China’s drug regulator has given approval for the conditional mass use of COVID-19 vaccine produced by Chinese pharmaceutical firm Sinovac Biotech, China’s second COVID-19 vaccine, after Sinopharm’s vaccine, to receive conditional approval.
Sinovac Biotech announced on Saturday that CoronaVac, an inactivated vaccine candidate against COVID-19, received authorization from China’s National Medical Products Administration for conditional mass use in China on Friday.
The conditional approval was based on the results of the overseas Phase-III clinical trials of CoronaVac. Final data from the trials has not been made available yet and the results of its efficacy and safety require further confirmation, Sinovac said in a statement sent to the Global Times on Saturday.
Sinovac has completed its second production line for vaccine stock, and the two lines will ensure that the annual production capacity of Sinovac’s stock solution exceeds 1 billion doses.
CoronaVac has completed Phase-I and -II clinical trials for adults above 18 years old and seniors in China, and the enrollment of volunteers for the clinical trial of minors aged 3-17 has been completed. The study of the vaccine included more than 2,200 Chinese volunteers, with the results showing that the vaccine has good safety and immunogenicity for people of all ages.
CoronaVac was first approved for emergency use in China in June 2020, and it has received emergency approval in countries including Indonesia, Turkey, Brazil, Chile and Colombia since January. Sinovac has started providing vaccines to Brazil, Indonesia, Turkey and Chile since the end of last year.
CoronaVac is China’s second homegrown COVID-19 vaccine to be granted conditional approval for the country’s domestic market. The inactivated vaccine developed by Beijing Biological Products Institute under Sinopharm’s subsidiary China National Biotec Group (CNBG) was China’s first COVID-19 vaccine to receive conditional approval on December 31, 2020.
Sinovac photo: Li Hao/GT
