JYNNEOS
STN: 125678
Proper Name: Smallpox and Mpox Vaccine, Live, Non-replicating
Tradename: JYNNEOS
Manufacturer: Bavarian Nordic A/S
Indication:
- For prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
Product Information
- Package Insert - JYNNEOS (Refrigerator)
- Package Insert - JYNNEOS (Frozen)
- Demographic Subgroup Information - JYNNEOS
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- March 31, 2025 Approval Letter - JYNNEOS
- November 25, 2024 Approval Letter - JYNNEOS
- October 18, 2024 Approval Letter - JYNNEOS
- May 28, 2024 564A expiry extension letter - Jynneos
- September 29, 2023 Approval Letter - JYNNEOS
- March 16, 2023 Approval Letter - JYNNEOS
- March 14, 2023 Approval Letter - JYNNEOS
- September 2, 2022 Approval Letter - JYNNEOS
- June 16, 2021 Approval Letter - JYNNEOS
- June 7, 2021 Approval Letter - JYNNEOS
- September 24, 2019 Summary Basis for Regulatory Action - JYNNEOS
- September 24, 2019 Approval Letter- JYNNEOS
- Approval History, Letters, Reviews, and Related Documents - JYNNEOS