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宫颈癌疫苗Gardasil

——宫颈癌疫苗Gardasil

2006-06-26 12:16:19  作者:  来源:中国新特药网  浏览次数:198  文字大小:【】【】【

FDA已批准人乳头状瘤病毒(HPV)疫苗Gardasil(加德西)用于预防HPV 6、11、16和18型感染引起的宫颈癌、生殖道癌前病变和生殖器疣。这是第一个预防上述疾病的HPV疫苗,被批准用于9~26岁女性。FDA采取优先快速审批过程,在6个月内完成评估和审批程序,说明Gardasil对公共卫生和女性健康的重要性。 

Gardasil是一种重组疫苗,不含活病毒,在6个月内注射3次。4项共纳入21000名16~26岁妇女的研究结果显示,在感染HPV 6、11、16和18型前预防接种,Gardasil预防妇女的宫颈、阴道、外阴癌前病变和生殖器疣几乎100%有效,但感染HPV后再注射Gardasil无效,说明在接触HPV前预防接种的重要性。Gardasil对较不常见的HPV型也无预防作用,因此常规和定期的柏氏子宫颈涂片检查仍非常重要,以及时发现和治疗宫颈癌前病变。

 2项研究还评估了9~15岁女孩对Gardasil的疫苗应答,发现与16~26岁女性一样好,表明9~15岁女孩应用疫苗的效果应与16~26岁女性相同。在11000名妇女中观察了该疫苗的安全性,主要不良反应是注射部位轻度或中度反应,如疼痛或触痛。

 制造商还将继续研究以进一步评估疫苗的安全性和长期效果,对妊娠的影响以及对男性的安全性和预防效果。

   目前,Gardasil已获准在美国上市,跨国药企默克宣布,已向中国国家食品药品监督管理局提交申请并获受理,希望Gardasil(加德西)能在中国获准上市销售。

 HPV Vaccine Approved For Women In Developing Countries

The World Health Organization has approved Cervarix, a second cervical cancer vaccine, made by GlaxoSmithKline. This will hopefully mean good things for women in developing countries.

Before now, the only cervical cancer vaccine available was Gardasil, made by Merck & Co (this is still the only one available in the US, seeing as Cervarix has yet to be approved). The three-shot vaccine usually costs about $360, an expensive price to pay for many living in the West, and virtually impossible for women living in poor countries.

Last year, the global health association GAVI prioritized the purchase of HPV vaccines for the world's 73 poorest nations. An estimated 280,000 women die from cervical cancer each year, and 80% of the deaths are in developing countries. GAVI, formerly known as the Global Alliance for Vaccines and Immunization, is a major buyer of vaccines. The WHO has approved Cervarix for use in the developing world, but it is still unclear how the distribution will be financed.

"We're eager to work with our long-term partner GAVI as well as other private NGOs or governments of developing countries to identify financing mechanisms for the vaccine," said a spokesperson for GloxoSmithKline. "That is why we're exploring a variety of distribution partnerships to ensure Cervarix will protect women and girls around the globe."

"Cervarix can save millions of women's lives throughout the world, but only if it reaches those who need it most," said Jean Stephenne, President of GSK Biologicals.


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