Moderna requests FDA approval for vaccine use in adolescents

Kelly Smith, a Johnson County Public Health nurse, draws a dose of the Moderna COVID-19 vaccine during a free food box and vaccine clinic drive-thru event May 27 at the Johnson County Fairgrounds in Iowa City, Iowa. (Joseph Cress/Iowa City Press-Citizen) Photo credit Joseph Cress/Iowa City Press-Citizen via Imagn Content Services, LLC
By , WWJ Newsradio 950

U.S. teens could soon have another option for COVID-19 vaccination.

Moderna, a biotechnology company that produces two-dose mRNA COVID-19 vaccines, announced Wednesday it had requested Emergency Use Authorization from the Food and Drug Administration to provide vaccines to adolescents between 12 and 18.

“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,” said Moderna CEO Stéphane Bancel in a press release from the company. “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.”

More than 3,700 adolescents between 12 and 18 participated in a study of the two-shot Moderna vaccine. No cases were observed in any of the participants who received two doses of the vaccine, according to the company. All participants are to be monitored for 12 months following their second injection.

While the company said there are no significant safety concerns connected to vaccine use in adolescents, it did say there were some mild to moderate adverse effects, including injection site pain. Other adverse reactions include fatigue, muscle pain and chills.

Moderna’s COVID-19 vaccine was first approved for emergency use in adults over 18 by the FDA in December 2020.

Last month Pfizer and BioNTech, other companies that produce a mRNA vaccine that protects against COVID-19, received the first FDA authorization to administer a COVID-19 vaccine to adolescents between 12 and 15, according to a May 10 press release from Pfizer.

The Centers for Disease Control and Prevention recommends that everyone age 12 and older get a COVID-19 vaccine and as of Wednesday said the Pfizer and BioNTech vaccine was safe for those over 12.

“Widespread vaccination is a critical tool to help stop the pandemic,” said the CDC. “People who are fully vaccinated can resume activities that they did prior to the pandemic.”