Risks of FluMist Vaccine
Reprinted from http://www.redflagsweekly.com/extra/2003_oct03_2.html
An Investigation By Dr. Sherri Tenpenny
October, 3, 2003
"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
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 .
In addition, Wyeth, MedImmune's partner, plans a three-year, $100 million
campaign to encourage use of the nasal flu vaccine among physicians.
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."
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. 
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." These symptoms are nearly identical to those the
flu vaccine is designed to prevent. 
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,
and even longer from adults. Viral shedding also puts
breastfeeding infants at risk if the mother has been given FluMist.
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
- More than 8.5 million people have cancer. 
- There are reported to be 850,000 individuals with diagnosed and
undiagnosed HIV infection or AIDS  and
- Based on 2001 data, there were 184,000 organ recipients 
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
Will this make stores that administer the vaccines-like Walmart and the
other pharmaceutical chain stores that have announced they will carry FluMist -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, 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.
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. 
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.
Time will tell whether the live viruses in FluMist will become linked to cases
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.
- 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.
- 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
- 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,
- FluMist package insert.
- Knipe, David. M. Ed. Fields Virology. Philadelpthis:
Lippincott, 4th ed. 2001. pg. 1057