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Source: Press release.
September 28, 2021
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Pfizer-BioNTech request emergency approval for vaccine for children

Source: Press release.
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Pfizer and BioNTech announced over Twitter on Thursday that they have submitted a request to the FDA for an emergency use authorization of their COVID-19 vaccine in children aged 5 to 11 years.

The news comes just over a week after the companies submitted topline data on the inoculation to the FDA on Sept. 28.

Pfizer vaccine
Pfizer-BioNTech have submitted initial study results to the FDA on the performance and safety of their COVID-19 vaccine in children aged 5 to 11 years. Source: Adobe Stock

The submission came just over a week after the companies said the data showed that the vaccine was safe and generated “robust” neutralizing antibody titers in a phase 2/3 study.

In a statement, the companies confirmed that they had shared the data with the FDA for initial review, and said they expect to formally submit a request for an Emergency Use Authorization (EUA) for children aged 5 to 11 years “in the coming weeks.”

The vaccine, branded as Comirnaty, was fully approved by the FDA last month for people aged 16 years or older. It has been available under an EUA for children aged 12 to 15 years since May, and representatives from Pfizer have said that the vaccine could be authorized for the younger age group by Halloween.

The proposed regimen for children aged 5 to 11 years is two shots given 21 days apart — the same as in older age groups. However, they would receive smaller doses — two 10 µg shots.

In the phase 2/3 study of 2,268 children, SARS-CoV-2-neutralizing antibody geometric mean titer was 1,197.6 (95% CI, 1,106.1-1,296.6) — a response the companies said was noninferior to that seen among people aged 16 to 25 years who received two 30 µg doses in a previous study.

Pfizer and Biotech said topline study data for two younger groups — children aged 2 to 4 years and children as young as age 6 months — “are expected as soon as the fourth quarter of this year.”

References:

Pfizer and BioNTech to U.S. FDA From of COVID-19 in 5 to <12 of . https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal. Published Sept. 28, 2021. Accessed Sept. 28, 2021.