Advisors to the U.S. Food and Drug Administration are unanimously recommending that the COVID-19 vaccine be made available to children ages 6 months through 4 years of age.
On Wednesday, June 15, the Vaccine and Related Biological Products Advisory Committee voted 21-0 that the benefits of both the Pfizer/BioNTech and Moderna COVID-19 vaccine outweigh their risks in infants and children older than 6 months.
Moderna’s vaccine is currently recommended in two doses spaced four weeks apart, though there was discussion of eventually needing a third dose. Meanwhile, Pfizer’s shot is recommended in three doses, with the first two separated by three weeks and the third dose coming eight weeks later.
Both votes Wednesday followed a presentation from the vaccine developers, as well as a discussion from the independent vaccine experts who sit on the committee and a public comment period.
Now it’ll be up to the FDA to determine whether to expand authorization of the Pfizer and Moderna vaccines to the younger populations. Then the U.S. Centers for Disease Control and Prevention will go through a similar process before making the final judgement. The CDC’s advisory committee is scheduled to meet over the weekend.
Dr. Arnold Monto, chair of the committee, called the COVID-19 vaccines “nearly miraculous” and “highly effective at preventing severe disease.”
“I’m very delighted to have had the privilege of chairing these sessions and getting us these very, critically important vaccines. I just wish everybody would realize how well they work in preventing severe disease.”
Related: COVID vaccines for kids under 5 could be available this month
Moderna said its shot was 51% effective in preventing symptomatic infection in children 6 months to 2 year, and 37% effective in children 2 to 5 years old. Pfizer said its vaccine was 80% effective in children 6 months to 5 years of age in clinical trials, though it used a small sample size.
After Wednesday’s votes, a few committee members expressed concern that parents might stop short of the full recommended dosage of three shots, and have a false sense of security for their children. In clinical trials, three doses were needed for ideal protection.
“It does worry me that there was no protection after dose two, that was surprising,” said Dr. Paul Offit, who noted data from the third dose was more reassuring. “... For people who have gotten two doses of that vaccine, they have to know they’re not protected and they’re going to have to wait a few months until they are protected and I just wonder whether parents will understand that.”
Pfizer countered, indicating there was some protection against infection after two doses, and noting protection against severe illness is likely greater than the measured protection against infections.
Dr. Ofer Levy, a voting member, said he was pleased to reach the milestone, nearly 18 months after the first approval of a COVID-19 vaccine for older populations. He noted how far we’ve come in the pandemic, but said there’s more work to be done in combatting inequities and barriers to vaccine access.
The risk of severe illness from COVID-19 isn’t as high in children as it is in older individuals, however at least 442 children age 4 or younger have died from COVID, according to the CDC.
Full video of Wednesday’s committee meeting is available on YouTube, here.
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