FOOD ANIMAL VACCINES:
BIG MONEY & BIG RISKS
BY BARBARA LOE FISHER
republished below in full unedited for informational, educational and research
Most people are aware of Big Pharma’s global human vaccine franchise facilitated by business deals with governments and its attempt to silence skepticism about vaccine safety that could harm profits from sale of vaccines.1 2 Less well known is the existence of a lucrative food animal vaccine franchise, which is seldom mentioned in the mainstream press. Perhaps that is because the breadth of livestock diseases and types of vaccines given to food animals could kill people’s appetites, especially if the information was included on food labels.
Selling veterinary vaccines for animals that humans eat (cattle, pigs, poultry, fish) and human companion animals (cats, dogs, horses) is a big business. Financial forecasts predict it will be a $11.55 billion global market by 2025.3
Merck Leader in Animal Vaccine Sales
For example Merck & Co., which is a leader in sales of both human4
and animal vaccines, markets 49 vaccines for poultry alone.5
Those vaccines were created to prevent or control the spread of diseases like fowl pox, turkey coryza, bursal disease, coccidiosis, laryngotracheitis, hemorrhagic enteritis, avian encephalomyelitis, salmonella and E. coli
Merck markets at least 25 vaccines for cattle diseases6
and many vaccines for pigs, including Argus® SC/ST Avirulent Live Culture, which is “an aid in the prevention of pneumonia, diarrhea, septicemia and mortality caused by Salmonella choleraesuis and as an aid in control of disease and shedding of Salmonella typhimurium.”7
The global vaccine manufacturing giant even markets vaccines for salmon bred on fish farms (aquaculture).8
Infections Kill Animals in Industrial Factory Farms
The routine vaccination of healthy animals that are grown for human consumption has become the norm in modern agriculture for the same reason that antibiotics are now routinely given to farm animals. On the Eco Farming Daily
website, veterinarian Hubert J. Karreman explains that routine administration of antibiotics to animals on large farms is due to the “high concentration of animals in one location, whether it is a forty- to fifty-cow tie stall in a stone barn or a four hundred– to four thousand–cow free-stall system.9
Animals crowded together on industrial (“factory”) farms creates a breeding ground for disease. The underreported U.S. porcine epidemic diarrhea virus, which causes dreaded avian and porcine influenza pandemics on factory farms, killed one-tenth of all pigs in the U.S. between May 2013 and September 2014.10
In Ovo Vaccination: What Are the Risks?
More than 90 percent of broiler chickens in the U.S. are vaccinated “in ovo” according to 2018 research published in Veterinary Research
meaning that chicks are vaccinated as embryos.
At the hatchery, the vaccines are injected directly into the embryo or into the amniotic cavity at around day 18 or 19 of embryonic development. Systems to mass vaccinate embryos at hatcheries in this manner have been used for twenty years and the most common vaccinations are for three poultry diseases: Marek’s, Gumboro and Newcastle.
There are plenty of reported risks associated with these poultry vaccines.
This is what the Veterinary Research authors have reported:
It has been shown, for instance, that if Marek’s disease vaccine is accidentally deposited into the air cell or allantoic fluid, adequate protection is not achieved. The stage of embryonic development can have profound effects on vaccine safety and efficacy. One study, reported that vaccination of 10–12 day-old embryos with herpes virus of turkeys (HVT) led to pronounced lesions and embryonic deaths, while vaccination on days 16 did not cause detectable lesions.
Embryonic age at vaccination has also been shown to be correlated with antibody titers. Maternal antibody titers actually increase after the typical age for in-ovo vaccinations and peak just after hatch. This can interfere with proper vaccine responses. However, evidence suggests that some vaccine strains are more affected by maternal antibodies than others. Deliberate vaccine development may therefore limit the often disruptive effects that can be caused by maternal antibodies.
A Mycoplasma gallisepticum vaccine for in-ovo vaccination of layer chickens has also recently been evaluated, even though high chick losses at hatch were reported for the medium and high doses of the vaccine that were investigated.
