Pfizer asks FDA to clear updated COVID shot for kids under 5

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Pfizer asks FDA to clear updated COVID shot for kids under 5
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Pfizer is asking U.S. regulators to authorize its updated COVID-19 vaccine for children under age 5 — not as a booster but part of their initial shots.

The youngest tots already are supposed to get three extra-small doses of the original vaccine as their primary series. Pfizer and its partner BioNTech said Monday, Dec. 5, 2022 that if the Food and Drug Administration agrees, the updated vaccine would be used for the third shot. The FDA already has cleared COVID-19 vaccines tweaked to better target omicron as boosters for everyone 5 and older.

Children ages 6 months through 4 years already are supposed to get three extra-small doses of the original Pfizer COVID-19 vaccine — each a tenth of the amount adults receive — as their primary series. If the Food and Drug Administration agrees, a dose of Pfizer's bivalent omicron-targeting vaccine would be substituted for their third shot.

Pfizer and its partner BioNTech said Monday that may help prevent severe illness and hospitalization from COVID-19 in little kids, at a time when children’s hospitals already are packed with youngsters hit by other respiratory illnesses.: Just 2% of tots under 2 and about 4% of 2- to 4-year-olds have gotten their primary doses so far, according to the Centers for Disease Control and Prevention.Those combination shots contain half the original vaccine and half tweaked to match the BA.4 and BA.

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