Revised COVID-19 Vaccine Guidance Explains When FDA May Decline EUA Requests

The FDA may decline to review COVID-19 vaccine Emergency Use Authorization (EUA) requests from drugmakers who neglect to meet with the agency during product development, the agency said in a revised guidance released yesterday.

The updated recommendations, which supersede previous COVID-19 vaccine guidances released in October and February (DID, Feb. 23), said that prioritizing EUA vaccine requests would be in effect for the “remainder of the current pandemic.”

Developers who have been consistently engaging with the FDA during development of manufacturing processes and clinical trials have the benefit of agency feedback and the FDA is “more likely to be able to confirm the validity of the clinical and manufacturing information submitted in the EUA request,” the agency said.

The FDA noted that agency officials will conduct a “stringent evaluation of product quality,” which includes determining whether manufacturing plants meet appropriate standards, in addition to examining how clinical trials were conducted and assessing the trial data’s integrity.

The FDA said it will decline to review and process an EUA request if it can’t verify one of the characteristics cited in the guidance and emphasized that “early interaction with the agency is critical.”

Read the revised guidance here: www.fdanews.com/05-25-21-EUAVaccinesPreventCOVID19.pdf. ― Jason Scott