May 26, 2021 -- The U.S. Food and Drug Administration (FDA) issued a new guidance document on May 25 that updates previously issued guidance and sets expectations for future COVID-19 vaccine emergency use authorizations (EUAs) during the pandemic.
The document, titled "Emergency Use Authorization for Vaccines to Prevent COVID-19," restates that the agency's reviews of EUA requests will include:
- Evaluation of product quality, including a determination that manufacturing facilities meet appropriate standards
- Evaluation of the conduct of clinical trials
- Assessment of trial data integrity
However, the guidance includes key differences from previous FDA guidance documents in terms of prioritization of EUA requests moving forward and the information required to support an EUA request. The agency also said it may not accept additional requests for EUAs beyond ones that are already in the agency's pipeline.
The agency is requiring sponsors to report product information for various populations, including adults, pediatric age groups, and other specific populations (geriatric individuals, pregnant or lactating individuals, and immunodeficient individuals). The FDA is also taking into consideration the product's approval status -- either with the agency or authorization status in a foreign country.
Other required information about the product's chemistry, manufacturing, and controls remains largely unchanged from previous guidance documents. The agency has updated its requirements for phase III follow-up to be at least two months, and has mandated safety information for individuals with prior SARS-CoV-2 infection, including individuals who might have been asymptomatic.
The briefing document also stated that the agency will hold a session of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to the issuance of any EUA for a COVID-19 vaccine, and any EUA requests should be accompanied by briefing materials summarizing data to support the safety and effectiveness of the vaccine to be considered at the open session of the VRBPAC.
According to an appendix in the guidance, the agency is currently considering EUA amendments for COVID-19 vaccines that have already received EUA approvals and that have been modified against a SARS-CoV-2 variant made by the same manufacturer and process.
"It should be recognized that FDA's thinking regarding data needed to authorize a modified COVID-19 vaccine may evolve as additional information is accrued with SARS-CoV-2 variants and corresponding vaccines," the document stated.
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