A flu vaccine made by "

As the first to the State Food and Drug Administration
Center for Drug Evaluation, reporting a proposed review of the current vaccine, Beijing Sinovac Biotech Co., Ltd. (hereinafter referred to as Beijing Sinovac) development and production of influenza A H1N1 influenza split vaccine received 45 expert reviews. The experts of the vaccine safety, effectiveness and strict quality control review. After the scene to vote, to 43 experts will agree that the vaccine can be used for 3? 60-year-olds immunized. This marks the first of a flu vaccine in China by the expert review, will soon receive approval number. Rest of the world's vaccine production process, a sense of basic and China simultaneously.

It is reported that the review would be the largest one in history. 45 review experts from the vaccine, virology, immunology, epidemiology, statistics, vaccine quality control, respiratory medicine, geriatrics, pediatrics, gynecology, neurology and other 11 areas, with high authority and broad representation.

Previous expert review will be different, the expert review for the first time open to the media and the public, public representatives and 15 more than 20 journalists to attend review meetings. Reporter, as representatives of the media witnessed the vaccine through an expert review process.

Site to vote, the vaccine is safe and effective
"The effectiveness of the vaccine to meet internationally recognized evaluation criteria, see adverse reactions observed during the performance and incidence similar to seasonal influenza vaccine." Held today, the expert review meeting, the President, vaccine expert Zhao Armor Academy of Sciences will review the report first to open the August 30 to 31 experts in the review comments in the review form. He said experts believe the vaccine is safe and effective, can be 3? 60 years of age to immunize the population. At the same time remind the business, continue to observe the immune persistence and long-term stability of the vaccine, large-scale population immunity in enforcing risk management and pharmacovigilance plans.

It is reported that Beijing Sinovac has developed the basic conditions for a flu vaccine, approved by the State Food and Drug Administration organizations, development, production and clinical trial site inspection on-site inspection. General Manager of Beijing Branch Xing Wei-dong said the vaccine was from June 8 for the production of toxic species to August 31 by the review took only 85 days. Ministry of Health, State Food and Drug Administration and the Chinese Centre for Disease Control and Prevention (CDC) of the organization and coordination, the entire development, tight and efficient production process, but the vaccine production, testing and clinical trials of the procedure did not decrease further.

State Food and Drug Administration director of the Center for Drug Evaluation, said Li Guoqing, China's development and production of vaccine has been able in a relatively short period of time through the review, mainly due to the flu vaccine is a vaccine more mature, and our enterprises in the production of influenza vaccine has good foundation and strength. Currently there are 10 enterprises in China during a flu vaccine production, including Beijing Sinovac has six, including the request for review, drug review center is in accordance with the order to submit applications one by one expert review.

"Of course, inseparable from the Ministry of Health, Ministry of Industry, the State Food and Drug Administration and other government departments to actively promote." Academician Zhao Kai, this is our response to large-scale influenza vaccine and immune reserves accumulated experience.

Public participation, open and transparent review
"I signed up online to present my concerns and soon received an invitation to attend the review." From the Business School of Renmin University of China, Zhang said Professor Kay. He was concerned with three issues, namely, how the effectiveness of the vaccine? Second, what are side effects of vaccines? The third is what the crowd is not appropriate vaccine?

This, Zhao Kai Fellow in the review conference to explain that the current vaccine in mass immunization in the crowd yet, so no statistical validity rate, but the vaccine is based on a certain dose, certain procedures , according to the situation of antibodies obtained to infer the effectiveness of its current conclusion is that to meet internationally recognized evaluation criteria, that antibody is in line with the requirements, can play a protective effect against influenza.

For vaccine adverse events of public interest, epidemiologists Rongcheng that the current clinical trials adverse events seen in seasonal influenza vaccine use are ever occurred, and no new, serious, rare adverse reaction, based on this, experts determine the vaccine is safe.

Sincerely from Beijing Medical Technology Group Hai-Bo Wu also very concerned about what people should not be inoculated with the vaccine. Zhao Kai fellow told him, it is recommended to determine whether the actual situation of pregnant women vaccinated.

A lot of media attention

flu spread worldwide since what changes have taken place, showing how the trend, a new variation will occur. In this regard, from the Chinese CDC epidemiologists Professor Zeng Guang said that at present, the monitoring of a national sense of common susceptibility showed Xianchu, its ability to communicate than seasonal influenza, the severity of disease is also higher than the season influenza. "Can say with certainty that in the larger context of a flu pandemic is inevitable and will certainly come."