More than 1 million children in Ghana, Kenya and Malawi have now received one or more doses of the world’s first malaria vaccine, thanks to a pilot program coordinated by WHO.
The malaria vaccine pilots, first launched by the Government of Malawi in April 2019, have shown that the RTS,S/AS01 (RTS,S) vaccine is safe and feasible to deliver, and that it substantially reduces deadly severe malaria.
These findings paved the way for the historic October 2021 WHO recommendation for the expanded use of RTS,S among children living in settings with moderate to high malaria transmission. If widely deployed, WHO estimates that the vaccine could save the lives of an additional 40,000 to 80,000 African children each year.
More than US $155 million has been secured from Gavi, the Vaccine Alliance to support the introduction, procurement and delivery of the malaria vaccine for Gavi-eligible countries in sub-Saharan Africa. WHO guidance is available to countries as they consider whether and how to adopt RTS,S as an additional tool to reduce child illness and deaths from malaria.
“As a malaria researcher in my early career, I dreamed of the day we would have an effective vaccine against this devastating disease,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This vaccine is not just a scientific breakthrough, it’s life-changing for families across Africa. It demonstrates the power of science and innovation for health. Even so, there is an urgent need to develop more and better tools to save lives and drive progress towards a malaria-free world.”
RTS,S is a first-generation vaccine that could be complemented in the future by other vaccines with similar or higher efficacy. WHO welcomes progress in the development of R21/Matrix-M and other malaria vaccine candidates in early clinical development. The successful completion of clinical trials for these vaccines will be important to assess their safety and efficacy profiles. WHO also welcomes the news from BioNTech, manufacturer of the Pfizer-BioNTech COVID-19 vaccine, that it aims to develop a malaria vaccine using mRNA technology.
In the field of vector control, a number of new tools and technologies have been submitted to WHO for evaluation. Should they demonstrate efficacy in controlling the disease, WHO will formulate new recommendations or amend existing ones to support their deployment. These include, for example, new types of insecticide-treated nets, spatial mosquito repellents, gene-drive approaches and sugar baits designed to attract and kill Anopheles mosquitoes.
There are also new medicines in the pipeline. WHO welcomes the recent approval by the Australian Therapeutic Goods Administration of dispersible tablets of single-dose tafenoquine for the prevention of P. vivax malaria among children. Tafenoquine has also been approved for use in adults by the US Federal Drug Administration and by drug regulatory bodies in other countries, including Brazil, Peru and Thailand. As a single dose, tafenoquine is expected to support patient adherence to treatment. The current standard of care requires a 7- or 14-day course of medication.
A number of other antimalarial medicines with new modes of action are being developed for the treatment of uncomplicated and severe malaria. Ganaplacide-Lumefantrine, currently in a Phase II clinical trial, is the first non-artemisinin combination therapy and could be an asset in fight against emerging drug-resistant malaria in Africa.
In addition to drug resistance, WHO has reported other pressing threats in the fight against malaria, such as mosquito resistance to insecticides, an invasive malaria vector that thrives in urban and rural areas, and the emergence and spread of mutated P. falciparum parasites that are undermining the effectiveness of rapid diagnostic tests. Innovation in tools and strategies will be critical to contain these threats, together with a more strategic use of the tools that are available.
According to the 2021 World malaria report, global progress in reducing malaria cases and deaths has slowed or stalled in recent years, particularly in countries hardest hit by the disease. The report notes the need for continued innovation in the research and development of new tools if the world is to achieve the 2030 targets of the WHO malaria strategy.
Funding for malaria-related research and development reached just over US$ 619 million in 2020. An average annual R&D investment of US$ 851 million will be needed in the period 2021–2030.
Reaching global malaria targets will also require innovations in the way that currently available tools are deployed. Through the “ High burden to high impact” approach, launched by WHO and the RBM Partnership to End Malaria in 2018, countries hardest hit by malaria have been collecting and analysing malaria data to better understand the geographical spread of the disease.
Instead of applying the same approach to malaria control everywhere, they are considering the potential impact of tailored packages of interventions informed by local data and the local disease setting. These analyses will enable countries to use available funds in a more effective, efficient and equitable way.
WHO guidance is now available to countries as they consider whether and how to adopt the RTS,S vaccine into their national malaria control strategies. The WHO recommendation for the vaccine was recently added to WHO’s consolidated malaria guidelines, and WHO has also published an updated position paper on the vaccine.
To date, in routine use, the vaccine has been well accepted by African communities. Demand for the vaccine is expected to outstrip supply in the near to medium term; current vaccine production capacity stands at a maximum of 15 million doses per year, while demand is estimated to exceed 80 million doses annually.
WHO is working with partners to increase supply through increased manufacturing capacity of RTS,S and by facilitating the development of other first-generation and next-generation malaria vaccines. To guide where initial doses of the vaccine will be deployed, WHO is coordinating the development of a framework for the allocation of limited malaria supply; the aim is to prioritize areas of greatest need and highest malaria burden until supply meets demand.
The RTS,S pilot program is made possible by an unprecedented collaboration between in-country and international partners, including Ministries of Health of Ghana, Kenya and Malawi; in-country evaluation partners; PATH, GSK, UNICEF and others; and the funding bodies of Gavi, the Global Fund and Unitaid.
The RTS,S malaria vaccine is the result of 30 years of research and development by GSK and through a partnership with PATH, with support from a network of African research centers.