Bavarian Nordic Receives Approval of Smallpox and Mpox Vaccine in Switzerland

COPENHAGEN, Denmark, March 13, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Swiss Agency for Therapeutic Products, Swissmedic, has approved JYNNEOS^® (MVA-BN) for active immunization against disease caused by smallpox, mpox and vaccinia viruses in adults 18 years of age and older.

The approval represents the first national marketing authorization issued to Bavarian Nordic since 2019 and was facilitated by the Swiss authorities in response to the 2022 global mpox outbreak. During the outbreak, Bavarian Nordic supplied its mpox vaccine under emergency use provisions to countries where the vaccine was not approved, and which previously had not stockpiled the vaccine. In Switzerland, Bavarian Nordic committed to seeking marketing authorization of the vaccine and thus initiated the submission of its application in late December 2022. The review and subsequent approval with Swissmedic were completed in just 14 months, 4 months less than the standard review time.

With the approval from Swissmedic, MVA-BN is now approved for the prevention of smallpox and mpox disease in the U.S., Canada, EU/EEA, United Kingdom and Switzerland. Bavarian Nordic has also filed applications in several additional countries reflecting the larger customer base post the mpox outbreak. 

"During public health emergencies, speed and agility in the distribution of life-saving vaccines is paramount. For many countries, the absence of an approved vaccine during the mpox outbreak initially presented a significant barrier for access to our vaccine among risk populations. We are therefore pleased to obtain a national approval in Switzerland, which will help facilitate easier access to our vaccine,” 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. and Switzerland (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.

Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada as well as several other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore 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, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

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• 2024-03-13-en