FDA approves Jynneos for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk.- Bavarian Nordic A/S

Bavarian Nordic A/S announced that the 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 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..

MVA-BN is also approved in the EU under the trade name Imvanex for active immunization against smallpox of the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis), and in Canada under the trade name Imvamune for active immunization against smallpox in a public health emergency for persons 18 years of age and older who are contraindicated to replicating smallpox vaccines..