Vaccine-Associated Auto-Immune And Other Diseases by Dr. Michael W. Fox

October 22, 2012

Animal Vaccination Concerns:
Vaccine-Associated Auto-Immune And Other Diseases

by Michael W. Fox BVetMed, PhD, DSc, MRCVS*** 

By way of introduction to this critical review, I wish to make it clear at the onset that I am not opposed to the judicious use of vaccines. My approval is conditioned on the proviso that the deployed vaccines have high levels of proven safety and effectiveness for each species upon which they are used, and requires that they become part of an integrated, holistic health care and disease prevention program. When used as a sole therapy, vaccines do not constitute an effective preventive medicine regime. The myth of infectious and contagious diseases having a single cause—the infective organism—is at long last being abandoned as other co-factors are now being more widely recognized, extending the narrow view that developing a specific vaccine is all one requires to reduce the morbidity and mortality of a given disease.

As a veterinarian I am concerned about the consequences of the widespread dissemination of modified live virus (MLV) and genetically engineered (GE) virus strains through the mass vaccinations of humans, livestock and poultry, and in-house companion animals. Some GE vaccines have been widely used in several countries in bait to stop rabies in foxes, jackals, and other wild carnivores. These vaccines all contain live viruses, and supposedly weakened attenuated or inactivated strains recombined, like the pox virus which is used as an infective carrier, spliced with an attenuated strand of rabies virus DNA. In a different context, this is akin to the Cauliflower mosaic virus that is used as a carrier of engineered genes in GE crops conferring herbicide tolerance and the manufacture of insecticidal proteins (Bt in corn). But there is one big difference. The aim of vaccination is to trigger an antibody immune response to the antigens in the vaccine. A poor response could lead to actual disease from the vaccine or vaccine failure, just as immunologic over-reaction (via aggressive anti-self antibody production) could mean death to the recipient.

The US Government’s Agriculture Fact Book 98 states that the Animal and Plant Health Inspection Service “regulates the licensing and production of genetically engineered vaccines and other veterinary biologics. These products range from diagnostic kits for feline leukemia virus to genetically engineered vaccines to prevent pseudorabies, a serious disease affecting swine. — Since the first vaccine was licensed in 1979, a total of 79 genetically engineered biologics have been licensed; all but 20 are still being produced. More than a half-century ago, there were perhaps a half a dozen animal vaccines and other biologics available to farmers. Now there are 2,379 active product licenses for these animal vaccines and other biologics and 110 licensed manufacturers.” *

Hundreds of thousands of cats have been injected with a non-adjuvanted recombinant rabies vaccine spliced with the canary pox virus used as a ‘vector’. According to Meeusen et al (2007) ‘Vectored vaccines are genetically modified organisms that have the genes responsible for encoding the desired antigens incorporated into the genetic code of a “carrier” organism. The vector is non-infectious to the recipient and transmits the desired immunizing DNA/gene to susceptible cells where the antigens are produced and presented to immune cells. The vector with the hybridized DNA is also called a chimera—having genes of two or more unrelated agents. The common vectors are capripox and canarypox viruses, adenoviruses and flaviviruses. These vaccines stimulate both antibody and cell mediated immunity and, coincidentally, immunize with one dose. A concern is that repeated vaccinations may result in immunity to the vector virus eliminating its ability to infect/transmit the desired genes to the immune system. Currently, several vectored vaccines are used in companion animals.

Some genetically engineered viral vaccines consist of chimera viruses that combine aspects of two infective viral genomes. One example is the live flavivirus chimera vaccine against West Nile virus (WNV) in horses (PreveNile), registered in the United States in 2006. The structural genes of the attenuated yellow fever YF-17D backbone virus have been replaced with structural genes of the related WNV. Chimera avian influenza virus vaccines have been produced on a backbone of an existing, attenuated Newcastle disease virus vaccine strain to protection against wild-type influenza virus as well as against Newcastle disease virus.

DNA vaccines are also being developed that consist of gene segments of infectious organisms. They are injected directly into cells for the production of the desired immunizing antigens. Intradermal injectors are used to deliver the DNA directly to the dendritic cells of the dermis. This system induces antibody and cell mediated immunity with a single injection and provides prolonged immunity. A DNA vaccine is being tested for feline leukemia virus. A DNA vaccine licensed with the USDA has been developed to protect horses against viremia caused by WNV. WNV infection, caused by a flavivirus belonging to the Japanese encephalitis virus complex, is enzootic in parts of Africa and Asia. It was first detected in 1999 in the US in an outbreak involving birds, horses, and humans in New York, subsequently spreading rapidly to many states.

I was particularly concerned by research being conducted at Philadelphia’s Thomas Jefferson University, Jefferson Vaccine Center under the direction of a Dr. Matthias J. Schnell who co-authored a scientific paper entitled ‘Rabies virus-based vectors expressing human immunodeficiency’. The following is the Center’s own synopsis of the research and development that is underway at this institution:

Research interests of the laboratory are the development of novel vaccines and viral pathogenesis.

Vaccines: Our laboratory develops Rhabdovirus-based [Rabies] vectors as vaccines against other infectious diseases. We are particularly interested in using molecular adjuvants and other molecules to enhance antigen-specific immunity and manipulate and retarget immune cells. Using different molecular approaches, we perform detailed studies of highly attenuated RVs expressing HIV-1 or SIV genes and analyze their immunogenicity in mice. Our most promising HIV vaccine candidates are currently being analyzed in a monkey model for AIDS. Other approaches include using genetically modified RV G proteins or RV capsids to carry antigens of other pathogens as vaccines against Anthrax and Botulism. We also seek to develop safer and more potent RV vaccines for wildlife and humans. 

Pathogenesis: We are interested in understanding the interaction of rabies with the infected host at the molecular level. The molecular mechanism of rabies virus pathogenesis is not well understood, and our research analyzes the different functions of the rhabdoviral proteins (e.g. rabies virus) and their interactions with host proteins and the immune system.

