Saturday, February 8, 2014

#H7N9 New Vaccine From Preclinical Research to Clinical Trials & Then Approval Usually 2-3 Years Time

Translation - Excerpt:

The official declaration of the country a number of clinical trials of H7N9 vaccine has not been approved

As early as last April, people infected with H7N9 bird flu outbreak at the beginning, in conjunction with the Ministry of Health and Family Planning Commission launched a human infection with H7N9 avian influenza emergency prevention and control technology research projects focus on promoting the development of clinical diagnostic reagents, vaccine development and other priorities. At that time, the ministry official is expected to be completed clinical validation of nucleic acid diagnostic reagents within two months, the completion of human infection with H7N9 avian influenza preventive vaccine within seven months.
In early January of this year, the ministry website published the news that, H7N9 avian influenza virus vaccine research and development of key technologies and product development issues has been basically completed preclinical studies.
However, pre-clinical studies are completed, does not mean that H7N9 vaccine will soon be listed. Insiders said that a new vaccine, from preclinical research to clinical trials and then approved the listing will be subject to a lot of careful research, review links and sufficient time (usually 2 to 3 years). The length of this time, on the one hand depends on the vaccine development process and technical solutions are complete; the other hand, depends primarily on the development of the epidemic situation and the Government's judgment on the epidemic situation.

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