FDA advisers endorse 1st COVID-19 vaccine for children younger than 5
The Food and Drug Administration’s vaccine advisers gave a thumbs-up to COVID-19 vaccines from Moderna and Pfizer for infants, toddlers and preschoolers.
Outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5 — That’s roughly 18 million youngsters in the last age group in the U.S. without access to COVID- 19 vaccines.
If all the regulatory steps are cleared, shots should be available next week.
“There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them a choice to have the vaccine if they want to,” said one panel member, Dr. Jay Portnoy, of Children’s Hospital in Kansas City, Mo.
Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge’’ in young children’s hospitalizations during the omicron wave and noted 442 children under 4 died during the pandemic. That’s far fewer than adult deaths but should not be dismissed in considering the need for vaccinating the youngest kids, he said.
FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the meeting. Side effects, including fever and fatigue, were generally minor in both and less common than seen in adults.
If the FDA authorizes the shots, the Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers vote on Saturday. If the CDC signs off, shots could be available as soon as Monday or Tuesday at doctor’s offices, hospitals and pharmacies.
Pfizer’s vaccine is for children 6 months through 4 years; Moderna’s vaccine is for 6 months through 5 years.
Moderna’s shots are onequarter the dose of the company’s adult shots. Two doses appeared strong enough to prevent severe illness but only about 40% to 50% effective at preventing milder infections.
Pfizer’s shots are onetenth its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added.
Pfizer’s submitted data found no safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But that was based on 10 COVID19 cases; the calculation could change as more cases occur in the company’s ongoing studies.
Several advisers, noting that protection is low after two Pfizer doses, worried that some parents might end up skipping the third shot, or mistakenly think their kids are better protected between shots, leaving them vulnerable.
Educating parents must be done “very carefully so that they are not misled about what the vaccines actually provide,’’ said Dr. Archana Chatterjee of Rosalind Franklin University.
The same FDA panel on Tuesday backed Moderna’s half-sized shots for ages 6 to 11 and full-sized doses for teens. If authorized by the FDA, it would be the second option for those age groups. Currently, the Pfizer vaccine is their only choice.
The nation’s vaccination campaign started in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents first in line. Teens and school-age children were added last year.
In the U.S., it remains uncertain how many parents want their youngest vaccinated. By some estimates, three-quarters of all children have already been infected. And only about 29% of children ages 5 to 11 have been vaccinated since Pfizer’s shots opened to them last November, a rate far lower than public health authori