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http://www.redflagsweekly.com/conferences/vaccines/oct03_Tenpenny.html

 

 

Risks of FluMist Vaccine

 

An Investigation By Dr. Sherri Tenpenny

 

www.nmaseminars.com

 

 

 

" MedImmune, the manufacturer of FluMist, recently announced that it signed an

agreement that makes FluMist, the new intranasal influenza vaccine, readily

available to people as they shop at Wal-Mart, the worlds biggest retailer. " [1]

 

As the physician in charge of a bustling Integrative medical clinic, questions

about vaccines frequently arise. After reading about the MedImmune-Walmart joint

venture, I felt compelled to warn our patients and our internet rs of

the potentially serious complications that may come from direct and passive

exposure to this new vaccine. I also wanted to give a " heads up " to everyone

regarding the onslaught of advertising that is about to besiege them.

 

Hundreds of TV and print advertisements have been designed to persuade everyone

into taking the FluMist plunge. The campaign will be the " most intense,

direct-to-consumer marketing campaign ever waged for a vaccine, " costing an

estimated $25 million over the next 2.5 months [2]. In addition, Wyeth,

MedImmune’s partner, plans a three-year, $100 million campaign to encourage use

of the nasal flu vaccine among physicians.[3]

 

The television arm of the blitz campaign will focus on the " inconveniences " that

your family, friends and co-workers will endure if you don’t get the flu shot

and subsequently contract the flu. Print advertisements and magazine articles

apparently will use scare tactics–similar to those that were used while

promoting the smallpox vaccine–which warned of the high possibility of a

" bioterror attack using the flu virus. " [4]

 

Apparently, the goal seems to center around frightening–or inducing enough

guilt–that everyone would begin to demand the vaccine as soon as it is

available. And at nearly $70 a dose, this will be a financial bonanza for

MedImmune and Wyeth, who are expecting the vaccine to become the blockbuster new

drug that will push MedImmune’s revenues to more than $1billion/year. [5]

 

 

 

However, there are many reasons for caution. FluMist contains live (attenuated)

influenza viruses that replicate in the nasopharynx of the vaccine recipient.

The most common side effects include " cough, runny nose/nasal congestion,

irritability, headaches, chills, muscle aches and fever > 100° F. " [6] These

symptoms are nearly identical to those the flu vaccine is designed to prevent.

[7]

 

A cause for significant concern is the vaccine’s most prevalent side effects:

" runny nose " and " nasal congestion. " It has been documented that the live

viruses from the vaccine can be shed (and potentially spread into the community)

from recipient children for up to 21 days,[8] and even longer from adults.[9]

Viral shedding also puts breastfeeding infants at risk if the mother has been

given FluMist.[10]

 

In addition to shedding via nasal secretions, the virus can be dispersed through

sneezing. What is the normal physiological response when an irritant enters the

nasal passages? A sneeze…sometimes a big sneeze…sometimes several big sneezes.

Therefore, the risk for shedding–and spreading–live viruses throughout a school,

church, workplace, or store — especially one which is administering the vaccine.

 

In the section of the FlumMist package insert labeled " PRECAUTIONS, " the

manufacturer states the following warning:

 

" FluMist® recipients should avoid close contact with immunocompromised

individuals for at least 21 days. "

 

The warning is specifically directed toward those living in the same household

with an immunocompromised person, but the on-going release of live viruses

throughout the community may be a significant risk to everyone who has a weak,

or weakened, immune system.

 

The number of immunocompromised people in the United States is enormous:

 

It is estimated that at least 10%, or more than 28 million people have

eczema. [11]

More than 8.5 million people have cancer. [12]

There are reported to be 850,000 individuals with diagnosed and undiagnosed

HIV infection or AIDS [13] and

Based on 2001 data, there were 184,000 organ recipients [14]

 

An even more extensive list of at-risk people includes the untold millions on

drugs called corticosteroids. Prednisone®, Medrol®, and a variety of similar

medications are given to both adults and children. These drugs are prescribed

for dozens of conditions including asthma; allergies; eczema; emphysema; Crohn’s

disease; multiple sclerosis; herniated spinal discs; acute muscular pain

syndromes; and all types of rheumatoid and autoimmune diseases. As much as 60%

of the entire population could be considered to be " chemically

immunosuppressed. " It is important to realize that FluMist is CONTRAINDICATED

for people who are immunocompromised. People who receive FluMist and are living

with an immunocompromised person put their loved ones at risk.

 

Will this make stores that administer the vaccines–like Walmart and the other

pharmaceutical chain stores that have announced they will carry FluMist

[15]–risky places to shop for large segments of the population? What measures

will be taken in these stores to ensure that the virus will not become

commingled with food? What hand washing policy is going to be enforced in the

stores for all Walmart employees and customers who have received FluMist? These

are reasonable questions that deserve answers.

 

The target market for FluMist is " healthy children and adults, ages 5 to 49

yrs. " Some believe that by vaccinating these people, a type of " herd immunity "

will occur that will protect the very young and the elderly who are excluded

from getting this vaccine. However, it is these very " at-risk " populations who

may suffer the most from the flu by being exposed to people who are given

FluMist.

