The FDA is reportedly about to make approving a coronavirus vaccine before the election a lot tougher

Stephen Hahn.
(Image credit: SAUL LOEB/AFP via Getty Images)

The Food and Drug Administration is poised to roll out new, rigorous standards for an emergency approval for a coronavirus vaccine, The Washington Post reports.

The standards, which appear to be an example of the agency's efforts to increase public trust amid the politicization of vaccine development, could be unveiled as soon as this week and are expected to be much tougher than what was used for the controversial emergency clearances of potential COVID-19 treatments hydroxychloroquine and convalescent plasma, per the Post. Manufacturers will be asked to follow vaccine trial participants for at least two months after they receive their second shot, two individuals familiar with situation told the Post on condition of anonymity. The agency will also reportedly be looking for at least five severe COVID-19 cases in the placebo group for each trial, as well as some cases of the disease in older people to see if the vaccine works.

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Tim O'Donnell

Tim is a staff writer at The Week and has contributed to Bedford and Bowery and The New York Transatlantic. He is a graduate of Occidental College and NYU's journalism school. Tim enjoys writing about baseball, Europe, and extinct megafauna. He lives in New York City.