MAY 2020

Vol. 22 No.5
6 Convalescent Plasma From Smallpox to
COVID-19

12 Government Actions in Response to the

Pandemic

14 Controversial Uses of Blood Components

Collection and
Transfusion of
Convalescent
Plasma
INTRODUCTION
TO MOLECULAR
IMMUNOHEMATOLOGY
An approachable guide
to molecular testing
ORDER
NOW in blood banking and
Introduction immunohematology.
to Molecular Molecular testing methods have become remarkable
Immunohematology tools for the resolution of challenging problems in
blood transfusion needs for patients with complex
diagnoses and evolving treatment modalities.
Sunitha Vege Michael S. Gannett
As these methods expand into more facilities, staff
Meghan Delaney
are increasingly using technology they may have not
Foreword by: Tony S. Casina
been trained to use or interpret.

This approachable and complete guide to molecular

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interpretation of a report from an IRL.

aabb.org/marketplace
Contents

6
Something Old, Something
New: Convalescent Plasma from
Smallpox to COVID-19
Variolation by the Chinese in the 10th century is a
precursor to the modern use of convalescent plasma to
treat severe COVID-19.

COLUMNS & INTERVIEWS

President’s Message

12 2 Getting Answers to the

Community Quickly
COVID-19: NBF: Shaping the Industry
Responding to 4 New #TeamBlood Program; Beth

the Pandemic
Shaz: Effects of COVID-19 and
NBF Grand on Career

Government agencies White Coats

are responding to 22 Krystalyn Hudson, PhD: Working
Toward a Better Understanding
the pandemic with of How Tolerance to RBC
collaborations, guidances Antigens Fail
and regulatory changes.
DEPARTMENTS
20 Significant Findings

14
24 PEP Talk
26 Of Note
Controversial 28 Calendar

Uses of Blood
Components
Some claim that blood products
can reverse the effects of aging
and repair orthopedic
injuries. What does
the research say?

AABB.ORG APRIL 2020 AABB NEWS 1

President’s
Message
Getting Answers to the
Community Quickly
D
uring these
difficult
times,
I'm sending you
warm wishes.
AABB, the Board
and I are here
to support you.
Please don't
hesitate to reach Beth Shaz, MD
out. We need to
remain connected in this time of social
distancing and continue working
together to fight COVID-19.
An Opportune Time to Focus on
Plasma
We typically plan AABB News far
in advance. When we started on this
issue, we couldn't know how much the
COVID-19 pandemic would upend our
lives. It's a coincidence that this month's
theme, blood components, comes when
one particular component — plasma —
has become a hot topic.
COVID-19 convalescent plasma
(CCP), the focus of the first feature,
is on the minds of many collection
and transfusion professionals and
the physicians treating patients with
COVID-19. Fortunately, there are quali-
ty studies happening worldwide to help
answer some of our many questions.
These questions came up during
a recent Twitter chat about collecting
CCP. I was pleased to see so many come
together to share information that
could help us fight this deadly disease.
A recent Facebook Live Q&A with
AABB Chief Medical Officer Claudia
Cohn, MD, PhD; and Diana Berrent, a
COVID-19 survivor and founder of the
grassroots organization Survivor Corps,
also centered on CCP.
2 AABB NEWS MAY 2020 AABB.ORG
Expanded Efforts to Reach the
Community
AABB is reaching out in new
ways to members of the health care
community, donors and the public,
especially those who have recovered
from COVID-19. Our new website for
clinicians, collectors and patients,
COVIDPlasma.org, spells out the
potential benefits of CCP and includes
links to connect potential donors to
their nearest collection centers.
At last month's Board meeting,
COVID-19 overshadowed every discus-
sion. A significant challenge facing our
community is the financial impact of
the pandemic. Without office visits and
elective surgeries, hospitals and blood
centers are facing financial hardship,
and blood centers don't know how and
when to scale up production. Board
members reported that our colleagues
need data — and they need it fast. We
hear you and will do everything in our
power to get you the information you
need as quickly as possible.
We’re also aware of concerns
about the upcoming 2020 AABB
Annual Meeting, scheduled for Oct.
3-6 in Baltimore. AABB is working
on contingency plans to minimize
financial and travel disruptions while
maximizing the meeting’s benefits
of learning, sharing knowledge and
connecting. 
Beth Shaz, MD
AABB President
MAY 2020 | Vol. 22 No. 5
President
Beth Shaz, MD
Chief Executive Officer
Debra BenAvram, FASAE, CAE
Vice President, Engagement
Julia Zimmerman
Director of Marketing and Communications
Jay Lewis, MPH
Managing Editor
Jerilyn Schweitzer, MA
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 MARK YOUR
CALENDAR!
2020 AABB
ANNUAL MEETING
OCTOBER 3-6
in Baltimore, Maryland

