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Bavarian Nordic Secures Vaccine Order from European Country After Confirmed Monkeypox Cases

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Bavarian Nordic A/S (OMX: BAVA) announced today that the Company has secured a contract with an undisclosed European country to supply its IMVANEX® smallpox vaccine in response to new cases of monkeypox evolving during May 2022.

The first European case was confirmed on May 7, 2022, in an individual who returned from a travel to Nigeria, where monkeypox is endemic. Subsequently, more than 20 cases have been confirmed across England, Portugal and Spain with additional suspected cases currently being investigated. Evidence points to that most of the infections have been acquired locally in these countries. In the US, a single case has been confirmed in a traveler from Canada, where no cases are yet confirmed, but several remain under investigation.

Bavarian Nordic’s smallpox vaccine is approved in the U.S. as JYNNEOS® and in Canada as IMVAMUNE®, both places with the approval extended to cover the monkeypox indication. The vaccine is approved in Europe as IMVANEX® for only the smallpox indication but has previously been provided for off-label use in response to monkeypox cases.

Paul Chaplin, President and CEO of Bavarian Nordic said: “While the full circumstances around the current monkeypox cases in Europe remain to be elucidated, the speed of which these have evolved, combined with the potential for infections beyond the initial case going undetected, calls for a rapid and coordinated approach by the health authorities, and we are pleased to assist in this emergency situation. Infection control has been a high priority for societies during COVID-19, and this situation is an unfortunate reminder, that we cannot let our guard down, but must continue to build and strengthen our infectious disease preparedness to keep the world open.”

This order has no impact on the Company’s financial guidance for 2022.

About monkeypox: Monkeypox is a rare, but serious disease, which is endemic in Central and West Africa. The disease is quite similar to human smallpox, although it is less severe with an estimated fatality rate of 1-10%.

About Bavarian Nordic: Bavarian Nordic is a fully integrated vaccines company listed on the NASDAQ Copenhagen exchange and with operations in Europe and the USA. Our mission is to save and improve lives by unlocking the power of the immune system and we aspire to become one of the largest pure play vaccine companies by developing innovative life-saving vaccines, excelling in commercialization and being a best-in-class vaccine manufacturer. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next-generation COVID-19 vaccine and a vaccine against respiratory syncytial virus (RSV), which are both entering Phase 3 clinical trials in 2022.

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