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Stillbirths & other serious adverse events reported to TGA following pregnancy vaccine

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At least two stillbirths and other serious adverse events have been reported to the Therapeutic Goods Administration (TGA) since 2013 when a dTpa booster was first recommended for pregnant women in Australia.

A sample of these reports are provided in the table below.  In addition, the TGA database contains a large number of other adverse reports about women of childbearing age who received the dTpa vaccine, however, due to coding limitations, are impossible to confirm with absolute certainty as having been administered during pregnancy.

It states on the TGA website:

It is generally acknowledged that adverse events are under-reported around the world, with estimates that 90-95% of adverse events are not reported to regulators. [1]

According to a disturbing new article, the vaccine masters have grand plans to expand pregnancy vaccination far beyond the current Influenza and Pertussis vaccines, as if two weren’t already bad enough.

Developing a framework for implementation of vaccines for pregnant women which is cognizant of local and national cultural, epidemiological, behavioral and societal factors will enable a smooth transition and high uptake for new vaccines currently in development for pregnant women. [2]

The pregnancy dTpa booster is currently being funded by all state and territory governments, however the manufacturer, GlaxoSmithKline, has made an application to the Pharmaceutical Benefits Advisory Committee (PBAC) for it to be subsidised under the National Immunisation Program.  This application will be considered at the forthcoming July meeting of the PBAC.

Concerned members of the public may make submissions to the PBAC opposing the taxpayer funding of drugs and vaccines.  For those wishing to make such a submission, a step by step guide is provided below the table.

Submissions close on Wednesday 08 June 2016.

Case number

Report entry date Age (yrs)

Gender

Medicines reported as being taken MedDRA reaction terms

368358

01/10/2015

F

Boostrix (Dtpa Vaccine) – Suspected

Fluvax (Influenza Vaccine Trivalent) – Not suspected

Exposure during pregnancy

Stillbirth

367892

23/09/2015 30

F

Boostrix (Dtpa Vaccine) – Suspected

Fluvax (Influenza Vaccine Trivalent) – Suspected

Exposure during pregnancy

Stillbirth

Vaginal haemorrhage

366818

03/09/2015 < 1

F

Adacel (Dtpa Vaccine) – Suspected

Elevit with Iodine (Vitamin Preparation Compound) – Not suspected

Deafness congenital

Foetal exposure during pregnancy

366133

21/08/2015 36

F

Adacel (Dtpa Vaccine) – Suspect

Fluvax (Influenza Vaccine Trivalent) – Suspected

Pre-eclampsia

Premature labour

365493

12/08/2015 17

F

Boostrix (Dtpa Vaccine) – Suspected Haemorrhage in pregnancy

Influenza like illness

359509

15/05/2015 33

F

Adacel (Dtpa Vaccine) – Suspected

Vaxigrip (Influenza Vaccine Trivalent) – Suspected

Abdominal pain upper

Diarrhoea

Foetal hypokinesia

Headache

358839

05/05/2015 29

F

Boostrix (Dtpa Vaccine) – Suspected

Vaxigrip (Influenza Vaccine Trivalent) – Suspected

HELLP syndrome

Influenza like illness

Nausea

350748

25/11/2014 13

F

Boostrix (Dtpa Vaccine) – Suspected

Gardasil (Human Papillomavirus Recombinant Vaccine Quadrivalent) – Suspected

Not specified (Varicella Vaccine) – Suspected

Implanon Implant (Etonogestrel) – Not suspected

Exposure during pregnancy

Vaccination error

How to make a submission

Submissions opposing the funding of this pregnancy vaccine may be made via the PBAC online submission form.  Most questions are self-explanatory. The following information can be copy and pasted into the relevant sections of the form (in blue), and includes some suggested arguments under the headings of effectiveness and safety that you may wish to submit.   Alternatively, you may prefer your own arguments and wording.

Medicine to which this submission relates: Boostrix dTpa Vaccine 0.5 mL injection GlaxoSmithKline Australia Pty Ltd

Date of PBAC Meeting: July

Declaration of Interest Statement: Nil

Consumer input/interest: I am a supporter of evidence-based medicine and therapies, and as such take an active interest in the quality of evidence purporting to support taxpayer-funded medical interventions.

What comments would you like the PBAC to take into account when it considers this submission:

Effectiveness Issues

It was noted in editions 7 and 8 of the Australian Immunisation Handbook that “maternal antibodies do not protect newborn babies against pertussis”.  This statement mysteriously disappeared from edition 9 but the reasons for this are unclear.

