'Red flags' in Kenyan vaccine controversy demand answers

Nairobi, Kenya, Nov 13, 2014 / 13:15 pm

Organizers in charge of a controversial vaccination campaign in Kenya should be transparent and cooperate with the Kenyan bishops' request for investigation of the program, says a leading Catholic bioethicist.

"There are aspects of this that need to be raising red flags because of history and because of the way it was all being done. But raising red flags doesn't mean that there's something that actually has occurred," said Dr. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University.

"The way you prove that's not the case is by not being arrogant, but responding to it and being transparent."

Kenyan bishops have alleged that a vaccination campaign focused on eliminating neonatal tetanus, a deadly infection that infants can contract through birth in unsanitary conditions, may be a surreptitious sterilization campaign.

They say that the vaccine serum used in the campaign, sanctioned by the  Kenyan government and promoted by the World Health Organization and the United Nations Children's Fund, contains an element that can act as a contraceptive vaccine. This presence, coupled with a lack of cooperation from the sponsoring organizations and the targeting of the campaign to women of child-bearing age, makes the program problematic, the bishops have said.

The WHO and UNICEF deny that the vaccination campaign is a secret sterilization program, saying they are focused on eliminating a deadly disease. "These allegations are not backed up by evidence, and risk negatively impacting national immunizations programs for children and women," they say.

The controversy centers around a specific hormone, beta-human chorionic gonadotropin (beta-hCG), which plays a role in both normal human reproduction and pregnancy. However, when given at high doses along with a triggering agent, the human body can treat the hormone as a harmful substance – priming the body's response against the hormone and resulting in infertility and miscarriage.

This function of high doses fertility hormones has been used to create a temporary contraceptive vaccine in animals, used for population maintenance of animal populations in both zoos and in the wild. The success of this kind of vaccine has lead to the investigation of the use of beta-hCG in human contraceptive vaccines, though no studies have moved past stage II clinical trials. Thus, a contraceptive vaccine has not been approved for human use. Vaccines using hCG have also been investigated in the treatment of certain kinds of cancer.

Bishop Dominic Kimengich of Lodwar told CNA Nov. 12 that he and his fellow bishops were concerned because the campaign was "targeting women from the age of 15 to 49," or childbearing age, as well as their concern that the Catholic Health Commission in Kenya "had not been informed of this campaign."

They raised their concerns, along with concerns over allegations surrounding a similar campaign in the 1990s, to the Kenyan government, which "refused to cooperate in the matter" Bishop Kimengich said. The government even refused a "call for joint testing."

"All along the Bishops wanted that this vaccine be tested jointly so as to remove any suspicion" he said.

After this rejection, the "Catholic Health Commission went ahead to test the tetanus vaccine sending it to four unrelated laboratories in Kenya and one in South Africa."

"All the tests showed that indeed the tetanus vaccine was laced with the Beta HCG hormone," they said.They alleged that along with the otherwise "normal tetanus vaccine" was " laced with the hormone for the purposes of population control," Bishop Kimengich said.

The bishops raised their initial concerns in a Nov. 6 statement on government corruption "in all sectors of society" and its impact on Kenya.

While  copies of the lab results obtained by CNA do show positive test results for the presence of the beta-hCG, reference levels given on the lab reports show that levels present in the vaccines are within "normal values" for healthy men and women.

If organizations were launching a secret sterilization campaign, this would violate international law under the Rome Statute, which states that  "enforced sterilisation" is a crime against humanity.

Additionally, the program, should the bishops' allegations be true, may violate a clause prohibiting the persecution of "any identifiable group or collectivity on political, racial, national, ethnic, cultural, religious, gender…or other grounds that are universally recognized as impermissible under international law" due to the program's limitation to only 59 regions.

At the time of publication, neither the WHO's Kenyan office nor UNICEF responded to CNA's request for comment. The North American regional office for the WHO directed responses to the Kenyan office.

However, an internal WHO memo obtained by CNA explains the international health organization's reasons for conducting the vaccination program as it has, and questions the lab results given to the bishops.

The WHO said that they decided to focus the vaccination campaign on women of reproductive age "because of the focus on eliminating maternal and neonatal tetanus." They also said that the methods needed to provide adequate protection against tetanus for unborn and newborn children require a different testing schedule than the one usually used for other forms of tetanus.

The WHO also raised concerns over the methods used by the labs. They noted that while there "is a situation where ant- β-HCG antibodies can be produced by the body and that can act as a contraceptive," the levels reported in the independent labs' results are millions of times less than the amount needed to trigger this contraceptive response.

They also enumerated a list of concerns and observations on the lab results, including a lack of a control reference, blurred-out sections of the results, and their agreement with one of the lab technicians that the results do not " implicate anything that contravenes the use" of the vaccine.

The WHO suggested that the bishops "share the review with government officials to allow them deal locally with the situation," and that the government work with the Church "right from the beginning of any similar future immunization activities."
 
The Kenyan government has responded to the claims by forming a committee to investigate the vaccine, and has said they will consult Church officials during the investigation. "This is medical science but we want to make sure that we bring all stakeholders on board and move as a united front," said Kenyan Health Cabinet Secretary James Macharia in a statement.

Donovan expressed concern at "some discrepancies" in the conduction of the vaccination program, as well as in the lab results.

"The levels that I just saw are extremely low levels," he said, indicating that they were within normal ranges for healthy, fertile women and men. However, he continued, even the low levels of hCG hormones in the vaccines are still concerning. "The problem would be there should be no hCG."

He explained that there may be other explanations besides tampering that could lead to these positive results.

"If these were labs that were using tips to test for pregnancy and such, they may not be the appropriate measuring techniques for picking up small amounts of hCG, leading to false positives."

"I suspect that the tests that the hospital labs tried to do for the Catholic bishops weren't really designed to test the way that they did, maybe giving them erroneous results," he added.

However, he said, citizens should not accept the government's explanation that the samples were contaminated.

"I think that what really needs to be done is immediate testing of the vaccines that are being used by independent labs that can test and prove that there is no hCG in them at all."

"Basically, they should do a test designed to test for what they're testing for," he stated, adding that these tests should clarify "that they don't have hCG, that this isn't a surreptitious sterilization program."

Donovan stressed that the Kenyan government and its partners at the WHO and  UNICEF should take the lead in responding to this situation.

"Nothing improves trust more than transparency," he said, adding that officials refusal to take the bishops' objection seriously lead to people becoming "concerned that perhaps something was being hidden and that they did have something to hide."

After the proper testing is done and if those results show that the vaccine program has "nothing to hide," Donovan said, "there should be widespread support for the very important benefits of this program."