A COVID-19 vaccine for babies and young children may finally be around the corner after Moderna released data Wednesday showing its vaccine is safe and effective in kids ages 6 months to 6 years.
The vaccine developer said it plans to request emergency use authorization from the Food and Drug Administration in the coming weeks and has already submitted an EUA for its vaccine in children 6 to 11 years, according to a news release.
“We believe these latest results … are good news for parents of children under 6 years of age,” said Stéphane Bancel, the company’s chief medical officer. “We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages.”
Parents of small children eager to vaccinate their little ones have been awaiting an announcement like this for months after multiple setbacks and confusion over which shots might work and when.
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The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. Over 400 kids under 5 have died from COVID-19 during the pandemic, according to the Americans Academy of Pediatrics, many during the last few months.
“We saw the devastating impact omicron had on children under 5 who are still vulnerable without any access to vaccines,” said Dr. Katherine Matthias, pediatrician and co-founder of Protect Their Future, a grassroots group advocating for child COVID-19 vaccines. “A significant portion of pediatric deaths occurred during that surge, and we cannot permit any more of these preventable losses. No more parents should have to bury their children, especially when there is a safe and effective vaccine available.”
Competitor Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older. The company is testing even smaller doses for children under 5 but had to add a third shot to its study when two injections didn’t prove strong enough. Those results are expected by early April.
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Vaccinating the youngest “has been somewhat of a moving target over the last couple of months,” said Dr. Bill Muller of Northwestern University, an investigator in Moderna’s pediatric studies, in an interview before the company released its findings. “There’s still, I think, a lingering urgency to try to get that done as soon as possible.”
In Moderna’s study of 6,700 kids ages 6 months to 6 years, researchers found the young participants developed levels of virus-fighting antibodies after receiving two doses of the 25 micrograms vaccine that were comparable to adults 18 to 25 who received two doses of the full-strength 100 micrograms.
In the phase 3 study that took place during the omicron wave, researchers found the vaccine was 43.7% effective in children 6 months to 2 years and 37.5% in kids 2 to 6 years. Cases of COVID-19 in the vaccinated group were mild and no severe disease, hospitalization or death were reported.
The younger tots experienced many of the same mild to moderate side effects seen in adults, with 17% of kids 6 months to 2 years and 14.6% of kids 2 to 6 years reporting a fever of 100.4 degrees or higher.
No deaths, myocarditis or pericarditis, and multisystem inflammatory syndrome in children were reported.
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If regulators like what they see in Moderna’s data, parents may finally start vaccinating their youngest children by the summer, said Peter Pitts, former FDA associate commissioner.
“Vaccinations for young children will play an important role in speeding COVID-19’s path from pandemic to endemic,” he said.
While other countries already have allowed Moderna’s shots to be used in children as young as 6, the U.S. has limited its vaccine to adults.
A Moderna request to expand its shots to 12- to 17-year-olds has been stalled since June 2021. Moderna says its original adult dose is safe and effective for this age group.
For elementary-age kids, it’s using 50 micrograms – half the adult dose.
The FDA never ruled on Moderna’s application for teen shots because of concern about a very rare side effect. Heart inflammation sometimes occurs in teens and young adults, mostly males, after receiving either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny because its shots are a far higher dose than Pfizer’s.
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The risk also seems linked to puberty, and regulators in Canada, Europe and elsewhere recently expanded Moderna vaccinations to kids as young as 6.
But parents and pediatricians are urging the FDA to finish up this review and quickly look over Moderna’s data of school-aged and younger children so that all age groups can finally have access to COVID-19 vaccines.
“The FDA has a moral obligation to do everything possible to urgently review Moderna’s data, and if favorable, grant an emergency use authorization,” Matthias said. “Our children’s lives and health depend on it.”
Contributing: Associated Press. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
