FDA Posts Analysis of Pfizer Shots for Kids Under 5

Says the kid-sized dose appears to be safe and effective
By Newser Editors and Wire Services
Posted Jun 11, 2022 11:30 AM CDT
Updated Jun 13, 2022 12:00 AM CDT
Moderna, Pfizer to Lobby Next Week for Shots for Kids Under 5
Stock photo.   (Getty Images/Maksym Belchenko)

(Newser) Update: The FDA on Sunday posted its analysis of Pfizer’s COVID-19 vaccine for children under age 5, announcing that the kid-sized doses do appear to be safe and effective. The agency posted a similar analysis of Moderna's vaccine for the youngest age group last week. Next up: Wednesday's meeting, when votes will be held, the AP reports. Our original story from Saturday follows:

Parents anxious to finally vaccinate their youngest children against COVID-19, strap in: A lot is set to happen over the next week. On Wednesday, both Moderna and Pfizer will have to convince what's essentially a science court—advisers to the Food and Drug Administration—that their shots work well in babies, toddlers, and preschoolers. The FDA weighed in late Friday with its own analysis of Moderna's vaccine, finding the shots appear safe and effective for children as young as 6 months old, per the AP. A federal review of Pfizer's vaccine for the littlest kids is expected by Monday. Kids under 5 are the only group not yet eligible for COVID-19 vaccination in the US.

If the FDA's advisers endorse one or both shots for them—and the FDA agrees—there's still another hurdle. The CDC must recommend whether all tots need immunization or just those at high risk from the virus. Adding to the complexity, each company is offering different dose sizes and number of shots. And the week won't even start with the littlest kid debate: Moderna first will ask FDA's advisers to support its vaccine for older children. Pfizer's COVID-19 vaccine is the only type the FDA allows for children of any age. Two doses plus a booster are cleared for everyone 5 and older. Shots for the 5- to 11-year-olds contain a third of the dose given to teens and adults. For kids younger than 5, Pfizer and its partner BioNTech lowered the dose even more, to 1/10th of the adult dose. The trade-off is a need for three shots—the first two given three weeks apart, and the last at least two months later.

Moderna is seeking FDA clearance for two shots, each a quarter of its adult dose, given about four weeks apart for kids younger than 6. (Moderna tested a slightly different age limit than Pfizer.) If the FDA authorizes one or both shots—a decision expected shortly after its advisory panel's meeting—all eyes move to the CDC. That agency recommends how to use vaccines. Which tots should get COVID-19 vaccination will be an important debate as the coronavirus doesn't tend to make children as sick as adults, yet nearly 500 deaths in US children under 5 have been reported. The CDC's own vaccine advisers are scheduled to meet next Friday and Saturday, and a final decision by the CDC's director, Dr. Rochelle Walensky, should come shortly after they're done. If all those steps fall into place, vaccinations could begin in many areas June 21. Much more here for parents of small kids.

(Read more coronavirus vaccine stories.)

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