This article addresses the Infanrix Hexa (6-in-1) vaccine, manufactured by GSK (formerly GlaxoSmithKline) given in Ireland and the illnesses that it aims to protect against.  It outlines the ingredients, the possible risks, studies in support of its use and those highlighting concerns.  

Once you understand the risk associated with each disease and compare it to the risks and contraindications associated with the vaccine, you can then decide whether or not to vaccinate your baby.  Read this information carefully before making this important decision. 

Health Freedom Ireland (HFI) encourages you to become fully informed about vaccines and the associated illnesses so that you can give informed consent if you choose to vaccinate yourself or your child(ren). This information is for educational purposes only and is not intended as medical advice. HFI is simply bringing this information to you – we neither recommend nor advise against vaccination.

Summary

• The Infanrix Hexa (6-in-1) vaccine contains 32 times the amount of aluminium considered safe by the US Food and Drug Administration (FDA) to be administered via an IV.  Aluminium is classed as a neurotoxin.
• A study carried out by the Corvelva Association on the chemical composition of the Infanrix Hexa (6-in-1) vaccine showed that it did not contain any of the 6 antigens it is supposed to have and had 65 unexpected chemicals.
• There is a study in the Indian Journal of Medical Ethics and a letter to the medical journal Vaccine questioning unexplained sudden infant death after the administration of the Infanrix Hexa (6-in-1) vaccine.
• Most trials listed on clinicalTrials.gov monitored the safety of Infanrix Hexa (6-in-1) vaccine for 31 days or less.
• Vaccination is not mandatory in Ireland and is not necessary to attend school or creche.
• Those allergic to ingredients in the vaccine are advised not to take the vaccine.  However, this vaccine is given at 2, 4 and 6 months of age, while your baby’s immune system is still developing.  You cannot know whether your baby is allergic to any of the ingredients. 
• As of 1, Oct 2023, there were 68,005 reports of adverse events (ADR’s) for Infanrix Hexa (6-in-1) in The World Health Organisation VigiAccess database of adverse events.

Diseases it aims to protect against

The Infanrix Hexa (6-in-1) vaccine aims to protect your baby against six diseases: 

• Diphtheria
• Tetanus
• Pertussis (Whooping Cough)
• Hepatitis B
• Polio
• Haemophilus influenza type b (hib)

When is it given? 

The Infanrix Hexa (6-in-1) vaccine is given to babies in Ireland at 2, 4 and 6 months of age.  

What is in this vaccine?

The Infanrix Hexa (6-in-1) Vaccine Summary of Product Characteristics section 2 outlines ingredients in the vaccine as follows. This list excludes the 10 toxoids/disease strains.

Is the Infanrix Hexa (6-in-1) vaccine safe?

To begin to answer the question of whether vaccines are safe, one needs to delve a little into the history of vaccines. In the US, after establishing that vaccines were “unavoidably unsafe” the National Childhood Vaccine Injury Act of 1986 granted immunity from liability to all vaccine manufacturers and established the Vaccine Injury Compensation Program (VICP). No other product or medicine has ever enjoyed this level of immunity. In America, anyone sustaining an injury from a vaccine must seek redress directly from the VICP. See the Compensation Scheme section below for the legal situation in Ireland.

These favourable market conditions have led to a booming vaccine market currently worth in excess of $60bn and projected to grow to $125bn by 2028. Government lobbying, large scale funding and advertising spend means that media, influential institutions and medical journals cannot remain impartial. In addition, large portions of regulatory agencies’ budgets are funded by the industry they are supposed to regulate:

Although most vaccines are for children and newborns, they undergo much shorter clinical trials and safety review periods than regular drugs. Standard drugs, such as Lipitor (for cholesterol) and Eliquis (a blood thinner), that are not immune to liability, are tested for several years. Vaccines on the other hand are tested for a very short timeframe. The Guideline on clinical evaluation of vaccines published by the European Medicines Agency (EMA) in Jan 2023 states the following:

“Some additional considerations for the assessment of vaccine safety in clinical trials follows. Since most adverse reactions to vaccines occur within the first few days after each dose, it is common practise that solicited local and systemic symptoms are collected for approximately 5-7 days after each dose. A longer post-dose period of collection of solicited symptoms may be applicable for replication-competent live vaccines (e.g. 10-14 days or sometimes more), depending on what is known about the duration of shedding of the vaccine (s).”

The double blind placebo control study (with an inert placebo) which is the gold standard of drug safety testing required for all other drugs, is not required for vaccines. Instead, other vaccines or biologically reactive solutions in place of placebos are used which obscure safety issues with the new vaccine being tested. The EMA confirms in their guideline on vaccine trials (section 5.2) that other licenced vaccines can be used in place of a placebo.  

