[NVIC] FLU SHOT MANDATE LOOMS; FLU SHOT FAILS TO PROTECT

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FLU SHOT MANDATE LOOMS; FLU SHOT FAILS TO PROTECT

by Barbara Loe Fisher

In 2006, Mayo Clinic's Greg Poland, M.D., who has been a CDC vaccine

policymaker and promotes worldwide use of multiple vaccines throughout

life, called for mandatory vaccination of all health care workers with flu

vaccine.

http://www.sptimes.com/2 006/06/13/Tampabay/Expert_calls_for_heal.shtml.

This year, the CDC issued a formal recommendation for all health care

workers to do just that

http://www.cidrap.u mn.edu/cidrap/content/influenza/general/news/jul0207a

cip.html

Dr. Poland has also been instrumental in defending the " safety " of the

highly reactive anthrax vaccine the U.S. Department of Defense has required

all soldiers to get.

http://www.vaccines.mil/documents/l ibrary/MilitaryImztn2005fulc.pdf

Last week, he called for all 300 million Americans to get a flu shot every

year.

http://www.abcnews.go.com/Health/Flu/st ory?id=3781181

Dr. Poland, like so many doctors in public health and pediatrics today,

considers himself a " warrior " in the crusade to kill all infectious

microbes that cause human disease. He says, " Vaccines are the singularly

most important medical technology ever devised. We administer a series of

vaccines over a lifetime to every single human being on earth. "

http://mayoresearch.mayo.edu /mayo/research/vaccine_research_group/

When ideology blinds a doctor, scientific truth is often the first casualty.

A report out of Canada last week reveals that two of the three strains

(Soloman Islands A, Wisconsin A, Malaysia selected by doctors at the

World Health Organization and the CDC for North America " appear to be

drifting and mutating, raising questions about how much protection this

year's flu vaccine will offer. "

http://www.ctv.ca/servlet/ArticleNews/

story/CTVNews/20071024/flu_shot_071024/20071024 ?hub=TopStories

The Public Health Agency of Canada reports that the Wisconsin strain has

already mutated into a different form than is contained in the vaccine and

the Malaysia strain is also showing signs of mutating. This is similar to

what happened in the 2003-2004 flu season when there was a mismatch of

circulating flu strains with the ones selected for the flu vaccine.

http://www.nvic.org/History/Newsl etters/%203770Reaction.pdf

So just how effective will the flu shot be at preventing death and illness

from the flu this year, especially for children, the chronically ill and

the elderly?

Probably not any more effective than it has ever been, which is not very

effective according to yet another study in the medical literature ( Lancet

Infect Dis. 2007;7:658-666). The Lancet reported this month that the

elderly over age 70, who have always been targeted for flu vaccination

because they account for 90 percent of all flu related deaths, may not be

protected at all from dying from complications of the flu. Flu vaccine use

by the elderly and those with chronic diseases has increased from 15% to

65% in the US and other high-income countries since 1980 but there has been

no decrease in influenza-related mortality among these groups. The few

clinical trials that have included elderly people have indicated there is a

decrease in antibody responses and clinical benefits of flu vaccination as

people age beyond 70 years.

http://www.medscape.com/viewarticle/56339 3?src=mp This new report

reinforces an analysis of flu vaccine clinical trials published last year

in the British Medical Journal by Cochrane Collaboration researchers

http://www.bmj.com/cgi/content/full/333/7574/912 The 2006 Cochrane

Collaboration analysis found that the majority of published influenza

vaccine studies were methodologically flawed with selection biases,

cofounders and heavy reliance on non-randomized studies. Authors pointed

out that potential confusion between respiratory infections caused by flu

viruses and those caused by non-flu viruses can result in a misdiagnosis

and gross overestimation of the true impact of influenza on death and

illness in a given flu season (CDC officials have never produced documented

evidence for the 36,000 deaths they attribute to the flu every year).

