On Jan 14, the Kenya Conference of Catholic Bishops issued a statement reiterating their opposition to a WHO/UNICEF sponsored mass vaccination effort aimed at reducing maternal and neonatal tetanus. Their claim is that the vaccine is laced with Human Chorionic Gonadotropin and will result in permanent infertility in vaccinated women. They also state that the same was done in Mexico, Nicaragua, and the Philippines, also under WHO sponsorship. Their fears were triggered by reports of a group called the Kenyan Catholic Doctors association, who boldly stated:
This proved right our worst fears; that this WHO/UNICEF campaign is not about eradicating neonatal tetanus but is a well-coordinated, forceful, population control, mass sterilization exercise using a proven fertility regulating vaccine.
Well, let's unpack this.
Maternal and neonatal tetanus is most common among women who deliver their babies in unsterile conditions and/or with poorly trained assistants. While more than 90% of Kenyan women receive prenatal health care, fewer than half deliver their babies in a hospital. In 2013, Kenya abolished hospital fees for delivery in an effort to address the nation's rising maternal death rate. At least at first, this initiative didn't seem to have much impact.
WHO and UNICEF have targeted maternal and neonatal tetanus (MNT) and are making strides. WHO estimates a neonatal death toll of 49,000 in 2013, down from an estimated 787,000 in 1988. The original aim was to eliminate MNT through assiduous vaccination of women of child-bearing age and having women give birth in hygienic conditions, with target dates for elimination postponed and postponed, currently set at 2015. Currently 24 nations still struggle with MNT, among them Kenya. (Of course, as with all medical access questions, it is the poor who suffer most.)
The MNT tetanus vaccine protocol is different from the usual approach. WHO says:
For women who have never received TT vaccine, or have no documentation of such immunization, a total of five properly-spaced doses is recommended: 2 doses given one month apart in the first pregnancy, the 3rd dose is given at-least 6 months later, then 1 dose in each subsequent pregnancy (or intervals of at least 1 year), to a total of five doses.
(Readers may recall that children are commonly vaccinated with multi-injection series of tetanus with diptheria and whooping cough vaccines, and sometimes others as well. Adult tetanus shots are boosters of this childhood series.)
The bishops first raised their alarm last year. Among their claims is that WHO/UNICEF had a secret agenda to sterilize Kenyan women, just as they had perpetrated mass sterilizations of women in the Philippines, Nicaragua, and Mexico. They complained that they had not been adequately involved and that there was inadequate publicity of the program. They concluded with questions:
Is there a tetanus crisis in Kenya? If this is so, why has it not been declared?
Why does the campaign target women of 14 – 49 years?
Why has the campaign left out young girls, boys and men even if they are all prone to tetanus?
In the midst of so many life threatening diseases in Kenya, why has tetanus been prioritized?
All of their questions reveal a fundamental misunderstanding of the WHO/UNICEF endeavor. Nonetheless, the bishops demanded testing that would prove that the vaccine was not laced with HCG and lead to permanent sterility. WHO responded to all the bishops' concerns here.
Can HCG sterilize people? Not really. There is a injectable contraceptive that was developed using HCG. In fact, here's the likely source of the confusion: HCG on its own does not stimulate an immune response. In order to get the body to develop antibodies, the contraceptive researchers linked it to--you guessed it--tetanus toxoid. Thus the resultant contraceptive would have the happy side-effect of protecting women from tetanus. That was in 1992: subsequent versions of the contraceptive use a different carrier, not tetanus at all. It is, to be sure, a contraceptive, NOT a sterilizing agent. The contraceptive was found to be safe, effective and reversible. Continuing low antibody levels were demonstrated NOT to interfere with normal pregnancy. The contraceptive may prove useful in treating other disease conditions such as certain cancers as well.
But the bishops claim they found HCG in the vaccine! First, it's important to recognize that many lab tests have a level of "noise." That is, what's reported as a positive may in fact represent a cross-reaction with another chemical or chemicals. Second, the level of HCG is important. The WHO response notes that in order to provoke a contraceptive immune response, at least 100-500 micrograms of HCG bound to tetanus is required. That is 11,904,000 to 59,520,000 mlU/ml. Lab tests claiming "positive" for hcg are less than 5. Even if it were deliberate contamination, it wouldn't work. The current Kenyan restatement only reiterates that it found "positives" and notes the methodology, not the results, the results of controls, or what happens when tests on "positive" vaccine are repeated at other labs. They had stated last November that their lab results showed that ALL the vaccine was "laced" with hcg, and in their current statement that 3 of their 9 vials tested positive, and that testing another 50--all negative--was done to cover up the contaminated 3. No data are offered.
Further, MaterCare International, an international group of Catholic obstetricians and gynecologists, affirm that the results of all lab tests indicate only trace positives, nothing like the level needed to work even as a contraceptive. They note the nearly parallel baseless outcry in the 1990's in the Philippines, Nicaragua, Mexico, Peru, and Tanzania. They note also that if there had been such massive sterilization programs in other nations, surely by now someone would have noticed. Vaccinated mothers in all those countries continued to have babies.
Here's another account of the damage done by false and misleading information in the 1990's.
A few comments on this sad situation:
1. All credible evidence so far points to a situation in which Kenyan bishops have been misled by a group making baseless and irresponsible claims regarding an international effort to eliminate MNT.
2. In the face of responses by WHO and the Kenyan Ministry of Health, the bishops continue their campaign to keep Kenyan mothers and children away from vaccines that could save their lives.
3. Even if data about the level of HCG needed to be a contraceptive failed to convince them, common sense alone might have led them to investigate further the claims of mass sterilizations by tetanus vaccine in other nations. Surely someone would have noticed!
4. The extreme rightwing Catholic blogosphere plays its part in all this, too, parroting disproven claims without investigation.
5. To be sure, historical abuses of Africans (and others!) by drug companies and even international health groups play a role here--mistrust is understandable. But in this case it seems quite clearly to be misplaced.
6. Along the same lines, ensuring informed consent from women in programs actually aimed at sterilization is difficult, as is making sure they aren't swayed by financial inducements to undergo procedures they do not understand. This is an important matter of fundamental human rights. But this is NOT the case in this tetanus vaccine program.
7. There's a further difficult issue of medical communication--how is a program like the anti-MNT program presented? This would open the door to a host of questions involving medicine and culture, except that here is is WHO AND the Kenyan Ministry of Health vs. the Catholic bishops, not the Kenyans vs. the western medical establishment.
8. My thoughts and prayers are with the mothers, mostly poor women and their babies. They will continue to die from an easily preventable disease, one which international health care organizations stand ready to help.
9. And the bishops? When they get all the extra and unnecessary data they require to be convinced of the safety of the vaccine, how many preventable deaths will have occurred from their failure to do due diligence? Will they feel accountable? Will they notice?