WHO, UNICEF deny Kenyan bishops' claim that they supplied sterility-causing tetanus vaccines

United Nations health officials have again rejected accusations by Kenya's bishops that Kenya's Ministry of Health used tetanus vaccines tainted with a sterility-inducing hormone in a large-scale immunization program in 2014.

The latest charges were made in a four-page statement released in Nairobi, Kenya, on Feb. 13 by Bishop Paul Kariuki Njiru of Embu, chairman of the Kenyan bishops' Catholic Health Commission. He said laboratory tests proved vaccines used in a program sponsored and funded by the World Health Organization and UNICEF were "poisoned with Beta HCG," which he said leads to miscarriages and sterility.

"When sterility is induced in any woman, without her knowledge and/or consent, it amounts to a monumental human rights abuse," he said in the statement.

James Elder, UNICEF spokesperson in Nairobi, rejected the most recent charges in a statement to NCR Feb. 26: "The vaccines supplied through UNICEF and WHO are safe. Recent independent testing supported by the Government of Kenya and the Kenya Conference of Catholic Bishops doctors confirmed this."

"The Government of Kenya has a strict monitoring system for the safety of life-saving commodities, including vaccines. WHO and UNICEF will continue to ensure that safe vaccines are available to all children in Kenya," Elder said.

"Incorrect and unsubstantiated assertions such as these put children and women at risk from vaccine-preventable diseases, which kill hundreds of thousands of children per year, including children here in Kenya," he said.

Kenya's Catholic bishops began questioning last year a nationwide campaign to inoculate women and girls of child-bearing age with tetanus vaccine.

Njiru reiterated the Kenyan bishops' claims last month, saying, "No further vaccination campaigns should be undertaken in this country without an all-inclusive sampling and testing exercise done before, during and after the vaccination campaign."

Before the vaccination program began in October, the Kenyan bishops' conference publicly questioned whether a tetanus crisis existed and said: "We are not convinced that the government has taken adequate responsibility to ensure that Tetanus Toxoid vaccine laced with Beta human chorionic gonadotropin sub unit is not being used by the sponsoring developing partners. This has previously been used by the same partners in Philippines, Nicaragua and Mexico to vaccinate women against future pregnancy."

The representatives in Kenya of WHO and UNICEF issued a statement Nov. 13 in which they expressed concern about "misinformation circulating in the media on the quality of the Tetanus Toxoid Vaccine. ... The grave allegations are not backed up by evidence, and risk negatively impacting national immunization programmes for children and women."

The representatives also questioned the test results on which the allegations seemed to be based. "WHO and UNICEF confirm that the vaccines are safe and are procured from a pre-qualified manufacturer. This safety is assured through a three-pronged global testing system and the vaccine has reached more than 130 million women with at least two doses in 52 countries," they said.

A Tetanus Toxoid vaccine was given to women of reproductive age during the March and October 2014 Tetanus Immunization Campaign of the Kenya Ministry of Health. According to the Centers for Disease Control and Protection, the vaccine prevents maternal and neonatal tetanus by inducing the mother to produce specific antitoxins that also protect the baby. As many as five doses are needed to protect a mother and her children during the reproductive years.

Human chorionic gonadotropin (HCG) is a naturally occurring hormone necessary to sustain pregnancy. The bishops said if the beta form of HCG is carried by a Tetanus Toxoid molecule and injected into a woman, it becomes an antigen that stimulates production of anti-HCG antibodies, which destroy the natural HCG. As a result, women will be unable to conceive "or will have repeated early miscarriages leading to sterility," they said.

The Kenyan bishops said their concerns about vaccine contamination were dismissed by the Ministry of Health. As a result, they commissioned laboratory testing that found beta HCG in the vaccine, despite conflicting assurances from Ministry of Health, they said.

To resolve the impasse, the Kenyan bishops' conference and Ministry of Health formed a joint commission, which submitted 59 vials of the vaccine from three locations to two laboratories in December 2014. Three of the vials were found to contain beta HCG. According to a signed Jan 10 statement released by the joint commission, those three vials were "submitted as open vials having previously been tested in other laboratories." A Jan. 23 lab report commissioned by the joint commission from AgriQuest indicated the three open vials that tested positive were provided by the Kenyan bishops' conference.

The joint statement also said, "All the other 56 vials tests were found to be negative for beta HCG, including those with batch numbers corresponding to the three vials that tested positive."

The joint statement concluded: "Routine tetanus immunization programme is safe. Mass immunization campaigns remain a useful public health intervention but quality assurance mechanisms should be applied at all times."

In a November 2014 statement, the CDC said: "There is not, and never was, HCG in any Tetanus Toxoid vaccine used for tetanus prevention" by UNICEF or WHO. Also, "because of the adjuvants and preservative contained in tetanus toxoid, it is unlikely that HCG could remain active in a vial of TT."

In their Feb. 13 statement, the Kenyan bishops again referred to Mexico, Nicaragua and the Philippines, where they said "tetanus vaccination campaigns sponsored and funded by WHO and UNICEF were found to be poisoned with Beta HCG."

This is an apparent reference to a longstanding rumor that the vaccine used in immunization programs has been contaminated by HCG to reduce women's fertility. The CDC traces the rumor to the 1994 publication of a report on a small clinical trial in India of a contraceptive vaccine made of HCG and Tetanus Toxoid. WHO was not connected to the trial. Further, the experimental vaccine used in the trial was created by the researchers for that study and was not related to the vaccine produced by commercial suppliers, the CDC said.

The CDC said the presence of HCG in Tetanus Toxoid tests conducted in Mexico and the Philippines in 1994 was clearly shown by subsequent lab tests to be below the limits of accuracy of the test kits used. Six independent labs in five countries ran tests on Tetanus Toxoid from seven different manufacturers, including those supplying the countries involved in the controversy. All the tests were negative for presence of HCG. Former Global Programme for Vaccines and Immunization director-general Jong-Wook Lee said in a July 1995 WHO statement that the rumors "are completely false and are totally without any scientific basis," the CDC said.

The Kenyan bishops' conference did not respond to a request for an interview. A representative of the Kenya Ministry of Health initially offered to secure an interview with the director of medical services but did not do so.

[Beth Griffin is a freelance journalist based in New York.]