FDA Expands EUA for Moderna, Pfizer-BioNTech COVID-19 Vaccines to Children 6 Months and Up

After an FDA committee voted unanimously in favor of doing so, the FDA today authorized emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 Vaccine for children down to 6 months of age.

The FDA amended the Moderna EUA for individuals 6 months through 17 years of age; it had been authorized for adults 18 years of age and older. It amended the Pfizer-BioNTech COVID-19 vaccine for people 6 months through 4 years of age. The vaccine had been authorized for use in people 5 years of age and older.

Robert M. Califf, M.D.

“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. 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,” FDA Commissioner Robert M. Califf, M.D., said in a news release.

“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,” Califf added.

On June 15, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to expand FDA's emergency use authorization (EUA) for Moderna’s COVID-19 vaccine for children ages 6 months to 5 years, and Pfizer’s vaccine for children ages 6 months to four years old.

In addition, the VRBPAC unanimously voted to approve Moderna’s COVID-19 vaccine for children ages 7 to 16 on June 14.

Today and Saturday, CDC’s panel of expert advisers will consider whether to recommend the vaccines in those age groups for emergency use.

While all VRBPAC members voted to expand the EUA to the younger age groups — particularly those who are at high risk due to autoimmune conditions — many also expressed concerns.

“It’s very important that the communication or the messaging be made as clear as possible for parents to understand the relative risk and the relative benefits,” said Cody Meissner. M.D., professor of pediatrics at Tufts University School Medicine

For example, there have been 442 deaths in children younger than 5 since the start of the pandemic, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during the VRBPAC meeting.

Hospitalization rates for those younger than 5 are also very low, Meissner noted, at 23 per 1 million children.

Oveta Fuller, Ph.D.

Oveta Fuller, Ph.D., associate professor of microbiology and immunology at University of Michigan Medical School, noted concern about the one case of seizure reported in the Moderna study of 5,000 children ages 6 months to 5 years.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” Marks said. “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.”

However, the FDA noted that the agency and CDC’s safety surveillance systems have previously identified increased risks of myocarditis and pericarditis after vaccination with the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine, “particularly following the second dose.”

The observed risk is highest in males 18 through 24 years of age for the Moderna vaccine and in males 12 through 17 years of age for the Pfizer-BioNTech vaccine, the FDA said.

“The FDA and the CDC analyses of available safety surveillance data from the U.S. and other countries on myocarditis outcomes continue to strengthen the evidence that most cases of myocarditis associated with the Moderna and Pfizer-BioNTech COVID-19 vaccines are characterized by rapid resolution of symptoms following conservative management, with no impact on quality of life reported by most patients who were contacted for follow-up at 90 days or more after reporting myocarditis,” the FDA said.