By Daniel R. Lucey M.D., MPH, FIDSA
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.
Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee.He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus here since Jan. 6.