Top Israeli immunologist's views on vaccines trigger furor

Allowing an open discussion of the side effects of vaccines

Highlighting the possible, albeit rare adverse effects of vaccines, does not make one an anti-vaccineologist. We, the undersigned physicians and researchers in the field of rheumatology and autoimmunity from across the world, emphatically acknowledge the tremendous contribution of vaccines to our health. Dr. Yehuda Shoenfeld undoubtedly shares this standpoint. He has made this clear in many of his publications, conferences and talks to lay audiences.
However, we feel that the issue of vaccination should also be openly discussed from the perspective of its possible side effects. This does not in any way suggest that the benefits of vaccination are being questioned. The undesirable side effects of vaccination, however few, ought to be looked into, examined, and studied carefully in order to further augment the blessing of vaccines for mankind.

We are therefore appalled by the personal attack on Dr. Yehuda Shoenfeld for his scientific contribution in the fields of vaccinology and autoimmunity. Dr. Shoenfeld has described and presented abundant evidence that autoimmune disease starts with hyperstimulation of the immune system in genetically prone individuals, e.g. carriers of HLA DRB1 haplotypes, a genetic constellation which may provide some survival advantage (1, 2).

Hyperstimulation by environmental factors (such as viruses, bacteria, silicone breast implants (SBI) (3), vaccines, especially together with adjuvants, etc.), may cause the immune system in susceptible individuals to increase auto-reactivity, produce autoantibodies and autoreactive T cells, even autoimmune diseases and lymphoma (e.g. breast lymphoma in SBI (4), and in patients with Sjoegren's syndrome) (5).

A proof of concept for Dr. Shoenfeld's ideas has recently presented itself when employing new therapies for cancer, namely the use of check point inhibitors. When unleashing the suppressive effect exerted at check points (i.e. PD1, PDL1, CTLA4), the immune system reacts aggressively against tumors such as small cell lung carcinoma, leukemia, and others. Yet, the price to be paid for this over-stimulated immune system can be diverse inflammatory and autoimmune diseases (6). Interestingly, these immune-related adverse events (IrAEI) are more prevalent in HLA DRB1 bearers (7) than in other subjects. These appear to be the same individuals who might develop autoimmune diseases "spontaneously".

The seminal work of Noel Rose, one of the fathers of autoimmunity, showed that adding an adjuvant to thyroid autoantigens led to autoimmune thyroid disease, but this was not the case in the absence of an adjuvant (8). Rose's ideas are corroborated by thousands of papers, including reports of an eightfold increase in Guillain-Barré syndrome (GBS) following influenza vaccination of US soldiers in the late 1970s (9-11), and more recent papers showing that different vaccines caused different autoimmune diseases (12, 13).

In 1986, the US government signed the National Childhood Vaccine Injury Act (NCVIA) intended to eliminate the potential financial liability of vaccine manufacturers arising from vaccine injury claims. At the same time, a special compensation vaccine court in Washington DC was established for individual plaintiffs who claimed to have developed autoimmune diseases as a result of vaccination and the federal system of no-fault compensation was created. Recently, the standpoint of Dr. Shoenfeld and the cardiologist Dr. M. Eldar was endorsed by the court in the case of an 18-year-old college student who died following HPV vaccine (14). In the same court, a sum of US $ 3-4 billion was decreed as compensation for victims of injury in acknowledgment of various plaintiff cases over the years.

We believe that serious discussions and studies on this issue should be conducted and that they should not be performed by vaccine producers, consultants, or those supported by vaccine producers.

Dr. Shoenfeld is a well-known and respected organizer of the biannual Controversies in Rheumatology and Autoimmunity (CORA) meeting in Italy. In every single discussion in these international meetings, there is a pro and a con speaker at the podium, who are invited to present their views underpinned by solid scientific data (16). Such an approach contributes to an open scientific debate on both sides of any controversy in autoimmunity.

We believe that shedding light on the adverse effects of vaccines will bring honesty to the debate, and should in fact encourage the public to get vaccinated. Hiding the truth from the public and claiming that no side effects occur is likely to deter people from getting vaccinated.

The adverse effects of vaccine should be recognized and openly discussed: Should an individual manifest any adverse side effects, these ought to be diagnosed, treated and wherever appropriate - be deemed compensable. This is especially important for gaining public trust in countries where vaccination is mandatory or enforced by the authorities.

Vaccines with high levels of adverse events should be taken off the market. The
RotaShield vaccine in 2005 caused more children to develop intussusceptions than the indigenous virus (17), and raised serious concerns (18 - 21). Other examples of vaccines associated with significant adverse events are the cellular pertussis vaccine (associated with neurological adverse effects) (22) and the Dengue vaccine in the Philippines, which resulted in many hospitalizations (23, 24) (The N.Y. Times, 17 December 2017).

Other vaccines withdrawn from the market include a Lyme disease vaccine (25), and a mumps vaccine (26). The difficulties of detecting adverse effects of vaccine (27) point to the importance of the role of the Vaccine Adverse Event Reporting System (VAERS). In the words of the authors (27): "The identification of signals in adverse event surveillance may initiate further investigation of potential problems in vaccine safety or efficacy, and facilitate subsequent dissemination of safety-related information to the scientific community and the public".

A significant point to remember in this context is that ever since the human papilloma virus (HPV) vaccination had been discontinued in Japan, no additional adverse effects have been reported in that country (28).

