COVID-19 in children: medication and vaccine dosing, safety, and regulatory considerations

Rachel G. Greenberg, MD, MB, MHS, associate professor of Pediatrics, Duke University, Duke Clinical Research Institute, Durham, North Carolina offered an overview of the FDA drug approval process for children and a look at off-label drug use in this population. In an update from the Pediatric Trials Network (PTN), she observed, “Of more than 1.4 billion visits, physicians ordered more than 1 off-label systemic drug at 19% of visits.” Showing the audience a list of 20 medications used in the NICU, half were not approved in extremely low birth weight infants. Her discussion then transitioned into a brief discussion of the FDA drug approval process and how emergency use authorization works.

The challenges of pediatric drug trials, she noted, included expense, lack of feasibility, biomarker qualification, absence of adult indications, and lack of understanding of disease natural history. She further discussed the importance of the PTN, aimed at creating an infrastructure for investigators to conduct trials to improve pediatric labeling and child health. Among their successes: in trials with more than 11,000 participants, 26 products were submitted to the FDA, 18 therapeutic areas studied, with studies covered in nearly 100 publications.

Her talk also looked at various label changes, and what is next on the horizon for the PTN, which includes ongoing studies of:

--Sildenafil (for possible use in premature infants at risk of bronchopulmonary dysplasia

-Anesthetics/analgesics (including drugs of interest such as morphine, oxycodone, and ketamine)

-Long-term antipsychotic pediatric safety trial (LAPS)

-Pediatric opportunistic pharmacokinetics study (POPS)

-Commonly use drugs in lactating women and breastfed infants (CUDDLE)

“Performing trials in children remain challenging,” Greenberg concluded. The PTN designs and implements studies to improve knowledge of pediatric dosing, safety, and efficacy.”

Reference
Greenberg RG. Advances in pediatric medications and FDA labels: Update from the Pediatric Trials Network (PTN). 2022 AAP National Conference & Exhibition. October 8, 2022. Anaheim, California.