BY MICHAEL ERMAN, REUTERS
U.S. Food and Drug Administration
scientists said
on Wednesday that a third
booster dose of Pfi zer’s
COVID-19 vaccine generates
a higher immune response in
recipients, but stopped short
of saying the extra shots are
needed broadly.
The FDA staff members
said in a document prepared
for outside advisors that
Comirnaty – the COVID-19
vaccine Pfi zer developed with
Germany’s BioNTech SE –
met pre-specifi ed conditions
the regulator had set to show
that the shot was generating
an immune response.
Whether the vaccine’s effi -
cacy is declining and if boosters
are needed remains unproven,
the agency said.
“Some observational studies
have suggested declining
effi cacy of Comirnaty
over time against symptomatic
infection or against the
Delta variant, while others
have not,” they said in the
document. “However, overall,
data indicate that currently
U.S.-licensed or authorized
COVID-19 vaccines still afford
protection against severe
COVID-19 disease and death
in the United States.”
The FDA released the document
COURIER LIFE, S 18 EPTEMBER 17-23, 2021
on Wednesday for consideration
by a committee
of outside experts who will
meet on Friday to vote on
recommending if U.S regulators
should approve the extra
round of shots.
Pfi zer, in a document it prepared
for the meeting, argued
that U.S. regulators should approve
a booster shot of its vaccine
for use six months after
the second dose due to waning
effectiveness over time.
Pfi zer said data from its
own clinical trials showed
that the vaccine effi cacy diminished
by around 6% every
two months after the second
dose. It also said the incidence
of breakthrough COVID-19
cases in that trial was higher
among people who received
their shots earlier.
The drugmaker also
pointed to real world data
from Israel and the United
States showing declining effectiveness
of the vaccine.
The U.S drugmaker said
in a roughly 300-participant
clinical trial, the third dose
generated a better immune
response than the second. It
also pointed to data from the
booster program recently
started in Israel to show that a
third dose restores high levels
of protection from the virus.
President Joe Biden has
pushed for the additional shots
in the face of surging hospitalizations
REUTERS/Dado Ruvic/Illustration
and deaths caused by
the highly contagious Delta
variant, and set a Sept. 20 target
to begin administering 100
million booster shots in the
United States.
But it is not clear to many
scientists whether the additional
shots are necessary
broadly.
Earlier this week, two top
FDA vaccine scientists were
among the authors of an article
saying they do not believe
the current data supports giving
the shots. One of those
scientists – Marion Gruber,
director of the FDA’s Offi ce
of Vaccines Research and Review
– will be speaking at Friday’s
meeting.
Some offi cials are hoping
boosters might prevent mild
cases and reduce transmission
of the virus as well as
reducing serious infections,
which could hasten America’s
recovery.
Some countries have already
begun COVID-19 booster
campaigns. The United States
authorized extra shots for people
with vulnerable immune
systems last month.
Health
Pfi zer COVID-19 boosters
improve immunity but may not
be needed, according to FDA
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