Bacterial infections, such as pneumonia, neonatal sepsis, and gastrointestinal infections, are the leading causes of death among children worldwide
In March 2023, the World Health Organization (WHO) released a list of priority paediatric antibiotic formulations to focus on their research and development efforts. The document listed antibiotics with approved paediatric indications for which age-appropriate formulations are missing. This will ensure that children have access to appropriate treatment options.
Bacterial infections, such as pneumonia, neonatal sepsis, and gastrointestinal infections, are the leading causes of death among children worldwide.
Read more: Antimicrobial resistance: These steps can ensure AMR doesn’t develop in newborns
WHO provides guidance on developing and using antibiotics for children to address these challenges. In low- and middle-income countries, there are numerous challenges in the treatment of bacterial infections due to limited access to medicines and diagnostic services. The rise of antibiotic resistance, an insufficient pipeline of new antibiotics, and a lack of age-appropriate formulations further complicate treatment.
Global Accelerator for Paediatric Formulations Network (GAP-f) was conceived following the 69th World Health Assembly resolution on promoting innovation and access to quality, safe, efficacious, and affordable medicines for children.
“Defining the antibiotic priorities for children is vital: The development of medicines for children lags unacceptably behind that for adults. Antimicrobial resistance (AMR) complicates this even further,” said Hanan Balkhy, assistant director general of WHO’s AMR division, in a press release.
WHO has declared AMR a top 10 global public health threat and is working quickly with partners to combat it — from defining essential targets and raising awareness to surveillance and guidelines, Balkhy said.
WHO has developed a Model List of Essential Medicines for Children (EMLc) to improve their access to safe and effective medicines worldwide. The EMLc includes medicines that are considered to be the most necessary for treating common diseases in children.
In 2021-2022, a comprehensive analysis of the 2021 WHO EMLc was conducted in collaboration with GAP-f partners to inform the WHO EMLc update in 2023. Formulation gaps in various drugs, as well as antibiotics, were identified during the analysis, which informed the current Paediatric drug optimisation (PADO) antibiotics exercise.
Read more: Antimicrobial resistance: 5 years after AMR national plan came out, only 3 states have one of their own
PADO exercises identify key priority products, as well as preferred product characteristics for research and development. These have been carried out successfully for HIV, hepatitis C, and tuberculosis.
In addition to antibiotics that lack formulations appropriate to age, another set of antibiotics is in development. The number of antibiotics in development decreased to 27 in 2021 from 31 in 2017, according to the annual WHO pipeline analysis.
The document included two paediatric drug optimisation lists: Priority and watch list. While the priority list includes formulations that will be investigated and developed over the next three-five years, the watch list contains antibiotics that are in development or do not have a paediatric indication.
Their paediatric indications should be studied over the next five-ten years, with paediatric indication referring to their use in children as young as six years and no older than twelve years.
Furthermore, two medications were identified as noteworthy compounds that may be of interest for future formulations for children; they are:
|PADO Priority List|
|Amoxicillin-clavulanic acid||· Multiple therapeutic indications · Minimal side effects and drug-drug interactions|
|Nitrofurantoin||· First choice in WHO EML for urinary tract infections · Acceptable resistance and cross-resistance profile|
|Azithromycin||· Multiple therapeutic indications · Ongoing studies that may expand indications for children|
|Cefiderocol||· Efficacy against multiple pathogens in the WHO Bacterial Priority Pathogens List · Ongoing clinical trials involving children|
|PADO Watch List|
|Cefepime-taniborbactam||· Efficacy against multiple pathogens on the WHO priority list|
|Sulbactam-durlobactam||· Excellent efficacy against Acinetobacter baumanii|
|PADO Antibiotics Noteworthy Pipeline Agents|
|Cefepime-zidebactam||· Efficacy against multiple pathogens in the WHO Bacterial Priority Pathogens List · Earlier stage of development|
|Aztreonam-avibactam||· Broad activity against multiple WHO-priority pathogens · Both components studied individually and approved by the US FDA and EMA as an individual component|
This optimisation allows various stakeholders and regulators to agree on priority products to be investigated and developed.
“Priority-setting is the first step to enable a more targeted and efficient approach to research and development,” said John Reeder, director at GAP-f Secretariat.
Going forward, the GAP-f working group will review opportunities for accelerating ongoing programmes and discuss how to address research priorities, which will feed into a larger research priority-setting effort led by WHO’s antimicrobial resistance division.
We are a voice to you; you have been a support to us. Together we build journalism that is independent, credible and fearless. You can further help us by making a donation. This will mean a lot for our ability to bring you news, perspectives and analysis from the ground so that we can make change together.
Comments are moderated and will be published only after the site moderator’s approval. Please use a genuine email ID and provide your name. Selected comments may also be used in the ‘Letters’ section of the Down To Earth print edition.