Active monitoring of adverse reactions following COVID-19 and other vaccinations: a feasibility study as part of the CoVaKo project

Abstract

Background The Corona-Vakzin-Konsortium project (CoVaKo) analyses the efficacy and safety of COVID-19 vaccines in a real-world setting, as well as breakthrough infections in Bavaria, Germany. A subproject of CoVaKo aims to identify adverse reactions of the COVID-19 vaccine and compare these to adverse reactions of other vaccines in an online survey. In a preceding feasibility study, the study materials were tested for comprehensibility, visual design, and motivation to participate, as well as for their ability to be implemented and carried out in primary care practices and vaccination centres. Methods We used a mixed-methods research design. First, three focus groups consisting of general population participants were organised to evaluate the study materials and survey. Second, a test roll-out was conducted in vaccination centres and primary care practices that involved implementing and quantitatively evaluating the online survey. Third, interviews were conducted with participating general practitioners and heads of vaccination centres four weeks after the test roll-out. Results Parts of the information and registration form proved incomprehensible, specifically regarding the recruitment material and/or online survey. For example, headings were misleading given that, relative to other vaccinations, the COVID-19 vaccination was overemphasised in the title. Participants requested additional information regarding the procedure and completion time. Within 31 days, 2199 participants, who received either a COVID-19 vaccination (99%) or at least one of the control vaccinations (1%), registered for the study. Participants (strongly) agreed that the registration process was easy to understand, that the completion time was reasonable, and that the technical setup was straightforward. Physicians and heads of the vaccination centres perceived the study as easy to integrate into their workflow. The majority expressed willingness to participate in the main study. Conclusions Our study indicated that identifying and documenting adverse reactions following vaccinations using an online survey is feasible. Testing materials and surveys provided valuable insight, enabling subsequent improvements. Participation from health professionals proved essential in ensuring the practicality of procedures. Lastly, adapting the study’s organisation to external fluctuating structures and requirements confirmed necessary for a successful implementation, especially due to dynamic changes in the nation’s COVID-19 vaccination strategies. Trial registration The trial was retrospectively registered at the “Deutsches Register Klinischer Studien” (DRKS-ID: DRKS00025881) on Oct 14, 2021.

Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study

“…Recruitment strategy and surveys had been evaluated in a feasibility study [ 22 ] (registered at DRKS: ID DRKS00025881 [ 23 ], main study registered at DRKS: ID DRKS00025373 [ 24 ]). Recruitment of vaccinated participants commenced on April 17, 2021 (feasibility study), and May 20, 2021 (main study) respectively, in vaccination centres, primary care and company physician practices in Bavaria, Germany.…”

COVID-19 vaccine short-term adverse events in the real-life family practice in Krakow, Poland

“…So far, this is one of the few studies to actively investigate VAEs in the primary care setting (data from an Australian large-scale system are already available [ 17 ], while those from Europe have not yet been published [ 18 , 19 ]). Our findings reflect the possible daily experience of primary care physicians vaccinating their patients against COVID-19.…”

Patient-reported reactogenicity and safety of COVID-19 vaccinations vs. comparator vaccinations: a comparative observational cohort study

“…The recruitment strategy and the surveys were evaluated in a feasibility study [ 18 ] (DRKS ID DRKS00025881 [ 19 ]). Recruitment started on April 17th, 2021 for the feasibility study and on May 20th, 2021 for the main study (DRKS ID DRKS00025373 [ 16 ]) in vaccination centres as well as primary care and occupational physicians’ practices in Bavaria, Germany.…”