The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE)
Background: The coronavirus disease 2019 (COVID-19) vaccines have been rapidly implemented in national vaccination programs world-wide after accelerated approval processes. The large population exposure achieved in very short time requires systematic monitoring of safety. The Swedish Medical Product...
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| Format: | Article |
| Language: | English |
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Upsala Medical Society
2021-12-01
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| Series: | Upsala Journal of Medical Sciences |
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| Online Access: | https://ujms.net/index.php/ujms/article/view/8136/13878 |
| _version_ | 1797708026495369216 |
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| author | Rickard Ljung Anders Sundström Maria Grünewald Charlotte Backman Nils Feltelius Rolf Gedeborg Björn Zethelius |
| author_facet | Rickard Ljung Anders Sundström Maria Grünewald Charlotte Backman Nils Feltelius Rolf Gedeborg Björn Zethelius |
| author_sort | Rickard Ljung |
| collection | DOAJ |
| description | Background: The coronavirus disease 2019 (COVID-19) vaccines have been rapidly implemented in national vaccination programs world-wide after accelerated approval processes. The large population exposure achieved in very short time requires systematic monitoring of safety. The Swedish Medical Products Agency has launched a project platform for epidemiological surveillance to detect and characterise suspected adverse effects of COVID-19 vaccines in Sweden. Methods: The platform includes all individuals 12 years or older in Sweden in 2021 and will be updated annually. Data, including vaccine and COVID-19 disease data, socioeconomic and demographic data, comorbidity, prescribed medicines and healthcare utilisation outcomes, are obtained from several national registers in collaboration with other Swedish Government agencies. Data from 2015 to 2019 are used as a historical comparison cohort unexposed to both the COVID-19 pandemic and to the COVID-19 vaccines. Results: The primary study cohort includes 8,305,978 adults 18 years and older permanently residing in Sweden on 31 December 2020. The historical control cohort includes 8,679,641 subjects. By 31 July 2021, around 50% of those 18 years and older and two-thirds of those 50 years and older were vaccinated with at least one dose, 90% of those 70 years or older had two doses. Conclusions: The nationwide register-based study cohort created by the Swedish Medical Products Agency with regular updates of individual level linkage of COVID-19 vaccination exposure data to other health data registers will facilitate both safety signal detection and evaluation and other pharmacoepidemiological studies. |
| first_indexed | 2024-03-12T06:15:13Z |
| format | Article |
| id | doaj.art-f1e89f406ab945b6a21929bee5a40dfc |
| institution | Directory Open Access Journal |
| issn | 0300-9734 2000-1967 |
| language | English |
| last_indexed | 2024-03-12T06:15:13Z |
| publishDate | 2021-12-01 |
| publisher | Upsala Medical Society |
| record_format | Article |
| series | Upsala Journal of Medical Sciences |
| spelling | doaj.art-f1e89f406ab945b6a21929bee5a40dfc2023-09-03T02:40:11ZengUpsala Medical SocietyUpsala Journal of Medical Sciences0300-97342000-19672021-12-0112611110.48101/ujms.v126.81368136The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE)Rickard Ljung0Anders Sundström1Maria Grünewald2Charlotte Backman3Nils Feltelius4Rolf Gedeborg5Björn Zethelius6Swedish Medical Products Agency, Uppsala, SwedenSwedish Medical Products Agency, Uppsala, SwedenSwedish Medical Products Agency, Uppsala, SwedenSwedish Medical Products Agency, Uppsala, SwedenSwedish Medical Products Agency, Uppsala, SwedenSwedish Medical Products Agency, Uppsala, SwedenSwedish Medical Products Agency, Uppsala, SwedenBackground: The coronavirus disease 2019 (COVID-19) vaccines have been rapidly implemented in national vaccination programs world-wide after accelerated approval processes. The large population exposure achieved in very short time requires systematic monitoring of safety. The Swedish Medical Products Agency has launched a project platform for epidemiological surveillance to detect and characterise suspected adverse effects of COVID-19 vaccines in Sweden. Methods: The platform includes all individuals 12 years or older in Sweden in 2021 and will be updated annually. Data, including vaccine and COVID-19 disease data, socioeconomic and demographic data, comorbidity, prescribed medicines and healthcare utilisation outcomes, are obtained from several national registers in collaboration with other Swedish Government agencies. Data from 2015 to 2019 are used as a historical comparison cohort unexposed to both the COVID-19 pandemic and to the COVID-19 vaccines. Results: The primary study cohort includes 8,305,978 adults 18 years and older permanently residing in Sweden on 31 December 2020. The historical control cohort includes 8,679,641 subjects. By 31 July 2021, around 50% of those 18 years and older and two-thirds of those 50 years and older were vaccinated with at least one dose, 90% of those 70 years or older had two doses. Conclusions: The nationwide register-based study cohort created by the Swedish Medical Products Agency with regular updates of individual level linkage of COVID-19 vaccination exposure data to other health data registers will facilitate both safety signal detection and evaluation and other pharmacoepidemiological studies.https://ujms.net/index.php/ujms/article/view/8136/13878covid-19sars-cov-2pharmacovigilanceepidemiologicalsurveillancemonitoringsafetyefficacyvaccinesignal detection |
| spellingShingle | Rickard Ljung Anders Sundström Maria Grünewald Charlotte Backman Nils Feltelius Rolf Gedeborg Björn Zethelius The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE) Upsala Journal of Medical Sciences covid-19 sars-cov-2 pharmacovigilance epidemiological surveillance monitoring safety efficacy vaccine signal detection |
| title | The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE) |
| title_full | The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE) |
| title_fullStr | The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE) |
| title_full_unstemmed | The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE) |
| title_short | The profile of the COvid-19 VACcination register SAFEty study in Sweden (CoVacSafe-SE) |
| title_sort | profile of the covid 19 vaccination register safety study in sweden covacsafe se |
| topic | covid-19 sars-cov-2 pharmacovigilance epidemiological surveillance monitoring safety efficacy vaccine signal detection |
| url | https://ujms.net/index.php/ujms/article/view/8136/13878 |
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