The vaccine manufactured by Beijing-based Sinovac Biotech Ltd. has received approval from the State Food and Drug Administration’s drug registration department in China. The World Health Organization has stated that the results of clinical trials have been encouraging. The WHO had access to test results and has declared that there is no reason to doubt the reports of Sinovac.
Testing studies conducted involved more than 3,000 people. The company assures that the one-dose vaccine is effective in preventing influenza A (H1N1) in people between three and 60 years of age.
The single dose immunization offered by Sinovac has elicited discussions among experts. Vaccines are usually administered in two doses to provide adequate protection. Sinovac, however, has demonstrated the efficacy of a single dose.
The single dose sufficiency for H1N1 influenza virus immunization would greatly reduce manufacturing needs to cover the entire population. Another Chinese pharmaceutical, Hualan Biological Engineering Inc., is also awaiting approval of their vaccine this week.
Sinovac and Hualan have indicated that production capacity is 30 million and 160 million doses, respectively, in a year. However, the West remains skeptical of Chinese manufacturing after the recent health scandals in China such as the melamine contamination. Although, some countries like Mexico are considering the idea of buying vaccines from the Chinese market because they are 40 percent cheaper.
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