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FDA Gives Green Light to Test Lyme Disease Vaccine on Humans

tick

Valneva’s preclinical study on mice reveal protection against Lyme disease transmitted by ticks among the majority of Borrelia bacteria strains.

Clinical trials for a new Lyme disease vaccine will be conducted in the U.S. and Belgium after the U.S. Food and Drug Administration (FDA) and European Union’s Clinical Trial Application gave Biotech firm Valneva of France clearance to begin Phase I testing.1

Valneva is developing VLA15, a hexavalent, protein subunit-based vaccine for protection against Lyme’s disease, a tick-transmitted bacterial infection characterized by fever, headache, fatigue and skin rash that, if left untreated, can spread to the joints, heart and nervous system and cause severe, chronic health problems.2  The vaccine targets the outer surface protein A (OspA), one of the most dominant antigens expressed by the Borrelia bacteria transmitted by a tick.1

The serotypes expressed by the U.S. species of the Borrelia bacteria differ from the European version of the bacteria. In fact, there are six types of the proteins. Valneva’s vaccine aims to target all different strains of OspA and teach the body’s immune system to recognize the bacteria and launch an attack.3

First Lyme Vaccine Withdrawn After Injury Claims

This is not the first time a company has pursued a Lyme disease vaccine candidate, although there are no vaccines currently on the market.

In 1998, the FDA approved LYMErix, manufactured by SmithKline Beecham (now GlaxoSmithKline) of the United Kingdom. Patients received three doses of the vaccine, which was manufactured using a recombinant Burellia burgdorferi outer surface protein (OspPA).  The company claimed an effectiveness rate of 80 percent.

However, almost immediately after the vaccine was licensed and distributed, there were complaints that LYMErix vaccine was causing Lyme disease symptoms and in some cases was causing permanently disabling brain and immune system damage, including treatment resistant autoimmune arthritis. The biological mechanism hypothesis was that the outer surface protein A (OspA), which was the antigenic component of the LYMErix vaccine, induced autoimmunity in genetically susceptible individuals, including high levels of autoantibody to OspA in their synovial fluid. On Jan. 31, 2001, the FDA advisory committee held a public meeting to review the evidence for the vaccine’s safety and public comments were made by physicians, research scientists, individuals alleging LYMErix injury and attorneys.4

GSK  voluntarily withdrew LYMErix vaccine from the market in 2002 citing uncertainty about risk of the disease and low public demand. However, they stopped producing the vaccine soon after a class action lawsuit involving hundreds of patients, who claimed they were injured by LYMErix, was settled out of court. GSK denied the vaccine caused harm and the vaccine industry and public health officials placed  blame on the media for publicizing reports of vaccine reactions.

Other Lyme Vaccines Failed to Materialize

Pasteur Merieux Connaught of France moved its vaccine through to Phase III testing with positive results, however the company never sought licensure, citing a small market size.5 Baxter of Deerfield, IL was also recently developing a potential vaccine candidate against Lyme, but similarly abandoned the initiative.6

Seeing an experimental vaccine through to Phase III testing can cost a company more than $1 billion. About 86 percent of experimental drugs do not clear Phase I and II studies.

Valneva Vaccine Targets Six OspA Serotypes

Valneva’s preclinical study on mice reveal protection against Lyme disease transmitted by ticks among the majority of Borrelia bacteria strains.7

Phase I human trials at a U.S. site and a Belgium site will enroll 180 patients aged 18 to 40 years. The single-blind, partially randomized, dose escalation study will focus on evaluating VLA15’s safety and tolerability among different dose and formulation groups and time points. Researchers will measure immunogenicity by observing IgG antibodies against six OspA serotypes.

Call for Extensive Safety Testing of New Lyme Vaccine

According to the U.S. Centers for Disease Control and Prevention, approximately 300,000 Americans and 85,000 Europeans develop Lyme disease annually. The CDC states that Lyme disease is one of the fastest growing vector-borne infections in the U.S. and Congress made development of a new Lyme disease vaccine a funding priority in the 21st Century Cures Act passed at the end of 2016.8 9

Two researchers warned several years ago that new Lyme disease vaccines using the outer surface protein (OspA) must be thoroughly tested for safety. They said, “Any new Lyme vaccine will need extensive safety testing, more transparency about side-effects, and improved patient communication to allay patient concerns about safety. Let’s hope that history does not repeat itself because Lyme vaccine manufacturers, regulators, and promoters once again underestimate or ignore justified patient concerns about Lyme vaccination risks.”10 


References:

1 Valneva Receives FDA and European Approvals to Start Clinical Testing of Lyme Disease Vaccine Candidate. Valneva SE (Press Release) Dec. 9, 2016.
2 Centers for Disease Control and Prevention. Lyme Disease. CDC.gov Aug. 19, 2016.
3 
Mosher D. A new Lyme disease vaccine will soon be tested on Americans and Europeans. Business Insider Dec. 9, 2016.
4 Nigrovic LE, Thompson KM. The Lyme Vaccine: a cautionary tale. Epidemiol Rev 2007; 135: 1-8.
5 Liu, A. Valneva wins green light to test Lyme disease vax on humans. FiercePharma Dec. 13, 2016.
6 See Footnote 3.
7 
Comstedt P, Hanner M, Schuler W, et al. Design and Development of a Novel Vaccine for Protection against Lyme Borreliosis. PLoS ONE Nov. 19, 2014.
8 See Footnote 1.
9 See Footnote 5.
10 Stricker RB, Johnson L. Lyme disease vaccination: safety first (letter). The Lancet 2014; 14.

