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[PROVE] Useless Flu Vaccines Pushed More

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[PROVE NOTE: This article on the flu vaccine cites references to dozens of

studies showing " no evidence vaccination reduces flu-related deaths or

complications " in children under 2 and more studies showing " there was

absolutely no decline in influenza-attributable mortality between 1980, when 15

percent of elderly were vaccinated, and 2000, when 65 percent of elderly were

vaccinated. "

It is absolutely incomprehensible that the CDC still goes on to maintain " that

vaccination is the best way to protect children younger than 2 and people age 65

years and older from flu and its complications. " Think about this the next time

you are asked to follow some other CDC vaccine policy.

What is highlighted by this article and is just as ludicrous is that other

researchers are proposing that since vaccinating the very young the old for the

flu is useless, they suggest that we vaccinate everyone else who is healthy and

doesn't need it to begin with. Of course they forgot to mention the lives of

healthy people that are ruined by flu vaccine reactions. FluMist vaccine is

being pushed for healthy kids and adults - it is a live viral vaccine squirted

up your nose and it definitely has its own set of risks concerns. [see Risks of

FluMist Vaccine at http://www.redflagsweekly.com/extra/2003_oct03_2.html]

They want to come after everybody else now. The best protection against bad

policy is knowledge and Dr. Yazbak has just written another great article for

Red Flags called ”Influenza Vaccination of Infants: A Useless Risk. " This is a

good one to forward to pregnant friends and new parents. It is appended below

this article and posted at http://www.redflagsdaily.com/yazbak/2005_sep30.html.]

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Oct. 1, 2005, 11:49AM

Flu shots perhaps being aimed at wrong targets

Studies suggest vaccinating the young, not the old, is more effective

http://www.chron.com/cs/CDA/ssistory.mpl/health/3377513

By LEIGH HOPPER

Copyright 2005 Houston Chronicle

Are the wrong people first in line for flu shots?

New research shows flu vaccines may not be as effective as previously thought

for the elderly and very young. In fact, the best way to protect the elderly

from flu-related deaths may be to vaccinate schoolchildren — the biggest

spreaders of flu.

But federal health officials are limiting shots this month to seniors and other

" high-priority " groups — an approach some influenza experts say is

scientifically flawed and perhaps a waste of vaccine.

" (Rationing) didn't work last year and I don't think it will work this year

either, " said Baylor College of Medicine flu expert Glezen, who says he

thinks vaccinating children and adults as fast as possible is the best way to

protect the community from an outbreak. " It's simply a matter of missed

opportunities. One of the basic tenets of immunization practice is never miss an

opportunity. "

No flu vaccine shortage is expected this year, and beginning Oct. 24, flu shots

will be available to all. Until then, the U.S. Centers for Disease Control and

Prevention, which sets vaccine policy, is recommending shots for people 65 and

older and others thought to be at high risk for severe flu complications.

Today marks the beginning of flu season, which typically peaks in January or

February in Houston. Flu shot clinics in pharmacies and in nursing homes start

Monday. The flu shot offers no protection against avian influenza, a mounting

concern in Asia that is fueling consumer interest in protection against the

ordinary flu.

Rationing precaution

The rationing is a precaution against the temporary shortage that occurred last

year when flu vaccine maker Chiron Corp.'s manufacturing plant was shut down,

cutting the U.S. supply in half. In that case, shots were administered to the

elderly and those with chronic illnesses first, creating long lines.

Once the flu vaccine again became available to the general public, many people,

thinking the threat had passed, lost interest and the shots sat on shelves.

" I am a little concerned people will not remember to come back and get a vaccine

later on when this is available, " said Dr. Arnold Monto, a University of

Michigan flu expert who argues that vaccinating children as well as the elderly

for the flu has a significant impact on controlling epidemics.

Scientists know that the elderly are at greatest risk of dying from the flu, but

they also have the weakest responses to a vaccine because of their aging immune

systems — raising questions about whether they are the best target for flu shot

campaigns. The CDC's long-accepted recommendations are being challenged by fresh

analysis of flu death data and previously published research. For example:

* The British medical journal The Lancet in September published an analysis of

64 studies evaluating the effectiveness of flu vaccine for the elderly. The

analysis found flu shots were only modestly effective, cutting flu-related

hospitalizations by 30 percent to 42 percent.

