FDA Approves World's First Mosquito-Borne Chikungunya Vaccine

The FDA approved Valneva SE's VALN Chikungunya single-dose vaccine in individuals aged 18 and above.

The company plans to start selling the vaccine, dubbed Ixchiq, in the U.S. early next year.

Ixchiq was approved using the Accelerated Approval pathway

"Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies," Valneva said.

With this U.S. approval, Ixchiq becomes the world's first licensed chikungunya vaccine and the third vaccine Valneva has brought from early R&D to approval. 

Also Read: Bavarian Nordic Beefs Up Chikungunya Vaccine Race With Valneva With Encouraging Late-Stage Trial Data.

Valneva reported final pivotal Phase 3 data for the vaccine in March 2022, showing a 98.9% seroresponse rate at 28 days with a single vaccination and final lot-to-lot consistency results in May 2022. 

Ixchiq-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination. 

Valneva will continue to evaluate antibody persistence for at least five years.

The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat, with at least 5 million chikungunya virus infection cases reported in the past 15 years. 

The most common symptoms of chikungunya include fever and joint pain. Other symptoms may include a rash, headache, and muscle pain.

Treatment includes rest, fluids, and over-the-counter medications for pain and fever, the FDA said.

Price Action: VALN shares are up 6.04% at $14.58 premarket on the last check Friday.