Latest news with #ChikungunyaVaccine
Miami Herald
13-05-2025
- Health
- Miami Herald
After 2 reported deaths, health officials tell Ixchiq users age 60+ to stop vaccine temporarily
May 12 (UPI) -- U.S. health officials are advising patients using the drug Ixchiq to hold off while authorities seek newer information on vaccine results in the global fight against chikungunya. The pause for U.S. patients was initiated Friday by the FDA and CDC while the two federal agencies investigate "postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine" Ixchiq, otherwise known as live "Chikungunya Vaccine," according to a safety communication by the U.S. Food and Drug Administration. In November 2023, the FDA approved Ixchiq for the prevention of disease caused by the chikungunya virus in patients age 18 years and older. On Friday, health officials said the FDA will conduct an updated benefit-risk assessment for the use of Ixchiq in individuals 60 years of age and older after over 80,000 doses of Ixchiq were distributed worldwide. Since the start of this year, roughly 80,000 cases and 46 CHIKVD-related deaths have been reported in 14 countries or territories, says the EU-backed European Centre for Disease Prevention and Control. FDA officials said as of Wednesday that 17 "serious adverse events" were reported globally in people over age 62 who got Ixchiq, with two reported deaths. Of the 17 reports, six were U.S.-based, but American health officials did not indicate if any of those deaths were in the United States. However, officials pointed out that reported adverse events "may not be causally related to vaccination." According to the U.S. Centers for Disease Control and Prevention, the virus is transmitted by mosquitoes and the symptoms can last anywhere from one week to several months. Like dengue fever, chikungunya virus causes high fever, rashes, headache and joint pain. And while most patients recover with days, the joint pain can persist for months that can be managed with pain-relieving and anti-inflammatory medications. But while it has the potential to temporarily disable a victim, it does not often result in death. The single-dose shot approved November 2023 by the federal government was for use in adults with an increased risk of exposure to the chikungunya virus. Mosquitoes can infect people with Zika and chikungunya viruses at the same time, research has suggested, and may cause fatal brain infection which hit 24 victims by November 2015. The virus was observed and described in U.S. patients who traveled from the Caribbean area to Georgia and North Carolina as chikungunya hit Cuba around May 2014. Chikungunya, an illness caused by a virus spread via mosquito bites but not by person-to-person contact, was first detected in the Americas near the end of 2013 as it swiftly spread to other Caribbean nations, Africa and Asia. However, no cases have been reported on Europe's mainland. Friday's federal advisory on Ixchiq arrived amid a crackdown on vaccine use and its pertinent studies lead by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a known critic of effective and long-existing vaccines. More information Visit the U.S. Centers for Disease Control and Prevention for more on chikungunya virus. Copyright 2025 UPI News Corporation. All Rights Reserved.
Yahoo
12-05-2025
- Health
- Yahoo
After 2 reported deaths, health officials tell Ixchiq users age 60+ to stop vaccine temporarily
May 12 (UPI) -- U.S. health officials are advising patients using the drug Ixchiq to hold off while authorities seek newer information on vaccine results in the global fight against chikungunya. The pause for U.S. patients was initiated Friday by the FDA and CDC while the two federal agencies investigate "postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine" Ixchiq, otherwise known as live "Chikungunya Vaccine," according to a safety communication by the U.S. Food and Drug Administration. In November 2023, the FDA approved Ixchiq for the prevention of disease caused by the chikungunya virus in patients age 18 years and older. On Friday, health officials said the FDA will conduct an updated benefit-risk assessment for the use of Ixchiq in individuals 60 years of age and older after over 80,000 doses of Ixchiq were distributed worldwide. Since the start of this year, roughly 80,000 cases and 46 CHIKVD-related deaths have been reported in 14 countries or territories, says the EU-backed European Centre for Disease Prevention and Control. FDA officials said as of Wednesday that 17 "serious adverse events" were reported globally in people over age 62 who got Ixchiq, with two reported deaths. Of the 17 reports, six were U.S.-based, but American health officials did not indicate if any of those deaths were in the United States. However, officials pointed out that reported adverse events "may not be causally related to vaccination." According to the U.S. Centers for Disease Control and Prevention, the virus is transmitted by mosquitoes and the symptoms can last anywhere from one week to several months. Like dengue fever, chikungunya virus causes high fever, rashes, headache and joint pain. And while most patients recover with days, the joint pain can persist for months that can be managed with pain-relieving and anti-inflammatory medications. But while it has the potential to temporarily disable a victim, it does not often result in death. The single-dose shot approved November 2023 by the federal government was for use in adults with an increased risk of exposure to the chikungunya virus. Mosquitoes can infect people with Zika and chikungunya viruses at the same time, research has suggested, and may cause fatal brain infection which hit 24 victims by November 2015. The virus was observed and described in U.S. patients who traveled from the Caribbean area to Georgia and North Carolina as chikungunya hit Cuba around May 2014. Chikungunya, an illness caused by a virus spread via mosquito bites but not by person-to-person contact, was first detected in the Americas near the end of 2013 as it swiftly spread to other Caribbean nations, Africa and Asia. However, no cases have been reported on Europe's mainland. Friday's federal advisory on Ixchiq arrived amid a crackdown on vaccine use and its pertinent studies lead by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a known critic of effective and long-existing vaccines. More information Visit the U.S. Centers for Disease Control and Prevention for more on chikungunya virus.
