Abstract
As of May 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths. Anaphylactic reactions associated with the Food and Drug Administration (FDA)-authorized mRNA COVID-19 vaccines have been reported. To characterize the immunologic mechanisms underlying allergic reactions to these vaccines. This case series included 22 patients with suspected allergic reactions to mRNA COVID-19 vaccines between December 18, 2020, and January 27, 2021, at a large regional health care network. Participants were individuals who received at least 1 of the following International Statistical Classification of Diseases and Related Health Problems, Tenth Revision anaphylaxis codes: T78.2XXA, T80.52XA, T78.2XXD, or E949.9, with documentation of COVID-19 vaccination. Suspected allergy cases were identified and invited for follow-up allergy testing. FDA-authorized mRNA COVID-19 vaccines. Allergic reactions were graded using standard definitions, including Brighton criteria. Skin prick testing was conducted to polyethylene glycol (PEG) and polysorbate 80 (P80). Histamine (1 mg/mL) and filtered saline (negative control) were used for internal validation. Basophil activation testing after stimulation for 30 minutes at 37 °C was also conducted. Concentrations of immunoglobulin (Ig) G and IgE antibodies to PEG were obtained to determine possible mechanisms. Of 22 patients (20 [91%] women; mean [SD] age, 40.9 [10.3] years; 15 [68%] with clinical allergy history), 17 (77%) met Brighton anaphylaxis criteria. All reactions fully resolved. Of patients who underwent skin prick tests, 0 of 11 tested positive to PEG, 0 of 11 tested positive to P80, and 1 of 10 (10%) tested positive to the same brand of mRNA vaccine used to vaccinate that individual. Among these same participants, 10 of 11 (91%) had positive basophil activation test results to PEG and 11 of 11 (100%) had positive basophil activation test results to their administered mRNA vaccine. No PEG IgE was detected; instead, PEG IgG was found in tested individuals who had an allergy to the vaccine. Based on this case series, women and those with a history of allergic reactions appear at have an elevated risk of mRNA vaccine allergy. Immunological testing suggests non-IgE-mediated immune responses to PEG may be responsible in most individuals.
Highlights
As of May 21, 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths, which have disproportionately occurred in persons aged 65 years and older
Based on this case series, women and those with a history of allergic reactions appear at have an elevated risk of mRNA vaccine allergy
This study provides clinical data, including skin prick tests (SPTs), basophil activation tests (BATs), and tryptase levels for a case series of vaccine-associated allergic reactions to mRNA COVID-19 vaccines from a large regional health system that was among the first in the United States to distribute these Food and Drug Administration (FDA)-authorized vaccines
Summary
As of May 21, 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths, which have disproportionately occurred in persons aged 65 years and older. Uncontrolled transmission of the SARS CoV-2 virus continues throughout the United States and in much of the world. Subsequent safety analyses of Vaccine Adverse Event Reporting System (VAERS) data between December 14, 2020, and January 18, 2021, estimated vaccine-related anaphylaxis events at rates of 4.7 and 2.5 cases per million doses for BNT162B2 and mRNA-1273, respectively.[1] Of 66 confirmed anaphylaxis cases reported from 17 524 676 vaccine administrations, 95% occurred in women, and 79% and 32% of individuals with allergic reactions had a previous history of allergies and/or allergic reactions and anaphylaxis, respectively. The US Centers for Disease Control and Prevention (CDC) reviewed 3486 reports of death among individuals who had received the COVID-19 vaccinate and found “no evidence that vaccination contributed to patient deaths.”[2]
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