21 Responses to FDA Gives Green Light to Test Lyme Disease Vaccine on Humans

  1. caws Reply

    February 11, 2017 at 1:45 pm

    THEY NEED TO SPEND THE MONEY ON BETTER TESTING & TREATMENT FOR LYME & IT’S MANY COINFECTIONS. ESPECIALLY WHEN THEY ARE TRYING TO KILL BABESIA WITH ANTIBIOTICS & IT IS A PARASITE! DUH!

  2. M Reply

    February 5, 2017 at 10:02 pm

    Where did this start? Who was the person at the CDC who thought this would be a good idea and why? And where are they now?

  3. suzanne meub Reply

    January 29, 2017 at 8:07 pm

    IDSA ,Lyme ,Coinfections are oil and water 99% will use the crappy test that’s yields a false false negative 50-70% of the time … even if you get a positive you will get 2 weeks of doxy which is known to be inadequate .. then you can argue ( yup you are really sick and you have to argue With the ID guy then the insurance for 30 days of rosphin … then if you are still sick the you need psych, your pants are too tight, increase your fiber, exercise more .. and on and on …

    do yourself a favor , find a lyme literate provider and don’t waste you time, your money or your sprit with individuals who likely remain willfully ignorant .. sticking with one of these negative na bobs may cost you your life

  4. Karen Reply

    January 29, 2017 at 7:57 pm

    Ridiculous!!

  5. Dr. Horace Douty Reply

    January 28, 2017 at 8:14 am

    No sane person can reasonably trust our medical system on the subject of Lyme Disease. With a few notable exceptions, the public has been fed misinformation coming from the CDC on down.
    Seems strange that any company would risk spending a billion dollars to treat a disease many of our professionals claim does not even exist! The proposed vaccine? Don’t volunteer.
    Horace

  6. Alicia Reply

    January 27, 2017 at 12:37 pm

    https://madisonarealymesupportgroup.com/2016/08/04/vaccine-injuries-and-the-lyme-connection/ written by Joni Comstock, Founder at May12.org, Advocating for Patients’ Rights and Compassionate Care

    The CDC Fraud with vaccines and lyme (OspA) connection:

    The LYMEerix vaccine was manufactured with ‘outer surface protein A’ (OspA). OspA is fungal and therefore has an immunosuppressive effect – causing post-sepsis syndrome. People injected with this vaccine were effected similarly to those bitten by a tick -which injects spirochetes (toxic fungi). Ironically, this vaccine was making people sick with the exact thing it was supposed to prevent!
    The LYMErix vaccine gave people the same disease we know of as chronic neurologic Lyme, so then what is the disease? What is OspA?
    The LYMErix vaccine was patented by the U.S. Centers for Disease Control and prevention (CDC). The synthetic OspA injected into subjects in the trial for the vaccine were getting sick. They were injected with a fungal type antigen which is toxic to humans.
    LYMErix was pulled off the market when this fact was revealed to the FDA. But was anyone prosecuted like with the NECC scandal? Did anyone go to jail for racketeering? Was a fund set up for the victims?
    Petition for a Congressional Investigation
    It’s time to hold the CDC, Merck, Yale, IDSA (and others) responsible for the lives they have destroyed. Carl Tuttle started a petition with over 34k signatures so far – “Calling for a Congressional investigation of the CDC, IDSA and ALDF”
    https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf

  7. mark Reply

    January 27, 2017 at 9:59 am

    Since people are not protected from reinfection by ticks after a first one, that is they do not become immune, how will a vaccine cause immunity? I don’t think it will. And it is puzzling that they are again using OspA when that is tick expressed, changing to OspC in the human.

    And since no one ever admitted that a subgroup of vaccine recipients before had actual damage, and the pretense was that those ignorant people were making false claims and the demand was not great…..why should we believe this one is safe either? If the demand is not great, why do we have companies investing a billion bucks in their creation? Something does not add up here.

