VACCINATION - EFFICACY & SAFETY
An international vaccination bombshell by veterinary vaccine researcher reveals taxpayer-funded government agencies do not insure safety and that vaccinated pets (and people) are subjected to dangerous vaccines which serve the pharmaceutical companies far better than the patients.
The following is from one of the world’s leading authorities on vaccination safety and efficacy. We thank Elizabeth Hart for this information including excerpts from her communication with the World Small Animal Veterinary Association’s Vaccination Guidelines (WSAVA) and for her relentless crusade with other vaccine researchers.
TheDogPlace.org also thanks Science and Advisory Board member, Patricia Jordan, DVM, CVA, CTCVH, & Herbology for her invaluable research and input.
Elizabeth Hart, Research Australia
TheDogPlace excerpted information received August 2010
The new 2010 WSAVA guidelines contain these new key statements which are extremely important:
These are important new statements, with reference to “lifetime” immunity, and also noting that non-core vaccines should only be given if necessary. In Australia, with annual MLV (modified live) vaccination under threat, the vets are pushing blanket vaccination for non-core vaccines such as bordetella, which is not appropriate. Pet owners should think about these very carefully before allowing their pets to be vaccinated with non-core vaccines. There is great resistance from veterinarians to the new reduced vaccination protocols here in Australia.
An open letter to representatives of the Australian Pesticides and Veterinary Medicines Authority and representatives of the Australian and International Veterinary Profession/ Industry - June 2010
Attention: Allen Bryce, Program Manager, Veterinary Medicines * Australian Pesticides and Veterinary Medicines Authority (APVMA)
RE: UNNECESSARY, AND POSSIBLY HARMFUL, VACCINATION OF COMPANION ANIMALS AND THE APVMA’S POSITION STATEMENT ON VACCINATION PROTOCOLS FOR DOGS AND CATS
I see that the Australian Pesticides and Veterinary Medicines Authority has recently uploaded to its website a ‘Community Question’ entitled “Does my dog or cat need to be vaccinated every year?”
As with the publication of the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats in January this year, the APVMA’s past failure to ensure that manufacturers’ MLV vaccine product revaccination recommendations are evidence based is at the heart of the continuing problem of unnecessary vaccination of pets, coupled with the reluctance of many members of the veterinary profession to keep abreast of and acknowledge the latest science on duration of immunity and vaccination ‘best practice’.
The APVMA’s answer refers to “the vet’s knowledge of the canine/feline immune system” in relation to vaccination practice.1 This reference is ironic given that the World Small Animal Veterinary Association’s Vaccination Guidelines Group has warned that “there is an urgent requirement for education of practicing veterinarians in this area”.2
As you are aware from my previous correspondence to both the APVMA and AVA, annual vaccination with MLV core vaccines continues to be promoted in the media, particularly via local newspapers across Australia.3 Using the media to create fears about disease is a recognized ploy to sell pharmaceutical products, and is aptly described as ‘disease mongering’ when there is no scientific basis for a product’s use5 (e.g. repeated MLV core revaccination of already immunized adult dogs.)
Pet owners are not being made aware of a key statement in the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats i.e. that: “…the aim should be to ensure that all susceptible animals are vaccinated, rather than that already well-immunized animals are revaccinated.”9 (My emphasis.)
In its Position Statement, the APVMA has admitted its failure to ensure evidence based regulation of vaccine products, now acknowledging that it “does not support the retention of label statements that direct or imply a universal need for lifelong annual revaccination with core vaccines”11. Similarly, there is no evidence that lifelong triennial revaccination is required.
It is unacceptable that pet owners continue to be misled and coerced into paying for an intervention which has not been proven to be of benefit, particularly when the intervention has the potential to cause harm. Swift action must be taken by the APVMA to remove unproven prescriptive revaccination recommendations on vaccine product labels, and replace them with evidence based information on the minimum duration of immunity demonstrated to be provided by these products.
There is no scientific evidence that either ‘annual’ or ‘triennial’ revaccination of adult dogs with MLV core vaccines is necessary. In notes discussing the 2006 Canine and Feline Vaccination Guidelines, Richard Ford, Professor of Medicine, North Carolina State University, and a member of the AAHA Canine Vaccine Task Force, states:
It’s important to note that the recommendations of the AAHA Canine Vaccine Task Force for triennial booster administration are based on data derived from vaccines that were on the market 5 years ago. Independent studies support the fact that extended durations of immunity (protection) against canine distemper, parvovirus, and adenovirus-2 are provided by all of the licensed (core) vaccines that were on the market between 2000 and 2003.