Current projects are directed toward understanding: RV virus neurotropism and neuroinvasiveness; The transport of RV within neurons and the interaction of the RV phosphoprotein and glycoprotein with host proteins (receptors and transporter molecules); Immune responses of wild-type RV and RV-based vectors in the infected host (innate and adaptive) 

GE virus developers Dongming Zhou, Ann Cun, Yan Li, and co-workers with Philadelphia’s Wistar Institute, posted on line on June 22, 2006, (doi:10.1016/j.ymthe.2006.03.027 ) a report entitled A Chimpanzee-Origin Adenovirus Vector Expressing the Rabies Virus Glycoprotein as an Oral Vaccine against Inhalation Infection with Rabies Virus. Their summary read as follows:

Rabies has the highest fatality rate of all human viral infections and the virus could potentially be disseminated through aerosols. Currently licensed vaccines to rabies virus are highly effective but it is unknown if they would provide reliable protection to rabies virus transmitted through inhalation, which allows rapid access to the central nervous system upon entering olfactory nerve endings. Here we describe preclinical data with a novel vaccine to rabies virus based on a recombinant replication-defective chimpanzee-origin adenovirus vector expressing the glycoprotein of the Evelyn Rokitniki Abelseth strain of rabies virus. This vaccine, termed, induces sustained central and mucosal antibody responses to rabies virus after oral application and provides complete protection against rabies virus acquired through inhalation even if given at a moderate dose.

(These researchers used rodents, dogs, and primates in their research, and cultures of chicken fibroblasts).

This is a brief sample of the kind of vaccine research and development that is now going on world-wide. The use of recombinant replication-defective, vectored vaccines that express the proteins of rabies virus raises several issues, and comes close on the heels of using modified adenoviruses, herpesviruses and pox viruses as delivery systems for foreign antigens in livestock and poultry vaccines, and in bait to vaccinate and immuno-contracept wildlife. (For details see OIE/World Organization for Animal Health, Manual of Diagnostic tests and Vaccines for Terrestrial Mammals, 2008. www.oieint/eng/normes/mmanual/A_00099.htm)

In July 2009 the World health Organization reported several outbreaks of a mutated strain of poliomyelitis in children identified as causing paralysis originating from children who had been given the oral, modified live vaccine that they shed in their urine and feces which forseeably infected unvaccinated children. Oral vaccination of red foxes against rabies in Ontario Canada, using a modified live virus vaccine in bait (often distributed from airplanes) has actually caused rabies in red foxes, raccoons, striped skinks and domestic animals (a bovine calf), according to Fehiner-Gardiner et al (2008). 

Revisiting Vaccination Needs and Safety

The first vaccine was Jenner’s cow pox (vaccinia) that gave protection to a related human virus, small pox (variola) when injected into the skin. This practice of dispensing a mild infection in the form of a vaccine, to give protection against a more virulent, natural strain is an ancient one. Maasai and other African herders would make small incisions on healthy cattle’s thighs and shoulders and then rub in a paste that included the secretions from sores of infected animals suffering from diseases like rinderpest, a virus closely related to measles and canine distemper viruses.

Jenner’s discovery was a rare instance of cross-resistance, since subsequent vaccines did not have a less harmful related virus to use but instead were usually composed of killed organisms of the same natural infective virus or bacterium to induce an immune response. A few safe and effective vaccines were developed to give protection from tetanus and diphtheria using the inactivated toxins from these bacteria.

More recently, weaker, so called attenuated, modified live virus (MLV) strains of the same species have been developed that ideally trigger specific antibodies and an immune system ‘memory’ to enable recipients to fight off infection. Immunocompromised individuals might get the disease from the actual MLV. . In July 2006 Fort Dodge Animal Health recalled about 330,000 doses of a MLV rabies vaccine after a quality-assurance test indicated an issue with the duration of protection. The company confirmed one dog contracted rabies after receiving a dose from Serial 873113A of its Rabvac 3 TF vaccine. A statement from Fort Dodge added that the primary reason a vaccinated animal would contract the disease is because of a poor immune response. But this does raise a red flag over the potential risks of widespread dissemination of modified live virus vaccines.

Until recently, most vaccines were given by injection, a route that was actually abnormal and possibly problematic, especially when additives like mercury and aluminum were included in the antigen cocktail. Safer, more natural routes are via ingestion or inhalation, this latter route being the focus of new vaccine research and development, especially for use in farmed animals in confined housing systems. But since natural infectious viruses tend to mutate, the strain used in the vaccine may not prove effective, or gives incomplete protection so that the recipient becomes a carrier or succumbs to the new infection.

Already we have seen MLV vaccines infect non-target recipients, like nursing infants via the milk of recently vaccinated mothers. Some virologists believe that the feline distemper or panleukopenia virus mutated and crossed over from cats, or from some unidentified wild carnivore, to become canine parvovirus when it infected dogs. There is now a strain of canine parvovirus (CPV) that can infect cats with a similar disease. Vaccines can be contaminated by other virus strains, abortions and deaths being reported in pregnant bitches receiving a commercial canine parvovirus vaccine that was inadvertently contaminated with blue tongue virus of sheep. 

In-Field Problems with Vaccines

The interactions between administering and receiving vaccinations and existing viral infections in animal populations can be complex and have harmful outcomes. Wildlife biologist Dr Roger Burrows (personal communication, May 13, 2009) writes that ‘Lions in Serengeti National Park (SNP), followed by those in the Masai Mara of Kenya, died like flies in 1994 from a new strain of canine distemper (CD). This followed a period 1992-94 when domestic dogs of agropastoralist/farmers to the west, and Maasai pastoralists dogs to the east of the SNP boundaries were being experimentally vaccinated against rabies during a vaccination trial .The same new strain of CD in the rabies vaccinated domestic dogs was subsequently found in the lions and was then found to have caused the death from CD of most of a captive colony of wild dogs ( Lycaon pictus) in Mkomzai Game Reserve in Tanzania in 2000-2001 – these wild dogs had been vaccinated against CD (using an inactivated strain developed for North Sea Seals!).

Following this, in 2007 the same new CD strain was for the first time identified in free living African wild dogs in Maasai areas to the east of SNP where mass vaccinations of local domestic dogs were being carried out against CD, CPV and rabies. The outbreak confirmed in one large wild dog pack was associated with high mortality of this highly endangered canid species.’

