
Management’s review Financial statements Notes
Bavarian Nordic · H1 Report 2026 10
Product and pipeline update
Travel Health
Vimkunya
®
Chikungunya vaccine.
Regulatory approvals and launch status
Territory Approved
Launched
US Feb 2025
Mar 2025
EU Feb 2025
May 2025
UK May 2025
Sep 2025
Switzerland Apr 2026
Jun 2026
Canada Jun 2026
-
Vimkunya has been launched in the US, Germany, Switzerland,
France, UK, Denmark, Sweden, Norway, Finland, Italy, Spain,
Portugal, Austria, Belgium and the Netherlands.
New approvals in 2026
Vimkunya was approved by Swissmedic in April
2026 and was launched in Switzerland in June. In
June, Health Canada approved the vaccine.
Regulatory process initiated in Brazil
Bavarian Nordic’s partner, Eurofarma, has
submitted a marketing authorization application to
the Brazilian Health Regulatory Agency (Anvisa)
for the chikungunya vaccine. Through the
agreement entered with Eurofarma in January
2026, Eurofarma has exclusive rights to sell and
distribute the vaccine in Brazil and was also
granted the right of first refusal for any future
opportunity to register and commercialize the
chikungunya vaccine in the rest of Latin America.
Ongoing clinical development
The long-term immunogenicity of Vimkunya is
currently being evaluated in a follow-up study
(NCT06007183 →) in healthy adults and
adolescents enrolled in two previous phase 3
studies (NCT05072080 → and NCT05349617 →). The
study will evaluate both the safety and long-term
immunogenicity of a single dose of Vimkunya in
up to 5 years after vaccination and antibody
responses after a booster vaccination administered
3, 4, or 5 years post-initial vaccination.
A pediatric study (NCT07003984 →) is ongoing to
evaluate the safety and immunogenicity of the
vaccine in 720 children 2 to 11 years of age for
two years.
Additionally, in agreement with competent
regulatory agencies, an efficacy study
(NCT07467707 →) with more than 6,000
individuals is planned in a future outbreak area.
Public Preparedness
JYNNEOS
®
/IMVANEX
®
/IMVAMUNE
®
(MVA-BN
®
)
Mpox and smallpox vaccine
In June, the Committee for Medicinal Products for
Human Use (CHMP) under the European Medicines
Agency recommended approval of MVA-BN for
children aged 2 to less than 12 years. The
recommendation, supported by results from a
phase 2 clinical study (NCT06549530 →), was
referred to the European Commission for final
approval, which was granted in August 2026.
Ongoing clinical development
A phase 2b study (NCT07199569 →) comparing the
safety, immunogenicity and reactogenicity of MVA-
BN manufactured using different processes was
initiated in 2025. The study is part of the
Company’s efforts to scale manufacturing capacity
to meet future demand by introducing a
proprietary cell line, designed to significantly
increase manufacturing efficiency compared to the
current egg-based production
Other ongoing studies of MVA-BN, all co-funded by
CEPI, include two studies in the DRC, both led by
the University of Antwerp and the University of
Kinshasa: The first study (NCT06844487 →) is
evaluating the safety and immunogenicity of MVA-
BN in 344 infants aged 4-24 months and the
second study (NCT06844500 →) is evaluating the
safety and immunogenicity of MVA-BN in 359
women (pregnant or breastfeeding). A third
clinical study (NCT05745987 →) in the DRC, Uganda
and Nigeria, led by McMaster University in Canada,
is evaluating post-exposure vaccination with MVA-
BN in more than 3,000 participants including
children over 2 years of age.
Other pipeline updates
EBV
An IND for the Epstein-Barr Virus (EBV) vaccine is
expected to be filed in 2026, which, if successful,
could enable initiation of a phase 1 clinical trial
later this year.
Lyme disease
A novel Lyme vaccine candidate has been
developed, and preclinical studies have confirmed
the vaccine’s ability to induce a strong and durable
immune response against Lyme disease. Activities
to support clinical development, including clinical
trial manufacturing, will continue in 2027 and the
phase 1 study is now anticipated to start in 2028,
pending successful IND filing.
Equine encephalitis
The equine encephalitis vaccine program, funded
by the US Department of Defense (DOD), is
currently in phase 2 clinical development and
progressing according to plan.