“If a placebo control is considered inappropriate (e.g. because investigators and/or participants/care-givers would reject the possibility of randomisation to multiple placebo injections), a licensed vaccine without an effect on the disease to be prevented by the candidate vaccine could be administered to the control group.”

Once the vaccine is launched on the market it is considered unethical to leave any child in the “control group” unvaccinated, so all controls are vaccinated with the latest vaccine. This practice renders comparison of the longer term health outcomes of vaccinated and unvaccinated population essentially impossible.

In relation to the Infanrix Hexa vaccine specifically, most studies (47 out of 61) monitored babies for 31 days or less for adverse reactions. Serious adverse reactions were typically collected until one month after the final dose. Serious adverse reactions are typically defined in the trial details as any “medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.” We have compiled a table of all of the completed studies for Infanrix Hexa from clinicaltrials.gov showing how long they monitored general and serious side effects and the number of participants in each.

Vaccine side effects

The Health Services Executive (HSE) in Ireland states:

The vaccines used in Ireland are safe. All medicines can cause side effects, but with vaccines these are usually mild, like a sore arm or leg or a slight fever. Serious side effects to vaccines are extremely rare.

The Centre for Disease Control (CDC) in the US says the following:

“As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.”

The Patient Information Leaflet (PIL) for the Infanrix Hexa (6-in-1) vaccine lists all side effects observed during clinical trials in section 4:

Worldwide voluntary reports of side effects

What Parents Say

“Advice to new parents- research vaccines from sources not receiving payments for administering vaccines as much as you likely researched baby products you purchased. What I wish I had known – the ingredients. ALL the potential side effects (not just the 5 the HSE informed me about), the frequency at which side effects happen”

More from parents

There are a number of systems that healthcare practitioners and the general public can use to report any adverse effects they may have with any vaccine once they have been launched on the market (post marketing adverse events).

• VigiAccess – World Health Organisation platform 
• VAERS – US system managed by the Center for Disease Control (CDC)
• Eudravigilance – EU system managed by the European Medicines Agency (EMA)

Side effects to vaccines and other drugs in Ireland can be reported to the HPRA which is in turn added to the Eudravigilance database. The systems listed above are all passive reporting systems relying on voluntary rather than mandatory reporting.

The US government funded a study – carried out by Harvard Pilgrim Health Care – that found that less than 1% of adverse reactions are reported to VAERS. In this study, data on vaccines was collected over 3 years on 1.4 million doses given to 376,452 individuals. The study cost over 1 million dollars. Another study on the Italian reporting system, which is also a passive system, found a huge disparity in the numbers of Adverse Effects Following Immunisation (AEFIs) between passive and active reporting systems and said that “passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs “.

As of 1, Oct 2023, there were 68,005 reports of adverse events (ADR’s) for Infanrix Hexa (6-in-1) in VigiAccess including, 815 cardiac disorders, 885 blood and lymphatic system disorders, 13,487 nervous system disorders (such as seizures, tremors, speech disorders), 4,065 respiratory disorders and 3,931 vascular disorders (such as Kawasaki’s disease and bleeding).   

Compensation Schemes

In the US, the National Childhood Vaccine Injury Act of 1986 granted immunity from liability for all vaccine manufacturers and established the Vaccine Injury Compensation Program (VICP).  This overview of a number of such schemes published on oireachtas.ie points out that they “require standards of proof showing a causal link between vaccination and injury, although this has often led to overly strict standards of proof”. At the start of 2023, the US scheme had paid out in excess of $4.5 billion in childhood vaccine injury claims. A similar scheme in the UK paid out €86 million between 1979 and 2019. This is despite the fact that the UK scheme requires that claimants are severely disabled and caps awards at £120,000. Since the scheme began in 1979 until May 2017, 79% of claims were rejected based on the claimants’ inability to prove causation. 

Although there are numerous problems with VICPs, depending on how they are designed, as discussed in the Oireachtas overview, they should in theory make it more affordable and easier for parents whose child has been injured or killed by vaccines to be compensated as it is not normally required to pay legal fees. A detailed review of the different schemes carried by the Health Research Board (HRB) in Ireland sums it up as follows:

“The purpose of compensation schemes is to provide an alternative option to civil litigation. This is achieved by lessening the stringency around the standard of proof; crucially however, the compensation on offer is typically available more quickly, but the amount is usually lower than what a vaccine-injured individual may receive through litigation.”

