MedImmune, the manufacturer of FluMist, recently announced that it signed anagreement 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 announcement, I felt compelled to warn our patients and
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 us.
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 will use scare tactics --similar to those that were used
while promoting the smallpox vaccine -- which warn of the high possibility
of a bioterror attack using the flu virus. (4)
Apparently, the goal seems to center around scaring -- or inducing enough
guilt in everyone -- that they 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 100F (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 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 this country is enormous:
It is estimated that at least 10%, or more than 28 million people
in the United States 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? Hardly. The massive campaign to
vaccinate everyone this year appears to be motivated purely by economics.
The viruses suspected to be the most likely cause for the flu this season
was 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 that used last year. This marks the only the
second time that the same strains have been used during two consecutive flu
seasons.(17) Consider that the 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 contains 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 forceful 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 we are familiar with. 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.
The pharmaceutical companies rarely consider 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 nostrils since it could cause harm. It
would be wise to consider the same advice for adults. With all the known
risks involved, one should be extremely cautious about what one allows to
be sprayed in one's nose.
*****************
References:
1) DowJones Business News. Sept. 12, 2003. FluMist Available In Pharmacies
This Fall. http://biz.yahoo.com/djus/030910/0017000011_2.html
2) Washington Post. Nasal spray for flu to get big media launch. Sept. 10,
2003, pg. E01
3) Washington Post. Spray vaccine for flu wins FDA clearance. June 18,
2003. pg. A01.
4) Mohammed, Madjid. Influenza as a bioweapon. J.R.Soc.Med. 2003;96:345-346.
5) 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
6) FluMist package insert.
7) 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
8) ibid. (Chicago, IL). 2001
9) Zangwell, Kenneth. Cold-adapted, live attenuated intranasal influenza
virus vaccine. The Pediatric Infectious Disease Journal 2003; 22(3):273-274.
10) Drug information.
http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202297.html
11) 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.
12) National Cancer Institute. CanQues. Available at http://srab.
cancer.gov/Prevalence/canques.html. Accessed January 3, 2002.
13) 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
14) United Network for Organ Sharing (UNOS). All Recipients: Age at Time of
Transplant. Available at www.unos.org/. Accessed January 14, 2002.
15) Allan and Harold Rubin, MS, ABD, CRC. September 26, 2003. Vaccinations
and the Elderly. http://www.therubins.com/aging/vacine.htm
16) May 20-21, 2003, the National Influenza Summit. Chicago, IL.
http://www.partnersforimmunization.org/meetingupdates52021.html
17) ibid.
18) FluMist package insert.
19) Knipe, David. M. Ed. Fields Virology. Philadelpthis: Lippincott, 4th
ed. 2001. pg. 1057
Sincerely,
General Vaccine Information List
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