CONNECT WITH The 2020 AABB Annual Meeting is the premier meeting

AABB
connecting professionals in transfusion medicine and biotherapies,
while providing the information you need about groundbreaking

2020
research and practice-changing advancements. Expand your
knowledge while connecting with fellow attendees who share your
passion for the field.

Visit aabb.org/AnnualMeeting
for more information, OCTOBER 3-6
including meeting rates. aabb.org/AnnualMeeting
NBF: Shaping
the Industry
New #TeamBlood Program; Beth Shaz: Effects of
COVID-19 on Career
By Jerilyn Schweitzer, MA
Managing Editor
AABB and NBF Launch
New Initiatives to Foster
Community Engagement
AABB and the National
Blood Foundation are pleased
to introduce a new program,
#TeamBlood: In This Togeth-
er, to provide new ways for
members of the blood and
biotherapies communities to
connect during this time of forced separations. One
new offering, Share a Story, provides an opportuni-
ty for members to tell their account about working
during the COVID pandemic. These narratives can be
about happenings big or small, anything from a thank
you note to a novel intervention. Add your story about
the funny, the sad, the challenging or the generous via
the AABB website at aabb.org/teamblood. Stories may
appear in a future issue of AABB News.
The web page will also provide a means to dedicate
a donation in honor or memory of a friend or col-
league. Donations support innovative research that
could help launch the career of someone like Krysta-
lyn Hudson, the subject of this month's White Coats
column.
The pandemic is also creating financial hardship
for many in the community, especially those starting
a career. The NBF has introduced a means to spon-
sor AABB membership for a colleague who has been
forced to drop it. Contact the AABB Membership de-
partment for additional information at +301.215.6489
or membership@aabb.org.
Shared Stories in Quarantine: How Has
COVID-19 Affected You?
AABB President Beth Shaz, MD, is the executive
vice president and chief medical and scientific officer
at the New York Blood Center enterprises (NYBCe)
in New York. Being responsible for all medical and
scientific activities throughout the NYBCe, Shaz has
4 AABB NEWS MAY 2020 AABB.ORG
seen the pandemic unfold
from a broad vantage point.
Shaz told AABB News that
COVID-19 has had a drastic
impact on her work and NYBCe
as a whole. “NYBC employees
have been severely affected
by COVID-19 personally and
professionally,” she said.
“We are constantly adjusting
what we do — like stopping mobile blood drives,
increasing the collection of convalescent plasma and
changing the workplace environment — to protect
our employees and donors and to limit the destruction
from COVID on our community and nation.”
She said that she is thankful to have a phenomenal
team at NYBCe and to have met amazing individuals
through this experience, both in her community and
around the country. “Like Mordy and Chaim, who
have organized thousands of Orthodox Jews to donate
convalescent plasma and make sure we never have an
empty donor chair. They also help hospitals enroll in
the Mayo Clinic Expanded Access Protocol and edu-
cate physicians on the use of convalescent plasma,”
she said. “Like wonderful partners at Wadsworth
Center NYS Department of Health (Michael Ryan
and Victoria Derbyshire), Columbia University (Ian
Lipkin and Steve Spitalnik), Johns Hopkins Univer-
sity (Evan Bloch and Aaron Tobian) and Mayo Clinic
(Mike Joyner and Jeff Winters),” she added. “We are all
working together to help provide convalescent plasma
treatment and gain critical scientific knowledge.”
“Through all the death and destruction, there
is immense collaboration, respect and focus on
regaining the health of our community,” she
concluded. “We know we have to work together.”
Shaz received an NBF early-career Scientific
Research Grant in 2008, which she credits as being a
critical step in her academic career. She was inducted
into the NBF Hall of Fame in 2019. 
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Something Old,
Something New:
Convalescent Plasma
from Smallpox to
COVID-19
By Kerri Wachter
Contributing Writer

