Sinovac COVID-19 vaccine granted conditional market approval in China

BEIJING -- 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 Feb 6.

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 last year.

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 said.

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 percent.

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 reliable.

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.