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Business Upturn
2 days ago
- Health
- Business Upturn
Bavarian Nordic Initiates Phase 3 Study of Chikungunya Vaccine in Children
First children vaccinated in clinical study seeking to expand the target population for the chikungunya vaccine. COPENHAGEN, Denmark, June 12, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a Phase 3 clinical study of its single-dose, virus-like particle (VLP) chikungunya vaccine, CHIKV VLP in children 2 to 11 years of age. This first trial of CHIKV VLP in a pediatric population aims to expand the target population for the vaccine, currently approved for persons 12 years of age and older in the US, EU and United Kingdom under the trade name VIMKUNYA®. The global, randomized, double-blind, placebo-controlled study (NCT07003984), sponsored by Bavarian Nordic, will evaluate the safety and immunogenicity of CHIK VLP vaccine in 720 children 2 to 11 years of age for two years. Primary results from the study are anticipated in the first half of 2028. Paul Chaplin, President & CEO of Bavarian Nordic, said: 'Upon the successful approvals earlier this year of our chikungunya vaccine for persons aged 12 and older, we are pleased to initiate this Phase 3 study in children for whom there are currently no vaccines available to prevent against chikungunya. This study represents a significant part of our commitment to the further development of the vaccine to help ensure access for people of all ages.' About VIMKUNYA® Chikungunya vaccine (recombinant, adsorbed) VIMKUNYA (CHIKV VLP) is the first and only virus-like particle (VLP) vaccine for the prevention of chikungunya disease in individuals aged 12 years and above. It is designed to induce a robust seroresponse, with protective immunity starting to develop as early as 1 week after vaccination. VIMKUNYA is the only single-dose vaccine against chikungunya disease available in a prefilled syringe. VIMKUNYA 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 20251,2 and the United Kingdom in May 20253. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65-year-olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12–64-year-old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain4,5. About chikungunya Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). 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, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years6. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years7. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide8. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile9. 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 update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Contact investors: Europe: Rolf Sass Sørensen, Vice President Investor Relations, [email protected], Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600 Contact media: Nicole Seroff, Vice President Corporate Communications, [email protected], Tel: +45 53 88 06 03 1 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 2 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. 3 Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom. 4 Richardson JS, et al. Chikungunya Virus VLP Vaccine: Phase 3 Trial in Adolescents and Adults. medRxiv 2024.10.11.24315179. 5 Tindale LC, et al. Chikungunya Virus VLP Vaccine: Phase 3 Trial in Adults ≥65 Years of Age. medRxiv 2024.10.10.24315205. 6 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. 7 European Centre for Disease Prevention and Control. Chikungunya virus disease. 8 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 9 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/ PMID: 38711542; PMCID: PMC11070701. Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Yahoo
02-05-2025
- Health
- Yahoo
Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom
COPENHAGEN, Denmark, May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approvals from certain other regulatory bodies, in this case the recent approval by the European Commission. Bavarian Nordic is targeting launch of the vaccine in the UK during the summer of 2025. 'Chikungunya mostly represents a risk for UK citizens traveling overseas to affected regions in the Americas, Africa and Asia, but as recent research has shown, invasive mosquitos known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change1,' said Paul Chaplin, President and CEO of Bavarian Nordic. 'The mosquitos cannot be stopped, but with preventative measures such as vaccines, we can mitigate the impact of emerging diseases like chikungunya for those at risk, and we look forward to launching our vaccine in the UK later this year.' The UK approval of VIMKUNYA marks the third approval of Bavarian Nordic's chikungunya vaccine, which was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025.2,3 Bavarian Nordic has also submitted an application to Health Canada, potentially supporting approval of the chikungunya vaccine in the first half of 2026. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). 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, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years4. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years5. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide6. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile7. About VIMKUNYA® Chikungunya vaccine (recombinant, adsorbed)VIMKUNYA 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. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65 year olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12-64 year old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. 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 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. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: +45 53 88 06 031 European Centre for Disease Prevention and Control. Increasing risk of mosquito-borne diseases in EU/EEA following spread of Aedes species. 2 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 3 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. 4 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. 5 European Centre for Disease Prevention and Control. Chikungunya virus disease. 6 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 7 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/ PMID: 38711542; PMCID: 2025-05-02-enSign in to access your portfolio
Yahoo
16-04-2025
- Health
- Yahoo
