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 HINI Vaccine 
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http://online.wsj.com/article/SB125469946745562945.html

Public Faces Long Wait to Get New Flu Vaccine

OCTOBER 5, 2009
By BETSY MCKAY

The U.S. government is expecting delivery starting this week of enough doses of the new swine-flu vaccine for nearly every American who wants it, but state and local budget cuts coupled with limits on who can administer the vaccine could hamstring the campaign. A second wave of the new flu, known as the 2009 H1N1 virus, is widespread across more than half of U.S. states, but it will be weeks before millions of people who want shots can get them. Manufacturers are still producing the 250 million doses the government has ordered, and state health officials must then determine where to distribute them.

A big question is how many people will actually want the vaccine amid concerns that it has been rushed to market and could produce side effects, as well as a sense among some that the disease isn't serious enough to warrant seeking a shot. But health officials expect demand to rise as they unleash a media campaign to promote the vaccine and if the public hears more reports of deaths of otherwise healthy adults and children, such as the case of a 7-year-old girl in Dalton, Ga., last week.

The government set aside $1.5 billion to help fill in the blanks on a patchwork of public-health departments and private health providers and vendors to carry out what could be the country's largest-ever mass vaccination effort. While a huge vaccine-distribution system has been built to get the H1N1 vaccine quickly to about 90,000 sites across the country, it is connected to a "rusty faucet," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "This system is already under great stress."
About 12,000 public-health positions were eliminated in 2008, and the pace of reductions has quickened this year, according to the Association of State and Territorial Health Officials, or Astho, a nonprofit organization that advocates for more public-health funding. There are about 102,000 public-health workers for states and territories, a number that doesn't include local health departments. Local health departments had about 155,000 workers at the beginning of this year, including some who work in state health departments, but 8,000 of those positions had been eliminated by June 30, said Robert Pestronk, executive director of the National Association of County and City Health Officials. An additional 12,000 workers had their hours cut or were put on mandatory furlough, he said.

To meet potential demand for the vaccine, public-health officials are trying to attract volunteers and contract with private providers to administer shots in public clinics. "The cost of running a vaccine program has gone up dramatically," said Paul Jarris, Astho's executive director. Adding to the problem: At least 30 states normally limit pharmacists from administering some vaccines to children of various ages, even though drugstores and large retailers dispense a growing percentage of seasonal flu shots. Children and young adults through age 24 are among those who will get top priority for H1N1 vaccine. Some states are relaxing the rules or considering such a move to accommodate potentially huge demand. Massachusetts expanded the authority of pharmacists, paramedics, dentists and third- and fourth-year medical students to administer seasonal and H1N1 shots to all those who want them.

The first 600,000 doses are expected to be delivered by Tuesday, and state and local health officials are scrambling to figure out where to send them so they reach the people who need them most. While the virus makes most people only mildly ill, it has taken the lives of some children and young adults who were perfectly healthy until they were struck. One hundred pregnant women have been treated for H1N1 in intensive-care units, and 28 have died, said the Centers for Disease Control and Prevention.

The initial doses are all in the form of a nasal spray not recommended for pregnant women or people with chronic health conditions. Both groups are among the 159 million people the government has said should get the H1N1 vaccine first. So officials are trying to steer the initial doses to other priority patients. Some states say this week's nasal-spray doses will be targeted at health-care workers. Pregnant women and people with chronic health conditions will be offered shots that could be delivered as early as later this week.

Government health officials have warned the effort will be bumpy at first. Each state has been allotted a total amount of vaccine based on the size of its population, and deliveries will be made every week, with the trickle increasing to a steady flow by midmonth. Because the vaccine comes in varying formulations, from the nasal spray that can be given only to healthy 2- to 49-year-olds, to pediatric doses in shot form, officials have to be careful to direct vaccine to outlets where those populations are found. The uncertainty over supply is giving providers little time to prepare. "We're really going to have to be able to turn on a dime and be flexible," said Steve Pellito, national director of wellness for Maxim Health Systems, a division of Maxim Healthcare Services that offers seasonal-flu clinics and hopes to offer H1N1 clinics.

As for efficacy, the circulating virus and the vaccine are very well matched, according to government health officials, which would make the vaccine effective. The CDC is rolling out a media campaign to promote vaccination, with ads expected on buses in Chicago, Dallas and several other cities within the next two weeks. One will remind pregnant women that "flu can harm you and your baby" and urge them to get shots both against seasonal flu and the H1N1 influenza.

But the CDC doesn't plan an ad blitz yet because the shots aren't expected to be widely available for several weeks. The agency also wants to be careful not to promote the shot too aggressively, said Kristine Sheedy, a CDC communications expert involved in the campaign. "We want to take an approach where we don't want people to feel coerced into making a decision," she said. "We're all prepared for the fact there will be several people we hope would choose vaccination but will not."

John Rouse, health director for Harnett County, N.C., said he is "sitting on pins and needles" for word of whether expected budget cuts in the state will force him to lay off any of his department's 104 staff. If that happens, "that's going to curtail our ability to be able to respond," he said. The vaccination effort is "massive in scope, and it is complex," said Rhonda Medows, commissioner of Georgia's Department of Community Health. But approximately $38 million the state is receiving in federal funds to help carry out the H1N1 campaign and a reorganization that added staff to her department have helped, she said.

After learning only a week ago how many shots they could get in their first order, Maine health officials pored through a county-by-county list of about 500 health-care providers that had signed up to administer vaccine. Staff redeployed from other parts of the state's Center for Disease Control and Prevention spent all day Tuesday finding out how many doses each provider would need. "This has been very labor intensive," said Dora Anne Mills, the state's public-health director. Dr. Mills said she expects there to be enough vaccine for the general public, beyond the priority groups, in late November or early December, depending on demand. "We're going to go through a storm the next eight weeks," she said.

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Tue Oct 13, 2009 1:29 pm
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Post Re: HINI Vaccine
German Soldiers to Receive Different Swine Flu Vaccine Than German People

http://www.fightbackh1n1.com/2009/10/ge ... erent.html

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Tue Oct 13, 2009 1:31 pm
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Post Re: HINI Vaccine
Branswell: US study shows no problem giving seasonal, H1N1 vaccines at the same time
Via Google News, Helen Branswell of The Canadian Press writes: US study shows no problem giving seasonal, H1N1 vaccines at the same time. Excerpt:

New data from U.S. studies seems to confirm that only one dose of H1N1 vaccine will be needed to protect adults and seniors and that giving seasonal and pandemic flu shots at the same time should be fine, the head of the National Institute of Allergy and Infectious Diseases said Friday.

Testing showed that adults and seniors who received a second dose of the pandemic vaccine didn't get much additional benefit from the second shot, Dr. Anthony Fauci said in a media teleconference.

The response to one dose in both groups was already sufficiently strong to suggest that the vaccine should offer good protection and it has been the working assumption in the U.S. that adolescents and adults would only need one shot.

"We have data that looked good and suggesting to us (that) one dose of 15 micrograms would be sufficient for the adults and elderly," said Fauci, who added there was "no substantial difference between the second dose and (antibody levels seen at) 21 days following the first dose."

"That confirms the concept that a single dose of 15 micrograms is sufficient enough to induce a robust response."

Fauci also revealed preliminary data from another study looking at whether it was safe to give both seasonal and pandemic flu shots at the same. Both protect against an H1N1 virus - though the viruses are sufficiently different it is thought vaccine against one would not protect against the other.

There were theoretical concerns, though, that giving two flu vaccines at once might interfere with the immune system's ability to generate a good response to all the viruses covered in the shots. Seasonal flu shots protect against three families of viruses - seasonal H1N1 and H3N2, both influenza A viruses and an influenza B virus.

