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 The U.S. Food and Drug Administration said on Friday it was looking
to complete the data review as quickly as possible, likely in a
matter of weeks rather than months.
The FDA granted full approval last month for the use of Pfizer Inc's
vaccine in people over the age of 16 based on a six-month follow-up
from the trial. The shot was authorized in December for emergency
use based on a shorter, two-month follow up.
The agency is under pressure to approve a vaccine for children below
12 years of age amid a surge in infections fueled by the spread of
the Delta coronavirus variant, which has disrupted the reopening of
schools.
Pfizer and partner BioNTech SE as well as Moderna Inc are racing to
submit clinical data seeking regulatory approval for their vaccines
in children below 12 years of age.
Pfizer/BioNTech's vaccine has been currently authorized for children
aged 12 to 15 in the United States.
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 Pfizer said it expects to
report data needed for approval in five and 11
year olds sometime this month and could
potentially submit an application for emergency
use shortly after. The drugmaker said data for
kids aged two and under five could arrive soon
after. For children between six
months and two years, Pfizer has said it could have a safety and
immunogenicity data as early as October or November.
Moderna on Thursday said it has fully enrolled participants in a
trial testing its shot in children between six and 11 years and that
it was still conducting dose selection studies for younger age
groups.
(Reporting by Manojna Maddipatla in Bengaluru and Mike Erman in
Maplewood, New Jersey)
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