1,742 new reasons to avoid Infanrix Hexa vaccine cocktail

By CHRISTINA ENGLAND | VACTRUTH | DECEMBER 28, 2012

Last week, VacTruth reported details of the 1,271 page confidential GlaxoSmithKline document, regarding their six-in-one vaccine. More confidential papers have recently been leaked to the press. The Belgian website Initiative Citoyeene  reported both leaked documents.

The latest confidential document concerns the Prevenar 13 vaccine, a pneumococcal vaccine manufactured by Pfizer (now merged with Wyeth). [1] This vaccine replaced the original 2010 vaccine Prevenar, which, as reported by the manufacturer, has actually increased, rather than decreased, serious infections.

The Prevenar 13 protects infants against Streptococcus pneumoniae bacteria which can lead to cases of meningitis, bacteraemia (an infection of the blood), pneumonia and ear infections. [2] It is usual for the six-in-one vaccination Infanrix Hexa and the Prevenar 13 vaccine to be administered to small babies at the same time.

According to the leaked confidential Wyeth (Pfizer) documents and a reply from the European Medicines Agency (EMA), both the manufacturer and the agency are aware of a significantly higher number of adverse neurological events in children vaccinated with both Prevenar 13 AND Infanrix Hexa, as per the Belgian vaccination schedule at ages two months and four months.

 THE FIRST SET OF LEAKED DOCUMENTS

First, let’s revisit the leaked confidential document regarding the Infanrix Hexa vaccine information, which I revealed just days ago on VacTruth. I exposed a hidden GlaxoSmithKline document that had been leaked to the press, revealing 36 infant deaths. [3]

The document, titled Confidential To Regulatory Authorities Infanrix Hexa Summary Bridging Report [4] stated that between October 23, 2009, and October 22, 2011, GlaxoSmithKline received a total of 1,742 reports of adverse events, including 503 serious adverse events, after children had received the 6 in 1 vaccine, Infanrix Hexa.

(Infanrix Hexa is a 6-in-1 vaccination, which combines the Combined Diphtheria, Tetanus and Acellular Pertussis, Hepatitis B enhanced Inactivated Poliomyelitis and the Haemophilus influenzae type B vaccine. It is used in 92 countries worldwide.)

The GlaxoSmithKline confidential document detailed each and every one of the 1,742 adverse events. The list was so long, it required a full twenty pages. Here are some of the adverse events detailed on charts 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

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

However, if this information is not disturbing enough, in the document, GlaxoSmithKline revealed on page twenty a total of 68 cases of vaccination failure! This fact proves that, not only does their vaccine appear to cause death, injury and illness in multiple 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.

THE SECOND SET OF LEAKED DOCUMENTS

Now, let’s continue with the shocking new papers that the Belgian website Initiative Citoyeene have revealed. They stated:

“On the 4th of January this year, at the end of the required 6-week period, two Pfizer Group Regulatory Affairs Directors, Mary Allin and Helen Edwards, sent a response to Dr. S. Spinosa of the European Medicine Agency on the topic of ‘higher number of neurologic events reported in Italy following the coadministration of Pevenar 13 and hexavalent vaccines.’ The two directors specified at the end of this letter that based on data supplied, they did not feel there was any need to modify the vaccine’s reference safety information (RSI), in other words, its package insert.”

So, let’s take a closer look at one of the confidential reports that Initiative Citoyenne has been quoting. This confidential document reveals that over a two-year period, 22 deaths were reported, representing 2.6% of the total number of cases and a total of 51 reported cases of lack of efficacy, or vaccination failure! [4]

BRAIN DAMAGE AND DEATH

The next section relates to reports of neurological events.

The Master of Health Administration (MAH), was asked by the Committee for Medicinal Products for Human Use (CHMP), to provide a cumulative review of neurological reactions in those cases, which were reported to have received Prevenar 13 concomitantly (at the same time) with hexavalent (6-in-1) vaccine.

The MAH reported that during the two-year period between July 10, 2009, and July 9, 2011, a total of 1,691 cases of adverse events were reported after the Prevenar 13 vaccine. Of those adverse events, 312 cases (18%) were indicative of neurological reactions. [5] The 1,691 cases were then divided in three different datasets. The Initiative Citoyenne website explained the findings:

“An important fact is that Pfizer assessed the respective frequency of neurologic accidents in three different groups of children: those who had all received only the Prevenar 13 on the same day, those who had received both the Prevenar 13and other vaccines on the same day and those who had received both the Prevenar 13 and a hexavalent vaccine on the same day.

