Drugs / NVX-CoV2373
NVX-CoV2373
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | Nuvaxovid | COVID-19 | 2022-10-10 | “has submitted a Post Approval Change Application to the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine” novavax.com ↗ |
| Filed | Other | Nuvaxovid | COVID-19 | 2022-07-07 | “Novavax today announced the submission of a request to Swissmedic to expand the conditional marketing authorization (CMA) of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in Switzerland” novavax.com ↗ |
| Filed | UK (MHRA) | Nuvaxovid | COVID-19 | 2022-06-01 | “Novavax submitted a request to the MHRA for expanded CMA of Nuvaxovid as a booster in adults aged 18 and older on June 1, 2022” novavax.com ↗ |
| Filed | Other | Nuvaxovid | COVID-19 | 2022-05-13 | “Novavax today announced the submission of a request for emergency use authorization to Taiwan’s Food and Drug Administration for its COVID-19 vaccine, NVX-CoV2373” novavax.com ↗ “Novavax today announced the filing of a Supplement to a New Drug Submission with Health Canada to expand the label of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine” novavax.com ↗ |
| Filed | EU (EMA) | Nuvaxovid | COVID-19 | 2022-03-31 | “submission of its request to expand the conditional marketing authorization (CMA) of Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) in the European Union (EU)” novavax.com ↗ “completed the submission of all data and modules required by EMA for regulatory evaluation of NVX-CoV2373” novavax.com ↗ |
| Filed | Other | — | COVID-19 | 2022-02-28 | “Completed regulatory submissions for authorization for NVX-CoV2373 in the U.S. and Switzerland” novavax.com ↗ “SII completed submission to South Africa , for NVX-CoV2373 to be marketed as Covovax” novavax.com ↗ |
| Filed | US (FDA) | — | COVID-19 | 2022-01-31 | “today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373” novavax.com ↗ “Novavax submitted a request to the FDA for Emergency Use Authorization (EUA) for NVX-CoV2373 in January 2022” novavax.com ↗ “Completed regulatory submissions for authorization for NVX-CoV2373 in the U.S. and Switzerland” novavax.com ↗ |
| Filed | Other | Covovax | COVID-19 | 2022-01-10 | “submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorization (CMA) of NVX-CoV2373, its recombinant nanoparticle protein-based...” novavax.com ↗ “The submission for the regulatory evaluation by SAHPRA of NVX-CoV2373 includes data from two pivotal Phase 3 clinical trials” novavax.com ↗ |
| Filed | Japan (PMDA) | TAK-019 | COVID-19 | 2021-12-15 | “known as TAK-019 in Japan and NVX-CoV2373 outside Japan, is the first protein-based COVID-19 vaccine to be submitted under an NDA in Japan” novavax.com ↗ |
| Filed | Other | — | COVID-19 | 2021-11-01 | “today announced the submission of a Biologics License Application (BLA) for Novavax' COVID-19 vaccine to South Korea's Ministry of Food and Drug Safety (MFDS).” novavax.com ↗ “completion of its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate” novavax.com ↗ “Novavax has now completed the submission of all modules required by Health Canada and EMA for the regulatory evaluation of NVX-CoV2373” novavax.com ↗ “Novavax filed in Canada for the vaccine's use as a primary series in adolescents aged 12 through 17 in June 2022” novavax.com ↗ “NVX-CoV2373 is the first protein-based COVID-19 vaccine candidate submitted for BLA approval in Korea.” skbioscience.com ↗ “Novavax has made the submission for the regulatory evaluation by HSA of NVX-CoV2373” novavax.com ↗ “Novavax made the submission for the regulatory evaluation by MoHaP of NVX-CoV2373” novavax.com ↗ “A biologics license application was submitted to the MFDS in November.” novavax.com ↗ |
| Filed | UK (MHRA) | — | COVID-19 | 2021-10-27 | “completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373” novavax.com ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04889209 | May 2021 → Jun 2023 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT04712110 | Feb 2021 → Mar 2022 | COVID-19 | Takeda | Completed | No outcome recorded |
| Phase 1/2 | NCT04368988 | May 2020 → Jun 2022 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06027229 | Nov 2023 → Apr 2024 | COVID-19, immunodeficiency disease | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 2 | NCT05112848 | Feb → May 2022 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05925127 | Oct 2023 → May 2024 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 2/3 | NCT05468736 | Jul 2022 → Jan 2024 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 37 trials · 6 met primary | ||||||
| Phase 3 | NCT05875701 | Mar → Nov 2023 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 3 | NCT05463068 | Jul → Aug 2022 | COVID-19 | Novavax | Completed | Met primary |
| Phase 3 | NCT05372588 | May → Jul 2022 | COVID-19 | Novavax | Completed | Met primary |
| Phase 3 | NCT05299359 | Apr → Jun 2022 | COVID-19 | Takeda | Completed | Met primary |
