Pharmaceutical Moderna announced Thursday that it has applied to the Food and Drug Administration (FDA) for authorization for emergency use of its COVID-19 vaccine in adolescents between 12 and 18 years of age.
“We are encouraged that Moderna’s COVID-19 vaccine was very effective in preventing COVID-19 and SARS-CoV-2 infections in adolescents,” said the firm’s CEO, Stéphane Bancel, in a statement.
Moderna reiterated that the request is based on a study conducted with 3,700 people in the United States, which showed that the product is safe and 100% effective for adolescents, according to data it released in May.
SIDE EFFECTS OF THE MODERN VACCINE IN ADOLESCENTS
Regarding side effects, Moderna cited situations similar to those registered with adults, such as arm pain, fatigue and headaches.
So far, the US pharmaceuticals vaccine is used only in people over 18 years of age and, if approved, it would become the second to receive the green light for use in that age group, after Pfizer’s, already authorized in the US, Europe and Canada.
Moderna, like Pfizer, has ongoing studies with younger children, ages 6 months to 11 years.
The Joe Biden government plans to make the donations in two installments: one this year and the other in 2022.
The biotech also requested this month from US regulators the full approval of its vaccine for adults, which would allow it, among other things, to sell doses directly to consumers and continue to market the vaccine once the end of the emergency is declared. sanitary.
Moderna also requested authorization from the European Union and Canada this week, and has announced its intention to do so in other countries, ensuring “high effectiveness in preventing COVID-19 and infection with SARS-VoV-2” in this age group.