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.
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The government is paying a premium for updated vaccines despite the much smaller data packages that will be available at the time of a potential authorization and rollout. The administration also currently lacks funding for boosters for all, but demand may not necessitate such a supply.
If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.
CDC’s ACIP members say goal for now should not be preventing infection. FDA’s Doran Fink notes that the agency will act diligently on EUA of vaccines in children under five once it receives submissions, cites the complexity of reviewing Novavax’s EUA request for its vaccine.