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With federal regulators set to decide whether or not they plan to allow COVID vaccines for children under 5 this month, when could parents expect the shots? begin ?

Families have been lucky enough to protect the nation’s smallest children as the highly contagious omicron subvariants continue to spread.

The country’s 18 million children under 5 are the only age group not yet eligible for vaccination.

As the race is on to get the youngest members of the population vaccinated, which vaccine will work best and when might it be approved?

Here’s what we know so far.

What vaccines are being approved for children under 5 and where are they at?

The Food and Drug Administration’s group of outside advisers will meet June 14-15 to evaluate Pfizer’s and Moderna’s vaccines for young children.

Moderna has asked US regulators to allow low doses of its COVID-19 vaccine for children under the age of 6.

Moderna submitted data to the Food and Drug Administration in April that it hopes will prove that two low-dose injections can protect babies, toddlers and preschoolers — but not as effectively during the omicron push only at the start of the pandemic.

“There is a significant unmet medical need here with these younger children,” Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two injections for children “will protect them safely. I think it is likely that over time they will need additional doses. But we are working on it.

Currently, Pfizer’s COVID vaccine is the only one approved for emergency use in the United States for children ages 5 to 17.

The vaccine competitor also recently announced that three doses of its COVID-19 vaccine provide strong protection for children under 5 years old.

Pfizer had a harder time understanding his approach. He aims to give toddlers an even lower dose – just a tenth of the amount adults get – but found during his trial that two shots didn’t seem strong enough for preschoolers. The researchers therefore gave a third injection to more than 1,600 young people – aged between 6 months and 4 years – during the winter surge of the omicron variant.

In a press release, Pfizer and partner BioNTech said the extra dose did the trick, boosting anti-virus antibody levels enough to meet FDA criteria for safe emergency use of the vaccine. of security.

What else needs to happen before shooting can begin and when are they expected?

The FDA will publicly debate the evidence with its scientific advisors before making a decision.

If the FDA allows vaccinations for toddlers, the Centers for Disease Control and Prevention should then recommend who needs them — all toddlers or just those at higher risk for COVID-19.

Chicago Department of Public Health Commissioner Dr. Allison Arwady said she expects the FDA to be able to pave the way for injections to begin this summer.

“I currently assume it will be June when we potentially have a vaccine available for these younger children,” she said during a Facebook Live. “But it all depends on the advice of the FDA and the CDC and its outside experts.”

The Biden administration said Thursday that children under age 5 could receive their first doses of the COVID-19 vaccine as early as June 21, if federal regulators allow shots for the age group, as planned.

White House COVID-19 coordinator Ashish Jha said shipments to doctors’ offices and pediatric care facilities would begin shortly after FDA clearance, with the first hits possible the following week.

Jha said states can begin placing orders for pediatric vaccines on Friday, and said the administration has an initial supply of 10 million doses available. He said it could take a few days for vaccines to arrive across the country and for vaccine appointments to become widespread.

How effective are vaccines in children?

Whether it’s one company’s vaccines or both, FDA vaccine chief Dr. Peter Marks said the agency “will move quickly without sacrificing our standards” in deciding whether early doses are safe and effective.

“It’s extremely important that we have the right evaluation so that parents have confidence in all the vaccines that we authorize,” Marks told a Senate committee.

Earlier this year, the FDA, concerned about the toll of the omicron variant on children, took the extraordinary step of urging Pfizer to seek approval of the ultra-low-dose vaccine before it was clear whether all- little ones will need two or three injections. The agency’s plan could have allowed vaccinations to begin within weeks.

But in February, the FDA backtracked and said it had become clear the agency should await data on the effectiveness of a third vaccine for the youngest age group. Pfizer said in a statement at the time that it expected the data in early April.

Marks said he hoped parents would understand the agency’s decision was part of its careful scientific review of the evidence presented by Pfizer so far.

This information “made us realize that we needed to see data from a third dose of the ongoing trial in order to make a decision,” Marks told reporters. “We take our responsibility to review these vaccines very seriously because we are also parents.”

In a study of children aged 6 months to 5 years, two injections of Moderna – each representing a quarter of the usual dose – triggered high levels of anti-virus antibodies, the same amount proven to protect young adults. , Burton said. There were no serious side effects and the injections triggered less fever than other routine vaccinations.

But the vaccine was found to be between about 40% and 50% effective in preventing symptomatic COVID-19 during the trial. Burton blamed the omicron variant’s ability to partially evade vaccine immunity, noting that unboosted adults similarly showed less efficacy against milder omicron infections. Although no children became seriously ill during the study, he said high antibody levels are an indicator of protection against more serious illnesses – 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.

Meanwhile, preliminary data suggests that the three-dose series from Pfizer and its partner BioNTech is 80% effective in preventing symptomatic COVID-19, the companies said, but cautioned that the calculation is based on only 10 cases diagnosed among study participants by end. From April. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer has promised an update as soon as more data becomes available.

“The study suggests that a low dose of 3 micrograms of our vaccine, carefully selected based on safety data, provides young children with a high level of protection against recent strains of COVID-19,” he said. he said in a statement.

Why do health officials want children vaccinated?

Although COVID-19 is generally not as dangerous in young people as it is in adults, some become seriously ill or even die. About 475 children under the age of 5 have died of COVID-19 since the pandemic began, according to the CDC, and hospitalizations of children have soared at omicron’s peak.

Still, it’s unclear how many parents intend to vaccinate younger children. Less than a third of children aged 5 to 11 have received two vaccines, and 58% of those aged 12 to 17.

Would children receive the same dose as adults?

The younger the child, the smaller the dose tested.

Moderna enrolled about 6,900 children under the age of 6 — including babies as young as 6 months old — in a study on the 25-microgram doses.

Competitor Pfizer currently offers children’s doses for school-aged children and full-strength injections for ages 12 and older. The company is testing even lower doses for children under 5.

What about side effects?

Parents may find it confusing that Moderna seeks to vaccinate younger children before it is allowed to vaccinate teenagers. While other countries have already authorized the use of Moderna’s vaccines in children as young as 6 years old, the United States has limited their vaccine to adults.

The FDA has not acted on Moderna’s earlier request to expand its vaccines to ages 12 to 17 due to concerns about a very rare side effect, heart inflammation.

Cardiac inflammation sometimes occurs in adolescents and young adults, mostly men, after receiving Pfizer or Moderna vaccines. Moderna comes under more scrutiny because its injections are at a much higher dose than Pfizer’s.

But the CDC recently found that the risk of myocarditis and other inflammatory syndromes was higher after COVID infection than after a Pfizer or Moderna vaccination in men and women ages 5 and older.

The company said that, armed with additional evidence, it is updating its FDA submission for teen injections and also seeking a green light for children ages 6 to 11. Dr Stephen Hoge, president of Moderna, said he was optimistic the company would be able to offer its vaccine “to all age groups in the United States by summer”.

Moderna says its original adult dose — two 100-microgram injections — is safe and effective in ages 12 to 17. For children of primary school age, it uses half the adult dose.

About 1.5 million teenagers have used the Moderna vaccine in other countries, “and so far we’ve seen very reassuring safety from that experience,” Hoge said.

Cardiac risk also appears to be linked to puberty, and regulators in Canada, Europe and elsewhere have recently extended Moderna vaccinations to children as young as 6 years old.

“This concern has not been observed in young children,” said Muller of Northwestern.

Although the study was not large enough to detect very rare side effects, Moderna said the small doses were safe and mild fevers, like those associated with other common childhood vaccines, were the main reaction.

NBC Chicago

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