USA – FDA issues COVID-19 vaccine EUA guidance after clash with White House

Amid reports that the White House had blocked stricter guidance from the US Food and Drug Administration (FDA) on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency on Tuesday issued guidance hours after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting.
 
Last month, agency officials, including FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director Peter Marks, indicated that additional guidance on COVID-19 vaccine EUAs would be forthcoming. (RELATED: Marks, Hahn confirm COVID vaccine EUA guidance comingRegulatory Focus 11 September 2020).
 
At the time, the Washington Post and other outlets reported that FDA was looking at a median of two months of follow-up of Phase 3 trial participants following their last vaccine, which would make a vaccine authorization before the November election unlikely. (RELATED: Hahn insists FDA will stick to guidelines for COVID-19 vaccine decisionsRegulatory Focus 29 September 2020)…