The 2006 study concluded that too few clinical trials have been conducted

to prove flu vaccine safety and current evidence indicates that use of

inactivated influenza vaccine has only a modest or no effect on preventing

flu in children or the elderly. Co-author Tom Jefferson, an Italian

epidemiologist said " There is a big gap between policies promoting annual

influenza vaccinations for most children and adults and supporting

scientific evidence. "

NVIC has taken the position that the CDC should stop recommending annual

influenza vaccination for all young children when there is insufficient

scientific justification for it.

http://www.nvic.org/PressReleases/pr1031flu.htm

Unfortunately, when the CDC makes a recommendation for universal use of

vaccines, state mandates soon follow. Greg Poland's call for 300 million

Americans to get an annual flu shot is a pretty good indicator the CDC will

eventually follow suit and drug company lobbyists seeking higher profits

will pressure state legislatures to institute flu vaccine mandates. Once

every American has been softened up to accept an annual flu shot, more

shots and mandates will follow.

Only this time, the vaccine mandates will not just mean being barred from

getting an education. Today, parental refusal to get a child vaccinated

with all state mandated vaccines means the child can be barred from going

to school or getting health insurance. Tomorrow vaccine mandates may mean

being barred from getting a job or a driver's license unless you show proof

you've saluted smartly and rolled up your sleeve for scores of new vaccines

now being developed in more than 200 clinical trials worldwide. And that is

a future that drug companies selling vaccines are convincing stockholders

they can take all the way to the bank.

http://www.abcnews.go.com/Health/Flu/st ory?id=3781181

Top Vaccine Expert Suggests Guideline for Vaccination for Every Man, Woman

and Child

" In Dr. Poland's war, there are no rules of engagement; anything goes. The

enemy is what Dr. Poland calls " unwarranted death. " These are deaths caused

by infectious diseases that could have been prevented by vaccinations. It

is an enemy that is as ruthless as it is resourceful. Says Dr Poland: " I

was born into a Marine Corps family, and I spent my childhood growing up on

military bases. As I went through medical school and residency, I knew

right then and there that the warrior I was meant to be was the warrior

taking on infectious diseases, to prevent them-because I just have a really

hard time with death. Unwarranted death, the unexpected death. "

http://mayoresearch.mayo.edu/ mayo/research/vaccine_research_group/

Universal Flu Vaccine Recommendation May Be Coming

Top Vaccine Expert Suggests Guideline for Vaccination for Every Man, Woman

and Child

ABC News

October 26, 2007

by by Raja Jagadeesan, M.D.

ABC News Medical Unit

The time may soon come when doctors recommend that every American man,

woman and child be vaccinated every year for influenza an idea offered

Wednesday by a leading expert in vaccines and preventive medicine.

Dr. Poland, director of the Vaccine Research Group at the Mayo

Clinic in Rochester, Minn., testified Wednesday at a meeting of the

Advisory Committee on Immunization Practices (ACIP), the subcommittee at

the Centers for Disease Control and Prevention that issues federal

recommendations for the use of vaccines in the United States.

In his testimony, Poland recommended that the United States should move to

a so-called " universal recommendation " for vaccination against influenza,

the virus that causes the flu.

A universal recommendation would make official that Americans of all ages

should receive an influenza vaccination every year. The testimony came at a

time when the committee is considering a smaller step of recommending that

all school-age children receive a yearly vaccine.

" I think it's a good idea to expand [vaccination] to all school-age

children, " Poland said. " But a better idea is to say, 'let's not just go

age group by age group; let's just recommend that everybody get it.' "

Review of recent changes in the CDC recommendations shows that ACIP has

been steadily increasing the indications for a flu vaccine for several

years. Current estimates are that more than 70 percent of the U.S.

population now meets one of the 15 published criteria for recommendation of

a yearly flu vaccine.

" We've changed the recommendation every year or two since '97, " Poland

said. " It's sort of a creeping incrementalism. "

Instead of marking out ever-increasing numbers of groups that should get

the flu vaccine yearly, Poland espoused a universal recommendation that all

Americans should be getting the shot, with particular emphasis on

vulnerable groups.

" Let's just make a universal recommendation that all Americans should get

vaccinated. But then note that there are particular high-risk groups that

should be particularly recommended to get the vaccine. "

How Do You Deliver 300 Million Vaccines?

Such a move would not come without difficulty. Currently, less than 40

percent of America's 300 million people receive yearly flu shots and many

of those for whom it is recommended do not receive their immunizations.

Other vaccine experts pointed out that any effort to vaccinate all

Americans would face many logistical hurdles. Concerns included the

availability of enough flu vaccine for the entire American population and

the lack of a public health infrastructure to deliver that many vaccines.

