Www.health.gov.au



Australian Immunisation HandbookResponses to Public Consultation SubmissionsRevised Maternal Pertussis Vaccination RecommendationsPublic consultation period: 10 January 2019 to 9 February 2019Contents TOC \o "1-3" \h \z \u 1Introduction PAGEREF _Toc3977061 \h 32Responses to public consultation submissions PAGEREF _Toc3977062 \h 62.1Revised Maternal Pertussis Vaccination Recommendations PAGEREF _Toc3977063 \h 63Appendix A – Public consultation distribution list PAGEREF _Toc3977064 \h 32IntroductionPublic consultation for the revised maternal pertussis vaccination recommendations in The Australian Immunisation Handbook (the?Handbook) was conducted over a four-week period from 10?January 2019 to 9 February 2019, during which time the draft recommendations were available on the Citizen Space website. The Immunisation Branch invited a range of stakeholders, committees, working groups and interested people to provide submissions. A list of organisations formally invited to comment on the draft guidelines is provided in REF _Ref396300770 \h \* MERGEFORMAT Appendix A. This report outlines the public consultation comments received for the revised maternal pertussis recommendations. 87 submissions were received using the submission template provided on Citizen Space. Of these, 10 were on behalf of an organisation and 77 were as individuals.The Australian Technical Advisory Group on Immunisation (ATAGI) considered all responses from the public consultation in February 2019 and, where necessary, revised the maternal pertussis vaccination recommendations in accordance with the submissions. Comments from the public consultation submissions and the ATAGI responses are summarised in the following section.This report was submitted to, and approved by, the National Health and Medical Research Council (NHMRC) in March 2019.Responses to public consultation submissions Revised Maternal Pertussis Vaccination Recommendations anisationCommentProposed ActionRationale1aImmunisation Unit, Department of Health & Human Services VictoriaImprove access issues in a range of service provision models so vaccine can be administered at antenatal visits without the need to make a separate appointment at another health service provider.Reviewed. No change in recommendation made.This comment relates to implementation and will be managed by Department of Health as per standard processes.1bImmunisation Unit, Department of Health & Human Services VictoriaClear and consistent patient held antenatal record book to document vaccination and ensure vaccine is not accidentally readministered.Reviewed. No change in recommendation made.This comment relates to implementation and will be managed by state and territory health departments.1cImmunisation Unit, Department of Health & Human Services VictoriaBroad Commonwealth communication including marginalised/at risk/remote and use of translations.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.1dImmunisation Unit, Department of Health & Human Services VictoriaEducation of key workforce so they can confidently recommendation vaccination – midwives, obstetricians & GPs to improve vaccine coverage rates.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.2IndividualNew recommendations are likely to lead to a higher number of pregnant women being captured for pertussis vaccination at an optimal time compared to currently. We often have women in the final weeks of pregnancy getting vaccinated as they were unaware or had forgotten about the recommended vaccine. Had they been advised at the 20 week scan to attend the clinic for vaccination, they would have done so.Reviewed. No change in recommendation ment noted with thanks.3aIndividualIncreased potential risk for public misconception of vaccination effects on adverse foetus/pregnancy outcomes with vaccination prior to 20 weeks – this has the potential to impact significantly on community based clinics providing vaccines.As above – community based clinics need consideration of protection for staff that provide vaccines outside of antenatal medical settings.Reviewed. No change in recommendation made.The proposed recommendation is for vaccine from 20 weeks and not prior to this. The issue of early vaccination and misconception of vaccine safety has been considered by ATAGI. Studies to examine the potential impact on safety of earlier pregnancy vaccination are underway overseas and planned in Australia.3bIndividualThe information does not mention subsequent pregnancy recommendations – is this in another section still?Reviewed. No change in recommendation made.The public consultation document states dTpa vaccine is recommended as a single dose in each pregnancy. There has been no change to this current recommendation from what is already contained in the Handbook.4aIndividual‘… vaccine-induced pertussis antibodies wane over time…’Antibodies after a pertussis infection also wane over time. Should this be included so that those mothers and healthcare providers remember to also offer this vaccination?Reviewed. No change in recommendation made.This section about waning vaccine-induced antibodies is included as rationale for vaccination every pregnancy. Waning from natural infection is outside the scope of this document and is already described in the Handbook.4bIndividualThe plain English summary is excellent. The documents answered all our questions. Thank you!Reviewed. No change in recommendation ment noted with thanks.5aIndividualIncreasing herd immunity with earlier coverage.Reviewed. No change in recommendation ment noted with thanks.5bIndividualIncreased local reactions with multiple close pregnancy immunisations.Reviewed. No change in recommendation ment noted with thanks. There has been no change to the current recommendation regarding the frequency of vaccination, only the optimal timing has been during pregnancy has been expanded. Injection site reactions are addressed in the ‘Adverse Events’ section of the Handbook.6aWA Health Communicable Disease Control DirectorateWA Health supports the proposed changes to recommend pertussis-containing vaccine between 20 to 32 weeks gestation during each pregnancy. But there are some refinements in the wording that may facilitate implementation and promote update.Reviewed. No change in recommendation ment noted with thanks.6bWA Health Communicable Disease Control DirectorateYes, Many clinicians, notably public sector nurses, can follow guidelines very literally. We often see with childhood immunisations where a child may present one day early for their scheduled vaccination, and the immunisation will be postponed, resulting in potential missed opportunity and delayed vaccinations. With the maternal pertussis vaccination we are concerned that some women might present at 19 weeks and several days for the “20 week” scan. It would be helpful if ATAGI had access to date to establish how common or rare a situation this is, i.e. that 20 week booking happens slightly early. If not rare, it would be good if the ATAGI language were more permissive, saying something like: “The optimal time for pertussis vaccination in pregnancy is between 20 to 32 weeks gestation, but it is acceptable to administer the vaccine from 13 weeks gestation until delivery.”Reviewed. Change made to recommendation.Text has been edited to soften the 20 week recommendation wording. Additional information has been added regarding the fact there is no safety concern if the vaccine is administered prior to 20 weeks.6cWA Health Communicable Disease Control DirectorateThe text should include that it is safe to co-administer influenza vaccine and pertussis vaccines to pregnancy women. Maybe even going farther saying something like, “If seasonal influenza vaccine is available and the woman has not already received an influenza vaccination for upcoming influenza season, influenza vaccine should be administered at the same visit when her pertussis-containing vaccine is administered.Reviewed. No change in recommendation made.The timing of influenza vaccines during pregnancy and co-administration with pertussis vaccine is described in the influenza chapter of the Handbook and the annual ATAGI influenza statement. This information will be added to the pertussis chapter of the Handbook.7aIndividualEducation for women.Education for midwives, GPs and obstetricians.Vaccination administrator training.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.7bIndividualSome jurisdictions have a requirement that only appropriately trained health professionals can administer a vaccine, even if the woman is in a hospital setting. Access to appropriate education and training is required to ensure there is a critical mass of health professionals particularly midwives that can administer vaccinations to pregnant women and new mothers.Reviewed. No change in recommendation made.This comment relates to implementation and communication, and will be managed by Department of Health as per standard processes.8IndividualI think this is a great idea and support fully.Reviewed. No change in recommendation ment noted with thanks.9aIndividualInfants born extremely preterm (28 weeks or earlier) may be born to mothers who have not yet received pertussis vaccination and thus have not benefited from the transfer of maternal antibodies. Does the literature and research support earlier vaccination of mothers, for example from 12 or 16 weeks?Reviewed. No change in recommendation made.The timing of pertussis vaccination in pregnancy has been considered by ATAGI and the optimal timing is presented in the public consultation document. Expansion of the recommended timing to 20–32 weeks will increase the opportunity for preterm babies to be adequately protected.9bIndividualNot directly related to maternal vaccination: does the literature support earlier immunisation of newborns? Is there a future possibility of a birth dose of pertussis-containing vaccine?Reviewed. No change in recommendation ment not applicable to this document.10aWide Bay Public Health UnitI think the benefits and risks are well outlined in the paper.Reviewed. No change in recommendation ment noted with thanks.10bWide Bay Public Health UnitI support the recommended changes.Reviewed. No change in recommendation ment noted with thanks.11aIndividualPossible side effects from repeated doses of vaccine that contains 3 antigens, when only one is needed. It may well prove beneficial for some vaccine suppliers to bring forward a suitable pertussis-only vaccine for use during pregnancy AND for use in other family/contact personnel.Reviewed. No change in recommendation ment noted with thanks. No monovalent pertussis vaccines currently exist and a discussion of potential future vaccines is outside the scope of the public consultation document.11bIndividualClinical implications of repeated unnecessary dosing with tetanus vaccine in the triple antigen vaccine.Reviewed. No change in recommendation ment noted with thanks. No monovalent pertussis vaccines currently exist and a discussion of potential future vaccines is outside the scope of the public consultation document.12aIndividualNo evidence based other benefits or risks other than those outlined.Reviewed. No change in recommendation ment noted with thanks.12bIndividualEducation will as always be needed to explain the change, particularly given the generally low awareness of the incidence and severity of pertussis amongst young mothers.