By Moira Terese Dolan, M.D.

"Scientific studies do not support claims that influenza vaccine largely prevents illness, reduces missed workdays, shortens hospitalizations or lowers death rates in the general population."

What is the flu?

Influenza is characterized by a sudden onset of a fever and body aches, headache and tiredness, cough, sore throat and runny or stuffy nose. Stomach symptoms can occur, more commonly in children. It resolves in 3 to 7 days without any specific treatment. Spread of the virus requires close contact, as it is shed in the droplets from coughing and sneezing. Complications are more likely in people who are elderly, are already debilitated from serious underlying diseases or those who have faulty immune systems. Complications such as pneumonia or super-infection from bacteria can lead to death. However, keep in mind that it is probable that the vast majority of people who come into contact with influenza virus shrug it off with no symptoms whatsoever.

This is not the flu:

The majority of people who have fever with either cough, sore throat, headache or muscle aches do not have influenza. This syndrome is called influenza-like-illness. Influenza vaccine does not prevent this common illness. The CDC estimates that 80% of people with flu like symptoms do not have influenza.  Since the symptoms overlap with influenza, the only sure way to tell the difference is by testing for the virus. Of over 60,000 cases worldwide of suspected influenza that were tested, only 28% actually had influenza virus. This suggests that some 72% of the time the doctor is likely to mis-diagnose the flu. 
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What is the death rate from influenza?

Influenza was recorded as the cause of death in only 1,100 cases in 2004, which is the last year for which the CDC website has statistics. That’s a death rate of 4 people per 1 million population. From 1979 to 2001 the average numbers of influenza deaths have ranged from 257 to 3006 per year.

The CDC advertises a different statistic, the combined pneumonia and influenza deaths, called “P & I”.  Pneumonias caused 58,584 deaths in 2004. Adding the 1,100 deaths caused by influenza, the “P & I” deaths were 59,664. As you can see it is mostly the pneumonias that make up that number, not influenza. Anyone interested in selling flu vaccines would prefer to use the P & I number, as the influenza deaths alone are not very impressive.

The combined statistic is defended because some cases of influenza are complicated by pneumonia or super-infection with bacteria, which can progress to a death. But neither the CDC nor any other national reporting body has published exact numbers of deaths from this scenario of proven influenza infection followed immediately by fatal pneumonia.

It appears that the CDC compromised by advertising what they call “flu-associated deaths”. Before 2003, the yearly number of flu-associated deaths was given as 20,000, but in 2003 this took an 80% jump, up to 36,000.  There is no actual record of this many documented flu-associated deaths. This number came from mathematical models with lots of guessing and fudge factors. In fact, the documented influenza deaths dropped by 30%, so it just does not make sense that the models came up with an 80% increase in flu-associated deaths.

What is influenza vaccine?

The influenza viruses are constantly changing as they are passed through millions of people around the world. Last years’ vaccine is not protective against this years’ virus strains. Every year, an advisory committee at the FDA tries to predict which flu strains will be landing in the US by studying what just swept though Asia and the Pacific. They work with vaccine manufacturers to come up with a combination vaccine that is a best guess, and the CDC helps the manufacturers rapidly get it into broad distribution. Of course there is no time in this calendar for adequate testing to conclude that the vaccine works and is safe.

Vaccines for children contain inactivated virus particles. Adult vaccines and inhaled vaccines can contain live virus. Vaccines are made in chicken eggs, and they contain a variety of additives which may include mercury.

Does the flu vaccine work in the lab?

Each years’ batch of vaccine gets tested in the lab to prove that the vaccine has the ability to provoke antibodies against particular influenza viruses. This is called efficacy. The vaccines are routinely shown to have efficacy in the laboratory setting. Just because a vaccine provokes antibody production does not mean that those antibodies will be made in enough volume or with adequate strength to prevent illness in a person. In other words, laboratory efficacy is not proof that the vaccine will work in the real world.

Does the flu vaccine prevent influenza illness?

There is no way to do studies in the population to show that it prevents this years’ strains of influenza illnesses before the virus hits our shores.  During the flu season, there are a smattering of studies done on small groups to see if the vaccine did prevent influenza and its complications. This is called field efficacy. Some years, the guess for the most likely viruses to include in the vaccine are not exactly matched to the strains that ended up causing the flu. So any field efficacy studies done during those mismatch or poor match years are not good. This leaves a few very studies. They do not consistently show that the vaccines prevent influenza.

Does the flu vaccine keep you from getting sick?

The actual value of a vaccine would be its ability to keep people from having to stay home sick with the flu and flu-like illnesses. This is called effectiveness, and is the only useful information for the everyday person. Like field efficacy, effectiveness can only be studied after the fact. Therefore no doctor can assure you that this years’ vaccine is likely to work.

The doctor can only tell you about flu vaccines’ effectiveness in years past.  These studies give a mixed picture. A problem is the tendency to compare a jumble of patients, which is called selection bias. Some studies seem to show that healthier people who got the vaccine were more likely to stay healthy compared to unhealthy people who did not get the vaccine. In other studies, more of the chronically ill people got the vaccine, and fewer of the healthy people did. All of the different variables, such as age, income status or having other diseases are called confounders, making it impossible to draw any conclusion about the vaccine itself. The studies that had unacceptable selection bias or had too many confounders cannot be used to support effectiveness.

