NEWSGROUP FAQ'S - A Lyme Vaccine
From: JWismille (jwismille_at_aol.com)
Date: 08/29/04
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Date: 29 Aug 2004 02:01:04 GMT
After a decade of research and pressure from patient advocates and Congress
[29], the FDA licensed the first vaccine for Lyme borreliosis on December 21,
1998. The vaccine, called Lymerix, was derived from a recombinant version of
the OspA lipoprotein of B. burgdorferi. Lymerix was intended for "at-risk"
individuals between the ages of 15 and 70 years. Given in three separate
injections and an annual booster, the vaccine appeared to be effective in
preventing infections.
Yet, after years of pre-license clinical trials and three years of commercial
sales, the manufacturer, GlaxoSmithKline, pulled the vaccine off the market on
February 26, 2002. Glaxo cited poor sales and a projected market this year of
less than 10,000 people [30] as the basis for their decision to end production
and distribution of Lymerix. The suddenly demise of Lymerix may give other
vaccine manufacturers pause in considering the development of future vaccines
against infections that readily respond to common antibiotic therapies, have
little associated morbidity, and almost no associated mortality.
Ironically, many of the original advocates for a vaccine turned against Lymerix
as soon as it hit the market. Citing its less than perfect efficacy and
anecdotal evidence of vaccine-induced arthritis and other injuries, they
crowded FDA hearings with tales of personal injury, flooded the Internet with
anti-vaccine tautologies, and jointed lawsuits seeking compensation from Glaxo
and Pasteur Mérieux Connaught, the maker of a second, but never licensed
vaccine [31].
Despite the lawsuits and the web site tales of personal anguish, repeated
studies have failed to find any evidence of specific adverse events associated
with Lymerix. Neal Halsey, who helped monitor the first vaccine trial, said, an
"active, aggressive search for patients who developed arthritis" after
vaccination found no evidence of increased arthritis risk [32]. A CDC study
published in the February 2002 issue of Vaccine also failed to detect any
"unexpected or unusual patterns" of adverse reactions to vaccination [33].
Reports of adverse reactions to Lymerix, and other vaccines, can be searched
for on the Vaccine Adverse Event Reporting System (VAERS) Web site.
As another tick season approaches, it is interesting to note the results of a
recent survey of parental attitudes toward Lymerix [34]. The survey authors
found that respondents in Nassau County, New York indicated they would
"definitely" (23%) or be 'likely" to (65%) request Lymerix for their children.
The positive response to Lymerix may be due to the fact that most survey
respondents got their information about Lyme disease and the vaccine from a
friend or an advertisement (49% and 44%, respectively). The Internet was not
identified as a source of information. Yet, the survey found that most
respondents were "surprisingly misinformed" about Lyme infections. For example,
they considered Lyme infections to be a chronic, difficult-to-treat disease.
"Chronic Lyme disease" is a term favored by support groups and patient
advocates, but has no basis in medical fact or practice [35]. The endless
public repetition of this misleading mantra may have influenced parental
opinions in favor of vaccination as a prevention to a chronic infection that
does not exist. That option ceased to exist on February 26, 2002.
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