By Renee Simar, Ph.D., Elligo Pediatric Advisory, Board Chair
Vaccine clinical trials against COVID-19 in adults are leading the effort before studies begin in children. Although early reports show COVID-19 symptoms tend to be milder in children, some develop severe manifestations of the disease. With an even larger gap in symptomology between adults and children, adult trials will not be easily adaptable to children.
Despite decades of progress in pediatric product development, pediatric clinical research remains challenging. A comment from FDA’s Dr. Dianne Murphy in 1999 highlights a relevant keystone during the rapid pace of this pandemic, “We have a very high bar to pass if we are going to enroll children in clinical trials.”1 Adapting the accelerated activities in the adult vaccine programs to children will be inherently difficult as clinical trials will be needed to establish safety and efficacy. However, this goal is achievable with strategic, early planning to ensure ethical trial conduct.