FDA Committee Recommends Novavax COVID-19 Vaccine for Authorization

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) have voted in favor of a recommendation that the agency authorize the use of the Novavax COVID-19 vaccine for adults aged 18 and older. The final vote was 21-0, with one abstension.¹

Unlike the COVID-19 vaccines by Pfizer-BioNTech and Moderna, the Novavax vaccine is a “more traditional type of vaccine,” according to a report by Reuters, using decades-old protein-based technology found in vaccines for diseases like hepatitis B and influenza.

The recommendation comes after a year of development and manufacturing setbacks, which saw Novavax file for emergency use authorization on January 31, 2022.² The filing was based on results and data from 2 late-stage clinical trials that took place in the United States, Mexico, and the United Kingdom which demonstrated an overall vaccine efficacy of approximately 90%.

The hope, according to Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, is that the Novavax vaccine will appeal to unvaccinated Americans who are wary of mRNA technology.

“We do have a problem with vaccine uptake that is very serious in the United States,” said Marks during the meeting. “Anything we can do to get more people comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do.”

The Novavax COVID-19 vaccine is currently available in the European Union.

References

1. Erman M, Mishra M. Novavax COVID vaccine backed for authorization by US FDA panel. Reuters. Published June 7, 2022. Accessed June 7, 2022. https://www.reuters.com/world/us/novavax-covid-vaccine-heads-us-fda-advisory-committee-2022-06-07/
2. Leo L, O’donnell L. Novavax, after delays, files for US authorization of COVID-19 vaccine. Reuters. Published January 31, 2022. Accessed June 7, 2022. https://www.reuters.com/world/us/novavax-files-us-authorization-covid-19-vaccine-2022-01-31/