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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Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.
US FDA drug center is evaluating how to handle the end of the coronavirus public health emergency, which would mean unapproved products would no longer be available, but officials likely have plenty of time to consider options.
In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.