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Thursday,
August 20, 2009
- Maryland /
Regional
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Testing begins on experimental flu vaccine for children
(Baltimore Sun)
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Pregnant Women in D.C. Area Cautious About Flu Shot
(Washington Post)
-
Employers Advised on Swine Flu; Local Colleges Making
Plans
(Washington Post)
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Officials may recommend 3 flu shots
(Baltimore Sun)
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- National /
International
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Study: Vaccinating school kids best to stop flu
(Associated Press)
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Flu
fighters battle pandemic online
(Reuters)
-
- Opinion
- ----
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- Maryland /
Regional
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Testing begins on experimental flu vaccine for children
- Parents, children volunteer for clinical trials
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- By Stephanie Desmon
- Baltimore Sun
- Thursday, August 20, 2009
-
- On one of his last days of summer vacation, Hunter
Sears would have preferred to still be in bed at 10
a.m., or maybe just settling in for a few good hours of
television.
So why, exactly, was the 13-year-old Anne Arundel County
boy sitting in his Annapolis pediatrician's office
yesterday, his orange T-shirt rolled up to his shoulder
as a nurse first took blood from his arm and then gave
him a shot he didn't need to get?
Hunter was pediatric volunteer No.1 of an expected 600
nationwide for an experimental vaccine against the H1N1
influenza virus, a new strain of flu that appeared in
April and which officials fear will be widespread come
fall. But before a mass vaccination can be rolled out -
one that could involve hundreds of millions of
inoculations - hundreds of adults and children have
volunteered for clinical trials to test the vaccine's
safety.
Officials with the University of Maryland, Baltimore,
which is running the trials, strongly believe the
vaccine is harmless.
"There really is no scientific rationale to believe it
is going to be unsafe," said Dr. Wilbur Chen, a flu
researcher at the at Maryland's Center for Vaccine
Development, who was handling some of the trial
paperwork yesterday. "The vaccine is being manufactured
in exactly the same way as the seasonal flu vaccine,"
which is approved for children 6 months and older.
Still, the vaccine is considered experimental, not yet
approved by the Food and Drug Administration and could
have unknown risks; that's why it is being tested on a
small group first.
While being on the cutting edge of something unproven
might be frightening for some parents, especially when
the trial starts with babies as young as 6 months old,
many have lined up to put their kids' arms out to
further science. Besides, some said, if there's a
shortage of vaccine coupled with a severe swine flu
outbreak, they won't have to worry. Their children will
already be protected - and they won't have to miss
school and sports.
"If it works, then we have a leg up," said Kate Houley,
an Annapolis mother who signed up her three boys - ages
7, 10 and 11 - for the trial. "If it doesn't, it
doesn't. And these guys don't really mind shots."
Researchers have only had difficulty recruiting one
group of children: those ages 6 months to 3 years; about
20 are needed locally. Some parents might be more
reluctant to give babies and toddlers an unproven
vaccine, researchers said. And parents of such young
children might already be overburdened with doctors'
appointments, and unwilling to participate in a trial
that would require an extra three (as well as taking the
child's temperature daily).
A total of 600 children will be enrolled by Maryland and
five other sites around the country to test the
pediatric vaccine. For years, little medical research
was done on children due to worries about what might
happen to them. But this put them at a disadvantage, as
doctors were left without guidance as to how much of a
certain medication, for example, a sick child should
receive.
Dr. Holly Taylor, who is on the faculty at the Johns
Hopkins Berman Institute of Bioethics, said many factors
have to be considered when determining whether something
should be tested on children, but the risk to the child
should be as small as possible, and there should be a
benefit to the child and to children at-large.
"We're always more careful when we conduct research with
children," she said. "We learned a long time ago that
kids are not mini-adults and might have different kinds
of responses" to medications or vaccines than adults.
On Tuesday, the National Institute of Allergy and
Infectious Diseases said it had reviewed enough data
from adult trials of the H1N1 vaccine that began two
weeks ago to determine there were "no safety concerns in
those trials that would preclude trials from proceeding
in children."
