Comparative assessment of allergic reactions to COVID-19 vaccines in
Europe and the United States
Abstract
Background: COVID-19 vaccines are safe and effective at
preventing severe disease. Among the rare complications that may
compromise vaccine acceptance are allergic reactions. This study aimed
at comparing the incidence and potential triggers of the most commonly
reported allergic reactions related to licensed COVID-19 vaccines in
Europe and the United States (US) based on data of the two of the
world’s largest vaccine adverse event reporting systems, EudraVigilance
and VAERS. Methods: Data pertaining to allergic reactions post
COVID-19 vaccination reported from week 52/2020 to week 39/2021 were
collected from EudraVigilance and VAERS databases and analyzed.
Incidence rates were calculated using the corresponding administered
vaccine doses as denominators for all licensed vaccines and both
platform types (mRNA or vectored). The composition of the novel mRNA and
vectored vaccines was examined to identify potential allergic triggers.
Results: Anaphylactic reactions and anaphylactic shock were the
most common allergic reactions, predominantly reported by females, at
estimated incidence rates of 9.91/million and 1.36/million vaccine
doses, respectively. A 2- to 5-fold higher incidence of both allergic
reactions was found in Europe compared to the US for both vaccine
platforms. Most cases were benign. Fatalities were extremely rare and
associated with vectored rather than mRNA vaccines.
Conclusions: The precise mechanism(s) for allergic reactions
after vaccination with COVID-19 vaccines are not fully known. Plausible
explanations include exposure to components of the final pharmaceutical
product and cross-reactivity to ingredients or unintentional impurities
in the final formula. Additional research is warranted to further
improve vaccine safety.