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The Times, Gainesville, Georgia | gainesvilletimes.com
Friday, December 11,2020 3A
US panel endorses widespread use of Pfizer vaccine
MARK LENNIHAN I Associated Press
A pharmacist labels syringes in a clean room where doses of COVID-19
vaccines will be handled, Wednesday, Dec. 9, at Mount Sinai Queens
hospital in New York.
BY LAURAN NEERGAARD
AND MATTHEW PERRONE
Associated Press
WASHINGTON - A U S. gov
ernment advisory panel endorsed
widespread use of Pfizer’s coro-
navirus vaccine Thursday, put
ting the country just one step away
from launching an epic vaccina
tion campaign against the outbreak
that has killed close to 300,000
Americans.
Shots could begin within days,
depending on how quickly the
Food and Drug Administration
signs off, as expected, on the expert
committee’s recommendation.
In a 17-4 vote with one absten
tion, the government advisers
concluded that the vaccine from
Pfizer and its German partner
BioNTech appears safe and effec
tive for emergency use in adults
and teenagers 16 and over.
That endorsement came despite
questions about allergic reactions
in two people who received the
vaccine earlier this week when
Britain became the first country to
begin dispensing the Pfizer-BioN-
Tech shot.
While there are a number of
remaining unknowns about the
vaccine, in an emergency, “the
question is whether you know
enough” to press ahead, said panel
member Dr. Paul Offit of Chil
dren’s Hospital of Philadelphia.
He concluded that the potential
benefits outweigh the risks.
The decision came as COVID-19
cases surge to ever-higher levels
across the U.S., with deaths set
ting an all-time, one-day record of
more than 3,100 on Wednesday.
Pfizer has said it will have about
25 million doses of the two-shot
vaccine for the U.S. by the end of
December. But the initial supplies
will be reserved primarily for health
care workers and nursing home res
idents, with other vulnerable groups
next in line until ramped-up produc
tion enables shots to become widely
available on demand — something
that will probably not happen until
the spring.
Next week, the FDA will review
a second vaccine, from Moderna
and the National Institutes of
Health, that appears about as pro
tective as Pfizer-BioNTech’s shot.
A third candidate, from Johnson
& Johnson, which would require
just one dose, is working its way
through the pipeline. Behind that
is a candidate from AstraZeneca
and Oxford University.
U.S. health experts are hoping a
combination of vaccines will ulti
mately enable the U.S. to conquer
the outbreak.
Still, experts estimate at least
70% of the U.S. population will
have to be vaccinated to achieve
herd immunity, the point at which
the virus can be held in check.
That means it could be several
months before things start to get
back to normal and Americans can
put away their masks.
All eyes now turn to the FDA
staff scientists who will make the
final decision of whether to press
ahead with large-scale immuniza
tions with Pfizer-BioNTech’s vac
cine. FDA’s vaccine director Dr.
Peter Marks said a decision would
come within “days to a week.”
Dr. William Moss of Johns
Hopkins University, who was not
involved in the expert panel’s
review, welcomed the outcome,
saying, “Given how bad the pan
demic is now, we need to move.”
The independent review by non
government experts in vaccine
development, infectious diseases
and medical statistics was consid
ered critical to boosting Ameri
cans’ confidence in the safety of
the shot, which was developed at
breakneck speed less than a year
after the virus was identified.
Regulators not only in Brit
ain but in Canada have already
approved the vaccine for use in
their countries, and President
Donald Trump and White House
officials have complained for
weeks that the FDA was moving
too slowly.
FDA scientists issued a glow
ing review of the vaccine earlier
in the week. Agency staffers said
data from Pfizer’s ongoing study
of 44,000 people showed strong
protection across different age
groups, races and health condi
tions with no major, unexpected
safety problems.
The Pfizer-BioNTech shot
remains experimental because
that final-stage study isn’t com
plete. As a result, the expert panel
wrestled with a list of questions
that have yet to be answered.
For example, while the vac
cine is more than 90% effective in
blocking the symptoms of COVID-
19, the FDA’s advisers stressed it
is not yet clear whether it can stop
the silent, symptomless spread that
accounts for up to half of all cases.
“Even though the individual effi
cacy of this vaccine is very, very,
very high, you really as of right
now do not have any evidence”
that it will lower transmission, said
Dr. Patrick Moore of the Univer
sity of Pittsburgh. He urged Pfizer
to take additional steps to answer
that question.
Several of the dissenting panel
members objected to authorizing
the shot for 16- and 17-year-olds,
given their small numbers in the
study and the low risk they face
from COVID-19.
Members worried, too, that
Pfizer will lose its opportunity to
answer critical questions once it
begins offering the real vaccine to
study participants who had been
getting dummy shots up to now.
The company proposed gradu
ally moving those patients to the
vaccine group, with priority based
on age, health conditions and other
factors. Under that plan, 70-year-
old participants would cross over
before healthy 30-year-olds.
Pfizer must still show whether
the vaccine works in children
younger than 16 and in pregnant
women.
On the safety front, as wide
spread vaccinations begin, the first
recipients will be closely tracked
by government health authorities,
since studies in tens of thousands
of people can’t detect side effects
that strike 1 in a million. Hanging
over the meeting were the British
allergic reactions and a warning
from authorities there that people
with a history of serious reactions
shouldn’t get the vaccine for now.
