Chinese drug regulators accept application for Sinopharm vaccine rollout
Published: Dec 24, 2020 02:59 PM

Sinopharm's COVID-19 vaccine. Photo: VCG

Chinese drug regulators formally accepted the country's leading vaccine producer Sinopharm's application for market rollout of its COVID-19 vaccines on Wednesday, which marks a closer step to China's approval for this vaccine candidate to combat the coronavirus.

The Center for Drug Evaluation of China's National Medical Products Administration has formally accepted the application and started examination procedure, the Global Times learned from the Sinopharm.

Chinese experts predicted that conditional approval could be granted from January 1, 2021. 

Shares of Sinopharm jumped 9 percent following the news. Shares linked to cold chain transport for vaccines also saw gains.

Sinopharm submitted its application on November 25. The company told the Global Times in a previous interview that it had collected data from countries carrying out clinical trials on its vaccine candidates, such as the United Arab Emirates. The results are expected to be good but it is up to Chinese health authorities to make the decision as the authorities have strict review standards.

It had reported phase III clinical data to China's State Food and Drug Administration and is in the process of giving more detailed data, as requested.

The vaccine maker will release its trial data in academic journals after approval, reports said.

Tao Lina, a Shanghai-based expert on vaccines and former Shanghai disease prevention and control employee, told the Global Times on Thursday that there could be a conditional market rollout of the COVID-19 vaccine around January 1, 2021 after the phase III clinical data is published.

Many areas in China including Zhuhai in South China's Guangdong Province, Yiwu, Jiaxing and Shaoxing in East China's Zhejiang Province, and Southwest China's Sichuan Province have authorized out emergency COVID-19 vaccine inoculation for high-risk groups to tackle imported infections and resurgence of sporadic local cases.

Meanwhile, some residents reached by the Global Times have expressed their concerns over the safety and efficacy of the vaccines. As China is basically safe thanks to the national anti-epidemic work, some said they would like to wait for the official approval before being vaccinated. 

Some of those among the high-risk groups who had been vaccinated said they experienced no or not obvious adverse reactions after the shots. 

Sinopharm's vaccines, which use inactivated virus unable to replicate in human cells to trigger an immune response, require two doses, clinical trial registration data showed.

The inactivated COVID-19 vaccine produced by Sinopharm was officially approved by UAE earlier this month. The vaccine has a proven efficacy of 86 percent,  UAE health ministry said in early December, based on interim analysis of phase III clinical trials.