Food and Drug Administration (FDA) advisers on Wednesday said they had been given too little new data to determine if a Lyme disease vaccine might cause autoimmune arthritis.

The FDA asked its Vaccines and Related Biological Products Advisory Committee to examine the most recent data on Glaxo SmithKline's LYMErix.

A majority of panelists said the data did not shed new light on concerns raised before approval.

Patricia Ferrieri, a panel consultant and former committee member from the University of Minnesota Medical School, noted an increase in side effect reports and testimony from a vocal group of people who received the vaccine, many of whom claimed they developed autoimmune arthritis from LYMErix.

Barbara Loe Fisher, the panel's consumer representative, urged the agency not to ignore these anecdotal reports. "We cannot continue to dismiss these as coincidental events," said Fisher, president of the National Vaccine Information Center.

Glaxo SmithKline has distributed 1.4 million doses of LYMErix, but it did not estimate how many people might have received the vaccine, delivered in three to five shots over the course of a year.

The agency has received 1,048 reports of events potentially related to LYMErix, including 133 reports of arthritis or arthritic-type symptoms. Robert Ball of the FDA said that, so far, they do not provide clear evidence that LYMErix had caused the effects.

There were more reports in 2000 than in 1999. The uptick might be due to a late onset of symptoms, or news stories suggesting a link between the vaccine and arthritis, Ball said.

The agency is hoping to get to the bottom of the issue. It is interviewing people who reported symptoms and will compare them with other vaccine recipients in the FDA database.

A pregnancy registry for human vaccine recipients and reproductive toxicity trials in rats showed no unexpected events in mothers or fetuses, said Glaxo SmithKline. But panelists were not convinced; one noted a high rate of abortions.

Steven Sheller, a Philadelphia attorney representing vaccine recipients who claim they got arthritis from LYMErix, called for a moratorium on LYMErix sales until more information was gathered. Consumer advocate Sidney Wolfe, director of Public Citizen Health Research Group, urged FDA to change LYMErix labeling to highlight potential problems.

New York Times February 1, 2001