The vaccination of children between the ages of 5 and 11 has been authorized by the European Medicines Agency, so that in the next period the process will be started including in Romania, CNCAV explaining how everything will unfold.
"The European Medicines Agency (EMA) recommends the administration of the Pfizer vaccine against COVID-19 for children between the ages of 5 and 11!
In children between 5 and 11 years of age, the dose of Comirnaty will be lower than that used in people over 12 years of age (10 µg compared to 30 µg).
According to the Committee for Medicinal Products for Human Use (CHMP), the vaccine for children could be available after December 20, 2021. As with the other age groups, the vaccine is administered as two doses, intramuscularly, at an interval of 21 of days.
The study in children aged 5 to 11 years showed that the immune response to Comirnaty administered at a lower dose (10 µg) was comparable to that seen at the higher dose (30 µg) administered to those over 16 years of age (measured by the level of antibodies against SARS-CoV-2).
The effectiveness of Comirnaty was calculated in almost 2.000 children aged 5 to 11 years who had no signs of previous infection. These children received either the vaccine or a placebo. Of the 1.305 children who received the vaccine, three developed COVID-19, compared with 16 of the 663 children who received the placebo. This means that in this study the vaccine was 90,7% effective in preventing COVID19.
"In the case of vaccination with Comirnaty, the benefits outweigh the risks, especially in children with comorbidities who could develop severe forms of the disease," the review by the EMA's CHMP states.
