The role of skin tests with polyethylene glycol and polysorbate 80 in the vaccination campaign for COVID-19: results from an Italian multicenter survey

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Authors Information

1University Hospital "O.O.R.R. San Giovanni di Dio and Ruggi d'Aragona", Salerno, Italy
2UO University Hospital "O.O.R.R. San Giovanni di Dio and Ruggi d'Aragona", Salerno, Italy
3Unit of Immunology, Rheumatology, Allergology and Rare Diseases, IRCCS San Raffaele Hospital, Milan, Italy
4Vita-Salute San Raffaele University, Milan, Italy
5Agostino Gemelli University Hospital Foundation IRCCS, Rome, Italy
6Università Cattolica del Sacro Cuore, Rome, Italy
7ASST Rhodense, Rho Hospital, Milan, Italy
8Allergology Unit, IRCCS San Martino Polyclinic Hospital, Genoa, Italy
9SSD Dermatology, Beauregard Hospital, Valle d'Aosta, Italy
10Turin Local Health Authority 4, Turin, Italy
11UOS Dermatology Hospital of Mirano, Venice, Italy
12UOSD. Allergology Giulianova, Teramo, Italy
13SSVD Allergology, Spedali Civili, Brescia, Italy
14SSI Allergology Romagna Health Authority, Rimini Hospital, Italy
15Pneumology Unit, Busto Arsizio Hospital, Varese, Italy
16ASST Bergamo Ovest, Bergamo, Italy
17Simple Operating Unit of Allergology, Guglielmo da Saliceto Hospital, Piacenza, Italy
18Section of Allergy and Clinical Immunology, Unit of Internal Medicine- "F. Miulli" Hospital, Acquaviva delle Fonti, Bari, Italy
19ASL2 Allergology Clinic, Savona, Italy
20Department of Clinical and Experimental Sciences (DSCS), University of Brescia, Brescia, Italy
21SOS Allergology Clinical Immunology, San Giovanni di Dio Hospital, Florence, Italy
22Allergology Clinic, Casa di Cura Palazzolo, Bergamo, Italy
23Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari - Aldo Moro, Bari, Italy
24Division of Internal Medicine, Ospedale Maggiore della Carità, Novara, Italy
25UOC General Medicine, Immunology and Allergology, IRCCS Cà Granda Foundation, Maggiore Policlinico Hospital, Milan, Italy
26Ospedale del Sacro Cuore di Gesù - Fatebenefratelli, Benevento, Italy
27Specialist Outpatient Allergy Unit, ASP 6 Palermo, Palermo, Italy
28SS Allergology and Clinical Immunology, Maggiore della Carità Hospital, Novara, Italy


Published: 16 March 2023
Accepted: 06 March 2023
Received: 18 December 2022


Background. International guidelines suggested skin tests with Polyethylene-glycol (PEG) and polysorbate 80 (PS-80), to investigate a possible hypersensitivity to these excipients either to identify subjects at risk of developing allergic reactions to COVID-19 vaccines, or in patients with suspected IgE mediated hypersensitivity reactions (HR) to the COVID-19 vaccine. The main purpose of this study was to investigate the prevalence of PEG and PS sensitization in patients with a clinical history of HR to drugs containing PEG/PS and in patients with a suspected COVID-19 vaccine immediate HR. Methods. This was a multicenter retrospective study conducted by allergists belonging to 20 Italian medical centers. Skin testing was performed in 531 patients with either a clinical history of suspected hypersensitivity reaction (HR) to drugs containing PEG and/or PS-80 (group 1: 362 patient) or a suspected HR to COVID-19 vaccines (group 2: 169 patient), as suggested by the AAIITO/SIAAIC guidelines for the “management of patients at risk of allergic reactions to COVID-19 vaccines”. Results. 10/362 (0.02%) had positive skin test to one or both excipients in group 1, 12/169 (7.1%) in group 2 (p < 0.01). In group 2 HRs to COVID-19 vaccines were immediate in 10/12 of cases and anaphylaxis occurred in 4/12 of patients. Conclusions. The positivity of skin test with PEG and or PS before vaccination is extremely rare and mostly replaceable by an accurate clinical history. Sensitization to PEG and PS has to be investigated in patients with a previous immediate HR to a COVID-19 vaccine, in particular in patients with anaphylaxis.

PEG; skin test; vaccines; anaphylaxis; COVID-19.

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