Медицинская библиотека · Vaccine · 2023

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

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Аннотация

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.

Для цитирования: 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. Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination.. Vaccine. 2023. DOI: 10.1016/j.vaccine.2023.05.029.

Предметные рубрики MeSH

Female Humans Male Anaphylaxis COVID-19 COVID-19 Vaccines Immunoglobulin E Immunoglobulin G Immunoglobulin M Immunosuppressive Agents Polyethylene Glycols RNA, Messenger Vaccination

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