Europe – EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age

EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. 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. Comirnaty and Spikevax are already approved in both adults and children aged from 5 and 6 years, respectively.

Compared to the doses for already authorised age groups,1 the doses of both vaccines in these new younger age groups will be lower. 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. 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. For children within these age groups, both vaccines are given as injections in the muscles of the upper arm or the thigh…