EMA Recommends Approval of Spikevax for Children Aged 6 to 11

EMA has recommended approval of Spikevax for children aged 6 to 11.

EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting approval of Moderna’s COVID-19 vaccine Spikevax to include use in children aged 6–11. Spikevax is already approved for use in adults and adolescents aged 12 and up.

The CHMP has concluded that the efficacy and safety of Spikevax in children aged 6–11 are also similar to those in adults, and that the benefits of using the vaccine on this age group outweigh the risks. The CHMP will send its recommendation to the European Commission (EC), which will issue a final decision.

The dose of Spikevax in children aged 6–11 will be lower than that used in people aged 12 and above. The most common side effects of the vaccine are similar between children aged 6–11 and adults, some of which include pain, redness and swelling at the injection site, tiredness, headache, and chills. These side effects are usually mild or moderate and improve within a few days.

Ongoing and additional studies are being conducted by the company as well as European authorities to further monitor the safety and efficacy of the vaccine in both children and adults.

Source: EMA