This article addresses the Prevenar 13 (pneumococcal) vaccine, manufactured by Pfizer 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 deciding to vaccinate your child.
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.
- The Prevenar 13 (pneumococcal) contains 5 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.
- Prevenar 13 does not protect against infection and disease caused by Streptococcus pneumoniae strains not present in the vaccine.
- Research finds that the risk of serious side effects and death from vaccines increases significantly the more doses of vaccines are given at one time. Babies in Ireland get 9 vaccines at 2 months of age.
- Scientific literature shows that vaccines may cause autoimmune disorders.
- 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 will be one of the first vaccines for your child so you can’t know whether they are allergic or not.
- As of 5 October 2023, there were 267,265 reports of adverse events (including 2,151 deaths) for the pneumococcal vaccine in the World Health Organisation VigiAccess database.
Diseases it aims to protect against
The Prevenar 13 (pneumococcal) vaccine aims to protect your baby against Pneumococcal disease which is a disease caused by bacterial infection. Read our article on pneumococcal disease for more information.
When is it given?
It is given to children in Ireland at 2, 6 and 13 months of age.
What is in this vaccine?
The Prevenar 13 Vaccine Summary of Product Characteristics section 2 outlines ingredients in the vaccine as follows. This list excludes the 10 toxoids/disease strains.
What Parents SayMore from parents
“My child is not vaccinated , I made a decision after reading all the ingredients in each vaccine. That made me realize that it is something not right. How come a child who is only two months old can digest all the toxins injected into his body considering that all the organs are not fully developed and strong. Then I thought if a baby is only allowed to drink milk how come a dose of so many vaxxs are allowed. Made no sense to me.”
Mother of 3 year old.
Is the Prevenar 13 (pneumococcal) 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 Prevenar 13 (pneumococcal) vaccine specifically, the (FDA) Package Insert gives the results of 13 clinical trials. 4,729 infants were given one dose of Prevnar 13 and 2,760 were given at least one dose of the Prevnar active control. The Prevnar active control, which is referred to as the placebo numerous times in the document, is actually a previous version of this vaccine that had extracts from 7 strains of pneumococcal bacteria rather than 13.
Serious adverse effects were collected until 6 months after the final dose (given between 12 and 15 months) for 7 of the studies. The package insert mentions that this is longer than the 30 day period used in other vaccine trials so as a result, there may be more adverse events reported for this vaccine than others.
They also state that the vaccines were given at the same time as other vaccines as per the schedules in the specific countries. In one trial in Brazil, there were 4 hypotonic-hyporesponsive episodes. This means the babies had a sudden onset of poor muscle tone, reduced consciousness, and pale or bluish skin. The document states that all 4 babies received the pertussis (whooping cough) vaccine at the same time.
The Prevenar 13 vaccine was given to 4,729 infants, without a true placebo, was administered along with a variety of other vaccines and only monitored until 6 months after the last dose. Can we be sure that it is safe?
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 Prevenar 13 (pneumococcal) vaccine lists all side effects observed during the clinical trials in section 4:
Like all vaccines, Prevenar 13 can cause side effects, although not everybody gets them.
The following side effects include those reported for Prevenar 13 in infants and children (6 weeks to 5 years of age):
The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:
- Decreased appetite
- Fever; irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site; drowsiness; restless sleep
- Redness, hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the booster dose and in older children [aged 2 to 5 years])
Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:
- Vomiting; diarrhoea
- Fever of more than 39°C; tenderness at the vaccination-site interfering with movement, redness, hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the initial course of injections)
Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:
- Seizures (or fits), including those caused by a high temperature
- Hives (urticaria or urticaria-like rash)
- Redness, swelling, or hardness at the vaccination-site of more than 7 cm; crying
Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:
- Collapse or shock-like state (hypotonic-hyporesponsive episode)
- Allergic (hypersensitivity) reaction, including swelling of the face and/or lips, difficulty in breathing
The following additional side effects have been seen with Prevenar 13 in postmarketing experience
- Severe allergic reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)
- Hives (urticaria), redness and irritation (dermatitis) and itching (pruritus) at the vaccination-site; flushing
- Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm or in the groin
- A rash causing itchy red blotches (erythema multiforme)
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 5, October 2023, there were 267,265 reports of adverse events (ADR’s) for the pneumococcal vaccine in VigiAccess including 2,151 deaths, 770 cases of sudden infant death syndrome, 215 sudden deaths, 414 cardiac arrests, 51,228 nervous system disorders (such as seizures, tremors and Guillain-Barre syndrome) and 15,880 vascular disorders (such as Kawasaki’s disease and bleeding).