| Phase 3 | NCT05249816 | Mar 2022 → May 2023 | COVID-19 | Cogna Technology Solutions LLC | Completed | Met primary |
| Phase 3 | NCT04611802 | Dec 2020 → Apr 2023 | COVID-19 | Novavax | Completed | Met primary |
| Phase 3 | NCT04583995 | Sep 2020 → Mar 2022 | COVID-19 | Novavax | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT05775887 Comparator | May → Dec 2023 | COVID-19 | The University of Queensland | Completed | No outcome recorded |
| Phase 3 | NCT05973006 Comparator | Aug 2023 → Apr 2024 | COVID-19 | Novavax | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 119
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | Novavax | Regulatory Novavax's Partnership Strategy Continues to Deliver with XFG-adapted Nuvaxovid™ Approvals in the U.S., EU and Japan for 2026-2027 Vaccination Season novavax.com ↗
Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major markets including the U.S., European Union (EU) and Japan. |
| 2025-10-07 | Novavax | Regulatory Novavax Continues to Deliver on Sanofi Partnership, Completing Nuvaxovid® EU Marketing Authorization Transfer and Triggering $25 Million Milestone Payment novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX) has completed the transfer of the marketing authorization for its COVID-19 vaccine, Nuvaxovid® to Sanofi, in the European Union (EU) enabling Sanofi to take full responsibility for commercial and regulatory activities in the EU. |
| 2025-09-04 | Novavax | Regulatory Nuvaxovid® Now Approved in Japan Triggering Takeda Milestone Payment novavax.com ↗
We are pleased that Japan's Ministry of Health, Labour and Welfare has approved our vaccine, Nuvaxovid ® , which has a history of clinical use in many countries around the world and provides value for public health. |
| 2025-08-27 | Novavax | Regulatory Novavax's Nuvaxovid™ 2025-2026 Formula COVID-19 Vaccine Approved in the U.S. novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration has approved the Nuvaxovid ™ 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. |
| 2024-03-11 | Novavax | Regulatory Canada National Advisory Committee Publishes Recommendation for Use of Novavax's Nuvaxovid™ XBB.1.5 COVID-19 Vaccine novavax.com ↗
Canada’s National Advisory Committee on Immunization has published guidance on the use of Nuvaxovid™ XBB.1.5, a recombinant protein subunit COVID-19 vaccine, in Canada. |
| 2023-10-18 | Novavax | Regulatory Novavax's Prototype COVID-19 Vaccine Nuvaxovid™ Receives Full Approval in Singapore novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M ™ adjuvant, today announced that Singapore's Health Sciences Authority (HSA) has granted full approval for Novavax's prototype COVID-19 vaccine Nuvaxovid™ (NVX-CoV2373) for active immunization to prevent COVID-19 in individuals aged 12 and older. |
| 2023-10-18 | Novavax | Regulatory Novavax Receives Full Marketing Authorization for Prototype COVID-19 Vaccine Nuvaxovid™ ▼ in United Kingdom novavax.com ↗ |
| 2023-08-22 | Novavax | Results Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6 novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies. |
| 2023-08-08 | Novavax | Regulatory Novavax Reports Second Quarter 2023 Financial Results and Operational Highlights novavax.com ↗
Initiated FDA submission for approval of our updated XBB COVID vaccine for the 2023 fall vaccination season and reiterated plan to be in market by September; submissions to EMA and Health Canada in the coming weeks |
| 2023-07-06 | Novavax | Regulatory Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid™ (NVX-CoV2373). |
| 2023-06-15 | Novavax | Results Novavax Prepared to Deliver Protein-based Monovalent XBB COVID Vaccine Consistent with FDA VRBPAC Recommendation for the Fall novavax.com ↗
Novavax data showed that its XBB.1.5 COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants. |
| 2023-05-26 | Novavax | Regulatory Novavax's Nuvaxovid™ Receives Positive CHMP Opinion for Full Marketing Authorization for the Prevention of COVID in the EU novavax.com ↗ |
| 2023-05-12 | Novavax | Regulatory Access to Novavax's COVID Vaccine Grows with Extended Interim Authorization for Adolescents in Singapore novavax.com ↗
We are pleased with this adolescent authorization in Singapore as it ensures a protein-based option as part of public health measures. |
| 2023-05-09 | Novavax | Results Novavax Reports First Quarter 2023 Financial Results and Operational Highlights novavax.com ↗
Announced positive Phase 2 COVID-Influenza Combination (CIC) vaccine, standalone influenza, and high-dose COVID vaccine data, which evaluated safety and immunogenicity of different formulations |
| 2023-04-27 | Novavax | Results PREVENT-19 Adolescent Data Published in the Journal of the American Medical Association Network Open novavax.com ↗