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.12cIndividualThere will be the expected objections from the anti-vaccine lobby to handle.Reviewed. No change in recommendation ment noted with thanks.13IndividualMinimum frequency between repeated vaccination.Reviewed. No change in recommendation made.There has been no change to the current recommendation regarding the frequency of vaccination, only the optimal timing has been during pregnancy has been expanded. Injection site reactions are addressed in the ‘Adverse Events’ section of the Handbook.14aIndividualNo I don’t believe so. Based on current evidence, benchmarking of similar healthcare systems and countries, the recommendations are sound, logical, based on evidence and should improve outcome particularly for our most vulnerable. Reviewed. No change in recommendation ment noted with thanks.14bIndividualThere does need to be a concerted effort to counter the prevalence of incorrect, inappropriate or simply ambivalent advice provided during antenatal care by midwives, general practitioners and to a lesser degree obstetricians who hold alternative views, not based on valid evidence. The education about an issue, understanding of the matter and delivery of information by a health practitioner is probably the single most important aspect in helping a person make a sound decision about healthcare. To allow practitioners who are registered as a profession with AHPRA to provide anything but the correct, internationally accepted and in-line with best current evidence advice without consequences is unacceptable.Reviewed. No change in recommendation ment noted with thanks.14cIndividualI whole heartedly support the promulgation of the singularly most effective, efficient and preventative measure in modern medical population health along with the consideration of the actual individuals concerned – infants and children who bear the consequences of these diseases through no fault of their own. I applaud your ongoing efforts to provide the best possible advice for their wellbeing. Reviewed. No change in recommendation ment noted with thanks.15aIndividualGeneral practitioners/GP surgeries could administer the dTpa vaccination which would lighten the clinical load of hospital based and communities midwives. This would allow more time to spend with women.Reviewed. No change in recommendation made.This comment relates to implementation and will be managed by Department of Health as per standard processes.15bIndividualClear documentation of the administration of dTpa. Many women are unsure if they have received the dTpa vaccination when asked. Often they might be confused between a flu-vax or the dTpa.Reviewed. No change in recommendation made.This comment relates to implementation and will be managed by state and territory heath departments as per standard processes.16aIndividualI think that there are potential benefits with increased access to the vaccinations if women over 20 weeks have access to this vaccine. Access is always enhanced when it is part of the recommended vaccination programme and also available for free. Reviewed. No change in recommendation ment noted with thanks.16bIndividualIt is very helpful if this vaccine is recorded on AIR for all patients.Reviewed. No change in recommendation made.This comment relates to implementation and will be managed by Department of Health as per standard processes.16cIndividualFor many refugee patients, this vaccination sometimes contributes to their personal coverage for DTP as well as benefiting their baby – when they are under immunised.Reviewed. No change in recommendation ment noted with thanks.16dIndividualIt would be helpful for the advice for clinicians to address the concerns raised in early studies about increase chorioamnionitis – to allay concerns.Reviewed. No change in recommendation made.Both the public consultation document and the ‘Adverse events’ section of the Handbook discuss study findings regarding chorioamnionitis.16eIndividualIt would be helpful for advice for clinicians to address the understanding of clinicians that a positive and high titre of pertussis Ab does not necessarily reflect the actual immunity being achieved. In some places, the literature suggests that measuring antibody levels of pertussis does not necessarily reflect immunity, yet it seems that the presence of Ab in the cord blood is to be accepted as evidence of effectiveness for protection of the baby – there appears to be some inconsistency within the literature and addressing this could assist clinicians in feeling confident in their recommendations.Reviewed. No change in recommendation made.It is correct that pertussis antibody titres do not correlate specifically with protection, however there is widely accepted consensus that higher pertussis antibodies represent better and longer lasting protection. It is on this basis that studies measuring antibody levels have been evaluated for this public consultation document. This aligns with international standards.16fIndividualIt would be helpful for the issues around safety of the vaccine to be clearly stated. In recent times, in Qld, there was a requirement for all women receiving this vaccine to sign a waiver understanding that although the vaccine was being recommended, it was not necessarily safe. While this is no longer the case, the existence of this document caused great concerns and hesitation that persists within the community. Highlighting how and why this vaccination is considered and demonstrated to be safe at this present time (as opposed to previous statements) would be helpful.Reviewed. No change in recommendation made.Both the public consultation document and the ‘Adverse events’ section of the Handbook discuss the safety of pertussis vaccines in pregnancy.16gIndividualMany grandparents and family members are told AFTER the baby is born that they need vaccination – it would make much more sense for families to be told that they should arrange this vaccination while the pregnancy continues, so that there is less urgent need to access vaccination after the baby is born.Increased awareness within the community suggesting that those who are having grandchildren, or friends/other family members of people having children to consider their vaccination status for pertussis would be worthwhile. The community awareness seems to be low.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.17aIndividualNone extra. Tremendous benefit for pregnant women to be vaccinated earlier in the pregnancy.Reviewed. No change in recommendation ment noted with thanks.17bIndividualWidespread, clear communication to hospitals, GP’s, Primary Health Networks, State/Territory Health Departments, Obstetricians, Paediatricians.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.17cIndividualAdvertising campaign to ensure consumers are aware.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.17dIndividualState/Territory Health run birthing hospitals should be opportunistically delivering this vaccine to pregnant women at hospital visits. This is not happening. Pregnant women are sent away and told to see their GP.Reviewed. No change in recommendation made.This comment relates to implementation and will be managed by Department of Health as per standard processes.18IndividualThere needs to be a strong publicity/communication of the changes focused at a number of groups: the general public, pregnant women, practice nurses, GPs, obstetricians, and midwives.Each group needs focused information to ensure they receive the information relevant to them.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.19aThe Immunisation Foundation of AustraliaAny alterations to vaccination recommendations can potentially affect consumer confidence in vaccination recommendations. The “Why” in the change will need to be communicated clearly to pregnant women to minimise this.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.19bThe Immunisation Foundation of AustraliaBy expanding into the second trimester, there will naturally be a significant increase in the number of anecdotal stories about a stillbirth following the whooping cough vaccine. A stronger message of safety will be needed in response to minimise this.Reviewed. No change in recommendation made.The issue of early vaccination and misconception of vaccine safety has been considered by ATAGI. Both the public consultation document and the ‘Adverse events’ section of the Handbook discuss the safety of pertussis vaccines in pregnancy. Any communication materials produced will also address vaccine safety.19cThe Immunisation Foundation of AustraliaThis is of significant benefit to babies born in multiples (twins, triplets etc) who are more likely to be born pre-term (and are at higher risk of complications from respiratory infections). Clear communication to Multiples Associations is recommended to optimise this benefit.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.19dThe Immunisation Foundation of AustraliaCurrent recommendation messaging to consumers has been very strong. Some states have opted for “From 28 weeks” terminology, other health departments have used “Third trimester” to communicate the time-frame. The new time-frame (midway through second trimester to partially through third trimester) is more difficult to communicate to consumers in a concise, easy-to-understand way. This will need to be carefully considered.Reviewed. No change in recommendation made.This comment relates to communication materials and will be managed by Department of Health.19eThe Immunisation Foundation of AustraliaThe change in recommendation may be costly to not-for-profit groups who will need to update flyers, websites, posters, social media graphics and other health promotion materials at their own cost.Reviewed. No change in recommendation ment noted with thanks. This comment relates to communication materials and will be managed by Department of Health.19fThe Immunisation Foundation of AustraliaIt could be worth considering a targeted campaign aimed at GPs, as the likelihood of a pregnant woman accessing a GP during this new timeframe is significantly higher.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.19gThe Immunisation Foundation of AustraliaIt may also be worth considering the timing of the Department of Health’s new whooping cough vaccination in pregnancy campaign (a social media campaign) to coincide with the launch of these changes.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.19hThe Immunisation Foundation of AustraliaConsider whether timing alongside Glucose Tolerance Test is appropriate. With fasting, blood tests and the unpalatable drink, nausea and an upset stomach are common side effects. This may not be the optimal time to vaccinate, for the comfort of the pregnant mother and for the potential increased reporting of adverse reactions.Reviewed. No change in recommendation made.The optimal timing for pertussis vaccination described in the public consultation document is 20–32 weeks. The glucose tolerance test is usually performed between 24–28 weeks. There is opportunity for vaccination to be given independently of this test.19iThe Immunisation Foundation of AustraliaOverall, there are far more benefits than risks when it comes to changing these recommendations and we support them.Reviewed. No change in recommendation ment noted with thanks.19jThe Immunisation Foundation of AustraliaWe recommend harnessing the social media research of our “Light for Riley” project to help promote new recommendations about the whooping cough vaccine during pregnancy.Reviewed. No change in recommendation ment noted with thanks.20aIndividualI have read the proposal and see no evidence that the consequences of multiple vaccinations of women ‘with each’ pregnancy has been taken into consideration. Not only from pertussis but the combination vaccine. Many women receive a vaccination yearly for a number of years. Where is the evidence of no risk to these women for this.Reviewed. No change in recommendation made.The recommendation to give pertussis vaccine in every pregnancy has previously been approved and there is no proposed change to this frequency as part of this public consultation document. Further discussion of this is outside the scope of this document.20bIndividualI think it should be noted that the administration of pertussis to the mother during pregnancy has had implication on the infant vaccine schedule with the infant now requiring a further vaccination of pertussis.Reviewed. No change in recommendation made.The addition of an 18 month dose to the NIP schedule in Australia in 2016 was not related to maternal pertussis vaccination. Discussion of this schedule change is outside the scope of the current public consultation document.20cIndividualI’d like to see the statistics on how many infants contract whooping cough – not just the statistics of how many die once ill with the disease. Consumers can’t make informed choice if you only have half of the information.Reviewed. No change in recommendation rmation on the number of pertussis cases and rate of infection in infants is publicly available on health department websites and in peer-reviewed journal publications. Such information is referenced in the public consultation document.21IndividualI support the proposed change as being a common sense move to increase the capture rate of pregnant women to have the vaccine.Reviewed. No change in recommendation ment noted with thanks.22aIndividualDefinitely beneficial to increase the window. In my experience with women attending antenatal care at an Aboriginal Medical Service, some have minimal and random visits between 20 weeks and term. Being advised to immunise before 28 weeks increases the likelihood that babies will be protected by transplacental antibodies.Reviewed. No change in recommendation ment noted with thanks.22bIndividualCommunication through the Primary Health Network is essential for prompt uptake of the new recommendations by GPs, as well as through antenatal shared care programs.