The Human Use Medications Committee (CHMP) of the European Medicines Agency (EMA) has given green light to vaccination in children from 5 to 11 years with the Pfizer and Biontech vaccine for the COVID-19.
The indicated dose will be a third of the approved in people aged 12 or older (10 ?g versus 30 ?g).
As in the rest of age groups, it is administered in two intramuscular injections at the top of the arm.
EMA bases its positioning as a result of a phase III clinical trial in children from 5 to 11 years, which showed that the immune response (according to the levels of antibodies) to the dose vaccine of 10 ?g was comparable to that of the dose
of 30 ?g in population of 16 to 25.
In total, almost 2,000 children from 5 to 11 participated, who did not show signs of prior infection.
Of the 1,305 children who received the vaccine, three developed Covid-19 compared to 16 in the Placesbo group, which yields an effectiveness of 90.7%.
The most common side effects were pain, redness and swelling at the place of injection, fatigue, headache, muscle pain and chills.
These effects are usually mild or moderate and improve within a few days of vaccination.
