Moderna COVID-19 vaccine gets Swiss approval for 12- to 17-year-olds

Swissmedic has approved the Moderna COVID-19 vaccine for 12- to 17-year-olds, the Swiss agency said on Monday.

“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,” it said

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.

Back in July, the European medicines watchdog on Friday approved the use of Moderna’s coronavirus vaccine for children aged 12 to 17.

“The use of the Spikevax vaccine in children from 12 to 17 years of age will be the same as in people aged 18 and above,” the European Medicines Agency (EMA) said, using Moderna’s brand name.

The vaccine will be given in two injections, each four weeks apart.