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No U.S. Decision On H1N1 Vaccine Orders: Official

WASHINGTON (Reuters) – The United States has not made a decision on whether to cancel or sell any of its orders for the H1N1 vaccine, unlike some countries in Europe, a federal health official said on Thursday.

Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said demand remains steady and the government’s focus is on having as many people vaccinated as possible

“Right now we are at a point where we have ample supply. We’re really encouraging people to get vaccinated. So we haven’t made decisions here in the U.S. about giving back vaccines,” Schuchat told a media briefing.

Germany plans to cancel half the 50 million vaccines it ordered from GlaxoSmithKline (GSK) to combat the H1N1 flu virus, a German health official said on Thursday.

Earlier this week, France canceled over half the H1N1 flu vaccines it had ordered because of the pandemic.

The U.S. government has paid for 251 million doses of bulk vaccine from five makers — Glaxo, AstraZeneca, Sanofi-Aventis, Novartis and CSL Ltd.

Swine Flu Far Less Severe In Latest Calculations

By Steve Sternberg, USA TODAY

porky

A team of researchers from the USA and Britain on Monday dramatically scaled back estimates of the severity of the swine flu epidemic.

The analysis suggests that the death rate from the current wave of H1N1 flu cases probably will fall in a range that extends from far lower to slightly higher than the estimate of 36,000 deaths caused by seasonal flu in a typical year.

The analysis doesn’t project how many people will contract swine flu but “how bad it will be,” says lead author Marc Lipsitch of the Harvard School of Public Health.

At the low end, the estimates suggest that for every 10% of the population to develop flu symptoms, there will be 1,500 to 2,700 deaths, 6,600 to 11,000 people in intensive care, and 36,000 to 78,000 hospitalizations. At the high end, for the same percentage of the population, swine flu could cause 7,800 to 29,000 deaths, 40,000 to 140,000 people needing intensive care, and 250,000 to 790,000 hospitalizations.

The calculations represent a marked reduction from an August report by the President’s Council of Advisors on Science and Technology. That report proposed a “plausible” death toll that could fall anywhere between 30,000 and 90,000. Lipsitch, who worked on the August report, says the earlier estimate was based on “limited data” because the researchers began their work not long after the virus first surfaced in April, when little was known about the shape of the epidemic to come.

To fill gaps, Lipsitch and his team at Harvard and Britain’s Medical Research Council used data from Milwaukee and New York City. The data confirmed that swine flu has its biggest effect on children younger than 4 and adults 18 to 64. The study appears in the Public Library of Science (PLoS) Medicine journal.

Last month, the Centers for Disease Control and Prevention released its own estimate of the scope of the epidemic. The agency says at least 22 million Americans have gotten the flu since April. About 3,900 have died, including about 540 children.

Beth Bell of the CDC says the fact that researchers used “real live data” lends credibility to the research. She says the estimates roughly agree with those released last month by the CDC.

“It’s an insight into how flu kills,” says institute director Anthony Fauci.

Glaxo’s Swine Flu Shot May Give Kids Fever

high fever

LONDON (AP) — The European Medicines Agency warns that young children given GlaxoSmithKline’s swine flu shot may get a fever after their second dose.

In a statement issued Friday, the European drug regulator said data from GlaxoSmithKline PLC showed a higher number of children aged six months to 3 years had a fever after their second dose of the Pandemrix vaccine, compared with the first. Kids were also more likely to have side effects like muscle pain, drowsiness, and irritability.

The European regulator recommends children get two doses of swine flu vaccine, though Glaxo says one dose is enough.

Glaxo’s vaccine contains an adjuvant, a chemical compound to boost the immune response. It is sold across Europe and Canada.

Another formulation of Glaxo’s vaccine, without the adjuvant, is available in the U.S. Vaccines with adjuvants usually cause more side effects. No flu vaccines with adjuvants are licensed in the U.S.

Last month, Glaxo advised health authorities not to use one batch of its Canadian-manufactured swine flu vaccine in case it triggered life-threatening side effects like anaphylactic shock.

In a press briefing on Thursday, the World Health Organization’s flu chief Keiji Fukuda said that more than 150 million doses of swine flu vaccine have been distributed in more than 40 countries and that they had not seen any evidence to suggest the vaccines caused worrying side effects.

Signs Swine Flu Wave May Have Peaked in U.S.

