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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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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

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US FDA Meeting Drought Ends … With A Vengeance

 
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EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 
• By Neena Brizmohun

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
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Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.