Vaccines from Sinovac Biotech and Hualan Biological Engineering are likely to be approved in the next few days after the Chinese Center for Drug Evaluation (CDE) recommended the products.
The Chinese State Food and Drug Administration (SFDA) will now make the final decisions. Approval is an important step in China’s efforts to control the spread of the virus, which is believed to have infected 3,700 people on the mainland.
Between them Sinovac and Hualan claim to have capacity to produce 190m doses of H1N1 vaccine a year but in a country with 1.3bn people this represents a small proportion of the potential requirements.
The companies’ efforts will likely be supported by other vaccine manufacturers, with the SFDA reporting that there are 10 businesses developing H1N1 vaccines in China, seven of which have filed applications for product registration.
Currently no further information regarding the status of the five other applications but, with the Health Ministry hoping to vaccinate five per cent of the population by the end of 2009, extra capacity would be beneficial.
The vaccines are expected to be approved on the basis that one dose confers immunity, unlike some other regulators that believe two may be required.
Sinovac claims that in its clinical trials the European Union criteria for immunity was reached after a single dose was administered. Furthermore, the vaccine was demonstrated to have a good safety profile and immunogenicity factors.
The vaccine is applicable to people from three to 60 years old and will be administered as 15ug/0.5ml/dose.