By DONALD G. McNEIL Jr.

via www.nytimes.com

pig fly

Although federal health officials decline to use the word “peaked,” the current wave of swine flu appears to have done so in the United States.

Flu activity is coming down in all regions of the country, the Centers for Disease Control and Prevention said Friday, though it is still rising in Hawaii, Maine and some isolated areas.

The World Health Organization said Friday that there were “early signs of a peak” in much of the United States.

On Wednesday, the American College Health Association, which surveys over 250 colleges with more than three million students, said new cases of flu had dropped in the week ending Nov. 13. It was the first drop since school resumed in the fall, and it was significant — new cases were down 27 percent from the week before.

And on Friday, Quest Diagnostics, the country’s largest laboratory, said its tests of 142,000 suspected flu specimens since May showed that the flu peaked in late October.

Nonetheless, Dr. Anne Schuchat, the director of immunization and respiratory diseases at the C.D.C., chose her words carefully, saying: “I wish I knew if we had hit the peak. Even if a peak has occurred, half the people who are going to get sick haven’t gotten sick yet.”

Dr. Schuchat also noted that even when new infections topped out, hospitalizations and deaths were still on the way up, because most took place days or weeks later.

Privately, federal health officials say they fear that if they concede the flu has peaked, Americans will become complacent and lose interest in being vaccinated, increasing the chances of another wave.

In New York, where cases peaked last May, vaccine clinics have gone begging for takers as long lines form in the rest of the country.

Epidemiologists expected a peak about now, because flu waves typically last six to eight weeks.

How U.N. Redefined ‘Pandemic’ to Heighten Alarm Over H1N1

CDC h1n1

By Chelsea Schilling via www.wnd.com

In light of a perceived swine flu outbreak, the World Health Organization raised its influenza pandemic alert to its second highest level in May – but evidence reveals the agency may have made it easier to classify the flu outbreak as a pandemic by changing its definition to omit “enormous numbers of deaths and illness” just prior to making its declaration.

WHO, a specialized agency of the United Nations, issued its pandemic declaration – the first in 40 years – just as 74 countries had reported 144 deaths from the novel H1N1 infection.

The world was gripped with fears of swine flu as the alert increased from Phase 5 to Phase 6, the highest level. Immediately, pharmaceutical companies began working to develop vaccines, and countries tailored their responses to address the situation.

Dr. Thomas Frieden, who assumed leadership of the U.S. Centers for Disease Control and Prevention, or CDC, on June 8, announced that the U.S. would respond aggressively to the virus.

“There has been excellent global cooperation with the World Health Organization, with countries around the world,” Frieden said. “This is one of the many conditions that reminds us that we are all connected and many of our decisions in the U.S. will rely on good information from countries in Latin America, in Africa, in Asia, Australia and elsewhere. It’s very important that we confront this jointly.”

The current WHO phase of pandemic alert remains at 6, indicating a full-blown global pandemic.

But in early May, just prior to the initial declaration, WHO made little-noticed changes to its definition of a pandemic.

The previous definition of a pandemic stated:

An influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in several, simultaneous epidemics worldwide with enormous numbers of deaths and illness. With the increase in global transport and communications, as well as urbanization and overcrowded conditions, epidemics due the new influenza virus are likely to quickly take hold around the world (emphasis added).

h1n1

The WHO changed that definition, omitting the section indicating “enormous numbers of deaths and illness.” It now states:

Vaccination: A Conversation Worth Having by Bill Maher

bill maher

While America is still in the grips of swine flu mania, let me use this opportunity to clear up a few things about my beliefs concerning the flu shot, vaccines, and health in general. I do this because there is obviously a lot of curiosity about this subject of vaccines — it comes up in every interview I do these days, and I’ve been finding that people, including doctors, are privately expressing a skepticism that is still not very prevalent in public. I feel like I’ve become a confessor for people who want someone to be raising questions about vaccines.

But I don’t want the job. I agree with my critics who say there are far more qualified people than me — its just that mainstream media rarely interviews doctors and scientists who present an alternative point of view. There is a movement to stop people from asking any questions about vaccines — they’re a miracle, that’s it, debate over. I don’t think its that simple, and neither do millions of other people. The British Medical Journal from August 25 says half the doctors and medical workers in the U.K. are not taking the flu shot — are they all crazy too? Sixty-five percent of French people don’t want it. Maybe its not as simple as the medical establishment wants to paint it.

