Tag Archives: informed consent

Petition against HPV vaccines – please consider signing this petition!

hThe Institute for the Protection of Natural Health (Institut pour la Protection de la Santé Naturelle), based in Brussels, in conjunction with French oncologist and surgeon Professor Henri Joyeux, has launched a French petition against the HPV vaccines Gardasil and Cervarix.

This petition has currently raised 359,840 signatures. Originally, the goal was to reach 500,000 signatures then submit the petition to government authorities in France.  However, interest in this petition has expanded to other countries where medical professionals, scientists and medical consumers are also seriously questioning universal HPV vaccination programs.

Due to so many requests from people outside France who wish to sign the petition, Professor Joyeux and the Institute for the Protection of Natural Health have agreed to open their petition to every country in the world.

If you are concerned that HPV vaccines are of questionable value, please access and sign the petition via this link:  http://petition.ipsn.eu/papillomavirus/?utm_source=VIDEO&utm_medium=Newsletter-gratuite&utm_campaign=201409-29-HPV_VdT

The petition is in French, but an English translation is available, see below.

You need only fill in four boxes: Your first name, last name, postal code (or country if you do not live in France) and your email address.

More information is available on the SaneVax website, including details of concerns raised by Professor Joyeux:  http://sanevax.org/french-petition-hpv-vaccines/

Also refer to my previous post HPV vaccine promotion and government interference for more background on the questionable implementation of HPV vaccination in Australia

Please consider signing the French petition against HPV vaccines, we need to challenge questionable HPV vaccination on an international basis.

_____________________________________________

English translation of the French petition against HPV vaccines: 

Sign the petition by clicking on this link

Institut Pour La Protection de la Santé Naturelle

The right to alternative treatment

NO to widespread vaccination of children against HPV

Petition

For the attention of The President of the French Republic, The French Minister of Health and Social Affairs, and the French Minister of National Education 

Mr. President, Mme Health and Social Affairs Minister, Mme. National Education Minister,

On the 15th of September 2014, the French High Council for Public Health published a statement recommending that:

  • HPV (human papillomavirus) vaccination should be introduced in French schools in an attempt to prevent cervical cancer and other sexually-transmitted diseases;
  • If necessary, the starting age for vaccination of both young girls and young boys would be lowered to 9.

This plan has aroused very deep concern in the French people and the medical profession.

There are a very large number of us who fear that our schools are being used as a front for a widespread HPV vaccination campaign targeting our children, without providing families transparent information on the effectiveness and risks of this vaccine and without allowing them to consider the pros and cons.

May we remind you that the analysis of pharmacovigilance data revealed 26,675 cases of serious adverse effects connected with these vaccines, including 113 cases of multiple sclerosis.

May we also remind you that the only method which has been proven to prevent cervical cancer is the Pap smear.  If precancerous lesions are found, they can then be treated.

The vaccine however does not confer 100% protection, far from it.  All medical sources concur on this point.  It is a very dangerous situation if vaccinated individuals go off thinking that they are fully protected.

We the undersigned therefore demand that the plan for widespread HPV vaccination in French schools be stopped:

  • Until reasonable vaccine effectiveness has been proven;
  • Until we are aware of and can control all the adverse effects of these vaccines;
  • Until we can be assured that such widespread vaccination will not cause a drop in Pap smear screening, the only proven method of preventing cervical cancer.

This is the only way to protect a large number of children from unnecessary accidents and considerable suffering.  You will also be making a step towards maintaining the trust of parents and keeping necessary peace in our schools.

Yours sincerely,

Number of Signatures

 

UPDATE: Interim response from NHMRC re vaccination policy and practice in Australia

Questions for NHMRCAs posted previously on Over-vaccination.net, I am forwarding letters to the National Health and Medical Research Council (NHMRC) questioning the ethics of vaccination policy and practice in Australia.

As a public record, I am publishing my correspondence with the NHMRC on this webpage: Letters to NHMRC re vaccination and ethics

On 15 April 2014, I forwarded a letter to Professor Warwick Anderson, CEO of the NHMRC, suggesting the ethical spotlight needs to be shone on the way vaccination policy and practice is being implemented in Australia.  I provided examples of the lack of transparency and accountability in the vaccination bureaucracy, including the problem of potential conflicts of interest and lack of disclosure by people involved in vaccination policy.