However, there is no such scheme in Ireland at present. This is the case even though the Oireachtas Joint Committee on Health and Children recommended that a vaccine damage compensation scheme be set up at the earliest possible date in 2001 according to the HRB. The Oireachtas overview which was published in April 2021 notes that the issue has taken on increased significance now due to the fact that the manufacturers of the covid vaccines are being given “legal indemnity through purchase agreements which means that they cannot be pursued for compensation for vaccine-related harm”. The HRB review, says the urgency in introducing a VICP scheme is increasing since claims are being taken against the Minister for Health, the HSE and GlaxoSmithKline by individuals claiming that they developed narcolepsy after getting the H1N1 (swine flu) vaccine.  According to the review, this will result in exposure of the State to a large number of claims. 

The lack of a VICP scheme in Ireland means that the only avenue open to parents is taking legal action against the state. The HRB review points out the problems with this: 

“However, a more strict form of causation applies in tort law, so mounting a successful case is more difficult and often more time-consuming and costly, restricting access to litigation to those with adequate resources.”

Proving causation is also hampered by the fact that adverse reactions listed in manufacturers leaflets are not accepted as causing the reaction when it comes to getting compensation. This is evident given that claimants have to prove that their child’s adverse reaction was due to the vaccine even with the VICP schemes which should have a lower standard of proof.

How serious are these diseases?

In prosperous first-world countries like Ireland, where there is clean water and sanitation, diseases being vaccinated against are rarely serious anymore. The introduction of antibiotics and other treatments is also a factor. The graph below depicts the mortality trajectory of four diseases; diphtheria, pertussis, scarlet fever and measles in Ireland since the beginning of the twentieth century. In the three vaccine diseases (diphtheria, pertussis, measles) the decline was evident before the vaccine was introduced. Scarlet fever declined from being a fatal disease to one that is generally a mild infection despite the fact that there was no vaccine for it. This highlights the impact of improvement in social conditions on disease outcomes.

According to Our World In Data, poor sanitation is a leading risk factor for infectious diseases. This was highlighted in the Irish CSO annual reports also. For example, the 1867 report (on page 18), recorded a marked decrease in death from disease epidemics after sanitation measures were implemented:

“The benefits resulting from sanitary improvements were well illustrated in the condition of the Milltown Malbay District, Ennistimon Union, which afforded a striking contrast when compared with Mullingar. The Registrar of Milltown Malbay recorded 70 births against 30 deaths, and made the following observations :-
“Dependent on its improved sanitary condition; my district enjoys an immunity from disease epidemic or endemic. Nothing can be more marked than the difference betwixt it and the preceding quarters of the same season when unhappily less preventive measures existed”.

Disease Vs Vaccine Risk Profile

Using CSO mortality data, the disease risk profile for each disease the Infanrix Hexa (6-in-1) aims to protect against is outlined alongside the risk of side effects listed on the latest available Infanrix Hexa (6-in-1) Patient Information Leaflet. The Patient Information Leaflet includes side effects from the trials and reports after the vaccine rollout (post-marketing surveillance). It is worth bearing in mind that side effects may be significantly underreported in passive reporting systems like VigiAccess as discussed above – this means that the rates of vaccine side effects below could be many times higher. For information on the disease itself click on the disease name to bring you to the HFI information sheet for each one. 

Adverse reaction reports by vaccine manufacturer GSK shows that vaccine is safe and sudden deaths reported are below expected numbers

Safety profile of Infanrix hexa – 17 years of GSK’s passive post-marketing surveillance

This study was carried out in Ireland and was funded and managed by GSK – the manufacturer of this vaccine.  The Declaration of Interest section on the study confirms that all four authors were employed by GSK at the time of manuscript development and three of them held shares in the GSK group of companies.

Read More

“From 23 February 2000 to 22 October 2017, GSK received a total of 31,892 spontaneous AE reports worldwide following vaccination with DTPa-HBV-IPV/Hib, of which 8,838 reports (27.7%) were considered as serious. 

A total of 238 spontaneous reports with a fatal outcome were reported to GSK from launch up to 22 October 2017. After medical assessment based on clinical information, event history, and autopsy, an underlying condition(s) or disease that was likely to have caused the death could be identified in 104 of these cases. The remaining 134 cases were suggestive of SD (64 cases of Sudden Infant Death Syndrome and 70 cases of Sudden Unexpected Death).

