FDA OKs Updated Novavax COVID-19 Vaccine

An updated emergency use authorization for the Novavax COVID-19 vaccine has been OK'd by the FDA, allowing distribution of an updated version of the monovalent vaccine that addresses the currently circulating omicron variants.¹

The authorization follows similar actions for the other mRNA COVID-19 vaccines, including updated approvals for the use of Moderna's and Pfizer-BioNTech's monovalent COVID-19 vaccines for individuals age 12 and older, as well as updated emergency authorization for individuals age 6 months through 11 years.²

“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. "As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

The updated emergency use authorization for the Novavax COVID-19 vaccine, Adjuvanted was based on manufacturing data as well as non-clinical immune response data that suggests that the vaccine provides protection against the currently circulating variants. Safety and efficacy have been established based on clinical trials of the original monovalent vaccine, as well as trials of the investigational monovalent and bivalent adjuvanted vaccines, in addition to postmarketing data. With this update, the original monovalent vaccine is no longer authorized for use in the US.

Cases of COVID-19 have begin to rise again as variants of omicron circulate, including the EG5 variant, which accounts for approximately 21.5% of cases, and the FL151 variant, which accounts for 14.5% of reported cases. The Centers for Disease Control and infectious disease health care professionals are also monitoring the BA286 variant, which reportedly has more than 30 mutations and may be more capable of causing infection in those previously vaccinated against COVID-19 or those recently infected. Cases related to this variant remain low as of now, but it is being closely monitored by health authorities.

Notably, Moderna recently released data on its updated COVID-19 vaccine, mRNA-1273.815, reporting that it generated an 8.7-fold increase in neutralizing antibodies against BA286.

Pfizer similarly confirmed their updated vaccine's efficacy in a meeting with the CDC's Advisory Committee on Immunization Practices (ACIP), during which they reported that their booster vaccine was equally immunogenic against XBB15, EG51, and BA286 in a COVID-19 vaccine-experienced preclinical study.

All 3 manufacturers have stated that they are prepared for vaccine distribution this fall.

COVID-19 isn't the only respiratory virus in the spotlight this season. Check out our special series, RSV: A New Era in Prevention.

REFERENCES

1. FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants. News release. US Food & Drug Administration. October 3, 2023. Accessed October 3, 2023. https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-formulated-better-protect-against-currently
2. FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. News release. US Food & Drug Administration. September 11, 2023. Accessed October 3, 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating