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US FDA Appears To Quickly Renege On Next-Gen COVID Vaccine Guidance With Updated Booster Announcement

 
• By Sarah Karlin-Smith

After issuing guidance and making public statements saying the first updated COVID-19 vaccines would require clinical trial data, agency picks new vaccine composition that will make obtaining such data highly unlikely before a planned fall booster campaign. 

omicron ba.4/ba.5
FDA wants updated COVID-19 vaccines to add an Omicron BA.4/BA.5 spike component • Source: Shutterstock

The US Food and Drug Administration asked COVID-19 vaccine manufacturers to develop modified bivalent vaccines that add an Omicron BA.4/BA.5 spike component to the current vaccine composition for use as booster shots as early as fall 2022. The agency plans to stick with the prototype COVID vaccines as the primary series for now.

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