Breaking: FDA Issues EUA for Novavax COVID-19 Vaccine, Adjuvanted

Update, July 21, 2022:

Following their endorsement of the Advisory Committee on Immunization Poractices' (ACIP) recommendation of the Novavax COVID-19 vaccine, the CDC announced on July 19 the agency's recommendation of this vaccine as an additional primary series option for adults aged 18 and older. The vaccine will be made available to the public in the coming weeks.²

Originally published July 14:

The FDA has issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted, for the prevention of COVID-19 in adults aged 18 years or older, according to an agency press release.¹

The vaccine has “met the statutory criteria for issuance of an EUA,” the release noted, adding that available data confirm that the known and potential benefits outweigh the known and potential risks in adults.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, MD. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

“COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

Safety data were assessed from an ongoing, randomized, blinded, placebo-controlled, multinational study.

The Novavax COVID-19 Vaccine, Adjuvanted, is administered as a 2-dose primary series, 3 weeks apart, and contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants, the release explained, “are incorporated into some vaccines to enhance the immune response of the vaccinated individual.”

“Novavax COVID-19 Vaccine, Adjuvanted provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States,” said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research. “The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”

References

1. Coronavirus (COVID-19) update: FDA authorizes emergency use of Novavax COVID-19 Vaccine, Adjuvanted. News release. FDA. July 13, 2022. Accessed July 14, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted

2. CDC recommends Novavax's COVID-19 vaccine for adults. News release. CDC. July 19, 2022. Accessed July 21, 2022. https://www.cdc.gov/media/releases/2022/s0719-covid-novavax-vaccine.html