Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination
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 polyethy...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Zhou, Zhao-Hua [verfasserIn] Cortese, Margaret M. [verfasserIn] Fang, Jia-Long [verfasserIn] Wood, Robert [verfasserIn] Hummell, Donna S. [verfasserIn] Risma, Kimberly A. [verfasserIn] Norton, Allison E. [verfasserIn] KuKuruga, Mark [verfasserIn] Kirshner, Susan [verfasserIn] Rabin, Ronald L. [verfasserIn] Agarabi, Cyrus [verfasserIn] Staat, Mary A. [verfasserIn] Halasa, Natasha [verfasserIn] Ware, Russell E. [verfasserIn] Stahl, Anna [verfasserIn] McMahon, Maureen [verfasserIn] Browning, Peter [verfasserIn] Maniatis, Panagiotis [verfasserIn] Bolcen, Shanna [verfasserIn] Edwards, Kathryn M. [verfasserIn] Su, John R. [verfasserIn] Dharmarajan, Sai [verfasserIn] Forshee, Richard [verfasserIn] Broder, Karen R. [verfasserIn] Anderson, Steven [verfasserIn] Kozlowski, Steven [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Vaccine - Amsterdam : Elsevier, 1983, 41, Seite 4183-4189 |
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| Übergeordnetes Werk: |
volume:41 ; pages:4183-4189 |
| DOI / URN: |
10.1016/j.vaccine.2023.05.029 |
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ELV010560009 |
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| 100 | 1 | |a Zhou, Zhao-Hua |e verfasserin |0 (orcid)0000-0002-9998-0381 |4 aut | |
| 245 | 1 | 0 | |a Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination |
| 264 | 1 | |c 2023 | |
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| 520 | |a 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. | ||
| 650 | 4 | |a COVID 19 | |
| 650 | 4 | |a mRNA vaccines | |
| 650 | 4 | |a Polyethylene glycol | |
| 650 | 4 | |a Anaphylaxis | |
| 650 | 4 | |a IgE | |
| 650 | 4 | |a Antibodies | |
| 700 | 1 | |a Cortese, Margaret M. |e verfasserin |4 aut | |
| 700 | 1 | |a Fang, Jia-Long |e verfasserin |4 aut | |
| 700 | 1 | |a Wood, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Hummell, Donna S. |e verfasserin |4 aut | |
| 700 | 1 | |a Risma, Kimberly A. |e verfasserin |4 aut | |
| 700 | 1 | |a Norton, Allison E. |e verfasserin |4 aut | |
| 700 | 1 | |a KuKuruga, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Kirshner, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a Rabin, Ronald L. |e verfasserin |4 aut | |
| 700 | 1 | |a Agarabi, Cyrus |e verfasserin |4 aut | |
| 700 | 1 | |a Staat, Mary A. |e verfasserin |4 aut | |
| 700 | 1 | |a Halasa, Natasha |e verfasserin |4 aut | |
| 700 | 1 | |a Ware, Russell E. |e verfasserin |0 (orcid)0000-0001-9582-0594 |4 aut | |
| 700 | 1 | |a Stahl, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a McMahon, Maureen |e verfasserin |4 aut | |
| 700 | 1 | |a Browning, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Maniatis, Panagiotis |e verfasserin |0 (orcid)0000-0001-5240-0848 |4 aut | |
| 700 | 1 | |a Bolcen, Shanna |e verfasserin |0 (orcid)0000-0002-7464-9967 |4 aut | |
| 700 | 1 | |a Edwards, Kathryn M. |e verfasserin |0 (orcid)0000-0003-3912-9832 |4 aut | |
| 700 | 1 | |a Su, John R. |e verfasserin |0 (orcid)0000-0002-5897-8031 |4 aut | |
| 700 | 1 | |a Dharmarajan, Sai |e verfasserin |4 aut | |
| 700 | 1 | |a Forshee, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Broder, Karen R. |e verfasserin |4 aut | |
| 700 | 1 | |a Anderson, Steven |e verfasserin |0 (orcid)0000-0002-2517-0271 |4 aut | |
| 700 | 1 | |a Kozlowski, Steven |e verfasserin |0 (orcid)0000-0002-7240-3605 |4 aut | |
