SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges

Dan M. Cooper, Behnoush Afghani, Carrie L. Byington, Coleen K. Cunningham, Sidney Golub, Kim D. Lu, Shlomit Radom-Aizik, Lainie Friedman Ross, Jasjit Singh, William E. Smoyer, Candice Taylor Lucas, Jessica Tunney, Frank Zaldivar, Erlinda R. Ulloa

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


Abstract: As the nation implements SARS-CoV-2 vaccination in adults at an unprecedented scale, it is now essential to focus on the prospect of SARS-CoV-2 vaccinations in pediatric populations. To date, no children younger than 12 years have been enrolled in clinical trials. Key challenges and knowledge gaps that must be addressed include (1) rationale for vaccines in children, (2) possible effects of immune maturation during childhood, (3) ethical concerns, (4) unique needs of children with developmental disorders and chronic conditions, (5) health inequities, and (6) vaccine hesitancy. Because COVID-19 is minimally symptomatic in the vast majority of children, a higher acceptable risk threshold is required when evaluating pediatric clinical trials. Profound differences in innate and adaptive immunity during childhood and adolescence are known to affect vaccine responsiveness for a variety of childhood diseases. COVID-19 and the accompanying social disruption, such as the school shutdowns, has been disproportionately damaging to minority and low-income children. In this commentary, we briefly address each of these key issues, specify research gaps, and suggest a broader learning health system approach to accelerate testing and clinical trial development for an ethical and effective strategy to implement a pediatric SARS-CoV-2 vaccine as rapidly and safely as possible. Impact: As the US begins an unprecedented implementation of SARS-CoV-2 vaccination, substantial knowledge gaps have yet to be addressed regarding vaccinations in the pediatric population.Maturational changes in the immune system during childhood have influenced the effectiveness of pediatric vaccines for other diseases and conditions, and could affect SARS-CoV-2 vaccine responsiveness in children.Given that COVID-19 disease is far milder in the majority of children than in adults, the risk–benefit of a pediatric SARS-CoV-2 vaccine must be carefully weighed.The needs of children with developmental disabilities and with chronic disease must be addressed.Minority and low-income children have been disproportionately adversely affected by the COVID-19 pandemic; care must be taken to address issues of health equity regarding pediatric SARS-CoV-2 vaccine trials and allocation.Research and strategies to address general vaccine hesitancy in communities must be addressed in the context of pediatric SARS-CoV-2 vaccines.

Original languageEnglish (US)
Pages (from-to)966-970
Number of pages5
JournalPediatric Research
Issue number5
Early online dateFeb 24 2021
StateE-pub ahead of print - Feb 24 2021

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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