    • Kathy Ambrosat Reply

      January 30, 2017 at 10:46 am

      Of course GSK denied any wrong doing and blamed all the hoopla on the media! These were not accusations from those infected, it’s the damn truth and GSK and the CDC along with the IDSA all know the truth behind what they did! 1 billion dollars to move forward with phase III of this vaccine, are you freaking kidding me? Please, take that billion dollars and apply it to better testing methods, better research and for F%&$ sakes, please start trying our med students on the TRUTH BEHIND LYME DISEASE AND HOW TO RECOGNIZE AND TREAT IT, were dying out here…

  8. Gillian Reply

    January 27, 2017 at 7:56 am

    I have multiple family members who have Lyme Disease or had Lyme Disease, it’s very unclear if it ever goes away. The doctors know nothing about this disease and rarely test for it unless you specifically ask for it. I recently diagnosed a co-workers mom who was having all sorts of weird symptoms including heart problems and I told her to get tested for Lyme and sure enough she had it. The point here, is that I find it very hard to believe that they have figured out a vaccine when they haven’t figured out the disease itself or how to treat patients with Lyme. If you try to research Lyme Disease it doesn’t seem to me that is has been well researched by the CDC or any other entity. So, I find it very hard to believe that they now have figured out a vaccine when they don’t fully understand the disease itself.

    • Jaimie Reply

      January 27, 2017 at 10:22 am

      You took the words out of my mouth!
      Also, isn’t it bad enough our own country created Lyme Disease and wreaked havoc on countless lives? Do they really need to add to the damage?

    • kim Reply

      January 27, 2017 at 12:20 pm

      You are absolutely right!!!!!!!!!!!!!

  9. Bob Reply

    January 27, 2017 at 5:19 am

    One of the problems with Lyme is that there are many co-infections. It’s not just the one spirochete. Vaccines are not the answer to every illness.

  10. Dee G. Reply

    January 26, 2017 at 6:12 pm

    The lyme vaccine is still given to dogs. It was created before the Lymerix was and is still in use. I’m wondering how the ingredients of the dog one compares to this new toxic garbage for humans.

    Furthermore, PREVENTION is key, not a toxic vaccine. Wear long sleeves, long pants, check scalp, use a deterrent spray (I make my own using essential oils for mosquitos and the like). Certain ticks carry certain diseases, Rocky Mountain spotted fever, Lyme etc so you have to be bit by one of these certain ticks. And if the tick is not pryed off within 24hrs, chances are, it could carry a bacteria and pass it to you. Also KNOW the symptoms of Lyme disease. If you see a BULLSEYE RASH anywhere on your body (typically leg or arm) Get to an Infectious disease doctor that will prescribe the CORRECT antibiotic and do bloodwork. Dont ignore the rash. If you feel flu like symptoms, achy joints and never saw a rash, dont ignore those symptoms either. Tell the doctor if you have been camping, hiking etc. AND….. One last thing. If you do pry a tick off, you can send it to labs to get it tested for lyme disease. Do not douse it in alcohol, put in a zip lock bag or sealed container and do some research where to send it. It may cost you $100 but peace of mind is worth it.

  11. Trudy Phelps Reply

    January 26, 2017 at 4:52 pm

    In my previous post awaiting moderation, I MEANT to say, vaccinating against borrelia only is likely to be very INeffective, not effective. This was a typo. Apologies.

  12. Trudy Phelps Reply

    January 26, 2017 at 4:50 pm

    Biofeedback frequency screening shows up just as many babesia, bartonella, and other co-infections as borrelia in the average person. All contribute to the patterns of symptoms, and seem to work together – the more there are, the more illness is experienced. Vaccinating against borrelia only is imo likely to be very effective.

  13. Debra Prisk Reply

    January 26, 2017 at 4:16 pm

    You’d have to be a fool to take any vaccination…I agree with Richard who asked about the adjuvants added to the vaccine…Mercury, Aluminum, fetal cells, etc.

  14. Tim Reply

    January 26, 2017 at 3:03 pm

    Most likely loaded with Mercury and Aluminum so they can continue their onslaught of vaccine injuries and Autism!!! Evil!! Thanks for the story and keeping us informed as to what Big Pharma is trying to Lie and Deceive us into now!!!

  15. Robert L . Wachsmuth s Reply

    January 26, 2017 at 2:20 pm

    Don’t worry Monsanto is going to Poison us all and call it Lyme Disease . Ha Ha

  16. Walter Allen Haxton Reply

    January 26, 2017 at 12:16 pm

    What about the parasite that goes with the bacteria.. How will the vaccine kill it?

    • Angel P Permaloff Reply

      January 27, 2017 at 8:08 am

      I agree! There are many co-infections that come along with tick/spider/mosquito bites that carries lyme. Parasites, babesia bacteria, various viral strains…it’s pointless to vaccinate just for one bacteria caused by lyme and assume you’re protecting someone from the whole disease. Then, we have to consider the adjuvents they’ll have included and the horrible track record those have for nervous system and brain damage. I’m a sufferer of chronic/latent lyme, and given the choice, I’d still take my chances with the wild bugs over the vaccine!!

  17. RICHARD L. BRANDON, MD Reply

    January 26, 2017 at 11:56 am

    THEY FAILED TO MENTION ANY ADJUVANTS THAT MAY BE IN THE VACCINE. i WOULD BE SURPRISED IF THE BENEFITS OUTWEIGH THE RISKS.

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