
Management’s review Financial statements Notes
Bavarian Nordic · Q1 Report 2026 9
Product and pipeline update
Travel Health
Vimkunya
®
Chikungunya vaccine.
Regulatory approvals and launch status
Territory Approved
Launched
US Feb 2025
Mar 2025
EU
1
Feb 2025
May 2025
2
UK May 2025
Sep 2025
Switzerland Apr 2026
-
Canada
3
-
-
1
The approval is valid in all EU member states, in addition to
Iceland, Liechtenstein, and Norway.
2
Vimkunya was launched in Germany in May 2025 and
subsequently in 10 other EU countries during 2025. In 2026
to-date, the vaccine has furthermore been launched in
Belgium and the Netherlands.
3
Application for licensure has been submitted to Health
Canada, potentially supporting approval in the first half of
2026
Expanding access through partnerships
During the first quarter Bavarian Nordic entered
into new agreements and partnerships aimed at
expanding availability of Vimkunya worldwide,
including low- and middle-income countries.
In January, an agreement was entered with
Eurofarma, granting them exclusive rights to sell
and distribute the chikungunya vaccine in Brazil.
Eurofarma 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.
In March, the strategic partnership with Serum
Institute of India was expanded to include a
contract manufacturing agreement covering a full
tech transfer of the manufacturing process for the
chikungunya vaccine to SII to allow for scaling of
capacity to enable future supply to endemic low-
and middle-income countries.
Ongoing clinical development
The long-term immunogenicity of Vimkunya is
currently being evaluated in a follow-up phase 3
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 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 March, clinical data was submitted to the
European Medicines Agency (EMA) to support the
extension of the indication for MVA-BN to include
children aged 2 to 11 years.
The submission is based on positive topline results
from a Phase 2 clinical study (NCT06549530 →) in
227 children aged 2-11 years and 224 adults
demonstrating non-inferiority of the immune
responses as well as a similar safety profile,
between both age groups after vaccination with
two standard doses of the MVA-BN vaccine. The
study was co-funded by the Coalition for Epidemic
Preparedness Innovations (CEPI) and was
conducted at sites in the Democratic Republic of
Congo (DRC) and Uganda.
Following review of the data by EMA, the
Marketing Authorisation for MVA-BN could be
extended to include use of the vaccine for
individuals from 2 years of age later in 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
In 2026, our R&D investments have been
prioritized for life-cycle management of the
commercial portfolio as well as continued—though
slower—advancement of the early-stage pipeline
assets (EBV and Lyme). Both programs are
expected to enter clinical development in 2027.
We continue the development of the equine
encephalitis vaccine program, funded by the U.S.
Department of Defense’s (DOD) Joint Program
Executive Office for Chemical, Biological,
Radiological and Nuclear Defense (JPEO-CBRND).