Proper Name: Smallpox and Monkeypox Vaccine, Live, Non-Replicating
Manufacturer: Bavarian Nordic
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.
- Package Insert - JYNNEOS
- 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.
- 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