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10.1016/j.vaccine.2023.05.029 doi (DE-627)ELV010560009 (ELSEVIER)S0264-410X(23)00568-6 DE-627 ger DE-627 rda eng 610 VZ 44.45 bkl Zhou, Zhao-Hua verfasserin (orcid)0000-0002-9998-0381 aut Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. COVID 19 mRNA vaccines Polyethylene glycol Anaphylaxis IgE Antibodies Cortese, Margaret M. verfasserin aut Fang, Jia-Long verfasserin aut Wood, Robert verfasserin aut Hummell, Donna S. verfasserin aut Risma, Kimberly A. verfasserin aut Norton, Allison E. verfasserin aut KuKuruga, Mark verfasserin aut Kirshner, Susan verfasserin aut Rabin, Ronald L. verfasserin aut Agarabi, Cyrus verfasserin aut Staat, Mary A. verfasserin aut Halasa, Natasha verfasserin aut Ware, Russell E. verfasserin (orcid)0000-0001-9582-0594 aut Stahl, Anna verfasserin aut McMahon, Maureen verfasserin aut Browning, Peter verfasserin aut Maniatis, Panagiotis verfasserin (orcid)0000-0001-5240-0848 aut Bolcen, Shanna verfasserin (orcid)0000-0002-7464-9967 aut Edwards, Kathryn M. verfasserin (orcid)0000-0003-3912-9832 aut Su, John R. verfasserin (orcid)0000-0002-5897-8031 aut Dharmarajan, Sai verfasserin aut Forshee, Richard verfasserin aut Broder, Karen R. verfasserin aut Anderson, Steven verfasserin (orcid)0000-0002-2517-0271 aut Kozlowski, Steven verfasserin (orcid)0000-0002-7240-3605 aut Enthalten in Vaccine Amsterdam : Elsevier, 1983 41, Seite 4183-4189 Online-Ressource (DE-627)266886078 (DE-600)1468474-3 (DE-576)075961857 1873-2518 nnns volume:41 pages:4183-4189 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.45 Immunologie VZ AR 41 4183-4189 |
| spelling |
10.1016/j.vaccine.2023.05.029 doi (DE-627)ELV010560009 (ELSEVIER)S0264-410X(23)00568-6 DE-627 ger DE-627 rda eng 610 VZ 44.45 bkl Zhou, Zhao-Hua verfasserin (orcid)0000-0002-9998-0381 aut Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. COVID 19 mRNA vaccines Polyethylene glycol Anaphylaxis IgE Antibodies Cortese, Margaret M. verfasserin aut Fang, Jia-Long verfasserin aut Wood, Robert verfasserin aut Hummell, Donna S. verfasserin aut Risma, Kimberly A. verfasserin aut Norton, Allison E. verfasserin aut KuKuruga, Mark verfasserin aut Kirshner, Susan verfasserin aut Rabin, Ronald L. verfasserin aut Agarabi, Cyrus verfasserin aut Staat, Mary A. verfasserin aut Halasa, Natasha verfasserin aut Ware, Russell E. verfasserin (orcid)0000-0001-9582-0594 aut Stahl, Anna verfasserin aut McMahon, Maureen verfasserin aut Browning, Peter verfasserin aut Maniatis, Panagiotis verfasserin (orcid)0000-0001-5240-0848 aut Bolcen, Shanna verfasserin (orcid)0000-0002-7464-9967 aut Edwards, Kathryn M. verfasserin (orcid)0000-0003-3912-9832 aut Su, John R. verfasserin (orcid)0000-0002-5897-8031 aut Dharmarajan, Sai verfasserin aut Forshee, Richard verfasserin aut Broder, Karen R. verfasserin aut Anderson, Steven verfasserin (orcid)0000-0002-2517-0271 aut Kozlowski, Steven verfasserin (orcid)0000-0002-7240-3605 aut Enthalten in Vaccine Amsterdam : Elsevier, 1983 41, Seite 4183-4189 Online-Ressource (DE-627)266886078 (DE-600)1468474-3 (DE-576)075961857 1873-2518 nnns volume:41 pages:4183-4189 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.45 Immunologie VZ AR 41 4183-4189 |
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10.1016/j.vaccine.2023.05.029 doi (DE-627)ELV010560009 (ELSEVIER)S0264-410X(23)00568-6 DE-627 ger DE-627 rda eng 610 VZ 44.45 bkl Zhou, Zhao-Hua verfasserin (orcid)0000-0002-9998-0381 aut Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. COVID 19 mRNA vaccines Polyethylene glycol Anaphylaxis IgE Antibodies Cortese, Margaret M. verfasserin aut Fang, Jia-Long verfasserin aut Wood, Robert verfasserin aut Hummell, Donna S. verfasserin aut Risma, Kimberly A. verfasserin aut Norton, Allison E. verfasserin aut KuKuruga, Mark verfasserin aut Kirshner, Susan verfasserin aut Rabin, Ronald L. verfasserin aut Agarabi, Cyrus verfasserin aut Staat, Mary A. verfasserin