Pfizer seeks emergency permit for COVID-19 booster for children ages 5 to 11 years

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Pfizer-BioNTech on Tuesday submitted an application to the U.S. Food and Drug Administration for children ages 5 to 11 to receive the COVID-19 vaccine booster, the company announced.

In a statement, Pfizer said it submitted the application for approval under the Emergency Use Authorization following data from a study involving 4,500 children in the United States, Finland, Poland and Spain, which sought to establish “safety, tolerability and immunogenicity”. of vaccine gave a positive result.

“Data from this study showed a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 vaccine without new safety signals,” the company said.

FILE - The Pfizer logo is displayed at the company's headquarters, February 5, 2021, in New York.

FILE – The Pfizer logo is displayed at the company’s headquarters, 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 years; age 2 to under 5 years; and aged 6 months to less than 2 years.

Pfizer intends to release the data for the ongoing study of children from 6 months to under 5 years later in the year.

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FILE - A syringe has been prepared with the Pfizer COVID-19 vaccine at a vaccination clinic at the Keystone First Wellness Center in Chester, Pa., On December 15, 2021.

FILE – A syringe has been prepared with the Pfizer COVID-19 vaccine at a vaccination clinic at the Keystone First Wellness Center in Chester, Pa., On December 15, 2021.
((AP Photo / Matt Rourke, File))

Emergency approval from the FDA under the Emergency Use Authorization would not constitute a complete vaccine approval and license from the FDA, it would only mean that the mitigating circumstances of the pandemic justify a rapid implementation of the vaccine.

“Submissions to pursue regulatory approvals in the countries where emergency use permits or similar were originally granted are planned,” the company added.

Jamie Onofrio Franceschini, 11, watches as RN Rosemary Lantigua prepares a syringe with his first dose of the Pfizer-BioNTech COVID-19 vaccine for children aged five to 12 at the Children's Hospital of Montefiore, Wednesday, November 3, 2021, in the Bronx borough in New York.  (AP Photo / Mary Altaffer)

Jamie Onofrio Franceschini, 11, watches as RN Rosemary Lantigua prepares a syringe with his first dose of the Pfizer-BioNTech COVID-19 vaccine for children aged five to 12 at the Children’s Hospital of Montefiore, Wednesday, November 3, 2021, in the Bronx borough in New York. (AP Photo / Mary Altaffer)

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The submission comes the same day that the Centers for Disease Control and Prevention released a study finding that three out of four children have had coronavirus infections.

Pfizer listed fainting and several other side effects of receiving the Pfizer-BioNTech COVID-19 vaccine, including: injection site pain; fatigue; headache; muscle pain; goosebumps; joint pain; fever; swelling at the injection site; redness at the injection site; nausea; feeling uncomfortable; swollen lymph nodes (lymphadenopathy); reduced appetite; diarrhea; and vomiting.

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