Previously, I forwarded two letters (19 March 2014 and 12 April 2014) to Professor Ian Olver, Chair of the NHMRC Australian Health Ethics Committee, challenging the Australian Government’s requirement for revaccination of children with a second dose of live Measles/Mumps/Rubella (MMR) vaccine, as children are likely to be immune after the first dose of effective live MMR vaccine, given at the appropriate age (i.e. after maternally derived antibodies have waned).

I have received an interim response from the NHMRC dated 20 May 2014

In regards to my queries re the MMR vaccine second dose the NHMRC advises:

AHEC discussed your correspondence at its recent meeting on 7 May 2014.  The issues you have raised in relation to the dose requirements for the MMR vaccination raise matters of both a scientific/technical nature as well as procedural matters relating to the current process.  Before providing you with a considered response, AHEC wishes to seek further information from the relevant government agencies responsible for Australia’s immunisation policy and its implementation.

In an email to Professor Anderson dated 16 April 2014, I again raised the problem of the lack of transparency about members of committees and groups who provide advice to the Australian Federal Government on vaccine products, also noting that the NHMRC Australian Health Ethics Committee webpage provides no information about committee members, not even their affiliations. 

In their letter dated 20 May 2014, the NHMRC responded:

In your email to Professor Anderson you raised that the declared interests of AHEC members are not publically available on the NHMRC website.  Thank you for drawing this to our attention.  The Office is in the process of rectifying this omission and you will be notified once these declarations are available…” 

As two months have now passed since this interim response from the NHMRC, I am following up on progress on these matters.

Boy given Gardasil HPV vaccine against mother’s wishes

An article in the Gold Coast Bulletin reports a 15 year old boy has been given the Gardasil HPV vaccine against his mother’s explicit wishes which were made clear on a consent form.[1]

According to the article, Ms Blakemore’s son “came home from school last Tuesday and said he had been given the vaccination after he was told to sign his own consent form”.[2]

????????????????????????????????????????????????????????????????Ms Blakemore said: “My son doesn’t comprehend that sort of stuff, they don’t actually get the other side of the story so he’s not well informed enough to make those decisions when put on the spot.”  According to the article, “Ms Blakemore said 15-year-olds were too young to make decisions about their body”.  She said: “They can’t vote, they can’t drink and legally they can’t  have sex but yet they’re allowed to sign a form for vaccine for a sexually transmitted disease…If they don’t have consent forms from parents they should be sending a note home to say they weren’t vaccinated, not just go ‘here’s a form, we think you’re old enough to make these decisions’”.[3]

Ms Blakemore said: “From a parent’s point of view, giving us consent forms then going over our heads is just abominable and terrible.”[4]

When her son was vaccinated with the HPV vaccine, Ms Blakemore said: “He questioned the lady doing it as he was only supposed to get one vaccination, and she said ‘Your name’s on the list, so you’re getting the shot’.”  The boy’s mother said when her son came home he was “really upset…He asked if there is an injection that could get rid of it and I said ‘No’”.[5]  (It appears the boy was given another vaccine product at the same time, but this is not identified in the article.) 

According to The Australian Immunisation Handbook, for consent to vaccination to be legally valid, the following elements must be present:

  1. It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of being vaccinated.
  2. It must be given voluntarily in the absence of undue pressure, coercion or manipulation.
  3. It must cover the specific procedure that is to be performed.
  4. It can only be given after the potential risks and benefits of the relevant vaccine, risks of not having it and any alternative options have been explained to the individual. 

Whether vaccination was legally valid in the case of Ms Blakemore and her son appears questionable, particularly as the Queensland Government’s information sheet on HPV vaccination states: “IMPORTANT! Consent of a parent/legal guardian is needed before any student can be vaccinated.”[7]

Ms Blakemore has complained to Queensland Health, the Gold Coast City Council and the school.[8]  It remains to be seen what steps will be taken to respond to this matter.

The Gold Coast Bulletin article also acknowledged Ms Blakemore “was concerned about lack of research into the vaccine and potential side effects”. [9]

I suggest Ms Blakemore has grounds for her concern as mass populations of children around the world are currently being used as guinea pigs for this experimental vaccine, the long-term effects of which are unknown.

Indeed all citizens should be concerned about the way in which the vaccine industry, i.e. the mutually beneficial alliance of vaccine manufacturers and the medical/scientific establishment, is encroaching upon people’s bodily autonomy in pressing an increasing number of lucrative vaccine products of dubious value.

For further background on the questionable implementation of HPV vaccination, see Over-vaccination.net’s webpage on HPV Vaccination and my letter to The Australian newspaper on this topic: Is universal HPV vaccination necessary?

___________________________________________

References:  (Accessible as at 23 May 2014.)

