FDA suspends Valneva vaccine license after new adverse event report
Due to safety concerns, the sale of safety issues in the U.S. market is no longer allowed, so for most of the year, the valneva chikungunya vaccine was conducted under regulatory scrutiny. According to new reports on safety issues, the FDA has suspended biologics licenses for vaccine Ixchiq.
According to Valneva, the FDA cites new reports of four serious adverse events consistent with the chikungunya. The Saint-Hebrin-based vaccine manufacturer said on Monday that the suspension of the license requires the company to immediately stop shipping and selling IXCHIQ.
Chikungunya is a mosquito-borne virus that circulates in tropical and subtropical regions. The virus can cause infection, causing fever, headaches, joint and muscle pain. IXCHIQ consists of an active but weak version of the single intramuscularly injected Chikungunya virus. In the second half of 2023, the FDA awarded IXCHIQ accelerated approval for adults, making the vaccine the first to prevent diseases caused by Chikungunya. A rapid regulatory nod requires Valneva to undergo post-business testing to assess the risk of severe chikungunya-like adverse reactions.
Last spring, among the elderly who received ixchiq, 17 serious adverse events were reported worldwide. Two of the reports were death. Some of these reports include complications consistent with severe chikungunya disease requiring hospitalization. In May, the FDA and the Centers for Disease Control and Prevention recommended that IXCHIQ dose pauses at ages 60 and older, and these agencies investigated the incidents. The European Medicines Agency conducted its own investigation.
In early August, the FDA canceled the pause after its risk-benefit assessment of IXCHIQ. An update was added to the product label, pointing to post-market reports for people aged 65 and over. But late Friday, the FDA released a new secure communication, noting that the IXCHIQ license has been suspended. The decision is based on the Center for Biologics Assessment and Research (CBER) Assessment Center and found that IXCHIQ appears to cause chikungunya-like disease in vaccine recipients. The agency said that in a growing number of 20 serious adverse events, consistent with chikungunya-like disease, there were 21 hospitalizations and 3 deaths. The FDA added that the clinical benefits of IXCHIQ have not been identified in a confirmatory study.
“In most reasonable cases, CBER's risk of interest analysis broadly shows that the risk of a vaccine without benefits outweighs the risk,” the FDA said in a safety newsletter. “For these reasons, Cber believes that this vaccine is not safe and that continuing to impose administration on the public would pose a health hazard.”
Vaneva said the new serious adverse events were four cases outside the United States. Three of them were from 70 to 82 years old; the 82-year-old vaccine recipient was hospitalized and discharged two days later. The fourth case is a 55-year-old man. The company said it believes all cases describe symptoms consistent with those reported in previous clinical trials and postmarket experiences, especially among older people. The company said the risk for that age group is already reflected in the product label. Valneva is continuing to investigate these cases and will take further FDA steps if necessary.
“Our goal is to continue to provide IXCHIQ to all countries with licensed products and continue to work with partners to accelerate vaccine access in low and middle-income Chikungunya-Dempomenty countries, especially in response to any current or future Chikungunya outbreak, ensuring the outbreak of vaccines to ensure the largest announcement of the vaccine from Valneva Ceo Thomas lingeelback.
In addition to approvals in the United States and the European Union, IXCHIQ also has marketing authorizations in Canada, the United Kingdom and Brazil. April approval in Brazil is the first time that Chikungunya has been obtained in the product. In the first half of 2025, Valneva reported that IXCHIQ accounted for 7.5 million euros of the company's 91 million euros revenue. The company is still evaluating the potential financial impact of IXCHIQ's suspension in the U.S., but has not yet revised its revenue guidance.
Americans seeking chikungunya vaccine do have other options. Earlier this year, the FDA awarded standard approval for the Chikungunya vaccine developed by Bavarian Nordic.
Illustration: Getty Images
