Sinovac COVID-19 vaccine granted conditional market approval in China
Pub Date:2021-02-07 13:17 Source:Xinhua
China's National Medical Products Administration on Friday granted
conditional market approval to CoronaVac, an inactivated COVID-19
vaccine developed by Sinovac Biotech, the company said on Saturday.
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. The vaccine started being used for
emergency inoculation among some special groups in the country from July
From this January, countries including Indonesia, Turkey, Brazil,
Chile, Colombia, Uruguay and Laos successively approved the emergency
use of the Sinovac vaccine locally.
These countries recognize the clinical research results of the
vaccine, believing it has obvious effects on reducing the medical
treatment, hospitalization, critical cases and deaths caused by
COVID-19, and is of great importance to pandemic prevention and control,
Sinovac Biotech said in a press release on its website.
Sinovac Life Sciences Co Ltd on Feb 3 filed an application for
conditional market approval of CoronaVac, which was granted on the basis
of the vaccine's overseas phase-3 clinical trials for two months, it
The NMPA requested the company to continue to carry out relevant
clinical trials, fulfill the conditional requirements, and submit the
follow-up research 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
track," said Yin Weidong, chairman and CEO of Sinovac.
According to the company, 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.
Clinical trials in Turkey involved both health care workers aged
18-59 who are at high risk and the general population at normal risk.
Results in Turkey showed that the vaccine has an efficacy rate of 91.25
The vaccine production quality management system has passed GMP
inspections in many countries including China, Brazil, Indonesia and
Chile. Hundreds of batches of large-scale production have proved that
the vaccine production process is controllable and the quality is
Sinovac's first production line which went into operation in August
2020 has an annual production capacity of 500 million doses. The company
has constructed a second production line, which will start operation in
February, increasing its annual production capacity to 1 billion doses.
Sinovac will also export semi-finished jabs to some countries with
filling and packaging capabilities such as Brazil, Indonesia and Turkey.
The supply of vaccines in the form of both finished and semi-finished
products will help fill the gap of the company's filling and packaging
capacity, save the international transportation cost, and improve the
accessibility and affordability of vaccines, the company said.
It is China's second self-developed COVID-19 vaccine that has got
conditional market approval in the country. The vaccine developed by
China National Biotec Group affiliated with Sinopharm was approved in
December last year.