Table 1.
Timeline of key pediatric TB R&D milestones.
| Year | Preventive Treatment | Vaccines | Diagnostics | Treatment |
|---|---|---|---|---|
| 2010 | WHO recommended revisions to pediatric dosing for first-line medicines | |||
| 2011 | ||||
| 2012 | ||||
| 2013 | WHO endorsed Xpert MTB/RIF as initial test in children (strong: MDR- or HIV-associated TB; conditional: all children) | Pediatric investigations of delamanid initiated | ||
| 2014 | FDA expanded approved indication for rifapentine to children (2+ years) | |||
| 2015 | WHO endorsed LF-LAM for testing HIV-positive children with signs and symptoms of TB | |||
| 2016 | Pediatric investigation of levofloxacin initiated | Pediatric investigation of bedaquiline initiated; Pediatric formulation of pyrazinamide approved by WHO Pre-Qualification Program |
||
| 2017 | New pediatric fixed-dose combinations aligned with 2010 WHO dosing guideline revision approved by WHO Pre-Qualification Program; Pediatric formulation of ethionamide approved by WHO Pre-Qualification Program | |||
| 2018 | Pediatric formulations of ethambutol, levofloxacin, moxifloxacin, cycloserine approved by WHO Pre-Qualification Program | |||
| 2019 | Pediatric investigation of rifapentine (including children less than 2 years old and children living with HIV) initiated Pediatric investigation of delamanid initiated |
Ph 3 study of Mycobacterium Indicus Pranii (MIP) and VPM1002 (6+ years old) initiated | WHO expanded LF-LAM recommendations to include HIV-positive adolescents and children that are seriously ill, have advanced HIV disease, or a CD4 count less than 200 (for inpatients) or 100 (for outpatients) | Pediatric formulation of isoniazid approved by WHO-Pre-Qualification Program |
| 2020 | Ph 3 study of VPM1002 (infants) initiated | WHO endorsed Xpert MTB/RIF as initial test in children (strong: all) + expanded sample types to include gastric aspirate (GA), nasopharyngeal aspirate (NPA), stool WHO endorsed Xpert Ultra as initial test in children (strong: all) but limited sample types to sputum or NPA WHO endorsed Truenat MTB or MTB Plus as initial test in children (conditional) |
Pediatric investigations of DLM completed FDA approved pediatric BDQ formulation Pediatric formulation of clofazimine approved by WHO Pre-Qualification Program |
|
| 2021 | WHO endorsed expanding pediatric sample types for use on Xpert Ultra as initial test in children to include GA and stool samples | EMA approved pediatric delamanid formulation |