(Washington) American biotech company Moderna announced Thursday that it has applied for approval for its COVID-19 vaccine for adolescents aged 12 to 17 in the United States.
The case will now be reviewed by the US Medicines Agency (FDA).
On Monday, Moderna made a similar request for this age group to the European Medicines Agency (EMA) and Health Canada.
The Moderna vaccine is currently only approved for people aged 18 and over.
The first vaccine, created by the Pfizer / BioNTech alliance, has already been licensed since the age of 12 in the United States, Canada and the 27 countries of the European Union.
At the end of May, Moderna announced the full results of clinical trials of more than 3,700 participants aged 12 to 17 in the United States.
“No cases of COVID-19 were observed in participants who received two doses of Moderna’s COVID-19 vaccine,” meaning “100% effective using the same case definition” as for adults, according to the company.
The vaccine was “generally well tolerated,” and “no safety issues have been identified so far,” she said. The observed side effects were similar to those seen in adults (pain at the injection site, fatigue, headaches, muscle aches, chills, etc.).
“We are encouraged that the Moderna COVID-19 vaccine has shown great effectiveness in preventing COVID-19 in adolescents,” Moderna boss Stefan Bansel said Monday.
“We will be filing regulatory inquiries around the world for this large young population,” he added.
Adolescents usually develop milder forms of COVID-19 than older adults, but are not immune to infection and are involved in the transmission of the virus to the general public.
According to experts, therefore, their immunization is necessary in order to stop the epidemic.