How to ensure we can track and trace global use of COVID-19 vaccines?

Abstract

In response to the devastating SARS-Cov-2 pandemic, an unprecedented surge in vaccine development has occurred. More than 250 vaccines are being developed, at least 50 of which are in clinical trials [1]. Several companies have already started vaccine production ahead of the results of the pivotal Phase III trials. In anticipation of rapid availability of COVID-19 vaccines, shortcuts in the development and regulatory approval processes have been suggested and warned against to combat vaccine hesitancy [2]. Many COVID-19 vaccines are using novel technology platforms little or never used in clinical care previously [1]. Combined with the inherent limited sample size, duration, and population heterogeneity of pre-licensure clinical trials, there is a critical need to monitor safety and effectiveness of the COVID-19 vaccines post-introduction [3]. Several COVID-19 vaccines should be available to meet the global need, mostly via COVAX, a new alliance to ensure equitable access [4]. In addition, national mass vaccination programs will be aimed mostly at adults, not children -- whom vaccinations traditionally target. Moreover, these programs will likely be conducted in a highly dispersed manner in healthcare institutions, nursing homes, workplaces, schools, etc… [5] Sophisticated systems are needed therefore to track and trace on a global scale who was immunized with which COVID-19 vaccine product, where and when. This “exposure” data is vital for any post-introduction study.