The full results from the pediatric expansion of Novavax’s Phase 3 PREVENT-19 trial were published in the Journal of the American Medical Association Network Open . |
| 2023-01-27 | Novavax | Results Novavax Announces Plan to Deliver Updated Protein-based Vaccine Consistent with FDA Recommendations for 2023/2024 Vaccination Season at VRBPAC Meeting novavax.com ↗
During the meeting, Novavax shared data demonstrating that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), when used as a booster induces a broad functional immune response, including against forward drift variants. |
| 2023-01-18 | Novavax | Regulatory Novavax Nuvaxovid COVID-19 Vaccine Approved in South Korea as an Adult Booster novavax.com ↗
partner SK bioscience has received expanded manufacturing and marketing approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) for use as a booster for active immunization to prevent COVID-19 in adults aged 18 and older. |
| 2023-01-05 | Novavax | Regulatory Spanish, Italian and French Health Authorities Expand Recommendations for Use of Novavax COVID-19 Vaccine novavax.com ↗
Novavax today announced that Spain’s Public Health Commission (CSP), Italy’s Ministry of Health (MoH), and France’s Haute Autorité de Santé (HAS) have released updated recommendations expanding use of Nuvaxovid™(NVX-CoV2373) in their respective countries. |
| 2022-12-16 | Novavax | Regulatory German Health Authority Expands Recommendation for Use of Novavax COVID-19 Vaccine as a Booster novavax.com ↗
Novavax today announced that the Standing Committee on Vaccination (STIKO) in Germany has expanded its recommendations for use of Nuvaxovid™(NVX-CoV2373) as a COVID-19 booster. |
| 2022-12-12 | Novavax | Regulatory Swiss and French Health Authorities Expand Recommendations for Use of Nuvaxovid COVID-19 Vaccine as a Booster novavax.com ↗
Novavax today announced that Switzerland’s Federal Office of Public Health (FOPH) and France’s Haute Autorité de Santé (HAS) have expanded their recommendations for use of Nuvaxovid™(NVX-CoV2373) as a COVID-19 booster. |
| 2022-12-07 | Novavax | Regulatory Novavax Nuvaxovid COVID-19 Vaccine Approved in Canada for Use as a Primary Series in Adolescents novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Health Canada has approved a supplement to a New Drug Submission (sNDS) for Nuvaxovid™ (COVID-19 Vaccine (Recombinant protein, Adjuvanted)) (NVX-CoV2373) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series of two doses in adolescents aged 12 through 17. |
| 2022-11-29 | Novavax | Regulatory World Health Organization Updates Emergency Use Listing for Novavax Nuvaxovid COVID-19 Vaccine as a Primary Series in Adolescents and as a Booster in Adults novavax.com ↗
Today's updated Emergency Use Listing from the WHO allows us to offer our protein-based vaccine as a primary series to adolescents and as a booster for adults around the world, |
| 2022-11-18 | Novavax | Regulatory Novavax Nuvaxovid COVID-19 Vaccine Receives Expanded Authorization in Canada as a Booster in Adults novavax.com ↗
Health Canada has granted expanded authorization for Nuvaxovid™ |
| 2022-11-09 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine▼ Authorized in the United Kingdom for Use as a Booster in Adults novavax.com ↗ |
| 2022-11-08 | Novavax | Results Novavax Reports Third Quarter 2022 Financial Results and Operational Highlights novavax.com ↗
Following a single homologous booster dose, adult participants demonstrated increased anti-spike IgG levels and increased functional antibody levels measured by hACE2 receptor inhibition against Omicron BA.1, BA.2 and BA.5 variants, approximating levels observed in our Phase 3 efficacy studies |
| 2022-11-08 | Novavax | Results Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster novavax.com ↗
The data demonstrate that the BA.1 vaccine candidate neutralizing responses in those not previously exposed to COVID-19 were greater than those of the prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if necessary (see chart 1). |
| 2022-10-20 | Novavax | Results Novavax Showcases Data from Expanding Vaccine Portfolio at IDWeek 2022 novavax.com ↗
These data showed that following a booster dose, anti-spike antibody and neutralizing responses for the original prototype strain increased significantly relative to pre-boost levels, regardless of the dosing regimen or age group across adult participants. |
| 2022-10-19 | Novavax | Regulatory U.S. Centers for Disease Control and Prevention Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults novavax.com ↗
Today the U.S. Centers for Disease Control and Prevention (CDC) recommended the use of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a booster for adults. |
| 2022-10-19 | Novavax | Regulatory U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults novavax.com ↗ |
| 2022-10-12 | Novavax | Results Novavax Prototype COVID-19 Vaccine Data Support Homologous and Heterologous Boosting and Suggest Benefit Against Variants novavax.com ↗
