US FDA’s Two-Month Safety Window For COVID Vaccines Based On Adverse Events In Other Products
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.
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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.
Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.
The median of two months of follow-up is not absolute, but agency flexibility is limited.