A Randomized, Double-blind, Phase 2b Comparability Trial in Adults 18 to 49 Years of Age to Assess Immunogenicity, Safety, and Reactogenicity of the MVA-BN Vaccine Manufactured in Different Production Cells

andomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken
embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in adults

Start Date27 Oct 2025

Sponsor / Collaborator

Bavarian Nordic A/S

[+1]

TCTR20240812007

/ Not yet recruitingPhase 3

A Phase 3b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Adjuvanted Chikungunya Virus Virus-like Particle (CHIKV VLP) Vaccine for the Prevention of Chikungunya Disease in Adolescents (12 to 18 Years) and Adults (18 Years or more than)

Start Date24 Aug 2025

Sponsor / Collaborator

Bavarian Nordic A/S

NCT07003984

/ RecruitingPhase 3

A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 2 to <12 Years of Age

The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 2 to <12 years of age.

Start Date05 Jun 2025

Sponsor / Collaborator

Bavarian Nordic A/S

100 Clinical Results associated with Bavarian Nordic A/S

0 Patents (Medical) associated with Bavarian Nordic A/S

Literatures (Medical) associated with Bavarian Nordic A/S

01 Jan 2025·ANIMAL WELFARE

Contactless body temperature assessment for signalling humane endpoints in a mouse model of sepsis

Article

Author: Miranda, Catarina ; Franco, Nuno H ; Oliveira, Liliana ; Carmo, Alexandre M ; Olsson, I Anna S

Abstract:

Minimising suffering is an ethical and legal requirement in animal research. This is particularly relevant for research on animal models of sepsis and septic shock, which show rapid progression towards severe stages and death. Specific and reliable criteria signalling non-recovery points can be used as humane endpoints, beyond which a study cannot be allowed to progress, thus preventing avoidable suffering. Body temperature is a key indicator for assessing animal health and welfare and has been suggested to have potential for monitoring the status of mouse models of sepsis. In this study, we monitored temperature variations using contactless methods – thermal imaging and subcutaneously implanted PIT tags – in a surgical model of sepsis by caecal ligation and puncture (CLP). We monitored body temperature variation following mid-grade CLP, high-grade CLP and sham surgery. All mice (Mus musculus) were monitored four times per day in the high-grade CLP model and three times per day in the mid-grade CLP model by both PIT tag readout and infrared thermography for ten days post-surgery, or until animals reached a predefined humane endpoint. Thermal data were compared with the clinical score and weight loss threshold used at our facility. Mean body surface temperature (MBST) assessed by thermal imaging and subcutaneous temperature (SCT) measured by PIT tags correlated, albeit not strongly. Moreover, while MBST does not appear to be a reliable predictor of non-recovery stages, SCT showed promise in this regard, even surpassing the widely used weight loss criterion, particularly for the high-grade CLP model of induced sepsis.

01 Dec 2024·VACCINE

A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study

Article

Author: Welte, Tobias ; Schultz, Stephanie ; Jordan, Elke ; De Moerlooze, Laurence ; Salgado, Fernanda ; Chen, Liddy ; Schmidt, Darja ; Silbernagl, Günter ; Schnorfeil, Frauke ; Chávez, Maria Paulina Velasco ; Jacquet, Jeanne-Marie ; Jenkins, Victoria