[1] Megan Weymes. Merrimac State High School student given Gardasil vaccination against mother’s wishes. Gold Coast Bulletin, 22 May 2014: http://www.goldcoastbulletin.com.au/news/gold-coast/merrimac-state-high-school-student-given-gardasil-vaccination-against-mothers-wishes/story-fnj94idh-1226926116790

[2], [3], [4], [5] Ibid.

[6] 2.1.3 Valid consent. 2.1 Pre-vaccination. The Australian Immunisation Handbook. 10th Edition 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-2-1

[7] Human Papillomavirus (HPV) vaccination. Year 8 students. Year 10 male students. Queensland Government. Immunise Australia Program – A joint Australian, State and Territory Government initative: https://publications.qld.gov.au/storage/f/2014-01-21T01%3A13%3A25.907Z/hpv-consent-form.pdf

[8] Megan Weymes. Merrimac State High School student given Gardasil vaccination against mother’s wishes. Gold Coast Bulletin, 22 May 2014: http://www.goldcoastbulletin.com.au/news/gold-coast/merrimac-state-high-school-student-given-gardasil-vaccination-against-mothers-wishes/story-fnj94idh-1226926116790

[9] Ibid.

France: Aluminium adjuvants and HPV vaccines up for debate

A recent press release from SaneVax reports:

syringeThe use of aluminum adjuvants and HPV vaccines’ benefit versus risk profile will be under intense scrutiny and open scientific debate on May 22, 2014. 

Stakeholders from both sides of the vaccine debate will have an opportunity to present their case to members of the French Parliament, French Senate, health authorities, medical professionals and the public due to massive efforts on the part of E3M, a non-governmental organization of patients with MMF (macrophagic myofasciitis), and OSTA, a Parliamentary Office for Evaluation of Scientific and Technological Choice.

Obviously, the French government cares enough about the health and well-being of their citizens to listen to both sides of the vaccine debate – the very same ‘debate’ that government health officials in other countries claim doesn’t exist…

Read more on the SaneVax website: France: Aluminium adjuvants and HPV vaccines up for debate

Over-vaccination of dogs with parvovirus and other vaccines remains prevalent practice

dreamstime_xs_29221605

Dogs in Australia and elsewhere continue to be grossly over-vaccinated.  These companion animals and their owners are being exploited by the veterinary industry.

See below my recent email on this matter to Ms Kareena Arthy, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority (APVMA).  

The APVMA is the body responsible for ‘regulating’ veterinary vaccine products in Australia.

_____________________________________________________________

23 April 2014

Ms Arthy

Further to my previous extensive correspondence with the APVMA and others on the subject of over-vaccination of dogs.  (Please refer to hyperlinked list of correspondence below, including correspondence with Dr Allen Bryce, Executive Director of the APVMA’s Veterinary Medicines Program.  My colleague Bea Mies has also undertaken extensive correspondence on this matter.)

The APVMA’s Position Statement – Vaccination Protocols for Dogs and Cats, last amended in September 2010, notes: “The APVMA does not support the retention of label statements that direct or imply a universal need for life-long annual revaccinations with core vaccines.  The APVMA supports the AVA’s vaccination policy and is of the view that product labels should be amended to align with that policy.  The APVMA is working with vaccine registrants with a view to updating labels.” (My emphasis.)

It is now April 2014 and still core vaccine products with an annual revaccination ‘recommendation’ remain on the market.  For example Virbac Australia’s Canigen C4 DHA2PPI Quadrivalent Living Vaccine states: “An annual booster is recommended”.  (Note: The label for Virbac’s Canigen DHA2P Trivalent Living Vaccine is currently not accessible on the PUBCRIS website.)

On what evidence is this ‘recommendation’ for an ‘annual booster’ with core vaccines based?

In August 2013, I forwarded a letter to Professor Ronald Schultz of the World Small Animal Veterinary Association’s Vaccination Guidelines Group, challenging the confusing and misleading use of the term ‘booster’ in relation to canine core modified live virus (MLV) vaccines for parvovirus, distemper virus and adenovirus, suggesting that use of the term ‘booster’ is resulting in extensive over-vaccination of already immune dogs.  My letter can be accessed via this link:  http://users.on.net/~peter.hart/Query_re_MLV_boosters.pdf

