Chinese bird flu vaccine has three characteristics When to be evaluated

since humans first discovered a decade ago that the H5N1 avian influenza virus could be transferred from poultry to humans, the virus, which has a fatality rate of more than 60%, has become a sword hanging over human heads, and tackling H5N1 has become a common goal of the world'smedicalYesterday, Beijing Kexing Biological Products Co., Ltdand China'sDiseasePrevention and Control Center announced that the two sides jointly developed the human avian influenza vaccine - pandemic influenza all-virus vaccine Phase II clinical trial successfully completed, the preliminary analysis results proved that the vaccine is safe and effective for human bodyChina has thus become one of the few countries in the world that has mastered the technology of preparing human avian influenza vaccine" Double-blind" trial to verify the effectiveness of the vaccine
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, Beijing Kexing Biological Products Co., Ltdconference roomThis has hosted domestic and foreignmedicalmany celebrities in the conference room, the day ushered in an unprecedentedly strong guest lineupChinese Academy of Engineering academician Zhao Wei, Ministry of Health Emergency Office Director Chen Xianyi, as well as the Ministry of Science and Technology, China CDC about 30 experts and officials are sitting on the back, China's independent research and development of human avian influenza vaccine Phase II clinical trial results will be announcedThe experiment used a strict "double-blind method"The 40
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volunteers from Huairou were divided into three groups and given three doses of 5 micrograms, 10 micrograms and 15 micrograms to test which dose performed bestEach subject did not know which group they were in and what dose of the vaccine they were given, as did doctors and serum testers, known as "blinding"Experts said that the participants in the test in a "blind state" is to ensure the objectivity of the test processThe grouping of subjects was top secret, and the Data Security Monitoring Committee, composed of three experts, kept it in a closed envelope and only opened it in public until the data was exposedAt 2 p.m., an expert from the Data Monitoring Commission came on boardIn the eyes of the crowd, he opened the closed envelope and "blinded" the experimentWho was divided into which group was finally revealed, the site staff immediately began to carry out intense data processingPreliminary analysis shows that three dosage vaccines can induce the human body to produce a certain degree of antibodies, of which 10 micrograms and 15 micrograms dose vaccine protective antibody-positive rate, antibody impotence rate and GMT increase multiple three indicators have reached the internationally recognized standards of vaccine evaluationMoreover, theof adverse reactions caused by the vaccine are local pain, fever and other primary and secondary reactions, there is no serious adverse reactions An hour later, the experts gave a unanimous assessment: vaccine is safe and effective! China's vaccine highlights three characteristics
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early 004 with china CDC signed a contract to jointly undertake the "human avian influenza vaccine development" issue, to the successful completion of phase II clinical trials, Chinese scientists in a short period of 4 years successfully conquered H5N1 According to reports, at present, only Pasteur, GlaxoSmithKline and other companies have mastered this technology China relies on independent research and development among the world's forefront, not only that, China's vaccine has three characteristics - universal After receiving the research and development task in 2004, which strain was used as the object of study became a choice question for Chinese scientists "After weighing, we decided to abandon the practice of extracting wild strains from diseased birds in southern China and use the strains built by the World Health Organization through reverse genetic technology as a study subject." Yan Weidong, general manager of Beijing Kexing, said that at that time, the research and development staff in mind with a strong energy: we develop edited vaccine not only for their own use, but also to look at the export, so that foreigners also use our! This is the "pandemic influenza vaccine" of today Highly purified In the first half of 2004, vietnam
