COVID-19 Vaccines: Ex-FDA Leaders Urge High Bar For Emergency Use Authorization
Eschewing the standard approval mechanisms for COVID-19 vaccines is likely only appropriate in very limited high-risk populations, unless clinical efficacy outcomes are available, former FDA leaders say.
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CDC developing vaccine distribution plans with four states and one large city that will serve as a ‘foundation’ for other jurisdictions; plans include provisions for all potential vaccines, but logistics will vary depending on product, especially given the cold chain issues associated with mRNA vaccines from Pfizer and Moderna.
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
The best vaccine development program would include robust clinical trials, CBER Director Marks says in an interview, but that depends on what’s happening with viral transmission on the ground.