VACCINE POSITION PAPER * ( This LDA position paper applied to the vaccine LymeRix which was withdrawn by the manufacturer citing poor sales. It does not apply to any current Lyme vaccine).
The Association recognizes the need for a safe effective vaccine against Lyme Disease. Several pharmaceutical companies have developed vaccines that are going through the FDA’s vaccine approval process. One has been FDA approved.*
The Association does not recommend for or against products, including the vaccine, used for the treatment or prevention of Lyme disease. An individual and his/her doctor need to make the decision whether or not to receive the vaccine.
Several questions about the vaccine:
· Since there is no effective test for active Lyme, what happens to individuals who have active Lyme disease and receive the vaccine?
· Since the vaccine is effective against certain strains of the Lyme bacteria, Borrelia burgdorferi, what happens if someone is infected with a different strain?
· What happens to individuals who receive the vaccine and become vaccine failures and contract Lyme? After receiving the vaccine, they will now have a positive test for Lyme. Will doctors know enough about the vaccine effects on LD testing to diagnose Lyme, and will insurance companies pay for treatment, or will the record of the vaccine and subsequent positive test prevent diagnosis and treatment?
· Since having had Lyme disease itself does not confer immunity, can one conclude that a positive titer means immunity to the disease? Are positive titer and conference of immunity the same thing?
· What tests have been done to determine the length of protection of the vaccine beyond 2 years?
· In the vaccine trials, people were not challenged with the disease; they were just monitored to see if they came down with it. What happens if someone actually is infected?
· Bacteria inside a tick that is feeding on a vaccinated animal are mostly destroyed. Can the remainder enter the human body and produce disease?
· Some researchers have found that OspA may trigger an autoimmune arthritis in certain susceptible people. Since this vaccine is OspA based, will getting the vaccine produce arthritis in some otherwise healthy individuals?
Revised: 5/19/98, 2/16/99
[*Note: This vaccine, LymeRix, was withdrawn from the market by manufacturer on Feb. 25, 2002. Currently, there are no vaccines on the market for humans]