TheraRadar
Data updated: May 26, 2026

Jynneos (smallpox and mpox vaccine, live, non-replicating)

Approved 2019-09-23
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-09-23
Routes
Subcutaneous
Dosage Forms
Injection, For Injection

Companies

Bavarian Nordic
Active Ingredient: Smallpox and Mpox Vaccine, Live, Non-replicating , Smallpox and Mpox Vaccine, Live, Non-replicating

Jynneos Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
Sep 2019 ORIGINAL
Update · CBER biologic (Purple Book)

What Jynneos Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • Other (1)
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT06829238 (MET-IH) 000543853 1R01DA060692-01A1 Ph 4 recruiting Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
NCT05512949 results posted 22-0020A Ph 2 completed Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
NCT07199569 POX-MVA-046 Ph 2 active not recruiting Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells
NCT05740982 results posted 22-0020B Ph 2 completed A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Jynneos FDA Label Details

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Data Sources

FDA Approval: BLA125678 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.