6 AABB NEWS MAY 2020 AABB.ORG

T
he concept of immunity to infectious diseases
has been around literally for centuries. The
ancient Greeks recognized that individuals
who had recovered from an infection would no longer
develop the disease when exposed again. In his
account of the Peloponnesian war, the Greek historian
Thucydides describes a plague — now considered by
many to have been smallpox — that ravaged Athens
around 430 B.C., noting that he himself had survived
the disease.
“Those who had recovered from the disease …
had now no fear for themselves; for the same man was
never attacked twice — never at least fatally.”
In the 10th century, there are reports from China
of collecting material from open sores of infected
patients, drying it and introducing it into the noses
of uninfected individuals with the hope of inducing
some immunity to the infection.1 This technique,
called variolation, is one of the forbears of today’s
modern vaccines and a close relation to convalescent
plasma (CP).
Fast forward several centuries to 2020, which
brought with it the coronavirus disease (COVID-19)
pandemic. At press time, there were 1.23 million
confirmed infections and 71,532 deaths from severe
acute respiratory syndrome coronavirus 2 (SARS-
CoV-2). Even as you read this article, experts around
the world are racing to identify treatments from
existing drugs and biologics, develop new treatments
and manufacture vaccines.
Convalescent plasma
— plasma collected from
individuals who have recovered
from a disease — has emerged
from history to become one of
the most sought-after treatments to minimize the
severity of COVID-19 symptoms. Patients and families
are desperate to find it. Physicians, other health care
professionals and hospitals are scrambling to secure
supplies for their sickest patients. Blood centers and
laboratories are working as fast as possible to identify
and screen potential donors, collect plasma and
run a battery of screening tests. AABB has worked
closely with federal regulators and other experts to
develop guidance and resources for blood and plasma
collection facilities.
What’s behind all of this excitement? CP is a simple
concept, similar to the way that a mother passes
protective antibodies to her newborn. CP is a form of
passive immunity that, when collected from someone
who has recovered from an infection, transfers
antibodies developed by the survivor’s body to
combat bacteria or viruses — in this case SARS-CoV-2
— passively to someone who has a current infection.2
The antibodies in the CP are released into the
recipient’s body and begin fighting the infection,
allowing a faster recovery. CP is not a cure, nor does
it offer prolonged immunity. The patient’s immune
system does not learn to recognize and destroy this
viral foreign invader, it simply borrows some measure
of protection from a recovered patient.
From Smallpox to Ebola
Variolation — typically using powdered pus
from an open wound —
was a known, but not well
understood, practice in the
late 1700s. Around that time,
the English began introducing
the infectious material into a

Left: Edward Jenner, an English physician, observed that milk-

maids infected with cowpox did not develop smallpox.
Center: Japanese physician and bacteriologist Shibasaburoˉ
Kitasato's work with tetanus helped found the field of immunology.
Right: Emil von Behring, working with Kitasato, developed "anti-
toxins" (now called antibodies) using blood serum that provided
protection against diphtheria and tetanus.

