RECOVAC: Register-based large-scale national population study to monitor Covid-19 vaccination effectiveness and safety

RECOVAC aims to deliver continuous Covid-19 vaccination follow-up and research on effectiveness and safety in a nationwide linked multi-register, regularly updated, observational study for timely response to key scientific questions.

For this effort, we have linked the Covid-19 vaccination data from the National Vaccination Register to SCIFI-PEARL, which is a large case-cohort register study, where all Covid-19 cases in Sweden are continuously identified from data sources including SmiNet, National Patient Register, Cause-of-Death Register, national quality registers, and primary care (Region Västra Götaland and Region Stockholm). Individuals with events that could be potential vaccine adverse events (AEs) will be similarly identified from the population, using national register or primary care diagnoses and a person-centered web app based symptom reporting system. A comparison population of approximately 10% of the Swedish population with corresponding data is also available, sampled from general population registers. In the analyses, potential vaccine AEs will be related to vaccination status and subject characteristics. Study population and data are updated every 1-3 months.

The study cohort will capture all Swedish Covid-19 cases, potential vaccine AE cases and 10% of the general population on an ongoing basis with broad healthcare data, and will now link to vaccination data for a comprehensive longitudinal view of the Covid-19 pandemic and vaccination program. The project provides a unique resource of timely and continuous data for epidemiological research on SARS-CoV-2 vaccination, to support public health and safety. The web app will enable patient participation and reporting of symptoms, in order to directly contribute to vaccine monitoring and safety.