The FDA has granted emergency use authorization for an updated Novavax COVID-19 vaccine targeting current variants.
RT’s Three Key Takeaways:
- Updated Protection: The FDA has authorized an updated version of the Novavax COVID-19 vaccine that targets the Omicron JN.1 strain.
- Eligibility and Dosing: The updated vaccine is available for individuals aged 12 and older, with specific dosing schedules based on prior vaccination status, including options for those who have never been vaccinated or those who have previously received a COVID-19 vaccine.
- Regulatory Approval: The FDA’s emergency use authorization for the updated Novavax vaccine follows recent approvals and authorizations of updated mRNA COVID-19 vaccines by Moderna and Pfizer.
The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.
The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.
“The COVID-19 vaccines have had a tremendous positive impact on public health, and vaccination continues to be the most effective method for COVID-19 prevention,” says Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a release. “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible.”
What to know:
- Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses of this updated vaccine, three weeks apart.
- Individuals who have been vaccinated only with one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least three weeks after the previous dose.
- Those who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of the Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least 2 months after the last dose of a COVID-19 vaccine.
The FDA assessed manufacturing and nonclinical data to support the change to the 2024-2025 formula. The updated vaccine is manufactured using a similar process as previous formulas of this vaccine.
The FDA has determined that the updated Novavax COVID-19 vaccine has met the statutory criteria for issuance of an EUA, including that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals 12 years of age and older.
The FDA granted the emergency use authorization of the Novavax COVID-19 vaccine to Novavax Inc of Gaithersburg, Maryland.
This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2024-2025 manufactured by Moderna and Pfizer.
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