Sinovac Biotech received conditional commercial approval from China's National Medical Products Administration for its COVID-19 vaccine in the country on Friday, according to the company's statement on Saturday.
It marks the second COVID-19 vaccine approved for public use in China after a shot developed by a Beijing institute affiliated to the state-owned China National Pharmaceutical Group (Sinopharm) was approved in December.
Sinovac's CoronaVac has been approved for emergency use in China since last June and used for targeted groups who are at higher risk of facing the virus.
According to the company's statement, Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay, and Laos have granted emergency authorization for the CoronaVac vaccine. Multiple countries have rolled out vaccination programs targeting medics and the elderly.
Approval of the two-dose regimen by China's National Medical Products Administration is based on the results from two months of late-stage clinical trials overseas, from which the final analysis data has not yet been obtained, Sinovac said. The company will continue its research on the vaccine to provide the full report later for its full authorization.
Sinovac's vaccine is being tested in phase-3 clinical trials in countries including Brazil, Turkey, and Indonesia, where varied efficacy readings had been released separately.
The vaccine was found 50.65 percent effective against COVID-19 disease in the Brazil trial, which had recruited 12,396 health workers older than 18 as of December 16 and recorded 253 cases, Sinovac said in a statement on Friday.
The success rate from the Turkey trial was 91.25 percent, local researchers said, based on a preliminary analysis of 29 cases. There was a 65.3 percent efficacy rate in the Indonesia trial.
SinoVac has built up its first production line last August to make 500 million doses in the form of the bulk ingredient. The production is expected to increase to 1 billion doses this February as the second production line has just been completed.
Since the end of last year, the company has exported semi-finished products to the countries such as Brazil, Indonesia, Turkey, and Chile, which are able to bottle vaccines to expedite the process.
(With input from Reuters)