Bavarian Nordic Receives Approval of Smallpox and Mpox Vaccine in Singapore

COPENHAGEN, Denmark, August 27, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today that Singapore’s medicines regulatory authority, Health Sciences Authority (HSA), has approved JYNNEOS^® (MVA-BN) 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.

This marks the transition to a full approval for JYNNEOS in Singapore, where like in many other countries, the vaccine was made available under emergency use provisions to mitigate the last mpox outbreak.

“The recent declaration from the World Health Organization (WHO) that mpox again represents a Public Health Emergency of International Concern highlights the importance of removing barriers for access to approved vaccines all over the globe, and we are pleased to add Singapore to the list of countries where our smallpox and mpox vaccine is now approved. We continue to work with regulators in other countries as well to further broaden its access. Importantly, we are currently supporting the WHO Emergency Use Listing process and the Africa CDC to ensure rapid availability of the vaccine in the African continent, where prophylactic solutions are urgently needed,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

About the smallpox/mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only 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 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

Attachment

• 2024-08-27-en