Moderna faces delay in Emergency Use Authorization for adolescents

Moderna Vaccine
Posted at 10:53 AM, Nov 01, 2021

NASHVILLE, Tenn. (WTVF) — Moderna said they were notified by the FDA that they will take additional time to assess their Emergency Use Authorization request. The request is specifically for using the vaccines on kids aged 12-17.

"On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA notified Moderna that this review may not be completed before January 2022," The company said in a statement.

Moderna said the vaccine has been give to more than 1.5 million adolescents.

"To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population. Moderna is committed to conducting its own careful review of new external analyses as they become available. The Company does not yet have access to data from some recent international analyses," the statement said.

The CDC's website specifically addresses COVID-19 vaccines on kids and teens. It said cases of myocarditis and pericarditis have been reported more after the second dose than the first of the MRNA vaccines.

"These reports are rare and the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericaditis," the CDC said.

Moderna said they will delay filing the EUA for kids 6-11 until the review is complete.

Editor's note: The video has been removed from this story because a graphic incorrectly cited Moderna for information, instead of the CDC.