Category Archives: Adverse Reactions

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

 

 

International Medical Researchers Issue Warning about HPV Vaccine Side Effects

Further to my previous post Adverse events after HPV vaccination – international symposium held in Japan, February 2014.

SaneVax reports the international symposium and associated events have “sparked a high-profile debate over HPV vaccine safety, efficacy and need…”

Read more on the Sanevax website.

‘Informed consent’ and the Measles/Mumps/Rubella (MMR) vaccine – challenging the US Advisory Committee on Immunization Practices

As I have argued previously on Over-vaccination.net, it’s likely that most children will be immune after the first dose of the live Measles/Mumps/Rubella (MMR) vaccine.

However, mass populations of already immune children are being arbitrarily revaccinated with a second dose of the live MMR vaccine because a small proportion of children may not have responded to the first dose.  

In other words, millions of children are being over-vaccinated with the second dose of live MMR vaccine.

INFORMED CONSENTAre parents being given the opportunity to properly give their ‘informed consent’ to the second dose of live Measles/Mumps/Rubella (MMR) vaccine?  

See below my letter forwarded to Professor Jonathan Temte, Chair of the US Advisory Committee on Immunization Practices, challenging government mandated revaccination of children with the live MMR vaccine second dose.

_________________________________________

5 March 2014

Professor Temte

CHALLENGING MANDATED REVACCINATION OF CHILDREN WITH THE MEASLES/MUMPS/RUBELLA (MMR) VACCINE ‘BOOSTER’ SECOND DOSE

The Advisory Committee on Immunization Practices recommends that children in the United States receive two doses of live measles/mumps/rubella (MMR) vaccines at 12-15 months and 4-6 years.[1]  As a result of the ACIP’s recommendation, two MMR vaccine doses are mandated in many US states.[2]

However, according to the Merck M-M-R II Information Sheet, most seronegative children are likely to be immune after one dose of live MMR vaccine.[3]

In regards to measles vaccination, the Advisory Committee on Immunization Practices report on MMR vaccination (June 2013) admits that: “The second dose of measles-containing vaccine primarily was intended to induce immunity in the small percentage of persons who did not seroconvert after vaccination with the first dose of vaccine (primary vaccine failure).[4]

Given that most children are likely to be immunised after the first dose of live MMR vaccine, I question whether parents are being given the opportunity to properly give their ‘informed consent’ to the second dose of live MMR vaccine, also often described as a ‘booster’.[5]  This question is particularly pertinent as adverse events have been reported after MMR vaccination.

I request that the Advisory Committee on Immunization Practices respond to me on this matter, and I provide further supporting information below.

According to the Information Sheet for Merck’s M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) “clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated. In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons.”[6]  (My emphasis.)

The Merck M-M-R II Information Sheet also notes: …a small percentage (1-5%) of vaccinees may fail to seroconvert after the primary dose”.[7]  It is my understanding that failure to seroconvert after vaccination with the primary dose is most likely due to interference of maternally derived antibodies, i.e. if the child is vaccinated at an age before maternally derived antibodies have waned.  Other reasons could be problems with the effectiveness of the vaccine product that results in vaccine failure, or that the individual is a poor responder.

No reference to published details of the “clinical studies of 284 triple seronegative children” is provided in Merck’s M-M-R II Information Sheet.  However, the ACIP report on MMR vaccination appears to support Merck’s information re the high seroconversion rate after primary vaccination, particularly in regards to the measles and rubella components of the MMR vaccine, (although there appears to be some ambiguity about the effectiveness of the mumps component of the MMR vaccine).[8]

Are healthcare providers informing parents (and other individuals) of the high likelihood of seroconversion after the first dose of live MMR vaccine, i.e. that most vaccinees are likely to be immune after the first dose of live MMR vaccine, given at the appropriate age? 

Are healthcare providers informing parents (and other individuals) of the option of antibody titre testing to verify a response to MMR vaccination?  It is possible that some careful parents (and other individuals) may prefer to pay for antibody titre testing before having the medical intervention of repeated MMR vaccination.  Parents of small children (and other individuals) 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’”.[9]

The blanket recommendation for two live MMR vaccine doses by the Advisory Committee on Immunization Practices appears to be at odds with the Authorizing Legislation of the US National Vaccine Injury Compensation Program, Sec. 300aa-26, i.e. legal representatives of any child or any individual receiving a vaccine set forth in the Vaccine Injury Table should be provided with information on the vaccine, including “a concise description of the benefits of the vaccine” and a concise description of the risks associated with the vaccine”.[10]

In regards to “a concise description of the benefits of the vaccine”, there are no benefits to the individual if the individual is already immune.  Most children are likely to be immune after the first live MMR vaccine dose, particularly the measles and rubella components.  This can be verified with an antibody titre test for those parents/individuals who want evidence of a response.

