Topline
Moderna on Thursday asked the Food and Drug Administration to authorize its Covid-19 vaccine for use in children under six, paving the way for the first coronavirus shot to be available to infants and young children.
Key Facts
Moderna said it has asked the FDA to grant emergency use authorization for its coronavirus vaccine for children ages 6 months through five years.
The company cited positive early results from its mid- to late-stage clinical trial, which found the vaccine—given in two 25 μg (micrograms) doses, one quarter the strength used for adults, 28 days apart—produced a “robust” immune response and had a “favorable safety profile.”
Moderna said the submission will be complete “next week.”
Similar requests are “underway” with international regulators, Moderna added.
Moderna chief executive Stéphane Bancel said the company was “proud” to have started the application, which “will be especially welcomed by parents and caregivers.”
If authorized, Moderna’s shot will be the first coronavirus vaccine available to children under five in the U.S.
Key Background
While Moderna has lagged behind its main competitors Pfizer and BioNTech in the Covid vaccine market for teens and children—it’s still only authorized for use in adults—it could be set to jump ahead in the race to vaccinate very young children and infants. Pfizer’s shot is only authorized for use in children five and up and trials for younger groups are still ongoing after disappointing early results. Pfizer is now testing a three-dose regimen in younger children, which it hopes will generate a stronger immune response.
What To Watch For
Pediatric boosters. Moderna said it is also studying booster doses for children six months and up. It has previously said it had plans to test both its original shot as a booster and a new booster containing the original formula and an omicron-specific component, to address slipping efficacy against the now-dominant variant. On Tuesday, Pfizer asked the FDA to greenlight a booster dose for kids aged 5-11 after evidence of rapidly waning immunity emerged during the omicron surge.
Further Reading
Pfizer Asks FDA To Authorize Covid Booster For Kids 5-11 (Forbes)
Moderna Will Seek Emergency Use Approval For Low-Dose Covid Vaccine In Kids Under 6 (Forbes)
