An FDA advisory panel voted unanimously in favor of authorizing the Moderna and Pfizer/BioNTech COVID-19 vaccines for children as young as 6-months old, according to multiple media reports.

According to Time, the FDA’s Vaccine and Related Biological Products Advisory Committee voted 21-0 that the benefits of Moderna’s vaccine outweigh its risks for kids ages 6 months through 5 years of age, and that the benefits of Pfizer-BioNTech’s vaccine outweigh risks for kids ages 6 months through 4 years.

Moderna’s vaccine for children ages 6 months through 5 years old is given in two shots, and each dose is one-quarter the dose of that used in adults. Those immunized with Moderna would get two doses spaced four weeks apart.

Moderna tested its two-dose vaccine in more than 6,300 children. Among those ages 2 to 5, the shots were about 37% effective at preventing symptomatic disease when Omicron was prevalent. For kids ages 6 months to 2 years, efficacy was around 50% against symptomatic disease.


The Pfizer-BioNTech vaccine for kids ages 6 months to 4 years old is a three-shot regimen, and each dose is one-tenth the dosage given to adults. Children would receive two doses three weeks apart, and a third dose at least two months later.

In a company study involving more than 4,500 children, antibody levels generated by these children were compared to those produced by vaccinated people ages 16 to 25 years old. In the pediatric group, three-dose vaccine efficacy against symptomatic disease was 80.4% during a time when Omicron was circulating widely in the US.


fda advisory panel