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赛诺菲脑膜炎疫苗Menomune通过WHO资格预审

  1. 赛诺菲
  2. 脑膜炎疫苗
  3. Menomune
  4. WHO资格预审

来源:生物谷 2013-09-03 22:33

2013年9月3日讯 /生物谷BIOON/ --赛诺菲(Sanofi)疫苗事业部赛诺菲-巴斯德(Sanofi Pasteur)9月3日宣布,四价脑膜炎疫苗Menomune已通过世界卫生组织(WHO)的资格预审,成为首个通过WHO资格预审的四价脑膜炎球菌疫苗。 WHO资格预审程序接受Menomune被联合国各机构采购。

2013年9月3日讯 /生物谷BIOON/ --赛诺菲(Sanofi)疫苗事业部赛诺菲-巴斯德(Sanofi Pasteur)9月3日宣布,四价脑膜炎疫苗Menomune已通过世界卫生组织(WHO)的资格预审,成为首个通过WHO资格预审的四价脑膜炎球菌疫苗。

WHO资格预审程序接受Menomune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Menomune已通过WHO的验收。

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。

Menomune疫苗旨在用于2岁及以上人群的主动免疫,预防由脑膜炎奈瑟氏菌血清型A、C、Y、W-135引发的侵袭性脑膜炎球菌病。(生物谷Bioon.com)

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:SANOFI : Menomune? Is the First Quadrivalent Meningococcal Vaccine Prequalified by the WHO

PRESS RELEASE Menomune? Is the First Quadrivalent Meningococcal Vaccine Prequalified by the WHO - Prequalification Makes the Vaccine Eligible for Purchase by United Nations Agencies -

Lyon, France - September 3, 2013 - Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that one of its quadrivalent vaccines to prevent invasive meningococcal disease has been prequalified by the World Health Organization (WHO). The prequalification procedure accepts Menomune? vaccine for purchase by United Nations Agencies. The UNICEF supply division has been notified of Menomune vaccine's acceptance by the WHO.

The purpose of the United Nations prequalification assessment is to provide assurance that candidate vaccines meet WHO recommendations on quality, safety and efficacy, including compliance with WHO's recommended standards for good manufacturing practice (GMP) and good clinical practice (GCP). This Menomune vaccine prequalification was performed through a streamlined procedure in which the WHO worked closely with the United States Food and Drug Administration (FDA).

Menomune vaccine is designed for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 for use in persons 2 years of age and older. It is the first quadrivalent meningococcal vaccine pre-qualified by the WHO. The WHO notification to UNICEF states that following the evaluation of consistency of final product characteristics, GMP and quality system audits of the manufacturing facilities, and follow-up of implementation of recommendations made by WHO reviewers during the evaluation, Menomune vaccine has been found acceptable. It is manufactured in Pennsylvania, USA.

"Sanofi Pasteur's commitment to help protect against meningococcal disease began almost 40 years ago with the introduction of a monovalent vaccine that offered protection against serogroup A and a bivalent vaccine that offered protection against serogroups A and C," said Olivier Charmeil, President and Chief Executive Officer, Sanofi Pasteur. "Our commitment to remaining at the forefront of advancing the prevention of meningococcal disease, worldwide, continues today."

Menomune - A/C/Y/W-135 vaccine was first licensed by the U.S. FDA in 1981. It is now licensed in 17 countries with more than 22 million doses shipped worldwide since it first became available.

"The value of a quadrivalent meningococcal vaccine is becoming more and more realized as evidenced by the circulation of the W-135 strain in the western part of the African meningitis belt this past year," explained Luc Kuykens, M.D., M.P.H., Sanofi Pasteur's Chief Medical Officer. "Menomune is a proven vaccine with a 32-year track record of providing broad protection against this serious disease, so we try to keep a stockpile of the vaccine in case of any outbreaks."

About Meningococcal Disease

Although rare, meningococcal disease can cause meningitis (swelling of the brain or spinal cord) or meningococcemia (blood infection). The disease can be spread through common everyday activities, such as sharing eating utensils and drinking glasses, living in close quarters or attending crowded events. Meningococcal disease can be hard to recognize, especially in its early stages, because symptoms are similar to those of more common viral illnesses. Unlike more common illnesses, the disease can progress quickly and may cause death or disability in just a single day.

About Menomune Vaccine

Indication :Menomune-A/C/Y/W-135 vaccine is indicated for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menomune-A/C/Y/W-135 vaccine is approved for use in persons 2 years of age and older. Menomune-A/C/Y/W-135 vaccine does not prevent N. meningitidis serogroup B disease.

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