" If a universal flu vaccine is recommended, it would need a plan, " said Ira

M. Longini Jr., a professor in biostatistics and biomathematics at the

University of Washington School of Public Health. " Right now, if you look

at vaccine supply, we can't make 300 million dose of vaccine and get them

to the right people. Even if we could make enough dose, we would need to

put in place a program to reach everyone. "

A move to vaccinate everyone could also face significant financial hurdles.

" Who is going to pay for all of this? " asked Dr. Schaffner, chair

of the department of preventive medicine at Vanderbilt University. " For

example, we know that there are 40 million people who don't have medical

insurance. Who is going to get the vaccine to those people? "

According to Poland, though, vaccine supplies have been increasing steadily

since the widely publicized vaccine shortages from several years ago.

" This year, manufacturers are going to make 130 million doses in America.

Last year & we threw away about 12 million doses, " he said. " Every year

this decade, we've leaned on the manufacturers to make more vaccine, and

we've thrown away doses in the millions. "

" Until this year, there were concerns that we'd even have enough vaccines

to cover our indicated patients, " said Schaffner. " However, that concern is

receding. We are having more manufacturers coming into the U.S. market.

This year we'll have 130 million doses or even more. This year, we are

faced with the idea of, 'can we even use it all?' "

Preparing America for Pandemics and Bioterrorism

According to Poland, however, there could be a very important hidden

benefit to addressing these issues now: Americans would learn how to be

prepared in case of a bioterrorist attack or a pandemic infectious disease.

" Once you've made a recommendation and then implement the recommendations,

you go a long way towards figuring out the ways to operationalize the ways

to administer these things to all Americans, " Poland said. " You can't make

that happen in the middle of an emergency. "

Schaffner agreed that the development of such public health infrastructure

could be a critically important step for the future.

" If we undertook to vaccinate a very substantial proportion of the U.S.

population each year, you'd have to organize everything from vaccine

development to production to delivery, " he said. " It'd be like a training

session or a fire drill that we'd conduct each year.

" So if we had to do it in any kind of emergent situation for example,

anthrax, smallpox vaccine, delivering cipro [antibiotics] we'd have a

trained provider network and a trained public, " he said. " Just as most of

us know where to go to vote, we'd be trained on where to go to get

vaccinated or get your antibiotics or whatever the public health

intervention would be. "

" It may be something that could lay the groundwork for something looming

down the line in the form of an avian flu pandemic, " said Dr. Hotez,

chair of the Department of Microbiology, Immunology and Tropical Medicine

at The Washington University. " By getting this infrastructure into

place by vaccinating the whole population against [seasonal] flu, you lay

the groundwork to combat deadly avian influenza.

" In effect, you would be killing two birds with one stone. "

But according to Poland, this type of recommendation would likely need some

advance warning to allow for the infrastructure to be built.

" I suggest we make the recommendation in advance, " Poland said. " For

example, something like 'starting next year, we'll be recommending all

Americans get a flu vaccine.' "

Carla and Dan Childs contributed to this report.

This year's flu shot missing new strains of virus

CTV.ca

October 24, 2007

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20071024/flu_shot_071024

/20071024?hub=TopStories

Canadians heading out to get their annual flu shot may want to know that

the strains of the influenza aiming for North America appear to be drifting

and mutating, raising questions about how much protection this year's flu

vaccine will offer.

The process of creating the annual flu shot is a complicated one and

actually begins almost a year ahead of time.

The World Health Organization monitors flu activity around the world,

looking for predominant strains.

As flu viruses reproduce, they often trigger slight changes in their

genetic code, which scientists call antigenic drift.

The WHO researchers take particular note of what's happening in the

southern hemisphere to see what strains are emerging there, since they go

through their winter flu season long before we do.

The WHO then selects the strains that they think are most likely to

predominate in the northern hemisphere. They generally select three -- two

subtypes of influenza A viruses and one influenza B virus-- to go into the

vaccines to be used the following fall and winter.

Each year, authorities change one or two of the three strains in the

vaccine, which is why it is important to get a new flu shot every year to

ensure protection against the most recent strains.

This year's supply of shots is already being sent out to clinics and

doctor's offices across Canada. But experts say it's beginning to appear

that this year's vaccine may have two relative mismatches -- two viruses

have been changing and may no longer match the viruses contained in this

year's vaccine.

