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.
Some European governments have restricted the use of Moderna’s injections for younger age groups after research revealed a link to an increased risk of heart inflammation.
Myocarditis is a known danger of the vaccination, according to the FDA, but the drugmaker’s paediatric studies were not big enough to assess the prevalence of the uncommon heart inflammation in paediatric age groups.
The Pfizer/BioNTech vaccine is already approved in the United States for persons aged 5 and up. The Centers for Disease Control and Prevention (CDC) in the United States reported in May that reports of myocarditis following that vaccine were substantially lower in 5- to 11-year-old boys than in adolescents and young men, suggesting just a slightly higher risk than normal.
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