COVID Vaccine Authorization Changes Without Advisory Committee Becoming More Common
Decision to allow boosters for 12- to 15-year-old recipients of the Pfizer/BioNTech vaccine will go before CDC's ACIP, but like several other recent changes for COVID vaccines, the US FDA opted to skip its advisory committee.
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The FDA commissioner said several aspects of the advisory committee system should be considered for updates or adjustment. A revamp effort has predated his return trip to the agency.
Advisory committee member says FDA's decision to authorize extra shots of Pfizer and Moderna vaccines for those 50 and older was a short-term solution and that VRBPAC should prioritize long-term issues related to the coronavirus.
Complete Response Letters: US FDA Tells Congress Broader Disclosures To Sponsors Could Be ‘Chilling’
A lengthy hearing that addressed everything from Aduhelm to advanced manufacturing serves as the formal kick off of the user fee reauthorization season and offers a preview of many possible FDA reforms that House members could seek to include in the legislation.