Yahoo
16-04-2025
- Health
- Yahoo
Bavarian Nordic's Chikungunya Vaccine Receives Recommendation from U.S. CDC's Advisory Committee on Immunization Practices (ACIP)
Recommendation of first chikungunya vaccine for persons as young as 12 years old expands access for US travelers to regions with outbreak or elevated risk of chikungunya. COPENHAGEN, Denmark, April 16, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the virus-like particle (VLP)-based, single-dose vaccine, VIMKUNYA™ (Chikungunya Vaccine, Recombinant) for injection, for the prevention of disease caused by chikungunya virus. ACIP recommends VIMKUNYA for persons aged 12 and older traveling to a country or territory where there is a chikungunya outbreak. In addition, VIMKUNYA may be considered for persons traveling or taking up residence in a country or territory without an outbreak but with elevated risk for US travelers if planning travel for an extended period of time. ACIP also recommends VIMKUNYA for laboratory workers with potential for exposure to chikungunya virus. According to CDC, there has been evidence of chikungunya virus transmission to humans in more than 50 countries within the last five years. Paul Chaplin, President and CEO of Bavarian Nordic said: 'The ACIP's recommendation of our chikungunya vaccine for Americans aged 12 and older is a big step forward to expanding access to this vaccine in the United States. Chikungunya is an emerging public health threat around the world, and today's decision is another milestone in our mission to protect more people from this virus.' The recommendation from ACIP is pending final approval by the Director of the CDC and the U.S. Department of Health and Human Services. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years1. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years2. In 2024, 620,000 cases of chikungunya were reported worldwide, an increase of more than 20% compared to 20233,4. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile5. About VIMKUNYA™ (Chikungunya Vaccine, Recombinant) VIMKUNYA is a vaccine for prevention of disease caused by chikungunya virus in people 12 years of age and older. VIMKUNYA was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 20256,7. Bavarian Nordic has also filed for approval of the vaccine in the United Kingdom and Canada. Additional clinical trials are required to confirm the clinical profile. VIMKUNYA is supplied as a single-dose 1-mL glass pre-filled syringe with 0.8 mL dose volume. Important Safety InformationThe following information is based on the U.S. Prescribing Information for VIMKUNYA. Please consult the full Prescribing Information for all the labelled safety information for VIMKUNYA. You should not get VIMKUNYA if you are allergic to any of the ingredients of the vaccine or if you have had an allergic reaction following a previous dose of VIMKUNYA. People with a lowered immune system, including people receiving medications that affect the immune system, may have a diminished response to VIMKUNYA. Tell your healthcare provider about all medications you are taking. Fainting may occur with administration of injected vaccines including VIMKUNYA. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. These are not all the possible side effects. Tell your healthcare provider if you are pregnant, planning to become pregnant, or are breastfeeding. Tell your healthcare provider about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by visiting or call 1-800-822-7967. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: +45 53 88 06 03 Visit for additional media information. Company Announcement no. 14 / 20251 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. 2 European Centre for Disease Prevention and Control. Chikungunya virus disease. 3 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 4 European Centre for Disease Prevention and Control. Chikungunya virus disease cases January - December 2023. Chikungunya virus disease cases January - December 2023. 5 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/ PMID: 38711542; PMCID: PMC11070701. 6 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 7 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. Attachment 2025-14-en
