* Regulatory review of the single-dose CHIKV VLP vaccine candidate for
immunization to prevent disease caused by chikungunya virus infection in
individuals 12 years of age and older is now underway in both the EU and in
the U.S.
COPENHAGEN, Denmark, June 26, 2024 - Bavarian Nordic A/S (OMX: BAVA) today
announced the submission of a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) seeking approval of the Company's vaccine
candidate for immunization to prevent disease caused by chikungunya virus
infection in individuals 12 years of age and older. The application was granted
accelerated assessment by the Committee for Medicinal Products for Human Use
(CHMP) in February 2024, supporting the potential approval of the vaccine by the
European Commission in the first half of 2025.
The MAA submission includes results from two phase 3 clinical trials in more
than 3,600 healthy individuals 12 years of age and older. The results showed
that the CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong
induction of chikungunya neutralizing antibodies 21 days after vaccination, with
antibody titers equal to or above the threshold agreed with authorities as a
marker of seroprotection in the majority of individuals. The CHIKV VLP vaccine
was well-tolerated across both studies and vaccine-related adverse events were
mainly mild or moderate in nature.
"The MAA marks our second major submission in just a few weeks as part of our
efforts to launch the chikungunya vaccine next year in the U.S. and Europe.
Chikungunya, like other mosquito-borne infectious diseases, represents an
increasing public health threat due to factors such as climate-change, but also
resulting from improved disease surveillance and diagnosis. Our CHIKV VLP
vaccine is designed for ease of use in individuals 12 years of age and older at
risk of chikungunya virus and represents an important contribution to the
development of preventative solutions against this debilitating disease," said
Paul Chaplin, President and CEO of Bavarian Nordic.
About CHIKV VLP vaccine
CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization
to prevent disease caused by CHIKV infection. Pending regulatory approval, the
single-dose vaccine will be made in a pre-filled syringe, designed to ease
administration by saving vaccinators' time and reducing the risk of
administrative errors.
The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and
Fast Track designation from the FDA in October 2020 and April 2018,
respectively, and PRIME designation from the EMA in September 2019. These
designations are designed to facilitate the development or expedite review of
medicines that either target an unmet medical need or may demonstrate
substantial improvement over available therapy. In February 2024, the Committee
for Medicinal Products for Human Use (CHMP) under EMA granted accelerated
assessment for the MAA for the CHIKV VLP vaccine candidate based on the
vaccine's major interest for public health and therapeutic innovation.
About chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), which belongs to the group of arboviruses like dengue virus. CHIKV
disease typically presents with acute symptoms, including fever, rash, fatigue,
headache, and often severe and incapacitating joint pain. While mortality is
relatively low, morbidity is high; nearly 50% of individuals with CHIKV disease
have debilitating long-term symptoms that can intensify with age. In the past
20 years, the CHIKV has emerged in several previously non-endemic regions in
Asia, Africa, southern Europe, and the Americas, often causing large
unpredictable outbreaks. Recent data(1) suggest that chikungunya is severely
underreported and often misdiagnosed as dengue fever due to lack of proper
testing.
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
Company Announcement no. 19 / 2024
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(1) Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes
Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is
dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr
30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID:
PMC11070701.
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