"The vaccine when given simultaneously does not impair the immune response to either of those (shots)," Fauci said.

http://crofsblogs.typepad.com/h5n1/2009 ... -time.html

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Tue Oct 13, 2009 1:32 pm
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Post Re: HINI Vaccine
U.S. could potentially use controversial adjuvants in swine flu vaccine

BY LJ ANDERSON
Posted: 10/13/2009 08:09:34 PM PDT
Updated: 10/13/2009 08:09:35 PM PDT

The World Health Organization estimates that a worldwide production capacity of 3 billion doses of pandemic H1N1 vaccines will be used to prevent the outbreak and spread of the 2009 H1N1 flu, or "swine flu," as it is better known. This ambitious plan for widespread vaccine use, albeit inadequate for a total population of 6.8 billion people, has drawn criticism regarding the vaccine's safety, and the use and potential use of vaccine adjuvants.

In the alternative health community, chiropractor Ginger Mills, DC, of Redwood City, is concerned that adjuvants, especially squalene, will be added to vaccines used in the U.S., should the number of cases rise. "Squalene is an oil that is found in olives and in certain other foods, and is perfectly healthy when you ingest it — but when injected into the bloodstream, it can have adverse effects."

Adjuvants enhance or "supercharge" the immune response, reduce the number of vaccines needed, and allow supplies to last longer. Currently, aluminum salts are the only approved vaccine adjuvants for use in the United States. The use of adjuvants has been suspected, but not confirmed, in the development of illnesses in Gulf War veterans who may have received squalene-containing anthrax vaccines.

However, the current stock of U.S. swine flu vaccines does not contain adjuvants, according to Anne Schuchat, MD, in an informational video produced by the Centers for Disease Control and Prevention (CDC).
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Schuchat does acknowledge that there is an emergency provision to use them — should the pandemic accelerate.

Adjuvants are being used in swine flu vaccines in countries outside of the United States, including Canada, Europe and Australia. However, even though Canada is using an adjuvanted vaccine, it has also ordered 1.8 million doses of the unadjuvanted vaccine for use in pregnant women and children under the age of 3.

Maine physician Meryl Nass, MD, has written widely on the use of vaccines. "If novel adjuvants do get added (in the U.S.) — only if conditions change — it would preclude the quick licensure process that took place for the licensed H1N1 vaccines. Recipients would need to sign an informed consent for an experimental product," said Nass. "I do not believe they would be 'secretly' added."

The World Health Organization has tried to allay concerns about the vaccine and states that clinical trials suggest this vaccine is as safe as the seasonal influenza vaccines, and that most countries have vaccine monitoring systems in place. Without specifically addressing the use of adjuvants, WHO states that any vaccine side effects are expected to be of short-term duration, such as injection site soreness, swelling and redness, and possibly, headache, fever and muscle aches. However, WHO also has a disclaimer that "even very large clinical trials will not be able to identify possible rare events that can occur when pandemic vaccines are administered to many millions of people."

With a pivotal and profitable role played by the pharmaceutical industry in vaccine production, Nass suggests that there is a lack of "unconflicted data" available about adjuvants. "Nearly all of the MF59 (adjuvant) data were derived from the manufacturer of MF59, for example," said Nass. "It is more the lack of reliable data, and gives the impression that something is being hidden. Those of us who are familiar with the subject are concerned that if these adjuvants were used en masse, we would face some bad outcomes. The FDA has been sitting on them for 10 years, and usually, that means that the FDA is aware of significant problems."

snip

Another pandemic expert and Google executive, Larry Brilliant, led the WHO team that was responsible for smallpox eradication in Southeast Asia and India. Brilliant, a physician and epidemiologist, is now president of the Skoll Urgent Threats Fund, and recently became one of the expected 100 million Americans to develop the swine flu.

"But while I was never sick enough to consider going to see my doctor or going to an ER, I would not wish this disease on anyone and I certainly would have preferred a vaccination to this teeth-rattling bug," wrote Brilliant on Huffington Post.

"Most poignantly, even though I tried to stay isolated, I infected one of my children who also spent a lousy sweat-soaked, teeth-chattering week dancing with the swine. No loving parent would ever want to spread this disease to his or her kids. If the sole reason to get vaccinated were to prevent my spreading this disease to my family and community, that alone would make getting vaccinated an easy choice for me."

http://news.google.com/news/url?fd=R&sa ... DwmDCYbnOw

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Wed Oct 14, 2009 8:57 am
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Post Re: HINI Vaccine
Mass. to give swine flu shots to prisoners first

Thursday, October 15, 2009
http://www1.whdh.com/news/articles/local/BO127005/

BOSTON -- Massachusetts health officials have decided to give swine flu vaccinations to state prisoners before the rest of the population.

Prison officials warn that inmates could quickly spread the flu if not inoculated -- particularly those in high-risk groups such as AIDS patients.

Middlesex Sheriff James DiPaola told the Boston Herald that prisons were the perfect flu "breeding ground." DiPaola dealt with riots in a Cambridge jail when rumors of swine flu spread there.

But state Sen. Mark Montigny said several groups are more vulnerable than prisoners. The New Bedford Democrat said the inoculations should be given to the public immediately.

The vaccines, which are voluntary, will be sent to correctional facilities the second week of November. They are set to be available to the general public by Nov. 27.

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Thu Oct 15, 2009 6:36 pm
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Post Re: HINI Vaccine
Lawsuit seeks to halt US swine flu vaccination campaign
Via Physorg.com, an AFP report: Lawsuit seeks to halt US swine flu vaccination campaign.

New York medical workers took legal action Thursday to halt a massive swine flu inoculation program being rolled out across the United States, claiming the vaccines have not been properly tested.

Lawyers for the group filed a temporary restraining order in a Washington federal court against government medical regulators they claim rushed H1N1 vaccines to the public without adequately testing their safety and efficacy.

"None of the vaccines against H1N1 have been properly tested," attorney Jim Turner, one of half a dozen lawyers working on the case, told AFP.

The complaint filed Thursday argued that far from preventing a massive outbreak of swine flu, the "live attenuated influenza virus nasal mist vaccine could trigger" an H1N1 pandemic.

"I don't know of another live vaccine for flu. So you have immediately a new problem you don't have with a killed vaccine," Turner told AFP.

Officials at the National Institutes of Health have said that trials of swine flu vaccine began in August and delivered results last month, showing that the vaccine was well tolerated and produced a robust immune response in older children and adults in good health with just a single dose.

But Turner insisted that "the FDA did not do the proper testing to show safety and efficacy of this vaccine, which is under the law a new drug.

"When I say test data, I don't mean some professor at some medical school somewhere infected some students and said 'I don't see any problems.'

"What I mean is carefully conducted double blind placebo controlled studies trials done in accordance with FDA regulations, and a whole series of them to look at dosing... which are then reviewed by FDA scientists.

"None of that has been done on this vaccination and we're saying the law requires it to be done," Turner said.

The suit was brought on behalf of a group of doctors, nurses and other medical personnel in New York, where health care professionals who see patients are required to be vaccinated against H1N1, Turner said.

If the complaint is upheld, it would stop the roll-out of the H1N1 vaccine nationwide, said Turner, who accused public health officials of hyping the swine flu outbreak.

http://crofsblogs.typepad.com/h5n1/2009 ... paign.html

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Thu Oct 15, 2009 8:09 pm
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Post Re: HINI Vaccine
US: Massachusetts will immunize prisoners first
Thanks to the reader who sent the link to this report from WBZTV.com Mass. To Give Swine Flu Shots To Prisoners First. Excerpt:

Massachusetts health officials have decided to give swine flu vaccinations to state prisoners before the rest of the population.

Prison officials warn that inmates could quickly spread the flu if not inoculated -- particularly those in high-risk groups such as AIDS patients.

Middlesex Sheriff James DiPaola told the Boston Herald that prisons were the perfect flu "breeding ground."

