Moderna Seeks FDA Approval of its COVID-19 Vaccine for Children Under Age 6

By Lauren Lisle

Good news for parents waiting to receive the green light on vaccination for their little ones: Moderna announced last Thursday that it has submitted a request for emergency use authorization of its COVID-19 vaccine for children ages 6 months through 5 years.

“We are proud to share that we have submitted for authorization for our COVID-19 vaccine for young children,” said Stéphane Bancel, chief executive officer of Moderna, in a statement. “We believe [the vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers.”

Currently, no COVID-19 vaccines have been authorized in the U.S. for the estimated 18 million children younger than age 5. Moderna says its low-dose vaccine will be ready for FDA review in June. Pfizer Inc. is also expected to have its pediatric vaccine data available by the June review.

The Results

In a study of 6,700 children within the specified age range, researchers found that two 25-microgram doses of the vaccine given 28 days apart triggered levels of antibodies comparable to what has protected older children and young adults. The company claims this similar immune response should predict protection from COVID-19 for these younger ages down to 6 months.

According to Moderna, the vaccine appears to be 51 percent effective for ages 6 months to less than 2 years, and 37 percent effective for children ages 2 to less than 6 years. While not as high as some previous studies, the numbers are still promising.

“51 percent, while less than what we are used to seeing … is a level that says you certainly have great protection against severe disease and hospitalization,” said Dr. Paul Burton, chief medical officer of Moderna, to USA TODAY. “The antibody result that we have is what we saw in the 12- to 24-year-olds, and we know in that group we have a strong protection against severe disease.”

For parents feeling apprehensive about the vaccine, Moderna says the small doses used in the study were safe, and the main side effects included mild fever and pain at the injection site, both of which are commonly associated with other pediatric vaccines. Additionally, there were no cases of myocarditis (heart inflammation) in the study. Myocarditis has been a very rare side effect of the mRNA vaccines; experiencing heart inflammation is more common after COVID-19 infection than vaccination.

The Next Steps

The FDA has said it will convene with outside advisors to evaluate Moderna’s submission. Pending its approval for authorization, the Centers for Disease Control and Prevention (CDC) will then vote on whether the EUA of the vaccine should be recommended. Once it gets an official sign-off from the CDC director, shots will then be able to be administered.

The FDA is also awaiting the data findings from Pfizer and BioNTech regarding the effectiveness of their three-dose approach to vaccinating children under age 5. (Two doses proved too low in initial studies.) Whether the administration chooses to consider these vaccines together or separately, parents and some lawmakers are urging the FDA to act more quickly.

“We have very reassuring data. This is an unmet need here for these young children. They have no other opportunity for protection right now. So I would be hopeful that the FDA will take the data, do their normal very thorough but excellent review, and approve this as soon as possible,” said Dr. Burton in an interview with NPR.

If authorized for emergency use, vaccines for these younger children could be available this summer.