| Autor: |
Ciccimarra F; Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy., Luxi N; Department of Medicine, University of Verona, 37134 Verona, Italy., Bellitto C; Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy., L'Abbate L; Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy., Raethke M; Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands., van Hunsel F; Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands.; Department of PharmacoTherapy, Epidemiology & Economics, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, 9712 CP Groningen, The Netherlands., Lieber T; Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands., Mulder E; Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands., Riefolo F; Teamit Institute, Partnerships, Barcelona Health Hub, 08025 Barcelona, Spain., Dureau-Pournin C; University of Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, 146 rue Léo Saignat, 33076 Bordeaux, France., Farcas A; Pharmacovigilance Research Center, Iuliu Hatieganu University of Medicine and Pharmacy, 400347 Cluj-Napoca, Romania., Batel Marques F; Laboratory of Social Pharmacy and Public Health, School of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal., Morton K; Drug Safety Research Unit, Southampton SO31 1AA, UK.; University of Portsmouth, Portsmouth PO1 2UP, UK., Roy D; Drug Safety Research Unit, Southampton SO31 1AA, UK.; University of Portsmouth, Portsmouth PO1 2UP, UK., Sonderlichová S; Faculty of Medicine, SLOVACRIN, Pavol Jozef Šafárik University in Košice, 040 01 Košice, Slovakia., Thurin NH; University of Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, 146 rue Léo Saignat, 33076 Bordeaux, France., Villalobos F; Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), 08007 Barcelona, Spain., Sturkenboom MC; Department of Data Science and Biostatistics, Julius Global Health, University Medical Centre Utrecht, 3584 CG Utrecht, The Netherlands., Trifirò G; Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy. |
| Abstrakt: |
In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021-February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee's characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection. |
