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. 2024 Sep 17;12(9):1059.
doi: 10.3390/vaccines12091059.

Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study

Nicoletta Luxi  1 , Francesco Ciccimarra  2 , Chiara Bellitto  2 , Monika Raethke  3 , Florence van Hunsel  3   4 , Thomas Lieber  3 , Erik Mulder  3 , Luca L'Abbate  2 , Francisco Batel Marques  5 , Fabiana Furci  6 , Andreea Farcas  7 , Janneke Giele-Eshuis  8 , Kathryn Morton  9   10 , Simona Sonderlichová  11 , Nicolas H Thurin  12 , Felipe Villalobos  13 , Fabio Riefolo  14 , Miriam C Sturkenboom  8 , Gianluca Trifirò  2
Affiliations

Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study

Nicoletta Luxi et al. Vaccines (Basel). .

Abstract

Background: 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. those without a history of allergy. Methods: From February 2021 to February 2023, a web-based prospective study gathered vaccinee-reported outcomes using electronic questionnaires across eleven European countries. Baseline and up to six follow-up questionnaires captured data on vaccinee demographics, as well as both solicited and unsolicited adverse reactions. Results: Overall, 3476 vaccinees with a history of allergy were matched with 13,872 vaccinees from the general population at the first vaccination cycle and were included in the analysis. A total of 825 vaccinees with a history of allergy who had received a booster dose, matched to 3297 vaccinees from the general population, were included in the analysis. Higher rates of ADRs occurred after the first vaccination cycle compared to after the booster dose (64-91% vs. 56-79%). However, most reported ADRs were solicited and not serious, and no case of anaphylaxis was reported. Women and vaccinees with a history of allergy reported ADRs more frequently than men and the matched controls, respectively. Compared to other COVID-19 vaccines, a higher proportion of vaccinees experiencing at least one ADR following their first vaccination cycle was observed with Comirnaty and Vaxzevria. Statistically significant differences were observed among the study cohorts for median TTO after the second dose, and for median TTR following the first vaccination cycle and booster dose (p < 0.001). Conclusions: Typically, any drug or vaccine use carries a risk of severe allergic reactions, yet the benefits of vaccination generally outweigh these potential risks, as shown with the COVID-19 vaccines.

Keywords: COVID-19 vaccines; adverse reactions; allergy history; anaphylaxis; safety profile.

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Conflict of interest statement

Miriam Sturkenboom is the head of a department that conducts studies for regulatory agencies and pharmaceutical companies, which provide research grants to the institution; they include Pfizer, Janssen, and AstraZeneca. All studies were conducted according to the ENCePP code of conduct. Gianluca Trifrò has served in the last three years on advisory boards/seminars funded by SANOFI, Eli Lilly, AstraZeneca, Abbvie, Servier, Mylan, Gilead, and Amgen, He was the scientific director of a master’s program on pharmacovigilance, pharmacoepidemiology, and real-world evidence which has received a non-conditional grant from various pharmaceutical companies. He coordinated a pharmacoepidemiology team at the University of Messina until October 2020, which has received funding to conduct observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, and PTC Pharmaceuticals). He is also the scientific coordinator of the academic spin-off “INSPIRE srl” which has received funding to conduct observational studies from contract research organizations (RTI Health Solutions and Pharmo Institute N.V.). None of these listed activities are related to the topic of the manuscript. Francesco Ciccimarra, Nicoletta Luxi, Chiara Bellitto, Luca L’Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Caroline Dureau-Pournin, Andreea Farcas, Francisco Batel Marques, Kathryn Morton, Debabrata Roy, Simona Sonderlichová, Nicolas H. Thurin, and Felipe Villalobos have no conflicts of interest that are directly relevant to the content of this article.

Figures

Figure 1
Figure 1
Flowchart of vaccinees recruited in the study who completed baseline and follow-up questionnaires.
Figure 2
Figure 2
Proportions of female and male participants who reported at least one ADR (A), at least one local solicited ADR (B) and at least one systemic solicited ADR (C) after receiving a first, second or booster dose of different COVID-19 vaccines, among people with a history of allergy and matched controls.
Figure 3
Figure 3
Combination of violin plots and boxplots depicting the median time to onset and median time to recovery, measured in hours, of ADRs reported by vaccinees after receiving first, second, and booster doses, among people with a history of allergy and matched controls. Abbreviations: TTO = time to onset; TTR = time to recovery.
Figure 3
Figure 3
Combination of violin plots and boxplots depicting the median time to onset and median time to recovery, measured in hours, of ADRs reported by vaccinees after receiving first, second, and booster doses, among people with a history of allergy and matched controls. Abbreviations: TTO = time to onset; TTR = time to recovery.
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