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Bavarian Nordic pledges to support global efforts to tackle the mpox situation in Africa by donating 15,000 doses of mpox vaccine
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Emergency use authorization for MVA-BN vaccine has been issued in DR Congo
COPENHAGEN, Denmark, 28 June 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced an extensive commitment to help fight the current mpox epidemic in Africa. The Company’s MVA-BN vaccine, the only FDA- and EMA-approved mpox vaccine, which served as an important tool during the 2022-2023 mpox epidemic, could soon become available in the Democratic Republic of the Congo (DRC) and in other African countries.
Mpox is on the rise in African countries with an increasing incidence of the more severe clade I. So far in 2024, more than 9,000 mpox cases and over 400 deaths have been reported in seven African countries, of which the vast majority (96%) it has happened in the DRC1. Earlier this week, the DRC’s regulatory authorities, ACOREP (Autorité Congolaise de Réglementation Pharmaceutique), issued an Emergency Use License allowing the use of the MVA-BN vaccine for people at risk of mpox.
Locally, in the PRC, clinical studies are also planned to support full regulatory approval of the MVA-BN vaccine, as recently was announced from Bavarian Scandinavian.
To further strengthen the response in the DRC and across the African region, Bavarian Nordic will work with global health partners, including WHO, UNICEF and Gavi. Bavarian Nordic welcomes the decision of the Gavi Board of Directors to approve a new Vaccine Investment Strategy that includes the creation of a global stockpile of mpox vaccines. In the short term, Bavarian Nordic is committed to working in partnership with Gavi, WHO and UNICEF to coordinate ration donations in response to the ongoing outbreak in the DRC and other African countries.
To support these efforts, Bavarian Nordic has pledged to donate 15,000 doses of the MVA-BN mpox vaccine to the African response.
“The spread of mpox in the Democratic Republic of Congo and elsewhere is extremely worrying and could become a global threat if not urgently contained,” he said. Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. “Gavi and its partners welcome Bavarian Nordic’s determination to help fight this epidemic and its contribution in installments. Our Alliance welcomes the availability of new vaccines to the countries and is committed to working with Bavarian Nordic and the relevant authorities to facilitate their arrival and timely administration in accordance with the country’s plans.”
“Smallpox has been a public health threat in several African countries for more than 50 years and is now spreading across the continent with higher frequency and severity. Global partners are coming together to build a stronger public health response across the affected region. and we are proud to contribute through a donation of our mpox vaccine,” he said Paul Chaplin, Chairman and CEO of Bavarian Nordic.
About mpox in DRC and other African countries
Africa is currently experiencing one of the largest and deadliest mpox outbreaks to date. Over 8,700 mpox cases and 408 deaths have been reported in the DRC this year alone, with children accounting for the majority of infections and deaths. Cases have also been confirmed in the Republic of Congo, Cameroon, Central African Republic, Ghana, Liberia and South Africa.
Mpox was first identified in DR Congo in 1970. In most cases, the symptoms of mpox – typically fever and headache, followed by painful lesions – resolve within a few weeks. However, for some, mpox can lead to medical complications, such as bronchopneumonia, sepsis, encephalitis, vision loss, or death. The strain of mpox virus behind the current outbreak, known as clade I, is estimated to be fatal in up to 10% of cases.
About the smallpox/pox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicable smallpox vaccine and the only mpox vaccine approved in the USA and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and EU/EEA and UK (marketed as IMVANEX®). Originally developed in collaboration with the US government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals for whom vaccination with traditional smallpox booster vaccines is not recommended, MVA-BN has been indicated for use in general adult population (18 years and older) in people considered to be at risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the vaccine received an Emergency Use License from the US FDA for both pre- and post-exposure use in adolescents.
Bavarian Nordic is a long-term supplier of the vaccine to the US and Canada as well as many other countries as part of their national biopreparedness. During the 2022-2023 mpox epidemic, Bavarian Nordic supported additional governments and supranational organizations by expanding access to the vaccine in 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 world leader in smallpox and mpox vaccines, which are provided 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 release includes forward-looking statements that involve risks, uncertainties and other factors, many of which are beyond our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements regarding our plans, goals, objectives, 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 that may accompany the forward-looking statements. We undertake no obligation to update publicly or revise forward-looking statements to reflect subsequent events or circumstances after the date they are made, except as required by law.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.comTel: +45 61 77 47 43
USA: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.comTel: +1 781 686 9600
1 https://africacdc.org/download/africa-cdc-weekly-event-based-surveillance-report-june-2024/
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