Pfizer asks FDA to authorize its COVID-19 vaccine for kids 5 and up – CNET
Pfizer and its partner BioNTech on Thursday officially submitted a request to the US Food and Drug Administration for their COVID-19 vaccine to be used in children 5 to 11.
The Pfizer-BioNTech vaccine was fully approved by the US Food and Drug Administration for people 16 and older in August, but is still under emergency use authorization for kids 12 to 15. Pfizer remains the only vaccine authorized for use in kids as young as 12 in the US.
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In anticipation of the formal submission, the FDA last week scheduled an advisory committee meeting for Oct. 26 to discuss the use of Pfizer’s COVID-19 vaccine in children ages 5 to 11.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said Janet Woodcock, acting FDA commissioner, in a release.
Pfizer didn’t immediately respond to a request for additional comment.
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October 7, 2021 at 07:12AM