The FDA can be sued—Aluminium adjuvants never approved for vaccines

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Aluminium Adjuvants Have Never Been Approved For Use In Vaccination

VacTruth.com

Within the first year of life, the CDC recommends that children receive a total of 29 vaccinations, many of which contain the adjuvant aluminum, a substance used in vaccinations to increase the immune response to the antigen (the component of the vaccine that stimulates the immune system to make antibodies). [1]

According to Professor Christopher Exley’s recent research, there are currently two main aluminum adjuvants commonly used in vaccinations today. These are AlHydrogel, a semi-crystalline (boehmite) form of aluminium oxyhydroxide and AdjuPhos, an amorphous salt of aluminium hydroxyphosphate. The sulphate salt of the latter is also listed as being one component of an adjuvant system used in vaccinations against HPV. AlHydrogel™ and AdjuPhos™ are commonly referred to as clinically-approved aluminum adjuvants, and yet this is not the case.

There are no aluminum adjuvants that have been approved for intramuscular or subcutaneous injection into humans. There are no requirements for their approval; they are only “approved” as part of vaccine preparations.

His words are extremely worrying, especially when you consider just how many vaccinations on the childhood vaccination schedule contain the adjuvant aluminum as an ingredient.

In a press release, describing Professor Exley’s latest paper, the founder of the Dwoskin Family Foundation, Mrs. Claire Dwoskin wrote:

“Research at Keele University led by Professor Christopher Exley aims to understand the toxicity of aluminum adjuvants in vaccinations and their latest findings are now published in Nature’s ‘Scientific Reports.

In a project funded by the Medical Research Council (MRC) and the Dwoskin Foundation the group at Keele investigated the relationship between the physicochemical properties of aluminum adjuvants and the immune response. Specifically, they show that the reaction of the aluminum adjuvant at the injection site will determine its subsequent fate and therefore its activity both at the injection site and away from the injection site.

One form of aluminum adjuvant which is most commonly used in vaccines is an aluminum hydroxyphosphate salt and is more toxic at the injection site than the second form of aluminum adjuvant, also commonly used in vaccines, aluminum oxyhydroxide salt. However, the latter is more easily loaded into immune reactive cells with the possibility to be transported throughout the body. It is suggested by the Keele research that this loading of aluminum into viable cells offers a mechanism whereby significant amounts of aluminum, a known neurotoxin, might be translocated throughout the body and even across the blood brain barrier and into the central nervous system.” [2, 3, 4]

Countless Childhood Vaccinations Contain Aluminum

According to the CDC’s Vaccine Excipient & Media Summary -Excipients Included in U.S. Vaccines by Vaccine, many of the childhood vaccinations used today include an aluminum adjuvant. However, there are two six-in-one vaccinations that are not listed by the CDC that contain an aluminium adjuvant that have been extremely problematic from the beginning. These are the Infanrix Hexa and Hexavac vaccines. [5, 6, 7]

Authors of Vaccine Studies State One Thing but Mean Another

In 2011, Giuseppe Traversa and his team wrote a study titled Sudden unexpected deaths and vaccinations during the first two years of life in Italy: a case series study, which, at the time, was considered to be a success. [8]

Studying the incidence of sudden infant death after hexavalent vaccinations in Germany and Italy, the team concluded that their findings were globally reassuring. However, after reading the study in depth, it appears that the team’s outcome was anything but reassuring.

In their abstract, the team stated:

“The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy.”

In their introduction, they stated:

“Most deaths occurring during the first two years of life are attributable to defined causes, mainly represented by congenital malformations, malignancies, and accidents. The events in otherwise apparently healthy subjects, without any evident cause for the death, are classified as SIDS (Sudden Infant Death Syndrome) during the first year of life and SUD (Sudden Unexpected Deaths) at older ages.

In 2003 the suspicion of a possible association between the immunisation with a hexavalent vaccine (Hexavac) and the occurrence of SUD was raised in Germany. The signal was based on the observation of three deaths occurring between November 2000 and June 2003 in toddlers in their second year of life within 48 hours following the administration of the fourth dose. No signal was detected for vaccinations administered during the first year of life.

Two hexavalent products were licensed in the European Union through a centralised licensure procedure in the year 2000: Hexavac (by Aventis Pasteur MSD) and Infanrix hexa (by Glaxo SmithKline Biologicals). These combined vaccines contained antigens to immunise against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and haemophilus influenzae type b. Since licensure the two vaccines were extensively used in some EU countries (e.g., Germany, Italy, Austria).” (emphasis added)

They continued:

