Pfizer asks FDA to clear updated COVID shot for kids under 5
Deborah Sampson, left, a nurse at a University of Washington Medical Center clinic in Seattle, gives a Pfizer COVID-19 vaccine shot to a 20-month-old child, June 21, 2022, in Seattle. Pfizer is asking US regulators to authorize its updated COVID-19 vaccine for children under age 5. 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, December 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. (AP Photo/Ted S Warren, file)

Pfizer is asking United States (US) regulators to authorise its updated COVID-19 vaccine for children under age five — not as a booster but part of their initial shots.

Children ages 6 months through four 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 it may help prevent severe illness and hospitalisation from COVID-19 in little kids, at a time when children’s hospitals already are packed with youngsters hit by other respiratory illnesses.

Few of the nation’s youngest children have gotten their COVID-19 vaccinations since the shots were OK’d in June: Just two per cent of tots under two and about four per cent of two- to four-year-olds have gotten their primary doses so far, according to the Centers for Disease Control and Prevention.

The FDA has authorised the new bivalent COVID-19 shots — versions made by Pfizer and rival Moderna — as a booster for everyone ages five and older. Those combination shots contain half the original vaccine and half tweaked to match the BA4 and BA5 omicron strains that until recently were dominant. Now BA5 descendants are responsible for most COVID-19 cases.

The CDC last month released the first real-world data showing that an updated booster, using either company’s version, does offer added protection to adults. The analysis found the greatest benefit was in people who’d never had a prior booster, just two doses of the original COVID-19 vaccine -- but that even those who’d had a summertime dose were more protected than if they’d skipped the newest shot

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