The first and only licensed vaccine against Lyme disease was developed by SmithKline Beecham (now GlaxoSmithKline). Given in a three-dose series, the vaccine had an unusual method of action: it stimulated antibodies that attacked the Lyme bacteria in the tick’s gut as it fed on the human host, before the bacteria were able to enter the body. This was about 78% effective in protecting against Lyme infection.
The vaccine, called LYMERIX, was licensed in 1998 and showed good results in clinical practice: 76% of the half of the 10 902 adults between ages 15 to 70 who received all three parts of the vaccine (at month 1,2 and 11) were protected against Lyme infection and had no significant side effects.
Like every other vaccine, Lymerix had some limitations: it showed slightly less than 80% efficacy; it required three injections over one year before it was fully protective; it was not tested in young children; it was not clear how long the immunity to Borrelia would last. Nevertheless, it was officially recommended for people in endemic areas with frequent exposure to ticks, and received wide spread news coverage.
In 1999, a class action suit was filed against SmithKlineBeecham alleging that the manufacturer had concealed known potential risks of the vaccine, particularly arthritis.
A post vaccine study by the FDA’s Vaccine Adverse Events Reporting System (VAERS) showed that in more than one million Lyme vaccine doses administered, only fifty-nine people reported arthritis associated with the vaccination. Finding no suggestion that the Lyme vaccine caused harm to its recipients, the FDA did not revoke the vaccine’s license.
But the popularity of Lymerix was short-lived. After only one year on the market, adverse media coverage, ongoing litigation and falling sales prompted the manufacturer to withdraw the product in 2002. No further vaccination trials have been reported in the US since. However, in recent months, Valneva, a French-based pharmaceutical company, has completed the first human trial of a Lyme vaccine which is expected to prevent 96% of Lyme infections.