FDA issues guidance on data needed to support COVID-19 vaccine safety, efficacy

The Food and Drug Administration yesterday released guidance and a briefing document outlining the key data needed to support an emergency use authorization for a COVID-19 vaccine candidate and further explaining the EUA process. Both the EUA and standard approval processes require the sponsor to demonstrate a vaccine candidate’s safety and effectiveness.

The agency plans to convene an open session of its vaccine advisory committee to discuss each EUA request and whether the available safety and effectiveness data support authorization. The committee has scheduled an Oct. 22 meeting to discuss COVID-19 vaccine development, authorization and licensing generally.