Valneva's US License for Chikungunya Vaccine Suspended by FDA

The FDA has suspended Valneva's chikungunya vaccine license in the US. Valneva is a specialty vaccine company that develops and commercializes prophylactic vaccines for infectious diseases. The company has a strong track record and markets two proprietary travel vaccines as well as third-party vaccines. Its commercial business fuels the advancement of its vaccine pipeline, including the first vaccine against the chikungunya virus and the only Lyme disease vaccine candidate in advanced clinical development, partnered with Pfizer.

The United States Food and Drug Administration (FDA) has suspended the license for Valneva SE's chikungunya vaccine, IXCHIQ®, effective immediately. The decision, announced on August 25, 2025, follows four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, as reported to the Vaccine Adverse Event Reporting System (VAERS).

The suspension comes after the FDA's decision on August 6, 2025, to remove its recommended pause in the use of IXCHIQ® in individuals 60 years of age and older. The new suspension is based on updated VAERS data, which now includes four additional SAEs that occurred outside the United States. Of the four reported cases, three occurred in individuals aged 70 to 82 years, including one hospitalization of an 82-year-old individual who was discharged after two days; the remaining case occurred in a 55-year-old individual.

Valneva, a specialty vaccine company, has stated that all cases describe symptoms consistent with those previously reported during clinical trials and post-marketing experience, particularly among the elderly individuals for whom the vaccine's Prescribing Information (PI) includes warnings and precautions. The company is continuing to investigate these cases in detail and will engage proactively with health authorities in all territories where IXCHIQ® is licensed.

The suspension of IXCHIQ® in the US is expected to impact Valneva's revenue. Sales of IXCHIQ® contributed €7.5 million to the company's €91 million total product sales in the first half of 2025. Valneva is evaluating the potential financial impact of a permanent withdrawal of the IXCHIQ® license in the United States but is not modifying its revenue guidance at this time.

Valneva remains committed to maintaining access to its vaccine as a global health tool for addressing and preventing outbreaks of chikungunya. The company aims to continue providing IXCHIQ® to all countries where the product is licensed and to accelerate vaccine access in low- and middle-income chikungunya-endemic countries, especially in response to any current or future chikungunya outbreaks.

References:
[1] https://finance.yahoo.com/news/valneva-announces-fda-decision-suspend-050000615.html