The children being tested in Maryland will receive
vaccines at three sites: pediatric practices in
Annapolis, Frederick and at the University of Maryland,
Baltimore. They will get either 15 or 30 micrograms per
shot and two doses spaced three weeks apart. Older
children will have their blood drawn over five separate
visits. For their trouble, the children will receive $40
Target gift cards at each visit - not a small carrot,
several said.
"The purpose of these tests, yes, are to assess whether
there are any safety issues or reactions to these
vaccinations," Chen said. "Our real scientific question
is what are the best doses of vaccine to use for these
vaccines because we have a limited supply and the
government wants to know how to use this best come
October."
Officials had planned to have 120 million doses
available in October, but factory problems have cut that
estimate to 45 million doses. Chen expects to start a
trial next month that would add a substance called an
adjuvant to the vaccine, which is designed to boost the
effectiveness of the inoculation. That could mean
smaller doses of vaccine would be needed for each person
and more people could ultimately be vaccinated. But the
adjuvant has not been approved for use in the United
States as it has been in Europe and Chen worries it
could be controversial.
In the exam room, with 11-year-old Ethan waiting for his
shot, Houley said even though the H1N1 vaccine is
technically experimental, she doesn't see it that way.
"It's not like if you have cancer or something and
you're going through an experimental drug trial - that's
experimental," she said. "This is a flu vaccine. I
didn't think about it ... as a huge risk. If I did, I
wouldn't be here with my kids."
Hunter Sears was there because of his grandmother,
Gladys Sears, who has worked at Annapolis Pediatrics for
46 years. In 1976, when there was a different swine flu
outbreak, she got vaccinated. The next day, the
government canceled the vaccination campaign, in part
because it appeared to be making some people sick. That
didn't color her opinion of whether her grandson should
enroll in the study.
"After years of working here, I don't worry about things
like that," she said. "Some people have to be guinea
pigs."
Research nurse Linda Wadsworth, who gave the H1N1
vaccine to adult subjects last week, had new concerns
with the kids. Would they cry? More importantly, which
bandages did they want: multicolored, animal print or
Nemo?
Hunter, with his sandy mop-top practically covering his
eyes, looked away as nurse Tamekah Godfrey slipped the
needle into his bicep. He didn't react when she was
done.
After a bit, he asked: "You already put it in?"
"Yeah," answered another nurse, Kathy Cantrell. "You did
great."
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- Copyright © 2009, Baltimore Sun.
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Pregnant Women in D.C. Area Cautious About Flu Shot
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- By Annie Gowen
- Washington Post
- Thursday, August 20, 2009
-
- They are usually urged not to drink coffee, sip wine
or pop aspirin. But now pregnant women find themselves
high atop the federal government's priority list for
those who ought to receive the new swine flu vaccine --
a prospect that some mothers-to-be are greeting with
caution.
-
- Although the vaccine is in clinical trials and won't
be available until fall, expectant moms in the region
are starting to ask their doctors, and each other,
whether the H1N1 vaccine is safe for them and their
babies. Swine flu questions now mingle with sale notices
for strollers and nanny postings on local community
e-mail lists.
-
- The Centers for Disease Control and Prevention and
the American College of Obstetricians and Gynecologists
are recommending that all pregnant women be vaccinated
against swine flu after a study in the Lancet medical
journal last month showed that pregnant women are four
times more likely to be hospitalized from the disease
than people in general. Fifteen swine flu patients in
the United States were expectant mothers -- about 6
percent of all swine flu deaths reported to the CDC.
Pregnant women make up 1 percent of the U.S. population.
-
- The CDC and the obstetricians' group have long urged
pregnant women to get the seasonal flu vaccine and said
it is safe for all trimesters. But a surprisingly low
number -- less than 15 percent -- do so, according to
the CDC. That's in part because some expectant mothers
are loath to get vaccines or take over-the-counter
medicines, experts said.