Many studies are simply too small to support any conclusion, with less than 200 subjects. That is why it is more useful to combine the results of several different studies. When this is done, it is shown that in healthy people under 65, the flu vaccine does not cause any less time off of work due to illness, it does not affect how long a person is in the hospital and does not lessen the death rate from influenza or its complications. The inactivated vaccine is no better than a dummy shot in children under 2. The flu shot does not improve the health of people with asthma or cystic fibrosis, and yet there seems to be some effect on people with emphysema. Elderly people or those in institutions may get some benefit.

Is the flu vaccine safe?

There are only a handful of studies examining the safety of flu vaccine. There are few small safety studies on children under age 2. Authors of a large study using the Vaccine Safety Datalink concluded flu vaccine was safe for infants. However the Datalink is not open to outside reviewers, so the study cannot be scrutinized to see if it is accurate. There is no medical or security reason for this type of secrecy in public health research. Without being able to get at the raw data, such a study cannot honesty be held up as proof of safety.

Even without being able to look at the Datalink, there is an obvious problem with the study. Researchers cut it off at May 2003, covering a time period when mostly high risk infants were vaccinated. The cut off was before the newer recommendations to vaccinate all healthy babies. They ignored more recent information. Looking at reports of vaccine side effects to the Vaccine Adverse Event Reporting System (VAERS), there has been over a 2000% increase in reports of adverse events since 2003. These baby deaths occurred mostly in children who were previously healthy, with no special risks for the flu or for vaccine side effects. Considering that only 1%-10% of actual adverse events ever get reported, the true number of adverse events is much higher.

There are less than ten acceptable studies on adults, giving information on vaccine reactions within one week of the shot. Some neurologic effects of the vaccine occur later than one week. These few studies are not enough to assure the short term safety of the vaccines, much less the long term consequences of getting a new shot every year. Of course, relative safety of this years’ vaccine is only known after the fact.

Common reactions to the flu shot are fever, fatigue, painful joints and headache. The
most frequently reported serious reaction is Guillain-Barré syndrome, a type of paralysis that can be temporary or permanent and may result in death.

People with allergy to eggs should not have the vaccine. Vaccines should not be given when there is fever or other infection. Many flu vaccines contain mercury which is a toxin at any dose, but this should especially be avoided in pregnancy.

Inactivated virus vaccines are marketed to children. Live virus vaccines, including the aerosol mists, may cause shedding of the influenza virus, infecting unvaccinated bystanders.

What about natural immunity?

Flu vaccine causes the body to temporarily make antibodies to certain viral strains. On the other hand, when someone actually gets infected with the influenza virus they make antibodies that give longer term immunity. It is a theoretical possibility that by relying on flu shots to make our antibodies we may actually become dependent on repeat shots.

What drugs treat the flu?

The CDC advises that two of the four flu drugs, rimantadine and amantadine, should not be used because the influenza A virus has become resistant to them. 

Zanamivir and oseltamivir are related to drugs used to treat HIV infection. They reduce the length of illness caused by influenza A and B viruses by about 1 day if taken within the first 2 days of sickness. They have not been shown to be effective in the more common influenza-like-illness, which is not caused by influenza A or B. This year it is expected that there will be an increase in the numbers of influenza viruses that will develop resistance to zanamivir and oseltamivir. Both drugs can cause nausea, vomiting and diarrhea, and oseltamivir carries warnings for self injury and delirium, particularly in children.

The risks of taking anti-viral drugs around the time of receiving a flu shot have not been adequately studied.

Alternatives

Most influenza and flu like illness is self-limited and does not need any treatment beyond fluids and bed rest. Nutritional support with vitamin C, magnesium and zinc could theoretically be effective and relatively harmless. Homeopathic remedies have a strong following and cannot hurt. Herbal preparations can ease symptoms and provide comfort.

Summary

Advertising and public awareness campaigns greatly exaggerate the frequency, severity and deadliness of influenza.

Scientific studies do not support claims that influenza vaccine largely prevents illness, reduces missed workdays, shortens hospitalizations or lowers death rates in the general population. Evidence is stronger for a possible vaccine benefit in people with emphysema and for the elderly or those in institutions.

There have not been enough safety studies done on the vaccines. There is a risk of less common but severe vaccine effects, including Guillain-Barre syndrome and death. There are additives in some vaccines, such as mercury, that are toxins at any age. Live virus vaccines may promote the spread of influenza. Unanswered questions remain about the wisdom of bypassing our natural immunity.

Drugs to treat influenza do not significantly change the natural course of the illness.

For any one person, the decision to accept or refuse the influenza vaccine is individual and should be based on the careful consideration of full information.

Disclaimer: The information presented here is not intended to be medical advice or to supplant your doctor’s treatment recommendations.

Resources:

Jefferson, T. Influenza vaccination: policy versus evidence BMJ  2006;333:912-915 (28 October), doi:10.1136/bmj.38995.531701.80

Guillain Barre Fact Sheet, National Institute of Neurological Disorders and Stroke, National Institutes of Health http://www.ninds.nih.gov/disorders/gbs/detail_gbs.htm

National Vaccine Information Center www.nvic.org

Vaccine Risk Awareness Network www.vran.org

Sherri Tenpenny, D.O.: Vaccinations and The Right to Refuse www.newswithviews.com

CDC Centers for Disease Control and Prevention Influenza Flu Homepage www.cdc.gov/flu/