Drugs / VSVG-ZEBOV
VSVG-ZEBOV
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | ERVEBO | Ebola hemorrhagic fever | — | “In September 2019, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) and granted priority review for V920.” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02344407 | Jan 2015 → Jun 2016 | Ebola hemorrhagic fever | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2019-11-11 | 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. |
All press releases naming this drug 7 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VSVG-ZEBOV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02344407 ↗ |
| Known as | ERVEBO | “BACKGROUND: ERVEBO®, a live recombinant vesicular stomatitis virus (VSV) vaccine containing the Zaire ebolavirus glycoprotein (GP) in place of the VSV GP (rVSVΔG-ZEBOV-GP), was...” PMID 36208978 ↗ Oct 2022 |
| Known as | rVSVΔG-ZEBOV-GP | “BACKGROUND: ERVEBO®, a live recombinant vesicular stomatitis virus (VSV) vaccine containing the Zaire ebolavirus glycoprotein (GP) in place of the VSV GP (rVSVΔG-ZEBOV-GP), was...” PMID 36208978 ↗ Oct 2022 |
| Known as | V920 | “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 | VSVdeltaG-ZEBOV | “The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope...” NCT02344407 ↗ |
| Modality | Vaccine | “The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope...” NCT02344407 ↗ |