Lymerix

Federal health authorities are investigating whether some people who received the Lymerix vaccine against Lyme disease later developed severe cases of arthritis and even Lyme disease itself as a result.

The Food and Drug Administration has received reports of such problems, mainly from doctors and researchers in the Northeast. The FDA approved the vaccine, made by SmithKline Beecham Biologicals, a subsidiary of the British pharmaceutical giant SmithKline Beecham, two years ago, and about 440,000 Americans havereceived it.

It is too early to know how many people have been injured by the Lymerix vaccine. But in interviews, reported in the New York Times, more than a dozen doctors in areas where Lyme disease is common say they have treated 170 people with arthritis and Lyme disease that they attribute to the Lymerix vaccine.

In May 1998, the FDA advisory committee endorsed the vaccine. But when the drug agency's vaccine advisory committee recommended that the vaccine be approved for marketing, several members expressed concern that the vaccine could set off an autoimmune condition that, in turn, would result in arthritis. Some also said they feared it could cause flare-ups of Lyme disease among people who had been previously infected with the Lyme bacteria, Borrelia bergdorferi.

The New York Times also reports that some doctors say the drug agency should never have approved the Lyme vaccine or should have responded more quickly to adverse reports. Dr. Andrea Gaito, a New Jersey rheumatologist and president of the International Lyme and Associated Disorders Society, said she had told the agency that 21 patients developed severe arthritis soon after being given the vaccine by other doctors.

In the New York Times article, Dr. Gaito stated that she believed the vaccine caused arthritis and Lyme disease itself but that the problems were not always linked to it because the vaccine took effect only after three immunization shots given over the course of a year. Dr. Gaito believes the FDA should withdraw the Lymerix vaccine immediately.

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