Re: Drug regulator: China stockpiles Human bird flu vaccine for possible outbreak
At the end of successful stage two clinical trials the chineese say they could only go to trial three if it would be because of these factors....
The general public can not be vaccinated." Beijing Center for Disease Control and Prevention is the test of the unit, the director of the CDC immunization Wu Jiang, "This vaccine is not a conventional vaccine. Vaccines usually require Ⅲ Clinical observation can be put into use.
The vaccine is currently only completed Phase Ⅱ, Ⅲ need to have a period when the epidemic broke out before it can go ahead and the world at present there are only a few cases, there have been no outbreak of the epidemic, the country has not carried out Ⅲ clinical environment. However, given the special nature of this vaccine in the successful completion of Phase Ⅱ, when the response to pandemic influenza, and other emergencies, can be carried out under the approval of the national production and vaccination. "
那么，什么时候这些疫苗可以派上用场呢？
In that case, when these vaccines may be of some use it?
吴疆谈到，普通人能够接种这种疫苗的时间需要国际组织或国内相关部门组织评估，如果认为疫情达到一定程度就 会批准疫苗上市。
Wu Jiang said that ordinary people can be against such a vaccine needs time to international organizations or national organizations
to assess the relevant departments, that if the disease reaches a certain level of approval of the vaccine will be listed. ?这个评估标准可能包括出现少量人与人之间禽流感传播，或者大量禽类与人类之间的传播。?
"
The evaluation criteria may include the emergence of a small number of human-to-human spread of bird flu, or a large number of poultry and human transmission."
http://news.yule.com.cn/html/200812/28410.html
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China Announces Successful Completion of Phase II Human Bird Flu Vaccine Trials
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".....Beijing Kexing Biological Products Co., Ltd. and the Chinese Center for Disease Control and Prevention announced that they jointly developed with a bird flu vaccine - the whole pandemic influenza virus vaccine clinical trials Ⅱ successful completion of the preliminary results of the analysis proved that the vaccine Safe and effective on the human body...."
snip
The test uses a strict "double-blind method."
来自怀柔区的402位志愿者被分成三个组，分别注射5微克、10微克和15微克三种剂量的疫苗，以检测哪种 剂量综合表现最佳。
From the Huairou District, 402 volunteers were divided into three groups, each injection of 5 micrograms, 10 micrograms and 15 micrograms of the three-dose vaccine in order to detect what the best dose and overall performance.
每一位受试者都不知道自己被分在哪个组、注射的是何种剂量的疫苗，医生及血清检测人员同样如此，这叫?设盲 ?。
Every subjects do not know what was in the group, which is the injection of doses of vaccine, doctors and serum testing the same staff, called the "blind set up."
专家介绍说，让试验的参与者处于?盲态?，是为了保证试验过程的客观性。
Experts said the trial so that the participants in a "blind" in order to guarantee the objectivity of the trial process.
受试者的分组情况属于绝密，由3名专家组成的数据安全监察委员会将其放在一个密闭的信封内保存，只有等到数 据揭盲时才当众启封。
The group belonging to the situation were top secret, from 3 data security experts to the commission in a sealed envelope to preserve only when data revealed only blind unsealed in public.
2:00 pm, a data monitoring committee of experts of the game.
在众人的注视中，他打开了这个密闭的信封，为这次试验?揭盲?。
In the public gaze, he opened the sealed envelope, in order to test the "open-blind."
谁被分在哪个组终于揭晓了，现场的工作人员立即着手进行紧张的数据处理。
Who was in the group which was finally announced, on-site staff to immediately proceed with the tension of data processing.
初步分析结果显示，3个剂型的疫苗都可诱发人体产生一定程度的抗体，其中10微克和15微克剂量疫苗的保护 性抗体阳性率、抗体阳转率和GMT增高倍数三项指标均达到国际公认的疫苗评价标准。
Preliminary analysis showed that 3 of the vaccine formulations can induce the human body produce antibodies to a certain extent, 10 mg and 15 mg doses of the vaccine protective antibody-positive rate of antibody positive rate and GMT increased in multiples of three indexes are up to Internationally recognized standards for evaluation of the vaccine.
而且疫苗引起的不良反应绝大部分是局部疼痛、发烧等一二级反应，没有出现严重不良反应。
And vaccine adverse events caused by the vast majority of local pain, fever, and other 12 responses, there is no serious adverse reactions.
一个小时后，专家们给出了一致评价：疫苗安全有效！
After an hour, the experts are given the same evaluation: the vaccine is safe and effective!
snip
Adjuvant technology.
?佐剂好比化学反应中的催化剂，把它加到疫苗里，疫苗的免疫效果可以明显提高。?尹卫东说，?这意味着生产 同等剂量抗原的前提下，由于加了佐剂，我们就可以生产出更多的疫苗。?正是佐剂技术的使用，使国产疫苗在价 格上具有明显优势。
"Adjuvant is like a catalyst in chemical reactions, it added to the vaccine, the vaccine can significantly improve the immune effect." YIN Wei-dong said, "This means that the production of the same dose of antigen under the premise that as a plus adjuvant, we can To produce more vaccine. "Adjuvant is the use of technology so that China-made vaccines in the price of an obvious advantage.
