卫生监管机构昨日宣布,为宫颈癌疫苗的安全性研究日益关注严重的副作用。每个女孩在中学是提供人类乳头瘤病毒疫苗针对疾病。许多专家说,计划是重要的因为它是在35岁以下的最常见的癌症。
但是,欧洲药品管理局将进行正式审查将集中在两个罕见的条件可能的联系。这些复杂区域疼痛综合征–慢性疼痛状况影响四肢–和体位性心动过速综合征(盆),导致心率异常。
活动人士一直呼吁多年的调查,几十户警告他们女儿的健康受到严重影响的刺。原本健康的青少年遭受适合,极度疲劳甚至没有坐轮椅。官方数据显示,HPV疫苗接种计划吸引了8228个疑似不良反应报告以来推出的2008,几乎是所有其他常规疫苗放在一起。
超过四分之一被归类为严重,包括症状严重到需要住院治疗甚至是致命的。医生强调,然而,这是一个很小的比例,在同一时期的800万剂量。昨天,EMA表示仍有信心,HPV疫苗的益处大于其风险,并称将在戳审查仍在使用。监管机构说:“这些条件的年轻女性接受HPV疫苗的报告已经在日常安全监测以前被认为是不成立的,但他们的疫苗之间的因果联系。“这两种情况都会发生在未接种疫苗的人群,如果报道的HPV疫苗的病例数量大于它是进一步审查重要的会。”卡隆赖亚尔斯,对HPV疫苗的受伤的女儿,该协会秘书长说:“他们必须采取行动,所以这并不奇怪,但它是受欢迎的。
“我担心的是,这些问题导致如果官员正在寻找确认诊断,很可能错过。“我希望评审会听家庭不只是制药公司。”海伦Drake,51,竞选调查自从女儿开始遭受严重的疲惫后两剂量HPV注射五年前12岁。她被诊断为盆症状去年,享年17岁,德雷克夫人说,回顾辉煌的消息,补充说:“任何医疗干预必须有压倒性的证据证明利大于弊的。
宫颈癌,造成现实电视明星杰德古蒂2009只有27岁,影响到3000的女性每年在英国。HPV疫苗一直被给予12和13岁女孩自2008。据认为,接种疫苗可以节省近一半的1000人的生命,每年损失的疾病。疫苗通过性传播的人乳头瘤病毒预防感染,这是在大多数癌症病例。审查之后,最近的两项研究显示HPV疫苗的潜在风险。莎拉博士的分支,英国药物和保健产品监管署,说近90个符合条件的青少年接种过疫苗。她说:“有很高的吸收水平,这样的报道是可以预期的。但是疫苗不是原因。”葛兰素史克,这使得一个疫苗Cervarix,说其安全性已经经过严格的测试和公司的利益风险的信心。
原文
Safety probe into cervical cancer jab: Families win action over side-effects
Health regulators yesterday announced an investigation into the safety of the cervical cancer vaccine amid mounting concerns over severe side-effects.
Every girl at secondary school is offered the human papilloma virus jab against the disease.
Many experts say the programme is essential as it is the most common cancer among the under-35s.But the European Medicines Agency will now carry out an official review which will focus on possible links to two rare conditions.These are complex regional pain syndrome – a chronic pain condition affecting the limbs – and postural orthostatic tachycardia syndrome (PoTS), which causes abnormal heart rate.
Campaigners have been calling for an investigation for years as dozens of families warn that their daughters’ health had been severely affected by the jab.Previously healthy teenagers have suffered fits, extreme tiredness or even been left wheelchair-bound. Official figures show the HPV vaccination programme has drawn 8,228 reports of suspected side-effects since being launched in 2008, almost as much as all other routine jabs put together.
More than a quarter were classed as serious, which includes symptoms severe enough to require hospital treatment or even be life-threatening. Doctors stress, however, that this represents a tiny proportion of the 8million doses given in the same period.Yesterday the EMA said it remains confident ‘the benefits of HPV vaccines outweigh their risks’, adding that the jab would remain in use during its review.The regulator added: ‘Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring but a causal link between them and the vaccines was not established.‘Both conditions can occur in non-vaccinated individuals and it is important to further review if the number of cases reported with HPV vaccine is greater than would be expected.’
Caron Ryalls, secretary of the Association of HPV Vaccine Injured Daughters, said: ‘They had to take action so it is not surprising but it is welcome.
‘My concern is these problems are underdiagnosed so if officials are looking for confirmed diagnoses, a lot might be missed.‘I hope the review will listen to the families and not just the pharmaceutical companies.’Helen Drake, 51, has campaigned for an inquiry since her daughter started suffering severe exhaustion after two doses of the HPV jab five years ago aged 12. She was diagnosed with PoTS symptoms last year, aged 17,Mrs Drake said the review is ‘brilliant news’, adding: ‘Any medical intervention must come with overwhelming proof that the benefits outweigh the risks’.Cervical cancer, which killed reality TV star Jade Goody in 2009 aged only 27, affects 3,000 women in Britain each year.The HPV jab has routinely been given to 12 and 13-year-old girls since 2008. It is thought the vaccinations could save almost half of the 1,000 lives lost each year to the disease.The jab prevents infection by the sexually transmitted human papilloma virus, which is behind most cases of the cancer.The review comes after two recent studies highlighted the potential risks of the HPV jab.Dr Sarah Branch, of the UK Medicines and Healthcare products Regulatory Agency, said nearly 90 per cent of eligible teenagers had been vaccinated.
She added: ‘With this very high level of uptake, such reports are to be expected. But the vaccine isn’t necessarily the cause.’GlaxoSmithKline, which makes one vaccine Cervarix, said its safety has been ‘rigorously tested’ and the firm is ‘confident in the benefit-risk profile’.