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Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination.
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.
  • Zhou ZH; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Cortese MM; 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.
  • Fang JL; National Center for Toxicological Research, FDA, Jefferson, AR, USA.
  • Wood R; Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Hummell DS; Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine, Nashville, TN, USA.
  • Risma KA; Division of Allergy Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
  • Norton AE; Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine, Nashville, TN, USA.
  • KuKuruga M; Center for Biologics Evaluation and Research, Food and Drug Administration, USA.
  • Kirshner S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Rabin RL; Center for Biologics Evaluation and Research, Food and Drug Administration, USA.
  • Agarabi C; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Staat MA; Division of Infectious Disease, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
  • Halasa N; Division of Infectious Diseases, Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine, Nashville, TN, USA.
  • Ware RE; Division of Hematology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
  • Stahl A; Division of Infectious Diseases, Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine, Nashville, TN, USA.
  • McMahon M; Division of Infectious Disease, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
  • Browning P; Microbial Pathogenesis and Immune Response Laboratory, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Maniatis P; Microbial Pathogenesis and Immune Response Laboratory, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Bolcen S; Microbial Pathogenesis and Immune Response Laboratory, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Edwards KM; Division of Infectious Diseases, Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University School of Medicine, Nashville, TN, USA.
  • Su JR; 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.
  • Dharmarajan S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Forshee R; Center for Biologics Evaluation and Research, Food and Drug Administration, USA.
  • Broder KR; 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.
  • Anderson S; Center for Biologics Evaluation and Research, Food and Drug Administration, USA.
  • Kozlowski S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Electronic address: steven.kozlowski@fda.hhs.gov.
Vaccine ; 41(28): 4183-4189, 2023 06 23.
Article in English | MEDLINE | ID: covidwho-2320920
ABSTRACT

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 31 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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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 / Anaphylaxis Type of study: Experimental Studies / Observational study Topics: Vaccines Limits: Female / Humans / Male Language: English Journal: Vaccine Year: 2023 Document Type: Article Affiliation country: J.vaccine.2023.05.029

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 / Anaphylaxis Type of study: Experimental Studies / Observational study Topics: Vaccines Limits: Female / Humans / Male Language: English Journal: Vaccine Year: 2023 Document Type: Article Affiliation country: J.vaccine.2023.05.029