gms | German Medical Science

Background and status of (inter)national research: Clinical trials have shown a high efficacy and safety of the licensed COVID-19 vaccines. These vaccines are currently given to millions of people within a very short period of time. Until now, data on rare but potentially serious side effects under real-world conditions are limited. The reliable estimation of adverse events after COVID-19 vaccination requires the active surveillance of side effects of COVID-19 vaccines in comparison to other frequent vaccines (e.g. influenza, pneumococcus and zoster).

Question and objective: This pilot study aims to evaluate the feasibility of a Bavarian-wide prospective cohort study investigating adverse events of COVID-19 vaccines in comparison to other vaccines. The study focuses on adverse events that caused outpatient care, hospitalization, medication use, or incapacity for work.

Method or hypothesis: Aim of this study is to prove the feasibility of an observational online questionnaire study. Participants are recruited at COVID-19 vaccination centers or in primary care practices where they are informed about the study by flyers or posters. Registration for the study is performed by using a QR code or web link, which are provided on the information materials. The observation period is 18 weeks during which participants will be invited via e-mail to complete online questionnaires at up to four points of times. The following data are collected: General health status, medical complaints, physician’s office visits or hospital admissions with medical treatment and severity of disorders (long-term consequences).

A pretest using qualitative, online focus groups will be conducted to evaluate the online questionnaires and recruitment materials. Questions will be asked about comprehensibility and readability, clarity of the study process, perceived effort, and motivation to participate. To simulate and test the feasibility of the whole process a first group of vaccinated people will be recruited. Interviews with the vaccinating medical staff and walk-in protocols will be prepared for the same purpose.

Results: Data collection was ongoing at the time of abstract submission. Results will be available by the time of the congress.

Discussion: The study is expected to make an important contribution to the question of what methodology may be appropriate for recording adverse vaccine reactions.

Practical implications: Findings on the conduct of studies in primary care practices.

Appeal for practice (science and/or care) in one sentence: Feasibility studies are essential to test the implementation of studies in real-world care.