November 14, 2023
The Food and Drug Administration recently approved Ixchiq (Valneva Austria), the first vaccine for chikungunya virus disease (CVD), for adults who are at increased risk of CVD exposure. Ixchiq is a single-dose vaccine that contains a live, weakened version of the chikungunya virus (CHIKV). It may cause symptoms in vaccine recipients similar to those experienced by people who have CVD.
FDA based the approval of Ixchiq on immune response data from a clinical study of adult patients in the U.S. who received the vaccine (266 patients) or placebo (96 patients). In the trial, almost all vaccinated participants achieved an antibody level shown to be protective in non-human primates that had received blood from people who had been vaccinated. As a condition for approval for Ixchiq, FDA is requiring confirmatory clinical studies to be conducted to verify clinical benefit.
In addition, FDA considered safety data from a trial of about 4,500 adult patients in North America (approximately 3,500 and 1,000 patients in the treatment and placebo groups, respectively). Among vaccine recipients, the most reported side effects were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site. Severe chikungunya-like adverse reactions occurred in 1.6% of vaccine recipients, some of which lasted for at least 30 days. The prescribing information includes a warning to inform that the vaccine may cause severe or prolonged chikungunya-like adverse reactions.
In its approval, FDA noted that transmission of CHIKV to newborn babies from pregnant individuals with viremia at delivery has been reported and can cause severe, potentially fatal CVD in newborns. The prescribing information includes a warning to inform that it is not known if the vaccine virus can be transmitted from pregnant individuals to newborns, nor is it known if the vaccine virus can cause any adverse effects in the newborn.
AABB has contacted FDA’s Center for Biologics Evaluation and Research to inquire about the possible need for a donor deferral following vaccination with Ixchiq. AABB will update the community upon receiving the agency’s response.