英国药监局撤销基孔肯雅疫苗 IXCHIQ 上市许可：效益风险平衡不再有利，产品撤出英国市场
英国药品与保健品监管局（MHRA）10月在伦敦公布，经人类药物委员会建议，该局认定基孔肯雅疫苗 IXCHIQ 的效益与风险平衡不再有利，已撤销其英国上市许可，该产品正撤出英国市场，医疗专业人员不得再处方、供应或接种该疫苗，并应处置现有库存。
MHRA 在10月《安全通讯》中表示，前往基孔肯雅流行地区的旅客应咨询其他预防选项，包括其他基孔肯雅疫苗及防蚊叮咬措施。已接种该疫苗的人无需采取特别行动，但如有疑问应寻求医疗建议，并通过黄卡系统报告任何疑似不良反应。
基孔肯雅病由受感染蚊子传播，常见症状包括发烧与关节疼痛，目前没有特效治疗。MHRA 表示，该决定是基于对现有安全性与有效性证据的检视作出的，相关细节载于同期发布的药物安全更新。
MHRA 提醒，任何人如怀疑自己出现疫苗或药品的不良反应，可向医疗专业人员查询，并透过黄卡计划向 MHRA 报告，以助持续监测药品安全。
UK Regulator Withdraws IXCHIQ Chikungunya Vaccine: Benefit-Risk Balance No Longer Favourable, Product Removed From UK Market
The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced in London in October that, on the advice of the Commission on Human Medicines, it has concluded the benefit-risk balance of the IXCHIQ chikungunya vaccine is no longer favourable. The vaccine's UK marketing authorisation has been withdrawn and the product is being removed from the UK market. Healthcare professionals must not prescribe, supply or administer it, and should dispose of stock.
In its October Safety Roundup, the MHRA said travellers to regions where chikungunya circulates should be advised on alternatives, including other chikungunya vaccines and mosquito-bite avoidance. People who have already received the vaccine need take no specific action, but should seek medical advice if concerned and report any suspected side effects through the Yellow Card scheme.
Chikungunya is spread by infected mosquitoes and typically causes fever and joint pain; there is no specific treatment. The MHRA said the decision followed a review of the available safety and effectiveness evidence, with details set out in the accompanying Drug Safety Update.
The agency reminded the public that anyone who suspects a side effect from a vaccine or medicine can speak to a healthcare professional and report it to the MHRA via Yellow Card, which supports the continuous monitoring of medicine safety.
来源：GSM·美国（原文链接）
图片来源：埃及伊蚊（埃及斑蚊）。NIAID 摄，CC BY 2.0，经 Wikimedia Commons。 / Aedes aegypti mosquitoes. Photo by NIAID, CC BY 2.0, via Wikimedia Commons.
