The majority of COVID-19 vaccine clinical trials are targeting adults more than children. However, this situation needs to be remedied – and quickly. Although early reports show that  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.

The disparity between adult and pediatric product development is nothing new. Developmental differences in immune responses from infancy through adolescence often warrant age-group specific endpoints in pediatric trials. Adding pediatric studies into a diverse array of vaccine platforms increases the challenges for  vaccine developers. But the collective experience of vaccine developers, pediatric investigators, and advocates can reduce missteps or duplicative efforts. Harmonizing plans for pediatric vaccine programs will best serve the needs of children and their parents.

Managing challenges begins with planning protocol rollout through the lens of pediatric investigators and their clinical trial teams. Equally important is appreciating the perspective of parents and their children to aid in planning for recruitment, compliance, and retention. Protocol feasibility should be thoroughly explored with potential investigators prior to finalizing the protocol.

During the  pandemic, sponsors and sites should prepare answers to foreseeable questions from parents and children related to the public discourse on COVID-19 and vaccine trials. Checklists could be used for important points and consistent messaging across study sites. Ideally, dry runs should also include investigator and staff role-playing for the parental consent and child-assent process to answer questions about procedures and safety.

Sponsors and pediatric sites rely on age-appropriate materials for children and their parents to promote recruitment and compliance through the final study visit. These materials will need to counteract inaccurate information about vaccine research in general, and specifically about COVID-19 spread and prevention. Time involved in collecting vital signs is also longer, especially when  corralling active toddlers. The same applies to nasal swabs, blood collection, injections, and other procedures that will  be included in COVID-19 studies.

Anticipating and managing these additional considerations will help increase pediatric COVID-19 trials to ensure protection and treatment for this special population.

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