Swissmedic, Switzerland’s drug approval agency, extended approval of the Moderna Covid-19 vaccine for use on 12 to 17 year olds this week.
On 9 August 2021, Swissmedic said that it had carefully examined an application from Moderna Switzerland and had decided to extend the temporary authorisation for the use of its Spikevax vaccine on 12 to 17 year olds.
The application, which included data on 3,732 vaccinated children aged between 12 and 17, was submitted on 11 June 2021. Those included in the study received the same dose as adults and had a similar immune response to adults aged 18 to 25.
The side effects most frequently experienced by the children aged 12 to 17 in the study were similar to those aged 18 and over. In the clinical trial, the vaccine showed an efficacy against symptomatic disease (at least one symptom and a positive PCR test) of about 93% 14 days after the second dose. Side effects usually lasted between one and three days, and were typically more pronounced after the second dose.
Previously, the only vaccine authorised for use on adolescents in Switzerland was the Pfizer/BioNTech vaccine, which had its temporary approval extended to 12 to 15 year olds on 4 June 2021.