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【drug-news】中国批准禽流感疫苗上市
HONG KONG (Reuters) - Beijing has given the go-ahead to a Chinese drug maker to begin large-scale production of a human bird flu vaccine, after a second clinical trial showed the vaccine was safe and effective, the company said on Thursday.
The vaccine uses an inactivated whole H5N1 virus from Vietnam, said an official for Sinovac Biotech, which jointly developed the vaccine with China's Centers for Disease Control.
"We finished our second trial in November. We checked our 402 participants for antibodies and they met international standards used in the United States and the European Union both for safety and immune response," Sinovac's publicity supervisor Liu Peicheng told Reuters by telephone.
China's State Food and Drug Administration said on Wednesday it had authorized production of the vaccine.
The vaccine was used in amounts of 5, 10 and 15 micrograms but the 10 microgram dose was found to be ideal.
"The 10 and 15 microgram doses met standards but we decided on 10 as it's good enough. It would use less antigen," said Liu.
Antigens are substances like toxins, viruses and bacteria that stimulate the production of antibodies when introduced into the body. But they can be difficult to culture and scientists have been trying to fix that by using boosters, or adjuvants.
Participants in the Chinese trial were between the ages of 18 and 60. Liu said only some minor side effects were recorded, in line with those sometimes seen with seasonal flu vaccines. He did not elaborate.
For years now, experts have warned of a flu pandemic and many have held up the H5N1 virus as a prime candidate because people have no immunity against this bird virus, and because of the high mortality rate associated with it so far.
The virus has infected 376 people in 14 countries since late 2003 and killed 238 of them, or 63 percent.
An eventual vaccine to protect people against a flu pandemic can only be made 4-6 months after the start of such a disaster, when the culprit virus strain has been identified.
But human populations still need some form of protection in those initial months of a pandemic, and drug companies are in a race to design what are known as "prepandemic" vaccines, which is what Sinovac is producing now.
The company is conducting tests to see if the vaccine may offer cross protection against other strains of the virus found in Indonesia, Turkey and Anhui province in China, Liu said.
"This vaccine is reserved for emergencies in the country and we have to get instructions on how much to produce," he added.
On March 2, GlaxoSmithKline company said a vaccine it designed to protect people against H5N1 may be effective in warding off a few different sub-types of the virus.
(Editing by Jerry Norton) 昨天，国家食品药品监督管理局正式批准北京科兴生物制品有限公司生产大流行流感疫苗(人用禽流感疫苗)，此举标志着我国成为全球少数几个掌握人用禽流感疫苗制备技术的国家，为我国在奥运会召开之前做好大流行流感疫苗储备奠定了基础。
国家食品药品监督管理局新闻发言人颜江瑛介绍，为防范高致病性禽流感病毒(H5N1)的人际传播，国家食品药品监督管理局批准研制大流行流感疫苗，2007年4月疫苗研制进入二期临床。今年3月28日，国家食品药品监督管理局对大流行流感疫苗启动特别审批程序，并于4月2日正式签发大流行流感疫苗的药品批准证明文件和药品批准文号。这是自2005年颁布实施《药品特别审批程序》以来首次启动特别审批程序。
此次获批生产的大流行流感疫苗将不上市销售，仅在大流行流感发生时或紧急情况下，在政府有关部门指导下启用。
国家食品药品监督管理局表示，我国是全球少数几个掌握人用禽流感疫苗制备技术的国家，目前世界上只有美国、比利时等掌握这一技术。
已有500多志愿者接受注射
北京科兴生物制品有限公司总经理尹卫东介绍，我国自主研制的疫苗，可以应对由H5N1型流感病毒引起的流感大流行，也能在流感病毒发生变异后，按照已经成熟的技术和工艺路线迅速采用新的变异株进行疫苗生产。
尹卫东透露，目前已经有500多名志愿者接受了注射，疫苗的安全性和有效性得到了证实。
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作者:admin@医学,生命科学 2010-12-08 17:11
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