In his email response of 22 August 2013, Professor Schultz said: “I agree that the term “booster” is misleading in that many of the already immune dogs probably receive no beneficial “booster effect” from an infectious vaccine because the virus (e.g. CDV, CPV-2, CAV-2)* is immediately neutralized.  Therefore, it cannot infect the cells and replicate! It is only in those dogs that have no viral antibody that the vaccine will booster the immune system, both the cellular and humoral response to the virus.  It is these antibody negative dogs that I recommend revaccinating, not dogs with detectable antibody.  There are, however, components of the vaccines that are almost always boostered such as fetal bovine serum components and other extraneous proteins that are in all vaccines.  Obviously, these are components of the vaccine we don’t want to boost especially in a dog that genetically is predisposed to an adverse reaction (e.g. hypersensitivity).  That is why we are trying to prevent annual revaccination with the Core Vaccines that provide long term immunity in a majority of most dogs, but not all!” (*Note: CDV, CPV-2 and CAV-2 are the canine diseases distemper virus, parvovirus and adenovirus [hepatitis]).

It is my strong suspicion that annual revaccination of dogs with core MLV vaccine products remains prevalent practice in Australia.  See for example the attached article published in Dogs NSW in September 2013: “The Deadly Canine Parvovirus – Is Your Dog At Risk?”.  My response to this article is attached.  Also attached is the response by pro-annual vaccination vet Robert Zammit, and Virbac/ASAVA’s Mark Kelman.

See also this ‘Vaccination Guide’ from Greencross Vets which recommends revaccination every year with core vaccines for distemper, hepatitis and parvovirus (and non-core vaccines parainfluenza and bordetella).

Pet owners and their pets are being grossly exploited by the prevalent practice of over-vaccination due to the non-evidence based revaccination ‘recommendations’ on APVMA approved core MLV vaccine product labels.  I also strongly suspect most pet owners are not being informed of the option of in-clinic and lab-based antibody titre testing to verify a response to core MLV vaccination.

Ms Arthy, on what evidence does the APVMA continue to re-register canine core MLV vaccine products which recommend repeated revaccination of adult dogs?

I request your urgent response on this matter.

Sincerely

Elizabeth Hart

See below hyperlinks to some of my correspondence, submissions and articles on over-vaccination of pets:

Key documents:

Correspondence with the Australian Pesticides and Veterinary Medicines Authority (APVMA), Australian Veterinary Association (AVA), and others:

Correspondence with the UK Veterinary Medicines Directorate (VMD):

Correspondence with Virbac Animal Health (Disease WatchDog):

Submissions on the subject of unnecessary vaccination of pets:

Correspondence to Members of Parliament:

Articles and summaries re over-vaccination of pets:

Media reports re over-vaccination of pets:

UPDATE: NHMRC Ethics Committee and the MMR second dose

Ethics and vax

On 19 March 2014, I forwarded a letter to Professor Ian Olver, Chair of the NHMRC Australian Health Ethics Committee, challenging the Australian Government’s requirement for revaccination of children with a second dose of live MMR vaccine, as children are likely to be immune after the first dose of effective live MMR vaccine, given at the appropriate age (i.e. after maternally derived antibodies have waned).

Jillian Barr, Director of the NHMRC Health and Research Ethics Section, has acknowledged receipt of my submission regarding the MMR second dose, and advised that this matter will be considered by the NHMRC Australian Health Ethics Committee at its next meeting in early May 2014.

In the meantime, I have forwarded another letter re the MMR second dose to Professor Olver and his AHEC colleagues, see below:

_________________________________________________________

12 April 2014

Professor Olver

RE:  Measles/Mumps/Rubella (MMR) vaccination – refer to my previous letter dated 19 March 2014

Professor Olver, in my previous letter to you, I argued that most children are likely to be immune after the first dose of effective live Measles/Mumps/Rubella (MMR) vaccine, and I challenged the Australian government’s requirement for children to have a second dose of live Measles/Mumps/Rubella (MMR) vaccine, which is linked to obtaining Immunisation Related Payments for Parents.

In my letter I questioned the ethics of coercing parents to have vaccinations of questionable benefit for their children.

In this regard I draw your attention to a ‘MEASLES ALERT’ letter (see attached), forwarded to 13,117 parents in Queensland by Chief Health Officer Dr Jeannette Young in September 2013, which tells these parents that “Two doses of measles containing vaccine are needed to provide a high level of protection.”  This advice was also included in a Queensland Government media statement[1] and reported in an article published in The Courier-Mail on 14 October 2013: “Vaccination no-shows prompt top-level measles outbreak warning[2]

Professor Olver, I suggest it is misleading to tell parents that “two doses of measles containing vaccine are needed to provide a high level of protection”.  As I argued in my previous letter, it is likely one dose of effective GSK PRIORIX live MMR vaccine is likely to provide protection for previously seronegative subjects.

