Lyme disease vaccine pushed by FDA

Drug records successful trials

A Food and Drug Administration advisory panel has urged fast-track approval of a first-ever vaccine for Lyme disease, following a successful national trial of 11,000 subjects.

Dubbed Lymerix by SmithKline Beecham, the vaccine provided immunity to 90% of the people tested, ranging in age from 15 to 65. The vaccine works by attacking the tick-borne bacteria Borrelia burgdorferi by launching antibodies just as the tick begins sucking a victim's blood, thwarting the bacteria before it leaves the insect.

Still at issue with the vaccine are its fairly complicated regimen of three shots over a 12-month period and limitations on the types of patients not currently recommended for the vaccine. Pending further testing, the FDA panel decided against recommending that pregnant women, those suffering from chronic arthritis, and people under 18 (one of the highest-risk groups coming in contact with ticks in the wild) should be among the first to be vaccinated upon final approval.

Still, the vaccine is good news against a disease for which there's no clear drug of choice, dosage or therapy duration, though a host of oral and IV antibiotics are used for treatment. Even diagnosis and determining when a patient is cured is difficult. Chills, fever, headache, and joint pain are the symptoms. A telltale, often large bulls-eye shaped rash at the point of infection is a clearer sign. If untreated, the infection can lead to severe arthritis, facial palsy, and irregular heartbeat.

The Lyme Disease Foundation in Hartford, CT, says even estimating the number of annual or all time cases is difficult based on diagnosis problems. The foundation has documented 111,000 cases since 1980 - with a peak to date of 16,000 in 1996 - but says the real number is closer to one million cases over the last 17.5 years.

[For more information, contact the Lyme Disease Foundation at (517) 839-0635.]