The Trump administration seems to be going to great lengths to get a COVID-19 vaccine produced by election day. How much can they get away with?
The FDA’s guidelines to vaccine makers require them to keep track of each person in their clinical trial for two months after receiving a dose of vaccine. That’s how long it should take for roughly half of the vaccine-related “adverse events” to crop up, according to, director of the FDA’s Center for Biologics Evaluation and Research. That lengthy follow-up is needed to boost the agency’s confidence in the vaccine safety data it reviews.
With that requirement in place, there is no way for any vaccine clinical trial in the U.S. to wrap up in time for a pre-election day announcement. Perhaps that’s why Trump shifted his focus this week andWorkers at Regeneron Pharmaceuticals inspect vials of the company’s experimental antibody treatment for COVID-19.
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