Vaccine injuries in Africa being covered-up

By CHRISTINA ENGLAND | VACTRUTH | FEBRUARY 14, 2013

Millions of children across Africa have been included in meningitis vaccine trials, many without parental consent. VacTruth recently revealed this information, resulting in many agencies desperately trying to cover up this travesty and the sacking of two leading heads of state.

Shortly after VacTruth published the first of three articles covering the MenAfriVac vaccine tragedy in which dozens of children were paralyzed, in Gouro, Chad, in northern Africa, the prime minister of Chad, Emmanuel Nadingar, was relieved of his duties and replaced by the former chief of cabinet, Djimrangar Dadnadji. According to an excellent article by the human rights organization Ecoterra International, this abrupt change in leadership was ordered by Chad’s president Idris Déby, a patron of the anti-meningitis campaign. [1]

BIG NAMES, BIG MISTAKE

On January 13, 2013, VacTruth published the second of the three articles. By this time, Chadian authorities had reported that a total of 38 children who were suffering from adverse reactions to the vaccine had been evacuated to hospitals in N’Djamena, Chad’s capital. [2]

A few weeks later, VacTruth was informed that the health minister of Chad, Mamouth Nahor N’Gawara, had also been relieved of his duties and replaced by Dr. Mahamat Ahmat Djidda. [3]

So, why the sudden changes in leadership? It may have had something to do with the fact that VacTruth had reported the conflicting views from involved organizations on whether or not the MenAfriVac vaccine could be used outside of the usual controlled temperature chain (CTC) of 2 – 8 °C.

The organizations involved with the promotion of the vaccine had stated that MenAfriVac was a vaccine specifically designed to meet the needs of Africa’s meningitis belt, which stretches across sub-Saharan Africa. These organizations stated that the vaccine could be kept in a controlled temperature chain (CTC) at temperatures of up to 40°C for up to four days without the need for ice packs or refrigeration.

The organizations involved in the promotion of this information were the CDC, FDA, BMGF, PATH, MVP, WHO and UNICEF. (For meanings of these acronyms, please refer to key at the end of this article.)

YOU WON’T BELIEVE WHAT HAPPENED NEXT

Of course this information would have been fantastic news for Africa, except for one vital point: at the time we published our articles, Serum Institute of India, the manufacturer of the vaccine, was promoting conflicting information. They had stated on their website:

“MenAfriVac should be stored and transported between 2-8ºC. Protect from light. The diluent should be stored at 25°C. It is recommended to protect the reconstituted vaccine from direct sunlight. Do not exceed the expiry date stated on the external packaging.

Here is a snapshot of the original page.

An archived snapshot of the vaccine manufacturer’s website show they changed information about the storage of the vaccine shortly after the children became paralyzed.

However, when this information was checked for verification last week, the recommendations for vaccine storage had mysteriously changed to the following statements:

“MenAfriVac should be stored and transported between 2-8ºC. Protect from light. The diluent should be stored at 25°C. It is recommended to protect the reconstituted vaccine from direct sunlight. Do not exceed the expiry date stated on the external packaging. Immediately prior to reconstitution the vaccine is stable and can be used when exposed up to 40ºC for period of 4 days provided the vaccine has not reached its expiry date and the vaccine vial monitor has not reached the discard point.” [4]

Why was this information suddenly changed, after the vaccine had already been stored and administered according to the previous guidelines? Was it because we reported that dozens of children were paralyzed and suffering other adverse reactions after receiving MenAfriVac? Was it because we reported that this vaccine was administered to third-world children before it was licensed?

In October 2012, WHO had stated:

“The session began with an introduction by Mr. Michel Zaffran, who highlighted the groundbreaking progress made with MenAfriVac®, which will be the first EPI vaccine licensed for use in a controlled temperature chain (CTC).

… This is the final review of the document by IPAC prior to the planned field testing during the MenAfriVac® campaign in Benin in November 2012, where one district will use the vaccine in a CTC. After the field testing has been conducted, the revised final guidance document will come back to IPAC for endorsement in 2013.” [5]

The reasons why the manufacturer suddenly changed their recommendations for storage and transport remain a mystery. However, this new controversy still does not take away the fact that MenAfriVac was not licensed to travel in a CTC of temperatures of up to 40°C at the time the children of Gouro were vaccinated.