When local breeds of domestic dogs around Serengeti National Park (SNP) and the Masai Mara of Kenya were vaccinated against rabies and then soon after succumb to a virulent outbreak of CD it would seem to indicate that the rabies vaccinations caused some immunosuppression and thus increased susceptibility to CD. Attenuated vaccines should not be given to stressed and immunocompromised animals or humans.

Giving multivalent vaccines such as attenuated CD and CPV together could also be problematic, where one could make the other revert to a more virulent form due to the kind of reaction by the recipient to the other vaccine. Sensitization may occur following vaccination, and subsequent vaccinations could cause an acute inflammatory reaction, the so called cytokine storm, which could be fatal. This may explain why some dogs have severe reactions to vaccinations given a year or so after being given the same cocktail of vaccinations toward which they showed no overt adverse reactions. 

Vaccine Adjuvants & Preservatives

The inflammatory response to vaccinations, for which adjuvants have been blamed, is associated with the development of injection-site fibrosarcomas in cats and also dogs.

While the move toward developing preservative and adjuvant-free vaccines in order to minimize harmful side-effects (such as vaccine hypersensitivities, and mercury-based preservatives exacerbating pre-existing autoimmune disease), they are still widely used. Adjuvants are thought to enhance the immune response for small protein and glycoprotein antigens that elicit a weak immune response alone, by direct stimulation of the immune innate response (inducing local inflammatory reactions and stimulating the nonspecific proliferation of lymphocytes).

Aluminum salt and water/oil emulsions adjuvants are used in food animal vaccines, but can lead to granulomas developing at injection sites. Particulate or microsphere adjuvants are in limited veterinary usage in companion animal vaccines. They are made of biodegradable polymers that allow for a slow release of the antigen to the immune system.

Immunostimulatory complexes (ISCOMS) are being developed and have been introduced into companion animal vaccines. They consist of a complex matrix of saponins, phospholipids and cholesterol incorporating the selected antigen. Their particulate structure enhances their interactions with antigen processing cells. ISCOMS tend to localize in lymph nodes draining the injection site, prolonging the immune response, and can be administered at mucosal surfaces enhancing local antibody responses. Glycoside products called Quill A from the Chilean soap bark tree, and saponins are used in some companion animal vaccines. Being quite toxic these adjuvants require extensive purification to minimize toxicity. Squalene, a hydrocarbon triterpene, normally present in the human body as well as in shark liver and wheat germ, is used in conjunction with DL-a-tocopherol and polysorbate 80 as an adjuvant in flu and other vaccines (See Novartis MF59 and GlaxoSmithKline AS03 and AS 05. Injected squalene is suspected to cause a chronic inflammatory immune response in some individuals and may induce lupus antibodies and autoimmune arthritis.

The widely used vaccine preservative, Thimerosal, is a mercury-based compound that may damage DNA, neurons and T-cells. 

Viruses Evolve and Mutate

Now that we have the new influenza viral strain that on its evolutionary journey in pigs and poultry has killed wild birds, humans, dogs, and cats, we should honor the nature of viruses. And most importantly, not fight them with vaccine cocktails of antigens with or without preservatives and adjuvants, which may make recipients extremely ill, and even die. The latest influenza viral strain A/H1N1 isolated in human patients in the US has a genetic sequencing indicating recombination of North American swine influenza, human influenza, avian influenza and Eurasian swine influenza virus.

The entire field of vaccinology and vaccine development, which appeals to and has attracted many brilliant scientists, is fraught by a reductionist paradigm which equates vaccinations with preventive medicine rather than seeing it as a last resort at best: or a response in contexts where alternative methods of disease prevention and control have been tried and failed, (e.g. sanitation).

The environmental and ecological consequences affecting inter-species balance, where modified live vaccines may be transferred horizontally as well as vertically and where one or more species and particular at risk individuals (‘at risk’ identified as those who are already immunocompromised by stress, malnutrition, and infection) may put other species and individuals at risk due to population disruptions, are not being considered in the decision to vaccinate: Or else the consequences of vaccination are simply dismissed. In many instances mild viral infections are often best treated symptomatically and with nutraceutical supplements given as preventatives rather than run the risk of vaccinosis which could be for life and cause much suffering and expense.

Genetic factors – individual, familial, sub-species (or hybrid and selected breed or race) and species – represent important biogical variables in vaccine risks and benefits and are now gaining some belated attention. But the epigenetic effects and trans-generational consequences of introducing live vaccines into human and animal (domestic and wild) populations have yet to be significantly addressed as representing potentially one of the greatest long-tem risks, far outweighing any benefits except to their manufacturers and dispensers.

Application of the precautionary principle is clearly called for, along with a vigorous bioethical evaluation, not simply to assess risks and benefits, and safety and effectiveness, but of real need and in-context determination instituting application wherever appropriate, of alternative disease-prevention measures. These alternatives include improved housing and humane treatment of animals raised for food; better husbandry of free-range livestock and poultry to control diseases spread to wildlife (and vice-versa); not allowing pet cats and dogs to roam free, community spay-neuter programs; and improved shelter, nutrition, sanitation, clean water and socio-economic security incentives to facilitate the acceptance of family planning in many human communities around the world. In the developed world we should not be surprised when pig and poultry-specific viruses mutate under certain conditions, as in pig poultry and rabbit factory farms, to become infectious to humans, cats, dogs and wildlife.

The widespread dissemination of small pox and rinderpest vaccinations have been touted as signal successes in eliminating these global scourges of human and wild and domestic ruminant animal populations respectively. Such triumphalism needs to be tempered by the fact they have done little to alleviate human starvation, overpopulation and the adverse environmental impact of livestock over-grazing and over-stocking, to which they are now contributing until the next pandemic strikes.

Viruses are clearly an ‘indicator’ species reflecting their hosts’ quality and kind of life. Repeated mass inoculations of people and their domestic animals can indirectly foster the selective evolution of other pathogens, or more virulent mutations, especially when the consequences of such ‘public health’ measures are not fully considered and addressed, such as within ever increasing population numbers and concentrations/densities. This means no end to business for investors and vaccine and drug manufacturers.

