America’s youngest children may soon have access to two COVID-19 vaccines.
A panel of experts on Wednesday unanimously found that Moderna’s vaccine is safe for children ages 6 months to 6 years, providing protection against COVID-19. The committee voted in favor of a Pfizer-BioNTech vaccine for children ages 6 months to 5 years.
If their decisions are confirmed by the commissioner of the Food and Drug Administration and the Centers for Disease Control and Prevention, the vaccines will be available for young children beginning 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 released by the FDA.
Half of the young children hospitalized with COVID-19 did not have any pre-existing conditions before they became ill, the FDA said.
Because the risks of COVID-19 infection in young children are relatively low, the risk of side effects from 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 need to be transparent about the real risks of COVID-19 to children. Tens of millions of children in this age group have been infected and doing well,” said Dr. James Hildreth Sr., CEO of Meharry. Medical. University in Nashville, Tennessee. “For those parents who choose to do so, especially those parents of children who have underlying conditions, this is an option they should have, and I’m glad they do.”
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 children contracting COVID-19. “This will certainly alleviate a lot of his concerns,” said Portnoy, a patient representative on the committee. “I think it was the right vote.”
All other age groups of Americans have long had access to vaccines, except for infants younger than 6 months, who can gain protection from parental vaccination during pregnancy.
The committee voted nearly 18 months ago to approve vaccines for adults, first from Pfizer and then from Moderna.
“Essentially, the entire American population can now choose to be vaccinated,” 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 FDA criteria for safety and efficacy in younger children and that its benefits outweigh its risks. He voted the same way to support the Pfizer-BioNTech vaccine.
Adding a layer of confusion for parents, Moderna studied its two-dose vaccine; Pfizer-BioNTech found that 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 likely need a third injection to receive protection against circulating variants, committee members, FDA staff and the company said, though the review covered only two doses.
Because the two vaccines were studied separately, they cannot be directly compared.
Committee members said they are concerned that the Pfizer-BioNTech vaccine may not provide much protection until after the third dose; Moderna’s shot can provide more protection faster.
Moderna’s injections are given four weeks apart, which means a child might have some protection against serious infections and illnesses in mid-summer. A child would have to wait until two doses of the Pfizer-BioNTech vaccine three weeks apart and a third dose eight weeks later, about three months, to gain protection.
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said Pfizer-BioNTech may have chosen too low a dose for young children. He said he is concerned that parents will think their child is protected after two doses and will take fewer precautions to prevent COVID-19.
Before any of the vaccines are available, the FDA commissioner must approve them, which he likely will do almost immediately.
A second expert advisory panel, this time from the CDC, is scheduled to consider the vaccines on Saturday. If the CDC director approves the vaccines, they will be rolled out on Tuesday.
The Biden administration allowed pre-orders for up to 10 million doses of vaccines for young children, half from Moderna and half from Pfizer-BioNTech, which would be available at pediatricians’ offices, pharmacies, clinics, some libraries, children’s museums and other places. .
The government pre-purchased the vaccines so that parents did not have to pay for them.
On Tuesday, parents will likely have access to Moderna’s vaccine for older children. Until now, it could only be provided to children by Pfizer-BioNTech, but this week the FDA advisory committee said the benefits of Moderna’s vaccine outweighed its risks. The FDA commissioner is likely to approve the vaccine and the CDC advisory committee will review it on Friday.
The vaccines available for children are the same as 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 years of age would receive three 10-microgram doses at the same time, and children 6 months to 5 years would receive three 3-microgram doses.
Adults receive two 100 microgram doses of the Moderna vaccine one month apart, followed by a 50 microgram booster at least six months later. Teens would get the same dose and schedule, once shots and boosters are authorized.
Children aged 6 to 11 years would receive two initial 50-microgram 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 Wednesday’s question-and-answer period trying to understand whether one COVID-19 vaccine is more effective in young children than another, but were frustrated by a lack of data.
Both vaccines appear to be safe. Short-term side effects, such as fever and fatigue, are quite common, but there has been no evidence of the more serious side effects that are rarely seen in adults: severe allergic reactions and myocarditis, an inflammation 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 had more side effects from the first dose. Otherwise, no safety differences were observed 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.
Because the studies in young children were relatively small: 5,000 who received at least one dose of active vaccine in the Moderna trials and 3,000 in the Pfizer-BioNTech trials: Those rare or other side effects could appear as more children are vaccinated.
As with adults and older children, it’s unclear how long vaccines will protect against COVID-19 or if boosters will be needed.
Both companies will continue to study the effects of their vaccines on young children, including those with immunocompromised health conditions.
Committee member Dr. Archana Chatterjee, a pediatric infectious disease specialist and dean of Chicago Medical School, said the data reviewed by the FDA convinced her that both vaccines are safe and effective.
“As a pediatrician, today is a special day for me,” Chatterjee said. “Being able to vote to authorize two vaccines that will protect children up to 6 months of age against this deadly virus is a very, very important thing.”
Collaboration: Elizabeth Weise
Contact Karen Weintraub at kweintraub@usatoday.com.
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