FDA Schedules Vaccines Panel On COVID Boosters As Questions Linger About Data Adequacy
VRBPAC could help restore some confidence in any booster decision after White House moved ahead of FDA and CDC, but without hard outcomes data and no proven immune correlate of protection, support for Pfizer’s sBLA at the 17 September advisory committee meeting seems far from guaranteed.
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CBER director Peter Marks notes efforts to bring in more staff to deal with ‘crushing’ workload; says there has been no political pressure for the center to approve COVID-19 booster shots.