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Search the VAERS Database Vaccine Adverse Event Reporting System (VAERS) - Under Vaccine: - choose Lyme to view all the reports to VAERS regarding this vaccine - 2181 events reported and it is estimated by some that less than 10% of adverse reactions are reported
TICKED OFF The much-heralded vaccine against Lyme disease is now said to cause crippling side effects
Concerns (and Lawsuits) Grow Over Reactions to Lyme Vaccine 12/24/00
Lyme Disease Vaccine Questioned May 23, 2001 STATEMENT BY BARBARA LOE FISHER
The Lyme vaccine: a cautionary tale Lyme Vaccine Lymerix Leaves Market, but Others in Wings numerous individuals experienced adverse reactions, including joint and muscle pain, after receiving the vaccine. In others with Lyme disease who were treated with antibiotics and later received the vaccine, its use appeared to trigger a return of Lyme symptoms, such as fatigue or memory loss, she says. However, when patients complained of such side effects, many of them were told that the symptoms were not related to the vaccine. Hence, few reports were sent into the federal Vaccine Adverse Events Reporting System (VAERS).
Did Lyme Vaccine Give People The Disease & Arthritis? 11-21-00
LYME DISEASE VACCINATIONS led to 298 reports of adverse
reactions last year
Date: Sat, 11 Mar 2000
New Jersey minister Zelma Johnson is filing a lawsuit against the drug company, alleging that the vaccine caused her arthritis.
Lyme Vaccine Fears
Concerns newly approved drug can cause arthritis
By Ridgely Ochs
LYME DISEASE VACCINATIONS led to 298 reports of adverse reactions last year, the first year the vaccine was on the market, according to reports to the FDA obtained by Newsday under the Freedom of Information Act. Of those, about 10 percent reported symptoms of chronic arthritis, which some doctors and scientists fear could be a potential side effect of the vaccine.
The theoretical possibility of the vaccine's prompting such an autoimmune response, in which the body attacks its own tissue, was known to the scientists, drug makers and the FDA before the vaccine was approved, although it is not included in the warning label. I'm stunned. Looking at these data, I'm highly concerned by the number of the reactions and the severity of the reactions," said Karen Vanderhoof-Forschner, chairwoman of the board of directors of the nonprofit Lyme Disease Foundation in Hartford. Vanderhoof-Forschner testified in May, 1998, before the FDA advisory panel urging the vaccine's approval by the FDA. "This is a voluntary reporting system, so this is probably the tip of the iceberg. How is the public supposed to evaluate this data?"
Most of the other events reported -- a very small number of the 600,000 people who took the vaccine in its first year -- appear to be allergic reactions, some quite severe, or failures of the vaccine to work. About one-third of the patients who had a reaction ended up in the emergency room. Both the FDA and SmithKline Beecham Pharmaceuticals of Philadelphia, maker of the vaccine marketed as LYMErix, say that the reports of adverse events don't raise any red flags. An FDA spokeswoman, Lenore Gelbsaid the reports are not proof the adverse events were caused by the vaccine. "If we do have concerns, we make an effort to change the labeling to reflect that ... There is no effort to change the label," she said. She declined to comment further.
Dennis Parenti, group director of adult vaccines for SmithKline Beecham, said 600,000 people got the vaccine in 1999, after it was approved in December, 1998; 20,000 more had participated in trials testing it, and there is no evidence of an increase in arthritis because of it. "We've sliced it and diced it and every way looked at it and repeated some tests, and we and the FDA found there was no association," Parenti said. But several lawsuits, including a class action suit in Pennsylvania, have been filed against SmithKline Beecham alleging the vaccine can cause arthritis in some people. The suit charges that the drug-maker failed to warn doctors and the public that LYMErix exposes people of a certain genetic type -- 20 to 30 percent of the population -- "to the risk of a chronic, degenerative and incurable autoimmune disease which is much greater than the risk posed to these individuals by an ordinary Lyme-carrier tick bite."
The suit wants the company to relabel its vaccine, warn the public and tell doctors to screen for those who might be susceptible to a reaction. And it wants the drug manufacturer to create a trust fund to pay for blood tests for those who already have had the vaccine to see if they are at risk. "There is a lot of smoke here, and underneath we believe there is a fire. This is a chance for SmithKline Beecham to do the right thing and do it early on their liability," said Albert Brooks of Sheller, Lugwig & Bader of Philadephia, which filed the suit. A New Jersey minister, Zelma Johnson, is also in the process of filing a lawsuit against the drug company alleging that the vaccine caused her arthritis.
Ira Maurer, a White Plains lawyer representing Johnson as well as three others who were in the clinical trials for the vaccine, said, "You go under the assumption that side effects will be the typical aches and pains, but when you look at these reports [of adverse events], many are far more serious." All drugs have potential side effects that may not show up until used in a large population. What is unusual about this vaccine is that the chief researcher, the drug company, the FDA advisory panel that recommended its approval and the FDA knew beforehand there was the theoretical possibility this one could lead to arthritis.