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.23aIndividualMy concern in this area is of the safety of repeated doses of currently available vaccines (essentially DTPa/”Boostrix”) in subsequent pregnancies. There is no single antigen PERTUSSIS vaccine currently in production to my knowledge.Reviewed. No change in recommendation made.There has been no change to the current recommendation regarding the frequency of vaccination, only the optimal timing has been during pregnancy has been expanded. The safety of repeated doses is addressed in the ‘Adverse Events’ section of the Handbook. No monovalent pertussis vaccines currently exist.23bIndividualMy only concern regarding implementation is that supplies of vaccine need to be assured.Reviewed. No change in recommendation made. This comment relates to implementation and will be managed by Department of Health as per standard processes.24aIndividualThe New Zealand study on the safety of the vaccine is inadequate. 403 is a very small group and the follow up period (12 months) is also inadequate. An observational study is also prone to poor design, oversight, subjectivity and confrontational bias.Reviewed. No change in recommendation made. Minor change to reference for vaccine safety section.The public consultation document references 9 pregnancy safety studies that include data from >1,000,000 women. None of these is a New Zealand safety study. Whilst reviewing comments a recently published New Zealand safety study containing >68,000 women was identified, which will be included in the document.24bIndividualThere is no information on the specific action of the vaccine (i.e. what component causes an immune response and how). Since vaccines are far from being pure, there needs to be information on the various other components of the vaccine and evidence that there are no unintended adverse effects either immediate or future. This is a big ask but the burden of proof on vaccine manufactures seems to be much lower than that for routine pharmaceuticals where precise information is known about the content and often, about the mechanisms of action.Reviewed. No change in recommendation made.There has been no change in the vaccine formulations to be used for the recommended vaccination schedule described in the public consultation document. They are registered in Australia and have already been recommended for use in pregnancy for >5 years. Detailed discussion of vaccine components and mechanism of action is outside the scope of this public consultation document. Both the public consultation document and the ‘Adverse events’ section of the Handbook discuss the safety of pertussis vaccines in pregnancy.24cIndividualOften drugs are prescribed where the mechanisms of action are uncertain and side effects are unpredictable. Amiodarone is such a drug. Amiodarone however is used because it is life saving in the short term and there are many people who have appropriate cardiac conditions (the need is significant). Where is the evidence here that there is a significant need for this vaccine to be recommended in light of its poorly described composition and action?Reviewed. No change in recommendation made.Both the public consultation document and the ‘Epidemiology’ section of the Handbook discuss the burden of disease in newborn infants. As pertussis vaccine has already been recommended for use in pregnancy for >5 years a more detailed discussion of the disease burden was outside the scope of the public consultation document. 24dIndividualVaccines are increasingly being described to lay people as completely efficacious and free of significant side effects. Their compositional complexity makes such assurances both unbelievable and careless. Before any vaccine is “recommended”, there needs to be significant evidence that there is a major public health threat.The world of epidemiology is commonly based on statistical processing of “reported” data. You would think that the evidence would have a more scientific dimensions but it often doesn’t.Vaccines do save lives and we would probably be in a lot of trouble without them. The problem with putting them on a “recommended” list is that it’s a short jump to them being mandated by unscientific people (politicians, public servants and even many GPs).I would have a greater burden of proof placed on vaccine makers and in marginal benefit cases, I would merely provide information that the vaccine is available. I would be very hesitant to give a vaccine “recommended” status.Reviewed. No change in recommendation ment noted with thanks.25aWA Primary Health AllianceI think it should increase the opportunity to vaccinate, from a GP point of view, as they normally organise the anatomy scan around 19 weeks which gives a good opportunity to discuss the pertussis vaccine and potentially give it with follow up of results. I have seen a few patients come in late for their pertussis vaccines as unless they are having shared care with the GP, from 20 weeks their antenatal care is usually done by the hospital/private obstetrician and they often find it difficult to make a separate appointment to see the GP just for a vaccine (especially if they have other young kids and are needing it close obstetric follow up with lots of appointments).Reviewed. No change in recommendation ment noted with thanks.25bWA Primary Health AllianceA point that has already been made in the submission is about the potential risks regarding a potential for a chance association between vaccination and adverse pregnancy outcomes when giving the vaccine earlier. It would be useful to have more evidence included around this to be able to explain benefits vs risks to the mother about timing of the vaccine and allow her to choose when to be vaccinated i.e. there is a mention of a study showing increased PPH and chorioamnionitis if vaccinated early – is this something that should be discussed with the mother and included in the handbook?Reviewed. No change in recommendation made.As noted, the issue of early vaccination and misconception of vaccine safety has been considered by ATAGI. Communication materials for maternal pertussis vaccination discuss the risk vs benefit of vaccination. Chorioamnionitis is discussed in the ‘Adverse events’ section of the Handbook.25cWA Primary Health AllianceA general question – the recommendation is to vaccinate in each pregnancy, are there any guidelines around a minimum interval between vaccines or a maximum number of vaccines that can be given safely within a time period? I.e. If a woman has a prem delivery and falls pregnant again soon after should she wait till 3rd trimester for the vaccine in the next pregnancy? Also if she has more than 2 or 3 children in a short period of time are there any increased risks to having the vaccine close together in each pregnancy?Reviewed. No change in recommendation made.There has been no change to the current recommendation regarding the frequency of vaccination. Minimum intervals are addressed in the ‘Vaccine information’ section of the Handbook. Internationally there is no upper limit to the number of dTpa vaccines a person can safely have.26IndividualWe do not need vaccinations.Reviewed. No change in recommendation ment noted with thanks.27aIndividualI don’t think so. Main issue is unambiguous explanation so women are not anxious.Reviewed. No change in recommendation ment noted with thanks.27bIndividualClear info plain English pamphlet or postcard would be good.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.28IndividualEarly immunisation of the mother will allow more time and opportunity to immunise other family members and friends before the baby is born. This may reinforce community immunity to pertussis.Reviewed. No change in recommendation ment noted with thanks.29IndividualPossibility of an increase in localised reaction at injection site in the mother associated with frequently repeated doses – multiple pregnancies or the development of a systemic sensitivity to other antigens within the vaccine or other additives in the vaccine in relation to frequent administration.Reviewed. No change in recommendation made.There has been no change to the current recommendation regarding the frequency of vaccination, only the optimal timing has been during pregnancy has been expanded. Injection site reactions are addressed in the ‘Adverse Events’ section of the Handbook.30IndividualAs a practice nurse and nurse immuniser I support the changes.Reviewed. No change in recommendation ment noted with thanks.31aIndividualNo, pregnant women should have the opportunity to be vaccinated against pertussis to protect themselves and their unborn baby.Reviewed. No change in recommendation ment noted with thanks.31bIndividualProviding the public and immunisers more informed knowledge based on evidence based guidelines, this will enable pregnant women and those who would like to become pregnant more informed decisions on their healthcare.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.31cIndividualAccess to vaccine in rural and remote communities.Reviewed. No change in recommendation made.This comment relates to implementation and will be managed by Department of Health as per standard processes.31dIndividualIssues with translating information into consumer available material and follow ups by maternity staff.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.32aIndividualWith larger window and influenza vaccinations also being given if multiple care providers and poor communication may get double dosing of pertussis vaccination.Reviewed. No change in recommendation made.This comment relates to communication and implementation, and will be managed by Department of Health as per standard processes.32bIndividualNo think it is a good idea and increases chances of having the vaccine as some hospital based care patients, particularly those in midwife led care, seem to miss out on the vaccination and as often these care models are not in place until after the 20 week scan a routine 22 week GP review may assist in getting more women vaccinated.Reviewed. No change in recommendation ment noted with thanks.32cIndividualExcellent idea evidence based and practical simply need way to communicate with all care providers when the vaccine has already been given.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.33aNSW Health – Health Protection NSWNSW welcomes the opportunity to provide feedback on the proposed changes to pertussis recommendations for pregnant women. NSW has reviewed the changes in detail and agrees with the recommendation to offer pertussis containing vaccine to pregnant women from their 20-week scan onwards and acknowledges that earlier vaccination may also help to protect preterm infants.Reviewed. No change in recommendation ment noted with thanks.33bNSW Health – Health Protection NSWIn response to the ATAGI’s request for comments on two specific questions, NSW Health advises the following:1. Are there additional potential benefits, risks or unintended consequences which could arise from the proposed changes to the use of pertussis vaccines in pregnant women, not already outlines and how likely are they to occur? No. The science and rationale are non-controversial.Reviewed. No change in recommendation ment noted with thanks.33cNSW Health – Health Protection NSWNSW will consider minor program/implementation considerations to accommodate the changes.Reviewed. No change in recommendation ment noted with thanks.34SESLHD Public Health Unit"After consultation with Prof Mark Ferson (SESLHD PHU) and A. Prof Nicholas Wood from NCIRS re this issue, we have decided to ask you the folowing question: Is it possible to have a booster for pregnancy /newborn close contacts (ie like the Coocooning Strategy) every 5 years. This should include Category A High Risk Health Care Workers (as well as Aged Care Facility Workers). Research has shown that the dTpa vaccine doesn't last for 10 years which is the recommendation now. Therefore people who think they are covered by their previous vaccination, end up spreading pertussis because the vaccine is no longer effective and the guidelines say they are not due for revaccination under 10 years "Reviewed. No change in recommendation ment noted with thanks. A discussion of changes to recommendations for close contacts is outside the scope of the public consultation document.35aRACGPThe RACGP agrees with the proposed changes from ATAGI. Expanding the