Drugs / Novavax COVID-19 vaccine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2023-08-08 | “Initiated rolling submission of U.S. Biologics License Application (BLA) for full approval of the Novavax COVID-19 Vaccine, Adjuvanted” novavax.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03305341 | May 2025 → Nov 2026 expected | COVID-19 | Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06291857 | Dec 2024 → Dec 2025 | COVID-19 | Novavax | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT06633835 Comparator | Sep → Dec 2024 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 4 | NCT06065176 Comparator | Nov 2023 → Sep 2024 | COVID-19, respiratory tract infectious disorder, upper respiratory tract disorder | Sarang K. Yoon, DO, MOH | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 43
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2024-10-09 | Novavax | Regulatory Novavax's Updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine Receives Authorization in the EU novavax.com ↗
This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). |
| 2024-08-30 | Novavax | Regulatory Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. novavax.com ↗
Today's authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide, |
| 2024-06-27 | Novavax | Regulatory U.S. CDC & ACIP Recommend Use of Authorized and Approved 2024-2025 COVID-19 Vaccines novavax.com ↗
Today the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of a universal recommendation for the use of 2024-2025 COVID-19 vaccines authorized under Emergency Use Authorization (EUA) or approved by Biologics License Application in individuals aged six months and older. |
| 2024-02-28 | Novavax | Regulatory Novavax’s Protein-based Non-mRNA COVID-19 Vaccine Available Now as Additional Dose for Individuals Aged 65 and Older Following U.S. CDC Advisory Committee Recommendation novavax.com ↗ |
| 2024-01-24 | Novavax | Regulatory Novavax’s Updated COVID-19 Vaccine▼ Authorized in the United Kingdom novavax.com ↗
“Today’s MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year,” said John C. Jacobs, President and Chief Executive Officer, Novavax. |
| 2023-12-18 | Novavax | Regulatory Novavax's Updated COVID-19 Vaccine Receives Emergency Use Authorization in Taiwan novavax.com ↗
the Taiwan Food and Drug Administration has granted emergency use authorization for Nuvaxovid ™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older. |
| 2023-12-05 | Novavax | Regulatory Novavax's Updated COVID-19 Vaccine Now Authorized in Canada novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M ™ adjuvant, today announced that Health Canada has granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. |
| 2023-11-28 | Novavax | Regulatory Novavax's Updated Protein-based COVID-19 Vaccine Now an Option for All 194 Member States of the World Health Organization novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Nuvaxovid™ XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older. |
| 2023-10-31 | Novavax | Regulatory Novavax's Updated Nuvaxovid™ COVID-19 Vaccine Receives Positive CHMP Opinion in the EU novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M ™ adjuvant, today announced that the Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) has been recommended for approval for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older in the European Union by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. |
| 2023-10-31 | Novavax | Regulatory Novavax's Updated COVID-19 Vaccine Now Approved in the EU novavax.com ↗
today announced the European Commission has granted approval for Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. |
| 2023-10-03 | Novavax | Regulatory Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. 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). |
| 2023-05-12 | 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. |
| 2023-01-27 | 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. |
| 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. |
| 2022-11-18 | 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 ↗ |
| 2022-10-20 | 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 ↗
Study 307 (Lot Consistency) met its primary endpoint, showing that three lots of the Novavax COVID-19 vaccine tested as a heterologous booster induced consistent immune responses in previously vaccinated adults aged 18 to 49. |
| 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 ↗ |
| 2022-09-13 | 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. |
| 2022-09-01 | 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 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. |
| 2022-07-26 | 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 ↗ |
| 2022-07-13 | 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. |
| 2022-06-28 | 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. |
| 2022-06-07 | 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 |
| 2022-06-02 | 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. |
All press releases naming this drug 63 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Novavax COVID-19 Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06291857 ↗ |
| Modality | Vaccine | “NOVAVAX COVID-19 VACCINE” NCT03305341 ↗ |
| Route | Intramuscular | “in the deltoid muscle of the arm” NCT06065176 ↗ |