SAN FRANCISCO (KRON) — Moderna has filed for emergency use authorization of its COVID-19 vaccine for 12-17-year-old adolescents.
The vaccine is currently only authorized for adults, ages 18 and older.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna.
The filing comes after Moderna had encouraging results from a study that enrolled 3,732 participants ages 12 to less than 18 years in the U.S.
“The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills,” the company said. The adolescents will be monitored for a year to test long-term protection and safety.
Pfizer’s COVID-19 vaccine is the only one on the market now that was approved for kids 12 and older in the United States.