-
- Maggie Little, director of the Kennedy Institute of
Ethics at Georgetown University, who has written
extensively about pregnancy and risk, said there is
often a strong reticence by pregnant women and providers
to take medications -- even ones that are relatively
low-risk.
-
- The culture "tends toward perfectionism and control
around pregnancy," Little said. "Pregnant women drive
themselves crazy sometimes, doing more harm than good,
like not taking the medication they need."
-
- She is worried about the consequences of that
mindset, warning that "if we get a bad resurgence of the
flu and these women don't get vaccinated, we're going to
have a lot of dead mommies and babies."
-
- Acadia Roessner, 31, a D.C. resident and government
contractor pregnant with her second child, said she was
"still a little bit on the fence" about whether to get
the vaccine but is leaning toward getting it if it is
deemed safe. Her due date is in January, so she wonders
whether she could avoid the vaccine and remain flu-free
for the last eight weeks of her pregnancy just by being
careful, washing her hands and taking Vitamin C.
-
- "Certainly it's not something to take lightly. I'm
weighing all the options," Roessner said.
-
- But many moms -- as well as some special interest
groups concerned about vaccine safety -- worry about
whether the new vaccine will have been tested enough
before millions of doses are administered this year.
-
- The National Institute of Allergy and Infectious
Diseases is testing the vaccine on 2,800 children and
adults and will be testing it on 360 to 720 pregnant
women beginning in mid-September, said Anthony S. Fauci,
the institute's director.
-
- "This influenza vaccine . . . is being made in the
same way and by the same companies we have worked with
every year for seasonal flu vaccine, literally for
decades," Fauci said. "Although you never take the
safety issue lightly or presume anything, historically
the use of it [with pregnant women] has not been a red
flag-issue."
-
- A new Washington Post-ABC News poll shows that
Americans are not as concerned about a possible swine
flu pandemic as public safety and health officials seem
to be -- more than six in 10 are not worried, although
more than half said they would probably get the vaccine,
according to the poll.
-
- "My chances of actually getting swine flu are slim
to none," said Keenia Adams, 23, a student at Marymount
University who is pregnant. "Why take this vaccine? What
if it makes me sick in other ways? What if I find out
after I take it it could be harmful to my baby? I'm a
little worried about that."
-
- Wendy Lubell, 36, a personal trainer who is pregnant
with her second child, said she will not get the
vaccine, in part because she said she had a bad reaction
to a seasonal flu vaccine in college. She's careful
about what she eats while pregnant, she said, but will
occasionally treat herself to a cup of coffee or ice
cream.
-
- "I'm a not an expert. I am not a scientist. I am not
a doctor," Lubell said. "I have to make my decision
based on the information I hear and my intuition."
-
- Her intuition is saying no.
-
- "I personally don't understand if you're perfectly
healthy person why you'd inject yourself with something
that could potentially cause risk to you and your
fetus," Lubell said.
-
- A pregnant woman's body is more susceptible to flu
for several reasons, experts say. Pregnant women
typically have altered immune systems and, in the
advanced stages, their growing bellies compress lung
capacity, which can make them vulnerable to pneumonia --
a potentially fatal complication of swine flu.
-
- Local obstetricians and midwives say they have been
fielding more questions about the vaccine in recent
days.
-
- "I get a couple of phone calls and patients every
day asking about it," said obstetrician Laura Pickford,
who delivers babies at Inova Fair Oaks Hospital. "Most
of them are wanting to know how to get it. I tell them
it's not out yet." But she will probably recommend that
they get it.
-
- Laurel Todd, 30, a health policy analyst who lives
in Glover Park, said she has been monitoring media
reports about the spread of the flu -- as well as
fielding concerned calls from her mother-in-law on the
topic. She plans to get the vaccine when it's available
if her doctor says it's safe.
-
- "I'm totally comfortable with it," Todd said.
-
- Copyright 2009 Washington Post.
-
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Employers Advised on Swine Flu; Local Colleges Making
Plans
-
- By Annys Shin and Daniel de Vise
- Washington Post
- Thursday, August 20, 2009
-
- Bracing for a second wave of the swine flu pandemic,
the federal government urged employers Wednesday to
offer flexible sick-leave policies, while local colleges
and universities worked on plans that included confining
ill students to their rooms.
