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Pfizer-BioNTech has applied to the US Food and Drug Administration on Tuesday for children aged 5 to 11 to receive a booster of the COVID-19 vaccine, the company said.
In a statement, Pfizer said it had applied for approval under the emergency authorization, following a study of 4,500 children in the United States, Finland, Poland and Spain to determine the “safety, tolerability and immunogenicity” of the vaccine. .
“Data from this study showed a strong immune response in this age group after a booster dose of Pfizer-BioNTech COVID-19 without new safety signals,” the company said.
FILE – The Pfizer logo was displayed at the company’s headquarters on February 5, 2021 in New York. (AP Photo / Mark Lennihan, file)
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The study included children in three different age groups: aged 5 to under 12; age from 2 to 5 years; and aged 6 months to less than 2 years.
Pfizer intends to publish data on the still ongoing study of children from 6 months to under 5 years later in the year.
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FILE – A syringe was prepared with the Pfizer COVID-19 vaccine at a vaccination clinic at the Keystone First Wellness Center in Chester, Pennsylvania, on December 15, 2021 (AP Photo / Matt Rourke, File).
Emergency approval by the FDA under an emergency authorization would not constitute full approval of the vaccine and licensing by the FDA, it would only mean that the mitigating circumstances of the pandemic justify the rapid administration of the vaccine.
“Applications for regulatory approvals are planned in those countries where emergency authorizations or equivalent were originally granted,” the company added.
Jamie Onofrio Francescini, 11, watches RN Rosemary Lantigua prepare a syringe with her first dose of Pfizer-BioNTech COVID-19 for children ages 5 to 12 at Montefiore Children’s Hospital, Wednesday, November 3, 2021, in the Bronx, New York. (AP Photo / Mary Altaffer)
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The presentation comes on the same day as the Centers for Disease Control and Prevention published a study that found that three out of four children had coronavirus infections.
Pfizer listed seizures and several other side effects from receiving the Pfizer-BioNTech COVID-19 vaccine, including: pain at the injection site; fatigue; headache; muscle pain; chills; joint pain; fever; swelling at the injection site; redness at the injection site; nausea; I feel bad; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; and vomiting.
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