Respiratory syncytial virus (RSV) causes a significant disease burden in older adults. The live recombinant vaccine based on a nonreplicating modified vaccinia Ankara (MVA-BN) poxvirus, MVA-BN-RSV, encoding for multiple proteins of RSV subtypes A and B, was assessed for efficacy against respiratory disease caused by RSV. Adults aged ≥60 years, with or without underlying chronic conditions, were enrolled and randomized in a 1:1 ratio to receive a single dose of vaccine or placebo and were followed for disease caused by RSV infection during the 2022-2023 season. The 2 primary endpoints were RSV-associated lower respiratory tract disease (LRTD) with ≥3 and ≥ 2 symptoms; acute respiratory disease (ARD) was a key secondary endpoint. The humoral RSV-specific immune response was assessed at baseline and 14 days post-vaccination. Safety was evaluated by collection of solicited adverse events (AEs) and unsolicited AEs for 7 and 28 days post-vaccination respectively, and SAEs for the entire study period. In total, 18,348 participants were included in the final efficacy and safety analyses. Vaccine efficacy was 42.9 % (95 % CI: -16.1; 71.9) against RSV-associated LRTD with ≥3 symptoms, 59.0 % (95 % CI: 34.7; 74.3) against LRTD with ≥2 symptoms, and 48.8 % (95 % CI: 25.8; 64.7) against ARD. The primary objective was not met for LRTD with ≥3 symptoms since the lower bound of the 95 % CI was below 20 %, the prespecified success criterion. The vaccine-elicited immune response showed mean fold-increases of 1.7 for RSV A and B neutralizing antibodies and 2.9 and 4.3 for RSV-specific IgG and IgA, respectively. The vaccine displayed mild to moderate reactogenicity, and no safety concerns were identified. MVA-BN-RSV induced suboptimal protection against RSV-associated LRTD, likely due to suboptimal neutralizing antibody response. The vaccine had an acceptable safety profile and confirmed immunogenicity, overall showing promise for MVA-BN-vectored constructs targeting other diseases. Trial Registration:Clinicaltrials.gov Identifier NCT05238025 (Registered February 14, 2022).

01 Apr 2024·Vaccine

Safety and immunogenicity of a novel trivalent recombinant MVA-based equine encephalitis virus vaccine: A Phase 1 clinical trial

Article

Author: Weidenthaler, Heinz ; Stroukova, Daria ; Vidojkovic, Sanja ; Volkmann, Ariane ; Schmidt, Darja ; Zwiers, Susan ; Fierro, Carlos ; Müller, Jutta ; Gafoor, Zarina

BACKGROUND:

Three encephalitic alphaviruses-western, eastern, and Venezuelan equine encephalitis virus (WEEV, EEEV and VEEV)-can cause severe disease and have the potential to be used as biological weapons. There are no approved vaccines for human use. A novel multivalent MVA-BN-WEV vaccine encodes the envelope surface proteins of the 3 viruses and is thereby potentially able to protect against them all, as previously demonstrated in animal models. This first-in-human study assessed the safety, tolerability, and immunogenicity of MVA-BN-WEV vaccine in healthy adult participants.

METHODS:

Forty-five participants were enrolled into 3 dose groups (1 × 10E7 Inf.U, 1 × 10E8 Inf.U, and 2 × 10E8 Inf.U), received 2 doses 4 weeks apart, and were then monitored for 6 months.

RESULTS:

The safety profile of MVA-BN-WEV was acceptable at all administered doses, with incidence of local solicited AEs increased with increasing dose and no other clinically meaningful differences between dose groups. One SAE (Grade 2 pleural effusion) was reported in the lowest dose group and assessed as possibly related. No AEs resulted in death or led to withdrawal from the second vaccination or from the trial. The most common local solicited AE was injection site pain, and general solicited AEs were headache, fatigue, and myalgia. MVA-BN-WEV induced humoral immune responses; WEEV-, EEEV- and VEEV-specific neutralizing antibody responses peaked 2 weeks following the second vaccination, and the magnitude of these responses increased with dose escalation. The highest dose resulted in seroconversion of all (100 %) participants for WEEV and VEEV and 92.9 % for EEEV, 2 weeks following second vaccination, and durability was observed for 6 months. MVA-BN-WEV induced cellular immune responses to VEEV E1 and E2 (EEEV and WEEV not tested) and a dose effect for peptide pool E2.

CONCLUSION:

The study demonstrated that MVA-BN-WEV is well tolerated, induces immune responses, and is suitable for further development.

CLINICAL TRIAL REGISTRY NUMBER:

NCT04131595.

