Lyme vaccine history: Why LYMErix failed and thereβs no alternative yet.
Why LYMErix failed and thereβs no alternative yet.
We had one, once. The Food and Drug Administration approved LYMErix, manufactured by SmithKline Beecham (now GlaxoSmithKline), for use in 1998. LYMErix worked by inducing antibodies into human blood, which would then go into any ticks that attached to your body. There, they would neutralize the bacteria that cause Lyme, Borrelia burgdorferi, before the bacteria could go from the tick into you. In clinical trials, the shot showed about 78 percent effectiveness after the required three doses (hey, I’d take it). But some patients who got the shot after it went on the market testified that they developed arthritis after vaccination. The FDA investigated, but decided the evidence that the vaccine was linked to patients’ arthritis wasn’t strong enough to withdraw its approval for LYMErix. Sales fell nonetheless, and the company pulled the vaccine in 2002.
The story of LYMErix’s downfall has become a case study in the history of vaccines, in part because of its complexity. In his book on the Cutter Incident—a disastrous episode in the mass distribution of the Salk polio vaccine—and its impact on vaccine production, vaccine historian Paul Offit described what happened with LYMErix as a story about liability. The Lyme vaccine was an optional shot, so it wasn’t covered by the National Vaccine Injury Compensation Program. (The program was set up in the 1980s to encourage pharmaceutical companies to continue production of vaccines by reducing the fear of liability.) Because of that exemption from the federal program, writes Offit, there was no cushion between the manufacturers of LYMErix and anyone who might claim it caused their arthritis. The vaccine “was left to survive the abuses of personal injury lawyers and the inaccurate media reports that inevitably follow.” Advertisement The perception was that people got Lyme disease from their beautiful lawns in Connecticut.
This is how I have seen it explained, in shorthand form: We don’t have a Lyme vaccine because of anti-vaxxers. Retelling the LYMErix story in 2018, Vox’s Brian Resnick described it as “a stark reminder of how anti-vaccine mania of the past few decades is leaving us all more susceptible to disease.” Brittany Flaherty pointed out in a 2019 STAT piece about the Lyme vaccine that LYMErix hit the market at a bad time for vaccine hesitancy and anti-vax activism. The infamous Lancet report claiming that the MMR shot was linked to autism was published in 1998 (it does not; the paper has been widely debunked and retracted), and the rotavirus vaccination RotaShield was withdrawn from the market in 1999, after a number of infants who received it suffered intussusception, or bowel obstruction. There was an unease in the public climate around any new shot, especially an optional one.
But there’s another reason LYMErix had trouble: It had what I think of as a “New England problem.” The perception was that people got Lyme disease from their beautiful lawns in Connecticut. “For many individuals in Lyme-endemic areas, it is precisely the environmental privilege of being able to live in or close to ‘nature’ that makes possible the environmental risk of Lyme disease,” wrote Abigail Dumes, an anthropologist who has published a book about Lyme. Lyme does not stand to affect everyone; it is dependent on the range of the deer tick and cannot be transmitted between people, so it has a unique status among infectious diseases. The LYMErix shot was not like the MMR vaccine, a key tool of public health that would be recommended for all children so that transmissible diseases would stop spreading; it was seen as a choice, one made by privileged adults who wanted to live freer of fear. Chinh Le, a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, called the shot a “yuppie vaccine” for people who “will pay a lot of money for their Nikes and their Esprit and shop at L.L.Bean’s” and who “will have no consideration for cost-effectiveness when they want a vaccine because they’re going to travel to Cape Cod.” (I’m in this picture, and I don’t like it!) Historian Robert Aronowitz cites Le’s testimony in a retrospective of LYMErix as evidence that regulators were lukewarm about the shot. Aronowitz notes that the lack of enthusiasm showed up in their recommendations for who should get it: The government issued a “should consider” recommendation for people at high risk for tick bites in areas where Lyme was present, and a “may consider” for people sometimes exposed to tick habitats. Some experts Aronowitz interviewed thought these designations may have made it hard to encourage uptake.