Bavarian Nordic has submitted its chikungunya vaccine for approval by the US Food and Drug Administration (FDA), the company announced in a press release on Monday.

This means that the potential vaccine is expected to be approved in the first half of 2025. The application to the European Medicines Agency, EMA, is also nearing completion, as the company expects to submit it before the end of the first half of 2024, according to the announcement.

”The completion of the regulatory submission to the US health authorities marks a significant milestone in the development of our CHIKV VLP vaccine and represents an important contribution to the development of preventive solutions for people over 12 years of age who are at risk of contracting chikungunya virus through bites from infected mosquitoes,” said Paul Chaplin, CEO of Bavarian Nordic, in the statement.

The registration application is for the company’s vaccine candidate for immunization against chikungunya virus, CHIKV VLP, for people aged 12 years and older.

”With the imminent planned submission of the registration application to the European Medicines Agency, we are looking forward to a potential approval of the vaccine in the first half of 2025 and subsequent launch in both the US and EU,” says Chaplin.

The EMA has previously granted the application accelerated review status, which means that the candidate could potentially be approved by the European Commission in the first half of 2025.

The application to the FDA includes results from two Phase III clinical trials involving more than 3,600 healthy individuals aged 12 years and older.

Both trials showed that high levels of chikungunya-neutralizing antibodies were generated 21 days after vaccination. Side effects were predominantly mild to moderate, according to Bavarian.

Chikungunya is a mosquito-borne viral disease related to the dengue virus which typically causes acute symptoms including fever, rash, fatigue and headaches and often severe and debilitating joint pain.

English edit: Catherine Brett