COVID vaccines for children under the age of 5 took a major step forward last month as many parents anxiously await approval for the only age group not yet eligible for vaccination, but little has been heard since.
With cases of the omicron subvariant BA.2 on the rise across the U.S. and restrictions largely lifted across much of the U.S., parents of children still not eligible for vaccination are wondering when their time might come.
The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination.
While the race is on to get the youngest members of the population vaccinated, which vaccine will work best and when might one be approved?
Here's what we know so far.
Which vaccines are seeking approval for children under 5 and where do they stand?
Currently, Pfizer's COVID vaccine has been the only one approved for emergency use in the US for children between the ages of 5 and 17.
Competitor Pfizer currently offers kid-size 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 didn’t prove strong enough. Those results are expected by early April, though no announcement have been made so far.
Moderna announced last month that in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6 — a development that could pave the way for the littlest kids to be vaccinated by summer if regulators agree. The company also is seeking to have larger doses cleared for older children and teens in the U.S.
But as of Thursday, no such request has been filed.
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How effective are the vaccines in children?
Earlier this year, the Food and Drug Administration, worried about the omicron variant's toll on kids, had taken the extraordinary step of urging Pfizer to apply for OK of the extra-low dose vaccine before it's clear if tots will need two shots or three. The agency's plan could have allowed vaccinations to begin within weeks.
But in February, the FDA reversed course and said it had become clear the agency needed to wait for data on how well a third shot works for the youngest age group. Pfizer said in a statement that it expected the data by early April.
FDA's vaccine chief Dr. Peter Marks said he hoped parents would understand that the agency's decision was part of its careful scientific review of the evidence Pfizer has submitted so far.
That information "made us realize that we needed to see data from a third dose from the ongoing trial in order to make a determination," Marks told reporters. “We take our responsibility for reviewing these vaccines very seriously because we’re parents as well."
Data posted online last month showed two doses of the Pfizer-BioNTech COVID-19 vaccine offer almost no protection against coronavirus infection in kids ages 5 to 11, but did offer protection against serious illness.
Researchers from the New York State Department of Health found that the vaccine’s effectiveness dropped to 12% from 68% in the age group in December and January when the omicron variant of the coronavirus began circulating widely in the United States.
The Pfizer shots still offered protection against serious illness from COVID, the researchers found, with protection against hospitalization declining to 48 percent from 100 percent over the same time period.
COVID-19 vaccines aren't as effective against the super-contagious omicron mutant — in people of any age — and Moderna's study found the same trend.
Moderna last revealed that its COVID-19 vaccine works in babies, toddlers and preschoolers. The company said early study results showed tots develop high levels of virus-fighting antibodies from shots containing a quarter of the dose given to adults. But that key antibody finding isn't the whole story.
There were no severe illnesses during the trial but the vaccine was only about 44% effective at preventing milder infections in babies up to age 2, and nearly 38% effective in the preschoolers.
“The vaccine provides the same level of protection against COVID in young kids as it does in adults. We think that’s good news,” Dr. Stephen Hoge, Moderna’s president, told The Associated Press.
What still needs to happen?
Once Moderna and Pfizer submit the full data from their trials, the FDA will have to determine if youngsters are as protected against severe illness as adults.
If the FDA eventually authorizes vaccinations for little kids from either company, there still would be another hurdle. The Centers for Disease Control and Prevention recommends who should get them — and Goodman said there may be debate about shots for higher-risk children or everyone under 5.
Vaccinating the littlest “has been somewhat of a moving target over the last couple of months,” Dr. Bill Muller of Northwestern University, who is helping study Moderna's pediatric doses, 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.”
Why do health officials want to get children vaccinated?
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.
Would children be given the same size dose as adults?
The younger the child, the smaller the dose being tested.
Moderna enrolled about 6,900 kids under 6 — including babies as young as 6 months — in a study of the 25-microgram doses.
Competitor Pfizer currently offers kid-size 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.
What about side effects?
Parents may find it confusing that Moderna is seeking to vaccinate the youngest children before it's cleared to vaccinate teens. 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.
The FDA hasn't ruled on Moderna's earlier request to expand its shots to 12- to 17-year-olds 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.
But the CDC recently found the risk of myocarditis and other inflammatory syndromes was higher following infection from COVID than after Pfizer or Moderna vaccination in males and females ages 5 and older.
The company said 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. Hoge said he’s optimistic the company will be able to offer its vaccine “across all age groups in the United States by the summer.”
Moderna says its original adult dose — two 100-microgram shots — is safe and effective in 12- to 17-year-olds. For elementary school-age kids, it’s using half the adult dose.
About 1.5 million adolescents have used the Moderna vaccine in other countries, “and so far we've seen very reassuring safety from that experience," Hoge said.
The heart 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.
While the study wasn't large enough to detect very rare side effects, Moderna said the small doses were safe and that mild fevers, like those associated with other common pediatric vaccines, were the main reaction.
