| georgia 2006-08-29, 4:23 pm |
| A Lyme Vaccine
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 M=E9rieux
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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