VACCINATION - EFFICACY & SAFETY

Is it a “vast conspiracy”? Yes. You are about to be convinced of that frightening fact. The following document was prepared by one of the world’s leading authorities on vaccination safety and efficacy.  Dr. Patricia Jordan’s disseminations on vaccines have spanned the globe, bringing together the best minds in the field of veterinary medicine. We thank Elizabeth Hart for permission to share her relentless crusade with other vaccine researchers.

Elizabeth Hart TheDogPlace August 2010

UPDATE: The new 2010 WSAVA guidelines contain some interesting updates, although they are still ambiguous, and still do not explain the reference to “every three years”.

However, the new key statements are very important. These are:

• “Core vaccines should not be given any more frequently than every three years after the 12 month booster injection following the puppy/kitten series, because the duration of immunity (DOI) is many years and may be up to the lifetime of the pet.” (My emphasis.)

• “We should aim to vaccinate every animal with core vaccines, and to vaccinate each individual less frequently by only giving non-core vaccines that are necessary for that animal.” (My emphasis.)

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 vets to the new reduced vaccination protocols here in Australia, so we have to maintain the pressure for change.

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)

Dear Allen:

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’, i.e.:

“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, it is most disappointing that neither Bea Mies nor I were informed of this development, particularly in light of our ongoing research and extensive correspondence with the APVMA and AVA on this topic...

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

Allen, can you please advise me what action the APVMA is taking to proactively promote information on companion animal vaccination to the community, particularly after all the years of inexcusable delay in acknowledging the problem of unnecessary vaccination of pets, and with pet owners continuing to be misled about companion animal vaccination? Merely posting information on the APVMA’s website does not fulfill the government regulator’s responsibility in this matter, particularly as most pet owners or veterinarians are unlikely to come across this information on the APVMA’s website serendipitously...

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, 4} Dubious media advertorials about anecdotal parvovirus reports promote indiscriminate revaccination of dogs and appear to be the only publicly accessible information on parvovirus in the community.

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.)

For example, a recent article titled “Alert on canine virus outbreak” in the Gympie Times (11 June 2010) reports that:

Gympie dog owners are being warned of another outbreak of the deadly canine parvovirus (CPV)…CPV is easily preventable; all dog owners need do is make sure their puppies are vaccinated and bring older dogs in for their yearly booster shots....”^{6 7} (My emphasis.)

Alarmingly, it appears pet owners continue to receive a non-evidence based MLV core revaccination message from members of the veterinary profession who are not keeping up to date with scientific developments in this area. No wonder that repeated (unnecessary) vaccination is suspected to be a “convenient income generator”.⁸

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.)

The APVMA’s Position Statement confirms that: “State and Territory legislation that controls use of veterinary medicines allows registered veterinarians to use veterinary medicines “off-label” in dogs and cats. Veterinarians may therefore use vaccines at whatever interval they (and the client) determine is best for each particular animal. Veterinarians and pet owners are under no obligation to follow revaccination intervals recommended on vaccine labels.”¹⁰ (My emphasis.)

I suggest the term ‘off-label’ is inappropriate with vaccines, which are so-called ‘preventive’ products rather than therapeutic medicines. In the case of MLV core vaccines, it has not been demonstrated that repeated revaccination of adult dogs is efficacious or beneficial.

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.

The APVMA’s Position Statement notes that: “The APVMA supports the AVA’s vaccination policy.”¹² The AVA’s MLV core vaccination policy is ambiguous but ostensibly ‘triennial’.¹³ The APVMA reiterated its support for the AVA’s ‘triennial’ revaccination policy in February 2010, in a joint media statement¹⁴ in response to a newspaper story headlined “Too many needles for pets” which reported that “hundreds of thousands of cats and dogs are being over-medicated with unnecessary annual vaccinations”.¹⁵ (Incidentally, Allen, why is there no record of this joint AVA / APVMA media statement on the APVMA’s website? Why is it only located externally on the AVA’s website and not in the list of APVMA media releases?)

There is no scientific evidence that either ‘annual’ or ‘triennial’ revaccination of adult dogs with MLV core vaccines is necessary.

The 2006 AAHA canine vaccine guidelines advise that vaccines produced by the major biologics manufacturers against parvovirus, distemper virus and adenovirus all produce excellent immune responses, and can be soundly and reliably administered at the discretion of the clinician in extended duration of immunity protocols.¹⁶ It is not necessary to use a designated ‘three year vaccine’ and it has not been proven necessary to revaccinate ‘every three years’.

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

When the AAHA guidelines were first issued in 2003¹⁸, Richard Ford said that the decision to recommend a three-year cycle for vaccines was a compromise. When asked about the three yearly intervals for vaccination Ford said: “That’s another embarrassing question. It’s completely arbitrary…I will say there is no science behind the three-year recommendation…”¹⁹ (My emphasis.)

In other words, effective MLV vaccines with the traditional ‘annual’ revaccination recommendation provide long duration of immunity. It has not been proven beneficial for adult dogs that have been properly vaccinated as puppies to be repeatedly revaccinated with so-called ‘annual’ or ‘triennial’ MLV vaccines.

