FDA asking COVID-19 vaccine developers for two months of safety data, raising doubts about approval by Election Day
October 7, 2020
The Food and Drug Administration (FDA) wants coronavirus vaccine developers to submit two months of safety data before applying for emergency approval, circumventing the White House, which has expressed concerns about the stringent requirements.
The FDA, in documents posted online Tuesday, advised drugmakers conducting COVID-19 vaccine clinical trials to monitor patients for at least two months to assess potential negative effects from their candidates.
President Trump has recently called those steps a “political move” that would surely mean a vaccine is not approved by Election Day.