Some virologists now recognize that a gap of at least 3-4 weeks is desirable between giving one vaccine and then a different one, because if not so spaced the immune response to the second vaccine may be inadequate and not produce sufficient specific antibodies to give protective immunity. If there is a dormant/latent viral infection already present in the recipient, vaccination against another pathogen could depress the immune system leading to the latent viral infection activating and expressing a new illness. This may be the case in cats, for example, who can come down with feline leukemia or herpes virus infections after receiving a feline distemper or rabies vaccine. Therefore, it concerns me that both humans, especially children, and animals are given combinations of vaccines—‘cocktails’, an all in one visit rather than carefully sequenced series of different vaccinations. It also concerns me that veterinarians seem to give little or no consideration to the role of vaccinations in the etiology of animal diseases, especially since more such cases are being more widely diagnosed following repeat-vaccination of dogs and of certain canine breeds in particular.

In their discussion of possible causal co-factors in the genesis of neonatal pancytopenia in a herd of beef cattle, authors Bell and others (2010) make no mention of the potential role of vaccinations, the herd in question receiving six different booster vaccinations two months before the start of calving. Similarly, Shiel and others (2010) inexplicably did not raise the possibility of adverse vaccine reactions (vaccinosis) in a kennel of greyhounds all receiving several vaccinations prior to dogs developing non-suppurative meningioencephalitis.

To make no mention of the possibility of vaccinosis may or may not reflect some taboo or complacent attitude toward questioning the role of modified live, attenuated and new-generation genetically engineered, DNA vaccines (and their adjuvant additives and substrate contaminants) in the aetiology of various disease conditions, (Kamal 2009), notably those now increasingly diagnosed as auto-immune diseases, (Duval & Giger 1996,Goggs and others 2008, Botch and others 2009).

Many modified live vaccines are grown on mammalian cells which can harbor retroviruses. Miyazawa and others (2010) write:

The genomes of all animal species are colonized by endogenous retroviruses (ERVs). Although most ERVs have accumulated defects that render them incapable of replication, fully infectious ERVs have been identified in various mammals. In this study, we isolated a feline infectious ERV (RD-114) in a proportion of live attenuated vaccines for pets. Isolation of RD-114 was made in two independent laboratories using different detection strategies and using vaccines for both cats and dogs commercially available in Japan or the United Kingdom. This study shows that the methods currently employed to screen veterinary vaccines for retroviruses should be reevaluated.

Substrate contaminants have led to adverse reactions such as kidney disease in cats (Lapin and others, 2006), and also to drug recalls, as with human measles vaccine contaminated with low levels of avian leukosis retrovirus; rotovirus vaccine with porcine circovirus, and Simian virus 40 in Polio vaccines possible leading to non-Hodgkin lymphoma ( Vilchez et al 2002). Adjuvants added to vaccines to stimulate the immune response can also pose problems (Spickler & Roth 2003).Vaccines derived from cell cultures, such as from canine kidney cells and human fetal cells, and intended for use in that same species, may cause auto-immune disease.

Veterinarians O’Toole and Van Campen (2010), expressing concern over the high incidence of abortions following cow vaccinations with MLV vaccines, particularly to bovine diarrhea virus, for which there are over 150 different vaccination brands available, urge government to require vaccine manufacturers to provide genetic sequence information to enable diagnosticians to be able to differentiate between vaccine and field strains of viruses causing animal health problems.

The correlation between vaccinations and neurological diseases in humans was demonstrated 15 years ago (Montinari and others 1996). Several human autoimmune diseases have been shown since then to be associated with both genetic factors and vaccinations ( Orbach and others 2010). The latter authors state: “Infectious agents contribute to the environmental factors involved in the development of autoimmune diseases possibly through molecular mimicry mechanisms. Hence, it is feasible that vaccinations may also contribute to the mosaic of autoimmunity. Evidence for the association of vaccinations and the development of these diseases is presented in this review. Infrequently reported post-vaccination autoimmune diseases include systemic lupus erythematosus, rheumatoid arthritis, inflammatory myopathies, multiple sclerosis, Guillain-Barré syndrome, and vasculitis. In addition, we will discuss macrophagic myofasciitis, aluminum containing vaccines, and the recent evidence for autoimmunity following the use of human papillomavirus vaccine.”

These two associations (i.e.genetics (breed) and vaccinations) in the aetiology of various diseases in dogs, (Scott-Moncrieff and others, 2002), some hitherto believed to be of ‘idiopathic’ origin such as epilepsy and cutaneous atopy in dogs, have been reviewed ( Dodds 2001, Hogenesch 1999), nutritional factors ( Beck 2000) also being considerable, including prenatal and epigenetic influences. Adverse canine vaccination reactions were documented several years ago, notably interstitial nephritis and corneal opacity following vaccination with one type of infectious canine hepatitis (Appel and others 1973), and encephalitis occurred when co-administered with a canine distemper virus vaccine (Cornwell and others 1988). 

Vaccinoses – Adverse Vaccine Reactions

This is the roulette of vaccine-based preventive medicine. It has become an industry that we are learning to censor because of the increasing incidence of adverse vaccine reactions, so called vaccinosis, in human and companion animal recipients. Selling annual vaccinations along with manufactured, highly processed pet foods has become the bread and butter of conventional small animal veterinary practice. Yet this combination, as in the consumer populace eating junk and convenience foods and being hypervaccinated in childhood, is the cause of a host of iatrogenic health problems, compounded by genetic susceptibility in certain pure-breeds and individuals.

