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Pfizer Seeks EUA for COVID-19 Vaccine in Children
The announcement was made by Pfizer and BioNTech on Twitter
Pfizer announced on Twitter that it and BioNTech have officially asked for an emergency use authorization (EUA) for its COVID-19 vaccine for children 5 to 11 years of age.
The companies announced positive topline results from the pivotal trial on Sept. 20, 2021, and they began submitting data from this trial to the FDA on Sept. 28.
In the trial, which included 2,268 participants 5 to less than 12 years of age, the vaccine demonstrated a favorable safety profile and elicited antibody responses using a two-dose regimen of 10 μg doses. These results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to less than 12 years of age.
Related: Pfizer and BioNTech Submit Initial Data of COVID-19 Vaccine in Children
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
