Political violence in Kenya threatens world’s largest malaria vaccine trials

By Gatonye Gathura

Political activities in Kenya are threatening the world’s largest malaria vaccine trials whose preparations should have taken off in September.

Preparatory work for the trials to involve 240,000 children, their families and thousands of workers in western Kenya may have slowed down due to political tensions.

Kenya, Malawi and Ghana have been selected by the World Health Organization (WHO) for Phase III repeat trials of the. World’s most clinically advanced malaria vaccine.

The trials of the vaccine RTS, S or Mosquirix developed by the UK pharmaceutical giant GlaxoSmithKline will involve 240,000 children aged 5-18 months in each of the three countries.

Through an international tender WHO has engaged vaccine evaluators with on ground preparations initially planned to start in the last quarter of 2017.

In Kenya the clinical trials will take place in some of the eight counties with the highest malaria prevalence in the country.

These include Bungoma, Busia, Homa Bay, Kakamega, Kisumu, Migori, Siaya and Vihiga all in western Kenya and currently hotspots of political agitation.

While the actual vaccination starts next year preparations were supposed to get underway in the last quarter of this year.

But sources in the health sector indicate recent political electioneering activities may have slowed down preparations or put the whole exercise into doubt.

Last week the UK Foreign and Commonwealth Office asked its citizens to be cautious while visiting Kenya citing possible political related clashes in coming days.

Western Kenya— former Western and Nyanza provinces— was flagged as one of the regions to avoid where possible.

“We hope political temperatures will quickly cool down to allow planned activities to go on,” a senior official with the Ministry of Health told RS.

“Planning for the vaccine trial in Kenya is on track,” the WHO Kenya office assured in a press statement in October. The statement seemed to dispel fears that political activities, could hold up or lead to the cancelling of the trials in Kenya.

Following the post-election violence of 2007/8 in Kenya, an international study had questioned the ethics of starting or continuing such clinical trials in the face of ongoing or expected political disruptions.

The study published in the Journal of Medical Ethics in October 2015 had been carried out by Indiana University, US,  the  Academic Model Providing Access to Healthcare (AMPATH), Eldoret,  and  Moi University, Eldoret.

The team has recommended that if disruptions make it difficult for the researchers to fulfill their ethical obligations to participants the work should be stopped.

“Studies that have been approved but not yet started should not begin until the disruption has ended and ethical standards can again be assured,” recommends the study.

In Kenya the vaccine trials will cover an area of not less than five million people mainly in the Lake Victoria region generating thousands of direct and indirect jobs.

Apart from highly skilled health and research professionals, the WHO tender documents show thousands of data collectors and entry clerks, data verifiers, and other casual workers will be engaged.

The Kenya exercise is closely synchronized with trials in the other participating countries of Ghana and Malawi and any delay or disturbances could have catastrophic consequences.

Political tensions, could also affect the implementation of the US President’s Malaria Initiative (PMI) which two weeks ago announced a $30 million allocation for the 2018 financial year.

In December the Global Fund, the biggest funder of malaria control in Kenya announced a $63 million package for the 2018–2020 period.

For both packages the eight counties of Lake Basin and western Kenya will host the bulk of activities and finances.

The AMPATH study also recommends caution in such as the developing scenario in Kenya incase international groups including the UN are tagged as taking political sides.

The researchers are adamant that such a situation should be avoided at all costs.

Some facts

  1. Kenya’s 2018 population is projected to be 47.9 million
  2. Approximately 70% of the population at malaria risk
  3. 1 million Kenyans live in a malaria-endemic zone
  4. 6 million in eight lake endemic counties
  5. National malaria prevalence at 8%
  6. Malaria prevalence at lake region at 27 %
  7. Malaria take 16% of outpatient consultations
  8. Baringo, classified as highland-epidemic prone
  9. Children under age 5 and pregnant woman most at risk
  10. Malaria kills about 400,000 people globally
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