Coronavirus: Chinese firm says its vaccine candidate passes phase two clinical trials
- China National Biotec Group (CNBG) says tests show its vaccine is safe, and now looks to clinical trials overseas
- China has five vaccines under clinical study, with Sinovac Biotech’s candidate also completing a phase two trial
A potential Chinese Covid-19 vaccine, which has completed phase one and phase two human trials, is generally safe and can generate immune response in test subjects, the vaccine’s developer, China National Biotec Group, said on Tuesday.
The vaccine candidate, developed by a CNBG subsidiary, the Wuhan Institute of Biological Products, began human trials in Henan province in April. Volunteers 18 to 59 years old were inoculated with low, medium and high doses and were given a second shot two weeks, three weeks or four weeks later to study the safety and immunity response of the vaccine, CNBG said.
A total of 1,120 volunteers have been given the vaccine, which involves the full inactivated Sars-CoV-2, the virus that causes Covid-19. The study, which was randomised, double-blind and placebo-controlled, shows that the vaccine is safe with no accident or severe adverse events, according to the company.
“High levels of antibodies” have been induced among different inoculation programme and in different dose groups, it added.
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The programme inoculating volunteers with two doses four weeks apart induced neutralising antibodies – blocking pathogens from infecting human cells – in all its test subjects, the company said.
“This study is the world’s first clinical trial to obtain safety and effectiveness data of a two-dose inactivated Covid-19 vaccine … The research also involves the longest period, the most comprehensive data and the most satisfying clinical research results of Covid-19 vaccine clinical trial,” the group said.
The company said that it was “actively advancing” the phase three clinical trial overseas and that it had reached “intention of cooperation” with companies and institutions in numerous countries. China is not considered suitable for the trial, which would involve at least thousands of volunteers, because the number of Covid-19 patients has dropped significantly there and it would be difficult to determine whether the vaccine could actually prevent a test subject from getting sick.
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China has five vaccines under clinical study, with four inactivated vaccines and another using adenovirus-based viral vector vaccine technology.
A second CNBG subsidiary, the Beijing Institute of Biological Products, also has a vaccine candidate undergoing clinical trials, and for both units, CNBG has built facilities with high levels of biosafety to process the highly pathogenic virus for vaccine production. The two plants will have a combined annual production capacity of 200 million to 220 million doses.
CNBG’s announcement came only days after another Chinese vaccine developer, Sinovac Biotech of Beijing, said that its experimental Covid-19 vaccine candidate induced neutralising antibodies in “above 90 per cent” of volunteers after receiving two injections, two weeks apart, in its phase one and phase two trials.
Sinovac also said that its vaccine was safe and without serious side effects.
Sinovac said It would submit the clinical study report and a phase two clinical study protocol to China’s drug regulator, the National Medical Products Administration, and apply for phase three clinical trials outside China.
The company announced earlier that it has reached an agreement with Instituto Butantan in Brazil to prepare and conduct a phase three clinical study.
