The details of a vaccine campaign disaster that occurred last month in a north African country continue to unfold, while headlines of this tragedy are strangely absent from news organizations around the world. VacTruth shared the story last week with the world in an exclusive report, and we have additional updates to share with you about the plight these families are now facing.
On January 6, 2013, I wrote an article entitled Minimum of 40 Children Paralyzed After New Meningitis Vaccine describing how at least 40 children in Gouro, Chad, located in northern Africa, became paralyzed after they had received the meningitis A vaccine, MenAfrivac. 
Further research about the Meningitis Vaccine Project shows the effort was a massive collaboration among major organizations. The vaccine, developed by the India Serum Institute, was funded by The Bill and Melinda Gates Foundation, in partnership with WHO and PATH, specifically to combat meningitis in Africa. We wonder why none of these groups are offering a statement about this devastating event.
A TIMELINE OF DISTURBING EVENTS
On January 8, 2013, Mr. M., who wishes to remain anonymous, managed to leak television footage from the local television station TeleTchad, showing the Prime Minister of Chad, Emmanuel Nadingar, making an impromptu visit to one of two hospitals accommodating the sick children in hopes of reassuring parents and children. 
On January 9, 2013, a full-page article was published by La Voix, entitled The Fate of the Paralyzed Children is Worrying. La Voix, a print-only publication, reported that one parent, speaking from the bedside of her sick son, told reporters that some time after receiving the vaccination, three of the children became ill and their health became increasingly disturbing.
Another citizen told the newspaper, “It took three to four people just to stabilize the children. Panicked by the turn of events, the team took to their heels.”
On January 10, 2013, an article was published by the Journal Du Chad titled Chad: A Vaccine Against Meningitis Caused Casualties, reporting that fifty children aged between 1 and 29 years were admitted to two hospitals, the Hospital of the Mother and Child and the General Hospital National Reference. 
Bemadji Benoit, journalist for the Journal Du Tchad, wrote that on day one of the vaccination program, three of the children were said to have become ill, suffering from convulsions, vomiting, headaches, and diarrhea. Their conditions were described as critical. Worried by what had happened to their children, parents reported that they had tried to alert the vaccinators but said that the team continued with the vaccination program.
WHAT WENT WRONG?
By watching this video, you will have learned that the following organizations were involved with the MenAfriVac vaccination project:
- 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 Fund
So, let us examine what information some of these organizations have shared about this vaccine. Most of them make statements that contradict recommendations from the manufacturer of MenAfriVac.
The CDC provided a statement about the new meningitis vaccine on their website:
“The ‘Meningitis Belt’ in Africa includes 26 of the world’s poorest countries. Frequent outbreaks and sporadic explosive epidemics result in tens of thousands of meningitis cases. Elimination of this disease could reduce morbidity and mortality, disabilities, and countries’ health expenditures.
CDC’s work in meningitis prevention spans several decades and was important in establishing the burden of disease that contributed to the investment case for development of and the mass campaigns that first introduced MenAfriVac™ in Burkina Faso in 2010. This meningococcal A conjugate vaccine was developed specifically to combat epidemic meningitis in sub-Saharan Africa by a consortium of partners including CDC, PATH, WHO, FDA, the Health Protection Agency and the National Institute for Biological Standards and Control, with funding from the Bill & Melinda Gates Foundation.” 
THE MENINGITIS VACCINE PROJECT
According to the Meningitis Vaccine Project, the MenArfriVac vaccine was specifically designed to meet the needs of Africa’s Meningitis Belt because the vaccine can be transported and stored for as long as four days without refrigeration or icepacks. 
The World Health Organization repeated similar information on their website, clearly stating:
“The meningitis A vaccine known as MenAfriVac®, created to meet the needs of Africa’s meningitis belt, can now be kept in a controlled temperature chain (CTC) at temperatures of up to 40°C for up to four days.” 
THE BILL AND MELINDA GATES FOUNDATION
And The Bill and Melinda Gates Foundation, which funded the project, also gave similar information:
“Banikoara is home to the world’s first controlled temperature chain (CTC ) campaign. MenAfriVac, a vaccine produced by Serum Institute of India through the Bill & Melinda Gates-funded Meningitis Vaccine Project a partnership between WHO and PATH, is the first vaccine to be prequalified by WHO for use at ambient temperatures of up to 40°C for up to four days.” 
On its website, PATH, a nonprofit global health organization, emphasized the importance of partnerships in the development of MenAfrivac, praising the role of the U.S. government for making the vaccine a reality. The US government assisted with the campaign by offering funding, improving surveillance of the disease, addressing regulatory issues, providing technical expertise to India Serum, developing the conjugation method used in the vaccine, facilitating licensure of U.S.-based intellectual property, and testing the immune response of clinical trial participants. 
UNICEF, another major organization involved with the vaccination program, stated on their website:
“On October 31, 2012, MenAfriVac® received approval to be kept outside the cold chain for up to four days at up to 40°C, in a controlled temperature chain (CTC). MenAfriVac® is the first vaccine intended for use in Africa approved for this type of use, potentially setting a regulatory path that other heat-stable vaccines can follow.” 
WHAT THE MANUFACTURER SAID
However, in 2010, the manufacturer of MenAfriVac, Serum Institute of India, stated completely different information:
“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.” 
These words from Serum Institute lead us to ask the vital question, Can MenAfriVac be stored outside the cold chain?
WAS THIS VACCINE PROPERLY LICENSED?
In April 2012, OPTIMIZE Immunization Systems and Technologies for Tomorrow shared additional information about the MenAfriVac vaccine in a document authored by two individuals from PATH and one individual from WHO. The document, entitled MenAfriVac™ Planned for Use in a Controlled Temperature Chain, contained key evidence about the lack of appropriate licensure for this vaccine to be used outside of the cold chain:
“Unpublished data obtained from the vaccine manufacturer show that MenAfriVac has proven stable at temperatures of 40°C for limited periods of time. This indicates that the vaccine could be safely distributed outside of the 2°C to 8°C range for a specific period under controlled conditions during campaign activities. The data are currently being reviewed and Serum Institute of India plans to formally submit the request for a MenAfriVac license variation within the next few months.” 
So, was a revised license ever granted for the use of MenAfriVac?
Apparently not. According to the report of a meeting which took place in October 2012 between the World Health Organization’s Immunizations, Vaccines and Biologicals group and the Immunization Practices Advisory Committee (IPAC), the vaccine would not be endorsed until 2013, at the earliest:
“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.” 
As the days turn into weeks, the paralyzed children continue to lie in their hospital beds, immobile and frightened. Their parents feel confused and worried about their children’s future health. These families deserve an explanation of how this tragedy was allowed to happen and reassurance for their new future.
This project was organized and paid for by the leading organizations governing vaccines today, groups with millions of dollars available to make sure vaccines are as safe as possible. Why did these groups ignore the advice of the India Serum Institute, which stated that their product must be stored within a specific cold temperature range? Why have none of these organizations issued a statement about what happened to these paralyzed children? Who is going to explain how the vaccines were stored and transported? What is the African government going to do to help the children and parents at the heart of this vaccination disaster? How many children must be injured before the use of the MenAfriVac vaccine is suspended?