COVID Vaccine Strain Changes Could Be Made By US FDA Ahead Of WHO Recommendation
Influenza vaccine strain change process could provide framework to update composition of COVID-19 vaccines, agency says. Advisory committee to discuss when changes could be supported by manufacturing information alone, and timing and populations for use of additional boosters.
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US FDA Appears To Quickly Renege On Next-Gen COVID Vaccine Guidance With Updated Booster Announcement
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.
US FDA’s advisory committee members question when it will be clear current vaccines are not providing sufficient protection and express concern about the time it will take to change their composition given the need for clinical data to gain authorization.
Advisory committee tells FDA that the agency, not vaccine manufacturers, should dictate the conversation around variants and reformulations; panelists also want better government research on immune correlates of protection ahead of any decision on a composition change.