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The Food and Drug Administration on Tuesday approved the first COVID-19 vaccine booster for children ages 5 to 11.
The approval qualifies all children of that age who received their second shot at least five months ago to receive the third shot of the Pfizer-BioNTech vaccine.
The agencies requested approval on the basis of a small study that the agencies and the FDA said was safe and that a third shot could significantly increase antibody levels, lower immunity, and provide additional protection against viruses, including more contagious omikron variants.
So far, only children and adults 12 years of age or older were eligible for the booster.
“While it has happened in most cases that Kovid-19 tends to be less severe in children than in adults, Omicron Wave has seen more children being hospitalized with the disease and children may experience long-term effects, even mild disease followed initially,” he said. FDA Commissioner Robert M. Calif. In a statement.
“The FDA approves the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years of age to provide continued protection against COVID-19,” said Calif. “The vaccine continues to be the most effective way to prevent COVID-19 and its deadly consequences, and it is safe.”
It is unknown at this time what he will do after leaving the post. Less than a third of children aged 5 to 11 have been fully vaccinated, and only a quarter of adolescents have received a booster.
Many doctors and parents are hoping for approval, saying it is important to protect children as much as possible, especially since the number of people infected with the virus is rising again and very few people are now wearing masks.
“Since the vaccine was approved for children under 5 years of age in October 2021, emerging data suggest that vaccines against COVID-19 will be less effective after the second dose of the vaccine is given to all approved populations,” said Peter Marks, director of the FDA’s Center for Biological Evaluation and For research, in a statement.
“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-Bioentech COVID-19 vaccine at least five months after the completion of the initial series are known to children 5 to 11 years of age and outweigh the potential risks. Can help provide endless protection against -19, “said Marx.
Others, however, are skeptical, saying the two shots still provide strong protection against serious illness and death, and it is not yet clear how much extra protection the third shot will provide or how long it will last.
The FDA did not ask its outside advisers for input into the decision because the agency said the committee had discussed these issues before and no new questions had been raised.
Vaccine practice advisers at the Centers for Disease Control and Prevention are expected to meet Thursday and discuss implementing a booster dose for this age group.