Fact Check


Are the new spray flu vaccines safe to use?

Published Oct 15, 2003

Claim:   FluMist, a flu vaccine delivered as a nasal mist, poses a greater risk to the public than the flu virus itself.

Status:   Undetermined.

Example:   [Collected via e-mail, 2003]

October 2, 2003
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.

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 rest of the article can be found on Dr. Tenpenny's site by clicking here.]

Origins:   Although influenza is no longer the unchecked grim reaper of years past (in 1918 it killed half a million Americans and twenty million folks worldwide), it continues to present a very real danger even in these more modern times. According to the Centers for Disease Control (CDC), millions of people in the United States — about 10% to 20% of U.S. residents — will get the flu each year. Influenza also costs Americans $10 billion annually in lost wages and medical expenses. Worst of all, every year about 36,000 people in the United States die from it, and 114,000 have to be admitted to the hospital because of it. The flu is not just a week of feeling lousy and missing work; it is a disease that can, has, and does kill.

Some people are more vulnerable to the ravages of the flu than others, which is why those who are most at risk need to be shielded from its contagion. Folks 65 years old and up, very young children, and those of any age who have chronic medical conditions need to be vaccinated annually against the flu. However, even those who aren't especially young, old, or

infirm should get that annual vaccination because avoiding the flu also means sidestepping many dangerous complications such as bacterial pneumonias, ear and sinus infections, and even heart disease and strokes. Yet it remains a sad fact that only a handful of people think to do this. Worse, their personal aversion is carried over to those they are responsible for: a parent who does not herself get an annual flu shot is far less likely to seek one for her child, even for one in the highest risk group. Flu vaccines have been available for many years, yet only 9% to 25% of children and young people with asthma get flu shots, and young asthmatics are one of the groups most at risk.

Cost, inconvenience, and dread of injection keep people from availing themselves of this preventive. The stumbling blocks of cost and inconvenience are being eroded, however: the price of a flu shot is down to $17, and inject 'n' go stations spring up in pharmacies and other locations every October and November, so it's no longer a question of having to make an appointment with the family doctor and take time off from work to keep it. But a needle is still a needle.

Aversion to needles explains the appeal of vaccines that are sprayed into the nose: do away with the needle, and more people will choose to guard themselves from the flu. FluMist, a nasally-delivered spray, requires one squirt per nostril of a very fine mist to accomplish what an injection does, and every bit as effectively. There are trade-offs, though: the price of a spritzing with the nasal protectant starts at $53, making the injected version the more budget-conscious choice. Also, just as the more traditional encounter with a hypodermic can result in a couple of days of a sore arm, the inhaled vaccine has been known to cause runny noses.

But these are minor concerns compared to the more troubling aspects of this new form of medicine. Flu shots are made from killed flu viruses and are suitable for anyone 6 months or older. FluMist is made from a weakened live virus, so it isn't deemed safe for people with chronic medical problems or weak immune systems. For this reason, the Food and Drug Administration (FDA) approved FluMist only for healthy 2- to 49-year-olds. Those under two years of age or over forty-nine must continue to make do with the injected vaccine, as must those who have other health problems.

But even for the healthy 2- to 49-year-olds, the spray vaccine poses a risk, if not to them, then to those they come into contact with. In a few rare instances, those who receive this live vaccine will as a consequence spread it to others, so FluMist isn't recommended for people who take care of those with severely compromised immune systems who are being tended in protective environments. However, the CDC says: "People who have contact with others with lesser degrees of immunosuppression (for example, people with diabetes, people with asthma taking corticosteroids, or people infected with HIV) can get LAIV (FluMist®)."

The live virus can be transmitted to others by way of coughing, sneezing, or talking, or via a fomite, an item touched by someone who has the virus. (Common cold, flu, and stomach viruses can live on the fingertips for hours, and they can survive on the surfaces of objects for days.) However, says the CDC: "Because the viruses are weakened, infection is unlikely to result in influenza illness symptoms since the vaccine viruses have not been shown to mutate into typical or naturally occurring influenza viruses."

