COVID Vaccine Trials May Need Active Comparators Once Adequate Supply Reached, CBER’s Marks Says
US FDA’s biologics center director Peter Marks discusses future COVID-19 vaccine trials, post-market safety monitoring, and how FDA is juggling reviewing two emergency use authorization requests at once in an interview with Pink Sheet.
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US FDA’s global first for Moderna’s vaccine gets a small mention as agency looks to pharmacovigilance, follow-up studies for both coronavirus inoculations that have now been authorized. Moderna's 18 December EUA comes after an even faster review than for Pfizer/BioNTech's vaccine.
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.
US FDA will simultaneously review the vaccines, with Moderna’s advisory committee set a week after Pfizer’s. ACIP emergency meeting scheduled for 1 December with vote likely on distribution priority for health care personnel.