Key Takeaways:
- Novavax COVID-19 Vaccine Authorization: The U.S. FDA has granted Emergency Use Authorization (EUA) to Novavax’s 2024-2025 COVID-19 vaccine formula for individuals aged 12 and older, offering the only protein-based option in the U.S.
- Widespread Availability: Pre-filled syringes of Novavax’s updated vaccine will be accessible at thousands of locations, including pharmacies and grocers, across the U.S.
- Targeted Protection: The vaccine specifically targets the JN.1 variant of SARS-CoV-2 and demonstrates robust cross-reactivity against other related variants, enhancing its effectiveness in preventing COVID-19.
Gaithersburg, Md., August 30, 2024 – Novavax, Inc. (Nasdaq: NVAX), a leading global company in vaccine development, has announced that its 2024-2025 COVID-19 Vaccine, Adjuvanted (NVX-CoV2705), has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). This authorization permits the vaccine’s use for active immunization to prevent COVID-19 in individuals aged 12 and older. Notably, this vaccine is the only protein-based option available in the U.S. market, providing a unique alternative in the fight against COVID-19.
The authorization follows the CDC’s Advisory Committee on Immunization Practices’ unanimous vote in June 2024, recommending the use of updated COVID-19 vaccines for the 2024-2025 season. Novavax’s vaccine targets the JN.1 variant, identified as the parent strain of many currently circulating variants, which are contributing to ongoing COVID-19 cases. The vaccine has demonstrated robust cross-reactivity against several related variants, including KP.2.3, KP.3, KP.3.1.1, and LB.1, making it a critical tool in ongoing public health efforts.
With the authorization in place, Novavax has ensured that its COVID-19 vaccine will be widely accessible across the United States. Pre-filled syringes of the vaccine are expected to be available at thousands of locations, including retail pharmacies, independent drugstores, and regional grocery chains. This widespread distribution is crucial as the nation prepares for the upcoming fall and winter virus seasons.
John C. Jacobs, President and Chief Executive Officer of Novavax, emphasized the company’s commitment to making the vaccine easily accessible: “Today’s authorization enables Novavax to launch our updated COVID-19 vaccine in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide. Our updated vaccine targets JN.1, the ‘parent strain’ of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.”
The convenience of pre-filled syringes and the vaccine’s availability in familiar, easily accessible locations underscore Novavax’s focus on public accessibility and ease of vaccination. This effort is expected to significantly aid in increasing vaccination rates, especially as concerns about COVID-19 variants persist.
Scientific Rationale and COVID-19 Vaccine Technology
Novavax’s 2024-2025 COVID-19 vaccine is built upon the company’s established recombinant nanoparticle technology, coupled with its proprietary Matrix-M™ adjuvant. This protein-based vaccine works by replicating the SARS-CoV-2 spike protein, which primes the immune system to recognize and combat the virus. The Matrix-M adjuvant enhances the immune response, making it broader and more durable, a crucial factor in maintaining immunity against evolving variants.
The updated vaccine specifically targets the JN.1 variant, which has been identified as the parent strain of many of the most common currently circulating COVID-19 variants. This focus on the JN.1 variant follows guidance from the U.S. FDA, the European Medicines Agency (EMA), and the World Health Organization (WHO), all of which have recommended targeting this lineage for the upcoming virus season. The EUA was granted based on non-clinical data demonstrating the vaccine’s efficacy in providing cross-reactivity against various JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.
Clinical trials for Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) have shown that the most common adverse reactions include headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise. These findings are consistent with the safety profile of the new 2024-2025 formula, ensuring that the vaccine remains a safe option for broad public use.
Implications for Public Health and Vaccine Strategy
The authorization of Novavax’s updated COVID-19 vaccine comes at a crucial time, as the United States prepares for the fall and winter virus seasons. With its unique protein-based formulation, Novavax offers an alternative to mRNA and vector-based vaccines, which may appeal to individuals seeking different vaccine technologies.
The vaccine’s ability to target the JN.1 variant and its cross-reactivity with related strains provides a significant advantage in protecting against the evolving landscape of COVID-19. As the pandemic continues to present challenges, particularly with the emergence of new variants, Novavax’s vaccine is expected to play a key role in ongoing vaccination campaigns.
Furthermore, the availability of the vaccine in pre-filled syringes at thousands of locations ensures that it will be easily accessible to the public. This broad distribution is essential for achieving high vaccination coverage, which remains a critical component of the public health response to COVID-19.
Looking Forward: Novavax’s Commitment to Vaccine Development
As Novavax continues to innovate in the field of vaccine development, the company remains committed to improving global health through the creation and distribution of effective vaccines. The 2024-2025 COVID-19 vaccine is part of a broader portfolio that includes not only COVID-19 vaccines but also pipeline candidates for influenza and COVID-19-Influenza combination vaccines.
Novavax’s Matrix-M adjuvant is also featured in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine, demonstrating the versatility and efficacy of Novavax’s technology across different infectious diseases. This commitment to innovation is central to Novavax’s mission to protect public health and address serious infectious diseases worldwide.
Resource: Novavax, August 30, 2024
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