15 JANUARY

Donald Kaye, Section Editor

News
From the section editor: There has been
so much fast moving news on ebola that I
decided to cover succinctly a number of
stories that are of interest but have not
been front page news.
New York Unveils Incentives
for Workers in West Africa
Ebola Fight
14 October 2014 (Reuters [Ellen Wulfhorst])New York ofcials on Thursday
announced a program to encourage healthcare professionals to work in Ebola-hit
West Africa, an effort to deect criticism
that the states mandatory quarantine could
hamper the battle against the disease.
The program will provide nancial incentives and employment protections
similar to the benets and rights provided to military reservists, New York
Governor Andrew Cuomo and New York
City Mayor Bill de Blasio said in a joint
statement.
Copyright 2014 Reuters Limited. All rights reserved.

Editorial comment. This is a welcome

step to soften the initial harsh mandatory
quarantine policy enacted in New York
and New Jersey.
Judge Rejects Strict Limits on
US Nurse Who Treated Ebola
Patients
14 October 2014 (Reuters [Joel Page])
Declaring Ebola fears in the United States
not entirely rational, a judge rejected
Maines bid for a quarantine on a nurse
who treated victims of the disease in
West Africa but tested negative for it,
and instead imposed limited restrictions.

Nurse Kaci Hickoxs challenge of the

Maine quarantine became a key battleground for the dispute between ofcials
in some US states who have imposed strict
quarantines on health workers returning
from 3 Ebola-ravaged West African countries and the federal government, which
opposes such measures.
Maine Governor Paul LePage said that
while he was disappointed by the order
from Charles LaVerdiere, the chief judge
of Maine District Court, the New England state would abide by it.
US public concern about the virus is
high even though only one person in
the country is currently being treated
for it, a New York doctor, Craig Spencer,
who cared for patients in West Africa.
Copyright 2014 Reuters Limited. All rights reserved.

Editorial comment. The characterization of Ebola fears as not entirely rational is generous.
Aethlon Medical Discloses
Ebola Treatment Pathways in
the United States
29 October 2014 (PRNewswire)Aethlon
Medical, Inc, the pioneer in developing
targeted therapeutic devices to address
infectious disease and cancer, disclosed
today that it will provide Hemopurier
therapy under US Food and Drug Administration (FDA) compassionate use
access provisions to support potential requests by qualied physicians and institutes that may seek to treat Ebola virus
infection in the United States.
The Aethlon Hemopurier is a rstin-class bio-ltration device that targets
the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals.
Aethlon also disclosed that it plans to
submit its rst Ebola treatment data to the

FDA as a means to support the goal of further expanding treatment access through
emergency use regulatory pathways.
On 14 October 2014, the company announced that Hemopurier therapy had
been administered to an Ebola-infected
patient at Frankfurt University Hospital
in Germany.
In the care of Ebola-infected individuals, the Hemopurier targets 2 unmet
medical needs: the rapid elimination of
circulating viruses to inhibit continued
progeny virus replication and the direct
targeting of shed glycoproteins that overwhelm the host immune response. The device can be deployed for use within the
global infrastructure of dialysis and continuous renal replacement therapy machines
already located in hospitals and clinics.
To date, Hemopurier therapy has
been successfully administered in approximately 100 treatment experiences
in health-compromised HIV and hepatitis C virus-infected individuals. These
studies were conducted in India. In vitro
validation studies that demonstrated the
ability of the Hemopurier to capture
Zaire and other strains of Ebola virus
were conducted by researchers at the
United States Army Medical Research Institute for Infectious Diseases and the
United States Centers for Disease Control
and Prevention.
Editorial comment. This is a novel approach to viremic diseases that has been
reported in the literature (Tullis et al, Reduction of hepatitis C virus using lectin
afnity plasmapheresis in dialysis patients, Blood Purif 2009; 27:649).
Flublok Inuenza Vaccine Now
Approved for Adults Ages 18
and Older
29 October 2014 (PRNewswire)Protein
Sciences Corporation announced today