vaccination period provides more opportunities for GPs to confirm that pregnant patients are immmunised, and that preterm babies are better protected. It also provides an opportunity to link the provision of the vaccine to an early antenatal visit, thus simplifying care, and allowing further time for the vaccine to take effect.Reviewed. No change in recommendation ment noted with thanks.35bRACGPIt is important that the changes are widely communicated and implemented effectively, with a notification to all relevant stakeholders.In addition to the changes to the Australian Immunisation Handbook, the RACGP suggests that a modification should be made to the Shared Care Management Guidelines. The antenatal care schedule (sent to the GP, along with the letter of acceptance) could include the changes to the pertussis vaccines, highlighted in a different colour.The benefits of earlier vaccination should be clearly communicated. For example:? Earlier administration of the vaccine ensures higher antibody levels are achieved in neonates, providing better protection? There is no significant risk to the fetus or the mother? An earlier vaccine provides coverage should there be a preterm delivery? The vaccine needs to be repeated for each pregnancy.Finally, a more concise document from ATAGI on the rational for the changes would be useful resource.Reviewed. No change in recommendation made.This comment relates to communication and will be managed by Department of Health as per standard processes.36aRACPAlthough the current evidence for optimal timing of maternal pertussis immunisation is not conclusive at this point in time, the RACP supports broadening the time window for maternal pertussis immunisations to include the second trimester, based on the evidence and rationale outlined in the consultation paper. This recommendation should be supported by a proactive approach to maternal pertussis vaccine pharmacovigilance through data collection and monitoring of any associated adverse pregnancy outcomes.Reviewed. No change in recommendation ment noted with thanks.36bRACPThe RACP also supports the integration of this advice under the pregnancy vaccination recommendations in the Australian Immunisation Handbook to allow timely updates in the future, especially where new evidence is available. With respect to the summary box on page 4 of the consultation paper, the RACP suggests the inclusion of the information on vaccine effectiveness; prescribers will be better informed by quantitative representations of the actual risk reduction by percentage and will better understand the magnitude of the issue.Reviewed. Change made to ment noted with thanks. The VE data will be included in the recommendation sub text to provide more detail of the benefit of maternal vaccination.36cRACPThe RACP agrees with the benefits and potential risks stated in the consultation paper and maintains that the broader time window will not only greatly benefit those pregnant women who attend antenatal appointments less regularly, but will also improve immunisation equity overall.Reviewed. No change in recommendation ment noted with thanks.37IndividualThere are no studies proving that giving pregnant women vaccines aren’t harmful to foetus or mother. Yes proper studies need to be done and disclosed to the public.Unless there is proof of safety this should not be mandated and informed consent needs to be completely allowed by the individual.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.38IndividualDon't inject neurotoxins into pregnant women."Neurotoxins are bad for foetuses.Vaccine ingredients contains neurotoxins and in trace amounts also.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.39IndividualI can't find any safety studies of this vaccine for pregnant women. Actually I can't find any double blind placebo safety testing for this vaccine . Does this mean it will be a case of post marketing surveillance as usual ? Can you reassure pregnant women that collecting of this data will be done vigorously? I'm not confident that this will be followed up .I would like to see informed consent becoming a part of this conversation when giving women this option . A copy of the manufacturers sheet just as if you were buying medicine from your pharmacist . Mums need to know the risks .As this vaccine has been ineffective in preventing Pertussis I'm not sure what you are hoping to achieve ? I would predict that this extra load of toxins and immune stimulation will result in an increase in miscarriage and neurodevelopmental delays . Unintended consequences are unknown , there should be a long term study as for other drugs .Reviewed. No change in recommendation ments not applicable or supported by body of evidence.40IndividualThere are risks for using the pertussis vaccine in pregnancy that are not outlined prior to administering this vaccine in pregnancy. For informed consent the true risks should be given as per the insert and the full ingredients given. The insert should be given to a patient as per any other medication given in pregnancy.Give a full list of ingredients and list of risks to a pregnsnt mother prior to administering the vaccine.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.41IndividualYou are using pregnant women and precious unborn babies as a trial! My own child died in utero at 31 weeks gestation. You have NO IDEA what that does to a mother. A family. Extended family. Friends. This proposal is absolute stupidity. Test it on your self before others. Do not administer ANYTHING DURING PREGNANCY. The foetus can not detox from the heavy metals in the vaccine therefore their will be detrimental long lasting effects. Healthcare can not keep up with the physical needs and mental demands of society as is. Dementia rates are rising who will cate for all these people if your using unborn babies as guinea pigs. ?"No VACCINES IN PREGNANCY FULL STOP!No sensible mother would want to be used as a trial in pregnancy and it is morally wrong for the government to force them into it through a mandatory or a suggested schedule.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.42IndividualMany potential consequences of this. One being the health of the babies and their fragile immune systems by injecting a known toxin into them at such a important stage of life. Especially when it is one of least effective vaccines. Such a toxic chemical should NOT be subjected to a unborn child. No way of knowing if a adverse reaction has occurred as a resultThe vaccine industry and the people who promote fear of sickness are a disgrace to humanity. Shame on anyone who tries to force anything into anyone.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.43IndividualRisks not adequately outlined... I received the pertussis vaccine while pregnant and immediately succumbed to respiratory infection. I had a severe cough for 6 months from which I broke ribs, suffered bronchitis which needed 2 courses of antibiotics, gastro, laryngitis, tonsillitis and conjunctivitis all whilst having to go into labour and look after a newborn. A pregnant mothers immune system is suppressed! Don't vaccinate immune suppressed individuals. Why don't you just teach people to quarantine themselves while baby is young instead? Over the top pharmaceutical companies trying to make more money. Thanks to that experience I have now done my research and am thoroughly antivax now (was thoroughly privacy before). But didn't that backfire on you greedy pharmaceutical companies because now my son is completely unvaccinated! I didn't get the shot during my first pregnancy and so unfortunately my daughter had all her shots but I won't be giving her any more I feel so guilty what I put her through she was always sick that first year of her life. Shame on you! Lucky I didn't lose my baby.Why don't you start with a real safety test first where you have a true double blind placebo???Stop focussing on profits and let's make this world a happier healthier place for the next generation?????Reviewed. No change in recommendation ments not applicable or supported by body of evidence.44IndividualYes. Maternal immune activation can cause brain damage in the Fetus. This is highly dangerous. You should know this before even questioning this vaccine.Also viral encephalopathy, which can be an adverse reaction causes inflammation on the brain which can lead to all types of neurological disorders. Show us truely independent safety studies, not studies funded by anyone or organisation that can financially benefit from the sale of this vaccine. I want to see vax vs non vax studies before any approval of this type. Hold vaccine manufacturers 100% accountable for any adverse reactions so their product is safe before use.Aluminium adjuvants and egg protein are used to cause allergies in mice for clinical testing on new antihistamine products.Aluminium adjuvants and egg protein can be found in vaccines.Now why are their so many allergies these days?Put people over profit. Stop letting pharmaceutical industry influence policy for profit.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.45Individual"In the past has it always been strongly recommended that during pregnancy women not be vaccinated. There have never been any valid studies done to prove the efficacy and safety of vaccines. In the manufacturers product statement it lists possible adverse effects. It states clearly that the product has never been tested for efficacy or safety for pregnant women and actually advises that it not be administered to them.So why does this government think it a good idea to endanger the safety of pregnant women and the child they carry?"That no vaccine has been thoroughly and effectively tested for efficacy and safety. That toxicity levels of components alone and in combination has never been establishedUntil efficacy and safety has been firmly established by independent studies done by research facilities that are not financed by companies that have a pecuniary interest in the outcome, that this vaccine not be used on pregnant women.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.46IndividualRisks for aluminium containing vaccine, with aluminium known to be neurotoxin, and implications for developing brain. Risk of increased miscarriage rates, many anecdotal reports, but I have not seen any study on this issue. Risk of maternal immune stimulation and impacts on pregnancy.Paper states that there have been relatively few safety studies. Why is vaccination being recommended earlier in pregnanxy, at more vulnerable developmental time, when the safety studies have not been done. Where are long term developmental studies on infants born to mothers vaccinated or not vaccinated during pregnancy. Pertussis vaccine does not prevent perrussis infection. It may reduce severity of illness (or not), but a vaccinated person can get pertussis without being ill, but they are still infectious.Whether the studies say this intervention is safe or not (whose data I am highly sceptical of given how easy it is to manipulate and what kinds of financial reward for pharmaceutical companies are at stake), I am appalled at the push to vaccinate all pregnant women. It is even stated that there are very few studies in existence on the safety of this vaccine in pregnant women. Also, I know enough women who have miscarried after this vaccine to know that the studies are not entirely reflective of the truth. This vaccine has not been proven safe in pregnancy and you only have to google forums to hear about how many women have lost their babies as a result. Please stop this madness nowGive us a study using genuine placebo and straightforward data presentation instead of highly “cleansed” data that don’t adequately demonstrate the very present risks.We need to separate profit from science. Only then can we stop the devastating corruption and wide scale deaths and disease occurring from iatrogenic causes. It is acknowledged that iatrogenic causes are the third leading cause of death in the US, however these stats are only based around what has been reported. How can we allow this to continue unchecked?Reviewed. No change in recommendation ments not applicable or supported by body of evidence.47IndividualAluminium phosphate is a reactive neurotoxin, highly damaging to cellular biochemistry.Aluminium found in vaccines is a potential contributor to the onset, progression and aggressiveness of conditions such as Alzheimer’s, Parkinson’s Disease and Multiple Sclerosis. Clinical studies have provided a link between aluminium toxicity and neurodegenerative conditions. These conditions often lead to further health issues and also contribute to emotional health decline, which impacts severely both social and economically.Aluminium is toxic and should not be injected into the human body.Formaldehyde is a highly toxic poison causing corrosive internal injury, which can include metabolic acidosis, respiratory distress and renal failure. There is absolutely no grounds that warrant the necessity of injecting formaldehyde into the human body and thus should not be. Ammonium Sulfate is an inorganic salt most commonly used as fertiliser within the agricultural industry. It can negatively affect pulmonary function in humans and cause chromosomal aberrations (mutation).In a developing foetus, this can cause physical and mental abnormalities and should not be injected into the human body.Due to the damaging and toxic nature of ingredients contained within the DTap vaccine, government input, regarding vaccine application, is irrelevant and has no place or right in administering legislation pertaining to it’s usage. Government, in it’s role of serving the citizens of this country, should recommend further investigative studies pertaining to the risks involved to human human health and the social and economic ramifications that accompany adverse affects from vaccination scheduling.