*Although Jenner has gone down in history as the first person to make the connection between cowpox and smallpox, and to provide vaccinations based
on this premise, he may not have been the first. In 1774, an English farmer named Benjamin Jesty recognized that two of his milkmaids, who had recovered
from cowpox, appeared to be immune to smallpox despite close exposure. Jesty — who had also recovered from cowpox — vaccinated his wife and two sons
in 1789 using cowpox pus from a neighbor’s cows. The family avoided infection during a local outbreak of smallpox. (Summary from “The Myth of the Medical
Breakthrough: Smallpox, Vaccination, and Jenner Reconsidered,” Cary Gross, MD; and Kent A. Sepkowitz, MD)

AABB.ORG MAY 2020 AABB NEWS 7

 small puncture wound in the patient. Variolation,
which had a number of proponents advocating its
use to avoid smallpox, had a downside, as well: the
prospect of infecting the recipient with full-blown
infection.3
The English surgeon Edward Jenner is credited
with performing the first vaccination in 1794, after
hearing about milkmaids who were immune to
smallpox after being infected with the closely related
cowpox virus, ushering in the era of vaccinations.4
Work by Japanese physiologist Shibasaburō
Kitasato and German physiologist Emil von Behring
in the late 1800s led to the use of blood serum to
treat diphtheria.5 Serum differs from plasma in that
its clotting factors have been removed. Antibody-
containing serum was first collected from animals,
before the use of human whole blood donations.6
While research continued in the early 1900s on
the use of blood products to prevent or treat other
diseases, the Spanish influenza pandemic triggered
a number of studies of CP as a potential treatment for
various viral infections. Since then, CP has been tried
— with mixed results — as a treatment for infectious
agents ranging from influenza and chickenpox to the
2013-2016 Ebola virus outbreak in Western Africa.
The Evidence for Convalescent Plasma
At least 27 reports assessed the use of CP during the
1918 influenza pandemic (also known as the Spanish
flu), according to a 2006 meta-analysis of the findings.8
Only eight studies met the inclusion criteria, and data
quality was considered poor. Nonetheless, patients
who received CP faired considerably better than
controls, with overall crude case-fatality rates of 16%
and 37% respectively.
In 2013-2016, an Ebola virus outbreak ravaged
Western Africa, reaching as far away as the United
States. More than 11,300 deaths occurred as a result
of the highly contagious and often fatal Ebola virus
disease, a hemorrhagic illness spread through contact
with infected animals or bodily fluids from infect-
ed humans.9 Despite a handful of successful cases
of convalescent plasma treatment,10, 11 results were
generally disappointing for this approach.12 No sig-
nificant improvement was seen in a non-randomized
trial of 99 patients in Guinea.13
However, CP did prove to reduce mortality risk
in a meta-analysis of 32 studies of SARS coronavirus
infection and severe influenza.14
Enter COVID-19
In the midst of the worldwide COVID-19 pandemic,
preliminary evidence suggests that CP may lessen
the severity of COVID-19. A study from Shenzhen,
8 AABB NEWS MAY 2020 AABB.ORG
China reported a preliminary uncontrolled study
of five severely ill patients with COVID-19 who were
treated using COVID-19 convalescent plasma (CCP).
The patients continued to receive antiviral treatment
along with CCP.15 Their condition improved and
antibody titers (both specific to SARS-CoV-2 and
neutralizing antibodies) increased. A similar study
(though not peer reviewed or published at press time)
from Wuhan province in China — where the virus is
thought to have originated — six patients with severe
disease were treated with CCP.16 Clinical condition
improved and antibody levels rose in these patients as
well.
In early March, immunology and infectious
disease specialists Arturo Casadevall, MD, PhD, and
Liise-anne Pirofski, MD, laid out the case for the use
of CCP to treat COVID-19 in the Journal of Clinical
Investigation and urged emergency use of CCP as soon
as possible.17
In early April 2020, the Food and Drug
Administration announced a program to expand
national access to investigational CCP for patients
hospitalized with severe or life-threatening