Bavarian Nordic's Chikungunya Vaccine Receives Recommendation from U.S. CDC's Advisory Committee on Immunization Practices (ACIP)
Recommendation of first chikungunya vaccine for persons as young as 12 years old expands access for US travelers to regions with outbreak or elevated risk of chikungunya. COPENHAGEN, Denmark, April 16, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the virus-like particle (VLP)-based, single-dose vaccine, VIMKUNYA™ (Chikungunya Vaccine, Recombinant) for injection, for the prevention of disease caused by chikungunya virus. ACIP recommends VIMKUNYA for persons aged 12 and older traveling to a country or territory where there is a chikungunya outbreak. In addition, VIMKUNYA may be considered for persons traveling or taking up residence in a country or territory without an outbreak but with elevated risk for US travelers if planning travel for an extended period of time. ACIP also recommends VIMKUNYA for laboratory workers with potential for exposure to chikungunya virus. According to CDC, there has been evidence of chikungunya virus transmission to humans in more than 50 countries within the last five years. Paul Chaplin, President and CEO of Bavarian Nordic said: 'The ACIP's recommendation of our chikungunya vaccine for Americans aged 12 and older is a big step forward to expanding access to this vaccine in the United States. Chikungunya is an emerging public health threat around the world, and today's decision is another milestone in our mission to protect more people from this virus.' The recommendation from ACIP is pending final approval by the Director of the CDC and the U.S. Department of Health and Human Services. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). 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, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years1. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years2. In 2024, 620,000 cases of chikungunya were reported worldwide, an increase of more than 20% compared to 20233,4. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile5. About VIMKUNYA™ (Chikungunya Vaccine, Recombinant) VIMKUNYA is a vaccine for prevention of disease caused by chikungunya virus in people 12 years of age and older. VIMKUNYA was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 20256,7. Bavarian Nordic has also filed for approval of the vaccine in the United Kingdom and Canada. Additional clinical trials are required to confirm the clinical profile. VIMKUNYA is supplied as a single-dose 1-mL glass pre-filled syringe with 0.8 mL dose volume. Important Safety InformationThe following information is based on the U.S. Prescribing Information for VIMKUNYA. Please consult the full Prescribing Information for all the labelled safety information for VIMKUNYA. You should not get VIMKUNYA if you are allergic to any of the ingredients of the vaccine or if you have had an allergic reaction following a previous dose of VIMKUNYA. People with a lowered immune system, including people receiving medications that affect the immune system, may have a diminished response to VIMKUNYA. Tell your healthcare provider about all medications you are taking. Fainting may occur with administration of injected vaccines including VIMKUNYA. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. These are not all the possible side effects. Tell your healthcare provider if you are pregnant, planning to become pregnant, or are breastfeeding. Tell your healthcare provider about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by visiting or call 1-800-822-7967. 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 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. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: +45 53 88 06 03 Visit for additional media information. Company Announcement no. 14 / 20251 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. 2 European Centre for Disease Prevention and Control. Chikungunya virus disease. 3 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 4 European Centre for Disease Prevention and Control. Chikungunya virus disease cases January - December 2023. Chikungunya virus disease cases January - December 2023. 5 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/ PMID: 38711542; PMCID: PMC11070701. 6 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 7 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. Attachment 2025-14-en
Yahoo
14-02-2025
- Health
- Yahoo
Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older
First chikungunya vaccine approved for persons as young as 12 years old, addressing an unmet need for chikungunya prevention for younger travelers. On track for commercial launch in the U.S. in the first half of 2025. A Tropical Disease Priority Review Voucher was awarded to the Company upon approval. COPENHAGEN, Denmark, February 14, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Food and Drug Administration (FDA) has approved VIMKUNYA™ (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older. The FDA approved VIMKUNYA under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals and demonstrated a rapid immune response starting to develop within one week. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature1. VIMKUNYA is a VLP vaccine, which means that it uses virus-like particles designed to mimic the chikungunya virus without the ability to infect cells, replicate or cause disease. 'The approval of our chikungunya vaccine is a testament to our unwavering commitment to addressing unmet medical needs and protecting communities worldwide,' said Paul Chaplin, President and CEO of Bavarian Nordic. 'As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travelers and vulnerable populations. We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.' Concurrent with the approval, the FDA awarded Bavarian Nordic a Priority Review Voucher (PRV) under the Tropical Disease PRV program, which the Company intends to monetize when appropriate. Bavarian Nordic aims to provide commercial availability of VIMKUNYA in the U.S. in the first half 2025. The vaccine recently received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and will also be launched in key European markets in the first half of 2025, pending adoption of a final decision on the marketing authorization by the European Commission. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). 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, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years2. 