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The ADVANCE, January 13, 2021 /Page 3A
Antibodies
continued from page 1A
off harmful antigens such
as viruses, according to the
U.S. Food & Drug Admin
istration (FDA) website.
REGN-COV2 combines
two antibodies: casirivimab
and imdevimab.
In November of last
year, the FDA issued emer
gency use authorizations
(EUA) for two monoclonal
antibody pharmaceuticals.
The first to be greenlighted
was a drug produced by Eli
Lilly — bamlanivimab. It
was authorized for use to
treat mild to moderate cas
es of COVID-19 in adults
and pediatric patients (12
years of age or older weigh
ing at least 88 pounds) with
positive results of direct
SARS-CoV-2 viral testing
and who are at high risk
for progressing to severe
COVID-19. This includes
patients who are 65 years
of age or older or who have
certain chronic medical
conditions.
Regeneron’s REGN-
COV2 (casirivimab and
imdevimab) was autho
rized a few days later.
“Though we’ve learned
a lot about treating patients,
we haven’t had a definitive
treatment for the virus,”
notes Geoff Conner, MD.
“Right now, the monoclo
nal antibody treatment is
as important as the vaccine,
but it isn’t getting the pub
licity because everyone is
focused on the vaccine.”
Conner remarks that
many folks will have to wait
weeks — maybe months
— to be vaccinated. Since
the virus’ mortality rate is
much greater in patients
who are 65 or older and/or
have certain contributory
health problems, there’s a
high probability of some
one in that group contract
ing the virus before they
get vaccinated.
“If he or she contracts
the virus and gets a posi
tive COVID test, then their
doctor can prescribe the
monoclonal antibody treat
ment, and it may keep them
out of the hospital, and it
may save their life,” he says.
“The sooner you get the
treatment, the better. It’s an
infusion that’s done at the
hospital and takes a couple
of hours to administer.”
However, patients who
are hospitalized due to
complications of the virus
are not eligible to receive
the mAbs treatment, as
stated in the FDA’s guide
lines.
“It’s an important tool
in our toolbox,” Dr. Con
ner says. “Studies show that
when given early, it may
reduce the likelihood of a
patient’s condition worsen
ing. Monoclonal antibod
ies can possibly keep our
hospitals from filling up,
and that’s why it is critical
for everyone to know it is
available here.”
The studies the FDA
cites on their website are
small but paint a hopeful
picture. Among the study
group, patients receiving
the Regeneron infusion
were three times less likely
to visit a hospital or emer
gency room (9% of pa
tients who did not receive
the therapy compared to
3% who did). Four percent
of patients treated with
Eli Lilly’s infusion (bam
lanivimab, which is avail
able at Meadows Regional
Medical Center) were
hospitalized or visited the
ER compared to 15% of
the patients who did not
receive the drug, accord
ing to a study published in
the Journal of the Ameri
can Medical Association
(JAMA) in December.
Dr. Conner has seen
the results firsthand. He
has prescribed the mAbs
infusion to several patients
who tested positive for CO -
VID-19 in the last month.
“Meadows has re
ceived several doses of Eli
Lilly’s bamlanivimab, so
that’s what my patients re
ceived,” he says. “I’m happy
to report that all of my pa
tients are doing well. Again,
the monoclonal antibody
treatment is available now
and can be used to keep
our hospitals from exceed
ing their capacity.”
It is important to note
that hospitals can’t freely
administer the drug. It has
to be ordered by a physi
cian.
THEROLLOUT
According to a U.S.
Department of Health and
Human Services (HHS)
Public Health Emergency
webpage, mAbs pharma
ceuticals are being allo
cated at the federal gov
ernment level to states,
territories, and federal en
tities on a two-week cycle.
An online graphic presents
ONANOTHER
COVID-RELATED TOPIC
Recently, the New England Journal of Medicine
found that the plasma donated by patients who have
been previously infected by COVID-19 also improves
the outcome of those who are actively infected with
the virus. The plasma works best when given to pa
tients in the early stages of the infection.
