Companies cite climbing cases of pediatric COVID-19 infection in their announcement
Pfizer and BioNTech have requested the Food and Drug Administration for emergency authorization of their COVID-19 vaccine for children ages 5 to 11, the companies announced Thursday.
Sharing the news on Twitter, Pfizer wrote: “As new cases in children continue to high in the US, this submission is an important step in our ongoing effort against #COVID19.”
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The news comes just a week after Pfizer-BioNtech presented clinical trial data COVID-19 Vaccination Study among children aged 5-11 years for FDA. The trial data included recent findings among 2,268 participants aged 5-11, which suggested that a small-dose shot was safe, well tolerated and resulted in neutralizing antibody responses. The companies chose a two-dose 10 microgram (UG) dose for children ages 5-11, while a two-dose 30 microgram (UG) dose was used for children 12 years of age and older. Dose selected.
The companies had earlier announced that test results on younger age groups such as children aged 6 months to less than 5 years were expected by the fourth quarter.
The FDA has scheduled an advisory committee meeting on October 26 to inform its decision-making on the Pfizer-BioNTech vaccine for children ages 5-11.
“We know from our vast experience with other pediatric vaccines that children are not young adults, and we are using the presented clinical trial data to support the safety and effectiveness of the vaccine used in the young pediatric population. Will evaluate, which may require a different dosage or formulation to be used in an older pediatric population or adults,” Acting FDA Commissioner Dr. Janet Woodcock said on Oct. News releaseIn anticipation of Pfizer-BioNTech’s request for vaccine use in younger age groups.
As of September 25, US children ages 5–11 held one of the highest rates of weekly COVID-19 cases per 100,000 population in 202.9, with teens ages 12-15 and teens ages 16-17. followed by 211 and 219.5 per 100,000, respectively, according to federal figures. Hospital admissions for COVID-19 patients aged 0-17 declined from a record high of 0.50 per 100,000 in early September to 0.34 by the end of September.
Heat surge in pediatrics hospital admission stirred up because respiratory illnesses occurred and young children were ineligible to receive COVID-19 Vaccines in the middle of the beginning of the school year.