Valneva withdraws chikungunya vaccine Ixchiq from US amid new FDA investigation

 Following an FDA marketing suspension, Valneva has decided to voluntarily withdraw its chikungunya vaccine Ixchiq in the U.S.

The French company announced the decision Monday, noting that the FDA has also opened an investigation into a newly reported serious adverse event.

The FDA suspended Ixchiq’s approval in August after raising serious safety concerns related to the vaccine. At that time, the agency said it had received reports of one death from encephalitis “directly attributable” to the vaccine and more than 20 serious adverse events—hospitalizations and deaths—that were “consistent with chikungunya-like illness.”

According to Valneva, the agency recently placed a clinical hold on Ixchiq’s development program to investigate a new case reported outside the U.S. The event involved a younger adult who received three vaccines together, including Ixchiq. Valneva described the case as “plausibly related to Ixchiq vaccination" but caveated that "causality has not been determined.”

With an FDA accelerated approval in November 2023, Ixchiq became the world’s first shot for chikungunya. Its retreat leaves Bavarian Nordic’s Vimkunya the only available chikungunya vaccine in the U.S.

To confirm Ixchiq’s efficacy and safety profile, Valneva has planned to start a post-marketing phase 4 program, including a randomized controlled efficacy and safety study for adults in endemic countries and an observational effectiveness study in Brazil. In its Jan. 19 release, the company said it “intends to move forward” with the post-marketing activities “subject to further discussions with relevant regulatory authorities.”

With the withdrawal, it appears that Valneva does not wish to bring Ixchiq back to the U.S., even upon completing the post-marketing study.

“This is a permanent decision,” a Valneva spokesperson told Fierce Pharma.

“The withdrawal of our Ixchiq BLA in the U.S. does not have any impact on Valneva’s workforce,” the spokesperson added.

As the vaccine was in its early launch phase and had been suspended since August, Valneva didn’t factor any U.S. Ixchiq sales into its projections for 2025 and beyond.

Despite the safety issues and U.S. withdrawal, Valneva said it continues to engage with other health regulators in Europe, Canada, the U.K. and Brazil, where Ixchiq is licensed. While the vaccine’s various marketing authorizations target travelers, Valneva argues that “Ixchiq’s benefit-risk profile also remains favorable for people living in the endemic and outbreak settings.”

Meanwhile, Valneva investors’ focus remains on a potentially imminent phase 3 readout from VLA15, a Lyme disease vaccine partnered with Pfizer. There are about 476,000 annual cases of Lyme disease in the U.S. and 87 million people living in endemic regions in the country, with no vaccine currently available, according to Valneva.

VLA15 uses a primary series of three doses, followed by a booster dose before the second tick season. That’s different from the two-plus-one regimens by LYMErix and ImuLyme, both of which were withdrawn from the market in the early 2000s amid poor market performance. VLA15’s efficacy will be evaluated after that second season in the phase 3 trial. 

https://www.fiercepharma.com/pharma/valneva-withdraws-chikungunya-vaccine-ixchiq-us-amid-new-fda-investigation