{"id":"jynneos","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Injection site erythema"},{"rate":"30-40","effect":"Injection site swelling"},{"rate":"20-30","effect":"Myalgia"},{"rate":"20-30","effect":"Fatigue"},{"rate":"15-25","effect":"Headache"},{"rate":"5-15","effect":"Fever"}]},"_chembl":null,"_dailymed":{"setId":"b115e2e7-c24d-4306-b26c-8696ac61c9f7","title":"JYNNEOS (VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [BAVARIAN NORDIC A/S]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"JYNNEOS contains a modified vaccinia Ankara (MVA) virus strain that has been attenuated through serial passage in cell culture, making it non-replicating in human cells while retaining immunogenicity. The vaccine triggers both cellular and humoral immune responses by expressing orthopoxvirus antigens, providing protection against monkeypox and smallpox without the safety concerns of older replicating smallpox vaccines.","oneSentence":"JYNNEOS is a live attenuated vaccinia virus vaccine that stimulates immune responses against orthopoxviruses including monkeypox and smallpox.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:50:43.046Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of monkeypox (mpox) in adults 18 years and older at risk of exposure"},{"name":"Prevention of smallpox in adults 18 years and older at risk of exposure"}]},"trialDetails":[{"nctId":"NCT05740982","phase":"PHASE2","title":"A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2023-03-22","conditions":"Monkeypox","enrollment":450},{"nctId":"NCT05734508","phase":"PHASE4","title":"Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2023-03-23","conditions":"Monkeypox","enrollment":500},{"nctId":"NCT07199569","phase":"PHASE2","title":"Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells","status":"RECRUITING","sponsor":"Bavarian Nordic","startDate":"2025-10-27","conditions":"Monkeypox (Mpox)","enrollment":744},{"nctId":"NCT06366672","phase":"EARLY_PHASE1","title":"Evaluating the Human Immune Response to the JYNNEOS Vaccine","status":"ACTIVE_NOT_RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2024-06-10","conditions":"Vaccinia, Virus Diseases","enrollment":20},{"nctId":"NCT04957485","phase":"PHASE2","title":"Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS","status":"ACTIVE_NOT_RECRUITING","sponsor":"SIGA Technologies","startDate":"2022-04-05","conditions":"Smallpox","enrollment":100},{"nctId":"NCT02977715","phase":"PHASE3","title":"JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo","status":"ACTIVE_NOT_RECRUITING","sponsor":"Centers for Disease Control and Prevention","startDate":"2017-02-23","conditions":"Monkeypox Virus Infection","enrollment":1600},{"nctId":"NCT05512949","phase":"PHASE2","title":"Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2022-09-09","conditions":"Monkeypox","enrollment":229},{"nctId":"NCT06829238","phase":"PHASE4","title":"Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2025-04-07","conditions":"Systemic Inflammation, Immune Dysregulation, Injection Drug Use","enrollment":100},{"nctId":"NCT05513313","phase":"","title":"Assessment of Myocarditis After Replication-Deficient Smallpox Immunization","status":"NOT_YET_RECRUITING","sponsor":"Womack Army Medical Center","startDate":"2029-03","conditions":"Myopericarditis, Small Pox","enrollment":2350},{"nctId":"NCT05438953","phase":"NA","title":"Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-07-12","conditions":"Monkey Pox, Monkey Diseases","enrollment":164}],"_emaApprovals":[],"_faersSignals":[{"count":4,"reaction":"FATIGUE"},{"count":3,"reaction":"BACK PAIN"},{"count":3,"reaction":"CONSTIPATION"},{"count":3,"reaction":"ERECTILE DYSFUNCTION"},{"count":3,"reaction":"GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY"},{"count":3,"reaction":"HEPATITIS A"},{"count":3,"reaction":"HERPES SIMPLEX"},{"count":3,"reaction":"HYPERGLYCAEMIA"},{"count":3,"reaction":"INSOMNIA"},{"count":3,"reaction":"MICROALBUMINURIA"}],"_approvalHistory":[],"publicationCount":184,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"JYNNEOS","genericName":"JYNNEOS","companyName":"Womack Army Medical Center","companyId":"womack-army-medical-center","modality":"Biologic","firstApprovalDate":"","aiSummary":"JYNNEOS is a live attenuated vaccinia virus vaccine that stimulates immune responses against orthopoxviruses including monkeypox and smallpox. Used for Prevention of monkeypox (mpox) in adults 18 years and older at risk of exposure, Prevention of smallpox in adults 18 years and older at risk of exposure.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}