PREVENT-19 data in both adults aged 18 and older and adolescents aged 12 through 17 showed the prototype Novavax COVID-19 vaccine (NVX-CoV2373) achieved its pre-specified immunologic endpoint. |
| 2022-10-10 | Novavax | Regulatory Switzerland’s Federal Office of Public Health Recommends Novavax Nuvaxovid™ COVID-19 Vaccine as a Booster in Adults Aged 18 and Older novavax.com ↗
The FOPH now recommends use of Nuvaxovid as an adult booster regardless of previous vaccine history as part of its autumn 2022 COVID-19 vaccine booster campaign. |
| 2022-10-10 | Novavax | Regulatory Novavax and SK bioscience File a Post Approval Change Application in South Korea for Nuvaxovid™ COVID-19 Vaccine as a Booster in Adults Aged 18 and Older novavax.com ↗ |
| 2022-09-16 | Novavax | Regulatory Novavax Requests Updated Emergency Use Listing from World Health Organization for Nuvaxovid™ COVID-19 Vaccine as a Booster in Adults Aged 18 and Older novavax.com ↗ |
| 2022-09-16 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Receives Expanded Emergency Use Authorization in Taiwan for Use in Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-09-16 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Now Available in Israel for Individuals Aged 12 and Older novavax.com ↗
Nuvaxovid is now available for use in Israel in individuals aged 12 and older as both a primary series and a booster regardless of previous vaccine history. |
| 2022-09-13 | Novavax | Regulatory Novavax and Serum Institute of India Announce Full Product Registration in South Africa of Novavax COVID-19 Vaccine as a Primary Series for Adults Aged 18 and Older novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the South African Health Products Regulatory Authority has granted full product registration with conditions for Novavax' protein-based vaccine, NVX-CoV2373, as a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults aged 18 and older. |
| 2022-09-12 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the European Union for Use as a Booster for Adults Aged 18 and Older novavax.com ↗
Nuvaxovid™ is now authorized in the EU for use in adults aged 18 and older as a booster regardless of previous vaccine history |
| 2022-09-02 | Novavax | Regulatory World Health Organization Approves SK bioscience as a Supplier of Novavax Nuvaxovid™ COVID-19 Vaccine novavax.com ↗
Novavax today announced that the World Health Organization (WHO) has approved a variation to allow SK bioscience to manufacture and supply the active substance in the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine. |
| 2022-09-02 | Novavax | Regulatory Swissmedic Authorizes Novavax Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 Through 17 and as a Booster in Adults Aged 18 and Older novavax.com ↗ |
| 2022-09-01 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Recommended by CHMP for Expanded Conditional Marketing Authorization in the European Union as a Booster for Adults Aged 18 and Older novavax.com ↗
today announced that Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) as a homologous and heterologous booster for active immunization |
| 2022-08-26 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the United Kingdom for Use in Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-08-22 | Novavax | Regulatory U.S. Centers for Disease Control and Prevention Expands Recommendation for Novavax COVID-19 Vaccine, Adjuvanted to Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-08-19 | Novavax | Regulatory U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-08-18 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand for Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-08-17 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand as a First and Second Booster for Adults novavax.com ↗ |
| 2022-08-15 | Novavax | Regulatory Novavax Files in Taiwan for Expanded Emergency Use Authorization of Nuvaxovid™ COVID-19 Vaccine in Adolescents Aged 12 Through 17 novavax.com ↗
Novavax today announced the submission of a request for expanded emergency use authorization (EUA) to Taiwan’s Food and Drug Administration (TFDA) for Nuvaxovid™ (NVX-CoV2373) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17. |
| 2022-08-15 | Novavax | Regulatory 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 novavax.com ↗ |
| 2022-08-12 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Approved in South Korea for Use in Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-08-10 | Novavax | Regulatory Novavax and Serum Institute of India Receive Expanded Emergency Use Authorization for Novavax’ COVID-19 Vaccine in Thailand in Adolescents Aged 12 Through 17 novavax.com ↗
The Thai FDA has issued EUA for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for individuals 12 years old and above. |