DiPaola dealt with riots in a Cambridge jail when rumors of swine flu spread there.

But state Sen. Mark Montigny said several groups are more vulnerable than prisoners. The New Bedford Democrat said the inoculations should be given to the public immediately.

http://crofsblogs.typepad.com/h5n1/2009 ... first.html

:flame These #$@% have no conscience - guinea pigs - they may be prisoners but they are human! They will kill them, just as the homeless men in Poland were sickened and killed. Aaarrrgh!!!

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Thu Oct 15, 2009 8:31 pm
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Post Re: HINI Vaccine
Top insurer tells 1,000 GPs NOT to give swine flu vaccine


[link to http://www.independent.ie]

An insurance company has warned 1,000 GPs not to administer the swine flu vaccine.

The HSE plans to enlist family doctors to give the swine flu vaccine to patients with pre-existing medical conditions.

But an insurance company which covers around 1,000 of the 2,200 to 2,500 GPs in the country advised them not to sign up for the work because of legal indemnity issues.

The HSE has given GPs until today to sign up to give the vaccine to 400,000 of their patients with certain medical conditions from next week.

Medisec Ireland, which covers around 1,000 GPs, told their members yesterday not to sign up until all indemnity issues were resolved.

GP sources said last night this may lead some doctors who have signed up to withdraw their participation in the programme.

In a letter to the doctors Medisec said it was unclear where a GP would legally stand if they exercised their discretion not to give the vaccine to their patients.

There are also unresolved legal issues around the doctors identifying and offering the vaccine to at-risk patients.

The company said the Irish Medical Organisation had been trying to negotiate an acceptable resolution to the serious medico/legal issues with the HSE, but had not been successful.

Other concerns relate to the cost of legal representation for doctors who may find themselves before their disciplinary body the Medical Council if they fail to give the vaccine to a patient.

They could also have to go before the same body for exercising their clinical judgment not to administer the vaccine to a patient of another doctor who had been referred to them.

Concern

The letter to GPs said that while the administration of the vaccine would be deemed normal work and covered by a doctor's policy, the outstanding issues of concern might not fall into this category due to the amount of work involved and could lead to "adverse indemnity consequences".

It added: "Accordingly, in the circumstances, we do not recommend our members to sign up for the programme until all issues have been resolved."

The other company indemnifying doctors, the Medical Protection Society, is believed to have indicated GPs could go ahead with the vaccinations.

The HSE may have to extend today's deadline for more clarification. It plans to publicise the rollout of the vaccine to at-risk patients tomorrow.

http://www.independent.ie/health/swine- ... 12502.html

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Fri Oct 16, 2009 12:16 am
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Post Re: HINI Vaccine
Doctor Wants Flu Shot Priority for Team Canada
By IAN AUSTEN

OTTAWA — Canadians will not be vaccinated against the swine flu until November, and the federal government has released a priority list for who should receive the shots first. Another suggestion for the list — to move Team Canada near the front of the line in preparation for the Vancouver Olympics this winter — has generated swift and strong reaction from the public.

The proposal by Robert G. McCormack, the team’s chief medical officer, became public on Tuesday. The federal government has so far resisted the idea, although McCormack remains hopeful.

“It has the potential to be emotionally charged because it’s presented as elite athlete getting special treatment,” he said from Vancouver, where he is an associate professor of orthopedic surgery at the University of British Columbia. “But our position is that they need to be protected.”

McCormack described the Olympics as being “where the viruses of the world come to meet.”

Since the Canadian Broadcasting Corporation first reported his proposal, the reaction has been pretty much as he expected. Because waiting times for treatments are a perpetual political issue for Canada’s public health-care system, any suggestion that a particular group might receive priority treatment can be explosive.

Although several readers posted comments on the CBC’s Web site backing the idea, they were a clear minority among the several hundred people who offered comments.

“What ridiculous self importance,” one reader wrote. Another added, “Next they will want all N.H.L. hockey players to get priority!”

Many members of Canada’s hockey team, the contingent that will attract the greatest attention from the home crowd, live in the United States and will not be vaccinated under Canada’s program.

The issue is about timing rather than availability. The Canadian government has ordered 50.4 million doses of vaccine for a country with a population of about 33.7 million. McCormack estimates that about 200 athletes from Canada will compete.

The Canadian government’s priority list is similar to those of many other countries and includes pregnant women, people under 65 with chronic health conditions, children between the ages of 6 months and 5 years old, as well as essential health-care workers.

McCormack said he was still talking with Health Canada, the federal government department that is buying the vaccines, and the health ministries of the country’s 10 provinces that are responsible for administering them. But the Public Health Agency of Canada, the branch of Health Canada that set the priority list, appears unwilling to change its plan to accommodate the athletes.

“Other groups, such as Olympics workers, volunteers and athletes, were considered for prioritization but not selected given expected vaccine availability prior to the Olympics and the absence of epidemiological evidence to warrant early prioritization of this group,” Nadia Mostafa, a spokeswoman for the agency, wrote in an e-mail message.

McCormack has a two-part argument. First, he said, while Olympic athletes are obviously fit, they are also a high-risk group for the swine flu. Training, travel and team accommodations put them in constant contact with others, increasing the risk of infection. He also pointed to research showing that intense exercise weakens the immune system.

His second main point concerns scheduling. Many athletes will head overseas for training and competitions just as Canada’s vaccination program begins and may not return until afterward. It is important to protect them early, he said, to prevent the swine flu from disrupting their training and competition schedules.

He was not suggesting that athletes move ahead of pregnant women and high-risk groups. But his request that athletes receive their shots as early as possible in November suggested that, at the very least, they would be in line at the same time.

“If you lose a month of training, it’s very serious,” McCormack said. “These are people who train 10, 12 years for one day of competition. We live vicariously through our athletes.”

http://www.nytimes.com/2009/10/17/sports/17flu.html

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Fri Oct 16, 2009 11:28 am
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Post Re: HINI Vaccine
Swine flu vaccine delivery delayed as US deaths climb

WASHINGTON — US health officials warned Friday that deliveries of swine flu vaccine are likely to be delayed even as influenza deaths climb, with children hit particularly hard.

Eleven more children were reported to have died of flu in a single week, 10 of them from swine flu, bringing the number of pediatric deaths from H1N1 flu since April to 86, Anne Schuchat, a senior official at the Centers for Disease Control and Prevention (CDC) told reporters.

In the worst of the past three flu seasons in the United States, which usually run from August to March, 88 children died.

As of mid-week, 11.4 million doses of H1N1 vaccine were available and around eight million had been ordered by the states.

Inoculation clinics got under way in several US states last week, targeting children, health care workers, people who work with infants, and young, healthy adults.

Long lines have been reported outside the clinics, as parents rushed to get their children -- one of the most at-risk groups -- inoculated against swine flu.

"About half the deaths we've seen in children since September 1st have occurred in teens, between the ages of 12 and 17," said Schuchat, warning that deaths of older children from swine flu were likely to increase as the season progresses.

Overall, deaths in the United States from flu have leapt above the "epidemic threshold," and widespread disease from influenza has been reported in 41 of the 50 states. The remainder of the states are seeing higher-than-average rates of illness, Schuchat said.

"It's unprecedented for this time of year to have the whole country seeing such high levels of activity," Schuchat said.

But as deaths rose and flu spread across the United States, H1N1 vaccine manufacturers have warned of slow-downs in production, Schuchat said.

"It doesn't look like we're going to be able to make the estimates we had projected by the end of this month," she said, scaling back earlier projections of 40 million doses of vaccine by the end of October to 28-30 million.
http://www.google.com/hostednews/afp/ar ... 5SuOWfuWrQ

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Fri Oct 16, 2009 4:40 pm
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Post Re: HINI Vaccine
Walgreens, CVS shifting flu battle from seasonal to H1N1

October 16, 2009
http://www.suntimes.com/lifestyles/heal ... 16.article

Walgreen Co. and CVS Caremark Corp., the two largest drugstore chains, will stop providing seasonal flu vaccines at many locations to shift their focus to swine flu immunization.

