Novavax COVID-19 Vaccine FDA Approval Status

Last updated by Melisa Puckey, BPharm on Oct 19, 2022.

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

The Novavax COVID-19 Vaccine (NVX-CoV2373) is an investigational SARS-CoV-2 vaccine for the prevention of COVID-19.

• Novavax COVID-19 Vaccine, Adjuvanted indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
• Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant.
• Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.

Indication & Authorized Use

Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 

Primary series:
Two-dose primary series given three weeks apart, for individuals 16 years and older.

Booster dose:
A booster dose for individuals 18 years of age and older, given at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine:
-for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and
-for individuals who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.

The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19).

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 (NVX‑CoV2373) 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 Phase 1/2 randomized, observer-blinded, placebo-controlled trial of NVX‑CoV2373 commenced in May 2020 and included 131 healthy volunteers aged 18-59 years at two Australian sites (Melbourne and Brisbane). The study evaluated two doses (administered 21 days apart) of NVX‑CoV2373 across two dose levels (5 µg and 25 µg), with and without the Matrix‑M™ adjuvant. Novavax reported Phase 1 data in early August 2020, and announced the vaccine was generally well-tolerated and elicited robust antibody responses.
  • The most commonly reported local reactions (80%) were pain and tenderness, and the most common systemic reactions (>60%) were headache, fatigue and myalgia. Most reactions were mild or moderate, but reactogenicity was greater following the second dose.
• The Phase 2 clinical trial commenced August 2020 expanding on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial’s population. The trial assessed two doses (5 and 25 µg), each with 50 µg of Matrix‑M. The study targeted enrollment of up to 1,500 healthy volunteers, with approximately 50 percent of participants ≥60 years of age, at up to 40 sites across the U.S. and Australia.
• The UK Phase 3 pivotal clinical trial commenced September 2020 to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Half the participants received two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, and half of the trial participants received placebo (saline). An additional Phase 3 pivotal clinical trial conducted in the United States and Mexico commenced December 2020 and included 30,000 participants with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age, and those living with co-morbidities.

More Information

• Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine With/Without Matrix-M Adjuvant (ClinicalTrials.gov)

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.

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