Drugs / MVA Vaccine
MVA Vaccine
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01256853 | Sep 2006 → Sep 2010 | Epstein-Barr virus infection, nasopharyngeal carcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05438953 | Jul 2022 → Oct 2024 | monkeypox | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-08-07 | Bavarian Nordic | Regulatory Bavarian Nordic Receives European Commission Approval of Mpox/Smallpox Vaccine for Children Aged 2 to Less than 12 Years bavarian-nordic.com ↗
The European Commission's approval of MVA-BN for children aged 2 to less than 12 years represents an important advancement in our efforts to broaden access to protection against mpox and smallpox. |
| 2026-03-27 | Bavarian Nordic | Regulatory Bavarian Nordic Submits Data to EMA to Extend Mpox and Smallpox Vaccine Approval to Children Aged 2-11 Years bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the MVA-BN ® mpox and smallpox vaccine indication to include children aged 2 to 11 years. |
| 2025-12-18 | GeoVax, Inc. | Regulatory GeoVax Receives Formal EMA Scientific Advice Supporting Pivotal Phase 3 Immunobridging Trial for GEO-MVA geovax.com ↗
Receipt of this formal Scientific Advice represents a significant regulatory milestone and enables GeoVax to accelerate operational planning toward implementation and initiation of the Phase 3 program, currently projected to begin in the second half of 2026. |
| 2025-10-07 | Bavarian Nordic | Results Bavarian Nordic Reports Positive Topline Data for Mpox/Smallpox Vaccine in Pediatric Population bavarian-nordic.com ↗
The vaccine was generally well tolerated in the pediatric population, with a safety profile similar to adults and no unexpected signals. |
| 2025-07-21 | GeoVax, Inc. | Regulatory GeoVax Highlights EMA Regulatory Milestone as Catalyst for Near-Term Revenue from GEO-MVA Mpox Vaccine geovax.com ↗
The EMA’s feedback indicated that a single Phase 3 immuno-bridging trial—bypassing the need for Phase 1 and 2 studies—may be sufficient to support a Marketing Authorization Application (MAA) under the EU’s centralized procedure. |
| 2025-06-16 | GeoVax, Inc. | Regulatory GeoVax Receives Favorable European Regulatory Guidance Supporting Streamlined Development Pathway for GEO-MVA geovax.com ↗
GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced that it has received positive Scientific Advice (SA) from the European Medicines Agency (EMA) for GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine for the prevention of Mpox and smallpox. |
| 2024-09-13 | Bavarian Nordic | Regulatory Bavarian Nordic Receives WHO Prequalification for Mpox Vaccine bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) today announced that the Company has obtained prequalification from the World Health Organization (WHO) for IMVANEX ® (MVA-BN ® ) as the first mpox vaccine to be added to the WHO prequalification list. |
| 2024-05-31 | Bavarian Nordic | Regulatory Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS ® for prevention of smallpox and mpox disease in adults 18 years of age and older. |
| 2022-07-22 | Bavarian Nordic | Regulatory Bavarian Nordic Receives Positive CHMP Opinion on the Extension of Vaccine Label to Include Monkeypox bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that the marketing authorization for the Company’s smallpox vaccine, IMVANEX ® , is extended to include protecting people from monkeypox disease. |
| 2020-08-24 | Bavarian Nordic | Results Bavarian Nordic Announces Positive Topline Results from Phase 3 Clinical Study of Freeze-dried Smallpox Vaccine bavarian-nordic.com ↗
The three lots of MVA-BN induced equivalent antibody responses, meeting the primary endpoint of the study, while the favorable safety profile, in line with the cumulative safety experience of the approved liquid-frozen formulation, was also confirmed with no serious adverse reactions reported among the subjects. |
| 2019-09-24 | Bavarian Nordic | Regulatory Bavarian Nordic Announces U.S. FDA Approval of JYNNEOS™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) for Prevention of Smallpox and Monkeypox Disease in Adults bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the U.S. Food and Drug Administration (FDA) has approved JYNNEOS™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) (MVA-BN ® , liquid-frozen) for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. |
All press releases naming this drug 11 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MVA Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01256853 ↗ |
| Known as | IMVANEX | “Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)” NCT05438953 ↗ |
| Known as | JYNNEOS | “Vaccination with MVA vaccine ( IMVANEX® and JYNNEOS®)” NCT05438953 ↗ |
| Modality | Vaccine | “Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine” NCT01256853 ↗ |