Walgreens will not restock the seasonal flu vaccine after it runs out. Some Walgreens already are out. CVS said it will halt its seasonal flu clinics Oct. 22. Depending on how available the vaccine is, it will continue to offer shots at its 500 clinics throughout the flu season.

Fear of pandemic swine flu, H1N1, has heightened public awareness of seasonal influenza, causing vaccine shortages at doctors' offices, clinics and retail drugstores. Manufacturers are behind in delivering supplies because they're using factories to make both vaccines.

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Post Re: HINI Vaccine
U.S., Mexico face shortage of H1N1 flu vaccine
Production is running behind, the CDC says. In Mexico, response to the outbreak is more muted than in the spring.
By Thomas H. Maugh II and Ken Ellingwood

October 17, 2009

Reporting from Los Angeles and Mexico City

As the so-called swine flu sweeps through the Northern Hemisphere once again, U.S. officials on Friday downplayed the impact of vaccine shortages, and Mexican officials stressed good hygiene and prompt medical treatment for flu-type symptoms.

Officials at the federal Centers for Disease Control and Prevention had expected about 40 million doses of the swine flu vaccine to be distributed by the end of the month, but it looks as though a maximum of 28 million to 30 million doses will actually be shipped, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. That's about 25% fewer than expected.

"Vaccine production is pretty complex, and it is taking a bit longer than we would hope," she said at a news conference Friday.

In particular, growing the virus in eggs has not yielded as much antigen -- the crucial component of the vaccine -- as is normally obtained with the seasonal flu.

Despite the current low production, however, there are no plans to use adjuvants -- chemicals added to increase the immune response to the antigen -- to extend the supply of the pandemic H1N1 vaccine, said Dr. Jesse Goodman of the U.S. Food and Drug Administration. Many people who are reluctant to get vaccinated believe, mistakenly, that the adjuvants are toxic. :roll

As of Wednesday, 11.4 million doses of vaccine were available, slightly more than half of that in the injectable form; states had ordered 8 million doses; and nearly 6 million doses had been shipped -- including 836,900 doses to California.

Mexico was facing similar shortages of the H1N1 vaccine. Officials had promised 30 million doses, but now say they don't expect the first batch of 5 million to 8 million doses until late December. The delay was attributed to the huge demand for vaccines around the world.

Despite those delays, reaction to the H1N1 pandemic in Mexico has been more muted than it was in the spring, when the country was the first to be hit hard by the outbreak.

Nearly 20,000 new cases of swine flu infection have been confirmed in that country since early September, with at least 61 fatalities, according to health authorities there. That contrasts with the nearly 42,000 cases and 260 deaths reported since the outbreak began in the spring -- though authorities cautioned that the winter flu season has just begun.

In April and May, authorities in Mexico City tried to prevent further infection by closing schools, cinemas and museums and allowing restaurants to serve only take-out food. Those shutdowns, along with a drastic drop in tourism because of the flu outbreak, damaged Mexico's already limping economy.

This time, health officials are stressing good hygiene and prompt medical treatment for flu-type symptoms, but say there is no need for widespread precautionary closures. :stars

Health Secretary Jose Angel Cordova said Thursday that the H1N1 virus, though new, has proved no worse than ordinary seasonal flu. Pandemic H1N1 influenza "is a benign illness, caused by a viral cousin of the seasonal [flu], with the same rate of transmission and mortality, so there is no reason for alarm," Cordova told a gathering in the western state of Jalisco. :(

Mexican newspapers carry regular updates on the latest outbreak, and many restaurants offer customers a squirt of antibacterial gel, but there is no sign of panic in the streets. Few residents are seen wearing the surgical face masks that were ubiquitous in the spring.

Meanwhile, in the United States, spot shortages of seasonal flu vaccine have also been occurring because manufacturers have had to juggle production of the two types to ensure the availability of swine flu vaccine. Some retail pharmacies and groups have had to postpone vaccination clinics because of the shortages, and some doctors say they have been unable to get enough vaccine to meet demand.

About 82 million doses of the vaccine have been shipped, amounting to about 71% of the 114 million doses expected for this season, Schuchat said. But most of the rest should be available by December, when the traditional flu season begins to peak.

Swine flu activity is widespread in 41 states, up from 37 last week, and all the other states are reporting regional or local activity, Schuchat said. That level of activity "is unprecedented for this time of year." On average nationally, 6.1% of visits to doctors' offices are for influenza-like illness, which is generally assumed to be swine flu.

"That's very high at any time, but particularly in October," Schuchat said.

In the week ending Oct. 10, there were 11 deaths of children from swine flu complications. That brings the total number of pediatric deaths since Aug. 30 to 43, and the total since the swine flu pandemic began in April to 86. About half of the deaths were among teenagers, Schuchat said. "Those are very sobering statistics."

Schuchat warned parents with sick children to be alert for signs that medical attention is required. Those signs include not eating well, difficulties breathing, and turning blue or gray. A particularly important sign is when children start to get better, then have a relapse. That is usually a sign that pneumonia is developing, and immediate treatment should be sought.

Physicians should be on the lookout for viral pneumonia in all flu patients, officials from the World Health Organization warned Friday at the end of a three-day meeting in Washington of more than 100 experts from around the world.

The swine flu virus travels deeper into the lungs than the seasonal flu virus, and is thus more likely to produce pneumonia on its own, said Dr. Nikki Shindo of the WHO's epidemic and pandemic alert and response department. In contrast, pneumonia produced by seasonal flu is more often a complication caused by a bacterial infection.

http://www.latimes.com/news/nationworld/nation/la-sci-swine-flu17-2009oct17,0,4189877.story

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Post Re: HINI Vaccine
1st H1N1 shots shipped: Aglukkaq

Last Updated: Monday, October 19, 2009 | 12:20 PM ET
CBC News

Canada has shipped two million doses of swine flu vaccine to provinces and territories, Health Minister Leona Aglukkaq said Monday.

The federal government is expected to approve the release of the H1N1 vaccine this week. Local health authorities will be able to start administering the vaccine once approval is granted.

The approval process is well underway, Aglukkaq told a news conference. "Pre-positioning" the vaccine across the country before the approval comes is part of good planning, she said.

The two million doses all included a chemical booster known as an adjuvant :flame , said Canada's chief public health officer, Dr. David Butler-Jones.

It's anticipated that three million doses per week or more will be available, he added.

The federal government has also purchased nonadjuvanted vaccine for pregnant women and young children. It's too soon to say when those doses will be available, Butler-Jones said.

The federal government has said Canadians won't have access to the vaccine until the first week of November.

The plan has been to give local health authorities until early November to organize the rollout of the pandemic vaccine. But privately, it has been co-ordinating an earlier rollout for weeks, CBC's Ioanna Roumeliotis reported on Sunday.

British Columbia and the Northwest Territories are well into their flu seasons, with sporadic flu activity elsewhere in the country, Butler-Jones said.

Timing of the H1N1 vaccine is crucial since outbreaks such as the one in B.C. can last up to 12 weeks. The goal is to get the vaccine to as many people as possible before the worst is over, Roumeliotis said.

Once a person is vaccinated, it can take up to two weeks for that person to develop antibodies to the virus.

http://www.cbc.ca/health/story/2009/10/ ... ccine.html


Mon Oct 19, 2009 10:11 am
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Post Re: HINI Vaccine
Swine flu vaccines are safe and time-tested, experts assert

Researchers trying to quell fears that vaccine was made in haste

By William Mullen
Tribune reporter
October 19, 2009
http://www.chicagotribune.com/news/chi- ... full.story

Untested? No.

Rushed into production? Not really.