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 of VICPs, 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 pneumococcal disease is outlined alongside the risk of side effects listed on the latest available Prevenar-13 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. Read our article on pneumococcal disease for more information on the disease itself.
|DISEASE RISK – PNEUMOCOCCAL DISEASE|
|Risk of getting pneumococcal disease in Ireland 2008 to 2017 (after PCV7 vaccine was introduced, 2008)||Extremely rare: < 1 in 13,394 (0.007%)|
Extremely rare: < 1 in 232,168 (0.0004%) for under 5s
|Risk of dying from pneumococcal disease in Ireland in the decade before vaccine was introduced in 2000||Extremely rare: < 1 in 17,431 (0.006%)|
Negligible: < 1 in 12 million for under 5s (0.000008%)
|Risk of dying from pneumococcal disease in Ireland in decade after the PCV7 vaccine introduced in 2008||Extremely rare: < 1 in 164,108 (0.0006%)|
Extremely rare: < 1 in 3M (0.00003%) for under 5s
|RISK OF PNEUMOCOCCAL VACCINE SIDE EFFECTS|
see section 4 of patient information leaflet for full list of side effects
**Severe allergic reactions can occur to any vaccine but they are very rare and are usually seen in less than 1 in 10,000 people who are vaccinated
|Prevenar-13 (pneumococcal) vaccine|
(3 doses recommended at 2, 6 and 13 months)
|Risk of anaphylactic reaction including shock, swelling of lips, face, throat (angioedema), dermatitis, lymphadenopathy, erythema multiforme||Frequency unknown (additional side effects once the product launched on market)|
|Risk of seizures or fits||Uncommon: up to 1 per 100 doses (1%)|
|Risk of collapse or shock-like state (hypotonic-hyporesponsive episode), allergic reaction||Rare: up to 1 in 1,000 doses (0.1%)|
What if I delay giving this vaccine or choose not to vaccinate?
In Ireland, vaccines are not mandatory, so you as a parent can decide whether to give a vaccine, to delay it until your child is older or not give it at all. You can check with your GP to see if they support a modified / delayed vaccine schedule or a decision not to vaccinate. Every family has the right to make this decision for their particular circumstances. The information in this article is intended as a starting point to do your own research so that you can be truly informed. When you know the risks and benefits of the vaccine and the risks of the illness if your child should get it, you can make the best decision for them.
Can my child attend creche/school if not vaccinated?
Vaccines are not required for childcare or school in Ireland. The Citizens Information site states:
The consent of parents is required for vaccinations for children and young people up to the age of 16. Vaccination is not compulsory, but is strongly advised by the Department of Health.
Some private creches may ask about vaccines but are not permitted to ask for medical records. Delaying the vaccine until the child is due to start creche is always an option.
Vaccine trials are outlined on the longer FDA Package Insert (see Is the Prevenar 13 (pneumococcal) vaccine safe section above). Drug trials need to be carried out free from any conflicts of interest with the object under scrutiny. Unfortunately, many of the studies in support of the vaccine listed below do not comply with industry ethics in this regard. There are no longer term studies included in the leaflets.
