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 The vaccine is currently authorized for emergency use in the United
States for people aged 16 and up. The companies said on Friday that
they requested an expansion of the authorization from the U.S. Food
and Drug Administration to include the younger age group.
In March, the drugmakers said the vaccine was found to be safe,
effective and produced robust antibody responses in 12- to 15-year
olds in a clinical trial.
It is unclear how long the regulator will take to review the data
from the trial, although U.S. Centers for Disease Control director
Rochelle Walensky told ABC News on Thursday she expects the vaccine
to be authorized for 12- to 15-year-olds by mid-May.
Dr. Janet Woodcock, acting commissioner of the FDA, said https://twitter.com/DrWoodcockFDA
on Twitter the agency would review Pfizer's request "as
expeditiously as possible", but cannot predict how long data
evaluation would take.
The regulator said it does not plan to hold a meeting of the
independent advisory board that recommended the vaccine's initial
authorization, for expanding its use in adolescents.
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 Moderna Inc and Johnson &
Johnson are also testing their vaccines in 12-
to 18-year olds, and data from Moderna's trial
could come soon. Pfizer and
Moderna have also launched trials in even younger children, aged six
months to 11 years old. Both companies have said they hope to be
able to vaccinate children under 11 as soon as early 2022.
Inoculating children and young people is considered a critical step
toward reaching herd immunity and taming the pandemic, according to
many experts.
Pfizer and BioNtech said they plan to ask other regulatory
authorities globally to allow the use of their vaccine in 12- to
15-year olds in the coming days.
(Reporting by Michael Erman in Maplewood, N.J. and Mrinalika Roy in
Bengaluru; additional reporting by Manojna Maddipatla; Editing by
Ramakrishnan M. And Grant McCool)
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