It is no surprise that in ovo vaccination allows for other sorts of “Brave New Foods.” For example, in ovo grafting in which small pieces of tissue from a different animal can replace similar size tissue inside the egg can be performed in ovo, although “heavy bleeding may prevent success.” The shell “is then sealed with adhesive tape and incubation is resumed,” write researchers in Practical Aspects of Poultry Vaccination.12
Are You Eating Meat and Drinking Milk from Cloned Animals?
Since the 1980s, scientists have been experimenting with creating poultry chimeras – defined as animals composed of different cell populations from more than one fertilized egg.13
While clones, transgenic animals and chimeras are no longer rare, the potential risks of consuming cloned animal products are seldom discussed by journalists writing for mainstream news outlets.
In fact, few Americans are aware that for more than a decade, they have been eating FDA-approved meat and drinking milk from cloned animals and their offspring, while the European Union prohibits animal cloning and purchase of food products derived from cloning animals.14 15
In a published response to public comments regarding the FDA’s 2006 Animal Cloning Risk Assessment, Risk Management Plan and Guidance for Industry, the federal agency responsible for ensuring the safety of drugs, vaccines and other products stated:16
Because the risk assessment process has clearly shown that there are no food safety concerns for the meat and milk from cattle, swine, and goat clones and the progeny of all clones and that meat and milk from cattle, swine, and goat clones and the progeny of all clones are not materially different from their conventional counterparts, we do not believe, at this time, that there is a material fact that would be required to be included in the labeling of these foods based on the fact they are from clones or the progeny of clones.
Investigative journalist Martha Rosenberg wrote in January 2019 that, “Both Big Meat and Big Pharma welcome the trend of cloned and genetically engineered animals because they make more money. The Franken products are often presented as environmental advances.”
She observed that former FDA Commissioner Scott Gottlieb, MD was OK with Americans eating food derived from genetically engineered animals, including leftover lab animals used to produce the products. Rosenberg reported that Dr. Gottlieb touted the benefits of eating genetically engineered animals like the EnviroPig, which is reputed to excrete 75 percent less phosphorus and use 33 percent less land, thus reducing the carbon footprint. 17
Right now, eating animal meat and fish certified “organic” appears to be the only way to be reasonably sure it is not the product of cloning. In 2011, the USDA issued a National Organic Program Policy Memorandum on Cloning and Organic Livestock Production, stating that, “Cloning as a production method is incompatible with the Organic Foods Production Act (OFPA) and is prohibited under the National Organic Program (NOP) regulation” and “animals produced using cloning technology are incompatible with OFPA and cannot be considered organic under the NOP regulations.” However, USDA added that, “Based on a recommendation of the National Organic Standards Board, USDA’s Agricultural Marketing Service is preparing the necessary public rule making to address the organic status of the progeny of animal clones.”18
Neurotoxic Smallpox Vaccine and Contamination of Vaccines
Vaccine products administered to both humans and animals have a long history of containing toxic ingredients and being contaminated with viruses, viral DNA and other adventitious agents that have known and unknown effects on human and animal health.19
The first human vaccine developed by Edward Jenner in 1796, was a human-animal hybrid live virus smallpox vaccine.20 21
The crude smallpox vaccine was notoriously dirty and neurotoxic, responsible for causing severe brain and immune system damage, including death.22 23
The extreme reactivity of smallpox vaccine given routinely to infants and children by doctors drew protests from parents, who watched their healthy children die or be left with brain damage, and was the origin of anti-vaccination movements in Europe and the U.S. in the 19th
and early 20th
There have been a number of cases where residual adventitious agents, which have known and unknown effects on human health, have been found to contaminate FDA licensed vaccines.26 27
These include identification of a cancer-causing monkey virus (SV40) in polio vaccines; bacteriophage in measles and polio vaccines; reverse transcriptase (RT) in measles and mumps vaccines, and porcine (pig) virus DNA sequences in rotavirus vaccines.28
Today, there are still technological limitations to adequate routine testing of human vaccine ingredients for contaminants.29 30
The U.S. Food and Drug Administration allows human vaccines licensed for use in the U.S. to contain residual DNA and proteins from dog kidney cells; army worm cells; yeast; and human lung tissue cells from a 14 week old aborted Caucasian male fetus, as well as mercury, aluminum, formaldehyde, 2-phenoxyethanol, Polysorbate 8031
and other potentially toxic ingredients.33 34
Are Vaccine Residues or Adjuvants in the Food?
