Pharmaceutical made the announcement of the test results on the Chinese social network WeChat
The CNBG (National Biotec Group of China) reported on Sunday (28), that the first results of clinical trials suggest that the immunization resulting from the vaccine under development by the company is safe and effective against Covid-19.
The experimental doses, produced by a state-owned unit in Beijing, induced the creation of “high-level” antibodies in all participants inoculated in a Phase 1 and 2 clinical trial with more than 1,000 and 100 volunteers.
According to the Reuters agency, the drugmaker made the announcement on the Chinese social network WeChat, and cited the production of a study that was not released.
Researchers in China are evaluating eight vaccine candidates, already in the human testing phase, both in the Asian country and abroad. Last week, the Butantan Institute and the São Paulo government announced a partnership to test another Chinese candidate for the virus’s immunization.
First, there is an exploratory phase, with research and identification of promising molecules (antigens). The the second is the pre-clinical phase, in which the vaccine is validated in living organisms, using animals (rats, for example). Only then is it reached the clinical phase, in humans, divided into three moments:
- Phase 1: preliminary assessment with few adult volunteers closely monitored;
- Level 2: tests on hundreds of participants that indicate information about doses and times that will be used in phase 3. Patients are chosen at random (random) and are well controlled;
- Phase 3: large-scale trial (with thousands of individuals) that needs to provide a definitive assessment of efficacy / safety and predict adverse events; only then is there a health record