Studies that support the Prevenar 13 (pneumococcal) vaccine
Vaccine manufacturer proposes that new versions of vaccine need to protect against more strains of pneumococcal disease
The lead author of this paper is an employee of Pfizer (the manufacturer of the Prevenar vaccine) while his co-author is a consultant for Pfizer who receives research funding from the company. They confirm that pneumococcal disease is primarily an issue in developing countries. (It may be worth keeping this in mind when weighing up the risk/benefits of this vaccine for a child in Ireland where we have good sanitation, clean water and nutrition – see Pneumococcal article for figures on the disease prevalence in Ireland). They propose that vaccines need to have protection against additional strains of the disease:
“Pneumococcal disease (PD) is the leading cause of vaccine preventable deaths in children <5 years of age worldwide, with most of the deaths occurring in the developing world. Prevention of PD in children has been achieved by vaccination with pneumococcal conjugate vaccine (PCV), the basis for which is induction of a protective antibody response against the bacterial polysaccharide capsule…
A new GAVI alliance program has been put into place to have PCVs available to the developing world where the majority of the burden of PD exists. This program started with PCV7 and is continuing with the new PCVs, PCV10 and PCV13.“
A review of clinical trials shows Prevenar 13 to be safe and effective
Three of the authors of this paper worked for institutions that received funding from Pfizer. All of the authors declared that they had no known financial conflicts of interest. This paper compared the vaccine effectiveness (VE) between the 7 valent version of the vaccine and the 13 valent one (which aims to protect against 13 strains of the disease). The authors found that there were breakthrough infections (infections of pneumococcal disease) in 27 fully vaccinated children to 3 strains or serotypes of the disease. Overall they conclude that the 13 valent vaccine offers increased benefit.
“In conclusion, Canadian surveillance data show high VE for PCV7, but lower for PCV13. However, in the use of an indirect cohort method, the VE is calculated based on the serotypes in each vaccine and not looking at IPD incidence overall, which is declining in Canada . Therefore, PCV13 still offers the increased benefit over PCV7 of covering a higher number of serotypes. The lower VE of PCV13 may be due to a combination of low effectiveness of the PCV13 against serotypes 3 and 19A and the change in dosing schedule from 3 + 1 to 2 + 1 with the introduction of PCV13 in Canada combined with moderate vaccine uptake of 80%.”
Immune response of children to booster dose of 13 valent pneumococcal vaccine was robust
Immunogenicity and safety of a booster dose of the 13-valent pneumococcal conjugate vaccine in children primed with the 10-valent or 13-valent pneumococcal conjugate vaccine in the Czech Republic and Slovakia
The lead author of this study has received grants and lecture fees outside of the submitted work from Pfizer. Serotype 19 is one of the strains of the pneumococcal disease that these vaccines aim to protect against. They found that the booster dose of the 13 valent vaccine showed a robust immune response whether given after the 10 valent or 13 valent vaccines.
“A total of 98 subjects in the Czech Republic and 89 subjects in Slovakia were included. One month after the PCV13 booster dose, the IgG and OPA immune responses to serotype 19A in subjects primed with 2 or 3 doses of PHiD-CV were non-inferior to those in subjects primed with PCV13. Non-inferior and persistent immune responses to most other vaccine serotypes were also observed after the PCV13 booster in PHiD-CV-primed subjects. No safety issues were raised in either study.“
Paper finds the pneumococcal vaccines to be effective
The content of this paper was based on a symposium (sponsored by Pfizer) held at the 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Berlin in 2013. The lead author has received consulting fees/honorarium from Pfizer. Four of the other authors have received fees from Pfizer and the fifth is a Pfizer employee. Pfizer is the manufacturer of Prevenar 13 which replaces Prevenar 7 (manufactured by its subsidiary Wyeth Pharmaceuticals Inc).
The article looks at the reduction in Invasive Pneumococcal Disease (IPD) after the PCV7 vaccine (which covers 7 strains of the disease) was introduced.
