The American biotech company Moderna announced Monday that it has submitted applications in Canada and the European Union for the authorization of the use of its coronavirus vaccine in adolescents.
Moderna said it plans to apply for emergency approval to the United States Food and Drug Administration (FDA), where the vaccine from Pfizer / BioNTech is already being administered to 12-year-olds onwards.
“We are pleased to announce that we have applied for conditional marketing approval of our Covid-19 vaccine with the European Medicines Agency for use in adolescents in the European Union,” reported Moderna CEO Stephane Bancel.
He also claimed in late May that his vaccine was “highly effective” in adolescents aged 12 to 17 years, sAccording to the results of clinical trials conducted with more than 3,700 participants in that age range in the United States.
“We are encouraged by the fact that Moderna’s Covid-19 vaccine has been highly effective in preventing infection by Covid-19 and SARS-CoV-2 in adolescents,” Bancel added in a statement that further details that they requested the authorization before Health Canada, responsible for Health in the country.
Adolescents are much less susceptible to the virus than older age groups, and the main reason to vaccinate them is to reduce transmission. However, extremely rare severe cases of Covid-19 can occur, as well as a postviral complication called multisystem inflammatory syndrome, the French agency said.
Moderna’s two-injection regimen has a efficacy of about 90% against symptomatic covid-19 and 95% against severe disease.
The vaccine was “generally well tolerated” among adolescents, and “to date, no significant safety concerns have been identified”they said from the company.
Last month, the American Academy of Pediatrics called the licensing of Pfizer’s Covid vaccine for teens an important tool for more schools to return to face-to-face modality in the coming months.