China National Biotec Group announced Tuesday that its experimental coronavirus drug has induced antibodies in clinical trials, and the company is preparing late-stage human trials abroad.
Based on preliminary data from a clinical trial initiated in April involving 1,120 healthy participants aged between 18 and 59, the vaccine, formulated by the Wuhan-headquartered research institute affiliated with mother company Sinopharm, was discovered to have triggered high-level antibodies in all inoculated subjects with no adverse reaction.
No vaccines have been reliably proved capable of successfully shielding people from COVID-19. As of Monday morning, the total tally breached 8 million cases, of which almost 3.5 million are still active.
The fatality toll is nearing 440,000, a number that seemed unfathomable just months ago. As this developed, many other drug candidates are at various stages of development around the globe.
The Chinese-developed inactivated treatment for coronavirus has provided positive results in Phase One and Two clinical trials, becoming the world's first potential vaccine to show very promising immunogenicity and safety.
As of Tuesday, all 1,120 participants in the Phase One and Two study were administered two doses of the vaccine, either 14 days, 21 days or 28 days apart, at low, medium or moderate dosing strengths - or placebo, according to CNBG. The seroconversion rate for the mid-dose period of 14 days and 21 days was 97.6 percent. It was 100 percent at 28 days.
Neutralizing antibodies are special proteins that can be produced by the immune system in response to each new pathogen, and may prevent the entity from entering cells. In this case the antibodies will block the coronavirus from infecting lung cells, where the virus begins the process of multiplication, health experts say.
The vaccine is one of two inactivated shots on which CNBG operates. The Wuhan version was pushed into clinical trials on April 12, and in late April another one developed by its Beijing Institute entered human trial.
According to state news agency Xinhua, CNBG plans to manufacture 200 million doses of inactivated COVID-19 vaccines a year through two new vaccine manufacturing facilities in Beijing and Wuhan.
As local COVID-19 outbreaks were contained, Chinese vaccine makers looked for other markets to test their vaccine candidates. Similarly, researchers working on an Oxford vaccine have been looking at other Phase 3 markets, as they are concerned that there may not be enough sick people in the UK to complete the study by September.
Meanwhile, Sinopharm has been actively promoting its Phase Three clinical trials for international partnership and is currently communicating with a number of vaccine developers and research groups with regards co-producing the vaccine.
