Century-old vaccine gives new hope to fibromyalgia community

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This article was originally published on Prohealth.com. It is being republished here with permission from the editor. 

If someone could give you a vaccine that would cure your fibromyalgia, would you do it? That may sound like a dream but it’s closer to reality than you might think. Los Angeles-based biomedical firm EpicGenetics and Massachusetts General Hospital researchers are seeking approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical trial next year to test the Bacille Calmette-Guerin (BCG) vaccine as a potential treatment for fibromyalgia.

“BCG is a generic tuberculosis vaccine that is almost a 100 years old and has been safely administered millions of times,” explained Dr. Denise Faustman, head of the Faustman Lab at Massachusetts General Hospital. “For over 10 years, our research group at Massachusetts General Hospital have been actively investigating the role that the BCG vaccine could play in treating various forms of autoimmunity. Our current focus is type 1 diabetes, but globally BCG is being tested in a number of autoimmune diseases. Over the next two years we will begin clinical testing of BCG in fibromyalgia.”

A century-old vaccine for tuberculosis may head to clinical trials next year as a potential treatment for fibromyalgia.  | Fed Up with Fatigue

According to the World Health Organization, more than 100 million children are given the BCG vaccine each year. It’s mainly used in developing countries where tuberculosis is still active. The BCG vaccine is not available in the United States because of the low risk of infection. In the U.S., BCG is used in a small number of patients to treat bladder cancer.

So, the obvious question is why would a vaccine for an infectious lung condition be used for fibromyalgia? The answer lies within the immune system.

Vaccines are typically given to healthy people to prevent infection. In this case, however, the BCG vaccine would be administered to fibromyalgia patients in an effort to quell their symptoms.

When EpicGenetics was tasked with creating a diagnostic test for fibromyalgia several years ago, researchers ran all sorts of lab tests on fibromyalgia patients to figure out how they differed from healthy control subjects and what might be causing their symptoms. Researchers discovered several white blood cell abnormalities in fibromyalgia patients, leading them to conclude symptoms are associated with a suppressed immune system.

“We believe [the term] fibromyalgia is a misnomer,” said Dr. Bruce Gillis, EpicGenetics’ CEO. “These people aren’t suffering with anything that’s affecting the muscles, per say. What they are suffering with is their immune system cannot produce normal quantities of protective proteins. …There are cells in the immune system called peripheral blood mononuclear cells. They are not producing normal quantities of the protective proteins called chemokines and cytokines.”

The finding led to the development of the FM/a blood test for fibromyalgia. (Yes, despite what your doctors may have told you, there IS a blood test for fibromyalgia! It’s just not widely accepted in the medical community.) The test analyzes the levels of four chemokines and cytokines found at reduced levels in fibromyalgia patients. These four chemokines and cytokines just happen to be the same ones that are boosted by the BCG vaccine.

“Given what’s been published in the medical literature, we believe this vaccine will reverse the immune system abnormalities [of fibromyalgia],” Gillis said.

Gillis and Faustman are seeking FDA approval to administer the first BCG vaccines to fibromyalgia patients early next year.

“This is the first time ever that a direct treatment of fibromyalgia will be done,” Gillis said. “As you know, the medications [currently on the market] for fibromyalgia only treat symptoms. They have no immune system benefits. [The pharmaceutical companies] concede they’re only treating symptoms but you need to treat the disease, and that’s why we’re moving ahead with the vaccine application [to the FDA].”

If Gillis’ theory holds true, then “the chemokines and cytokines that are deficient in patients with fibromyalgia will no longer be deficient [once the BCG vaccine is administered],” Gillis said. “Production levels will normalize, and you have to assume then that their symptoms will disappear. … We think we are on the cusp of something major.”

Because the vaccine has such a long history, it’s not expected to cause any major side effects in patients.

The BCG vaccine is anticipated to cost $20-$25 per dose – a nominal amount when compared to the ongoing expense of taking pharmaceuticals every day.

“We think a fibromyalgia patient would need one or two doses maximum so you can understand why I’m not getting much support from drug companies,” Gillis said.

In addition to the vaccine trial, EpicGenetics is partnering with the University of California, Los Angeles (UCLA) and the University of Illinois College of Medicine Chicago to sequence the genomes of up to 250,000 fibromyalgia patients.

“We’re looking for any type of genetic patterns or anomalies or mutations,” Gillis said.

Patients who test positive for fibromyalgia using the FM/a test will be able to participate in the genomic study.

