FDA Schedules Review for Maryland Produced COVID-19 Vaccine

Maryland-based Novavax, Inc. recently announced that the U.S. FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) would review the company's NVX-CoV2373 Vaccine (Nuvaxovid) for active immunization against SARS-CoV-2 at a meeting scheduled for June 7, 2022.

Novavax submitted the Authorization request to the FDA in January 2022.

The VRBPAC frequently reviews and evaluates data regarding the safety and efficacy of vaccines and related biological products intended to prevent, treat, or diagnose human diseases.

"We continue to hear from physicians, healthcare organizations, and consumers anxiously awaiting another vaccine option. We believe our vaccine, built on a well-understood protein-based vaccine platform, can play a part in fulfilling this need," said Stanley C. Erck, President, and CEO, of Novavax, in a press release issued on April 29, 2022.

"We look forward to a productive VRBPAC meeting and will continue to work with the FDA throughout the review process."

As of April 30, 2022, Novavax's vaccine had received various authorizations in over 170 countries, including in the EU, and is Listed by the World Health Organization.

Note: The company's press release was edited and curated for mobile readership.