Statement by MPAC on the RTS,S/AS01 malaria vaccine

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Statement by MPAC on the RTS,S/AS01 malaria vaccine
4 October 2019 MPAC [Malaria Policy Advisory Committee]
Globally, 219 million cases of malaria were reported in 2018, and an estimated 435,000 people, including 260.000 African children, died from malaria in 2017. Scale up of WHO-recommended preventive measures resulted in a substantial decline in malaria morbidity and mortality between 2000 and 2015. However, in 2015 and 2016, progress with malaria control stalled and started to reverse, with an upswing in malaria cases, particularly in sub-Saharan Africa. A malaria vaccine such as RTS,S has the potential to help get malaria control back on track, and may prove to be an important addition to current control tools.

The RTS,S vaccine, with its reported level of efficacy, has been shown to provide substantial and significant added protection on top of that provided by optimal case management and high coverage of insecticide-treated mosquito nets (ITNs), reducing clinical malaria by 55% during the 12 months following primary vaccination, and by 39% over 4 years. Recent data from long term follow-up are reassuring regarding its long term efficacy and safety. The well-established Expanded Programme on Immunization can reach even the poorest children, who are generally at highest risk of malaria, and suffer the highest mortality rates.

The opportunity to evaluate the feasibility of delivery, safety and effectiveness of the RTS,S vaccine, through pilot implementation in three countries, comes at a critical time in malaria control: no other malaria vaccine has entered phase 3 clinical trials. Additional preventive tools are in the development pipeline, and MPAC looks forward to reviewing their potential to reduce the malaria burden. However the development, evaluation and deployment of these new tools is expected to take several years. Moreover, it is likely that they will also offer only partial protection.

At a time when the downward trend in malaria cases and deaths has stalled, when our current control efforts are threatened by resistance, and when no new intervention approaching the efficacy of RTS,S is available, MPAC looks forward to reviewing the results of the pilot implementations, in accordance with the Framework for Policy Decision on RTS,S/AS01 approved at the April 2019 MPAC and SAGE meetings. If these results are promising, the RTS,S vaccine, in combination with ITNs and other control measures, is likely to be an important additional tool to change the course of malaria incidence and reduce malaria deaths in African children.