* In February, The Lancet published a similar analysis of 25 studies of flu

shots in children younger than 2, the other group targeted by CDC campaigns.

There is no evidence vaccination reduces flu-related deaths or complications in

that group, researchers concluded.

* A study published in February in the Archives of Internal Medicine examined

decades of U.S. data and found no decrease in flu deaths among seniors despite

increased vaccine coverage.

" There was absolutely no decline in influenza-attributable mortality between

1980, when 15 percent of elderly were vaccinated, and 2000, when 65 percent of

elderly were vaccinated, " said Boston flu researcher Dr. Tom Reichert, a

co-author of the National Institutes of Health study.

The CDC maintains that vaccination is the best way to protect children younger

than 2 and people age 65 years and older from flu and its complications.

Some flu experts think there is a better way: Immunize schoolchildren,

well-known to parents and doctors as petri dishes of germs.

Study supports theory

A study co-authored by Glezen supports this strategy. In that study, close to

15,000 children within the and White Health Plan HMO in Temple and Belton

were recruited for free vaccinations during three years.

That community was compared with another and White site (Waco, and

College Station) where schoolchildren weren't actively recruited.

What researchers found: Vaccination of only 20 percent to 25 percent of eligible

children significantly reduced respiratory illness in people older than 35.

A study of Japanese health data makes the same point. Between 1972 and 1987,

Japan's schoolchildren were required by law to receive flu vaccinations, said

Reichert. Almost no elderly were vaccinated during that time — but deaths among

seniors dropped dramatically.

When the campaign stopped, flu deaths among the elderly rose again.

" The truth is, nobody's going to stop vaccinating these high-risk groups, " said

Reichert. " In my view, it's not necessary to divert vaccine but to enhance our

vaccination program ... by vaccinating schoolchildren. Really, it would cost

about $150 million. There's no good reason why we shouldn't do it. "

Incidentally, there is an ouch-free flu vaccine available now for children older

than 5 who are healthy, as well as healthy adults younger than 50. FluMist,

developed in part by Baylor and made by MedImmune, is a nasal-spray vaccine

which is not part of the CDC's rationing plan.

Healthy people 5 to 49 years old who are not pregnant, including health-care

workers who are not caring for severely immuno-compromised patients in

special-care units, can receive FluMist at any time, according to CDC.

At $25 a dose, FluMist — which is made with a weakened live virus and therefore

more powerful than shots — is about twice as expensive as an injection and is

generally available only through private physicians.

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

Influenza Vaccination of Infants: A Useless Risk

By Red Flags Columnist, F. Yazbak, MD, FAAP

(tlautstudy@...)

Dr. Yazbak, a pediatrician, now devotes his time to the research of autoimmune

regressive autism and vaccine injury.

http://www.redflagsdaily.com/yazbak/2005_sep30.html

In the spring of 2004, the Advisory Committee on Immunization Practices (ACIP)

of the Centers for Disease Control and Prevention (CDC) recommended that all

children 6- to 23-months of age be vaccinated against influenza because they

were at “substantially increased risk for influenza-related hospitalizations.”

(1)

A review in The Lancet suggests that influenza vaccination of infants is

useless.

The influenza vaccines

There are two types of influenza vaccines on the U.S. market.

One is the recently released intranasal live virus vaccine that is not

recommended for infants and children under five. MedImmune’s FluMist® will not,

therefore, be discussed in this article.

The second is the older and well-known inactivated (killed) influenza vaccine

that is administered by injection in the following dosage:

Children 6- to 36-months: 0.25 ml/dose

Children older than 3 years: 0.5 ml/dose

Adults: 0.5 ml/dose

Infants and young children receiving the vaccine for the first time should

receive two doses one month apart. They, in fact, receive an adult dose within

one 30-day period.

Only split-virus, subvirion, or purified surface antigen vaccines should be

administered to children because of their decreased potential for causing

febrile reactions. (1)

This year, Sanofi Pasteur will produce between 50 and 60 million doses of

influenza vaccine for the U.S. market. GlaxoKline (GSK) is planning to

produce and sell about 8 million doses in the U.S., since the FDA licensed its

product on Aug. 31, 2005. (2)

Chiron’s Liverpool facility has been trying to correct its manufacturing

problems for more than a year and will need approval by the British MHRA

(Medicines and Healthcare products Regulatory Agency) and the U.S. Food and Drug

Administration (FDA) before it can ship out its first dose of vaccine. It is

clear that Chiron is already too late for the start of the season. In the best

scenario, it will provide 18 million to 26 million doses of vaccine for use in

the United States.

