America’s youngest children could soon have access to a COVID-19 vaccine made by Moderna.
An expert panel on Wednesday unanimously found Moderna’s vaccine safe for children ages 6 months to 6 years old and provided protection against COVID-19. The committee is scheduled to vote on a Pfizer-BioNTech vaccine for a similar age group later in the afternoon.
If its decision is upheld by the Food and Drug Administration’s commissioner and then 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 worse of COVID-19, they can still become seriously ill and more than 200 have died from their infections, according to data presented by the Food and Drug Administration.
Half of the young children hospitalized with COVID-19 did not have any pre-existing 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 vaccine 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, Nashville. “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, who is 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 by vaccination during pregnancy.
Moderna’s vaccine met the FDA’s criteria for safety and effectiveness and its benefits outweigh its risks, the committee decided 21-0.
Adding a layer of confusion for parents, Moderna studied its vaccine in two doses, while Pfizer-BioNTech found three doses of its vaccine were needed to provide adequate protection during the omicron wave.
Modern recipients will likely need a third shot to receive protection against currently circulating variants, committee members, FDA staff and the company said, although the current review includes only two doses.
Because the two vaccines were studied separately, they cannot be compared directly.
Before either vaccine can be made available, the FDA commissioner must sign off on them, which he is expected to do almost immediately.
A second expert advisory panel, this time for the CDC, is scheduled to consider the same vaccines on Saturday. If the CDC director then approves of the shots, they are set to roll out Tuesday.
The Biden administration has already allowed pre-orders of up to 10 million vaccine doses for young children, half of Moderna and half of Pfizer-BioNTech, which will be made available beginning Tuesday at pediatricians offices as well as pharmacies, clinics and some libraries, children’s museums and other venues.
The government has pre-purchased vaccines, so parents won’t have to pay for them.
Also beginning Tuesday, parents are expected 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 expected 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.
For the Pfizer-BioNTech vaccine, adults receive two 30 microgram doses three weeks apart followed by a booster at least five months later. Adolescents receive the same dose, while 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.
For the Moderna vaccine, adults receive two 100-microgram doses 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 eventually 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 if one COVID-19 vaccine is more effective in small children than the other – but ultimately they were frustrated by the lack of data.
Both vaccines appear to be safe, with short-term side effects like fever and fatigue fairly common, but no evidence of the more serious side effects seen rarely in adults: severe allergic reactions and myocarditis, a swelling of the heart muscle.
As with adults, young children generally had more side effects after the second dose, except if they had previously been infected with COVID-19, when they felt more effects from the first dose. Otherwise, there were no safety differences noted between 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 still 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 more boosters will be needed.
Contributing: Elizabeth Weise
Contact Karen Weintraub at [email protected].
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.
George is Digismak’s reported cum editor with 13 years of experience in Journalism