FDA Authorizes Novavax COVID-19 Vaccines for Circulating Variants

Yesterday, on October 3, 2023, the United States Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine to protect against the currently circulating SARS-CoV-2 variants.

According to the release, the newest Novavax vaccine includes components targeting the XBB.1.5 omicron variant lineage, one of the most common strains to date. The updated vaccine builds off the previously authorized monovalent Novavax COVID-19 Vaccine, Adjuvanted.

Under the new EUA, the FDA is authorizing a single dose of the updated vaccine as a booster for individuals 12 and older who have not received a recently updated mRNA COVID-19 vaccine. Eligible patients should have received their initial vaccine series. Individuals who have not been vaccinated can receive two doses of the 2023–2024 Novavax COVID-19 vaccine as their primary series.

“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the press release.

This approval follows an announcement from the FDA on September 11, 2023, authorizing new versions of the mRNA COVID vaccines manufactured by Moderna and Pfizer.

“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. 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,” continued Marks.

Despite the availability of vaccines to protect against serious illnesses, over 50% of adults in the US do not plan to get an updated booster. According to a KFF survey published last month, 19% of survey respondents stated that they were unlikely to get the booster, while an additional 33% of participants stated they would definitely not get the booster.

Evidence-based vaccine recommendations from the Centers for Disease Control and Prevention (CDC), World Health Organization, and other public health organizations continue to emphasize the utility of COVID-19 vaccines for preventing hospitalizations and severe illness.

As new vaccines become available, public health messaging must underscore the importance of vaccination, providing safety data and clear guidelines.