Domestic first flows vaccine is commented through examining Bureau of Drugs Supervision makes the decision to examine and approve in three days

Domestic first flows vaccine is commented through examining Bureau of Drugs Supervision makes the decision to examine and approve in three days
Have already examined and commented through the expert; The middle and primary schools of Beijing start a new term for first week and must train and defend first and flow
Yesterday afternoon, under the witness of the public and representative of medias, 43 vaccine, epidemic disease, quality control and clinical expert, agree with the unanimous vote through being revitalized 15 micrograms of first type H1N1 influenza virus cracked vaccine that biologicals Co., Ltd. produced by Beijing subject, can be used in the immunizing of crowd of 3-60 years old, inoculate the procedure as a stitch.
Global and first to reveal it through examining and commenting
National food medicines supervise administration bureau medicines examining and commenting Li Guoqing, director of centre, and claiming, the expert panel will examine and comment the opinion in writing to present national Bureau of Drugs Supervision tomorrow, according to especially examining commenting the procedure of this office, national Bureau of Drugs Supervision will examine and approve the decision within three days.
Person in charge of research and development group Yin WeiDong estimates vaccine, first domestic first flows vaccine will get the medicines authentication code within this week, can come into operation in our country formally, can be used in the large-scale crowd and inoculate the immunity.
This global and first too reveals that finishes the clinical trial smoothly, it is safe and effective to verify, and examine first type H1N1 influenza vaccine commented through the national medicines supervision department.
Our country have 10 seasonal the intersection of influenza and the intersection of vaccine and manufacturing enterprise carry on first development to shed vaccine at present. Li Guoqing introduce, tomorrow, national medicine examine centre, finish the intersection of Henan and the intersection of China and blue living beings of clinical research produce to another first flow vaccine go on and examine and comment already, the result will be announced on the same day.
Meanwhile, other 6 of influenza vaccine manufacturing enterprise, has already referred to the expert to examine and comment and apply too, medicine will examine the centre according to the application time of every enterprise and declare the materials to finish the intensity, examine and comment sequentially as soon as possible.
Produce 65 million people and a piece of vaccine at the end of the year
To the tactics of prevention and control of the first type H1N1 influenza according to the country, Li Guoqing expects, if All goes weight, before National Day, our country can produce first in immune demands of 1% of the people vaccine flows; Before the the end of this year, at least can guarantee national 5% population, that is to say 65 million people first of copy vaccine flows.
However, Li Guoqing emphasizes, vaccine is that the country should store the emergency of the epidemic situation that first flows, will not be listed and sold; After it obtains approval to bottle and produce, are used in the large-scale crowd and inoculate the immunity immediately, the official reserves, will depend on the epidemic situation develops situation, Ministry of Public Health make the concrete immune tactics.
Ministry of Public Health said yesterday, all parts were stepping up inoculating vaccine of seasonal influenza at the same time, according to first type the intersection of H1N1 and the intersection of influenza vaccinations and scheme that issue soon, organize to key vaccine inoculation of crowd.
-The expert understands
It is not everybody that needs vaccine inoculation
Examine and comment whether mean first flows vaccine can be listed and used immediately through the expert, inoculate for the public? How does the public vaccine get first to flow in time and fairly?
[Understand ] national medicines examine and comment Li Guoqing, director of centre: The country will judge according to the development of the epidemic situation and extent of injury that launches vaccine and makes the corresponding immune tactics. When the epidemic situation is popular, first flow vaccine can be use for protecting high-risk group and more easily infected group first, function its to reduce case fatality rate, set up immune protective screen in crowd, it is every citizen that need, inoculate first shed vaccine.
It can be immune that 15 micrograms inoculate a stitch
Before this, examine and comment people's bird flu (H5N1) At the vaccine, need 90 micrograms to inoculate two stitches continuously, the human body could produce immunoreaction, H1N1 one brand-new virus too, why need, inoculate 15 first stitch can only?
[Understand ] China should accuse of expert, vaccine of Committee of Experts, guide Zhao Kai, group leader of group and academician of Chinese Academy of Engineering to first type the intersection of H1N1 and the intersection of influenza and the intersection of joint defence and antithetical couplet: More than 2000 people's result of study reveals, dosage of 15 micrograms of H1N1 vaccine is in children 3 years old to 60 years old, teenager and three age groups of adult, the original result of immunity for 14 days and 21 days reaches about the internationally acknowledged evaluation criterion after immunity inoculation.
The vaccine inoculation expenses will be born by government
How does vaccine price? If need to inoculate, who bears the expenses?
[Understand ] national medicines examine and comment Li Guoqing, director of centre: Meet an urgent need as country medicines store, first flow pricing of vaccine can fluctuate according to market conditions, but after deducting enterprises and researching and developing cost and reasonable profit by the country, stipulate prices, purchased in unison by the government. Reach the intersection of we and everyone specifically, if need vaccine inoculation, expense for country's or local government's account.
If virus makes a variation and changes vaccine in time
Is developed constantly by H1N1 epidemic situation that the new virus causes, the virus make a variation at present? If virus make a variation, first present flow vaccine effective?
[Understand ] examine, comment the intersection of expert panel and member, China disease accuse of the intersection of centre and national director of influenza in the center Shu YueLong: Monitor the result to watch according to the network of the whole world and China at present, H1N1 virus morphed yet.
We will continue strengthening and flow to first the monitoring of the epidemic situation, once find the virus makes a variation, will change vaccine in time.
-Examine and comment the scene
The public audits and examines and comments and pays close attention to vaccine safely
Medicine examine expert say clinical research reveal first flow vaccine bad reaction relatively little
Yesterday, through to audit half one day, 15 public representative question at the forum after the expert is examined and commented and will finish, focus on the security of vaccine.
First the public of speech hope, understand children on behalf of HaiBo Wu and pregnant woman inoculate flow behind the vaccine by first, will the bad reaction increase? And the public representatives from school, pay close attention to the fact even more how the colony of students in middle and primary schools resists first to flow and attack at present, what guarantee is the security of vaccine that the children 3 years old to 11 years old inoculate first and flow?
To the security question which the public pays close attention to, examine and comment Rongcheng Li, expert of group, and introduce, because the clinical trial is divided into four age brackets, the concrete data result really reveals, there are certain differences between children, old man and adult, but seen from bad reaction of the report after inoculation, vaccine is basically identical with vaccine of seasonal influenza that first has flowed, there are less bad reactions, take slight general bad reaction as the core, reveal security is better.
Reporter Wei Ming's speech
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