Original Article- Hesitate Before You Vaccinate

By Lucy Barnes- 1999

There is a new vaccine, available by prescription, that was developed to protect humans from Lyme disease. The vaccine, LYME-RIX, (developed by the SmithKline Beecham Company) is advertised on local television stations, in magazines and in the newspapers. Employers and insurance companies are currently considering paying the costs for workers to be vaccinated. Some health departments have considered making the vaccine available to those in high risk groups, however, many have decided to not use it, or have taken a "wait and see" approach.

Maryland State outdoor workers are required to have the vaccine to be able to receive Worker's Compensation benefits. [This regulation was repealed by HB 765 during the 2006 Maryland legislative session.]

For those who spend a great deal of time in the outdoors, the vaccine sounds very promising. However, before you vaccinate....HESITATE. Take time to read the "small print" and warnings the manufacturer's of the vaccine have documented from their studies. Keep in mind the clinical test trials of almost 11,000 people included subjects who were vaccinated, but not directly infected with the Lyme disease spirochete afterward.

Results from the trials were published on test subjects who were bitten by ticks and came down with the disease after receiving the vaccine. In other words, many of the test subjects were never known to be exposed to a tick bite after having the vaccine, and many questions remain unanswered.

It is also troubling that occasionally some of those responsible for vaccinating patients have not taken time to read the LymeRix warnings or the fine print contained in the manufacturer's literature. Recently a local resident who had been diagnosed with Lyme disease was told to start the series of vaccines, regardless of his active infection. The patient realized later that the manufacturer warns against such practices. As a matter of fact, that is the first issue discussed in the warnings or contraindications for the vaccine.

Another disturbing case involves a young patient in good health who was at risk of exposure for Lyme disease and voluntarily received the vaccine. Something went terribly wrong and he suffered the acute symptoms of Lyme disease, was hospitalized, developed major pain syndromes and heart block. This unfortunate individual will now have to live with a pacemaker and be dependent on narcotic drugs to ease the pain. This is not an isolated case, as others have reported serious problems after having received the vaccine.

Before you make your decision to vaccinate, please take time to consider the following information :

1. LYME-RIX vaccine is not recommended for:

a. anyone who may have either active or unrecognized infection by Borrelia burgdorferi, the spirochete that causes Lyme disease. Note: At the present time, there are no tests that can positively confirm or deny the existence of Lyme disease in humans (blood or urine tests). You also need to understand the series of vaccines is administered over a 14 month period, and protection isn't considered to be at full peak until after the last injection. Caution must be exercised that you are not exposed to ticks during that time period.

b. people with known hypersensitivity to any component of the vaccine.

c. anyone who does not have epinephrine and other appropriate agents available on hand in case of an acute anaphylactic reaction to the vaccine.

d. any immuno-suppressed persons or those with HIV/AIDS.

e. anyone on anti-coagulant therapy or other prescribed drugs that may cause a reaction.

f. nursing mothers and pregnant women (studies will need to be done to test the effects of the vaccine on future pregnancies, reproductive organs or occurrence of birth defects in children).

g. anyone under the age of 15 years (the highest number of reported cases of Lyme disease occurs in children 2-15 years old).

h. anyone over the age of 70.

i. anyone, in my opinion, who isn't feeling really lucky. LYME-RIX was effective for only 78% of the 10,936 clinical test trial individuals that were later exposed to ticks. (As is stated in the advertisements, "As with any vaccine, LYME-RIX may not be 100% effective".)

j. anyone who may object to having symptoms similar to Lyme disease. LYME-RIX may be associated with local injection reactions, such as pain, redness and swelling (three injections over a 14 month period are necessary to complete the vaccine series). The vaccine may also cause (as reported in SmithKline Beecham clinical trials) achiness, chills, fevers, fatigue, flu-like symptoms, nausea, muscle pain, back pain, arthritis like pain, stiffness, dizziness, headache, bronchitis, coughing, pharyngtis, rhintis, sinusitis, upper respiratory infections, hypertension, diarrhea, tendinitis, depression, hypesthesia, and a rash, in a percentage of individuals. These symptoms were reported to last as little as a few days, or longer than 30 days.

k. anyone with heart disease or arthritis. The clinical trials excluded these individuals from the studies, so it is unknown how the vaccine may react in these individuals.