Veterinarian Dodds (2001) has linked the following health problems in dogs to vaccinations, which can harm some breeds more than others and appear more randomly in the ‘mixed breed’ segment of the population: fever, stiffness, sore joints and abdominal tenderness, neurological disorders, polyneuropathy, transient seizures, and encephalitis, increased susceptibility to infections, collapse with autoimmune hemolytic anemia, immune mediated thrombocytopenia, immune-mediated hemolytic anemia, autoimmune thyroiditis, necrotizing vasculitis, joint disease, polyarthritis, and hypertrophic osteodystrophy. Hogenesch and others (1999) conducted several studies to determine if vaccines can cause changes in the immune system of dogs that might lead to life-threatening immune-mediated diseases such as lupus and glomerulonephrosis. The vaccinated, but not the non-vaccinated, dogs in the Purdue studies developed autoantibodies to many of their own biochemicals, including fibronectin, laminin, DNA, albumin, cytochrome C, transferrin, cardiolipin and collagen. Autoantibodies to cardiolipin are frequently found in genetically susceptible patients with systemic lupus erythematosus, and also in individuals with other autoimmune diseases. The presence of elevated anti-cardiolipin antibodies is significantly associated with cardiomyopathy.

Vaccinosis-prone dog breeds may mirror vaccinosis prone ethnic groups and individuals in the human population.Diabetes Types 1 & 2 have been linked to early vaccinations in human infants, (Classen 1996). Montinari et al (1996) were the first to use immunogenetics to show the antigenic linkage between brain damage (demyelination) and a recombinant hepatitis vaccine in humans.

PfizerAnimal Health has acknowledged evidence of a ‘strong association’ between the use of its PregSure bovine viral diarrhoea (BVD) vaccine and the later development of ‘Bleeding Calf Syndrome’.The company voluntarily suspended sales of PregSure BVD in Germany in April 2010 and then in other member states in June 2010. (reprted by A. Driver in Farmer’s Guardian, May 3, 2011). This action was initiated as a precautionary measure in light of reports that the vaccine may have an association with Bovine Neonatal Pancytopaenia (BNP), the disease also known as ‘Bleeding Calf Syndrome’ that was first recognised in the UK in 2009.

The risks of growing vaccines in cells derived from the same species has been underscored by the research of Deutskens et al (2011). They found that cows given Pfizer’s bovine viral diarrhea virus vaccine produced from cultured bovine cells caused some cows to produce alloantibodies in response to the major histocompatability complex class 1 (MHC1) proteins which are released during the production process of the vaccine. If the mother cows MHC1 allotype differs from that present in the vaccine, they will produce antibodies, but are not harmed. If the cows then produce calves with a different MHC1 allotype derived from the father bull, the calves’ cells will be targeted by their mothers’ antibodies, transferred in the colostrums. The alloantibody destruction of the calves’ megakaryocytes results in the calves being unable to produce blood-coagulating platelets which results in bovine neonatal pancytopenia, the Bleeding Calf syndrome. 

Interference or interreaction effects between different vaccines given in combination at the same time or separately at close intervals are a legitimate concern, potentially causing increased virulence and immunosuppression, or as Taguchi and others (2010) have shown, such immunization schedules depress the immune response and lowering anitbody titers, which may prompt the expression of latent infection or autoimmune disease to arise.

Humans and other animals with inherited faulty B and/or T cell immunodeficiencies should not receive live-virus vaccines due to the risk of severe or fatal infection. B and T cell immunodeficiencies are also associated with food allergies, inhalant allergies, eczema, dermatitis, neurological deterioration and heart disease.

Dog breeds vary in the titers they develop following vaccination, a low titer not necessarily meaning poor immunity because of other components of immune defense mechanisms that blood titers do not measure, including mucosal immunity, cell-mediated immunity, and immune memory ells. The innate immune system modulates the quality and quantity of long-term T and B cell memory and protective immune response to pathogens.

Patients on steroidal and non-steroidal anti-inflammatory drugs may not produce a good antibody response to vaccinations, while pre-vaccination sensitization of dogs with an allergen such as pollen can lead to hypersensitivity associated with excess amounts of IgE antibodies and subsequent chronic inflammation of the skin, conjunctivitis and rhinitis.(Frick & Brooks,1981).

Long-term over-activation of the immune system, as through hyperimmunization with repeated annual ‘booster’ vaccinations, may be a major cause of cancer. Smith and Missailidis (2004) have proposed that inflammation could prevent the body from recognizing a foreign substance and may therefore serve as a hiding place for invaders. Cancers are like wounds that never heal and are surrounded by inflammation. This is generally thought to be the body’s reaction to try to fight the cancer, but this may not the case. The inflammation is not the body trying to fight the infection. It is actually the virus or bacteria deliberately causing inflammation in order to hide from the immune system. That dogs surpass humans in the incidence of certain cancers raises the probability of hyperimmunization with MLVs which is a widespread practice in the US, the UK, Australia and many other countries.

Holistic equine veterinarians have informed me that most horses are given so many different vaccines that many become immunocompromised. Vaccinating horses against West Nile virus can cause swelling in the front legs, fever, diarrhea and other systemic reactions like purpura hemorrhagica, urticaria and anaphylaxis. West Nile vaccine is also found to cause abortions in mares. Pickles and others (2011) found that 27 perecent of horses given gonadotrophin-releasing hormone vaccinations had adverse reactions including one “severe, presumed immune-mediated myositis.” (Expressed in the horse’s typical behavioural response to pain as evidently excruciating and potentially fatal muscular inflammation).

In part because of the immunocompromised condition of many racehorses infected with equine influenza and who passed the infection on to greyhounds at the same track, a variant canine influenza vaccine is now marketed across the U.S. 

The Behavior and Ecology of Viruses

Even seemingly harmless viruses like the coxsackievirus can become virulent in selenium-deficient human hosts (Beck,2000). Stress and malnutrition go hand in hand, impairing the immune system’s ability to respond effectively against viral infections—and even against weaker strains in vaccines that then convey no immunity. Given this extreme variability of viruses that proliferate more as population densities increase, especially down on the CAFOs—confined and crowded animal feeding operations for pig, poultry and cattle industry “farms”, we should not be adding to the genetic diversity of the viral community by introducing live GE vaccines. The same reservations hold true for the ‘philanthropic’ vaccination programs in the urban slums and impoverished rural communities where humans, rats, rabid dogs, and Ebola virus- and AIDS virus-carrying monkeys are part of the inter-species matrix for viral proliferation and evolution. We must look to safer and in the long term less costly solutions by addressing the ecology and behavior of infectious viruses.