A response to live MMR vaccination can be verified by antibody titre testing.  I suggest there may be some cautious parents who would prefer to have an antibody titre test for their child rather than an arbitrary live MMR revaccination, and who might be willing to pay for an antibody titre test themselves.  Yet, in contravention of The Australian Immunisation Handbook’s criteria for consent to vaccination to be legally valid, i.e. that any alternative options be explained to the individual,[3] it appears healthcare providers are not informing parents about the option of antibody titre testing.

In another jurisdiction, the state of New Jersey in the United States, the health department provides information on antibody titre testing.  The Antibody Titer Law (Holly’s Law)[4] allows parents to seek testing to determine a child’s immunity to measles, mumps and rubella before receiving the second dose of MMR vaccine.  The law was enacted in response to the death of five year old Holly Marie Stavola who died of encephalopathy which she developed seven days after receiving her second dose of MMR vaccine.[5]  Holly’s family campaigned for this law, wishing they had known about the option of the antibody titre test before Holly’s arbitrary revaccination with the second dose of live MMR vaccine.[6]

All parents should be informed about the option of antibody titre testing to verify a response to live MMR vaccination.  All parents should be informed of the reportedly high seroconversion rates after live MMR vaccination at the appropriate age.  All parents should be properly informed about the risks and benefits of individual vaccine products.  This is not happening.  Instead, the media is being used as a blunt instrument to bully parents into unquestioning compliance with all vaccination ‘requirements’ mandated by the government’s vaccination bureaucracy and the vaccine industry, see for example:

Professor Olver, we are on a slippery slope when governments dictate questionable medical interventions for citizens (including ‘pre-citizens’, i.e. children).  The arbitrary second dose of the MMR vaccine, often inappropriately described as a ‘booster’[10], is a questionable medical intervention.  Vaccination/immunisation is a complex matter that requires thoughtful discussion, not the polarised discourse currently evident in Australia.[11]  I request that you and your AHEC colleagues urgently consider this matter.

Sincerely

Elizabeth Hart                         

*Please note this letter will be circulated to other parties.

cc:        Members of the NHMRC Australian Health Ethics Committee (AHEC)

  • Dr Gary Allen
  • Professor Vicki Anderson
  • Professor Samar Aoun
  • Professor Susan Dodds
  • Associate Professor Ian Kerridge
  • Dr Tammy Kimpton
  • Rabbi Aviva Kipen
  • Reverend Kevin McGovern
  • Professor John McGrath AM
  • Dr Eleanor Milligan
  • Professor Robin Mortimer
  • Ms Kay Oke
  • Professor Margaret Otlowski
  • Professor Debra Rickwood
  • Professor Wendy Rogers
  • Professor Loane Skene

and Professor Brian Martin, Social Sciences, University of Wollongong

Attachments:

  • Measles Alert.  Letter to parents/carers from Dr Jeannette Young, Chief Health Officer, Queensland Government Department of Health, 17 September 2013.
  • Antibody Titer Law – Information for Parents pamphlet.  The Antibody Titer Law gives parents a choice BEFORE they consent to a second dose of measles, mumps and rubella vaccine.

References:  (All links accessible as at 12 April 2014. It may be necessary to copy and paste long links in a web browser.)

_______________________________________________

[1] Queensland Department of Health Media Statement, 14 October 2013.

[2] Vaccination no-shows prompt top-level measles outbreak warning. The Courier Mail, 14 October 2013: http://www.couriermail.com.au/news/queensland/vaccination-noshows-prompt-toplevel-measles-outbreak-warning/story-fnihsrf2-1226739273248

[3] 2.1.3 Valid Consent. 2.1 Pre-vaccination. The Australian Immunisation Handbook. 10th Edition 2013:

http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-2-1

[4] Antibody Titer Law – Information for Parents. (Holly’s Law) (NJSA 26:2N-8-11), passed on January 14, 2004, concerns vaccination of children with the Measles, Mumps, Rubella (MMR) vaccine.  The law allows parents to seek testing to determine a child’s immunity to measles, mumps, and rubella, before receiving the second dose of the vaccine.  This brochure has been prepared by the New Jersey Department of Health and Senior Services to assist parents in making the decisions related to the MMR vaccine and the test: http://www.state.nj.us/health/cd/documents/antibody_titer_law.pdf

[5] HopeFromHolly. Providing NJ physicians and pParents with more knowledge about childhood vaccines: http://hopefromholly.com/blog/our-purpose/