In regards to “a concise description of the risks associated with the vaccine”, there are risks, i.e. possible adverse reactions, as detailed in the Merck M-M-R II Information Sheet.[11]  Reports of adverse events after MMR vaccination have also been submitted to VAERS (the Vaccine Adverse Event Reporting System).[12]  Are healthcare providers bringing this information to the attention of parents (and other individuals)?

The VAERS database contains reports of children of four years and over who have experienced adverse events after vaccination with the MMR vaccine.  As it is likely many of these children had already been vaccinated with an MMR vaccine at 12-15 months of age, they were likely already immune (i.e. if the Merck M-M-R II vaccine is as effective as claimed), and they underwent revaccination for no benefit.  (It is also notable that reports of adults suffering adverse events after MMR vaccination are recorded in the VAERS database, which again raises the question whether these people were offered the option of antibody titre testing before MMR vaccination.)

VAERS is a passive surveillance system to which adverse events after vaccination are voluntarily reported.  The FDA has acknowledged that “VAERS is a crude tool” and that adverse events are likely to be under-reported.[13]  In regards to the lack of safety information re 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.”[14]  I suggest there has been inadequate research undertaken on the possibly deleterious long-term effects of repeated vaccination, and that unnecessary vaccination should be avoided.

Professor Temte, I again question whether parents (and other individuals) are being properly informed by healthcare providers about MMR vaccination, in accordance with the Authorizing Legislation of the US National Vaccine Injury Compensation Program, Sec. 300aa-26, and whether ‘informed consent’ is being obtained before this medical intervention. 

As the US Advisory Committee on Immunization Practices is responsible for making recommendations on vaccine use, recommendations which have far-reaching impact not just in the United States, but are also influential around the world, I would appreciate your urgent response on this matter to my email address eliz.hart25@gmail.com

Sincerely

Elizabeth Hart                         

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

References:  (All links accessible as at 5 March 2014.)


[1] Recommended Immunization Schedules for Persons Aged 0 Through 18 Years, United States, 2014: http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

[2] Centers for Disease Control and Prevention. School and Childcare Vaccination Surveys. School Vaccination Requirements, Exemptions & Web links: http://www2a.cdc.gov/nip/schoolsurv/schimmrqmt.asp

[3] Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. M-M-R® II. (Measles, Mumps, and Rubella Virus Vaccine Live). Information Sheet. 9912202: http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

[4] Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps, 2013. Summary Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. Vol. 62, No.4. June 14, 2013: http://www.cdc.gov/mmwr/pdf/rr/rr6204.pdf  (See page 3.)

[5] For example, the CDC “Measles Vaccination: Who Needs It?” webpage states: “A second dose of the vaccine is recommended to protect those 5% who did not develop immunity in the first dose and to give “booster” effect to those who did develop an immune response.”  http://www.cdc.gov/vaccines/vpd-vac/measles/vacc-in-short.htm  I question the benefit of this so-called ‘booster’ effect for children who are already immune, particularly to measles and rubella.

[7] Ibid.

[8] Op cit. Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps:  http://www.cdc.gov/mmwr/pdf/rr/rr6204.pdf   (See pages 7-11.)

[9] 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    (See page 7.)

[10] 300aa-26. Vaccine information. National Vaccine Injury Compensation Program: http://www.hrsa.gov/vaccinecompensation/authoringleg.pdf

[12] Vaccine Adverse Event Reporting System (VAERS): http://vaers.hhs.gov/data/index

[14] 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

Adverse events after HPV vaccination – international symposium held in Japan, February 2014

dreamstime_xs_17754200A recent SaneVax release reports: Breaking news from Japan: International symposium on the adverse reactions experienced by those vaccinated with human papillomavirus vaccines

Well done to SaneVax for their efforts in helping organise this international symposium, and for their support for people who have suffered adverse events after HPV vaccination.

It’s time for an investigation into the government lobbying and aggressive global marketing for this very questionable and experimental vaccine product.  See Over-vaccination.net’s webpage on HPV vaccination for more background.

Court orders girls must have MMR vaccination against their and their mother’s wishes

dreamstime_xs_17754200Recently a UK court ruled that two sisters must have the measles/mumps/rubella (MMR) vaccine against their and their mother’s wishes.

