COVID-19 Vaccine-associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group

Abstract

In the era of novel coronavirus epidemics, vaccines against coronavirus disease 2019 (COVID-19) have been recognized as the most effective public health interventions to control the pandemic. An adverse event following immunization (AEFI) is defined as any untoward occurrence following immunization, and the majority of AEFIs are caused by protective immune responses stimulated by vaccines. Most of the reported AEFIs are not serious, and many are not immunologically mediated or even reproducible on re-exposure. However, uncommon severe allergic adverse reactions, such as anaphylaxis or other allergic reactions, can occur after vaccinations. Confirmed allergic reactions to vaccines may be caused by residual non-human protein, preservatives, or stabilizers in the vaccine formulation (also known as excipients). There are 2 main potential allergenic/immunogenic excipients in COVID-19 vaccines, polyethylene glycol (PEG) and polysorbate 80. PEG, also known as macrogol, is an ingredient in various laxatives and injectable formulations, such as depot steroids. Polysorbate 80 is present in various medical products, creams, ointments, lotions, and medication tablets. Contraindications to the administration of COVID-19 vaccines include a previous history of severe allergic reactions to the first dose of COVID-19 vaccine or proven hypersensitivity to a vaccine component, such as PEG or polysorbate 80. Anaphylaxis or other allergic reactions following immunization can cause fear and loss of confidence in the safety of vaccines among the public. A better understanding of these events is thought to help alleviate concerns about the current COVID-19 vaccines and provide reassurance to the general population by analyzing the exact incidence of anaphylaxis and potential risk factors. COVID-19 vaccine-associated anaphylaxis could be prevented and managed by risk stratification based on our local and global experience.

Postmortem investigation of fatalities following vaccination with COVID-19 vaccines

“…In fact, most reactions are not caused by the active vaccine itself, but by excipients, which are inert substances added to vaccines for improving certain properties such as solubility or stability [ 34 ]. Current reviews name two excipients in COVID-19 vaccines mainly suspected for allergic reactions: polyethylene glycol in the mRNA-based vaccines and polysorbate 80 in the vector-based ones [ 31 , 34 ].…”

COVID-19 Disease, Women’s Predominant Non-Heparin Vaccine-Induced Thrombotic Thrombocytopenia and Kounis Syndrome: A Passepartout Cytokine Storm Interplay

“…General and personal protective equipment for all people, and especially for the healthcare workers, is the final line of protection [138]. The incidence of severe adverse reactions and anaphylaxis is very low [139,140] but is highly encouraged to support vaccination against COVID-19 because vaccines are the only means to fight this pandemic. Further investigations of relevant risk identification and management approaches for COVID-19 consequences are required.…”

Acute urticarial rash after COVID-19 vaccination containing Polysorbate 80

“…On May 2021 the woman accessed the emergency room showing small, pruritic, ovalar urticarial wheals on the trunk, rapidly migrating, with a white center and red erythematous flare [ 1 2 3 4 ], occurred 3 hours after the second dose of Oxford-AstraZeneca vaccination (AstraZeneca, Cambridge, UK) ( Fig. 1 ).…”

“…Vaccines against coronavirus disease 2019 (COVID-19) are administered worldwide to control the pandemics we are currently dealing with, but as the number of people receiving vaccination rises, we are inevitably faced with increasing adverse drug reactions [ 1 ]. The most common cutaneous adverse reactions to vaccines are non-allergic, as flu like-symptoms and injection site reactions [ 2 3 ], whereas immediate hypersensitivity (Coombs and Gell type I) reactions, probably directed against sensitizing excipients of vaccines, are fortunately rare [ 1 4 ].…”