Drugs / PXVX0317
PXVX0317
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | chikungunya | 2026-07-13 | “Eurofarma, has submitted a marketing authorization application to the Brazilian Health Regulatory Agency (Anvisa) for Bavarian Nordic’s chikungunya vaccine, CHIKV VLP” bavarian-nordic.com ↗ |
| Filed | Other | — | chikungunya | 2025-07-22 | “Health Canada has accepted for review the Company’s application for licensure of the single-dose, virus-like particle (VLP) chikungunya vaccine candidate, CHIKV VLP” bavarian-nordic.com ↗ |
| Filed | UK (MHRA) | — | chikungunya | 2025-03-07 | “MHRA has validated the marketing authorization application and accepted to start the review of the Company’s single-dose chikungunya vaccine” bavarian-nordic.com ↗ |
| Filed | EU (EMA) | — | chikungunya | 2024-06-26 | “announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA)” bavarian-nordic.com ↗ |
| Filed | US (FDA) | — | chikungunya | 2024-06-17 | “completion of the rolling submission process which was initiated in April 2024 with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA)” bavarian-nordic.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05065983 | Oct 2021 → May 2022 | chikungunya | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT03992872 | Nov 2019 → Jan 2021 | chikungunya | Bavarian Nordic | Completed | Missed primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05349617 | May 2022 → Jun 2023 | chikungunya | Bavarian Nordic | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| 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. |
| 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. |
| 2025-03-07 | 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 |
| 2025-01-31 | 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. |
| 2024-07-18 | 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. |
| 2024-02-23 | Bavarian Nordic | Regulatory Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency bavarian-nordic.com ↗
We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market. |
| 2023-08-06 | Bavarian Nordic | Results Bavarian Nordic Reports Positive Phase 3 Topline Results for Chikungunya Virus Vaccine in Adults and Adolescents bavarian-nordic.com ↗
The results up to day 22 post vaccination showed that CHIKV VLP was highly immunogenic in healthy adolescents and adults, as demonstrated by the strong induction of chikungunya neutralizing antibodies in 98% of vaccinees in the active group. |
| 2023-06-20 | Bavarian Nordic | Results Bavarian Nordic Reports Data from a Phase 3 Clinical Trial of its VLP-Based Chikungunya Virus Vaccine in Adults ≥65 Years of Age bavarian-nordic.com ↗
Importantly, seroprotective neutralizing antibodies were also observed in the majority of the subjects (82%) at Day 15 post the single vaccination, clearly demonstrating a fast onset of protection for the VLP-based CHIKV vaccine candidate. |
| 2022-11-01 | Emergent BioSolutions | Results Emergent BioSolutions Presents Data from Phase 2 Study Evaluating Safety and Immunogenicity of Chikungunya Vaccine Candidate in Prior Recipients of Other Alphavirus Vaccines emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced results from a Phase 2 study evaluating the safety and immunogenicity of the company’s adjuvanted single dose chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in prior recipients of other investigational alphavirus vaccines. |
| 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. |
| 2020-01-13 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives EMA Agreement for Proposed Development Path of Investigational Chikungunya VLP Vaccine Candidate emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced that it has received agreement from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. |
| 2019-11-22 | Emergent BioSolutions | Results Emergent BioSolutions Presents Positive Immunogenicity Results From Phase 2 Study of Its Investigational Chikungunya VLP Vaccine Candidate emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced updated results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate across a series of dosing regimens. |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PXVX0317 | “The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).” NCT05065983 ↗2“PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant” NCT05349617 ↗ “an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine)” NCT03992872 ↗ |
| Known as | CHIKV VLP | “PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], Aluminum Hydroxide Adjuvanted)” NCT05065983 ↗ |
| Known as | CHIKV VLP vaccine | “an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine)” NCT03992872 ↗ |
| Modality | Vaccine | “an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine)” NCT03992872 ↗ |