The Phase II clinical trial of the vaccine developed by Fosun Pharma has completed the enrollment of 960 subjects ahead of schedule and shown no serious side effects, bringing it a step closer to being sold on market.
Its Phase II clinical trial, which recruited 960 volunteers aged between 18 and 85, was activated on November 24.
The mRNA vaccine has already completed Phase III clinical trials abroad, which means they won’t need to be carried out in China, as overseas clinical trial data can help in getting the vaccine sold in China.
For Fosun Pharma, the status of the Phase II clinical trial will be evaluated before judging whether the vaccine still requires Phase III clinical trials in China.
“It is impossible for the Phase II clinical trial to achieve a statistically significant infection rate given the epidemic in China. The company has previously held repeated discussions with the drug evaluation center of the State Food and Drug Administration on how to evaluate the vaccine effect,” Hui Aimin, the chief medical officer of Fosun Pharma, told Chinese media.
This Phase II clinical trial will mainly evaluate the subjects’ neutralizing antibodies, cell response and safety, Hui said.
Previously, the Chinese pharmaceutical company, partner of German vaccine producer BioNTech, announced on Wednesday that it had signed a supply order with BioNTech Manufacturing, and will supply no less than 100 million doses of its COVID-19 vaccine product for the Chinese mainland in 2021.