In a breakthrough development, a new drug undergoing stage 3 trials in several African countries could potentially provide a treatment option for malaria in newborns. The Switzerland-based pharmaceutical company Novartis is leading the trials, which are supported by the PAMAfrica Consortium and co-funded by the European & Developing Countries Clinical Trials Partnership and Medicines for Malaria Venture.

Malaria, a deadly disease prevalent in Africa, has long been a leading cause of child deaths on the continent. Shockingly, nearly 80% of all malaria-related deaths in Africa are among children, according to a 2023 malaria report. In 2022 alone, Africa accounted for 94% of all malaria cases. Despite the severity of the issue, there has been a lack of focus and resources dedicated to malaria treatments for newborns.

The trials of the Novartis drug are taking place in Burkina Faso, Kenya, the Democratic Republic of the Congo, Nigeria, Mali, and Zambia, and the results are eagerly awaited in early 2024. Currently, there is no specific malaria treatment available for infants weighing under 5kg (11lbs), leaving them vulnerable to the potentially fatal disease. Babies in this age range are often diagnosed late, as the symptoms of malaria can be mistaken for common childhood illnesses or go unnoticed altogether.

Dr Bérenger Kaboré, a research associate with the Nanoro Health and Demographic Surveillance System in Burkina Faso and principal investigator on the trials, highlighted the challenges faced by health workers in treating newborns with malaria. The absence of clinical trials for this age group has further hindered progress in finding effective treatments. Existing antimalarial tablets, intended for larger infants, are imprecisely divided and pose the risk of overdosing and potential organ damage.

Maternal immunity has been a common assumption, leading to the exclusion of newborns from clinical trials for malaria prevention and treatment. However, recent studies have shown that newborns are at risk of contracting the disease, especially when their mothers are infected during pregnancy or if the family lacks access to insecticide-treated bed nets to protect against mosquito bites.

It is estimated that the prevalence of newborn malaria is not as high as in older children but remains under-diagnosed due to insufficient routine testing on infants in hospitals. Shortages of diagnostic kits and lab staff have contributed to the inadequate testing practices. The situation underscores the need to prioritize the diagnosis and treatment of newborns with malaria.

Nekoye Otsyula, the global medical affairs director at Novartis, emphasized the importance of addressing this neglected population. Otsyula acknowledged the challenges faced by healthcare workers, who often overlook the possibility of malaria in newborns and rule out other conditions before considering malaria as a potential cause.

The ongoing trials of the Novartis drug offer hope for an effective treatment option for newborns with malaria. The outcomes of these trials will play a crucial role in determining the future of malaria management in this vulnerable population. Medical experts and public health organizations stress the urgency of prioritizing treatments for newborns and ensuring their inclusion in malaria prevention and control efforts across Africa.

As the fight against malaria continues, it is crucial to recognize the unique healthcare needs of newborns and strive for equitable access to effective treatments. The Novartis drug trials represent a significant step forward in addressing the silence surrounding malaria in newborns, offering hope for a brighter and healthier future for Africa's youngest population.