On Sept. 24, 2019, Bavarian Nordic announced that the U.S. Food and Drug Administration (FDA) had approved JYNNEOS™ (Smallpox and Mpox Vaccine, Live, Non-replicating) (MVA-BN^®, liquid-frozen) for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection. JYNNEOS is the only approved non-replicating smallpox vaccine in the U.S. and the only approved mpox 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 was a major breakthrough in meeting the U.S. government’s long-standing commitment to developing a vaccine that can be administered to people who are at high risk of adverse reaction to traditional, replicating smallpox vaccines. 

Concurrent with the approval, FDA granted Bavarian Nordic a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure PRV program. A PRV can be used to accelerate the FDA’s review of a future human drug application and is also transferrable. The Company intends to sell the voucher to a third party.