EMA recommends Moderna vaccine approval for ages 12 and up

29.7.2021

Spikevax will then become the second vaccine after Comirnaty that can also be administered to young people. The recommendation is based on a randomised, placebo-controlled clinical trial with 3,732 children and adolescents ages 12 to 17. It suggests that after two vaccinations with Spikevax, this age group’s immunisation response achieves comparable values as those in young adults ages 18 to 24. Children and adolescents are therefore protected against COVID-19 disease of any severity with a high probability. According to the manufacturers, this also applies to diseases such as long COVID and PIMS, which are thought to be associated with SARS-CoV-2. The vaccine efficacy in the study was 100 percent 14 days after the second vaccination. There were no cases of COVID-19 in the double-vaccinated group (n = 2163) and four cases in the placebo-injected group (n = 1063). According to the PEI, the analysis of common side effects showed a similar profile as in adults. Serious adverse effects were observed in 0.2% of both vaccinated subjects and subjects receiving a placebo. None of these events were attributed to the vaccine. According to the PEI, Spikevax’s risk-benefit ratio also proved positive in this age group. As with any approval process, however, information on the occurrence of rare side effects is limited, the PEI admits. In young adults, heart muscle inflammation (myocarditis) and pericarditis had been reported in very rare cases. No cases of myocarditis or pericarditis were observed in the study with children and adolescents. However, due to the small number of participants, no fundamental statement can be made about new, occasional side effects, nor about the risk of known side effects in the age group studied.