(ABC4) – Moderna has requested emergency use authorization for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration.
Moderna recently released data saying its vaccine strongly protects kids as young as 12 from COVID-19. The company studied more than 3,700 12- to 17-year-olds. Preliminary findings showed the vaccine triggered the same signs of immune protection in kids as it does in adults, and the same kind of temporary side effects such as sore arms, headache, and fatigue.
“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” says Stéphane Bancel, Chief Executive Officer of Moderna. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”
According to Moderna, its COVID-19 vaccine was “generally well-tolerated,” with no significant safety concerns identified. The most common side effect was injection site pain. With the second dose, the most common side effects were headaches, fatigue, muscle pain, and chills.
If approved, this would be the second available COVID-19 vaccine for teenagers. Pfizer received emergency use authorization earlier this year.
Moderna, in early June, announced it had initiated the submission process with the FDA for the licensure of its mRNA COVID-19 vaccine, which would drop the emergency use authorization.