“Italy represented the second largest market of Hexavac in the world and no signal of a possible association with the occurrence of SUD emerged from the Italian pharmacovigilance reporting system. Childhood vaccination schedules differed slightly between Germany and Italy as four administrations were recommended in Germany (at the 2nd, 3rd, 4th, and between the 11th and 15th months of life) and three in Italy (at the 3rd, 5th, and 11th-12th months of life). Despite these differences, it was deemed necessary to carry out further investigations and a study protocol was agreed with the CHMP-EMA (Committee for Medicinal Products for Human Use – European Medicines Agency). The study was carried out on the entire Italian population of newborns over a five year period (1999–2003) and a report was presented in 2005 at the CHMP-EMA.” (emphasis added)

Describing the vaccination policies in Italy, the team stated that:

“The Italian infant immunisation schedule includes three doses of vaccines against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and haemophilus influenzae type b, to be administered in the first year of life (at the 3rd, 5th, and 11th-12th months of age); the first MMR vaccination is recommended between the 12th and 15th months. During the six-year study period, combined vaccines have largely replaced the use of single antigens concomitantly administered. Hexavalent vaccines reached 96% of the doses administered in the first year of life in 2004.”

Already, a subtle difference can be established between the two study groups. In Germany, infants were vaccinated with the hexavalent vaccination four times in the first two years of life, whereas, in Italy, infants were only vaccinated three times in their first year of life.

Now this is where the research gets interesting.

The concern that was raised in Germany centered on the fact that three toddlers had died within 48 hours after receiving their fourth dose of the vaccine, which was given in their second year.

Despite this being the case, however, the team decided to conduct their study in Italy and stated:

“Since the largest use of hexavalent products was reached in 2004 we subsequently decided, with the intent to increase the power of the study, to extend the observation period and to include all infants immunised in 2004. As for the preliminary study, the main aim was to assess whether immunisation with hexavalent vaccines in the first two years of life was associated with higher short term risk of unexplained death in the Italian setting. We are now reporting the final findings of the study for the entire period 1999–2004.”(emphasis added)

They concluded that:

“In conclusion, our findings do not confirm the signal raised in Germany of a 23 fold increase in the risk of SUD in association with the administration of a hexavalent vaccine. Differently from the German signal, where the increased risk concerned the forth dose (infants in the second year of life), in our study only the first dose, which is administered when the incidence of SUD is greater, appears to carry a smaller, though statistically significant, increase in the risk of SUD. The residual uncontrolled confounding effect of age may partly explain this finding. Given the extremely low mortality rate for SUD in Italy, the power of the study was too limited to rule out a small increase in the risk of death in association with any specific vaccine either during the second year of life or following the third vaccine dose. At present, even though many studies investigated the potential association between vaccinations and the occurrence of SUD, only limited evidence is relevant to the role of hexavalent vaccines. Further studies conducted on similar populations may contribute additional evidence and allow a meta-analysis to obtain more precise estimates.”

I believe that there were two major problems with this study.

Germany gave their infants four doses of the vaccine while Italy gave them only three.

There were two different hexavalent vaccinations licensed in Europe in the year 2000; however, there was no data provided by the team to identify which vaccination was being used at the time of vaccination.

It appears that I am not the only one to be concerned with this study. Pooja Anthwal, Sonalika Mehta and Jacob Puliyel, from St. Stephens Hospital in Delhi, India, also noted their concern in a comment. [9]

2012 Confidential Papers Leaked Reported 36 Deaths

In 2012, a confidential GlaxoSmithKline document titled Confidential To Regulatory Authorities – Biological Clinical Safety and Pharmacovgilance – GlaxoSmithKline Research and Development Avenue Fleming 20 1300 Wavre Belgium was leaked to the press, exposing that within a two-year period, a total of 36 infants had died after they had received the 6-in-1 vaccine, Infanrix Hexa. [10]

According to the website Initiative Citoyenne, which reported the news, the 1271-page document revealed that GlaxoSmithKline had received a total of 1,742 reports of adverse reactions between October 23, 2009, and October 22, 2011, including 503 serious adverse reactions and 36 deaths. Initiative Citoyenne stated:

“It’s not that 14 deaths were recorded by GSK between October 2009 and end in October 2011 as we had originally calculated but 36 (14 from 2010 to 2011 and 22 from 2009 to 2010). In addition to these 36 deaths at least 37 other deaths (sudden death mainly), bringing the total to at least 73 deaths since the launch of the vaccine in 2000, and again, this concerns only the death by sudden death, no further recovery of under-reporting.” [11]

Using the figure of 36 deaths over a two-year period, this averages 1.5 deaths per month, which by anyone’s standard is extremely high. Note that only one to ten percent of adverse reactions to vaccines are actually reported. Therefore, in reality, the problem could potentially be far more serious and the actual number of fatalities much higher.

