In June: Tianyuan started the research and development of H1N1 Influenza A vaccine and the established a research team in accordance with national requirements and directives
On 18 June: Tianyuan received the virus strain NYMCX-179A recommended by WHO from NIBSC
On 28 June: Tianyuan completed the preliminary screening of strains and established the production seed bank for H1N1 influenza A vaccine, and finished the control tests
On 10 July: 4 batches of final bulk were prepared and sent to NICPBP for synchronous testing. Both results from NICPBP and in-house control complied with requirements. Shanghai Sangon Biological Engineering Technology & Services Co., Ltd were entrusted for gene sequencing to detect the primary seed with batch number of H120090601MSL and working seed with batch number of H120090601WSL. The test results showed exactly the same as the nucleotide sequence of NYMCX-179A from U.S. National Center for Biotechnology Information Gene Bank
On 30 July: Tianyuan carried out clinical trials in Hebei Province according to "Clinical Trial Protocol of H1N1 Influenza A vaccine". It was evaluate that the vaccine had good safety with slight side effects
On 30 August: Tianyuan completed interim clinical trial overviews (unblinding)
On 4 September: Tianyuan applied for Batch Release
On 10 September: Tianyuan got production permission
On 22 September: Tianyuan's H1N1 influenza A vaccine passed the evaluation by Chinese CDC and National Center for New Drug Evaluation. 11 experts including 3 academicians named Hou Yunde , Zeng Guang and Ruan Li attended this evaluation conference
On 25 September: Tianyuan's registration application for H1N1 influenza A vaccine were approved by State Food and Drug Administration and Tianyuan got new drugs certificate and registration approval certivaccine
On 28 September: Tianyuan passed the GMP tracking inspection carried out by SFDA GMP
Up to 26 September 2009, Tianyuan have produced 13 batches of H1N1 Influenza A vaccine totaled nearly 3 million human doses.
Since 1 October, the monthly yield will be more than 5 million human doses.
According to the instruction from Ministry of Industry and Information Technology, so far Tianyuan has
supplied 2.3 million doses of H1N1 vaccine to Guangdong, Zhejiang and Hunan provinces.
|
