As safety flags hang over Valneva’s chikungunya vaccine in the U.S. and beyond, French authorities are clamping down on the shot’s use in older adults.
France’s public health agency, the Haute Autorité de Santé (HAS), has temporarily suspended the use of Valneva’s vaccine Ixchiq in adults ages 65 years and older as authorities investigate several serious adverse events experienced by elderly people during an ongoing vaccination campaign on the French islands of La Reunion and Mayotte.
While France initially prioritized use of Valneva’s shot in adults 65 and older, especially among people with comorbidities, the country’s health agency changed its tune on April 25 following three reported cases of serious adverse events that led to hospitalizations, and even one death, after people in La Reunion were vaccinated with Ixchiq.
The three people who were hospitalized were more than 80 years old and had preexisting health conditions, Valneva explained in a Saturday press release. The adverse events were reported through the French health authority’s official pharmacovigilance system, and causality between the side effects and Valneva’s shot has not been “definitely established,” the company noted.
Valneva says it's now working with regulators on next steps, and the company pointed out that HAS is maintaining its recommendation for Ixchiq’s use in people ages 18 to 64 as part of France’s ongoing vaccination campaign. The current suspension will remain in place “pending further investigation” into the adverse event reports, the company added.
France is currently carrying out chikungunya vaccination campaigns on the islands of La Reunion and Mayotte. In the case of La Reunion, the island has tallied more than 40,000 confirmed chikungunya cases since the start of the year, Valneva said. In turn, the company has delivered 40,000 doses of Ixchiq to the island.
Valneva, which is headquartered in Saint-Herblain, France, supports the move by French health authorities to restrict Ixchiq use in older adults as potential safety issues are sussed out.
“Valneva is committed to the highest standards of safety and agrees on the importance of continuing the stringent safety surveillance protocols that are in place,” the company’s chief medical officer, Juan Carlos Jaramillo, M.D., said in a statement.
“We appreciate the precautionary decision of the authorities while investigations remain ongoing and in the context of the active vaccination campaign,” he explained, noting that Valneva is working on a potential update of its vaccine’s indication.
The potential safety concerns around Valneva’s shot aren’t strictly a French phenomenon, with the U.S.’ Centers for Disease Control and Prevention (CDC) in February launching its own probe in the wake of several hospitalizations among older adults who’d recently received Ixchiq.
Meanwhile, at a delayed meeting of the CDC’s Advisory Committee on Immunization Practices earlier this month, the panel voted to recommend a precaution tied to Ixchiq’s use in people ages 65 years and older, Valneva said in an April 18 press release.
“This precaution is a response to an ongoing investigation by the CDC of six cases of serious adverse events, including five hospitalizations, among persons aged 67-86 years after vaccination with Ixchiq,” Valneva said.
Valneva was first to reach the FDA finish line with its chikungunya shot back in November 2023, beating out vaccine rival Bavarian Nordic, which has since won a recent FDA nod for its own chikungunya immunization Vimkunya.
Despite the excitement around Ixchiq’s approval, the vaccine delivered “lower than anticipated” launch-year sales of just 3.7 million euros in 2024, Valneva said in its annual earnings release in March.
Nevertheless, shepherding Ixchiq’s debut is still top of mind for Valneva this year, with the company planning to target four types of customers with its vaccine, CEO Thomas Lingelbach said in an interview with Fierce Pharma earlier this month.
Valneva will direct Ixchiq toward people who live in areas where the chikungunya virus is prevalent, to travelers who visit those areas, to military units with troops stationed in those areas and to governments stockpiling for outbreaks, Lingelbach said.
Valneva has guided its annual chikungunya sales to exceed 100 million euros ($107 million) within three years of launch. Last year, the company’s total product revenue came out to 163 million euros (about $186 million).