Impact of coronavirus disease-19 pandemic on pediatric vaccine clinical trials

Abstract

T he World Health Organization declared coronavirus disease (COVID)-19 a public health emergency of international concern on January 30, 2020, and later declared a pandemic on March 11, 2020 [1]. The first confirmed case of coronavirus in Maharashtra was reported on March 9, 2020, in our city of Pune. Gradually, the pandemic spreads to all parts of the country, and eventually, the tally of COVID-19 cases by December 2020 touched 10 million.The COVID-19 pandemic has affected nearly every facet of life, including clinical research and has had an adverse and extensive impact on clinical trials including pediatric vaccine trials. Across the globe, countries implemented a variety of restrictions to people's everyday lives which included, countrywide lockdowns, and social distancing, which have been major detrimental factors for the conduct of pediatric vaccine trials [2]. The present study was proposed to assess the impact of the COVID-19 pandemic on enrollment and follow-up of clinical trial participants in pediatric vaccine clinical trials and simultaneously to explore various strategies used for overcoming these challenges during the COVID-19 pandemic. MATERIALS AND METHODSThis observational, cross-sectional study was conducted in the Clinical Research Unit of a tertiary care multispecialty hospital in Pune, where pediatric vaccine clinical trials are routinely