Moderna seeks FDA authorization for COVID-19 vaccine for 12-17-year-olds

Updated June 10, 2021

Moderna has filed with the US Food and Drug Administration for emergency use authorization for its Covid-19 vaccine for adolescents ages 12 to 17. Last month, Moderna reported that its coronavirus vaccine triggers a powerfully effective immune response in adolescents between the ages of 12 and 17.

If the vaccine is approved, Moderna will follow in Pfizer’s footsteps as the second COVID-19 vaccine available to U.S. adolescents.

Adolescents between 12 and 16 began receiving the Pfizer vaccine last month; Pfizer was initially approved for use in anyone age 16 or older.

In Moderna’s clinical trial, 3,732 people ages 12 to 17 received two vaccine doses. There were no cases of symptomatic COVID-19 in fully vaccinated adolescents, according to a statement from the company—this means an efficacy rate of 100 percent, just like the Pfizer vaccine in 12 to 15-year-olds. There was an efficacy rate of 93 percent in trial participants after just a single dose.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, Chief Executive Officer of Moderna in a release last month. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”

The adolescent participants reported similar vaccine side effects as adult recipients: pain at the site of the injection, headache, fatigue, muscle pain and chills. The adolescents who participated in the study will be monitored for a year after their second dose.

“No significant safety concerns have been identified to date,” Moderna said.

Pfizer has already announced they could be ready to begin vaccinating children between the ages of two and 11 as soon as September. These advancements in vaccine efficacy and safety in children will be a huge step toward keeping schools open and operating safely for the upcoming school year.

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