Moderna Asks FDA To Authorize Its COVID Vaccine For Kids Ages 12 To 17

By Bill Galluccio

June 10, 2021

Photo: Getty Images

Moderna has asked the Food and Drug Administration for an emergency use authorization for its COVID-19 vaccine in adolescents between the ages of 12 and 17

“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,” Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement. “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.”

The drugmaker said that results of its Phase 2/3 clinical trials, which were published a few weeks ago, showed that the vaccine had a 100% efficacy in adolescents who received both doses. There were no cases of COVID-19 in the study participants who received the vaccine and just four cases in those who received a placebo.

The company said the data shows that the vaccine is safe. The most common side effects were injection site pain, headache, fatigue, muscle pains, and chills.

The FDA is expected to grant the approval, which could take about a month. Pfizer filed for an emergency use authorization for its vaccine in adolescents on April 9, which was granted on May 10.

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