A report in Family Law Week, “Children ordered to receive MMR vaccination” (13/10/13) notes that one of the girls was vaccinated soon after her birth.  Given the first dose of live MMR vaccine was effective and administered at the right age (i.e. after maternally derived antibodies had waned), it is highly likely the girl would have been immune after the first vaccine dose.  This can be verified by a blood test (i.e. antibody titre testing).  (See my webpage about the MMR ‘booster’ for further background.)

Have these girls and their mother been advised there is a blood test available to determine if they are already immune to measles/mumps/rubella?  

How can these girls give their ‘informed consent’ before the medical intervention of vaccination if the court rules they must have this medical intervention?  

This case has set a dangerous precedent.  

Are we all on course for compulsory vaccination, as dictated by the state?  Consider for example the prospect of mandated annual influenza vaccination.  This looks like the start of a slippery slope.  We need to be alert to the implications, and mindful of vested interests in the vaccine industry, governments, and the scientific/medical establishment.

See below my email forwarded to one of the solicitors involved in this matter of court ordered MMR vaccination, Philippa Dolan of Ashfords Solicitors.

______________________________________

From: Elizabeth Hart <eliz.hart25@gmail.com>
Date: Thu, Nov 14, 2013 at 11:16 PM
Subject: MMR Case
To: p.dolan@ashfords

Ms Dolan

Re the case about the two girls and the MMR vaccine in which I understand you are involved, i.e. High Court rules sisters must have MMR jab against their and their mother’s wisheshttp://www.independent.co.uk/news/uk/home-news/high-court-rules-sisters-must-have-mmr-jab-against-their-and-their-mothers-wishes-8876035.html?origin=internalSearch

Note this comment in the article: “The elder daughter received the MMR jab but not a second dose, and the younger daughter did not receive either.”  (My emphasis.)

The measles/mumps/rubella vaccine is a ‘live’ vaccine.  When vaccinated at the right age with an effective vaccine, i.e. after maternally derived antibodies have waned, most children are likely to be immune for life.  The reason given for the second dose is that a small proportion of children might not respond to the first vaccine (usually because of interference of maternally derived antibodies, or possibly because of a fault in the vaccine).

My argument is, it is not ethical to force people to have a second dose of the vaccine if they’re likely to be immune after the first dose.  At the very least they should be offered the opportunity of a blood test (antibody titre test) to verify a response to the first vaccine, even if they have to pay for it themselves.  I suggest there is a very important principle at stake here, particularly when the state dictates that healthy people have to have medical interventions, it’s a slippery slope….

I suggest both those girls should be offered the opportunity of a blood test to measure antibodies (although it would have been better to have had the check soon after initial vaccination).  Even the second unvaccinated girl should be offered the opportunity in case she has had natural exposure to the disease.

For further background see my webpage: https://over-vaccination.net/questionable-vaccines/mmr-jab/

Also see my letter to Professor Paul Offit on this subject: http://users.on.net/~peter.hart/Letter_to_Paul_Offit_re_MMR_booster.pdf

Given the controversy about the MMR vaccine in the UK, and elsewhere, I think there could be a lot of fallout about this, there are some parents out there who I suspect would be very angry they weren’t given the opportunity of a blood test for their child, rather than an arbitrary second shot.

I request that you bring this information to the attention of the parents and children in this case, plus the presiding judge, Mrs Justice Theis.

I would appreciate your response on this matter.

Yours sincerely

Elizabeth Hart

HPV vaccine promotion and government interference

 

hThe co-inventor of the technology enabling the HPV vaccines, Professor Ian Frazer, has acknowledged that the risk of cancer associated with the HPV virus is very low.[1]  Yet mass populations of children around the world are being coerced into HPV vaccination, while the long-term consequences of these vaccines are unknown.

We need an investigation into why these questionable vaccines are being mass-marketed, and the lack of adequate ‘informed consent’ before this medical intervention.

Let’s start by demanding an investigation into how the Gardasil HPV vaccine was fast-tracked onto the Australian vaccination schedule in 2007.

