Cuban regulatory authority approves start of Phase III Clinical Trial of Soberana 02

HAVANA, Cuba, Mar 4 (ACN) The Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) approved the start of the Phase III Clinical Trial of Vaccine Candidate Soberana 02, from the Finlay Vaccine Institute.

A note from the BioCubaFarma group on social networks points out that after a rigorous process of evaluation of the results of the previous stages (Preclinical, Phase I and Phase II), the Cuban Regulatory Authority was able to confirm that Soberana 02 is a vaccine candidate that has shown an adequate safety profile, so it has decided to grant its approval for the start of the Phase III clinical trial.

According to the note, the Phase III clinical trial will involve 44,010 people between 19-80 years of age in eight municipalities of the capital.

This trial aims to demonstrate the efficacy of the vaccine candidate in the prevention of symptomatic disease caused by SARS-CoV2.

The approval is an important step forward in the development strategy of the Cuban AntiCovid19 vaccines.

The note specifies that strict compliance with sanitary measures by the population is a requirement for the success of this trial.