COVID-19 Vaccines: Need for Global Tracking System

As the world's first COVID-19 mass vaccination programmes are underway in the UK, the U.S. and some other countries, a new paper (Vander Stichele et al. 2020) highlights the need for global monitoring of vaccine use (who was inoculated with which vaccine product, where and when) as well as its safety and effectiveness.

"Many COVID-19 vaccines are using novel technology platforms little or never used in clinical care previously," the report points out. "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."

Specifically, the paper cites two key elements that make for a robust pharmacovigilance strategy:

 1) Unique 'univocal' global identification of COVID-19 vaccines

 Each vaccine product should have its global univocal identification (named Pharmaceutical Product Identifier or PhPID), as described in the ISO/CEN suite of IDMP standards. This helps with recognising branded variations of the same global vaccine, marketed in different countries. This requirement is supported for all medical products by the FDA and by EMA, and facilitated by the EU Action Project UNICOM. The WHO Collaborating Centre for International Drug Monitoring in Uppsala (WHO UMC) is ready to assign such global identification for every unique vaccine.