Only about 28% of children ages 5 to 11 had received their primary series of two doses as of April, according to CDC data.
In January, the FDA authorized Pfizer booster doses for teenagers 12 to 15 years old as the Omicron variant swept the nation. The protection the vaccines provide against infection has declined over time, particularly in the context of Omicron, which is competent at evading the antibodies that block the virus from infecting human cells. However, the vaccines are still providing strong protection against severe illness.
It’s unclear whether the FDA’s advisory committee will meet to discuss the data and make a recommendation. The FDA did not call meetings of the outside expert panel before authorizing third shots for kids ages 12 to 15 in January and fourth shots for people ages 50 and older last month.
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In a statement, Pfizer said it applied the request 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.
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“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 plans to publish 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 give a full vaccine approval and license from the FDA. It would only mean that the extenuating circumstances of the pandemic justify the rapid implementation of the vaccine.
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"Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned," the company added.
The submission comes on the same day the Centers for Disease Control and Prevention published a study defining that three out of every four children have had Coronavirus infections.
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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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