China approves for the first time commercial use of a vaccine against COVID

That of Sinopharm and its subsidiary, the Beijing Institute for Biological Products

REUTERS/TINGSHU WANG  -   China National Biotec Group (CNBG) coronavirus vaccine

For the first time, Chinese authorities gave the green light to the marketing of one of the country's developed COVID-19 vaccines, that of Sinopharm and its subsidiary, the Beijing Institute of Biological Products. 

Both companies applied yesterday to the National Medical Products Administration (NMPA) for authorisation after reporting that the vaccine's efficacy was 79.34%, according to provisional data from phase 3 clinical trials. 

At a press conference held in Beijing, NMPA's number two, Chen Shifei, explained that the institution concluded that "the known and potential benefits of this vaccine outweigh its known and potential risks" and that it meets the standards set for conditional marketing approval. 

The condition is that Sinopharm continues to carry out its clinical trials according to the agreed deadlines and to send the data collected to the country's medical authorities for verification and final registration. 

Chen explained that, according to local laws, a vaccine can be conditionally approved when it is "urgently needed to respond to major public health emergencies". 

Yesterday's brief announcement of the results of phase 3 testing did not provide data such as the number of participants who did contract the virus or reported side effects. 

Nor did the press conference provide these data, which will be published "later in Chinese and other countries' medical journals", according to Wu Yonglin, president of CNBG - a subsidiary of Sinopharm, on which the Beijing Institute of Biological Products depends. 

Wu said that the tests were carried out with standards "that surpass existing ones, including those of the WHO (World Health Organization)". 

Although China has approved the release of the serum, several of the vaccine candidates developed in the country were approved in June to be administered in "emergency" cases, i.e. people at high risk of infection. 

The deputy director of the National Health Commission, Zeng Yixin, revealed that more than 1.5 million doses of the vaccines were administered between approval in June and November. 

Following this, on December 15 China launched a more ambitious vaccination campaign for risk groups. Since then, another 3 million doses have been injected.