Vaccination is a nuanced subject, and I’ve never said all vaccines in all situations are bad. The point I am representing is: Is getting frequent vaccinations for any and all viruses consequence-free? I feel its unnecessary and counterproductive to try and silence people with condescension. Michael Shermer wrote me an open letter and felt I needed to be told that “vaccinations work by tricking the body’s immune system into thinking that it has already had the disease for which the vaccination was given.” Thanks, Doc, I thought there might be a little man inside the needle. Yes, I read Microbe Hunters when I was eight, I have a basic idea how vaccines work.

That’s not — or shouldn’t be — where the debate is. I admit, its hard to get as clear a picture of my beliefs, as you could, say, if I had written a book on vaccines, versus someone in the setting of a talk show. So I understand why its easy to take bits of things I have said and extrapolate into something I actually have never said. I understand it, but its not exactly “scientific.”

But rather than responding to every absurd thing said, let me just tell you want I do think — because I will admit, I have gone off half cocked on this issue sometimes, and often only had time on my show to explain a fraction of what needed to be explained, and for that I am sorry. Some of it can’t be helped, some of that is the nature of the show we do: live, off the cuff, lots of interruptions. Some of it was just from me being overexcited about finally finding a health regimen that actually made me healthier and feel better. And many a time I have wanted to stop the show and clarify a point or provide the nuance I think it deserves, but I am serving many masters, and you have to get out of the way as much as you can so the guests can say their piece.

But some of it I would do differently. For example, I recently joined Twitter Nation — what can I say, Demi Moore is a very convincing salesperson — and what everybody told me about Twitter was that it was supposed to be whatever stray thought or thing just happened to you — you know, for people who find blogging too formal and stuffy.

But apparently it’s taken very seriously, because there was Scott Pelley on 60 Minutes asking the Secretary of Health and Human Services what she thought about the fact that “Bill Maher told his viewers anyone who gets a flu shot is an idiot.”

Well, not quite. It was twittered, which I guess doesn’t make a huge difference, but as 60 Minutes is the last bastion of TV journalism, accuracy is appreciated. And I see that counts for Twitter, too — my bad — so yes, some people are not idiotic to get a flu shot. They’re idiotic if they don’t investigate the pros and cons of getting a flu shot. But, come on — it was a twitter from a comedian, not a treatise in the New England Journal of Medicine, that’s not what I do.

I’m just trying to represent an under-reported medical point of view in this country, I’m not telling a specific pregnant lady what to do. With unlimited air time, I would have, for example, added to my discussion with Dr. Bill Frist on October 2 that, yes, any flu or health challenge can be dangerous when you’re pregnant, and if your immune system is already compromised by, for example, eating a typical American diet, then a flu shot can make sense. But someone needs to be representing the point of view that says the preferred way to handle flus is to have a strong immune system to begin with, and getting lots of vaccines might not be the best way to accomplish that over the long haul.

Virginia Teen Suffers Rare Illness After Swine Flu Shot

Boy diagnosed with Guillain-Barre syndrome, but CDC says no clear link

jordan

By JoNel Aleccia, Health writer

Nov. 12, 2009

A 14-year-old Virginia boy is weak and struggling to walk after coming down with a reported case of Guillain-Barre syndrome within hours after receiving the H1N1 vaccine for swine flu.

Jordan McFarland, a high school athlete from Alexandria, Va., left Inova Fairfax Hospital for Children Tuesday night in a wheelchair nearly a week after developing severe headaches, muscle spasms and weakness in his legs following a swine flu shot. He will likely need the assistance of a walker for four to six weeks, plus extensive physical therapy.

“The doctor said I’ll recover fully, but it’s going to take some time,” the teenager said.

Jordan is among the first people in the nation to report developing the potentially life-threatening muscle disorder after receiving the H1N1 vaccine this fall. His alarming reaction was submitted via msnbc.com’s reader reporting tool, First Person, by his stepmother, Arlene Connin.

Increased cases of GBS were found in patients who received a 1976 swine flu vaccine, but government health officials say they’ve seen no rise in the condition associated with the current outbreak.

So far, the federal Centers for Disease Control and Prevention have received five reports of GBS in people who received the H1N1 vaccine since Oct. 6, not including Jordan’s case, said Dr. Claudia J. Vellozzi, deputy director for immunization safety.

Out of about 40 million doses of H1N1 vaccine available to date, that’s a far lower rate of GBS than the 1 case that develops in every 1 million people who receive the regular flu vaccine.

