Review and Feature Article
mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach

https://doi.org/10.1016/j.jaip.2020.12.047Get rights and content

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.

Key words

mRNA
COVID-19
Vaccine
Allergy
Allergic reactions
Anaphylaxis
Guidelines
Risk stratification
Polyethylene glycol
Polysorbate

Abbreviations used

CDC
Centers for Disease Control and Prevention
COVID-19
Coronavirus disease 2019
EUA
Emergency Use Authorization
FDA
Food and Drug Administration
PEG
Polyethylene glycol
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
VAERS
Vaccine adverse event reporting System

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No funding was received for this work.

Conflicts of interest: E. Phillips reports grants from the National Institutes of Health (grant nos. P50GM115305, R01HG010863, R01AI152183, R21AI139021, and U01AI154659) and from the National Health and Medical Research Council of Australia; receives Royalties from Uptodate and consulting fees from Janssen, Vertex, Regeneron, and Biocryst; is codirector of IIID Pty Ltd, which holds a patent for HLA-B57:01 testing for abacavir hypersensitivity, and has a patent pending for Detection of Human Leukocyte Antigen-A32:01 in connection with Diagnosing Drug Reaction with Eosinophilia and Systemic Symptoms without any financial remuneration and not directly related to the submitted work. Funders played no role in any aspect of this review. The rest of the authors declare that they have no relevant conflicts of interest.

Co-senior authors.

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