THIS DOESN’T MAKE SENSE!

What exactly is a controlled temperature chain? If these vaccines do not need refrigeration or ice packs for up to four days, how does the word “controlled” come into the process? Surely, without ice packs or refrigeration, there is no controlled temperature chain.

MenAfriVac is an inactivated vaccine (a vaccine which does not use a live virus). Previously, according to the CDC guidelines for vaccine temperature and storage, inactivated vaccines needed refrigerator storage at temperatures between 35°F and 46°F (2°C to 8°C), with a desired average temperature of 40°F (5°C). (Note, that is 40°F not 40°C.) [6]

So, what makes the MenAfriVac vaccine so different from other vaccines, that it does not require refrigeration for up to four days?

Another important point to consider is the fact that temperatures across Africa can exceed 40°C. According to the website Weather Spark, the average weather for N’Djamena, Chad varies between 15°C and 41°C. Their temperatures are rarely below 12°C or above 44°C. This means that outdoor temperatures can reach 44°C in a typical year. [7] In fact, in June 2010, temperatures in Chad reached an all-time high of 47.6°C. [8]

MORE UNANSWERED QUESTIONS

This information leads me to ask the following questions:

If the outdoor temperatures can reach 44°C in a typical year and the MenAfriVac vaccine is traveling inside a vehicle which may not have air-conditioning, in a container without ice packs or refrigeration, then how do the vaccinators know the true temperature the vaccine has reached at any given time?

If the truck carrying the vaccines is traveling across Africa at the time that the outdoor temperatures rise above 40°C, does the team return to base and scrap that particular batch of vaccines?

Can both the vaccine and the diluents be kept at the same temperature?

I ask the third question because it is usual for the vaccine and the diluents to be kept at different temperatures in accordance with recommendations from the manufacturer and the CDC.

ANOTHER SUSPICIOUS TRIAL

Another interesting point to consider is this: at the time the MenAfriVac vaccine was being administered to the children in Gouro, it was being tested to see whether or not it was safe to be administered to children in temperatures of up to 40°C. Therefore, it is odd that the vaccinators chose to vaccinate the children at the time of year when temperatures are usually below 30°C.

The children of Gouro were not the only children being used in clinical trials for the MenAfriVac vaccine. Babies between the ages of 14 –18 weeks were also being used for clinical trials in Ghana.

According to the Meningitis Vaccine Project (MVP), a MenAfriVac phase 2 clinical trial was carried out in Ghana, testing the vaccine for use in the under-one age group. The trial was carried out over a four-year period from November 2008 to November 2012 at the Navrongo Health Research Center, Navrongo, Ghana. A total of 1,200 infants took part in the trial, aged between 14 to 18 weeks on enrollment. MVP stated:

“Study results: Preliminary results show that the vaccine is safe and highly immunogenic. Final results will be presented in a forthcoming scientific publication.” [9]

The MVP News Digest reported the following:

“Research to document an indication for MenAfriVac™ use in infancy (in under 1-year-olds) is progressing well and according to schedule. A database lock for PsA-TT-004 was completed on December 21. PsA-TT-004 is a Phase 2 study that evaluates the safety and immunogenicity of different dosages and schedules of the MenA conjugate vaccine in 1,200 healthy infants when administered concomitantly with EPI vaccines. The study is conducted at the Navrongo Health Research Centre in Ghana and is scheduled for completion in early 2013.” [10]

On February 4, 2013, Spy News Ghana stated that the research findings show that MenAfriVac is safe and can be given to children under one year old, providing long-term protection from Group-A meningococcal meningitis in this age group. [11]

CONCLUSION

Today, the latest news from Gouro is that 40 children remain paralyzed in hospitals in both Chad and Tunisia, and a further 56 remain ill in the village of Gouro. However, news from Ecoterra International on February 9, 2013, said that the new heath minister wants to send them back home to their ill-equipped village. [12]

Until our intervention, there had been no publicity about the serious vaccine injuries in Chad. However, since our articles were published, there has been a flurry of worldwide media attention, including an extremely biased report in the Guardian UK telling the world that MenAfriVac is a wonderful vaccine. Mind you, to be fair, as you will see from the article, The Bill and Melinda Gates Foundation, a well-known supporter of vaccination initiatives, funded this section of the Guardian. [13]

The whole debacle is one coverup after another. The Chadian government has not asked any independent experts to evaluate the safety and efficacy of the MenAfriVac campaign, stirring up anger among the citizens of Chad. They have been left to cope with extremely sick children, many of whom are still reported to be paralyzed and suffering from severe convulsions. The children need appropriate medical care and their parents deserve answers.

