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Correspondence Nature 440, 278 (16 March 2006) | doi:10.1038/440278c
Lyme vaccine: studies have raised genuine concerns
Carl Brenner
Lamont-Doherty Earth Observatory of Columbia University, Route 9W, Palisades, New York 10964, USA
Sir:
The lamentable hostilities between researchers into Lyme disease and the patients on whose behalf they purportedly labour will not be eased by Nature's account of the issues surrounding GlaxoSmithKline's decision to pull its vaccine, LYMErix, from the market ("Uphill struggle" Nature 439, 524-525; 2006).
The News Feature portrays truth-seeking researchers on one side and angry patients and their advocates on the other, with the latter torpedoing a perfectly good vaccine with scare tactics and bad publicity. But a significant portion of the Lyme research community had strong reservations about the product.
LYMErix's initial approval by the vaccine advisory committee of the US Food and Drug Administration (FDA) was hedged with caveats that questioned its safety and even its usefulness (J. Am. Med. Assoc. 279, 1937-1938; 1998). One case series in the peer- reviewed medical literature describes a group of six patients, with no history of neurologic problems, who developed neuropathy or cognitive impairment shortly after receiving the vaccine (J. Peripher. Nerv. Syst. 9, 165-167; 2004).
And there were other factors that hindered its success in the marketplace.
It was relatively expensive at $50 per inoculation, and it required three doses, spaced over a period of one year, to achieve its full efficacy rate, which topped out at only 79%. Perhaps most disappointingly, study subjects lost their immunity relatively quickly, meaning that booster shots would be required every year or two - shots that the FDA's advisory committee refused to sanction without further study (http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3422t1.pdf).
In addition, the vaccine was not approved for children under the age of 15.
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