Swine flu: Answers to your H1N1 questions

As more and more people are getting infected by the dreaded swine flu, questions linger about the dangers of the virus and the effectiveness of inoculations. Here are edited queries from Tribune readers, with answers:

Q: What is the comparison between the fatality rates for H1N1 flu and seasonal flu, and is H1N1 considered more of a danger than seasonal flu?

A: Since the pandemic began in April, more than 1,000 deaths from H1N1 have occurred, including about 100 children, and more than 20,000 hospitalizations in the United States, according to the U.S. Centers for Disease Control and Prevention. The CDC estimates that about 36,000 people die of seasonal flu-related causes annually, although the number fluctuates.

It is good news, according to Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, that the swine flu continues to be "very mild" for most people. "But there is no question we are seeing very severe cases hit in populations normally not susceptible to the flu, and without underlying health conditions in some cases," she said this week. "Young people and pregnant women have been particular targets of that."

Q: Is it true that people who get the H1N1 mist are getting a live virus which they can shed, infecting people with depressed immune systems?

A: The nasal spray is made from live, weakened virus. There is a bit of "shedding" -- where some of the vaccine escapes. But the amount is so small, there is no need to worry about spreading it in the general population, according to Dr. Julie Morita, medical director of the Chicago Department of Public Health's immunization program.

The only concern, she said, is among health care professionals who care for people whose immune system is compromised. "A doctor in a regular setting can get the nasal spray and not worry about shedding, but those taking care of people with a weakened system should not get the vaccine or go to work immediately after taking it," she said.

Clinical studies show the risk of getting infected after contact with attenuated, or weakened, vaccine virus is minuscule -- between 0.6 and 2.4 percent.

Q: My children, ages 2 and 5, got the first round of H1N1 shots, but the doctor said she wasn't sure she will have the second dose a month later. Are they protected with just one shot?

A: Health officials recommend that children under the age of 10 receive two doses of vaccine, separated by four weeks. Health officials said every attempt should be made to obtain the second dose in order to achieve full protection. More vaccine is on its way so people should check regularly with their doctor, school and local health departments.

Q: Our mom is really sick and we aren't sure if it's swine flu. If we wear masks and sort of keep a distance from her, will we be OK?

A: A bit more than that is needed to avoid the virus, according to the CDC. If possible, your mom should be in a private room away from common areas of the house and use a separate bathroom. If she has to be around others, she should wear a mask. Everyone should wash hands regularly. If you are under 24, you might consider getting an H1N1 vaccine.

Q: I am pregnant with triplets, due to give birth in 10 days. I brought my 2-year-old son, my husband and my mom (our caretaker) to Truman College's clinic on Saturday. We waited in line for 5 1/2 hours for the vaccine. ... What kind of screening are they doing for these shots, just first come, first served?

A: With a limited supply of vaccine at each clinic, Chicago Health Department officials are trying to limit it to high-priority groups. But mostly they are relying on people being honest when asked in line if they fall into one of those groups.

"We're trusting people to do the right thing," said Julie Morita, director of the department's immunization program.

According to Tim Hadac, a department spokesman, officials are confident that nearly everyone who got vaccines at the first clinics was in a high risk group, although a "small percentage" might have slipped through. Some people had asthma, diabetes, immune disorders and other chronic illnesses that would not always be obvious to other people in line, he said.

Overall, those eligible for early vaccines are health care workers; pregnant women; children and young adults ages 6 months to 24 years; people who live with or care for infants younger than 6 months; and people ages 25 to 64 with chronic health conditions. The public clinics are being offered Tuesdays, Thursdays and Saturdays at six City Colleges campuses as long as there is demand and supply.

Q: We are going to visit my in-laws for Thanksgiving and we were told we can't see my father-in-law unless we have H1N1 shots. I have chronic sinusitis plus a diminished immune system, so how likely am I to find the vaccine before Thanksgiving? Is there a list of locations that have the vaccine?

A: You should call your doctor or health care provider to see if it is available, and where. Once the vaccine is readily available, a list of health departments and pharmacies will be made available on the Illinois Department of Public Health Web site, www.idph.state.il.us.

The vaccine continues to be in short supply across the country because of production delays. Health officials have said they expect a better supply by mid-November and that by early December, the vaccine should be widely available. Most vaccine is now going to local health departments and hospitals.