The analysis showed that for any risk period between 0 and 19 days post-vaccination, the number of SD cases reported after DTPa-HBV-IPV/Hib was significantly below the number of cases expected in children in their first year of life, and lower than the number expected in children in their second year of life”

8 years of experience shows 6-in-1 to be safe

Review of 8 years of experience with Infanrix hexa™ (DTPa–HBV–IPV/Hib hexavalent vaccine)

Funding for the preparation of the manuscript was provided by GSK. The lead author and second author listed both received consulting fees and research funds from GSK. The remaining authors were all employees of GSK at the time the study was done.

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Abstract – These data show DTPa-HBV-IPV/Hib to be highly immunogenic and well tolerated across a range of different primary and booster vaccination schedules, as well as when administered concomitantly with other licensed vaccines (e.g., pneumococcal conjugate vaccine).

Comparison of two 6-in-1 vaccines shows lower adverse reactions for Infanrix Hexa

Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines

Four of the authors including the lead author were GSK employees and three of those hold shares in the GSK group of companies. Two of them have fees paid to them or their institutions by GSK.

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Conclusion: ORs of analyzed local and systemic solicited adverse reactions after primary vaccination with DT3aP-HBV-IPV-Hib appear to be slightly lower than with DT2aP-HBV-IPV-Hib.

Infanrix hexa is the cornerstone of the Australian infant immunization program, providing sustained protection against six childhood diseases since 2009.

Control of vaccine preventable diseases in Australian infants: reviewing a decade of experience with DTPa-HBV-IPV/Hib vaccine

GlaxoSmithKline Biologicals S.A. funded this study and all costs related to the development of the publication.  Four of the authors including the lead author were GSK employees and two of those hold shares in the GSK group of companies. Two of the others received funding from GSK. 

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Abstract: Between 2009 and 2018 vaccine coverage for infants aged 12 months increased from 91.7% to 94.0% and from 84.9% to 92.6% for all and for Indigenous infants, respectively. Over the same time period, there were no reports of poliomyelitis, diphtheria or tetanus in infants <12 months of age. The incidence of hepatitis B among Australian infants <12 months of age remains 10 to 20-fold lower than the national average.

Studies expressing concern about the Infanrix Hexa (6-in-1) vaccine

Higher than expected number of sudden deaths reported soon after the administration of Infanrix Hexa

Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency

This was an independent study.  Vaccine manufacturer GSK submits periodic safety update reports (PSURs) on the Infanrix Hexa (6-in-1) vaccine to the EMA.

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“The clustering of deaths soon after immunisation suggests that the deaths could have been caused by the vaccine.

Our analysis shows that the deaths acknowledged in the PSUR 16 have been deleted from the PSUR 19. The observed deaths are spontaneously reported to GSK and are likely to be underestimated. Adding in the deaths deleted from the PSUR 16, there is a statistically significant increased risk of death in the first four days after vaccination, compared to the expected deaths. The manufacturers will need to explain why these deaths were not included in the PSUR 19. The increased risk of death was not communicated to the regulatory authorities or to the health personnel administering this vaccine.

The number of observed deaths was less than what was expected (Table 1). However, among the infants, there was a clustering of deaths immediately following vaccination, with 42 deaths taking place in the first three days after vaccination, and only 8 in the next 3 days. Among those below one year of age, 54 deaths (93%) occurred in the first 10 days, and 4 (7%) in the next 10 days. Had the deaths been “coincidental SIDS deaths”, this disparity in the number of deaths in the two time periods would not have been observed. SIDS deaths would have been spread uniformly over the 20-day period

Similarly, among children older than one year, 5 deaths (83.3%) occurred in the first 10 days and 1 death (17%) occurred in the next 10 days.”

Analysis of the 6-in-1 vaccine Infanrix Hexa finds serious contaminants and that it lacks the antigens it claims to have

Vaccinegate: Study on the chemical composition profile of Infanrix Hexa 
Article: What did we find in the 6-in-1 (Infanrix Hexa) vaccine?

Corvelva is an Italian non profit association that has commissioned independent testing on a number of vaccines including the Infanrix Hexa (6-in-1) vaccine Infanrix given here in Ireland. The funders had no role in the design of the study, the collection and analysis of data, the decision to publish or the preparation of the manuscript”. The analyses were carried out both by a prestigious European university and by other certified laboratories located in different parts of the world. The study above has not been published as yet. However a study has been published that validates the method that was used to test vaccines. More details here.