2. If you are given the vaccine, it can interfere with the results of your future blood tests (ELISA) and you may always show a positive reading for Lyme Disease. Note: These blood tests already have been found to have many problems when a positive diagnoses of Lyme disease is being sought. Having a continuing positive reading may complicate a Lyme disease diagnosis in the future if you are ever exposed to the spirochetes that cause Lyme disease. It may also delay your treatment, possibly causing permanent, irreversible damage.

3. The vaccine clinical trial subjects were followed originally for 20 months. There is no data suggesting the vaccine will or will not be effective after that time period, or if it will be necessary to have booster shots in the future. Studies in this area are ongoing and the FDA has not approved boosters at this time.

4. It has been reported by Dr. Ronald Schell of the University of Wisconsin School of Medicine, that studies on live hamsters given a vaccine for Lyme disease later developed SDA (severe destructive arthritis) and became very ill when exposed to an infection of b. burgdorferi, the spirochete that causes Lyme disease. Controversy over the studies continue. There are those who support the use of the vaccine, and those who are fighting the use at this early stage. Some of the supporters of the vaccine who attended the 12th International Conference on Lyme Disease voiced concerns over the hamster studies. They objected to the use of hamsters as a suitable model for human Lyme disease, as well as, the testing lab using "culture grown organisms" instead of allowing the hamsters to have direct contact with infected ticks.

5. There have been a number of various strains of Lyme Disease reported, as well as, other tick borne diseases affecting humans. Co-infections with other tick borne diseases are on the rise and are currently being researched. The current Lyme Disease vaccine hopefully will protect individuals against a specific strain of Lyme disease (Osp A). Some researchers believe if you come in contact with a strain that is different than the one found in your vaccine, you may still develop Lyme Disease, or a co-infection which could go un-diagnosed. For example: The flu vaccine contains protection against limited strains of the flu. Even though you have the flu shot you may still develop symptoms from being exposed to other strains of flu.

6. Having the vaccine may give some people a false sense of security, or cause individuals to let down their guard. They may feel that since they are protected, they do not need to use repellents, or perform regular tick checks. It is important to note that the LYME-RIX vaccine will NOT protect individuals against babesia, ehrlichia, Rocky Mountain Spotted Fever and other tick-borne diseases.

7. Since most people don't feel the bite of a deer tick, Lyme Disease may not be suspected as the culprit when someone becomes ill with a variety of symptoms. Lyme Disease is also famous for mimicking other chronic diseases that are not treatable with antibiotics. Doctors have a difficult time diagnosing Lyme Disease as it is, and it would be a shame to have someone misdiagnosed and treated for a disease that they didn't have while the Lyme Disease continued to spread throughout their body.

8. A number of Lyme organizations, state and local health departments, pharmacists, and doctor's offices have decided to not offer the vaccine after they have reviewed the information available, or have taken a "wait and see" approach until more studies are completed. When contacting Lyme organizations, ask if they receive any donations or funding from anyone promoting or manufacturing the vaccine before they offer opinions or literature that may influence your decision.

9. The cost for the series of vaccines and the doctor's office visits can range in price from $300.00 to $600.00 or more, depending on local charges in your area.

A vaccine for Lyme Disease would be a wonderful thing, however, after reading the literature and studies available, I have decided not to have my family vaccinated at this time. I congratulate those doing research in the field of Lyme disease and the doctors who are aggressively treating and assisting those who remain chronically ill.

I appreciate companies working to develop a vaccine, and hope they soon find a safe, effective, and universal solution to this menacing problem. You may contact the SmithKline Beecham Company at 1-888-LYMERIX, ext. 600 for more information (or visit their site at, www.lymerix.com).