Lyme vaccine history: Why LYMErix failed and there's no alternative yet.

This is a game I have played over the years with woodsmen: How much would it cost to get vaccinated for Lyme disease? I settle for a number between three and four figures. It's too much for my budget and a large chunk of my monthly mortgage payment, but it would be worth it to alleviate the anxiety I feel about being outdoors, an activity that is otherwise No. 1. This question is hypothetical because there is no Lyme vaccine. However, I'm not the only one who would go to great lengths to get Lyme vaccines for my dog. A colleague of mine recently admitted to trying to convince her vet friend to give her canine Lyme shots. (Yes, Lyme vaccines are available for dogs, but not for humans.) She was probably kidding.AdvertisementAdvertisementAdvertisementThis year I've been playing the What-would-you do-for-a Lyme-vax more often, as my friends have spent most of their social time bushwhacking along the banks of overgrown creeks while our children run wild. We were also the year that we became unlikely heroes for giant pharmaceutical companies by boasting about our Pfizer, Moderna, or J&J blood. Because the COVID vaccine was unlike any other vaccine, it helped us solve a major problem in our lives.This is a different way of thinking about vaccines. They are preventive measures for diseases that seem controlled, or even obsolete. Yes, I would be happy if my child got the DTaP shot. But, the vaccines against them have done their work and made it seem like they are no longer relevant. The COVID shot was a ticket. It was a Get Out of Jail Free Card that took the fear out of visiting Kroger and seeing vaccinated family members in their homes. Science could provide that kind of liberation from a disease, and I am more interested in science doing the same with bacteria lurking in tall grass ticks. I am about to depart for my Fourth of July vacation and head straight to the New Hampshire forest, where Lyme is at its epicenter.AdvertisementAdvertisementOne was ours. LYMErix was approved by the Food and Drug Administration. It was manufactured by SmithKline Beecham (now GlaxoSmithKline) and is available for use since 1998. LYMErix works by injecting antibodies into the blood of humans, which then would be absorbed into ticks attached to your body. They would then neutralize Borreliaburgdorferi bacteria, which causes Lyme. The shot was effective in clinical trials at 78 percent after three doses. I'd still take it. However, some patients who received the shot after its introduction testified that they had developed arthritis. FDA conducted an investigation but did not find sufficient evidence to withdraw approval for LYMErix. Despite falling sales, the company withdrew the vaccine from the market in 2002.AdvertisementBecause of its complexity, the story of LYMErix's fall has been a fascinating case study in vaccine history. Paul Offit, a vaccine historian, described the story of LYMErix's downfall as a tale about liability in his book The Cutter Incident. This was a tragic episode in mass distribution of the Salk polio vaccine. The National Vaccine Injury Compensation Program did not cover the Lyme vaccine because it was an optional shot. The program was established in 1980 to encourage pharmaceutical companies to produce vaccines and reduce the risk of being sued. Offit writes that there was no protection between the manufacturers and any person who could claim that LYMErix caused their arthritis. The vaccine survived the misinformation and abuses by personal injury lawyers.AdvertisementAdvertisementLyme disease was believed to be spread from Connecticut's beautiful lawns.Here's how I understand it: Anti-vaxxers have prevented us from having a Lyme vaccine. Voxs Brian Resnick recounted the LYMErix story 2018 as a stark reminder that anti-vaxxers have made it impossible to get a Lyme vaccine. This was at a time when vaccine hesitancy was high and anti-vax activism was low. Lancet published a 1998 Lancet report that claimed the MMR shot was linked with autism. The paper has since been widely discredited and retracted. Rotavirus vaccine RotaShield was pulled from the market in 1999 after several infants who had received it developed intussusception or bowel obstruction. The public was not happy about any new shot, particularly an optional one.AdvertisementThere was another reason LYMErix got into trouble. It had what I consider a New England problem. People thought they had contracted Lyme disease from the beautiful Connecticut lawns. Abigail Dumes, an author and anthropologist, said that Lyme disease is not only possible for many Lyme-endemic people. It is the environment privilege of living in or