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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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.
Pfizer’s COVID Vaccine Raises No Safety Red Flags, But Managing Reactogenicity May Be Practical Challenge
Phase III data show no specific safety concerns that would preclude issuance of an EUA, US FDA says in advisory committee briefing document; however, high rate of local injection site and systemic adverse events could complicate compliance with 21-day, two-dose regimen.