FDA getting cold feet on EUA nod for COVID-19 vaccines

• STAT New reports that that FDA appears to be losing some enthusiasm for issuing emergency use authorizations (EUA) for COVID-19 vaccines that would open the floodgates to widespread deployment.
• Recent surveys have shown that a large portion of Americans would be reticent about vaccination over concerns that the vaccines have been rushed through the clinical trial and review processes without thorough vetting for safety.
• Instead, the agency is apparently mulling an expanded access approach, a more limited program typically used for investigational drugs in areas of high unmet need, in the early stage of rollouts.
• During yesterday's FDA advisory committee meeting on COVID-19 vaccine approval criteria, Marion Gruber, director of the FDA's Office of Vaccine Research and Review, said, “We are concerned about the risk that the use of a vaccine under an EUA would interfere with long-term assessment of safety and efficacy in ongoing trials and potentially even jeopardize product approval. And not only the first vaccine, but maybe even follow-on vaccines.”
• University of Michigan's Arnold Monto added that the maker of a COVID-19 vaccine that nabs an EUA nod might not be able to generate enough additional data to support full licensure.
• Pfizer (PFE +1.7%) and partner BioNTech SE (BNTX +1.7%) appear to be the frontrunners to file an EUA application, expected around mid-November. Moderna (MRNA -2.2%) should follow in December if results from the Phase 3 COVE study are positive.
• Selected tickers: AstraZeneca (AZN -0.3%), Johnson & Johnson (JNJ +0.2%), Sanofi (SNY +0.2%), GlaxoSmithKline (GSK +0.0%), Dynavax (DVAX -2.7%), Novavax (NVAX -3.5%)
• https://seekingalpha.com/news/3625386-fda-getting-cold-feet-on-eua-nod-for-covidminus-19-vaccines