According to the deputy director of the Finlay Vaccine Institute, Yury Valdes, in the last hours and after vaccinating the second group of 20 volunteers aged from 60 to 80 who participate in the clinical trial, the country’s drug regulatory institutions check the candidate’s safety.
‘At the Finlay Institute’s clinical trial coordinating center, we assessed that after 40 vaccinated subjects, # Soberana01 is still on the path of proving its safety. All under a high standard verified by the Center for State Control of Medicines, Medical Equipment and Devices, during two days of inspection,’ Valdes tweeted.
The first group to obtain the dose of the vaccine consisted of 20 individuals aged 19 to 59 years, and they were injected on August 24. According to reports from its developers, all are in good health.
Currently, the only adverse effect is mild pain at the injection site, a common side effect for all vaccines, early reports indicated.
Soberana 01 is an adaptive, multicenter, controlled and randomized clinical trial, that is, the 20 volunteers receive the injectable in two of its variants, a lower dose and a higher dose.
Once its phase I has concluded, the vaccine candidate will enter the next stage on September 11 with a sample size of 676 volunteers, including 40 from the initial period.
The research, which all its stages must conclude in January 2021, joins the group of 30 vaccines that internationally received authorization from the World Health Organization to advance the clinical trial in humans.