Alongside the announcement of the World Health Organization’s (WHO) framework for the allocation of limited malaria vaccine supply published earlier this week, Malaria Consortium published Vaccines: The cornerstone of disease burden reduction, calling for sustainable vaccine interventions through country ownership, improved vaccine supply constraints and widespread availability of vaccines through equitable coverage.
In October 2021, after more than 30 years of research, WHO issued a recommendation that children in moderate-to-high malaria transmission settings should be given the RTS,S/AS01 malaria vaccine to curb malaria infections with Plasmodium falciparum. This vaccine, given in four doses, was found to be safe and effective following pilot introduction in Malawi, Ghana and Kenya, where over a million children received at least one dose through the malaria vaccine implementation programme (MVIP). If widely deployed, WHO estimates that the vaccine could save the lives of an additional 40,000 to 80,000 African children each year.
International financing of vaccine doses for country implementation was secured in December 2021 when the Board of Gavi, the Vaccine Alliance, approved funding for the malaria vaccine programme. An initial investment of US $155.7 million will support malaria vaccine introduction, procurement, and delivery for Gavi-eligible countries in sub-Saharan African in 2022 – 2025.
Gavi aims to open applications for country-level procurement of doses by the end of July, initially for MVIP countries. Countries across Africa, including Uganda, are now announcing their plans to start malaria vaccine rollouts from as early as 2023. However, demand for this vaccine is expected to outstrip supply over the next four to six years. Current vaccine production capacity stands at a maximum of 15 million doses per year, while demand is estimated to exceed 100 million doses annually. Recent announcements by GSK plc on the signing of an agreement to transfer manufacturing of the antigen part of the vaccine, is critical for creating confidence in governments who are looking to adopt the WHO recommendation. GSK plc also indicate a potential doubling in production of the adjuvant to the vaccine, AS01, which will contribute to an increase in vaccine supplies.
Given this concerning disparity between the demand for the vaccine and the supply available, in large part due to a shortage of antigen production, the WHO framework for allocation outlines guiding principles for countries seeking to introduce the malaria vaccine and create a fair, transparent and equitable mechanism to prioritise areas of greatest need until supply meets demand.
Dr James Tibenderana, Malaria Consortium’s Global Technical Director said:
“Malaria Consortium welcomes the global effort and commitment that has gone into developing this framework and supports its intent to ensure the malaria vaccine reaches populations with the highest disease burden. It will be critical to monitor that the vaccine is reaching the most vulnerable and that equity is achieved. Vaccine hesitancy should be seen as a possible reaction and adequate plans be put in place to mitigate it.
Sufficient support, funding and guidance should be provided to countries needing to further strengthen their health systems in order to secure adequate allocation; and indicators provided by the WHO to measure this appropriately - as well as recommendations for lower burden countries to prepare for implementation of RTS,S vaccines in case of available supply or next generation malaria vaccines - should be clear.”
Whilst progress in operationalising a roll out of the RTS,S malaria vaccine is good news, Malaria Consortium continues to emphasise that the vaccine will be most effective when used in combination with the existing mix of proven malaria interventions, including seasonal malaria chemoprevention (SMC), long-lasting insecticidal nets (LLINs), parasite-based diagnosis and case management. The framework outlines that countries will have the option for seasonal use of the vaccine which provides opportunities to optimise the impact of the two preventive strategies, SMC and RTS,S, which is a positive inclusion.
Alongside the introduction and roll-out of the RTS,S malaria vaccine, cost evaluations and political-economy analyses should be carried out to get a full understanding of how national health budgets and decision-making will be affected by the rollout. Careful consideration will also need to be given to how such a vaccine is introduced within communities. Extensive social behaviour change communications and operations research will be important success factors for effective rollout.
“Achieving malaria elimination across the African continent is complex and countries will not be able to embed a rollout of a malaria vaccine without compromising coverage of existing malaria tools unless new financing is secured. Achieving this vision will demand robust investment and new public and private partnerships to increase manufacturing capacity swiftly, in particular the capacity to manufacture malaria vaccines and their accessory supplies in Africa. Donors investing in child health interventions are in a position to help liberate such financing, if there is the will to explore blended and innovative financing solutions that can also positively impact on strengthening countries’ health systems more broadly”, added Dr Tibenderana.
The WHO and partners are exploring other ways to increase malaria vaccine supply including supporting the development of new and next-generation malaria vaccines with similar or higher efficacy, such as R21/Matrix-M and Sanaria PfSPZ. BioNTech, manufacturer of the Pfizer-BioNTech COVID-19 vaccine, announced in 2021 that the company had started work on the saRNA vaccine, for which GSK and Yale University have already submitted a patent application in the United States of America.