-
- The secretaries of commerce, education and homeland
security offered guidance to businesses on how to
prevent the spread of the H1N1 virus and how to prepare
for a major outbreak. They stressed the importance of
allowing employees who exhibit flu symptoms to go home
and stay home until at least 24 hours after their fevers
subside. They also said that businesses should consider
eliminating policies requiring a doctor's note to
justify a sick day and that employers should be prepared
to operate with fewer people.
-
- "If an employee stays home sick, it is not only the
best thing for that employee's health . . . but the
productivity of the company," Commerce Secretary Gary
Locke said at a news conference.
-
- The resurgence of the first pandemic in more than 40
years could cause disruptions for businesses, schools
and governments. This spring, the arrival of the virus
in the United States led to the closure of more than 700
schools, including several in the Washington region.
-
- With the school year about to begin, public health
officials expect to see a resurgence of the virus, which
is now the dominant form of influenza circulating
globally. The federal government has been stockpiling
flu treatments such as Tamiflu and is working with
GlaxoSmithKline, Novartis and a few other drugmakers to
produce 45 million doses of vaccine. The vaccines are
expected to be available in mid-October.
-
- That sense of urgency, however, is not shared by
most Americans, who are either "not too" or "not at all"
worried about the swine flu hitting home, according to a
new Washington Post-ABC News poll. Most said they have
confidence that the government and local health
providers will be able to effectively deal with an
outbreak. About 55 percent of Americans said they are
apt to get the vaccine for themselves or someone in
their household.
-
- Most people who have become infected have
experienced relatively mild illness. Scientists are
watching to see whether the virus mutates into a more
dangerous form.
-
- Government officials said even if the severity of
the virus does not change, it is still likely to infect
more people during the autumn and winter than it did in
the spring. Children and younger adults appear to be
more vulnerable.
-
- Emergency planners from several Washington area
colleges met Wednesday to review flu preparations. Local
colleges are generally advising students who develop
flulike symptoms to call -- rather than visit -- the
campus health center. Those with mild symptoms are
likely to be voluntarily confined to their rooms until
their symptoms pass. Schools are setting up protocols
for friends or roommates to bring food to the sick, as
well as procedures for healthy students to be separated
from ill roommates for a few nights.
-
- "We don't have the capability to move all the sick
kids into one dorm," said James Turner, head of student
health at the University of Virginia. The University of
Delaware, which had 22 confirmed swine flu cases in the
spring, is blanketing the campus with touch-free
sanitizer stations, said Marcia Nickle, the school's
emergency preparedness coordinator.
-
- Many schools are determining the number of cases or
the rate of absenteeism that would trigger class
cancellations. "No one really knows what that tipping
point is at this stage of the game," said John Williams,
George Washington University's provost and a physician.
-
- The H1N1 virus surfaced this spring in Mexico and
spread to at least 168 countries. As of Friday, there
had been more than 177,000 confirmed cases and at least
1,462 deaths, including 477 in the United States,
according to the Centers for Disease Control and
Prevention. As many as 2 billion people could contract
the flu before the pandemic is over, the World Health
Organization estimates.
-
- To minimize H1N1's spread, the Cabinet secretaries
told employers Wednesday to consider limiting
face-to-face meetings and travel, to encourage
telecommuting and to make alternate work arrangements
for employees such as pregnant women who are at high
risk for complications from the virus.
-
- Asked whether the government would order businesses
to close if the circumstances warranted it, Locke said
that it would be up to businesses to decide and that
each industry is so different, it is "impossible to make
a sweeping statement."
-
- The Cabinet secretaries also said employers should
be flexible in the event that schools are closed and
employees have to make alternate child-care
arrangements.
-
- Staff writer Jon Cohen contributed to this
report.
-
- Copyright 2009 Washington Post.
