Bavarian Nordic Submits BLA to FDA for Chikungunya Vaccine

Bavarian Nordic A/S, a prominent vaccine company, has announced the completion of its rolling submission process to the U.S. Food and Drug Administration (FDA) for its CHIKV VLP vaccine. This Biologics License Application (BLA), initiated in April 2024, seeks approval for the vaccine aimed at protecting individuals aged 12 and above from chikungunya virus infection. If accepted, this application could lead to vaccine approval by mid-2025.

The submission is backed by data from two phase 3 clinical trials involving over 3,600 healthy participants aged 12 and older. The trials showed that the CHIKV VLP vaccine is highly effective, inducing strong neutralizing antibodies against chikungunya 21 days post-vaccination. The antibody levels met or exceeded the agreed threshold for providing protection. The vaccine was generally well-tolerated, with most side effects being mild or moderate.

Additionally, Bavarian Nordic plans to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by mid-2024. This application has already received accelerated assessment, indicating that the vaccine could be approved by the European Commission by mid-2025.

Paul Chaplin, President and CEO of Bavarian Nordic, highlighted the importance of the BLA submission as a milestone for the CHIKV VLP vaccine. He emphasized the vaccine's potential to offer preventative solutions for those at risk of chikungunya virus from mosquito bites. Pending approval, the vaccine could be launched in both the US and Europe by mid-2025.

The CHIKV VLP vaccine candidate is an adjuvanted, virus-like particle (VLP) based vaccine. Upon regulatory approval, it will be available as a single-dose pre-filled syringe, simplifying administration and reducing the risk of errors.

The vaccine has received several special designations from regulatory agencies to expedite its development and review. The FDA granted it Breakthrough Therapy and Fast Track designations in October 2020 and April 2018, respectively. The EMA awarded it PRIME designation in September 2019. More recently, in February 2024, the EMA's Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for the MAA.

Chikungunya is a viral disease transmitted by mosquitoes, causing symptoms like fever, rash, fatigue, headache, and severe joint pain. While the disease has low mortality, it has high morbidity, with about half of the infected individuals experiencing long-term debilitating symptoms. Over the past two decades, chikungunya has spread to previously non-endemic regions, causing large outbreaks in Asia, Africa, southern Europe, and the Americas. The disease is often underreported and misdiagnosed as dengue fever due to inadequate testing.

Bavarian Nordic is a leading vaccine company focused on protecting lives through innovative vaccines. Known for its smallpox and mpox vaccines, the company supplies these to governments to bolster public health preparedness. It also has a robust portfolio of vaccines for travelers and diseases endemic to specific regions.