A new Lyme disease vaccine could be available next year. Will it be another flop?

A pharmaceutical giant is developing a vaccine it hopes will be a powerful weapon against Lyme disease as soon as next year, as cases of the serious tick-borne illness increase on Long Island and across parts of the Northeast. But growing vaccine hesitancy could stand in the way of public acceptance.

If this sounds familiar, that’s because it is.

In the late 1990s, a Lyme disease vaccine called LYMErix rolled out to great fanfare only to be pulled from the market a few years later by the manufacturer. Some people who received the vaccine complained of side effects. But even after the Food and Drug Administration said the vaccine did not cause any injury, public opinion had turned.

This time, New York-based Pfizer Inc. and the French firm Valneva hope the outcome will be different.

The partnership has developed a Lyme vaccine called VLA15 that is finishing up its clinical trials and could be up for FDA approval as early as 2026.

Experts say the scope of Lyme disease’s impact on the population and its serious symptoms have changed the landscape since LYMErix was introduced. While first concentrated on the East End of Long Island, Lyme disease cases — which can cause serious symptoms including rash, fatigue, joint pain, facial paralysis and meningitis — are now found throughout Suffolk and Nassau. That comes as deer ticks, also known as black-legged tickets, which carry the bacteria that causes Lyme disease, have spread.

"It was called the ‘yuppie vaccine’ because it was kind of viewed as a vaccine of luxury, and that only people of means were really at risk of getting Lyme disease," said Dr. Andrew Handel, a Stony Brook Children’s Hospital pediatric infectious disease specialist who has a focus on tick-borne illnesses. "I don’t think anyone views Lyme disease that way anymore ... It’s a problem for everyone across large swaths of land."

The Centers for Disease Control and Prevention said more than 89,000 cases of Lyme were reported nationally in 2023. More than 21,000 were reported in New York, including 3,299 in Suffolk County and 697 in Nassau County. In all those areas, cases increased over 2022, when the CDC and epidemiologists revised how Lyme disease cases were counted, so prior years are not comparable.

Experts said the actual number of cases is likely much higher — the CDC estimates that 476,000 people each year could be diagnosed and treated for Lyme disease in the United States.

"We see a lot of tick-borne illnesses," said Dr. Michael Huang, chief of infectious diseases at Peconic Bay Medical Center in Riverhead. He would like to see a vaccine available.

"I would tell my patients to consider it because we have a lot of business from Lyme disease,  and we don't need that kind of business," he said.

A rise in vaccine hesitancy — caused by a number of factors including COVID-19 pandemic mandates and the spread of misinformation — could impact a rollout of the new vaccine.

"I’ve spoken with some families who live in the far eastern part of Long Island who desperately want a Lyme disease vaccine so they don’t need to be as worried about tick bites," said Handel. "Other families have no interest, saying they would never want their child vaccinated with a Lyme disease vaccine ... There are a lot of strong emotions out there."

Rocky history

The late 1990s was a tough time to sell the idea of a new vaccine. A London doctor had made waves with a medical journal article claiming there was a link between some childhood vaccines and autism. His methods did not stand up to scientific standards and the article was eventually retracted, but its impact remains to this day.

At the same time, Rotashield, a new rotavirus vaccine had been unveiled, designed to protect babies and young children from the illness that causes severe vomiting and diarrhea. It was found to cause an intestinal blockage that could be life-threatening in some infants and was discontinued.

This was the backdrop for the introduction of LYMErix in 1998.

A 2006 article in the journal Epidemiology and Infection titled "The Lyme vaccine: a cautionary tale" outlines some other issues facing LYMErix: The vaccine required three doses and possibly follow-up boosters; even with a 76% reduction of Lyme disease among vaccinated people, the remaining 24% of people who took it could still get Lyme disease. Finally, it may have made people think they didn’t need to limit their exposure to ticks, the authors said.

People who were vaccinated complained about side effects, such as arthritis, and more than 100 people sued manufacturer SmithKlineBeecham, which later merged into GlaxoSmithKline, in a class-action suit. The FDA and other researchers found people who received the vaccine had no greater risk of developing these symptoms than those who were not vaccinated. Even so, public interest in the vaccine dropped and the company stopped production. They settled the lawsuit by agreeing to pay for the plaintiffs' attorney fees but denied any wrongdoing and did not pay damages.

John Gilmore, of Long Beach, who heads the Autism Action Network, said though he has "long-standing issues with American vaccine licensing policies," including how they're approved, he does not have a position on the Lyme disease vaccine currently being developed.

Dr. Luis Marcos, an infectious disease expert and researcher with Stony Brook Medicine who treats many patients with Lyme disease and other tick-borne illnesses, said he believes people will have a different attitude toward a new Lyme disease vaccine than with other vaccines.

"People are definitely interested in this vaccine — more than the flu, more than the COVID vaccine," he said. "And it’s a different vaccine than the previous one."

Participants in the clinical trial received a primary series of three doses — the initial dose, another after 2 months and a third between 5 and 9 months later. In addition, they received a booster dose one year after the third dose.

Mixed feelings on vaccines

Many Long Islanders who spoke with Newsday said they were open to getting a Lyme disease vaccine but also understood why others might have reservations.

"I think outdoors people would definitely be interested" in a vaccine, said Tim Cody, a Manorville resident who founded Long Island's East End Hiking Group. "They don’t want to have to worry about ticks, and that is our biggest worry."

He plans the group’s activities, in part, to avoid the warm months when ticks are most active.

Richard Byrnes, an 81-year-old retired police detective from East Yaphank, said he makes sure his husky, Sammy, takes his medication that repels ticks and protects against Lyme disease. Byrnes said he has no interest in getting the vaccine himself.

"It’s always been that way with me," Byrnes said while watching his dog at Blydenburgh County Park's dog park in Smithtown. "I don’t get any shots."

Alexandra Placide, of Bay Shore, said she is careful to protect herself and her dog, Gracie, from ticks when they go to Gardiner County Park in Bay Shore. Gracie is also vaccinated against Lyme disease.

If there were a vaccine for humans, Placide would get it too.

"If it was available and approved by the FDA — for sure," she said.

Newsday's Lauren Zola contributed to this story.

Sources: Centers for Disease Control and Prevention, New York Department of Health¶*In 2022, the CDC and an epidemiologist group revised how Lyme disease cases were counted.