-
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Officials
may recommend 3 flu shots
- Two would be for swine flu, or H1N1, the other for
the seasonal strain. Employers are warned to brace for
workers' absences.
-
- By Rong-Gong Lin II and Kim Geiger
- Baltimore Sun
- Thursday, August 20, 2009
-
- Washington, D.C. Bureau - In a sign of heightened
concern that the upcoming flu season could be severe,
top national and local health officials warned Wednesday
that employers should brace for worker absences and
cautioned the public that as many as three shots this
season may be needed to protect against the H1N1 strain
and seasonal flu.
-
- In Washington, Commerce Secretary Gary Locke urged
that common sense take precedence over "the Puritan work
ethic."
-
- He joined two other Cabinet secretaries to tell
business owners to prepare for losing key employees to
swine flu for days at a time. Federal officials told
employers to encourage hand washing and aggressively
clean work areas and to send ill workers home at the
first hint of flu symptoms, expecting that they will be
out for three to five days.
-
- Locke also suggested that employers consider
curtailing face-to-face meetings and limiting company
travel to prevent swine flu's spread. Business owners,
officials said, should be open to telecommuting and
other options that could allow employees to work from
home.
-
- "Be responsible and understanding for the
absenteeism that needs to occur with this strain of the
flu," said Homeland Security Secretary Janet Napolitano.
-
- In Los Angeles County, health officials asked the
public to get not only the regular seasonal flu shot,
but also as many as two additional inoculations to
protect against the H1N1 strain.
-
- Dr. Jonathan Fielding, the county's health officer,
said at a news conference Wednesday that three shots may
be needed because initial studies suggest a single
swine-flu inoculation may not be sufficient. Fielding
asked doctors and other medical providers to sign up for
the H1N1 flu vaccine by registering online at the county
Department of Public Health's website.
-
- Whether world health officials will recommend two
doses remains unclear. Officials say they are still
waiting for tests before finalizing their
recommendations. The first batches of swine-flu vaccine
are expected to become widely available in October. The
seasonal flu vaccine should be in clinics and pharmacies
by September, Fielding said.
-
- Inoculations for both -- which can be administered
by injection or nasal spray -- can be given on the same
day. But the second swine flu vaccination, if
recommended, would probably be given three or four weeks
after the first dose.
-
- Health officials acknowledged that recommending as
many as three flu shots this fall could cause some
confusion, but said the possibility was unavoidable
because H1N1 emerged as a threat after the seasonal flu
shot was in production.
-
- The U.S. Centers for Disease Control and Prevention
is recommending that the most at-risk populations
receive the H1N1 vaccine first. Those populations
include pregnant women, healthcare workers, parents and
caregivers for children under 6 months old, people ages
6 months to 24 years, and those ages 25 through 64 with
chronic health disorders or compromised immune systems.
-
- Those groups constitute 159 million people in the
United States -- more than half of the population.
-
- Once those groups have been vaccinated, U.S. health
officials will recommend that people ages 25 through 64
receive H1N1 shots.
-
- Those 65 and older actually have a lower risk of
contracting swine flu, because they encountered flu
strains as children that offer them some protection,
Fielding said. But health officials said seniors should
get shots for the seasonal flu as soon as the vaccine is
available. Once demand for the swine flu vaccine is met
for those under 65, inoculations will be recommended for
seniors, CDC officials said.
-
- Fielding offered some common-sense guidelines,
urging people to wash hands with soap and water for at
least 20 seconds, to cover their sneezes or coughs with
a tissue -- or at least to sneeze or cough into the
crook of their arm. People should avoid touching their
eyes, nose or mouth -- places where the flu virus enters
the body.
-
- Federal officials advised parents to limit an ill
child's contact with other family members by creating a
"sick room." If a member of the household is sick,
parents are asked to keep school-age children home five
days because they are at high risk of falling ill and
spreading the flu to classmates.
-
- Earlier this month, after first recommending that
schools close when a student was diagnosed with swine
flu, federal officials said they would leave decisions
on to local authorities.