aut Halasa, Natasha verfasserin aut Ware, Russell E. verfasserin (orcid)0000-0001-9582-0594 aut Stahl, Anna verfasserin aut McMahon, Maureen verfasserin aut Browning, Peter verfasserin aut Maniatis, Panagiotis verfasserin (orcid)0000-0001-5240-0848 aut Bolcen, Shanna verfasserin (orcid)0000-0002-7464-9967 aut Edwards, Kathryn M. verfasserin (orcid)0000-0003-3912-9832 aut Su, John R. verfasserin (orcid)0000-0002-5897-8031 aut Dharmarajan, Sai verfasserin aut Forshee, Richard verfasserin aut Broder, Karen R. verfasserin aut Anderson, Steven verfasserin (orcid)0000-0002-2517-0271 aut Kozlowski, Steven verfasserin (orcid)0000-0002-7240-3605 aut Enthalten in Vaccine Amsterdam : Elsevier, 1983 41, Seite 4183-4189 Online-Ressource (DE-627)266886078 (DE-600)1468474-3 (DE-576)075961857 1873-2518 nnns volume:41 pages:4183-4189 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.45 Immunologie VZ AR 41 4183-4189 |
| allfieldsGer |
10.1016/j.vaccine.2023.05.029 doi (DE-627)ELV010560009 (ELSEVIER)S0264-410X(23)00568-6 DE-627 ger DE-627 rda eng 610 VZ 44.45 bkl Zhou, Zhao-Hua verfasserin (orcid)0000-0002-9998-0381 aut Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. COVID 19 mRNA vaccines Polyethylene glycol Anaphylaxis IgE Antibodies Cortese, Margaret M. verfasserin aut Fang, Jia-Long verfasserin aut Wood, Robert verfasserin aut Hummell, Donna S. verfasserin aut Risma, Kimberly A. verfasserin aut Norton, Allison E. verfasserin aut KuKuruga, Mark verfasserin aut Kirshner, Susan verfasserin aut Rabin, Ronald L. verfasserin aut Agarabi, Cyrus verfasserin aut Staat, Mary A. verfasserin aut Halasa, Natasha verfasserin aut Ware, Russell E. verfasserin (orcid)0000-0001-9582-0594 aut Stahl, Anna verfasserin aut McMahon, Maureen verfasserin aut Browning, Peter verfasserin aut Maniatis, Panagiotis verfasserin (orcid)0000-0001-5240-0848 aut Bolcen, Shanna verfasserin (orcid)0000-0002-7464-9967 aut Edwards, Kathryn M. verfasserin (orcid)0000-0003-3912-9832 aut Su, John R. verfasserin (orcid)0000-0002-5897-8031 aut Dharmarajan, Sai verfasserin aut Forshee, Richard verfasserin aut Broder, Karen R. verfasserin aut Anderson, Steven verfasserin (orcid)0000-0002-2517-0271 aut Kozlowski, Steven verfasserin (orcid)0000-0002-7240-3605 aut Enthalten in Vaccine Amsterdam : Elsevier, 1983 41, Seite 4183-4189 Online-Ressource (DE-627)266886078 (DE-600)1468474-3 (DE-576)075961857 1873-2518 nnns volume:41 pages:4183-4189 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.45 Immunologie VZ AR 41 4183-4189 |
| allfieldsSound |
10.1016/j.vaccine.2023.05.029 doi (DE-627)ELV010560009 (ELSEVIER)S0264-410X(23)00568-6 DE-627 ger DE-627 rda eng 610 VZ 44.45 bkl Zhou, Zhao-Hua verfasserin (orcid)0000-0002-9998-0381 aut Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination 2023 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. COVID 19 mRNA vaccines Polyethylene glycol Anaphylaxis IgE Antibodies Cortese, Margaret M. verfasserin aut Fang, Jia-Long verfasserin aut Wood, Robert verfasserin aut Hummell, Donna S. verfasserin aut Risma, Kimberly A. verfasserin aut Norton, Allison E. verfasserin aut KuKuruga, Mark verfasserin aut Kirshner, Susan verfasserin aut Rabin, Ronald L. verfasserin aut Agarabi, Cyrus verfasserin aut Staat, Mary A. verfasserin aut Halasa, Natasha verfasserin aut Ware, Russell E. verfasserin (orcid)0000-0001-9582-0594 aut Stahl, Anna verfasserin aut McMahon, Maureen verfasserin aut Browning, Peter verfasserin aut Maniatis, Panagiotis verfasserin (orcid)0000-0001-5240-0848 aut Bolcen, Shanna verfasserin (orcid)0000-0002-7464-9967 aut Edwards, Kathryn M. verfasserin (orcid)0000-0003-3912-9832 aut Su, John R. verfasserin (orcid)0000-0002-5897-8031 aut Dharmarajan, Sai verfasserin aut Forshee, Richard verfasserin aut Broder, Karen R. verfasserin aut Anderson, Steven verfasserin (orcid)0000-0002-2517-0271 aut Kozlowski, Steven verfasserin (orcid)0000-0002-7240-3605 aut Enthalten in Vaccine Amsterdam : Elsevier, 1983 41, Seite 4183-4189 Online-Ressource (DE-627)266886078 (DE-600)1468474-3 (DE-576)075961857 1873-2518 nnns volume:41 pages:4183-4189 GBV_USEFLAG_U SYSFLAG_U GBV_ELV GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.45 Immunologie VZ AR 41 4183-4189 |
