Drugs / IMVAMUNE
IMVAMUNE
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed smallpox 1 milestone | |||||
| Filed | US (FDA) | — | smallpox | 2018-11-09 | “A Biologics License Application for MVA-BN ® smallpox vaccine (formerly IMVAMUNE ® ) was submitted to the U.S. Food and Drug Administration (FDA).” bavarian-nordic.com ↗ “We filed a BLA for the vaccine, which was accepted with priority review by the FDA in December” bavarian-nordic.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Imvanex | — | 2013-07-31 | europa.eu ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06366672 | Jun 2024 → Sep 2026 overdue | vaccinia | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03953196 | Apr → Dec 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT00565929 | Sep 2008 → May 2012 | variola major infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00082446 | May 2004 → Aug 2007 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00189917 | Apr 2004 → Dec 2005 | allergic rhinitis, atopic eczema | Bavarian Nordic | Completed | No outcome recorded |
| Phase 1 | NCT00189943 | Apr 2001 → Jul 2003 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04410874 | Nov 2020 → May 2023 | basal cell carcinoma, skin squamous cell carcinoma | Ivan Litvinov | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01461447 | Mar → May 2012 | — | Muhimbili University of Health and Allied Sciences | Completed | No outcome recorded |
| Phase 1/2 | NCT00437021 | Apr 2007 → Apr 2009 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT00189904 | Jul 2005 → ? | HIV infectious disease | Bavarian Nordic | Completed | No outcome recorded |
| Phase 213 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT06839989 | Aug 2025 → May 2026 overdue | monkeypox | Institute of Tropical Medicine, Belgium | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06549530 | Oct 2024 → May 2026 overdue | monkeypox | Bavarian Nordic | Active not recruiting | Met primary |
| Phase 2 | NCT05740982 | Mar 2023 → Aug 2024 | monkeypox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT05512949 | Sep 2022 → Oct 2023 | monkeypox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
| Phase 2 | NCT02038881 | Apr 2014 → May 2017 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT01827371 | Jun 2013 → Apr 2015 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT01668537 | Mar 2013 → Jan 2014 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00914732 | Feb 2010 → Apr 2011 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00857493 | Jun 2009 → Aug 2010 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00686582 | Aug → Dec 2008 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00316602 | Jul 2006 → Nov 2009 | atopic eczema | Bavarian Nordic | Completed | Met primary |
| Phase 2 | NCT00316589 | Jun 2006 → Mar 2009 | HIV infectious disease | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00316524 | Apr 2006 → Feb 2007 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT06844500 | Jun 2025 → Jun 2026 overdue | — | Jean-Pierre Van geertruyden | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06844487 | May 2025 → Jun 2026 overdue | monkeypox | Jean-Pierre Van geertruyden | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02977715 | Feb 2017 → Oct 2025 | monkeypox | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 3 | NCT01913353 | Mar 2015 → Mar 2017 | — | Bavarian Nordic | Completed | Met primary |
| Phase 3 | NCT01144637 | Feb → Nov 2013 | smallpox | Bavarian Nordic | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT06829238 | Apr 2025 → Nov 2028 expected | HIV infectious disease, autoinflammatory syndrome, immune dysregulation, autoimmunity, and autoinflammation | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 4 | NCT05734508 | Mar 2023 → Jun 2024 | monkeypox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT03472014 | Apr 2010 → Nov 2014 | — | Bavarian Nordic | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT00390078 Comparator | Jan → Dec 2007 | HIV infectious disease | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT07253675 Comparator | Dec 2025 → Feb 2027 expected | monkeypox | Shanghai Institute Of Biological Products | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07199569 Comparator | Oct 2025 → Nov 2026 expected | monkeypox | Bavarian Nordic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00189956 Comparator | Apr → Nov 2003 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 3 | NCT03699124 Comparator | Jun 2019 → Jan 2020 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| 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 ↗
MVA-BN approval expanded to include children aged 2 to less than 12 years for protection against mpox, smallpox and disease caused by vaccinia virus |
| 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. |
| 2025-10-07 | Bavarian Nordic | Results Bavarian Nordic Reports Positive Topline Data for Mpox/Smallpox Vaccine in Pediatric Population bavarian-nordic.com ↗
Bavarian Nordic A/S (OMX: BAVA) today reported topline results from a clinical study of its MVA-BN ® mpox/smallpox vaccine in children 2 to 11 years of age. |
| 2025-03-31 | Bavarian Nordic | Regulatory Bavarian Nordic Receives U.S. FDA Approval of Freeze-Dried Smallpox and Mpox Vaccine bavarian-nordic.com ↗
