| Autor: |
Zhao-Hua Zhou, Margaret M. Cortese, Jia-Long Fang, Robert Wood, Donna S. Hummell, Kimberly A. Risma, Allison E. Norton, Mark KuKuruga, Susan Kirshner, Ronald L. Rabin, Cyrus Agarabi, Mary A. Staat, Natasha Halasa, Russell E. Ware, Anna Stahl, Maureen McMahon, Peter Browning, Panagiotis Maniatis, Shanna Bolcen, Kathryn M. Edwards, John R. Su, Sai Dharmarajan, Richard Forshee, Karen R. Broder, Steven Anderson, Steven Kozlowski |
| Rok vydání: |
2023 |
| Předmět: |
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| DOI: |
10.1101/2023.04.11.23288372 |
| Popis: |
BackgroundThe mechanism for anaphylaxis following mRNA COVID-19 vaccination has been widely debated; understanding this serious adverse event is important for future vaccines of similar design. A mechanism proposed is type I hypersensitivity (i.e., IgE-mediated mast cell degranulation) to excipient polyethylene glycol (PEG). Using an assay that, uniquely, had been previously assessed in patients with anaphylaxis to PEG, our objective was to compare anti-PEG IgE in serum from mRNA COVID-19 vaccine anaphylaxis case-patients and persons vaccinated without allergic reactions. Secondarily, we compared anti-PEG IgG and IgM to assess alternative mechanisms.MethodsSelected anaphylaxis case-patients reported to U.S. Vaccine Adverse Event Reporting System December 14, 2020 – March 25, 2021 were invited to provide a serum sample. mRNA COVID-19 vaccine study participants with residual serum and no allergic reaction post-vaccination (“controls”) were frequency matched to cases 3:1 on vaccine and dose number, sex and 10-year age category. Anti-PEG IgE was measured using a dual cytometric bead assay. Anti-PEG IgG and IgM were measured using two different assays. Laboratorians were blinded to case/control status.ResultsAll 20 case-patients were women; 17 had anaphylaxis after dose 1, 3 after dose 2. Thirteen (65%) were hospitalized and 7 (35%) were intubated. Time from vaccination to serum collection was longer for case-patients vs controls (post-dose 1: median 105 vs 21 days). Among Moderna recipients, anti-PEG IgE was detected in 1 of 10 (10%) case-patients vs 8 of 30 (27%) controls (p=0.40); among Pfizer-BioNTech recipients, it was detected in 0 of 10 case-patients (0%) vs 1 of 30 (3%) controls (p>0.99). Anti-PEG IgE quantitative signals followed this same pattern. Neither anti-PEG IgG nor IgM was associated with case status with both assay formats.ConclusionOur results support that anti-PEG IgE is not a predominant mechanism for anaphylaxis post-mRNA COVID-19 vaccination. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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