Any implication that a “3-year vaccine” must be used when adhering to current vaccination recommendations is wrong…and misrepresents the intent of the 2006 AAHA Canine Vaccine Guidelines.17
A recent paper, (published in the Journal of Comparative Pathology in January 2010), coauthored by Ronald Schultz, Professor and Chair of the Department of Pathobiological Sciences University of Wisconsin-Madison, and a member of the WSAVA Vaccination Guidelines Group and AAHA Canine Vaccine Task Force, reiterates what has been well-known within the veterinary industry for years, i.e.: “In general, adaptive immunity following vaccination with modified live virus (MLV) vaccines develops earliest and most effectively in that it is often complete (e.g. sterile immunity is induced) and duration of immunity (DOI) is often lifelong.”20 (My emphasis)
In a recent paper titled “How I Vaccinate an Animal with Previous History of Adverse Reaction”, presented at the WSAVA congress in Geneva (June 2010), Michael Day, Professor of Veterinary Pathology, University of Bristol, and Chair of the WSAVA Vaccination Guidelines Group, provides a telling example which is very pertinent to all dogs…
The first consideration is whether this dog requires revaccination at all. This is an adult dog that was appropriately immunized as a pup and received DHP boosters at 3 and 6 years with LPi boosters annually. Although the licensed duration of immunity (DOI) for the core vaccine components (DHP) is three years, there is now evidence for a minimum DOI of 9 years for CDV and CPV and, in reality, a dog that is appropriately immunized as a pup probably never requires another core vaccine during its lifetime.(My emphasis)
The non-core components of this animal's vaccine schedule (LPi) are also unnecessary. Although they do not have a DOI greater than 1 year, this is a city dog that is never kenneled in a boarding establishment and its lifestyle means that its risk of exposure to Leptospira or the canine respiratory complex is minimal. If the owner is in any doubt as to whether the animal is protected against the core vaccine-preventable diseases, then serological testing may be used to allay any fears. The presence of any titre of antibody to CDV, CAV and CPV is indicative of protection.21 (My emphasis.)
Richard Squires, Associate Professor in Companion Animal Medicine at James Cook University, and a member of the World Small Animal Veterinary Association's Scientific Advisory Committee, acknowledged that the Australian veterinary profession had lagged behind the rest of the world in accepting that there is no scientific justification for annual revaccination of pets, and noted “there is strong and mounting evidence that most vaccinations administered to adult dogs and cats serve no beneficial 'immunological' purpose whatsoever.”22 (My emphasis.)
Pet owners must be properly warned that neither ‘annual’ nor ‘triennial’ revaccination of adult dogs with MLV core vaccines has been proven to be necessary. ... It is unacceptable that pet owners continue to be badgered into having unnecessary, and potentially harmful, repeated MLV core revaccination for their pets.
On the topic of vaccine safety, in his letter to The Veterinarian, Peter Bracken attempts to play down “misconceptions about safety” of vaccine products.38 Similarly, in its Position Statement on Vaccination Protocols for Dogs and Cats, the industry-funded APVMA makes assertions about the low incidence of adverse experiences with dog and cat vaccines, i.e.:
The incidence of adverse experiences associated with dog and cat vaccines reported to the APVMA’s Adverse Experience Reporting Program (AERP) is low: less than 1 in 10,000 doses. The incidence of more serious reactions such as anaphylaxis is very low, and appears to be similar for initial vaccinations and revaccination, which is also true for human vaccines.39
A low ‘reported’ incidence of adverse experiences is no excuse for prescription of so-called ‘preventive’ products that have not been proven to be efficacious or beneficial with repeated application.
The 2010 WSAVA guidelines acknowledge that:
…there is gross under-reporting of adverse events which impedes knowledge of the ongoing safety of these products.40
…we should aim to reduce the ‘vaccine load’ on individual animals in order to minimize the potential for adverse reactions to vaccine products.41
Who really knows how many adverse reactions result from unnecessary vaccination? Inadequate vaccine safety trials and ineffective post-marketing surveillance mean that many adverse reactions, including delayed adverse reactions and long term health problems, are likely to go unacknowledged and unreported.
