FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older
* Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee
* If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S.
GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (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 advisory committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “In today’s VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision.”
The VRBPAC considered data from the pivotal Phase 3 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. In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy (95% confidence interval [CI], 82.9 to 94.6; P
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