尹卫东介绍说，?人用禽流感疫苗价格跟生产数量有关，我们预计其价格不会高于季节性流感疫苗。 ?
YIN Wei-dong said, "with a bird flu vaccine production with prices, we expect the price will not be higher than the seasonal flu vaccine."
我国疫苗已经具备储备的条件
China has reserves of vaccine conditions
?Ⅱ 期临床试验不仅取得了疫苗的安全有效性数据，而且确定了疫苗的免疫剂量和程序，为我国应对流感大流行提供了 科学、有效的手段。?尹卫东表示，临床试验的结 果表明我国已完成应对流感大流行的技术储备，具备了疫苗储备的条件，使我国在人感染禽流感疫情发生时，有能 力依靠自己的科研成果满足疫情防控的需要，以保 障人民群众的健康和社会的稳定发展，为全面构建和谐社会提供有力的科技支撑。
"Ⅱ
clinical trials not only made the security of the effectiveness of the vaccine, and determine the vaccine dosage and immunization program for our country to deal with influenza pandemic and provides a scientific and effective means." YIN Wei-dong said that the results of clinical trials show that China has Complete response to the influenza pandemic of technical reserves with a reserve of vaccine, so that our people are infected with the bird flu outbreak, the ability to rely on its own scientific research to meet the needs of the epidemic prevention and control in order to protect people's health and social And steady development of the comprehensive building of a harmonious society to provide strong scientific and technological support.
疫苗的生产周期大约为4个月。
Vaccine production cycle for about 4 months.
由于人用禽流感疫苗生产周期较长，而禽流感又具有传染性，一旦爆发疫情再生产很可能难以满足需要，各国纷纷 出台了人用禽流感疫苗储备计划，以备不时之需。
As the human bird flu vaccine production cycle is longer, but also has a contagious bird flu, the outbreak of the epidemic, once production is likely to be difficult to meet the needs of the countries have introduced a human bird flu vaccine plans to reserve for emergency use.
根据今年2月有关国际会议上专家介绍的数据，美国计划储备4000万剂，当时已经储备1200万剂；日本储 备了1000万剂，澳大利亚储备了5000万剂，瑞士储备了800万剂，英国、法国、墨西哥等也根据自身情 况作了适当储备。
In February this year, in accordance with relevant international meeting of experts, the United States plans to reserve 40,000,000, when reserves have been 12,000,000; Japan had reserves of 10,000,000, Australia reserves the 50,000,000, Switzerland reserves of 8,000,000, the United Kingdom, France, Mexico, have also made appropriate in accordance with their own reserves.
目前北京科兴在国家发改委的支持下已经拥有了年产2000万支大流行流感全病毒疫苗的生产能力 。
At present, Beijing Kexing in the National Development and Reform Commission already has the support of the annual output of 20,000,000-wide pandemic influenza vaccine production capacity.
据了解，我国目前还没有具体的储备数量计划，有关部门和专家正在进行论证和制定疫苗储备策略。
It is understood that our country there is no specific plan to reserve the number of relevant departments and experts to develop and demonstrate the ongoing vaccine reserve strategy.
普通市民何时接种需国家评估
When the general public to be against the national assessment
1997年禽流感首次在香港爆发，并造成人类感染H5N1亚型禽流感病毒。
1997 bird flu outbreak in Hong Kong for the first time, and would result in human infection of avian influenza virus subtype H5N1.
2003年以来高致病性H5N1亚型禽流感病毒在我国和周边的越南、泰国、柬埔寨、印尼以及土耳其、伊拉克 、埃及等国造成了近340例人类感染，其中209人死亡，仅2007年就有77人感染，50人 死亡。
Since 2003, highly pathogenic H5N1 subtype avian influenza virus in China and around Vietnam, Thailand, Cambodia, Indonesia, as well as Turkey, Iraq, Egypt and other countries resulted in nearly 340 cases of human infection, of which 209 people were killed and only in 2007 on the 77 people infected, 50 people were killed.
我国截止到目前已有27人感染，17人死亡，死亡率超过60%。
Up to now China has infected 27 people, 17 people were killed and more than 60% mortality rate.
今年新增的5个病例中有3例死亡。
New this year, 5 cases, 3 deaths.
有专家表示，这些病例中尚不能排除人与人之间传播的可能性。
Some experts said that these cases can not rule out the possibility of human-to-human transmission.
人用禽流感疫苗Ⅱ期临床试验的完成，说明我国已经具备了疫苗储备的技术条件，可以满足我国应对流感大流行的 需要。
With a bird flu vaccine Phase Ⅱ clinical trials, our country has a reserve of vaccine technology to meet China's response to pandemic influenza.
