Swiss Approve SpikeVax COVID-19 Vaccine for Adolescents

Switzerland's drug regulator, Swissmedic, announced it had extended the temporary approval of Moderna Switzerland GmbH's Covid-19 vaccine Spikevax to prevent COVID-19 for adolescents aged 12 to 17 years on August 9, 2021.

In a recent clinical study, SpikeVax showed a comparable immune response (measured by the antibody level against the SARS-CoV-2 coronavirus) as in young adults aged 18 to 25 years and at the same dose as in adults. 

Also, the most common side effects in adolescents aged 12 to 17 years are similar to those seen in those aged 18 and over. 

In the clinical study, this vaccine showed efficacy against symptomatic COVID-19 of around 93% in the examined age group from 14 days after vaccine dose #2. The side effects usually lasted one to three days and could be more pronounced after the second vaccine dose.

As with people over 18 years of age, the vaccine must be administered twice, 4 weeks apart.

SpikeVax (mRNA-1273, elasomeran) is an mRNA vaccine targeted against the novel coronavirus SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein.

On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use Authorization that enables SpikeVax to be distributed in the USA for use in individuals 18 years of age and older. However, SpikeVax has not been Approved or licensed by the FDA as of August 10, 2021.