Just a reminder; today the FDA Advisory Committee will meet from 8:30 AM to 5:00 PM, ET today to discuss Covid-19 vaccine boosters. I’ll be unable to post a “play by play” as I have in the past because I have something else on my schedule.
Especially noteworthy is the Briefing Document in the meeting materials, entitled:
“Considerations for COVID-19 Vaccine Booster Doses and Process for COVID-19 Vaccine Strain Selection to Address Current and Emerging Variants.”
Section 7 starts on page 17, “Topics for VRBPAC Discussion.” The important issue is determining strain composition of Covid-19 vaccines and what goes into consideration for the optimal use of additional booster doses.
April 6, 2022 Update:
“Topics for VRBPAC Discussion
Following the scheduled presentations and open public hearing, the VRBPAC will be asked to discuss and provide input on the following topics (no voting questions):
• What considerations should inform strain composition decisions to ensure that available COVID-19 vaccines continue to meet public health needs, e.g.:
-Role of VRBPAC and FDA in coordinating strain composition decisions
-Timelines needed to implement strain composition updates
-Harmonization of strain composition across available vaccines
• How often should the adequacy of strain composition for available vaccines be assessed?
• What conditions would indicate a need for updated COVID-19 vaccine strain composition, and what data would be needed to support a decision on a strain composition update?
• What considerations should guide the timing and populations for use of additional COVID-19 vaccine booster doses?”