FDA Advisory Committee Recommends LYMErix for Approval
FDA Advisory Committee Recommends LYMErix for Approval

BETHESDA, MD. (LymeNet) -- The U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee has recommended SmithKline Beecham Corp.'s Lyme disease vaccine, LYMErix, for approval.  Specifically, the advisory panel felt that the data presented by SmithKline proved the vaccine was safe and effective in the immunization of a subset of individuals between the ages of 15 and 70 when given a dosage on a 0, 1, and 12 month schedule.

Panel members were vocal in their belief that LYMErix should only be approved for the specific patient populations studied in SmithKline's clinical trials.

Earlier, panel members questioned how safe and effective the vaccine was in individuals with a history of Lyme disease, in patients who developed Lyme disease and arthritic patients.

Virtually all panel members expressed the need for follow-up of patients taking LYMErix.  "We need to pursue the long-term follow-up (of these patients) very closely," panel member Mary K. Estes indicated.

The panel endorsed the vaccine unanimously for immunizing people ages 15 to 70.  SmithKline is eager to get LYMErix on the market soon, because competitor Pasteur Merieux Connaught, a Rhone-Poulenc SA (RP) unit, also has a Lyme disease vaccine, Immulyme, that has completed phase III clinical trials.

"I would say for those in the process of developing the vaccine and getting it licensed, not to sell it immediately tomorrow and push it as hard as you can for all the money you can get," Dr. Caroline Hall, a panelist from the University of Rochester, said.

"It may be worthwhile getting a little bit more data, getting better timing, scheduling of the dosage and the amount and just waiting a little bit longer."

During the clinical trial of 10,936 people, SmithKline found LYMErix to be the most effective in preventing the disease in people under age 65. Half of the trial participants received an initial injection of LYMErix, followed by a booster shot after one month and another after 12 months.

Dr. Robert Schoen, professor of medicine at Yale School of Medicine, said the number of Lyme disease cases has been steadily rising since the 1980s.   Schoen, who spoke to the panel on behalf of SmithKline, said the disease is seasonal, with most cases surfacing in the late spring and early summer months.

Panel members urged the company to study the vaccine's long-term efficacy, because the trial participants were only followed for 20 months. "We don't seem to have much evidence on long-term effects," said Hall.

"It's like buying a computer," said panelist Dr. Raymond Dattwyler, professor of medicine at SUNY at Stony Brook School of Medicine. "You know there will be something better next month. It needs to be studied in the long term."

Dr. Patricia Ferrieri of the University of Minnesota, who chaired the FDA advisory panel, summarized the committee's sentiment: "It's rare that a vaccine be voted on with such ambivalence and a stack of provisos."

The panel also wants the company to examine the number of booster shots necessary for individuals to remain inmmunized.

Released: 26-MAY-1998 20:15

Revised: 27-MAY-1998 18:10

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