The USDA’s Food Safety and Inspection Service (FSIS) publishes a yearly residue report that screens food for the presence of veterinary drugs, pesticides and heavy metals in meat, poultry and processed egg products sold in the U.S. Samples are tested for aluminum, copper, strontium, lead, zinc, eight other heavy metals and also arsenic, and whether the residues have a soil, petrochemicals/fuel, fertilizer, sewage, coal burning or other origin.34
While heavy metal residues are generally found at lower levels than the residues of the many drugs given to food animals in the U.S., the veterinary literature also issues some warnings about the safety of eating the meat of vaccinated animals.
For example, researchers published a study in the Archives of Virology
in 2011 advising that a “vaccine, particularly if injected subcutaneously, should be introduced into an area of the animal not used for human consumption such as behind the animal’s ear or in the area of the chest wall behind the elbow.” That way, wrote the researchers, “if there is any residual vaccine left or any reaction to it, there will be neither involvement of an edible part of the carcass nor trim losses in food animals.”35
Researchers writing in the journal ISRN Veterinary Science
noted the success of “inducing immunity through nonoral routes of administration,” and suggested using such nonorally administered vaccines in situations where “drug and vaccine residues are an important consideration for food safety.”36
Also, authors of a 2003 report on environmental pollution called “The Potential Impact of Technological Innovation on the Aquaculture Industry,” noted that, because some vaccines used in fish farming contain aluminium hydroxide, glucans, potassium aluminium sulphate or dimethyl sulphoxide, “where there is any possibility of vaccine residues remaining in the fish flesh, a suitable withdrawal period is established.”37
Vaccines Provide Lucrative Markets for Animal Pharma
In 2015, a marketing study estimated the global animal-vaccine market will be worth $7.2 billion by 2020, up from $5.5 billion in 2010. Industry officials report that, already, about one-third of the industry’s revenue is from vaccines.38
What is behind the vaccine boom?
In 2014, the World Health Organization declared that antibiotic resistance is a threat to global health.39
Growing antibiotic-resistance has rendered many antibiotics that are important to humans ineffective and government regulators and medical professionals often blame the practice of giving antibiotics to factory farm animals, although indiscriminate prescription of antibiotics by doctors to patients with viral, rather than bacterial, infections is clearly also responsible for antibiotic resistance.
Although many consumers no longer want to eat food containing antibiotics, the public is not aware of the use of vaccines in animals grown for food on factory farms. The popularity of using genetically modified organisms to create new vaccines presents new risks, especially with vaccines derived from spores. Here is a chilling quote from a 2018 article in Veterinary Research
Despite the progress being made with spore vaccines one key issue remains: the containment of GMOs. Because spores are dormant with the potential to survive indefinitely in the environment, the use of recombinant spores in spore vaccines is likely to raise environmental concerns and successful regulatory approvals may be slow or impossible to secure. For human use, it is likely that a case can be made that the recombinant spore vaccines addresses an unmet clinical need, but for animal use devising a method for biological containment will be crucial.
Animal and Human Vaccines Present Similar Questions and Risks
A quick look at veterinary vaccine literature reveals that the risks plaguing human vaccine production are similar to those of food animal vaccines. These include crippling side effects, unpredictable immune reactions, vaccines that may prevent disease but don’t prevent infection and transmission, vaccines that activate rather than contain a disease and even creation of new, deadlier pathogens.41 42
An example of all the things that can and do go wrong is found in a 2018 article, “Vaccines as Alternatives to Antibiotics for Food Producing Animals,”published in Veterinary Research
Potentially severe side-effects are a concern for many veterinary vaccines, in particular for attenuated-live vaccines and certain adjuvants, and can result in abortions, malformations and deaths…Even for vaccines with less dramatic side-effects, such as coccidia vaccines, productivity losses can be impactful and discourage routine use. Attenuated live vaccines can also carry a risk of reversion to virulent wild type strains, particularly when the molecular changes responsible for the attenuation of the vaccine strain have not been well-characterized.