养鸽爱好者、养鸡专业户都是经常跟禽类打交道的人，听说我国研制出安全有效的人禽流感疫苗，很多人都希望能 够马上注射，预防禽流感。
Pigeon enthusiasts, young professionals to raise chickens are often dealing with the birds, heard about the development of our country safe and effective human bird flu vaccine, many people had hoped to be able to immediately injection, to prevent bird flu.
?目 前一般市民还不能接种。?北京市疾病预防控制中心是本次试验的承担单位，疾控中心免疫预防所所长吴疆介绍， ?这种疫苗不是一种常规疫苗。通常疫苗研制需要 Ⅲ期临床观察才能投入使用。目前这种疫苗只完成了Ⅱ期，Ⅲ期需要在有疫情爆发时才能进行，而目前全世界只有 几百例病例，没有出现过疫情爆发，因此各个国家 都没有进行Ⅲ期临床的环境。但鉴于这种疫苗的特殊性，在Ⅱ期试验成功完成的情况下，当应对流感大流行等紧急 状况时，可以在国家批准下进行生产和接种。?
"
The general public can not be vaccinated." Beijing Center for Disease Control and Prevention is the test of the unit, the director of the CDC immunization Wu Jiang, "This vaccine is not a conventional vaccine. Vaccines usually require Ⅲ Clinical observation can be put into use. The vaccine is currently only completed Phase Ⅱ, Ⅲ need to have a period when the epidemic broke out before it can go ahead and the world at present there are only a few cases, there have been no outbreak of the epidemic, the country has not carried out Ⅲ clinical environment. However, given the special nature of this vaccine in the successful completion of Phase Ⅱ, when the response to pandemic influenza, and other emergencies, can be carried out under the approval of the national production and vaccination. "
那么，什么时候这些疫苗可以派上用场呢？
In that case, when these vaccines may be of some use it?
吴疆谈到，普通人能够接种这种疫苗的时间需要国际组织或国内相关部门组织评估，如果认为疫情达到一定程度就 会批准疫苗上市。
Wu Jiang said that ordinary people can be against such a vaccine needs time to international organizations or national organizations to assess the relevant departments, that if the disease reaches a certain level of approval of the vaccine will be listed.
?这个评估标准可能包括出现少量人与人之间禽流感传播，或者大量禽类与人类之间的传播。?
"The evaluation criteria may include the emergence of a small number of human-to-human spread of bird flu, or a large number of poultry and human transmission."
http://news.yule.com.cn/html/200812/28410.html
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-------------------------------------------------- ------------------------Corn: Then China holds an open press release this week
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niman @ Ft
Ministry of Health in February 2009 a regular press conference notice
Ministry of Health will be held February 10, 2009 10:00 am in the Ministry of Health (Xizhimen outside the South on the 1st) on the fifth floor of the Office of the Press Release routine press conference held
to introduce the health sector of human infection with highly pathogenic avian influenza outbreak and spring of communicable diseases prevention and control work, the participants will welcome Chinese and foreign reporters.
Contacts and Contact: Ma dust 010-68792084
Ministry of Health Press Office
February 9, 2009
http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohbgt/s3582/200902/39054.htm
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Corn: Now we have a press release in English from China stating they are going to trial 3 criteria.
Commonground @ FT
State Food and Drug Administration: people with bird flu vaccine production conditions have been
http://www.gog.com.cn 09-02-12 10:31 Beijing Times
Journalist from the State Food and Drug Administration was informed yesterday, the council recently
launched a pandemic influenza virus inactivated vaccine (commonly known as "human avian influenza vaccine")批签发synchronization procedures. At present, our country has a pandemic influenza virus vaccine production
reserve conditions at the time of pandemic influenza or emergency circumstances, by the state to start for the pandemic influenza vaccination.
This year, our country successively more cases of human bird flu cases, the State Food and Drug Administration official said,
given the current situation of avian influenza prevention and control, in order to protect public health, it officially launched a few days ago for a pandemic influenza vaccine批签发process synchronization that manufacturers test and drug regulatory departments at the same time批签发testing, and vaccine production conducted a site inspection.
Pandemic influenza viruses are inactivated vaccine by Beijing Kexing Biological Products Co., Ltd. and the Chinese Center for Disease Control and Prevention jointly developed by commodity called hope Seoul to Fuk, applies to 18-year-old to 60-year-old adults. The vaccine from the State Food and Drug Administration approval process through, inter alia, the approval in April 2008 on access to medicines Register documents.
Author: Editor: Cheung Yuk
http://66.102.1.100/translate_c?hl=...rev=_t&usg=ALkJrhh9T4EVSMy6DaPndhPgN0042lg_8Q
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Corn:
So, Trial one and two complete and holding back on trial three which would be actual clinical testing in an out break environment, The started disseminating the vax a few days ago and had a press conference to state this,
