Yan Jiangying, spokeswoman with State Food and Drug Administration (SFDA), said at a regular press conference held on Friday that the SFDA has been prepared to give a prioritized approval procedure to the production of A/H1N1 influenza vaccines by using new strains provided by the WHO.
Yan said all seasonal human flu vaccines in China were only permitted to be made based on virus strains given by the WHO, which would take scientists about 27 days to segregate from patients.
"To acquire the virus's strain as soon as possible, the SFDA has created a direct communication channel between Chinese vaccine manufacturers and the WHO," said Yan, adding that all approved departments will give green lights to the vaccine production.
According to the SFDA's prioritized procedure, the authority will issue approval within three days of the A/H1N1 flu vaccine's production application.
The SFDA is still waiting the WHO's judgment of the A/H1N1 influenza on whether it is a pandemic or a seasonal flu, which will determine the production authorization of the vaccine in China.
"If it is determined as a seasonal flu, licensed vaccine makers could start their production after they acquire the strain and submit their production records to the SFDA," the spokeswoman said, adding that there are scores of such vaccine makers in China.
"If it is a pandemic, according to the SFDA's regulation, only one company, Sinovac, is licensed to make the vaccine," she said.
Sinovac Biotech Co. Ltd. is a Beijing-based biotechnology company which has built a reputation for development of human vaccines against SARS, or Severe Acute Respiratory Syndrome, and bird flu.
(Xinhua News Agency May 8, 2009)
