Dar Awaits WHO Approval on Malaria Vaccine

Tanzania will consider to start using the malaria vaccine candidate RTS’S, also known as Mosquirix, for children only after pre-qualification by the World Health Organisation (WHO) and assessment by local experts, the government announced.
The WHO pre-qualification aims to make quality priority medicines available for the benefit of those in need and this is achieved through evaluation and inspection activities and by building national capacity for sustainable manufacturing and monitoring of quality medicines.

Just recently, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a ‘positive scientific opinion’ for RTS,S, for infants and young children aged between 6 weeks and 17 months.

In a telephone interview, Deputy Minister for Health, Dr Stephen Kebwe, said the approval by EMA was a significant step towards the adoption of the vaccine.

“Tanzania, however, will not use the vaccine until prequalification by the WHO and opinion of our local experts; it should be noted that our country has made significant success on malaria research,” Dr Kebwe told the ‘Daily News’.

Available figures put the prevalence rate of malaria at between 8 and 9 per cent, Dr Kebwe said, noting, however, that even if the vaccine is adopted, the country will use it jointly with other measures of controlling the disease such as treated mosquito nets and preventive drugs for expectant mothers.

“The target is to eradicate malaria in Tanzania Mainland as it has been in Zanzibar where the prevalence rate is below one per cent,” he explained.

According to the Deputy Minister, the prevalence rate was 18 per cent during 2007/2008, stating that there is an ongoing assessment of the current situation.

The positive opinion by EMA paves the way for the WHO and African countries health authorities to assess whether and how the vaccine could be introduced in national immunisation programmes across the continent.

“These authorities will need time to make these decisions so we cannot provide any potential timelines for adoption of the vaccine in Africa. “If introduced, this vaccine would be just one tool in the prevention of malaria alongside bed nets and insecticides,” the executives of pharmaceutical GSK were quoted as saying in a statement.

Adding: “Nevertheless, the EMA approval is regarded by GSK and its partners as an important milestone in the 30-year journey to discover a vaccine against malaria.”

The vaccine which was developed in partnership with the PATH Malaria Vaccine Initiative, with support from the Bill & Melinda Gates Foundation, is the first vaccine candidate for the prevention of malaria.

It targets a type of malaria caused by the Plasmodium falciparum parasite, which is prevalent in sub-Saharan Africa. The positive opinion by the Europe medicines regulator was based on a review of data assessing the vaccine’s safety, effectiveness and quality gathered from trials conducted by 13 African research centres.

The centres were based in eight African countries namely Tanzania, Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Nigeria.

Data from this trial programme demonstrated the vaccine’s efficacy against clinical malaria in children aged 5-17 months of close to 50 per over a 12-month follow-up period.

After the positive opinion, two of the WHO’s independent advisory groups will now jointly review the evidence base for RTS,S and make a joint policy recommendation for how it might be used alongside other tools to prevent malaria in the event the vaccine candidate is approved.

The bodies include the Strategic Advisory Group of Experts (SAGE) on Immunisation and the Malaria Policy Advisory Committee (MPAC). The WHO has indicated that such a policy recommendation may be possible by end of this year.