COVID-19, or those at high risk of progression to
severe or life-threatening disease.18 The program
facilitates access to CCP and hyperimmune globulin
(hyper-IG) — a blood product made from CCP — using
multiple pathways. FDA’s initial effort was focused
on facilitating access to CCP through an emergency
investigational new drug (IND) process.
FDA and industry, academic and government
partners developed and implemented a protocol to
provide CCP to patients who may not have access to
institutions with clinical trials in place. The Biomed-
ical Advanced Research and Development Authority
(BARDA) also announced it will collaborate with electronic medical record. “There has also been extra
multiple non-government organizations to develop work for study coordinators and nurses as they learn
investigational treatments, including convalescent about CCP. Finally, the social workers, nurses and
plasma and hyperimmune globulin, from the plasma doctors have been educating patients as they recover
of those who have recovered from COVID-19. from COVID, in the hope that they will donate CCP 14
From a blood collector’s perspective, much of to 28 days after they are symptom-free.”
the plasma collection process is the same as usual. Unfortunately, while the demand for CCP is high,
“We’re trying to do this through the normal supply the potential donor pool lags. “This is happening in
chains, where a physician orders a unit of fresh frozen real time,” said Joyner. “If you look at the requirements
plasma for one of their patients in a hospital. The to qualify as a donor, the first donors who are now
collection goes through the normal process in a blood eligible would have had to have been infected in early
facility, and it’s delivered to a hospital from their March. This donor pool is always going to be delayed
normal supplier,” said Michael J. Joyner, MD, a Mayo — 21 days behind the crest of a wave.”
anesthesiologist who is the principal investigator for
the Expanded Access to Convalescent Plasma for the Reaching out to Donors
Treatment of Patients With COVID-19 protocol. FDA is encouraging individuals who have
“The problems with convalescent plasma are recovered from COVID-19 to contact their local
logistical: getting people identified, getting it blood collection center to discuss CCP donation.
collected, getting it distributed in a safe way that Preliminary findings indicate that CCP has the
is consistent with blood banking systems and potential to lessen the severity or shorten the length of
procedures,” said Joyner. “You’ve got to take that extra illness caused by COVID-19. Agency representatives
step of screening a potential donor to determine if emphasized that those who have recovered from
the person was COVID positive; that they’ve been COVID-19 could have an immediate impact in
convalescing for the required amount of time; and helping others who are severely ill, noting that one
that they are either negative on a second COVID-19
test or they’re 21-28 days post recovery,” he said.
To qualify as a donor, a recovered COVID patient
must prove they have had the disease. This means “FDA is encouraging individuals who have
either a positive viral test when they were ill or a
positive antibody test drawn 14-28 days after they
recovered from COVID-19 to contact their local
recovered and were symptom-free. Blood centers will blood collection center to discuss CCP donation.
ask for proof of these tests when someone signs up to Preliminary findings indicate that CCP has the
donate, but most blood centers will do the antibody
test on the day of donation, if necessary.
potential to lessen the severity or shorten the
Claudia Cohn, MD, PhD, director of the blood bank length of illness caused by COVID-19.”
laboratory at the University of Minnesota Medical
School agreed. “It seems that the
largest barrier to collections has
been the FDA requirement to
have laboratory proof of a COVID
diagnosis for donation. The test
shortage has left thousands of
recovered patients with no proof
that they were infected with the
SARS CoV 2 virus.”
Collection and distribution
of CCP have also required
“significant work for IT
professionals as new component
codes were added to our
laboratory information system,”
said Cohn. At the University of
Minnesota lab, IT developed and
validated a new order set in the

