Novavax, Inc. last week received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated version of its Covid-19 vaccine NVAX.OCOVID shot.
The vaccine is designed for active immunization to prevent the JN.1 strain of the virus in individuals aged 12 and older, signaling a significant advancement in the ongoing battle against the pandemic.
The authorization on August 30 follows a positive recommendation from the U.S. Centers for Disease Control and Prevention (CDC), which had earlier endorsed the usage of the 2024-2025 Covid-19 vaccines for all individuals aged six months and up.
The Novavax vaccine specifically targets the JN.1 strain, known as the “parent strain” of the most prevalent variants currently circulating, including KP.2.3, KP.3, KP.3.1.1, and LB.1.
According to John C. Jacobs, President and CEO of Novavax, the vaccine will be available in pre-filled syringes across thousands of locations nationwide, including retail pharmacies and regional grocers. The extensive availability is part of Novavax’s commitment to ensuring widespread access to the vaccine, particularly as the virus continues to mutate and spread in various regions, he said.
The updated vaccine leverages Novavax’s protein-based technology with the Matrix-M™ adjuvant, a formulation designed to enhance the immune response and provide increased protection against the virus. In clinical trials and non-clinical studies, the NVX-CoV2705 vaccine demonstrated strong cross-reactivity against various lineages of the JN.1 strain, suggesting robust efficacy against multiple variants.
Earlier this month, the FDA had approved updated vaccines from Pfizer and Moderna, which target the KP.2 variant. However, the JN.1 strain, while not currently the dominant strain in the U.S., continues to circulate and pose a significant public health threat. CDC data indicates that JN.1 accounts for a small but notable percentage of recent cases.
Novavax’s protein-based vaccine provides an alternative to the mRNA vaccines developed by Moderna and Pfizer-BioNTech. While mRNA vaccines have been at the forefront of the Covid-19 vaccination efforts, Novavax’s traditional approach using a protein subunit could offer benefits for individuals who prefer or require an alternative due to medical reasons.
Despite the introduction of new vaccines and ongoing efforts by health authorities, public demand for Covid-19 vaccines has seen a decline since the peak of the pandemic. This trend poses challenges to vaccination campaigns aimed at curbing the spread of the virus amidst evolving variants.
Novavax anticipates that the overall demand for Covid-19 vaccines in the U.S. will remain steady compared to last year, although it expects its own performance to improve due to the differentiated technology and efficacy of its updated vaccine.
The timely introduction and distribution of Novavax’s updated vaccine are crucial as COVID-19-related hospitalizations and deaths have been on the rise over the past three months in the U.S. The company’s strategy to enhance vaccine accessibility and effectiveness is aligned with national efforts to manage and mitigate the health impacts of the virus.
Science magazine reports that clinical trials suggest Novavax’s vaccine is less prone to causing side effects such as headaches and fatigue compared to mRNA vaccines. According to the CDC, that the Novavax vaccine, when unopened and refrigerated, has a shelf life of 9 months.
With the FDA’s authorization and CDC’s backing, Novavax is set to play a pivotal role in the next phase of the Covid-19 vaccination drive. As the virus continues to evolve, the adaptation and responsiveness of vaccine technology will be key in safeguarding public health and navigating the complexities of the pandemic.