A Deadly Chemical Cocktail

The charts show that many of the babies who died passed away within the first few days of receiving the vaccine. A total of three infants were reported to have died within hours of receiving the vaccine. [12]

This tragedy is hardly surprising, given the vaccine’s ingredients listed on the GSK Infanrix Hexa product information leaflet, which parents are rarely given the chance to read prior to vaccinations. Ingredients include non-infectious substances from tetanus, diphtheria bacteria, purified proteins of pertussis bacteria, the surface protein of the hepatitis B virus (HBsAg, derived from genetically engineered yeast cells) and inactivated poliovirus. [13]

Each 0.5mL dose contains:

  • diphtheria toxoid
  • tetanus toxoid
  • pertussis toxoid
  • filamentous haemagglutinin
  • pertactin
  • recombinant HBsAg protein
  • poliovirus Type 1
  • poliovirus Type 2
  • poliovirus Type 3
  • purified capsular polysaccharide of Hib covalently bound to tetanus toxoid
  • aluminium hydroxide
  • aluminium phosphate
  • 2-phenoxyethanol, lactose
  • Medium 199
  • neomycin
  • polymyxin
  • polysorbate 80
  • polysorbate 20
  • sodium chloride
  • water

This product information leaflet proves that not only does Infranrix Hexa contain aluminum hydroxide but it also contains aluminum phosphate, which together are potentially lethal.

GlaxoSmithKline Listed the 1,742 Adverse Reactions in Detail

Interestingly, not only did the leaked GlaxoSmithKline document reveal that 36 infants had died after receiving the Infanrix Hexa vaccination, but they also listed each and every one of the 1,742 adverse reactions in detail. In fact, the list was so long, it required a full twenty pages.

Here, I have listed just a few of the adverse reactions recorded between pages 11 and 31 of their document:

  • 106 cases of cyanosis
  • 69 cases of loss of consciousness
  • 165 cases of hypotonia
  • 102 cases of hypotonic-hyporesponsive episodes
  • 107 cases of convulsions
  • 20 cases of epilepsy
  • 98 cases of febrile convulsions
  • 33 cases of grand mal convulsions
  • 47 apnea attacks
  • 108 cases of vomiting
  • 43 cases of Gaze Palsy
  • 12 cases of anemia
  • 1 case of bone marrow failure
  • 6 cases of cardiac arrests
  • 53 cases of diarrhea
  • 593 cases of pyrexia (high temperature)
  • 22 cases of gait disturbance
  • 6 cases of anaphylaxis
  • 62 cases of pertussis (whooping cough)
  • 2 cases of meningitis pneumococcal
  • 3 cases of arthritis
  • 16 cases of muscle twitching
  • 22 cases of tremors
  • 264 cases of crying (does not indicate the severity)
  • 2 cases of Guillain-Barre syndrome
  • 10 cases of respiratory arrest
  • 7 cases of Kawasaki’s disease [14]

All of these adverse events occurred after the children received the Infanrix Hexa vaccination, some just hours after being vaccinated. I am sure that you will agree that these documented facts make extremely uncomfortable reading.

However, if this information is not disturbing enough, the GlaxoSmithKline document also revealed that there was a total of 68 cases of vaccination failure! This proves that, not only did their vaccination cause death, injury and illness to nearly 2,000 children, but that this vaccine failed to give any “protection” at all to at least 68 children.

The document was signed by Safety Scientist Vanessa Corman and Vice President, Lead Biological Clinical Safety and Pharmacovigilance Dr. Felix Arellano, M.D., from GlaxoSmithKline Biologicals.

Conclusion

Over the years, hexavalent vaccinations have been responsible for many deaths and disabilities worldwide, and yet they remain in use today. It is shocking to know that a leading pharmaceutical company such as GlaxoSmithKline has known of the danger of these vaccines for years, and yet they continue to portray them as safe and effective.

This is just one of the many papers that have been hidden over the years. How many more scholarly papers that reveal similar adverse reactions have the pharmaceutical industries and governments hidden in their archives?

To learn more about hidden documents, read At Last! Government Documents Locked Up for 30 Years Proving This Vaccine Unsafe Finally Revealed and Gulf War Syndrome: Documents Prove UK and US Military Personnel were Injected with Untested Vaccines.

References

  1. www.cdc.gov/vaccines/parents/downloads/parent-ver-sch-0-6yrs.pdf
  2. info.cmsri.org/blog/significant-breakthrough-in-study-of-aluminum…
  3. https://about.me/dwoskin_family_foundation
  4. www.nature.com/articles/srep31578
  5. www.cdc.gov/vaccines/vac-gen/additives.htm
  6. ca.gsk.com/media/537989/infanrix-hexa.pdf
  7. novaccine.com/hexavac/
  8. journals.plos.org/plosone/article?id=10.1371/journal.pone.0016363
  9. http://journals.plos.org/plosone/article/comments…
  10. ddata.over-blog.com/xxxyyy/3/27/09/71/2012-2013/confid.pdf
  11. ddata.over-blog.com/…6-dec.-2012-_doc-confidentie.pdf
  12. www.initiativecitoyenne.be/article-infanrix-hexa…
  13. www.betterhealth.vic.gov…pdf
  14. ddata.over-blog.com/xxxyyy/3/27/09/71/2012-2013/confid.pdf

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