The European Medicine Agency (EMA) on Friday authorized the US’ Moderna’s COVID-19 vaccine for use in children aged 12-17.
The EMA “has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine Moderna) to include use in children aged 12 to 17 years,” the agency said in a statement.
Moderna’s vaccine is already authorized for use in people aged 18 and above.
“The study showed that Spikevax produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years,” it said.
The side effects, including pain and swelling at the injection site, tiredness, and headache, were similar to the ones young adults experienced after vaccination.
“These effects are usually mild or moderate and improve within a few days from the vaccination,” the EMA said.
The application of the jab will be the same with two injections that are four weeks apart.
Based on the decision, the EU states will be free to decide whether to extend their vaccination programs to young adolescents.
The Moderna vaccine was the second COVID-19 shot authorized in the EU after Pfizer/BioNTech.
In late May, the EMA authorized the BioNTech/Pfizer vaccine for children aged 12-15.
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