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

Area of Science:

• Immunology
• Vaccinology
• Allergy and Immunology

Background:

• The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for two highly effective mRNA COVID-19 vaccines.
• Despite strong safety data, reports of allergic reactions have caused public concern regarding COVID-19 vaccination.
• Allergists play a crucial role in providing clear guidance amidst widespread vaccination efforts.

Purpose of the Study:

• To summarize vaccine allergy epidemiology.
• To propose a risk stratification schema for allergists to guide safe COVID-19 vaccination.
• To assist in managing individuals with varied allergy histories and those who experience reactions to their first vaccine dose.

Main Methods:

• Review of vaccine allergy epidemiology.
• Development of an expert opinion-informed risk stratification schema.
• Integration of regulatory guidance from the FDA and CDC.

Main Results:

• The proposed schema guides the safe administration of the first mRNA COVID-19 vaccine dose for individuals with diverse allergy histories.
• The schema also addresses the care of individuals who develop a reaction to their initial mRNA COVID-19 vaccine dose.
• Provides a framework for allergists to manage patient concerns and ensure safe vaccination practices.

Conclusions:

• Expert-informed risk stratification is essential for safe mRNA COVID-19 vaccine administration.
• This approach supports public health goals by addressing allergy-related concerns and facilitating widespread vaccination.
• Allergists are key in interpreting and applying this guidance for individual patient care.