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October 21, 2020

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60,000 receive COVID-19 shots

A TOTAL of about 60,000 volunteers have been given Chinese COVID-19 vaccines as part of phase-3 clinical trials, with no severe side-effects reported, a Chinese official said yesterday.

Four Chinese vaccine candidates have entered international phase-3 clinical trials so far, said Tian Baoguo with the Ministry of Science and Technology. All trials are progressing well, he said, with initial indications that the vaccines are safe.

According to Tian, the most common adverse reactions in phase-3 clinical trials are pain and swelling at the injection site, followed by fever, both of which are mild.

The two inactivated vaccines developed by China National Biotec Group, which is affiliated to Sinopharm, and the Wuhan Institute of Biological Products, have started phase-3 clinical trials in 10 countries, with more than 50,000 volunteers taking part, said Liu Jingzhen, chairman of Sinopharm. “The testing is in the last kilometer of a long march.”

The drugmaker is setting up production lines in Beijing and Wuhan to supply 1 billion doses of the two possible coronavirus vaccines.

Sinovac Biotech, another vaccine developer, said that the company’s partners in Brazil, Indonesia and Turkey have established monitoring systems for adverse reactions in accordance with internationally accepted standards. So far, no severe adverse reactions related to COVID-19 vaccines have been reported.

Sao Paulo’s Butantan Institute, one of Brazil’s leading biomedical research centers, which is carrying out the phase-3 tests, said on Monday the two-dose vaccine, called CoronaVac, proved to be safe in a trial so far involving 9,000 volunteers.

Butantan director Dimas Covas said there were no severe adverse reactions to the vaccine, with 20 percent of the volunteers reporting mild pain from the injection while 15 percent reported headaches after the first dose, dropping to 10 percent for the second. Less than 5 percent reported nausea or tiredness, and even less had muscle aches, he said.

Sao Paulo state health secretary Jean Gorinchteyn said the vaccine appeared to produce protective anti-bodies. The state hopes to obtain regulatory approval for CoronaVac by the end of the year to start inoculating its population early in 2021, in what could the first vaccination programs in the Americas. Sao Paulo signed a deal with Sinovac to buy 60 million doses by the end of February.

China is expected to produce up to 610 million doses of COVID-19 vaccines by the end of this year, Zheng Zhongwei, head of China’s coronavirus vaccine development task force said.


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