The US Food and Drug Administration (FDA) has authorized the updated 2023-2024 formulation of the Novarax COVID-19 vaccine with adjuvant for emergency use (EUA) in people 12 years of age and older.
Through a statement dated October 3, it was determined that the population of this age with a COVID-19 vaccine (and who have not yet been vaccinated with a recently updated COVID-19 mRNA vaccine) are eligible to receive one dose and unvaccinated people receive two doses.
The updated vaccine addresses the variants currently circulating to provide better protection against the serious consequences of COVID-19, including hospitalization and death. Based on the totality of the evidence and input from FDA expert advisors, the adjuvanted Novavax COVID-19 Vaccine, a monovalent vaccine, has been updated to include the spike protein from the omicron variant lineage of SARS-CoV-2. CoV-2 XBB.1.5 (Formula 2023-2024).
This authorization follows recent FDA approvals and clearances of updated 2023-2024 COVID-19 mRNA vaccines manufactured by ModernaTX Inc. and Pfizer Inc.
"COVID-19 vaccines have saved countless lives and prevented serious consequences of COVID-19 caused by the SARS-CoV-2 virus," said Dr. Peter Marks , director of the Center for Biologics Evaluation and Analysis at the FDA.
“Today’s authorization provides an additional COVID-19 vaccine option that meets FDA safety, efficacy, and manufacturing quality standards necessary to support emergency use authorization. “As we approach the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against the variants currently circulating,” he added.
The FDA evaluated manufacturing data to support the change to the 2023-2024 formulation of the adjuvanted Novavax COVID-19 vaccine. Additionally, the FDA evaluated nonclinical immune response data that suggests the vaccine provides protection against currently circulating COVID-19 variants.
The agency also relied on its evaluation of safety and efficacy data from clinical trials of Novavax COVID-19, the adjuvanted vaccine (original monovalent), and the investigational monovalent and bivalent adjuvanted Novavax COVID-19 vaccines, as well as in post-marketing data. The data accumulated with these Novavax COVID-19 vaccines is relevant to the Novavax COVID-19 vaccine with adjuvant (2023-2024 formula), as the vaccines are manufactured using a similar process.
The FDA has determined that the Novavax COVID-19 Vaccine with Adjuvant (2023-2024 Formulation) has met the legal criteria for issuance of an EUA, and that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals. 12 years old. old and older.
As part of the October 3 action, the adjuvanted Novavax COVID-19 vaccine (original monovalent) is no longer authorized for use in the United States.
The FDA granted emergency use authorization of the Novavax COVID-19 vaccine with adjuvant (2023-2024 formulation) to Novavax Inc. of Gaithersburg, Maryland.
