Moderna Seeks Approval for COVID Vaccine for Young Children

April 28, 2022

Moderna has applied for emergency use authorization (EUA) for its COVID-19 vaccine for children under 6, company officials announced today.

The company plans to finish submitting the data for its full application for children between 6 months and 6 years old by May 9, The New York Times reported. The application joins the company’s previous requests for review of its vaccine for children between 6 and 11, and between 12 and 17.

"We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," Moderna CEO Stéphane Bancel said in a statement. "We believe mRNA-1273 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."

Here’s what you need to know:

• Moderna dosage:  Moderna is seeking approval for a two-dose vaccine for children under 6 that is 25 micrograms. That’s compared to the 100-microgram dose for adults.
• Timeline:  The nation’s independent vaccine advisors are scheduled to meet during June, but the immediate timeline for their review of the Moderna application has not been announced. The CDC and FDA are expected to announce details about the review process within the week.
• Efficacy:  Moderna’s vaccine for children under 6 generated similar protection against the Omicron variant when compared to adults, company officials said today. Efficacy was 51 percent against symptomatic infection for those between 6 months and 2 years, and 37 percent for 2- to 6-year-olds.
• Pfizer-BioNTech:  During December, Pfizer-BioNTech announced they were testing a three-shot regimen, using a 3-microgram dose in children under 5. The FDA and CDC are awaiting information on the results of the third dose trials.
• Quotable:  “It’s critically important that we have the proper evaluation, so that parents will have trust in any vaccines that we authorize,” Peter Marks MD, PhD, director for the FDA’s Center for Biologics Evaluation and Research, said this week.

HAP will continue to monitor the latest COVID-19 public health developments and provide updates to members.

More information about Moderna’s application is available online.