On Monday, Cuba's Finlay Institute of Vaccines (IFV) began clinical trials of the Sovereign 02 COVID-19 vaccine in 25 children aged 3 to 11 years.
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The IFV scientists stated the results of their research revealed that this vaccine had no adverse side effects in adolescents. Therefore, they included younger children in the group of volunteers who participate in pediatric clinical trials.
IFV director Yury Valdes explained this pediatric clinical trials will eventually include 350 minors, who will get vaccinated with two doses of Sovereign 02 and one dose of Sovereign Plus. The study does not include the application of placebos.
He also pointed out that this vaccination scheme was previously applied in the adult population with an efficacy of 62 percent.
Phase one of Sovereign pediatric clinical trial will take place at Juan Marquez Pediatric Hospital in Havana, while its phase two will be conducted at the primary care level, which involves several community polyclinics.
Although COVID-19 is usually mild or asymptomatic in pediatric ages, health authorities have pointed out that vaccinating children is essential to reach herd immunity and limit the disease severity.
Sovereign 02 vaccine fuses an antigen with a carrier coronavirus molecule to enhance its stability and efficacy. This vaccine only require between 8 and 2°C of refrigeration, which is a great advantage to countries of low resources.