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 mentionedconfirmed its COVID-19 vaccine was protected 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 final word aim of serving to defend youngsters towards this critical public well being risk.”
The Pfizer-BioNTech vaccine was absolutely accredited by the US Meals and Drug Administration for individuals 16 and older in August, however remains to be below emergency use authorization for youngsters 12 to fifteen. 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 assembly 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 are going to conduct a complete analysis of scientific trial information submitted in assist of the protection 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, appearing FDA commissioner, in a launch.
With many youngsters again in school rooms, the US has seen a wave of COVID-19 circumstances in youngsters, based on the American Academy of Pediatrics. There have been practically 850,000 baby circumstances added over the previous 4 weeks. As of Sept. 19, 56% of children 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 youthful youngsters 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 seemingly” 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 extra remark.