Of the 934 children who had only received the Prevenar 13 and experienced adverse effects, 87 displayed neurologic events (87/934 = 9%).

Of the 287 children who had received the Prevenar 13 plus other vaccines on the same day, and experienced adverse effects, 62 had had neurologic episodes (62/287 = 21%).

Of the 470 children who received the Prevenar 13 plus a hexavalent vaccine, on the same day, and reported adverse effects, 163 had experienced neurologic reactions (163/470 = 34%!!). It is therefore clear that the concomitant administration of several vaccines, particularly those recommended in the Belgian vaccine schedule (Prevenar 13 alongside Infanrix Hexa), multiplies the risk of neurologic reactions including serious and potentially irreversible adverse events!”

To describe the enormity of the situation, they further stated, in easy-to-understand terms:

“To grasp the extent of the problem, just remember that the Belgian annual birth rate is approximately 128,000, a very large majority of whom receive BOTH the Prevenar and the Infanrix Hexa. A simple calculation reveals therefore that the annual number of serious adverse effects, taking ONLY this vaccine into account, could be 3% x 128,000 births = 3,840 children!”

MORE REASONS TO AVOID THIS SIX-IN-ONE VACCINE

Interestingly, the Prevenar 13 leaflet mentioned earlier states reasons why your child should not be given Prevenar 13:

“Your child should not have Prevenar 13 if he or she has ever had an allergic reaction to pneumococcal or DIPTHERIA VACCINES, or any of the ingredients listed at the end of this leaflet.”

Despite this warning, the Prevenar 13 vaccine is often given at the same time the Infanrix Hexa vaccine, which includes a diptheria component! These vaccines are recommended from as early as six weeks of age, according to the leaflet, at which time a parent would not know whether their child was allergic to the diptheria component or not.

One Belgian child who lost her life as a consequence of being given several vaccinations in one visit, which included the Infanrix Hexa vaccine together with Prevenar, was Stacy Sirjacobs. Stacy was an eight week-old premature twin who died in December 2011. [6]

These vaccines were given to Stacy despite advice given by the European Medicines Agency in their ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS for Infanrix Hexa report which stated:

“When Infanrix Hexa is co-administered with Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of Infanrix Hexa alone.”
[7]

Furthermore, the document contained information about administering the vaccine to premature infants:

Limited data in 169 premature infants indicate that Infanrix Hexa can be given to premature children. However, a lower immune response may be observed and the level of clinical protection remains unknown.

The potential risk of apnea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.”

TROUBLING QUESTIONS

The European Medicines Agency offered warnings about administering the vaccine concomitantly with another vaccine and cautioned health care providers to consider the additional risks of vaccinating premature infants. Then why was little Stacy, a baby born one month prematurely, delivered by Caesarean section, resuscitated at birth, who spent the next four days in an incubator, given these vaccinations and then sent home without any extra advice?

Her death was a tragedy, yet babies are still dying and being neurologically damaged on a regular basis. The proof is in the manufacturer’s report in black and white. The drug companies know, the regulatory agencies know and worse still, our governments know.

Slowly, day-by-day, the depth of their corruption is being uncovered. Parents are not being told the truth, they are being deceived and lied to and the price they pay is extremely high.

CONCLUSION

These adverse events were being reported as far back as 2009.  So, why are these two vaccines still being recommended for babies as young as 6 weeks old? Surely, the most sensible and responsible action would be for the manufacturers GlaxoSmithKline and Pfizer to suspend the use of these vaccines until their use can be shown to be reliable, effective, and safe. Instead, this information is being hidden from the public.

Furthermore, the mainstream media is so quiet you could hear a pin drop. Dr. Rebecca Carley, an expert specializing vaccine-induced diseases syndromes, has often stated on her radio shows that vaccinations are the ‘True Weapons of Mass Destruction,” and the evidence contained in these leaked, confidential documents shows she could be right.

Acknowledgements

The author would like to thank the website Initiative Citoyenne for bravely revealing the truth.

The staff at VacTruth wishes to express their heartfelt condolences to the family of Stacy Sirjacobs and other families whose children have suffered injuries or death following vaccination.

