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.