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.
You may also be interested in...
Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters
If regulators agree with Pfizer’s conclusions – and briefing documents suggest that’s a big if – about real-world studies showing Comirnaty’s effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.
Biden’s Trump Moment? COVID Booster Messaging Complicated After Top FDA Scientists Raise Doubts
As questions of political interference continue to swirl around the issue of whether additional vaccine shots will be needed, the Biden administration is facing communication challenges commonly seen with his predecessor, Donald Trump.
Remote Working May Help Delay Retirement Of Senior US FDA Officials
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.