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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Sponsors seek clarity about the transition process, which could last a year or longer.
Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.
J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.