The world's first phase III clinical trial of the COVID-19 inactivated vaccine is officially launched
On June 23, the world's first phase III clinical trial of the COVID-19 inactivated vaccine officially kicked off. The ceremony of "Sinopharm's China National Biotec Group (CNBG) COVID-19 inactivated vaccine International Clinical (Phase III) trial and the United Arab Emirates" was held simultaneously in Beijing and Abu Dhabi via video conference.
CNBG and UAE Group 42 signed a clinical cooperation agreement. This is the first company in China to conduct an overseas clinical trial of the COVID-19 vaccine.
During the ceremony, the UAE Minister of Health & Prevention, Abdul Rahman Mohammed Al Owais, issued a Phase III of the COVID-19 inactivated vaccine clinical approval certificate to Ni Jian, Chinese Ambassador to the UAE. At the same time, Dr. Ali Obaid Al Dhaheri, UAE Ambassador to China, issued the Phase III clinical approval certificate of the COVID-19 inactivated vaccine to the Chair of CNBG Yang Xiaoming.
This inactivated vaccine has passed phase I and II clinical trials, showing no "serious adverse reactions" with all volunteers generating antibodies after two doses in 28 days, its developer CNBG said.
The human trials began in Wuzhi County, central China's Henan Province, on April 12. A total of 1,120 volunteers aged 18-59 were inoculated with two doses in 28 days, according to CNBG. In the randomized, double-blind and placebo-controlled trial, all volunteers generated high levels of neutralizing antibodies, which can block pathogens from infecting human cells, the company said.
The study is the world's first clinical trial to obtain safety and effectiveness data of a two-dose inactivated COVID-19 vaccine, CNBG said, adding that the clinical trial has lasted the longest period of time (66 days) and got the most comprehensive data , as well as the most satisfying results among all COVID-19 vaccines to date.
In the past two months, the company has worked to build the world's largest, highly-efficient COVID-19 inactivated vaccine production facility, with construction standards and quality levels meeting international requirements. Experts say that the vaccine could enter the market by the end of 2020 or early next year. The facility is able to produce more than 200 million doses of inactivated COVID-19 vaccines annually.
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