FDA meeting on boosters is live!

[BumRushDaShow]

3. They are discussing one of the questions that they will vote on

Whether a "booster" (in quotes because some consider it a "3rd dose" ) be approved for age groups 16 plus (my paraphrase).

ETA - here is the slide with the question -



Members are asking some questions to get clarifications on what they are voting on and why - including to get some additional info from Pfizer and FDA reps.

One of the things that is consistently coming up at the moment is the myocarditis in younger people so I think they seem to want to narrow the approval question to limit "boosters" to the older demographic.

I know the younger demographic (12 - 15) only recently got approval for the vaccine as it is, so there is really not much data on them at this point. But Pfizer had submitted the booster approval request down to that younger "16" age (since they were originally included in the Biologics License Approval - BLA - for the "2-dose" regime).

Have to see if they have multiple questions - i.e., whether they have an option to vote to allow for an older demo and immuno-compromised (have to look through the docs to see) only at this time.

Slide deck is here - https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement#event-materials