References

  1. Initiative Citoyenne Press Release http://ddata.over-blog.com/3/27/09/71/2012-2013…
  2. Prevenar 13 leaflet Consumer Medical Information http://www.nps.org.au/__data/assets…
  3. http://vactruth.com/2012/12/16/36-infants-dead-after-vaccine/
  4. Confidential To Regulatory Authorities Infanrix TM hexa Summary Bridging Report http://ddata.over-blog.com/3/27/09/71/2012-2013/confid.pdf
  5. Prevenar 13 PSUR 04 – Response to RSI Neurological Events PFIZER CONFIDENTIAL Page 1 Prevenar 13 Pneumococcal saccharide conjugated vaccine, 13 valent adsorbed PSUR 04 – Response to Question on Neurological events http://ddata.over-blog.com/xxxyyy/3/27/09/71/2012-2013/emea-responses–Prevenar-13-Pfizer-Confidential.pdf
  6. http://vactruth.com/2012/01/19/baby-dies-after-first-shots/
  7. European Medicines Agency ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS for Infranrix Hexa http://www.ema.europa.eu/docs/en_GB/document_library

Australia Blames Fluvax for Children Convulsions

Australian Department of Health and Ageing reported that flu vaccination was “causally related” to fever and convulsions in 99 Australian children this year. Of those, 74 had no other possible cause.

New Scientist

Image: Reuters

As the northern hemisphere braces itself for the flu season, and for the first time the US recommends flu vaccination for everyone over 6 months of age, Australia has confirmed that its main seasonal flu vaccine, Fluvax, caused convulsions in 99 children, all of whom recovered. Fluvax is made by the Australian firm CSL.

Epidemiologists insist that the benefits of flu vaccines outweigh the risks, however, and are calling for better surveillance to pick up occasional problems faster.

Last March, Australia started vaccinating ahead of the southern hemisphere’s flu season. All the drug firms’ vaccines contained three killed strains of flu, one of which was last year’s pandemic strain, which persists as the dominant seasonal virus in Australia, North America and elsewhere.

In early April, reports came in of children with fever and convulsions following vaccination. On 22 April Australia suspended flu vaccination for children under 5. In late July, vaccination resumed with other makers’ vaccines, but not CSL’s Fluvax.

Fevers and convulsions

Last week the Australian Department of Health and Ageing reported that flu vaccination was “causally related” to fever and convulsions in 99 Australian children this year. Of those, 74 had no other possible cause, and Fluvax had been given to all 66 of those where the vaccine’s name was known, CSL says it is trying to identify the problem.

Fever is an occasional side effect in children given flu vaccines, and about 1.4 per 10,000 people vaccinated have seizures. High fever can cause seizures in 2 to 4 per cent of otherwise normal children 3 years and under, though no one is sure why. Fluvax caused seizures 50 times as often as would be expected with a vaccine.

In an analysis published in the journal Eurosurveillance, Heath Kelly, head of epidemiology at the state infectious diseases laboratory in Melbourne, calculates that Fluvax might have been worse than flu, causing two or three cases of convulsions for every case of flu it prevented that would have required a hospital stay during the pandemic.

Pandemic flu

But David Isaacs, professor of paediatric infectious diseases at the University of Sydney says the comparison is unfair. Children usually recover completely from fever-related seizures, though there can be brain damage in rare cases. By contrast, 1 per cent of children admitted to hospital with pandemic flu in Australia died.

Fluvax may well have prevented additional cases of convulsions caused by flu itself. In the biggest study so far of the neurological effects of the 2009 pandemic, Joshua Bonkowsky of the University of Utah reported last week that swine flu caused as many cases of neurological complications in five months as ordinary flu had in the previous four years. The most common were seizures. Moreover, the complications were more severe and lasting than ordinary flu. “Given how bad some of the complications from the H1N1 influenza were, we are really encouraging people to get vaccinated,” he says.

Kelly is also adamant about the need for vaccination. “The issue is not influenza vaccines in general, but one manufacturer’s vaccine in one year,” he says. “Such problems must be acknowledged rapidly on the rare occasions when they occur.”

Partly due to the scare, only 19 per cent of Australians were vaccinated this year. So far swine flu is known to have killed 16, including some with no previous health problems.