CHMP backs Bavarian Nordic's chikungunya jab

The EMA's human medicines committee has recommended approval for Bavarian Nordic's chikungunya vaccine, which is shaping up to be the first alternative to a rival shot from Valneva.

The CHIKV VLP vaccine – which has the trade name Vimkunya in the EU – is also the first vaccine in the EU to protect adolescents from the age of 12 as well as adults from chikungunya, an emerging global health threat spread by the bite of an infected Aedes sp mosquito, according to the CHMP.

Valneva's Ixchiq vaccine – which was cleared in the EU, the US, and Canada last year – is currently indicated for preventing chikungunya disease in adults only, although, it is in clinical testing in younger individuals thanks to funding awarded by the Coalition for Epidemic Preparedness Innovations (CEPI) and EU last year.

Vimkunya has been reviewed under the EMA's PRIority MEdicines (PRIME) scheme, which allows early and enhanced scientific and regulatory support to medicines that have the potential to address an unmet medical need.

Chikungunya causes fever and excruciating joint pain, as well as muscle aches, joint swelling, headache, nausea, fatigue, and rash, with most people developing symptoms within three to seven days of exposure. In severe cases, it can cause systemic complications and death.

Chikungunya is not endemic in Europe, with the majority of cases in the EU seen in travellers to other parts of the world. That said, the threat posed by chikungunya and other mosquito-borne diseases is also thought likely to intensify in the coming years due to the impact of climate change on the range of the mosquito species that spread them.

The EMA said that there have been sporadic cases incidents of onward transmission by infected travellers after their return, mainly in Southern Europe where the Aedes albopictus species of mosquito is established.

The Danish pharma group is also hoping to secure approval for the vaccine shortly in the US, where the FDA is carrying out a priority six-month review, with a decision due by 14th February, and is also planning to file it in the UK in the first half of this year.

France-based Valneva recorded €1.8 million ($1.84 million) of Ixchiq sales in the first nine months of 2024 – from the US only – and was expecting to make the first sales in the EU and Canada in the final quarter of the year.

The vaccine is recommended by the US Advisory Committee on Immunisation Practices (ACIP) for adults travelling to a country or territory where there is a chikungunya outbreak, older adults (aged 65-plus) who may be exposed to mosquitos, and lab workers.

Valneva has acknowledged that the initial rollout of Ixchiq has been slow, but it expects sales to ramp up, potentially fuelled by label extensions in children, adolescents, and pregnant women, as well as new markets such as Brazil and the UK, where it is currently under review.