NEWS

CID 2015:60 (15 January)

that the US Food and Drug Administration (FDA) has approved Flublok inuenza vaccine for all adults aged 18 years
and older, granting approval for use in
people 50 and older under the accelerated
approval of biological products regulations. Flublok is the only licensed u
vaccine that is made using modern recombinant technology and the only u
vaccine that is 100% egg-free and highly
puried. It also contains 3 times more
active ingredients than traditional u vaccines. The expanded age indication means
Flublok is now available for everyone over
50 who has been waiting patiently to receive his or her vaccine.
Lisa Dunkle, MD, Chief Medical Ofcer of Protein Sciences, said, Flublok has
been shown to induce high antibody levels in seniors.
Dr Manon Cox, MBA, President and
CEO of Protein Sciences, said Flublok
is a modern vaccine with particular benets to individuals who want (need) to
avoid exposure to egg proteins, gelatin,
latex, formaldehyde, or antibiotics as Flublok is free of all of these unnecessary and
avoidable components.
Earlier this year the FDA approved a
shelf life extension for Flublok to 6 months.
Flublok is available at Passport Health
locations nationwide and select pharmacies, clinics, and doctors ofces. A
list of locations can be found at www.
ublok.com. Healthcare professionals
seeking Flublok should contact FFF
Enterprises at 800-843-7477 or online at
www.myuvaccine.com. FFF Enterprises
will begin shipment immediately or delivery dates can be specied.
Editorial comment. Flublok is a trivalent inuenza vaccine that has the advantages of high antigen dose and no
egg products.
Pzer Meningitis Vaccine Wins
US Approval
14 October 2014 (Reuters [Ransdell
Pierson])Pzer Inc has won US approval
for its Trumenba vaccine against menin-

ii

CID 2015:60 (15 January)

NEWS

gitis, the US Food and Drug Administration (FDA) said.

Trumenba, approved in individuals 10
to 25 years of age, has been considered
one of the most important products in
Pzers drug pipeline. It was granted accelerated approval following tests in
4500 people in the United States, Europe,
and Australia.
It is the rst approved US vaccine that
prevents invasive disease caused by the
bacterium Neisseria meningitidis B, a
strain that causes disease globally in an
estimated 20 000 to 80 000 people a
year, and accounts for an estimated 40%
of meningitis infections in the United
States, according to Pzer.
Pzer and Swiss drugmaker Novartis
had both won the FDAs coveted breakthrough therapy designation for their
rival meningitis B vaccines and were racing for the rst FDA approval.
Copyright 2014 Reuters Limited. All rights reserved.

Editorial comment. Ironically, the vaccine against N. meningitidis B that was

used on US campuses was Bexsero made
by Novartis.
Update on Lyme Carditis,
Groups at High Risk, and
Frequency of Associated
Sudden Cardiac DeathUnited
States
(MMWR 63:9823, 2014)On 13 December 2013, MMWR published a report
describing 3 cases of sudden cardiac
death associated with Lyme carditis.
State public health departments and the
Centers for Disease Control and Prevention (CDC) conducted a follow-up investigation on Lyme carditis. For surveillance
purposes, Lyme carditis is dened as acute
second-degree or third-degree atrioventricular conduction block accompanying a diagnosis of Lyme disease. During 2001
2010, a total of 256 373 Lyme disease case
reports were submitted to CDC, of which
174 385 (68%) included clinical information. Among these, 1876 (1.1%) were

identied as cases of Lyme carditis. Median

age of patients with Lyme carditis was 43
years (range = 199 years); 1209 (65%) of
the patients were male, which is disproportionately larger than the male proportion
among patients with other clinical manifestations (P < .001); 69% were diagnosed
during the months of JuneAugust, and
42% of the patients had accompanying
erythema migrans. Relative to patients
aged 5559 years, carditis was more common among men aged 2039 years, women
aged 2529 years, and persons aged 75
years.
In a convenience sample of cases meeting the surveillance case denition for
Lyme disease or Lyme carditis, among
121 894 cases reported during 19952013
(120 198 cases with any form of Lyme disease and 1696 cases with carditis specied), 702 (0.6%) died from all causes
within a year of Lyme disease diagnosis.
The observed all-cause mortality for
these 121 894 patients is below the predicted age-adjusted, all-cause mortality for this
population based on national, age-adjusted
death rates. Two of these deaths (0.002% of
the total) were classied as suspected cases
of Lyme carditisassociated mortality.
The 2 suspected cases in this report occurred during JuneNovember in 2 men
in their 40s and 50s. Presenting symptoms included fatigue, malaise, muscle
and joint pain, shortness of breath, chest
pain, and syncope. Both patients experienced cardiac arrest within 6 weeks of
Lyme disease symptom onset. One patient reported erythema migrans, and
both had clinical evidence of disseminated infection. Comorbidities included hypertension, diabetes, and hyperlipidemia.
Thus 2 additional suspected sudden
cardiac deaths associated with Lyme carditis were discovered, bringing the total
number of cases identied during this
investigation to 5 (3 conrmed and 2
suspected).
Published by Oxford University Press on behalf of the Infectious
Diseases Society of America 2014.
DOI: 10.1093/cid/ciu910