First Doses of Bavarian Nordic’s Mpox Vaccine Now Arriving in the Democratic Republic of Congo

• Vaccine donations from the European Commission, the U.S. government and Bavarian Nordic are now entering the DRC, the epicenter of the mpox outbreak
• More than 250,000 doses to arrive over the next week, marking a crucial turning point in the combat against mpox in Africa

COPENHAGEN, Denmark, September 5, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today that the first doses of its mpox vaccine, MVA-BN^®, also known as JYNNEOS^®, has arrived today in the Democratic Republic of Congo (DRC). Additional shipments to the DRC are planned within the next week adding to a total of more than 250,000 vaccines donated by the European Commission’s Health Emergency Preparedness and Response Authority (HERA), the U.S. government and Bavarian Nordic.

The vaccines delivered today represent the first mpox vaccines for the DRC, marking a turning point in the joint efforts by Africa CDC and the international community to combat the outbreak and bring life-saving vaccines to the people who need it the most. While broader deployment of the vaccine in Africa is pending an emergency use listing with the World Health Organization (WHO), the DRC health authorities have already issued a national emergency use authorization for MVA-BN, allowing for immediate deployment.

As epicenter of the African mpox outbreak, the DRC remains the worst affected country with more than 94% of the 24,000 reported cases and nearly 99% of the 600+ reported deaths year-to-date across the African continent. While disease surveillance and control are continuously improving, case numbers are underreported¹, thus presenting a significant challenge for the local healthcare system.

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: “Mpox cases are increasing at an alarming rate in the DRC, putting even more pressure on a highly burdened healthcare system, where aid is desperately needed. The Africa CDC has called for the international community to step up and mobilize the resources needed to combat the outbreak, and we are proudly responding to this call together with our partners in the European Commission’s Health Emergency Preparedness and Response Authority and the U.S. government, who have demonstrated strong leadership and determination during this serious health crisis. Time is of the essence, and we are pleased that the way has now been paved for our mpox vaccines to reach the people in the DRC who are most in need. We will continue our collaborative efforts with both international partners and local authorities to further broaden access to our vaccine in the region.”

About the mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland and Singapore (marketed as JYNNEOS^®), Canada (marketed as IMVAMUNE^®), and the EU/EAA and United Kingdom (marketed as IMVANEX^®). Originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general adult population in individuals considered at risk for smallpox or mpox infection.

Supported by data from a clinical study, conducted by the U.S. National Institutes of Health (NIH), Bavarian Nordic has recently filed a submission to the European Medicines Agency to extend the approval to adolescents 12-17 years of age and is also working with partners, including the Coalition for Epidemic Preparedness Innovations (CEPI) to evaluate the safety and efficacy of the vaccine in children 2-12 years of age.

Bavarian Nordic has been a long-term supplier of the vaccine to national stockpiles, and during the 2022-2023 mpox outbreak, the Company supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide.

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness, and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com.

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance, and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

¹ https://www.who.int/emergencies/disease-outbreak-news/item/2024-DON528

Attachment

• 2024-09-05-en