EMA Accepts and Validates Bavarian Nordic's Chikungunya Vaccine MAA

The European Medicines Agency (EMA) has initiated an accelerated assessment of Bavarian Nordic's chikungunya vaccine, CHIKV VLP, for which the marketing authorization application (MAA) was submitted in June 2024. This accelerated review process aims to expedite the evaluation of the vaccine, potentially enabling approval by the European Commission by mid-2025. The vaccine is designed for individuals aged 12 and older to prevent chikungunya virus infection.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted the accelerated assessment status in February 2024, intending to shorten the timeframe for reviewing the MAA. Paul Chaplin, President and CEO of Bavarian Nordic, emphasized the importance of this milestone, highlighting the company’s commitment to collaborating with the EMA to make the vaccine accessible to those at risk of chikungunya virus infection.

Simultaneously, Bavarian Nordic has also submitted a Biologics License Application (BLA) for CHIKV VLP to the U.S. Food and Drug Administration (FDA) in June 2024. This submission could lead to the vaccine's approval in the United States by the first half of 2025.

CHIKV VLP is an adjuvanted VLP-based vaccine intended for active immunization against chikungunya virus disease. If approved, the single-dose vaccine will be provided in a pre-filled syringe, making it easier to administer and reducing administrative errors. The vaccine has previously received Breakthrough Therapy designation and Fast Track designation from the FDA in October 2020 and April 2018, respectively, as well as PRIME designation from the EMA in September 2019. These designations are aimed at facilitating the development or speeding up the review of treatments that address unmet medical needs or offer significant improvements over existing therapies.

Chikungunya is a viral disease transmitted by mosquitoes, caused by the chikungunya virus (CHIKV), which is part of the arbovirus group that includes the dengue virus. The disease typically presents with acute symptoms such as fever, rash, fatigue, headache, and severe joint pain, which can be debilitating. Although the mortality rate is low, the morbidity rate is high, with nearly half of all affected individuals experiencing long-term symptoms that may worsen with age. Over the past two decades, CHIKV has spread to several new regions, including parts of Asia, Africa, southern Europe, and the Americas, often leading to large, unpredictable outbreaks. Recent research indicates that chikungunya is significantly underreported and frequently misdiagnosed as dengue fever due to inadequate testing.

Bavarian Nordic is a comprehensive vaccine company focused on protecting and saving lives through innovative vaccines. The company is a global leader in manufacturing smallpox and mpox vaccines, which are supplied to governments to bolster public health preparedness. Bavarian Nordic also has a strong portfolio of vaccines targeting travelers and endemic diseases.