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Cuban regulator approves clinical trials of COVID-19 vaccines in children, teens

The goal of the study is the evaluation of the reactogenicity, safety and immunogenicity of the Soberana 02 and Soberana Plus candidate vaccines

HAVANA, June 11. /TASS/. Cuba's Center for State Control of Medicines and Medical Devices (CECMED) has approved the clinical trials of two domestic vaccines in children and teenagers, the Cubadebate web portal reported on Thursday.

"The goal of the study is the evaluation of the reactogenicity, safety and immunogenicity of the Soberana 02 and Soberana Plus candidate vaccines used in two doses and a single dose [respectively]," as the web portal quoted the statement by CECMED. These vaccines against the coronavirus infection were developed at the Finlay Institute.

Children and young people from 3 to 18 years of age will participate in the trials. The 12-18 age group will be the first to be vaccinated followed by the 3-11 age group.

According to CECMED, the decision to launch the clinical trials of the vaccines in children and young people is explained by the current sanitary-epidemic situation in the country. Recently, Cuba has seen a noticeable growth of the coronavirus infections in the 3-18 age group. Although the majority of children infected with coronavirus have a light form of the disease, Cuban doctors are concerned with the consequences of the coronavirus infection for this age group.

The Soberana 02 and Soberana Plus vaccines have already been administered to thousands of adults in the country, and these jabs have demonstrated their safety and tolerability. In all, the Cuban doctors have developed five vaccines against the coronavirus infection.