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Pfizer/BioNTech's new crown vaccine for 5-11 years old children obtains FDA emergency use authorization

 Last Update: 2021-11-14
 Source: Internet
 Author: User

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Article source: Medical Rubik's Cube Info

Author: Sunshine

Recently, Pfizer and BioNTech announced that the COVID-19 vaccine Comirnaty (tozinameran, BNT162b2) for use in children aged 5-11 has received an emergency use authorization (EUA) from the FDA
.

For this age group, the dosage regimen is: a dose of 10 µg, with a second injection at 21 days intervals

The FDA's decision is based on data from a Phase II/III clinical trial
.

A total of 4,500 children aged 5-11 years were enrolled in the study

Pfizer and BioNTech have submitted authorization requests for the COVID-19 vaccine for this age group to global regulatory agencies such as the European Medicines Agency
.

At present, there are two clinical trials of Comirnaty for children (2-5 years old, 6 months-2 years old) are underway, and initial data will be released in the fourth quarter of 2021 or the first quarter of 2022 at the earliest

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