 

According to information presented at the May, 2003 National Influenza

Summit,[16] approximately 85% of Americans between the ages of 20 and 50 go

unvaccinated, and nearly 66% between the ages of 50 and 64 do not receive the

flu vaccine. Have there been " raging epidemics " across the country due to lack

of flu vaccinations? It appears that the massive campaign to vaccinate everyone

this year appears may be motivated, in part, by economics.

 

The viruses suspected to be the most likely cause for the flu this season were

negligibly different from the strains used in last year’s flu vaccine.

Therefore, the influenza vaccine produced for the 2003-2004 season is identical

in composition to the one used last year. This marks only the second time that

the same strains have been used during two consecutive flu seasons.[17] Consider

that antibodies from other viral vaccines–such as MMR, polio and chickenpox

vaccines–last at least 3 years, and in some instances, up to 15 years. If the

viruses used in the vaccine are the same as last year, why is this year’s

vaccine even necessary?

 

An ever greater concern about FluMist is the contents within the vaccine. Each

0.5ml of the formula contains 10 6.5-7.5 particles of live, attenuated influenza

virus. That means that between 10 million and 100 million viral particles will

be forcefully injected into the nostrils when administered. The viral strain was

developed by serial passage through " specific pathogen-free primary chick kidney

cells " and then grown in " specific pathogen-free eggs. " That means that the

culture media was free of pathogens that were specifically tested for, but not a

culture that was necessarily " pathogen-free. " The risk that the vaccine may

contain contaminant avian retroviruses still remains. In addition, a stabilizing

buffer containing potassium phosphate, sucrose (table sugar) and nearly 0.5 mg

of monosodium glutamate (MSG) is added to each dose. [18]

 

One of the most troubling concerns over the injection of this " chemical soup " is

the potential for the viruses to enter directly into the brain. At the top of

the nasal passages is a paper-thin bone called the cribriform plate. The

olfactory nerves pass through this bone and line the nasal passages, carrying

messenger molecules to the brain that are identified as " smells " familiar to us.

The olfactory tract has long been recognized as a direct pathway to the brain.

Intranasal injection of certain viruses has resulted in a serious brain

infection called encephalitis, presumably by direct infection of the olfactory

neurons that carried the viruses to the brain.[19] Time will tell whether the

live viruses in FluMist will become linked to cases of encephalitis.

 

The pharmaceutical companies do not necessarily always do a reasonable job of

considering the " down side " when they are pushing new drugs or new vaccines.

FluMist has the potential for causing the worst, most severe flu epidemic seen

in years. Parents tell their young children not to put things up their noses

because they might cause them harm. It would be wise to consider that advice for

adults. With all the risks involved, one should be extremely cautious about what

one allows to be sprayed in one’s nose.

 

 

 

REFERENCES

 

DowJones Business News. Sept. 12, 2003. FluMist Available In Pharmacies This

Fall. http://biz./djus/030910/0017000011_2.html

Washington Post. Nasal spray for flu to get big media launch. Sept. 10, 2003,

pg. E01

Washington Post. Spray vaccine for flu wins FDA clearance. June 18, 2003. pg.

A01.

Mohammed, Madjid. Influenza as a bioweapon. J.R.Soc.Med. 2003;96:345-346.

Adler, Neil. MedImmune awaits the $1 billion mark and a new flu drug. The

Business Gazette. Feb. 7, 2003.

http://www.gazette.net/200306/business/news/143250-1.html

FluMist package insert.

Vesikari T., et al. A randomized, double-blind, placebo-controlledtrial of

the safety, transmissibility and phenotypic stability of a live, attenuated,

cold-adapted influenza virus vaccine (CAIV-T) in children attending day care.

Presented at the 41st Annual Interscience Conference on Antimicrobial Agents and

Chemotherapy, (Chicago, IL). 2001

ibid. (Chicago, IL). 2001

Zangwell, Kenneth. Cold-adapted, live attenuated intranasal influenza virus

vaccine. The Pediatric Infectious Disease Journal 2003; 22(3):273-274.

Drug information.

http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202297.html

Diepgen TL. Is the prevalence of atopic dermatitis increasing? In: Williams

HC, ed. Atopic Dermatitis: The Epidemiology, Causes and Prevention of Atopic

Eczema. New York: Cambridge Univ Pr; 2000:96-112.

National Cancer Institute. CanQues. Available at http://srab.

cancer.gov/Prevalence/canques.html. Accessed January 3, 2002.

Joint United Nations Programme on HIV/AIDS. Epidemiological Fact Sheets on

HIV and Sexually Transmitted Infections: United States. Available at

www.unaids.org/ fact_sheets/index.html. Accessed January 14, 2002

United Network for Organ Sharing (UNOS). All Recipients: Age at Time of

Transplant. Available at www.unos.org /. Accessed January 14, 2002.

Allan and Harold Rubin, MS, ABD, CRC. September 26, 2003. Vaccinations and

the Elderly. http://www.therubins.com/aging/vacine.htm

May 20-21, 2003, the National Influenza Summit. Chicago, IL.

http://www.partnersforimmunization.org/meetingupdates52021.html

ibid.

FluMist package insert.

Knipe, David. M. Ed. Fields Virology. Philadelpthis: Lippincott, 4th ed.

2001. pg. 1057

 

 

 

 

 

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