Urgent need to develop antibiotics for newborns: Global experts
As many as 40 antibiotics approved for use in adults since 2000, only four have included dosing information for newborns in their labels, they said.
There is an urgent need to develop antibiotics for newborn babies, a population that is particularly vulnerable to antibiotic resistance, according to leading global public health experts including those from India.
Recent estimates show about 2.3 million newborns die of severe bacterial infections each year while an increasing number are becoming resistant to currently used antibiotics, the experts said in a report published in the December 2022 Bulletin of the World Health Organization.
Over the last decade, AMR has worsened to the point where around 50-70 per cent of common pathogens show a high degree of resistance to available first and second-line antibiotics, they said.
The paper is co-authored by international experts in the field of antimicrobial resistance (AMR), including those from the Global Antibiotic Research & Development Partnership (GARDP) and the All India Institute of Medical Sciences (AIIMS).
The authors noted that despite substantial progress in medical research and a steep decline in the number of children under the age of five who die of preventable diseases, many problems related to child health remain to be tackled. Severe bacterial infections are one of them.
“There is an urgent need to identify high-priority antibiotics to understand which ones work best and are safe in children, and then make them available where they are needed,” said Mike Sharland from St George’s, University of London (SGUL), and member of the Antimicrobial Resistance Programme at Penta – Child Health Research.
“By achieving global consensus, we can streamline the process of antibiotic development, allow for faster access to antibiotics, and reduce the burden of AMR on the vulnerable neonatal population,” added Manica Balasegaram, Executive Director of GARDP.
The report also highlights how collaborative antibiotic development and access networks specifically targeting newborns could also prove valuable compared to single independent studies.
A successful example, the authors noted, has been the collaboration between GARDP, Penta – Child Health Research, SGUL, and other partners on a recent global observational study of 3,200 babies with neonatal sepsis across 19 hospitals in 11 countries.
They are also partnering on an upcoming clinical trial, which will start in South Africa within the next few months before being expanded to other countries.
Despite a rising number of newborn deaths caused by AMR, very few effective antibiotics have been adequately studied to treat serious bacterial infections such as neonatal sepsis, the authors said.
As many as 40 antibiotics approved for use in adults since 2000, but only four have included dosing information for newborns in their labels, they said.
According to the report, ethical concerns, logistical issues and regulatory requirements have made it difficult to conduct clinical research in newborns.
There is a long delay in completing paediatric regulatory studies and they are also not harmonised globally to demonstrate clinical utility in newborns, it said.