By Gatonye Gathura
The ongoing malaria vaccination pilot in western Kenya has been accused of experimenting on children without parental consent.
The piloting in Kenya, Ghana, and Malawi has been described as a ‘serious breach of international ethical standards.’
“The failure to require informed consent is a serious breach of international ethical standards,” says a press statement from the British Medical Journal.
In a rare move for such an influential journal to make such accusations, BMJ says it had enquired and received unsatisfactory explanation from the World Health Organization (WHO) on the matter.
The journal is published by the British Medical Association, a trade union for doctors in the UK or the equivalent of the Kenya Medical Practitioners, Pharmacists and Dentists Union.
But Dr Rudi Eggers, the WHO representative in Kenya says BMJ has got it all wrong.
“First, and importantly, the malaria vaccine pilot introduction is neither a clinical trial nor an experimental vaccine,” said Dr Eggers
He said the vaccine has been authorized for use by the Kenya Pharmacy and Poisons Board, and the Ministry of Health and currently being provided to children as part of their routine immunization.
Some 120,000 children aged 5-24 months in Homabay, Kisumu, Migori, Siaya, Busia, Bungoma, Vihiga, and Kakamega counties are targeted for vaccination.
The exercise, says the WHO, is led by the participating countries and it is done in the context of routine vaccinations, where there is no requirement for written individual consent.
“Parents and caregivers are free to decline if they do not wish their child to receive the vaccine,” said a WHO spokesperson.
But Dr Charles Weijer, a co-author of the international ethics guidelines for human clinical trials says there is no substitute for parental or informed consent in such an exercise.
The vaccine, Mosquirix, had been approved in 2014 by the European Medicines Agency, but the WHO had raised safety concerns hence the current piloting in the three countries.
The concerns, the BMJ says included an increase of meningitis which was 10 times more in children receiving Mosquirix compared to those who did not, increased cerebral malaria cases, and a doubling in the risk of death in girls.
Dr Eggers also explained that alongside, but separate to the pilot, the Kenya Medical Research Institute (KEMRI) and the US Centers for Disease Control and Prevention (CDC) are evaluating among others the safety of the vaccine.
This study, happening in the three countries and registered with the clinicaltrials.gov database as required shows one of its key inquiries is the vaccines’ safety.
The study document shows the investigators will assess the cases of meningitis and cerebral malaria and the number of deaths by gender among children receiving Mosquirix.
“We will give it to the children for a two year period and monitor its effectiveness and safety and then another two years to see the extended period of protection,” Dr Eggers told the Kenya Television Network.
“So we expect by 2022 to have a final opinion. All the information from the three countries and the clinical trials will be brought together at WHO to make a final judgment.”
Our inquiries to the Ministry of Health over increasing criticisms on the safety of Mosquirix in the scientific media went unanswered.
In January, a team of vaccine experts led by Prof Christine Stabell Benn of the University of Southern Denmark accused WHO of being in a hurry to give the vaccine a clean bill of health just within two years.
“My great concern is that they are really not doing a very good job trying to investigate the cause of double mortality in vaccinated girls,” Prof Benn told the Standard.
Earlier experts from Johns Hopkins University, US University of Melbourne, Australia, and the Statens Serum Institute, of the Danish Ministry of Health had demanded vigorous investigations on the higher deaths among vaccinated girls than boys.
“We seek to raise awareness about the need for additional research into how the RTS, S vaccine is associated with greater mortality in girls but not boys,” they wrote in the scientific journal mBio.
Launching the pilot in September the former Cabinet Secretary for Health Sicily Kariuki said the malaria vaccine has been approved, is safe and effective.
September 2019 – pilot launched in western Kenya
8 counties to be covered -Homabay, Kisumu, Migori, Siaya, Busia, Bungoma, Vihiga, and Kakamega
120,000 children to be vaccinated
2022 evaluation of final data
3 countries – Kenya, Malawi, Ghana implementing the pilot
4 doses given to children in month 6, 7, 9 and 24
30 years to develop vaccine
$500 million cost of vaccine development
40 per cent efficacy