FDA delays decision on Moderna's COVID-19 vaccine for adolescents

U.S. regulators are delaying their decision on Moderna's COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation, the company said Sunday.

The U.S. Food and Drug Administration told the company Friday evening that its review could last until January, Moderna said.

The company also said it will delay filing a request for emergency-use authorization of a lower dose of the vaccine for 6- to 11-year-olds.

Heart inflammation is an exceedingly rare risk of both the Pfizer and Moderna vaccines, and it more commonly seen in young men or boys. It's difficult for clinical trials to detect such a rare problem. And public health officials have repeatedly stressed that COVID-19 itself can cause heart inflammation at higher rates than the rare cases caused by the vaccine.

In the U.S., the Moderna vaccine is authorized for people 18 and older.

Moderna said more than 1.5 million adolescents around the world have received its vaccine and that the number of heart inflammation reports "does not suggest an increased risk" for those under 18.

U.S. children from 12 to 17 can get the vaccine produced by Pfizer and its partner BioNTech. According to CDC data, more than 11.3 million American adolescents ages 12 to 17 have been fully vaccinated.

The FDA last week moved to allow use of the Pfizer shots in younger children between 5 and 11. The Centers for Disease Control and Prevention is expected to make its decision on that this week.

In an interview on "Face the Nation" Sunday, Dr. Claire Boogaard, a pediatrician who oversees the COVID vaccine program at Children's National Hospital in Washington, D.C., said research shows the Pfizer vaccine is "very safe" for kids, and she doesn't have any misgivings about the use of the mRNA vaccine technology.

"Vaccines, all they do is they give your body a chance to build a response to something that's non-harmful so it can protect you against something that is harmful," she said. 

For parents deciding whether to vaccinate their children, she said, "Everything is risk-benefit. So, you need to think about your own individual family situation. You also need to think about the community around you. For us as parents, we don't want anything bad to happen to our kids, right? COVID has bad complications with children — doesn't have it with all children, but has many. And it also has the complications in this young group of having long-term issues, whether it's having symptoms that last longer than two months, which is the long COVID that people talk about, or developing a very serious, life-threatening condition called multisystem inflammatory syndrome in children."

Moderna also has been testing two shots, one month apart, for children 6 to 11, at half the dose given to adults.