AABB.ORG MAY 2020 AABB NEWS 9

 donation has the potential to help up to four patients.
In addition, CCP can be used to manufacture hyper-
IG, which can likewise be used to treat patients with
COVID-19. Individuals who have fully recovered
from COVID-19 and been asymptomatic for at
least 2 weeks can contact their local blood center to
schedule an appointment. AABB’s COVIDplasma.
org web page features additional resources and
a blood bank locator for potential CCP donors, as
well as information for blood centers and hospital
transfusion services.  6. Ibid
Finding Survivors Without Symptoms
It is impossible to know how many individuals
who never had symptoms have recovered from a
COVIC-19 infection, although they undoubtedly
exist. Investigators at the National Institutes of Health
(NIH) have launched a new study to help determine
how many adults in the U.S. without a confirmed
history of infection have antibodies to the virus.
Investigators will collect and analyze blood
samples from as many as 10,000 volunteers to help
illuminate the extent to which the novel coronavirus
has spread in the U.S. and provide insights into which
communities and populations are most affected.
Healthy adults from anywhere in the U.S. can
participate, although individuals with a confirmed
history of COVID-19 or current symptoms consistent
with COVID-19 are ineligible. Those interested
may volunteer to join the study by contacting
clinicalstudiesunit@nih.gov.
The ability to screen individuals, especially
potential blood donors, to identify those with
antibodies to COVID-19 could significantly increase
the number of patients receiving CCP. Depending on
the as-yet-undetermined persistence of CCP-related
immunity, such a test and other necessary screening
tools could buy enough time to develop and rigorously
test an effective and safe vaccine. 
COVIDPlasma.org is AABB’s primary resource to educate interested donors, the health care community and the
public on the rapidly evolving therapy of COVID-19 convalescent plasma.
Additional information for AABB members is available on AABB's Coronavirus Resources web page at
Advocacy > Regulatory Affairs > AABB's Coronavirus Resources.
10 AABB NEWS MAY 2020 AABB.ORG
ENDNOTES
1. Gross CP, Sepkowitz KA. The myth of the medical breakthrough:
smallpox, vaccination, and Jenner reconsidered. Int J Infect Dis.
1998;3:54-60.
2. Ibid
3. U.S. National Library of Medicine. Small Pox: A Great and Terrible
Scourge. Last updated: July 30, 2013 https://www.nlm.nih.gov/
exhibition/smallpox/sp_variolation.html
4. Gross
5. Marano G, Vaglio S, Pupella S, et al. Convalescent plasma: new
evidence for an old therapeutic tool? Blood Transfus. 2016;14:
152–157.
7. Ibid
8. Luke TC, Kilbane EM, Jackson JL, et al. Meta-Analysis:
Convalescent Blood Products for Spanish Influenza Pneumonia: A
Future H5N1 Treatment?. Ann Intern Med. 2006;145:599–609.
9. U.S. Centers for Disease Control and Prevention, 2014-2016 Ebola
Outbreak in West Africa. Last reviewed: March 8, 2019. https://
www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html
10. Mora-Rillo M, et al. Acute respiratory distress syndrome after
convalescent plasma use: treatment of a patient with Ebola virus
disease contracted in Madrid, Spain. Lancet Respir Med. 2015.
doi:10.1016/S2213-2600(15)00180-0
11. Feldmann, H., Jones, S., Klenk, H. et al. Ebola virus: from
discovery to vaccine. Nat Rev Immunol 2003;3, 677–685.
12. Colebunders RL, Cannon RO. Large-scale convalescent blood and
plasma transfusion therapy for Ebola virus disease. Infect Dis.
2015;211:1208-10.
13. van Griensven J, Edwards T, de Lamballerie X, et al. Ebola-Tx
Consortium, Evaluation of convalescent plasma for Ebola virus
disease in Guinea. N. Engl. J. Med. 2016;374:33–42.
14. Mair-Jenkins J, Saavedra-Campos M, Baillie JK, et al. Convalescent
Plasma Study Group, The effectiveness of convalescent plasma
and hyperimmune immunoglobulin for the treatment of severe
acute respiratory infections of viral etiology: A systematic review
and exploratory meta-analysis. J. Infect. Dis. 2015;211:80–90.
15. Shen C, Wang Z, Zhao F, et al. Treatment of 5 Critically Ill Patients
With COVID-19 With Convalescent Plasma. JAMA. Published online
March 27, 2020. doi:10.1001/jama.2020.4783
16. Ye M, Fu D, Ren Y, et al. Treatment with convalescent plasma for
COVID‐19 patients in Wuhan, China. J Med Virol. 15 April 2020.
https://doi.org/10.1002/jmv.25882
17. Casadeval A and Pirofski LA. The convalescent sera option for
containing COVID-19. J Clin Invest. 2020;130(4):1545–1548.
18. F DA News Release, Coronavirus (COVID-19) Update: FDA
Coordinates National Effort to Develop Blood-Related Therapies
for COVID-19 https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-fda-coordinates-
national-effort-develop-blood-related-therapies-covid-19
Research Is Just
the Beginning
Future medical breakthroughs depend on the
innovative research of today.
Support advances in patient and donor care when you donate to the AABB’s National Blood Foundation (NBF).
The NBF has provided more than $9 million to fund the early-stage research of more than 200
investigators. This research has formed a basis for advanced treatments across many disciplines,
including pediatrics, oncology, cardiology and transplantation.