Full of substances that do harm? Hardly, and especially not compared with the dangers of the H1N1 flu virus.

That is the retort of researchers, scientists, federal health authorities and others familiar with how swine flu vaccine is being made, as they listen -- at times with disbelief -- to the debate about it unfolding around kitchen tables and online.

They hear the arguments -- about what's in the vaccine, whether it was made too fast, whether there are side effects -- all the while frustrated that decades of experience in making effective flu vaccines hasn't resulted in more public confidence that they got this one right too.

"We've been baking this bread for 60 years, and we're pretty good at it, buddy," said Kenneth Alexander, an infectious-disease expert at the University of Chicago.

For all who will listen, Alexander and other experts at research facilities, the U.S. Department of Health and Human Services, the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and elsewhere explain that the swine flu vaccine isn't a completely new brew cooked up in a panic.

They argue that it's actually the result of a 60-year-old, tried-and-true process of flu vaccine-making that was tested on thousands of people before being scheduled for distribution -- including on some researchers who volunteered themselves.

"A lot misinformation is being brought up and spread around," said Jesse Goodman, the FDA's acting deputy commissioner for public health. "We think it is important to have the actual facts laid out and let people make their own decisions."

The vaccine "is the absolute best protection and a perfectly safe one," Goodman said, adding that the risks from contracting the flu, which can be deadly, far outweigh any risk of side effects from the vaccine.

Here is how the vaccine is made:

When the H1N1 virus first appeared last April in Mexico and California, federal health officials identified it and sent it to pharmaceutical companies it contracts so they each could formulate their vaccine versions for field testing before mass production.

It is a monthslong process, but mass production geared up in August, and the first 2 million doses were delivered to doctors and clinics two weeks ago. On Friday, CDC officials acknowledged slower production than they'd hoped but predicted "widespread availability" by the beginning of November.

That turnaround from discovery to delivery was fast enough that many Americans worried that the vaccine was rushed into production before being tested adequately for potential side effects.

Nonsense, Alexander said.

"The only difference between this one and the seasonal flu shots is the virus it is made from, so we have no reason to believe this one will be any less safe," he said.

Pharmaceutical researchers around the globe are trying to find newer and speedier ways to make flu vaccines, but in the U.S., the only FDA-approved method is the original, 1940s way: injecting the virus into chicken eggs to be grown into larger quantities.

For the arm-shot vaccine, the virus eventually is harvested from the eggs, killed and chopped into segments. When injected into the recipient, it activates the body's immune system to produce antibodies that kill the actual flu virus if the recipient is exposed.

The alternative, nasal-spray vaccine is made using a live virus. It too is grown in eggs, but at lower temperatures, weakening or "attenuating" it so it can survive only in the nose, not at greater body temperatures in the lungs.

"The nasal vaccine infects the mucosal cells (in the nose), which are closely monitored by our immune system," said Patrick Wilson, a University of Chicago immunologist. Once that system detects the vaccine, Wilson said, it produces permanent immunity to the targeted flu virus.

The first testing of both vaccines was performed on 3,000 volunteer recipients in eight laboratories at Baylor University, Cincinnati Children's Hospital, Emory University, Seattle Group Health Cooperative, St. Louis University, University of Iowa, University of Maryland and Vanderbilt University.

It also is being tested on volunteers by the five firms licensed to make up to 250 million doses of the vaccine by next spring for the U.S. market -- CSL Limited, Novartis Vaccines, Sanofi-Pasteur Inc., GlaxoSmithKline and MedImmune. "It is tested to see if it produces the level of antibody production in the blood that reaches the FDA standard," said William Schaffner, an infectious-disease specialist at Vanderbilt. "It is also tested for safety in the volunteers, something I know a little bit about since I was one of the volunteers for this vaccine."

On its Web site last week, the FDA posted the contents of the vaccines produced by the five companies, including copies of the long, multipage ingredient lists included with the doses at clinics. Schaffner said that like many everyday foods and medicines, they contain a number of vital chemical substances that could be toxic in large volume but are included in harmless, trace amounts. "If we looked at acetylsalicylic acid, (the active ingredient) in aspirin, taken in the current dosage it is an effective product that can relieve headaches and reduce fevers. Taken by the handful, it can have serious adverse events," Schaffner said.

"So it is with vaccines. They have trace ingredients that are in the vaccine for a variety of reasons. Taken together, the vaccines have been proven safe not only in explicit clinical trials, but in demonstrated use in hundreds of millions of doses over the years."

The ingredient that anti-vaccine activists most question is thimerosal, a preservative added in trace amounts to keep vaccine in two-shot doses from deteriorating if stored while awaiting application.

Thimerosal contains ethyl mercury, and critics allege it can cause autism and other neurological disorders. But researchers say there is so little thimerosal in the vaccine that it poses no harm. Nevertheless, they have produced thimerosal-free, single-shot doses that can be ordered. Also, researchers say there is no thimerosal in the nasal spray.

"I continue to be amazed that people bring this issue up," said Paul Offit, a pediatrician and noted University of Pennsylvania vaccine researcher. "There have been six exhaustive studies (of a possible link between thimerosal and autism). ... They each came back with a definitive answer: No. Three other studies were done to see if thimerosal caused any signs of mercury poisoning. All three answered: No."

Others have raised concerns about "adjuvants" -- compounds sometimes added to vaccines to stimulate the immune response in recipients. It is added in several European nations, but not in the U.S. Anne Schuchat, the CDC's director of immunization and respiratory diseases, said the U.S. sees no need to add them unless the virus mutates into a far deadlier form.

"Since April this flu has caused tens of thousands of hospitalizations and more than a thousand deaths," Offit said. "This is only October and influenza is a winter disease, so no telling what we are about to see.

"We should thank the Lord that we have this vaccine at this stage."

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Post Re: HINI Vaccine
www.www.flu.gov/professional/hospital/1 ... efaqs.html

Top 10 frequently asked questions on use of influenza A(H1N1) 2009 monovalent vaccines (2009 H1N1 vaccines): Practical considerations for immunization programs and providers

October 21, 2009, 5:30 PM ET

Two different influenza vaccines are available this influenza season, and many people will be recommended to receive both the seasonal influenza vaccine and the 2009 influenza A (H1N1) 2009 monovalent vaccine (referred to in this document as 2009 H1N1 vaccine). Below are some practical considerations for use of influenza vaccines. They are only intended to address the current pandemic situation and might change as the situation unfolds. They are not intended to be applied to routine use during future seasonal influenza vaccination efforts.

1. Two Doses for Children
Children ages 6 months through 8 years receiving seasonal influenza vaccination for the first time are recommended to receive 2 doses. However, children ages 6 months through 9 years are recommended to receive 2 doses in the prescribing information for 2009 H1N1 vaccines.Does CDC recommend that clinicians follow the recommendation in the 2009 H1N1 vaccine package inserts, or use the standard seasonal vaccine recommendations?
The recommendations for use of seasonal vaccine are unchanged. Using the 2009 H1N1 vaccine schedule presented in the prescribing information is recommended (6 months through 9 years receive 2 doses). However, if considered necessary for consistency, vaccination providers can also follow the guidance for the seasonal vaccines for both vaccines, pending additional data from ongoing studies. The ongoing vaccine immunogenicity studies might provide additional information on which children should receive 2 doses, but these data are not yet available.

2. Definition of 1 Month Interval
The interval between doses stated in the 2009 H1N1 vaccine prescribing information is "approximately 1 month". What does "approximately 1 month" mean?
CDC recommends that the two doses of 2009 H1N1 vaccines be separated by 28 days (4 weeks).

