New Effort for Lyme Disease Vaccine Draws Early Fire
By 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.
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to Lymerix, the vaccine that was manufactured by SmithKline Beecham, now GlaxoSmithKline, from 1998 until it was withdrawn from the market in 2002.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 firstname.lastname@example.org
- Lymerix was not removed due to “low demand.” It actually caused 229 DEATHS and 43 SUICIDES: https://madisonarealymesupportgroup.com/2018/04/16/vl15-lyme-vaccine-another-fraud/
Death Count listed here (number of each in parenthesis):
- Hypertensive Cardiovascular Disease (54) 1 DAY AFTER THE SECOND DOSE
- Hypertensive & Cardiovascular Arteriosclerotic Disease (63) 3 DAYS AFTER THE FIRST DOSE
- Arthritis, Neurological Symptoms, and Suicided (43) 7 MONTHS AFTER THE 2nd DOSE
- Anemia, Thrombocytopenia, with Myelofibrosis diagnosis (69) 7 MONTHS AFTER THE FIRST DOSE AND DIED 6 MONTHS LATER AN UNKNOW TIME AFTER THE 3rd DOSE
- List of adverse effects (number of each in parentheses): https://madisonarealymesupportgroup.com/2018/01/28/the-secret-x-files-the-untold-history-of-the-lymerix-vaccine/
- ARTHRALGIA (322)
- MYALGIA (227)
- PAIN (196)
- ASTHENIA (167)
- FEVER (126)
- FLU SYNDROME (124)
- INJECTION SITE PAIN (117)
- RASH (85)
One doctor stated that 21 patients developed severe arthritis after receiving the LYMERIX vaccine: http://www.yourlawyer.com/topics/overview/lymerix
Dr. Marks lead the clinical trials for Lymerix’s competitor, the OspA vaccine produced and then abandoned by Aventis Pasteur. He states:
“In my opinion,” he told FDA officials, “there is sufficient evidence that Lymerix is causally related to severe rheumatologic, neurologic, autoimmune, and other adverse events in some individuals. This evidence is such as to warrant a significantly heightened degree of warnings and possible limitations or removal from marketing of Lymerix.” http://www.lymediseaseassociation.org/index.php/about-lyme/controversy/vaccine/261-lymerix-meeting (Go to link for an entire dirty laundry list of shenanigans)
Dr. Stricker writes about the problem with the research here:
Lyme Advocate Carl Tuttle writes about how antibody tests were deliberately stripped of important bands to facilitate vaccine development, leaving many patients unable to ever test positive: https://madisonarealymesupportgroup.com/2018/06/07/the-lyme-vaccine-russian-roulette/ He also points out how principle investigators of Lyme vaccines (Allen C. Steere & Gary Wormser) have flagrant conflicts of interest by sitting on the CDC Lyme guideline panel and purposely matching the definition of the disease to vaccine development.
In a vile cesspool of conflicts of interest are university patent holders, drug companies, and the FDA itself as another patent holder. It generated 40 million dollars before it was yanked. (2008, Drymon) https://madisonarealymesupportgroup.com/2017/07/01/pbs-lyme-vaccine/
- The article states that ticks can transmit other pathogens that cause “less-common” diseases such as anaplasmosis and babesiosis. Yes, they can but no, they are NOT less common. Frankly, no one really knows because as this article states, only 6 are required to be reported. There are 18 and counting diseases transmitted by ticks: https://madisonarealymesupportgroup.com/2018/07/10/we-have-no-idea-how-bad-the-us-tick-problem-is/
- Interestingly, “to assuage concerns about side effects,” they cut a gene sequence that had been identified in some scientific papers as possibly related to arthritis—though no evidence emerged of arthritis related to the vaccine…..yet, VAERS reported 322 people with arthralgia, or JOINT PAIN. I also listed one doctor who personally reported that 21 patients developed arthritis after the vaccine. Hello? Then, 227 reported Myalgia (muscle pain) and another 196 reported generalized pain.
That’s a whopping 745 people with PAIN after the vaccine! 322 with specific joint pain.
- Let’s talk about Sam Telford of Tufts for just a moment. Please see that he regularly publicly speaks out and has vested interests as delineated above by running a clinical trial for Lymerix as well as by forming an alliance to bring the vaccine back. In this rebuttal Zubcevik rebutted by Telford to a talk given by Dr. Nevena Zubcevik, http://www.mvtimes.com/2016/07/13/visiting-physician-sheds-new-light-lyme-disease/ he remarks that there is no research that negates the validity of the “well-known” grace period of 24 hours of tick attachment before the transmission of Lyme Disease. He also believes that two doses of doxy will do the trick and then goes on to remark that ILADS has no expertise with tick biology or tick-pathogen interactions and that their recommendations are opinions with no factual basis. He goes on to talk about things like “negative fitness factor” and that pathogens “go to sleep” during winter months, and that “very elegant, peer-reviewed molecular analysis” exists about heat pulses to bacteria in test tubes.
A wonderful reminder that scientists can be quite guilty of myopia.
It’s also a clear reminder that the Lyme Wars still exist for good reasons.
First, I’m no “tick expert,” but one thing I do know: ticks don’t understand the word “grace.” We also know for sure that some tick-borne viruses can be transmitted in mere minutes. There has NEVER been a study showing minimum attachment time to transmit Lyme or many other pathogens: https://madisonarealymesupportgroup.com/2017/04/14/transmission-time-for-lymemsids-infection/ Also, within that link is the fact that a little girl couldn’t walk or talk within 6 hours of tick attachment. (She’s far from alone)
Dr. Cameron states: “Only been one study (Nadelman et al) on the effectiveness of 1 pill of doxycycline and only found a reduction in the number of erythema migraines (EM) rashes compared to the placebo group. According to him, the IDSA 1 pill of doxy approach started in 2006 despite the fact that three previous prophylactic antibiotic trials for a tick bite had failed.”
According to Cameron, Nadelman’s study had several other limitations:
- “It was not designed to detect Lyme disease if the rash were absent.
- The six-week observation period was not designed to detect chronic or late manifestations of Lyme disease.
- It was not designed to assess whether a single dose of doxycycline might be effective for preventing other tick-borne illnesses such as Ehrlichia, Anaplasmosis, or Borrelia miyamotoi.”
I highly, highly doubt that adding one more pill is going to be any different.
For a great read on why the Lyme Wars exist: https://madisonarealymesupportgroup.com/2018/06/28/the-science-isnt-settled-on-chronic-lyme/