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Tetanus jab saga exposes serious flaws in Kenya's handling of medical products

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By GATONYE GATHURA | November 23rd 2014

The tetanus vaccine contest between the Government and the Catholic Church exposes a strong foreign hand driving the health sector, overly casual public officers and a suspicious clergy, missing key scientific sign posts.

The Government has refuted claims by the church that a tetanus vaccine being administered to women and girls aged between 14 to 49, is also being used to secretly sterilise them.

An analysis of the dispute so far, shows a Government that has entrusted crucial decisions to foreign agencies, casually brushing aside public concerns and failing to test the vaccine soon enough. This has created a mountain out of a molehill.

On Thursday, Health Cabinet Secretary James Macharia said pharmaceutical products that have gone through the UN system are considered safe and do not require more tests.

Dr Collins Tabu, the head of immunisation at the Ministry of Health, says vaccines procured through UN bodies are adequately tested and confirmed safe for use in humans. The organs responsible, Dr Tabu says, are the World Health Organisation (WHO), Unicef and the Global Alliance for Vaccines and Immunisations (GAVI).

WHO is involved in prequalification of manufacturers while UNICEF procures vaccines for more than 100 countries at a commission. GAVI shops for the ‘best’ vaccine deals for poor countries.

Anti-fertility agent

“But that is missing the point. We are saying there is a deliberate inclusion of the anti-fertility agent into the vaccine through the same UN system,” says Dr Wahome Ngare of the Kenya Catholic Doctors Association, the group advising the church on the vaccine.

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The Catholic Church sees a possible conflict of interest in such an arrangement where the UN bodies are too close to a ruthless global pharmaceutical industry. “It was only fair that this be tested by the Pharmacy and Poisons Board like any other medicine that is to be used in the country,” Dr Ngare told The Standard on Sunday.

“Indeed that should be the position” says Kipkerich Koskei, the Chief Government Chemist at the Pharmacy and Poisons Board. Dr Kipkerich said the tetanus vaccine was registered in the 1990s and went through the initial tests for safety but not for the alleged anti-fertility agent.

“We can only go out of our way to carry out additional tests if there are public concerns on any pharmaceutical product in the market, as is the case now with the tetanus vaccine,” he says.

Although the concerns were raised in March, Dr Kipkerich said they only conducted the tests last week and promised to share the results with us by the end of the week. This had not happened by the time of going to press despite numerous reminders.

By Friday last week, no Government agency had requested the Kenya Medical Research Institute (Kemri) to carry out such a test. Macharia had publicly said Kemri is the only institution in Kenya with the capacity to carry out the appropriate test on the said vaccine.

Quiet vaccinations

The Catholic leadership has questioned why the recent tetanus vaccinations activities are being carried out quietly, unlike other campaigns which have in the past been launched with lots of fanfare.

Campaigns such as that for polio, says Dr Ngare, are well advertised in the media and all faith-based health groups and other stakeholders involved.

“In this case, our people are not allowed to handle the vaccines. The vaccinating teams do not leave anything behind, not even empty vials. We do not understand the secrecy.”

But Dr Peter Okoth of UNICEF–Kenya says this is necessary for accountability purposes and to assess whether the campaign targets are being achieved. Rt Rev Paul Kariuki Njiru, the chairman of the Catholic Health Commission, says the church has not been adequately engaged despite their repeated demands for inclusion.

These demands were first made in March when John Cardinal Njue, the Head of the Catholic Church in Kenya, publicly voiced his opposition to the vaccine at a mass in Nyeri and asked women and girls to boycott the exercise.

The church had then asked the Government to stop the vaccination campaign until the safety issue had been discussed and settled. “But Macharia turned down our suggestion for joint testing then, against the advice of the recently retired director of Medical Services, Dr Francis Kimani,” says Dr Ngare.

When asked whether he had opposed a joint testing, Macharia said this was a blatant lie. “This was not suggested until I did so this month,” Macharia said.

Asked why he did not suggest a joint test earlier, the CS said products verified by UN agencies are safe for use and require no extra tests, a position contrary to that of the Chief Pharmacist who says any pharmaceutical product should be tested locally if there is credible public concern.

After the church protest in March, the Government removed the tetanus vaccine from media attention, giving the church more reason to be suspicious.

Days after Cardinal Njue’s public comments, Rachel Jones, an American media consultant, invited the media for a press conference on behalf of Unicef to discuss, among other things, the tetanus vaccine.

However, the event was cancelled abruptly a day before it was due without any explanation, giving more room to speculation.

Explaining this development, Dr Ephantus Maree, the head of Vaccines and Immunisation Services at the Ministry of Health, said the press conference was cancelled because the three top ministry officials were out of the country.

Dr Maree’s explanation did not sound convincing as the African Immunisation Week, which was part of the agenda of Jones’ press briefing, was marked with no public activity in Kenya despite the officials having returned into the country by then.

This may have been interpreted as an effort by Unicef and its partners to cancel any public platform on vaccines that could bring up the tetanus debate.

Appropriate tests

Armed with all these circumstantial evidence and suspicions, the Catholic Church, on advice from its doctors’ association, decided to take the fight against the vaccine to the Government.

In May, the Church contracted the first tetanus vaccine tests at the University of Nairobi, Lancet Kenya, Medi Plan Dialysis Centres and Metr Polis laboratories. Like the latest tests done in October, the earlier ones also showed traces of the anti-fertility agent hCG in the tested samples.

But interpreting the lab results, technologists said they only tested for pregnancy from human tissues, not the ingredients constituting the vaccines. Test reports indicate the names of the women whose samples had been collected incrementally as the pregnancy progressed.

The testing labs have since told the church, their doctors and the public that these were not the appropriate tests and hence could not determine the ingredients of the tetanus vaccine.

Chemists recommend that such a test be carried with a technology called high performance liquid chromatography (HPLC).

This technique is used to separate the components in a mixture, to identify and quantify each component.

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