The FM/a test currently costs $936 but is covered by some insurance companies and Medicare. EpicGenetics’ support team helps patients determine if their insurance company will cover the test. A no interest payment plan is available for people who are uninsured or whose insurance won’t pay for the test.

If you’d like to learn more about the FM/a test, visit FMTest.com. Click here to read more about EpicGenetics’ fibromyalgia genome project and the BCG vaccine study. If you’re interested in having the FM/a test, please fill out the application form on the home page at FMTest.com. If you have additional questions or experience any issues with submitting the form, you can email the company at ask@epicgtx.com or call (310) 277-4600.

Now it’s your turn: Would you try the BCG vaccine if it were approved as a fibromyalgia treatment? Share in the comments!

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    Hello there,
    I have found this article most interesting. As I am French, I was vaccinated, age 9, with the BCG.
    Yet, I still developed Fibromyalgia, and so did my sister, also vaccinated.
    I wonder if I should/could get vaccinated again
    Your views really matter to me. 😀

    • Donna Gregory/FedUpwithFatigue.com says:

      Hi Isabelle, I had a number of people share they were previously vaccinated and ask why that didn’t protect them from fibromyalgia. I posed that question to the company and this was their response:

      “These people would have not received the particular species we are using and believe will be effective. The vaccine can only be effective when the abnormal peripheral blood mononuclear cells are being produced, which doesn’t happen until the onset of the disease of FM. People are not knowingly born with FM. The vaccine doesn’t prevent the FM. It only reverses the biology of FM after the FM has occurred. Additionally, in the UK and elsewhere, people tended to only receive one dose of the vaccine and we believe it will take more than one dose for the BCG to be effective.”

      I hope this is helpful in answering your questions.

  2. Jean Price says:

    It’s so VERY sad that pain…and the people who have it…are judged AND misunderstood!! Yet PAiN has to be one of the most individual, most personal, and most difficult to communicate conditions there is in life!! Why it’s also has become one of the most maligned and most discriminated against…especially now…is beyond reason!! There has never been a verifiable technique to measure pain…so discernment and observation has always been the way pain was gauged, by knowledgeable and caring physicians. Now this has been largely been replaced by skewed judgments….and the deceit of the current anti-opioid hype!!

    We have technologies to show us our ancient global connections to other people with DNA….yet WE HAVE NOTHING that can show us the TRUE AND REAL quantifiable and qualifiable amount of pain a person is in!! Well, except the ridiculous 10 point scale…or the happy and sad faces of the 5 point scale, that is!! More of a joke than a tool, I’m afraid!

    For instance, when someone asks me my pain score…it would make much more sense for me to ASK THEM what their OWN 10 would be!! Before I answer! Because if their own 10 is a stubbed toe…which CAN really HURT…YET MY 10 is an almost amputated nerve root in my low back…then when I say MY pain NUMBER, they will assess it with only their OWN pain experiences as a reference…regardless of how bad I KNOW my pain truly is!! (Even when our experiences are close to the same, we still differ in how pain affects to us…and we know even those WITH pain judge others who have pain, too!!)

    So THIS current METHOD can definitely leave them with a lessened sense of the level of OUR pain, and how it is affecting all OUR functioning! And probably also leaves them wondering many times why WE would even consider taking a pain medication!! There is no good way to convey our pain to another…to be totally understood, without judgement being part of it!! Either the judgement of…yes, you must hurt! OR…no…you can’t possibly hurt as much as you say!! And these judgements all rely on what’s observed RIGHT THEN…like the issue with understanding Lady Gage’s pain…when most healthy people can’t imagine doing a show like she does…EVEN without pain!! And, like when nurses see a patient talking on the phone, or laughing…and think oh, they’re not in pain!! Or when our doctors see us showered with hair combed and out of pajamas…they don’t realize they aren’t really seeing our USUAL LEVEL OF LIFE…our pajamas for days on end…and rarely showering except when absolutely necessary!! And rarely getting out except to go to the doctor!!

    The basis for treating pain RELIES on the doctor BELIEVING what the patient says…within reason and with using their skills of perception and their skills of discernment, after observing and doing a thorough physical exam!! Yet these days…no one with pain is considered believable!! Doctors don’t do much in the way of physical exams…and they don’t practice their discernment enough to even trust it…about our pain, about how we are taking our meds, about being totally compliant, about being innocent of any abuse!!