Others in the medical field consider Dr. Tenpenny's analysis more alarmist than practical. For example, she writes:

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? Hardly. The massive campaign to vaccinate everyone this year appears to be motivated purely by economics.

As mentioned earlier in this piece, in the U.S. influenza annually causes about 36,000 deaths and 114,000 hospitalizations. While Dr. Tenpenny may not consider the loss of 36,000 lives a year to an easily-preventable malady a "raging epidemic," others do. To dismiss the drive to have everyone vaccinated against influenza as "motivated purely by economics" when such an initiative could easily prevent most of those deaths strikes many as flat-out wrong.

It is true FluMist's manufacturer, MedImmune Vaccines, and its marketer, Wyeth Vaccines, have been advertising the intranasal vaccine heavily, especially in television ads. They've a product to sell, and they're intent upon selling it. But it can also be reasonably concluded that the availability of a non-injected flu vaccine will motivate many who would otherwise have gone unprotected to guard themselves against a disease that kills. People do fear needles, and their trepidation influences them to delay or entirely eschew vaccination. Take away the needle, and more will seek out the vaccine.

Some sources suggest FluMist will result in a protection against the flu virus that will last far longer than the protection imparted by injected vaccines, but this claim has yet to be fully substantiated. However, if this does prove to be the case, it would become a strong argument in the favor of the nasally-delivered protectant, because a traditional flu vaccination given in October can lose its effectiveness by March, leaving its host vulnerable to infection. The buzz about FluMist suggests its protection will last a full year. (Repeated vaccinations are necessary to protect against new strains of the flu, and because the body's immunity to the flu declines over time.)

There is a risk that a small number of those who avail themselves of the intranasal vaccine will pass the live virus used in it to others, but is there not a far greater danger presented by those whose fear of needles keeps them from getting vaccinated? They catch the flu, and they pass it to others, with the contagion so transmitted living on through their victims to infect even more. Vaccine, no matter how delivered, can stop the spread of virus.

Barbara "marriage does not have to mean 'What's mine is yours'" Mikkelson

Update:   As of mid-November 2003, MedImmune had sold only 400,000 doses of FluMist and estimated that 50 to 80 per cent of those doses might be returned unused. The primary factors behind the low sales figures were retail giant Wal-Mart's canceling plans to offer the vaccine in 1,000 of its stores, the fact that members of the target group for whom the FDA approved FluMist (healthy people from ages 5 to 49) rarely get flu shots, and consumer reluctance to spend several times more than the cost of a conventional flu shot in order to avoid a needle.

Additional information:

Preventing Influenza Preventing Influenza   (Centers for Disease Control)
    FluMist   FluMist   (MedImmune Vaccines, Inc.)

Last updated:   3 September 2008


  Sources Sources:

    Long, Kim and Terry Reim.   Fatal Facts.

    New York: Arlington House, 1985.   ISBN 0-517-63216-0   (pp. 33-35).

    Marchione, Marilynn.   "Inhaled Flu Vaccine Not Shot in Arm for Disease Fight."

    Milwaukee Journal Sentinel.   6 October 2003   (p. G1).

    Olson, Elizabeth.   "An Option for the Needle-Shy: Spray Flu Vaccine."

    The New York Times.   4 November 2003   (p. D6).

    Pollack, Andrew.   "Anatomy of a Failed Product Introduction."

    The New York Times.   19 November 2003   (p. C9).

    Roan, Shari.   "Flu Shot Gave You the Flu? It's a Myth."

    Los Angeles Times.   3 November 2003   (p. F1).

    Snowbeck, Christopher.   "Some Hesitate on New Flu Mist."

    Pittsburgh Post-Gazette.   15 September 2003   (p. A1).

    Tierno, Philip.   The Secret Life of Germs.

    New York: Pocket Books, 2001.   ISBN 0-7434-2187-6   (pp. 50, 89, 99).

    Reuters.   "Wal-Mart Won't Offer Nasal-Spray Flu Vaccine."

    The New York Times.   18 October 2003   (p. C4).

    The Washington Post.   "Clearing the FluMist."

    30 September 2003   (p. F2).

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