Bavarian Nordic A/S (CPH:BAVA) (OTC: BVNRY), a fully integrated biotechnology company, announced on Tuesday the approval by the US Food and Drug Administration (FDA) of 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.

Reportedly, JYNNEOS is the only approved non-replicating smallpox vaccine in the US 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 US 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.

According to the company, this FDA approval of JYNNEOS is a tremendous milestone for both the company and the US Department of Health and Human Services. Together, both have shown that it is possible to develop a safe and effective medical countermeasure for national security threats like smallpox. JYNNEOS is the culmination of a 15-year partnership that started with a call from the NIH for a safer smallpox vaccine, successfully transitioned to BARDA and was delivered to the Strategic National Stockpile for use in an emergency.

Also, concurrent with this approval, the US FDA granted Bavarian Nordic a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure PRV programme. 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 immunisation 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 immunisation against smallpox in a public health emergency for persons 18 years of age and older who are contraindicated to replicating smallpox vaccines.

Bavarian Nordic is focused on the development of innovative therapies against infectious diseases and cancer.