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The Infanrix Hexa (6-in-1) vaccine should contain the following antigens: tetanus, diphtheria and pertussis toxoids; inactivated poliomyelitis viral strains 1-2-3; and hepatitis B surface antigen. Corvelva found NONE of these antigens in the vaccine, meaning that NO antibodies to the intended antigens will be created.  In addition, they found traces of 65 chemical cross-contaminants, chemical toxins, an unrecognisable macromolecule and various free bacterial peptides. Some comments from the report:

In addition to the fact that vaccination antigens have not been actually detected, 65 signals of chemical contaminants have been found, 35% of which were known, i.e. recognized for comparison with databases. 

Among these signals, 7 chemical toxins have also been identified; these toxins not yet uniquely defined in the structure, seem partly to derive from the reaction of formaldehyde, glutaraldehyde, and cyanogen bromide with other chemical contaminants present in the vaccine. We’d like to point out that a large proportion of these toxins have a proven and reported toxicity in Pubchem or Toxnet and pose a significant safety concern.

The study of the protein and peptide fraction has shown various free peptides (i.e. short fragments of amino acid chains) of bacterial and fungal origin. Bacterial peptides are reported in the literature as potential allergens and capable of inducing autoimmune reactions and these also pose a safety concern that will need to be clarified with regulatory agencies.

..we are inquiring the vaccines efficacy and safety and we can’t quite understand how it is possible to claim that this vaccine is even able to generate the 6 protective antibodies – reason why it is designed for – and furthermore to understand how this cluster made of 6 neurotoxic antigens bound together can be claimed as not toxic for newborns.

Infanrix Hexa hexavalent, as for the method we have commissioned, casts major doubts on both its effectiveness and on its safety…

6 unexplained cases of sudden infant death shortly after 6-in-1 vaccination

Unexplained cases of sudden infant death shortly after hexavalent vaccination

In this letter to the editor of the journal Vaccine, the authors reported 6 cases of children dying within 48 hours or receiving the newly available 6-in-1 vaccine. In the autopsies, there were several findings that were not consistent with typical SIDs cases including what they called an ‘extraordinary brain edema’ in all 6 children. There was no funding and no known conflict of interest.

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We report six cases of sudden infant death after hexavalent vaccination that were autopsied and examined at the Munich Institute of Legal Medicine from 2001 to 2004. Among those investigated children, three were male and three female, ageing between 4 and 17 months. Five children had been vaccinated with Hexavac®, one with Infanrix Hexa® during the past 48 h before death. Shortly after the vaccination, three of the children developed symptoms like tiredness, loss of appetite, fever up to 39 ◦C and insomnia. All children were found dead without explanation 1–2 days after the vaccination.

Prior to the release of hexavalent sera (in the years 1994–2000), we observed only one child out of 198 cases with sudden unexplained infant death who died shortly after vaccination (DTP). However, between 2001 and 2004 five of such cases were identified in our institution among 74 children with SID. This would indicate a 13-fold increase (the local autopsy rate for infants is about 70%).

Vaccines containing Aluminium present a high risk of toxicity

The meaning of aluminium exposure on human health and aluminium-related diseases

The Infanrix Hexa (6-in-1) vaccine given in Ireland contains aluminium hydroxide (0.5mg) and aluminium phosphate (0.32mg). (See the Health Freedom Ireland article  Aluminum in vaccines – why does it matter? for more on this topic).

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Aluminium is unquestionably neurotoxic, as has been well demonstrated in multiple experimental animals and in clinical practice. Some concerns have been raised in recent years regarding the possible adverse effects of aluminium in childhood vaccines on the maturation of the immune system. In fact, aluminium is used as an adjuvant in multiple childhood vaccines, including DtaP, Pediatrix (DtaP, hepatitis B, polio combination), Pentacel (DtaP, HIB, polio combina-tion), hepatitis A, hepatitis B, Haemophilus influenza B (HIB), human papillomavirus (HPV) and pneumococcal vaccines.

Taken all together, these data clearly indicate that alu-minium represents a significant component of exposure of humans to xenobiotics and contaminants and that newborns are at risk of aluminium-related toxicity not only in the perinatal period, but also in childhood and in adulthood.

Further resources

Join the parents support group to continue the discussion and learn from the experience of others.

Health Freedom Ireland:

Health Freedom Ireland Diphtheria
Health Freedom Ireland Tetanus
Health Freedom Ireland Polio
Health Freedom Ireland Pertussis (Whooping cough)
Health Freedom Ireland Hepatitis B
Health Freedom Ireland Hib

Other:

Health Service Executive (HSE) Childhood Immunisation Schedule
Health Service Executive (HSE) History of Vaccines
Medicines.ie Infanrix Hexa (6-in-1) Patient Information Leaflets 
European Medicines Agency (EMA) Infanrix Hexa (6-in-1)
HSE Diseases