On Tuesday, the Food and Drug Administration (“FDA”) authorized the use of a single booster dose of the COVID-19 vaccine produced by Pfizer-BioNTech for children ages 5 through 11.
FDA Commissioner Dr. Robert M. Califf said: “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.” Califf said that the authorization for the single dose in the youngest children eligible for the vaccine provides “continued protection against COVID-19,” adding that “vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences… and it is safe.”
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.
Last October, federal regulators first authorized use of the vaccine for children between 5 and 11; and late last month, a second booster shot of either the Pfizer-BioNTech or Moderna vaccine was approved for those 50 and older.
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