This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. |
| 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 ↗
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 ® |
| 2023-10-25 | Bavarian Nordic | Regulatory Bavarian Nordic’s Mpox Vaccine Receives Recommendation from U.S. CDC Advisory Committee for Routine Use in Adults at Risk bavarian-nordic.com ↗
the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted in favor of recommending the routine use of JYNNEOS ® , the Company’s FDA-approved mpox vaccine, in adults at risk of mpox infection. |
| 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 ↗
Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today topline results from the pivotal Phase 3 study of the freeze-dried formulation of its MVA-BN ® smallpox vaccine. |
| 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. |
| 2019-03-11 | Bavarian Nordic | Regulatory Bavarian Nordic Announces FDA Delay in the Review of the Biologics License Application for MVA-BN Smallpox Vaccine bavarian-nordic.com ↗
However, the FDA has assessed that due the amount of data submitted during the review phase, the agency now requires more time and has extended the target PDUFA action date to September 2019. |
| 2018-12-21 | Bavarian Nordic | Regulatory Bavarian Nordic Announces FDA Acceptance and Priority Review of Biologics License Application for MVA-BN Smallpox Vaccine bavarian-nordic.com ↗
The FDA has granted priority review to the BLA, which means that the agency is targeting completion of the review in six months rather than the standard time of ten months. |
| 2018-02-06 | Bavarian Nordic | Results Bavarian Nordic Announces Positive Results of Pivotal Phase 3 Study of IMVAMUNE® Smallpox Vaccine bavarian-nordic.com ↗
The study achieved both of its primary endpoints, demonstrating IMVAMUNE’s efficacy in comparison to ACAM2000 ® , the current U.S. licensed replicating smallpox vaccine. |
All press releases naming this drug 24 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imvamune | “This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system).” NCT00914732 ↗17“Imvamune/MVA-BN 1x10\^8 will be administered intramuscularly to Group F on day 0 and day 28.” NCT00082446 ↗ “Imvamune (licensed name of MVA being developed as a smallpox vaccine)” NCT01827371 ↗ “IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route” NCT00437021 ↗ “MVA-BN® (IMVAMUNE)” NCT00316524 ↗ |
| Known as | Imvanex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03953196 ↗ |
| Known as | JYNNEOS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02977715 ↗ |
| Known as | Modified Vaccinia Ankara | “The approved liquid-frozen formulation of Bavarian Nordic's Modified Vaccinia Ankara (MVA-BN) smallpox vaccine has specific cold-chain requirements” PMID 36460535 ↗ Nov 20224“In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population.” PMID 27327616 ↗ Jun 2016 “the administration of 2 standard subcutaneous doses of the Modified Vaccinia Ankara of Bavarian Nordic (MVA-BN) vaccine given 28 days apart” NCT06839989 ↗ “investigate the safety and immunogenicity of modified vaccinia Ankara (MVA)” PMID 25149431 ↗ Aug 2014 |
| Known as | Modified Vaccinia Ankara Smallpox Vaccine | “Modified Vaccinia Ankara Smallpox Vaccine” NCT04410874 ↗ |
| Known as | Modified Vaccinia Ankara Virus | “All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).” NCT06549530 ↗ |
| Known as | Modified Vaccinia Ankara-Bavarian Nordic | “The MVA-BN vaccine, with the active ingredient: Modified Vaccinia Ankara-Bavarian Nordic, will be administered as a standard two-dose regimen at 1x10\^8 TCID50 Inf.U./0.5 mL.” NCT06844487 ↗1“JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine” NCT06366672 ↗ |
| Known as | Modified virus Ankara (MVA)-BN | “Modified virus Ankara (MVA)-BN, a highly attenuated strain of vaccinia virus, was developed for vaccination with improved safety profile.” PMID 27357167 ↗ Jun 2016 |
| Known as | MVA | “In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population.” PMID 27327616 ↗ Jun 20161“Imvamune (licensed name of MVA being developed as a smallpox vaccine)” NCT01827371 ↗ |
| Known as | MVA-BN | “MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the...” NCT07199569 ↗20“All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).” NCT06549530 ↗ “In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population.” PMID 27327616 ↗ Jun 2016 “liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects” NCT01668537 ↗ “MVA-BN, a highly attenuated strain of vaccinia virus, was developed for vaccination with improved safety profile.” PMID 27357167 ↗ Jun 2016 “Imvamune/MVA-BN 1x10\^8 will be administered intramuscularly to Group F on day 0 and day 28.” NCT00082446 ↗ “JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine” NCT06366672 ↗ “IMVAMUNE (MVA-BN)” NCT00189956 ↗ “IMVAMUNE (MVA-BN)” NCT00189904 ↗ “IMVAMUNE (MVA-BN)” NCT00316589 ↗ |
| Known as | MVA-BN (CEF) | “MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the...” NCT07199569 ↗ |
| Known as | MVA-BN Smallpox vaccine | “MVA-BN Smallpox vaccine” NCT04410874 ↗ |
| Modality | Vaccine | “MVA vaccines” PMID 23349878 ↗ Jan 2013 |
| Route | Intramuscular | “will be administered intramuscularly to Group F” NCT00082446 ↗ |