Moderna Says COVID-19 Vaccine Safe and Effective for 12 - 17 Year Olds

The U.S. biotechnology firm Moderna said Tuesday that recent trials of its COVID-19 vaccine show it to be safe and effective on adolescents ages 12 to 17. The company said it will submit the findings to the U.S. Food and Drug administration (FDA) next month for emergency approval.

In a release posted to its website, Moderna said the trials involved more than 3,700 12 to 17-year-olds. It said preliminary findings showed the vaccine triggered the same signs of immune protection in young people it does in adults, and the same kind of temporary side effects such as sore arms, headache and fatigue.

In the statement, Moderna CEO Stéphane Bancel said the company was encouraged by the results, and said it will submit them to the FDA as well as other global regulators in early June to request authorization.

Earlier this month, the COVID-19 vaccine manufactured by Pfizer-BioNTech became the first one approved for use on adolescents in the United States and Canada. Europe’s drug regulator, the European Medicines Agency (EMA) is currently reviewing the company’s vaccine for use on adolescents.

Both Pfizer and Moderna have begun testing in even younger children, from age 11 down to 6-month-old babies. That testing is more complex. While teens receive the same dose as adults, smaller doses are needed for younger children. Experts hope to see the results of those trials later this year.