Drugs / Nuvaxovid
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Nuvaxovid | — | 2021-12-20 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 43 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07861542 | Oct → Nov 2026 expected | COVID-19 | Sanofi | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07051031 | Oct 2025 → Jun 2026 overdue | COVID-19 | Marcel Curlin | Active not recruiting | Met primary |
| Phase 4 | NCT05142319 | Oct 2021 → Jun 2023 | COVID-19 | Tan Tock Seng Hospital | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 0 | NCT07605520 Comparator | May 2026 → May 2028 expected | — | ANRS, Emerging Infectious Diseases | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05236491 Comparator | Mar 2022 → Jun 2023 | overlapping connective tissue disease, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis +2 | Paul R Fortin | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| 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 ↗
Sanofi's protein-based non-mRNA COVID-19 vaccine Nuvaxovid (NVX-CoV2705) demonstrated statistically significant lower systemic reactogenicity (the expected side effects that might occur following vaccination) compared to mNEXSPIKE (mRNA-1283), Moderna's latest mRNA COVID-19 vaccine, across all pre-specified endpoints in the COMPARE study. |
| 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 ↗
Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi. |
| 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). |
All press releases naming this drug 4 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nuvaxovid | “The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and...” NCT07861542 ↗6“For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid.” NCT05236491 ↗ “The version of the Nuvaxovid™ vaccine and the dose will be the one commercialised at the start of trial and authorised by EMA.” NCT07605520 ↗ “protein subunit vaccine (PSV) (Novavax NUVAXOVID)” NCT05236491 ↗ |
| Known as | NVX-CoV2705 | “Nuvaxovid (NVX-CoV2705)” NCT07051031 ↗ |
| Modality | Vaccine | “Study participants will be randomised to receive one of three vaccines in equal proportions: Comirnaty or Cormirnaty Bivalent (Original/Omicron BA.4/5), Moderna/Spikevax or...” NCT05142319 ↗ |
| Route | Other | “Single intradermal injection at 5mcg (0.5mL) per dose.” NCT05142319 ↗ |