SOBERANA, Cuba's COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD.

ABSTRACT

On August 13, 2020, Cuba's national regulatory agency, the Center for Quality Control of Medicines, Equipment and Medical Devices (CECMED), authorized clinical trials for SOBERANA 01-Cuba's fi rst vaccine candidate and the fi rst from Latin America and the Caribbean. On August 24, parallel Phase I/II double blind, randomized, controlled clinical trials were launched at clinical sites in Havana to evaluate the vaccine's safety and immunogenicity. Analysis of results and development of different formulations are currently under way and Phase III clinical trials are planned for early 2021. At the time of writing, a second vaccine candidate, SOBERANA 02, was in late-stage development and preparing to begin separate trials this fall.