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China

Chinese developer of coronavirus vaccine secures approval for final stage of human trials

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Bloomberg
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By
Bloomberg
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June 24, 2020, 1:04 AM ET

A Chinese state-owned vaccine developer secured regulatory approval to test its coronavirus shots in the United Arab Emirates, making it one of the first among a slew of global efforts to get the greenlight for the final stage of human trials.

Beijing-based China National Biotec Group Co. was awarded approval on Tuesday to conduct Phase III trials for its Covid-19 vaccines in the Middle Eastern country, the company said in a statement posted on its official WeChat account.

CNBG said it will partner with Abu Dhabi-based artificial intelligence and cloud computing firm G42 to carry out the trial and local production of the vaccine. It didn’t disclose details such as the timing or the number of people it plans to enroll for testing.

The world’s fast-developing vaccine programs are moving into the final stage of testing before they are approved for inoculation for the general public. Pharmaceutical companies across the globe are racing to be first to find an effective shot against the novel coronavirus, which has infected more than 9.2 million people and killed over 476,000.

CNBG is the first Chinese vaccine developer to proceed toward a Phase III trial to test whether the two shots it developed are effective against the pathogen.

Chinese companies have had to look for places with active virus outbreaks to complete the final stage of human testing, which requires thousands of people. The low number of cases in China has made it unfeasible for them to conduct such trials at home. The U.A.E. is still adding hundreds of cases a day, with a total of more than 45,000 infections.

Chinese biotech CanSino Biologics Inc. was approved last month to conduct human testing for the vaccine it co-developed with the Chinese military in Canada, but will need to re-do early safety studies before going into the Phase III trial. Beijing-based Sinovac Biotech Ltd. has partnered with Instituto Butantan to roll out testing of its shot on 9,000 people in the hot spot of Brazil, but has not yet won approval to proceed.

Vaccine candidates from companies outside of China are also headed for Phase III trials. A shot co-developed by the University of Oxford and AstraZeneca Plc will be tested among 2,000 people in Brazil starting as early as this month. Cambridge, Massachusetts-based Moderna Inc. is set to begin testing its shot next month in a 30,000-person trial in the U.S.

The two shots developed by CNBG have already been tested among some 2,000 people in phase I and II trials conducted in China. One of the vaccines has been found to be generally safe, while data from the other one will be revealed on June 28. The shots were already administered on more than 1,000 employees, including senior executives of CNBG and its parent company.

Employees of Chinese state-run companies are said to have also been offered voluntary shots of the CNBG vaccines if they are traveling for work overseas or if they live in high-risk areas in Beijing, which has recently seen a fresh virus outbreak.

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