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Enthalten in Vaccine 41, Seite 4183-4189 volume:41 pages:4183-4189 |
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Zhou, Zhao-Hua @@aut@@ Cortese, Margaret M. @@aut@@ Fang, Jia-Long @@aut@@ Wood, Robert @@aut@@ Hummell, Donna S. @@aut@@ Risma, Kimberly A. @@aut@@ Norton, Allison E. @@aut@@ KuKuruga, Mark @@aut@@ Kirshner, Susan @@aut@@ Rabin, Ronald L. @@aut@@ Agarabi, Cyrus @@aut@@ Staat, Mary A. @@aut@@ Halasa, Natasha @@aut@@ Ware, Russell E. @@aut@@ Stahl, Anna @@aut@@ McMahon, Maureen @@aut@@ Browning, Peter @@aut@@ Maniatis, Panagiotis @@aut@@ Bolcen, Shanna @@aut@@ Edwards, Kathryn M. @@aut@@ Su, John R. @@aut@@ Dharmarajan, Sai @@aut@@ Forshee, Richard @@aut@@ Broder, Karen R. @@aut@@ Anderson, Steven @@aut@@ Kozlowski, Steven @@aut@@ |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">ELV010560009</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230619073043.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230619s2023 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.vaccine.2023.05.029</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV010560009</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0264-410X(23)00568-6</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.45</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Zhou, Zhao-Hua</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-9998-0381</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2023</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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Zhou, Zhao-Hua |
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610 VZ 44.45 bkl Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination COVID 19 mRNA vaccines Polyethylene glycol Anaphylaxis IgE Antibodies |
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Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination |
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Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination |
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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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evaluation of association of anti-peg antibodies with anaphylaxis after mrna covid-19 vaccination |
| title_auth |
Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination |
| 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 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. |
| abstractGer |
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. |
| abstract_unstemmed |
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. |
| collection_details |
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| title_short |
Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination |
| remote_bool |
true |
| author2 |
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 |
| author2Str |
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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266886078 |
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| doi_str |
10.1016/j.vaccine.2023.05.029 |
| up_date |
2024-07-06T18:25:14.978Z |
| _version_ |
1803855137320468480 |
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|
| score |
7.40199 |