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赛诺菲儿科五合一疫苗Shan5通过WHO资格预审

2014年5月8日讯 /生物谷BIOON/ --赛诺菲(Sanofi)疫苗事业部赛诺菲-巴斯德(Sanofi Pasteur)近日宣布,儿科五价联合疫苗Shan5已通过了世界卫生组织(WHO)的资格预审(prequalification status)。Shan5是一种全液体五合一优质安全疫苗,可对6周龄及以上婴幼儿提供针对5种疾病的有效保护:白喉,破伤风,百日咳,乙型肝炎,乙型流感嗜血杆菌。该疫苗由赛诺菲旗下印度Shantha公司生产。

WHO资格预审程序接受Shan5被联合国各机构采购。联合国儿童基金会供应司(UNICEF supply division)已被通知Shan5已通过WHO验收。

联合国资格预审评估的目的是,保证候选疫苗满足WHO在质量、安全性和有效性方面的建议,包括符合由WHO推荐的良好生产规范(GMP)和良好临床实践(GCP)标准。Menomune疫苗的资格预审是通过一个精简程序审查,该程序中,WHO和美国FDA密切合作。
关于世卫组织药品资格预审:

世卫组织药品资格预审是世卫组织开展的一个服务项目,用以评估医药产品的质量、安全性和疗效。在2001年,最初重点关注的是艾滋病毒/艾滋病、结核病和疟疾治疗药物。2006年,药品审查范围进一步扩大,列入了促进生殖健康的药品和产品。2008年,又列入了用以治疗儿童急性腹泻的锌片。到2012年底,世卫组织通过资格预审的药物清单收入了316种用于治疗重点疾病的药品。

重要事实:

*每年儿童基金会、抗击艾滋病、结核和疟疾全球基金和国际药品采购机制等国际采购机构都要采购或通过这些机构采购数十亿美元的药品,投放到资源有限的国家的药物市场上。
*世卫组织药品资格预审规划帮助确保采购机构供应的药品符合可接受的质量、安全性和疗效标准。
*到2012年底,世卫组织通过资格预审的药物清单收入了316种用于治疗重点疾病的药品。
*世卫组织通过资格预审的药物清单现已成为国际采购机构的大宗药品采购指南,同时也为越来越多的国家所采用。
*世卫组织药品资格预审规划也对活性药物成分和质量控制实验室进行资格预审。

英文原文:SHANTHA’S PENTAVALENT PEDIATRIC VACCINE PREQUALIFIED BY WORLD HEALTH ORGANIZATION

- Shan5™ is the first vaccine jointly developed by the Indian company
and its parent company Sanofi Pasteur -
- WHO’s decision allows for the purchase of Shan5™ by United Nations agencies -

Lyon, France, - May 5, 2014 - Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its pediatric pentavalent vaccine Shan5™, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, India, has received prequalification status from the World Health Organization (WHO). This status is based on a review of a comprehensive set of data related to the process and the product characteristics, as well as on a positive recommendation of WHO’s auditors following a site inspection of Shantha's manufacturing facilities. It qualifies Shan5™ vaccine for purchase by United Nations agencies, mainly UNICEF. Shan5™ prequalification will give more children around the world access to the latest high-quality, fully-liquid, 5-in-1 vaccine and help secure the supply of pentavalent combination vaccines in over 50 emerging and low-income countries.

“Shan5™ is the first product that puts together the best of Shantha and Sanofi Pasteur’s assets and talents,” said Olivier Charmeil, Sanofi Pasteur President and CEO. “Today, a significant number of babies born every year do not have access to modern vaccination programs. By delivering large supplies of high-quality and affordable vaccines to emerging and low-income countries, Shantha will be contributing to filling this gap for the benefits of babies and their parents.”

Shan5™ is produced at Shantha’s state-of-the-art manufacturing facility in Hyderabad, India, and received Marketing Authorization in India in March 2014.

“The development of Shan5™ benefitted from Sanofi Pasteur’s more than 50 years of experience with whole-cell pertussis and combination vaccines - ensuring robust processes and guaranteeing international quality standards” said Harish Iyer, Shantha CEO. Shantha’s manufacturing platform in India will serve Indian needs and provide Sanofi Pasteur access to additional vaccine markets globally.”

About Shantha

Shantha, which was acquired by Sanofi Pasteur Holding in 2009, is a biotechnology pioneer from the emerging countries, founded by Dr. K I Varaprasad Reddy in 1993 in Hyderabad, India. Shantha is a fully integrated biotechnology company involved in R&D, manufacturing and marketing.
Shantha’s mission is to develop, produce and market human health care products which are affordable and meet the highest International standards. Shantha’s products complement Sanofi Pasteur’s portfolio. Besides Shan5™, three of its vaccines are WHO-prequalified: Shanchol™ cholera vaccine, Shanvac-B® hepatitis B vaccine and ShanTT™ tetanus vaccine. Sanofi Pasteur and Shantha are also developing a new vaccine against rotavirus and a pediatric combination vaccine based on Shan5™,that will incorporate Sanofi Pasteur’s Inactivated Polio Vaccine (IPV) in order to secure polio eradication.

About Shan5

Shan5 is a fully-liquid five-in-one, convenient, safe and high-quality vaccine that provides effective protection for children from 6 weeks of age against five diseases: diphtheria, tetanus, pertussis, Hib and hepatitis B. Shan5 vaccine has been developed and is produced by Shantha in Hyderabad, India.

关键词:赛诺菲,疫苗,Shan5,资格预审

信息来源:生物谷