First chikungunya vaccine approved by FDA

Valneva has claimed the accolade of becoming the first drugmaker to win FDA approval for a vaccine for chikungunya virus, a potentially life-threatening mosquito-borne disease.

The French biotech’s VLA1553 vaccine has been cleared under the Ixchiq brand for use in people aged 18 and over who are at increased risk of exposure to chikungunya, which causes fever and debilitating joint pain, as well as muscle aches, joint swelling, headache, nausea, fatigue, and rash. In severe cases, it can cause systemic complications and death.

The FDA said chikungunya – which means “disease that bends up the joints” in the language of the Makonde tribe in Africa – is an emerging global health threat with at least five million cases reported in the past 15 years, with the highest risk seen in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas.

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.

There are currently no approved drug treatments for chikungunya, and Valneva has won the race to bring a vaccine for the disease to the US market ahead of rivals like Denmark’s Bavarian Nordic.

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” commented Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research (CBER).

“Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options,” he added.

Ixchiq is based on a live, weakened version of the chikungunya virus that is administered as a single intramuscular injection. In clinical trials, the vaccine showed an antibody response rate of 98.9% in adult recipients 28 days after receiving a single dose, with almost all participants maintaining this response for at least 12 months.

The FDA approval is a welcome boost to Valneva, which is picking itself up from a challenging 2022 after the European Commission abandoned nearly all of its orders for the company’s COVID-19 vaccine VLA2001. It has, however, seen buoyant sales growth for its two travel vaccines – Ixiaro for Japanese encephalitis and Dukoral for cholera – which grew 43% to €106 million in the first nine months of this year.

Valneva has estimated that the global market for vaccines against chikungunya could exceed $500 million annually by 2032.

The company has also filed for approval of the chikungunya vaccine in Europe and Canada, with regulatory decisions there expected next year, and has said it expects sales of its vaccines to rise to €130-€150 million for the full year.

Bavarian Nordic acquired rights to its CHIKV VLP candidate from Emergent BioSolutions in May as part of a $380 million deal to transfer rights to the latter’s travel vaccines business and has already reported phase 3 results that it says will support regulatory filings.

India’s Bharat Biotech is also working on a vaccine, currently in a phase 2/3 trial, while MSD abandoned its candidate after disappointing clinical trial results.