481

News (Medical) associated with Bavarian Nordic A/S

02 Feb 2026

·www.biospace.com

Bavarian Nordic – Transactions in Connection with Share Buy-Back Program - February 2, 2026

COPENHAGEN, Denmark, February 2, 2026 – Bavarian Nordic A/S (OMX: BAVA) announces transactions under the share buy-back program launched on January 7, 2026, under which the Company will repurchase shares for an amount up to DKK 150 million in the period from January 7, 2026 to February 13, 2026. The program is executed in accordance with Regulation (EU) No. 596/2014 (as amended) of the European Parliament and of the Council on market abuse and Commission Delegated Regulation (EU) 2016/1052, which together constitute the Safe Harbour Regulation. Since the last announcement of transactions on January 26, 2026, the following transactions have been made by Nordea on behalf of Bavarian Nordic: Number of shares Average purchase price, DKK Transaction value, DKK Accumulated until January 26, 2026 439,121 197.47 86,712,870 January 26, 2026 3,389 196.90 667,294 January 27, 2026 36,000 198.11 7,131,928 January 28, 2026 78,000 196.42 15,320,737 January 29, 2026 79,000 192.07 15,173,206 January 30, 2026 799 190.87 152,504 Accumulated under the program 636,309 196.69 125,158,539 The details for each transaction made under the share repurchase program are published on bavarian-nordic.com . Following these transactions, Bavarian Nordic holds a total of 1,603,154 treasury shares, corresponding to 2.02% of the Company’s share capital. About Bavarian Nordic Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit 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 Contact investors: Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com , Tel: +1 781 686 9600 Contact media: Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com , Tel: +45 53 88 06 03 Company Announcement no. 05 / 2026 Attachments Bavarian Nordic – Transactions in Connection with Share Buy-Back Program Appendix with detailed transaction data

Vaccine

26 Jan 2026

·www.globenewswire.com

Bavarian Nordic – Transactions in Connection with Share Buy-Back Program

COPENHAGEN, Denmark, January 26, 2026 – Bavarian Nordic A/S (OMX: BAVA) announces transactions under the share buy-back program launched on January 7, 2026, under which the Company will repurchase shares for an amount up to DKK 150 million in the period from January 7, 2026 to February 13, 2026. The program is executed in accordance with Regulation (EU) No. 596/2014 (as amended) of the European Parliament and of the Council on market abuse and Commission Delegated Regulation (EU) 2016/1052, which together constitute the Safe Harbour Regulation. Since the last announcement of transactions on January 19, 2026, the following transactions have been made by Nordea on behalf of Bavarian Nordic: Number of sharesAverage purchase price, DKKTransaction value, DKKAccumulated until January 19, 2026189,897198.6737,727,433January 19, 2026 70,000192.98 13,508,621January 20, 2026 11,489190.98 2,194,204January 21, 2026 46,394195.38 9,064,339January 22, 2026 46,341199.27 9,234,556January 23, 2026 75,000199.78 14,983,718Accumulated under the program439,121197.4786,712,870 The details for each transaction made under the share repurchase program are published on bavarian-nordic.com. Following these transactions, Bavarian Nordic holds a total of 1,405,966 treasury shares, corresponding to 1.77% of the Company’s share capital. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit 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 Contact investors:Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03 Company Announcement no. 04 / 2026 Attachments Bavarian Nordic – Transactions in Connection with Share Buy-Back Program Appendix with detailed transaction data

Vaccine

23 Jan 2026

·www.globenewswire.com

Bavarian Nordic Signs Distribution Agreement with Eurofarma to Expand Access to Chikungunya Vaccine in Brazil