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 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide4. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile5. About VIMKUNYA™ (Chikungunya Vaccine, Recombinant)VIMKUNYA is a vaccine for prevention of disease caused by chikungunya virus in people 12 years of age and older. Additional clinical studies are required to confirm the clinical profile of VIMKUNYA, and confirmatory efficacy studies are also planned as part of the post-marketing commitments and requirements as agreed with the FDA. VIMKUNYA is supplied as a single-dose 1-mL glass pre-filled syringe with 0.8 mL dose volume. Important Safety InformationThe following information is based on the U.S. Prescribing Information for VIMKUNYA. Please consult the full Prescribing Information for all the labelled safety information for VIMKUNYA. You should not get VIMKUNYA if you are allergic to any of the ingredients of the vaccine or if you have had an allergic reaction following a previous dose of VIMKUNYA. People with a lowered immune system, including people receiving medications that affect the immune system, may have a diminished response to VIMKUNYA. Tell your healthcare provider about all medications you are taking. Fainting may occur with administration of injected vaccines including VIMKUNYA. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. These are not all the possible side effects. Tell your healthcare provider if you are pregnant, planning to become pregnant, or are breastfeeding. Tell your healthcare provider about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by visiting or call 1-800-822-7967. 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 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. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: + 45 53 88 06 03 Visit for additional media information. Company Announcement no. 07 / 20251 VIMKUNYA Prescribing Information 2025 2 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. Accessed February 14, 2025. 3 European Centre for Disease Prevention and Control. Chikungunya virus disease. Accessed February 14, 2025. 4 European Centre for Disease Prevention and Control. Chikungunya worldwide overview. Accessed February 14, 2025. 5 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/ PMID: 38711542; PMCID: PMC11070701. Attachment 2025-07-en
Yahoo
31-01-2025
- Health
- Yahoo
Bavarian Nordic Receives Positive CHMP Opinion for Chikungunya Vaccine for Persons Aged 12 and Older
First chikungunya vaccine recommended by the CHMP for persons as young as 12 years old. The virus-like particle (VLP) single-dose chikungunya vaccine is expected to launch in key European markets in the first half of 2025, pending final marketing authorization. COPENHAGEN, Denmark, January 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for VIMKUNYA® (CHIKV VLP vaccine) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. After accelerated assessment, the CHMP's recommendation is primarily based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older and demonstrated a rapid immune response starting to develop within one week. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals. The vaccine was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature. 'The recommendation of our chikungunya vaccine for approval in Europe marks a huge milestone in our efforts to deliver protection against this debilitating disease and, once approved, would represent a significant contribution to expanding the availability of vaccines to a broader population, including adolescents aged 12-17 years,' said Paul Chaplin, President and CEO of Bavarian Nordic. 'Chikungunya, like other mosquito-borne illnesses, represents an increasing public health risk across the globe due to factors such as climate change, and we look forward to making the vaccine available for travelers at risk later this year, while also continuing our efforts to expand access to endemic populations across the globe.' The European Commission, which grants central marketing authorizations in the European Union (EU), will review the CHMP recommendation and is expected to make a final decision in the coming months. If granted, the marketing authorization of VIMKUNYA would be valid in all EU member states, as well as in Iceland, Liechtenstein, and Norway. Based on the positive CHMP opinion, Bavarian Nordic will now also submit a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP), with potential approval of the chikungunya vaccine in the UK in the first half of 2025. The vaccine is also currently under priority review with the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for February 14, 2025. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). 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, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years1. 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 years2. In 2024, approximately 480,000 cases of chikungunya and over 200 deaths were reported worldwide3. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile4. About CHIKV VLPCHIKV VLP is an adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. Because VLPs contain no virus genetic material, the vaccine cannot infect cells, reproduce or cause disease. While the mechanism of action of CHIKV VLP vaccine still needs to be further characterised, it is thought that the vaccine can induce protection from CHIKV infection by inducing neutralising antibodies against certain CHIKV proteins resulting in neutralisation of live virus. An adjuvant is added to increase the magnitude of vaccine-mediated immune responses. Pending regulatory approval, CHIKV VLP vaccine will be supplied as a single-dose, pre-filled syringe. 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 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. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: + 45 53 88 06 03 Company Announcement no. 04 / 20251 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. Accessed January 30, 2025. 2 European Centre for Disease Prevention and Control. Chikungunya virus disease. Accessed January 30, 2025. 3 European Centre for Disease Prevention and Control. Chikungunya worldwide overview. Accessed January 30, 2025. 4 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/ PMID: 38711542; PMCID: PMC11070701. Attachment 2025-04-enSign in to access your portfolio
