Drugs / Ervebo
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ervebo | — | 2019-11-11 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT05202288 | Jan → Aug 2027 expected | Ebola hemorrhagic fever | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04822376 | Oct 2021 → Apr 2022 | Ebola hemorrhagic fever | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06841614 | Sep 2026 → Aug 2027 expected | Ebola hemorrhagic fever | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05959421 | Jun 2026 → Dec 2027 | Ebola hemorrhagic fever | University Medical Center Hamburg-Eppendorf | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06126822 | Feb 2025 → Oct 2026 expected | Ebola hemorrhagic fever | Institute of Tropical Medicine, Belgium | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| 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. |
| 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 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ervebo | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06126822 ↗ |
| Known as | rVSV∆G-ZEBOV-GP | “Participants will receive ERVEBO® (rVSV∆G-ZEBOV-GP) ≥72 million pfu/mL primary immunization And a single booster immunization with the same dose of study vaccine as the primary...” NCT05959421 ↗ |
| Modality | Vaccine | “Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live, attenuated)” NCT04822376 ↗ |
| Route | Intramuscular | “intramuscular vaccination” NCT05959421 ↗ |