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Califf Previews US FDA’s Authorization Rationale For COVID Bivalent Boosters

 
• By Nielsen Hobbs and Pink Sheet Team

FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’

• Source: Shutterstock

US FDA Commissioner Robert Califf offered a preview of what is likely to be the rationale for authorizing the reformulated, bivalent versions of the COVID vaccine that are now pending before the agency.

“As we enter the fall, the FDA has been preparing for how best to protect the public from ongoing and potential future surges of COVID-19,” Califf said in a Twitter...

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