FDA: Moderna Vaccine Safe for Kids 6 Months to 17 Years

U.S. Food and Drug Administration advisers say Moderna’s COVID-19 vaccine is safe and effective for children aged 6 months to 17 years, according to an FDA document made public on Friday.

Two doses of the Moderna vaccine caused an immune response in clinical trial participants that was similar to the immune response found in young adults who took the vaccine, the document said.

Children under 11 overall were noted to have had fewer adverse reactions than adolescents, while children 6 years and under reported more fevers than adolescents and adults. A booster shot will probably be needed.

“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 wrote.

The document release comes days before FDA meetings that could help make COVID vaccines available for millions of young children in the United States.

The FDA’s Vaccines and Related Biological Products Advisory Committee meets Tuesday to consider amending the Moderna emergency use authorization (EUA) to include children 6 years to 17 years. On Wednesday, the committee will consider amending the EAUs for the Moderna vaccine to include children between 6 months and 5 years and the Pfizer/BioNTech vaccine to include children 6 months through 4 years.