On 2 March 2022 the EU Commission agreed to extend the marketing authorisation of Moderna's COVID-19 vaccine Spikevax to include use in children aged 6 years and older. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a recommendation for the adjustment of the marketing authorisation on 24 February 2022. The vaccine had previously only been authorised for individuals 12 years of age and older. With the extension of the marketing authorisation, an adjusted vaccine dose can be used for ages six and up. The CHMP indicates that the benefit-risk ratio is favourable, particularly in children with comorbidities associated with an increased risk of severe COVID-19.
The approved dose of Spikevax is lower for children between 6 and 11 years of age than for older age groups. As with the older age groups, the vaccine is administered as two injections into the upper arm muscles at an interval of four weeks. A study in children aged 6 to 11 years showed that the immune response to the lower dose of Spikevax was comparable to that of the higher dose in 18- to 25-year-olds (as measured by the concentration (titre) of antibodies to SARS-CoV-2 in the blood).
The most common side effects observed in children aged 6-11 years were similar to those observed in people aged 12 years and older. These include pain, redness and swelling at the injection site, tiredness, headache, chills, nausea, vomiting, swollen or tender lymph nodes under the arm, fever, and muscle and joint pain. These side effects were usually mild or moderate and improved within a few days after vaccination.
The data suggests that the efficacy and safety of Spikevax in children aged 6 to 11 years is comparable to that in adults. The CHMP therefore concluded that the benefits of Spikevax outweigh the risks in this age group, particularly in children with conditions that increase the risk of severe COVID-19.
The safety and efficacy of the vaccine in both children and adults continues to be monitored using data obtained through the EU pharmacovigilance system from the EU-wide vaccination campaigns, as well as through additional ongoing studies by the pharmaceutical companies and the European authorities.
The Standing Committee on Vaccination (STIKO) has published specific recommendations for the use of authorised COVID-19 vaccines in the younger age group in Germany.
Updated: 04.03.2022
