Nuvaxovid FDA Approval History
Last updated by Judith Stewart, BPharm on May 21, 2025.
FDA Approved: Yes (First approved May 16, 2025)
Brand name: Nuvaxovid
Generic name: COVID-19 Vaccine, Adjuvanted
Dosage form: Injectable Suspension
Previous Name: Novavax COVID-19 Vaccine
Company: Novavax, Inc.
Treatment for: COVID-19
Nuvaxovid (COVID-19 Vaccine, Adjuvanted) is a protein-based, non-MRNA vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Nuvaxovid is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults 65 years and older, and for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
- Nuvaxovid (NVX-CoV2705) is an updated version of the Novavax COVID-19 Vaccine (NVX-CoV2373) formulated to target the JN.1 variant. Nuvaxovid is engineered using recombinant nanoparticle technology to create copies of the surface spike protein of SARS-CoV-2, which serve as the antigen that primes the body's immune system to recognize the virus. Nuvaxovid contains Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
- U.S. Food and Drug Administration (FDA) approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19. The FDA has also requested a new postmarketing commitment (PMC) to conduct a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19.
- Nuvaxovid is administered by intramuscular injection as a single dose. For individuals who have been previously vaccinated with any COVID-19 vaccine, Nuvaxovid should be administered at least 2 months after the last dose of COVID-19 vaccine.
- Warnings and precautions associated with Nuvaxovid include increased risks of myocarditis and pericarditis.
- The most commonly reported (> 10%) solicited adverse reactions after vaccination:
- in participants 12 years through 17 years of age include injection site tenderness (up to 65.2%), injection site pain (up to 61%), headache (up to 56.9%), fatigue (up to 49.9%), muscle pain (up to 49.1%), malaise (up to 40.2%), nausea/vomiting (up to 19.9%), fever (up to 16.9%), and joint pain (up to 16.1%)
- in participants 18 years through 64 years of age include injection site tenderness (up to 71.7%), injection site pain (up to 58.6%), muscle pain (up to 52.7%), fatigue (up to 50.5%), headache (up to 47.4%), malaise (up to 38.9%), joint pain (up to 22.2%), and nausea/vomiting (up to 12.1%)
- in participants 65 years of age and older include injection site tenderness (up to 52.9%), injection site pain (up to 40.1%), fatigue (up to 29.2%), muscle pain (up to 29.2%), headache (up to 24.9%), malaise (up to 21.2%), and joint pain (up to 12.7%)
- in participants 12 years through 17 years of age receiving a booster dose include injection site tenderness (65.9%), injection site pain (64.6%), headache (62.9%), muscle pain (60.4%), fatigue (57.1%), malaise (45.1%), nausea/vomiting (23.6%), joint pain (21.9%), fever (16.8%), and injection site redness (10.3%)
- in participants 18 years of age and older receiving a booster dose include injection site tenderness (67.2%), injection site pain (56.4%), muscle pain (51.1%), fatigue (49.9%), headache (44.3%), malaise (37.7%), joint pain (24.2%), and nausea/vomiting (11.6%). - The Novavax COVID-19 Vaccine has been available for use in the U.S since July 2022 under Emergency Use Authorization (EUA).
Development timeline for Nuvaxovid
Further information
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