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FDA Expands Pfizer Booster Eligibility to Kids Ages 12 to 15

  • The Food and Drug Administration on Monday expanded eligibility for Pfizer and BioNTech booster shots to children ages 12 to 15 years old.
  • New Covid infections have hit a pandemic high in the U.S. as the highly contagious omicron variant has supplanted delta as the dominant strain.

The Food and Drug Administration on Monday expanded eligibility for Pfizer and BioNTech booster shots to children ages 12 to 15 years old, as school restarts after winter break amid a surge of Covid infections across the U.S.

The FDA also shortened the time between primary vaccination and the booster dose to at least five months, down from six months. The agency also authorized a third vaccine dose as part of the primary series of shots for children ages 5 through 11 who have compromised immune systems.

“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” Pfizer CEO Albert Bourla said in a statement.

“We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations,” Bourla said.

The FDA said no new safety concerns had emerged after evaluating real-world data from Israel on 6,300 kids ages 12 through 15 who received a Pfizer booster dose. There were no new cases in this age group of myocarditis or pericarditis, rare conditions in which heart tissue is inflamed or swells.

The FDA said peer-reviewed data from multiple laboratories demonstrates that Pfizer booster doses greatly improve an individual’s antibody response to the omicron variant. Allowing people to get booster doses a month sooner may provide better protection faster as omicron rapidly spreads, the agency said.

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