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Pfizer and BioNTech have formally asked for that their COVID-19 vaccine be cleared for use amongst youthful youngsters.
In a tweet Thursday, Pfizer mentioned the providers submitted their request for an crisis use authorization (EUA) of their vaccine to the U.S. Food items and Drug Administration. They are seeking clearance for it to be made use of amongst youngsters aged five to 11 decades previous.
The request for EUA will be evaluated in the course of an upcoming Vaccines and Linked Organic Goods Advisory Committee (VRBPAC) conference on Oct 26.
“We know from our large practical experience with other pediatric vaccines that youngsters are not modest older people, and we will conduct a comprehensive evaluation of clinical demo info submitted in support of the security and performance of the vaccine made use of in a more youthful pediatric populace, which may perhaps have to have a unique dosage or formulation from that made use of in an older pediatric populace or older people,” Performing Fda Commissioner Dr. Janet Woodcock mentioned in a assertion.
WHY THIS Issues
The EUA submission comes as no surprise since the providers mentioned they would request regulatory acceptance “as shortly as attainable” last thirty day period when they launched vaccine info amongst youngsters aged five to 11.
The info showed that a scaled-down dose of Pfizer and BioNTech’s vaccine elicited a similar antibody reaction and experienced comparable side results as witnessed in persons 16 to 25 decades of age.
As pointed out in Pfizer’s tweet, COVID-19 situations amongst youthful youngsters are on the increase. In the course of the 7 days of September 30, 173,469 boy or girl COVID-19 situations have been reported, representing 26.seven% of all situations recorded that 7 days, in accordance to the American Academy of Pediatrics.
In the two-7 days period of time prior to September 30, there was a seven% maximize in the cumulative quantity of boy or girl COVID-19 situations since the beginning of the pandemic, the AAP found.
“With new situations in youngsters in the U.S. continuing to be at a substantial level, this submission is an critical action in our ongoing energy from #COVID19,” Pfizer mentioned in its tweet. “We’re fully commited to functioning with the Fda with the top target of serving to defend youngsters from this severe community health and fitness risk.”
THE Larger Pattern
In August, Pfizer and BioNTech’s COVID-19 vaccine turned the 1st to receive entire acceptance from the Fda. The vaccine is now promoted as Comirnaty and is permitted for the avoidance of COVID-19 for these 16 decades previous and older.
The providers have also gotten a EUA for a booster shot of Comirnaty amongst certain populations, these as these sixty five decades of age and older, individuals eighteen by 64 at substantial risk of critical COVID-19 and these aged eighteen by sixty four whose occupational exposure places them at substantial risk of severe difficulties of COVID-19.
Moderna and Johnson & Johnson have also submitted requests to the Fda for booster shot EUAs. The VRBPAC has scheduled meetings for Oct 14 and 15 to discuss attainable booster shot approvals.
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