Pfizer and BioNTech said Tuesday they accept submitted Covid-19 vaccine abstracts on accouchement ages 5 to 11 to the US Food and Drug Administration for antecedent review, but are not yet gluttonous emergency use authorization.
A academic acquiescence to appeal EUA for the vaccine is accepted to chase in the advancing weeks, the companies said in a statement.
Submissions to the European Medicines Bureau and added authoritative authorities are additionally planned, they said.
This is the aboriginal acquiescence of abstracts to the FDA for a Covid-19 vaccine for adolescent children. The Pfizer/BioNTech vaccine is accustomed for bodies age 16 and earlier and has an EUA for bodies ages 12 to 15.
Last week, Pfizer appear capacity of a Phase 2/3 balloon that showed its Covid-19 vaccine was safe and generated a “robust” antibiotic acknowledgment in accouchement ages 5 to 11. The balloon included 2,268 participants ages 5 to 11 and acclimated a two-dose dieting of the vaccine administered 21 canicule apart. This balloon acclimated a 10-microgram dosage — abate than the 30-microgram dosage that has been acclimated for those 12 and older.
Participants’ allowed responses were abstinent by attractive at acrid antibiotic levels in their claret and comparing those levels to a ascendancy accumulation of 16- to 25-year-olds who were accustomed a two-dose dieting with the beyond 30-microgram dose. Pfizer said the levels compared able-bodied with earlier bodies who accustomed the beyond dose, demonstrating a “strong allowed acknowledgment in this accomplice of accouchement one ages afterwards the added dose.”
Pfizer and BioNTech said Tuesday they plan to abide abstracts from the abounding Phase 3 balloon for accurate peer-reviewed publication.
FDA admiral accept said that already vaccine abstracts was submitted, the bureau could accredit a vaccine for adolescent accouchement in a amount of weeks — not months — but it would depend on the timing and affection of the abstracts provided.
The FDA has confused bound in the accomplished to extend vaccine allotment to added groups. For example, Pfizer approved emergency use allotment for its Covid-19 vaccine for bodies ages 12 to 15 on April 9 and the EUA was accepted May 10.
However, for these adolescent children, FDA is accepted to assemble is vaccine admiral to accomplish a advocacy on the vaccine afore authorization. If the FDA OKs it, a console of CDC vaccine admiral will accommodated to accede whether to acclaim its use.
Following the advertisement from Pfizer and BioNTech on Tuesday, Dr. Anthony Fauci, administrator of the National Institute of Allergy and Infectious Diseases, said hopefully vaccines can go into accoutrements by the end of October.
“The FDA takes actual actively the accent of accepting vaccines apparent to be safe and able in accouchement to accepting it into the accoutrements of children, in this case accouchement from eleven bottomward to five,” Fauci said on MSNBC’s Morning Joe Tuesday. “The FDA, you never appetite to get advanced of their judgement, but I would brainstorm in the abutting few weeks, they will appraise that abstracts and hopefully they’ll accord the OK so that we could alpha vaccinating children, hopefully afore the end of October.”Data on the allowed acknowledgment and assurance for two added age groups — accouchement ages 2 to 5 and 6 months to 2 years — are accepted “as anon as the fourth division of this year,” Pfizer and BioNTech said Tuesday.
CNN’s Naomi Thomas and Amanda Sealy contributed to this report
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