    So the judgments come in and then DISTORT our care…and INFLUENCE how others think OF us…whether we are just a regular person, or a nationally recognized entertainer! We are guilty until proven guilty…and condemned by our government for being drug seekers…instead of being people with legitimate life limiting pain! Regardless of our status in life, regardless of our diagnoses!

    The problems with pain care now are relatively easy to define..the solutions are not!! Because they involve too many layers of deception and greed, instead of just good solid medical knowledge and good practices!! A return to basics would help…a “pain-o-meter” being invented would maybe help, too! Mostly it’s a return to sanity I think we need now!! And I don’t see this happening anytime soon! Sad!

  3. N. Ferguson says:

    Absolutely- I am so tired of being in pain all the time. It is infuriating and exhausting for me, and frustrating and misunderstood by my family.

  4. StevefromMA says:

    Hi Donna,

    Hope you don’t mind my posting this here, you,of course, can also screen out. I’m kind of the unofficial (unpaid) poster boy for the Epicgenetics study and am doing all I can to publicize it to enroll people. Unless you’d rather have fibromyalgia than the faint chance of mercury being in the BCG vaccine (I have no idea if it is and don’t care) , enrolling in this is a no-brainer. If you don’t have insurance, they’ll help you figure out how to pay for it. At 69, with terrible and worsening FM for 30 years, at this point, I would try almost anything that won’t immediately kill me. As a Ph.D. scientist (not employed by Epicgenetics), I’m well aware of research protocols and risk/benefit calculations. I just don’t see the risk here and like some others, I hope to be the first to get it! I recently was interviewed by our ABC News affiliate after separate interviews by them with Drs. Gillis and Faustman. Some of you might find it interesting and you can see it here|:


    BTW, whoever noted that the vaccine is not a preventative but a treatment is correct;that issuewas discussed elsewhere by Dr. Gillis, so having gotten the vaccine at some point does not immunize you from getting FM.

    Stephen Golder

  5. Carole Sarvis says:

    I was born 1943. In 1962 I was working in a TB hospital and received BCG as did all people who worked there. 1996 I was diagnosed with fibromyalgia by a Rheumatology Professor and I had the symptoms for at least 4 years before that. I can’t imagine that the BCG would have any effect for me. For the last 15 months I have been going through the worst flare I have ever had.

  6. Michelle Alvarez says:

    Hell yes! Not only the vaccine but I want to do the other stuff too. Blood test and genome project. Also, I’m so grateful for this site!! I could never do all the research done here. So…THANK YOU.
    Best, Shelley A.

  7. Ingrid Hanson says:

    Hell yes! I immediately signed up for it. Some medications (in my case, Nasonex, a nasal steroid) could interfere with the blood test, so I need to be off of it for 30 days, then will have the blood test done, and wait for the next stage of the trials, the vaccinations, which begin after the first of the year. Donna, a huge thanks to you for posting this article! I’ve also let friends with fibro know about it, and if they know anyone with fibro, to pass it on.

  8. Pam Trotter says:

    I would try it! My life has been an uphill battle of pain and fatigue….. LDN has been so tricky to get on. I would love to be part of their test. At 57 my life feels over.

  9. I guess I’m a little leery of it because we don’t know if Fibro is a virus.

  10. I’ve had the BCG injection as a pre-teen upon immigration to Canada. I have FM and am wondering, if this injection is theoretically supposed to help – why am I suffering? Also, wouldn’t it be prudent to conduct a study on immigrants to find out how many people who have had the BCG injection also suffer from FM before spending a tonne of money injecting people unnecessarily?

  11. Dagmar MacQueen says:

    I had the vaccine as a youngster and tested negative for the booster in my teens. i probably wouldn’t take part in the trials as I agree with a previous comment, I feel my fibro is down to constant stress and trauma throughout my life. I’m much improved since taking LDN for about a year now but any stress leads to a flare. That can be any combination of energy collapse, pain and migraine.

  12. Tuknits says:

    Not sure if I would or not. Part of me says hell yes. The last rheumatologist I saw told me there was nothing else he could do for me so currently I take nothing but OTCs for my pain and it really sucks. Nothing really touches the pain. Another part of me thinks hold off. I have so much going wrong in my body (FM, arthritis, seizures, and moyamoya disease) can I really afford to throw an unknown into the mix with the chance that my body may not react kindly. Definitely something to think on.
    On a side note, I had no idea there was a test for FM. Thought I had been tested for everything under the sun.