It is evident that there will be a shortage of injectable influenza vaccine this

season and that the CDC will have to promote the use of the intranasal live

vaccine for those individuals for whom it is indicated.

Presentation and Preservatives

Sanofi Pasteur (Aventis Pasteur) offers four different options in its influenza

vaccine Fluzone®: three thimerosal-free single-dose presentations including a

0.25 ml syringe for children 6 months to 35 months of age; either a 0.5 ml

syringe or a 0.5 ml vial for persons aged 3 years and older; and a multi-dose

vial with thimerosal as a preservative, licensed for those ages 6 months and

above. (www.fda.gov/cber/products/inflave071405.htm)

The GSK U.S. product will be available in 0.5 ml syringes containing a trace

amount of thimerosal remaining from the production process. The vaccine is

licensed for adult use. http://www.fda.gov/cber/products/inflgla083105.htm

Chiron, if approved by the FDA and MHRA, will provide most of their U.S. product

in multi-dose vials with thimerosal as a preservative — presumably for adults.

They may also provide for children over the age of 4 years and for adults some

0.5 ml syringes containing trace amounts of thimerosal. (2)

The following table summarizes the relevant FDA information on the thimerosal

content of all licensed influenza vaccines as of Sept. 6, 2005. (3)

Trade Name Manufacturer Thimerosal Mercury

Concentration

Fluzone Aventis Pasteur Inc. 0.01% 25 µg/0.5 ml dose

Fluvirin 0.01% 25 µg/0.5 ml dose

Fluzone Aventis Pasteur Inc. 0 0

(no Thimerosal)

Fluvirin < 0.0004% < 1 µg/0.5 ml dose

(preservative free)

Fluarix Glaxo-Kline < 0.0005% < 1.25 µg/0.5 ml dose

To date, there is no national recommendation to use thimerosal-free or

preservative-free flu vaccines exclusively in infants and younger children.

The CDC recommendation seems to be that thimerosal-free brands are preferred if

they are available. If not, any available inactivated flu vaccine can be used in

order to “protect” the infants.

Few states have mercury-free pediatric vaccine laws.

Influenza vaccination of infants

Is influenza vaccination of 6- to 24-month-old infants effective?

Will it decrease influenza-related hospitalizations as claimed by the ACIP?

The answer to both questions appears to be no.

This answer is based on an extensive review published in the Feb. 25, 2005 issue

of The Lancet. The authors, Jefferson, , Demicheli et al, literally

analyzed every available reference on the subject that they could find in the

Cochrane Library, MEDLINE, EMBASE Biological Abstracts and Science Citation

Index to June 2004 — in any language. They included 14 randomized controlled

trials, eight cohort studies, one case-control study and one randomized

controlled trial of intraepidemic use of the vaccine. (4)

The authors also:

Contacted the vaccine manufacturers and the authors of all relevant studies

And included every study ever published that compared the efficacy of influenza

vaccines.

Surprisingly, they only found two small studies that assessed the effects of

influenza vaccines on hospital admissions (the alleged reason for the CDC’s ACIP

recommendation). And they could not find a single study that assessed reductions

in mortality, serious complications or even community transmission of the

disease.

Following a review of all the information they could find worldwide, the authors

came to the following conclusions concerning the use of inactivated influenza

vaccines in children younger than two years of age:

There is no evidence of the effectiveness of the vaccine or reduction in

symptomatic cases. The efficacy of the vaccine, reduction in

laboratory-confirmed cases, is similar to that of placebo. In its publication

Efficacy and Effectiveness of Inactivated Influenza Vaccine, dated Aug. 8, 2005

and intended to support its recommendation, the CDC concedes in its opening

statement that the effectiveness of inactivated influenza vaccine depends

primarily on the age and immunocompetence of the vaccine recipient and the

degree of similarity between the viruses in the vaccine and those in

circulation. (5)

The following is all the information concerning the effectiveness of the

inactivated influenza vaccine in children 6- to 23-months old that is available

in that publication on the CDC web site:

“Children aged > 6 months can develop protective levels of anti-influenza

antibody against specific influenza virus strains after influenza vaccination,

although the antibody response among children at high risk for influenza-related

complications might be lower than among healthy children….

