FDA guidance on COVID-19 vaccine includes minimal target of 50% efficacy

Simon Collins, HIV i-Base

In June 2020 the US FDA published guidelines for manufactures working on producing a vaccine against COVID-19.

The 20-page document includes guidelines for investigating, testing and manufacturing, including appropriate populations for different stages of development. The document references the importance of racial diversity, use in children and during pregnancy.

Approval will need to be based on direct evidence of safety and efficacy in protection against SARS-CoV-2 and/or clinical disease.

Phase 3 placebo-controlled studies need to show at least 50% effective for the primary efficacy endpoint point of protection.

Safety data needs to be provided for at least 3000 participants but post-licensing pharmacovigilance data is also expected. Details on the duration of protection are not discussed.


US FDA. Development and Licensure of Vaccines to Prevent COVID-19. (June 2020). (direct PDF)

This report was first published on 2 July 2020.

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