The failure in regulation and post-marketing surveillance means veterinarians who unnecessarily vaccinate and over-service continue to get away with this unethical practice, particularly as it has been recognized that ‘some’ veterinarians are reluctant to acknowledge and report adverse reactions.42, 43, 44 The status quo is being protected from scrutiny.
The true range of possible adverse reactions is unknown because it appears there was little pre-licensure safety testing done to test short-term and delayed effects of vaccination. According to a paper titled “Epidemiological approaches to safety investigations”, James Wood and Vicki Adams note:
Most safety testing is undertaken prior to granting of a marketing authorization and is generally on a small scale. Field trials are usually much larger, but still involve relatively low numbers of animals compared to the number to which authorized products are administered. Safety testing is generally aimed at detecting common events; the numbers of animals used in the tests are too small for detection of all but the most common reactions. The efficiency of the tests depends on the frequency and severity of the adverse reaction and the ability to associate the adverse event with the product.
In other words, dogs in the community are the guinea pigs for these vaccines. They (and their owners) are unknowingly part of a huge unregulated trial, the results of which are not being reported…
David Hustead, International Technical Director of Fort Dodge Animal Health, admits that the biologic necessity to revaccinate annually has not been demonstrated.49 Hustead also notes that “the quality and quantity of safety information on an animal vaccine label is much less than that found on the labels of common human vaccines”. According to Hustead “it is not unusual for an animal vaccine label to essentially ignore the safety concerns of vaccine administration with the exception of anaphylaxis”. Animal vaccine labels contain only “a few short safety statements, that in all probability do not accurately reflect the clinical safety of the product as observed by all users”.50 (My emphasis.)
Due to limited testing, vaccine labels generally only include details of possible immediate side effects; they do not include details of possible delayed adverse reactions to vaccination. In an article discussing adverse reactions to vaccination, Jean Dodds states “beyond the immediate hypersensitivity reactions, other acute events tend to occur 24 to 72 hours afterward, or 7 to 45 days later in a delayed type immunological response”.51 (My emphasis.)
Editor's Note: Paste a link in your web browser address bar or search for the document by name in a web search engine. The following vaccine related reference articles may have been moved.
(1) APVMA’s ‘Community Question – Does my dog or cat need to be vaccinated every year?’ 7 June 2010:
(2) Day, M.J. Report from the Vaccination Guidelines Group. 35thWorld Small Animal Veterinary Association 2010 WSAVA Congress, Geneva, June 2-5 2010: http://www.vin.com/proceedings/Proceedings.plx?CID=WSAVA2010&Category=&PID=56195&O=Generic
(3) Open letter to Allen Bryce, Program Manager, Veterinary Medicines Australian Pesticides and Veterinary Medicines Authority, 24 January 2010: http://users.on.net/~peter.hart/Open_letter_to_APVMA_AVA_ASAVA_CCPD_24-01-10.pdf
(4) Open letter to Mark Lawrie, President of the Australian Veterinary Association, 6 May 2010. Copied to Allen Bryce and other parties: http://users.on.net/~peter.hart/Open_letter_to_the_AVA_re_continuing_unnecessary_vax_May_2010.pdf
(5) Moynihan, R., Heath, I., Henry, D. Selling sickness: the pharmaceutical industry and disease mongering. British Medical Journal. Volume 324. 13 April 2002. 6 Alert on canine virus outbreak. The Gympie Times, 11 June 2010: http://www.gympietimes.com.au/story/2010/06/11/alert-on-canine-virus-outbreak/
(7) Media articles re parvovirus Dec 2009 to June 2010. List compiled by Elizabeth Hart: http://users.on.net/~peter.hart/Media_articles_re_parvovirus_Dec_2009_to_June_2010.pdf
(8) Radford, A. EDITORIAL: The hitchhiker's guide to dog and cat vaccination. Journal of Small Animal Practice. Volume 51 Issue 6 (June 2010). (p 293-294). Published Online: Jun 1 2010 1:46PM 9 Australian Pesticides and Veterinary Medicines Authority’s Position Statement on Vaccination Protocols for Dogs and Cats. Published 21 January 2010, revised 25 January 2010: http://www.apvma.gov.au/news_media/news/2010/2010-01-21_vaccination_position.php The statement was revised after my urgent criticism to include the statement: …the aim should be to ensure that all susceptible animals are vaccinated, rather than that already well-immunized animals are re-vaccinated. (My emphasis)
(13) Australian Veterinary Association – Vaccination of Dogs and Cats Policy, ratified by the AVA Board 26 June 2009.