Q: The city of Chicago has the vaccine. DuPage County has it. Cook County Department of Health -- nada. Why is Cook County so behind?

A: Cook County Health Department officials said they got their initial 20,000 doses of vaccine late last week. Six thousand doses were allocated to hospitals in suburban Cook County and about 5,000 doses to public schools in Palatine, the first district designated for student vaccinations. Other doses have been reserved for health care workers at the county Health Department. No vaccine is currently available for public clinics, a county spokesman said. Officials were "cautiously optimistic" the department will get more vaccine early next week that will allow for public clinics to begin soon in suburban Cook County.

Q: Are there precautions a family should take regarding trick-or-treat candy this Halloween?

A: State and local health officials recommend giving out wrapped candy. Rather than allowing children to reach into a bowl, hand it to them. Children should wash their hands, use sanitizer and wash any fruit or other food.


P.S. Boost your natural immunity by eating lots of Vitamin C and Vitamin D rich foods and fruits.




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Obama Declares Swine Flu a National Emergency

President Barack Obama has declared the H1N1 swine flu a national emergency.

His proclamation, signed Friday night and released by the White House Saturday morning, will allow hospitals and doctors' offices to get legal waivers of federal rules so they can handle large numbers of sick people as the outbreak spreads.

"The H1N1 is moving rapidly, as expected. By the time regions or health-care systems recognize they are becoming overburdened, they need to implement disaster plans quickly," White House spokesman Reid Cherlin said Saturday, according to the Washington Post.

The waivers, which will be issued by U.S. Health and Human Services Secretary Kathleen Sebelius, still require individual requests by the hospitals, Cherlin noted.

The goal, according to the Associated Press, is to remove bureaucratic roadblocks and make it easier for sick people to seek treatment and for medical personnel to provide it immediately. That could mean fewer hurdles involving Medicare, Medicaid or health privacy regulations, the AP added.

The H1N1 swine flu is now widespread in 46 states, and there have been 1,000 laboratory-confirmed deaths since April, according to the latest estimates released Friday by U.S. health officials.

Dr. Thomas R. Frieden, director of the U.S. Centers for Disease Control and Prevention, told a news conference Friday, "We have already had millions of cases of pandemic influenza in the United States, and the numbers continue to increase."

At the same time, he said, production delays continue to hamper distribution of the H1N1 swine flu vaccine.

The vaccine is growing more slowly in egg-based cultures than manufacturers had anticipated, resulting in fewer available doses at this time, Frieden explained.

As of Friday, there were 16.1 million doses on hand nationwide, up from 14.1 on Wednesday, Frieden said. And there will be far fewer than the 40 million doses originally planned for the end of October, he added.

"Vaccine availability is increasing steadily, but far too slowly," Frieden said. "It's frustrating to all of us. We are nowhere near where we thought we would be by now. We are not near where the vaccine manufacturers predicted we would be."

The vaccine that is available comes in both nasal mist and injectable forms. The first doses were only the nasal spray, called FluMist, designed for healthy people 2 to 49 years of age. But now, more than half the doses are injectable, he said.

While children continue to be particularly vulnerable to the disease, Freiden said, "we are seeing it increasingly affect young adults as well as children. We are still not seeing significant numbers of cases among the elderly, and that's characteristic of this virus."

That's also a marked difference from run-of-the-mill seasonal flu, which typically poses a much bigger threat to the elderly.

There is encouraging news, Frieden said. The genetic makeup of the H1N1 virus hasn't changed, meaning the swine flu vaccine and the antiviral drug Tamiflu are a good match.

Frieden said the H1N1 flu would probably occur in waves, but "we can't predict how high, how far or long the wave will go, or when the next will come."

"We are now in the second wave of pandemic influenza and whether this will continue through the fall into the winter, whether it will go away and come back in traditional flu season, only time will tell," he said.


P.S. Boost your resistance against swine flu by eating lots of Vitamin C and Vitamin D rich foods and fruits.



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Novartis Says Most U.S. Swine Flu Shots Ready in 2010

Most of Novartis AG’s swine flu vaccine may not reach the U.S. until the first quarter of 2010, almost at the end of flu season, Chief Executive Officer Daniel Vasella said today in an interview on CNBC.

“I feel compassion for those people who are waiting,” he said.

