The U.S. Food and Drug Administration (FDA) has granted authorization to the updated Novavax COVID-19 vaccine, allowing it to protect against hospitalization and death from circulating variants. This protein-based shot, targeting the XBB.1.5 strain as required by the FDA, serves as a non-mRNA option for the upcoming 2023-2024 season. The authorization comes after the FDA’s recent approvals of Pfizer and Moderna’s new vaccines for individuals aged 6 months and up.
The FDA’s authorization of the Novavax vaccine offers an alternative for individuals previously vaccinated with a different COVID-19 vaccine who have not yet received a dose of an updated mRNA vaccine. Those aged 12 years and older are eligible to receive one dose of the adjuvanted protein-based vaccine, while unvaccinated individuals can receive two doses. This expanded selection of vaccines aims to provide better protection against currently circulating variants of the virus.
Addressing Safety and Effectiveness
Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, stated that the Novavax vaccine 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.” Regulators evaluated the benefits and risks of the updated Novavax shot in individuals aged 12 and above. The decision was based on manufacturing, non-clinical immune response data, and the original clinical trial data supporting the initial authorization of the Novavax vaccine.
The Centers for Disease Control and Prevention (CDC) recently recommended the use of updated, monovalent COVID-19 shots targeting the XBB strain for the 2023-2024 season. This aligns with the FDA’s amended emergency use authorization for the Novavax vaccine. As a result, the original monovalent Novavax COVID-19 vaccine is no longer authorized for use in the United States.
As the fall season approaches and the transition into 2024 looms, health authorities strongly advise eligible individuals to consider receiving an updated COVID-19 vaccine. The FDA, CDC, and other medical experts emphasize the importance of maximizing protection against the ever-evolving variants of the virus. By offering a wider range of options, the authorization of the Novavax vaccine enhances the nation’s vaccination efforts and contributes to the ongoing battle against the pandemic.
The FDA’s approval of the Novavax COVID-19 vaccine provides a vital addition to the available options for vaccination against the virus. This protein-based shot offers an alternative to mRNA vaccines and is authorized for individuals aged 12 years and older. By expanding the selection of vaccines and targeting the circulating variants, health authorities aim to enhance protection and mitigate the impact of the ongoing pandemic. As the 2023-2024 season approaches, it is crucial for eligible individuals to consider receiving an updated COVID-19 vaccine for optimal protection. Together, these efforts bring us one step closer to overcoming the challenges posed by COVID-19 and regaining a sense of normalcy in our daily lives.