Source: FDA, National Drug Code (US) Revision Year: 2022
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. Each 0.5 mL dose is formulated to contain 0.5 × 108 to 3.95 × 108 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Each 0.5 mL dose may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.163 mcg) and ciprofloxacin (≤0.005 mcg).
JYNNEOS is a sterile vaccine formulated without preservatives. The vial stoppers are not made with natural rubber latex.
| Dosage Forms and Strengths |
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JYNNEOS is a suspension for injection. Each dose (0.5 mL) is supplied in a single‑dose vial. |
| How Supplied |
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Package of 20 single-dose vials (Package NDC number: 50632-001-02; Vial NDC number: 50632-001-01). Manufactured by: Bavarian Nordic A/S, Hejreskovvej 10a, DK-3490 Kvistgaard, Denmark |
| Drug | Countries | |
|---|---|---|
| JYNNEOS | Estonia, United States |
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