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.48Individual"There has not been a study that monitors for increased chance of risk and likelihood of occurrence in pregnant women who are vaccinated at 20w compared to 28w. There has also not been a study that has shown evidence of any significant health benefits to be gained from the change. Before any change in the schedule of vaccination recommendations for pregnant women, adequate studies need to be conducted to monitor for any increased chance of risk that may come with that change, and show evidence of the benefits so that a proper risk vs benefits assessment can be made. .Antibodies decline over time, so the earlier in the pregnancy the mother is vaccinated. the less time after birth, the baby has before the antibodies decline. "The only health benefit you have offered in your proposal is that preterm babies will have time before birth to receive adequate antibodies. Most preterm babies are born at 34-36w. Leaving 4w before approximate birth date, to allow for maximum results, vaccination by 30w would be sufficient, and this is also when the antibodies begin to generate substantially. Reviewed. No change in recommendation ments not applicable or supported by body of evidence.49Individual"This is not a single vaccine, yet the information leads you to think it is. There are many unknown risks which have not been studied and beyond the capablity of scientist at this point in time. The immune system, nervous system, general foetal growth is still not full understood and there is no understanding of what stimulating the immune system with inactivated cells will do to the developing foetus while in the womb during growth phases. There is no understand and no study of what effect this will have on the babies developement into a child, teen and adult. T"Does this transfer to the child? Is there a study for this?Provide all safety studies.There is not enough information to categorically state that this is ‘safe and effective’.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.50IndividualBefore any change in the schedule of vaccination recommendations for pregnant women, adequate studies need to be conducted to monitor for any increased chance of risk that may come with that change, and show evidence of the benefits so that a proper risk vs benefits assessment can be made."Antibodies decline over time, so the earlier in the pregnancy the mother is vaccinated. the less time after birth, the baby has before the antibodies decline.The only health benefit you have offered in your proposal is that preterm babies will have time before birth to receive adequate antibodies. Most preterm babies are born at 34-36w. Leaving 4w before approximate birth date, to allow for maximum results, vaccination by 30w would be sufficient, and this is also when the antibodies begin to generate substantiallyReviewed. No change in recommendation ments not applicable or supported by body of evidence.51Individual"Maternal immune activation can and does lead to brain damage, hindered fetal development or worse, death, for an unborn child. Hence why many diseases pose such a frightening risk to pregnant women.Inducing a whole body immune response and exposing a mother and her unborn child to diseases and toxins during such a crucial time is dangerous.Rather than focusing on antibody development alone, why aren’t we assessing the risk of death and disablement?""Aside from the studies mentioned, there are also a plethora of legitimate and credible scientific studies discussing the risks of vaccination readily available.Might a better approach be to encourage women to receive the vaccine whilst not pregnant? If they wish to at all or if they are not already immune."Reviewed. No change in recommendation ments not applicable or supported by body of evidence.52Individual"Yes I totally 100% disagree with this United Nations fed agendas, to aid in their 'Depopulation Plans' via 'Agendas 21 & 30 where with this 'Push' that your 'Usufruct' Administrative US Corporate governance gives you what you believe is the right to 'Forcibly' and also byways of 'Extortion' 'Toxify and Poison' both 'Expectant Mothers' and also our Nations new emerging babies.Shame on your corrupt people there for even thinking or in suggesting such 'inhumane measures'!You are the very people who are supposed to go out and work for us, instead, all we get is your arrogance and 'control freak methods'!For one... That vaccine isn't even tested on pregnant women. I have read the insert, which by the way is not "fake research" it's the real deal, the informed consent that we are all supposed to have from the medical professionals. How can it possibly be a good idea to add more vaccines that are not even tested for safety in pregnancy to the schedule? We need more research and more safety studies.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.53IndividualThere has been insufficient testing on the safety of this vaccine to the Fetus. Miscarriage and birth defects need to be eliminated.This vaccine contains aluminium which is surely not recommendable during pregnancy. Furthermore, maternal immune activation can and does cause brain damage. It is also very questionable that the Fetus will develop “immunity” through this procedure.Vaccines contain highly toxic substances, it is very questionable that injecting these into pregnant women will not have an adverse effect on a Fetus. Extensive testing and studies need to be undertaken, risks of miscarriage and birth defects eliminated before even considering this kind of procedure.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.53IndividualYes, risks - you haven't done enough studies to say there aren't.Do not put something that has been so poorly tested on pregnant women on the schedule. It's medically and ethically irresponsible.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.54IndividualIt has never been tested on pregnant women. It hasn’t passed ethics committees to be tested on pregnant women.Why give something untested ?Reviewed. No change in recommendation ments not applicable or supported by body of evidence.55Individualthe vaccine has not had the gold standard research performed to ensure safety to mother and unborn childThis recommendation has not passed the ethics counselReviewed. No change in recommendation ments not applicable or supported by body of evidence.56IndividualAs it has never been tested during pregnancy, it would be very hard to say. Quite dangerous also to assume it is safe for mother and especially for foetusReviewed. No change in recommendation ments not applicable or supported by body of evidence.57IndividualThere most likely will be unintended consequences to injecting pregnant women with heavy metals abortered faetuses, anti biotics and animal products that can contain retro viruses and glyphosate into a foetus . We are in dangerous territory when we start doing this to pregnant women. Most likely the autism rate will go up quickly and we will have an epperdemic of disabled children . I don't think this vaccine is worth the risk and should be given to pregnant women. Vaccine safety studies need to be done when used in pregnant women and babies. Informed consent needs to be given before a women injects herself with this vaccine ( ingredients and long term side effects for her and the childI believe there is no benefits to this vaccine to the mother or child.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.58IndividualThe pertitus vaccination has never been tested on pregnant women and HAS NOT passed the code of ethics to test on women who are pregnant. Has not been tested on pregnant women for passed the code of ethics to test on pregnant womenHas not been tested on pregnant womenReviewed. No change in recommendation ments not applicable or supported by body of evidence.59IndividualAny vaccinations during pregnancy should be BANNED!There are no safety studies and you are using women and their unborn children as Guinea pigs!Do NOT Vaccinate during pregnancyAustralia's Health Department is a joke!Reviewed. No change in recommendation ments not applicable or supported by body of evidence.60IndividualThere is a significant risk in all vaccination. We know this from injury, we don’t know the extent to this as it has never been tested on pregnant women. The risks and ingredients as well as the acknowledgement that no trials have been done need to be outlined.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.61IndividualThe safety has not been tested therefore it is a major concern that they are recommended The safety testing needs to take place in order for initial considerationIt's very concerning that adequate testing has not been completed to ensure safety to the mother and child, which is the same for all vaccines. I trusted my gp and had the vaccination, and all others for my child, then later found out it had not been safety tested, leaving concern for myself and my child's wellbeing both now and in the future.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.62IndividualNo drug during pregnancy is safeReviewed. No change in recommendation ments not applicable or supported by body of evidence.63IndividualReading the safety precautions from the package insert it specifically says that this vaccination is not tested for safety in pregnant women, therefore should not be recommended.The safety and efficiency in pregnant women NEEDS to be tested & deemed safe!Reviewed. No change in recommendation ments not applicable or supported by body of evidence.64IndividualHas it been tested before in pregnancy and has the effect on the baby been compared long term to babies that haven’t been vaccinated whilst in utero "Yes!If the vaccine is safe and effective why not give it to newborns and not pregnant women with developing babies. How can the effect on a developing fetus possibly be tested at different gestational "As a mother of a baby who received a vaccine at birth that almost killed him I think there needs to be a lot more research done. Vaccinations aren’t a one size fits all fixReviewed. No change in recommendation ments not applicable or supported by body of evidence.65Individual"Absolutely. Any changes should be based on research that shows clearly there is no risk of harm.In order to do that you need to have a study comparing the vaccine against an inert placebo, which does not have any financial ties to anyone who might benefit from a set outcome. Furthermore, there must be observation of any potential reactions while in the womb, but also a long term observation after birth to ensure there are no unintended cognitive or emotional consequences. Without doing such a study this is completely unethical and using the population as guinea pigs. The burden must be on the manufacturer to show proof of no harm before advising pregnant women to do something which may have effects on their baby. There must also be a proposed way to observe for effects in the public, such as a VAERS system which should be mandatory to report to if any changes occur during development. "You must provide each parent with the research studies previously mentionedReviewed. No change in recommendation ments not applicable or supported by body of evidence.66IndividualThere needs to be studies on the safety of vaccines in pregnancy. Pregnancy is when the most vital development of the brain occurs. Any illness or medication can have great effects on that development. Why would the “pertussis” vaccine be any different.