On June 22, Hualan Biological Engineering Inc. officially announced that it has successively produced China's first batch of the A/H1N1 influenza vaccine. The vaccine still requires a series of biological and biochemical experiments and expects to officially put on the market in September after its safety and effectiveness have been guaranteed.

On June 3, Hualan Biological Engineering Inc. received China's first strain of the A/H1N1 influenza virus from a UK laboratory, which is approved by the World Health Organization (WHO). On June 13, the company achieved its most significant step in the production of the A/H1N1 influenza vaccine: the initial screening of different strains of the A/H1N1 influenza virus from WHO which is used for vaccine production was completed. China's first vaccine seed storage was established and the A/H1N1 influenza vaccine officially entered the producing stage. To ensure the safety and effectiveness of the vaccine, Hualan Biological Engineering Inc. presented a clinical experimental program to the State Food and Drug Administration (SFDA) on June 17. The clinical program was finalized following discussion among experts. Hualan's annual production capacity of the A/H1N1 influenza vaccine will reach 160 million units.

Reporters learned that the vaccine still requires a 40 to 50 day-long clinical experiment after passing the preclinical test. At least two months are needed before the A/H1N1 influenza vaccine can be used.

Experts noted that there is uncertainty involved in the spread of the epidemic including risks in clinical tests, official approval of vaccine production from the SFDA, and other factors. When the A/H1N1 influenza vaccine will be put on the market, its sales volume and other aspects still remain uncertain.

By People's Daily Online

http://paper.people.com.cn/rmrb/html/2009-06/23/content_280475.htm