Does the Kenyan UNICEF Tetanus Vaccine contain HCG and make women infertile?

This week alarming reports from the bishops of Kenya and as well as a Catholic medical association about a tetanus vaccine program broke across the Christian blogosphere.  Before saying anything else, I want to be extremely clear that if a known sterility inducing vaccine was administered to women without their knowledge or consent, whether as part of a clinical trial or as a population control measure, the human rights of the Kenyan people have been violated.  Such an action would be a monstrous sin against those living in poverty.  Further it would be, in the words of Confederation of Kenya Consumers (Cofek) Programme Officer David Kedode,  “unlawful, immoral and must be condemned. ”

That said, there are some reasons that I am very skeptical that what has been claimed by the bishops in Africa has happened, or even could happen.  Looking at the claims made, only a few options seem possible.

1.  Instead of a standard tetanus toxoid (TT) vaccine, an actual infertility vaccine was administered, rendering women infertile.  This would either be the result of a specific eugenics program or a clinical trial where informed consent was not obtained from the women in question.

2.  A tetanus toxoid vaccine that was contaminated with HCG was administered,  rendering women infertile but no one knew or cared whether the vaccines were contaminated.

3.  The test results that the bishops and doctors of Kenya are discussion are actually false positives, and there is no effect on fertility of the women who received these vaccines.

It is important to understand that this is not the first time these claims have been made.  The accusation that a tetanus vaccine was laced with HCG first appeared in the 1990s.  Countries such as the Philippines became suspicious of the vaccines being administered and had them tested.  These tests showed that the vials of tetanus toxoid had low levels, below 5 mIU-ml, of HCG present.  Anything below the 5 mIU-ml mark is not considered positive for HCG even if there is a quantitative level given that is not 0.  However, the testing methods used were the same methods that are used on a blood test to determine pregnancy.  Two preservatives in the tetanus vaccines can create essentially a very low level false positive, so low level that it falls below the 5 unit threshold that is necessary for a positive test result for HCG.

A report by Milestein recounts

“The vaccines were sent to hospital laboratories and tested using pregnancy test kits which are developed for use on serum and urine specimens, and are not appropriate for a vaccine such as TT (tetanus toxoid), which contains a special preservative (merthiolate) and an adjuvant (aluminum salt.)When the vaccines were tested in laboratories which used properly validated test systems, the results clearly showed that the vaccines did not contain hCG.  The results found in six laboratories in five countries on tetanus toxoid vaccines from seven manufacturers are available on request.  The low levels of HCG like activity seen in some samples were the result of false positive reactions.  In fact, in a laboratory in Hungary, it was shown that the sterile water supply from the local hospital gave a higher false positive level of HCG than did the TT vaccine.”

Part of the confusion on this point is that in the early 1990s, and even earlier than that in the 1970s, a scientist (who had no relationship or funding from the World Health Organization) was working on an anti-HCG vaccine that could be used to render a woman infertile.  In order to trick the woman’s body into recognizing HCG as something to attack, though, HCG needed to be linked to a different antigen that would act as a carrier of sorts.  So, Dr. Talwar in India created his vaccine by initially grafting HCG onto tetanus in the hope that the body would recognize tissue that gave off HCG (in this case, the placenta of a developing baby*) and make implantation either impossible or unsustainable.  His vaccine was successful in this goal, but it required a significant number of boosters whenever antibody levels dropped, as they inevitably did.

I’m going to pause for a moment to explain a bit more about the Talwar HCG vaccine.  This fertility vaccine is *not* made by simply pouring some HCG into a batch of the standard tetanus toxoid vaccine.  It’s not clear to me that even if HCG somehow managed to contaminate a tetanus toxoid vaccine that there would be any effect whatsoever, because the Talwar vaccine is a recombinant vaccine.  The tetanus toxoid and HCG in this vaccine are linked together, grafted onto each other.   In this vaccine, there are literally millions of units of HCG linked to tetanus toxoid.  In a response to this controversy, the WHO noted that “There is a situation where ant- β-HCG antibodies can be produced by the body and that can act as a contraceptive, however, this requires the administration of at-least 100 to 500 micrograms of HCG bound to tetanus vaccine (about 11,904,000 to 59,520,000 mIU/ml) of the same hormone where currently less than 1 mIU-ml has been reported from the lab results.”

I have seen the lab results from the tests performed at the request of the bishops in Kenya, and my understanding is that they will be published shortly in an online news source.  I will update and link to them when that happens.  The lab results are all within the same range as that found in the initial testing from the Philippines: all below 5 mIU/ml.  The precise numbers are 0.3, 1.2, 2.7, and <1 mIU/ml.  However, given that the Talwar vaccine would contain millions of times more HCG than the lab values in the Philippines suggested, I think it is fair to say that at minimum the vaccine used in the Philippines was not the Talwar contraceptive vaccine.  The testing done initially using the most readily available but less reliable methods on the Philippine samples yielded very low levels of HCG, too low to definitively meet the threshold of saying that HCG was present in the vaccine.  These equivocal results are potentially explained by a reaction between the preservatives in a standard tetanus toxoid vaccine and a serum/urine HCG test kit, but are too low to be considered a significant threat when compared to the millions of times higher quantities of HCG present in a true HCG vaccine.

