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Proper Name
Smallpox and Monkeypox Vaccine, Live, Non-Replicating
JYNNEOS is a vaccine indicated 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.

When thawed, JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non-replicating) is a milky, light yellow to pale white colored suspension for subcutaneous injection. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion.

Key Regulatory Milestones

9/24/2019 - FDA approval date

9/24/2019 - PDUFA goal date


Advisory Committee

This submission was not discussed at a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting because FDA review of this submission did not identify concerns or issues which would have benefitted from an advisory committee discussion.

Advanced Facts