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The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
The European Medicines Agency announced on Oct. 19, 2022 that its Committee for Medicinal Products for Human Use (CHMP) has recommended approval of COVID-19 vaccines that target the original strain of SARS-CoV-2 for children aged six months to four years old for Comirnaty and six months to five years for Spikevax. Both vaccines are approved for adults and children ages five and up for Comirnaty and six and up for Spikevax.
According to EMA, the dosage of these vaccines will be lower in the younger age groups. Comirnaty will be given in three doses (of 3 micrograms each) with the first two doses given three weeks apart and the third dose given at least eight weeks after the second dose. Spikevax’s dosage for the younger age group will be two doses (of 25 micrograms each), given four weeks apart.
A study showed that Comirnaty had a comparable immune response at the lower dose in young children compared with the higher dose of 30 micrograms in people ages 16–25. Another study showed that Spikevax’s lower dose for young children was comparable to the higher dose of 100 micrograms in 18–25-year-olds. Side effects were also comparable to the older age groups.
“The CHMP therefore concluded that the benefits of Comirnaty and Spikevax in children aged from 6 months to 4 and 5 years, respectively, outweigh the risks. The safety and efficacy of both vaccines, in children and adults, will continue to be monitored closely as they are used in vaccination campaigns in EU [European Union] Member States through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and coordinated by European authorities,” the agency stated in a press release.
CHMP’s recommendation will be sent to the European Commission for final decision applicable to EU Member States.