  13. Deborah says:

    Some of you are arguing that it won’t work because you had it BEFORE you had Fibro. They are not proposing it prevents fibro, they are checking to see if it is effective as a TREATMENT for Fibro. Speaking as a former scientist, these two things are very different. I would try absolutely anything with some real science saying it works.

  14. I live in the UK where until the beginning of this century we received the BGC in year 9 (age 13-14) – if it actually cured fibro how come I, along with many others, have developed fibro?

    And yes, I definitely was immunised, age 13 I was old enough to remember it, and I have the scar from the vaccination!

    • I wondered about that while I was reading this article. However I quickly dismissed the thought that this study had any true potential without having read your query yet. If I come across as skeptical, I apologize. I really do want to be optimistic but chronic pain & fatigue, plus the vast research I have been able to do; (now that I can no longer work) have taught me that there is not likely to ever be some kind of miracle cure for people who suffer from fibromyalgia.

  15. Jacqueline Gladwin says:

    I live in Scotland, UK. I was given the BCG as a young child, but it was determined I didn’t need a second dose in Secondary (high) School. I don’t understand why they believe in this when so many people from countries that had TB programmes in place have this condition.

    • Linda Kearney says:

      Yes Jacqueline Gladwin I had it and they determined I didn’t need a booster I have had Fibromyalgia for years so I can’t see how something this old can help especially when you have already had this vaccine and yet developed Fibromyalgia, I think they just grasp at straws.

  16. Tammy Randall says:

    Why can I not copy and paste this page in order to print it out?

    • Donna Gregory/FedUpwithFatigue.com says:

      I had to install a program that stops people from being able to cut and paste articles on my site b/c I was having too many people steal my articles and then put them on other websites for profit. I’m sorry for the inconvenience but it was necessary to protect my work from being plagiarized by others. If you’d like, I can email you a copy of the article. Just let me know.

  17. Julie E Parsonshat happens in what the long term use of the vaccine says:

    No I think I’ll wait to see wair to see what will happens in the long term use of this vaccine.

  18. Yes definitely I would try it. I am willing to try anything that would take pain aeay. And get me off theall the medicines. I do not take any prescription pain pills, I refuse to take them. But my doctors they they are not afective on fibro pain anyway. If I could find something that would release the muscle tightness and spasms I have would be a article for me…

  19. Mary Mc Sherry says:

    BCG vaccination has been given to all babies in Ireland since the 1950’s. I was given it. My fibro developed 9 years ago after chronic pain post neck injury and previously I had no medical issues.
    Like others here, am very wary of vaccinations now due to the amount of additives

  20. It will be interesting to see what the clinical trials show.
    The article nicely describes that there are certain immune chemicals (cytokines) that are low in fibro. But it doesn’t discuss the fact that some cytokines are elevated in Fibro.
    The article incorrectly says that the ‘The immune system is suppressed’ in fibro.
    If anything, its the opposite in most cases, which is why we see so much fibro in people with autoimmune disease.
    The overall bulk of the research out there suggestions that its overactive immune system that is involved in fibro.

    Most of you probably know about the work of Jared Younger, and others, who have shown that the immune system produces too much of several cytokines. And that this is part of the mechanism of action of Low Dose Naltrexone (LDN), which reduces pro-inflammatory cytokine levels.

    That said, there are some cytokines that are anti-inflammatory. Not sure if the ones that the vaccine boosts are anti-inflammatory or pro-inflammatory.

    Anyway, I’m glad they’re trying….

    p.s for those who ask whether the BCG that they got when they were young would make a difference. Probably not. But as with everything else, its very individualized. Antibodies and cytokines are very dynamic and can change over the lifespan. It’s likely that the cytokine changes that happened to you when you got BCG as a kid are no longer persisting.
    May everyone have speedy and complete healing!

  21. Gloria Hurta says:

    I would probably be allergic to it, as I react to almost everything, so, no I would not chance it!

