Lyme Disease Vaccine Pioneered by Yale Researchers, Developed by SmithKline Beecham, Receives FDA Approval

LYMErix* Becomes First Lyme Disease Vaccine on the Market

New Haven, CT – LYMErix*, pioneered by Yale University researchers and manufactured by SmithKline Beecham Biologicals, has received approval from the U.S. Food and Drug Administration (FDA) for the prevention of Lyme disease.

LYMErix*, the world’s first vaccine to prevent Lyme disease, has been proven effective in the prevention of both definite Lyme disease (characteristic symptoms with serologic diagnosis) and asymptomatic infection (no symptoms, but serologic diagnosis of infection).

Lyme disease is a tick-borne illness first described in 1975 by Yale researchers. An emerging infectious disease, it is a potentially serious multi-stage bacterial infection with a wide range of symptoms – from a characteristic skin rash and flu-like symptoms to arthritis and heart abnormalities.

The approval of LYMErix* is welcome news for people who live in or travel to tick-infested areas, or people who enjoy outdoor activities in these areas. Lyme disease has rapidly become the most common tick-borne illness, with cases reported in 48 U.S. states. More than 99,000 cases have been reported to the Centers for Disease Control and Prevention from 1982 to 1996.

People at highest risk include those living in, working in or traveling to endemic areas in the Northeast, upper Midwest and Pacific coastal areas. According to a recent study published in Clinical Therapeutics, the economic burden of Lyme disease in the United States is projected to be $2.5 billion in direct and indirect medical costs over a five-year period.

LYMErix* was evaluated in a landmark clinical trial that enrolled 10,936 individuals ranging from 15 to 70 years of age at 31 U.S. sites, including Yale University. Results from the multi-center, double-blind, placebo-controlled clinical trial demonstrated vaccine efficacy rates of 78 percent against definite Lyme disease and 100 percent against asymptomatic infection after three doses (after two doses, vaccine efficacy rates were 50 and 83 percent, respectively). Study participants received three doses of LYMErix* or placebo on a 0, 1 and 12 month schedule. Compliance in the study was high, with 95 percent of participants completing the 20-month study.

“This action by the FDA is an important milestone in the prevention of Lyme disease,” said Eddie Gray, vice president and director, SmithKline Beecham’s U.S. Vaccine Business Unit. “The approval of LYMErix* means the threat of Lyme disease may be significantly reduced for millions of Americans who spend time outdoors or plan to travel to endemic areas.”

LYMErix* is a genetically engineered vaccine that contains lipoprotein OspA, an outer surface protein of the Lyme disease bacterium, Borrelia burgdorferi. A novel hypothesis has been proposed to explain the effectiveness of lipoprotein OspA vaccination: When infected ticks bite humans who have been vaccinated with LYMErix*, the vaccine-induced antibodies are taken up by the tick and interact with the Borrelia burgdorferi in the midgut of the tick, thereby preventing transmission of the organism to the host.

LYMErix* may be associated with local injection-site reactions including redness and swelling, flu-like symptoms, arthralgias and myalgias. The vaccine should be available within weeks. For more information on Lyme disease and LYMErix*, call toll-free 1-888-LYMERIX, ext. 500.

Lyme Disease: A Widespread and Potentially Debilitating Disease

Lyme disease is a multi-stage disease caused by infection with a spiral- shaped bacterium (called a spirochete) known as Borrelia burgdorferi, which is carried by ticks that transmit the infection from animals to humans. Experts believe Lyme disease may be underreported by as much as 12 times (Maryland). In Connecticut, data indicate that, at best, only 16 percent of Lyme disease cases were reported over one year.

The onset of Lyme disease is commonly associated with a characteristic skin rash known as erythema migrans (EM), which can vary in size and location. EM is often accompanied by flu-like symptoms including headache, fever, fatigue, joint aches, muscle aches and a stiff neck. When diagnosed early, Lyme disease can usually be successfully treated with antibiotics without any long-lasting complications. However, diagnosis can be difficult because symptoms may imitate other illnesses.

If undetected and left untreated, the Lyme bacteria can spread to other parts of the body months to years following a tick bite and progress to late-stage Lyme disease. The bacteria can affect the joints, tendons, heart or nervous system, potentially resulting in arthritis, heart abnormalities such as heart block and myocarditis (inflammation of the muscular walls of heart) and Bell’s palsy (paralysis of one or both sides of the face). Previous infection with Borrelia burgdorferi may not confer protective immunity. Therefore people with a prior history of Lyme disease may benefit from vaccination with LYMErix*.

In addition to getting vaccinated, people can decrease their risk by avoiding tick-infested areas, tucking in pants and shirts, wearing light-colored clothing to spot ticks, using insect repellent containing DEET and checking family members and pets for ticks.

*Trademark (TM) **or Richard Koenig, SmithKline Beecham, (215) 751-3415

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