Valneva’s chikungunya vaccine has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in individuals ages 18 years and older who are at an increased risk of exposure to the mosquito-borne disease.

The decision makes Ixchiq, which is administered as a single intramuscular injection, the world's first licensed chikungunya vaccine.

Chikungunya often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating.

Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash.

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

He added: “[The] approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”

The US regulator’s decision was supported by clinical trial data showing that the vaccine, which contains a weakened version of the chikungunya virus, generated an antibody response rate of 98.9% in adult recipients 28 days after receiving a single dose, with almost all participants maintaining this response rate six months post-vaccination.

Valneva said it expected to make Ixchiq available in the US “early next year”, adding that it has also filed for approval of the vaccine in Europe and Canada.

Juan Carlos Jaramillo, the company’s chief medical officer, said: “Chikungunya has already spread to over 110 countries and is currently regarded as one of the most likely viral infections to emerge in new geographic areas… As we are introducing Ixchiq, our objective is to make this vaccine available to the largest number of people that will benefit from it.”

Bavarian Nordic has its own chikungunya vaccine candidate in late-stage development, CHIKV VLP.

The company reported positive top-line results from a phase 3 study of the candidate in adults and adolescents earlier this year, with the readout demonstrating that the vaccine was highly immunogenic at up to 22 days post-vaccination.

Bavarian Nordic’s president and chief executive officer, Paul Chaplin, said at the time that the company’s focus “remains to finalise the studies and prepare for regulatory submissions next year".

https://www.pmlive.com/pharma_news/valnevas_chikungunya_vaccine_approved_by_fda_for_adults_at_increased_exposure_risk_1503690