FDA sets AdCom meeting to discuss Novavax COVID-19 shot
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Novavax (NASDAQ:NVAX) shares have spiked in the morning hours Friday after the U.S. Food and Drug Administration (FDA) scheduled a meeting to discuss the authorization for the companyâs COVID-19 vaccine.
FDAâs Vaccines and Related Biological Products Advisory Committee (VRBPAC) is set to meet on June 07 to discuss the request for the emergency use authorization (EUA) of the protein-based vaccine for use in those aged 18 years and older, the agency said.
Additionally, the FDA has scheduled June 8, 21, and 22 to discuss whether to expand the authorizations of Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) vaccines to include the younger populations.
On Thursday, Moderna (MRNA) announced it submitted a EUA seeking the FDA clearance for the use of the companyâs COVID-19 shot in children younger than six years.
âAs the sponsors complete their submissions and the FDA reviews that data and information, it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request,â the FDA said, adding that none of the submissions were complete.
Meanwhile, on June 28, the FDAâs vaccine experts are set to discuss if the composition of current COVID-19 shots should be updated. If so, they will discuss which COVID strains should be targeted for Fall 2022.
The latest meeting follows a previous VRBPAC discussion on future COVID-19 boosters and strain selection for vaccines.