near nature that allows them to be at risk. Lyme is not a disease that affects everyone. It depends on the tick range and can't be transmitted between people. The LYMErix vaccine was not recommended for all children as it is a crucial tool in public health. It was viewed more like an adult who chose to live without fear. Chinh Le of the Centers for Disease Control and Preventions Advisory Committee on Immuniization Practices called the shot a yuppie vaccination for those who can afford their Nikes and Esprits and shop at L.L.Beans and will not consider cost-effectiveness when purchasing a vaccine. Robert Aronowitz, a historian, cites Les' testimony in a retrospective on LYMErix to show that regulators were not enthusiastic about the shot. Aronowitz points out that there was a lack of enthusiasm in the government's recommendations on who should get it. The government issued a must consider recommendation to people at risk of being bit by ticks in Lyme-prone areas, as well as a may consider recommendation for those people who are often exposed to tick habitats. Aronowitz spoke with experts who believed these designations made it difficult to encourage people to get it.AdvertisementAdvertisementOther oddities are part of the LYMErix saga. The pharmaceutical company aggressively promoted the vaccine via direct-to-consumer marketing emphasizing tick-related anxiety to generate enthusiasm. This was despite the fact that Lyme is not a common condition. It is possible that the end result was suspicion about the company as it appeared to be trying to create fear. There was also the fact that the vaccine was in direct conflict with the decades-long, complicated struggle between Lyme patients (a clash so unique and complex that Dumes wrote an entire book about it). Although initially supportive of the vaccine, a small group of Lyme patient advocates ended up being against it. Aronowitz explains that they were not against the prevention of the disease but opposed the idea that the vaccine could reinforce the notion that Lyme disease is an acute, unproblematic, and clinical entity. The vaccine was to them a falsely simplistic solution to a complex problem that current medicine does not fully understand.AdvertisementThis history, viewed starting in 2021, gives me hope that the next round Lyme preventive shots will be successful in reaching my family's arms. The failure of LYMErix wasn't about anti-vaxxers as such, but rather about a specific strain of hesitancy that was fueled at least partially by a general ignorance of Lyme. The vaccine was also less needed. Lyme disease has grown in America over the past few years, with Lymerix being pulled from the market. The number of cases has tripled at most. Each year, the number of cases increases due to climate change and human expansion into wooded regions. Lyme is a costly disease that has been increasing in public health and government officials.AdvertisementAdvertisementAdvertisementPharmaceutical companies have taken action to address the increased demand for Lyme prevention. Two options exist for Lyme prevention: one vaccine that works in the same manner as LYMErix; and one shot that is administered annually in advance of tick season (technically a Preexposure Prophylaxis or PrEP shot). This vaccine was developed in collaboration with Valneva, a French biotech company, and Pfizer. It has shown promising results in Phase 2 trials. The companies announced in March that their candidate would be entering a Phase 2 study with a pediatric population. This will include children over the age of 5. (LYMErix was not approved for children under 15. This is another reason for low demand. Valneva and Pfizer hope to have their vaccine available by 2025.AdvertisementMassBiologics is currently developing a PrEP shot to treat Lyme. This shot would work immediately, unlike true vaccines that require you to wait for antibodies to develop before you are covered. Professor of medicine Mark Klempner, executive vice-chancellor for MassBiologics, stated via email that the MassBiologics Lyme PrEP shot had completed its Phase 1 clinical trial. The next phase is expected to be completed by 2022. Klempner also said that the company hopes to get FDA approval for the product in 2024 if everything goes well.AdvertisementThese shots may be more expensive than I imagined in my fantasy of shoving cash at a needle-wielding doctor covered by insurance. The government will give them a designation. It is probably unrealistic to assume that they will be free like COVID shots. However, I hope there will be enough support and enthusiasm for these vaccines once they are available on the market. I know that I'll be ready to take my shot and get out in the woods.