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Pfizer-BioNTech submitted an application to the U.S. Food and Drug Administration Tuesday, for children ages 5 through 11-years-old to receive the COVID-19 vaccine booster, the company announced.
In a statement, Pfizer said it submitted the application seeking approval under the Emergency Use Authorization after data from a study involving 4,500 children in the U.S., Finland, Poland, and Spain, seeking to determine the “safety, tolerability, and immunogenicity” of the vaccine produced a positive result.
“Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals,” the company said.
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The study included children in three distinct age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years.
Pfizer intends to release the data for the still-ongoing study of children 6 months to under 5 years old later in the year.
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Emergency approval from the FDA under the Emergency Use Authorization would not constitute a full vaccine approval and licensing from the FDA, it would only mean that the extenuating circumstances of the pandemic justify the rapid implementation of the vaccine.
“Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned,” the company added.
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The submission comes on the same day the Centers for Disease Control and Prevention released a study determining that three out of every four children have had coronavirus infections.
Pfizer listed fainting and several other side effects from receiving the Pfizer-BioNTech COVID-19 vaccine, including: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; and vomiting.
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