The kinds of viral research going on today, including applications in biowarfare, are primarily driven to develop new vaccines to market in the name of ‘preventive’ human and veterinary medicine. The risks of genetically engineering new vaccines are considerable. Pair the release of such GE vaccines into the environment with the recent reporting of the rabies virus rapidly evolving in Arizona and other parts of the US. It is cross-infecting bats, foxes, and skunks, and health authorities are rightly concerned that the virus could soon jump into the human population, like the Hanta virus, and West Nile virus. Adding attenuated live vaccines into such a pathogenic milieu is counter-intuitive.

Using the proteins expressed from the rabies virus DNA, albeit replication-defective, and splicing it on to a highly attenuated avian influenza virus for manufacture and use by the poultry industry world wide is patently absurd in terms of potential risks and ultimate costs. Widespread vaccinations against one infectious strain may open the door for the proliferation of a different pathogenic virus, as in the viral epidemic-vaccine associated outbreaks of canine distemper and rabies in Maasai dogs and lions, wild dogs, and other endangered carnivore species. This is now being compounded by the spread of canine parvovirus into their communities. It should not be forgotten that without rigorous manufacturing protocols and safety tests, vaccines can become contaminated, not only with potentially hazardous DNA and RNA elements, but also with live viruses such as the bluetongue virus in canine distemper vaccine (Wilbur et al 1994).

The development of vaccines and biowarfare agents that can be dispensed as aerosols or nose-drops, (in part justified in order to reduce adverse reactions to adjuvants in injected vaccines that can cause cancer and other diseases), has obvious military value. But such aerosol vaccines, like those of pig brains in mid-west slaughter houses that caused neurological disease in several workers, include foreign proteins that could trigger neurological and auto-immune diseases, allergic reactions and anaphylactic shock. 

Safety and Consequences

Even if such government endorsed, pharmaceutical company funded, and ‘philanthropically’ supported institutions like the Jefferson Vaccine Center and Wistar Institute pass with flying colors on biosecurity, the actual biosafety of their new vaccines can only be really determined after they are released. The bioethics and biological consequences of these innovations have never been satisfactorily answered from a purely objective and scientific rather than profit-driven perspective. The same must be said with regard to the creation of vaccine-producing plants, like the potato with Hepatitis B oral vaccine that cooking will not destroy, and of genetically engineered and cloned farmed animals producing monoclonal antibodies in their milk and blood for use in ‘the war on cancer’ and other anthropogenic diseases. Developers of GE vaccines are gambling with life for primarily pecuniary ends especially when the use of such vaccines is the primary if not sole response to potential pandemics and to the challenges of public health and disease prevention.

Berkelman (2003) in her review of zoonotic consequences of vaccinations notes that human cases of Brucellosis and Bordetella infections from animal vaccines have been documented, and that Buffalopox virus epidemics were first noted during the smallpox vaccination era in India, Egypt and Indonesia. (See also Damasco et al 2000). Berkelman echoes my concerns over the widespread dissemination of wildlife bait containing an oral rabies vaccine composed of recombinant vaccinia-rabies glycoprotein virus, noting that human vaccinia infection associated with this product have been reported. With escalating use of such baits especially in the U.S., the creation of a wildlife reservoir for vaccinia virus is highly probable.

The misanthropy behind commercial vaccinology is more of consequence than design. Or so I wish to believe. The new generation of live GE vaccines being developed, tested and marketed could amount to a chaos-sustaining genetic pollution that will predictably be far worse than radioactive ‘waste’, because it will be impossible to ever recall or contain. There are enough DNA damaging pollutants in our food, water and air which need to be cleaned up as it is. Indirectly profiting from the health problems these are causing with ever more pharmaceutical and other conventional, often iatrogenic, medical treatments is ethically questionable. Infections to a large extent are anthropogenic, and so disease control has always been best achieved through such common sense reduction of exposure risk, good hygiene, mechanical barriers/quarantine, and assuring good nutrition and healthy (especially non-crowded) environments.

It therefore may be prudent for those who are vaccinating billions of farmed and companion animals around the world to consider the long-term health and environmental implications of vaccines, and the related concerns being expressed and documented by virologists and other scientists over the safety, effectiveness and need for various vaccines currently being introduced into human and animal populations (Chan 2006, Traavik 1999). Because of the shorter lives of animals being killed for food the long-term adverse effects of vaccinations may only be evident in longer-lived breeding stock. DNA vaccines that purportedly need no cold-chain preservation, are normally bacterial plasmids into which are spliced a promoter active in mammals, such as the cytomegalovirus promoter. This drives the coding sequence for an antigen. The plasmid is taken up by the mammalian cells and reaches the nucleus of some of those cells. There it is transcribed into RNA, which is translocated to the cytoplasm and translated into antigen protein. DNA vaccines thus induce a full spectrum of immune responses. These include antibodies, cytotoxic T lymphocytes, and T helper cells. Concerns have been expressed over the induction of autoimmunity and anti-DNA antibodies, which were observed in rabbits immunized with plasmids bearing a HIV reverse transcriptase gene.

Chan (2006), following up on the earlier concerns expressed by T. Travik writes:

Despite major therapeutic advances, infectious diseases remain highly problematic. Recent advancements in technology in producing DNA-based vaccines, together with the growing knowledge of the immune system, have provided new insights into the identification of the epitopes needed to target the development of highly targeted vaccines. Genetically modified (GM) viruses and genetically engineered virus-vector vaccines possess significant unpredictability and a number of inherent harmful potential hazards. For all these vaccines, safety assessment concerning unintended and unwanted side effects with regard to targeted vaccinees has always been the main focus. Important questions concerning effects on nontargeted individuals within the same species or other species remain unknown. Horizontal transfer of genes, though lacking supportive experimental or epidemiological investigations, is well established. New hybrid virus progenies resulting from genetic recombination between genetically engineered vaccine viruses and their naturally occurring relatives may possess totally unpredictable characteristics with regard to host preferences and disease-causing potentials. Furthermore, when genetically modified or engineered virus particles break down in the environment, their nuclei acids are released. Appropriate risk management is the key to minimizing any potential risks to humans and environment resulting from the use of these GM vaccines. There is inadequate knowledge to define either the probability of unintended events or the consequences of genetic modifications.

