Sinovac has reported positive top-line results from the completed clinical trial for its H1N1 vaccine.
In the study, a total of 1,614 participants over three years old received the H1N1 vaccine. Blood samples were collected from the participants on the vaccination date, 14 days post vaccination date and 21 days post vaccination date.
The National Institute for the Control of Pharmaceutical and Biological Products (NICBPB), the central laboratory of China State Food and Drug Administration (SFDA), have completed the HI antibody tests on all blood samples.
The analysis of the clinical trial results showed that the H1N1 vaccine developed by Sinovac induces good immunogenicity after one dose. None of the volunteers participating in Sinovac’s clinical trials have exhibited any signs of severe adverse reactions.
Weidong Yin, chairman, president and CEO of Sinovac, said: As demonstrated in the clinical trial of our H1N1 vaccine, we can confirm the immunization schedule and dosage, which can provide the scientific reference to the state government to establish the inoculation strategy of H1N1 vaccine. Sinovac plans to complete the summary report as soon as possible and fully evaluate the safety and immunogenicity of the H1N1 vaccine. Thereafter, we intend to apply for the Production License for H1N1 vaccine in compliance with SFDA’s regulations.