Cambridge-based Moderna today announced that it has requested emergency use authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine for children from ages 12 to 17.
“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents,” Stéphane Bancel, Chief Executive Officer of Moderna, saidin a statement. “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.”
Moderna’s mRNA vaccine is already approved for people 18 and older. In May, the company had announced positive results from its trials on more than 3,000 adolescents, proving that its vaccine produced the same effective immune response in that age group as in adults. The company says no significant safety concerns have been observed.
Moderna’s trials on children between the ages of 6 and 11 are already underway and has plans to expand it to younger kids.
In May, the FDA announced its emergency use authorization of the Pfizer-BioNTech vaccine for children ages 12 to 15.