Clinical study of human avian influenza vaccine in China

Introduction: Xinhua Beijing, Nov 22 (reporter Zhang Xiaosong) the State Food and Drug Administration decided on Nov 22 to approve the human avian influenza vaccine developed by Beijing Kexing Biological Products Co., Ltd., "pandemic influenza vaccine" for clinical research This indicates that China has made new progress in the research and development of pandemic influenza drugs According to the relevant person in charge of the State Food and drug administration, the "pandemic influenza vaccine" approved for clinical research this time is the inactivated influenza H5N1 whole virus vaccine; the strain used is the NIBRG-14 strain recommended and distributed by the World Health Organization, which is prepared by reverse genetic technology and has non pathogenicity; the product contains aluminum hydroxide adjuvant, which can increase Strengthen the human body's response to the vaccine, reduce the effective dose of single dose antigen vaccination, and cover more people According to the expert technical review organized by the State Food and drug administration, the strains used in the "pandemic influenza vaccine" are relatively reliable, the production process is relatively mature, and the preclinical trials preliminarily prove that they have certain safety and effectiveness Scientists in China have been developing pandemic influenza vaccines since last year The State Food and drug administration is very concerned about this It adopts the early intervention mode and keeps tracking the development of vaccine After receiving the application from the enterprise, the State Food and drug administration, in accordance with the special approval procedure for drugs, organized the early intervention of experts and carried out the inspection and technical review of vaccine samples at the first time On November 2, at the International Symposium on pandemic influenza vaccine held by the World Health Organization, China's research results were affirmed by experts, who believed that the research progress basically kept pace with the international At present, there are seven companies in the United States, the European Union, Japan and other countries and regions that are developing such vaccines