In 2021, WHO recommended the first malaria vaccine, RTS,S/AS01, for children at risk, followed by a decision by Gavi, the Vaccine Alliance, to fund malaria vaccine roll-out in sub-Saharan Africa. Together, these two decisions pave the way for broader roll-out of this new vaccine.
Three WHO experts – Dr Mary Hamel, Dr Richard Mihigo and Dr Akpaka Kalu – provide updates on next steps for RTS,S, and how WHO and partners are supporting the vaccine’s wider roll-out.
Q: Dr Hamel, you lead the malaria vaccine pilot programme that informed the WHO recommendation for the first malaria vaccine. Can you share some reactions to the recommendation?
The recommendation is a historic breakthrough – after more than 60 years of research and the efforts of thousands of people, we finally have the first malaria vaccine, which has the potential to reach millions of children and save tens of thousands of children’s lives annually. It is also a breakthrough for child health – the pilot introductions showed that this vaccine can substantially reduce severe malaria and all-cause mortality when provided through the routine child immunization clinics. If introduced widely, the addition of this vaccine to other recommended malaria control tools will result in millions of malaria cases averted and can help get malaria control back on track.
The leadership of the Ministries of Health in Ghana, Kenya and Malawi, and their decision to participate in the pilot malaria vaccine introductions, were instrumental in generating the information necessary to support the WHO recommendation of the malaria vaccine. The pilot implementations are only possible with the generous contributions from Gavi, the Global Fund and Unitaid. I also want to recognize the important contributions of the evaluation partners who have evaluated the vaccine introduction, health workers, and key partners such as PATH, UNICEF and GSK.
The pilots will continue in the three countries through 2023 to understand the added value of the 4th vaccine dose and to measure the longer-term impact on child deaths.
Q. And do you have key updates to share on next steps for the vaccine?
Since October, another key milestone for the malaria vaccine was achieved – international financing of vaccine doses for country implementation was secured when on 2 December 2021 the Board of Gavi, the Vaccine Alliance, approved funding for the malaria vaccine programme. The 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.
Design for the Gavi malaria vaccine programme is underway, with WHO and partners in support, to streamline the procurement process and expand introduction of the life-saving vaccine as rapidly as possible. We understand that Gavi aims to open applications for country-level procurement of doses sometime in the third quarter (Q3) of this year.
Q: Dr Mihigo, as the lead for child immunization in Africa, can you tell us what to expect on malaria vaccine supply and demand in the region?
Demand for the malaria vaccine from endemic countries in Africa is expected to be high. It is an unfortunate fact that supply of the vaccine is expected to be insufficient to meet demand in the coming years. A recent WHO-commissioned study found that vaccine supply will likely be constrained through the medium term (potentially 4-6 years) unless additional investments and timely actions are taken.
Q. How will the limited malaria vaccine supply be allocated in the coming years?
In response to the situation, WHO is coordinating the development of a Framework to guide global decisions about malaria vaccine allocation and help inform national decisions about vaccine prioritization while supply is limited. The Framework will be based on best available scientific evidence, shared values, input by expert advisers and broad consultation with affected countries and communities and other malaria vaccine stakeholders.
The target date to complete the framework is the end of the first quarter (Q1) of this year.
Q: Given the constrained supply, what is being done to expand production of the malaria vaccine?
WHO and partners continue to support efforts to accelerate malaria vaccine access and a healthy malaria vaccine market. Achieving this vision will demand robust investments and new public and private partnerships to increase manufacturing capacity swiftly.
In January 2021, GSK, Bharat Biotech of India, and PATH announced the product transfer of the RTS,S antigen to Bharat Biotech, which will become the sole supplier of the vaccine no later than 2029 (GSK will continue to supply the AS01 adjuvant). The product transfer is an important step toward ensuring the long-term, sustainable supply of the vaccine to meet expected demand.
WHO and partners are exploring other ways to increase malaria vaccine supply – for example, in support of the development of new and next-generation malaria vaccines that could increase access.
Q: Dr Kalu, as a malaria expert for the Africa region, what guidance can countries expect from WHO to guide their use of the vaccine to reduce malaria illness and deaths?
The WHO recommendation and position on the RTS,S vaccine is now published in an updated WHO position paper on the malaria vaccine (Weekly Epidemiological Record, 4 March 2022) and as part of WHO Guidelines for malaria, an online platform called the MAGICapp.
WHO guidance for malaria control is moving away from a “one-size fits all approach” to apply an optimal mix of tools that fit the local context and can generate the most impact – the malaria vaccine is an additional tool for countries to consider as part of their national malaria control strategies.
WHO is also developing an operational manual on the sub-national tailoring of malaria interventions that will include the RTS,S vaccine, and a malaria vaccine implementation guide will inform planning for vaccine introduction in countries.
Q: Thank you very much Drs Hamel, Mihigo and Kalu. As we look to the future of the RTS,S malaria vaccine, any closing words you’d like to share?
Dr Hamel: This malaria vaccine is a big step forward in the fight to reduce malaria illness and death, but there is more to do. The vaccine can only reach its full potential if it reaches children at risk. This means accelerated increased supply is of utmost importance. WHO is working with partners to find ways to increase access to this vaccine and to facilitate development of future vaccines, while supporting research and development (R&D) for other innovative malaria control interventions.
Dr Mihigo: The community demand for the malaria vaccine is a bellwether for what we expect to come – caregivers want this vaccine for their children and will bring them for vaccination. The malaria vaccine is a positive step for child survival and malaria progress through the existing immunization platform.
Dr Kalu: African children are at highest risk of dying of malaria – one child died of malaria every minute, in 2020. The long-awaited malaria vaccine will benefit Africa, which shoulders the heaviest burden of the disease, if we can deliver it to the children who need it. We must seize this opportunity to help get malaria progress back on track and improve child health.
With thanks to the WHO experts: Dr Hamel leads the MVIP and malaria vaccines, Dr Kalu is the Africa region lead for malaria control, and Dr Mihigo is the Africa region lead for immunization.