U.S. regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week, but one thing still needs to happen first.
Parents have been pressing federal officials for months for the opportunity to protect their smallest children as more adults shed masks and abandon other public health precautions.
The nation’s 18 million children under 5 were the only age group not yet eligible for vaccination.
Here's what we know so far.
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Which vaccines are now authorized for children under 5?
The Food and Drug Administration on Friday authorized shots from both Moderna and Pfizer. That means U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots, about 1 1/2 years after the vaccines first became available in the U.S. for adults, who have been hit the hardest during the pandemic.
The vaccines are for children as young as 6 months.
The FDA also authorized Moderna's vaccine for school-aged children and teens. Pfizer's shots had previously been the only ones available for those ages.
Moderna next plans to study its shots for babies as young as 3-months-old. Pfizer has not finalized plans for shots in younger infants. A dozen countries, including China, already vaccinate kids under 5.
What still needs to happen before shots can begin and when are they expected?
There's one step left: The Centers for Disease Control and Prevention recommends how to use vaccines and its vaccine advisers are set to discuss the shots for the youngest kids Friday and vote on Saturday. A final signoff would come from CDC Director Dr. Rochelle Walensky.
At a Senate hearing Thursday, Walensky said her staff was working over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.”
For weeks, the Biden administration has been preparing to roll out the vaccines. States, tribes, community health centers and pharmacies preordered millions of doses. FDA's emergency use authorization allows manufacturers to begin shipping vaccine across the country. Vaccinations could begin as early as Monday or Tuesday.
How effective are the vaccines in children?
In a study of kids ages 6 months through 5 years, two Moderna shots — each a quarter of the regular dose — triggered high levels of virus-fighting antibodies, the same amount proven to protect young adults, the company said. There were no serious side effects, and the shots triggered fewer fevers than other routine vaccinations.
But the vaccine proved between about 40% and 50% effective at preventing symptomatic COVID-19 during the trial. The company blamed the omicron variant's ability to partially evade vaccine immunity, noting that unboosted adults showed similarly less effectiveness against milder omicron infections. While no children became severely ill during the study, Moderna noted high antibody levels are a proxy for protection against more serious illness — and the company will test a child booster dose.
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.
At the same time, preliminary data suggested Pfizer and its partner BioNTech's three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.
“The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” he said in a statement.
Federal health officials said Sunday that kid-sized doses of Pfizer’s COVID-19 vaccines appear to be safe and effective for kids under 5. Late last week the FDA posted a similar analysis of Moderna’s shots for children under 6.
The FDA said children who received Pfizer’s shots during testing developed high levels of virus-fighting antibodies expected to protect them against coronavirus. That’s the basic threshold needed to win FDA authorization. But additional testing turned up key differences, with stronger results for Pfizer.
Why do health officials want to get children vaccinated?
While young children generally don’t get as sick from COVID-19 as older kids and adults, their hospitalizations surged during the omicron wave and FDA’s advisers determined that benefits from vaccination outweighed the minimal risks.
Walensky said pediatric deaths from COVID-19 have been higher than what is generally seen from the flu each year.
“So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said.
Would children be given the same size dose as adults?
The two brands use the same technology but there are differences.
Pfizer's vaccine for kids younger than 5 is one-tenth of the adult dose. Three shots are needed: the first two given three weeks apart and the last at least two months later.
Moderna's is two shots, each a quarter of its adult dose, given about four weeks apart for kids under 6.
What about side effects?
Studies from Moderna and Pfizer showed side effects, including fever and fatigue, were mostly minor.
Heart inflammation sometimes occurs in teens and young adults, mostly males, after receiving either the Pfizer or Moderna vaccines.
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.
Moderna previously said that, armed with additional evidence, it was updating its FDA application for teen shots and requesting a green light for 6- to 11-year-olds, too. Dr. Stephen Hoge, Moderna’s president, 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.
