Swissmedic has authorised an extension of the indication of the Spikevax® COVID-19 vaccine from Moderna to children aged 6 to 11 years. Children aged 6 years and over, as opposed to adults and adolescents aged 12 years and above, will receive two half doses (50 micrograms), administered at an interval of four weeks.
Swissmedic approves application for indication extension of Spikevax® for children 6 years and olderSwissmedic approves application for indication extension of Spikevax® for children 6 years and older
The main study in children aged 6 to 11 years found that the immune response triggered by the vaccine against the SARS-CoV-2 virus is comparable with that in young adults.
The most commonly reported side effects such as pain, redness or swelling at the injection site, fatigue, headache, shivering or nausea, were similar to those in adolescents and young adults.
Fever occurred more frequently in children, whereas muscle and joint pains were seen less often than in adolescents or adults. The undesirable effects were generally mild to moderate and lasted for a few days.
Vaccination is particularly beneficial for children with previous illnesses in whom the risk of severe COVID-19 is increased. Children aged 6 to 11 years will receive a half dose of the vaccine (50 rather than 100 micrograms) compared to older children and adults at an interval of four weeks.
The safety, efficacy and quality of all COVID-19 vaccines in use continue to be monitored closely worldwide in both children and adults, both through spontaneous reporting (pharmacovigilance system) and in ongoing and additional clinical trials.