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US FDA Signals New COVID-19 Vaccines Could Be Authorized With Just Immunogenicity Studies

 
• By Sarah Karlin-Smith

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.

scientist working in lab on vaccine
Sone new COVID-19 vaccines could get an FDA EUA without an efficacy study. • Source: Alamy

Current immune response data is likely sufficient to allow regulators to authorize new COVID-19 vaccines using comparative immunogenicity studies that evaluate a second-generation vaccine against an already cleared product, a move that could likely speed up the availability of additional vaccines, Marion Gruber, US Food and Drug Administration director of the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research, said.

Correlates of protection have not been established that can be applied across vaccines to predict protection, Gruber acknowledged, speaking at...

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