New York: Moderna’s Covid-19
vaccine works in babies, toddlers and preschoolers the company announced
Wednesday—and if regulators agree it could mean a chance to finally start
vaccinating the littlest kids by summer.
Moderna said in the coming
weeks it would ask regulators in the US and Europe to authorise two small-dose
shots for youngsters under 6. The company also is seeking to have larger-dose
shots cleared for older children and teens in the US.
The nation’s 18 million
children under 5 are the only age group not yet eligible for vaccination.
Competitor Pfizer currently offers kid-sized doses for school-age children and
full-strength shots for those 12 and older.
But parents have anxiously
awaited protection for younger tots, disappointed by setbacks and confusion
over which shots might work and when. Pfizer is testing even smaller doses for
children under 5 but had to add a third shot to its study when two didn’t prove
strong enough. Those results are expected by early April.
Vaccinating the littlest “has
been somewhat of a moving target over the last couple of months,” Dr Bill
Muller of Northwestern University, an investigator in Moderna’s pediatric
studies, said 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.”
The younger the child, the
smaller the dose being tested. Moderna said a quarter of the dose it uses for
adults worked well for youngsters under age 6.
Moderna enrolled about 6,900
tots in a study of the 25-microgram doses. Early data showed after two shots,
youngsters developed virus-fighting antibody levels just as strong as young
adults getting regular-strength shots, the company said in a press release.
Moderna said the small doses
were safe, and the main side effects were mild fevers like those associated
with other commonly used pediatric vaccines.
Once Moderna submits the data
to the FDA, regulators will debate whether to authorize emergency use of the
small doses for tots. If so, the Centers for Disease Control and Prevention
then will decide whether to recommend them.
While Covid-19 generally isn’t
as dangerous to youngsters as to adults, some do become severely ill. The CDC
says about 400 children younger than 5 have died from Covid-19 since the
pandemic’s start. The omicron variant hit children especially hard, with those
under 5 hospitalized at higher rates than at the peak of the previous delta
surge, the CDC found.
Covid-19 vaccines in general
don’t prevent infection with the omicron mutant as well as they fended off
earlier variants—but they do still offer strong protection against severe
illness.
Moderna reported that same
trend in the trial of children under 6, conducted during the omicron surge.
While there were no severe illnesses, the vaccine proved just under 44%
effective at preventing any infection in babies up to age 2, and nearly 38%
effective in the preschoolers.
Moderna said also said
Wednesday it will ask the Food and Drug Administration to clear larger doses
for older children.
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 for months.
The company said Wednesday
that, armed with additional evidence, it is updating its FDA application for
teen shots and requesting a green light for 6- to 11-year-olds, too.
Moderna says its original
adult dose—two 100-microgram shots—is safe and effective in 12- to
17-year-olds. For elementary-age kids, it’s using half the adult dose.
But 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.
The risk also seems linked to
puberty, and regulators in Canada, Europe and elsewhere recently expanded
Moderna vaccinations to kids as young as 6.
“That concern has not been seen in the younger children,” said Northwestern’s Muller.
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