FDA Advisory Committee recommends Emergency Use Authorisation for Novavax COVID 19 vaccine for individuals 18 years and older.
Novavax, Inc. announced the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.
The VRBPAC considered data from the pivotal Phase III clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (previously cited).
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