| 2022-07-29 | Novavax | Regulatory Novavax Requests Expanded Emergency Use Listing with World Health Organization for Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-07-26 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Granted Provisional Registration in Australia for Use in Adolescents Aged 12 Through 17 novavax.com ↗ |
| 2022-07-26 | Novavax | Regulatory Novavax Announces Expanded Approval of Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 through 17 in Japan novavax.com ↗
Nuvaxovid™ is the first protein-based COVID-19 vaccine approved for use in adolescents in Japan |
| 2022-07-19 | Novavax | Regulatory U.S. Centers for Disease Control and Prevention Endorses Advisory Committee on Immunization Practices’ Recommendation for Novavax COVID-19 Vaccine, Adjuvanted novavax.com ↗
Today the U.S. Centers for Disease Control and Prevention (CDC) endorsed the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) for active immunization against SARS-CoV-2, following the Advisory Committee on Immunization Practices’ (ACIP) unanimous vote to recommend the vaccine as a two-dose primary series in individuals aged 18 and older. |
| 2022-07-19 | Novavax | Regulatory U.S. CDC Advisory Committee Unanimously Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Primary Series for Individuals Aged 18 and Older novavax.com ↗ |
| 2022-07-14 | Novavax | Regulatory Novavax Statement on European Medicines Agency Nuvaxovid™ Label Update Related to Allergic Reaction novavax.com ↗
Today, the European Medicines Agency (EMA) updated the label for our COVID-19 vaccine (NVX-CoV2373) to include the risk of severe allergic reactions. |
| 2022-07-13 | Novavax | Regulatory U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and over. |
| 2022-07-07 | Novavax | Regulatory Novavax Files in Switzerland for Expanded Conditional Marketing Authorization of Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 Through 17 and as a Booster in Individuals Aged 18 and Over novavax.com ↗ |
| 2022-07-07 | Novavax | Regulatory European Medicines Agency Approves SK bioscience as a Supplier of Novavax Nuvaxovid™ COVID-19 Vaccine novavax.com ↗
Novavax today announced that the European Medicines Agency has approved a variation to allow SK bioscience to manufacture and supply the active substance in the Nuvaxovid (NVX-CoV2373) COVID-19 vaccine to the European Union (EU). |
| 2022-07-05 | Novavax | Regulatory Novavax Nuvaxovid™ COVID-19 Vaccine Conditionally Authorized in the European Union for Adolescents Aged 12 Through 17 novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17. |
| 2022-06-28 | Novavax | Results Novavax COVID-19 Data Presented at FDA VRBPAC Meeting Demonstrates Broad Antibody Responses to Both Prototype and Omicron-Specific Variants novavax.com ↗
Novavax presented preclinical trial data showing that boosting with either the prototype (NVX-CoV2373), Omicron BA.1 (NVX-CoV2515), or bivalent vaccine generated antibody levels that were consistent with dosing regimens in the Phase 3 clinical trials. |
| 2022-06-23 | Novavax | Regulatory Novavax Files Supplement to a New Drug Submission in Canada for Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 Through 17 novavax.com ↗
Novavax today announced the filing of a Supplement to a New Drug Submission with Health Canada to expand the label of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 to adolescents aged 12 through 17 years. |
| 2022-06-23 | Novavax | Regulatory Novavax' Nuvaxovid™ COVID-19 Vaccine Receives Emergency Use Authorization in Taiwan for Use in Individuals Aged 18 and Over novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Taiwan Food and Drug Administration has granted emergency use authorization (EUA) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in individuals aged 18 years and over. |
| 2022-06-23 | Novavax | Regulatory Novavax COVID-19 Vaccine Nuvaxovid™ Recommended for Expanded Conditional Marketing Authorization in the European Union by CHMP for Adolescents Aged 12 Through 17 novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) for adolescents aged 12 through 17. |
| 2022-06-13 | Novavax | Regulatory Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over novavax.com ↗ |
| 2022-06-07 | Novavax | Regulatory FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older novavax.com ↗
Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee |
| 2022-06-03 | Novavax | Results Novavax Statement on US FDA Briefing Document Related to Myocarditis/Pericarditis novavax.com ↗
The data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%). |
| 2022-06-02 | Novavax | Regulatory Novavax Files in the United Kingdom for Expanded Conditional Marketing Authorization of COVID-19 Vaccination as a Booster in Adults Aged 18 and Over novavax.com ↗