3. Acceptable Interval for 2009 H1N1 Inactivated Vaccines
The influenza A (H1N1) 2009 monovalent inactivated vaccine trials that are currently underway have often used a 21 day (3 week) interval between doses. Is a 21 day interval acceptable?
CDC recommends that the two doses of 2009 H1N1 vaccines be separated by 28 or more days (4 weeks). However, trials of the inactivated 2009 H1N1 vaccines have often used a 21 day interval. Administering the two doses of a 2009 H1N1 inactivated vaccine at least 21 days apart is safe. Therefore, if the second dose of an inactivated 2009 H1N1 vaccine is separated from the first dose by at least 21 days, the second dose can be considered valid. If the interval separating the doses is less than 21 days, the second dose should be repeated 28 or more days after the first dose (21 days acceptable). Trials of 2009 H1N1 live attenuated vaccines have used a 28 day interval between doses and therefore 28 days is the appropriate valid interval. Additional information about intervals for both types of 2009 H1N1 vaccines (inactivated and live attenuated) from the ongoing clinical trials will be considered when available.

4. Using Seasonal Inactivated Influenza Vaccine and 2009 H1N1 Inactivated Vaccine at the Same Time
Can the seasonal inactivated vaccine (trivalent inactivated vaccine or TIV) and the 2009 H1N1 inactivated vaccine be given at the same time?
Yes.

5. Use ofSeasonal Live Attenuated Influenza Vaccine (LAIV) and 2009 H1N1 LAIV at the Same Visit
If seasonal LAIV and 2009 H1N1 LAIV are given at the same visit, do either or both doses need to be repeated, and if so, when?
Seasonal LAIV and 2009 H1N1 LAIV should not be administered at the same visit. There are no data from studies in humans on the administration of seasonal and H1N1 2009 monovalent live attenuated vaccines at the same visit. Use of the 2 types of LAIV at the same time could result in reduced immunogenicity for one vaccine, according to some experts. However, if both types of LAIV are inadvertently administered at the same visit neither vaccine needs to be repeated.

6. Minimum Interval between Different LAIV Formulations
What is the minimum interval between doses of seasonal LAIV and 2009 H1N1 LAIV?
There are no data on sequential administration of the two types of LAIV (seasonal and 2009 H1N1). The ACIP General Recommendations on live attenuated vaccines indicates that 28 days (4 weeks) is the recommended minimum interval, and can be applied to use of a seasonal LAIV and a 2009 H1N1 LAIV, because these are considered 2 different vaccines. The ACIP recommendations were developed based on data from studies using attenuated live virus vaccines such as measles, mumps and rubella vaccine that are injected. However, based on previous studies of LAIV replication and immune response, as little as 14 days (2 weeks) might be sufficient to allow for an appropriate immune response to both vaccines. Therefore, an interval between the two types of LAIV of 2 weeks or more may be acceptable, although an interval of 28 days is preferred.

7. Repeating Doses whenSeasonal LAIV and 2009 H1N1 LAIV are Used in Shorter Intervals than is Accepted (between 1 and 13 days)
If seasonal and H1N1 LAIV are not administered on the same day, but are separated by less than 14 days (2 weeks), do either or both doses need to be repeated, and if so, when?
Seasonal LAIV and 2009 H1N1 LAIV should not be administered at the same visit, and should be separated by at least 14 days and ideally by at least 28 days based on previous studies of attenuated influenza vaccine virus replication and immune response. If the interval between administration of seasonal LAIV and 2009 H1N1 LAIV is from 1-13 days, the vaccine more recently administered should be repeated.

8. Using an Inactivated Vaccine and a Live Attenuated Vaccine at the Same Time

Can a live attenuated vaccine be given at the same time as an inactivated influenza vaccine (e.g., seasonal LAIV and 2009 H1N1 inactivated vaccine, or 2009 H1N1 LAIV and seasonal trivalent inactivated influenza vaccine [TIV])?Yes, these two types of vaccines can be given at the same time, based upon ACIP's General Immunization recommendations. Any interval between the two types of vaccines is also acceptable.

9. Using an Inactivated 2009 H1N1 Vaccine and a Live Attenuated 2009 H1N1 Vaccine in the Same Series
Can a child who requires 2 doses of a 2009 H1N1 vaccine and who received the first dose with a inactivated 2009 H1N1 vaccine complete the series with the 2009 H1N1 LAIV, or vice versa?
When feasible, the same type of vaccine (live attenuated or inactivated) should be used in a two dose schedule, but mixed schedules are preferable to not completing the series. A 28 day interval between doses is recommended, but 21 days is acceptable. There are limited data on mixed schedules.

10.Use of 2009 H1N1 Vaccines Outside Approved Age IndicationsCan 2009 H1N1 vaccines be used outside the age range approved by the Food and Drug Administration?
Whenever possible, vaccines should be administered in accordance with FDA-approved labeling. Vaccines approved for an age group will have undergone the required testing for that age group. There are no known safety concerns with use of inactivated vaccines in appropriate doses outside their labeled age indications. Data on vaccine effectiveness for influenza vaccines use outside of labeled age indications are limited.
LAIV should not be used outside the approved age indications (ages 2 years through 49 years).
Inactivated influenza vaccines should not be given to infants younger than 6 months.
However, clinicians may use inactivated 2009 H1N1 vaccines for persons 6 months and older outside their labeled age range if a vaccine licensed for use in a particular age group is not available, and the need to provide vaccination is urgent. For instance, an inactivated 2009 H1N1 influenza vaccine licensed for people 18 years and older (e.g., CSL H1N1 vaccine) may be used for a child younger than 18 years if no other vaccine is available, and the alternative would be for the child to not receive a 2009 H1N1 influenza vaccine at that visit. Similarly, an inactivated 2009 H1N1 vaccine labeled for use in older children or adults (e.g., Novartis, CSL, or some Sanofi Pasteur formulations) can be given to an infant or younger child if the alternative would be for the child to not receive any influenza vaccine at that visit. For children ages 6 months through 35 months, a half dose (0.25 mL) of a vaccine licensed for older children or adults should be used. If possible, children who require 2 doses should receive at least 1 dose in a formulation approved for their age. Use of vaccines outside approved indications is a temporary measure that applies only to the special circumstances faced during the 2009 H1N1 pandemic, and should be avoided if possible.

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 Re: HINI Vaccine
Sweden: Further deaths linked to swine flu vaccine

Via The Local: Further deaths linked to swine flu vaccine. Excerpt:

Health investigators are under more pressure as two elderly women are reported to have died, days after receiving the swine flu vaccine. It brings the total number of deaths linked to the vaccine in Sweden to four.

The two latest deaths were reported to the Swedish Medical Products Agency (Läkemedelsverket) on Friday.

A 74-year-old woman from Sollefteå in northern Sweden died four days after receiving the swine flu vaccine. The woman, who suffered from heart and lung disease, was classified as a high-risk patient.

“Naturally a report will be undertaken,” said Dr. Markus Kallionen in a press statement released by Västernorrland County Council. “We must take this case seriously and investigate what has happened.”

A further case of a 90-year-old woman who also died after receiving the vaccine has been reported by newspaper Expressen.

Läkemedelsverket are currently investigating circumstances surrounding the deaths of two high-risk patients, a 50-year-old man with a serious heart condition and woman with an acute muscle disease.

“It’s important to say that they had complicated illnesses,“ Gunilla Sjölin Forslund from Läkemedelsverket told news agency TT.

“We still do not know if the deaths are connected to the vaccine.”

http://crofsblogs.typepad.com/h5n1/2009 ... ccine.html

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Post Re: HINI Vaccine
Swine flu jab boy rushed to hospital

By Lisa smyth
Tuesday, 27 October 2009
7

The safety of Northern Ireland’s swine flu vaccination programme was called into question today by the parent of a young special needs pupil who ended up in hospital just hours after getting the jab.

Anne Marie Fletcher said she feared her 15-year-old son Rhys was going to die as she rushed him to hospital less than 24 hours after receiving the swine flu vaccine.