The archived fact sheet on the Australian Government Funding of Gardasil states “The Government has agreed with the recommendation of its expert advisory committee, the Pharmaceutical Benefits Advisory Committee (PBAC), that GARDASIL should be funded under the National Immunisation Program, commencing in the 2007 school year…”[2]

However the Gardasil HPV vaccine was originally rejected by the PBAC in 2006.  An article in The Australian at the time, “Howard rescues Gardasil from Abbott poison pill”, reports the PBAC rejected Gardasil because it was “too expensive and, just maybe, not what it was cracked up to be anyway”.  According to the article, Tony Abbott, then the Australian Federal Health Minister “took to the airwaves, passing on PBAC’s concerns about the efficacy of Gardasil and even floating the bizarre idea that a misplaced confidence in the effectiveness of the vaccine might actually result in “an increase in cancer rates”.”[3]

According to Matthew Stevens’ report in The Australian, it took just 24 hours for the then Australian Prime Minister, John Howard, to “put an end to the nonsense”, delivering “sparkling prime ministerial endorsement to Gardasil along with a clear direction to Minister Abbott that the immunisation program should proceed. And pronto.”[4]

In her report “Government response to PBAC recommendations”, Marion Haas also provides some commentary on the Australian government’s interference with the PBAC’s initial rejection of Gardasil, noting the then Prime Minister, John Howard, “intervened personally by announcing that the drug would be subsidised (ie listed) as soon as the manufacturer offered the right price.  The PBAC subsequently convened a special meeting and recommended that Gardasil be listed on the PBS”[5] (Pharmaceutical Benefits Scheme).

Haas notes the main objectives “of the PBAC are to consider the effectiveness and cost-effectiveness of medicines in making recommendations to government regarding the listing of drugs for public subsidy.  A perceived willingness to interfere in this process may undermine these objectives…”  Government reaction which results in reversal of PBAC decisions has “the potential to send signals to manufacturers and lobby groups that a decision made by the PBAC may be reversed if sufficient public and/or political pressure is able to be brought to bear on the PBAC…this may undermine the processes used by the PBAC to determine its recommendations and hence the perceived independence of the PBAC.”[6] 

After the Australian government’s interference in this matter, other countries adopted HPV vaccination, resulting in multi millions of dollars’ worth of sales for the makers of the HPV vaccines, i.e. Merck (Gardasil) and GlaxoSmithKline (Cervarix)[7], and royalties for Ian Frazer from sales of HPV vaccines in developed countries[8].

Ian Frazer has acknowledged that the risk of cancer associated with the HPV virus is very low[9].  Since the introduction of the National Cervical Screening Program, the mortality from cervical cancer has halved.[10]  Given the low risks associated with the HPV virus, the Australian government’s role in over-turning the PBAC’s original rejection of the Gardasil vaccine, and the lobbying involved, should be subjected to scrutiny.

It’s time for an investigation into the establishment of the lucrative international market for the questionable HPV vaccines.

For further background refer to my previous post “Is universal HPV vaccination justifiable?”

Also refer to the Sanevax website for more information on this topic, including personal reports of adverse experiences after HPV vaccination.

_________________________________

References:  (Links active as at 11 November 2013.)

[1] In his article “Catch cancer? No thanks, I’d rather have a shot!”, Ian Frazer states: “Through sexual activity, most of us will get infected with the genital papillomaviruses that can cause cancer. Fortunately, most of us get rid of them between 12 months to five years later without even knowing we’ve had the infection. Even if the infection persists, only a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells.” The Conversation, 10 July 2012: https://theconversation.com/catch-cancer-no-thanks-id-rather-have-a-shot-7568

[2] Archived Fact Sheets. Australian Government Funding of Gardasil. Updated 28 November 2006: http://archive.is/pm19

[3] Howard rescues Gardasil from Abbott poison pill. The Australian, 11 November, 2006: http://www.theaustralian.com.au/archive/business/howard-rescues-gardasil-from-abbott-poison-pill/story-e6frg9lx-1111112503504

[4] Ibid.

[5] Haas, Marion. “Government response to PBAC recommendations”. Health Policy Monitor, March 2007: http://hpm.org/en/Surveys/CHERE_-_Australia/09/Government_response_to_PBAC_recommendations.html

[6] Ibid.

[7] FierceVaccines special report on the 20 Top-selling Vaccines – H1 2012 states that H1 2012 sales for Gardasil (Merck) were $608 million, and sales for Cervarix (GlaxoSmithKline) were $285 million: http://www.fiercevaccines.com/special-report/20-top-selling-vaccines/2012-09-25

[8] “Catch cancer? No thanks, I’d rather have a shot!”. The Conversation, 10 July 2012: https://theconversation.com/catch-cancer-no-thanks-id-rather-have-a-shot-7568 The disclosure statement on this article by Ian Frazer states: “Ian Frazer as co-inventor of the technology enabling the HPV vaccines receives royalties from their sale in the developed world.”

[9] See ref 1 for quote from “Catch cancer? No thanks, I’d rather have a shot!”. The Conversation, 10 July 2012: https://theconversation.com/catch-cancer-no-thanks-id-rather-have-a-shot-7568

[10] Key Statistics. National Cervical Screening Program: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/facts