There is no empirical evidence that Pertussis antibodies in a newborn equates to immunity to Pertussis.

The only randomised controlled trial purporting to support vaccine effectiveness for the purpose of this application is an immunogenicity study, that is, the production of antibodies.  See: Munoz et al, 2014, Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial, JAMA. Notably, the vaccine used in this study was a five Pertussis antigen vaccine, whereas Boostrix is a three Pertussis antigen vaccine. [3]

All other studies purporting to support vaccine effectiveness are observational studies (NHMRC Level III evidence).  See for example: Amirthalingam et al, 2014, Effectiveness of maternal pertussis vaccination in England: an observational study, Lancet.  This study also used a five Pertussis antigen vaccine, whereas Boostrix is a three Pertussis antigen vaccine. [4]

Studies conducted to date, have not considered the overall incidence/notifications of all-cause respiratory illness of similar severity and presentation to Whooping Cough.  This is essential to ensure that any purported reduction in Whooping Cough notifications isn’t attributable to diagnostic substitution.  A recently published study found that in as many as 37.5% of ICU admissions coded as Whooping Cough, another allegedly dangerous pathogen, for example, respiratory syncytial virus,  was co-detected, raising questions about attribution of causation.  See: Kaczmarek et al, 2016, Epidemiology of pertussis-related paediatric intensive care unit (ICU) admissions in Australia, 1997–2013: an observational study, British Medical Journal. [5]

Safety Issues

Two stillbirths and other severe adverse events have been reported to the Therapeutic Goods Administration (TGA) since dTpa vaccination has been recommended in pregnancy. According to the TGA, it is generally acknowledged that adverse events are under-reported around the world, with estimates that 90-95% of adverse events are not reported to regulators. [1]

The only randomised controlled trial purporting to support vaccine safety for the purpose of this application is about a different five Pertussis antigen vaccine.  In addition, the study did not control for receipt of an Influenza vaccine during pregnancy.  See: Munoz et al, 2014, Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial, JAMA. [3]

A published study found a statistically significant increased risk of chorioamnionitis in women receiving dTpa vaccination during pregnancy.  See: Elyse et al, 2014, Evaluation of the Association of Maternal Pertussis Vaccination With Obstetric Events and Birth Outcomes, JAMA. [6]

All other studies purporting to support vaccine safety are observational studies (NHMRC Level III evidence) and did not control for receipt of Influenza vaccine during pregnancy. See for example: Donegan et al, 2014, Safety of pertussis vaccination in pregnant women in UK: observational study, British Medical Journal. [7]

The monitoring of adverse events following vaccination is being carried out via a passive surveillance system which is entirely inadequate considering the dearth of high quality evidence supporting the safety of this vaccine during pregnancy.  See: Beard, 2015, Communicable Diseases Intelligence Volume 39 No 3 – September 2015. [8]

How did you learn about this consumer submission process: Social Media

References

[1] https://www.tga.gov.au/media-release/new-web-service-helps-consumer-reporting-side-effects

[2] Marshall et al, 2016, Vaccines in pregnancy: The dual benefit for pregnant women and infants, Human Vaccines & Immunotherapeutics

https://www.ncbi.nlm.nih.gov/pubmed/26857450

[3] Munoz et al, 2014, Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial

https://www.ncbi.nlm.nih.gov/pubmed/24794369

[4] Amirthalingam et al, 2014, Effectiveness of maternal pertussis vaccination in England: an observational study

https://www.sciencedirect.com/science/article/pii/S0140673614606863

[5] Kaczmarek et al, 2016, Epidemiology of pertussis-related paediatric intensive care unit (ICU) admissions in Australia, 1997–2013: an observational study

https://bmjopen.bmj.com/content/6/4/e010386.full

[6] Elyse et al, 2014, Evaluation of the Association of Maternal Pertussis Vaccination With Obstetric Events and Birth Outcomes

https://jama.jamanetwork.com/article.aspx?articleid=1930817

[7] Donegan et al, 2014, Safety of pertussis vaccination in pregnant women in UK: observational study

https://www.bmj.com/content/349/bmj.g4219

[8] Beard, 2015, Pertussis immunisation in pregnancy: a summary of funded Australian state and territory programs, Communicable Diseases Intelligence Volume 39 No 3 – September 2015

https://www.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi3903c.htm

 

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