial data on safety and effectiveness.
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