US FDA issues guidance for industry on Emergency Use Authorization for vaccines to prevent COVID-19

The US FDA has issued final recommendations on the data and information needed to support the issuance of an Emergency Use Authorisation for an investigational vaccine to prevent COVID-19, for the duration of the public health emergency.

SPS commentary:

Among the recommendations on required safety and efficacy information are that data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen, to help provide adequate information to assess a vaccine’s benefit-risk profile.


US Food and Drug Administration