FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants
03 Oct 2023
VaccineEmergency Use AuthorizationmRNA
SILVER SPRING, Md., Oct. 3, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 VaccineCOVID-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 vaccineCOVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccineCOVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses.
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 VaccineCOVID-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, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Today's authorization provides an additional COVID-19 vaccineCOVID-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 vaccineCOVID-19 vaccine to provide better protection against currently circulating variants."
The FDA evaluated manufacturing data to support the change to the 2023-2024 formula of the Novavax COVID-19 VaccineCOVID-19 Vaccine, Adjuvanted. Additionally, the 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 VaccineCOVID-19 Vaccine, Adjuvanted (2023-2024 Formula) as the vaccines are manufactured using a similar process.
The FDA has determined that the Novavax COVID-19 VaccineCOVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has met the statutory 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 of age and older.
As part of today's action, the Novavax COVID-19 VaccineCOVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.
The FDA granted the emergency use authorization of the Novavax COVID-19 VaccineCOVID-19 Vaccine, Adjuvanted (2023-2024 Formula) to Novavax Inc. of Gaithersburg, Maryland.
Additional Resources:
Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)
FDA Resources for the Fall Respiratory Illness Season
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023
June 15, 2023, Meeting of the Vaccines and Related Biological Products Advisory Committee
Media Contact: Cherie Duvall-Jones, 301-357-0607
Consumer Inquiries: 888-INFO-FDA
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 also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.