Successful SARS-CoV-2 vaccine allergy risk-management: The experience of a large Italian University Hospital.

BACKGROUND

Novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines have been approved recently, and public concern regarding the risk of anaphylactic reactions arose after a few cases during the first days of mass vaccination. Polyethylene glycol (PEG) has been suggested as the most probable culprit agent for allergic reactions.

OBJECTIVE

We describe the allergy work-up protocol implemented for the vaccination campaign in our Center, aiming to allow the greatest number of people to be vaccinated safely.

METHODS

The protocol included the self-report of a history of suspected drug or vaccine allergies, and subsequent teleconsultation and allergometric tests for PEG and Polysorbate 80 (PS80). A desensitizing protocol of vaccine administration was applied to patients sensitized only to PS80, and to those with a suspect allergic reaction after the first vaccine dose.

RESULTS

10.2% (414 out of 4042) of the entire vaccine population have been screened: only one patient resulted allergic to PEG and therefore excluded from the vaccination. Another patient was sensitized to PS80 only and safely vaccinated applying the desensitizing protocol. Seven subjects without a previous history of allergic disease experienced suspect hypersensitivity reactions to the first administered dose: one of them resulted allergic to PEG and was excluded from the second dose, while the others safely completed the vaccination with the desensitizing protocol.

CONCLUSION

A careful allergological risk-assessment protocol significantly reduces the number of patients who would have avoided SARS-CoV-2 vaccination for their allergies and to effectively identify and manage those rare patients with sensitization to PEGs and/or PS80.

Informations de copyright

© 2021 The Author(s).

Déclaration de conflit d'intérêts

-Giovanni Paoletti does not have any conflict of interest to report.-Francesca Racca does not have any conflict of interest to report.-Alessandra Piona does not have any conflict of interest to report.-Giulio Melone does not have any conflict of interest to report.-Morena Merigo does not have any conflict of interest to report.-Francesca Puggioni reports personal fees from Astrazeneca, Chiesi, GSK, Guidotti, Menarini, Mundipharma, Novartis, Sanofi, Valeas, Allergy therapeutics, Almirall outside the submitted work.-Sebastian Ferri does not have any conflict of interest to report.-Elena Azzolini does not have any conflict of interest to report.-Michele Lagioia does not have any conflict of interest to report.-Donatella Lamacchia does not have any conflict of interest to report.-Giuseppe Cataldo does not have any conflict of interest to report.-Maurizio Cecconi does not have any conflict of interest to report.-Enrico Heffler reports participation to advisory boards and personal fees from AstraZeneca, Sanofi, GSK, Novartis, Circassia, Nestlè Purina, Boheringer Ingheleim, Valeas, Stallergenes Greer outside the submitted work.-Giorgio Walter Canonica reports grants as well as lecture or advisory board fees from: A. Menarini, Alk-Abello, Allergy Therapeutics, AstraZeneca, Boehringer-Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, Glaxo Smith Kline, Hal Allergy, Mylan, Merck, Mundipharma, Novartis, Regeneron, Sanofi-Aventis, Sanofi-Genzyme, StallergenesGreer, UCB pharma, Uriach Pharma, Valeas, ViborPharma.