“PCV7 has significantly reduced the burden of pneumococcal diseases in children. PCV7 was introduced in the USA in 2000. The Centers for Disease Control and Prevention (CDC) reported a 77 % reduction in overall IPD rates and a 98 % reduction in PCV7 serotype disease in children aged <5 years for 2005 compared with pre-PCV7 years (1998–1999), based on an analysis of laboratory and population surveillance data . Reductions in overall and/or PCV7 serotype IPD cases have also been documented in children aged <2 or <5 years in many other countries, including Australia, Canada, France, Norway and Spain, following the introduction of PCV7 [44–49]. Furthermore, reductions in hospitalisation rates for all-cause pneumonia (39 %) and pneumococcal pneumonia (65 %) in children <2 years of age have been observed in an US analysis of admissions data .“
The authors do note that there has been a significant increase of one of the stains of this disease – serotype 19A – globally. They expect the introduction of PCV13 which covers 13 disease strains to provide improved coverage:
“Since the availability of PCV7 in 2000/2001, there have been changes in the overall serotype distribution of S. pneumoniae, in particular, a rise in serotype 19A has been observed globally. The estimated proportion of IPD caused by serotype 19A has ranged from 22 % reported in a Spanish study (2001–2005) in 85 vaccinated and unvaccinated individuals <5 years of age to 40 % in a US study (2005) in 1.26 million individuals <5 years of age [43, 58]. A rate of 27 % has also been reported in cases of pneumococcal pneumonia in a French study . This changing serotype epidemiology has led to the development and introduction of higher-valent pneumococcal conjugate vaccines, including PCV13, which includes serotype 19A, to provide improved serotype coverage against pneumococcal diseases.“
Studies expressing concern about the Prevenar 13 (pneumococcal) vaccine
Case control study shows pneumococcal vaccine was ineffective in high risk group
This was a case study with 89 patients hospitalised for pneumococcal disease that included a control group that did not receive the vaccine. It found that the patients with the disease were slightly more likely to be vaccinated. This was the case even though most (65%) of the bacterial strains that the vaccinated patients had were those included in the vaccine.
“If the vaccine were protective, vaccination rates should be higher among the control patients, and serotype distribution should be different in vaccinated and nonvaccinated bacteremic patients. There were no differences between vaccination rates among bacteremic patients (29 percent) and control patients (24 percent). Furthermore, 65 percent of the blood isolates from nonvaccinated bacteremic patients were serotypes included in the vaccine, as compared with 69 percent of the isolates in vaccinated bacteremic patients. Pneumococcal vaccine did not appear to be protective in this high-risk population.”
A 2017 study looks at cases of autoimmune reactions caused by vaccines
The article references other scientific literature that shows that vaccines cause autoimmune disorders:
“In the 1994, Stratton and coworkers published the first report on a causal relationship between several vaccines (e.g., diphtheria, tetanus toxoids, oral polio vaccines) and autoimmune disorders (e.g., Guillain–Barre syndrome, type 1 diabetes, and multiple sclerosis) .
These autoimmune disorders (rheumatic, endocrinological, and gastrointestinal diseases) are increased significantly over the last 30 years and affect more than 5% of the individuals worldwide at the age of vaccination programs, which is quite different compared to the spontaneous autoimmune disease incidence [6–9]. These observations raise the problem whether vaccination should be recommended or avoided in autoimmune risk patients .“
It looks at the mechanisms by which vaccines can trigger autoimmune reactions.
“In this review, we discuss the possible underlying mechanisms of autoimmune reactions following vaccinations and review cases of autoimmune diseases that have been correlated with vaccination. Molecular mimicry and bystander activation are reported as possible mechanisms by which vaccines can cause autoimmune reactions.“
It goes on to discuss a potential mechanism whereby the Hepatitis B virus (HBV) vaccine could trigger Systemic lupus erythematosus (SLE). SLE is a chronic, multisystemic autoimmune inflammatory disease. The possible mechanism is supported by another study proving cross-reactivity between pneumococcal antibodies and the generation of antiDNA antibodies, in SLE patients:
“The cause-and-effect interaction between HBV vaccine and SLE is unclear, although the post-HBV vaccination autoimmunity might be related to an increase in the number of immune complexes as well as to the molecular mimicry between some components of the vaccine (e.g., aluminum, yeast, thimerosal) and self-antigens . This theory is supported by the study of Kowal et al.  that proved cross-reactivity, at the molecular level, between pneumococcal anti-bacterial antibodies and generation of antiDNA antibodies, in SLE patients.”
