Novel mRNA Lyme Shots Could Be Released in 2025

Two novel messenger RNA (mRNA) shots for Lyme disease currently in late-stage clinical trials could hit the market as early as 2025, Moderna announced earlier this year. Also in the race to develop the first-ever mRNA product to prevent Lyme disease are Pfizer and Austria-based Valneva, which entered into a collaborative agreement in April 2020 to develop VLA15, another mRNA technology contender to combat the disease caused by deer or blacklegged ticks.^{1 2}

The latest race to develop mRNA based products described as “vaccines” comes only two years after Pfizer/BioNTech’s Comirnaty COVID-19 shots became the first-ever mRNA product to be released to the public by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) in 2020, and then be fully licensed for adults and teenagers in 2021.³

Cases of Lyme disease continue to skyrocket in the United States Some scientists suggest that climate change is largely to blame for the proliferation of tick life and rising Lyme cases which have doubled in the U.S. and even tripled in some high-risk countries since 2000. But the road to developing the first-ever mRNA vaccine to combat Lyme disease is filled with controversy and safety concerns.^{4 5}

“Good Clinical Practice” Violations Halt Phase 3 Clinical Trial for VLA15 Vaccine

Almost half of the 18,000 participants enrolled in Pfizer and Valneva’s Phase 3 clinical trials for their new VLA15 were removed following Good Clinical Practice (GCP) violations in February 2023, resulting in a major setback for the Lyme vaccine contenders. While a press release issued by the pharmaceutical partners did not disclose which GCP violations occurred, some of the most common GCP violations in pharmaceutical clinical trials include protocol adherence; confirming clinical records warrant study participants’ involvement; informed consent; safe drug handling and storage conditions, and expeditious adverse event reporting.⁷

In a Feb. 17, 2023 press release, Pfizer and Valneva attributed the GCP violations to a third-party clinical trial site operator.

Valneva Funds Safety Study for Its Own Lyme Vaccine

The study conducted to determine the safety and efficacy of the new VLA15 vaccine was funded by Valneva. Considering that as many as one-quarter of clinical trials might be flawed or even entirely made up, according to some researchers, pharmaceutical companies funding studies for the products they manufacture adds yet another layer to the growing public mistrust of the medical and pharmaceutical industries.^{7 8}

But this is not the first time ethical concerns have plagued pre-licensure clinical trial results for product, which were later approved by the FDA. In an effort to speed up FDA approval of its blockbuster arthritis drug Vioxx, Merck manipulated the science and hid evidence that the drug increased patients’ risk of heart attacks. After an alarming 88,000 people suffered heart attacks after taking Vioxx and 38,000 people died, the drug was eventually withdrawn from the market in 2004, five years after the FDA gave the Merck the green light to put Vioxx on the market.⁹

As with most vaccine safety studies that do not use a double-blind placebo—which is considered the gold standard in medical research—control group participants in the study for VLA15 were given an aluminum adjuvant. According to the U.S. Centers for Disease Control and Prevention (CDC), adjuvants are used in vaccines to elicit a stronger immune response in people receiving a vaccine.

Aluminum is a known neurotoxin. Aluminum salts (aluminum hydroxide, aluminum phosphate and alum) have been a widely used adjuvant in inactivated vaccines for the past 80 years; yet how aluminum adjuvants work once injected and which adverse effects they may cause are still largely disputed today. Still, from local symptoms like pain and swelling to more serious adverse effects like encephalopathy (swelling or inflammation of the brain, which can lead to chronic neurological dysfunction), the outcomes of aluminum adjuvants are widely documented in years of medical research. It is clear that an aluminum adjuvant is not a true placebo and has not been proven safe when injected intravenously.^{10 11}

Previous Lyme Vaccine LYMErix Taken Off Market in 2002

LYMErix, the only previous Lyme vaccine introduced in the U.S., was discontinued in 2002 after a class-action lawsuit alleged that the vaccine sickened recipients and caused autoimmunity, including arthritis. Over 900 adverse-event reports cited a wide variety of symptoms ranging from swollen joints, a aching muscles and extreme fatigue to more serious rheumatologic, neurologic, and autoimmune adverse effects.¹²

“It wasn’t a perfect vaccine, but it was good,” said Eugene Shapiro, MD, professor of epidemiology and investigative medicine at the Yale School of Medicine, of the vaccine that had a 75 percent efficacy rate. In voluntarily pulling LYMErix off the market in 2002, the vaccine’s manufacturer, GlaxoSmithKline, only cited a lack of consumer demand rather than admitting public concern about the vaccine’s serious side effects and vaccine injury lawsuits played a role.^{13 14}

In July 2003, GSK settled the class action suit. The agreement included $1 million for legal fees for the prosecuting attorneys but no compensation for the plaintiffs. The prosecuting attorneys expressed that the voluntary withdrawal of LYMErix from the market was the primary focus of the lawsuit.¹⁵

Study Found Herbal Remedies Proved Effective Against Lyme

Apart from vaccinating for Lyme disease, antibiotics and a number of herbal remedies have been found to effectively kill the bacterium that causes Lyme. A Johns Hopkins University study touted seven herbal medicines—Black Walnut, Cat’s claw, and Chinese skullcap, to name a few—which killed B. burgdorferi, the name of the bacterium transmitted to humans through tick bites, in test tubes.

“Because patients are currently turning to herbal remedies to fill the treatment gaps left by antibiotics, this research is a critical step in helping clinicians, as well as patients, understand which ones may offer the most potential benefit,” said the study’s co-author Sunjya Schweig, MD, who is founder and president of the California Center for Functional Medicine (CCFM) and an advisory board member of the Bay Area Lyme Foundation.¹⁶

According to the CDC, Lyme disease is the most common vector-borne (or disease caused by parasites) disease in the U.S. Rarely life-threatening, typical symptoms include fever, headache, and fatigue and accompany a characteristic skin rash called erythema migraines. Untreated infections can spread to joints, the heart, and the nervous system. However, most cases of Lyme disease are treated successfully with antibiotics.¹⁷

Other advanced development projects to combat Lyme disease currently in the pipeline include Mass Biologics’ monoclonal antibody, the Lyme Pre Exposure Prophylaxis (Lyme PrEP), and another mRNA vaccine developed by Yale University researchers that identifies a tick’s saliva and prompts a skin reaction that repels the tick from attaching and feeding. The treatments could see late-stage clinical trials and hit the market as early as 2025.^{4 18}

The global market for a Lyme vaccine is estimated at just under $100 million a year, promising pharmaceutical companies their next payday after demand for vaccines and other COVID drugs plummeted this year.¹⁹

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