The Basel, Switzerland, drugmaker is the biggest U.S. supplier of the new vaccine, and U.S. health officials have reported the country’s overall supply will reach 28 million doses by the end of the month after previously projecting 40 million to 50 million by mid-October. H1N1 is widespread in 41 states, has hospitalized more than 5,000 and has caused the deaths of 292 people since Sept. 1, 90 percent of whom were younger than 65, the U.S. Centers for Disease Control and Prevention reported Oct. 20.

Production at Novartis is not being held up now, Vasella said today. The initial problem was the lack of antigen, the key ingredient that induces immunity, he said.

“There was one-fifth of the normal yield,” Vasella said.

Novartis received the first seed strains from the CDC and Geneva-based World Health Organization and was forced to go back and get others, Sarah Coles, a spokeswoman for the company, said in an e-mail.

Half the Yield

All the other vaccine makers with contracts to supply to the U.S. -- Paris-based Sanofi-Aventis SA, London-based GlaxoSmithKline Plc and AstraZeneca Plc, and CSL Ltd. based in Melbourne -- received seed strains at the same time to develop the shots, CDC officials have said. The strains yielded half as much antigen as that for a typical seasonal flu, Aphaluck Bhatiasevi, a WHO spokesman, said Sept. 18.

Novartis is moving swiftly to increase the pace of its output including transferring 300 workers to the swine flu vaccine production lines, Vasella said.

U.S. Health and Human Services Secretary Kathleen Sebelius said yesterday there were “manufacturing glitches” because new production lines were set up to accommodate the swine flu vaccine. Sebelius didn’t specify which companies had the glitches. Novartis is contracted to deliver about 35 percent of the 250 million doses ordered by the U.S. government, according to statements from HHS.

Novartis Statement

“Novartis has taken steps to accelerate the post- production process and delivery of vaccine,” according to a statement from the company released after Vasella’s interview. “Among other things, we have prioritized production of pre- filled syringes despite substantially slower filling rates. Along with the low yields, these efforts have led to delays in vaccine supply.”

Novartis began a large-scale fill-and-finish operation on the swine flu vaccine in early September after completing its seasonal flu campaign, the company said in its statement.

AstraZeneca’s MedImmune Inc., producer of a nasal spray version of the vaccine, was about 300,000 doses behind in its production, Karen Lancaster, a company spokeswoman, said Oct. 20. MedImmune, based in Gaithersburg, Maryland, had shipped at least 6.5 million doses to the U.S. government and planned to send a total of 11 million by the end of October, she said.

Sanofi said it began shipping its vaccine on Sept. 29, “a little bit earlier than anticipated,” and was tracking “pretty much on schedule,” Donna Cary, a spokeswoman, said Oct. 20.

CSL was “on schedule” to delivery its 36 million doses, Sheila Burke, a spokeswoman, said Oct. 20.



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FDA warns: Swine flu scams lurk on the Internet

People be warned. Many people feared this pandemic and are desperate themselves to seek a vaccine which could protect them against this dreaded disease. But some are capitalizing on this tragic event by claiming they have the means to battle this global pandemic.

Air "sterilizers." A photon machine. Supplement pills to boost the immune system. Protective shampoos and face masks. Even fake Tamiflu.

These and other products making bogus claims to prevent or treat swine flu are flooding the Internet as scam artists prey on the public's fears while the vaccine is delayed and real Tamiflu — made by Switzerland's Roche Group — is rationed.

Every problem, it would seem, is a sales opportunity. Some of the products appear to have been pitched for other emergencies, such as one called "Quake Kare" and masks and purifiers sold during the SARS scare.

Federal officials have sent warning letters to promoters of more than 140 swine flu-related products, including well-known alternative medicine advocate Dr. Andrew Weil for his "Immune Support Formula."

Consumer Reports also has warned subscribers to be wary.

"It's harmful, disappointing, frustrating to see folks take advantage of the public like this," said Dr. John Santa, who evaluates health claims for Consumer Reports.

Fraudulent products emerged shortly after swine flu did last spring — about 10 a day, said Alyson Saben, head of a swine flu consumer fraud team formed by the Food and Drug Administration. The pace slowed over the summer as the flu abated, but "it's picked up" in recent weeks, she said. "We are seeing new sites pop up."

Most worrisome: sites that claim to sell Tamiflu without a prescription. The FDA bought and tested five such products. One contained powdered talc and generic Tylenol — no Tamiflu. Several others contained some Tamiflu but were not approved for sale in the U.S.

