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DHMH Daily News Clippings
Thursday, August 20, 2009
 
 
Maryland / Regional
Testing begins on experimental flu vaccine for children (Baltimore Sun)
Pregnant Women in D.C. Area Cautious About Flu Shot (Washington Post)
Employers Advised on Swine Flu; Local Colleges Making Plans (Washington Post)
Officials may recommend 3 flu shots (Baltimore Sun)
 
National / International
Study: Vaccinating school kids best to stop flu  (Associated Press)
Flu fighters battle pandemic online (Reuters)
 
Opinion
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Maryland / Regional
Testing begins on experimental flu vaccine for children
Parents, children volunteer for clinical trials
 
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."
 
Copyright © 2009, Baltimore Sun.

 
Pregnant Women in D.C. Area Cautious About Flu Shot
 
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.

 
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.

 
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.

 
National / International
Study: Vaccinating school kids best to stop flu
 
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.

 
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