Reliance on vaccinations as the cornerstone of preventive medicine and the top priority of the new ‘One Health’ movement being promoted by the BVA, AVMA, and World Health Organization among others, including philanthropic organizations such as the Bill & Melinda Gates Foundation and even some scientists in wildlife conservation and research, may be unwise, scientifically unsound, and medically unjustified when avoidable. Governmental health agencies’ insistence on certain vaccinations, be they for children or animals, should recognize their full liablity to compensate victims for adverse reactions, and to empower attending physicians and veterinarians with the authority to grant waivers where there is informed dissent, or conditions where such blanket regulations are inappropriate, as with companion animals who are always kept indoors, farmed animals raised in accordance with organic farming standards, and all patients who are immunocompromised.

Above all, natural ecosystems must receive emergency CPR—conservation, preservation and restoration analysis and action. Unhealthy, human-infested and degraded ecosystems are ideal environments for viruses to spill over from healthy carrier hosts, like bats who have brought us from their desecrated forests, the Hendra, Nipah and Ebola viruses that killed people and, respectively, horses, pigs and neighboring chimpanzees and gorillas. The Simian immunodeficiency virus spilled over into humans as HIV-1. Anthropozootic diseases (from the people to the wildlife) include polio, measles, influenza and tuberculosis.

In the absence of relevant bioethics,(Potter 1977 & Fox 2006), vaccinations and other medical and veterinary practices may cause more harm than good, especially when altruism is misguided and or uninformed, and the Earth’s ‘carrying capacity’ and biodiversity-dependent functionality are not considered, ( Hardin 1977).

Vaccinations are neither the end-all of preventive medicine nor its proper foundation, but used with caution they may play a useful role in integrated (animal-human-environment) medicine and health care maintenance. The behavior of viruses would seem to make them an indicator bell-weather species for us to monitor and understand for our own good rather than reflexively seek to eradicate them, since they reflect dysfunctional ecosystems and animal and human communities and populations.


Michael W. Fox, Fox’s Pen Inc., 2135 Indiana Ave N., Golden Valley Minnesota 55422USA e-mail

My thanks to W.Jean Dodds DVM, Patricia M. Jordan DVM & Scott Kale MD, JD, for input on this topic. For more detailed reviews of vaccination issues in animals, and the critical health and immune system associations with diet, nutrition and genetically engineered ingredients in pet foods, visit   

Postscript: Vaccination Protocols for Companion Animals

The World Small Animal Veterinary Association (WSAVA) guidelines include the statement that “dogs that have responded to vaccination with MLV core vaccines (parvovirus, distemper virus and adenovirus) maintain immunity (immunological memory) for many years in the absence of any repeat vaccination”. The 2007 WSAVA guidelines specifically warn that core vaccines should not be given any more frequently than every three years after the 12 month booster injection following the puppy/kitten series. The American animal Hospital Association’s Canine Vaccine Task Force in 2003 noted that MLV vaccines are likely to provide lifelong immunity, stating “when MLV vaccines are used to immunize a dog, memory cells develop and likely persist for the life of the animal”.

While the World Small Animal Veterinary Association now advocates a minimal 3-year interval between core ‘booster’ vaccinations for dogs and cats, the UK government’s Veterinary Medicines Directorate (VMD) remains adamant that veterinarians should follow the manufacturers’ guidelines posted on their website as per Pfiizer Ltd Vanguard 7 Canine vaccine description in the VMD’s Summary of Product Characteristics (SPC). (

“The duration of immunity for canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2 and the leptospiral components are at least 12 months. However, the duration of immunity for canine parainfluenzavirus has not been determined.—Re-vaccination Scheme:A single dose of Vanguard 7 to be given annually thereafter”.(Italics mine).

The VMD chief executive, Prof. Steve Dean, in a letter to the UK’s Canine Health Concern, while acknowledging the WSAVA basic 3-year core vaccination regimen is accepted by many on clinical and science-based grounds, insists that the manufacturers’ protocols published in the SPC, as per re-vaccination, should be adhered to by prescribing veterinarians, stating that “if departing from the SPC, veterinary surgeons do so under their own responsibility, and would be well advised to do so with the client’s agreement.”

Meeusen and others (2007) write: “A concern is that repeated vaccinations (with canarypox or other vectored vaccines) may result in immunity to the vector virus eliminating its ability to infect/transmit the desired genes to the immune system. Currently, several vectored vaccines are used in companion animals”. Young adult small-breed neutered dogs that are given multiple vaccines per office visit are particularly at risk of a vaccine-associated adverse event within three days of being vaccinated (Moore et al 2005).

NB The U.S. Supreme Court ruling, Feb 22, 2011 to protect vaccine manufacturers from law suits following adverse reactions in children by denying parents the right to sue in state courts is a disturbing matter of public record. U.S. Congress set up an informal “vaccine court” in 1986 to settle claims, paying out $1.9 billion to more than 2,500 plaintiffs. The case that went to the Supreme Court was rejected by the vaccine court even though the child suffers from residual, post-vaccination seizures. 


Isolation of an Infectious Endogenous Retrovirus in a Proportion of Live Attenuated Vaccines for Pets

Takayuki Miyazawa1 et al, J.Virol. April 2010 84:3690-3694


The genomes of all animal species are colonized by endogenous retroviruses (ERVs). Although most ERVs have accumulated defects that render them incapable of replication, fully infectious ERVs have been identified in various mammals. In this study, we isolated a feline infectious ERV (RD-114) in a proportion of live attenuated vaccines for pets. Isolation of RD-114 was made in two independent laboratories using different detection strategies and using vaccines for both cats and dogs commercially available in Japan or the United Kingdom. This study shows that the methods currently employed to screen veterinary vaccines for retroviruses should be reevaluated.


Vaccines Backfire: Veterinary Vaccines Found to Combine Into New Infectious Viruses

ScienceDaily (July 12, 2012) — Research from the University of Melbourne has shown that two different vaccine viruses- used simultaneously to control the same condition in chickens- have combined to produce new infectious viruses, prompting early response from Australia’s veterinary medicines regulator.