[6] Holly’s story – Holly Marie Stavola, January 18, 1995 – February 4, 2000:

http://hopefromholly.com/blog/category/holly-stavola/

[7] Scientists call for end of handouts to parents who don’t vaccinate children. The Telegraph, 6 April 2014: http://www.dailytelegraph.com.au/news/nsw/scientists-call-for-end-of-handouts-to-parents-who-dont-vaccinate-children/story-fni0cx12-1226874673399

[8] Doctors want vaccination reforms for childcare centres. The Australian, 11 April 2014: http://www.theaustralian.com.au/news/doctors-want-vaccination-reforms-for-childcare-centres/story-e6frg6n6-1226880381081

[9] Peter Dutton considers plan to withhold family tax benefits if children aren’t immunised. ABC News, 11 April 2014: http://www.abc.net.au/news/2014-04-11/govt-may-withhold-family-tax-benefit-if-children-not-vaccinated/5382054

[10] For example the NPS Medicinewise website states: “Separate vaccines for measles, mumps and rubella are not available in Australia. So the combined measles, mumps and rubella (MMR) vaccine is given in a single injection with a second booster dose.” http://www.nps.org.au/medicines/immune-system/vaccines-and-immunisation/for-individuals/vaccines-a-z/measles-mumps-and-rubella-mmr

[11] In his article “On the suppression of vaccination dissent”, Professor Brian Martin says: “Suppression of dissent, through its chilling effect, can skew public debates, by discouraging participation.  In Australia, critics of vaccination have become aware that if they become visible, they are potentially subject to denigration and complaints.  Because of the level of personal abuse by pro-vaccinationists, many of those who might take a middle-of-the road perspective, perhaps being slightly critical of some aspects of vaccine policy, are discouraged from expressing their views.  The result is a highly polarized public discourse that is not conducive to the sort of careful deliberation desirable for addressing complex issues.”  (My emphasis.) Source: Science & Engineering Ethics. March 2014, doi 10.1007/s11948-014-95303  http://www.bmartin.cc/pubs/14see.html

 

Measles/Mumps/Rubella (MMR) vaccination and ‘informed consent’ – a letter to the NHMRC Australian Health Ethics Committee

Further to  my letter to the US Advisory Committee on Immunization Practices, challenging government mandated revaccination of children with the second dose of live Measles/Mumps/Rubella (MMR) vaccine.

I have now forwarded a letter on this matter to the NHMRC Australian Health Ethics Committee, challenging the Australian Government’s requirement for revaccination of children with a second dose of live MMR vaccine, as children are likely to be immune after the first dose of effective live MMR vaccine, given at the appropriate age (i.e. after maternally derived antibodies have waned).

Informed Consent 3The medical establishment, pharmaceutical industry, and governments are imposing an ever-increasing amount of lucrative vaccine products on healthy people.  Vaccines are medical interventions and it is imperative that citizens give their ‘informed consent’ to these interventions.  Children, i.e. ‘pre-citizens’, also have a right to bodily integrity, and it is essential that parents are properly informed before medical interventions for their children.

See below my detailed letter forwarded to Professor Ian Olver, Chair of the NHMRC Australian Health Ethics Committee.  The letter has also been forwarded to each member of the committee, see membership list also noted below.

______________________________________________

19 March 2014

Professor Olver

RE:    The Australian Government’s requirement for revaccination of children with a second dose of live Measles/Mumps/Rubella (MMR) vaccine / lack of ‘informed consent’ / adverse events 

The Australian Government’s National Immunisation Program Schedule stipulates that children receive two doses of live measles/mumps/rubella (MMR) vaccines[1], and meeting this requirement is linked to obtaining Immunisation Related Payments for Parents.[2]

However, according to the GlaxoSmithKline PRIORIX Product Information leaflet, most seronegative children are likely to be immune after one dose of live MMR vaccine.[3]

I question whether parents are being given the opportunity to properly give their ‘informed consent’ to the second dose of the live MMR vaccine (or the MMR+varicella i.e. GlaxoSmithKline PRIORIX-TETRA MMRV vaccine) for their children.  This question is particularly pertinent as adverse events have been reported after MMR and MMRV vaccination.

I request that the NHMRC Australian Health Ethics Committee respond to me on this matter, and I provide further supporting information below.

