Bavarian Nordic Announces U.S. FDA Approval of JYNNEOS™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) for Prevention of Smallpox and Monkeypox Disease in Adults
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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Source: GlobeNewswire
First FDA approved non-replicating smallpox vaccineOnly FDA approved vaccine for prevention of monkeypoxCompany granted Priority Review VoucherConference call and webcast tomorrow at 3:00 PM CEST COPENHAGEN, Denmark, September 24, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the U.S. Food and Drug Administration (FDA) has approved JYNNEOS™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) (MVA-BN®, liquid-frozen) 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. JYNNEOS is the only approved non-replicating smallpox vaccine in the U.S. and the only approved monkeypox vaccine anywhere in the world. JYNNEOS is approved for use broadly, including in people with weakened immune systems and those with eczema or with household members with eczema. This approval is a major breakthrough in meeting the U.S. government’s long-standing commitment to developing
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