Sinovac Biotech Ltd. received an approval from the China State Food and Drug Administration (SFDA) for the commencement of human clinical trials for Sinovac's pandemic influenza (H5N1, bird flu) vaccine.
In response to the severe nature a potential pandemic based on the avian virus, the SFDA fast-tracked Sinovac's October 21st, 2005 application in one month. The SFDA's regulatory agency for drug and biological products validation, the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), closely monitored and tested Sinovac's vaccine throughout the preclinical phase. Sinovac plans to initiate clinical trials as soon as possible, states a company release.
Due to this vaccine's uniqueness, the clinical trial process will be modified slightly, from three phases, to only two stages. Preclinical trial results demonstrated the company's pandemic vaccine safely induces a high quality immune response in animals (i.e. immunogenicity). Scientists will use clinical trials to further examine safety and immunogenicity in humans, and to establish the ideal dosage and immunization schedule. Once initiated, it is expected to take about three months to complete preliminary testing for the first clinical stage.
The British National Institute for Biological Standards and Control (NIBSC) provided Sinovac with a reassortant virus strain. This highly infectious H5N1 strain is reassortanted with a human influenza virus strain through reverse genetic technology; which is used to imitate the potential pandemic strain. The NIBSC reported it conducted safety tests on mice, rats, and ferrets. The results showed the strain is safe and it should not have biosafety problems while conducting R&D and clinical trials.
Sinovac Biotech Ltd. is a world leader in the research, development, manufacture and commercialisation of vaccines for endemic and pandemic viruses such as hepatitis and influenza, and for fast emerging viruses such as SARS and avian influenza (bird flu).