Key FDA Panel Recommends COVID-19 Vaccines for Kids Under 5

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  • A key FDA advisory panel has voted to recommend both Pfizer/BioNTech and Moderna COIVD-19 vaccines for children agessix months to 5 years.
  • The vote was unanimous.
  • Children under age five are the only age group with no access to COVID-19 vaccines.

The independent vaccine advisory committee for the Food and Drug Administration (FDA) voted June 15 to recommend emergency authorization of COVID-19 vaccines for infants and children as young as six months.

After a full day of presentations and discussions, the 21-member committee voted unanimously in favor of the two-dose Moderna vaccine for children ages 6 months through 5 years.

It also voted unanimously in favor of the three-dose Pfizer-BioNTech vaccine for children ages 6 months through 4 years.

What happens next?

The FDA will now decide whether to authorize the vaccines for these age groups. The agency is not obligated to follow the committee’s recommendation, but it generally does.

After that, a vaccine advisory panel for the Centers for Disease Control and Prevention will meet on June 17 and 18 to vote on these vaccines.

If the CDC’s panel recommends the use of these vaccines in younger children, CDC director Dr. Rochelle Walensky needs to sign off before the vaccines will be available to the public.

The federal government plans to immediately launch the rollout as soon as the vaccines are authorized. So doses could be available as soon as June 20 at pediatrician’s offices and certain pharmacies.

However, some pediatricians’ offices will be closed on that Monday to observe Juneteenth.

Parents can find a vaccination site by checking with their pediatrician’s office, local pharmacy, or online at Vaccines.gov.

Committee emphasizes parent choice on vaccination

The FDA’s Dr. Peter Marks opened the meeting by highlighting the impact that COVID-19 has had on younger children.

Although children are less likely than adults to have severe illness due to coronavirus infection, hospitalizations spiked among this age group during the Omicron wave, Marks noted.

In addition, as of June 2, 442 children under the age of 5 in the United States have died of COVID-19, according to data presented at the meeting.

“We have to be careful we don’t become numb” to pediatric deaths due to COVID-19 just because they are outnumbered by deaths in older adults, Marks said.

Several committee members welcomed the vote to authorize these vaccines for younger children but emphasized the need to clearly communicate to the public the benefits and risks of the vaccines.

“Families will now have a choice that they did not have before,” said committee member Dr. Michael Nelson of the University of Virginia School of Medicine.

“I fully believe in the intelligence of families to make the right choice for their family and children,” he added, “particularly when we provide clear recommendations with respect to the information we have on hand regarding the risks and benefits.”

Committee chair Dr. Arnold Monto of the University of Michigan said rolling out two vaccines with different regimens will be challenging.

One danger is that parents who choose the Pfizer-BioNTech vaccine may not bring their children in for their third dose.

Dr. Paul Offit of The Children’s Hospital of Philadelphia said during the meeting that data presented by the companies showed that the protection offered by two doses is insufficient against Omicron.

Parents should know that their child is not fully protected until they have had the third dose, he added.

Pfizer-BioNTech’s vaccine

The Pfizer-BioNTech COVID-19 vaccine is currently available as a two-dose primary series for most Americans 5 years and older — or three doses for some people with a weakened immune system. It is also available as a booster for these age groups.

In May, the companies submitted a request to the FDA to expand this use to infants and children 6 months through 4 years of age.

This would be a three-dose primary series at one-tenth the strength of the adult dosage. The first two doses are given three weeks apart, with a third dose at least eight weeks after the second.

According to a briefing document prepared by the FDA for the meeting, studies conducted by the companies showed that the three-dose regimen generated an immune response similar to what was seen in people 16 to 25 years old who received two doses.

FDA scientists estimated the vaccine efficacy against infection for children 6 to 23 months as 75.6 percent and 82.4 percent in children 2 to 4 years of age.

All coronavirus cases in the studies occurred while the Omicron variant was dominant in the United States.

The FDA’s Dr. Susan Wollersheim said during the meeting that because of the small number of coronavirus cases that occurred after the third dose — due to the short follow-up period — these efficacy estimates should be viewed with caution.

A longer follow-up period should give a better estimate of the efficacy, something the companies already plan on doing.

Given that the immune responses after three doses is similar to that seen in older age groups, Pfizer’s Dr. William Gruber said during the meeting that he is confident that three doses will offer strong protection against Omicron in younger children.

Data from the studies also showed that the vaccine was safe in younger children, with most side effects mild to moderate, according to the document.

The most common side effects in children 6 to 23 months of age were irritability, drowsiness, decreased appetite, and tenderness at the injection site.

In children 2 to 4 years of age, the most common side effects were pain or redness at the injection site and fatigue.

There were no reports of heart inflammation (myocarditis or pericarditis), no cases of an allergic reaction (anaphylaxis) related to vaccination, and no deaths.

Because myocarditis and pericarditis after COVID-19 vaccination are rare, additional monitoring will be needed after approval of the vaccine to know if this side effect occurs in younger children.

In addition, due to the limited length of the study, it is not clear how long the protection offered by three doses will last.

But given what has occurred in adults after two doses, the FDA said in the document that “it is likely that a booster dose will be needed in addition to the three-dose primary series.”

Moderna’s vaccine

Moderna’s COVID-19 vaccine is available to people 18 years and older and as a booster for that age group.

On June 14, the FDA vaccine advisory committee voted to recommend authorization of the Moderna COVID-19 vaccine for 6- to 17-year-olds. This use will also require approval from the FDA and CDC.

On June 15, the FDA vaccine advisory committee reviewed data from Moderna for its two-dose COVID-19 vaccine for children 6 months through 5 years.

The doses for this age group are one-quarter the strength of the adult dose and are given four weeks apart.

Studies showed that the Moderna COVID-19 vaccine generated a favorable immune response, similar to what was seen in young adults, according to an FDA briefing document prepared for the meeting.

The vaccine had an estimated efficacy against infection of 36.8 percent in children 2 to 5 years of age and 50.6 percent in children 6 to 23 months of age. These results come from a time when Omicron was the dominant variant.

This efficacy was similar to that of two doses of the Moderna vaccine in adults during the Omicron wave, according to the document.

The data presented at the meeting also showed that the Moderna vaccine was safe in younger children.

Side effects were “mostly mild to moderate in severity, generally of short duration,” and occurred more commonly after the second dose than the first, according to the document.

The most common side effect across all pediatric age groups was pain at the injection site.

Fever occurred in about a quarter of vaccinated children, more commonly after dose two. High fevers were rare.

In children 6 to 36 months of age, irritability, crying, and sleepiness were frequently reported. In older children, fatigue and headaches were frequently reported.

There were no cases of myocarditis or pericarditis associated with the vaccine. Additional follow-up will be needed to confirm whether this rare side effect occurs in younger children.

No deaths were reported.

Moderna will continue to follow children enrolled in the study and will offer them a booster dose of the current vaccine or a newer one that is tailored to Omicron.

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