HOW SAFE IS ANY LYME DISEASE VACCINE?

 

Many people today are concerned about the safety of vaccines in general. What are the long term side effects? No long term studies have been conducted....that the public has been made aware of. Are we the long term covert studies? What  long term effects does the artificial hyper-activation of the immune system cause? Vaccines do include ingredients to hyper-activate the immune system. It's not a far stretch to suppose or conclude that this unnatural method of immune activation could cause autoimmune disease which is a hyper-activation of the immune system. Could this be one of the reasons or THE reason why autoimmune disease has exponentially risen in the population in conjunction with increased numbers of required vaccines?

I'm bringing up the subject of vaccines because many people were harmed by the Lymerix vaccine for Lyme disease....that was marketed a few years back. It was known to Smithkline Beecham that 30% of the population had a specific genetic susceptibility and could react to the Lymerix vaccine with a lyme arthritis that would be untreatable...but this information was not shared openly with the public! I personally spoke to several people who had received the vaccine and now they have what is called"fibromyalgia" 

I also attended a Lyme Disease conference put on by the Lyme disease Foundation a few years back...after the Lymerix vaccine had been on the market and had harmed many people. There was a Smithkline Beecham representative attending who gave a presentation. The audience of doctors, patients and activists expected that this rep would share some safety data and side effects of the vaccine. However, his whole presentation was about Lyme rashes and no mention was made of the vaccine. At the end of the presentation a doctor stood up and expressed this concern. He asked what some of the side effects of the vaccine were. The representative had the gaul to stand there and say that there had been no significant side effects  reported. The whole audience groaned and several doctors got up and walked out.
Lyme disease has been in the news lately spurred by a press release put out by the CDC. Normally the lyme community has found the CDC to downplay the seriousness of Lyme....to the detriment of many lyme patients. It's interesting that all of a sudden ...according to the CDC... Lyme is a very serious disease and a new Lyme disease vaccine is in the wings. What are the real financial connections between the CDC and Lyme vaccines?

It's also interesting that when people acquire Lyme disease from a tick and recover, that this infection evidently does not prevent the body from coming down with Lyme again from another tickbite. In other words the infection does not seem to create immunity like with most other diseases. I am not a scientist so maybe someone reading this could post a comment as to how then a lyme vaccine could provide immunity. The following recent article expresses many of my concerns

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970319-0/fulltext

Lyme disease vaccination: safety first

Raphael B Stricker a, Lorraine Johnson a

In the Article by Nina Wressnigg and colleagues1 and the related Comment by Paul Lantos2 describing a novel Lyme vaccine, the authors attempt to avoid discussion of the side-effects of the previous Lyme vaccine, LYMErix (SmithKline Beecham, Pittsburgh, USA). This approach to safety issues bodes ill for the new Lyme vaccine candidate.

LYMErix was put on the market in 1998 and withdrawn by the manufacturer in 2002, ostensibly because of poor sales. However, the so-called poor sales were related to safety concerns raised in a class-action lawsuit by more than 400 patients who claimed that they developed Lyme-like symptoms after vaccination with LYMErix.3, 4 Subsequent studies showed that outer surface protein A (OspA), the antigenic component of Borrelia burgdorferi used to create both LYMErix and the new candidate vaccine, induced joint-reactive and nerve-reactive antibodies in animals and human beings vaccinated with the protein antigen.3—6 Even more disturbing, other studies indicated that LYMErix induced reactivity against multiple target antigens that were never characterised, and these studies called into question the OspA specificity of the vaccine.7, 8 By withdrawing LYMErix when it did, the manufacturer avoided releasing phase 4 post-marketing data that probably would have shown increased side-effects related to the vaccine.9 The data have never been disclosed, and this lack of disclosure has fostered persistent patient mistrust of Lyme vaccine manufacturers.

Wressnigg and colleagues provide minimum safety data about the new OspA-based Lyme vaccine, whereas Lantos glosses over the “largely unsubstantiated safety concerns” about LYMErix. Adoption of this view by Lyme vaccine manufacturers, regulators, and promoters has shaken patient confidence in Lyme vaccines despite the fact that this patient population is generally pro-vaccination.10 Any new Lyme vaccine will need extensive safety testing, more transparency about side-effects, and improved patient communication on the part of the vaccine manufacturer to allay valid patient concerns about safety.4, 10 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.

RBS serves without compensation on the medical advisory panel of QMedRx Inc. He has no financial ties to the company. LJ declares that she has no conflicts of interest.

References

1 Wressnigg N, Pöllabauer E-M, Aichinger G, et al. Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial. Lancet Infect Dis 2013; 13: 680-689. Summary | Full Text | PDF(256KB) | CrossRef | PubMed

2 Lantos PM. Lyme disease vaccination: are we ready to try again?. Lancet Infect Dis 2013; 13: 643-644. Full Text | PDF(94KB) | CrossRef | PubMed

3 Stricker RB. Lymerix risks revisited. Microbe 2008; 3: 1-2. PubMed

4 Smith P, Gaito A, Marks DH. Transcript of FDA Lymerix meeting, Bethesda, MD. http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=532: lymerix-meeting&catid=129: hhsfood-a-drug-administration-fda&Itemid=531. (accessed Nov 29, 2013).

5 Souayah N, Ajroud-Driss S, Sander HW, Brannagan TH, Hays AP, Chin RL. Small fiber neuropathy following vaccination for rabies, varicella or Lyme disease. Vaccine 2009; 27: 7322-7325. CrossRef | PubMed

6 Marks DH. Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med 2011; 23: 89-96. PubMed

7 Molloy PJ, Berardi VP, Persing DH, Sigal LH. Detection of multiple reactive protein species by immunoblotting after recombinant outer surface protein A Lyme disease vaccination. Clin Infect Dis 2000; 31: 42-47. CrossRef | PubMed

8 Fawcett PT, Rose CD, Budd SM, Gibney KM. Effect of immunization with recombinant OspA on serologic tests for Lyme borreliosis. Clin Diagn Lab Immunol 2001; 8: 79-84. PubMed

9 Nardelli DT, Munson EL, Callister SM, Schell RF. Human Lyme disease vaccines: past and future concerns. Future Microbiol 2009; 4: 457-469. CrossRef | PubMed

10 Smith P. Remarks to Vaccines and Related Biological Products Advisory Committee, Bethesda, MD. http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=262: vaccine-remarks&catid=80: controversy&Itemid=76. (accessed Nov 29, 2013).

a International Lyme and Associated Diseases Society, PO Box 341461, Bethesda, MD 20827-1461, USA