Failed Lyme Vaccine Removed From Market
UPDATE- September 12, 2014- Information on various new Lyme vaccines coming to the market, and details on past Lyme disease vaccines at LymeVaccine.org
The Lymerix Vaccine, once highly promoted by the Infectious Diseases Society of America (IDSA) and Johns Hopkins, was removed from the market after over 2,200 Adverse Event Reports were filed with the FDA by patients and their doctors. Several individual and class action law suits were initiated against those involved with the vaccine.
"Stephen Sheller, the Philadelphia attorney representing some 250 LYMErix vaccinees in personal injury suits against GlaxoSmithKline, says Ball is manipulating data "by focusing almost exclusively on 'serious' events that result in hospitalization, permanent disability, or death, while discounting the far more prevalent 'severe' event. I've been contacted by hundreds of individuals whose lives have been drastically affected by a chronic inflammatory process which is neither life-threatening nor requires hospitalization, and whose permanence has not yet been determined," Sheller explains."
"Moreover, the LDA adds, the government and corporate entities with vested interest in LYMErix and associated Lyme disease products are vast. U.S. government agencies, including the CDC, the National Institutes of Health, and the Department of Defenseown partial rights to revenue from more than a third of the 56 U.S. patents identified as especially significant for Lyme disease vaccines and tests. What's more, GSK may not be the only company with revenue rights to LYMErix. Also poised to derive benefit based on possible interest in the patent are multinational life science giants Aventis and AstraZeneca."
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The Bitter Feud Over LymeRix
Once developed, the Lyme Vaccine was highly promoted.
Johns Hopkins Information on Lyme Vaccine
Vaccine Fact Sheet
What vaccines are available?
A Lyme disease vaccine, LYMErix, is now available and has been approved by the Food and Drug Administration for use in persons aged 15 to 70 years. LYMErix is the only currently approved vaccine that is available. You may have heard about LYMErix through advertisements on television or in magazines.
How does the vaccine work?
The LYMErix vaccine is made from a single protein. The protein is found on the outer surface of the Lyme disease bacterium. The protein is not infectious. Therefore, you have no risk of contracting Lyme disease through the vaccine.
After receiving the vaccine, people develop proteins in their blood, called antibodies in response to the proteins contained in the vaccine. During a bite from an infected tick, the tick may inject the Lyme disease bacteria into your blood stream. The antibodies help to kill the Lyme disease bacteria. These antibodies probably kill the bacteria in the gut of the tick. Antibody levels have to remain at a certain level in the blood to provide protection.
How many doses of vaccine are needed?
The LYMErix vaccine is currently approved for a three dose series. After the first dose, you need to come back for an additional dose 1 month later. You need to receive the third dose 11 months after the second dose. New studies suggest that alternative dosing schedules, such as 0, 1, and 6 months or 0, 1, and 2 months may be as effective as the approved 0, 1, and 12 month schedule.
During the past three years, a large scientific study in over 10,000 people was conducted to evaluate the LYMErix vaccine. The researchers found that, after TWO injections, the vaccine was 49% effective, and after THREE injections it was 76% effective, in preventing definite Lyme disease. The researchers looked for the spreading red “bulls-eye” rash and a positive test on a sample of skin from the rash as signs of Lyme disease.
The level of antibody declined relatively rapidly in vaccinated people. By 8 months after the third dose, antibody levels had declined to low levels offering minimal protection for vaccinated people. It is likely that boosters will be necessary every one to two years, but this is not yet clearly known.
How safe is the vaccine?
In the large study of 10,000 people the vaccine was found to be safe with few side-effects. Soreness at the injection site was the main side effect. Achiness, fevers and chills were other reported complaints due to the vaccine.
What does the vaccine cost?
The LYMErix vaccine is sold by the manufacturer (SmithKline Beecham) for approximately $60 per dose to hospitals, clinics, and pharmacies. The cost to you to receive it will be higher. Some health insurance companies will not pay for it.
