Placebo Unblinding Process For Pfizer’s COVID Vaccine No Detriment To US FDA Safety Analysis
Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.
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But agency assessors also said there did not appear to be a biological reason for the vaccine to cause depression when granting the emergency use authorization for use of the Novavax vaccine in 12- to 17-year-olds.
The unblinding process began months before a third dose was added to the study in the 6 months-4 years group. Consequently, only about one-third of vaccine recipients in each age cohort received three doses of BNT162b2.
Updated guidance says variant-directed vaccines should demonstrate statistically superiority to the prototype vaccine in a comparison of geometric mean titers against the particular variant of concern; seroresponse rates can be assessed on the basis of either noninferiority or superiority.