"We have no idea of the conditions under which they were manufactured. They could contain contaminated, counterfeit, impure or subpotent or superpotent ingredients," Saben said.

Tamiflu and GlaxoSmithKline's Relenza are the only drugs recommended for treating swine flu.

Rogue Web sites are not the only ones trying to cash in on flu fears. Makers of some well-established products are making claims that may be close to the line, the FDA says.

This week, the makers of Dial Soap, Kleenex, Clorox and other big brands launched a joint promotional campaign costing up to $1 million. The FDA is reviewing the campaign, which includes a video that says:

"Germs are tiny organisms that can cause disease. According to the CDC, up to 80 percent of infectious diseases, like the flu, are spread by your hands. That's why frequent, proper handwashing is so important in preventing spread of the flu, other viruses and germs. An antibacterial soap like Dial Complete foaming hand wash kills 99.9 percent of germs."

Flu is caused by a virus, so killing bacteria is of uncertain benefit.

The campaign is "not being specific down to swine flu," said Scott Moffitt, an official with Dial Corp.'s parent company, Germany-based Henkel AG. He also contends the video is not misleading, even though the germ-killing claim follows a sentence about flu and other viruses.

One product that drew a warning letter from the FDA is the Photon Genie, a gadget that delivers "energy waves." Its Web site claimed it "helps strengthen the immune system, and a strong immune system is KEY to preventing swine flu symptoms and KEY to treating swine flu."

The site has since removed the swine flu claim but "other claims remain," Saben said.

The group behind the Web site, the Skilling Institute of Phoenix, "is not marketing, and will not market in the future, any product that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 flu virus," its director, Warren Starnes, wrote in an e-mail.

Some products the FDA warned about contain silver, such as "Swine Flu...Gone," made by Secrets of Eden.

"Spray 'Swine Flu...Gone' with ionic silver on your hands and on any surface where these germs may exist and kill the virus," its site had claimed.

Secrets of Eden sells supplements and oils with a biblical flair, said its general manager, Rick Strawcutter, a former pastor in Adrian, Mich. The staff "got a little carried away" on marketing for one product and "drew the ire of the FDA," he said.

"It was not worth contesting," so he ordered a stop to it, Strawcutter said.

The federal Agency for Toxic Substances and Disease Registry says silver "may cause harmful health effects," depending on the amount and type of exposure.

Dr. Andrew Weil's site had this problem language, the FDA's warning letter said: "...during the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider ... the Weil Immune Support Formula which contains both astragalus and immune-supportive polypore mushrooms."

Weil issued a statement saying the content "was primarily educational" about how to avoid the flu, and that he had directed his Web site team to remove and review it for compliance with federal rules.

Doctors, too, are being warned not to prescribe unproven remedies, such as drugs not shown to be safe and effective for swine flu. In this week's New England Journal of Medicine, three FDA doctors caution against use of ribavirin, a drug approved in the U.S. for treating hepatitis C and respiratory syncytial virus, or RSV, a childhood illness.

There have been reports of doctors wanting to try it for seriously ill flu patients, but it can cause a dangerous type of anemia and cannot be used in pregnant women because of the risk of birth defects, said the FDA's Dr. Debra Birnkrant.

"It shouldn't be used lightly" and needs to be tested in a clinical trial for flu, she said.

P.S. Boost your immune system by eating lots of Vitamin C or Vitamin D rich foods or fruits.

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Flu Story: A Pregnant Woman’s Ordeal

The group most threatened by swine flu and most in need of the new vaccine, world health authorities agree, is that of pregnant women.

For example, Aubrey Opdyke.

On June 27, Ms. Opdyke, a 27-year-old waitress and former high-school swimmer who weighed 135 pounds before her pregnancy and had no health risks other than a smoking habit, came down with mild flu symptoms.

She finally came home from the hospital three weeks ago.

“At first, I didn’t think anything of it — just another flu bug,” Ms. Opdyke said recently. “But it really wrecked me. I probably shouldn’t have made it.”

In the four months she was hospitalized, she spent five weeks in a coma, suffered six collapsed lungs and a near-fatal seizure. High-pressure ventilation blew her up like a molten balloon until “she looked like she weighed 400 pounds,” her husband, Bryan, said, and she has stretch marks from her neck to her ankles. Her muscles and lungs are still so weak that she uses a walker.

