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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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.
CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says
Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.