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HERA will procure 175,420 doses as an immediate measure to combat the worrying MPOX outbreak in Africa and in addition, Bavarian Nordic will donate 40,000 doses to HERA, which will also be distributed to the Africa CDC.
COPENHAGEN, Denmark, August 13, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced a new order from HERA (the European Health Emergency Preparedness and Response Authority) for the company’s MVA-BN® vaccine, the only FDA and EMA approved vaccine against MPOX. HERA will procure and donate 175,420 doses of the vaccine to the Africa CDC (Centres for Disease Control and Prevention) to support their enhanced response to the MPOX outbreak spreading across the African continent. In addition, Bavarian Nordic will donate 40,000 doses to HERA, which will also be donated to the Africa CDC.
This major donation follows a recent commitment from the company for 15,000 doses as part of the coordinated response in the African region by Gavi, WHO and UNICEF.
Currently, only two African countries have granted emergency use authorization for the MVA-BN vaccine, but the WHO last week invited Bavarian Nordic to submit an expression of interest for emergency use authorization (EUL) of the vaccine, which could accelerate its availability in African countries that do not yet have national regulatory authorizations. In addition, the Africa CDC today declared a continental public health emergency, a new framework aimed at further strengthening and accelerating the public health response against Mpox across the region.
“Strong global partnerships are at the core of our European Health Union. Health threats know no borders and today, thanks to the collaboration between the European Commission, the African Centre for Disease Control and Bavarian Nordic, we can provide 215,000 vaccines to protect the most vulnerable people in the countries affected by the Mpox outbreak in Africa. Preparing for and responding to health threats is a global endeavour that we are determined to pursue together and in solidarity across borders,” said Stella Kyriakides, EU Commissioner for Health and Food Safety
“Mpox is spreading at an alarming rate in Africa and requires further action from the international community. We are proud to support HERA’s vaccine donation to the region and are pleased to announce an additional donation from Bavarian Nordic. We also welcome the initiatives of the Africa CDC and WHO to strengthen and coordinate public health efforts to ensure that our vaccine can reach more people on the African continent,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.
The HERA order does not impact the company’s financial forecast for 2024, but brings the total value of the secured contracts close to the lower level of the revenue forecast for the Public preparation The company expects sales of DKK 2,700-3,000 million in 2024, with expected total sales of DKK 5,000-5,300 million for the full year.
About HERA
The European Health Emergency Preparedness and Response Authority (HERA) was established by the European Commission in 2021 with the aim of strengthening Europe’s capacity to prevent, detect and rapidly respond to cross-border health emergencies by ensuring the development, manufacturing, procurement and equitable distribution of essential medical countermeasures. HERA is also committed to assisting in health crises outside Europe.
Bavarian Nordic has been working with HERA since the Mpox outbreak in 2022, initially under direct procurement agreements, followed by the signing of a joint procurement agreement that has enabled EU Member States and other European Economic Area (EEA) countries as well as Western Balkan countries to procure the Mpox vaccine for national use.
About the mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only smallpox vaccine approved in the United States and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®) and the EU/EEA and the United Kingdom (marketed as IMVANEX®). MVA-BN was originally developed in collaboration with the U.S. government to ensure supply of smallpox vaccine to the entire population, including immunocompromised individuals who are not recommended for vaccination with conventional replicating smallpox vaccines. It is intended for use in the general adult population (ages 18 years and older) in persons considered at risk for smallpox or mpox. During the 2022–2023 mpox outbreak, the vaccine received emergency use authorization from the U.S. FDA for pre- and post-exposure use in adolescents.
Bavarian Nordic has long been a supplier of the vaccine to the US and Canada, as well as several other countries as part of their national biological preparedness. During the 2022-2023 Mpox outbreak, Bavarian Nordic has also 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 the world leader in smallpox and mpox vaccines, supply governments to improve public health, and have a strong portfolio of vaccines against travel and endemic diseases. For more information, visit www.bavarian-nordic.com.
Forward-looking statements
This announcement contains forward-looking statements that involve risks, uncertainties and other factors, many of which are beyond our control and which could cause actual results to differ materially from those discussed in the forward-looking statements. Forward-looking statements include statements about our plans, objectives, future events, performance and/or other information that is not historical information. All of these forward-looking statements are expressly qualified by this cautionary statement and any other cautionary statements that may accompany the forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances after the date of this release, except as required by law.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, [email protected]Phone: +45 61 77 47 43
USA: Graham Morrell, Paddock Circle Advisors, [email protected]Phone: +1 781 686 9600
Company Announcement No. 23 / 2024
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