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COVID-19 Vaccines: EUA Route Offers Advantage In Review Speed, Not Level Of Evidence

 
• By Sue Sutter

US FDA’s ‘may be effective’ standard for granting an emergency use authorization is expected to be comparable to the substantial evidence of effectiveness needed to support full licensure of a COVID-19 vaccine, although EUA allows for a more rapid review, agency officials say.

UNINCORPORATED DEKALB COUNTY, GA -Â?Â? MARCH 30: The US Centers for Disease Control and Prevention headquarters on March 30, 2013. The CDC is the national public health institute of the United States.
A CDC advisory committee heard about the level of evidence needed for an emergency use authorization. • Source: Shutterstock

The level of evidence needed by the US Food and Drug Administration to support emergency use authorization of a COVID-19 preventive vaccine will be closer to that required for full licensure, as opposed to what might be the amount of data which could support an EUA for a drug to treat the novel coronavirus infection.

In a presentation to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices on 29 July, Doran Fink from the Center for Biologics Evaluation and Research repeatedly said the agency expects the evidence needed to

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