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.)

In an article published in The Veterinarian in September 2009, titled “Fur flies over small animal vaccination”, 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.)

Given that the Australian veterinary profession has blatantly ignored the developing scientific knowledge on companion animal vaccination for many years, I suggest it is inappropriate for the APVMA to rely on the AVA for advice on vaccination ‘best practice’, particularly as the AVA has only very reluctantly acknowledged international dog and cat vaccination guidelines in recent times.

I suggest it would be more appropriate for the APVMA, and other international government regulators, to consult directly with the WSAVA Vaccination Guidelines Group on this matter, (although it must be acknowledged that the updated 2010 WSAVA guidelines²³ contain some ambiguous and inconsistent information which requires clarification).

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. Pet owners must be given the opportunity to consider information on long duration of immunity in the scientific literature and international dog and cat vaccination guidelines. It is unacceptable that pet owners continue to be badgered into having unnecessary, and potentially harmful, repeated MLV core revaccination for their pets.

The APVMA’s Position Statement also states that “…veterinarians should provide pet owners with pertinent, up-to-date information on vaccination best practice to assist in a joint decision as to whether and when to re-vaccinate their pet”.²⁴

In this regard it is relevant to refer to an article, (published in the April edition of The Veterinarian magazine), by pro-annual vaccination veterinarian Aine Seavers, who makes the outrageous demand that the AVA remove the information on vaccination currently openly available on its website,²⁵ i.e. the AVA’s policy on vaccination of dogs and cats ratified by the AVA Board in June 2009, and publicly released in August 2009.²⁶

For information, I attach a copy of my ‘Letter to the Editor’ of The Veterinarian in response to Seavers’ article and the vaccination controversy. My letter also refers to comments made by Peter Bracken, a vaccine manufacturer representative, in his ‘Letter to the Editor’ in response to Seavers’ article.²⁷

My letter to The Veterinarian seeks to give a 'pet owner's perspective' of the vaccination controversy, a perspective that has been completely disregarded by the veterinary industry in past years... This disregard for the rights of pet owners is unacceptable, particularly as pet owners are the major stakeholders in pets' health and wellbeing.

My letter to The Veterinarian includes commentary about the APVMA’s Position Statement, and about the 2010 World Small Animal Veterinary Association (WSAVA) Guidelines for the Vaccination of Dogs and Cats (recently published online in the June 2010 issue of the Journal of Small Animal Practice, and expected to be freely available soon on the WSAVA website) which include the following updated key statements:

• Vaccines should not be given needlessly. Core vaccines should not be given any more frequently than every three years after the 12 month booster injection following the puppy/kitten series, because the duration of immunity (DOI) is many years and may be up to the lifetime of the pet.²⁸ (My emphasis.)

• We should aim to vaccinate every animal with core vaccines, and to vaccinate each individual less frequently by only giving non-core vaccines that are necessary for that animal.²⁹ (My emphasis.)

In his letter to The Veterinarian, Peter Bracken encourages “veterinarians to use evidence based medicine and the latest science to guide vaccination decisions”.³⁰ Which begs the obvious question, what action have vaccine manufacturers taken over the many years of the vaccination controversy to correct non-evidence based ‘annual’ and ‘triennial’ prescriptive revaccination ‘recommendations’ on modified live virus (MLV) vaccine product labels? Little or none as far as I am aware…

In this regard, it is alarming that, in its response to the discussion paper “A National Scheme for Assessment Registration and Control of Use of Agricultural and Veterinary Chemicals”, the APVMA believes:

…it should be the responsibility of each individual product registrant to ensure the ongoing safety of their products and adequacy of their labels in-line with contemporary scientific thinking and evidence.³¹

Isn’t this the equivalent of leaving the foxes in charge of the chicken coop? There is an obvious conflict of interest here in that it is hardly likely that vaccine manufacturers will voluntarily take action which will decrease sales of their products.

In his summary of a presentation on Good Clinical Practice at the APVMA’s recent Science Fellows Symposium in April 2010, Ted Whittem, Professor of Veterinary Clinical Sciences, University of Melbourne, notes:

To consolidate end-user confidence in the use of veterinary medicines, the consumer requires effective implementation of the registration process. Effective regulation relies on both consumer pressure for and industry acceptance of quality standards. Self imposed quality standards can be either an individual or industry lead practice. Self imposed quality standards lay the base of the regulatory pyramid for registration of veterinary medicines.³² (My emphasis.)

Whittem also warns:

However, self imposed quality standards have potential to lead to an uneven base-level quality since some sponsors apply higher standards than others. In evaluation of regulatory rigor, self imposed quality systems are usually regarded as less rigorous than enforced codes or mandatory laws.³³ (My emphasis.)

In other words, vaccine manufacturers are unlikely ‘to ensure the ongoing safety of their products and adequacy of their labels in-line with contemporary scientific thinking and evidence’ unless there is an effective regulatory system in place to enforce this.

