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

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

Research project
Active research
Website
The Institute of Medicine
Project period
2021 - ongoing
Project owner
The Institute of Medicine
Financier
Knut and Alice Wallenbergs Foundation/SciFiLab; Swedish Research Council
Area
Health and medicine
Topic
Public Health, Global Health and Social Medicine Epidemiology

Short description

RECOVAC is the name we have chosen for the vaccination research subprojects within the SCIFI-PEARL project.

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.

Swedish COVID-19 & Pandemic Preparedness Data Portal

For data visualization related to the overall adult population, and data specifically related to those diagnosed with specific comorbidities in Sweden, check the regularly updated RECOVAC dashboard in collaboration with SciLifeLab on the Swedish COVID-19 & Pandemic Preparedness Data Portal.

Published vaccine studies

  • Xu Y, Nyberg F. Clarification on methodology used in the study investigating COVID-19 vaccination and cardiovascular events. Eur Heart J. 2025 Apr 22;46(16):1558-1559. doi: 10.1093/eurheartj/ehaf063. PMID: 39960846.
  • Barker MM, Kõiv K, Magnúsdóttir I, Milbourn H, Wang B, Du X, Murphy G, Herweijer E, Gísladóttir EU, Li H, Lovik A, Kähler AK, Campbell A, Feychting M, Hauksdóttir A, Joyce EE, Thordardottir EB, Frans EM, Hoffart A, Mägi R, Tómasson G, Ásbjörnsdóttir K, Jakobsdóttir J, Andreassen OA, Sullivan PF, Johnson SU, Aspelund T, Brandlistuen RE, Ask H, McCartney DL, Ebrahimi OV, Lehto K, Valdimarsdóttir UA, Nyberg F, Fang F. Mental illness and COVID-19 vaccination: a multinational investigation of observational & register-based data. Nat Commun. 2024 Sep 26;15(1):8124. doi: 10.1038/s41467-024-52342-1. PMID: 39327436; PMCID: PMC11427681.
  • Gustafson Hedov E, Nyberg F, Gustafsson S, Li H, Gisslén M, Sundström J. Person-Centered Web-Based Mobile Health System (Symptoms) for Reporting Symptoms in COVID-19 Vaccinated Individuals: Observational Study of System, Users, and Symptoms. JMIR Form Res. 2024 Oct 30;8:e57514. doi: 10.2196/57514. PMID: 39476854; PMCID: PMC11561448.
  • Xu Y, Li H, Santosa A, Wettermark B, Fall T, Björk J, Börjesson M, Gisslén M, Nyberg F. Cardiovascular events following coronavirus disease 2019 vaccination in adults: a nationwide Swedish study. Eur Heart J. 2024 Sep 30:ehae639. doi: 10.1093/eurheartj/ehae639. Epub ahead of print. PMID: 39344920.
  • Søfteland JM, Li H, Magnusson JM, Leach S, Friman V, Gisslén M, Felldin M, Schult A, Karason K, Baid-Agrawal S, Wallquist C, Nyberg F. COVID-19 Outcomes and Vaccinations in Swedish Solid Organ Transplant Recipients 2020-2021: A Nationwide Multi-Register Comparative Cohort Study. Viruses. 2024 Feb 8;16(2):271. doi: 10.3390/v16020271. PMID: 38400046.
  • Lundberg-Morris L, Leach S, Xu Y, Martikainen J, Santosa A, Gisslén M, Li H, Nyberg F, Bygdell M. Covid-19 vaccine effectiveness against post-covid-19 condition among 589 722 individuals in Sweden: population based cohort study. BMJ. 2023 Nov 22;383:e076990. doi: 10.1136/bmj-2023-076990. PMID: 37993131; PMCID: PMC10666099.
  • Ljung R, Xu Y, Sundström A, Leach S, Hallberg E, Bygdell M, Larsson M, Arthurson V, Gisslén M, Gedeborg R, Nyberg F. Association between SARS-CoV-2 vaccination and healthcare contacts for menstrual disturbance and bleeding in women before and after menopause: nationwide, register based cohort study. BMJ. 2023 May 3;381:e074778. doi: 10.1136/bmj-2023-074778. PMID: 37137493.
  • Spetz M, Lundberg L, Nwaru C, Li H, Santosa A, Ng N, Leach S, Gisslén M, Hammar N, Nyberg F, Rosvall M. An intersectional analysis of sociodemographic disparities in Covid-19 vaccination: A nationwide register-based study in Sweden. Vaccine. 2022 Nov 2;40(46):6640-6648. doi: 10.1016/j.vaccine.2022.09.065. Epub 2022 Sep 28. PMID: 36210254; PMCID: PMC9515344.
  • Xu Y, Li H, Kirui B, Santosa A, Gisslén M, Leach S, Wettermark B, Vanfleteren LEGW, Nyberg F. Effectiveness of COVID-19 Vaccines over 13 Months Covering the Period of the Emergence of the Omicron Variant in the Swedish Population. Vaccines. 2022; 10(12):2074. https://doi.org/10.3390/vaccines10122074.
  • Spetz M, Lundberg L, Nwaru C, Li H, Santosa A, Leach S, Gisslén M, Hammar N, Rosvall M, Nyberg F. The social patterning of Covid-19 vaccine uptake in older adults: A register-based cross-sectional study in Sweden. Lancet Reg Health Eur. 2022 Apr;15:100331. doi: 10.1016/j.lanepe.2022.100331. Epub 2022 Feb 26. PMID: 35252941; PMCID: PMC8881226.
  • Nyberg F, Lindh M, Vanfleteren L, Hammar N, Wettermark B, Sundström J, Santosa A, Kirui BK, Gisslén M. Adverse events of special interest for COVID-19 vaccines - background incidences vary by sex, age and time period and are affected by the pandemic. Preprint. medRxiv 2021.10.04.21263507; doi: https://doi.org/10.1101/2021.10.04.21263507
  • Xu Y, Nyberg F, Santosa A, Marking U, Jonsson J, Gisslén M, Wastesson JW, Johnell K. Regional differences in COVID-19 vaccine uptake and their determinants among Swedish older adults. Public Health. 2025 May;242:324-331. doi: 10.1016/j.puhe.2025.03.028. Epub 2025 Apr 3. PMID: 40179817.
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