The European Medicines Agency (EMA) has approved the use of Moderna's coronavirus vaccine (called Spikevax) for teenagers aged from 12 to 17, it announced on Friday.
EMA’s human medicines committee (CHMP) recommended the granting of an extension of indication for the vaccine to include use in children aged 12 to 17 years. The vaccine is already authorised for use in people aged 18 and above.
The recommendation for use in children will be the same as in adults: given in two shots in the muscles of the upper arm, four weeks apart.
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The effects of Moderna's vaccine have been investigated in a still ongoing study involving 3,732 children aged 12 to 17 years old, in accordance with Spikevax’s paediatric investigation plan (PIP), which was agreed by EMA's Paediatric Committee (PDCO).
The result showed that the vaccine produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years.
Additionally, none of 2,163 children receiving the vaccine developed Covid-19, compared with four of 1,073 children given a dummy injection.
"These results allowed the CHMP to conclude that the efficacy of Moderna's vaccine in 12- to 17-year-olds is similar to that in adults," EMA said.
The most common side effects in children aged 12 to 17 are also similar to those in people aged 18 and above, and include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting and fever.
However, these effects are usually mild or moderate and improve within a few days from the vaccination.
"The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns across the Member States," the EMA added.
