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VRBPAC Meeting to Review Novavax EAU for Adult COVID-19 Vaccine

June 7 @ 8:30 am EDT

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The FDA VRBPAC will meet in open session on 7 June 2022 to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older.  

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.

This meeting will be held to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older. The meeting will be open to the public. FDA is
establishing a docket for public comment on this document. The meeting will be held virtually on June 7, 2022, from 8:30 a.m. to 5 p.m. Eastern Time.

Novavax submitted a request to the FDA for Emergency Use Authorization in January 2022 for NVX-CoV2373 for immunization of individuals 18 year of age and older against SARS-CoV-2.

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Submit either electronic or written comments on this public meeting by June 6, 2022. Comments received on or before June 1, 2022, will be provided to the committee. Comments received after June 1, 2022, and by June 6, 2022, will be taken into consideration by FDA. Submit electronic comments by visiting the Federal eRulemaking Portal and use docket number FDA-2022-N-0895.

Learn more about the VRBPAC meeting.

 

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Vaccines and Related Biological Products Advisory Committee (VRBPAC)