, Thailand, a series of human deaths from avian influenza virus, caused a panic in Southeast Asia Time is running out, what kind of vaccine do you want to come up with? Refined or rough? Crude vaccines may soon bear fruit, but refined vaccines are undoubtedly more technical and valuable The task force chose the latter without hesitation "We have the international advanced level of the laboratory, and China CDC such a strong partner, as well as the country's strong support, why not ask for some , to do a higher purity , more effective vaccine?" This idea was immediately supported by the Ministry of Science and Technology and the Ministry of Health Adjuer technology "Adjorgators are like a catalyst in a chemical reaction, and by adding it to the vaccine, the vaccine's immune effect can be significantly improved." "This means that with the same dose of antigen, we can produce more vaccines with the adjour," he said "It is the use of adjuative technology that makes domestic vaccines have a clear price advantage "The price of human avian influenza vaccine is related to the quantity produced, and we do not expect the price to be higher than the seasonal influenza vaccine, " Mr Yu said "
China's vaccine already has the conditions to reserve
" Phase II clinical trial not only obtained the safe and effective vaccine data, but also determined the vaccine's immunization dose and procedures, for China to respond to the influenza pandemic provides a scientific , effective means Yan Weidong said that the results of clinical trials show that China has completed the technical reserves to deal with the influenza pandemic, with the conditions of vaccine reserves, so that China in the human infection avian influenza outbreak, the ability to rely on their own scientific research results to meet the needs of epidemic prevention and control, in order to protect the people's health
and the stable development of society, to provide a comprehensive construction of a harmonious society to provide strong scientific and technological support The production cycle of the vaccine is approximately four months Because of the long production cycle of human avian influenza vaccine, and the infectious nature of avian influenza, once the outbreak of re-production is likely to be difficult to meet the needs, countries have issued a human avian influenza vaccine reserve plan, in case of need According to data presented at the international conference in February, the United States plans to stockpile 40 million doses, at that time it already has 12 million doses, Japan has stockpiled 10 million doses, Australia has 50 million doses, Switzerland has stockpiled 8 million doses, the United Kingdom , France, Mexico and so on according to their own situation has made appropriate reserves At present, Beijing Kexing in the National Development and Reform Commission's support has an annual output of 20 million pandemic influenza all-virus vaccine production capacity It is understood that , China has no specific reserve quantity plan , relevant departments and experts are in the process of demonstration and formulation of vaccine reserve strategy When the general public should be vaccinated requires a national assessment
the first outbreak of avian influenza in Hong Kong in 1997 , and cause human infection with the H5N1 subtype avian influenza virus Since 2003, the highly pathogenic H5N1 subtype avian influenza virus has caused nearly 340 human infections in China and neighboring Vietnam, Thailand, Cambodia, Indonesia and Turkey, Iraq, Egypt and other countries
, 209 people died , in 2007 alone 77 people infected, 50 people died So far, 27 people have been infected and 17 have died, with a mortality rate of more than 60 per cent Three of the five new cases this year have been fatal Some experts say the possibility of human-to-human transmission cannot be ruled out in these cases The completion of phase II clinical trial sonofing of human avian influenza vaccine shows that China already has the technical conditions for vaccine reserve to meet the needs of China's response to the influenza pandemic Pigeon lovers, chicken farmers are often dealing with poultry people, heard that China has developed a safe and effective human avian influenza vaccine, many people hope to be able to immediately inject, prevent avian influenza " At present, the general public can not be vaccinated "Beijing Disease Center for Disease Prevention and Control is the commitment unit of the trial, CDC Director of Immunization, Wu Jie, said, "This vaccine is not a conventional vaccine." Usually the vaccine development needs phase III clinical observation before it can be put into use At present, the vaccine has only completed Phase II, Phase III needs to be carried out in the event of an outbreak, and there are only a few hundred cases worldwide, there has been no outbreak, so there is no clinical environment in each country However, given the particularity of the vaccine, production and vaccination may be carried out with national approval in the event of successful phase II trials, when emergencies such as influenza pandemics are responding "
, when will these vaccines come in handy?" Wu said that the time for ordinary people to be vaccinated will need to be assessed by international organizations or relevant domestic organizations, and if the outbreak is considered to be at a certain level, the vaccine will be approved for market "This assessment criteria
which may include a small human-to-human transmission of avian influenza, or a large number of poultry-to-human transmission." (
Fangfang Wang Liufang)