Moderna has asked the FDA to authorize its 2-shot COVID-19 vaccine for children under 6 in the US.- Moderna's CEO said the vaccine "will be especially welcomed by parents and caregivers."
COVID-19 shots for babies and toddlers across the US are one step closer to reality.
On Thursday, Moderna announced the company has filed for emergency approval of its COVID-19 vaccine for kids from 6 months to 6 years old in the US.
Moderna said in a statement that it has applied to the US Food and Drug Administration for emergency-use authorization of its vaccine, and that the submission "will be complete next week," suggesting that the filing is not totally ready for regulators to review yet.
The company added that "similar requests are underway" with regulators in other countries.
CEO Stéphane Bancel said Moderna's vaccine "will be able to safely protect these children" against COVID "which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers."
One doctor, the father of a 4 year old child, says Moderna's results look good
Moderna's vaccine for kids 6 months to 6 years old is a two-shot series, and each is a smaller, 25% dose of what adults get.
According to Moderna, during the recent Omicron wave, the vaccine was:
- 51% effective at preventing PCR-confirmed COVID-19 infections in trials of kids 6 months to 2 years old, and
- 37% effective at preventing PCR-confirmed COVID-19 infections in trials of kids 2 years to 6 years old.
Dr. Jeremy Faust, an emergency physician in Boston, and an instructor at Harvard Medical School, said these results may sound "mediocre," but that as a parent of a 4-year-old daughter, he was more impressed that the vaccine was both safe, and elicited a strong neutralizing antibody response in kids.
"I'm pretty sure my kid will get COVID at some point, vaccine or not," he said on Twitter. "But with a vaccine beforehand, she's far less likely to suffer for very long at all."
'Dire' delays in shots for young kids
Many parents of babies and toddlers have been eagerly waiting for a vaccine that can protect their youngest children for many months now. Pfizer's COVID-19 vaccine for teens as young as 12 years old was authorized and recommended almost a year ago (May 2021) and shots for kids as young as 5 have been out since November.
"The lack of immunization options for children under 5 has become a dire situation," pediatrician Elias Kass from Seattle said during a recent Centers for Disease Control and Prevention meeting on vaccines. "It's been at least 6 months since we were expecting vaccines for this age group."
Several frustrated and eager parents spoke out at the meeting, describing how difficult it's become to protect kids under 5, especially against the highly-transmissible Omicron sub-variants circulating now.
Pfizer's COVID-19 vaccine for children as young as six months old, which was slated to be ready in February, did not elicit a strong neutralizing antibody response in the 2- to 5-year-old age group, leading to months of delays as the company shifted strategy to include a third dose in its regimen for little kids. (Pfizer's pediatric dosage is, notably, much smaller than Moderna's — only one-tenth of what adults get.)
The FDA's Doran Fink, who helps review vaccine applications at the agency, has said that the FDA will work "diligently" to authorize a vaccine for young kids, as soon as it is in receipt of a completed application from any company.
But Politico reported earlier this month that regulators may actually be "leaning toward postponing any action until the early summer, arguing that it would be simpler and less confusing to simultaneously authorize and promote two vaccines to the public" — one under 5's vaccine from Pfizer, and one under 6's vaccine from Moderna.