Pfizer representatives said
they have seen no signs of allergic
reactions in their trial. But some
of the FDA advisers fear the Brit
ish warning will deter millions
of Americans with allergies who
might benefit from the COVID-19
vaccine from giving it a try, and
urged additional studies to try to
settle the issue.
COVID-19
■ Continued from 1A
Department of Public
Health. NGHS has recorded
464 deaths across its facili
ties in the region, with six
coming from Wednesday
into Thursday.
The U.S. recorded 3,124
deaths Wednesday, the
highest one-day total yet,
according to Johns Hopkins
University. Up until last
week, the peak was 2,603
deaths on April 15, when
New York City was the epi
center of the nation’s out
break. The latest number
is subject to revision up or
down.
Wednesday’s national
death toll eclipsed Ameri
can deaths on the opening
day of the Normandy inva
sion during World War II:
2,500, out of some 4,400
allied dead. And it topped
the toll on Sept. 11, 2001:
2,977.
Locally, the Northeast
Georgia Health System
continues to see record
high numbers of COVID-
19 patients at its facilities.
Thursday, Dec. 10, was the
second consecutive record-
breaking day this week,
with 221 COVID-19 patients.
As a further illustration of
the rising peaks, cots are
being set up in a gym on
the campus of Northeast
Georgia Medical Center in
Gainesville, and the system
expects that overflow space
to open some time next
week.
New cases per day are
running at all-time highs of
over 209,000 on average.
And the number of people
in the hospital with COVID-
19 is setting records nearly
every day.
A U.S. government advi
sory panel convened on
Thursday and endorsed
mass use of Pfizer’s COVID-
19 vaccine to help conquer
the outbreak. Depending on
how fast the FDA signs off
on the panel’s recommen
dation, shots could begin
within days, inaugurating
the biggest vaccination
campaign in U.S. history.
In St. Louis, respiratory
therapist Joe Kowalczyk
said he has seen entire
floors of his hospital fill up
with COVID-19 patients,
some of them two to a room.
He said the supply of ven
tilators is dwindling, and
the inventory is so thin that
colleagues on one shift had
to ventilate one patient by
using a BiPAP machine,
similar to the devices used
to treat sleep apnea.
When he goes home to
sleep during the day at the
end of his grueling over
night shifts, he sometimes
has nightmares.
“I would be sleeping and
I would be working in a unit
and things would go com
pletely wrong and I would
shock myself awake. They
would be very visceral and
very vivid,” he said. “It
would just really spook me. ”
In South Dakota, Dr. Clay
Smith has treated hundreds
of COVID-19 patients while
working at Monument
Health Spearfish Hospital
and at Sheridan Memorial
Hospital in neighboring
Wyoming.
He said patients are
becoming stranded in the
emergency room for hours
while they await beds on
the main floor or transfers
to larger hospitals. And
those transfers are becom
ing more challenging, with
some patients sent as far
away as Denver, 400 miles
from the two hospitals.
“That is a huge burden
for families and EMS sys
tems as well when you take
an ambulance and send
it 400 miles one way, that
ambulance is out of the
community for essentially a
whole day,” he said.
Smith added that some
patients have gone from
thinking “I thought this was
a hoax” to “Wow, this is real
and I feel terrible.” But he
has also seen people with
COVID-19 who “continue to
be disbelievers. It is hard to
see that.”
“At the end of the day the
virus doesn’t care whether
you believe in it or not,” he
said.
In New Orleans, city
Health Director Dr. Jen
nifer Avegno described a
recent visit to a hospital
where she watched doc
tors, nurses, respiratory
therapists and others risk
exposure to the disease in a
long, futile attempt to save
a dying COVID-19 patient.
Some broke down in tears
afterward, she said.
“These are seasoned
emergency and critical
care personnel,” she said.
“We do not cry very often
— and especially not a num
ber of us all at once.”
She cited “the sheer
exhaustion of giving their
all for similar patients over
and over and over again
for the past nine months,
coupled with the knowledge
that much of this could be
prevented with really sim
ple measures.”
In Virginia, Gov. Ralph
Northam, a doctor by train
ing, announced a midnight
curfew and expanded mask
rules to require the wearing
of face coverings outdoors,
not just inside.
In New York City, which
was ravaged by the virus
in the spring, one doctor
sounded a note of relative
optimism, saying that at
least physicians are more
capable of managing the
virus now.
“Early in the spring we
did not know enough,” said
Dr. Jolion McGreevy, who
directs Mount Sinai Hos
pital’s emergency depart
ment. “We really are
operating from a place of
knowledge, now — which
is a big leap from where we
were in the spring.”
AP National Writer Jocelyn
Noveck in New York
contributed to this report.
Associated Press journalists
from around the globe
contributed to this report.
Earthquake reported in Northeast Forsyth County
Forsyth County News
According to the US Geological Ser
vice, a 1.8 magnitude earthquake was
recorded in Northeast Forsyth County
at about 8:45 p.m. Dec. 9.
In a Facebook post on Thursday
night, Forsyth County Sheriff Ron
Freeman stated that “dozens of calls”
were made to 911 as the quake was
felt in Forsyth County, but no damage
was reported. Freeman’s post stated
that the quake occurred at a depth of
5 kilometers.
There were no impacts in Hall
County, said Casey Ramsey, the coun
ty’s Emergency Management Agency
director.
This article originally appeared
in the Forsyth County News,
a sister publication of The Times.
