WHO approves second malaria vaccine R21

The World Health Organization (WHO) has recommended a new vaccine, R21/Matrix-M, for the prevention of malaria in children.

It is the second malaria vaccine approved by WHO, following the approval of RTS,S. Nigeria approved the R21 vaccine in April, becoming the second country after Ghana to do so.

WHO also issued recommendations for new vaccines for dengue and meningitis, along with immunization schedule and product recommendations for COVID-19.

The global body said its recommendation was informed by the results of the WHO-coordinated Malaria Vaccine Implementation Programme, through which nearly 2 million children in Ghana, Kenya and Malawi have been reached with the RTSS/AS01 malaria vaccine since 2019.

The pilot introduction of the first malaria vaccine has resulted in a substantial impact in reducing severe malaria illness, hospitalizations and child deaths.

Developed by Oxford University and manufactured by the Serum Institute of India, R21, also known as Matrix-M, showed 80% protection in early trials and has been described as a “world-changer” by the scientists who developed it.

The vaccine can be used in children aged between five months and three years old. This age group is at highest risk of death from malaria. It requires three initial doses followed by a booster after one year. The vaccine is being considered for approval by the World Health Organization.

Ghana approved the vaccine after a successful large study, following a preliminary trial in Burkina Faso. The final trial covered nearly 5,000 children in Burkina Faso, Kenya, Mali and Tanzania.

The vaccine can be manufactured at mass scale and modest cost, “enabling as many as hundreds of millions of doses to be supplied to African countries” and reduce “over half a million malaria-related deaths annually,” according to the University of Oxford team behind it.

The Serum Institute of India has been working on producing between 100-200 million doses per year and a vaccine factory is being built in Accra, Ghana’s capital.

– Why this matters

Malaria kills more than 600,000 people a year, most of them children in sub-Saharan Africa. Although the disease is also found in other subequatorial regions, like India, about 96% of all cases occur in Africa, WHO data shows.

Over half of those occur in Nigeria, the Democratic Republic of Congo, Uganda, Mozambique, Angola, and Burkina Faso. Malaria is transmitted throughout Nigeria, with 97% of the population at risk of malaria, NAFDAC said.

According to the 2021 World Malaria Report, Nigeria had the highest number of global malaria cases (27 % of global malaria cases) and the highest number of deaths (32 % of global malaria deaths) in 2020.The country accounted for an estimated 55.2% of malaria cases in West Africa in 2020.

“As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria. Now we have two,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Demand for the RTS,S vaccine far exceeds supply, so this second vaccine is a vital additional tool to protect more children faster, and to bring us closer to our vision of a malaria-free future.”

Matshidiso Moeti, WHO Regional Director for Africa, said: “This second vaccine holds real potential to close the huge demand-and-supply gap. Delivered to scale and rolled out widely, the two vaccines can help bolster malaria prevention and control efforts and save hundreds of thousands of young lives in Africa from this deadly disease.”

The R21 and RTS,S vaccines act against P. falciparum, the deadliest malaria parasite and the most prevalent on the African continent.

RTS,S was developed by GSK over more than 35 years and in partnership with U.S.-based PATH since 2001. Clinical testing began in 1987 and trials have been conducted or are ongoing in ten African countries, Thailand, and the United States. GSK sponsored the Phase 3 licensure trials and provided vaccine doses.

PATH welcomed the approval by WHO on Monday.

“Malaria still kills a child in Africa nearly every minute,” said Nanthalile Mugala, MD, MMed, PATH’s Chief of the Africa Region. “The availability of a second malaria vaccine for children in the region should increase access to this valuable addition to the malaria toolbox. Malaria vaccines, used alongside other proven interventions, can help bring this deadly disease under control and take us another step closer to a world free from malaria.”