Novavax’s Updated COVID-19 Vaccine Receives FDA Emergency Use Authorization

Novavax has secured Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated COVID-19 vaccine, the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) [NVX-CoV2705], for individuals aged 12 and older. The vaccine is now approved for active immunization against COVID-19, with distribution expected to begin soon through various outlets, including pharmacies and regional grocers, once the Center for Biologics Evaluation and Research gives the green light to vaccine batches.

Following the EUA, the U.S. Centers for Disease Control and Prevention (CDC) has also recommended the vaccine. This aligns with the CDC’s Advisory Committee on Immunization Practices, which unanimously endorsed the use of 2024-2025 COVID-19 vaccines for people as young as six months earlier this year. The committee did not specify a preference for any particular strain of the virus.

The Novavax vaccine targets the JN.1 strain, the parent of the most prevalent variants currently circulating, based on public health data reviewed in June by the FDA’s Vaccines and Related Biological Products Advisory Committee. The decision to focus on the JN.1 lineage is consistent with guidance from the FDA, the European Medicines Agency (EMA), and the World Health Organization.

The EUA was granted based on non-clinical data showing that the vaccine produces cross-reactivity against the JN.1 strain and related viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.1. Common side effects reported in clinical trials include headaches, nausea, muscle pain, and fatigue.

Novavax President and CEO John Jacobs stated, “This authorization allows us to bring our updated COVID-19 vaccine to the U.S. market. We have worked diligently to ensure broad access, and the vaccine's robust cross-reactivity against JN.1 lineage viruses positions it as a strong defense against the currently circulating variants.”