The teenager fell seriously ill after receiving the injection, along with thousands of other pupils across Northern Ireland last Friday. He was later diagnosed with swine flu.

“My husband drove us to Antrim (Area Hospital) and I sat in the back with Rhys,” she told the Belfast Telegraph.

“By this stage he was going into spasms. He couldn’t bend his fingers. I was absolutely terrified.

“He was rambling and becoming incoherent. I honestly thought he was going to die in the back of the car.

“He kept saying he wanted to sleep but I wouldn’t dare let him close his eyes because I was frightened that if I did he would never wake up.”

Read more: http://www.belfasttelegraph.co.uk/news/ ... z0V9c2mp5n

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Post Re: HINI Vaccine
Branswell: Canada importing adjuvant-free vaccine

Via the Chronicle Herald, Helen Branswell of The Canadian Press reports: Adjuvant-free vaccine coming. Excerpt:

Canada is importing adjuvant-free H1N1 vaccine from Australia for pregnant women, hoping to be able to offer that product sooner than if it waits for unadjuvanted vaccine from Canada to make it through the licensing process.

Health Minister Leona Aglukkaq announced Monday she signed an interim order that will allow 200,000 doses of adjuvant-free vaccine from CSL Ltd. to be used in this country.

The CSL vaccine should be available starting next week, said Dr. David Butler-Jones, head of the Public Health Agency of Canada.

"We have heard the concerns about pregnant women about having to wait for an unadjuvanted vaccine and we have been working very hard on providing it earlier, given they have always been considered a priority group," Aglukkaq said at a news conference in Ottawa.

CSL doesn’t have a licence to sell flu vaccine in Canada but the product is licensed in Australia and the United States.

http://crofsblogs.typepad.com/h5n1/2009 ... ccine.html

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 Swine Flu Vaccination Regimen Divides Nations as WHO Weighs
Swine Flu Vaccination Regimen Divides Nations as WHO Weighs In

By Jason Gale and Kanoko Matsuyama
http://www.bloomberg.com/apps/news?pid= ... wR28sUqrMY

Oct. 28 (Bloomberg) -- A World Health Organization advisory panel will be asked today to answer a question dividing governments from the U.S. to Japan: whether one or two doses of swine flu vaccine are needed to fight the pandemic virus.

Initial results of tests on pandemic vaccines produced by companies including Sanofi-Aventis SA, the world’s largest maker of flu shots, suggested one inoculation protects most adults. The U.S. and Australia have begun a mass immunization program based on a single-dose regimen. Japan and the European Union aren’t convinced and are calling for two shots.

The number of shots given will determine how many people can be immunized before infections peak, especially in poor nations which may receive only 10 percent of global supply. In making their recommendation, WHO’s so-called strategic advisory group of experts on immunization will need to balance optimal protection for an individual against sufficient protection for an entire population, said Albert Osterhaus, head of virology at Erasmus University Medical Center in Rotterdam.

“There is a definitely an issue of equitable distribution,”
said Osterhaus, who was invited to participate in today’s discussion, in an interview yesterday.

About 3 billion doses of the pandemic vaccine may be produced within 12 months, the WHO estimated in September, not enough to cover a world population of 6.8 billion people in which “virtually everyone is susceptible to infection by a new and readily contagious virus.”

At least 1.5 billion doses have been accounted for by developed nations, according to WHO. France contracted to buy 94 million doses for its 64 million people. The U.K., with 61 million people, ordered 90 million.

‘Safe and Sound’

“There are extra options in Europe which might not be the case in other countries,” said John Oxford, professor of virology at Queen Mary’s School of Medicine and Dentistry in London, in an interview yesterday. “You are playing ‘safe and sound’ with two doses.”

Most low- and middle-income nations lack money to compete for an early share of limited doses, Geneva-based WHO said in a Sept. 24 statement, adding that vaccine supplies in these countries will largely depend on donations from manufacturers and other nations.

Preliminary data from a study on GlaxoSmithKline Plc’s Pandemrix showed 98 percent of those aged 18 years to 60 years had an immune response indicative of protection after one shot. Tests on the elderly found 87 percent of those older than 70 had a sufficient immune response after one dose, London-based Glaxo said yesterday.

Antibody Levels

The findings are based on antibody levels used to gauge the efficacy of seasonal flu shots, and support results from similar trials in China, the U.S. and Australia.

The WHO panel will probably be swayed by the data and join the U.S. National Institutes of Health and agencies in Australia and China in recommending a single-dose regimen, Oxford said.

“That would relinquish supplies for either countries that have not bothered to prepare themselves -- which is quite a lot of them -- or haven’t got the wherewithal to do it,” he said. “WHO has to factor in all these political and economic things.”


The discussion on flu vaccine is scheduled to begin at 3:30 p.m. Geneva time and result in a set of recommendations for WHO Director-General Margaret Chan to consider. Reporters are slated to be briefed on the final outcome on Nov. 6.
Some authorities have already decided.

Glaxo, Novartis

Though data available for Glaxo’s Pandemrix and Novartis AG’s Focetria vaccines indicate that one dose may be sufficient in adults, the information is too limited to allow the European Medicines Agency to recommend the general use of a single shot, the regulator said in a statement last week.

Japan’s health ministry said on Oct. 20 that most of its citizens should get two doses to maximize protection. Health- care workers should be vaccinated first, followed by pregnant women, people deemed to be at higher risk because of existing conditions like diabetes, and children ages 1 to 6, it said.

Some experts said the decision would limit the amount of vaccine available for children, who won’t be given priority though they are most likely to catch the bug and develop complications.

“If Japan keeps the rule to give a two-shot course to high-risk people, the country won’t have enough vaccine to cover children,” Yoshihiro Kawaoka, a virology professor at the University of Tokyo, told a scientific meeting in the Japanese capital on Oct. 26.

Priority Groups

Japan began immunizing health-care workers this month and plans to have vaccine for as many as 77 million people, or 61 percent of its population, by March. Children aged 1 year to 6 years will be inoculated starting early December, with the program extended to older children about two weeks later, according to the ministry.

“We need to start a discussion on the priority ranking for vaccination,” said Hitoshi Oshitani, a professor at Tohoku University in Sendai, northern Japan. “In Japan, more children with swine flu are in serious condition compared with other high-risk groups.”

Pandemic vaccines have their greatest impact as a preventive strategy when administered before or near the peak incidence of cases in an outbreak, according to the WHO.

To contact the reporters on this story: Jason Gale in Singapore at j.gale@bloomberg.net; Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net.

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Post Re: Swine Flu Vaccination Regimen Divides Nations as WHO Weighs
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Post Re: HINI Vaccine
Canada: Two bad vaccine reactions in Winnipeg
]
Via the Winnipeg Free Press: Two bad reactions from immunization in city. Excerpt:

The H1N1 vaccine isn't for everyone. Since the mass immunization began in Winnipeg Monday, two people have had rare allergic reactions to it, according to the Winnipeg Regional Health Authority.

"We have had two incidents involving some allergic-type symptoms," said Dr. Sande Harlos, a WRHA medical officer of health. "This is what we're prepared to deal with."

The maker of the H1N1 vaccine, GlaxoSmithKline, warns that up to one in 1,000 doses may result in an allergic reaction leading to a "dangerous decrease of blood pressure."

"That's why you're asked to wait 15 minutes afterwards," Harlos said. A severe reaction will happen within minutes of getting the shot.

By 3 p.m. Tuesday, 15,695 Winnipeggers had been immunized without incident. When someone reacts badly to the vaccine, there are medical staff on hand to help, Harlos said. The vaccine recipient is taken to hospital to be kept under observation.

