TY - JOUR
T1 - SARS-CoV-2 vaccine testing and trials in the pediatric population
T2 - biologic, ethical, research, and implementation challenges
AU - Cooper, Dan M.
AU - Afghani, Behnoush
AU - Byington, Carrie L.
AU - Cunningham, Coleen K.
AU - Golub, Sidney
AU - Lu, Kim D.
AU - Radom-Aizik, Shlomit
AU - Ross, Lainie Friedman
AU - Singh, Jasjit
AU - Smoyer, William E.
AU - Lucas, Candice Taylor
AU - Tunney, Jessica
AU - Zaldivar, Frank
AU - Ulloa, Erlinda R.
N1 - Funding Information:
The authors acknowledge NIH NCATS UCI Clinical and Translational Science Award UL1 TR001414. Support was provided in part by the Robert Wood Johnson Foundation to E.R.U.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to the International Pediatric Research Foundation, Inc.
PY - 2021/2/24
Y1 - 2021/2/24
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85101528975&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85101528975&partnerID=8YFLogxK
U2 - 10.1038/s41390-021-01402-z
DO - 10.1038/s41390-021-01402-z
M3 - Article
C2 - 33627824
AN - SCOPUS:85101528975
VL - 90
SP - 966
EP - 970
JO - Pediatric Research
JF - Pediatric Research
SN - 0031-3998
IS - 5
ER -