Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination
Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination
Abstract 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.
Maniatis Panagiotis、Fang Jia-Long、Wood Robert、Norton Allison E.、KuKuruga Mark、Kirshner Susan、Staat Mary A.、Halasa Natasha、Ware Russell、Stahl Anna、Bolcen Shanna、Edwards Kathryn M.、Zhou Zhao-Hua、Forshee Richard、Cortese Margaret M.、Risma Kimberly A.、Browning Peter、Hummell Donna S.、Kozlowski Steven、Agarabi Cyrus、Su John R.、Dharmarajan Sai、Anderson Steven、McMahon Maureen、Broder Karen R.、Rabin Ronald L.
Microbial Pathogenesis and Immune Response Laboratory, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionNational Center for Toxicological ResearchDepartment of Pediatrics, Johns Hopkins University School of MedicineDivision of Pediatric Allergy, Immunology, and Pulmonary Medicine, Monroe Carell Jr. Children?ˉs Hospital at Vanderbilt, Vanderbilt University School of MedicineCenter for Biologics Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionCenter for Drug Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionDivision of Infectious Disease, Cincinnati Children?ˉs Hospital Medical CenterDivision of Infectious Diseases, Department of Pediatrics, Monroe Carell Jr. Children?ˉs Hospital at Vanderbilt, Vanderbilt University School of MedicineDivision of Hematology, Department of Pediatrics, Cincinnati Children?ˉs Hospital Medical CenterDivision of Infectious Diseases, Department of Pediatrics, Monroe Carell Jr. Children?ˉs Hospital at Vanderbilt, Vanderbilt University School of MedicineMicrobial Pathogenesis and Immune Response Laboratory, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionDivision of Infectious Diseases, Department of Pediatrics, Monroe Carell Jr. Children?ˉs Hospital at Vanderbilt, Vanderbilt University School of MedicineCenter for Drug Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionCenter for Biologics Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionImmunization Safety Office, Division of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionDivision of Allergy Immunology, Department of Pediatrics, Cincinnati Children?ˉs Hospital Medical CenterMicrobial Pathogenesis and Immune Response Laboratory, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionDivision of Pediatric Allergy, Immunology, and Pulmonary Medicine, Monroe Carell Jr. Children?ˉs Hospital at Vanderbilt, Vanderbilt University School of MedicineCenter for Drug Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionCenter for Drug Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionImmunization Safety Office, Division of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionCenter for Drug Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionCenter for Biologics Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and PreventionDivision of Infectious Disease, Cincinnati Children?ˉs Hospital Medical CenterImmunization Safety Office, Division of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionCenter for Biologics Evaluation and Research, Food and Drug Administration, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention
医药卫生理论医学研究方法预防医学
COVID 19mRNA vaccinespolyethylene glycolanaphylaxisIgEantibodies
Maniatis Panagiotis,Fang Jia-Long,Wood Robert,Norton Allison E.,KuKuruga Mark,Kirshner Susan,Staat Mary A.,Halasa Natasha,Ware Russell,Stahl Anna,Bolcen Shanna,Edwards Kathryn M.,Zhou Zhao-Hua,Forshee Richard,Cortese Margaret M.,Risma Kimberly A.,Browning Peter,Hummell Donna S.,Kozlowski Steven,Agarabi Cyrus,Su John R.,Dharmarajan Sai,Anderson Steven,McMahon Maureen,Broder Karen R.,Rabin Ronald L..Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination[EB/OL].(2025-03-28)[2025-08-11].https://www.medrxiv.org/content/10.1101/2023.04.11.23288372.点此复制
评论