After EUA, COVID Vaccine Sponsors Need Plans For Continuing Trials
EUA request should also include plan for a sponsor’s active follow-up for safety among individuals given the vaccine under EUA – including assessing deaths, hospitalizations and other clinically significant adverse events – to inform ongoing benefit-risk determinations to support the continued authorization, US FDA says in its finally-released guidance.
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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.
Pfizer intends to notify placebo patients that an EUA has been issued and offer the vaccine to keep them in the study, but FDA appears to want to maintain placebo control for as long as possible.
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.