Seniors should avoid this vaccine after deadly complications discovered, FDA says
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 – stock.adobe.com
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.
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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.
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Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta TherapeuticsSarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Forward-Looking StatementsThis statement contains "forward-looking statements." Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believe," "anticipate," "plan," "expect," "will," "may," "intend," "prepare," "look," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials and ELEVIDYS. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Internet Posting of InformationWe routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Source: Sarepta Therapeutics, Inc. View source version on Contacts Investor Contact: Ian Estepan617-274-4052iestepan@ Media Contacts: Tracy Sorrentino617-301-8566tsorrentino@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
