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
Development timeline for Novavax COVID-19 Vaccine
Date | Article |
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Nov 8, 2022 | Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster |
Oct 19, 2022 | U.S. Centers for Disease Control and Prevention Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults |
Aug 22, 2022 | U.S. Centers for Disease Control and Prevention Expands Recommendation for Novavax COVID-19 Vaccine, Adjuvanted to Adolescents Aged 12 Through 17 |
Aug 19, 2022 | U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17 |
Aug 15, 2022 | Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults Aged 18 and Older |
Aug 4, 2022 | Novavax Announces Initiation of Phase 2b/3 Hummingbird Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11 Years |
Jul 13, 2022 | U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over |
Jun 7, 2022 | FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older |
Apr 22, 2022 | Novavax Announces Initiation of COVID-19 Vaccine Booster Study in Adolescents in Phase 3 PREVENT-19 Trial |
Feb 17, 2022 | Health Canada Authorizes Novavax COVID-19 Vaccine |
Feb 10, 2022 | Novavax Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial |
Feb 3, 2022 | New Zealand's Medsafe Grants Provisional Approval for Novavax' COVID-19 Vaccine |
Jan 31, 2022 | Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine |
Dec 31, 2021 | Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine |
Dec 22, 2021 | Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies |
Dec 21, 2021 | Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study |
Dec 20, 2021 | World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine |
Dec 17, 2021 | Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine |
Dec 15, 2021 | Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine |
Dec 2, 2021 | Novavax Statement on Omicron Variant Response |
Nov 17, 2021 | Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization |
Nov 4, 2021 | Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization |
Nov 3, 2021 | Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand |
Nov 1, 2021 | Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia |
Nov 1, 2021 | Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency |
Oct 29, 2021 | Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia |
Oct 27, 2021 | Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom |
Sep 17, 2021 | Novavax Statement on Proof of COVID-19 Vaccine Requirements for PREVENT-19 Clinical Trial Participants in the U.S. |
Sep 16, 2021 | Novavax to Participate in University of Oxford Com-COV3 Study Comparing Mixed COVID-19 Vaccine Schedule in Adolescents |
Aug 30, 2021 | Novavax Statement on CDC Guidance Update for COVID-19 Clinical Trial Participants |
Aug 25, 2021 | Novavax to Participate in OCTAVE-DUO Study to Evaluate Third Dose of Vaccine in Participants with Impaired Immune Systems |
Aug 5, 2021 | Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination |
Jun 30, 2021 | Novavax 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, 2021 | Novavax Announces Positive Results from First Study of Influenza Vaccine and COVID-19 Vaccine Candidate Administered Simultaneously |
Jun 14, 2021 | Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial |
Jun 14, 2021 | U.S. Clinical Trial Results Show Novavax Vaccine is Safe and Prevents COVID-19 |
Jun 11, 2021 | Novavax Announces Positive Data from Three Complementary Studies of COVID-19 Beta (B.1.351) Variant Strain Vaccine |
May 5, 2021 | New 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, 2021 | Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine |
Apr 14, 2021 | Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations |
Apr 5, 2021 | Novavax Initiates COVID-19 Vaccine Clinical Trial Crossover |
Mar 11, 2021 | Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials |
Feb 25, 2021 | Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan |
Feb 22, 2021 | Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico |
Feb 18, 2021 | Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine |
Feb 15, 2021 | Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine for South Korea |
Feb 4, 2021 | Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization |
Feb 3, 2021 | Novavax and Government of Switzerland Announce Agreement in Principle to Supply COVID-19 Vaccine |
Jan 28, 2021 | Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial |
Jan 22, 2021 | Novavax and Government of Canada Finalize Advance Purchase Agreement for COVID-19 Vaccine |
Jan 7, 2021 | Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine |
Dec 28, 2020 | Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico |
Dec 16, 2020 | Novavax Announces Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine |
Nov 30, 2020 | Novavax Announces COVID-19 Vaccine Clinical Development Progress |
Nov 9, 2020 | Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA |
Nov 4, 2020 | Novavax and Commonwealth of Australia Announce Agreement in Principle for Acquisition of Novavax COVID-19 Vaccine |
Nov 2, 2020 | Novavax Announces Facility Expansion to Support Global Vaccine Development |
Oct 27, 2020 | Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update |
Sep 24, 2020 | Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom |
Sep 15, 2020 | Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2 Billion Doses Annually |
Sep 2, 2020 | Novavax Announces Publication of Phase 1 Data for COVID-19 Vaccine Candidate in The New England Journal of Medicine |
Aug 24, 2020 | Novavax Initiates Phase 2 Portion of Phase 1/2 Clinical Trial of COVID-19 Vaccine |
Aug 17, 2020 | Novavax Initiates Efficacy Trial of COVID-19 Vaccine in South Africa |
Aug 7, 2020 | Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan |
Aug 6, 2020 | Novavax and Serum Institute of India Announce Development and Commercial Collaboration |
Aug 4, 2020 | Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate |
Jul 23, 2020 | Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate |
Jul 7, 2020 | Novavax Announces $1.6 Billion Funding from Operation Warp Speed |
Jun 4, 2020 | Novavax Awarded Department of Defense Contract for COVID-19 Vaccine |
May 25, 2020 | Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine |
Further information
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