FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children 6 Months and Older

Following VRBPAC recommendations earlier this week, both the Pfizer-BioNTech and Moderna COVID-19 vaccines were FDA-authorized for children as young as 6 months.

Today, the US Food and Drug Administration (FDA) authorized expanding the Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 vaccine for children as young as 6 months old.

“Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data,” said Robert M. Califf, MD, the FDA commissioner.

These authorizations come a few days after the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend both mRNA COVID-19 vaccines for these youngest children.

“In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

Now, the US Centers for Disease Control and Prevention (CDC) must sign off on these approvals, which could happen within days, and all Americans 6 months and older can be vaccinated against COVID-19.

“Many parents, caregivers, and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” Califf said.“As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.”

The Moderna COVID-19 vaccine was previously only available to adults 18 years and older, but VRBPAC recommended expanding its EUA to children and adolescents 6-17 years of age on Tuesday, June 14. At VRBPAC’s meeting the following day, Moderna was unanimously recommended for children 6 months-23 months of age, and children 2 years-5 years of age.

The Pfizer-BioNTech COVID-19 vaccine, previously available as a primary vaccination series and booster dose to people 5 years and older, was unanimously recommended by VRBPAC for children 6 months-4 years of age.

With these recommendations, VRBPAC noted that their objective is to provide options to parents. Some families may decide not to vaccinate their youngest children, given the relatively low rate of hospitalization and death in this age group. However, the Omicron variant has caused severe and fatal COVID-19 infections to rise in young children, so some parents may want to ensure the best possible protection for their children.

Immunocompromised children in particular were a discussion point in the FDA and VRBPAC decisions. Additionally, as children return to school and mask mandates are dropped, there are concerns of young children contracting COVID-19 and passing it to immunocompromised family members.

The approved pediatric COVID-19 vaccinations were 2 doses of Moderna, 25 μg each dose, for children 6 months-5 years of age. Pfizer-BioNTech was authorized as a 3-dose primary series, at 3 μg a dose, for children 6 months-4 years of age.