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China approves first vaccine for commercialization

Chinese authorities gave the green light this Thursday for the marketing of one of the vaccines against covid-19 developed in the country, by Sinopharm and the subsidiary Institute of Biological Products of Beijing.

Both companies asked the Chinese regulatory authority on Wednesday for approval of the vaccine, after informing that the effectiveness is 79.34%, according to provisional data from phase 3 clinical trials.

At a press conference held this Thursday in Beijing, the number two regulator, Chen Shifei, explained that the institution concluded that “the known and potential benefits of this vaccine outweigh the known and potential risks” and that it meets the standards set for the conditional approval of marketing.

The condition is that Sinopharm continues to carry out clinical trials according to the agreed deadlines and to send the collected data 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”.

In Wednesday’s brief announcement about the results of the Phase 3 tests, data such as the number of participants who contracted the virus or reported side effects were not provided.


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