Currently accessible via this link: http://ava.informz.net/ava/data/images/documents/ava-vaccination-policy-final-june09.pdf and on the AVA’s home page: http://avacms.eseries.hengesystems.com.au//AM/Template.cfm?Section=Home&WebsiteKey=bbfd2ab3-e7fc-4456-bc66-
(14) Australian Veterinary Association and Australian Pesticides and Veterinary Medicines Authority Joint Media Statement on Vaccination of Dogs and Cats, dated 5 February 2010: http://avacms.eseries.hengesystems.com.au/AM/Template.cfm?Section=20104&Template=/CM/ContentDisplay.cfm&Con
(15) “Too many needles for pets”, Courier Mail, 5 February 2010: http://www.news.com.au/couriermail/story/0,23739,26677705-23272,00.html
(16) Paul, M.A., Carmichael, L.E., Childers, H., Cotter, S., Davidson, A., Ford, R., Hurley, K.F., Roth, J.A., Schultz, R.D., Thacker, E., Welborn, L. 2006 AAHA Canine Vaccine Guidelines, Revised: http://www.aahanet.org/PublicDocuments/VaccineGuidelines06Revised.pdf
(17) Ford, Richard B. 2006 Canine & Feline Vaccination guidelines – A forum on Issues and Controversies http://www.hcvma.org/notes/SpeakerNotesRichardFord.pdf
(18) Paul, M.A., Appel, M.J., Barrett, R., Carmichael, L.E., Childers, H., Cotter, S., Davidson, A., Ford, R., Keil, D., Lappin, M., Schultz, R.D., Thacker, E., Trumpeter, E., Welborn, L. 2003. Report of the American Animal Hospital Association (AAHA) Canine Vaccine Task Force: 2003 Canine Vaccine Guidelines, Recommendations, and Supporting Literature
(19) Baumgardner, K. Industry, profession questions AAHA vaccine guidelines; minor changes made. DVM Newsmagazine. June 1 2003
(20) Schultz, R.D., Thiel, B., Mukhtar, E., Sharp, P., Larson, L.J. (2010). Age and long-term protective immunity in dogs and cats. J. Comp. Path. 142, S102-S108.
(21) Day, M.J. How I Vaccinate an Animal with Previous History of Adverse Reaction. 35th World Small Animal Veterinary Association 2010 WSAVA Congress, Geneva, June 2-5 2010: http://www.vin.com/proceedings/Proceedings.plx?CID=WSAVA2010&Category=&PID=56260&O=Generic
(22) Fawcett, A. Fur flies over small animal vaccination. The Veterinarian. September 2009, p. 3.
(23) Day M.J., Horzinek, M.C., Schultz, R.D. WSAVA Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Journal of Small Animal Practice. Volume 51 Issue 6 (June 2010). (p 338-356). Published Online: Jun 1 2010 1:46PM.
(24) Australian Pesticides and Veterinary Medicines Authority’s Position Statement on Vaccination Protocols for Dogs and Cats. Published 21 January 2010, revised 25 January 2010: http://www.apvma.gov.au/news_media/news/2010/2010-01-21_vaccination_position.php
(25) Seavers, A.. Three-year vaccination intervals: a different view from the parvo trenches of practice-land. The Veterinarian. April 2010, pp 23-27.
(26) Australian Veterinary Association – Vaccination of Dogs and Cats Policy, ratified by the AVA Board 26 June 2009. Currently accessible via this link: http://ava.informz.net/ava/data/images/documents/ava-vaccination-policy-final-june09.pdf and on the AVA’s home page: http://avacms.eseries.hengesystems.com.au//AM/Template.cfm?Section=Home&WebsiteKey=bbfd2ab3-e7fc-4456-bc66-
(27) Bracken, P. ‘Letter to the Editor’. The Veterinarian. May 2010.
(28) Day M.J., Horzinek, M.C., Schultz, R.D. WSAVA Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Journal of Small Animal Practice. Volume 51 Issue 6 (June 2010). (p 338-356). Published Online: Jun 1 2010 1:46PM.
(30) Bracken, P. ‘Letter to the Editor’. The Veterinarian. May 2010.
