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The US gives full approval to the use of Pfizer's vaccine
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The Food and Drug Administration US
(
FDA
, in English) gave Monday its full approval to the vaccine
Covid-19
to
Pfizer
, the first serum of this type in the country you get has a
green light full of the regulator, since until now it had only of "emergency".
This was reported by the
FDA
in a statement, where its acting commissioner, Janet Woodcock, stressed that it is a "milestone" in the fight against the pandemic.
Following this approval, people "can be very confident that this
vaccine
meets the highest standards of safety, effectiveness, and build quality that the FDA requires for a (fully) approved product," Woodcock said.
The head of the FDA was hopeful that the full approval will overcome the distrust of some people towards the serums against
Covid-19
.
"Today's milestone brings us one step closer to changing the course of the pandemic," Woodcock said.
The vaccine was cleared for emergency use in the
US
.
in mid-December for those over 16 years of age, and it was extended in May for those over twelve years of age.
Full approval applies only to those 16 and older, as
Pfizer
has to provide more data on the use of the vaccine in children between the ages of 12 and 15 to achieve full authorization, which could take months.
Emergency clearances can be used by the
FDA
during health emergencies to provide access to medical products that can be effective in preventing, diagnosing, or treating disease.
Unlike an approval for emergency use, the full authorization lasts indefinitely unless some kind of unexpected side effect develops.
To achieve this type of approval, the company must provide extensive data on the manufacturing process and is subject to thorough
FDA
inspections
.
The
US
authorities
.
they hope that with full approval the immunization rate in the country will increase.
It may also encourage universities, companies and other institutions to require the vaccination record.
More than 170 million Americans in the US are fully vaccinated against
Covid-19
, of which more than 92 million have received serum from
Pfizer
.
The
FDA
is reviewing the information provided by
Moderna
, the other pharmaceutical company that has developed a messenger-RNA vaccine, like
Pfizer's
, to obtain full approval, as it only has emergency use approval.
The decision could take weeks.
Johnson & Johnson, which has developed the third vaccine to be approved for emergency use in the US (in this case from an adenovirus, like traditional vaccines), is expected to apply soon for full authorization.
This Monday's decision by the
FDA
is released as cases and hospitalizations have soared in the last month due to the expansion of the
delta variant
in the
US
.
The
FDA is
also now reviewing the possibility of giving a booster dose of the
Pfizer
and
Moderna
vaccines
to already immunized people, which the Government wants to start administering as of September 20 due to the spread of the delta variant
According to the criteria of The Trust Project
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