“It’s much less than we’d expect,” she said, adding that many cases go unreported.

In 1976, about 1 additional case of GBS developed in every 100,000 people who were vaccinated against the swine flu, according to the CDC.

Jordan’s parents said doctors diagnosed the teen with GBS, a rare muscle disorder that develops when a person’s own immune system attacks the nerves, causing muscle weakness, difficulty walking and sometimes paralysis and death.

Hospital officials didn’t dispute that the boy had GBS, but refused to comment on the boy’s condition or treatment, even after his family granted permission.

“They don’t want to create a fear or panic in the community,” said Jordan’s stepmother, Connin.

Connin and Jordan’s father, Calvin McFarland, both 38, believe the shot sparked the illness that came on 18 hours after the boy’s vaccination.

No clear link

But Vellozzi said there’s no clear link between the new vaccine and the disease.

“We know that GBS and other illnesses occur routinely in the U.S.,” Vellozzi said, noting that 80 to 120 cases are diagnosed each week in the general population.

“There are events that follow vaccination. That’s what they are, they happened to follow vaccination.

GBS is among the most severe adverse events being tracked with updated systems developed by the CDC, the Food and Drug Administration and the American Academy of Neurology in order to monitor the rollout of the H1N1 flu vaccine.

So far, CDC officials have received about 1,700 reports of adverse events linked to the new shot, Vellozzi said. Of those, only about 4 percent, or 68, were coded as serious. That’s on par with reports regarding seasonal vaccine.

While any harmful side effect can be devastating for an individual, when it comes to larger public health issues, the H1N1 virus is considerably riskier than the vaccine, experts say.

“The H1N1 illness is making lots of children very ill,” Vellozzi said. “There’s lots of illness and lots of death.”

So far, more than 4,000 people have died from H1N1 infection in the U.S., according to latest estimates by the CDC.

Since the start of the H1N1 vaccine campaign, the CDC has repeatedly warned that certain conditions, such as miscarriage, heart attack and even GBS occur regardless of immunization, and officials have urged the public not to blame the vaccine for the illnesses, but to report promptly any suspected side effects.

As of early Wednesday, CDC officials said they had received no report from Inova Fairfax about Jordan’s condition. Later in the day, however, hospital spokesman Tony Raker indicated the hospital had submitted the report.

After hearing about Jordan’s case from msnbc.com, CDC officials advised the family to report Jordan’s case themselves.

Vaccine critic Barbara Lowe Fisher, president of the National Vaccine Information Center in Vienna, Va., said assuming all potential side effects are coincidence is a mistake. Such an attitude is likely to prevent doctors and other health workers from reporting adverse events in a timely manner, obscuring a true picture of any problems.

Fisher said only between 1 percent and 10 percent of adverse events are reported to the government’s Vaccine Adverse Event Reporting System, which was set up to track problems with vaccines. A 1986 law requires reporting of certain adverse events to VAERS, but there are no sanctions for not reporting, Fisher noted. CDC officials said general reporting to VAERS is voluntary.

Fisher said she suspects that many more cases of GBS have occurred in the wake of the H1N1 vaccines.

“We basically have people blowing it off,” she said. “We need to make sure people are reporting.”

Eager for protection
Like many parents across the country, Arlene Connin said she was eager to protect Jordan and his brother, Lleyton, 7, against the flu. When she took the boys to their pediatrician for seasonal flu shots on Nov. 5, the provider said H1N1 vaccine was available, too.

There was “not even a thought,” that either boy would have a reaction, Connin said. Within hours, however, Jordan developed severe headaches, chills and back spasms. The family rushed him to the closest hospital, Dewitt Army Community Hospital, where doctors conducted neurological exams, a CT scan and an EKG test.

The small hospital didn’t have the facilities to diagnose or treat Jordan’s illness, so he was transferred by ambulance on Nov. 6 to Inova Fairfax Hospital in Falls Church, Va., a spokesman said. Doctors there quickly gave Jordan intravenous immunoglobulin, a standard treatment for GBS, Connin said.

“GBS, that’s the diagnosis they gave us and that’s how they were treating him,” Connin said.

A hospital spokesman, Tony Raker, declined further comment on Jordan’s case. When an msnbc.com photographer asked to view Jordan’s chart, even with his father’s permission, hospital officials refused.