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.67Individual"Possible miscarrage, because there never been safely tested. The pregnant person, may have all ready had the vannice before they got pregnant, there the time between being pregnant, would he too close. This is forcly making person have vaccines.""What are the risk factor ? We all ready have a huge amount ans range of vaccines, we should not be told what we should and should not do.Person pregnant or not, has the right to chose wheayher they get get vannaced or not. "Reviewed. No change in recommendation ments not applicable or supported by body of evidence.68IndividualPregnant women are not gunea pigs. We do not know the affects of all the vaccine ingredients to a developing brain in utero especially the neuro toxins and potential DNA component of the vaccine ingredient. There is no safe limit of aluminium and is a known neurotoxin. Up until 3yrs ago it wasnt recommended and I find it hard to believe how all of a sudden its "safe". The effects on the baby will most probably not be known till 10plus yrs time and by that point it will be to late. Also with a already low immune system whilst pregnant we are exposing the woman to potentially develop pertussis as well as pass it on to other community members as there has been studdies showing the bacteria stays in the nose and throat for up to 4weeks post vaccination..We do not know its safe for a developing brain and many healthcare professionals are not educated on all the side effects of vaccinations let alone to a developing fetus. The risk does not outweigh the benefit.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.69Individual"That vaccine is not tested properly for safety in pregnant women let alone for any human being. You will kill babies. PeopleSpread whooping cough as the vaccine makes them show no symptoms, therefore vaccinated people become carriers. Only natural immunity is transferred from mother to baby. This vaccine only transfers neurotoxins and chemicals through the placenta. "Yes a vaccinated vs unvaccinated study. In this study the placebo must be a placebo, not a different cocktail of poison to compare this one withI hope this scam is exposed to the public before you kill and damage too many innocent babies and peopleReviewed. No change in recommendation ments not applicable or supported by body of evidence.70IndividualThere are risks to pregnant women in all stages of pregnancy that were not considered in the design of the original clinical trials."Please refer to the clinical study 116945[DTPA (BOOSTRIX) which can be accessed online from the following web link: 047 is one of the studies done on pregnant women at 27-36 weeks, either being given dTpa (Boostrix) plus saline placebo after delivery, or saline placebo at 27-36 weeks plus dTpa after delivery. The adverse events in this study recorded for both ""placebo"" and ""dTap"" groups are corrupted because they measured outcomes for both groups after the babies had had their 2 month vaccines of Infanrix Hexa (6-in-1 vaccine of dTap-IPV-HepB-Hib). Babies in both the placebo and the dTap at 27 weeks group both received the Infanrix Hexa 2 month vaccines. In order to sign up to the study you had to pre-agree for your baby to receive their 2 month vaccines. All subjects were also ""encouraged"" to receive their flu vaccines while pregnant. The difference between the adverse events compared between the two groups are not comparing the results of just the dTap vaccine in pregnant women, they are muddied by adding Infanrix Hexa and flu vaccine adverse events into the results."Reviewed. No change in recommendation ments not applicable or supported by body of evidence.71IndividualIt has never been tested on pregnant women in a randomised controlled clinical study, please stop using uninformed women and the fetus as your pare outcomes of vaccinated vs non-vaccinated: hospital admissions, GP visits, days sick from childcare, illnesses diagnosed, etc.If it’s never been tested and the handout says not for use on pregnant women, why is it encouraged to receive it?Reviewed. No change in recommendation ments not applicable or supported by body of evidence.72IndividualI think that before you could recommend this untested vaccine on pregnant women that you would conduct a double blind placebo controlled study on both the safety and efficacy of this vaccine on pregnant women and their unborn child.Yes. It is important for you to recognise that due to ethical considerations, the safety of this vaccine has never been tested on pregnant women, therefore it is also unethical to recommend this vaccine to pregnant women.It is deplorable that Australia relies upon the so called safety and efficacy studies conducted by another country (ie. the USA's FDA and CDC) which are ultimately funded by the very company that produces the product that is in question, ie. the vaccines.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.73Individual"Nothing that carries even a minuscule risk should be performed on pregnant women. The medical science still does not know fully how immunity reacts to vaccines. The medical scientists admit that DTaP has killed more babies than it has saved. Also, the women have been already fully vaccinated and are supposed to have immunity to all the diseases they are proposed to be vaccinated against, yet again. So, the potential benefits do not outweigh potential risks.There are NO studies that researched the increased chance of risk in pregnant women who are vaccinated at 20w compared to 28w. "If the mother has the immunity (or has been immunized) against a particular disease, she should pass the antibodies for that disease to the baby. Also, antibodies decline over time, so the earlier in the pregnancy the mother is vaccinated. the less time after birth, the baby has before the antibodies decline.This proposal has no scientific grounds and, therefore, must be fully researched (by independent scientists) before it is adopted.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.74IndividualHas this vaccination been tested on pregnant women for safety? No it hasn’t.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.75Individual"Risks to unborn babiesUnintended consequences.Lack of proper studies on the indirect health implications to mothers and their children."Implementation consideration.The choice to vaccinate should be voluntary. This vaccine should be administered only with the full outline of risks and side effects properly communicated to all mothers and parents in general. Most will find that the risks of the vaccination far outweigh the risks from the supposed infection altogether."Vaccine legislation in this country is a joke. Australia should implement an Italian style culling of ill informed, fascist and corrupt medical and government officials.Pharmaceutical companies should be banned from sponsoring and donating to any political figure/organisation."Reviewed. No change in recommendation ments not applicable or supported by body of evidence.76Individual"It is not about your outlining benefits etc. about your 'Shameful Push' to have expecting mothers Vaccinated with extremely harmful and lethal toxins.Your (so-called) Government there are acting more like some mad scientists under the Nazi WW2 Regime in their labs!Over 500,000 people by means our contact alone, are aware of now and totally reject your simple-minded and barbaric means of 'forcefully vaccination' innocent women and unborn children with your methods of highly 'Illegal Extortion'!"Indeed there are many like this for instance > March against Monsanto "KEEP YOUR HANDS OF LOVED ONES AND OUR FAMILIES! AND ESPECIALLY THE MOST INNOCENT AND VULNERABLE! (THE UNBORN BABIES AND THERE MOTHERS TO BE)YOU LOT ARE ALWAYS SEEN GOING OUT AND KISSING BABIES JUST BEFORE ANY ELECTIONS, AND THEN YOU TURN AROUND AND IMPOSE THIS 'BLATANT ACT OF INHUMANE POISONING THE YET TO BE BORN'???WE IN NO WAY CONSENT TO WHAT YOU ARE PROPOSING HERE TO BE DONE!BY THE WILL OF (OUR JOINED GROUPS ON SOCIAL MEDIA WHICH NUMBER OVER 500,000)!THERE ARE MILLIONS MORE HERE IN AUSTRALIA THAT ALSO DOES NOT AGREE TO YOUR EVIL AND BARBARIC LAWS THAT YOU ARE ATTEMPTING TO SNEAK THROUGH WITHOUT EVEN PROPPER NOTIFICATION ON YOUR MANIPULATED GENERAL NEWS SOURCES, SO AS TO ADVISE THE MASS POPULACE AND TO HAVE A FAIR AND BALANCED VOTE BY 'WE THE PEOPLE'!(THE VERY ONES THAT YOU ARE SUPPOSED TO BE REPRESENTING AND TAKE CARE OF)!"Reviewed. No change in recommendation ments not applicable or supported by body of evidence.77Individual"There are no studies done on pregnant woman. My concern are the risks involved "I don’t think pregnant woman should be used as lab ratsReviewed. No change in recommendation ments not applicable or supported by body of evidence.78IndividualPertussis vaccine hasn't been tested on pregnant women, so it is unknown what the consequences are or will be if the recommendations change.Safety studies and clinical trials need to be performed.It would be unethical to recommend a vaccine to pregnant women that has never been tested on pregnant women, and the affects on the fetus unknown.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.79IndividualThere ARE risks and consequences with giving pregnant women this Vaccine. Or ANY vaccine for that matter.NO vaccine is tested for safety on pregnant women. Cause to do so would be so dangerous for the Developing foetus, A’s is STATED on the Vaccine insert.If the pharmaceutical want to do this, they should be help liable for the consequences, as should the Australian government!If you had 5 hours to listen to my concerns, I would state them... but there is way too much to state.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.80IndividualPertussis vaccine have not been tested or proven to be safe or effective in pregnant women. Significant numbers of sids cases and spontaneous abortions occur after these vaccinations. Patients should not be coerced into vaccinations, full informed consent must be obtained. All the risks as well as the possible benefits must be identified to every patient for their to be informed consent. If not the government, the manufacturers and the attending physician must be liable for any harm done.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.81IndividualThe vaccine insert warns of the possibility of it causing SIDS, autism and a number of other serious consequences...risking potential trauma or death to a wanted unborn child is not worth any benefits claimed....how can our department of health even consider such risky behaviour....The responsibility and duty of care will lay with TDoH as soon as it advises this protocolSee above...potentially huge legal ones for our country too.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.82IndividualComplete adverse event surveillance data is not available in order to make change.There is no knowing who will suffer side effects as a result of vaccination.A recent Italian study published in the International Journal of Vaccines and Vaccination show that vaccines are full of crud that top scientists can't even define. It makes a mockery of health oversight committees and the TGA as well as USA's FDA and CDC.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.83IndividualYes, there are critical consequences of recommending vaccination during pregnancy, without informing pregnant mothers that they are participating in a trial. There is a huge risk to affecting public confidence if people find out.Pregnant women need to be given fully informed consent.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.84IndividualThere are no benefits to these proposed changes, only major risks to the health of the pregnant mother, the foetus, and financial consequences to the person or clinic providing the vaccination, as the safety of vaccinating in pregnancy has never been done. See other comments for more information.There are many vaccines used in Australia for vaccination against pertussis (whooping cough), including:- Adacel - Adacel Polio - Boostrix - Boostrix IPV - Hexaxim - Infanrix - Infanrix Hexa - Infanrix IPV - Quadracel - Tripacel Details from the relevant manufacturers' Product Information publications on their products show some concerns.Adacel No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparitive safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo (Sanofi-Aventis, 2007).Regarding use in pregnancy (Category B2): "The effect of ADACEL on the development of the embryo and foetus has not been assessed. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis." , hence has not been tested for safety or efficacy in pregnant women (Sanofi-Aventis, 2007).The vaccine contains, amongst other ingredients, 0.33mg aluminium phosphate and formaldehyde. The former being a neurotoxin, and the latter being carcinogenic.Adacel Polio No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo (Sanofi-Aventis, 2007).Regarding use in pregnancy (Category B2): " The effect of ADACEL? POLIO on the development of the embryo and foetus has not been assessed. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis." , hence has not been tested for safety or efficacy in pregnant women (Sanofi-Aventis, 2007).The vaccine contains, amongst other ingredients, 0.33mg aluminium phosphate, polysorbate 80 and formaldehyde. The former being a neurotoxin, and the latter being carcinogenic, with polysorbate 80 is a neurotoxin nanoparticle, which can cross the blood brain barrier to cause damage in some studies (Zhao et al, 2010).Boostrix No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo (GlaxoSmithKline, 2014a). Regarding use in pregnancy (Category B1): Testing in pregnancy was performed on animal studies only, the product information says "As with all inactivated vaccines, one does not expect harm to the fetus.However, adequate human data on use during pregnancy are not available", hence has not been tested for safety or efficacy in pregnant women (GlaxoSmithKline, 2014a).Also, "BOOSTRIX must not be mixed with other vaccines" but this is regularly recommended and given with other vaccines (GlaxoSmithKline, 2014a).The vaccine contains, amongst other ingredients, 0.5mg aluminium phosphate and aluminium hydroxide, both being neurotoxins, formaldehyde (carcinogen), and polysorbate 80 (neurotoxic nanoparticle that crosses the blood brain barrier) (GlaxoSmithKline, 2014a; Zhao et al, 2010).Boostrix IPV No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo (GlaxoSmithKline, 2014b). Regarding use in pregnancy (Category B1): Animal studies of the vaccine in pregnancy were performed. This is irrelevant as we are not rats or rabbits. The product information states "As with other inactivated vaccines, it is not expected that vaccination with BOOSTRIX IPV harms the fetus". "Not expected" is not good enough, as it has not been tested in humans. However, adequate human data on use of BOOSTRIX-IPV during pregnancy are not available, hence has not been tested for safety or efficacy in pregnant women (GlaxoSmithKline, 2014b).The manufacturer suggests a high efficacy of antibody production, but states "There are currently no data which demonstrate a reduction of transmission of pertussis after immunisation with BOOSTRIX-IPV" (GlaxoSmithKline, 2014b), meaning that while an individual may be protected, the vaccine does not prevent further infections to others (GlaxoSmithKline, 2014b). Or in other words, the vaccine doesn't work to stop transmission or spread of the infection. The vaccine contains, amongst other ingredients, 0.5mg aluminium phosphate and aluminium hydroxide, both being neurotoxins, formaldehyde (carcinogen), and polysorbate 80 (neurotoxic nanoparticle that crosses the blood brain barrier) (GlaxoSmithKline, 2014b; Zhao et al, 2010).Hexaxim No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo (GlaxoSmithKline, 2018). Regarding use in pregnancy, there is nothing in this product information insert regarding testing, safety or efficacy on pregnant women or their foetuses, hence has not been tested for safety or efficacy in pregnant women The vaccine contains, amongst other ingredients, 0.6mg aluminium hydroxide which is a neurotoxin, and formaldehyde (carcinogen) (GlaxoSmithKline, 2018). Infanrix No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo. The control group used was given the tetanus and diptheria vaccine! (GlaxoSmithKline, 2015).Regarding use in pregnancy (Category B2): The manufacturer's product information states "As INFANRIX is not intended for use in adults, adequate human data on use during pregnancy and adequate animal reproduction studies are not available", hence has not been tested for safety or efficacy in pregnant women (GlaxoSmithKline, 2015).The vaccine contains, amongst other ingredients, 0.5mg aluminium hydroxide which is a neurotoxin (GlaxoSmithKline, 2015). Infanrix Hexa No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo. (GlaxoSmithKline, 2016).Regarding use in pregnancy (Category B2): The manufacturer's product information states "As INFANRIX hexa is not intended for use in adults, adequate human data on use during pregnancy and adequate animal reproduction studies are not available", hence has not been tested for safety or efficacy in pregnant women (GlaxoSmithKline, 2016).The vaccine contains, amongst other ingredients, 0.82mg aluminium hydroxide which is a neurotoxin, formaldehyde (carcinogen), and polysorbate 80 (neurotoxic nanoparticle that crosses the blood brain barrier) (GlaxoSmithKline, 2016; Zhao et al, 2010). Infanrix IPV No control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo. (GlaxoSmithKline, 2002).Regarding use in pregnancy, the manufacturer's product information states "Adequate human data on use during pregnancy and adequate animal reproduction studies are not available", hence has not been tested for safety or efficacy in pregnant women (GlaxoSmithKline, 2002).The vaccine contains, amongst other ingredients, an unpublished amount of aluminium which is a neurotoxin (GlaxoSmithKline, 2016), formaldehyde (carcinogen), and polysorbate 80 (neurotoxic nanoparticle that crosses the blood brain barrier) (GlaxoSmithKline, 2002; Zhao et al, 2010). QuadricelNo control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo. The "control" group were given a vaccine containing diptheria and tetanus toxoids! (Sanofi-Aventis, 2012).Regarding use in pregnancy (Category B2): The manufacturer's product information states "Not applicable. QUADRACEL should not be used in adults", hence has not been tested for safety or efficacy in pregnant women (Sanofi-Aventis, 2012).The vaccine contains, amongst other ingredients, an 1.5mg of aluminium phosphate which is a neurotoxin (Sanofi-Aventis, 2012), formaldehyde (carcinogen), and polysorbate 80 (neurotoxic nanoparticle that crosses the blood brain barrier) (Sanofi-Aventis, 2012; Zhao et al, 2010). TripacelNo control group with an inert placebo was used to compare against the vaccine test group in the manufacturer's own studies. Hence no true comparative safety or efficacy study was done of those who received the vaccine vs. those who should have received an inert placebo. The "control" group were given a vaccine containing diptheria and tetanus toxoids! (Sanofi Pasteur, 2017).Regarding use in pregnancy: The manufacturer's product information states "This vaccine is not intended for administration to women of child-bearing age", hence has not been tested for safety or efficacy in pregnant women (Sanofi Pasteur, 2017).The vaccine contains, amongst other ingredients, an 1.5mg of aluminium phosphate which is a neurotoxin (Sanofi Pasteur, 2017). If manufacturers do not test for efficacy or safety of their vaccines, then you cannot be recommending that any of these vaccines be given to pregnant women. Yet we know that doctors and health departments across Australia are recommending that pregnant women be vaccinated! But this is not based on any safety studies! Such recommendations are extremely dangerous - to pregnant women and to their foetus, as well as to the staff member performing the vaccination (doctor or nurse etc), the hospital or health clinic and the government's health department, for legal reasons, if a pregnant woman were to sue based on false information or outright lies that they are given that such vaccinations in pregnancy are safe, when there is no scientific proof of this.NONE of these vaccines used good scientific methods of testing, as NONE of them used an inert placebo (such as saline) to obtain accurate safety and efficacy results. This is a deliberate method used by all vaccine manufacturers to make the vaccine side effects and reactions appear similar in both the test group and control group, and therefore not dissimilar. This result makes the vaccine look much better than if an inert placebo were used in the control group instead. This practice must stop, as it is scientific fraud. Due to scientific protocols and ethics boards used to ratify and approve scientific studies, scientists and ethics boards know that pregnant women and/or foetuses CANNOT be used as test subjects. Yet doctors and health departments have taken it upon themselves to ASSUME (as some of the wording in the above product information inserts show) that vaccines in pregnant women are expected to be safe, when it is not possible to make that assumption. These vaccines are not safe for the pregnant woman or her foetus, clearly with some of the toxic ingredients such as neurotoxins and carcinogens present in them.DosingAnother issue with all of these vaccines is in their recommended dosing. The amounts of antigens, toxoids, adjuvants and preservatives in a vaccine dose for a teen (such as in the Infanrix IPV vaccine) of each vaccine remains the same for a premature newborn as for a teen and for an adult. This has not been scientifically tested either, and the body weight and metabolism of these different stages of life will vary greatly. If vaccination of pertussis vaccines is being considered to be safe and effective, different doses must be used per bodyweight, to reduce the risks of over stimulating the immune systems in those who are youngest and perhaps weakest, being the newborns and unborns.ApprovalHow do these vaccines even get approved, when the product information clearly states how badly the manufacturer performed testing of their own products? Not using correct scientific protocols regarding use of inert placebos, used deliberately to make the vaccine results look safer, needs to be banned. Aluminium The use of a neurotoxic mineral such as aluminium in various forms needs to be banned until further studies are performed to confirm safety of this ingredient in many vaccines. More recent studies are showing that aluminium from vaccines can cross the blood-brain barrier through activation of the immune system cells which phagocytose the aluminium to accumulate in brain tissue to have a neurotoxic effect (Gherardi, Eidi, Crépeaux, Authier & Cadusseau, 2015).Aluminium in injectable vaccines has been linked to motor neuron degeneration (Amytrophic Lateral Sclerosis or ALS), cognitive dysfunction and motor neuron disease, Gulf War Syndrome (Shaw & Petrik, 2009), autism spectrum disorders (Mold, Umar, King & Exley, 2018), serious immunological disorders (Tomljenovic & Shaw, 2011), and other neurotoxicity condition, especially in early development (foetuses, preterms and small newborns) (Dorea, 2015). CoverageProtection against pertussis by vaccination is not 100% guaranteed currently, especially when not all bacterial types or strains which can cause pertussis are contained in the available pertussis combination vaccines. These vaccines contain antigens against Bordetella pertussis only, but other bacterial strains can also cause pertussis. Bordatella parapertussis is another bacterium which causes pertussis, but this is not used in vaccines against pertussis. In a study by He et al (1998), in an immunised population, 60.8% had a B. pertussis infection, but 32% had the B. parapertussis infection, and 7.2% had both (He, Viljanen, Arvilommi, Aittanen & Mertsola, 1998). ConclusionsThe use of and regulation of aluminium as a neurotoxic adjuvant in all vaccines must be reconsidered in the light of these (and other) studies, to prevent neural damage in foetuses (and pregnant women) by not vaccinating in pregnancy with an adult dose. The current pertussis vaccines are inadequate, unsafe and ineffective, as they do not provide protection from other bacteria which can cause this infection. They are also not investigated for safety or efficacy in pregnant women or foetuses, so any government or medical advice to the contrary is untruthful and cannot continue or legal cases will ensue.References:Dorea, J.G. (2015). Exposure to Mercury and Aluminum in Early Life: Developmental Vulnerability as a Modifying Factor in Neurologic and Immunologic Effects. International Journal of Environmental Research and Public Health, 12(2): 1295–1313. Doi: 10.3390/ijerph120201295Gherardi, R.K, Eidi, H., Crépeaux, G., Authier, F.J., & Cadusseau, J. (2015). Biopersistence and Brain Translocation of Aluminum Adjuvants of Vaccines. Frontiers in Neurology, 6: 4. Doi: 10.3389/fneur.2015.00004GlaxoSmithKline. (2014a). Boostrix Product Information. Retrieved 7th February 2019 from . (2014b). Boostrix IPV Product Information. Retrieved 7th February 2019 from . (2018). Hexaxim Product Information. Retrieved 7th February 2019 from . (2015). Infanrix Product Information. Retrieved 7th February 2019 from . (2016). Infanrix Hexa Product Information. Retrieved 7th February 2019 from . (2002). Infanrix IPV Product Information. Retrieved 7th February 2019 from , Q., Viljanen, M.K., Arvilommi, H., Aittanen, B., & Mertsola, J. (1998). Whooping cough caused by Bordetella pertussis and Bordetella parapertussis in an immunized population. Journal of the American Medical Association, 280(7):635-7. , M., Umar, D., King, A., & Exley, C. (2018). Aluminium in brain tissue in autism. Journal of Trace Elements in Medicine and Biology, 46: 76-82. Doi: 10.1016/j.jtemb.2017.11.012Sanofi-Aventis. (2007a). Adacel Product Information. Retrieved 7th Feb 2019 from . (2007b). Adacel Polio Product Information. Retrieved 7th Feb 2019 from . (2007c). Hexaxim Product Information. Retrieved 7th Feb 2019 from . (2012). Quadricel Product Information. Retrieved 7th Feb 2019 from Pasteur. (2017). Tripacel Product Information. Retrieved 7th Feb 2019 from , C.A, and Petrik, M.S. (2009). Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration. Journal of Inorganic Biochemistry, 103(11): 1555. doi: 10.1016/j.jinorgbio.2009.05.019Tomljenovic , L., & Shaw, C.A. (2011). Aluminum vaccine adjuvants: are they safe? Current Medicinal Chemistry, 18(17):2630-7. Zhao, Y.M., Xia, A.X., Wei, Y.H., Ruan, Y.P., & Li, F.Z. (2010). Polysorbate-80 modified neurotoxin nanoparticle with its transport and cytotoxicity against blood-brain barrier. Acta Pharmaceutica Sinica, 45(10):1312-6. Retrieved 7th February 2019 from . No change in recommendation ments not applicable or supported by body of evidence.85Maternity Choices AustraliaThere has not been a study that monitors for increased chance of risk and likelihood of occurrence in pregnant women who are vaccinated at 20w compared to 28w. There are no studies that sho evidence of any significant health benefits to be gained from the change. Before any change in the schedule of vaccination recommendations for pregnant women, adequate studies need to be conducted to monitor for any increased chance of risk that may come with that change, and show evidence of the benefits so that a proper risk vs benefits assessment can be made.Antibodies decline over time, so the earlier in the pregnancy the mother is vaccinated. the less time after birth, the baby has before the antibodies decline.The only health benefit you have offered in your proposal is that preterm babies will have time before birth to receive adequate antibodies. Most preterm babies are born at 34-36w. Leaving 4w before approximate birth date, to allow for maximum results, vaccination by 30w would be sufficient, and this is also when the antibodies begin to generate substantially.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.86IndividualSince the last time that your committee would have met there have been a number of updates regarding our knowledge about vaccines that the public of Australia do expect you will be taking this into consideration and acting upon.Dr Andrew Zimmerman the top witness for the Department of Justice (DOJ) in their case in the US Vaccine court saying vaccines do not cause Autism has written an affidavit stating that he told the DOJ attorneys vaccines can cause Autism and that they lied to the court. He states he told the DOJ that vaccines do cause Autism and they ignored this.“I explained that in a subset of children… vaccine induced fever and immune stimulation .... did cause regressive (brain disease) with features of autism spectrum disorder”Robert F. Kennedy, Jr., Chairman, Children’s Health Defense has sent letter to 7,300 politicians and bureaucrats along with the book “How to End the Autism Epidemic” by J.B. HANDLEY. In this book you will apparently find a statement by Centre Disease Control (CDC) staff member Dr Judith Pinborough-Zimmerman, Principal Investigator ADDM Network Utah, (Centers for Disease Control)“Ten years of my research was spent doing ASD prevalence research. We documented staggering changes in prevalence only to be downplayed by the same government who had funded the research … the world is crazy”The Australian public will be paying close attention to the actions your committee takes regarding the unfolding revelations in the U.S. Indeed countries such as the U.S. who have citizens in Australia will all be watching your actions.Please be aware that Dr Andrew Wakefield, who was the first person to identify a link between vaccines and Autism was recently invited to the White house photographed with top US officials. His research has apparently been reinstated after his colleague took action in a British court, and Robert Kennedy Jr has stated that there are thousands of pending vaccine damage court cases in the US. Regarding Autism.Conversely there has apparently been arrest warrant issued for one of worlds foremost vaccine safety research scientist “Poul Thorsen” regarding his “research” The Australian public will be expecting this committee to verify such claims and to ensure that it does not used his research in until the outcome of the pending court case against him is known.Harvard neurologist Dr Pole was apparently able to show that his daughter developed autism as a result of her vaccines. Dr Pole, had enrolled Hannah in a “wellness study” and had pre and post vaccine MRI’s to show the court. He apparently received a $1,500,000.00 in vaccine damages. The family was interviewed on CNN on 6th March 2008. Dr Polings findings were published in the, Journal of Child Neurology, Vol. 21. No. 2. 170 – 172 (2006) “For the record Hannah Poling has Autism”The Australian public would expect that this committee ensures that a warning is put on any vaccine you recommend that individuals with the genetic traits identified by U.S. scientists as putting them at risk of developing Autism are advised of this.As you are aware vaccines contain foetal cells. Can this committee provide the Australian public with research proving that injection of male DNA into a woman pregnant with a female baby does not effect that babies DNA by way of “gender” definition, and can this committee prove that injection of “foreign” female DNA into a woman pregnant with a male baby does not cause “gender” changes. The Australian public will expect that this committee has robust vaccinated verses unvaccinated research of at least 1,000 children over a 20 year period to prove that injection of foreign DNA into a pregnant women is safe.I would like to express my concern that in 2018, when I phoned a facility doing research into flu vaccines in pregnancy (in Western Australia - funded by Westfarmers) the team are using a placebo that contains vaccine ingredients. It is normal to use Normal Saline is such research, not a compound that contains the ingredients of the vaccine. Scientist familiar with normal research practices are expressing concern that this is happening, and trust that the individuals on this committee would not accept such “studies” as research. There is also grave concern about practices where “other vaccines” are used as the placeblo rather than using control groups of unvaccinated people or people who received normal saline as the placebo.There are individuals who are unvaccinated and thus studies of vaccinated verses unvaccinated are still possible and the Australian public would expect that this committee is using such research, and only such research to base their decision on.If I gave you an injection of the bacteria E Coli or Pseudomonas you would not expect to develop immunity. How is pertussis any different? It is a bacteria and I am unaware of any conclusive evidence that proves that vaccination with a bacteria is effective. Conversely I am aware of allegations that the incidence of Whooping Cough increased when the vaccine was a “live” bacteria being injected into the Australian public as it is highly contagious.We need to be mindful about apparent quotes (from an autobiography) of doctors such as Melbourne Dr Archie Kalokerinos, MD, who was awarded “Greek Australian of the Century” and Australian Medal of Merit in 1978“Only after realizing that routine immunizations were dangerous, did I achieve a substantial drop in infant death rates. The worst vaccine of all is the whopping cough (Pertussis) vaccine… it is responsible for a lot of deaths and for a lot of infants suffering irreversible brain damage.”I was one of the first women to ever receive a vaccine in pregnancy in 1989. The flu shot that was given made me more sick than I have ever been with the flu, to the point where I thought I might die, and did request to be taken to hospital. My son has developed a neurological disorder that doctors report would have been caused by the mercury in that vaccine. While doctors and the Australian public are being told that we no longer have mercury in our vaccines an Australian who had a flu vaccine analyse in a Sydney lab in 2015 found mercury in that vaccine.Can this committee provide evidence that you have had the ingredients of vaccines independently tested?I am asking that this committee suspend all vaccination during pregnancy until we can verify with robust research the safety of what is being injected.Reviewed. No change in recommendation ments not applicable or supported by body of evidence.87Society of Hospital Pharmacists of AustraliaIn Australia, acellular pertussis immunisation is only available as part of a combined vaccine e.g. dTPa (diphtheria-tetanus-acellular pertussis) or dTPa-IPV (diphtheria-tetanus-acellular pertussis- inactivated polio). These are a mix of subunits (inactivated parts of the bacteria) and toxoid components. By the suggested broadening of recommended vaccination timing from mid second trimester to early third trimester (i.e. from 20 to 32 weeks gestation rather than the previous 28 to 32 weeks gestation), there is the potential extension of placental antibody transfer from mother to foetus by up to eight weeks.Pertussis antibody levels do not peak until about two weeks after vaccination. While transplacental antibody transfer begins as early as 13 weeks gestation, maximum transfer occurs from 30 weeks gestation onwards1. There is recent evidence of vaccine efficacy when administered to mothers in second trimester, with comparable antibody levels in cord blood after maternal dTPa vaccine administration in either second or third trimester1,2. This provides reassurance that the proposed extended timing window will enhance the success of passive immunity being provided to the infant until they can receive their first dose of pertussis-containing vaccine (from six weeks of age). Earlier vaccination may also assist in protection if the infant is born preterm3,4.Pregnant women are concerned about the safety of medication use in pregnancy and a significant proportion overestimate risk.5. Pertussis vaccine administration after the initial 13 weeks’ gestation period (i.e. after the critical period of organogenesis6), allows clinicians to confidently reassure pregnant women that pertussis vaccine can be considered safe for both mother and baby. Theoretical safety has been supported by the results from a large retrospective observational cohort study that compared the outcomes of 123,494 pregnant women vaccinated with dTPA versus 29,261 unvaccinated women, using administrative health care databases from two California Vaccine Safety Datalink sites7. The study concluded that vaccination was not associated with an increased risk of adverse birth outcomes in this cohort of women with singleton pregnancies that ended in a live birth.Reviewed. No change in recommendation ment noted with thanks.Appendix A – Public consultation distribution listAn email was sent on 10 January 2019 to the following organisations/committees to provide advice on the consultation:Australian Health Ministers Advisory Council;Australian Health Protection Principal Committee;Communicable Diseases Network Australia;National Immunisation Committee;Australian Technical Advisory Group on Immunisation;Pharmaceutical Benefits Advisory Committee;Advisory Committee on Vaccines;General Practice Roundtable;Royal Australasian College of Physicians;Primary Health Networks;Consumers Health Forum of Australia; andAustralian Association of Practice Managers. ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download