Novavax today announced the submission of a request to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to expand the conditional marketing authorization (CMA) of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine▼ as a homologous and heterologous booster dose for individuals aged 18 and over. |
| 2022-05-20 | Novavax | Regulatory Novavax Files in the European Union for Expanded Conditional Marketing Authorization of COVID-19 Vaccine as a Booster in Individuals Aged 18 and Over novavax.com ↗ |
| 2022-05-13 | Novavax | Regulatory Novavax Files for Emergency Use Authorization of COVID-19 Vaccine in Taiwan novavax.com ↗
Novavax today announced the submission of a request for emergency use authorization to Taiwan’s Food and Drug Administration for its COVID-19 vaccine, NVX-CoV2373, for active immunization against SARS-CoV-2 in individuals aged 18 and over. |
| 2022-05-06 | Novavax | Regulatory Novavax Submits Variations to Expand Australian and New Zealand Provisional Approval of Nuvaxovid™ COVID-19 Vaccine to Adolescents aged 12 Through 17 Years novavax.com ↗
Novavax today announced the submission of variations to the Australian Therapeutic Goods Agency (TGA) and Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, to expand the provisional approval of its Nuvaxovid™ (NVX-CoV2373) COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years. |
| 2022-05-04 | Novavax | Regulatory Novavax Requests Expanded Authorization of Nuvaxovid™ COVID-19 Vaccine to Adolescents Aged 12 through 17 Years in Great Britain* novavax.com ↗ |
| 2022-04-29 | Novavax | Regulatory FDA Announces Vaccines and Related Biological Products Advisory Committee Review of Novavax' COVID-19 Vaccine novavax.com ↗ |
| 2022-04-19 | Takeda | Regulatory Takeda Announces Approval of Nuvaxovid ® COVID-19 Vaccine for Primary and Booster Immunization in Japan takeda.com ↗
Nuvaxovid Intramuscular Injection, containing Matrix-M TM adjuvant, is the first recombinant protein-based COVID-19 vaccine approved for use in Japan |
| 2022-04-19 | Novavax | Regulatory Novavax Announces Approval of Nuvaxovid™ COVID-19 Vaccine for Primary and Booster Immunization in Japan novavax.com ↗
Nuvaxovid (NVX-CoV2373 outside Japan and TAK-019 in Japan ) is the first protein-based vaccine to be authorized for use in Japan . |
| 2022-04-13 | Novavax | Regulatory Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine novavax.com ↗
The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Switzerland. |
| 2022-04-08 | Novavax | Regulatory Novavax and Serum Institute of India Receive Emergency Use Authorization for Novavax' COVID-19 Vaccine in Thailand novavax.com ↗
The Thailand Food and Drug Administration (Thai FDA) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above. |
| 2022-03-31 | Novavax | Regulatory Novavax Submits Request to Expand Conditional Marketing Authorization of COVID-19 Vaccine in the European Union to Adolescents (Ages 12-17) novavax.com ↗
today announced submission of its request to expand the conditional marketing authorization (CMA) of Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) in the European Union (EU) to adolescents aged 12 through 17 years. |
| 2022-03-22 | Novavax | Regulatory Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax' COVID-19 Vaccine in Adolescents ≥12 to <18 in India novavax.com ↗ |
| 2022-03-11 | Joincare Pharmaceutical Group Industry Co., Ltd | Results 最新研究：第三针丽珠二价苗对Omicron中和水平具显著优势 joincare.com ↗ |
| 2022-02-28 | Novavax | Results Novavax Announces Extended Durability of Protection Against Infection and Disease in United Kingdom COVID-19 Vaccine Phase 3 Clinical Trial novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today shared extended analysis from its pivotal Phase 3 clinical trial conducted in the United Kingdom (UK), showing that a high level of efficacy for its protein-based COVID-19 vaccine, NVX-CoV2373, was maintained over a 6-month period of surveillance. |
| 2022-02-17 | Novavax | Regulatory Health Canada Authorizes Novavax COVID-19 Vaccine novavax.com ↗
The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Canada . |
| 2022-02-14 | Novavax | Regulatory Singapore Health Sciences Authority Issues Interim Authorization for Novavax COVID-19 Vaccine novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Singapore Health Sciences Authority (HSA) has issued interim authorization for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. |
| 2022-02-14 | Novavax | Regulatory Novavax Files for Conditional Marketing Authorization of COVID-19 Vaccine in Switzerland novavax.com ↗
today announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorization (CMA) of NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant, for use in adults. |
| 2022-02-10 | Novavax | Results Novavax Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S. |
| 2022-02-03 | Novavax | Regulatory New Zealand's Medsafe Grants Provisional Approval for Novavax' COVID-19 Vaccine novavax.com ↗