Agreement to enable the first entry in Latin America for Bavarian Nordic’s chikungunya vaccinePotential to expand agreement to cover rest of Latin America COPENHAGEN, Denmark, January 23, 2026 – Bavarian Nordic A/S (OMX: BAVA) today announced an agreement with Eurofarma, granting them exclusive rights to sell and distribute Bavarian Nordic’s chikungunya vaccine, CHIKV VLP, in Brazil. Eurofarma is also granted the right of first refusal for any future opportunity to register and commercialize the chikungunya vaccine in the rest of Latin America. The agreement is transfer price and royalty-based with no associated upfront or milestone payments. Eurofarma will be responsible for seeking and maintaining regulatory approval of the vaccine in exclusive territories, as well as sales and distribution costs. Bavarian Nordic will remain the manufacturer of the vaccine, which is made available to Eurofarma through a transfer price agreement. Pending discussions with the Brazilian Health Regulatory Agency, Anvisa, regulatory submission is expected to occur later in the first half of 2026, potentially supporting launch of the chikungunya vaccine in Brazil in the second half of 2027. “Following a successful launch of our chikungunya vaccine for travelers in the first Western markets in 2025, we are pleased to expand the commercial availability also for endemic populations through this first distribution agreement,” said Paul Chaplin, President & CEO of Bavarian Nordic. “Brazil remains severely impacted by chikungunya, representing half of all reported cases and related deaths worldwide. Together with Eurofarma, a local partner with strong regional presence, we continue our efforts to make a lasting impact on public health globally.” “Our partnership with Bavarian Nordic reinforces Eurofarma’s commitment to innovation and to expanding access to high‑quality healthcare. It builds on our strong capabilities to deliver high‑impact solutions for people in Brazil and across Latin America—so that everyone has the opportunity to live longer and better,” says João Siffert, Eurofarma’s Vice President of Innovation. While the agreement aims to significantly improve access to chikungunya vaccines in Brazil, it is not expected to have a material short- to medium-term financial impact on Bavarian Nordic. // About CHIKV VLPCHIKV VLP is a single dose, prefilled, adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. It is designed to induce a robust seroresponse, with protective immunity starting to develop as early as 1 week after vaccination. The vaccine does not contain viral genetic material and is therefore non-infectious and unable to cause disease, ensuring a broad range of people can benefit from vaccination. The vaccine was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025 and the United Kingdom in May 2025 under the trade name VIMKUNYA®1. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus. In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, chikungunya has been identified in more than 110 countries2. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that can last for months or even years3. In 2025, as of December, nearly 500,000 cases of chikungunya and over 200 associated deaths were reported worldwide4. More than half of the reported cases and associated deaths were reported from Brazil5. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile6. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com. About EurofarmaFounded in 1972, Eurofarma covers key pharmaceutical segments and is the leader in medical prescriptions in Brazil. A Brazilian multinational company operating in 24 countries, with full coverage across Latin America and retail leadership in the region, the company also maintains operations in the United States and Africa, with more than 13,500 employees and 11 manufacturing facilities. In 2024, Eurofarma produced 600 million units. That same year, the company invested over USD 122 million in innovation projects and achieved net revenue exceeding USD 1.78 billion. For more information: www.eurofarma.com.br Contact investors:Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.comUS: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03 1 Marketed as VIMKUNYA™ in the US. Marketed as VIMKUNYA® in EU and the United Kingdom. 2 World Health Organization (WHO). Chikungunya.https://www.who.int/news-room/fact-sheets/detail/chikungunya 3 European Centre for Disease Prevention and Control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-disease. 4 European Centre for Disease Prevention and Control. Chikungunya virus disease worldwide overview. https://www.ecdc.europa.eu/en/chikungunya-monthly. 5 Pan American Health Organization (PAHO). Chikungunya: analysis by country. https://www.paho.org/en/arbo-portal/chikungunya-data-and-analysis/chikungunya-analysis-country 6 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. Attachment Bavarian Nordic Signs Distribution Agreement with Eurofarma to Expand Access to Chikungunya Vaccine in Brazil

VaccineDrug Approval

100 Deals associated with Bavarian Nordic A/S

100 Translational Medicine associated with Bavarian Nordic A/S

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Pipeline

Pipeline Snapshot as of 12 Feb 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 1

Phase 2

Phase 3

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Smallpox and Monkeypox Vaccine, Live, Nonreplicating(Bavarian Nordic A/S)	Monkeypox More	Approved
Chikungunya Vaccine, Recombinant (Bavarian Nordic)	Chikungunya Fever More	Approved
Cholera Vaccine Live Oral(Emergent Travel Health)	Cholera More	Approved
Typhoid vaccine live Ty21a(Berna Biotech AG)	Typhoid Fever More	Approved
Rabies vaccine(Novartis)	Rabies More	Approved

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