Drugs / rVSVDG-ZEBOV-GP
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | ERVEBO | Ebola hemorrhagic fever | 2019-10-29 | “FDA acceptance and priority review for its Biologics License Application (BLA) for V920.” merck.com ↗ |
| Filed | EU (EMA) | ERVEBO | Ebola hemorrhagic fever | — | “The approval is based on data submitted to the European Medicines Agency for accelerated assessment in March 2019.” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05992480 | Dec 2025 → Nov 2026 expected | Ebola hemorrhagic fever | Tulane University | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-09-07 | Merck Sharp & Dohme LLC | Regulatory European Commission Expands Merck’s ERVEBO® [Ebola Zaire Vaccine, (rVSVΔG-ZEBOV-GP) live] Indication to Include Children 1 Year of Age and Older merck.com ↗
The EC’s decision follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) received on July 20, 2023. |
| 2023-08-03 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves Merck’s ERVEBO® (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and Older merck.com ↗ |
| 2020-02-14 | Merck Sharp & Dohme LLC | Regulatory ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification merck.com ↗ |
| 2019-12-20 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live) merck.com ↗ |
| 2019-11-13 | Merck Sharp & Dohme LLC | Regulatory ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Awarded Prequalification Status by the World Health Organization (WHO) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that ERVEBO [Ebola Zaire Vaccine (rVSVΔ-ZEBOV-GP live)] has been awarded prequalification status by the World Health Organization (WHO). |
| 2019-11-11 | Merck Sharp & Dohme LLC | Regulatory Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union merck.com ↗
The European Commission’s marketing authorization of ERVEBO is the result of an unprecedented collaboration for which the entire world should be proud. |
| 2019-10-18 | Merck Sharp & Dohme LLC | Regulatory Merck Receives EU CHMP Positive Opinion for Investigational V920 Ebola Zaire Vaccine for Protection Against Ebola Virus Disease merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a conditional marketing authorization for V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live). |
All press releases naming this drug 8 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 | rVSVDG-ZEBOV-GP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05992480 ↗ |
| Known as | ERVEBO | “This particular vaccination study will focus on the anamnestic response to the ERVEBO® vaccine, (full name - rVSVDG-ZEBOV-GP Ebola Virus Vaccine).” NCT05992480 ↗ |
| Modality | Vaccine | “It is an Ebola virus vaccine” NCT05992480 ↗ |