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Novavax COVID-19 Vaccine FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 12, 2021.

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

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

  • 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

Development Timeline for Novavax COVID-19 Vaccine

Dec 31, 2021Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine
Dec 22, 2021Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies
Dec 21, 2021Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study
Dec 20, 2021World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine
Dec 17, 2021Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
Dec 15, 2021Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine
Dec  2, 2021Novavax Statement on Omicron Variant Response
Nov 17, 2021Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization
Nov  4, 2021Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization
Nov  3, 2021Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand
Nov  1, 2021Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
Nov  1, 2021Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency
Oct 29, 2021Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia
Oct 27, 2021Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom
Sep 17, 2021Novavax Statement on Proof of COVID-19 Vaccine Requirements for PREVENT-19 Clinical Trial Participants in the U.S.
Sep 16, 2021Novavax to Participate in University of Oxford Com-COV3 Study Comparing Mixed COVID-19 Vaccine Schedule in Adolescents
Aug 30, 2021Novavax Statement on CDC Guidance Update for COVID-19 Clinical Trial Participants
Aug 25, 2021Novavax to Participate in OCTAVE-DUO Study to Evaluate Third Dose of Vaccine in Participants with Impaired Immune Systems
Aug  5, 2021Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination
Jun 30, 2021Novavax Publishes Results of United Kingdom Phase 3 Clinical Trial in New England Journal of Medicine, Demonstrating High Levels of Efficacy of COVID-19 Vaccine
Jun 14, 2021Novavax Announces Positive Results from First Study of Influenza Vaccine and COVID-19 Vaccine Candidate Administered Simultaneously
Jun 14, 2021Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial
Jun 14, 2021U.S. Clinical Trial Results Show Novavax Vaccine is Safe and Prevents COVID-19
Jun 11, 2021Novavax Announces Positive Data from Three Complementary Studies of COVID-19 Beta (B.1.351) Variant Strain Vaccine
May  5, 2021New England Journal of Medicine Publishes Phase 2b Clinical Trial Results Demonstrating Efficacy of Novavax COVID-19 Vaccine Against the B.1.351 Variant
May  3, 2021Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine
Apr 14, 2021Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations
Apr  5, 2021Novavax Initiates COVID-19 Vaccine Clinical Trial Crossover
Mar 11, 2021Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials
Feb 25, 2021Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan
Feb 22, 2021Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico
Feb 18, 2021Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine
Feb 15, 2021Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine for South Korea
Feb  4, 2021Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization
Feb  3, 2021Novavax and Government of Switzerland Announce Agreement in Principle to Supply COVID-19 Vaccine
Jan 28, 2021Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
Jan 22, 2021Novavax and Government of Canada Finalize Advance Purchase Agreement for COVID-19 Vaccine
Jan  7, 2021Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine
Dec 28, 2020Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico
Dec 16, 2020Novavax Announces Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine
Nov 30, 2020Novavax Announces COVID-19 Vaccine Clinical Development Progress
Nov  9, 2020Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA
Nov  4, 2020Novavax and Commonwealth of Australia Announce Agreement in Principle for Acquisition of Novavax COVID-19 Vaccine
Nov  2, 2020Novavax Announces Facility Expansion to Support Global Vaccine Development
Oct 27, 2020Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update
Sep 24, 2020Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom
Sep 15, 2020Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2 Billion Doses Annually
Sep  2, 2020Novavax Announces Publication of Phase 1 Data for COVID-19 Vaccine Candidate in The New England Journal of Medicine
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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