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Medscape
11-07-2025
- Health
- Medscape
EMA Lifts Chikungunya Vaccine Restriction
The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has issued a safety update on the chikungunya vaccine after review of the Ixchiq live-attenuated jab. It said that it would now lift the temporary restriction put in place in May on vaccinating people aged 65 years and above as a result of reports of serious side effects. However, the committee emphasized that the vaccine should only be used after careful consideration of risks and benefits when there is significant risk of chikungunya infection. Chikungunya is a viral disease that is most common in Africa, Asia, the Caribbean, and South and Central America, with a few cases also reported in Europe and the US. It is carried by mosquitoes, most often Aedes aegypti and Aedes albopictus , that may also transmit dengue and Zika viruses. Person-to-person transmission does not occur, though rarely the infection may be passed on via blood. Crippling Joint Pain The incubation period is 3-7 days. Common symptoms are fever, rash, muscle pain, and severe arthralgia. The name chikungunya comes from a Tanzanian word to describe the way severely affected patients often assume a stooped appearance due to crippling pain. Most infections are mild, with only about 2% leading to severe symptoms. There may be a risk of encephalitis, but this is rare and unclear. Most of those affected recover within a week to 10 days of the start of symptoms. But 30%-40% of those affected develop ongoing chronic joint pain and chronic arthritis that can last for months or even years. Treatment is largely symptomatic. Side Effect Risk Groups Ixchiq was authorized in the EU in June 2024. When the recent PRAC review began, around 36,000 doses of the vaccine had been used worldwide. Safety data recorded 28 cases of serious side effects, mainly in people aged 65 years and older and those with multiple underlying comorbidities, particularly chronic or uncontrolled medical conditions such as cardiovascular diseases, diabetes mellitus, or chronic kidney disease. There had been three deaths. Although serious vaccine side effects most often affected this group, these were also the people at highest risk of severe chikungunya infection, the PRAC noted. Many of the serious side effects reported were similar to symptoms of chikungunya infection itself, the committee said. These could include fever, malaise, anorexia, and confusion, which can lead to falls. In some cases, vaccine side effects had worsened patients' medical conditions or caused deterioration in their general health, in some instances resulting in hospitalization. Avoid Vaccinating Immunocompromised People The committee also reminded healthcare professionals that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatment, as they are at greater risk of having complications from vaccines containing live-attenuated viruses. This contraindication remains in place following the review. The product information for Ixchiq will be updated with the latest recommendations following the review. A direct healthcare professional communication will be sent to healthcare professionals prescribing, dispensing, or administering Ixchiq and will be published on a dedicated page on the EMA website. The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use, which will adopt the agency's opinion before adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Reuters
11-07-2025
- Health
- Reuters
Europe lifts restriction on Valneva's chikungunya vaccine for elderly adults
July 11 (Reuters) - The European Union's health regulator has lifted the temporary restriction on the use of French drugmaker Valneva's ( opens new tab chikungunya vaccine, Ixchiq, in adults aged 65 and above, following a safety review. The European Medicines Agency's (EMA) safety committee had temporarily suspended use of the vaccine, branded Ixchiq, among the elderly in May as a precautionary measure. Chikungunya is a mosquito-borne disease that causes sudden fever and joint pain, transmitted by bites from infected Aedes mosquitoes. Ixchiq, the first preventive vaccine for chikungunya approved in both Europe and the United States, uses a weakened form of the virus to stimulate an immune response. Since its approval in the EU in 2024, more than 36,000 doses have been administered globally. The EMA panel found that while serious adverse events, including two deaths, were reported in people aged 62 to 89—often those with underlying health conditions—the vaccine remains effective in generating immunity. Older adults are at higher risk of severe chikungunya infection, making vaccination important in certain circumstances. As a result, the panel recommends the vaccine should now be reserved for situations where there is a significant risk of chikungunya infection, after careful benefit-risk assessment. The agency warned against administering Ixchiq to patients with compromised immune systems. Valneva did not immediately respond to Reuters' request for a comment. The agency will update product information to reflect the new recommendations.
