By Gatonye Gathura
Kenya has applied to participate in repeat trials for the Mosquirix vaccine whose rollout was stopped by the World Health Organisation for safety, efficacy and logistical concerns.
On Tuesday the head of the National Malaria Control Programme, Dr Waqo Ejersa said the country is just waiting for word on the date of implementation and required number of participants.
The vaccine RTS, S or Mosquirix was to be rolled out for widespread use in Africa after its approval last year by the European Medicines Agency.
However in January, the WHO Strategic Advisory Group of Experts on Immunization recommended against a widespread rollout citing serious safety, logistical and efficacy concerns.
Most importantly the WHO was concerned over the high rates of meningitis, cerebral malaria and convulsions that were recorded among various groups of children during vaccination trials.
“Among children in the older age group, an increase in the number of cases of meningitis and cerebral malaria was found in the group receiving the malaria vaccine compared to the control group,” said WHO.
The vaccine tested was on 15,460 children from Kenya, Burkina Faso, Gabon, Ghana, Malawi, Mozambique and Tanzania.
The other problems cited by WHO was the vaccines modest protection against malaria and a requirement for a 4 dose administration.
The first 3 doses are given at monthly intervals and a fourth dose 18 months later which may prove difficulty for such children to be brought back for the final dose.
The WHO recommended for a large scale re-evaluation trial that would involve almost one million children in field conditions.
“Such a programme will generate critical evidence to enable decision-making about the potential wider scale use of this vaccine in 3-5 years time,” said a WHO update.
Would be funders of such a vaccine in Africa, Dr Seth Berkley of Gavi, the vaccine alliance and Dr Mark Dybul of the Global Fund to Fight Aids, Tuberculosis and Malaria have welcomed the caution adopted by the WHO.
“It was a smart call.” The two say in response to the WHO recommendations. “Mosquirix comes with complex caveats and some outstanding questions that the clinical studies were not able to address.”
Delivering the vaccine, the duo advises will require unprecedented efforts to inform and mobilise people to bring their children to health clinics at the prescribed time to complete all four doses.
Apart from Dr Ejersa, who in an official post is all praise for the vaccine, no other scientist or health official in Africa has raised issues with the controversial product.
However several researchers including Dr Mae-Wah Ho and Prof Joe Cummins of the London-based Institute of Science in Society have since 2009 raised safety and ethical concern over RTS, S trials.