Pfizer asks FDA to authorize its COVID-19 vaccine for kids 5 and up Pfizer is the only vaccine authorized for use in kids as young as 12 in the US.

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Pfizer is the only vaccine authorized in the United States for use in children under the age of 12.

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Pfizer and its partner BioNTech on Thursday officially submitted a request The US Food and Drug Administration is touted for their COVID-19 vaccine to be used in children ages 5 to 11.

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The Pfizer-BioNTech vaccine was fully approved by the US Food and Drug Administration in August for people 16 and older, but is still under emergency use authorization for children 12 to 15 years old. Pfizer is the only vaccine authorized for use in children under 12 years of age. in America.

In anticipation of a formal submission, the FDA last week scheduled an advisory committee meeting on October 26 to discuss the use of Pfizer’s COVID-19 vaccine in children ages 5 to 11.

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“We know from our vast experience with other pediatric vaccines that children are not young adults, and we are using the presented clinical trial data to support the safety and effectiveness of the vaccine used in the young pediatric population. Will evaluate, which may require a different dosage or formulation to be used in an older pediatric population or adults,” Janet Woodcock, acting FDA commissioner, said in a release.

Pfizer did not immediately respond to a request for additional comment.



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