US FDA authorizes Novavax Covid-19 vaccine for use in 12 years of age and above

The US Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax Covid-19 vaccine, adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a Covid-19 vaccine (and who have not already been vaccinated with a recently updated mRNA Covid-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses.

The Covid vaccine roll out will soon include a third option, after the US FDA on Tuesday authorized an updated Novavax shot for emergency use in people age 12 and older.

Novavax's product will be the only non-mRNA Covid-19 vaccine available in the US and could ease logistical issues that have disrupted the roll out amid a surge in new cases.

The US FDA authorization was the last regulatory hurdle for Maryland-based Novavax. The updated vaccine is covered under recommendations the Centers for Disease Control and Prevention issued in September.

The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of Covid-19, including hospitalization and death. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax Covid-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).

This authorization follows the FDA’s recent approvals and authorizations of updated mRNA Covid-19 vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc.

“The Covid-19 vaccines have saved countless lives and have prevented serious outcomes of Covid-19 caused by the SARS-CoV-2 virus,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s 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. As we head into 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 currently circulating variants.”

US FDA evaluated manufacturing data to support the change to the 2023-2024 formula of the Novavax Covid-19 vaccine, adjuvanted.

Additionally, the US FDA evaluated non-clinical immune response data suggesting that the vaccine provides protection against the currently circulating Covid-19 variants. The agency also relied on its evaluation of safety and effectiveness data from clinical trials of Novavax Covid-19, Vaccine, Adjuvanted (Original monovalent) and investigational monovalent and bivalent Novavax Covid-19 adjuvanted vaccines, as well as postmarketing data. The data accrued with these Novavax Covid-19 vaccines are relevant to Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) as the vaccines are manufactured using a similar process.

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