The domestically produced A class virus decomposition vaccine immune effect achieves over 90% _healthy channel _New China net

This entry was posted by znnw on Wednesday, 3 March, 2010

    New China net Shanghai on August 26 special news (by Qiu Yi) reporter learned from the Chinese biological technology Group Shanghai biological preparations research institute that the first batch of more than 40,000 bottles of domestically produced Type A H1N1 influenza virus decomposition vaccine has loaded separately the winding and enters the end product examination procedure, on 26th, the strict third party “uncovered test result to make known blindly”, the product immune effect achieved over 90%.

    In order to deal with the Type A H1N1 flu pandemic and prevention and control flu high prevalence, the Chinese biological technology Group Shanghai biological preparations research institute on May 6 was founded rapidly was appointed the group leader by manager Yang Zhongdong “has dealt with flu work team”, production, research and development, nature Bulgaria, material and other departments invested the domestically produced Type A H1N1 influenza vaccine whole-heartedly the emergency research and development production and clinical declaration work.

    The Chinese biological technology Group Shanghai biological preparations research institute in the European Economic Community standard provision, uses the Japanese most superior technology, forms has now produced can be biggest, the quality most controllable domestic product Type A H1N1 influenza virus decomposition vaccine production line, and organized everywhere outstanding talent team to step up to research and develop, production and quality control. After on June 18 obtained the Type A H1N1 flu poisonous kind which the World Health Organization announced that on July 7 diluted compounds and loads separately, completes the complete 3 specification altogether 9 batch of clinical trial samples, on July 14 self-checks the haemagglutinin result to be qualified, on July 24 afternoon attained 9 batch of samples and 1 batch of placebo examined to examine the qualified report. On July 25 started, unified the organization in the Chinese Center for Disease Control and Prevention coordinated, proved after the expert, according to the double blind stochastic principle, started the human body clinical trial, the experimental plan considered fully conner’s safety and after the informed consent, the test object population reached 1980 people much.

    According to the newest test result, 15 micrograms /0.5 milliliters specification domestic product Type A H1N1 influenza virus decomposition vaccine immune effect which the Chinese biological technology Group Shanghai biological preparations research institute produces, is the protection ratio achieves over 90%, 30 micrograms /0.5 milliliters specification product’s protection ratio achieves over 93%, achieves and surpasses state food pharmaceutical supervision administrative bureau “Type A H1N1 Influenza vaccine Research and development Technology the immunogenic assessment standard which Considers Main point” stipulated.

    It is reported that the product examination and national medicine supervises the examination of department after the Chinese drugs biological preparations examination, the Chinese biological technology Group Shanghai biological preparations research institute high-grade domestic product Type A H1N1 influenza virus decomposition vaccine will go on the market, at the end of this year anticipated will produce 10 million people of shares the vaccine dose, produces can achieve the home to be biggest with the supply, meets the national prevention and control Type A H1N1 flu prevention and control needs.

    The Chinese biological technology Group Shanghai biological preparations research institute is our country produces flu decomposition vaccine the first enterprise, until now has produced goes on the market 25 million people of share flu decomposition vaccines, undergoes for many years observation, the production seasonal influenza vaccine is not serious the untoward effect.

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