The FDA has lifted its previously recommended pause on the use of the Chikungunya virus vaccine in individuals 60 and older, following a benefit-risk assessment.
The agency also approved updated labeling for the vaccine, which includes expanded warnings about adverse reactions reported during postmarketing use. The pause, recommended May 9, was prompted by reports of serious neurologic and cardiac events in older adults, according to an Aug. 6 FDA news release.
The updated labeling clarifies that the vaccine is intended for individuals at high risk of exposure to the virus, rather than those at an increased risk. The agency also added a limitation of use note stating the vaccine is not advisable for most U.S. travelers given typically low exposure risk.
A postmarketing safety study required by the FDA is expected to begin by Oct. 1.
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