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Pfizer and BioNTech requested Food and Drug Administration emergency authorization of their COVID-19 vaccine for children ages 5 to 11, the companies announced Thursday.
Pfizer took to Twitter to share the news, writing: "With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19."
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PFIZER-BIONTECH SUBMIT COVID-19 VACCINE DATA TO FDA FOR KIDS 5-11
The news comes just over a week after Pfizer-BioNTech submitted clinical trial data from a COVID-19 vaccine study among kids ages 5-11 to the FDA. Trial data included recent findings among 2,268 participants ages 5-11, which suggested a smaller dose shot was safe, well tolerated and resulted in neutralizing antibody responses. The companies selected a two-dose regimen of 10 microgram (ug) doses for kids ages 5-11, versus the two-dose regimen of 30 ug doses used for everyone 12 and older.
The companies previously announced that trial results on younger age groups, like children ages 6 months to under 5 years, are expected by the fourth quarter.
The FDA has scheduled an advisory committee meeting on Oct. 26 to inform its decision-making on the Pfizer-BioNTech vaccine for kids ages 5-11.
"We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults," Acting FDA Commissioner Dr. Janet Woodcock said in an Oct. 1 news release, in anticipation of Pfizer-BioNTech's request for use of the vaccine in younger age groups.
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As of Sept. 25, U.S. kids ages 5-11 held one of the highest rates of weekly COVID-19 cases per 100,000 population at 202.9, following adolescents ages 12-15 and teens ages 16-17 at 211 and 219.5 per 100,000, respectively, per federal figures. Hospital admissions for COVID-19 patients ages 0-17 declined from a record high in early September at 0.50 per 100,000, down to 0.34 by late September.
The summer surge in pediatric hospital admissions stirred alarm as respiratory illnesses coincided and younger children remained ineligible to receive COVID-19 vaccines amid the start of the school year.