US FDA ‘Flexible’ With Vaccine Safety Data Requirements, CBER’s Peter Marks Says
The median of two months of follow-up is not absolute, but agency flexibility is limited.
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COVID Vaccines For 5 and Under: Pfizer Pivot To 3 Shots Leaves Meager Data Package Compared To Moderna
Pfizer’s decision to add a third shot to the primary vaccination series for children under five means it didn’t hit FDA’s goal of a median follow-up of two months post-vaccination – at least with blinded data – and the sponsor could only do a preliminary descriptive efficacy analysis since the study had not hit the protocol-specified number of COVID cases.
Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says
COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.
Older patients appear to have lower efficacy in a Moderna application amendment that the agency hasn’t fully digested, but along with the original submission, data still supports evaluation for an emergency use authorization, the FDA said.