Who should get vaccinated?
You should only consider the vaccine if you are at significant risk for getting Lyme disease. Several medical committees have published recommendations on the use of the vaccine. The recommendations are all based on your risk of contracting lyme disease where you live, work, or recreate. Although the vaccine is safe and effective, up to 90% effective after three doses in persons ages 15 to 65 years, some of the committees have recommended that the use of the vaccine be limited. This was mainly because of concern about long-term safety, the fact that lyme disease is treatable, and the need for booster dose. To date, there is no consensus on who should receive it.
If you are at significant risk for Lyme disease and do not feel that you can adequately protect yourself from tick bites when outdoors, it may be appropriate for you to discuss the issue of receiving the Lyme disease vaccine with your physician.
In considering whether to get vaccinated, remember that Lyme disease is a treatable disease and can be cured with safe antibiotics. In this respect Lyme disease is different from other vaccine-preventable diseases such as measles, polio, diphtheria, hepatitis A and hepatitis B for which no specific treatment exists for infected people.
Why you still need to practice Protect-Detect-Remove!?
Here are three important reasons that you will continue to need to protect yourself from tick bites by protectingyourself from ticks, detecting ticks with body checks andremoving immediately any ticks you do find, even if you do receive the vaccine:
- The vaccine is not 100% effective as protection against Lyme disease, even after three doses.
- The protection that you do have after 3 doses declines over time. The level of antibody against Lyme disease drops rapidly, so booster injections will probably be required, at least every two years.
- The Lyme disease vaccine does not protect you against three other diseases transmitted by ticks: Ehrlichiosis, Babesiosis and Rocky Mountain Spotted Fever.
You are encouraged to continue to practice Protect-Detect-Remove if you want to be safe from tick-transmitted diseases!
Fighting Lyme disease with a new vaccination
Health: The preventive might be a good idea for those who can't avoid exposure.
June 20, 1999|By LINELL SMITH | LINELL SMITH,Sun Staff
Adele and Charles Sands cherish their daily hike in Oregon Ridge Park. But as the vegetation has grown more lush, the Timonium couple has become increasingly apprehensive about the ticks they find clinging to their dog, Samantha. Although the Australian shepherd has had shots to prevent Lyme disease for several years, the Sandses recently joined the first wave of humans to try vaccination as protection from the tick-borne illness.
Adele Sands has already had a brush with the infection. About a year ago, she developed a circular rash that looked suspiciously like the classic bull's-eye rash of Lyme disease, a bacterial infection that can invade different systems of the body. Her physician prescribed oral antibiotics, the usual treatment for early stages of the infection, and Sands suffered no further symptoms.
But the experience left her shaken. In addition to a rash, early indications of Lyme's disease can include fatigue, chills, fevers and joint pain. Untreated, it can cause numbness, arthritis, paralysis, irregular heartbeat and, in rare cases, death.
When she learned the U.S. Food and Drug Administration had approved LYMErix a few months ago, Sands was ready to try it.
"The alternative to not taking the vaccine was not pleasant," she says. "We thought, 'Let's give ourselves an edge.' "
The new vaccine does not guarantee immunity to Lyme. Given in three shots over the course of a year, LYMErix is judged to be only 78 percent effective. So far, the Sandses have each had two shots, which confers about 50 percent protection.
Injections are expensive: Each one can cost from $65 to $100 at a doctor's office, says Rob Stoltz, an internist at Greater Baltimore Medical Center who has given the vaccine to roughly 75 people, including the Sandses, during the last few months.
Although the clinical trials for the vaccine tested only people aged 15 to 70, Stoltz feels comfortable giving it to older patients -- the Sandses are in their early 70s -- who spend a lot of time in areas with many ticks.
Most of the reported cases of Lyme disease, however, are adults between 30 and 59 and children. Results from the first study of LYMErix's effects on children 4 to 15 in age should be available later this year, according to a spokesperson for SmithKline Beecham, the drug's manufacturer.