today announced that New Zealand's Medsafe has granted provisional approval of NVX-CoV2373, Novavax' COVID-19 vaccine (adjuvanted), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. |
| 2022-02-03 | Novavax | Regulatory Medicines and Healthcare Products Regulatory Agency Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine in Great Britain* novavax.com ↗ |
| 2022-01-31 | Novavax | Regulatory Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine novavax.com ↗ |
| 2022-01-19 | Novavax | Regulatory Australia Therapeutic Goods Administration (TGA) Grants Provisional Registration for Novavax COVID-19 Vaccine novavax.com ↗ |
| 2022-01-12 | SK Bioscience Co., Ltd. | Regulatory SK bioscience Obtained Biologics License Application Approval of Novavax’ COVID-19 Vaccine in Korea skbioscience.com ↗
This is the first authorization of a recombinant protein nanoparticle COVID-19 vaccine in South Korea. |
| 2022-01-12 | Novavax | Regulatory South Korea Ministry of Food and Drug Safety Approves Novavax COVID-19 Vaccine novavax.com ↗
Nuvaxovid™, Novavax' COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience. |
| 2022-01-10 | Novavax | Regulatory Novavax and Serum Institute of India File for Emergency Use Authorization of Novavax' COVID-19 Vaccine in South Africa novavax.com ↗
today announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. |
| 2021-12-31 | Novavax | Regulatory Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the U.S. Food and Drug Administration (FDA) for NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. |
| 2021-12-28 | Serum Institute of India Pvt. Ltd. | Regulatory Serum Institute of India and Novavax Receive Emergency Use Authorization in India for COVOVAX™ seruminstitute.com ↗
Drugs Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above. |
| 2021-12-28 | Novavax | Regulatory Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India novavax.com ↗
today announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. |
| 2021-12-22 | Novavax | Results Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies novavax.com ↗
New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months. |
| 2021-12-20 | Novavax | Regulatory World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine novavax.com ↗
Today's EUL pertains to vaccine to be marketed by Novavax as Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) in Europe and other markets. |
| 2021-12-20 | Novavax | Regulatory Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine novavax.com ↗
today announced that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older. |
| 2021-12-20 | Novavax | Regulatory European Commission Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine novavax.com ↗
The authorization follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states. |
| 2021-12-17 | Serum Institute of India Pvt. Ltd. | Regulatory Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine seruminstitute.com ↗ |
| 2021-12-17 | Novavax | Regulatory Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine novavax.com ↗
The EUL prequalifies Novavax' COVID-19 vaccine as meeting the established WHO standards for quality, safety and efficacy. |
| 2021-12-15 | Novavax | Results Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine novavax.com ↗
The trial demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy against COVID-19 of any severity during the time period evaluated. |
| 2021-12-15 | Novavax | Regulatory Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Company Limited (Takeda). |
| 2021-12-13 | Novavax | Regulatory Novavax Files for Emergency Use of COVID-19 Vaccine in the United Arab Emirates novavax.com ↗
Novavax made the submission for the regulatory evaluation by MoHaP of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. |
| 2021-12-02 | Novavax | Results Novavax Statement on Omicron Variant Response novavax.com ↗
The responses were encouraging for the protection against new variants: NVX-CoV2373 produced robust anti-Spike IgG responses following a booster dose at Day 189. |
| 2021-11-24 | Novavax | Regulatory Novavax Files for Interim Authorization of COVID-19 Vaccine in Singapore novavax.com ↗
Novavax has made the submission for the regulatory evaluation by HSA of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. |
| 2021-11-18 | Novavax | Results Novavax Statement on Publication of Positive Results from First Study of Co-administered COVID-19 and Influenza Vaccines novavax.com ↗
The previously announced results demonstrate that vaccine efficacy and safety appeared to be preserved in those receiving both NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate, and Seqirus’ adjuvanted, trivalent seasonal influenza vaccine (aTIV) or a cell-based, quadrivalent seasonal influenza vaccine (QIVc), compared to those vaccinated with NVX-CoV2373 alone. |
| 2021-11-17 | Novavax | Regulatory Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines novavax.com ↗