The APVMA notes:

Under the existing arrangements there is no clear legislative path that allows the APVMA to require that underpinning scientific knowledge…be brought in line with or reviewed for compliance with contemporary standards. The APVMA first needs some indication of likely undue harm that would warrant taking regulatory action against the product.³⁴

Firstly, it is a significant failure in the regulatory system that agvet products are not regularly reviewed to ensure that they are in line with contemporary scientific knowledge.

Secondly, in the case of MLV vaccines, I suggest the APVMA is justified in taking immediate action to remove prescriptive ‘annual’ and ‘triennial’ revaccination recommendations from these products on safety grounds, as the original regulatory process failed to ensure there was evidence underpinning the prescriptive revaccination recommendations, or adequate safety testing. This matter is particularly urgent in that vaccine products have known (and unknown and unacknowledged) risks. It is unacceptable that dogs be placed at any unnecessary risk in having these products because repeated revaccination of adult dogs with MLV vaccines has not been proven to be efficacious or beneficial.

Consumer advocate CHOICE makes the point that:

CHOICE believes that public and environmental safety is the overriding concern and products whose neither efficacy nor safety is proven should not be allowed on the market. No data, no market. CHOICE very strongly believes the regulator must continue to require efficacy data. How could they ever be regarded as an effective regulator without looking at efficacy? The discussion paper notes that it is of critical importance to the user (pages 29, 30). Efficacy is of prime importance to the entire community. Moreover it is one thing to risk manage a chemical that is both efficiently and effectively serving a purpose. It borders on negligent to allow chemicals – all of which have risks attached – into the environment for no ostensible purpose.³⁵ (My emphasis.)

It is unacceptable that potentially harmful vaccine products, that have not been proven to be efficacious and beneficial with repeated application, be allowed to have prescriptive revaccination recommendations. Due to a failure in regulation, pet owners are continuing to be misled into having unnecessary and potentially harmful vaccinations for their pets, and this situation is compounded in that members of the veterinary profession use their influence and authority to coerce pet owners into having these products for their pets, a practice which is to veterinarians’ financial advantage.³⁶

The emphasis should be on attracting the attention of pet owners who have never had their pets properly vaccinated, rather than urging other pet owners to have their pets unnecessarily, and possibly harmfully, revaccinated over and over again. In regards to checking the status of dogs with an unknown vaccination history, the 2010 WSAVA guidelines advise:

the principles of ‘evidence-based veterinary medicine’ would dictate that testing for antibody status (for either pups or adult dogs) is better practice than simply administering a vaccine booster on the basis that this should be ‘safe and cost less’.³⁷

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.

Aside from this, I also dispute the APVMA’s statement on ‘reported’ incidence of adverse experiences. As I have previously pointed out to the APVMA in my correspondence and papers (refer to links at the end of this letter) this scant information is misleading.

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

and

…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.

I suggest the paragraph on adverse experiences in the APVMA’s Position Statement should be replaced with a more thoughtfully worded statement that adequately reflects the lack of knowledge of the full range of potential adverse reactions, including possible delayed reactions and long term health problems, and the shortcomings of a voluntary adverse experience reporting system.

This statement regarding adverse events on the US Department of Agriculture’s website is an interesting example to consider:

Good estimates of the rates of various types of adverse events after the use of veterinary immunobiologics are not readily available. The information we have is based on voluntary spontaneous reports to manufacturers and the USDA. While it may be possible to calculate a reporting rate, the relationship between a reporting rate and an incidence rate is not clear. This relationship may vary by type and severity of event, species, manufacturer, and even from one month to the next…⁴⁵

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.

The latter is affected by the period of time between administration and the event, as well as by its underlying frequency.⁴⁶ (My emphasis.)

In a paper titled “Post marketing surveillance for dog and cat vaccines: new resources in changing times”, Moore et al note:

Adverse events that are relatively uncommon or that occur in high-risk subgroups (eg. elderly animals or specific breeds) are usually only detected through post marketing surveillance. The full safety profile for a given vaccine can only be determined after the vaccine has been licensed and administered to large numbers (often millions) of individuals.⁴⁷

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…

In a paper titled “Vaccine-associated adverse events”, Kathryn Meyer advises that the results of safety testing are not routinely required on product labeling. This means that “rare events, events that occur after repeated exposure and events that occur in a subgroup (e.g. specific breed, age)” are not noted on product labels. Meyer also notes that adverse event information derived from post marketing surveillance is also not routinely required on the product’s label.⁴⁸

David Hustead, who at the time of writing his paper “What you can and cannot learn from reading a vaccine label” was 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.)

http://www.thedogplace.org/VACCINES/Vaccine-Efficacy&Safety-10081_Hart.asp

Endnotes & REFERENCES for Part 1 of 2 provided by author, Elizabeth Hart

Note: Past a link in your web browser address bar or search for the document by name in a web search engine.

(1) APVMA’s ‘Community Question – Does my dog or cat need to be vaccinated every year?’ 7 June 2010:

http://www.apvma.gov.au/news_media/community/vaccination_dogs_cats.php

(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)

(10) Ibid.

(11) Ibid.

(12) Ibid.

(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-

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(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

tentID=16206

(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-

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(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.

(29) Ibid.

(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

(33) Ibid.

(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.

(41) Ibid.

(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.

(50) Ibid.

(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.