The U.S. Food and Drug Administration (FDA) has granted  an emergency use authorization (EUA) for an updated version of Novavax’s COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against severe COVID-19 outcomes, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the JN.1 strain of the SARS-CoV-2 omicron variant. 

“COVID-19 vaccines have had an enormous positive impact on public health, and vaccination remains the most effective method for preventing COVID-19,” said Peter Marks , Ph.D. , director of the FDA’s Center for Biologics Evaluation and Research. “COVID-19 remains a very real risk for many people, and we encourage people to consider receiving the updated COVID-19 vaccine when they are eligible. Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s safety, effectiveness, and manufacturing quality standards required to support emergency use authorization.”

This authorization follows  recent  FDA approvals and authorizations of updated mRNA COVID-19 vaccines for 2024-2025 manufactured by ModernaTX Inc. and Pfizer Inc.

What you need to know

• People 12 years of age or older who have never received any COVID-19 vaccine can receive two doses of this updated vaccine, 3 weeks apart.
• People who have received a single dose of any Novavax COVID-19 vaccine may receive a dose of the updated Novavax COVID-19 vaccine at least 3 weeks after the previous dose.  
• People who have received a previous formulation of a COVID-19 vaccine from another manufacturer or two or more doses of a previous formulation of the Novavax COVID-19 vaccine may 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 evaluated manufacturing and nonclinical data to support the change to the 2024-2025 formulation. The updated vaccine is manufactured using a process similar to that of previous formulations of this vaccine. People who receive this vaccine may experience side effects similar to those reported by people who received previous formulations of this COVID-19 vaccine and described in the  fact sheets . 

The FDA has determined that Novavax’s updated COVID-19 vaccine has met the statutory criteria for issuance of an EUA, including that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 12 years of age and older. 

As part of today's action, the Novavax adjuvanted COVID-19 vaccine (formula 2023-2024) is no longer authorized for use.

The FDA has granted emergency use authorization for Novavax's adjuvanted COVID-19 vaccine (formulation 2024-2025) to Novavax Inc. of Gaithersburg, Maryland .

Related information

• Novavax COVID-19 vaccine with adjuvant (2024-2025 formula)
• FDA Resources for the Fall Respiratory Illness Season
• Updated COVID-19 vaccines for use in the United States beginning in fall 2024
• June 5, 2024, Vaccines and Related Biological Products Advisory Committee Meeting 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Media Information: Gloria Sánchez-Contreras, 301-796-7686, gloria.sanchez-contreras@fda.hhs.gov
Consumer Information: 888-INFO-FDA
www.FDA.gov/Espanol 

 

Source: prnewswire.com

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