GALICIA begins Pfizer Vaccine trial in children under 12. The Galician Health Service this week began the clinical trial in children under 12 years of age with the Pfizer-BioNTech vaccine that is being carried out at the Hospital Clínico de Santiago. The first volunteers already received the first dose of the vaccine or placebo this Monday, June 7, while throughout the week the 25 immunisations planned in this first phase will be completed, in children between five and 12 years old. In later phases, it will be de-escalated in ages up to six-month-old children with 55 participants in total.
As reported by La Opinion de Malaga, this is a double-blind study that consists in that a part of the children will be given, at first, a placebo. Participants will receive an injection approximately three weeks apart and those who receive a placebo, which is one third, will have the opportunity to receive the vaccine within the study. The Hospital Clínico de Santiago is the only Galician health centre to participate in this global study that seeks to delve into the evaluation of the safety, tolerability and immunogenicity of the Pfizer-BioNTech Covid-19 vaccine in the prevention of this disease in healthy children ranging from six months to 11 years old.
In this vaccine trial, 55 healthy children will participate, who will be part of the global study in which 4,644 children are expected to be included, 557 of them being from Spain. In order to carry out the trial, control visits are scheduled and there will be a two-year follow-up period for each child. Parents and caregivers are asked to record any changes in the children’s health in an electronic diary provided to them.