Johnson & Johnson pause also delays FDA’s process to expand vaccines to children

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RN Connie Garcia extracts a dose of the Moderna Covid-19 vaccine which will be administered to a Texas Tech University Health Science Center student at Texas Tech University Health Science Center’s Academic Building Monday, Jan. 4, 2021, in Odessa, Texas. (Jacob Ford/Odessa American via AP)

KANSAS CITY, Mo. — The Food and Drug Administration spent the past two weeks researching reports of rare blood clots in women who received the Johnson & Johnson vaccine. The amount of attention needed to determine if the J&J vaccine is safe delayed the process to expand another vaccine to children, according to doctors.

Pfizer has submitted data for review to show that its vaccine is safe for children between the ages of 12 and 16. The FDA needed to finish its investigation into concerns about J&J before looking at Pfizer’s study.

“As soon as they clear that out, they’re going to be able to read the data and if the data looks good, we’re going to be able to bring a vaccine for children approved for ages 12 and above,” Dr. Barbara Pahud, Research Director, Pediatrics Infectious Diseases at Children’s Mercy said during a Facebook Live with the University of Kansas Health System Friday.

Like Pfizer, Moderna is also conducting trials to determine if it’s vaccine is safe to give to younger children.

Children’s Mercy Hospital said it is one of six locations worldwide involved in Moderna’s Phase One Trial. The trial started about two weeks ago. Right now researchers are working to find the correct dosage for children.

“We grab the dose for adults, and we’d give a percentage of that maybe 10% to the babies, and we see how they do. If they do well, then we go up on the dose. And we see how they do until we reach a point where they start having side effects that we may not tolerate as parents, for example, if they develop a high fever,” Pahud said.

There are also trials underway to determine dosage for children six-months to 11 years old. The FDA will need to expand Emergency Use Authorization again to include younger children, if the vaccines work.

After getting the dosage right, the biggest concerns are making sure parents are comfortable with their children getting the vaccine, according to Children’s Mercy.

“I don’t know how the rest of you guys felt after the vaccine, but imagine that in a six month old baby. We want to make sure that parents feel comfortable getting the vaccine,” Pahud said.

Currently, Pfizer’s vaccine is the only one with an Emergency Use Authorization from the FDA to be given to teenagers who are 16 and 17 years old.

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