And because it takes at least six months to manufacture the vaccines, it's

far too late to change them.

This year, scientists picked these three strains:

Influenza A - Islands/3/2006 (H1N1)-like

Influenza A - Wisconsin/67/2005 (H3N2)-like

Influenza B - Malaysia/2506/2004-like antigen

The Wisconsin strain, says the Public Health Agency of Canada, has already

mutated into a different form than the one used for the vaccine, and the

Malaysia strain shows signs of changing too.

" There is an inherent vulnerability in trying to develop a vaccine now for

what might happen six months from now when flu season starts, " says

infectious disease specialist Dr. Neil Rau. " And with a strain mutating or

gradually mutating, sometimes the guess is good, sometimes the guess is

sub-optimal and sometimes it's bad. "

" The process of making the vaccination is something of an educated guess

based on what happened in the southern hemisphere during the preceding

season. "

No one knows how severe this year's flu season will be but Rau says it's

theoretically possible the mismatch could result in more flu illnesses and

hospitalizations.

" The worst case scenario with a bad match situation would be lot of disease

in the elderly, manifesting in nursing home and cruise ships outbreaks, and

with children you might see a lot of absenteeism and therefore a lot of

parents off work as a result trying to care for them, " he says.

Flu bug 'drift' speeding up

But other experts say these viral drifts are not unusual and happen on a

regular basis because of the dynamic nature of the flu virus. They also

note that in the past five years, the flu bugs have been drifting faster,

though no one is sure why.

" We have noticed that there have been, certainly in one of the influenza A

subtypes more recently, more frequent or rapid change in the virus, more

rapid evolution, " says Danuta Skowronski of the epidemiology services

branch of the B.C. Centre for Disease Control.

" Having said that, though, that more rapid evolution has not been

associated with more severe or intense outbreaks, so how meaningful that is

ultimately is uncertain. "

" It certainly makes it more difficult in terms of keeping pace with the

changes in the vaccine to match those changes in the virus, " she says. " But

in terms of overall illness impact in the community, we have not seen that

that has increased. "

No drug or vaccine is ever 100 per cent effective and this year's vaccine

won't be a perfect match either. But scientists point out that the

antibodies the vaccine helps produce will offer some immunity over whatever

strains do arrive.

" In recent seasons, even where there has been a vaccine mismatch, the

vaccine can afford 40-50 per cent protection, " says Dr. Theresa Tam of the

Public Health Agency of Canada.

And some protection is better than none, especially for the elderly, she

says, for whom the flu can actually be fatal.

" Even if it doesn't protect you from actually getting it, it can reduce the

severity of the illness and complications, " she notes.

That's why public health experts say, despite the complex science of

tracking drifting strains, the flu vaccine is still the best protection

against a tricky disease.

Influenza and pneumonia killed 4,725 Canadians in 2002, the last year for

which detailed statistics are available, according to Statistics Canada.

Health Canada estimates that 700 to 2,500 deaths a year may be attributable

to influenza.

The National Advisory Committee on Immunization recommends that everyone

over the age of six months be vaccinated against the flu.

With a report from CTV medical specialist Avis Favaro and producer

St. Philip

Annual Flu Shots May Be of Little Benefit to the Elderly

Medscape Today

September 26, 2007

by Laurie Barclay, MD

http://www.medscape.com/viewarticle/563393?src=mp

The elderly may receive little to no benefit from annual influenza

vaccinations, according to a review of current evidence study reported in

the October issue of Lancet Infectious Diseases.

" Influenza vaccination policy in most high-income countries attempts to

reduce the mortality burden of influenza by targeting people aged at least

65 years for vaccination, " write Lone Simonsen, from Washington

University in Washington, DC, and colleagues. " However, the effectiveness

of this strategy is under debate. Although placebo-controlled randomised

trials show influenza vaccine is effective in younger adults, few trials

have included elderly people, and especially those aged at least 70 years. "

Nearly every year, winter influenza epidemics in the United States affect

approximately 5% to 20% of the population, causing about 300,000

hospitalizations and 36,000 deaths. People aged 65 years and older account

for up to 90% of all influenza-related deaths.

