A Major Breakthrough: WHO Approves World's First Vaccine Against Malaria

The Geneva-based World Health Organization (WHO) announced on 6 October that it is now recommending the widespread use of RTS,S/AS01 malaria vaccine among children in all the regions with moderate to high risk of malaria transmission.

This is the world's first vaccine against the mosquito-borne disease that kills over 400,000 people each year, and most of them are African children. The global health body said that the recommendation is based on the outcomes of a pilot programme that has touched over 800,000 children in Ghana, Kenya, and Malawi since 2019.

WHO director-general Dr Tedros Adhanom Ghebreyesus said: “This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”

The WHO noted that the RTS,S/AS01 malaria vaccine is the culmination of 30 years of research and development by GSK, in collaboration with PATH (a global health organisation) and with the assistance of a network of African research centres.

However, based on the recommendations of two WHO global advisory committees—one for vaccination and the other for malaria, which remains the primary cause of childhood illness and death in sub-Saharan Africa—WHO advises that the RTS,S/AS01 malaria vaccine be used in the context of comprehensive malaria control for the prevention of P. falciparum malaria in children residing in WHO-defined moderate to high transmission areas.

According to the UN agency, the RTS,S/AS01 malaria vaccine should be given to children starting at the age of 5 months on a 4-dose schedule to reduce malaria disease and burden.

Based on the pilot program, WHO highlighted some key findings. It said that with good and equitable RTS,S/AS01 coverage seen through routine vaccination systems, vaccine introduction is possible, improves health and saves lives. WHO also added that “this occurred even in the context of the COVID-19 pandemic”.

The findings also revealed that more than two-thirds of children in the three countries are benefitting from the RTS,S/AS01 vaccine. More than 2.3 million doses of the vaccine have been given out in those African nations so far, and the vaccine has a good safety profile, said WHO adding that as per the findings, there was “no negative impact on the uptake of bednets, other childhood vaccinations or health-seeking behaviour for febrile illness”.

“Significant reduction (30 per cent) in deadly severe malaria, even when introduced in areas where insecticide-treated nets are widely used and there is good access to diagnosis and treatment,” the health agency noted. It also said that modelling estimates that the vaccine is cost-effective in places where malaria transmission is moderate to high.

Pedro Alonso, director of the WHO Global Malaria Programme said that RTS,S/AS01 is "a first-generation, really important one," but the agency hopes that “it stimulates the field to look for other types of vaccines to complement or go beyond this one".

A Glimmer Of Hope

Dr Matshidiso Moeti, WHO regional director for Africa said: “We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”

According to WHO’s database, in 2019, there were an estimated 229 million cases of malaria worldwide, with 409,000 malaria fatalities. Children under the age of five are the most vulnerable to malaria, accounting for 67 per cent (274,000) of all malaria deaths globally in that year—more specifically, malaria infections and fatalities accounted for 94 per cent of all cases and deaths in the WHO African region in 2019.

Dr Ghebreyesus urged for an aggressive new approach to jump-start progress against malaria at the World Health Assembly in May 2018. In November 2018, a new country-led approach called "High Burden, High Impact" was introduced in Mozambique, East Africa.

Currently, 11 countries with the highest illness burden are driving the strategy that includes India, Burkina Faso, Cameroon, the Democratic Republic of the Congo, Ghana, Mali, Mozambique, Niger, Nigeria, Uganda and the United Republic of Tanzania.

Additionally, the World Health Assembly endorsed the WHO Global technical strategy for malaria 2016-2030 in May 2015, which provides a technical foundation for all malaria-endemic countries. Its purpose is to advise and support regional and country-level malaria control and elimination efforts.

The strategies include a set of goals which are:

• Reducing malaria case incidence by at least 90 per cent by 2030

• Reducing malaria mortality rates by at least 90 per cent by 2030

• Eliminating malaria in at least 35 countries by 2030

• Preventing a resurgence of malaria in the malaria-free countries

However, the next step in getting the newly recommended immunisation to children in need is to raise funds. Kate O'Brien, director of WHO's Department of Immunization, Vaccines and Biologicals said: "That will be the next major step... Then we will be set up for scaling of doses and decisions about where the vaccine will be most useful and how it will be deployed.”

Additionally, the Gavi vaccine alliance said in a statement following the WHO’s RTS,S/AS01 approval news that global stakeholders, including Gavi itself, “will consider whether and how to finance a new malaria vaccination programme for countries in sub-Saharan Africa”.

In April, the campaign against malaria gained a boost after a study revealed that experts from the University of Oxford and the Clinical Research Unit of Nanoro had conducted a clinical trial of a new malaria vaccine candidate called R21/MM and they found that the vaccine demonstrated 77 per cent efficacy in children in western Africa’s Burkina Faso. This Matrix-M vaccine candidate became the first to meet the WHO's effectiveness requirement.

Moreover, German company BioNTech, which collaborated with American drug giant Pfizer to produce the mRNA Covid-19 vaccine, said it plans to begin malaria vaccine trials next year using the same revolutionary technology.