Is the Lyme Disease Vaccine a Lemon?
But a series of researchers from Glaxo SmithKline maintained that the vaccine was unrelated to arthritis or other mysterious conditions, and outlined a set of studies that it has under way. The company says that the product's safety profile hasn't changed since it was approved.
The patients' testimonials clearly had an effect on the advisory committee. In his closing remarks, W. Michael O'Fallon, PhD, an invited participant in the panel's discussion, said, "Would I take the vaccine? No."
Benjamin Luft, MD, another invited participant, cited a "twilight zone" of disconnect in the conflicting accounts of the vaccine recipients and the drug firm.
According to panel member David Stephens, MD, a "huge body of anecdotal data" suggests that "we may be missing something."
Almost 1,000 adverse event reports have been filed on the Lyme vaccine, with around 70 citing arthritis-like side effects. Four deaths also have been reported following administration of the vaccine.
But according to Glaxo SmithKline, the events have taken no particular clinical pattern and "no cluster in time to onset."
According to the FDA, the rates of arthritis suffered by those who've taken the vaccine aren't higher than rates among the general population.
The FDA holds that more adverse events are occurring than are reported, but agrees with the vaccine maker that most of the reported events involve side effects already described in the vaccine's physician labeling.
The company says it has experience with more than 18,000 subjects in controlled investigations, including more than 8,000 post-licensure vaccinees.
Glaxo SmithKline presented animal study data that it claimed supported its position that the vaccine is unrelated to the arthritis. But panel member Steve Kohl, MD, and others said the study was irrelevant to the nature of the possible problem in humans.
The drugmaker also said that it was tracking actual vaccinations as delivered by physicians through three HMOs, so it can closely follow thousands of doses, possible side effects, and follow-up medical care. By the end of the year, said Glaxo researcher Richard Platt, MD, "We will have real information about the relative risks."