For those of us who live in this part of the country and spend any time messing around outdoors in the grass and weeds, this is the time to be careful about Lyme disease. I had a bout of Lyme 16 years ago, and it descended on me when we were on vacation, driving through Nova Scotia. I had no idea what had hit me – I was very chilly in the hot weather, developed a fairly high fever, and felt truly lousy. I discovered that I had a nasty bite on my leg just behind my knee, and when (after a couple of days) I consulted an MD in Northern Maine, he thought it was a spider bite. I got to feeling a little better but not a whole lot. When we returned home, I went to see my own excellent regular PCP, who took one look at me and said, “Bingo! Lyme disease! The most obvious bulls-eye rashes I’ve ever seen.”
I felt like a nincompoop, to be sure. I knew about bulls-eye rashes, but I had never actually seen one at that point. I thought they would be a whole lot more distinct – bulls-eye-ish, like a Target logo. The reality is that there is a clear border between the rash area and the unaffected skin, and the area in the middle of the rash is less red. That’s what makes it a “bull’s-eye.” I hadn’t noticed.
My doctor put me on a 28 day course of doxycycline and told me to stay out of the sun as much as I could. The next month was not much fun, but as far as I have been able to tell, I fully recovered with no residual effects whatever.
Quite naturally, my interest in the possibility of a Lyme disease vaccine spiked about that time. There actually was a vaccine for Lyme disease then. It was called LYMErix, and it had been developed a pharma outfit called SmithKline Beecham, which is now Glaxo SmithKline (GSK). After three doses of the vaccine, it was effective about three-quarters of the time. But a lot of talk soon emerged about nasty side effects, including joint symptoms similar to those experienced by persons with rheumatoid arthritis.
The combination of a vaccine that was 75% effective at most and the possibility – although unproven – that the vaccine was burdened with fairly significant side effects meant that it wasn’t taken up enthusiastically by the public. And, in addition to that, the maker was hit with a number of lawsuits from parties who claimed that LYMErix had caused them significant harm.
So SmithKline took it off the market in 2003, shortly after I had that Lyme disease episode. In the 15 years since 2003, no Lyme vaccine has been available. During that time, according to the CDC, close to half a million people in the US have been officially diagnosed with Lyme disease, and infectious disease experts believe that the actual number, including cases not reported to the CDC, may be closer to five million.
A number of highly knowledgeable infectious disease authorities consider that the withdrawal of the Lyme vaccine was something of a public health disaster. They point out that the adverse effects claim against LYMErix did not have much factual substantiation. In the clinical trial that led to FDA approval, 6,478 subjects received a total of 18,407 doses of the vaccine. The most common adverse events noted within 30 days of receiving at least one dose of the vaccine included pain or reaction at the injection site, joint pain, muscle pain, and headache. Of these, only injection site pain and reactions occurred more frequently in the vaccine recipients than in those who received a placebo.
The result of the LYMErix withdrawal essentially meant that a large number of persons – perhaps millions – were infected with Lyme disease. A considerable fraction of these persons could have been spared if the vaccine had continued to be available.
… but there’s a bit of good news!
A French pharma company that specializes in developing vaccines has completed Phase 1 investigation of a Lyme disease vaccine. This outfit, Valneva SA, is fairly small, but has operations in Austria, Sweden, the United Kingdom, France, Canada and the US. They have proprietary vaccines against cholera and infectious diarrhea, and several vaccines other than their Lyme vaccine under development.
Their Lyme vaccine, identified as VLA15, addresses the outer surface protein (OspA) of the Borrelia burgdorferi bacterium. Valneva reported positive Phase 1 results in March 2018, including a good safety profile and high antibody against all types of the target protein. FDA requirements for entering Phase 2 trials have been met, and Valneva expects to be able to present completed data for approval within five years.