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Lyme disease vaccine is fast-tracked for FDA approval

Lyme disease, also known as Lyme borreliosis, is

Lyme disease, also known as Lyme borreliosis, is transmitted through the bite of an infected blacklegged tick, often called the deer tick. Photo Credit: AP / Victoria Arocho

A vaccine to prevent Lyme disease is being fast-tracked for approval by the U.S. Food and Drug Administration to address what public health officials say is the most rapidly growing vector-borne disease in the United States.

Currently, there is no Lyme vaccine for humans, although one is available for dogs. The human vaccine being expedited for approval by the FDA is known in its preapproval phase as VLA15, a product of French vaccine-maker Valneva. Only 180 participants in a preliminary clinical trial have received the inoculation so far.

Valneva has been authorized to move its research into the FDA’s program called Fast Track. Designated products are aimed at unmet medical needs, agency officials said.

Long Island doctors and those in other regions infested with ticks said a Lyme vaccine would be a welcome addition to the medical arsenal.

“The incidence of Lyme disease has increased dramatically,” said Dr. Benjamin Luft, the Edmund D. Pellegrino Professor of Medicine at Stony Brook University and a specialist in infectious diseases. He said the number of people who have contracted Lyme disease and other tick-related illnesses has risen as the bugs have expanded their range.

Luft, who himself has developed a Lyme vaccine, said that any inoculation aimed at Borrelia burgdorferi — the bacterium that causes Lyme disease — must address the variations seen in the organism. Otherwise, he said, the vaccine is of no benefit to those who receive it.

Luft’s vaccine was licensed to the Illinois-based Baxter pharmaceutical company, but the license now is held by Shire Plc, he said.

Shire, with headquarters in Dublin, Ireland, acquired Baxter’s biopharmaceutical division last year.

Valneva officials, meanwhile, said their vaccine appears to be effective against the six most common types of B. burgdorferi that are prevalent in the United States and Europe. Under the fast-track designation, the company will advance to a larger clinical study of the vaccine early next year.

The expedited approach with fast-tracked therapies, such as the Lyme vaccine, means the FDA will accept less data for approval and that studies of the vaccine can continue after it goes on the market.

Lyme disease, also known as Lyme borreliosis, is transmitted through the bite of an infected blacklegged tick, often called the deer tick. The bug is a parasite of the white-footed mouse, whose populations have exploded on the Island, especially in recent months.

Early Lyme symptoms include a rash that gradually expands and a constellation of other, less specific ailments — fever, a stiff neck, joint pain and fatigue. Antibiotic therapy can effectively treat the infection in a majority of patients.

One of the most basic problems in the Lyme disease dilemma, experts said, is the mounting number of patients. The national Centers for Disease Control and Prevention now suggests the actual number of diagnosed cases may be 10 times higher than reported by states across the country. The agency estimates 300,000 cases occur annually nationwide based on a variety of factors, even though their actual tally is 30,000.

In New York, there were 3,252 confirmed cases of Lyme disease in 2015, the most recent year for which there are complete statistics, according to the state Department of Health. About one-fifth of those cases — 669 — occurred in Suffolk County, the Island’s epicenter of Lyme and other tick-borne infections.

Concern about ticks and the illnesses they cause have been quantified in other quarters of the medical community as well. Calls to the Tick-Borne Disease Resource Center at Southampton Hospital, for example, jumped 46.6 percent from 2015 to 2016, according to the hospital’s website.

The CDC defines Lyme as the fastest-growing vector-borne disease in the United States. More people come down with tick-transmitted Lyme than diseases borne by fleas, mosquitoes or any other biting insects. Lyme disease cases are concentrated along the Eastern Seaboard and throughout portions of the Midwest, experts said.

“It’s a serious public health concern,” Dr. Alan Bulbin, director of infectious diseases at St. Francis Hospital in Flower Hill, said of Lyme disease during an interview last week.

But Bulbin questioned the value of an inoculation that offers protection against only one of the pathogens carried by ticks.

“Lyme captures most of the media attention, but you potentially can get Lyme, anaplasmosis and babesiosis — the big three — all from one tick bite. So there are other infections that can make you acutely sicker than Lyme disease,” he said.

Like Lyme, anaplasmosis is a bacterial infection that causes headaches, muscle pain and fatigue. The infection can prove fatal for some people. Babesiosis is a debilitating parasitic infection that zeros in on red blood cells and causes a malarial-like disease, which also can be fatal in some cases.

Dr. Luis Marcos, an associate professor of clinical medicine in Stony Brook’s division of infectious diseases, is working on a project led by Luft that routinely studies the blood of 250 outdoor workers on the East End. The aim is to assess their exposure to ticks.

Marcos said he agrees with Bulbin: A vaccine against Lyme alone offers only a fraction of the protection needed by those who are exposed to ticks.

“A Lyme disease vaccine is important,” Marcos said. “But it is also important to recognize other tick-borne diseases.”


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