I-ACT for Children Commentary Published in Pediatric Infectious Disease Journal
Sept. 1, 2020 – The FDA’s inclusion of children in its Emergency Use Authorization for use of remdesivir in treating serious COVID-19 disease is an important milestone, as it provides children with access to the medication at the same level of urgency afforded adults, according to an I-ACT for Children commentary published this week in the September 2020 issue of the Pediatric Infectious Disease Journal.
The commentary, written by I-ACT for Children Chief Medical Officer Gary Noel, MD, and Chairman of the Board Edward Connor, MD, MBE, can be found here.
The EUA for use of remdesivir does not obviate the need for rigorous trials involving children as remdesivir and other agents are being studied, Drs. Noel and Connor note. But it does demonstrate that innovative methodology can play an important role in improving treatment for children, particularly when urgency is required. It also underscores FDA’s commitment to advancing pediatric drug development.
For studies of COVID-19 investigational agents, adolescents should be included in adult trials (or studies in adolescents should be conducted in parallel), given adolescents’ physiologic similarity to adults and the potential benefit of these agents for treating this life-threatening infection, the authors write, adding that studies of younger children should be launched as soon as ethically justified.