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Pfizer, BioNTech submits data seeking FDA approval for its COVID-19 vaccine in children ages 5-11

Rockland-based Pfizer and BioNTech submitted data to the Food and Drug Administration Tuesday on their COVID-19 vaccine trials in children ages 5-11.

News 12 Staff

Sep 28, 2021, 9:18 PM

Updated 994 days ago

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Rockland-based Pfizer and BioNTech submitted data to the Food and Drug Administration Tuesday on their COVID-19 vaccine trials in children ages 5-11.
The FDA is expected to take several weeks to analyze data.
The company announced positive results from a pivotal trial on Sept. 20, 2021.
In the trial, which included 2,268 participants 5 to 11 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a smaller two-dose regimen.
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 a larger dose.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
Right now, the vaccine is available to anyone 12 and up. The state has already implemented mandatory mask mandates in schools and is requiring either a vaccination or weekly negative test for faculty and staff.
According to the state's COVID 19 report card, the Mid-Hudson region ranks fourth highest in the state for COVID cases among students, with just under 1,100 cases since Sept. 13.


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