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

Aleena Banerji, Paige G. Wickner, Rebecca Saff, Cosby A. Stone, Lacey B. Robinson, Aidan A. Long, Anna R. Wolfson, Paul Williams, David A. Khan, Elizabeth Phillips, Kimberly G. Blumenthal

Research output: Contribution to journalReview articlepeer-review

25 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1423-1437
Number of pages15
JournalJournal of Allergy and Clinical Immunology: In Practice
Volume9
Issue number4
DOIs
StatePublished - Apr 2021

Keywords

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

ASJC Scopus subject areas

  • Immunology and Allergy

Fingerprint

Dive into the research topics of 'mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach'. Together they form a unique fingerprint.

Cite this