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.
9/24/2019 - FDA approval date
9/24/2019 - PDUFA goal date
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.