China's First Successful Development Of A World Behind The Flu Vaccine
September 3, Beijing Sinovac Biotech Co., Ltd
September 3, Beijing Sinovac Biotech Co., Ltd. Production of influenza A H1N1 Influenza Vaccine States Food And Drug Administration issued a drug approval number, which is world's first production batch of influenza A H1N1 was the flu vaccine. June 8 from the enterprise received from the World Health Organization can be directly used for vaccine production strains counting, the vaccine development cycle in just 87 days short.
Development, trial production, clinical trials, on-site inspection, registration inspection, review and approval ... ... to be completed in the shortest time H1N1 flu influenza vaccine development, vaccine manufacturers in China, drug testing oversight body, disease control and other departments Contact Cooperation Battle against time, so that the people in order to achieve the goal of vaccination as early as one day, go all out.
"Development of a vaccine as early as one day, one day people will be able to be protected"
2009 4 months, influenza A H1N1 influenza virus spread from North America to the world, influenza prevention and control of a sudden started this campaign. Prevention and control of influenza as the most effective means of communication, H1N1 vaccine development and production were high hopes. Can developed a vaccine as early as one day, it means that people can one day be protected. Access to the World Health Organization
strains is the basis for enterprises to develop vaccines. At 20 o'clock on the June 3, in customs, quality inspection departments with the cooperation of the WHO-accredited laboratories in the influenza A H1N1 influenza strain used for vaccine production in Henan arriving at headquarters in stock limited Hualan Biological Engineering company. As China's first obtain strains for vaccine production enterprise, Hualan things started in the first influenza H1N1 influenza vaccine.
"Whether it is scientific research, management, or front-line workers, from this moment on, all against the clock." Looking back over the past three months, Hualan Biological Engineering Co., Ltd. Deputy General Manager Fan Bei sighed, To Influenza H1N1 influenza vaccine, nearly all regard the corporate masters of the staff, daily work around the clock, skip meals is common.
9 1st, Hualan material developed influenza A H1N1 influenza split vaccine formal review by the Centre National Drug expert review, and is expected to be in the September 4 issued by the State Food and Drug Administration drug approval number. This from the company to get the standard strains, only 3 months, with Beijing Sinovac almost simultaneously.
"Population is compared with other countries facing a major challenge, the vaccine can be put into use as early as one day, one day, and susceptible populations of key groups, we can minimize the damage caused by an influenza pandemic." Beijing Branch Xing Wei-Dong Yin, Managing Director of Biological Products, said.
In business while stepping up research and development, government departments has also been active. June to August, the State Food and Drug Administration have issued "on the good Influenza H1N1 influenza vaccine production preparation work to inform," "special approval of pandemic influenza vaccine program of emergency," a series of documents, review and approval for the vaccine work laid the basis of a policy.
In the "does not reduce the standard does not reduce the" principle, the State Food and Drug Administration requested the review of Influenza H1N1 influenza vaccine approved part of the "three simultaneous", ie drugs to the technical review and evaluation center sub-synchronous enterprise reporting, drug Certification Center will produce on-site inspection and the production process of synchronization of Pharmaceutical and Biological Products for use in clinical samples and the batch release testing and simultaneous self businesses.
"It is the deployment of science to achieve optimum workflow and maximize efficiency for influenza H1N1 influenza vaccine development and production for a time." State Food and Drug Administration drug registration Secretary Zhang Wei said.
"No matter how much pressure head, we only believe in the principle that science"
Influenza H1N1 influenza is a new virus, Epidemic The early spread, the virus worldwide do not have enough understanding.
China's First Successful Development Of A World Behind The Flu Vaccine
By: yoyo
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