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mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach.
J Allergy Clin Immunol Pract. 2021 04; 9(4):1423-1437.JA

Abstract

The U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. This has brought hope to millions of Americans in the midst of an ongoing global pandemic. The FDA EUA guidance for both vaccines is to not administer the vaccine to individuals with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of the COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) additionally advises individuals with a history of an immediate allergic reaction to a vaccine or injectable or any history of anaphylaxis be observed for 30 minutes after COVID-19 vaccination. All other individuals should be observed for 15 minutes after COVID-19 vaccination. Staff at vaccine clinics must be able to identify and manage anaphylaxis. Post-FDA EUA, despite very strong safety signals in both phase 3 trials, reports of possible allergic reactions have raised public concern. To provide reassurance and support during widespread global vaccination, allergists must offer clear guidance to individuals based on the best information available, but also in accordance with the broader recommendations of regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes drug and vaccine allergy expert opinion informed risk stratification for Allergy specialist use in conjunction with guidance of public health and regulatory authorities. The risk stratification schema guide care for (1) individuals with different allergy histories to safely receive their first mRNA COVID-19 vaccine and (2) individuals who develop a reaction to their first dose of mRNA COVID-19 vaccine.

Authors+Show Affiliations

Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass. Electronic address: abanerji@mgh.harvard.edu.Harvard Medical School, Boston, Mass; Division of Allergy and Immunology, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.Allergy Division, University of Washington School of Medicine, Seattle, Wash.Division of Allergy & Immunology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass; Edward P. Lawrence Center for Quality and Safety, Massachusetts General Hospital, Boston, Mass.

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

33388478

Citation

Banerji, Aleena, et al. "MRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach." The Journal of Allergy and Clinical Immunology. in Practice, vol. 9, no. 4, 2021, pp. 1423-1437.
Banerji A, Wickner PG, Saff R, et al. MRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. J Allergy Clin Immunol Pract. 2021;9(4):1423-1437.
Banerji, A., Wickner, P. G., Saff, R., Stone, C. A., Robinson, L. B., Long, A. A., Wolfson, A. R., Williams, P., Khan, D. A., Phillips, E., & Blumenthal, K. G. (2021). MRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. The Journal of Allergy and Clinical Immunology. in Practice, 9(4), 1423-1437. https://doi.org/10.1016/j.jaip.2020.12.047
Banerji A, et al. MRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. J Allergy Clin Immunol Pract. 2021;9(4):1423-1437. PubMed PMID: 33388478.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. AU - Banerji,Aleena, AU - Wickner,Paige G, AU - Saff,Rebecca, AU - Stone,Cosby A,Jr AU - Robinson,Lacey B, AU - Long,Aidan A, AU - Wolfson,Anna R, AU - Williams,Paul, AU - Khan,David A, AU - Phillips,Elizabeth, AU - Blumenthal,Kimberly G, Y1 - 2020/12/31/ PY - 2020/12/28/received PY - 2020/12/28/accepted PY - 2021/1/4/pubmed PY - 2021/4/24/medline PY - 2021/1/3/entrez KW - Allergic reactions KW - Allergy KW - Anaphylaxis KW - COVID-19 KW - Guidelines KW - Polyethylene glycol KW - Polysorbate KW - Risk stratification KW - Vaccine KW - mRNA SP - 1423 EP - 1437 JF - The journal of allergy and clinical immunology. In practice JO - J Allergy Clin Immunol Pract VL - 9 IS - 4 N2 - The U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. This has brought hope to millions of Americans in the midst of an ongoing global pandemic. The FDA EUA guidance for both vaccines is to not administer the vaccine to individuals with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of the COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) additionally advises individuals with a history of an immediate allergic reaction to a vaccine or injectable or any history of anaphylaxis be observed for 30 minutes after COVID-19 vaccination. All other individuals should be observed for 15 minutes after COVID-19 vaccination. Staff at vaccine clinics must be able to identify and manage anaphylaxis. Post-FDA EUA, despite very strong safety signals in both phase 3 trials, reports of possible allergic reactions have raised public concern. To provide reassurance and support during widespread global vaccination, allergists must offer clear guidance to individuals based on the best information available, but also in accordance with the broader recommendations of regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes drug and vaccine allergy expert opinion informed risk stratification for Allergy specialist use in conjunction with guidance of public health and regulatory authorities. The risk stratification schema guide care for (1) individuals with different allergy histories to safely receive their first mRNA COVID-19 vaccine and (2) individuals who develop a reaction to their first dose of mRNA COVID-19 vaccine. SN - 2213-2201 UR - https://www.unboundmedicine.com/medline/citation/33388478/mRNA_Vaccines_to_Prevent_COVID_19_Disease_and_Reported_Allergic_Reactions:_Current_Evidence_and_Suggested_Approach_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2213-2198(20)31411-2 DB - PRIME DP - Unbound Medicine ER -