Article
CoVaKo: Corona vaccine consortium – an online observational study to evaluate reactogenicity after various vaccines
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Authors
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Susann Hueber
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Lisette Warkentin
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Nikoletta Lippert
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Maria Sebastiao
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Felix Werner
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Carolin Nürnberger
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Christine Gall
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Medizininformatik, Biometrie und Epidemiologie (IMBE), Erlangen, Deutschland
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Isabelle Kaiser
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Medizininformatik, Biometrie und Epidemiologie (IMBE), Erlangen, Deutschland
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Philipp Steininger
- Universitätsklinikum Erlangen, Virologisches Institut, Erlangen, Deutschland
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Klaus Überla
- Universitätsklinikum Erlangen, Virologisches Institut, Erlangen, Deutschland
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Thomas Kühlein
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
| Published: | September 30, 2022 |
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Outline
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Background and status of (inter)national research: The efficacy and safety of COVID-19 vaccines have been demonstrated in large randomized controlled trials. In addition, observational studies provide further important insights into the safety and efficacy of the vaccines under real-life conditions.
Research question and objective: In the CoVaKo safety study, we aim to assess reactogenicity and health problems after COVID-19 vaccination (= observation group) compared to other vaccinations like influenza or pneumococcal vaccination (= control group). The study focus is on health problems occurring within 18 weeks after vaccination and leading to medical consultation, medication intake, or sick-leave.
Method or hypothesis: In a longitudinal observational cohort study reactogenicity and safety of vaccinations were assessed 14 to 19 days, 40 to 45 days and 124 to 129 days after vaccination using web-based surveys. Recruitment of vaccinated participants commenced on April 17, 2021 in vaccination centres and primary care practices in Bavaria, Germany. Enrollment ended in April 2022. After a vaccination, individuals received a leaflet with information on the study and had the possibility to voluntarily register on a web-based platform (www.covako.org). Afterwards participants received the links to the surveys via E-Mail.
Results: Until March 2022, 17.177 participants registered for the study. The cohorts are as follows: prime vaccination: 9.624 persons received one of the mRNA vaccines, 3.491 persons received the vaccine ChAdOx1 and 237 persons received the Janssen vaccine; second vaccination: 11.665 persons received one of the mRNA vaccines and 627 persons received ChAdOx1. The control group comprises 571 subjects, thereof 76 % (n = 437) received the influenza vaccination. The study is currently being analysed. The final results will be available at the conference.
Discussion: The CoVaKo safety study will provide insights regarding reactogenicity and safety under real-world-conditions.
Practical implications: CoVaKo shows how an observational study can be conducted when facing dynamic changes as in COVID-19 vaccination strategies and under high workload in the health care system.
Appeal for practice (science and/or care) in one sentence: Systematic collection of data on vaccinations and vaccination adverse events is essential for patient care and health services research.
Funding: Sonstige Förderung
