Scientists and pharmaceutical companies are racing to develop a human vaccine for Lyme disease, but increasing vaccine skepticism more broadly has some advocates concerned that politics will stand in the way of new Lyme vaccines advancing.

Lyme disease, the most common vector-borne disease in the United States, is not life-threatening and is treatable if detected early, but it can have devastating neurological and autoimmune consequences long term, including chronic pain, arthritis, and severe headaches. 

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The Centers for Disease Control and Prevention estimates between 300,000 and 500,000 people contract Lyme disease annually in the U.S., but these statistics are largely based on suspected cases, as opposed to confirmed infections. The vast majority of cases are in the north and mid-Atlantic coast and the northern Midwest.

Pfizer is likely to be the first to have a long-awaited vaccine ready for market within the decade, with some advocates expecting it to be ready for Food and Drug Administration approval by 2027.

But scientists in the field are concerned that changes to vaccine policy from Health and Human Services Secretary Robert F. Kennedy Jr., a longtime skeptic of vaccines, as well as rising anti-vaccine sentiment since the COVID-19 pandemic, could jeopardize the chances of a new Lyme vaccine getting to market.

Richard Marconi, professor of microbiology specializing in tick-borne diseases at Virginia Commonwealth University, said he is “absolutely” worried. 

“I am very concerned about the current political climate as it pertains to Lyme disease and vaccines in general,” said Marconi.

A complex bacterium

Part of the reason it has been a struggle to develop a human Lyme disease vaccine is that the bacteria, Borrelia burgdorferi, have proven difficult to research.

Marconi told the Washington Examiner that the Lyme bacteria essentially mutate when traveling between ticks and humans as the tick takes a blood meal when it bites. Marconi likened the bacteria’s adaptation process to a human changing their clothes depending on the weather.

“If we go outside on the coldest day in the winter, we’re going to wear different clothes than we wear if we go outside on the hottest day in the summer,” Marconi explained. “So we change our coat, so to speak, to adapt to the environment.”

The bacteria that cause Lyme disease do the same thing by producing different external proteins, known as outer surface proteins, depending on whether it is living in a tick or a mammal. This has been a point of difficulty that vaccine makers have struggled with for years.

The nature of the bacteria and how they grow once they infect a human has also made it difficult to develop diagnostic tests for Lyme disease. 

Borrelia burgdorferi doesn’t grow easily in a lab, said Andrea Love, immunologist and head of the American Lyme Disease Foundation. Love told the Washington Examiner that the microbiological properties of the Lyme-causing bacteria make it such that scientists haven’t been able to develop rapid tests to diagnose infections, like they have for flu, COVID-19, and other infections. 

“These bacteria, they exist in low numbers. There isn’t a region of the body you can swab. You can’t really grow it that easily, and so there’s not a lot of precise methods where you could assess for different components of the bacteria,” said Love. 

Both Love and Marconi said that developing rapid diagnostic tests for Lyme disease is just as important as getting a vaccine to market, since Lyme is relatively easy to treat with common antibiotics if caught early.

Pfizer’s almost there

The duo of Pfizer and French biotech firm Valneva is the closest to getting their Lyme disease vaccine for humans to market, with late-stage clinical trials taking place in New England, the Midwest, and parts of Northern Europe where Lyme is endemic. 

Pfizer’s vaccine works by targeting a specific protein dominant on the bacteria’s surface while it is still in the tick, called outer surface protein A, or OspA.

Human antibodies for OspA that are created after taking the vaccine are designed to be ingested by the tick when it takes a blood meal as it bites the human, a Pfizer spokesperson told the Washington Examiner. 

“Binding of vaccine-induced antibodies to OspA on Borrelia inside the tick inhibits the bacterium’s ability to leave the tick, preventing it from being transmitted to the host and causing infection,” said the Pfizer spokesperson. 

Marconi, who is working on his own version of a Lyme vaccine at his lab at VCU in Richmond, Virginia, said that, to maintain a high enough level of antibody production for OspA, a patient will need multiple booster shots of the Pfizer vaccine within the first year.

The vaccine Marconi and his team are working to develop induces a different type of antibody to attack the outer surface protein found on the Lyme bacteria once it adapts to the environment of the human host, or OspC. The goal for their product is to only need one shot to provide immunity, but the team is still in the early research phases. 

Other researchers at different institutions are working on other mechanisms to prevent Lyme disease, such as monoclonal antibody treatments. Marconi said the more the merrier.

“Any vaccine that works will be welcome, and that’s an important step, and it’s very important to have multiple vaccines available. You don’t want to put all your eggs in one basket, so to speak,” he said.

Vaccine skepticism as a stumbling block

Advocates in the Lyme disease community have expressed concerns that rising rates of vaccine skepticism could hinder the development of a new Lyme vaccine in the next few years. 

Those concerned point to vaccine skepticism and anti-vaccine rhetoric surrounding the first Lyme disease vaccine, LYMErix, approved by the FDA in 1998. LYMErix, made by what today is GlaxoSmithKline, or GSK, was voluntarily pulled from the market in 2002. 

The company cited a lack of market interest at the time that made production no longer financially viable as the reason for withdrawing, but there were also a plethora of reports of vaccine injuries and side effects from LYMErix, including claims of vaccine-induced arthritis. 

The FDA’s post-market review of LYMErix found no evidence that those who received LYMErix developed arthritis at a higher rate than the general population, but GSK in 2003 settled a class action lawsuit for about 100 patients who blamed the vaccine for lingering health problems.

Love said that the blowback against LYMErix coincided with rising skepticism of vaccines in general following the release of falsified data about a connection between the measles vaccine and autism, published by Andrew Wakefield in the medical journal the Lancet in 1998.

“People were really kind of looking to target, really any vaccine, and particularly new vaccines like this,” said Love. “And this was not a super well-known disease at the time. There wasn’t a lot of information.”

In the early 2000s, Kennedy was a strong proponent of the now-debunked connection between autism and the measles vaccine. Now, as HHS secretary, he’s made significant changes to the primary vaccine safety review panel, discontinued mRNA vaccine development grants, and more.

Kennedy wasn’t directly involved in advocacy or litigation against LYMErix, but advocates are worried that new Lyme vaccines could face similar anti-vaccine obstacles that LYMErix faced with Kennedy at the helm of HHS. 

“Because of misinformation floated about vaccines in general and specifically about the measles vaccine, there has been a very significant decline in people getting vaccinated. That is a shame,” said Marconi. “Vaccines are the most cost-effective way to deal with infectious diseases.”

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HHS spokesman Andrew Nixon told the Washington Examiner that when Pfizer’s Lyme vaccine comes to market, ensuring it is safe and effective is of paramount importance.

“With all drug approvals, the FDA will ensure the gold-standard of science is used for these decisions. We will make sure that any product that is headed to the market is safe and effective,” said Nixon.