In most high-income countries, one of the strategies of vaccination policy

against influenza is to target people 65 years of age and older in hopes of

decreasing the mortality burden of influenza. However, the apparent

benefits of this strategy may have been exaggerated by frailty selection

bias, in which healthier elderly are vaccinated more often than frail

elderly, as well as by the use of all-cause mortality and other nonspecific

trial endpoints.

When these factors are considered, the authors suggest that the remaining

evidence base is at present insufficient to determine the magnitude of the

mortality benefit, if any, that influenza vaccination offers the elderly.

Few trials demonstrating the efficacy of influenza vaccination have

included elderly people, but those that have done so have indicated that

clinical benefits and antibody responses decrease as age increases for

individuals older than 70 years.

In 1960, US policy began targeting influenza vaccination at individuals at

high risk for poor outcomes by virtue of chronic comorbid conditions and/or

advanced age. Other high-income countries have followed suit, and the World

Health Organization has endorsed these policies. From 1980 to the present,

vaccination coverage increased from 15% to 65%, but recent excess mortality

studies have not documented a corresponding decrease in influenza- related

mortality.

" Paradoxically, whereas those studies attribute about 5% of all winter

deaths to influenza, many cohort studies report a 50% reduction in the

total risk of death in winter - a benefit ten times greater than the

estimated influenza mortality burden, " the authors write. " New studies,

however, have shown substantial unadjusted selection bias in previous

cohort studies. "

This review includes a suggested analytical approach to identify this type

of residual bias, which should help elucidate what mortality benefits can

and cannot reasonably be expected from influenza vaccination.

The authors recommend use of more specific endpoints in future trials. For

example, vaccine effectiveness should be measured against laboratory-

confirmed influenza virus. This highly specific outcome would yield more

reliable estimates of vaccine efficacy, thereby justifying higher costs and

labor involved in its measurement. In addition, use of actual virus

surveillance data, and not the arbitrary 4-month period used at present,

would help identify each seasonal epidemic period. Although performing

randomized controlled trials may seem ethically problematic, the authors

suggest that such evidence is sorely needed.

Recognizing that the aged immune system may not efficiently respond to

influenza vaccination should facilitate development of other options for

influenza control, such as more immunogenic vaccines or larger doses of

vaccine to be used in the elderly, a combination of live and killed vaccine

formulations, more aggressive use of antivirals for treatment and

prophylaxis, and indirect protection via increased vaccination of

transmitter populations. Ongoing evaluation would need to determine the

effectiveness of such approaches.

" While awaiting an improved evidence base for influenza vaccine mortality

benefits in elderly people, we suggest that this group should continue to

be vaccinated against influenza, " the authors conclude. " Influenza causes

many deaths each year, and even a partly effective vaccine would be better

than no vaccine at all. But the evidence base concerning influenza vaccine

benefits in elderly people does need to be strengthened. "

The authors report no relevant financial relationships. Dr. worked

on this paper under a contract between National Institute of Allergy and

Infectious Diseases and LTS Corporation in Bethesda, land.

In an accompanying Comment, Tom Jefferson and Carlo Di Pietrantonj, from

Cochrane Vaccines Field in Alessandria, Italy, discuss future options to

resolve the present uncertainty regarding the efficacy of influenza

vaccination in the elderly.

" Simonsen and colleagues suggest that refocusing on the likely

complications of immune senescence would require vigorous pursuit of other

options, " Dr. Jefferson and Dr. Di Pietrantonj write. " They also confront

the ultimate taboo that drew so much scorn in the evidence overview: doing

randomised trials in elderly people to settle the issue conclusively. That

suggestion, which seems to fly in the face of current policies, is in our

opinion the only ethical and scientific way to have a definitive answer to

the question of whether or not current influenza vaccines protect elderly

people. "

Dr. Jefferson has received consultancy fees from Sanofi Synthelabo and

Roche. Dr. Di Pietrantonj reports no relevant financial relationships.

Lancet Infect Dis. 2007;7:658-666.

************************************************************

National Vaccine Information Center

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web: http://www.nvic.org

NVIC E-News is a free service of the National Vaccine Information Center

and is supported through membership donations.

NVIC is funded through the financial support of its members and does not

receive any government subsidies. Barbara Loe Fisher, President and Co-

founder.

Learn more about vaccines, diseases and how to protect your informed

consent rights at www.nvic.org

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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