today announced that the Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. |
| 2021-11-17 | Novavax | Regulatory Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization novavax.com ↗
today announced that European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for Novavax' COVID-19 vaccine, which will be marketed in the European Union under the brand name Nuvaxovid™. |
| 2021-11-15 | SK Bioscience Co., Ltd. | Regulatory SK bioscience Submits Biologics License Application to the KMFDS for Novavax Covid-19 Vaccine Candidate skbioscience.com ↗
SK bioscience (CEO Jae-yong Ahn) announced on November 15th that the company has completed a biologics license application (BLA) submission process to the Ministry of Food and Drug Safety (KMFDS) in Korea for approval of Novavax’ COVID-19 vaccine candidate, NVX-CoV2373. |
| 2021-11-15 | Novavax | Regulatory Novavax Announces Submission of Biologics License Application in South Korea for Approval of NVX-CoV2373 novavax.com ↗
today announced the submission of a Biologics License Application (BLA) for Novavax' COVID-19 vaccine to South Korea's Ministry of Food and Drug Safety (MFDS). |
| 2021-11-04 | Novavax | Regulatory Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate. |
| 2021-11-03 | Novavax | Regulatory Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand novavax.com ↗
Novavax has now completed the submission to Medsafe of all modules required for the regulatory evaluation of NVX-CoV2373, a recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. |
| 2021-11-01 | Novavax | Regulatory Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia novavax.com ↗
Badan POM has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above. |
| 2021-11-01 | Novavax | Regulatory Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate, the first filing of a protein-based COVID-19 vaccine in Canada . |
| 2021-10-29 | Novavax | Regulatory Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its COVID-19 vaccine candidate. |
| 2021-10-27 | Novavax | Regulatory Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom novavax.com ↗
Novavax has now completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. |
| 2021-10-19 | Novavax | Results Novavax Statement on Initial Com-COV2 Phase 2 Clinical Trial Results Presented at World Vaccine Congress Europe novavax.com ↗
The study showed that NVX-CoV2373 remains well-tolerated and generates a robust immune response when given as the second dose in a mixed, or heterologous, regimen after either the Oxford/Astra Zeneca or Pfizer/BioNTech vaccines as the first dose. |
| 2021-10-11 | Novavax | Results Complete PREVENT-19 Phase 3 Clinical Trial Results Manuscript for COVID-19 Vaccine Posted to medRxiv novavax.com ↗
The trial achieved its primary endpoint in which NVX-CoV2373, Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. |
| 2021-09-23 | Novavax | Regulatory Novavax and Serum Institute of India Announce Submission to World Health Organization for Emergency Use Listing of Novavax' COVID-19 Vaccine novavax.com ↗
Today's submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world, |
All press releases naming this drug 127 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 127 releases opens the full record — a long page | ||
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NVX-CoV2373 | “Immunogenicity and safety of a single booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine:...” PMID 37198021 ↗ May 202317“Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised,...” PMID 34800364 ↗ Nov 2021 “Group 15E - previously EUA-dosed vaccination with Janssen (two doses for Group 15E) - Ad26.COV2.S at 5x1010 vp followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV-2 rS...” NCT04889209 ↗ “NVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins...” PMID 32877576 ↗ Sep 2020 “Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial.” PMID 35501178 ↗ Apr 2022 “and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants” NCT05468736 ↗ “A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601.” NCT05973006 ↗ “2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart” NCT05468736 ↗ “NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine” PMID 34910859 ↗ Dec 2021 “including NVX-CoV2373 (an adjuvanted recombinant protein vaccine).” PMID 37652823 ↗ Aug 2023 “Drug: NVX-Cov2373” NCT05372588 ↗ |
| Known as | Nuvaxovid | “a single booster dose of either UQSC2 or the approved comparator NVX-CoV2373 (Nuvaxovid; Novavax)” PMID 41285172 ↗ Feb 2026 |
| Known as | NVX-CoV2372 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06027229 ↗ |
| Known as | TAK-019 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04712110 ↗ |
| Modality | Vaccine | “NVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine” PMID 32877576 ↗ Sep 2020 |
| Route | Intramuscular | “Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.” NCT04583995 ↗ |