Drugs / Vimkunya
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vimkunya | — | 2025-02-28 | europa.eu ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05072080 | Sep 2021 → Apr 2023 | chikungunya | Bavarian Nordic | Completed | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Bavarian Nordic | Regulatory Bavarian Nordic’s Chikungunya Vaccine Submitted for Regulatory Approval in Brazil bavarian-nordic.com ↗
The submission represents a key milestone in the partnership established between Bavarian Nordic and Eurofarma and marks an important step toward making the vaccine available in one of the countries most affected by chikungunya. |
| 2026-06-29 | Bavarian Nordic | Regulatory Bavarian Nordic Receives Health Canada Approval for Chikungunya Vaccine bavarian-nordic.com ↗
Health Canada has approved VIMKUNYA ® (recombinant, adsorbed) for immunization to prevent disease caused by chikungunya virus infection for individuals 12 years of age and older. |
| 2026-04-16 | Bavarian Nordic | Regulatory Bavarian Nordic Receives Swissmedic Approval for Chikungunya Vaccine bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) today announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved VIMKUNYA ® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals aged 12 years and above. |
| 2025-07-22 | Bavarian Nordic | Regulatory Bavarian Nordic Receives Acceptance from Health Canada for Review of the New Drug Submission for its Chikungunya Vaccine bavarian-nordic.com ↗
The application screening acceptance by the Directorate confirms that the New Drug Submission is complete and begins a standard review procedure, potentially supporting approval of the vaccine in the first half of 2026. |
| 2025-05-02 | Bavarian Nordic | Regulatory Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom bavarian-nordic.com ↗
The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approvals from certain other regulatory bodies, in this case the recent approval by the European Commission. |
| 2025-04-16 | Bavarian Nordic | Regulatory Bavarian Nordic’s Chikungunya Vaccine Receives Recommendation from U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the virus-like particle (VLP)-based, single-dose vaccine, VIMKUNYA™ (Chikungunya Vaccine, Recombinant) for injection, for the prevention of disease caused by chikungunya virus. |
| 2025-03-07 | Bavarian Nordic | Regulatory Bavarian Nordic Announces Acceptance of Marketing Authorization Application for Chikungunya Vaccine in the UK for Persons Aged 12 and Older bavarian-nordic.com ↗
the UK Medicines and Healthcare products Regulatory Agency (MHRA) has validated the marketing authorization application and accepted to start the review of the Company’s single-dose chikungunya vaccine, CHIKV VLP vaccine |
| 2025-02-28 | Bavarian Nordic | Regulatory Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) today announced that the European Commission has granted marketing authorization in Europe for VIMKUNYA ® for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. |
| 2025-02-14 | Bavarian Nordic | Regulatory Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older bavarian-nordic.com ↗
The FDA approved VIMKUNYA under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. |
| 2025-01-31 | Bavarian Nordic | Regulatory Bavarian Nordic Receives Positive CHMP Opinion for Chikungunya Vaccine for Persons Aged 12 and Older bavarian-nordic.com ↗
First chikungunya vaccine recommended by the CHMP for persons as young as 12 years old. |
| 2022-06-21 | Emergent BioSolutions | Results Emergent BioSolutions Announces Publication of CHIKV VLP Phase 2 Safety and Immunogenicity Data in The Lancet Infectious Diseases emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that two-year persistence data from its phase 2 clinical study evaluating the safety and immunogenicity of the company’s investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate were published in The Lancet Infectious Diseases. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vimkunya | “Vimkunya (previously chikungunya virus virus-like particle vaccine, previously PXVX0317) is a single-dose, pre-filled syringe for intramuscular injection.” PMID 40158526 ↗ Mar 2025 |
| Known as | PXVX0317 | “Vimkunya (previously chikungunya virus virus-like particle vaccine, previously PXVX0317) is a single-dose, pre-filled syringe for intramuscular injection.” PMID 40158526 ↗ Mar 2025 |
| Route | Intramuscular | “Vimkunya (previously chikungunya virus virus-like particle vaccine, previously PXVX0317) is a single-dose, pre-filled syringe for intramuscular injection.” PMID 40158526 ↗ Mar 2025 |