Novavax COVID-19 Vaccine FDA Approval Status
Last updated by Judith Stewart, BPharm on Oct 10, 2023.
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 (2023-2024 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 (2023-2024 Formula) is authorized under an Emergency Use Authorization (EUA) for use in individuals 12 years of age and older. 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.
- 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 (2023-2024 Formula) was based on non-clinical data showing that Novavax's vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as robust CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.
- Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered by intramuscular injection.
- Individuals 12 years of age and older previously vaccinated with any COVID-19 Vaccine may receive a single 0.5 mL dose at least 2 months after receipt of the last previous dose of COVID-19 vaccine.
- Individuals 12 years of age and older not previously 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 with certain kinds of immunocompromise may receive an additional dose at least 2 months following the last dose. Additional doses 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 Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