“Supplies of the antibody-enriched plasma are
low,” says Geoff Conner, MD. “I strongly encourage
anyone who has been previously infected with the vi
rus and is able to donate plasma to do so to help others
have a better chance of recovering from the infection.”
CONGRATULATIONS
2020 People’s Bank
Employee of The Year
§ Peoples
Bank
2301 E 1st St., Vidalia, GA 30474 • 912-537-9900
299 West Liberty Ave., Lyons, GA 30436 • 912-526-8171
912-524-2000
www.ourpeoplesbank.com
the distribution process,
often referred to as the “roll
out.” According to their
dashboard, 414,195 mono
clonal antibody therapeu
tics have been delivered to
the states as of January 5,
2021, and of those, 17,174
were delivered to Georgia.
“As of January 7, we’ve
received 33 total doses,”
says Jeffrey Harden, Chief
Nursing Officer and VP
of Patient Care Services at
Meadows Regional Medi
cal Center in Vidalia. “Of
those, we’ve administered
27.”
Harden explains that
the roll out has been an
imperfect process and frus
trations have run high, but
they are committed to serv
ing the community and
making the best of a tough
situation.
“For us, it’s been im
possible to plan ahead be
cause we don’t know when
the treatments are coming
in and how many treat
ments will be in individual
shipments until the day be
fore,” he says. “Even when
we have vials of the mono
clonal antibody available
for patients, it’s challeng
ing for us to administer the
drug.”
Though the infusion
itself takes an hour to ad
minister, the total patient
care window is about three
hours including consulta
tion prior to the infusion
and a 1-hour post-infusion
period where the patient
is monitored by a trained
professional to safeguard
against life-threatening
reactions. During the con
sultation, the patient is
asked to read the mAbs fact
sheets that explain its cat
egorization as a non-FDA-
approved pharmaceutical
product. Patients sign a re
lease before accepting the
infusion. Harden notes that
some patients who have
had the medication or
dered chose not to proceed
with the treatment.
“Our nursing staff is
already stretched thin,”
Harden continues. “And
just like everyone else, we
have to deal with day-to-
day staffing shortages when
a nurse or two tests positive
for COVID and can’t come
to work for several days. As
the cases in our area rise,
hospitalizations rise, and
we need more nurses to
care for everyone. It’s hard
to pull one away for three
hours. We have managed
to do it so far, but it hasn’t
been easy.”
Another challenge is
the strict requirements on
where the monoclonal an
tibody infusion can be ad
ministered to patients. In
a Lilly Playbook outlining
the implementation and
protocols of the mAbs pro
gram for hospitals across
the United States, treat
ment sites are defined as
existing hospital or com
munity-based infusion cen
ters, existing clinical spaces
like urgent care facilities,
and “hospitals without
walls.” The Playbook also
itemizes other require
ments of mAbs infusion
sites to manage patient flow
and ensure HIPAA compli
ance.
Since infusion candi
dates have already tested
positive for the virus, they
can not be placed in areas
near non-COVID patients.
Fifty-four percent of hos
pital beds at Meadows are
currently filled with pa
tients who are struggling
with the virus, and that
number will likely rise in
the upcoming weeks. It’s
what hospital administra
tors across the country are
referring to as a “logistical
nightmare.”
“Doctors in our area
have offered to administer
the treatment for us, but
because the [monoclonal
antibody] treatments were
shipped directly to our
pharmacy, we are not al
lowed to re-distribute the
drugs to other entities,”
Harden says. “Like every
one else, we are hoping
that the treatment will gain
FDA approval soon, and
that will allow it to be ad
ministered in many other
facilities.”
The Lilly Playbook
notes that “sites that would
like to be considered for
product allocation should
contact their State or Ter
ritory Health Author
ity.” The state and territory
health authorities allocate
the mAbs products to in
dividual infusion sites like
Meadows.
Harden’s understand
ing is that the state makes
their allocation decisions
based on “the number of
patients presenting with
the virus” in individual
counties. If so, the alloca
tion numbers would be
greater for state “hot spots,”
but again, capacity and
staffing challenges may
render an infusion site in
capable of administering
the mAbs product to more
patients.
