Advertisement

UW-Health will move onto next phase of Moderna Pediatrics Covid-19 vaccine trial

In the coming weeks, Moderna plans to ask for ‘Emergency Use Authorization’ from the Food and Drug Administration for its vaccine in babies and toddlers, under
Published: Mar. 27, 2022 at 10:14 PM CDT
Email This Link
Share on Pinterest
Share on LinkedIn

GREEN BAY, Wis. (WBAY) - A COVID-19 vaccine for babies and toddlers may soon become reality for parents who have been waiting for years to protect their children against the deadly virus.

We first told you about Moderna’s plan on Wednesday after the company released data that shows its Covid-19 vaccine for kids under the age of 6 works.

In the coming weeks, Moderna plans to ask for ‘Emergency Use Authorization’ from the Food and Drug Administration for its vaccine in babies and toddlers, under the age of 6.

However, it leads to another question: What happened to Moderna’s vaccine for older kids and teens? The companies original request was stalled by the FDA.

Dr. William Hartman – principal investigator for UW-health Moderna, pediatric covid 19 vaccine trial

“With Moderna, they spent extra time working with the FDA to investigate some cases of myocarditis that showed up in that post-puberty age group,” said Dr. William Hartman, principal investigator for UW-Health’s Moderna pediatric Covid-19 vaccine trial. According to the CDC, myocarditis is the inflammation of the heart muscle, a rare side-effect of a covid-19 vaccine.

Dr. Hartman said Moderna’s vaccine received extra scrutiny because its shots include a higher dose than Pfizer’s shot. Pfizer’s single adult dose is 30 micrograms, while Moderna’s single adult dose is 100 micrograms.

“It’s not exactly apples to apples, but it’s not apples to oranges either,” said Dr. Hartman. “There is a dosing difference there that may also be the reason we have seen prolonged immunity with the Moderna vaccine vs. the Pfizer vaccine.”

As more data was collected and analyzed, Dr. Hartman said researchers found the number ‘of myocarditis cases associated with the vaccine is less than we thought.”

When Moderna submits an EUA request for its kids vaccine, it also plans to update its current FDA application for teen shots. Moderna also plans to request EUA approval for its vaccine in kids ages 6 to 11, who would receive half of an adult dose, in a two-dose series.

While it could be weeks before the FDA rules on Moderna’s data, Dr. Hartman said if approved, everyone in the U.S. that is 6-months or older that is eligible for the vaccine, will have the chance to get one.

“Over the last two years we’ve gone from having nothing except talking about needing ventilators to now talking about all people in society being protected,” said Dr. Hartman.

UW-Health has been part of Moderna’s pediatric covid-19 vaccine trial since December.

Although his team submitted their data, their trial continues with Moderna. Next Dr. Hartman’s team will be looking at the next phase of the trial which includes a a booster that contains omicron mRNA in it. Dr. Hartman said it could make results even stronger as we move toward an endemic.

Copyright 2022 WBAY. All rights reserved.