A consortium of companies Pfizer and Biontech, following the results of the third phase of drug trials, reported that its COVID-19 vaccine was 100% effective among adolescents from 12 to 15 years old.
The results of the study, which involved 2,228 people, showed that in the group of patients who received both components of the vaccine, four months after vaccination, no cases of COVID-19 infection were recorded. In the placebo group, 30 cases were identified.
“The side effects were broadly in line with other data on the clinical safety of the vaccine,” the companies said in a press release. The safety of the vaccine was analyzed based on six months of data (rather than four as in the efficacy analysis), as study participants who received a placebo were later told about it and were also asked to be vaccinated.
The results of the study are planned to be published and sent to the US Food and Drug Administration (FDA). They will form the basis of an application for approval for vaccination of this age group (in May, the agency approved the drug for use in emergencies, that is, in special situations and until full review by regulators).
The US Centers for Disease Control and Prevention (CDC) also approved Pfizer and Biontech’s vaccines for children aged five to 11 in early November. Then it was reported that the drug showed 91% effectiveness in this age group.