-
- Copyright 2009 Baltimore Sun.
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- National / International
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Study: Vaccinating school kids best to stop flu
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- By Lauran Neergaard
- Associated Press
- Friday, August 21, 2009
-
- WASHINGTON (AP) - New research says the best way to
protect society's most vulnerable from the flu:
Vaccinate school-age children and their parents.
-
- Kids already top the government's priority list for
swine-flu shots this year because that new influenza
strain targets the young. That's unusual, as flu usually
is most dangerous to older adults.
-
- But Thursday's study, in the journal Science, says
vaccinating students should be a priority every year _
because schoolchildren are influenza's prime spreaders
and their parents then are the virus' bridge to the rest
of the community. The idea: Inoculating spreaders could
create something of a cocoon around the people most at
risk of flu-caused death.
-
- Clemson University mathematical biologist Jan
Medlock modeled what would happen if a virus like the
ones that caused the 1918 and 1957 pandemics struck
today. He tested multiple vaccination strategies against
viruses of varying virulence to see which would give the
best outcome for the least vaccine.
-
- In typical winters, the U.S. has 85 million to 100
million doses of flu vaccine. If at least 40 million
doses are available, then vaccinating children ages 5 to
19 and adults in their 30s _ their parents' average age
_ gives society the most protection, Medlock and
co-author Alison Galvani of Yale University reported.
-
- In just one example, using a hypothetical flu strain
as deadly as the notorious 1918 virus, the model
predicted that deaths could be cut by more than half if
just those ages are vaccinated, compared with
vaccinating only the more usual targets _ people over 50
and under 5.
-
- Flu specialists increasing are focusing on children.
-
- The research is "very much in line with the
evidence" that schoolkids in crowded classrooms act as
flu factories, said epidemiologist John Brownstein, of
Harvard and the Children's Hospital of Boston.
-
- Brownstein has tracked Boston-area influenza cases
and found that neighborhoods with the most kids are
where flu strikes first and worst: Every 1 percent
increase in the child population brings a 4 percent
increase in adult emergency-room visits.
-
- And just last year, the Centers for Disease Control
and Prevention started recommended routine flu
vaccination for children of all ages. While shots had
long been recommended for babies and preschoolers who
are at higher risk for flu complications, healthy
school-age children typically spend an achy, sneezy week
and bounce back.
-
- The change came as scientists began realizing flu
vaccine doesn't work as well in people over 65 _ who
account for most of the 36,000 flu-caused deaths each
winter _ as it does in the young. While flu vaccine
protects 75 percent to 90 percent of young healthy
people, some research suggests the protection may
plummet to 30 percent among their grandparents.
-
- But excluding other ages from vaccination, like in
Medlock's model, would be "obviously a very difficult
decision" rather than vaccinating schoolchildren in
addition to the usual high-risk groups, Brownstein said.
-
- Copyright 2009 The Associated Press. All rights
reserved.
-
-
Flu
fighters battle pandemic online
-
- By Miral Fahmy
- Reuters
- Thursday, August 20, 2009
-
- SINGAPORE (Reuters) - The world is gripped by a flu
pandemic and it's up to you to stop it -- that is, if
you choose to play a new game developed by a Dutch
medical center and available online for free.
-
- The Great Flu (www.thegreatflu.com) allows
players to choose their viral adversary, pick the part
of the world it spreads in and then control how to
manage the outbreak given a limited amount of funds and
medications.
-
- The game was developed by the Erasmus University
Medical Center, in Rotterdam, and launched in April, the
same month the H1N1 swine flu virus emerged.
-
- The World Health Organization declared H1N1 a full
pandemic in June and it has now spread to some 180
countries, causing at least 1,462 laboratory-confirmed
deaths.
-
- Earlier this year, another, humorous online game
based on the virus, called Swinefighter (www.swinefighter.com),
also allowed players to beat the spread of H1N1.
-
- (Writing by Miral Fahmy; Editing by Alex
Richardson)
-
- Copyright 2009 Reuters.
-
- Opinion
- ----
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