EMA supports approval of Bavarian Nordic’s vaccine for Chikungunya

NETHERLANDS – The European Medicines Agency (EMA) has taken a significant step in the fight against chikungunya, with its human medicines committee recommending approval for Bavarian Nordic’s vaccine, Vimkunya.

This vaccine is set to become the first option in the EU to protect both adolescents (from the age of 12) and adults against chikungunya, a mosquito-borne illness that is becoming a global health concern.

Chikungunya is transmitted through the bite of an infected Aedes mosquito and causes severe symptoms, including fever, debilitating joint pain, muscle aches, headaches, fatigue, and rashes. In some cases, the disease can lead to serious complications or even death.

While chikungunya is not endemic to Europe, most cases there occur in travelers returning from other parts of the world.

However, climate change is expected to increase the prevalence of mosquito-borne diseases like chikungunya in Europe, as warmer temperatures expand the habitat of mosquitoes such as Aedes albopictus.

The EMA has noted sporadic cases of local transmission in Southern Europe when infected travelers return home.

The approval of Vimkunya would make it the first chikungunya vaccine in the EU specifically targeting adolescents, filling a gap left by Valneva’s Ixchiq vaccine, which is currently only approved for adults.

Valneva’s Ixchiq vaccine, cleared last year in the EU, US, and Canada, is undergoing clinical trials in younger populations, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and the EU.

Vimkunya has been developed under the EMA’s PRIority MEdicines (PRIME) scheme, which offers early and enhanced regulatory support for medicines addressing urgent medical needs.

Meanwhile, Bavarian Nordic is also seeking approval in the US, with the Food and Drug Administration (FDA) expected to make a decision by February 14.

The company also plans to file for approval in the UK later this year. Chikungunya vaccines are gaining attention as the disease poses a growing threat worldwide.

Valneva’s Ixchiq vaccine has already been recommended by the US Advisory Committee on Immunization Practices (ACIP) for adults traveling to areas with active chikungunya outbreaks, older adults (65 and above) at risk of mosquito exposure, and laboratory workers.

Valneva recorded €1.8 million (US $1.84 million) in Ixchiq sales in the first nine months of 2024, primarily in the US, and expects sales to grow as it launches in the EU and Canada.

The company also anticipates label expansions to include children, adolescents, and pregnant women, as well as approvals in new markets such as Brazil and the UK. However, the initial rollout of Ixchiq has been slower than expected.

As chikungunya continues to spread, vaccines like Vimkunya and Ixchiq are crucial tools in preventing outbreaks and protecting vulnerable populations.