Tag: lyme disease

Lyme Vaccine Clinical Trials: History Repeating?

Why is there so much controversy surrounding Lyme disease? Why does it seem you can’t get an accurate Lyme disease test?

The State of Lyme

The incidence of Lyme disease is approaching half a million cases per year in the United States, according to a 2021 Centers for Disease Control & Prevention (CDC) report based on data from commercial insurance claims. Yet fewer than 40,000 cases are reported to the CDC in any given year, exposing a massive discrepancy between the actual prevalence of the disease and the few cases that meet the CDC’s surveillance reporting definition.

Despite its alarming incidence rate and often catastrophic effects on human health, there has been little advancement in diagnostic and therapeutic technologies for Lyme in the last 40 years. The CDC and Infectious Diseases Society of America (IDSA) continually support only the use of outdated serological techniques that are known to be inadequate, while simultaneously acknowledging that better tests are needed. The reasons for such double-speak and neglect are inextricably intertwined with the sordid history of Lyme disease vaccines.

Lyme vaccine development has continued for the last three decades despite evidence that the causative organism—the spirochetal bacteria Borrelia burgdorferi—evades immunity in multiple ways that may make it impossible for a vaccine to prevent infection. The most recent effort, a candidate known as VLA-15 from Pfizer and French biotech Valneva, is now in phase III trials. Last February it was revealed that due to alleged violations of good clinical practice, Pfizer had shut down all trial sites run by contractor Care Access, eliminating roughly half of the enrolled participants.

Pfizer’s record of “engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results” may alone warrant suspicion about their recent actions. But in the context of a Lyme vaccine, suspicion should be heightened. The last Lyme vaccine on the market, SmithKline Beecham’s LYMErix, was withdrawn in 2002 amid numerous injury claims, federal agency hearings, and class action lawsuits. Which begs the question, is history repeating?

Stepping back three decades

In June 1994, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) devoted a lengthy meeting to the three companies that had Lyme vaccines in development. According to the official meeting transcript, the primary order of business was to answer the question, “Is the CDC case definition for Lyme disease appropriate for a pivotal efficacy trial?”

Why would this even be a question? The standard diagnostics at the time—mainly the ELISA, a serologic assay that measures antibodies produced against the bacteria—were known to produce a large proportion of false negatives. When the CDC discontinued routine testing of samples in its labs in 1988, it stated in a letter to the Oregon Public Health Laboratory that the sensitivity of the ELISA ranged from 13% to 27% in clinically recognized cases. Obviously, this would hamper any trial operator’s ability to assess possible Lyme infection and the vaccine’s overall effectiveness. If you can’t diagnose cases, how can you determine whether your vaccine works?

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CIA accused of secret bioweapon experiments linked to major outbreak in its own people

A biochemist has claimed to have found evidence that the modern Lyme outbreak in the US could have been the result of CIA bioweapon experiments.

Dr Robert Malone, who helped lay the groundwork for mRNA vaccine technology, made the explosive allegations this week after analyzing declassified government documents, historical records from Cold War biological weapons programs and scientific research on tick-borne diseases.

Malone highlighted experiments in the 1960s that allegedly released more than 282,000 radioactive ticks in Virginia and open-air tick research at Plum Island, a federal laboratory located near the Connecticut community where Lyme disease was first identified.

The experiments were designed to track how disease-carrying ticks spread through the environment, with scientists marking the parasites using radioactive Carbon-14 so their movements could be detected with Geiger counters, a portable, gas-filled instrument. 

Malone’s report argued the research was part of a much larger Cold War biological weapons program known as Project 112, which involved dozens of secret tests aimed at studying how insects could be used to spread pathogens.

The program, authorized by Defense Secretary Robert McNamara in 1962, oversaw 134 planned tests and included facilities capable of breeding millions of infected insects each week.

According to the report, the same region where these experiments took place later experienced an unprecedented surge in tick-borne illnesses.

Malone’s claims follow calls from US officials to investigate whether federal agencies experimented with pathogen-laden ticks as tools of war.

In December 2025, an amendment by New Jersey Representative Chris Smith called for a review of military, NIH and USDA projects from 1945 to 1972 involving Spirochaetales and Rickettsiales, bacteria linked to tick-borne diseases. 

Health and Human Services Secretary Robert F Kennedy Jr has also suggested Lyme disease may have originated from a failed US bioweapons program in the 1970s tied to research at Plum Island. 

Plum Island is an 840-acre island off the northeastern coast of Long Island, New York, and home to the Plum Island Animal Disease Center, a government lab used since the 1950s to study infectious animal diseases.

However, the Department of Homeland Security has repeatedly said Lyme disease was never studied at the facility.

Malone’s report also claims key research into a second tick-borne pathogen may have been suppressed.

He alleged the government sidelined research on a pathogen known as the ‘Swiss Agent,’ which was detected in Lyme patients in Europe during the 1970s.

Malone, an expert in biology who earned multiple degrees at the University of California, also accused the government of suppressing research on a second disease called the ‘Swiss Agent’ found in Lyme patients in Europe in the 1970s.

Unpublished papers from Willy Burgdorfer, the scientist who discovered the bacterium that causes Lyme disease, suggested the pathogen complicated treatment because it triggered persistent symptoms that did not respond to standard antibiotics. 

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Declassified Documents Link U.S. Bioweapons Program to Lyme Disease Outbreak

An extensive investigation based on declassified government documents and previously suppressed scientific research has uncovered compelling evidence that U.S. biological weapons programs contributed to the emergence of Lyme disease, which now affects hundreds of thousands of Americans annually.

The investigation reveals a pattern of concealment spanning six decades, including the systematic suppression of critical medical research and the release of nearly 300,000 radioactive ticks across Virginia to study how the disease-carrying insects would spread.

CIA Deployed Infected Ticks Against Cuba

Declassified documents and testimony from a CIA operative describe the 1962 deployment of infected ticks against Cuban sugarcane workers as part of Operation Mongoose, the Kennedy administration’s effort to destabilize Fidel Castro’s regime.

The operative, now in his seventies, told researchers that the “strangest thing he ever did was drop infected ticks on Cuban sugarcane workers” using C-123 transport aircraft flying nighttime missions “almost skimming the surface of the Caribbean to avoid Cuban radar.”

After returning from Cuba, the operative’s four-month-old son developed life-threatening fever requiring emergency surgery. His CIA commander advised him to “burn all the clothes you took to Cuba. Burn everything,” indicating contamination concerns.

The deployment was canceled when “Cuba’s shifting winds made accurate payload delivery difficult,” according to the operative’s account.

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