Give to the future of patient and donor care – Donate to the National Blood Foundation today.

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 High
Priority
COVID-19: Responding to the Pandemic
By Drew Case
Communications Manager
BARDA Announces Partnerships to Develop
Investigational COVID-19 Therapies
The Biomedical Advanced Research and Devel-
opment Authority (BARDA), part of the United States
Department of Health and Human Services’ (HHS)
office of the Assistant Secretary for Preparedness
and Response, announced a new collaboration with
multiple non-government organizations to develop
investigational treatments for coronavirus disease
2019 (COVID-19). The products in development
include COVID-19 convalescent plasma (CCP) and
hyperimmune globulin, both developed from the
plasma of people who have recovered from COVID-19.
BARDA is collaborating with the American Red
Cross and America’s Blood Centers to ensure the
collection and distribution of convalescent plasma
across the country. The agency will also partner with
Emergent BioSolutions to collect donated plasma and
manufacture COVID-19 hyperimmune globulin and
with both the Department of Defense’s Joint Program
Executive Office for Chemical, Biological, Radiologi-
cal and Nuclear Defense (JPEO-CBRND) and Grifols
to collect plasma and manufacture CCP and hyper-
immune globulin.
Additionally, BARDA announced a new partner-
ship with JPEO-CBRND and SAb Biotherapeutics to
develop a new immunotherapy called SAB-185, which
is produced from human antibodies without plasma
donated from recovered patients. This approach pro-
duces greater quantities of the product than traditional
methods that rely on donated blood. BARDA could sup-
port a phase 1 clinical trial for initial testing in humans.
CMS Announces Expanded COVID-19 Testing,
Changes to Medicare Payment Programs
The Centers for Medicare and Medicaid Services
(CMS) recently announced several regulatory
12 AABB NEWS MAY 2020 AABB.ORG
waivers and rule changes to deliver expanded care
to Medicare and Medicaid beneficiaries and provide
flexibility to the health care system in response to
the COVID-19 pandemic. The agency announced
the actions to help ensure that states and localities
have the flexibility they need to ramp up diagnostic
testing and access to medical care — key precursors
to ensuring a phased, safe and gradual reopening
of the country. These changes include new rules to
support and expand COVID-19 diagnostic testing for
Medicare and Medicaid beneficiaries. Medicare will
now cover COVID-19 testing when ordered by any
health care professional authorized to do so under
state law. A written practitioner’s order is no longer
required for the COVID-19 test for Medicare payment
purposes, as well.
Medicare and Medicaid will also cover certain
serology tests, which may help determine whether
a person has developed an immune response
and might not be at immediate risk for COVID-19
reinfection. Medicare and Medicaid will cover
laboratory processing of certain tests authorized by
the Food and Drug Administration that beneficiaries
self-collect at home. Additional actions aim to
increase hospital capacity, expand the health care
workforce and reduce administrative burden.
These changes take effect immediately and will
last throughout the duration of the public health
emergency declaration.
CMS also announced its suspension of an ad-
vanced payment program to Medicare Part B sup-
pliers, effective immediately and plans to reevaluate
the amounts paid to health systems under an accel-
erated payment program, through which CMS has
paid health providers and suppliers more than $100
billion since March 28. Funding remains available to
hospitals and other health care providers responding
to COVID-19 through the provider relief fund.
CBER Issues Updated Letter to Sponsors,
Applicants and Regulated Entities on
COVID-19
The Center for Biologics Evaluation and Research
(CBER) updated a March 27 letter to sponsors,
applicants and regulated entities outlining the
agency’s efforts to advance the national response
to the COVID-19 pandemic. CBER converted in-
person meetings with industry representatives to
