PHILADELPHIA, Jan. 12 /PRNewswire/ -- LYMErix(TM) [Lyme Disease Vaccine (Recombinant OspA)], the world's first vaccine to prevent Lyme disease, is now available. Manufactured by SmithKline Beecham Biologicals (NYSE: SBH), LYMErix(TM) was proven safe and effective in the prevention of both definite Lyme disease (characteristic symptoms with serologic and culture diagnosis) and asymptomatic infection (no symptoms, but serologic diagnosis). LYMErix(TM) received approval from the U.S. Food and Drug Administration in December, 1998.
"People should talk to their doctors about getting vaccinated with LYMErix(TM) now in order to begin building immunity for the upcoming Lyme season," said Michael Caldwell, MD., clinical trial investigator and commissioner of the Dutchess County Department of Health in Poughkeepsie, New York. To provide consumers with information about Lyme disease and LYMErix(TM) [Lyme Disease Vaccine (Recombinant OspA)], including prescribing information, SmithKline Beecham has introduced a toll-free number -- 888-LYMERIX x500 -- and website located at http://www.lymerix.com.
LYMErix(TM) is a genetically engineered vaccine that contains lipoprotein OspA, an outer surface protein of the causative 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(TM), 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. In a landmark clinical trial with 10,936 individuals ranging from 15 to 70 years of age at 31 U.S. sites in endemic areas, LYMErix(TM) demonstrated vaccine efficacy rates of 78 percent against definite Lyme disease and 100 percent against asymptomatic infection after a complete immunization series (three vaccine doses given on a 0, 1 and 12 month schedule). Trials have been completed with vaccination on accelerated dosing schedules and SmithKline Beecham expects to file with the FDA shortly.
LYMErix(TM) is available in 30 mcg/0.5mL vials and Tip-Lok(TM) syringes. Each 0.5 mL of vaccine consists of 30 mcg of lipoprotein OspA adsorbed on 0.5 mg aluminum as aluminum hydroxide. LYMErix(TM) is indicated for individuals 15 to 70 years of age. LYMErix(TM) may be associated with local injection-site reactions including redness and swelling, flu-like symptoms, arthralgias and myalgias. As with any vaccine, LYMErix(TM) may not protect 100 percent of individuals.
"SmithKline Beecham is proud to be the first company in the world to offer safe and effective protection to millions of Americans at risk for this potentially debilitating and often misdiagnosed disease," said Eddie Gray, vice president and director, SmithKline Beecham's U.S. Vaccine Business Unit. Lyme Disease: A Widespread and Potentially Debilitating Disease Lyme disease 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. It has rapidly become the most common tick-borne illness, with cases reported in 48 U.S. states. Over 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 planning to travel to endemic areas in the U.S., including the Northeast, upper Midwest and Pacific coastal areas.
Lyme disease is caused by a bacterium, Borrelia burgdorferi, which is carried by ticks that transmit the infection from animals to humans. In the pivotal efficacy trial also published in The New England Journal of Medicine, approximately 20 percent of people infected with the Borrelia burgdorferi organism did not exhibit any symptoms (asymptomatic infection). Such infection, if undiagnosed and left untreated, can progress to late-stage Lyme disease. Those infected may develop debilitating symptoms months to years after including arthritic or neurologic problems possibly requiring extensive treatment.
A Leader in Healthcare SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.
SOURCE SmithKline Beecham Biologicals
CO: SmithKline Beecham Biologicals
ST: Pennsylvania
IN: MTC
SU: PDT
01/12/99 09:28 EST
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