According to Australian researchers, two new infectious laryngotracheitis viruses have arisen from vaccines used to prevent the disease in chickens. The study, which compared the new viruses to two ILT vaccines widely used in Australia’s poultry industry, found that the live portions of the vaccines recombined, forming the two new strains. The study supports the need for regulating the use of attenuated live vaccines across all species to protect against the formation of new viruses, researchers said.

The vaccines were used to control infectious laryngotracheitis (ILT), an acute respiratory disease occurring in chickens worldwide. ILT can have up to 20% mortality rate in some flocks and has a significant economic and welfare impact in the poultry industry.

The research found that when two different ILT vaccine strains were used in the same populations, they combined into two new strains (a process known as recombination), resulting in disease outbreaks.

Neither the ILT virus or the new strains can be transmitted to humans or other animals, and do not pose a food safety risk.

The study was led by Dr Joanne Devlin, Professor Glenn Browning and Dr Sang-Won Lee and colleagues at the Asia-Pacific Centre for Animal Health at the University of Melbourne and NICTA’s Victoria Research Laboratory.

Dr Devlin said the combining of live vaccine virus strains outside of the laboratory was previously thought to be highly unlikely, but this study shows that it is possible and has led to disease outbreaks in poultry flocks.

“Live vaccines are used throughout the world to control ILT in poultry. For over 40 years the vaccines used in Australia were derived from an Australian virus strain. But following a vaccine shortage another vaccine originating from Europe was registered in 2006 and rapidly became widely used,” Dr Devlin said.

“Shortly after the introduction of the European strain of vaccine, two new strains of ILT virus were found to be responsible for most of the outbreaks of disease in New South Wales and Victoria. So we sought to examine the origin of these two new strains.”

The team sequenced all of the genes (the genome) of the two vaccines used in Australia, and the two new outbreak strains of the virus. Following bioinformatic analysis on the resulting DNA sequence, in conjunction with Dr John Markham at NICTA’s Victoria Research Laboratory, they found that the new disease-causing strains were combinations of the Australian and European origin vaccine strains.

“Comparisons of the vaccine strains and the new recombinant strains have shown that both the recombinant strains cause more severe disease, or replicate to a higher level than the parent vaccine strains that gave rise to them,” Dr Lee said.

Professor Glenn Browning said recombination was a natural process that can occur when two viruses infect the same cell at the same time.

“While recombination has been recognised as a potential risk associated with live virus vaccines for many years, the likelihood of it happening in viruses like this in the field has been thought to be so low that it was considered to be very unlikely to lead to significant problems,” he said.

“Our studies have shown that the risk of recombination between different vaccine strains in the field is significant as two different recombinant viruses arose within a year. We also demonstrated that the consequences of such recombination can be very severe, as the new viruses have been responsible for the deaths of thousands of Australian poultry.”

“The study suggests that regulation of live attenuated vaccines for all species needs to take into account the real potential for vaccine viruses to combine. Measures such as those now being taken for the ILT vaccines will need to be implemented.”

Journal Reference:

Sang-Won Lee, Philip F. Markham, Mauricio J. C. Coppo, Alistair R. Legione, John F. Markham, Amir H. Noormohammadi, Glenn F. Browning, Nino Ficorilli, Carol A. Hartley, and Joanne M. Devlin. Attenuated Vaccines Can Recombine to Form Virulent Field Viruses. Science, 13 July 2012: 188 DOI: 10.1126/science.1217134 


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Vaccination protocols are under more intense scrutiny internationally for both children (visit and companion animals (1).. Noting the correlation in children receiving the MMR vaccination (triple live measles, mumps and rubella) and their subsequent development of inflammatory bowel disease(2), I see a possible parallel in puppies receiving the standard triple modified live distemper, hepatitis and parvovirus vaccine as a factor contributing to the evident increase in inflammatory bowel disease in dogs. But I would not rule out the possibility of dietary co-factors, especially considering the novel proteins in GM foods, (3,4), and also glyphosate and other herbicide residues contributing to dysbiosis and inflammatory bowel disease.

Also read Genetically-modified Ingredients in Pet Food By Dr. Michael W. Fox

(1 ) Fox, M.W. Healing Animals and the Vision of One Health. Tallevast, FL One Health Vision Press/ 2011

(2) Kawashima, H., Mori, T., Kashiwagi, Y., Takekuma, K., Hoshika, A., & Wakefield, A. Detection and sequencing of measles virus from peripheral mononuclear cells from patients with inflammatory bowel disease and autism. Dig Dis Sci 45:723-9, 2000..

(3) Dona A. and Arvanitoyannis,I.S., Health Risks of Genetically Modified Foods. Critical Reviews in Food Science and Nutrition. 49: 164-175, 2009 

(4) Smith, J.M. Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods Fairfield. Iowa Yes! Books 2007. 


* For more details see and . OIE/world Organization for Animal Health, Manual of Diagnostic tests and Vaccines for Terrestrial Mammals, (2008). www.oieint/eng/normes/mmanual/A_00099.htm

***This paper is included in the following Proceedings which provide further, extensive documentation of human risks of vaccinations from researchers and doctors from around the world:


Additional References & Resources

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United States Department of Agriculture (USDA), Center for Veterinary Biologics Notice Draft No. 327 on the subject of “Studies to Support Label Claims of Duration of Immunity:

Vascellari, M., Melchiotti E., Bozza, M.A et al (2003) Fibrosarcomas at presumed sites of injection in dogs: x characteristics and comparison with non-vaccination site fibrosarcomas and feline post-vaccinal fibrosarcomas. J Vet Med 50: 286-291

Villarreal, L.P. (2004) Viruses and the Evolution of Life. Washington DC, ASM Press.

World Small Animal Veterinary Association Dog and Cat Vaccination Guidelines:


“The only safe vaccine is one that is never used… No vaccine can be proven safe before it is given to children. ” James A. Shannon, while serving as Director of the U.S. National Institutes of Health.








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