mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions

 

• Aleena Banerji, MD 
• Paige G. Wickner, MD
• Rebeca Saff, MD, PhD
• David A. Khan, MD
• Elizabeth Phillips, MD ∗
• Kimberly G. Blumenthal, MD, MSc 
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DOI:https://doi.org/10.1016/j.jaip.2020.12.047

PDF: https://www.jaci-inpractice.org/action/showPdf?pii=S2213-2198%2820%2931411-2

Abstract

The recent Food and Drug Administration (FDA) approval of two highly effective COVID-19 vaccines from Pfizer-BioNtech and Moderna has brought hope to millions of American in the midst of an ongoing global pandemic. The FDA Emergency Use Authorization guidance for both vaccines is to not administer the vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the COVID-19 vaccine. The Centers for Diseases Control and Prevention (CDC) advises that all patients should be observed for 15 minutes after COVID-19 vaccination and staff must be able to identify and manage anaphylaxis. Post-FDA approval, 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 vaccination across America, allergists must offer clear guidance to patients based on the best information available, but also in accordance with the broader recommendations of our US regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes risk stratification schema: (1) for individuals with different allergy histories to safely receive their first COVID-19 vaccine and (2) for individuals who develop a reaction to their first dose of COVID-19 vaccine.

https://www.jaci-inpractice.org/article/S2213-2198(20)31411-2/abstract

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