Bavarian Nordic Seeks EMA Approval for Chikungunya Vaccine

Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older is now underway in both the EU and in the U.S.

COPENHAGEN, Denmark, June 26, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of its vaccine candidate designed to prevent chikungunya virus infection in individuals aged 12 years and older. The Committee for Medicinal Products for Human Use (CHMP) granted the application an accelerated assessment in February 2024, potentially paving the way for European Commission approval in the first half of 2025.

The MAA submission includes data from two phase 3 clinical trials involving over 3,600 healthy individuals aged 12 and above. These trials demonstrated that the CHIKV VLP vaccine induced a strong immune response, evidenced by the production of chikungunya neutralizing antibodies within 21 days post-vaccination. The antibody levels in most individuals reached or exceeded the seroprotection threshold agreed upon with health authorities. The vaccine was generally well-tolerated, with most adverse events being mild or moderate.

Paul Chaplin, President and CEO of Bavarian Nordic, highlighted the significance of the MAA submission, noting that it is the company's second major submission in recent weeks as part of its strategy to launch the chikungunya vaccine in the U.S. and Europe next year. He emphasized the growing public health threat posed by chikungunya, exacerbated by factors such as climate change and improved diagnostic capabilities. Chaplin described the CHIKV VLP vaccine as a user-friendly solution for those at risk of chikungunya, contributing to the broader effort to develop preventative measures against this debilitating disease.

The CHIKV VLP vaccine is an adjuvanted, VLP-based vaccine intended for active immunization against chikungunya virus infection. If approved, it will be available as a single-dose pre-filled syringe, simplifying administration and reducing the likelihood of administrative errors. The vaccine candidate has received several designations aimed at expediting its development and review, including Breakthrough Therapy and Fast Track designations from the FDA and PRIME designation from the EMA.

Chikungunya is a viral disease transmitted by mosquitoes, caused by the chikungunya virus (CHIKV), part of the arbovirus family like dengue. Symptoms of CHIKV infection often include fever, rash, fatigue, headaches, and severe joint pain, which can be debilitating. Although the mortality rate is low, the disease has a high morbidity rate, with nearly half of those infected experiencing long-term symptoms that can worsen with age. Over the past two decades, the virus has spread to new regions in Asia, Africa, southern Europe, and the Americas, leading to significant outbreaks. Recent studies suggest that chikungunya is often underreported and misdiagnosed as dengue fever due to inadequate testing.

Bavarian Nordic is an integrated vaccine company committed to protecting and saving lives through innovative vaccines. The company is a global leader in smallpox and mpox vaccines, provided to governments to bolster public health preparedness, and boasts a robust portfolio of vaccines for travelers and endemic diseases.