While hospitalized, she missed seeing her 4-year-old daughter, Hope, learn to swim and start pre-school.

And, most important, she lost her baby. Parker Christine Opdyke, almost 27 weeks in the womb, was delivered by emergency Caesarean section on July 18, when her fetal heart rate plummeted during Ms. Opdyke’s third lung collapse. Her airways were too blocked to let a breathing tube in, possibly a side effect of the drugs saving her mother. She lived seven minutes.

On Oct. 1, the Centers for Disease Control and Prevention said 100 pregnant women had been in intensive care with swine flu and 28 had died. That is a tiny fraction of what are believed to have been millions of cases in the country. But it is the best argument, federal officials say, for the drawn-out, expensive effort to make a swine flu vaccine.

Pregnant women are particularly susceptible because they are in the younger age group most likely to catch this new virus, while those over 50 who have had more flus rarely catch it. Moreover, pregnancy suppresses the immune system to protect the fetus, and the growing baby makes it harder for a mother to clear her lungs.

All but a few of the pregnant women who have died or been near death from swine flu are unknown. Privacy laws prevent health departments from releasing their names, and few families come forward.

The Opdykes did because “we wanted to get it out there how dangerous it can be,” Ms. Opdyke said.

“We have friends who get flu symptoms and say, ‘Oh, I’m not going to a doctor,’ ” Mr. Opdyke added. “And we say, ‘Do you not understand what we went through?’ I can’t imagine why there’s so much nonchalance.”

That nonchalance strikes close to home.

As they said this, Ms. Opdyke was doing her daily physical therapy, struggling to lift one-pound weights. Her therapist interrupted to announce that she opposed flu shots.

“Have you ever read the labels?” she asked. “They’re so full of toxins.”

Asked if she realized that a shot, had it existed in June, might have saved her client and her baby, she frowned and went back to her clipboard.

Unlike some other families that came forward, the Opdykes are not threatening to sue anyone.

They do not blame her obstetrician, even though she suggested acetaminophen the first time Ms. Opdyke called her and prescribed an antibiotic the second.

“Swine flu just wasn’t on our minds at all,” Ms. Opdyke said.

Nor are they angry at the Wellington Regional Medical Center. “I don’t think if I’d taken her anywhere else, she would have survived,” Mr. Opdyke said.

Her flu came on gradually, and she never had a high fever. But after a week of feeling exhausted and achy, she became delirious. When Mr. Opdyke drove her to the hospital, with his finger on the door-lock button for fear she would jump out, she could not tell the triage nurse her name.

Her blood oxygen level was below 70; normal is 95, and below 80 is life-threatening. Both lungs were full of fluid.

Thrashing, she knocked off oxygen masks and pulled out an intubation tube. Panic made her hyperventilate. Doctors finally sedated her into a paralytic coma to let the ventilator work.

She survived near-failure of her kidneys, then her lungs, damaged by continuous high-pressure oxygen, began collapsing. Mr. Opdyke was warned he might have to choose — her life or that of the baby, who was just at the border of survivability outside the womb.

“I said, ‘Save Aubrey,’ ” he said of the woman he married last year. “I can make another baby, but I can’t replace her.”

Her third lung collapse forced the issue. Parker had to be delivered, but she did not survive.

Now I Lay Me Down to Sleep, a photographers’ charity for families of premature infants, offered to take black-and-white pictures. Ms. Opdyke’s mother bathed Parker and brushed her hair.

“Some people don’t agree,” Mr. Opdyke said about having the photographs taken. “But for me there was no option. Aubrey wasn’t awake, she didn’t get to bond. If I didn’t do it, there’s no way I could make it up to her.”

Aubrey Opdyke started to recover, then developed a bacterial infection common to ventilator patients. She nearly succumbed, then rallied and doctors started to wean her off the coma-inducing drugs. She had weeks of hallucinations about a friendly white dog visiting her but could not ask about it because of the tube.

Mr. Opdyke took comfort from what he saw as divine signs. Dog is “God” backwards, he noted. And one day, in a panic because he had forgotten to wear his wife’s wedding ring around his neck, he saw a license plate reading “FAITH.”

Ms. Opdyke’s last crisis was a still-unexplained seizure during a family visit. Her mother had been painting her nails and blamed herself, thinking the fumes had done it.

Now that she is home, in the townhouse complex they rent near the West Palm Beach airport, Ms. Opdyke is struggling to regain her strength. Muscles atrophy into rubber bands; every day in a coma means two days’ recovery.

