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

Related Information

• October 2024 Dear Healthcare Provider Letter - Extension of expiration dates for JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non-replicating)