It’s very good news that the U.S. Food and Drug Administration announced last month a plan to expedite under a program it calls “Fast Track” the approval process for a vaccine to ward off Lyme disease.
The vaccine’s maker, Valneva, which specializes in vaccines — it declares its goal as “advancing vaccines for better lives” — has completed an initial clinical trial.
Valneva, headquartered in France, conducted the “phase one” clinical trial of the VLA15 vaccine in the United States and Belgium.
“Whether or when” the FDA will approve the vaccine is “uncertain,” noted Newsweek in its report on the FDA action, “but the FDA’s Fast Track designation indicates that the need is critical, now more than ever… The U.S. Centers for Disease Control and Prevention says that Lyme disease is the fastest growing vector-borne infection in the U.S.”
Suffolk County has long been a hotbed for Lyme disease.
And once there was an earlier vaccine to prevent the disease. Indeed, when that vaccine, called LYMErix and produced by SmithKline Beecham, first came out in 1998, I got a series of injections of it. Making a judgment based on a negative is problematic — but a terrific negative in this situation is that I have never come down with Lyme disease since. And in the ensuing years my wife, working with tweezers, has pulled off me at least 40 ticks, the vector or carrier of Lyme disease.
I went for the shots — from our family doctor, Dr. Dan Lessner, now retired, a very careful physician — after having written pieces on the devastating impacts of Lyme disease when not caught promptly and treated with antibiotics.
The first time I heard about Lyme disease was from a neighbor who got it bad in the early 1980s. The leadership of the Suffolk Department of Health Services then downplayed the gravity of Lyme disease. I wrote about how a tick bite is sometimes not apparent and if Lyme disease is not stopped in time, chronic Lyme disease can develop and be a long-lasting medical nightmare.
So as soon as I read about a new vaccine, I went for the injections.
But not long after I got the shots, LYMErix was taken off the market by its manufacturer following complaints of adverse reactions in some people, notably their developing arthritis after being vaccinated. A group of 121 individuals brought a class action lawsuit in 1999 citing this. 1999. The SmithKline Beacham settled the lawsuit in 2003. “The plaintiffs didn’t receive any compensation,” reported Newsweek, “because their attorney said SmithKline Beacham’s voluntary removal of LYMErix from the market was sufficient enough.”
“If You’ve Had Lyme Disease, Blame the Anti-Vaxxers,” screamed the headline of the investigative magazine Mother Jones last month. “Lyme disease has been spreading for years, and thanks to global warming it’s poised to explode over the next few years,” its article began.
“Influenced by now-discredited research … activists raised the question of whether the Lyme disease could cause arthritis. Media coverage and the anti-Lyme-vaccination groups gave a voice to those who believed their pain was due to the vaccine, and public support for the vaccine declined,” said Mother Jones. “But there was a control group — the rest of the U.S. population. And when the FDA reviewed the vaccine’s adverse event reports in a retrospective study, they found only 905 reports for 1.4 million doses. Still, the damage was done, and the vaccine was benched.”
The Mother Jones piece concluded: “All of you who have had Lyme disease should know this. You could have avoided it if not for the ravings of the anti-vax nitwits and the gullibility of the mainstream TV talkers who give them a platform. It’s long past time to put an end to this idiocy.”
The Mother Jones article also quoted Dr. Stanley Plotkin, an emeritus professor of the University of Pennsylvania who developed the rubella vaccine and co-invented vaccines for rabies and rotavirus. Dr. Plotkin was cited, too, in a recent editorial in the New England Journal of Medicine—considered among the finest medical journals—stating that the absence of a Lyme disease vaccine is “the worst recent failure to use an effective vaccine.”
I’m of a generation that still remembers fear of polio. I recall the concerns about polio in Boy Scout camp in the early 1950s. Franklin D. Roosevelt had contracted polio visiting a Scout encampment, also in upstate New York, a few decades earlier. I remember seeing an “iron lung” for the first time — a metal cylinder into which a person with acute polio and extreme difficulty with breathing was placed. And then the Salk polio vaccine arrived and eradicated the polio scourge.