Updated Guidance Regarding The Risk ofAllergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment, and International Consensus Approach

• Published in: Journal of allergy and clinical immunology 2023-06
• Main Authors: Greenhawt, Matthew, Dribin, Timothy E., Abrams, Elissa M., Shaker, Marcus, Chu, Derek K., Golden, David BK, Akin, Cem, Anagnostou, Akterini, ALMuhizi, Faisal, Alqurashi, Waleed, Arkwright, Peter, Baldwin, James L., Banerji, Aleena, Bégin, Philippe, Ben-Shoshan, Moshe, Bernstein, Jonathan, Bingeman, Theresa A., Bindslev-Jensen, Carsten, Blumenthal, Kim, Byrne, Aideen, Cahil, Julia, Cameron, Scott, Campbell, Dianne, Campbell, Ronna, Cavender, Michael, Chan, Edmond S., Chinthrajah, Sharon, Comberiatti, Pasquale, Eastman, Jacqueline J., Ellis, Anne K., Fleischer, David M., Fox, Adam, Frischmeyer-Guerrerio, Pamela A., Gagnon, Remi, Garvey, Lene H., Grayson, Mitchell H., Clarisse Isabwe, Ghislaine Annie, Hartog, Nicholas, Hendron, David, Horner, Caroline C., O'B Hourihane, Johnathan, Iglesia, Edward, Kan, Manstein, Kaplan, Blanca, Katelaris, Constance H., Kim, Harold, Kelso, John M., Kahn, David A., Lang, David, Ledford, Dennis, Levin, Michael, Lieberman, Jay A., Loh, Richard, Mack, Douglas P., Mazer, Bruce, Mody, Ketan, Mosnaim, Gissele, Munblit, Daniel, Mustafa, S. Shahzad, Nanda, Anil, Nathan, Richard, Oppenheimer, John, Otani, Iris M., Park, Miguel, Pawankar, Ruby, Perrett, Kirsten P., Peter, Jonny, Phillips, Elizabeth J., Picard, Matthieu, Pitlick, Mitchell, Ramsey, Allison, Rasmussen, Trine Holm, Rathkopf, Melinda M., Reddy, Hari, Robertson, Kara, Rodriguez del Rio, Pablo, Sample, Steven, Sheshradi, Ajay, Shiek, Javed, Sindher, Sayantani B., Spergel, Jonathan M., Stone, Cosby A., Stukus, David, Tang, Mimi LK, Tracy, James M., Turner, Paul J., Vander Leek, Timothy K., Wallace, Dana V., Wang, Julie, Wasserman, Susan, Weldon, David, Wolfson, Anna R., Worm, Margitta, Yacoub, Mona-Rita
• Format: Article
• Language: English
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2023.05.019

This guidance updates 2021 GRADE recomendations regarding immediate allergic reactions following COVID-19 vaccines and addresses re-vaccinating individuals with 1 st dose allergic reactions and allergy testing to determine re-vaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 re-vaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommenations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the UK, and the US formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy, and re-vaccination after a prior immediate allergic reaction. We suggest against >15-minute post-vaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest re-vaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise, in a properly equipped setting. We suggest against pre-medication, split-dosing, or special precautions because of a comorbid allergic history.