  22. Anita Meeks-Chambers says:

    I would like to know what preservatives or extenders will be used. I thought Mercury had not been used for ?? years in vaccines. But , I am definitely interested in relief from being so exhausted all the time

  23. Grant says:

    I’m certainly not against this, however I feel this is perhaps being driven without thought to further information gathering from other countries prior. The USA never had a mass population TB vaccination program like some countries did in efforts to fully immunise their populations.
    ((As an aside it is now known (as is discovered with many drugs years later) that the developed countries with full TB vaccination programs had no lessening of TB occurrence rates when compared with those that didn’t have vaccination programs but instead implemented better diagnosis, monitoring, prevention and treatment initiatives.))
    That aside there are countries like Australia who had almost total population vaccination programs running through the country by vaccinating all children in school from the 1950s to the 1980s before it was discontinued (excepting two states that remained independent and would not implement the program in schools). That is a vast number of vaccinated individuals to draw from. How many of these individuals have gone on to develop Fibromyalgia anyway?
    I seem to recall there being a stipulation around TB vaccines not being given to any individual with any compromised immune system issues. Now we know Fibromyalgia sufferers have compromised immune systems and I fear this could potentially be a mistake.
    There is a potential for partial temporary improvement as the bodies immune system is coerced to produce more compounds to attack the antigen. However Fibromyalgia sufferers have organs that are depleted of full functioning capacity all round due to the lifetime drain of being at elevated stress/response levels. This is part of the problem medical science is yet to realise. Placing a further demand may simply provide a short term boost as it forces organs to produce more whilst in reality actually draining the near last reserves and abilities the organs have to produce such. This has the potential to lead to an even greater crash after a relatively short term gain.
    Pushing the immune systems of immunocompromised individuals is prone to known negative medical outcomes and I’m hesitant regarding any long term benefits of this one.

  24. Ellen Saville says:

    I have had this illness for 40 plus years. I am now 71. To even begin to think of a life without all this pain and fatigue would be a dream come true. I don’t know much about medicine so I don’t understand the concern about the mercury and aluminum. But, if my doctor said it would be okay with me taking the vaccine, I would do so just to be able to have a few more years of life pain free.

  25. Linda McFarland says:

    Can I be the first? I’ve had disabling FM for the last 27 years and counting. What’s a little mercury if I could live the remainder of my life (I’m 65) like a normal person….

  26. we had this is secondary school UK, I didn’t have it done as the pre test indicated I didn’t need it!?!

  27. So if this is a solution being offered can they pinpoint the people who have already had this vaccine many years ago? If so can they find out if any vaccinated people have Fibro or symptoms as surely this would be a good place to start before new testing happens.

    • Nicola says:

      Try magnesium oil .. fibro sufferers are usually deficient in magnesium; every cell in the body needs magnesium to function correctly. I have only positive results from it..

    • Nicola says:

      Agree. I’ve had fibro since age 6 I’m now 49. I alao had the vaccine aged 14.

  28. Bonnie St George says:

    Yes I would be willing to participate in the trial. I have moved from Alaska to Kentucky last year and now I’m not able to find any medical help for my pain. Anything would be better than living most of my time in bed in terrible pain with no relief.

  29. Screnshaw says:

    If they want us to be guinea pigs they should pay for the test. They sure would have a lot more volunteers that way!

    • Becky says:

      Screnshaw, I totally agree with you.

      • J Taylor says:

        Hummm… what about we pay for our own test… to weed out any ‘wanna be’ subjects, and they pay for the treatment and any resulting ailments or conditions related to the treatment that the subject endures?

    • Rochelle says:

      Agreed! I live in Canada and contacted the company and was told I’d have to pay the full amount, which works out to about 20-25% higher in Canadian dollars. No way was I going to pay that! Most medical research pays the test subjects for their participation.

  30. StevefromMA says:

    I don’t know if the vaccine has mercury in it but it can’t be worse than my life-destroying FM. I “passed” the test, paid for by Social Security, and hope to be one of the first treated. Disappointing to hear you got FM, Donna, despite getting BCG in high school but there’s almost no one else out there offering real treatment with a theoretical basis. Nothing works for everybody and nothing has worked for me. Dr. Gillis is convinced the vaccine will work.

  31. I’d try it and I would hope that because my son has had it (some of my husband’s family is in India so we qualified) that he has less chance of getting it!!

  32. I’ll be keeping an eye on this with interest. I was actually given the BCG vaccine at high school; it was routinely administered and I think they stopped it the year after I had it. My gut feeling is I feel biased against it because of this. It was many years before I developed fibro but I was routinely sick all the way through my teenage years so I don’t think it had any positive impact on my immune system! It will be interesting to see how the studies turn out.

  33. Indeed this looks promising except for one thing. Vaccines usually contain mercury (thimerasol) as a preservative and aluminum to trigger the immune response. The aluminum crosses the brain barrier bringing the virus with it. I don’t like this particular approach to treatment.


  1. […] You can read my previous article about the FM/a test here and about EpicGenetics’ possible vaccine for fibromyalgia here.  […]

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