US FDA Signals New COVID-19 Vaccines Could Be Authorized With Just Immunogenicity Studies
As FDA lowers some expectations on timing of booster shots, agency’s outgoing vaccine chief says second-generation COVID vaccines may be authorized without efficacy studies. Marion Gruber's conclusion was supported by many of her international regulatory peers during a WHO meeting.
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Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.