Harlos said the two people who reacted badly to the vaccine -- one on Monday and one on Tuesday -- are OK. "They left in good condition."

http://crofsblogs.typepad.com/h5n1/2009 ... nipeg.html

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Post Re: HINI Vaccine
Flu vaccine additive helps immune system

By Helen Branswell, THE CANADIAN PRESS

Last Updated: 26th October 2009, 3:07pm

Long article touting the safety of adjuvants. Question and answer section at the end.

http://www.torontosun.com/news/canada/2 ... 31076.html

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Fri Oct 30, 2009 8:50 am
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Post Re: HINI Vaccine
Does this article scream out at you as it did to me? There are vaccine shortages - why are they so intent on vaccinating these "detainees"? Out of altruism? :pig

H1N1 Vaccinations To Be Offered To Guantanamo Bay Detainees


The Pentagon will offer the H1N1 vaccination to detainees at the U.S. facility at Guantanamo Bay, officials there said Friday.
Reporter: Mike Mount, CNN Senior Pentagon Producer

WASHINGTON (CNN) -- The Pentagon will offer the H1N1 vaccination to detainees at the U.S. facility at Guantanamo Bay, officials there said Friday.

The Pentagon made the decision based on U.S. government assessments that people held in detention facilities are at high risk for the pandemic, said Maj. Diana R. Haynie, a spokeswoman for Joint Task Force Guantanamo Bay, which is in charge of holding the suspected terrorists.

"Detainees at JTF Guantanamo are considered to be at higher risk and therefore they will be offered the H1N1 vaccination," Haynie said.

"JTF Guantanamo conducts safe, humane, legal and transparent care and custody of detainees. As such, we must provide detainees the medical care necessary to maintain their health," she said.

Base officials had not received the vaccinations and did not know when they were expected to arrive, Haynie said.

Once the vaccinations are received, doses will be administered to active-duty personnel before being offered to detainees and others on the base, Haynie said.

The vaccination is mandatory for all uniformed personnel, she said.

The vaccinations will be voluntary for the detainees, who will be briefed on the virus and the vaccine prior to deciding whether to receive the latter.

Some of the detainees have already voluntarily taken the seasonal flu shot, Haynie said.

http://www.wibw.com/nationalnews/headli ... 84717.html

_________________
"A time comes when silence is betrayal." - Martin Luther King

"The world will not be destroyed by those who do evil, but by those who watch them without doing anything." ~ Albert Einstein


Fri Oct 30, 2009 8:29 pm
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Post Re: HINI Vaccine
Must-read of the day
A jaw-dropping report from the Globe and Mail: Ottawa got last-minute warning of shortfall in H1N1 vaccine. Excerpt:

Canada's vaccine manufacturer did not inform federal health officials until Thursday that the number of H1N1 doses available to Canadians next week would shrink by much more than half – prompting provinces to suspend the rollout of the vaccine to the general public for at least a couple of weeks.

GlaxoSmithKline is forecast to ship 436,000 doses to provinces and territories, far less than the roughly two million anticipated, because it had to interrupt production at its Ste-Foy, Que., plant to make a version of the vaccine for pregnant women.

The last-minute admission of a shortfall is the latest and largest blow in a week marked by anxiety, confusion and mounting frustration. Problems with vaccine supply and underestimation in pandemic planning now threaten to undermine Canada's largest-ever inoculation campaign.

What's gone wrong?

It's a story of slower-than-expected vaccine production, a resurgent virus targeting the young, and a once-skeptical public suddenly rushing to get the shot.

As flu clinics prepared to open this week, rising anti-vaccination sentiment persuaded health officials that uptake would be low, prompting them to step up their campaign to persuade Canadians to be immunized.

What they didn't count on was the far more compelling effect of real-world events – the deaths of two seemingly healthy young Canadians. Panicked, parents hurried children of all ages to flu-shot clinics; healthy adults went too, ignoring the carefully planned protocol that the most vulnerable should come first.

And now this: the shortage that David Butler-Jones, Canada's Chief Public Health Officer, said the government only learned the extent of late Thursday.

Thursday? As in, yesterday? When I saw Butler-Jones and Health Minister Aglukkaq here in Vancouver a couple of weeks ago, they were sticking to "early November" as the roll-out date for the vaccine. They'd said the same thing in an earlier press conference from Iqaluit.

Both were so resistant to reporters' questions about an earlier vaccination start that I thought something sounded wrong. Then, without much explanation, the vaccinations started a week early after all.

In fairness, Dr. Butler-Jones is an old pro. He may simply have known from experience that pharmaceutical companies can't always be trusted to deliver the goods. Early November was a reasonable launch date, so he stuck to it.

But two kids' deaths, and resulting political pressure, forced the Canadian government to launch early, and GSK didn't have the vaccine in adequate quantities.

Professional soldiers remind each other that the battle plan is what disappears in the first moment of contact with the enemy. Evidently the same is true of pandemic plans.

Still, you would think that public-health professionals would know how much can go terribly wrong in any disease outbreak. What was their Plan B? And if they didn't have a Plan B, what's their excuse?

http://crofsblogs.typepad.com/h5n1/2009 ... day-1.html

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"A time comes when silence is betrayal." - Martin Luther King

"The world will not be destroyed by those who do evil, but by those who watch them without doing anything." ~ Albert Einstein


Fri Oct 30, 2009 8:56 pm
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Post Re: HINI Vaccine
Public school nurses give swine flu vaccine to kids without parents' OK, sends child to hospital

BY Ben Chapman and Rachel Monahan
DAILY NEWS WRITERS

Originally Published:Friday, October 30th 2009, 12:52 AM
Updated: Friday, October 30th 2009, 10:18 AM

School nurses mistakenly gave the swine flu vaccine to two students who didn't sign up for it - including a Brooklyn girl with epilepsy who wound up in the hospital.

"I was outraged," Naomi Troy, 26, told the Daily News after her 6-year-old daughter, Nikiyah Torres-Pierre, had a possible allergic reaction to the shot.

Officials at Public School 335 in Crown Heights called an ambulance to take Nikiyah to SUNY Downstate Medical Center when she fell ill following the arm jab.

"My stomach was hurting, and I was itching," Nikiyah said after she was released from the hospital.

The snafu and a similar mixup at a Staten Island school came in the first days of the city's in-school H1N1 vaccination program.

City officials have stressed the vaccine is safe and urged parents to sign up for it - though less than half have sent in permission slips.

Troy was waiting for advice from her family doctor on whether Nikiyah should get the shot since she takes medicine to control her epilepsy.

When the nurse called for a student Thursday morning, Nikiyah's teacher misunderstood and sent the wrong student, Troy said.

The error was compounded when the nurse didn't check Nikiyah's name before sticking her in the shoulder, the mother said.

"The school made a horrible mistake," she added. "They never asked for her name. They have no paperwork....How do you make a mistake like this?"

After the mistake was discovered, officials summoned Troy to the school, she said.

Troy said the nurse - a Department of Health employee - tried to get her to sign a consent form, after the fact.

"I was insulted. I was really angry. 'You just incriminated yourself even more,'" Troy recalled thinking.

"If they'd taken proper precautions in the school this never would have happened."

A student at PS 65 in Staten Island also received the vaccine without parental permission on Wednesday, but officials gave no further details.

Officials for the nurses union declined to comment. The Health Department said the incidents were under investigation.

"The Health Department does not expect any future adverse medical effects for these children, but we are working to determine how this misstep occurred," said spokeswoman Jessica Scaperotti.

"We will develop additional safeguards to prevent similar instances in the future."

She added that the vaccine is safe for kids suffering from epilepsy.

Roughly 1,800 students have received the vaccine in the first phase of the school blitz.

rmonahan@nydailynews.com

Read more: http://www.nydailynews.com/ny_local/edu ... z0Viqb8UOU

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"A time comes when silence is betrayal." - Martin Luther King

"The world will not be destroyed by those who do evil, but by those who watch them without doing anything." ~ Albert Einstein


Mon Nov 02, 2009 9:06 am
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