Doctors are reluctant to discuss GBS in connection with vaccines, Connin said. Anti-vaccine groups frequently cite the disorder as evidence of vaccine dangers, which public health officials fear will discourage people from getting life-saving protection, especially in the case of H1N1.

Jordan’s experience has made his parents think hard about immunization, even though they’ve always insisted on annual flu shots. Under CDC guidelines for children 9 and younger, Lleyton should receive another booster shot of H1N1 vaccine to protect him fully against the virus.

“I have mixed emotions on that one,” Calvin McFarland, the boys’ father, said. “We’re not sure what we’re going to do about that.”

original link: www.msnbc.com

New York Clinics See Few Crowds for Free Vaccine

By ERIC KONIGSBERG

Published: November 8, 2009

empty clinic

Perhaps it was fear of crowds that kept the crowds away on Sunday from the clinics offering free swine flu vaccinations to schoolchildren. Or, maybe, as some of the few who did show up suggested, the small numbers could be attributed to wariness about the new vaccine or a lack of knowledge about the clinics.

Whatever the reason, the seven clinics across the city were, depending on how you looked at it, puzzlingly underused or puzzlingly overprepared.

While the city’s health commissioner, Dr. Thomas A. Farley, said the clinics had the staff and enough vaccine to accommodate about 500 middle- and high-school students per clinic per hour — or as many as 31,500 vaccinations a day — a department spokeswoman put the total vaccinations administered on Saturday at 1,701.

So on Sunday, the clinics, operating out of public schools in all five boroughs, began offering the vaccine to pregnant women and increased the age limit for others to 24 from high school age. Still, the turnout was low: 1,749.

“It was very hard to predict how many people would be coming,” Dr. Farley said in an interview on Sunday. “We did a telephone survey, and about 50 percent said they were interested in getting the swine flu vaccine for themselves or their child.

“We are also providing vaccines in the city’s elementary schools, and we’ve gotten about 23 percent of the consent forms returned. So we had those two numbers to work with. If we’d had 23 percent of the children in the city’s middle and high schools come, we’d have had very full clinics, indeed.”

What the department had instead were large rooms that were mostly empty.

The clinics will be operating in various schools over five weekends. The Manhattan clinic this past weekend was at Marta Valle Secondary School on the Lower East Side. Mahmoud Ali, who took his daughter, Abida, 14, there, said he was “very surprised. I saw only one other child in there besides my daughter.

Officials: Swine flu confirmed in Iowa cat

By MICHAEL J. CRUMB
Associated Press Writer

cat pig

DES MOINES, Iowa (AP) — A 13-year-old Iowa cat has been infected with swine flu, veterinary and federal officials said Wednesday, and it is believed to be the first case of the H1N1 virus in a feline.

The domestic shorthaired cat was treated last week at Iowa State University College of Veterinary Medicine in Ames and has recovered, officials said. The virus also has been confirmed in two ferrets – one in Oregon and the other in Nebraska – but they died.

“We’ve known certainly it’s possible this could happen,” said Centers for Disease Control and Prevention spokesman Tom Skinner. “This may be the first instance where we have documentation that transmission occurred involving cats or dogs.”

The veterinarian who treated the cat, Dr. Brett Sponseller, said two of the three people in the cat’s Iowa home had flu-like symptoms before the cat became ill. The case was confirmed at both Iowa State and the U.S. Department of Agriculture.

Other influenza strains have been known to cross species, but Sponseller cautioned against drawing too many conclusions from the cat including whether other pets could also get the swine flu.

“It’s well documented in influenza in general, but this is the first highly suspected case of H1N1 going from humans into a cat,” he said.

The indoor cat was lethargic, had a loss of appetite and appeared to have trouble breathing after it became infected, Sponseller said. Its owners declined to comment.

Officials said pet owners should take the same precautions against spreading swine flu to pets as they would with humans.

Getting children vaccinated for swine flu can also help prevent the illness from spreading to pets. There is no swine flu vaccine for pets.

Dr. Ann Garvey, Iowa’s state health veterinarian, said it is not yet known how sick cats or other pets could get from swine flu.

“Because we haven’t seen that many cases, it’s difficult to give a blanket assessment on how sick it can make an animal,” she said.

Officials also stressed that there is no evidence that swine flu can be passed from pets to people.

“But it’s so early in the game we don’t know how it’s going to behave. But that doesn’t appear to be the concern. There’s no sense of them passing it on to people,” said Michael San Filippo, spokesman for the American Veterinary Medical Association.