Moderna COVID vaccine effective and safe for children, says USFDA

Moderna Inc’s (MRNA.O) COVID-19 vaccine is safe and effective for use in children aged 6 months to 17 years old, according to FDA staff reviewers on Friday, as a committee of scientists meets next week to vote on whether to recommend the regulator licence the vaccination in children.

In briefing materials released Friday evening, FDA reviewers stated that the vaccination elicited a comparable immunological response in children as it did in adults in prior studies.

“Available data support the effectiveness of the Moderna COVID-19 Vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age,” Reuters quoted the FDA as saying.

The FDA staff also said the vaccine generally had a similar side effect profile in children as seen in adults, although younger children had fevers more frequently.

Both of the messenger RNA-based COVID-19 vaccines made by Moderna and Pfizer/BioNTech have been linked to rare instances of a type of heart inflammation called myocarditis, particularly in young men.

“Available data support the effectiveness of the Moderna COVID-19 Vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age,” the FDA staff said.

The FDA staff also said the vaccine generally had a similar side effect profile in children as seen in adults, although younger children had fevers more frequently.

Both of the messenger RNA-based COVID-19 vaccines made by Moderna and Pfizer/BioNTech have been linked to rare instances of a type of heart inflammation called myocarditis, particularly in young men.