Drugs / CHIKV VLP vaccine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chikungunya | 2024-06-26 | “submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA)” bavarian-nordic.com ↗ |
| Filed | US (FDA) | — | chikungunya | 2024-06-17 | “rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA)” bavarian-nordic.com ↗ |
| Filed | UK (MHRA) | — | chikungunya | — | “The application was submitted to MHRA in February 2025 under the international recognition procedure” bavarian-nordic.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT07003984 | Jun 2025 → Dec 2028 expected | chikungunya | Bavarian Nordic | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT07467707 Comparator | May 2026 → May 2030 expected | chikungunya | Bavarian Nordic | Recruiting | No outcome recorded |
| Phase 3 | NCT06007183 Comparator | Aug 2023 → Apr 2028 expected | chikungunya | Bavarian Nordic | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2025-03-07 | 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. |
| 2025-01-31 | 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. |
| 2024-08-13 | Bavarian Nordic | Regulatory Bavarian Nordic Announces FDA Acceptance and Priority Review of the BLA for its Chikungunya Vaccine bavarian-nordic.com ↗
The Priority Review designation means the FDA is targeting completion of its review within six months, compared to 10 months under standard review, and thus has assigned a Prescription Drug User Free Act (PDUFA) target action date of February 14, 2025. |
| 2024-07-18 | Bavarian Nordic | Regulatory Bavarian Nordic Receives EMA Filing Acceptance and Validation of the MAA for its Chikungunya Vaccine bavarian-nordic.com ↗
Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure under accelerated assessment. |
| 2024-06-26 | Bavarian Nordic | Regulatory Bavarian Nordic Submits Marketing Authorization Application for its Chikungunya Vaccine Candidate to EMA bavarian-nordic.com ↗
Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older is now underway in both the EU and in the U.S. |
| 2024-06-17 | Bavarian Nordic | Regulatory Bavarian Nordic Completes BLA Submission to U.S. FDA for its Chikungunya Vaccine Candidate bavarian-nordic.com ↗ |
| 2024-04-29 | Bavarian Nordic | Regulatory Bavarian Nordic Initiates Rolling Submission of Biologics License Application with FDA for its Chikungunya Vaccine Candidate bavarian-nordic.com ↗ |
All press releases naming this drug 10 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 | CHIKV VLP vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07003984 ↗ |
| Modality | Vaccine | “Chikungunya Virus Virus-like Particle Vaccine” NCT06007183 ↗ |
| Route | Intramuscular | “to be administered via intramuscular (IM) injection” NCT06007183 ↗ |