More than a million children in Ghana, Kenya and Malawi have received one or more doses of the world’s first malaria vaccine, thanks to a pilot program coordinated by WHO. Pilot malaria vaccine trials, first conducted in April 2019 by the Government of Malawi, have shown that the RTS,S/AS01 vaccine (RTS,S malaria vaccine) is safe, feasible to administer, and substantially reduces the severe and deadly form of the disease.
These findings have paved the way for the historic October 2021 WHO recommendation for widespread use of the RTS,S malaria vaccine in children living in areas where transmission of the disease is moderate to high. If widely supplied, the WHO estimates that the vaccine could save the lives of an additional 40,000 to 80,000 African children each year.
Gavi, the Vaccine Alliance, has secured more than $155 million to support the introduction, procurement and delivery of malaria vaccine to eligible sub-Saharan African countries. Guidance is available from WHO for countries when considering whether and how to use the RTS,S malaria vaccine as an additional tool to reduce malaria deaths and cases in children.
“Early in my career as a malaria researcher, I dreamed of the day when 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, but a life-changer for families across Africa. It demonstrates the power of science and innovation for health. Yet more and better life-saving tools are urgently needed.” and drive progress towards a malaria-free world.
Prospects for new interventions
The RTS,S malaria vaccine is a first-generation vaccine that could be supplemented in the future by other vaccines of similar or greater efficacy. WHO welcomes the progress made in the development of R21/Matrix-M and other candidate malaria vaccines in the early stages of clinical development. To assess the safety and efficacy of these vaccines, it will be important to successfully complete the clinical trials. WHO also welcomes the news from BioNTech, maker of the Pfizer-BioNTech COVID-19 vaccine, of its intention to develop a malaria vaccine using mRNA technology.
In the area of ​​vector control, a number of new tools and technologies have been submitted to WHO for evaluation. If its effectiveness in controlling the disease is demonstrated, WHO will develop new recommendations or modify existing ones to support its distribution. Some of these are, for example, new types of insecticide-treated nets, space mosquito repellents, gene drive solutions, and sugar baits designed to attract and kill Anopheles mosquitoes.
New drugs are also being prepared. WHO welcomes the recent approval by the Australian regulatory body, the Therapeutic Goods Administration, of single-dose tafenoquine dispersible tablets for the prevention of P. vivax malaria in children. Tafenoquine has also been approved for use in adults by the US Food and Drug Administration and by drug regulatory agencies in other countries, including Brazil, Peru, and Thailand. As a single dose, tafenoquine is expected to support adherence to treatment. According to the current protocol, a medication course of 7 or 14 days is required.
Other antimalarial drugs with new modes of action are being developed for the treatment of uncomplicated and severe cases of malaria. Ganaplacide-Lumefantrine, currently in a phase 2 clinical trial, is the first artemisinin-free combination therapy and could be an asset in the 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 insecticide resistance in mosquitoes, an invasive malaria vector that thrives in urban and rural areas, and the emergence and spread of parasites mutated P. falciparum that are undermining the effectiveness of rapid diagnostic tests. Innovation in instruments and strategies will be essential to contain these threats, as well as a more strategic use of the instruments available today.
WHO calls for more investment against malaria
According to the World Malaria Report 2021, global progress in reducing cases and deaths from the disease has slowed or stalled in recent years, particularly in the most affected countries. The report points to the need for further innovation in research and development of new tools to achieve the 2030 global targets of the WHO malaria strategy.
Funding for malaria research and development reached just over $619 million in 2020. For the period 2021 to 2030, an average annual investment of $851 million will be needed.
Make better use of currently available instruments
Meeting the global targets for malaria will also require innovations in how currently available tools are used. Through the High Burden, High Impact strategy, launched in 2018 by WHO and the RBM Alliance to End Malaria, countries most affected by the disease collect and analyze data on malaria to better understand the geographic spread of the disease.
Instead of applying the same approach to malaria control everywhere, these countries are exploring the potential impact of using tailored packages based on local data and disease context. These analyzes will allow countries to use the available funds in a more effective, efficient and equitable way.
The RTS,S malaria vaccine and the pilot program
WHO guidance is now available for countries considering whether and how to use the RTS,S malaria vaccine in their national malaria control strategies. The WHO vaccine recommendation was recently added to the Organization’s consolidated guidelines on this disease. In addition, the 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 short to medium term; the current production capacity of the vaccine is a maximum of 15 million doses per year, while the demand is estimated to exceed 80 million.
WHO is working with partners to increase supply by increasing manufacturing capacity for the RTS,S malaria vaccine and facilitating the development of other first- and next-generation malaria vaccines. To provide guidance on where to provide the first doses of the vaccine, WHO is coordinating the development of a framework for the allocation of a limited supply of malaria vaccines; the goal is to prioritize areas of greatest need and highest malaria burden until supply meets demand.
The pilot program for the RTS,S malaria vaccine is made possible by an unprecedented collaboration between national and international partners, including the ministries of health of Ghana, Kenya and Malawi; country evaluation partners; PATH, GSK, UNICEF and others, and the funding agencies of Gavi, the Global Fund and Unitaid. The RTS,S malaria vaccine is the result of 30 years of research and development by GSK, in association with PATH and supported by a network of African research centres.
Source: WHO
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