| アブストラクト | BACKGROUND: The 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 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. METHODS: Selected 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 (DCBA). Anti-PEG IgG and IgM were measured using two different assays: DCBA and a PEGylated-polystyrene bead assay. Laboratorians were blinded to case/control status. RESULTS: All 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 >n 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. CONCLUSION: Our results support that anti-PEG IgE is not a predominant mechanism for anaphylaxis post-mRNA COVID-19 vaccination. |
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| 投稿者 | Zhou, Zhao-Hua; Cortese, Margaret M; Fang, Jia-Long; Wood, Robert; Hummell, Donna S; Risma, Kimberly A; Norton, Allison E; KuKuruga, Mark; Kirshner, Susan; Rabin, Ronald L; Agarabi, Cyrus; Staat, Mary A; Halasa, Natasha; Ware, Russell E; Stahl, Anna; McMahon, Maureen; Browning, Peter; Maniatis, Panagiotis; Bolcen, Shanna; Edwards, Kathryn M; Su, John R; Dharmarajan, Sai; Forshee, Richard; Broder, Karen R; Anderson, Steven; Kozlowski, Steven |
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| 組織名 | Center for Drug Evaluation and Research, Food and Drug Administration, Silver;Spring, MD, USA.;Immunization Safety Office, Division of Healthcare Quality and Promotion,;National Center for Emerging and Zoonotic Infectious Diseases, Centers for;Disease Control and Prevention, Atlanta, GA, USA.;National Center for Toxicological Research, FDA, Jefferson, AR, USA.;Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore,;MD, USA.;Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Monroe Carell;Jr. Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine,;Nashville, TN, USA.;Division of Allergy Immunology, Department of Pediatrics, Cincinnati Children's;Hospital Medical Center, Cincinnati, OH, USA.;Center for Biologics Evaluation and Research, Food and Drug Administration, USA.;Division of Infectious Disease, Department of Pediatrics, Cincinnati Children's;Division of Infectious Diseases, Department of Pediatrics, Monroe Carell Jr.;Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine,;Division of Hematology, Department of Pediatrics, Cincinnati Children's Hospital;Medical Center, Cincinnati, OH, USA.;Microbial Pathogenesis and Immune Response Laboratory, Division of Bacterial;Diseases, National Center for Immunization and Respiratory Diseases, Centers for;Spring, MD, USA. Electronic address: steven.kozlowski@fda.hhs.gov. |
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