US FDA reviewers say Moderna COVID-19 vaccine is effective and safe for children
On Friday, June 10, U.S. Food and Drug Administration staff reviewers said Moderna Inc’s COVID-19 vaccine appears safe and effective for use in children aged six months to 17 years, as a committee of scientists will meet next week to vote on whether to recommend the regulator authorize the vaccine in children.
FDA reviewers said in briefing papers released Friday evening that the vaccine elicited a similar immune response in children to that seen in adults in previous trials.
“Available data support the efficacy of the Moderna COVID-19 vaccine in preventing symptomatic COVID-19 in pediatric age groups 6 months through 17 years,” FDA staff said.
FDA staff also said the vaccine generally had a side effect profile in children similar to that seen in adults, although young children had a fever more frequently.
Both messenger RNA COVID-19 vaccines made by Moderna and Pfizer/BioNTech have been linked to rare cases of a type of heart inflammation called myocarditis, particularly in young men.
Some countries in Europe have restricted the use of Moderna’s vaccines for younger age groups after some studies showed it was linked to a higher risk of heart inflammation.
The FDA said myocarditis is a known risk associated with the vaccine, but the drugmaker’s pediatric trials were not large enough to quantify the frequency of rare heart inflammation in pediatric age groups.
The Pfizer/BioNTech vaccine is already licensed in the United States for people aged five and older. The US Centers for Diseases Control and Prevention (CDC) said in May that reports of myocarditis after this vaccine were much lower in boys aged five to 11 than in adolescents and young men, which does not represents only a slightly higher than normal rate. .