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FDA authorizes single booster dose of COVID-19 vaccine for ages 5 through 11

By Rich Klein & Darryl Coote
FDA authorizes single booster dose of COVID-19 vaccine for ages 5 through 11
An Israeli healthcare worker administers a Pfizer-BioNTech COVID-19 vaccine to a boy in Israel in December. On Tuesday, the U.S. Food and Drug Administration authorized the use of a single booster of that vaccine to children ages 5 to 11. File Photo by Debbie Hill/UPI | License Photo

May 17 (UPI) -- The Food and Drug Administration on Tuesday authorized the use of a single booster dose of the COVID-19 vaccine produced by Pfizer-BioNTech for children ages 5 through 11.

"While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease," said FDA Commissioner Dr. Robert M. Califf.

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Califf said that the authorization for the single dose in the youngest children eligible for the vaccine provides "continued protection against COVID-19."

He added that "vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences... and it is safe."

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Pfizer in late April asked the FDA for the emergency authorization to cover booster shots for children 5 to 11.

Earlier that month, Pfizer and BioNTech released clinical trial data from 140 children between the ages of 5 and 11 who had received a booster shot showing a six-fold increase in neutralizing antibodies against COVID-19.

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The federal regulators last October first authorized use of the vaccine for children between 5 and 11 while late last month approving a second booster shot of either the Pfizer-BioNTech or Moderna vaccine for those 50 and older.

A study released by Pfizer on Monday showed that the Pfizer-BioNTech vaccine prevented more than 110,000 deaths and 690,000 hospitalizations in the U.S. during 2021.

RELATED Pfizer asks FDA to authorize COVID-19 booster shots for children 5-11

RELATED Pfizer says it will ask FDA to authorize COVID-19 boosters for kids 5-11

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