CUBAN EXPERTS NOTE NO ILL EFFECTS OF SOBERANA 01 VACCINE

The development of the Soberana 01 vaccine candidate remains a top priority for Cuba's scientific community, which constantly assesses the performance of clinical trials on the drug, Prensa Latina reported on September 4, 2020 (September 5, 2020 in Manila.)

According to Yury Valdes, the deputy director of the Finlay Vaccine Institute, they have checked on the conditions of the second group of 20 volunteers aged from 60 to 80 who participated in the clinical trial and noted all of them were safe.

“At the Finlay Institute's clinical trial coordinating center, we assessed that after the vaccination of the 40 subjects, #Soberana01 is still safe to apply under the high standards set 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 of them 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, with the 20 volunteers receiving 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, with all the stages set for conclusion in January 2021, joins the group of 30 vaccines that received authorization from the World Health Organization (WHO) to advance the clinical trial to humans.