Pfizer, BioNTech request COVID-19 vaccine emergency authorization for kids ages 5 to 11
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."
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.
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