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NVX-CoV2373 FDA Approval Status

Reviewed by Judith Stewart BPharm. Last updated on Aug 27, 2020.

FDA Approved: No
Brand name: NVX-CoV2373
Generic name: SARS-CoV-2 vaccine
Company: Novavax, Inc.
Treatment for: Prevention of COVID-19

NVX-CoV2373 is an investigational SARS-CoV-2 vaccine in development for the prevention of COVID-19.

  • 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’ 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 includes 131 healthy volunteers aged 18-59 years across 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 results have been submitted for peer-review.
    • 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 and expands 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 will assess two dose sizes (5 and 25 µg), each with 50 µg of Matrix‑M. The study is targeting enrollment of up to 1,500 healthy volunteers, with approximately 50 percent of participants ≥60 years of age, at up to 40 sites in the U.S. and Australia.
  • Novavax has been awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population.

More Information

Development Timeline for NVX-CoV2373

Aug 24, 2020Novavax Initiates Phase 2 Portion of Phase 1/2 Clinical Trial of COVID-19 Vaccine
Aug 17, 2020Novavax Initiates Efficacy Trial of COVID-19 Vaccine in South Africa
Aug  7, 2020Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan
Aug  6, 2020Novavax and Serum Institute of India Announce Development and Commercial Collaboration
Aug  4, 2020Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate
Jul 23, 2020Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate
Jul  7, 2020Novavax Announces $1.6 Billion Funding from Operation Warp Speed
Jun  4, 2020Novavax Awarded Department of Defense Contract for COVID-19 Vaccine
May 25, 2020Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine

Further information

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