Some live vaccines carry a risk of horizontal and/or vertical transmission and outbreaks caused by vaccine strains have been described…Finally, for some diseases prior vaccination can actually lead to an exacerbation of clinical symptoms after infection. The immunological reasons for this exacerbation are generally not well understood, but are thought to be due to a shift in immune response after vaccination.
Unfortunately, “not well understood” vaccine reactions do not dampen aggressive marketing by manufacturers of both animal and human vaccines.
Veterinary vaccine literature also acknowledges how, as with humans, the age
of when an animal is vaccinated has a major effect on the vaccine’s outcome which can be very unpredictable, especially for very young animals with maternal antibodies and immature immune systems.44
Eliciting protective immune responses in young animals tends to be particularly challenging because the immune system is still developing, and because maternal antibodies can interfere with the development of protective immunity. Vaccination against diseases that require protective immunity in young animals can therefore be particularly challenging.
In addition, many veterinary vaccines effectively reduce the severity and economic impact of the disease, but do not fully prevent infection and shedding and therefore do little to reduce disease incidence…In some cases, vaccination can actually increase the survival time for infected animals and therefore enhance opportunities for disease transmission.
Emerging science is giving fair warning that, like with vaccines produced for human use, there are significant gaps in scientific knowledge about the known and unknown risks of veterinary vaccines, particularly those administered to animals eaten by humans.
Market and Markets. Vaccines Market worth $66.45 billion by 2027, at a CAGR of 6.7%.
2 Fisher BL. WHO, Pharma, Gates and Government: Who Calls the Shots? NVIC Newsletter Jan. 27, 2019.
3 Brandessence Market Research Co. Veterinary Vaccines Market 2019 Expected to Reach US $11.55 Billion by 2025 Growing at a CAGR of 6.80%. Sept. 17, 2019.
4 Mikulic M. Top 10 pharmaceutical companies based on global vaccine market share in 2017 and 2024. Statista Aug. 9, 2014.
5 Merck Animal Health. Poultry: Featured Products. 2019.
6 Merck Animal Health. Cattle: Featured Products. 2019
7 Merck Animal Health. Swine Product Guide. 2018.
8 Merck Animal Health. Aquaculture: Salmon. 2019.
9 Karreman HJ. Vaccination and Organic Cow Care. Eco Farming Daily.
10 Rosenberg M. The Big Get Bigger: Elanco’s Planned Acquisition of Bayer Animal Health Will Create Another Industry Giant. Organic Consumers Association Aug. 29, 2019.
11 Hoelzer K, Bielke L et al. Vaccines as alternatives to antibiotics for food producing animals. Part 2: new approach and potential solutions. Alternatives to Veterinary Research 2018; 49(70).
12 Bellairs R, Osmond M. In: The Atlas of Chick Development (Third Edition) 2014.
13 Davis K. Genetic Engineering and Cloning of Domestic Fowl. FDA Public Meeting on Cloning Issues Related to Animals Raised for Food Nov. 4, 2003.
14 U.S. Food and Drug Administration. A Primer on Cloning and Its Use in Livestock Operations. Aug. 29, 2018.
15 Hood M, Mollard P. The Dolly Legacy: As You Eating Cloned Meat? PhysOrg July 4, 2016.
16 U.S. Food and Drug Administration. FDA’s Response to Public Comment on the Animal Cloning Risk Assessment, Risk Management Plan, and Guidance for Industry. Sept. 14, 2018.
17 Rosenberg M. Let them eat genetically engineered and cloned lab animals says US FDA Commissioner. Intrepid Report Jan. 14, 2019.
USDA. Policy memorandum on Cloning and Organic Livestock Production
. Jan. 31, 2011.
