Drugs / NVX-CoV2705
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | COVID-19 | 2024-07-02 | “announced that it has filed for authorization with Health Canada for its 2024-2025 Formula COVID-19 vaccine (NVX-CoV2705)” novavax.com ↗ |
| Filed | EU (EMA) | — | COVID-19 | 2024-06-24 | “filed for a type II variation of existing Marketing Authorization with the European Medicines Agency (EMA) for its JN.1 COVID-19 vaccine (NVX-CoV2705)” novavax.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT07079670 | Oct 2025 → Jan 2026 | COVID-19 | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT06409663 | Oct 2024 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07086222 | Nov 2025 → Nov 2026 expected | COVID-19 | Novavax | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-04-18 | Sanofi | Results Press Release: ESCMID: Sanofi's Nuvaxovid COVID-19 vaccine showed better tolerability than mNEXSPIKE in head-to-head study sanofi.com ↗ |
| 2026-04-18 | Novavax | Results Nuvaxovid™ COVID-19 Vaccine Showed Better Tolerability than mNEXSPIKE in Head-to-head Sanofi-led Phase 4 Study novavax.com ↗
The study showed that Nuvaxovid demonstrated statistically significant lower systemic reactogenicity (the expected side effects that might occur following vaccination) compared to mNEXSPIKE across all pre-specified endpoints. |
| 2025-05-19 | Novavax | Regulatory U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine novavax.com ↗ |
| 2024-10-09 | Novavax | Regulatory Novavax's Updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine Receives Authorization 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 European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU). |
| 2024-08-30 | Novavax | Regulatory Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. |
| 2024-08-08 | Novavax | Regulatory Novavax Reports Second Quarter 2024 Financial Results and Operational Highlights novavax.com ↗
Filed with the U.S. FDA and EMA for authorization of updated 2024-2025 formula COVID-19 vaccine |
| 2024-07-02 | Novavax | Regulatory Novavax Submits Application to Health Canada for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine novavax.com ↗ |
| 2024-06-24 | Novavax | Regulatory Novavax Submits Application to European Medicines Agency for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has filed for a type II variation of existing Marketing Authorization with the European Medicines Agency (EMA) for its JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. |
| 2024-06-14 | Novavax | Regulatory Novavax Submits Application to U.S. FDA for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NVX-CoV2705 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07079670 ↗ |
| Modality | Vaccine | “a JN.1 subvariant SARS CoV-2 rS vaccine” NCT06409663 ↗ |
| Route | Intramuscular | “Intramuscular (deltoid) injection” NCT07079670 ↗ |