FDA schedules AdCom to discuss COVID-19 vaccines for October 22

The FDA disclosed that a meeting of the Vaccines and Related Biological Products Advisory Committee is scheduled to be held on October 22 to discuss vaccines against SARS-CoV-2. The agency noted that "in open session, the committee will discuss, in general, the development, authorisation and/or licensure of vaccines to prevent COVID-19," although "no specific application will be discussed."

The announcement follows a meeting earlier this week of the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), during which the panel was updated on Moderna's mRNA-1273, with new interim data showing the experimental COVID-19 vaccine was safe and generated an immune response in older and elderly adult populations. The ACIP panel also discussed Pfizer and partner BioNTech's mRNA vaccine candidate against SARS-CoV-2, as well as allocation strategies for initial COVID-19 vaccine supplies in the US.

The US government has reached advance purchase agreements with several drugmakers to secure millions of doses of COVID-19 vaccines, including with Moderna and the Pfizer/BioNTech alliance, as well as with AstraZeneca, Johnson & Johnson, Novavax, and a partnership between Sanofi and GlaxoSmithKline.

The FDA issued guidelines in late June outlining conditions for approving a COVID-19 vaccine, including that any vaccine would have to be at least 50% more effective than placebo at preventing the disease, a benchmark routinely used in influenza vaccines.

For related analysis, read ViewPoints: Moderna milks a competitive profile for COVID-19 vaccine.

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