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Immediate Release: November 09, 2023
Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. ...
Ixchiq is administered as a single dose by injection into the muscle. It contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.
The safety of Ixchiq was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo. The most commonly reported side effects by vaccine recipients were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.
In addition, although not commonly reported, severe chikungunya-like adverse reactions that prevented daily activity and/or required medical intervention occurred in 1.6% of Ixchiq recipients and none of the placebo recipients. Two recipients with severe chikungunya-like adverse reactions were hospitalized. In addition, some recipients had prolonged chikungunya-like adverse reactions that 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.
The FDA is requiring the company to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of Ixchiq. ...
Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. ...
Ixchiq is administered as a single dose by injection into the muscle. It contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.
The safety of Ixchiq was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo. The most commonly reported side effects by vaccine recipients were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.
In addition, although not commonly reported, severe chikungunya-like adverse reactions that prevented daily activity and/or required medical intervention occurred in 1.6% of Ixchiq recipients and none of the placebo recipients. Two recipients with severe chikungunya-like adverse reactions were hospitalized. In addition, some recipients had prolonged chikungunya-like adverse reactions that 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.
The FDA is requiring the company to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of Ixchiq. ...