Further complicating the issue?  The Talwar vaccine using HCG is about 20 years out of date, and Talwar has since moved on to using other vehicles to transport HCG.  In the story from the Kenyan newspaper The Standard linked above, Talwar states that “In our new vaccine, we have replaced tetanus toxoid by another carrier LTB, which would avoid the misinformation that has been associated with the valuable tetanus vaccination.” His more than 20 year old tetanus/HCG vaccine doesn’t appear to have ever even made it out of clinical trials.  Because his vaccine never made it out of clinical trials, this isn’t something anyone could access to execute a plan of mass sterilization of 2.3 million girls and women even if they wanted to.  You wouldn’t be able to get the kind of quantities needed to do this.  And if you did?  The Talwar vaccine is actually quite effective.  There should be a significant, obvious, conspicuous absence of expected pregnancies and births for the entire group of women who received the UNICEF vaccine, but no such report is being made.  For these reasons I do not think it is likely that the Talwar vaccine is being used in Kenya.

So, let’s go back to the environmental contamination theory wherein HCG could somehow contaminate tetanus toxoid vaccines and cause infertility.  HCG isn’t an ingredient that one would commonly find in a vaccine manufacturing plant.  It is medically produced (ironically for treatment of fertility issues) but the process of making vaccines is so stringent in terms of safety and testing requirements that the idea of a bunch of HCG accidentally getting mixed into millions of doses of vaccines is extraordinarily unlikely.  And if somehow it did happen, that is still HCG that is not linked through recombinant technology to the tetanus so it’s really uncertain that it would have any effect whatsoever, especially given that the actual amount of HCG required to induce antibody response against HCG is millions of times higher than what was found in the lab reports from Kenya. 

I still support the testing of these vaccines on the proper equipment in different countries done by independent laboratories to ensure that they are not tainted or altered in any way.  And I am glad to see reported that the bishops and the Kenyan government are jointly testing these vaccines to ensure that they are free from any contamination.  I do not think that any person should ever have to choose between being unprotected and using a vaccine that she is afraid may not be safe.  I can only imagine the fear of a woman who knows all too well the risks of maternal and neonatal tetanus but whose bishop raises the alarm that the vaccine she needs may serve as an inoculation against maternity.

But I do not see any reason to think that the results of testing done on the proper equipment with the right methodology will be any different from what was discovered 20 years ago when this same concern was raised.  There is virtually no way that the vaccine used in Kenya was the Talwar HCG vaccine, and it is also incredibly unlikely that HCG was somehow accidentally added to contaminate at a low level the standard tetanus vaccines being used.  I believe that the most likely scenario is that these vaccines were tested using instruments and methods that just aren’t equipped to determine environmental contamination as distinct from a very low level interaction between vaccine preservatives and an HCG test kit.  It is very understandable that seeing any HCG level detected in any vaccine would be concerning, especially given the way that the poor have historically been exploited in scientific research, but thankfully this seems likely to be a misunderstanding centered on false positive lab results not helped by a lack of transparency, collaboration and communication by the parties involved.

In the meanwhile, maternal and neonatal tetanus (MNT) as a threat is very real.  Maternal and neonatal tetanus is a disease of those who are born and give birth into poverty, a disease of birth contaminated by dirt and unsterile equipment.  It is a heartbreaking disease to witness (WARNING, that link has an image of a newborn with neonatal tetanus and it may be painful for anyone to look at.)  In the last year for which I could find numbers, fifty eight thousand children died of neonatal tetanus worldwide.  Fifty eight thousand, even more heartbreaking when considering that this constitutes a 93% reduction from the burden of neonatal tetanus in the late 1980s.  And these conditions are entirely possible to eliminate through the use of a primary series, and if a mother has had her entire five dose series she will be protected for life and all of her newborns will be protected at birth.

I stand with the bishops in supporting the immunization of all Kenyan women to prevent the threat of neonatal and maternal tetanus, using a safe and effective vaccine.  These mothers and their children deserve to live their already challenging lives with one less risk to worry about.

*  I was asked whether there could ever be a licit reason to even make an anti HCG vaccine several days ago, and the answer is yes.  Choriocarcinoma is just the most well known of several cancers that give off HCG.

UPDATE:

One of the labs which tested the tetanus vaccine has come out saying that they were never told that the sample they tested was pharmaceutical instead of a human sample and that the results detected a low level of “HCG like activity” which nonetheless is not HCG.