Novavax, Inc. (Nasdaq: NVAX), a leading company in protein-based vaccines, has announced that its latest COVID-19 vaccine, the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This authorization permits its use for active immunization to prevent COVID-19 in individuals aged 12 and older. This announcement comes on the heels of the U.S. Centers for Disease Control and Prevention (CDC) recommendation issued on June 27, 2024.

Widespread Distribution and Availability

The Novavax vaccine will be distributed in pre-filled syringes and made available at thousands of locations nationwide, including retail and independent pharmacies and regional grocers. This broad distribution strategy is expected to enhance accessibility and ensure that the vaccine reaches a wide population base, critical for combating the ongoing pandemic. The rollout will commence following the release of vaccine batches by the Center for Biologics Evaluation and Research.

John C. Jacobs, President and Chief Executive Officer of Novavax, emphasized the significance of the EUA, stating, “Today’s authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide.” Jacobs further noted that the updated vaccine specifically targets the JN.1 strain, identified as the ‘parent strain’ of several currently circulating variants. This vaccine has demonstrated robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.

Public Health Implications and CDC Recommendations

The CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended in June 2024 that 2024-2025 COVID-19 vaccines, including those authorized under EUA or approved through Biologics License Application, should be used universally in individuals aged six months and older. This recommendation underscores the importance of targeting the JN.1 strain, given its prevalence among circulating variants. The decision aligns with recommendations from the FDA, the European Medicines Agency (EMA), and the World Health Organization (WHO), all of which have advised focusing on the JN.1 lineage to provide optimal protection against emerging variants.

EUA Basis and Vaccine Efficacy

The EUA for Novavax’s updated vaccine is supported by extensive non-clinical data demonstrating its cross-reactivity against the JN.1 strain and several of its sub-lineages. Previous clinical trials of Novavax’s earlier vaccine version (NVX-CoV2373) indicated that the most common adverse reactions included headache, nausea, muscle pain, joint pain, injection site tenderness, fatigue, and malaise. This new formulation aims to offer enhanced protection while maintaining a manageable side effect profile.

Authorized Use and Future Prospects

While the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been formally approved by the FDA, it is authorized for emergency use to prevent COVID-19 in individuals aged 12 years and older. The EUA will remain in effect as long as the COVID-19 EUA declaration is in place, unless the authorization is revoked earlier. This step marks a significant advancement in the fight against COVID-19, particularly as new variants continue to emerge.

  2024-2025 Formula, CDC Recommendations, COVID-19 vaccine, EUA, FDA Authorization, JN.1 Strain, Novavax