Lyme Disease Vaccine Progress

FDA approves Lyme disease vaccine

The Food and Drug Administration (FDA) approved the first vaccine against Lyme disease on 21 December 1998. The vaccine, SmithKline Beecham’s LYMErix, contains a genetically engineered protein from the surface of Borrelia burgdorferi bacteria, which causes Lyme disease. This protein, called OspA, stimulates the immune system to produce antibodies "that appear to disable the bacterium’s ability to infect the individual," according to an FDA statement.

The vaccine is approved for use in people between the ages of 15 and 70, and is given in three doses over a one year period.

FDA Commissioner Dr Jane E Henney said that while the vaccine may be a good option for people who spend a lot of time outdoors where the ticks that spread Lyme disease are common, she also warned that the vaccine "is not 100% effective, so other precautions should be taken". These precautions include the traditional methods of protecting against the infection, such as wearing protective clothing, using tick repellent, and removing attached ticks.

The approval follows FDA review of a study of the vaccine in almost 11,000 people living in the north-east US and Wisconsin, where Lyme disease is common. After two doses of the vaccine in the first year of the trial, the protection rate against definitive Lyme disease was 50% and in the second year, after three doses, it was 78%. Safety and efficacy were shown when the vaccine doses were given between January and April, shortly before the peak tick season in the north-east US. But FDA officials also note that it is not known how long protection against Lyme disease lasts after vaccination, and that safety data on the use of the vaccine in pregnancy or in patients with chronic joint and neurological disease is "limited".

Side effects of the vaccine include redness, soreness and swelling at the injection site, and sometimes mild to moderate flu-like symptoms.

Dr Michael Caldwell, a principle investigator on the Lyme vaccine trials and Commissioner of Health for Dutchess County, New York, said that the most recent studies that he has conducted indicate that the same efficacy can be achieved when the vaccine is administered over a 3-month period. "We hope the FDA gets the information rapidly and will change the labelling," he commented. "That way, we can get the full vaccine in before the next tick seasons, which begins here in May".

The Centers for Disease Control and Prevention report that since Lyme disease tracking in the US began in 1982, over 99,000 cases have been reported, mostly from the north-east, upper mid-west, and Pacific coastal states.