|
 If
approved, the vaccine will be the first fully approved COVID-19 shot
and could help ease vaccine hesitancy due to longer-term data
required for an FDA approval.
The companies said they would submit data to support the so-called
biologic license application, which requires longer-term follow-up
data, on a rolling basis over the next few weeks.
In April, Pfizer-BioNTech said their vaccine was around 91%
effective at preventing COVID-19, supported by data on more than
12,000 people fully inoculated for at least six months, positioning
the duo to submit for full U.S. regulatory approval.
The companies said on Friday they have submitted nonclinical and
clinical data needed to support licensure of the shot for use in
individuals aged 16 and above, including updated data announced in
April.
The FDA will set a goal date for a regulatory decision once the
application is complete and formally accepted for review by the
agency.
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Under an emergency use authorization, the FDA makes a product
available to the public based on the best available evidence during
an emergency, without waiting for all the evidence needed for FDA
approval or clearance, according to the regulator. (https://bit.ly/3h9ncLy)
More than 170 million doses of Pfizer-BioNTech's vaccine have been
delivered across the U.S. since it was authorized for emergency use
in December.
Last month, the companies asked U.S. to allow the emergency use of
their vaccine in adolescents aged 12 to 15, with the FDA set to give
the nod by next week.
There are three vaccines available in the United States: Pfizer-BioNTech,
Moderna and Johnson & Johnson. All have been authorized for
emergency use.
(Reporting by Ankur Banerjee in Bengaluru; Editing by Shinjini
Ganguli)
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