Multiple doses of vaccines administered at a single doctor’s visit increases risk significantly
In this paper published in the Journal of American Physicians and Surgeons in 2016, Miller questions the common practice of administering multiple vaccines at one time. In Ireland, 2 month old babies receive nine different vaccines at one doctor visit:
- 6 in 1 Vaccine (Diphtheria, Tetanus, Whooping Cough, Hib, Polio & Hepatitis B)
- Prevenar 13 (pneumococcal)
- MenB Vaccine (meningitis b)
- Rotavirus oral vaccine
This paper concerns the schedule recommended by the Center for Disease Control (CDC) in the US but many of the vaccines are the same and the schedule is similar also:
“Although CDC recommends polio, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, Haemophilus influenzae type B, and pneumococcal vaccines for two-, four-, and six-month-old infants, this combination of eight vaccines administered during a single physician visit was never tested for safety in clinical trials. This is at odds with a CDC report that found that mixed exposures to chemical substances and other stress factors, including prescribed pharmaceuticals, may produce “increased or unexpected deleterious health effects.” This CDC report also noted that “exposures to mixed stressors can produce health consequences that are additive, synergistic, antagonistic, or can potentiate the response expected from individual component exposures.”12 Thus, CDC is well aware that mixing several pharmaceutical products increases the likelihood of synergistic toxicity and unexpected adverse reactions. Nonetheless, CDC urges infants to receive multiple vaccines concurrently without scientific evidence to confirm the safety of this practice. Administering six, seven, or eight vaccine doses to an infant during a single physician visit is certainly more convenient for parents, as opposed to making additional trips to the doctor’s office, and increases the likelihood that the infant will receive all the vaccines, but vaccine safety must remain the highest priority.“
In order to see if the number of vaccines given to babies has a negative effect, the author analysed the vaccine Adverse Event Reporting System (VAERS) database. The VAERS system is used to report side effects to vaccines in the US. (It is worth noting that a study – carried out by Harvard Pilgrim Health Care – that found that less than 1% of adverse reactions are reported to VAERS). The research found that the number of hospitalisations and death increased in proportion to the number of vaccine doses given:
“Of the 38,801 VAERS reports that we analyzed, 969 infants received two vaccine doses prior to the adverse event and 107 of those infants were hospitalized: a hospitalization rate of 11%. Of 1,959 infants who received three vaccine doses prior to the adverse event, 243 of them required hospitalization: 12.4%. For four doses, 561 of 3,909 infants were hospitalized: 14.4%. Notice the emerging pattern: Infants who had an adverse event reported to VAERS were more likely to require hospitalization when they received three vaccine doses instead of two, or four vaccine doses instead of three. The pattern continues: Of 10,114 infants who received five vaccine doses prior to the adverse event, 1,463 of them required hospitalization: 14.5%. For six doses, 1,365 of 8,454 infants were hospitalized: 16.1%. For seven doses, 1,051 of 5,489 infants were hospitalized: 19.1%. And for eight doses, 661 of 2,817 infants were hospitalized: 23.5%. The hospitalization rate increased linearly from 11.0% for two doses to 23.5% for eight doses.“
Similarly the babies that died following vaccination had a statistically significant higher mortality rate than those that had received fewer. The paper concludes:
“The safety of CDC’s childhood vaccination schedule was never affirmed in clinical studies. Vaccines are administered to millions of infants every year, yet health authorities have no scientific data from synergistic toxicity studies on all combinations of vaccines that infants are likely to receive. National vaccination campaigns must be supported by scientific evidence. No child should be subjected to a health policy that is not based on sound scientific principles and, in fact, has been shown to be potentially dangerous.“
Clear failure of PCV-13 vaccine in vitamin A deficient mice
“Given that vitamin A deficiency (VAD) is known to affect children in both developed and developing countries, we asked if VAD could be responsible, at least in part, for PCV-13 vaccine failures. In a mouse model for VAD, we found that PCV-13 failed to elicit binding and neutralizing antibody activities. Unlike vaccinated, vitamin-replete animals, vaccinated VAD animals were not protected from lethal pneumococcus infections. Results suggest that children with VAD may be susceptible to serious pneumococcal infections even after having received the PCV-13 vaccine.“
Join the parents support group to continue the discussion and learn from the experience of others.
Health Freedom Ireland:
Health Freedom Ireland Pneumococcal
Health Service Executive (HSE) Childhood Immunisation Schedule
Health Service Executive (HSE) History of Vaccines
Medicines.ie Prevenar 13 (pneumococcal) Patient Information Leaflet
US Food and Drug Administration (FDA) Package Insert for Prevenar 13 (pneumococcal) vaccine
European Medicines Agency (EMA) Prevenar 13