Drugs / V920
V920
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Ebola hemorrhagic fever | 2019-09-17 | “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)” merck.com ↗ |
| Filed | EU (EMA) | — | Ebola hemorrhagic fever | — | “The European Medicines Agency (EMA) recently accepted the Marketing Authorization Application (MAA) for V920 and will begin review of the application.” merck.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 1 met primary | ||||||
| Phase 1 | NCT02314923 | Dec 2014 → Jun 2016 | Ebola hemorrhagic fever | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1 | NCT02269423 | Oct 2014 → Aug 2015 | Ebola hemorrhagic fever | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02280408 | Oct 2014 → Dec 2015 | Ebola hemorrhagic fever | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02503202 | Aug 2015 → May 2016 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03031912 Comparator | Aug 2017 → Mar 2023 | Ebola hemorrhagic fever | Canadian Immunization Research Network | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| 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. |
| 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). |
| 2020-02-05 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Fourth-Quarter and Full-Year 2019 Financial Results merck.com ↗
Merck announced conditional approval in Europe as well as U.S. approval for ERVEBO (Ebola Zaire Vaccine, Live) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. |
| 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 ↗
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). |
| 2015-07-31 | Merck Sharp & Dohme LLC | Results In Interim Results from Phase 3 Study, Merck’s Investigational Ebola Vaccine Efficacious; Study is Continuing merck.com ↗
Merck (known as MSD outside the US and Canada) said today that its investigational Ebola vaccine candidate, rVSV-ZEBOV, was found to have 100 percent efficacy in an analysis of interim data from a Phase 3 ring vaccination trial in Guinea. |
All press releases naming this drug 15 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | V920 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02314923 ↗ |
| Known as | BPSC-1001 | “This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (V920; BPSC-1001) to see if it is safe and to see how it affects people's immune system.” NCT02280408 ↗ |
| Known as | rVSV-ZEBOV-GP | “V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection” NCT02503202 ↗ |
| Known as | rVSVΔG-ZEBOV-GP | “The vaccine referred to as V920 is a recombinant vesicular stomatitis virus (rVSV) in which the VSV-G envelope glycoprotein (GP) is completely replaced by the Zaire ebolavirus...” PMID 28647166 ↗ Jun 2017 |
| Known as | VSV ZEBOV | “This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (V920; BPSC-1001) to see if it is safe and to see how it affects people's immune system.” NCT02280408 ↗1“This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001.” NCT02269423 ↗ |
| Known as | VSVΔG-ZEBOV | “This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a live replicating vesicular stomatitis virus (VSV) replacing the gene encoding the G...” NCT02314923 ↗2“This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a live VSV replacing the gene encoding the G envelope glycoprotein with the gene...” NCT02280408 ↗ “(VSVΔG-ZEBOV also known as V920 and BPSC-1001).” NCT02269423 ↗ |
| Modality | Vaccine | “This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001.” NCT02269423 ↗ |
| Route | Intramuscular | “Participants will be randomized to receive V920/BPSC-1001 or Placebo by intramuscular injection.” NCT02269423 ↗ |