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

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U.S. regulators are delaying their decision on Moderna’s COVID-19 vaccine for 12- to 17-year-olds whereas they examine the uncommon threat of coronary heart irritation, the company stated Sunday.

The U.S. Food and Drug Administration instructed the company Friday night that its review might final till January, Moderna stated.

The company additionally stated it would delay submitting a request for emergency-use authorization of a decrease dose of the vaccine for 6- to 11-year-olds.

Heart irritation is an exceedingly uncommon threat of each the Pfizer and Moderna vaccines, and it extra generally seen in younger males or boys. It’s tough for medical trials to detect such a uncommon drawback. And public well being officers have repeatedly pressured that COVID-19 itself could cause coronary heart irritation at increased charges than the uncommon instances attributable to the vaccine.

In the U.S., the Moderna vaccine is allowed for folks 18 and older.

Moderna stated greater than 1.5 million adolescents all over the world have acquired its vaccine and that the variety of coronary heart irritation experiences “does not suggest an increased risk” for these below 18.

U.S. kids from 12 to 17 can get the vaccine produced by Pfizer and its associate BioNTech. According to CDC data, greater than 11.3 million American adolescents ages 12 to 17 have been totally vaccinated.

The FDA final week moved to permit use of the Pfizer photographs in youthful kids between 5 and 11. The Centers for Disease Control and Prevention is anticipated 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., stated analysis reveals the Pfizer vaccine is “very safe” for children, and she or he does not have any misgivings about the usage of the mRNA vaccine know-how.

“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 stated. 

For mother and father deciding whether or not to vaccinate their kids, she stated, “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 additionally has been testing two shots, one month apart, for kids 6 to 11, at half the dose given to adults.

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