teleconferences through May 29. The agency will
continue to assess whether in-person meetings
scheduled later than May 29 should be converted to
teleconferences and will provide periodic updates.
In addition, CBER’s document control center
ceased processing paper submissions received after
Wednesday, April 29, until further notice. CBER
strongly encourages sending submissions through
FDA’s preferred secure method of transmission, the
Electronic Submissions Gateway.
FDA, EC Issue Updated Guidances on
Conducting Clinical Trials During COVID-19
Pandemic
FDA recently added additional questions and
answers to the appendix of its March 2020 guidance
on conducting clinical trials during the COVID-19
pandemic. The guidance provides recommendations
on obtaining informed consent during the pandemic,
considerations for remote clinical outcome
assessments, remote site monitoring and electronic
common technical document waivers. The European
Commission (EC) also updated its guidance on
managing clinical trials during the pandemic to
include advice on distributing medicine to patients
participating in clinical trials, remote source data
verification and communicating actions to protect
trial patient safety with authorities.
House Members Release Concept Paper
to Improve Health Care Delivery, Pandemic
Response
Reps. Diana DeGette (D-Colo.) and Fred Upton
(R-Mich.) released a concept paper for their bipartisan
“Cures 2.0” effort, which aims to safely and efficiently
modernize the delivery of health care in the wake of
the coronavirus pandemic. Cures 2.0 is the follow-up
legislation to the bipartisan 21st Century Cures Act,
enacted in 2016, which aimed to accelerate the discov-
ery and development of new medicines and devices.
In the paper, DeGette and Upton address six high-
level focus areas comprising several topics of interest
to AABB members, including the following:
• I mproving the nation’s surveillance and testing
capabilities to support the U.S. response to the
COVID-19 pandemic, as well as future pandemics.
• Supporting innovative clinical trial design.
• Improving FDA-CMS communication regarding
transformative new therapies.
• Requiring HHS to establish a regulatory
framework for the recognition and utilization of
real-world evidence.
• Modernizing coverage and reimbursement
approaches for new medical products.
• Addressing barriers to coverage and patient
access to new cell and gene therapy products.
AABB will continue to monitor the development
of this bill and update members as new information
becomes available.
FDA Accepts Version 2.1 DHQ; AABB Issues
Association Bulletin #20-04
FDA formally recognized AABB’s version
2.1 full-length and abbreviated Donor History
Questionnaires (DHQs) as acceptable mechanisms
for collecting blood donor history information from
donors of blood and blood components. The scope of
revisions in these versions and related materials were
limited to those necessary for FDA’s expedited review
of recommendations to address the urgent need for
blood during the pandemic.
This expedited timeline captured
recommendations related to HIV risk, variant
Creutzfeldt-Jakob disease and malaria; it did not
permit a review of the full version 3.0 update planned
by the AABB Donor History Task Force (the DHTF),
including new donor eligibility questions related to
prophylactic use of HIV medications. Consequently,
it is necessary to capture these donor eligibility
questions at the end of the v2.1 DHQ, as described
in Association Bulletin (AB) #20-04, The Impact on
Blood Safety of Effective Antiretroviral Medications
for HIV Prevention and Treatment, which AABB
released concurrently to reduce the operational
complexity of implementing multiple updates.
These recommendations were developed by the
Transfusion Transmitted Diseases Committee and
the DHTF. AABB Regulatory Affairs also developed a
DHQ v2.1 Implementation Toolkit to help members
identify changes in DHQ v2.1 and related materials.
Facilities may contact regulatory@aabb.org with
any questions regarding the v2.1 DHQs and Related
Materials and their FDA consumer safety officer with
questions regarding implementation. 
AABB.ORG MAY 2020 AABB NEWS 13