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Pfizer asks FDA to authorize its COVID-19 vaccine for kids 5 and up

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Pfizer and its accomplice BioNTech on Thursday officially submitted a request to the US Meals and Drug Administration for his or her COVID-19 vaccine for use in youngsters 5 to 11. 

Final month, Pfizer mentioned topline results from its clinical trial confirmed its COVID-19 vaccine was secure and efficient in youngsters ages 5 to 11. In a sequence to tweets on Thursday, Pfizer mentioned it is “dedicated to working with the FDA with the last word aim of serving to shield youngsters towards this severe public well being menace.”

The Pfizer-BioNTech vaccine was fully approved by the US Food and Drug Administration for individuals 16 and older in August, however continues to be underneath emergency use authorization for kids 12 to 15. Pfizer stays the one vaccine licensed to be used in youngsters as younger as 12 within the US.

In anticipation of the formal submission, the FDA final week scheduled an advisory committee meeting for Oct. 26 to debate using Pfizer’s COVID-19 vaccine in youngsters ages 5 to 11.

“We all know from our huge expertise with different pediatric vaccines that youngsters should not small adults, and we’ll conduct a complete analysis of scientific trial information submitted in assist of the security and effectiveness of the vaccine utilized in a youthful pediatric inhabitants, which can want a distinct dosage or formulation from that utilized in an older pediatric inhabitants or adults,” mentioned Janet Woodcock, performing FDA commissioner, in a launch. 

With many youngsters again in lecture rooms, the US has seen a wave of COVID-19 instances in youngsters, based on the American Academy of Pediatrics. There have been nearly 850,000 child cases added over the previous 4 weeks. As of Sept. 19, 56% of kids 12-17 have obtained not less than one dose of the COVID-19 vaccine, based on the AAP. 

Medical trials for Moderna and Pfizer vaccines in even younger children are underway. Final month, Dr. Anthony Fauci, the director of the Nationwide Institute of Allergy and Infectious Illness, mentioned in an interview with ABC11 that it is “very probably” COVID vaccines can be obtainable for youths as younger as 5 and 6 “as we get into October and early November.” 

Pfizer did not instantly reply to a request for added remark. 

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https://www.cnet.com/information/pfizer-asks-fda-to-authorize-its-covid-19-vaccine-for-kids-5-and-up/#ftag=CADf328eec | Pfizer asks FDA to authorize its COVID-19 vaccine for youths 5 and up

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