Publications by authors named "Monika Raethke"
Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs.
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- The study investigates the safety of COVID-19 vaccines in immunocompromised patients by comparing their reported adverse drug reactions (ADRs) to a control group.
- It involved a cohort of immunocompromised individuals from 11 European countries who completed electronic questionnaires to track ADRs after vaccination between February 2021 and February 2023.
- Results show that immunocompromised participants reported higher rates of common ADRs, like injection-site pain and fatigue, compared to their matched non-immunocompromised counterparts, particularly after the first vaccine dose.
Article Synopsis
- The study examines adverse drug reactions (ADRs) reported by individuals who received COVID-19 vaccinations, comparing those with a history of SARS-CoV-2 infection to those without, across different vaccine brands and doses.
- Conducted from February 2021 to February 2023, it included 4,788 vaccinees and found that those with previous infections reported higher ADRs after the first and booster doses, but lower ADRs after the second dose.
- Overall, while the frequency of serious ADRs was low, the study highlights the variation in reported reactions based on prior infection history and the type and timing of vaccine doses.
Introduction: During the COVID-19 pandemic, EMA set-up a large-scale cohort event monitoring (CEM) system to estimate incidence rates of patient-reported adverse drug reactions (ADRs) of different COVID-19 vaccines across the participating countries. This study aims to give an up to date and in-depth analysis of the frequency of patient-reported ADRs after the 1st, 2nd, and booster vaccination, to identify potential predictors in developing ADRs and to describe time-to-onset (TTO) and time-to-recovery (TTR) of ADRs.
Methods: A CEM study was rolled out in a period ranging from February 2021 to February 2023 across multiple European countries; The Netherlands, Belgium, France, the United Kingdom, Italy, Portugal, Romania, Slovakia and Spain.
Background And Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.
Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022.
Introduction: COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees.
Methods: A prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries.
Background: Albeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reported AEFIs after COVID-19 vaccination between males and females in the Netherlands and provides a summary of sex-disaggregated outcomes in published literature.
Methods: Patient reported outcomes of AEFIs over a six month period following the first vaccination with BioNTech-Pfizer, AstraZeneca, Moderna or the Johnson&Johnson vaccine were collected in a Cohort Event Monitoring study.