FDA Grants Priority Review to Bavarian Nordic's Chikungunya Vaccine BLA

Bavarian Nordic A/S, based in Copenhagen, Denmark, has announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for their Biologics License Application (BLA) for the CHIKV VLP vaccine. This vaccine aims to prevent disease caused by the chikungunya virus in individuals aged 12 and older. The Priority Review designation shortens the FDA's review period to six months, aiming for a decision by February 14, 2025, compared to the standard ten-month review period.

Dr. Paul Chaplin, President and CEO of Bavarian Nordic, expressed optimism about the FDA's decision to prioritize the review of their chikungunya vaccine. This expedited process could lead to quicker availability of the vaccine for those at risk. The vaccine is also under accelerated assessment by the European Medicines Agency (EMA), potentially leading to European Commission approval in early 2025. These reviews mark significant steps toward the first regulatory approvals of a chikungunya vaccine for adolescents, potentially offering protection to broader populations at risk.

The CHIKV VLP vaccine is an adjuvanted vaccine designed to prevent chikungunya virus disease. It is intended to be administered as a single dose in a pre-filled syringe, simplifying the vaccination process and minimizing administrative errors. The vaccine has received several designations from the FDA and EMA, including Breakthrough Therapy, Fast Track, and PRIME, to facilitate its development and review. In February 2024, the EMA's Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for the Marketing Authorization Application (MAA) of the CHIKV VLP vaccine, recognizing its significant public health and therapeutic potential.

Chikungunya is a virus transmitted by mosquitoes, similar to the dengue virus. It typically causes acute symptoms such as fever, rash, fatigue, headache, and severe joint pain. While it has a low mortality rate, the disease significantly impacts morbidity, with around half of the infected individuals suffering long-term debilitating symptoms, which can worsen with age. Over the past two decades, chikungunya has spread to new regions, including parts of Asia, Africa, southern Europe, and the Americas, often leading to large and unpredictable outbreaks. Recent studies indicate that chikungunya is often underreported and misdiagnosed as dengue fever due to inadequate testing.

Bavarian Nordic is a comprehensive vaccine company dedicated to protecting and saving lives through innovative vaccine solutions. The company is a global leader in smallpox and mpox vaccines and supplies these to governments to bolster public health preparedness. Bavarian Nordic also has a robust portfolio of vaccines for travelers and endemic diseases.

This announcement underscores Bavarian Nordic's ongoing commitment to addressing significant public health challenges through groundbreaking vaccines. The company's efforts in developing the CHIKV VLP vaccine demonstrate its proactive approach to combating emerging infectious diseases and enhancing global health security. As regulatory reviews progress, Bavarian Nordic looks forward to making the chikungunya vaccine available to those most in need, potentially mitigating the impact of this debilitating disease on affected populations.