Murphy FA, Osburn BI. Adventitious Agents and Smallpox Vaccine in Strategic National Stockpile
. Emerg Infect Dis
2005; 11(7): 1086-1089.
20 Collier LH. The Preservation of Vaccinia Virus. Bacteriol Rev 1954; 18(1): 74-86.
21 Huygelen C. Jenner’s cowpox vaccine in light of current vaccinology. Verh K Acad Geneeskd Belg 1996; 58(5): 479-536.
22 Lane JM, Ruben FL, Abrutyn E, Millar JD. Deaths Attributable to Smallpox Vaccination, 1959 to 1966, and 1968. JAMA 1970; 212(3): 441-444.
23 Fulginiti V, Papier A et al. Smallpox Vaccination: A Review Part III. Adverse Events. Clin Infect Dis 2003; 37(2): 251-271.
24 Wolfe RM, Sharp LK. Anti-vaccinationists past and present. BMJ 2002; 325(7361): 430-432.
25 Harvard University Library Open Collection Program. Vaccination. In: Contagion – Historical Views of Diseases and Epidemics. 2013.
26 Krause PR. Adventitious Agents and Vaccines. Emerg Infect Dis 2001; 7(Suppl 3): 562.
27 Avanha H. Virus Safety of Biopharmacueticals: Absence of evidence is not evidence of absence. Contract Pharma Nov. 14, 2011.
28 Petricciani J, Sheets R et al. Adventitious agents in viral vaccines: Lessons learned from 4 case studies. Biologicals 2014; 42(5): 223-236.
29 U.S. Food and Drug Administration. Guidance for Industry: Characterization and Qualification of Cell Substrates and other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. Center for Biologics Evaluation and Research (CBER) February 2010.
30 Gombold J., Karakasidis S et al. Systematic Evaluation of In Vitro and In Vivo Adventitious Virus Assays for the Detection of Viral Contamination of Cell Banks and Biological Products. Vaccine 2014; 32(24): 2916-2926.
31 Parpia R. Polysorbate 80: A Risky Vaccine Ingredient. The Vaccine Reaction Feb. 6, 2017.
32 McGovern C. Dirty Vaccines: New Study Reveals Prevalence of Contaminants. The Vaccine Reaction Feb. 6, 2017.
33 CDC. Vaccine Excipient Summary: Excipients Included in U.S. Vaccines by Vaccine. January 2019.
34 USDA. U.S. National Residue Program for Meat, Poultry and Egg Products. FY2017 Residue Sample Results.
35 Heegaard PMH, Dedieu L et al. Adjuvants and delivery systems in veterinary vaccinology: Current state and future developments. In: Archives of Virology 2011; 156(2): 183-202.
36 Sadozai H, Saeidi D. Recent Developments in Liposome-Based Veterinary Therapeutics. ISRN Vet Sci 2013.
37 Bostock J, Telfer T et al. Report to the Royal Commission on Environmental Pollution: The potential impact of technological innovation on the acquaculture industry. Aquaculture Research Reports 2003.
38 Rosenberg M. The Big Get Bigger: Elanco’s Planned Acquisition of Bayer Animal Health Will Create Another Industry Giant. Organic Consumers Association Aug. 29, 2019.
39 World Health Organization. WHO’s first global report on antibiotic resistance reveals serious, worldwide threat to public health. Apr. 30, 2014.
40 Hoelzer K, Bielke L et al. Vaccines as alternatives to antibiotics for food producing animals. Part 2: new approach and potential solutions. Alternatives to Veterinary Research 2018; 49(70).
41 Fisher BL. Pertussis Microbe Outsmarts the Vaccine As Experts Argue About Why. NVIC Newsletter Mar. 27, 2016.
42 Fisher BL. The Science and Politics of Eradicating Measles. NVIC Newsletter May 25, 2019.
43 Hoelzer K, Bielke L et al. Vaccines as alternatives to antibiotics for food producing animals: Part 1: Challenges and needs. Veterinary Research 2018; 49(64).