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New Effort for Lyme Disease Vaccine Draws Early Fire

The Wall Street Journal. logo The Wall Street Journal. 7/9/2018 Sumathi Reddy

Efforts to bring a vaccine for Lyme disease to the market have run aground amid heated debate over the years.

Now, a European company is in the early stages of creating a vaccine for the increasingly common tick-borne disease. Lyme disease patient-advocacy groups—who disagree with the protocols used by most doctors for the diagnosis and treatment of Lyme disease—are already raising concerns.

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The Centers for Disease Control and Prevention estimate that there are more than 300,000 new cases of Lyme a year, about triple the rate from two decades ago. Most cases are in the Northeast, mid-Atlantic region and Upper Midwest states, but the disease is spreading across the country.

When blacklegged or deer ticks infected with the Borrelia burgdorferi bacterium bite humans, they can transmit Lyme disease, which typically causes flu-like symptoms such as a fever, headache, muscle and joint aches, and sometimes a ring-like skin rash. If untreated, the infection can spread and cause more serious health problems, including arthritis, heart palpitations and brain inflammation.

Ticks that transmit Lyme disease can also transmit other pathogens causing less-common diseases such as anaplasmosis and babesiosis.

In March, Valneva SE, a company based in France, announced initial Phase 1 clinical trial results after testing its proposed vaccine in 180 healthy adults who took the vaccine with no serious side effects. The study also showed that the vaccine stimulated an immune response, says David Lawrence, chief financial officer of the company.

Later this year it intends to start a Phase 2 clinical trial to determine the dosing of the vaccine. The U.S. Food and Drug Administration granted the vaccine candidate a fast-track status last year. Still, Mr. Lawrence estimates that it will take at least five years for a product to be commercially available.

The vaccine is similar to Lymerix, the vaccine that was manufactured by SmithKline Beecham, now GlaxoSmithKline, from 1998 until it was withdrawn from the market in 2002. The vaccine had a 78% efficacy rate after three doses were taken. The company voluntarily withdrew it after class-action lawsuits that alleged it caused side effects such as arthritis. The lawsuits were settled in 2003 with the company agreeing to pay attorney fees and costs associated with the cases.

“Lymerix was approved by FDA in December 1998 and was voluntarily discontinued in February 2002 due to low demand,” says a spokeswoman for GSK. “Currently there are no plans to bring it back.”

The data evaluated by the FDA supported the safety and effectiveness of Lymerix, the agency says.

Mr. Lawrence of Valneva says there are two main differences with the French company’s proposed vaccine. One, it protects against six strains of Lyme disease, whereas the old vaccine protected against only one, he says. And, to assuage concerns about side effects, the company cut a gene sequence in the vaccine that had been identified in some scientific papers as possibly related to arthritis—though no evidence emerged of arthritis related to the vaccine.

The company intends to test the vaccine in children as well as adults.

Lyme disease patient-advocacy groups—a powerful lobby that experts say has stopped previous vaccine efforts—are raising doubts.

“The last Lyme vaccine that came out had significant safety concerns,” says Lorraine Johnson, CEO of LymeDisease.org, a nonprofit patient advocacy group. “The feeling in the community is that whoever is going to be putting together [a vaccine] ought to be dialoguing with the community and ought to be transparent about the process.”

Ticks can cause co-infections and other diseases and the vaccine may offer a false sense of complacency, she says.

“We don’t feel that there has been enough research done to answer the questions as to what occurred with the prior vaccine,” says Patricia Smith, president of the Lyme Disease Association Inc., a New Jersey-based national nonprofit group, which raises money for Lyme research, education and patient support. “The vaccine that is now in development is something with the same base. There were a lot of patients that thought they were harmed from that vaccine. It’s very problematic.”

Many doctors and medical experts say there was never any evidence that the old vaccine caused serious side effects such as arthritis or neurological problems. They say a vaccine would greatly limit the spread of Lyme disease.

“There’s a lot of general tick prevention advice, such as using DEET and other insect and tick repellent, doing tick checks, and wearing long trousers and long sleeves. But despite that we still have abundant cases of Lyme disease every year,” says Paul Auwaerter, a professor of medicine at Johns Hopkins University School of Medicine and president of the Infectious Diseases Society of America.

It makes sense to have a vaccine for people in parts of the country where Lyme disease rates are high and for people who are outdoors a lot, he says.

Gregory Poland, director of the vaccine research group at Mayo Clinic in Rochester, Minn., published a 2011 study in the journal Clinical Infectious Diseases detailing what happened with the previous Lyme vaccine and lessons learned from it.

Lymerix, he says, “was actually very effective” but multiple factors led to its withdrawal.

The vaccine required taking three shots over a year and took two tick seasons to become effective, he says, and then would require periodic booster shots. Also, it couldn’t be used in children. The recommendations for taking the vaccine were vague, so it was unclear who should get it and insurance companies weren’t required to cover its cost. But anti-vaccine sentiments ultimately did it in, he says.

“In this country you can protect your dog with a vaccine for Lyme disease but you can’t protect yourself or your child,” says Dr. Poland. “We have a public health problem in this country with a disease that has short-, mid- and long-term consequences and for which all other prevention methods are wholly inadequate.”

Several Lyme disease vaccines similar to Lymerix are available for dogs.

Sam Telford, a professor of infectious disease and global health at Tufts University, helped discover the mechanism that led to the development of Lymerix and ran one of the clinical trials that tested it.

He is now part of a group of biotech professionals who have formed an alliance and want to bring back the vaccine and distribute it as a nonprofit.

“There’s a lot of legal issues that may prevent reviving the product as a generic,” he says. “There are many things that we can do to prevent Lyme disease but there’s nothing like a vaccine to reduce the incidence of any infection.”

Write to Sumathi Reddy at sumathi.reddy@wsj.com

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