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China's leading COVID-19 vaccine maker applies for government license

PTI Nov 26, 2020

China's leading vaccine producer Sinopharm announced on November 25 that it has submitted an application to the Chinese authorities for marketisation of its COVID-19 vaccine based on data collected from countries carrying out its clinical trials.

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A representative of Sinopharm told state-run Global Times that the company had collected data from major countries such as UAE carrying out its vaccine clinical trials. Results are expected to be good but it is up to the Chinese authorities to make the decision as the government has strict review standards. Sinopharm previously told the daily that it had reported the phase-III clinical data to China's State Food and Drug Administration and was in the process of giving more detailed data, as requested.

The vaccine maker says it is in the final stage before marketisation, and is now making approval for the marketisation of the vaccine its top priority. It will be possible to release the phase three data in academic journals after the approval. Our data is evaluated by relevant departments following protocols even stricter than in some Western countries, and we are in close communication with the WHO," a representative of Sinopharm told the daily earlier. A Chinese Foreign Ministry spokesman Zhao Lijian told a media briefing last week that five Chinese vaccine candidates are under clinical trials in countries including the UAE, Brazil, Pakistan and Peru.

Sinopharm, China's state-owned vaccine producer, said on November 19 that its vaccine has been administered to about a million people under the government's emergency use scheme. In terms of emergency use, the vaccines were applied to nearly a million people and there has not been a single case of a serious adverse event. People have had only mild symptoms, Liu Jingzhen, chairman of China National Pharmaceutical Group (Sinopharm), said in an interview with a Sichuan-based digital media company that was published on November 25.

Until now, all our progress, from research to clinical trials to production and emergency use, we have been leading the world, he was quoted as saying by the Hong Kong-based South China Morning Post on last November 26. His comments came amid criticism that Chinese firms have not publicised the clinical data of its vaccine studies.

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