According to the PRIORIX Product Information Leaflet, in “a more recent study comparing the formulation of PRIORIX (albumin-free) with the previous formulation containing albumin, antibodies against measles, mumps and rubella were detected in 98.4, 94.8 and 100% of previously seronegative subjects (n=191)”.  The leaflet also contains similarly high seroconversion rates from earlier studies.[4]

The PRIORIX Product Information Leaflet notes that: “Seroconversion has been shown to equate with protection against each of the measles, mumps and rubella viruses.”[5] The National Immunisation Program Schedule recommends the first MMR vaccination at 12 months of age[6], so presumably it is expected that most children will be seronegative at this age, i.e. maternally derived antibodies will have waned.

Despite the fact it appears one dose of PRIORIX MMR live vaccine is likely to provide protection for previously seronegative subjects, the PRIORIX Product Information Leaflet indicates two doses are to be given, i.e. “The Australian NH&MRC Immunisation Handbook recommendations for MMR vaccination are as follows: MMR vaccine is recommended for all children at 12 months of age and again at 4-6 years of age unless there is a genuine contraindication.”[7]

It is notable that neither the PRIORIX[8] nor the PRIORIX-TETRA[9] Consumer Medicine Information leaflets contain information on the reportedly high seroconversion rates after live MMR vaccination.  Does this indicate that parents are not being informed of the reportedly high seroconversion rates after vaccination of previously seronegative children with the PRIORIX MMR vaccine product? 

It is also notable that there is no reference to the option of antibody titre testing to verify a response to MMR vaccination in either the Consumer Medicines Information leaflet or the Product Information leaflet for PRIORIX or PRIORIX-TETRA.

What are the ramifications here for ‘informed consent’?

The Australian Immunisation Handbook provides criteria for consent to vaccination to be legally valid, i.e.:

1.     It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of being vaccinated.

2.     It must be given voluntarily in the absence of undue pressure, coercion or manipulation.

3.     It must cover the specific procedure that is to be performed.

4.     It can only be given after the potential risks and benefits of the relevant vaccine, risks of not having it and any alternative options have been explained to the individual.[10] 

Professor Olver, I question whether parents are being properly informed by healthcare providers before administration of the second dose of measles, mumps and rubella vaccine, (whether via the MMR or MMRV injection). 

In regards to point 2 above, I suggest parents are being pressured/coerced/manipulated to have the vaccine via the reward of Immunisation Related Payments.  While the Immunise Australia website notes that “benefits can be received without a child being fully immunised”[11] this is only the case after completion of an Immunisation exemption: Medical contraindication form[12] or Immunisation exemption: Conscientious objection form[13].  I suggest that neither of these forms in their current format is appropriate in the case of the questionable second dose of the live MMR vaccine.

In regards to point 4 above, I question whether parents are being properly informed of the potential risks and benefits of the second dose of the MMR vaccine.  There are no benefits to the child if the child is already immune after the first dose.  There are risks, i.e. possible side effects, as detailed in the PRIORIX and PRIORIX-TETRA Consumer Medicine Information leaflets and Product Information leaflets.  Are healthcare providers bringing this information to the attention of parents (and others)?

Reports of adverse events after MMR and MMRV vaccination have been submitted to the TGA’s Database of Adverse Events.[14] (Refer to reports attached.)  For example a TGA list of adverse events after vaccination with PRIORIX, generated for the dates 1 January 2012 to 20 November 2013, indicates 674 adverse event reports were made in that period.  253 of these cases occurred in four year olds.  Other age groups, (including adults), also reported adverse events after vaccination with PRIORIX.  As it is likely many of these children had already been vaccinated with PRIORIX at 12 months of age and were likely already immune, (if the PRIORIX MMR vaccine is as effective as claimed), they underwent revaccination for no benefit.

The MMRV vaccine was added to the Australian Government’s National Immunisation Program Schedule in July 2013[15], for vaccination of children at 18 months of age, after vaccination with the MMR at 12 months of age.  A TGA adverse event list generated for the dates 1 July 2013 to 20 November 2013 shows 80 reports of adverse events after vaccination with the PRIORIX-TETRA MMRV vaccine product.  If the children involved in these reports had already been vaccinated with the PRIORIX MMR vaccine at 12 months of age, again it is likely they were already immune to measles/mumps/rubella.

It should be recognised that adverse events after vaccination are likely to be under-reported.  The TGA acknowledges that reporting of adverse events to the TGA is voluntary, and that there is under-reporting in Australia, and around the world.[16]  In regards to the lack of safety information for the MMR vaccine, the Cochrane Collaboration’s systematic review of MMR vaccination notes: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”[17]

Again in relation to point 4 above, I also question whether “alternative options”, e.g. antibody titre testing to verify a response to MMR vaccination, are being explained to parents by healthcare providers.  It is possible that some careful parents might prefer to pay for antibody titre testing, rather than have their child revaccinated with a probably unnecessary second dose of live MMR vaccine.

