Lyme Vaccine Pulled Off Market
Tue Feb 26, 2002, 11:46 AM ET
By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - The maker of the nation's only Lyme disease vaccine pulled it off the market Tuesday, citing poor sales.
Lymerix had caused controversy in recent years, as patients who argued they were sickened by the vaccine asked the government to restrict sales and also filed numerous lawsuits against maker GlaxoSmithKline.
But after a year of investigation, the Food and Drug Administration (news - web sites) had found no proof that the vaccine was dangerous and thus did not tell the manufacturer to end sales, an agency spokeswoman said Tuesday.
"The reason is there's just no demand for it," said GlaxoSmithKline spokeswoman Ramona Dubose.
Lymerix had $40 million in sales its first year on the market, and hundreds of thousands were vaccinated. But GlaxoSmithKline projected that fewer than 10,000 people would seek vaccination this year, and thus decided it didn't make financial sense to keep selling, Dubose said.
The company's decision comes less than a month after federal health officials warned that Lyme disease cases had reached record highs in recent years.
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 required two shots given about a month apart and a third a year later to get about 80 percent protection from Lyme disease.
But some patients reported arthritis, muscle pain and other troubling symptoms after vaccination. Some also claimed doctors hid information about possible side effects before administering the vaccine, and then often dismissed symptoms.
Many of the alleged symptoms were similar to Lyme disease itself. While the vaccine is 80 percent effective, it's not that protective until all three doses are given - meaning some people with symptoms could have Lyme instead of a vaccine reaction. Or, because arthritis is so common that 15 percent of the population is afflicted, they could have arthritis unrelated to vaccination.
In one safety study, 5,000 people got Lymerix and another 5,000 got dummy shots. Two percent of each group developed arthritislike symptoms, reassuring to the FDA.
Still, the Centers for Disease Control and Prevention (news - web sites) re-examined all 905 possible side effects reported to the government between 1998 and July 2000, to see if regulators had missed any signs of real trouble.
The CDC's results, just published in the journal Vaccine, found no signs that arthritis or other side effects were being caused by the Lymerix vaccine. It did, however, find 22 cases of allergic reaction to the vaccine, and said scientists would continue to assess reported side effects closely.