Novavax’s (NASDAQ:NVAX) COVID-19 vaccine (NVX-CoV2373) receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC), recommending FDA to grant Emergency Use Authorization (EUA) for individuals aged 18 years and over.
The Advisory Committee’s decision was supported by data readout from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the United States.
Stanley C. Erck, President and Chief Executive Officer, said, "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 regulatory agency considers the recommendations of Advisory Committee when making decisions on Emergency Use Authorization (EUA).
The Novavax COVID-19 vaccine has received authorization for people aged 18 years and older from more than 40 countries, but it has not yet been authorized for use in the United States.
Novavax is trading high 19 percent at $56.35 in the after hours session.