“A 2-year randomized study of children aged 6--24 months determined that > 89%

of children seroconverted to all three vaccine strains during both years. During

year 1, among 411 children, vaccine efficacy was 66% (95% confidence interval

[CI] = 34%--82%) against culture-confirmed influenza (attack rates: 5.5% and

15.9% among vaccine and placebo groups, respectively). During year 2, among 375

children, vaccine efficacy was --7% (95% CI = --247%--67%; attack rates: 3.6%

and 3.3% among vaccine and placebo groups, respectively; the second year

exhibited lower attack rates overall and was considered a mild season). However,

no overall reduction in otitis media was reported….

“A retrospective study among approximately 5,000 children aged 6--23 months

conducted during a year with a suboptimal vaccine match indicated vaccine

effectiveness of 49% against medically attended, clinically diagnosed pneumonia

or influenza (International Classification of Diseases, Ninth Revision [iCD-9]

codes 480--487) among children who had received 2 doses of influenza vaccine. No

effectiveness was demonstrated among children who had received only 1 dose of

influenza vaccine, illustrating the importance of administering 2 doses of

vaccine to previously unvaccinated children aged <9 years).”

That’s it: 230 words.

A careful review of the CDC information reveals the following:

Antibody response among children at high risk for influenza-related

complications appears to be lower than among healthy children. In other words,

children who were more likely to be hospitalized had less antibody response and

less benefit from the vaccination.

First study: During year two, vaccine efficacy among 375 children, was --7%

against culture-confirmed influenza (95% CI = --247%--67%; attack rates: 3.6%

and 3.3% among vaccine and placebo groups, respectively) and there was no

reduction in ear infections. During year 1, vaccine efficacy was better. The

study did not examine complications or hospital admissions.

Second study: One dose of influenza vaccine was totally ineffective. Children

who received two injections of vaccine had a 49 percent reduction in “clinically

diagnosed” pneumonia or “influenza.” Because these were not culture-confirmed

cases, the clinical illnesses may not have been due to the influenza virus or

may have been due to a different strain of virus than that in the vaccine. In

either case, vaccination would not have influenced the course of the illness —

one way or the other.

Jefferson and associates concluded that immunization of very young children “is

not lent support by the findings” of their extensive and detailed research of

the world literature and could not find convincing evidence that vaccines can

reduce mortality, admissions, serious complications, and community transmission

of influenza. (4)

The Lancet study was funded by Regione Piemonte, Italy, the Oxford Childhood

Infection Study, University of Oxford and a program grant from the U.K. Medical

Research Council (MRC). Given that the MRC and The Lancet are two historically

pro-vaccine institutions, the results of this careful review must be taken very

seriously.

The two studies quoted by the CDC are limited, weak and irrelevant.

The CDC and its Advisory Committee on Immunization Practices have a simple

choice:

They can continue recommending the useless influenza vaccination of infants aged

6 to 24 months

Or

They can do the right thing and rescind the 2004 recommendation.

Now that is a tough choice!

References

http://www.aafp.org/afp/20040701/practice.html

http://www.redflagsdaily.com/yazbak/2005_sep26.html

http://www.fda.gov/cber/vaccine/thimerosal.htm

Jefferson T, S, Demicheli V, Harnden A, Rivetti A, Di Pietrantonj C.

Assessment of the efficacy and effectiveness of influenza vaccines in healthy

children: systematic review. Lancet 2005 Feb 26-Mar 4;365(9461):773-80. Review.

http://www.cdc.gov/flu/professionals/vaccination/efficacy.htm

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Dawn

PROVE(Parents Requesting Open Vaccine Education)

prove@... (email)

http://vaccineinfo.net/ (web site)

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PROVE provides information on vaccines, and immunization policies and practices

that affect the children and adults of Texas. Our mission is to prevent vaccine

injury and death and to promote and protect the right of every person to make

informed independent vaccination decisions for themselves and their family.

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This information is not to be construed as medical OR legal advice.

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