Sinovac’s vaccine granted conditional market approval
Print Edition
CHINA’S National Medical Products Administration granted conditional market approval to CoronaVac, an inactivated COVID-19 vaccine developed by Sinovac Biotech, the company said on Saturday.
It marks the second vaccine to be approved for public use in China, after one developed by a Beijing institute affiliated with China National Pharmaceutical Group (Sinopharm) was approved in December.
The Sinovac vaccine, produced by the Beijing-based Sinovac Life Sciences Co Ltd, affiliated with Sinovac Biotech, was approved for emergency use in China last June.
From January, countries including Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay and Laos successively approved the emergency use of the Sinovac vaccine locally.
The conditional approval means the vaccine can now be given to the general public, though research is still ongoing. The NMPA requested the company to continue to carry out relevant clinical trials, fulfill the conditional requirements, and submit the follow-up results in time.
“We expect to provide more safe and effective vaccines as soon as possible and help control COVID-19 ultimately by increasing inoculation rates, enabling social and economic development to return to the normal,” said Yin Weidong, chairman and CEO of Sinovac.
The vaccination procedure includes two shots with an interval of 14 to 28 days, and each dose is 0.5 ml.
In China, the vaccine has completed its phase-1 and phase-2 clinical trials for adults aged over 18 and the elderly, and the enrollment of volunteers aged 3 to 17 has been completed. The volunteers in China has reached more than 2,200 people and the results showed that the vaccine has good safety and immunogenicity in all age groups.
Since July 2020, Sinovac has conducted phase-3 clinical trials in four countries including Brazil, Chile, Indonesia and Turkey, involving more than 25,000 volunteers altogether.
As of December 16, 2020, 12,396 medical workers aged over 18 were enrolled in Brazil and 253 infection cases were collected during the observation period. Clinical studies in Brazil suggested that the vaccine was 100 percent effective in preventing hospitalized, severe, and fatal cases, 83.7 percent effective in preventing cases requiring medical treatment, and has a general efficacy rate of 50.65 percent.
Results in Turkey showed that the vaccine has an efficacy rate of 91.25 percent.
Sinovac’s first production line has an annual production capacity of 500 million doses. The company has constructed a second production line, which will start operation this month, increasing its annual capacity to 1 billion doses.
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