Kenya-tested malaria vaccine gets WHO approval

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A malaria jab that was tested in Kenya alongside other countries, has been prequalified for use by the World Health Organisation (WHO).

It is expected to cost Ksh300 to Ksh600 ($1.9 to $3.8), becoming the world’s second vaccine to be added to the global prequalified list.

The global health regulator had in October this year recommended the R21/Matrix-M jab for the prevention of malaria in children following the advice of the WHO Strategic Advisory Group of Experts (SAGE) on Immunisation and the Malaria Policy Advisory Group.

This came after Phase III trials which enrolled 4,800 children aged five months to three years in four countries across Africa namely Kenya, Mali, Burkina Faso and Tanzania.In Kilifi Kenya, where 600 children were enrolled, the trials were led by Prof Mainga Hamulaba, the head of clinical research and clinical trials at the Kemri-Wellcome Trust Research Programme (KWTRP).

As part of the prequalification process, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe, effective and manufactured to international standards.

WHO also ensures the continued safety and efficacy of prequalified vaccines through, for example, regular re-evaluation, site inspection and targeted testing.

This means that prequalification supports the specific needs of national immunisation programmes with regards to vaccine characteristics such as potency, thermostability, presentation, labelling and shipping conditions.

“The R21 vaccine is the second malaria vaccine prequalified by WHO, following the RTS, S/AS01 vaccine which obtained prequalification status in July 2022,” WHO explained in an official announcement.

“Both vaccines are shown to be safe and effective in clinical trials, for preventing malaria in children. When implemented broadly, along with other recommended malaria control interventions, they are expected to have a high public health impact,” the statement added.

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