I first came a flu vaccine does not affect the efficacy of different reactions
At 1:00 p.m. on the September 3, Beijing Sinovac Biotech Co., Ltd. vaccine production line, 2 human dose, 30 g/1.0ml / bottle of influenza H1N1 Influenza Vaccine began filling offline, each smallest packaging, are clearly marked "State Yaozhun Zi S20090012", and come out the name of "look forward to blessing .1 Seoul."
This is the world's first access to national (or regional government) drug approval number of influenza A H1N1 influenza vaccine. June 8 from the enterprise obtained can be used for vaccine production strains counting, the vaccine development cycle in just 87 days short.
For 3 years to 60 years old patients
10:30 yesterday, the State Food And Drug Administration briefing, Sept. 3 approved Beijing Sinovac Biotech Co., Ltd. developed influenza A H1N1 influenza vaccine drug registration. FDA Registration Secretary Zhang introduced, according to Epidemic Development and the state emergency reserve a flu vaccine allocation of resources will be used in the key vulnerable to attack people H1N1 immunized.
Li Guoqing, director of FDA drug trial briefing, Beijing Sinovac had completed the initial clinical trial results showed that the vaccine safety is good. A single dose of the vaccine 21 days after immunization, children, adolescents and adults of three age groups, 81.4% protection rate in the range of -98.0%, reaching an internationally recognized evaluation criteria (protection rate 70%).
As a vaccination or a flu shot can help the body get a good immune effect, Zhang said that the approval of a flow of current national immunization dose, a dose of 15 g per person.
First team approved vaccine available in three sizes: 30 g/1.0ml / bottle (2 with a dose vials), 15 g/0.5ml / bottles (1 with a dose vials) and 15 g/0.5ml / Support (1 human dose, pre-casting syringes), available in 3 to 60 people of influenza vaccination to prevent influenza A H1N1.
Can be output before the end of 3000 million people were
As the upcoming autumn and winter, living in the northern hemisphere of the Chinese public at any time may be subject to the violent invasion of H1N1, Food and Drug Administration approval of a stream with two doses of vaccine packaging, "in order to save production time, saving emergency transport and cold chain storage costs ", Beijing Sinovac Biotech Co., Ltd. Managing Director, Wei-dong said that at present, Beijing Sinovac started the business of all influenza vaccine production line, expected to be the eve of National Day, can produce 500 million doses of influenza A H1N1 influenza vaccine, used to meet the participation of the masses 60th anniversary, and related security sector staff immunization requirements; enrich the national response to the pandemic influenza drugs reserve.
Wei-dong is expected, if the national emergency medicines and store the end of this year, Beijing Sinovac can produce 3,000 copies of influenza A H1N1 influenza vaccine million.
The same time, Zhang said, at present, in addition to Beijing Sinovac Biotech Co., Ltd., the country other nine swine influenza vaccine companies have completed clinical trials of H1N1 influenza vaccine is being registered one after another to declare. Follow the special approval of pandemic influenza vaccine program, expected in mid-September, the State Food and Drug Administration to complete all of the above businesses a flu vaccine approved for registration.
China speed Development of only 87 days will affect safety?
Since June 8 strains from the WHO's access to productive use, to September 3 formally approved the production, made a vaccination only 87 days, why a new vaccine market with such a short time? Can ensure a safe and effective?
SFDA Guo-Qing Li, director of drug trial, said the WHO made clear, a vaccination can be applied to seasonal influenza vaccine production technology, China's 10 vaccine business practice is also true; In addition, WHO early in Jun. release of strain itself is validated through animal experiments.
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