FDA to announce stricter rules on emergency use authorization for COVID-19 vaccine

The FDA is expected to announce new standards for emergency use authorization of a COVID-19 vaccine as soon as this week, which would make it more difficult for any vaccine to be approved before Election Day, The Washington Post reported. 

The new guidance would require manufacturers seeking emergency use authorization to monitor clinical trial participants in late-stage trials for at least two months after they receive a second dose of the vaccine. The agency will also likely look for at least five cases of severe COVID-19 in the placebo group as well as some in older people, according to the Post

The new standards, in addition to the time it will take for drug makers to prepare their applications and the agency to review the data, make it highly unlikely any vaccine will be authorized before Election Day, the Post reported. 

The FDA has said it is issuing the guidance to increase transparency and public trust, as public health experts have become increasingly worried that President Donald Trump's prediction for a vaccine by Nov. 3 may cause Americans to reject the vaccine out of concern it was rushed. 

The updated guidance is much more rigorous than what was used for hydroxychloroquine or convalescent plasma, the Post reported. The standards are being reviewed by the White House Office of Management and Budget.

Pfizer said Sept. 22 that it still plans to have data on the effectiveness of the vaccine by the end of October and that it plans to collect safety data for two years. Moderna has said it's unlikely to have data in October, according to the Post. AstraZeneca's trial is still on halt in the U.S. while investigators try to figure out if a serious adverse reaction in a patient in Britain was caused by the vaccine. 

Read the full article here


Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars