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Vaccines For COVID Variants Will Require Clinical Data, US FDA Says

 
• By Brenda Sandburg

Safety and immunogenicity data may not be sufficient to get FDA authorization of COVID-19 vaccines against a variant, FDA’s Doran Fink says. For now, agency expects to see clinical data. Eventually, strain changes might be based on manufacturing information.

Covid variant
US FDA wants to see clinical data showing COVID-19 vaccine protection against variants • Source: Alamy

The US Food and Drug Administration may not authorize a modified COVID-19 vaccine to protect against SARS-CoV-2 variants based solely on safety and immunogenicity data, and at least for now expects to see clinical data, FDA’s Doran Fink said.

Speaking at the National Vaccine Advisory Committee’s 17 June meeting, Fink, deputy director for clinical review in the Division of Vaccines and Related Products Applications, noted that there are a...

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