For both vaccines, these effects were usually mild or moderate and improved within a few days of vaccination. Irritability, sleepiness, loss of appetite, rash and tenderness at the injection site were also common side effects in children aged 6 to 23 months with Comirnaty, while irritability, crying, loss of appetite and sleepiness were common side effects in children aged 6 to 36 months with Spikevax. The most common side effects for both vaccines, in children aged from 6 months to 4 or 5 years, were comparable to those seen in older age groups. Both studies evaluated the immune response triggered by the vaccines by measuring the level of antibodies against SARS-CoV-2. For Spikevax, a main study in children from 6 months to 5 years of age showed that the immune response to the lower dose of Spikevax (25 micrograms) was comparable to that seen with the higher dose (100 micrograms) in 18- to 25-year-olds. For children within these age groups, both vaccines are given as injections in the muscles of the upper arm or the thigh.įor Comirnaty, a main study in children from 6 months to 4 years of age showed that the immune response to the lower dose of Comirnaty (3 micrograms) was comparable to that seen with the higher dose (30 micrograms) in 16- to 25-year-olds.
In children from 6 months to 5 years of age, Spikevax can be given as primary vaccination consisting of two doses (of 25 micrograms each), four weeks apart. In children from 6 months to 4 years of age, Comirnaty can be given as primary vaccination consisting of three doses (of 3 micrograms each) the first two doses are given three weeks apart, followed by a third dose given at least 8 weeks after the second dose. Comirnaty and Spikevax are already approved in both adults and children aged from 5 and 6 years, respectively.Ĭompared to the doses for already authorised age groups, the doses of both vaccines in these new younger age groups will be lower. The Committee recommended including the use in children aged 6 months to 4 years for Comirnaty and use in children aged 6 months to 5 years for Spikevax. EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2.
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