The question, some say, is whether the risks of the vaccine's side effects outweigh the potential benefits. "I wouldn't take the vaccine," said Ronald Schell, a Lyme disease researcher from the University of Wisconsin. "I recognize that's a prejudice based on my animal research." He recently published a study that found hamsters injected with the vaccine were more likely to get arthritis. "I want people to be aware; they should know of the potential [to cause arthritis]. Right now, there's a lack of choice," said Dr. Charlene DeMarco, an emerging-diseases specialist in Egg Harbor, N.J., who has served as a consultant in the class action suit. DeMarco believes people who carry a gene that may predispose them to an autoimmune response should be warned before getting the vaccine.
The vaccine works by stimulating the immune system to produce antibodies to a protein found on the outer surface of the bacterium B. burgdorferi, which causes Lyme disease. But the lead researcher for the SmithKline vaccine, Dr. Allan Steere of New England Medical Center in Boston, knew -- and indeed published the fact six months before the vaccine was approved -- that a part of that outer-surface protein, called OspA, has the potential of inducing a "cross-reaction" with a human protein (hLFA-1) in about 20-30 percent of the population (those people who have the HLA-DR4 gene). Cross-reacting means that in these people, the body's immune system could attack the human protein, thinking it was part of an invading bacterium. Some experts think it is this part of the bacterium that induces so-called Lyme arthritis, which resembles rheumatoid arthritis.
Steere's study, published in the journal Science in July, 1998, was a test tube study, not proof it could occur in humans. But it has added fuel to concern about the possibility. In it, three groups of four to seven hamsters each were given different doses of a Lyme vaccine suspended in aluminum hydroxide. The vaccine was not LYMErix but was very similar to it. Seven others were injected with a commercially available canine version of the vaccine. A group of nonvaccinated hamsters and a group injected with just aluminum hydroxide were comparison groups.
All were then infected with the Lyme bacteria. All the vaccinated hamsters developed "severe destructive Lyme arthritis;" in some groups 100 percent of the vaccinated hamsters were afflicted. By comparison, none of the unvaccinated hamsters developed higher than normal levels of arthritis typical of hamsters with Lyme disease. The study, published last month in the journal Infection and Immunity, has caused a stir among Lyme experts. In fact, Schell initially refused to discuss the article, saying it was "too political." But he and his colleagues state unequivocally in the study:
Recently the FDA approved the use of OspA for vaccination of humans despite indirect evidence and concerns that OspA is associated with arthritis. In this study, we present direct evidence that vaccination ... can induce severe destructive arthritis in hamsters after challenge with the Lyme borreliosis spirochete." Schell says his study does not prove the vaccine can induce arthritis in people, but "it raises the flag, and I am concerned." While Schell was reluctant to discuss his findings, others were quick to assail them. Dr. Neal Halsey, director of Johns Hopkins University's Institute of Vaccine Safety, questioned the study's relevance, saying that hamsters are prone to develop arthritis and that the vaccine used was not LYMErix.
Schell countered that hamsters are not particularly prone to arthritis. "There's no evidence of that in the literature," he said. And he said he avoided using LYMErix in the study "for political reasons." His own formulation was different by "one amino acid." But Halsey and others said that animal studies are not as significant as the results of clinical trials in humans. Halsey was head of the data monitoring and safety board for the SmithKline vaccine trials. In that trial of 10,936 people begun in 1995, most side effects were minor, and only about 1 percent of those vaccinated and 1 percent of those in the placebo group developed arthritis, Halsey said. A trial of 10,305 of a similar vaccine made by Pasteur Merieux Connaught of Swiftwater, Pa. -- never brought for FDA approval -- showed similar results.
"No way would I have gone on to the pediatric studies if I had seen anything in the study to show there were worries," he said. Members of the FDA's advisory panel also said the data they saw showed no pattern of serious side effects in the clinical trial vaccine. "The advisory panel was aware of the theoretical risk of this vaccine causing autoimmunity. A careful evaluation of study patients did not reveal any problems, but the panel recommended the vaccine be monitored post-approval to see if anything occurred as greater numbers were vaccinated," said panel member Raymond Dattwyler, director of the Lyme disease research center at the State University of New York at Stony Brook.
"Regarding cross-reactivity, we were all very aware, and we looked at it very carefully," said Kathyrn Edwards, a vaccinologist at Vanderbilt University in Nashville and a panel member. "I think we take the very best data we can; we think about it very seriously ... No one has a crystal ball." Dr. Leonard Sigal, chief investigator for the Connaught vaccine trial, said there were no untoward side effects in his study. "Cross-reactivity wasn't seen in the Connaught trial under very controlled conditions." But there were signs that some participants felt they were having bad reactions.
Before the vaccine was approved, at least four lawsuits were filed by people who had participated in the vaccine trials -- highly unusual since participants sign informed consents. Three were filed against Connaught; the other was filed against SmithKline. In two of the Connaught suits and the SmithKline case, the participants said they had had debilitating arthritic-like problems. One case was settled for an undisclosed amount, another dropped and two are pending, said Maurer, the lawyer in those suits. And others who have experience with the vaccine since its approval are sure it has done them more harm than good, regardless of the clinical studies.
An East Northport woman who did not want to be identified decided to have her son, 16, get the vaccine after the repeated urging of his doctor. He had been diagnosed with Lyme disease in January, 1998. Now she thinks it has made his knee swell, sidelining the promising track star at a time when colleges are looking to offer athletic scholarships. "Had I known then what I know now, I never would have let him have it," the mother said.