Attacking individual scientists and physicians reporting vaccine-associated adverse effects is not the solution to the vaccine problem; nor is withdrawing their peer-reviewed, accepted and published articles from journals (29, 30, 31). Personal attacks on scientists have never brought constructive benefit to civilization. On the contrary, the assaults endured by scientists like Galileo Galilei in the middle ages, or Ignaz Semmelweis in 19th century Europe, have only hampered and slowed science down, before common sense at last prevailed.

We, of course support the use of vaccination as a major tool of progress in the reduction of morbidity and mortality for many millions of people across the world. We object, however, to any attempt to stop the open debate about possible adverse events by attacking the scientists who devote their expertise to this issue

______________________________

Professor Dr. Georg Wick, Austria,
On behalf of the signees listed below:

Anaya Juan Manuel, Colombia
Andrade Luis, Brazil
Antonelli Alessandro, Italy
Appenzeller Simone, Brazil
Belizna Cristina, France
Bizzaro Nicola, Italy
Bogdanos Dimitrios, Greece
Bombardieri Stefano, Italy
Carvalho Jozélio, Brazil
Cervera Ricard, Spain
Chan Edward, USA
Chapman Joab, Israel
Cohen Tervaert Jan Willem, Canada
Conrad Karsten, Germany
Cutolo Maurizio, Italy
Damoiseaux Jan, Netherlands
D'Cruz David, UK
Doria Andrea, Italy
Edwards Chris, UK
Espinoza Luis, USA
Fritzler Marvin J, Canada
Galarza Claudio, Ecuador
Galeazzi Mauro, Italy
Gerli Roberto, Italy
Gherardi Romain, France
Graham Hughes, UK
Jamin Christophe , France
Jara Luis, Mexico
Kanduc Darja, Italy
Karussis Dimitrios, Israel
Kaveri Srinivas, France
Koike Takao, Japan
Lavin Manuel Martinez, Mexico
Lazurova Ivica, Slovakia
Lerner Aaron, Germany
Lunardi Claudio, Italy
Matsuura Eiji, Japan
Matucci Cerinic Marco, Italy
Meroni Pier Luigi, Italy
Mosca Marta, Italy
Mouthon Luc, France
Nicoletti Ferdinando, Italy
Perricone Carlo, Italy
Perricone Roberto, Italy
Riemekasten Gabriela, Germany
Roccatello Dario, Italy
Sakkas Lazaros, Greece
Salvarani Carlo, Italy
Sarzi-Puttini Piercarlo, Italy
Scheinberg Morton, Brazil
Schlesinger Naomi, USA
Shu-ichi Ikeda, Japan
Sousa Maria, Portugal
Szekanecz Zoltan, Hungary
Tatsuya Atsumi, Japan
Tektonidou Maria, Greece
Tincani Angela, Italy
Toubi Elias, Israel
Tzioufas Athanasios, Greece
Vadas Zahava, Israel
Vasconcelos Carlos, Portugal
Wick Georg, Austria
Youinou Pierre, France

References

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2) Dunstan SJ, Hue NT, Han B, Li Z, Tram TT, Sim KS, Parry CM, Chinh NT, Vinh H, Lan NP, Thieu NT, Vinh PV, Koirala S, Dongol S, Arjyal A, Karkey A, Shilpakar O, Dolecek C, Foo JN, Phuong le T, Lanh MN, Do T, Aung T, Hon DN, Teo YY, Hibberd ML, Anders KL, Okada Y, Raychaudhuri S, Simmons CP, Baker S, de Bakker PI, Basnyat B, Hien TT, Farrar JJ, Khor CC. Variation at HLA-DRB1 is associated with resistance to enteric fever. Nature Genetics 2014; 46:1333-6. doi: 10.1038/ng.3143. Epub 2014 Nov 10.

3) Watad A, Bragazzi NL, Amital H, Shoenfeld Y. Hyperstimulation of adaptive immunity as the common pathway for silicone breast implants, autoimmunity, and lymphoma of the breast. IMAJ 2019; 21: 517-519.
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5) Gaetane Nocture, Elena Pontarini, Michele Bombardieri, Xavier Mariette. Lymphomas complicating primary Sjogren's syndrome: from autoimmunity to lymphoma. Rheumatology Oxford Academic 2019. Doi:10.1093/rheumatology/kez052

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14) Shani Dahan, Yahel Segal, Amir Dagan, Yehuda Shoenfeld, Michael Eldar, Darja Kanduc. Cardiac arrest following HPV Vaccination. Clinical Research and Trials 2019; Volume 5: 1-7. doi: 10.15761/CRT.1000279.

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29) Shoenfeld Y. Shoenfeld refers to Dr. Helen Petousis-Harris' attack on Dr. Manuel Martinez-Lavin's article. Clin Rheumatol 2016; 35: 833–834.

30) Withdrawn: Inbar R, Weiss R, Tomljenovic L, Arango MT, Deril Y, Shaw CA, Chapman J, Blank M, Shoenfeld Y. Behavioral abnormalities in female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil. Immunol Res 2017; 65:136–149. Dpi: 10.1007/s12026-016-8826-6
31) Withdrawn: Asin J, Pascual-Alonso M, Pinczowski P, Gimeno M, Perez M, Muniesa A, Pablo-Baiso L, Blas I, Lacasta D, Fermamdez A, Andres D, Maria G, Reina R, Lujan L. Cognition and behavior in sheep repetitively incoulated with aluminum adjuvant-containing vaccines or aluminum adjuvant only. Pharmacol Res. 2018; Nov.3. Doi: 10.1016/j.phrs.2018.10.019.