Novavax COVID-19 Vaccine FDA Approval Status
Last updated by Judith Stewart, BPharm on Sep 4, 2024.
FDA Approved: No (Emergency Use Authorization)
Brand name: Novavax COVID-19 Vaccine
Generic name: SARS-CoV-2 vaccine
Dosage form: Intramuscular injection
Previous Name: NVX-CoV2373
Company: Novavax, Inc.
Treatment for: COVID-19
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is a protein-based, non-MRNA vaccine for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is authorized under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
- The Novavax COVID-19 Vaccine, Adjuvanted is not licensed for any use.
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. - The Novavax COVID-19 Vaccine is engineered from the genetic sequence of SARS‑CoV‑2, and uses recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It contains Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
- The EUA for Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) was based on non-clinical data that showed Novavax's updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
- Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is administered by intramuscular injection.
- Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine may receive a series of two doses (0.5 mL each) 3 weeks apart.
- Individuals 12 years of age and older who have been vaccinated only with one dose of any Novavax COVID-19 Vaccine, Adjuvanted may receive a single dose at least 3 weeks after the previous dose to complete the 2- dose series of Novavax COVID-19 Vaccine, Adjuvanted.
- Individuals 12 years of age and older who have been vaccinated with any COVID-19 vaccine, other than Novavax COVID-19 Vaccine, Adjuvanted, or with two or more doses of Novavax COVID-19 Vaccine, Adjuvanted may receive a single dose at least 2 months after receipt of the last previous dose of COVID-19 vaccine.
- Individuals 12 years of age and older with certain kinds of immunocompromise may receive an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) at least 2 months following the last dose of a COVID-19 vaccine (2024-2025 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances. - Warnings and precautions associated with Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) include increased risks of myocarditis and pericarditis.
- Common solicited adverse reactions include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, and fever.
Development timeline for Novavax COVID-19 Vaccine
Further information
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