(31) APVMA’s response to the discussion paper “A National Scheme for Assessment Registration and Control of Use of Agricultural and Veterinary Chemicals”. February 2010: http://www.daffa.gov.au/agriculture-food/food/regulation-safety/agvet-chemicals/domestic-policy/psic/responses-to-discussionpaper/australian_pesticides_and_veterinary_medicines_authority
(32) Whittem, T. GCP and its role in veterinary clinical trials. APVMA Science Fellows Symposium. April 2010: http://www.apvma.gov.au/news_media/docs/symposium_2010/2_ted_whittem_summary.pdf
(34) APVMA’s response to the discussion paper “A National Scheme for Assessment Registration and Control of Use of Agricultural and Veterinary Chemicals”. February 2010: http://www.daffa.gov.au/agriculture-food/food/regulation-safety/agvet-chemicals/domestic-policy/psic/responses-to-discussionpaper/australian_pesticides_and_veterinary_medicines_authority
(35) CHOICE response to the discussion paper “A National Scheme for Assessment Registration and Control of Use of Agricultural and Veterinary Chemicals”. February 2010: http://www.daffa.gov.au/agriculture-food/food/regulation-safety/agvet-chemicals/domestic-policy/psic/responses-to-discussion-paper/choice
(36) A vaccine industry newsletter, published in 2005, illustrates this fact, reporting that 89% of veterinarians surveyed indicated that dog and cat vaccinations were the number one contributor to practice turnover, and that 91% of veterinarians felt that a change from annual vaccination would have an adverse effect on their practice turnover. The newsletter concluded: “Annual vaccination appears to be an important source of income for many veterinarians”. Virbac Newsletter “Facts on Vaccination”, August 2005.
(37) Day M.J., Horzinek, M.C., Schultz, R.D. WSAVA Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Journal of Small Animal Practice. Volume 51 Issue 6 (June 2010). (p 338-356). Published Online: Jun 1 2010 1:46PM.
(38) Bracken, P. ‘Letter to the Editor’. The Veterinarian. May 2010.
(39) Australian Pesticides and Veterinary Medicines Authority’s Position Statement on Vaccination Protocols for Dogs and Cats. Published 21 January 2010, revised 25 January 2010: http://www.apvma.gov.au/news_media/news/2010/2010-01-21_vaccination_position.php
(40) Day M.J., Horzinek, M.C., Schultz, R.D. WSAVA Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Journal of Small Animal Practice. Volume 51 Issue 6 (June 2010). (p 338-356). Published Online: Jun 1 2010 1:46PM.
(42) Dodds, Jean, Hemopet, Santa Monica, CA. Abstract of presentation on: Compliance or resistance to current vaccine guidelines?. Presented at The 5th International Veterinary Vaccines and Diagnostics Conference, July 19-24, 2009, Madison, WI USA.
(43) Dodds, W.J. 2001. Vaccination Protocols for Dogs Predisposed to Vaccine Reactions. Journal of the American Animal Hospital. May/June 2001, Vol. 37, 211-214.
(44) Schultz, R.D. 1998. Current and future canine and feline vaccination programs. Veterinary Medicine. March 1998, 233-254.
(45) Common questions about pharmacovigilance. US Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Biologics: http://www.aphis.usda.gov/animal_health/vet_biologics/vb_pharmacovigilance_faq.shtml#
(46) Wood, J.L.N., Adams, V.J. 2006. Epidemiological approaches to safety investigations. Veterinary Microbiology. 117, 66-70.
(47) Moore, G.E., Frana, T.S., Guptill, L.F., Ward, M.P., Lewis, H.B., Glickman, L.T. 2005. Postmarketing surveillance for dog and cat vaccines: new resources in changing times. JAVMA. Vol. 227, No. 7, October 1, 2005, pp. 1066-1069.
(48) Meyer, E.K. 2001. Vaccine-associated adverse events. Veterinary Clinics of North America: Small Animal Practice. Vol. 31, No. 3 May 2001, 493-513.
(49) Hustead, D.R. 2001. What you can and cannot learn from reading a vaccine label. Veterinary Clinics of North America: Small Animal Practice. Vol 31, No.3, May, 539- 556.
(51) Dodds, W.J. 2001. Vaccination Protocols for Dogs Predisposed to Vaccine Reactions. Journal of the American Animal Hospital. May/June 2001, Vol. 37, 211-214.
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