4:13 PM, Feb 27, 2020


FDA to meet & discuss next steps for COVID-19 vaccine for younger kids

Posted at 7:13 AM, Jun 10, 2021
and last updated 2021-06-10 07:13:13-04

(WSYM) — FDA advisers will meet on Thursday to discuss the next steps in considering giving the green light to vaccinate younger kids against COVID-19.

Currently, the Pfizer vaccine is authorized for use in kids 12 and up, but the company said Tuesday it will start testing in kids as young as 5 years old.

The advisory committee will convene virtually but won't vote or make any decisions. Instead, this is to pinpoint what exactly they will require from companies in order to give the go-ahead to vaccinate younger kids.

“So at this point, what they’re doing is saying, hey look guys, we need you to give us this specific information for us to feel comfortable with younger children getting the go-ahead," Dr. Molly O'Shea of Birmingham Pediatrics said.

This is likely to include how many kids must be enrolled in clinical trials and what safety data will be required.

Earlier this week, Pfizer said it would begin testing in kids as young as 5 using smaller doses. It plans to enroll up to 4,500 kids in its phase 2 and 3 trials, and if those results are positive, the company said it would ask health officials in September to approve access for younger kids.

Meanwhile, Henry Ford Health System has been chosen as a trial site for Moderna's vaccine in younger kids. It's currently looking for volunteers between the ages of 6 months old and 11 years old for its two-phased study. Participants will be monitored for more than a yea

“While as a group children do not suffer the same illness of COVID-19 as adults, it is still yet to be determined the long term consequences relating to their behavioral health, physical health and quite frankly their academic trajectory," Dr. Tisa Johnson Hooper, the interim chair of pediatrics a Henry Ford Health System, said.

Vaccine advisers to the CDC have reported a higher-than-expected number of cases of a heart issue among younger people called myocarditis, swelling of the heart muscle, after receiving a second dose of the Pfizer or Moderna vaccines. But, the CDC reports this is still rare and most patients responded well.

“And it isn’t even clear yet if the vaccine is a contributor or not," O'Shea said.

But it's another reason why she said the meeting is coming at an important time.

“Especially now that there’s this a little bit of question mark around the myocarditis, they’ll be able to ask more specific questions and have more specific data when that time comes," O'Shea said.

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