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FDA Lifts Pause on Valneva’s Chikungunya Vaccine for Seniors

Under the revised label, vaccination is advised only for adults at high risk of exposure to the virus.

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The European Centre for Disease Prevention and Control (ECDC) states that, as of July 2025, there are around 240,000 cases across 16 countries or territories. Credit: 418 House via Shutterstock.com.
FDA Lifts Pause on Chikungunya Vaccine IXCHIQ Use in Adults 60+ Following Safety Review

Overview

  • The FDA removed its May recommendation to pause Ixchiq in people aged 60 and older after reviewing safety data from roughly 80,000 global recipients.
  • Updated prescribing information restricts Ixchiq to adults 18 years and older at high risk of exposure and states it is not advisable for most U.S. travelers.
  • New warnings note that individuals 65 and older with chronic medical conditions may face higher risk of serious neurologic and cardiac adverse events.
  • The European Medicines Agency made parallel changes in July, advising use only when there is a significant risk of chikungunya infection.
  • Regulators are balancing rare severe reactions against the need for prevention as chikungunya spreads in tropical regions and parts of China.