New infant malaria drug, vaccines light path to hope

The death of seven children from malaria was a tragedy that shook Samson Okoth’s world.

The children, aged between one and five years, died from the mosquito-borne disease between 2018 and 2022.

Okoth was left in despair.

Narrating his ordeal to The Standard, the Ripe village resident in Homa Bay County said when the children first fell ill, he thought it was just a normal fever.

But the condition worsened, and despite hospital care, they all succumbed to the disease.

Okoth regrets delaying taking the children to hospital.

Keep Reading

“Malaria is a monster. I never realised how serious it could be until it swept through my children. Their deaths have left a permanent scar. I sit at their graves and imagine what they could have become, only for their light to be cut short by death,” said Okoth, father of 15, with two wives.

The first wife lost three of her 11 children, while the second wife lost four of her 10 children.

Had it not been for malaria, Okoth would now be a father of 21.

Since death struck the family, each one now sleeps under an insecticide-treated mosquito net.

Vaccine advocacy

Today, Okoth is a champion of the malaria vaccine, a jab he says should be administered to each child to avert malaria deaths.

Enrolment for the malaria vaccine, according to Okoth, is a silver lining in the fight against malaria. He is a champion of the vaccine in the community.

“My five children below two years have been vaccinated against malaria. I wish the jab had been introduced earlier, as it could have saved my children who died,” he said.

Okoth’s experience is not in isolation. In Kenya, there are an estimated 3.5 million new clinical cases and 10,700 deaths each year.

Data from the Ministry of Health shows children under five years and pregnant women are the most affected.

In 2010, the mortality rate for malaria stood at 13 per cent, with over 90 per cent of hospital admissions.

Due to these high numbers of cases and deaths, Kenya was among eight African countries that participated in clinical trials for a new malaria treatment designed for newborns, released this year.

Other countries involved in the research that led to the development of Coartem Baby (artemether-lumefantrine) included Nigeria, the Democratic Republic of Congo (DRC), Burkina Faso, Mali, and Zambia.

The medicine was approved by Swissmedic, Switzerland’s regulatory authority.

The approval marked a major milestone in the fight against malaria in infants, as Coartem Baby becomes the first-ever treatment tailored for babies.

The groundbreaking therapy is expected to be rolled out in Kenya and other malaria-endemic African countries in the coming months.

The medicine, also known as Riamet Baby, is intended for newborns and young infants amid rising malaria deaths.

It is dissolvable, including in breast milk, and has a sweet cherry flavour to make administration easier.

Coartem Baby was developed through the Medicines for Malaria Venture (MMV) in collaboration with Novartis to treat malaria prevalent across the African continent.

Kenya and seven other participating countries are expected to issue rapid approvals under Swissmedic’s Marketing Authorisation for Global Health Products procedure.

Infant dosage

The approval is based on phase two and three studies, which investigated a new ratio and dose of Coartem to account for metabolic differences in babies under five kilograms.

It is indicated for infants and neonates weighing between two and less than five kilograms with acute, uncomplicated infections caused by Plasmodium falciparum or mixed infections.

“Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,” said CEO of MMV Martin Fitchet.

“The approval of Coartem Baby provides a necessary medicine with an optimised dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox,” he added.

Globally, there has been no approved malaria treatment for babies, particularly those weighing less than 4.5 kilogrammes.

Babies have been treated for malaria using formulations intended for older children, risking overdose and toxicity, noted the international malaria research organisation.

Some 30 million babies are born in malaria-risk areas in Africa each year, with a large survey across West Africa reporting infections ranging between 3.4 and 18.4 per cent in infants younger than six months.

Limited data

MMV noted that current data on malaria in young babies is extremely limited, as they are rarely included in clinical trials of antimalarial agents.

“The available malaria treatments have only been properly tested in children aged at least six months because smaller infants are usually excluded from trials,” said Prof Umberto D’Alessandro, Director of the MRC Unit, The Gambia, at the London School of Hygiene and Tropical Medicine.

“That matters because neonates and young infants have immature liver function and metabolise medicines differently, so doses for older children may not be appropriate for small babies,” he added.

The new dose strength for young infants was developed by Novartis with scientific and financial support from MMV, and as part of the PAM Africa Consortium, co-funded by the European and Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.

The discovery of the treatment is a big relief to Kenya and the African continent.

In Kenya, malaria is a major public health problem, with at least 75 per cent of the population at risk.

Data from the World Health Organisation (WHO) documented 11,478 malaria deaths in the country in 2023.

Additional data from the Ministry of Health shows malaria kills about 10,700 people annually in Kenya, primarily children under five, with at least 3.5 million new clinical cases.

In 2023, at least 600,000 malaria deaths were reported globally, most of them in Africa.

Dr Simon Kariuki, a researcher at the Kenya Medical Research Institute (Kemri), described the discovery of the medicine as a big milestone in malaria treatment.

In an interview with The Standard, he noted the medicine has been trialled in infants.

“Discovery of Coartem Baby is groundbreaking. It has been found to be safe and treats malaria,” said the researcher.

“Existing malaria drugs had no proper safety or toxicity data. The availability of Coartem Baby is a big boost because it means we now have a safe drug for infants under five kilograms,” added Dr Kariuki.

Trials on Coartem Baby showed it to be safe in the target age group.

Preventive measures

Kariuki noted that alongside the new medicine, preventive measures such as mosquito nets and malaria vaccines remain essential.

“All these tools combined will help reduce the burden of malaria in Kenya and Sub-Saharan Africa,” said the researcher.

Although Kariuki was not part of the original Coartem Baby research, he is involved in studies on new drugs for complicated malaria and tracking resistance to current treatments.

To avert malaria-related deaths, supported by WHO, Gavi the Vaccine Alliance, and UNICEF, the malaria vaccine RTS,S/AS01 was introduced in eight endemic counties in Kenya.

The endemic counties where the vaccine is administered include Vihiga, Kakamega, Busia, Kisumu, Homa Bay, Migori, Siaya, and Bungoma.

The malaria vaccine triggers the immune system to defend against Plasmodium falciparum at the initial stages when the parasite enters the bloodstream and infects liver cells.

Annual global demand for malaria vaccines is estimated at 40 to 60 million doses by 2026, increasing to 80 to 100 million doses annually by 2030.

The Ministry of Health, through the National Vaccines and Immunisation Programme, leads the project in Vihiga, Homa Bay, Kisumu, Migori, Siaya, Busia, Bungoma, and Kakamega, counties that have recorded significant drops in malaria cases.

Malaria vaccines are administered in four doses: at seven, nine, 18, and 24 months of age.

Malaria elimination efforts in Kenya are heavily supported by the U.S. Government through the President’s Malaria Initiative (PMI).