Key

CDC – Centers for Disease Control
FDA – Food and Drug Administration
BMGF – The Bill and Melinda Gates Foundation
PATH – Program for Appropriate Technology in Health
MVP – Meningitis Vaccine Project
WHO – World Health Organization
UNICEF – United Nations International Children’s Emergency Funding

References

1.  http://www.tolerance.ca/Article.aspx?ID=157421&L=en
2.  http://www.sante-tchad.org/Renforcer-les-ressources-humaines-en…
3.  http://vactruth.com/2013/01/13/children-paralyzed-by-vaccine/
4.  http://www.seruminstitute.com/content/products/product_menafrivac.htm
5.  http://www.who.int/immunization_delivery/systems_policy/IPAC_2012_October_report.pdf
6.  http://www.cdc.gov/vaccines/pubs/pinkbook/vac-storage.html#temperatures
7.  http://weatherspark.com/averages/29142/N-Djamena-Chari-Baguirmi-Chad
8.  http://www.treehugger.com/clean-technology/9-countries-have-recorded…
9.  http://www.meningvax.org/clinical-004.php
10. http://www.meningvax.org/files/MVPnewsdigest_2010_Q4_27_EN.pdf
11. http://www.spyghana.com/research-shows-that-new-meningitis-vaccine-is-safe-for-children/
12. http://www.groundreport.com/World/Do-to-them-what-they-are-doing-to-you/2951229
13. http://www.guardian.co.uk/global-development/2013/feb/04/aid-vaccines…

Vasculitis and Vaccines: A Parent’s Primer

By NORMA ERICKSON | SANEVAX | OCTOBER 15, 2012

What is vasculitis?

Vasculitis is considered a rare group of disorders caused by inflammation of blood vessels. It is a condition which is easy to miss, or misdiagnose, because inflammation of blood vessels is capable of causing a wide range of symptoms which can be vague, generalized and/or non-specific depending upon whether veins or arteries are affected, where these blood vessels are located, how wide-spread the inflammation is, and the degree to which the blood flow is restricted in the affected area.[1] [2]

How vasculitis presents itself depends upon which tissues, organs or systems are affected, and to which degree they are affected by the impaired blood flow resulting from inflammation.

For example:

  • CNS (central nervous system) vasculitis[3] may cause headaches, confusion, changes in personality, seizures, vision problems, tingling, loss of feeling, weakness, paralysis or other neurological problems including permanent disability.
  • Churg-Strauss vasculitis[4] can have symptoms similar to asthma because of lung involvement. Can include shortness of breath, wheezing, chest pain, and coughing up blood.
  • Henoch-Schönlein purpura[5] can present as small raised purple areas under the skin (purpura) due to hemorrhage, abdominal pain, nausea, vomiting, joint pain, or blood in the urine (hematuria) because of its systemic involvement.
  • Temporal arteritis[6] can cause headache and tender thick blood vessels on the side of the forehead. Can also cause fatigue, loss of appetite (then weight), fever, heavy sweating, fever, joint and muscle pain.
  • Cutaneous vasculitis[7] may cause petechiae (small red dots), purpura, urticaria (hives), bruising, or ulcers of the skin.

The symptoms listed above are by no means an exhaustive list, but it does give you some idea of the various possible manifestations and how easily vasculitis can be mistaken for a multitude of other disorders.

What does vasculitis have to do with vaccines?

