28.06.2024 16:27:12 - dpa-AFX: GNW-Adhoc: Bavarian Nordic Joins Global Efforts to Fight Mpox Outbreak in Africa
* Bavarian Nordic is committed to support global efforts to address the mpox
situation in Africa through a donation of 15,000 doses of mpox vaccine
* Emergency Use Authorization for the MVA-BN vaccine has been issued in the DR
Congo
COPENHAGEN, Denmark, June 28, 2024 - Bavarian Nordic A/S (OMX: BAVA) today
announced an extended commitment to help fight the current mpox outbreak 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 outbreak,
could soon also become available in the DR Congo (DRC) and other countries in
Africa.
Mpox is on the rise in African countries with 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 across seven African countries of which the vast majority
(96%) having occurred in the DRC(1). Earlier this week, the regulatory
authorities in the DRC, ACOREP (Autorité Congolaise de Réglementation
Pharmaceutique), issued an Emergency Use Authorization allowing for the use of
the MVA-BN vaccine for individuals at risk of mpox.
Locally, in the DRC, clinical studies are also planned to support a full
regulatory approval of the MVA-BN vaccine, as recently announced
(https://www.bavarian-nordic.com/media/media/news.aspx?news=6958) by Bavarian
Nordic.
To further strengthen the response in the DRC and throughout the African region,
Bavarian Nordic will collaborate with global health partners, including WHO,
UNICEF and Gavi. Bavarian Nordic applauds Gavi's Board decision to approve a new
Vaccine Investment Strategy which includes the establishment of a global mpox
vaccine stockpile. In the near term, Bavarian Nordic is committed to work in
partnership with Gavi, WHO and UNICEF to coordinate dose donations in response
to the ongoing outbreak in the DRC and other African countries.
To support these efforts, Bavarian Nordic has committed to donating 15,000 doses
of its MVA-BN mpox vaccine to the African response.
"The spread of mpox in the Democratic Republic of the Congo and elsewhere is
highly concerning and could pose a global threat if it is not urgently
contained," said Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. "Gavi and
its partners welcome Bavarian Nordic's resolve to help fight this outbreak and
its contribution in doses. Our Alliance welcomes the availability of new
vaccines for countries and is committed to working with Bavarian Nordic and the
relevant authorities to facilitate their arrival and timely administration in
line with country plans."
"Mpox has been a public health threat in several African countries for more than
50 years and is now spreading across the continent with higher incidence and
severity. Global partners are uniting to build a stronger public health response
throughout the affected region. and we are proud to contribute through a
donation of our mpox vaccine," said Paul Chaplin, President and Chief Executive
Officer of Bavarian Nordic.
About mpox in the DRC and other African countries
Africa is currently tackling one of the largest and deadliest known mpox
outbreak 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 the DR Congo in 1970. In most cases, mpox symptoms
- 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, loss of vision, or death. The mpox virus
strain behind the current outbreak, known as clade I, is estimated to be fatal
in up to 10% of cases.
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/EEA 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 (18 years and older) in
individuals considered at risk for smallpox or mpox. During the 2022-2023 mpox
outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA
for both pre- and post-exposure use in adolescents.
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 (http://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 (mailto:rss@bavarian-nordic.com), Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com
(mailto:graham@paddockcircle.com), Tel: +1 781 686 9600
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(1) https://africacdc.org/download/africa-cdc-weekly-event-based-surveillance-
report-june-2024/
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