10 February 2021 | News
The approval is based on the results of the two-month data of phase III clinical trials
Source credit: Shutterstock
Sinovac Biotech Ltd has announced that the China National Medical Products Administration (NMPA) has granted a conditional marketing authorisation (CMA) to Sinovac for CoronaVac, Sinovac’s COVID-19 vaccine in individuals aged 18 and above.
Sinovac began rolling submission to the NMPA since September 2020 and the NMPA carried out rolling reviews when the submission was made. As of February 4, 2021, the company made more than 40 submissions to the NMPA. After obtaining the preliminary efficacy results, Sinovac formally filed for application of a conditional marketing authorisation on February 3, 2021. The approval is based on the results of the two-month data of phase III clinical trials. The final results are not yet available, and the efficacy and safety results shall be further confirmed.
Yin Weidong, Chairman, President and CEO, Sinovac, said, "Being granted a conditional marketing authorisation for CorornaVac is a significant milestone for Sinovac after commencing development at the beginning of 2020. We show our respect and appreciation to the volunteers for their contribution to this research and thank all experts, scientists and partners who participated in this international collaborative project. We look forward to providing safe and effective vaccines to as many individuals as possible to combat this epidemic by increasing the vaccination rate. It is our sincere hope that people’s lives and social and economic activities can return to normal as soon as possible, and that we can wear a smile without masks."
CoronaVac is being used under emergency use approval (EUA) in Indonesia, Brazil, Turkey and Chile. Sinovac is also actively seeking regulatory approval of CoronaVac in other countries and regions around the world in an effort to maximise global accessibility and affordability of the COVID-19 vaccine and to ensure global prevention and mitigate spread.