The human medicines committee (CHMP) of the European Medicines Agency (EMA) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously Moderna) to include use in adolescents aged 12 to 17 years.
The vaccine efficacy of Spikevax has been investigated in a study involving 3,732 adolescents aged 12 to 17 years.
This limited 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. In addition, none of 2,163 children receiving the vaccine developed COVID-19 compared with only four of 1,073 children given a placebo injection.
The most common side effects in children aged 12 to 17 are similar to those in people aged 18+. They 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 CHMP noted that due to the limited number of children and adolescents included in the study, the trial could not have detected new uncommon side effects or estimated the risk of known heart health side effects such as myocarditis and pericarditis.
The EMA publishes the agendas, minutes, and highlights of the plenary meetings of its Committee for Medicinal Products for Human Use at this website.