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# Covid-19 Vaccine ‘Emergency Use’ Guide Soon: FDA
- URL: https://www.fdaweb.com/covid-19-vaccine-emergency-use-guide-soon-fda/
- Published: 2020-09-11T12:00:00.000Z
- Updated: 2026-09-14T16:28:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147634

As Phase 3 clinical trials for Covid-19 are underway, FDA says it will soon issue a guidance for sponsors to request an Emergency Use Authorization (EUA) for their vaccines, which will also include recommendations on the data and information needed to support an EUA. A joint [Web posting](https://www.fda.gov/news-events/fda-voices/fdas-scientific-and-regulatory-oversight-vaccines-vital-public-health?utm%5Fmedium=email&utm%5Fsource=govdelivery) by FDA commissioner **Stephen Hahn** and CBER director **Peter Marks**, says that vaccine manufacturers, with input from FDA, will decide whether and when to submit an EUA request or BLA to the agency.

Public confidence in the pending vaccines is on shaky ground. FDA is reeling from problems with Covid tests that were not vetted before being released to the market, from an EUA for chloroquine and hydroxychloroquine that was subsequently revoked, and from the botched White House rollout of an EUA for convalescent plasma in which Hahn misstated the expected benefit from plasma. Amid complaints that FDA was being pressured by President Trump to move quickly on Covid vaccines and therapeutics, the agency also had to fend off his complaint that some of its staff are “deep state” members who want to delay approvals for Covid items until after the 11/3 election.

“The agency will review EUA requests and BLAs received and make appropriate determinations by looking at the totality of the available scientific evidence,” Hahn and Marks’ post says. “For a vaccine for which there is adequate manufacturing information, issuance of an EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine, but before the manufacturer has submitted all of the various data elements normally required and/or the FDA has completed its formal review of the BLA.”

The officials note the importance of transparency as the vaccines progress to the review stage. On 10/22, FDA will hold a meeting of its[ Vaccines and Related Biological Products Advisory Committee](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccines?ref=fdaweb.com) to discuss publicly the general development of Covid-19 vaccines. “While this meeting is not intended to discuss any particular vaccine candidates, the agency is also prepared to rapidly schedule additional meetings of this Committee upon submission of any BLAs or requests for EUAs to further ensure transparency,” they wrote.