Drugs / rVSVΔG-ZEBOV-GP
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Ebola hemorrhagic fever | 2018-11-13 | “that it started the submission of a rolling Biologics License Application to the FDA for V920 (rVSV∆G-ZEBOV-GP, live)” merck.com ↗ “submission is made pursuant to the FDA’s Breakthrough Therapy Designation for V920” merck.com ↗ |
| Filed | EU (EMA) | — | Ebola hemorrhagic fever | — | “the EMA recently accepted the Marketing Authorization Application for V920 (rVSV∆G-ZEBOV-GP), the company’s investigational vaccine for Ebola Zaire disease.” merck.com ↗ “The European Medicines Agency (EMA) recently accepted the Marketing Authorization Application (MAA) for V920 and will begin review of the application.” merck.com ↗ “In March 2019, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for V920 for review.” merck.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05130398 | Apr → Sep 2021 | Ebola hemorrhagic fever | Centre de Recherche Médicale de Lambaréné | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02876328 | Mar 2017 → Dec 2019 | Ebola hemorrhagic fever | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT03161366 | May → Jul 2018 | Ebola hemorrhagic fever | Epicentre | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| 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 ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved an expanded indication for ERVEBO for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus . |
| 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 ↗
announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ERVEBO, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older. |
| 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 ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today confirmed that four African countries, including the Democratic Republic of the Congo (DRC), have approved ERVEBO (pronounced er-VEE-boh). |
| 2019-12-20 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live) merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ERVEBO® (Ebola Zaire Vaccine, Live) (pronounced er-VEE-boh) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. |
| 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 ↗
KENILWORTH, N.J., Nov. 13, 2019—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 ↗
With this approval, the European Commission will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. |
| 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 ↗
The CHMP’s recommendation, completed under accelerated assessment, will now be considered by the European Commission. |
| 2019-09-17 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Merck’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus merck.com ↗
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Merck’s investigational Ebola vaccine (V920), under review for the prevention of disease caused by the Ebola Zaire virus. |
| 2018-11-13 | Merck Sharp & Dohme LLC | Regulatory Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration merck.com ↗
“By the FDA agreeing to accept our BLA on a rolling basis, we have together made another important step forward in accelerating the regulatory review process for V920,” said Paula Annunziato, M.D., vice president for clinical research, Merck Research Laboratories. |
| 2016-07-25 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920) merck.com ↗ |
| 2015-12-23 | Merck Sharp & Dohme LLC | Regulatory World Health Organization to Review Merck’s Investigational Ebola Vaccine for Emergency Use Assessment and Listing merck.com ↗
the application for Emergency Use Assessment and Listing (EUAL) for the company’s investigational Ebola Zaire vaccine, V920 (rVSV∆G-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization (WHO). |
All press releases naming this drug 15 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rVSVΔG-ZEBOV-GP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05130398 ↗ |
| Known as | ERVEBO | “The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease...” PMID 37967326 ↗ Apr 2024 |
| Known as | V920 | “Biological: rVSVΔG-ZEBOV-GP, V920” NCT05130398 ↗ |
| Modality | Vaccine | “The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine” PMID 37967326 ↗ Apr 2024 |
| Route | Intramuscular | “Participants of the experimental arm will receive a single intramuscular dose of ≥7.8 x 107 pfu of the rVSVΔG-ZEBOV-GP vaccine.” NCT05130398 ↗ |