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Key technologies support China's research and development of the world's leading influenza A (H1N1) vaccine

China is the first country in the world to apply the influenza A (H1N1) vaccine, which is not only gratifying, but also arouses some people's doubts: why can China go ahead of western developed countries except titanium dioxide? In this regard, Wang Junzhi, deputy director of the China Institute for the control of pharmaceutical and biological products, said in an interview a few days ago that in addition to the government's emphasis on cooperation with enterprises, technology is the key factor determining China's leadership

Wang Junzhi said that at present, influenza A (H1N1) vaccine is basically produced according to the procedure of seasonal influenza vaccine. When seasonal influenza vaccine is produced, all enterprises in the world need to obtain virus seeds from the World Health Organization every year. Every year, the World Health Organization appoints laboratories to reconstitute and screen the vaccine preparation virus seeds, and then distribute them to all enterprises in the world for production after completing the safety evaluation. "In this regard, we have the same starting point as all vaccine manufacturers in the world."

after the influenza virus seeds are distributed to various enterprises, enterprises should establish a virus seed database and conduct corresponding tests. When the vaccine stock solution produced by the virus seed is used for quantitative testing, the standard antiserum and hemagglutinin reference reagents provided by the World Health Organization are used. This reagent is also the standardized reagent prepared after the virus seed of the World Health Organization is established, which is equivalent to the establishment of a "ruler" by the World Health Organization first. According to past experience, it takes one to two months for this "ruler" to be established

how to quantify the vaccine stock solution produced with the influenza A (H1N1) virus provided by who this time? The difference in R & D time between countries reflects the competition during this period

Wang Junzhi said that in 2006, the World Health Organization encouraged laboratories in various countries to study quantitative alternatives to hemagglutinin for vaccine testing in emergencies. The China Institute for the control of pharmaceutical and biological products deployed its technical reserves when it developed the 220v/50hz H5N1 influenza vaccine in 2006 and began its research. This time, it happened to be used

"we successfully used our own established alternative methods and temporary standard reagents to quantify the stock solution produced by ten domestic enterprises, and then organized clinical trials by the China Center for Disease Control and prevention, which greatly shortened the time in this process." Wang Junzhi said that the standard reagent of who was obtained only after the results of the first injection of our clinical trial were released. Comparing the WHO standard reagent with the alternative reagent developed by us, the results are highly consistent, which means that the results of our clinical trials do not need to be proofread, which means that our clinical trials have started ahead of the world. This is a very important reason why our vaccines are in the forefront of the world

at the same time, Wang Junzhi pointed out that in the whole process of vaccine research, development and production, the verification items, standards and requirements of vaccine manufacturers in China and developed countries are basically the same. China now issues all vaccines on the market in batches, and carries out a full inspection of each batch of vaccines according to the standards approved by the state. When the products produced by the enterprise are inspected by themselves, the samples should be sent to the intermediate inspection institute for batch inspection. Only when both of them pass the inspection can the batch issuance report be issued, and the vaccine can be truly marketed

in addition, in order to ensure the quality of the vaccine, the State Food and drug administration also requires: start the on-site verification of batch issuance; Sampling at vaccination sites to ensure the cold chain delivery of vaccines; Sampling inspection should also be carried out at the vaccination sites. The support of this policy is a beneficial guarantee for the development of recycled plastic granulators to ensure the quality of vaccines on the market

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