Nordic Bavarian receives the marketing authorization in Europe for Chikungunya vaccine for people 12 years old and older

The first Chikungunya vaccine has approved in Europe for people aged 12.
On the way to launch on key European markets in the first half of 2025.

Copenhagen, Denmark, February 28, 2025 – Nordic Bavaria A/S (OMX: Bava) announced today that the European Commission has granted the marketing authorization in Europe for Vimkunya^® For active immunization to prevent diseases caused by Chikungunya virus in people with 12 years and older.

The one -dose vaccine with a particle similar to the virus (VLP) is the first Chikungunya vaccine approved in Europe for people aged 12. Approval, valid in all EU Member States, as well as in Iceland, Liechtenstein and Norway, marks the second approval of Vimkunya, following the approval by the US Food and Drug Administration (FDA) earlier this month. Bavarian Nordic recently submitted a request for marketing authorization (MAA) to the UK regulatory agency and health medicines (MHRA), with potential approval of the Chikungunya vaccine in the United Kingdom in the first half of 2025.

Nordic Bavarian will launch Vimkunya on key European markets in the first half of 2025.

–We are very encouraged by the accelerated decision of the European Commission to approve our Chikungunya vaccine in Europe, which offers a differentiated profile for travelers, including the little ones of 12,Said Paul Chaplin, President and CEO of Nordic Bavarian. –As we extend our presence in Europe, this vaccine will help to further strengthen our leading position in travel vaccines and look forward to making the vaccine on the key markets in the first half of 2025. “

The marketing authorization was granted by the European Commission at the recommendation of the Committee for Medical Products for Human (CHMP) of the European Medicines Agency (EMA) in January 2025 and was based on the results of two phase 3 clinical phases that registered more than 3,500 healthy people aged 12 years and older. Studies have achieved the primary objectives, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of vaccinated individuals and have shown a rapid immune response starting in a week.

About Chikungunya
Chikungunya is a disease transmitted by mosquitoes caused by Chikungunya virus (Chikv). Over the past 20 years, the virus has appeared in several regions of Asia, Africa and America, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, Chikv has been identified in more than 110 countries, with confirmed transmission evidence in more than 50 countries over the past five years¹. Chikungunya usually comes with acute symptoms, including fever, rash, fatigue, headaches and often severe and incapable joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that may take months or even years². In 2024, about 480,000 cases of Chikungunya and over 200 world deaths were reported³. Recent data suggests that Chikungunya is severely under -rated and often misdiagnosed as a dengue fever because of a similar symptoms profile⁴.

About Vimkunya^® Chikungunya vaccine (recombinant, adsorbit)
Vimkunya is a recombinant protein vaccine VLP adjuvant for active immunization to prevent the disease caused by the Chikungunya virus in people with 12 years and older. Because VLPs do not contain any genetic material of the virus, the vaccine cannot infect the cells, cannot reproduce or cause disease. Vimkunya will be available as an injection suspension in a pre-filled syringe.

While the mechanism of action of the VLP Chikv vaccine must continue to be characterized, it is believed that the vaccine can induce protection against Chikv infection by inducing neutralizing antibodies against certain Chikv proteins resulting in the neutralization of the living virus. A adjuvant is added to increase the extent of vaccine -mediated immune responses. The most common side effects are the pain of the injection place, fatigue, headaches and myalgia.

Full product information will be available from:

About Nordic Bavarian
Nordic Bavarian is a global vaccine company, with the mission to improve health and save lives through innovative vaccines. We are a favorite supplier of Mpox vaccines and variola to governments to increase the preparation of public health and to have a portfolio of travel vaccines. For more information, visit www.bavarian-rondic.com

Prospective statements
This announcement includes prospective statements that involve risks, uncertainties and other factors, many of them being outside our control, which could determine the real results to differ significantly from the results discussed in prospective statements. Prospective statements include statements regarding plans, objectives, objectives, future events, performance and/or other information that is not historical information. All these prospective statements are expressly qualified by these caution statements and any other caution statements that can accompany prospective statements. We assume no obligation to update or publicly review prospective statements to reflect subsequent events or circumstances after the date taken, unless they request the law.

Contact investors:
Europe: Rolf Sass Sørensen, Vice President Investor Relations, [email protected]Tel: +45 61 77 47 43
USA: Graham Morrell, Paddock Circle Advisors, [email protected]Tel: +1 781 686 9600

Contact the average:
Nicole Seroff, vice president of corporate communications, [email protected]Tel: + 45 53 88 06 03

The announcement of the company no. 08 /2025

¹ Centers for disease control and prevention. Areas at risk for chikungunya. https://www.cdc.gov/chikungunya/data-maps/index.html..

² European Center for disease prevention and control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-desease.

³ European Center for disease prevention and control. General presentation of Chikungunya worldwide. https://www.ecdc.europa.eu/en/chikungunya-monthly..

⁴ Ribas Freitas Ar, Pinheiro Chagas Aa, Siquiira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic is dengue and how much is Chikungunya? Lancet reg Health am. 2024 April 30; 34: 100753. Two: 10.1016/J.Lana.2024.100753. PMID: 38711542; PMCID: PMC11070701.