She apologizes for the messy yard; she would pick it up but barely has the strength to get upstairs to bed. Mr. Opdyke has gone back part-time to his job at UPS.

Mr. Opdyke worries he gave her the flu. “I was sick two weeks before,” he said. “I touch packages that have been touched a thousand times. If anybody’s going to catch it, it’s me.”

He said he had not yet looked at the bills. His insurance covered most, he said, “but it had to be over a million, and we owe 20 percent; I’m not ready for that many commas.”

Friends from their jobs and a Girl Scout charity that Ms. Opdyke once ran with her mother have raised over $10,000 by holding benefits, and small checks have come in after articles by local journalists. “It’s a lot of help,” Ms. Opdyke said. “It really shows the compassion of people.”

And does she want another baby?

“Yes,” she says firmly. “At first, I didn’t. Now I do. But I’ve got to get my strength back.”


P.S. Boost your immune system by eating Vitamin C & Vitamin D rich Foods and Fruits.



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Have H1N1 Swine Flu Symptoms? Beware false internet treatment promises

The U.S. Food and Drug Administration (FDA) issued an advisory on October 15th warning consumers to use caution when ordering anything from the internet that claims to "diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus", as many of these claims are questionable at best, even up to being outright lies. In addition, over 80 internet sellers of various products, largely dietary supplements, were warned on the 18th to remove claims that their products prevented or treated the H1N1 swine flu virus.

What Kind of Products for Swine Flu Were Being Offered?

Perhaps the most dangerous are false claims of supposed anti-viral drugs. One such product ordered by the FDA researchers, received in an unmarked envelope from India, contained no anti-viral drug at all, only talcum powder and acetaminophen.

Other products, the subject of the warning letters from the FDA, include ultraviolet lights which claim to kill the H1N1 swine flu virus, hand sanitizers, air filters, inhalers, and of course dietary supplements — one of which even claimed to be "more effective that the swine flu shot."

Does This Mean These Products are Completely Ineffective?

Not necessarily. What it means, is that none of these products have been scientifically tested for effectiveness against the H1N1 swine flu virus, and so under federal regulations they are not allowed to claim that they are. Many of them do help to combat viruses or help build the immune system to allow the body to fight off infection and symptoms. But the only products scientifically proven to be effective against the H1N1 swine flu virus, the FDA insists, are the swine flu vaccines, and the two anti-virals drugs approved for use with swine flu symptoms, Tamiflu and Relenza, and urges caution when considering anything else that claims to prevent or treat the H1N1 virus or swine flu symptoms.

P.S. boost your immune system by taking Vitamin C or Vitamin D rich Foods and Fruits.

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H1N1 Influenza Vaccine Trial in People with Asthma

NIH prepares to launch 2009 H1N1 influenza vaccine trial in people with asthma.

The National Institutes of Health is preparing to launch the first government-sponsored clinical trial to determine what dose of the 2009 H1N1 influenza vaccine is needed to induce a protective immune response in people with asthma, especially those with severe disease. The study is cosponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of NIH.

"People with severe asthma often take high doses of glucocorticoids that can suppress their immune system, placing them at greater risk for infection and possibly serious disease caused by 2009 H1N1 influenza virus," says NIAID Director Anthony S. Fauci, M.D. "We need to determine the optimal dose of 2009 H1N1 influenza vaccine that can be safely administered to this at-risk population and whether one or two doses are needed to produce an immune response that is predictive of protection."

The study plan has been submitted to the Food and Drug Administration for review. With FDA allowing it to proceed, the clinical trial will be conducted at seven sites across the United States that participate in NHLBI's Severe Asthma Research Program.

This program already has a well-characterized group of participants with mild, moderate or severe asthma who may be eligible for this new study. These groups are largely distinguished by the amount and frequency of glucocorticoids needed to control asthma symptoms. People with mild disease may not need glucocorticoids, or may require low doses of inhaled glucocorticoids; those with moderate asthma need low to moderate doses of inhaled glucocorticoids; and those with severe asthma need high doses of inhaled glucocorticoids and frequently use oral glucocorticoids as well.

Individuals who already have been infected with 2009 H1N1 influenza or have received a 2009 H1N1 influenza vaccination will not be eligible for the study.

