Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose
Monika Raethke (),
Florence Hunsel,
Nicolas H. Thurin,
Caroline Dureau-Pournin,
Dirk Mentzer,
Barbara Kovačić,
Nikica Mirošević Skvrce,
Evelien Clercq,
Martine Sabbe,
Gianluca Trifirò,
Nicoletta Luxi,
Alexia Giovanazzi,
Saad Shakir,
Olaf H. Klungel,
Sandor Schmikli and
Miriam Sturkenboom
Additional contact information
Monika Raethke: Netherlands Pharmacovigilance Centre Lareb
Florence Hunsel: Netherlands Pharmacovigilance Centre Lareb
Nicolas H. Thurin: Bordeaux PharmacoEpi, INSERM CIC-P 1401, Univ. Bordeaux
Caroline Dureau-Pournin: Bordeaux PharmacoEpi, INSERM CIC-P 1401, Univ. Bordeaux
Dirk Mentzer: Federal Institute for Vaccines and Biomedicines
Barbara Kovačić: Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Nikica Mirošević Skvrce: Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Evelien Clercq: Federal Agency for Medicines and Health Products (FAMHP)
Martine Sabbe: Federal Agency for Medicines and Health Products (FAMHP)
Gianluca Trifirò: University of Verona
Nicoletta Luxi: University of Verona
Alexia Giovanazzi: University of Verona
Saad Shakir: Drug Safety Research Unit
Olaf H. Klungel: Utrecht University
Sandor Schmikli: University Medical Centre Utrecht
Miriam Sturkenboom: Utrecht University
Drug Safety, 2023, vol. 46, issue 4, No 6, 404 pages
Abstract:
Abstract 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. Through the web applications, participants received and completed baseline and up to six follow-up questionnaires on self-reported adverse reactions for at least 6 months following the first dose of COVID-19 vaccine (Netherlands, France, Belgium, UK, Italy) and baseline and up to ten follow-up questionnaires for one year in Germany and Croatia. Rates of adverse reactions have been described by type (solicited, non-solicited; serious/non-serious; and adverse events of special interest) and stratified by vaccine brand. We calculated the frequency of adverse reaction after dose 1 and prior to dose 2 among all vaccinees who completed at least one follow-up questionnaire. Results Overall, 117,791 participants were included and completed the first questionnaire in addition to the baseline: 88,196 (74.9%) from Germany, 27,588 (23.4%) from Netherlands, 984 (0.8%) from France, 570 (0.5%) from Italy, 326 (0.3%) from Croatia, 89 (0.1%) from the UK and 38 (0.03%) from Belgium. There were 89,377 (75.9%) respondents who had received AstraZeneca vaccines, 14,658 (12.4%) BioNTech/Pfizer, 11,266 (9.6%) Moderna and 2490 (2.1%) Janssen vaccines as a first dose. Median age category was 40–49 years for all vaccines except for Pfizer where median age was 70–79 years. Most vaccinees were female with a female-to-male ratio of 1.34, 1.96 and 2.50 for AstraZeneca, Moderna and Janssen, respectively. BioNtech/Pfizer had slightly more men with a ratio of 0.82. Fatigue and headache were the most commonly reported solicited systemic adverse reactions and injection-site pain was the most common solicited local reaction. The rates of adverse events of special interest (AESIs) were 0.1–0.2% across all vaccine brands. Conclusion This large-scale prospective study of COVID-19 vaccine recipients showed, for all the studied vaccines, a high frequency of systemic reactions, related to the immunogenic response, and local reactions at the injection site, while serious reactions or AESIs were uncommon, consistent with those reported on product labels. This study demonstrated the feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials.
Date: 2023
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DOI: 10.1007/s40264-023-01281-9
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