New York Post
16-05-2025
- Health
- New York Post
Seniors should avoid this vaccine after deadly complications discovered, FDA says
Older adults are being warned against receiving the chikungunya vaccine before traveling. The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind. The approval applies to anyone aged 18 and older who has a risk of being exposed to the virus. But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications. 'FDA and CDC will continue the evaluation of post-marketing safety reports for Ixchiq,' the release reads. 'While the safety of Ixchiq for use in individuals 60 years of age and older is being further assessed, FDA and CDC are recommending a pause in use of the vaccine in this age group. FDA and CDC will update the public when the agencies complete their evaluation of this safety issue.' 3 The FDA is advising seniors to avoid getting the chikungunya vaccine before traveling. InsideCreativeHouse – The advisory follows reports of 'serious adverse events,' including neurologic and cardiac events in people who received the vaccine. Two of 17 events resulted in death from severe complications. One death was caused by encephalitis, or inflammation in the brain, the alert stated. 3 The Ixchiq vaccination was developed to prevent the mosquito-borne chikungunya virus. wirakorn – Those who experienced adverse effects of the vaccine were reported to be between the ages of 62 and 89. The FDA warned that Ixchiq, which contains a live, weakened version of chikungunya, may cause symptoms similar to the virus. Typical symptoms of chikungunya include fever, severe joint pain, headache, muscle pain and a rash, according to the CDC. Most people recover within a week, but some may experience 'severe and disabling' joint pain for weeks or months. 3 A patient infected with chikungunya looks out from mosquito netting at the Clinicas Hospital in San Lorenzo, Paraguay, in 2023. AP 'This virus is in a similar category as dengue or Zika and is carried by the same mosquitoes,' Fox News senior medical analyst Dr. Marc Siegel previously told Fox News Digital. At the time of the vaccine's approval, the FDA described chikungunya as an 'emerging global health threat,' with at least five million cases reported over the past 15 years. The FDA plans to conduct an 'updated benefit-risk assessment' for Ixchiq use in those over 60 years of age, according to the notice.
Yahoo
13-05-2025
- Health
- Yahoo
FDA warns seniors to avoid this vaccine after deadly complications
Older adults are being warned against receiving the chikungunya vaccine before traveling. The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind. The approval applies to anyone aged 18 and older who has a risk of being exposed to the virus. First Vaccine For Chikungunya Virus, An 'Emerging Global Health Threat,' Gets Fda Approval But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications. "FDA and CDC will continue the evaluation of post-marketing safety reports for Ixchiq," the release reads. Read On The Fox News App "While the safety of Ixchiq for use in individuals 60 years of age and older is being further assessed, FDA and CDC are recommending a pause in use of the vaccine in this age group. FDA and CDC will update the public when the agencies complete their evaluation of this safety issue." The advisory follows reports of "serious adverse events," including neurologic and cardiac events in people who received the vaccine. Two of 17 events resulted in death from severe complications. One death was caused by encephalitis, or inflammation in the brain, the alert stated. Those who experienced adverse effects of the vaccine were reported to be between the ages of 62 and 89. The FDA warned that Ixchiq, which contains a live, weakened version of chikungunya, may cause symptoms similar to the virus. Typical symptoms of chikungunya include fever, severe joint pain, headache, muscle pain and a rash, according to the CDC. Click Here To Sign Up For Our Health Newsletter Most people recover within a week, but some may experience "severe and disabling" joint pain for weeks or months. "This virus is in a similar category as dengue or Zika and is carried by the same mosquitoes," Fox News senior medical analyst Dr. Marc Siegel previously told Fox News Digital. At the time of the vaccine's approval, the FDA described chikungunya as an "emerging global health threat," with at least five million cases reported over the past 15 years. For more Health articles, visit The FDA plans to conduct an "updated benefit-risk assessment" for Ixchiq use in those over 60 years of age, according to the notice. Fox News Digital's Melissa Rudy contributed to this article source: FDA warns seniors to avoid this vaccine after deadly complications
Fox News
13-05-2025
- Health
- Fox News
FDA warns seniors to avoid this vaccine after deadly complications
Older adults are being warned against receiving the chikungunya vaccine before traveling. The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind. The approval applies to anyone aged 18 and older who has a risk of being exposed to the virus. But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications. "FDA and CDC will continue the evaluation of post-marketing safety reports for Ixchiq," the release reads. "While the safety of Ixchiq for use in individuals 60 years of age and older is being further assessed, FDA and CDC are recommending a pause in use of the vaccine in this age group. FDA and CDC will update the public when the agencies complete their evaluation of this safety issue." The advisory follows reports of "serious adverse events," including neurologic and cardiac events in people who received the vaccine. Two of 17 events resulted in death from severe complications. One death was caused by encephalitis, or inflammation in the brain, the alert stated. Those who experienced adverse effects of the vaccine were reported to be between the ages of 62 and 89. The FDA warned that Ixchiq, which contains a live, weakened version of chikungunya, may cause symptoms similar to the virus. Typical symptoms of chikungunya include fever, severe joint pain, headache, muscle pain and a rash, according to the CDC. Most people recover within a week, but some may experience "severe and disabling" joint pain for weeks or months. "This virus is in a similar category as dengue or Zika and is carried by the same mosquitoes," Fox News senior medical analyst Dr. Marc Siegel previously told Fox News Digital. At the time of the vaccine's approval, the FDA described chikungunya as an "emerging global health threat," with at least five million cases reported over the past 15 years. For more Health articles, visit The FDA plans to conduct an "updated benefit-risk assessment" for Ixchiq use in those over 60 years of age, according to the notice.