"The results of this study will have immediate implications for individuals with severe asthma as well as those who have milder asthma," says NHLBI Director Elizabeth G. Nabel, M.D.
Early results from other clinical trials of 2009 H1N1 influenza vaccines in healthy adults have shown that a single 15-microgram dose of 2009 H1N1 influenza vaccine without adjuvant is well tolerated and induces a strong immune response in most participants. The same vaccine also generates an immune response that is expected to be protective in healthy children ages 10 to 17 years. Ongoing trials are comparing the immune response to one and two doses of 15- or 30-micrograms of vaccine given three weeks apart in various populations.

The Centers for Disease Control and Prevention has recommended that certain at-risk populations receive the new H1N1 vaccine as a priority before the general population. These target populations include pregnant women, health care providers and individuals with underlying chronic medical conditions, including asthma.

People who have severe asthma may be particularly at risk for infection with the 2009 H1N1 influenza virus. A report published in 2004 suggested that some people who took high doses of glucocorticoids to treat their asthma may receive less protection from influenza vaccines against some strains of influenza. Early in the 2009 H1N1 flu outbreak a CDC review of hospital records found that people with asthma have a four-fold increased risk of being hospitalized with infection compared to the general population.

The study will enroll approximately 350 people with mild, moderate and severe asthma. Participants will be organized into two groups: those with mild or moderate asthma and those with severe asthma. Half of the participants in each group will receive a 15-microgram dose of vaccine, and the other half a 30-microgram dose. Three weeks later, each participant will receive a second dose of the same amount. The strength of the immune response induced by the vaccine will be determined in blood samples by measuring the level of antibodies against 2009 H1N1 flu virus.

Safety data will be collected and examined throughout the course of the study by trial investigators and by an independent safety monitoring committee. Participants will be monitored for any side effects they may experience because of the vaccine, as well as asthma attacks that occur during the study period.

The vaccine to be used in the trial, manufactured by Novartis, contains inactivated 2009 H1N1 influenza virus and therefore cannot cause anyone to become infected with the virus.

The trial will be conducted at the following locations:
Cleveland Clinic, Ohio
Emory University, Atlanta
University of Pittsburgh Asthma Institute
University of Virginia, Charlottesville
University of Wisconsin, Madison
Wake Forest University, Winston-Salem, N.C.
Washington University School of Medicine, St. Louis

Detailed information about this study can be found on the ClinicalTrials.gov Web site at http://clinicaltrials.gov/ct2/results?term=H1N1+AND+asthma.

Additional information about NIAID-sponsored clinical trials of candidate H1N1 vaccines can be found here: Clinical Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported Vaccine and Treatment Evaluation Units

(http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm); Pediatric Trials of Candidate 2009 H1N1 Vaccine at NIAID Vaccine and Treatment Evaluation Units (VTEUs)

(http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm); NIAID Launches 2009 H1N1 Influenza Vaccine Trial in Pregnant Women

(http://www3.niaid.nih.gov/news/QA/H1N1pregnanttrials.htm); NIH Launches 2009 H1N1 Influenza Vaccine Trial in HIV-Infected Pregnant Women: Trial in HIV-Infected Children, Youth to Begin Next Week

(http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1HIVTrials.htm).
Visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza.

Also, visit NIAID's Web sites for more information about flu(http://www3.niaid.nih.gov/topics/Flu/) and asthma (http://www3.niaid.nih.gov/topics/asthma/) and NHLBI's Web site for more information about asthma (http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html) .

For additional information about the NHLBI's Severe Asthma Research Program, contact the NHLBI Office of Communications at (301) 496-4236 or e-mail nhlbi_news@nhlbi.nih.gov.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.



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Benefits of swine flu vaccine greatly exceed the risks

In a typical year, seasonal flu kills about 36,000 people — nearly all of them older than 65 and many with underlying health problems. But that's not the way the H1N1 swine flu will look this year. It strikes hardest at children and young adults, who have none of the immunity to the strain that older people apparently have. And though only a fraction of 1% of sufferers is likely to get seriously ill, almost a third of those who die may be otherwise healthy and robust.

Such an outcome, says Anthony Fauci, the federal government's top infectious disease expert, is "almost unheard of." Fauci told USA TODAY's editorial board this week that he has been dealing with infectious diseases for decades, "and I've never seen, in seasonal flu, a normal, robust healthy person die from influenza."