Parents of small children might be surprised to discover that vaccination ‘best practice’ for companion animals is now more advanced than that for children, with international vaccination guidelines for dogs re live vaccines recommending antibody titre testing rather than an arbitrary ‘booster’, i.e.: “…the principles of ‘evidence-based veterinary medicine’ would dictate that testing for antibody status (for either pups or adult dogs) is a better practice than simply administering a vaccine booster on the basis that this should be ‘safe and cost less’”.[18]

Professor Olver, I question the ethics of coercing parents to have vaccinations of questionable benefit for their children.  According to the vaccine manufacturer’s data, it appears most seronegative individuals are likely to be immune after the first dose of MMR vaccine.  It appears likely from TGA adverse event database information that children (and possibly adults) have suffered after revaccination with a second dose of MMR vaccine.  I suggest there has been inadequate research undertaken on the possibly deleterious long-term effects of repeated vaccination, and so unnecessary vaccination should be avoided.

As the Australian Health Ethics Committee is responsible to advise the NHMRC on ethical issues relating to health, I would appreciate your urgent response on this matter to my email address elizmhart@gmail.com

Sincerely

Elizabeth Hart                         

*Please note this letter will be circulated to other parties.

cc:        Members of the NHMRC Australian Health Ethics Committee (AHEC)

  • Dr Gary Allen
  • Professor Vicki Anderson
  • Professor Samar Aoun
  • Professor Susan Dodds
  • Associate Professor Ian Kerridge
  • Dr Tammy Kimpton
  • Rabbi Aviva Kipen
  • Reverend Kevin McGovern
  • Professor John McGrath AM
  • Dr Eleanor Milligan
  • Professor Robin Mortimer
  • Ms Kay Oke
  • Professor Margaret Otlowski
  • Professor Debra Rickwood
  • Professor Wendy Rogers
  • Professor Loane Skene

and Professor Brian Martin, Social Sciences, University of Wollongong

References:  (All links accessible as at 19 March 2014.)


[1] National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

[2] Immunise Australia Program.  Immunisation Related Payments for Parents. (Webpage dated 12 September 2013): http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/related-payments

[4] Ibid.

[5] Ibid.

[6] National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

[8] GlaxoSmithKline PRIORIX Consumer Medicine Information Leaflet: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-05278-3

[9] GlaxoSmithKline PRIORIX-TETRA Consumer Medicine Information Leaflet: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2013-CMI-01069-1

[10] 2.1.3 Valid Consent. 2.1 Pre-vaccination. The Australian Immunisation Handbook. 10th Edition 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-2-1

[11] Immunise Australia Program.  Immunisation Related Payments for Parents. (Webpage dated 12 September 2013): http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/related-payments

[12] Immunisation exemption: Medical contraindication form: http://www.humanservices.gov.au/spw/customer/forms/resources/immu11.1310p.pdf on the Department of Human Services website: http://www.humanservices.gov.au/customer/forms/immu11

[13] Immunisation exemption: Conscientious objection form: http://www.humanservices.gov.au/spw/customer/forms/resources/immu12-1302en.pdf on the Department of Human Services website: http://www.humanservices.gov.au/customer/forms/immu12

[14] Adverse event information for medicines and medical devices can be accessed in the TGA’s Database of Adverse Notifications (DAEN): http://www.tga.gov.au/safety/daen.htm#.UyjVXfmSz-t

[15] National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

[16] “Adverse event reports from consumers and health professionals to the TGA are voluntary, so there is under-reporting by these groups of adverse events related to therapeutic goods in Australia. This is the same around the world.”  About the DAEN – medicines: http://www.tga.gov.au/safety/daen-about.htm#.UyglSfmSz-t

[17] Demicheli V, Rivetti A, Debalini MG, Di Pietrantonj C. Vaccines for measles, mumps and rubella in children. Cochrane

Database of Systematic Reviews 2012, Issue 2. Art. No.: CD004407. DOI: 10.1002/14651858.CD004407.pub3.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004407.pub3/abstract

[18] See page 7 under “Serological Testing to Determine the Duration of Immunity (DOI)”  in Day, M.J., Horzinek, M.C., Schultz, R.D. World Small Animal Veterinary Association’s (WSAVA) Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Vol. 51. June 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf