COVID-19: New EUA guidance in time for Oct. 22 FDA vaccine meeting?

On Sept. 11 the U.S. Food and Drug Administration Commissioner Dr. Hahn tweeted a link to a five-page FDA document, “The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health” in which he states: “The FDA also intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization (EUA)…for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA”.

In my opinion, this additional FDA guidance will be published within the next four weeks so that it can be discussed at the Oct. 22 FDA meeting of its “Vaccines and Related Biological Products Advisory Committee (VRBPAC)” that has been scheduled by FDA to discuss COVID-19 vaccines.

Dr. Hahn states in the document (page 5 of 5, with my boldtype added below) regarding the Oct. 22 FDA public meeting:

“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 transparence.”

This document is well-worth the brief read.

Here is the FDA link to attend the open Oct. 22 COVID-19 vaccine meeting (10am-5pm) online.