gms | German Medical Science

21. Deutscher Kongress für Versorgungsforschung

Deutsches Netzwerk Versorgungsforschung e. V.

05.10. - 07.10.2022, Potsdam

CoVaKo: Corona vaccine consortium – an online observational study to evaluate reactogenicity after various vaccines

Meeting Abstract

  • Susann Hueber - Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
  • Lisette Warkentin - Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
  • Nikoletta Lippert - Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
  • Maria Sebastiao - Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
  • Felix Werner - Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
  • Carolin Nürnberger - Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
  • Christine Gall - Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Medizininformatik, Biometrie und Epidemiologie (IMBE), Erlangen, Deutschland
  • Isabelle Kaiser - Friedrich-Alexander-Universität Erlangen-Nürnberg, Institut für Medizininformatik, Biometrie und Epidemiologie (IMBE), Erlangen, Deutschland
  • Philipp Steininger - Universitätsklinikum Erlangen, Virologisches Institut, Erlangen, Deutschland
  • Klaus Überla - Universitätsklinikum Erlangen, Virologisches Institut, Erlangen, Deutschland
  • Thomas Kühlein - Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland

21. Deutscher Kongress für Versorgungsforschung (DKVF). Potsdam, 05.-07.10.2022. Düsseldorf: German Medical Science GMS Publishing House; 2022. Doc22dkvf248

doi: 10.3205/22dkvf248, urn:nbn:de:0183-22dkvf2489

Published: September 30, 2022

© 2022 Hueber et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

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