Wednesday, the agency's scientific advisers expressed frustration that vaccine manufacturer GlaxoSmithKline has had two years to answer lingering safety questions, but still hasn't. Patients and their relatives said doctors hid possible side effects before administering the vaccine, then often dismissed symptoms when they appeared. One woman in the vaccine's original study charged that researchers refused to record her symptoms, which would be a violation of federal research rules if it occurred. Karen Burk of Bethlehem, Pa., asked panelists. Lyme disease, spread by deer ticks in the Northeast and certain other parts of the country, causes fatigue, fevers and joint pain that can persist for weeks.
Some patients develop severe arthritis.
If untreated with antibiotics, it also can severely damage the heart and nervous systems. Lyme sufferers begged the FDA to approve Lymerix, the world's first Lyme vaccine, in 1998. It requires two shots given about a month apart and a third a year later to get about 80 percent protection from Lyme disease. The FDA has received 1,048 reports of Lymerix recipients suffering possible side effects. GlaxoSmithKline, which insists the vaccine is safe, has distributed 1.4 million doses to doctors but can't say how many people have been inoculated.