Yet, that tragic scenario is already playing out around the nation with swine flu. H1N1 influenza has killed 28 pregnant women and 60 children since April, according to the Centers for Disease Control and Prevention. Officials don't know why some otherwise healthy people die from H1N1, and they won't predict how many more might. But the trends suggest that thousands of young lives are at stake.

This picture, based not on conjecture but on science and observation, is not meant to frighten. It is meant as a sobering counter to those who apparently have no use for science, government or vaccines and are warning people to forgo protection against a very real threat.

Typical of the skeptics is political pundit Bill Maher, who tweeted this sage advice to thousands of Twitter followers last month: "If u get a swine flu shot ur an idiot."

As the H1N1 vaccine is about to become widely available, the saddest thing is that many people seem to be listening to the Mahers of the world. A University of Michigan poll in August found that only 40% of parents planned to get the H1N1 shot for their children. Some parents are even holding ill-advised "flu parties" to expose their children to H1N1 — a potentially fatal disease.

Some of the antipathy to the shots no doubt dates to the 1976 swine flu outbreak at Fort Dix, N.J., which caused one death and sent the government into overdrive down a tragic path. President Ford pledged to vaccinate everyone in the USA against an expected epidemic. But the flu never escaped Fort Dix. More than 500 of the 45 million people vaccinated got a rare neurological illness, Guillain-Barré. Dozens died.

Whether that was related to the vaccine is still unclear. But the program, quickly suspended, left many Americans with a fear of vaccines. Little wonder. The episode involved all risk and no benefit, because the flu turned out to be no threat.

That is clearly not the case today. Around the world, H1N1 has sickened millions, and 4,100 deaths have been reported. In the USA, since Aug. 30, more than 16,000 people have been hospitalized and nearly 1,400 have died from H1N1 or seasonal flu. The benefits of the vaccine, which authorities say is as safe as the seasonal flu shot, far outweigh any risk of side effects.

The decision whether to get it, for yourself or your children, should be driven by facts and science, not advice from people who play doctors on TV or the Internet.


P.S. Boost your immune system by taking Vitamin C rich foods and fruits.




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Protect your baby against swine flu by getting vaccinated, CDC says

Babies can't get vaccinated for H1N1 virus, so parents and siblings should. Newborns have incomplete immune systems, putting them at higher risk for H1N1 flu virus. Babies under age 6 months cannot get flu vaccine, so the federal Centers for Disease Control and Prevention says parents and siblings living with infants should get vaccinated. Caregivers of those babies are first in line for swine flu vaccine, as are children up to age 4.

If you get sick, try to stay away from the baby. Have a healthy person take over care duties. If you can't, consider wearing a surgical mask when in close contact with the baby. A blanket between mother and baby can block the virus. And of course, wash hands and keep them away from the mouth, eyes and nose.

Mothers should keep breast-feeding even if they get sick. Mother's milk is a baby's best food, filled with antibodies that can fight infections (unclear if it fights swine flu). The virus does not travel in mother's milk and it's OK to take flu medicine while nursing. If sick, express the milk and have others do the feeding.


P.S. Boost your immune system by knowing Vitamin C Benefits.




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Swine flu nasal spray or shot?

We now know the first batch of the much anticipated swine flu vaccine has been shipped from the manufacturer and is on its way to undisclosed distribution centers around the country, including here in Central Florida. And according to the Orange County Health Department who gets its information from the State Health Department, the first batch is coming in the form of a nasal spray.

The next batch will be shipped next week, and is expected to come in the form of the shot. The mist, of course, is really geared toward children and adults who just don't like needles. But results of a new study just released comparing the seasonal flu shot with the flu mist show the shot is twice as effective. However, there have been no studies done comparing the swine flu mist vs. the shot.

In fact, health officials say that may not be the case with the swine flu, that the shot and the spray may be equally effective. Unfortunately for now, we'll have to wait to find out. The Orange County Health Department says both the mist and the shot will be available here in Central Florida by mid-October, but supplies will be limited.

"It's going to arrive initially in small amounts. Then we'll get more. People getting it first will be those at risk" "But with the FluMist, one little caveat, it has to go to healthy people, not the ones with underlying conditions and those at risk," said Orange County Health Department spokesman Dain Weister

The Health Department tells us anyone between the ages of 2 and 49 without any underlying health problems can get the nasal spray.

P.S. boost your immune system by heavy intake of vitamin C foods and supplements.

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