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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

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/jul0207acip.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
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 B) 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/563393?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.

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. Gregory 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. William 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. Peter Hotez,
chair of the Department of Microbiology, Immunology and Tropical Medicine
at The George 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 Williams and Dan Childs contributed to this report.

This year's flu shot missing new strains of virus

October 24, 2007


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 - Solomon 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

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

"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
Elizabeth St. Philip

Annual Flu Shots May Be of Little Benefit to the Elderly

Medscape Today
September 26, 2007

by Laurie Barclay, MD


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 George 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

"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. Taylor worked
on this paper under a contract between National Institute of Allergy and
Infectious Diseases and LTS Corporation in Bethesda, Maryland.

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

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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