Risk Assessment of therapeutic agents under consideration to treat
COVID-19 in Pediatric Patients and Pregnant Women
Abstract
Aim. Repurposing strategies to address the COVID-19 pandemic have been
accelerated. As both pregnant and pediatric patients are likely to be
excluded from most planned investigations, the list of repurposed
options and the available data on these drugs and vaccines provides a
baseline risk assessment and identifies gaps for targeted investigation.
Methods. Clinical trials have been searched and reviewed; twenty-three
repurposed drugs and drug combinations and 9 candidate vaccines have
been assessed regarding the availability of relevant data in pediatrics
and pregnant women and to evaluate expected or unanticipated risk.
Results. Thirteen of the repurposed drugs or drug combinations are
indicated for use in pediatrics in some age category albeit for
indications other than COVID-19; 10 of these are indicated for use in
pregnant women. Even in cases where these drugs are indicated in the
populations, source data from which safety and or dosing could be
extrapolated for use in COVID-19 is sparse. Vaccine trials are ongoing
and generally exclude pregnant women; only in a few instances have
pediatric subgroups been planned for enrollment. Data from individual
case studies and RWD may suggest that subpopulations of both pediatric
patients and pregnant women may be more at risk, particularly those in
an increased inflammatory state. Conclusion. In conjunction with more
prospective collaboration, plans are evolving to ensure that we will be
better prepared to address similar situations especially in pediatrics
and pregnant women where experience is limited and actual practice
relies heavily on leveraging data from other populations and
indications.