If you do a simple Google search for ‘vasculitis and vaccines,’ you will see over 500,000 results. Consider the following quotes from a few of the scientific articles referenced:

  • “A      14-year-old boy who had no relevant previous history and who was not      taking any drugs presented with a livedo reticularis (mottling of the      skin), fever, loss of weight, testicular pain, and paresthesias two months      after receiving the third dose of a hepatitis B vaccination. Inflammatory      parameters (ESR and CRP) were high. The patient met the ACR diagnostic      criteria for polyarteritis nodosa.”[8]      [9]
  • “Here      we describe 4 cases of new onset or relapsing antineutrophil cytoplasmic      antibodies associated vasculitis occurring in timely association with      influenza vaccination. In the literature different subtypes of vasculitis      have been repeatedly reported after influenza vaccination.”[10]
  • “…anecdotal      cases continue to be reported of autoimmune phenomena following influenza      vaccination, including SLE, RA, pericarditis and various forms of      vasculitis.”[11]
  • “Giant      cell arteritis (GCA) and polymyalgia rheumatica (PMR) are inflammatory      rheumatic diseases common in people over the age of 50 years. Herein, we      report 10 cases of previously healthy subjects who developed GCA/PMR      within 3 months of influenza vaccination (Inf-V). A Medline search      uncovered additional 11 isolated cases of GCA/PMR occurring after Inf-V.”[12]
  • “We      describe here a case of Henoch-Schönlein purpura (HSP) that occurred 10      days after administration of the meningococcal      polysaccharide vaccine and came to the attention of      a Vaccine Safety Datalink (VSD) investigator (but did not occur      in the VSD cohort). Periodic case reports have      linked vaccines to HSP.”[13]
  • “The      aim of this study was to characterize the adverse events of attenuated      measles vaccine in mainland China. …28 cases of Henoch-Schonlein      purpura (HSP) were reported.”[14]
  • “We      report the original case of cutaneous periarteritis nodosa that occurred      one month following vaccination against hepatitis B.”[15]
  • “We      report a case of biopsy proven vasculitis, presenting as mononeuritis      multiplex, following influenza vaccination. The clinical picture evolved      rapidly into a syndrome indistinguishable from axonal Guillain-Barré      syndrome. This suggests a differential diagnosis for post-vaccination      neuropathy, with implications for management. We believe this is the first      report in which there was an associated peripheral neuropathy at      presentation. It raises issues about the aetiology and pathogenesis of      vaccination associated neuropathy.”[16]

It is important to note that none of these studies have identified a direct causal relationship between the vaccine administered and the outcomes observed. Each one, however, exhibits a strong temporal association between the vaccine and the outcome. This means that the observed adverse events occurred within a time-frame where it is reasonable to consider the event was potentially caused by the vaccine.

In general, disorders caused by vasculitis are serious and need to be evaluated promptly. The problem is they may be difficult (even for doctors) to recognize because of the significant overlap of signs and symptoms with other more common conditions.

According to Dr. Yehuda Shoenfeld:[17] [18]

“Vaccination can have adverse autoimmune effects and may even trigger full-blown autoimmune disorders. At the moment, it is not possible to identify who is most prone to develop these side effects or disorders after immunization. Further research is needed to identify these individuals.”

The SaneVax Team could not agree more. More research does need to be done in the area of vaccine injuries – who is susceptible and why?

What do parents do while waiting for the research? 

Every time someone in your family receives a vaccination, have the person administering the vaccine record the name of the vaccine, the lot number and the expiration date. Keep a copy for your records.

Keep a journal of every new medical condition experienced after vaccination. Do not worry about whether or not you think it may be related to the vaccination – that is up to the experts to try and determine. The point is your written record may prove invaluable should you or your child actually be the victim of an adverse reaction to a vaccine.

Talk to your doctor if you suspect vasculitis or any other adverse reaction. Keep in mind that since adverse reactions to vaccines are considered rare, most physicians are not trained to recognize them. You may have to back up any concerns with your own research. Should you need to do this, stick to published scientific articles and studies. Medical professionals will not consider other sources credible.

If you and your doctor disagree, consider obtaining a second opinion. You have every right to do so.

Learn how vasculitis is typically diagnosed:

In general, disorders caused by vasculitis are serious and need to be evaluated promptly. The problem is they may be difficult for even doctors to recognize because of the significant overlap of signs and symptoms with other more commonly encountered disorders.

The diagnosis of any type of vasculitis involves tests to demonstrate the presence of a strong inflammatory process. Tests which reveal inflammation throughout the body include erythrocyte sedimentation rate, blood tests to reveal anemia/increased white blood cells, or tests to demonstrate the presence of immune complexes and/or antibodies circulating in the blood. An x-ray procedure called angiography can sometimes be used or biopsies taken from affected organs to demonstrate inflammation.[19]