FDA
D AND DRUG ADMINISTRATION (FDA)
r Biologics Evaluation and Research (CBER)
eting of the Vaccines and Related Biological
Products Advisory Committee
1. Pfizer has proposed a plan for contir
blinded, placebo-controlled follow-up
ongoing trials if the vaccine were ma
available under EUA. Please discuss
plan, including how loss of blinded, p
controlled follow-up in ongoing trials
addressed.
FDA
DISCUSSION 2. Please discuss any gaps in plans de
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