FOOD FORTHOUGHT
Geoff Conner’s con
cern is that only looking at
positivity numbers or hos
pitalization trends doesn’t
paint an adequate picture
to base allocation deci
sions at the state level. He
feels the state should also
consider other factors be
fore making decisions.
“Communities with
higher percentages of el
derly people in their popu
lation should get more,” he
says. “We have a lot of old
er folks here, and they are
more at risk than younger
people. It only makes sense
that we would receive
more of the monoclonal
antibody products here to
have onhand.”
U.S. Census numbers
report that 17% of the
Toombs County popula
tion are over 65 years of
age (Tattnall County: 15%,
Montgomery County:
17.5%, and Appling Coun
ty: 17.7%). In comparison,
Cobb County (north of
Atlanta) reports that only
12.7% of their community
members are over 65.
“They should make ad
justments,” he says.
And Conner feels that
the state should consider
the overall health profile of
communities in their equa
tion, as well. Community
health is a little more dif
ficult to determine. How
ever, studies reveal that
communities with greater
percentages of people liv
ing at or below the pov
erty level have higher inci
dences of obesity, diabetes,
COPD, and heart disease
among its population.
Checking the U.S.
Census data finds a greater
concentration of people
living in p over ty in To omb s
(19.2%), Tattnall (26.5%),
Montgomery (19.4%), and
Appling (20.9%) Counties,
compared to other areas of
the state. In Cobb County,
8.3% are living at or below
the poverty line (Houston
County: 11% and Gwin
nett County: 9.2%). There
is a strong argument to be
made that counties with
higher poverty rates have
populations with more
health problems and need
to be given more of the
mAbs products to admin
ister to COVID positive
patients.
Dr. Conner is also up
set that many of the doses
of the monoclonal anti
bodies are going unused.
Like so many, he’s frus
trated and wants to see
improvements made to the
system, problems solved
quickly, and more efficien
cy and logic added into the
process.
“At the end of the
day, my job is to help my
patients and find effec
tive treatments,” he says.
“That’s what I am trying to
do.”
Meadows Covid-19 Vaccines Now
Available By Appointment Only
Meadows Health
is currently administer
ing COVID-19 vaccine
in Phase 1A+, which in
cludes: healthcare workers
(physicians, nurses, labo
ratory technicians, EMS
personnel, environmental
services, etc.); law enforce
ment, firefighters, first re
sponders; and adults aged
65+ and their caregivers.
“There has been a lot
of interest in getting an ap
pointment,” said Meadows
Health Chief Medical Offi
cer Dr. Karen McColl. “We
are asking those who call to
please be patient. Our staff
is working very hard to get
everyone scheduled for an
appointment.”
Those interested in
scheduling a vaccine ap
pointment are asked to call
535-SAFE (535-7233) and
leave a message on voice-
mail, or email at Covid(a)
meadowsregional.org.
Walk-in patients will not
be accepted. Residents are
asked not to visit the office
to schedule an appoint
ment. There is no charge
for the COVID-19 vacci-
Murder
continued from page 1A
Corbin said that law
enforcement had deter
mined that Caesar was
the suspect who entered
a Soperton bank and gave
the teller a note saying
he had a gun and that she
had 30 seconds to turn
over the money. The teller
activated the silent alarm
and the suspect left the
bank without money. No
one was physically injured
nation.
Meadows Health Vac
cine Clinic is located at the
Lucy Pierson Medical Of
fice Building, 1707 Mead
ows Lane, Suite A (2nd
Floor), Vidalia.
in the incident. No other
suspects were identified in
the incident and the bank
robbery case has therefore
been closed.
Lindsey Wilkes of the
GBI’s Eastman office, who
is working with Vidalia
Police in the investigation
of Caesar’s death as a ho
micide, said the teenager
was positively identified
by dental records. Authori
ties are actively conducting
interviews and pursuing
leads in the case.