2021, Number 3-4
Cuba’s National Regulatory Authority & COVID-19: Olga Lidia Jacobo-Casanueva MS
Director, Center for State Control of Medicines and Medical Devices (CECMED)
Language: English
References: 3
Page: 9-14
PDF size: 370.86 Kb.
Text Extraction
As of this writing, more than 4.6 million Cubans (over 40% of the population on the island), had received at least their fi rst dose of Soberana 02 or Abdala, two of fi ve vaccine candidates for SARS-CoV-2 developed and produced on the island. Late-phase clinical trial data revealed that Abdala is 92.28% effective after the full, three-dose cycle and Soberana 02 is 91.2% effective after two doses, when followed by a booster of Soberana Plus. Cuban health authorities have committed to vaccinating the entire population, including children aged 3–18 years old, using these vaccines by the end of 2021. The fi rst pre-clinical, peer-reviewed data are available, with clinical trial results already submitted to various international journals.Building on decades of biotechnology know-how developing, producing and administering 11 preventive vaccines for childhood diseases—used in the nation’s universal health system and also marketed elsewhere—Cuba is the fi rst, and to date only, country in Latin America and the Caribbean to develop its own vaccine candidates for COVID-19 (Soberana 01; Soberana 02; Soberana Plus; Abdala and Mambisa; see Box on following page). In a strategy designed to ensure comprehensive and importantly, independent solutions to the global health crisis, research institutes and manufacturing facilities coordinated by BioCubaFarma—the country’s biopharmaceutical conglomerate—have also developed COVID-19 treatments and essential medical equipment.
REFERENCES
Valdes-Balbin Y, Santana-Mederos D, Quintero L, Fernández S, RodríguezL, Sanchez-Ramirez B, et al. SARS-CoV-2 RBD-Tetanus Toxoid ConjugateVaccine Induces a Strong Neutralizing Immunity in Pre-Clinical Studies. ACSChem Biol [Internet]. 2021 Jul 4 [cited 2021 Jul 7]. Available at: https://pubs.acs.org/doi/10.1021/acschembio.1c00272
Previous MEDICC Review articles about Cuba’s clinical trial regulatory authority andprocess include:http://mediccreview.org/science-at-the-service-of-public-health-rafael-perez-cristia-md-phd-center-for-state-control-of-medicines-and-medical-devices/https://mediccreview.org/the-abcs-of-clinical-trials-in-cuba/https://mediccreview.org/covid-19-requires-innovation-regulation-and-rigor-arteaga/