Lyme Disease Vaccines: A Cautionary Tale 255 The FDA licensed LYMErix in 1998 after a hedged recommendation for approval by its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee’s chair, Patricia Ferrieri, noted that “it’s rare that a vaccine be voted on with such ambivalence and a stack of provisos” (Altman 1998, A1). After the FDA’s approval, rec- ommendations for use in clinical practice were taken up by the highly influential Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). Some ACIP mem- bers considered LYMErix to be a “yuppie vaccine,” its “manufacturer- driven and consumer-driven” market limited to worried suburbanites who “will pay a lot of money for their Nikes and their Esprit and shop at L.L. Bean’s will have no consideration for cost-effectiveness when they want a vaccine because they’re going to travel to Cape Cod” (Dr. Chinh Le, testimony, ACIP meeting 1998). ACIP members concerned with this “yuppie vaccine” steered the committee to a lukewarm “should consider” recommendation for people at high risk and a “may be considered” for others “exposed to tick- infested habitat but whose exposure is neither frequent nor prolonged” (ACIP 1998). ACIP member Paul Offit (personal communication, 2011) noted that it was highly unusual for such a lukewarm recommendation to be given to a vaccine approved by the FDA. In addition to the small numbers of people who would unambiguously benefit, support for LYMErix among regulators and advisory boards was hedged because (1) the trials had excluded children, limiting the vaccine’s use until the efficacy and safety for children were established; (2) boosters would probably be needed to keep a high enough concentration of antibodies in the tick meal to kill spirochetes; and (3) concern that vaccine’s side effects might appear with a longer follow-up (especially concerns about vaccine-induced arthritis, discussed later). The Connaught vaccine was withdrawn even before licensing. Con- naught’s anticipated market edge for ImuLyme may have evaporated when the vaccine was not proved to be any safer than the SKB product in the efficacy trials.1 Leonard Sigal (personal communication, July 6, 2011), the lead investigator on the Connaught vaccine trial, believed that the manufacturer concluded that marketing and other costs would be greater than the low revenues expected from the sales. Connaught’s competition, SKB, also had superior resources and experience to market its vaccine in the United States. Stanley Plotkin (personal communi- cation, July 18, 2011), a prominent vaccine researcher and consultant