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Pfizer Asks FDA to Approve COVID Vaccine For Kids 5 and Under

Pfizer Asks FDA to Approve COVID Vaccine For Kids 5 and Under

The nation’s 19 million children under 5 are the only group not yet eligible for vaccinations against the coronavirus. Health experts contend that vaccinations are critical for opening schools and daycare centers and keeping them open, and for freeing up parents from child care duties so they can go back to work. Many parents have been pushing for an expansion of shots to toddlers and preschoolers, especially as the omicron wave sent record numbers of youngsters to the hospital.

Now Pfizer is seeking authorization of extra-low doses of its COVID-19 vaccine for children under 5, potentially opening the way for the very youngest Americans to start receiving shots as early as March. While young children are far less likely than adults to get severely ill from the coronavirus, it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic. While young children are far less likely than adults to get severely ill from the coronavirus, it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic.

In an extraordinary move, the Food and Drug Administration (FDA) had urged Pfizer and its partner BioNTech to apply earlier than the companies had planned, as the Biden administration has been trying to speed the authorization of COVID-19 shots for children.

If the FDA agrees, Pfizer shots containing just one-tenth of the dose given to adults could be dispensed to children as young as 6 months. The agency’s decision could come within weeks, but that isn’t the only hurdle. The Centers for Disease Control and Prevention also has to sign off.

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In December, Pfizer announced that children under 2 looked to be protected but that the antibody response was too low in 2- to 4-year-olds. It’s not clear why, but one possibility is that the extra-low dose was a little too low for the preschoolers. For kids under 5, Pfizer’s study is giving participants two shots three weeks apart, followed by a third dose at least two months later. The company is testing whether the youngsters produce antibody levels similar to those known to protect teens and young adults.

One lingering question is how many shots those youngsters will need. Pfizer is testing three shots after two of the extra-low doses turned out to be strong enough for babies but not for preschoolers, and the final data from the study isn’t expected until late March.

 

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