Swissmedic approves indication extension for Spikevax vaccine for 12- to 17-year-olds

previously COVID-19 Vaccine Moderna


Swissmedic has carefully examined the application from Moderna Switzerland GmbH for the indication extension and has extended the temporary authorisation for the Spikevax COVID-19 vaccines from Moderna for the prevention of the coronavirus disease in adolescents aged 12 to 17.

Swissmedic reviewed the application submitted on 11 June 2021 for the indication extension in an accelerated rolling procedure. The results of an ongoing study in 3,732 children aged 12 to 17 were submitted and subjected to review.

In the age group studied, and with the dosage remaining the same as for adults, the vaccine produced a similar immune response (level of antibodies against SARS-CoV-2) in this study compared to young adults aged 18 to 25 years. The side effects most frequently experienced by the children aged 12 to 17 were also similar to those in persons aged 18 and over. In the clinical trial, this vaccine showed an efficacy against symptomatic disease (at least one symptom and positive PCR test) of about 93% in the investigated age group from 14 days after dose 2. The side effects usually lasted between one and three days, and may be more pronounced after the second dose.

As for persons aged 18 and over, the vaccine must be administered in two doses given 4 weeks apart.

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