FDA Ends Suspension of Chikungunya Vaccine, Adjusts Label

Regulators in May effectively stopped administration of the vaccine.

A box of Ixchiq chikungunya vaccine at a pharmacy in Le Reunion, in this file photograph. Richard Bouhet/AFP via Getty Images

The Food and Drug Administration has lifted its hold on a vaccine against chikungunya, the agency announced on Aug. 6, as it adjusted the label for the shot.

The FDA is ending its recommended pause, which effectively stopped administration of Valneva’s vaccine Ixchiq, the agency said in a statement.

FDA officials in May advised adults aged 60 and up not to receive the vaccine, following reports that recipients who received it suffered severe symptoms usually experienced with infection of the chikungunya virus.

Several of the recipients died.

The FDA said on Wednesday that it finished an updated assessment of the risks and benefits of Ixchiq and that it is lifting the pause because the benefits outweigh the risks for some people.

The FDA cleared Ixchiq in 2023, and the Centers for Disease Control and Prevention recommended it in 2024 for adults traveling to certain countries.

The FDA also said in the new announcement that it has approved an updated label for the vaccine.

The label now says the vaccine is for adults “who are at high risk of exposure to CHIKV,” or the chikungunya virus. The label used to say, “at increased risk of exposure.”

The limitations section of the label now state: “Vaccination with Ixchiq is not advisable for most U.S. travelers. For most U.S. travelers, the risk of exposure to CHIKV is low. The Centers for Disease Control and Prevention provides resources for assessing likelihood of exposure to CHIKV among travelers and laboratory workers.”

The label now also says that administration of the vaccine should only be done after consideration of a person’s risk of severe or chronic problems if infected with the virus, as well as the risks of “serious, severe, or prolonged chikungunya-like illness caused by vaccination with Ixchiq.”

The warnings section highlights how some people have reported severe complications following receipt of the vaccine, including hospitalization and death. The vaccine “may cause serious, severe, or prolonged chikungunya-like illness,” it states.

Valneva made the adjustments under orders from the FDA. Officials approved the adjustments.

Dr. Vinay Prasad, the FDA’s top vaccine official, who supported the pause, left the agency recently.

Prasad said in an article published by the Journal of the American Medical Association in June that the pause was to let the agency investigate the reported problems and “ascertain whether additional, unreported adverse events exist.”

Valneva said in a statement that the recommended pause was lifted and the label has been updated.

“Ongoing FDA reviews are progressing regarding potential extension of Ixchiq’s label to adolescents and inclusion of additional persistence data,” the company stated.