Background rates of AESIs for COVID-19 vaccine safety monitoring published

A series of Excel files with background incidence rates for 26 adverse events of special interests (AESIs) for COVID-19 vaccine safety monitoring have now been published on the ENCePP website. These background rate data are part of the work done by the EMA-funded ACCESS (vACcine Covid-19 monitoring ReadinESS) project led by the University Medical Center Utrecht and Utrecht University.

They have been generated  from 7 data sources in 5 countries (United Kingdom, Spain, Italy, Denmark, Germany). Data from the Netherlands and France and additional data from Spain should be available in March.

ACCESS had already published in the EU PAS Register protocol templates for assessment of the effectiveness, safety and coverage of COVID-19 vaccines, with three entries:

• ACCESS template protocols for effectiveness of COVID-19 vaccines
• ACCESS template protocol for safety of COVID-19 vaccines
• Coverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project