EMA's CHMP backs approval of Comirnaty and Spikevax COVID-19 vaccines for infants

The European Medicines Agency’s (EMA) 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 six months to 4 years for Pfizer (NYSE: PFE) and BioNTech’s (Nasdaq: BNTX) Comirnaty and use in children aged six months to five years for Moderna’s (Nasdaq: MRNA) Spikevax. Comirnaty and Spikevax are already approved in both adults and children aged from five and six years, respectively.

Compared to the doses for already authorized age groups, the doses of both vaccines in these new younger age groups will be lower. In children from six months to four 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 eight weeks after the second dose. In children from six months to five 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.