• An expert opinion published in the prestigious British Medical Journal accuses the organisation of failing to inform parents of the malaria vaccine's potential risks.
•Ministry of Health says pilot exercise is taking place in 26 subcounties in the malaria-endemic areas
WHO has denied committing a "serious breach of international ethical standards" by injecting thousands of Kenyan children with a malaria vaccine, without proper consent.
The World Health Organization is leading the ongoing pilot to vaccinate about 150,000 children in Western Kenya.
An expert opinion published in the prestigious British Medical Journal accuses the organisation of failing to inform parents of the vaccine's potential risks.
“Parents of children should be aware of these risks and consent to them before children receive the vaccine,” writes Prof Charles Weijer.
Weije is a leading bioethicist at Western University in Canada and lead author of the Ottawa Statement, a global consensus document on the ethics of randomised trials.
In response, the WHO says the vaccine is being given as part of each country's routine vaccination schedule and consent is, therefore, "implied."
The novel vaccine, called Mosquirix or R,TSS, is being piloted in Kenya, Malawi and Ghana.
“Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent,” WHO's chief scientific officer Soumya Swaminathan says in a response published on BMJ last week.
The BMJ opinion argued that WHO’s implied consent process does not provide poor parents with any meaningful and informed consent regarding the piloting of the vaccine and its side-effects.
Peter Doshi, an associate editor of BMJ, notes that the pilot is partly meant to evaluate outstanding safety concerns that emerged during the vaccine's clinical trials.
"There was a rate of meningitis in those receiving Mosquirix 10 times than of those who did not, increased cerebral malaria cases, and a doubling in the risk of death (from any cause) in girls," he says.
The pilot began in Kenya on September 13 last year and will end around 2022.
The Ministry of Health told the Star the exercise is taking place in 26 subcounties in the malaria-endemic areas of Kisumu, Homa Bay, Migori, Siaya, Kakamega, Bungoma, Vihiga and Busia counties.
Children are being vaccinated in 533 health facilities.
"The demand for the vaccine is very high. As at now, the uptake is at 100 per cent," the ministry said in a statement.
Past trials showed Mosquirix prevents four in every 10 cases of malaria in children.
WHO is testing if the vaccine can be introduced in the routine immunisation calendar and its safety.
"It is not an experimental vaccine," WHO says. "Regulators (European Medicines Agency) concur in their assessment that the vaccine has an acceptable safety profile and that the benefits of the vaccine outweigh the risks."
WHO further says parents are educated through health talks and community barazas, among other methods.
"Parents receive information about the vaccine from the Ministry of Health and can decide to present for, or to opt-out of, any or all vaccinations," WHO said in its response.
Malaria is still the second biggest cause of reported deaths in Kenya after respiratory infections, according to the Kenya National Bureau of Statistics.
In 2018, there were 10.7 million malaria cases, up from 7.9 million in 2017.