Progress in clinical trials of COVID-19 vaccines in Cuba


As of 8 June, Cuba reported having administered 3,016,266 doses of Cuban candidate vaccines (Soberana 1, Soberana 2, Soberana Plus, and Abdala). A total of 1,833,775 people have received at least one dose of one of these vaccines; 969,119 people have already received a second dose, and 213,372 people have received a third dose. This number includes, beside the Phase III clinical trials, a health intervention involving at-risk groups and territories, authorized by the Minister of Public Health based on the epidemiological situation and availability of vaccine candidates which have provided evidence of safety and immunogenicity in Phases I and II clinical trials.

A sequential, open, adaptive, and multicenter Phase I/II clinical trial, recently approved by the Center for State Control of Medicines and Medical Equipment and Devices (CECMED), has been designed to evaluate the safety, reactogenicity, and immunogenicity of SARS-CoV-2 vaccine candidates in population under 18 years old  The proposed regimen for Cuban children and adolescents is heterologous, with two doses (0-28 days apart) of the vaccine candidate FINLAY-FR-2 (Soberana 02), and a third dose with the vaccine candidate FINLAY-FR-1 (Soberana Plus) on day 56. The trial will include 350 healthy subjects ages 3 to 18. As of the end of the first day of June, children and adolescents diagnosed with COVID-19 accounted for

12.1% of all individuals in the country infected with the disease.

Source: Cuban scientists offer details of the first clinical trial in the pediatric population with vaccine candidate Sovereign 02. Cuba debates. 11 June 2021   

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