Pfizer asks FDA to allow COVID-19 vaccine for kids under 5

The nation’s 19 million children under 5 are the only group not yet eligible for vaccination against the coronavirus. 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.

An open question is how many shots those youngsters will need. Two of the extra-low doses turned out to be strong enough for babies but not for preschoolers in early testing. Pfizer is testing three shots, and the final data is expected in late March. The question of how long to wait for new vaccine data — and how much to require — is a concern for FDA regulators, who face pressure to be more proactive against a virus that has repeatedly confounded health experts.

The FDA’s ultimate decision could come within the month but that isn’t the only hurdle. The Centers for Disease Control and Prevention also has to sign off. 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 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.

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