* African trial could potentially support licensure of mpox vaccine in endemic
countries and expansion of current regulatory approvals to include children
* CEPI has awarded USD 6.5 million in funding to support the Phase 2 clinical
trial which is projected to start later in 2024
COPENHAGEN, Denmark / OSLO, Norway, May 30, 2024 - Bavarian Nordic A/S (OMX:
BAVA) and the Coalition for Epidemic Preparedness Innovations (CEPI) today
announced a partnership to advance the development of Bavarian Nordic's mpox
vaccine in children in Africa.
CEPI has awarded USD 6.5 million(1) to support a Phase 2 clinical study
evaluating the immunogenicity and safety of the MVA-BN(®) non-replicating
vaccine in children from 2 years to less than 12 years of age compared to adults
aged 18-50 years of age for the prevention of smallpox, mpox and related
orthopoxvirus infections. Subject to regulatory approvals, the study plans to
enroll a total of approximately 460 healthy individuals in endemic regions
without previous mpox infection or poxvirus vaccination, who will receive two
doses of the MVA-BN vaccine. Bavarian Nordic will be the sponsor of the trial
which will be conducted in one or more African countries with planned initiation
later in 2024.
The new trial follows the publication of a continental plan
(https://africacdc.org/news-item/communique-united-in-the-fight-against-mpox-in-
africa-high-level-emergency-regional-meeting/) by Africa CDC and African
Ministries of Health to strengthen mpox preparedness and response efforts, as
well as the World Health Organization's (WHO) framework
(https://iris.who.int/bitstream/handle/10665/376839/9789240092907-
eng.pdf?sequence=1) for enhancing prevention and control of mpox.
Results from this study could provide assurance of the use of this vaccine in
children, and thus support an extension of the current regulatory approvals for
use of the vaccine in adults to also include children 2-12 years of age.
Importantly, the study will also generate evidence on the vaccine in endemic
African populations and could potentially support regulatory approval of MVA-BN
in endemic countries.
"We now understand that children suffer disproportionately from mpox, a
concerning and neglected disease that has spread rapidly in recent years"
said Dr Richard Hatchett, CEO of CEPI. "To address the risk that children face
in DR Congo and other areas where the disease is endemic, CEPI is supporting
this important trial which will provide key mpox vaccine safety and
immunogenicity data in children. The findings of this study will be crucial in
shaping mpox vaccine strategies to help protect children and potentially to
bringing an end to the widespread outbreak in the DR Congo as well as mpox
outbreaks that may strike in the future."
"We are very pleased to join forces with CEPI in their continued efforts to
provide equitable access to a much-needed vaccine against mpox for endemic
populations, and we are firmly committed to working with the local authorities
to develop solutions for vulnerable populations, including children who sadly
represent the vast majority of those affected by the ongoing mpox outbreak in
the DR Congo." Said Paul Chaplin, President and Chief Executive Officer of
Bavarian Nordic.
About mpox in the DRC and other African countries
Multiple countries in Central and East Africa are currently tackling the largest
and deadliest known mpox outbreak to date. Over 6,500 mpox cases and 345 deaths
have been reported (https://reliefweb.int/report/democratic-republic-congo/la-
variole-simienne-monkeypox-en-republique-democratique-du-congo-rapport-de-la-
situation-epidemiologique-sitrep-no013-29-avril-05-mai-2024) in the DR Congo
this year alone, with children accounting for the majority of infections and
deaths. Cases have also been confirmed in the Congo, Cameroon, Central African
Republic and Liberia.
Mpox was first identified in the DR Congo in 1970. In most cases, mpox
symptoms-typically fever and headache, followed by painful lesions-disappear
within a few weeks. However, for some, mpox can lead to medical complications,
such as bronchopneumonia, sepsis, encephalitis, loss of vision, and even death.
The mpox strain behind the current outbreak, known as Clade I, is estimated to
be fatal in around 8-12% 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 infection. 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 CEPI
CEPI was launched in 2017 as an innovative partnership between public, private,
philanthropic and civil organisations. Its mission is to accelerate the
development of vaccines and other biologic countermeasures against epidemic and
pandemic threats so they can be accessible to all people in need. CEPI has
supported the development of more than 50 vaccine candidates or platform
technologies against multiple known high-risk pathogens or a future Disease X.
Central to CEPI's pandemic-beating five-year plan for 2022-2026 is the '100 Days
Mission' to compress the time taken to develop safe, effective, globally
accessible vaccines against new threats to just 100 days.
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
CEPI:
press@cepi.net (mailto:press@cepi.net)
+44 7387 055214
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(1) Approximate funding figure. Final budget still pending.
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