Valneva’s chikungunya vaccine approved by FDA

The Food and Drug Administration on Thursday cleared drugmaker Valneva’s preventive chikungunya virus vaccine in adults, the first shot to prevent illness from the mosquito-borne disease.

The vaccine, which will be sold as Ixchiq, is approved for U.S. adults 18 years and older who are at increased risk of exposure to the chikungunya virus.

“The first-ever licensed chikungunya vaccine will play a crucial role in preventing the suffering caused by this debilitating disease,” said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, in a statement provided by Valneva. “Climate change is intensifying the threat posed by chikungunya, which means safe and effective vaccines are needed now more than ever before.”

The virus is typically transmitted through the bites of infected mosquitos. The most common symptoms are fever and joint pain, and can also include headaches, muscle pain or rash. While death is rare, the disease can cause lasting symptoms that can be debilitating in some, particularly for young children and older adults.

It’s most prevalent in tropical and subtropical regions of Africa and Southeast Asia, as well as some parts of the Americas. Earlier this year, the Pan American Health Organization warned of an increased number of infections and deaths due to the spread of the virus in the Americas.

The FDA’s approval was based on clinical trial data that was published in The Lancet earlier this year. Testing assessed the shot’s safety as well as its effectiveness based on an immune response analysis. The data showed Ixchiq spurred immune responses at levels that proved protective in non-human primate testing, the FDA said.

In a small number of trial participants, vaccination led to side effects that were similar to chikungunya. Two participants had severe chikungunya-like adverse reactions and needed to be hospitalized.

A live-attenuated vaccine, Ixchiq was cleared under an accelerated approval. The FDA is requiring Valneva conduct confirmatory testing, as well as further assess the risk of severe chikungunya-like adverse reactions following immunization. The shot’s labeling includes a warning noting this as a possible side effect.

Valneva plans to begin marketing the vaccine in the U.S. next year, and said it expects a Centers for Disease Control and Prevention panel to meet in February to form recommendations for the shot’s use. The company did not offer further details when reached by BioPharma Dive for comment.

Analysts at Stifel, an investment bank, forecast Ixchiq sales will reach $150 million by 2028 for both travel and military deployment use.

The approval comes after Valenva reported rising sales of its other vaccines due to “recovery of the travel industry.” And as a result of the OK, the company received from the FDA a priority review voucher, a sort of regulatory fast pass that can expedite drug reviews or be sold to other companies.