Tick target: New Lyme vaccine in clinical trials
If you can’t easily eradicate ticks or rid the Island of their deer hosts, the medical community has returned to a Lyme Disease vaccine, now that the numbers of people diagnosed with the disease is exploding.
Not so many years ago it seemed that, from a marketing perspective, it wasn’t worth the gamble to continue selling a vaccine dubbed LYMERix because there were too few seeking the vaccine and too many who might sue manufacturer SmithKline Beecham, now Glaxo SmithKline, because of possible side effects.
But today it appears a vaccine is more viable, according to researchers at Stony Brook University, Brookhaven National Laboratory and the drug manufacturer Baxter International.
It’s not LYMERix that researchers are trying to resuscitate, but a new vaccine the developers are testing in clinical trials in Europe.
Results of those trials revealed a new vaccine to be “promising and well tolerated,” according to report published by the prestigious medical journal, Lancet Infectious Diseases in May 2013.
“The vaccine was shown to produce substantial antibodies against all targeted species of Borrella, the causative agent of Lyme disease in Europe and the United States,” according to Stony Brook University Hospital.
SBUH professor Dr. Benjamin Luft, who has been working with BNL and Baxter on creating a vaccine since the early 1990s, credited the late biologist, John Dunn of BNL, with breakthroughs in circumventing problems inhibiting development of a viable product.
It’s not an immediate solution, since there are more clinical trials ahead, and there’s the hurdle to get it approved for use in this country. But it provides hope to those dismayed by the 2002 decision by SmithKline to stop selling LYMERix.
“Despite being quite effective in Lyme disease prophylaxis, LYMERix vaccine was withdrawn from the market because of [the] manufacturer’s fear of unsubstantiated anti-vaccine lawsuits in the era of measles/autism hysteria,” said Dr. Vincent DiGregorio, a member of Shelter Island’s Deer & Tick Committee and chief of plastic surgery at Winthrop University Hospital. “If we are unable to control the deer herd and ticks on Shelter Island, perhaps there is hope for prophylaxis, a poor second choice.”
Similar information on the new vaccine, still in clinical trials in Europe, came from Dr. Scott Campbell, laboratory chief in the Arthopod-Borne Disease Laboratory of the Suffolk County Department of Health, also a member of the Deer & Tick Committee; and Marsha Kenny, spokeswoman for Southampton Hospital, which recently launched its own Tick Borne Disease Resource Center of experts primed to educate and treat patients with Lyme and other tick-borne diseases.
The new vaccine won’t treat other tick-borne illnesses, but Lyme is the most frequent illness to affect people bitten by ticks.
That a new vaccine might surface is promising for veteran journalist Karl Grossman, whose column “Sufolk Closeup” appears weekly in the Reporter. Mr. Grossman knew he had been bitten sometime in the 1990s by a black-legged tick that carries the bacteria causing Lyme Disease. Concerned, he spoke with his doctor — a man he describes as very cautious about recommending new drugs. The doctor put him on the three-shot series of LYMERix. He never experienced any side effects, nor did he develop any of the often debilitating symptoms of Lyme Disease.
But what used to be the pleasure of rural life for him and his family in Noyac has him anxious these days about taking a stroll in a wooded area, now known to have a heavy tick infestation.
What he knows from his personal experience and his writing about tick borne diseases is that while Lyme might be easily tackled with a round of antibiotics that knock it out of a sufferer’s system, for some, it becomes chronic and can affect the heart and brain, resulting in a patient being “in big, big trouble.”
It’s why Mr. Grossman would happily submit to another vaccine, he said.
The same goes for Shelter Island Town Engineer John Cronin, who developed Lyme Disease long before it became common. He once worked at pharmaceutical company Merck and had some knowledge of how decisions are made to market or pull various drugs.
Even before word of an alternative Lyme vaccine being tested, Mr. Cronin was calling on town officials to encourage U.S. Senators Charles Schumer and Kirsten Gillibrand to introduce legislation to take on the cost of any litigation that might result if LYMERix.
LYMERix arrived on the scene in 1998, but was pulled from the market within four years. There has been no substitute.
Side effects of LYMERix were mainly temporary pain at the injection site. But in rare cases, people pre-disposed to what was called “Lyme arthritis,” could develop the disease, according to a report from the College of Physicians at Philadelphia.
Another threat, though rare, was that LYMERix might cause “intussusception,” a serious disorder in which part of the intestine slides into an adjacent part, possibly blocking the passage of food and fluid, according to the Mayo Clinic.
Intussusception also cuts off the blood supply to the part of the intestine affected and could lead to a tear in the bowel, the Mayor Clinic found. While it’s more common in cases of intestinal obstruction in children younger than three, it can on rare occasions develop in adults, But in most adult cases, it results from an underlying medical condition, such as a tumor. In contrast, the cause of most cases of intussusception in children is unknown, according to the same report.
When LYMERix was prescribed in the United States, it was recommended that the first two injections be given a month apart and then a third injection 12 months later and be administered before exposure to areas where Lyme might be contracted.
It was at a 2002 meeting among Lyme Disease Association members and the United States Food and Drug Administration that warnings were sounded about many doctors administering the vaccine who were not recognizing side effects and misdiagnosing symptoms related to the vaccine as other medical problems.
Ultimately, several reports to the Vaccine Adverse Events Reporting System and threats from various groups fighting to ban LYMERix, convinced SmithKline to cease production rather than fight court battles.
While pharmaceutical houses generally turned away from work on a Lyme vaccine in the wake of LYMERix being pulled from the market, Baxter International continued to work with scientists and doctors at Brookhaven National Laboratory and Stony Brook University Hospital.