Questions & Answers

Questions & Answers

The First Lyme Vaccine

1. What was the LYMERix vaccine and how did it work?

SmithKline Beecham developed and marketed the LYMERix recombinant vaccine that was licensed by the FDA in 1998. The vaccine contained an outer surface protein (OspA) from the Borrelia burgdorferi bacteria.

The vaccine was designed to stimulate human antibodies that could attack the Lyme bacteria in the tick’s gut as it fed on humans, before the bacteria entered the body. It was reported by its promoters to be about 78% effective in protecting against Borrelia burgdorferi after all three doses of the vaccine had been given.

The B. burgdorferi strain utilized in the development of the LYMERix vaccine is only one of more than 300 known Borrelia strains. In Europe and Asia for example, Lyme infection is most often caused by the Borrelia genospecies, B. afzelii and B. garinii, which results in variations of disease manifestations. Additional scientific research is needed to determine which Borrelia strains and sub-strains are capable of causing symptoms and diseases in animals and humans.

The LYMERix vaccine was not developed to protect humans against the varying Borrelia strains or the dozens of other tick and vector borne diseases (coinfections) found in nature.

2. Were there any negative effects from the vaccine?

During clinical trials 6,478 people received a total of 18,047 doses of the vaccine. The most common adverse events noted within 30 days of receiving at least one dose of the vaccine were pain or reaction at the injection site and symptoms similar to Lyme disease, including joint pain, muscle pain, and headache.

In less than two years, over 900 reports were made to the Vaccine Adverse Events Reporting System (VAERS) about adverse events. Of those reported, 66 resulted in a life-threatening illness, hospitalization, and/or disability. Reports of people also suffering from an incurable form of arthritis following the Lyme disease vaccination initiated a class-action lawsuit asking SmithKline Beecham to update the vaccine’s label to include the possibility that it could cause arthritis. Additional lawsuits were filed claiming the vaccine caused an irreversible chronic form of arthritis and various other serious side effects.

Unfortunately, researchers conducting the vaccine studies and clinical trials based their conclusions concerning the effectiveness and safety of the LYMERix vaccine partially on laboratory tests known to miss up to 75% of people who are infected with Lyme disease, a problem with Lyme disease testing that still exists today.

3. Was the vaccine recommended for everyone?

The Lyme disease vaccine was only to be considered for use in individuals between 15 and 70 years old who were living or working in areas with high rates of Lyme disease. People with very little exposure to ticks were not recommended to receive the vaccine. Some states passed laws requiring its outdoor workers to receive the vaccine within months of the vaccine becoming available.

4. Were children required to be vaccinated?

The vaccine was only given a “permissive recommendation”, meaning that the vaccine could not be added to the childhood or adult immunization schedules, like vaccines against other common diseases. Instead, the vaccine was to be considered for use only in individuals (15 - 70 years old) or groups of people who had specific risk factors for Lyme disease.

5. How many people received the vaccine?

Between the time of its licensure in 1998 and July 31, 2000 (less than 2 years) about 1.5 million doses of the vaccine were distributed. In 2000 and 2001 growing concerns over the vaccine’s safety were reported in the news, and as a result sales dropped dramatically. (“Concerns Grow Over Reactions to Lyme Shots,” “Lyme Vaccine May Cause Problems,” and “Lyme Disease Vaccine’s Safety Is Questioned”.)

6. Is the LYMERix vaccine still available?

In response to concerns about adverse effects, low vaccine sales and class action lawsuits, in 2002 SmithKline Beecham withdrew its short-lived vaccine from the market.