The Perfect Enemy | FDA panel recommends COVID vaccines for kids as young as 6 months old
July 7, 2022

FDA panel recommends COVID vaccines for kids as young as 6 months old

FDA panel recommends COVID vaccines for kids as young as 6 months old  USA TODAYView Full Coverage on Google News

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America’s youngest children could soon have access to two COVID-19 vaccines.

An expert panel on Wednesday unanimously found Moderna’s vaccine safe for children 6 months to 6 years old, providing protection against COVID-19. The committee voted to support a Pfizer-BioNTech vaccine for children ages 6 months to 5 years. 

If its decisions are upheld by the Food and Drug Administration’s commissioner and the Centers for Disease Control and Prevention, vaccines will be available for young children as soon as Tuesday.

Although young children have largely been spared the worst of COVID-19, they can become seriously ill, and more than 200 have died from infections, according to data presented by the FDA.

Half of the young children hospitalized with COVID-19 did not have any preexisting conditions before they fell ill, the FDA said.

Because risks from COVID-19 infection in young children are relatively low, the risk of side effects from the vaccines must also be low to justify their use.

Committee members said they want to give parents the option to vaccinate their youngest children.

“We’ve got to be transparent about the real risks of COVID-19 for children. Tens of millions of children in this age group have been infected and have done just fine,” said Dr. James Hildreth Sr., CEO of Meharry Medical College in Nashville, Tennessee. “For those parents who choose to do so, especially those parents of kids that have underlying conditions, this is a choice they should have, and I’m pleased that they’ll have it.”

Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, Missouri, said he hopes the committee’s decision will help parents who have lived in fear of their child catching COVID-19. “This will certainly alleviate a lot of their concerns,” said Portnoy, the patient representative on the committee. “I think it was the right vote.”

Every other age group of Americans has long had access to the vaccines, except babies younger than 6 months old, who can get protection from the parent’s vaccination during pregnancy.

The committee voted almost 18 months ago to approve vaccines for adults, first from Pfizer, then from Moderna.

“Essentially all of the American population can now choose to get vaccine,” said Arnold Monto, an infectious disease epidemiologist at the University of Michigan in Ann Arbor, who chaired each of the meetings. 

The committee voted 21-0 that Moderna’s vaccine met the FDA’s criteria for safety and effectiveness in the youngest children and that its benefits outweigh its risks. It voted the same way to support the Pfizer-BioNTech vaccine.

Adding a layer of confusion for parents, Moderna studied its vaccine in two doses; Pfizer-BioNTech found three doses of its vaccine were needed to provide adequate protection during a wave of infections caused by the omicron variant of the coronavirus. 

Moderna recipients will probably need a third shot to receive protection against circulating variants, committee members, FDA staff and the company said, although the review covered only two doses.

Because the two vaccines were studied separately, they cannot be compared directly.

Committee members said they worry the Pfizer-BioNTech vaccine won’t provide much protection until after the third dose; Moderna’s shot may provide more protection faster.

Moderna’s shots are given four weeks apart, meaning a child could have some protection against infection and severe disease by midsummer. A child would have to wait until two doses of Pfizer-BioNTech’s vaccine three weeks apart and a third dose eight weeks later – roughly three months – to get protection.

Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said Pfizer-BioNTech may have chosen too low of a dose for young children. He said he’s worried parents will think their child is protected after two doses and will take fewer precautions to prevent COVID-19. 

Before either vaccine can be made available, the FDA commissioner must sign off on them, which he is likely to do almost immediately.

A second expert advisory panel, this time for the CDC, is scheduled to consider the vaccines Saturday. If the CDC director approves the shots, they are set to roll out Tuesday.

The Biden administration allowed preorders of up to 10 million vaccine doses for young children, half of Moderna and half of Pfizer-BioNTech, which would be made available at pediatricians’ offices, pharmacies, clinics, some libraries, children’s museums and other venues.

The government pre-purchased vaccines, so parents won’t have to pay for them.

Tuesday, parents are likely to have access to Moderna’s vaccine for older children. Until now, only Pfizer-BioNTech could be provided to children, but this week, the FDA advisory committee said the benefits of Moderna’s vaccine outweighed its risks. The FDA commissioner is likely to sign off on the vaccine and the CDC advisory committee to review it on Friday.

Vaccines available to children are the same as those for adults but in lower doses. 

Adults receive two 30 microgram doses of the Pfizer-BioNTech vaccine three weeks apart, followed by a booster at least five months later. Adolescents receive the same dose, children 5 to 11 receive three 10-microgram doses on the same schedule and children 6 months to 5 years would get three 3-microgram doses.

Adults receive two 100-microgram doses of the Moderna vaccine a month apart, followed by a 50-microgram booster at least six months later. Adolescents would have the same dose and schedule, once shots and boosters are authorized.

Children 6 to 11 would receive two 50-microgram initial doses and a 25-microgram booster, and younger children would receive two 25-microgram doses, followed by a 10-microgram booster. 

Committee members spent much of the question-and-answer period Wednesday trying to understand whether one COVID-19 vaccine is more effective in small children than the other, but they were frustrated by the lack of data.

Both vaccines appear to be safe. Short-term side effects such as fever and fatigue are fairly common, but there’s been no evidence of the more serious side effects seen rarely in adults: severe allergic reactions and myocarditis, a swelling of the heart muscle.

Like adults, young children generally had more side effects after a second dose, except if they had previously been infected with COVID-19, in which case they felt more effects from the first dose. Otherwise, there were no safety differences noted in children infected with COVID-19 before vaccination, and they appeared to have greater protection against the virus, based on their levels of protective antibodies. 

As the studies in small children were relatively small – 5,000 who received at least one dose of the active vaccine in Moderna’s trials and 3,000 in Pfizer-BioNTech’s – those rare side effects or others could turn up as more children are vaccinated.

As with adults and older children, it’s unclear how long COVID-19 vaccines will be protective or whether  boosters will be needed.

Both companies will continue to study the effects of their vaccines in young children, including those with immunocompromising health conditions.

Committee member Dr. Archana Chatterjee, a pediatric infectious disease specialist and dean of the Chicago Medical School, said the data analyzed by the FDA convinced her that both vaccines are safe and effective.

“As a pediatrician, today is a red-letter day for me,” Chatterjee said. “To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly virus is a very, very important thing.”

Contributing: Elizabeth Weise

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.