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SOBERANA, Cuba’s COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD Director of Research, Finlay Vaccine Institute

2020; Volume: 22; Issue: 4 Linguagem: Inglês

10.37757/mr2020.v22.n4.11

1555-7960

Dagmar García-Rivera,

Healthcare Systems and Reforms

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.Cuba's biotech industry, comprised of more than 30 research institutes and manufacturing companies in the state-owned conglomerate BioCubaFarma, has developed and distributed vaccines according to international standards of good clinical and manufacturing practices and protocols for decades.BioCubaFarma supplies over 800 products to Cuba's national health system-349 of those are on Cuba's Basic Drug List, the medicines approved for use in the country's health system.Additionally, BioCubaFarma has 2438 patents registered outside Cuba and its products, including vaccines, medicines and medical equipment, are in 100 simultaneous trials at 200 clinical sites and are registered and sold in more than 50 countries.