Risks of FluMist Vaccine
An Investigation By Dr. Sherri
Tenpenny
"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 subscribers
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.yahoo.com/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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