Antibodies against polyethylene glycol in human blood: A literature review

Lu, Hong; Wang, Zongkui; Wei, Xin; Shi, Jianyou; Li, Changqing

doi:10.1016/j.vascn.2020.106678

Cited by 71 publications

(48 citation statements)

References 51 publications

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“…Studies have shown that the prevalence of anti-PEG antibodies in healthy populations ranges from 20 to 44% [ 12 ]. Population studies are required to determine the prevalance of anti-PEG or anti-BNT162b2 antibodies and to determine a cut-off value that could serve as a diagnostic test to distinguish the at-risk population who will develop anaphylaxis to mRNA COVID-19 vaccines.…”

Section: Discussionmentioning

confidence: 99%

Pseudo-Anaphylactic Reactions to Pfizer BNT162b2 Vaccine: Report of 3 Cases of Anaphylaxis Post Pfizer BNT162b2 Vaccination

Lim

Leung

et al. 2021

Vaccines

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Anaphylactic reactions were observed after Singapore’s national coronavirus disease 2019 (COVID-19) vaccination programme started in December 2020. We report the clinical and laboratory features of three patients in our institution who developed anaphylactic reactions after receiving the Pifzer BNT162b2 vaccine. IgM and IgG antibodies, but not IgE antibodies to the Pfizer BNT162b2 vaccine, were detected in all subjects. Similarly, mild to high elevated levels of anti-polyethylene glycol (PEG) IgG (1035–19709 U/mL, vs. vaccine-naive < 265 U/mL, vaccine-tolerant < 785 U/mL) and IgM (1682–5310 U/mL, vs. vaccine-naive < 1011 U/mL, vaccine-tolerant < 1007 U/mL) were detected in two out of three patients via commercial ELISA. High levels of serum anaphylatoxin C3a (79.0 ± 6.3 μg/mL, mean ± SD, vs. normal < 10 μg/mL) were observed in all three patients during the acute phase of the reaction, while tryptase levels, a marker of mast cell activation, were not elevated. Finally, one patient with the highest levels of anti-PEG IgG, IgM, and anti-Pfizer BNT162b2 IgG and IgM exhibited an enhanced Th2 cytokine serum profile during an acute reaction, with high levels of IL-4 (45.7 pg/mL, vs. vaccine-naive/tolerant < 2.30 pg/mL), IL-33 (86.4 pg/mL, vs. vaccine-naive/tolerant < 5.51 pg/mL) and IL-10 (22.9 pg/mL, vs. vaccine-naive/tolerant < 12.49 pg/mL) diminishing over time following corticosteroid treatment. Taken together, we propose these cases of anaphylaxis described are driven by a complement activation-related pseudoallergy (CAPRA), rather than classical IgE-mediated mechanisms.

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Section: Discussionmentioning

confidence: 99%

Pseudo-Anaphylactic Reactions to Pfizer BNT162b2 Vaccine: Report of 3 Cases of Anaphylaxis Post Pfizer BNT162b2 Vaccination

Lim

Leung

et al. 2021

Vaccines

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“…PEG may also be cross‐reactive with polysorbates, which are contained in some COVID‐19 vaccines 141,143–145 . However, measures of pre‐existing anti‐PEG antibodies vary widely, range from 0.2% to 72% of healthy individuals 146 . This has become immediately relevant because PEG 2000, a high‐molecular weight version of PEG, is a component in two of the three authorized COVID‐19 vaccines.…”

Section: Section V: Proven and Suspected Allergenic Components Of Vaccinesmentioning

confidence: 99%

Vaccines and allergic reactions: The past, the current COVID‐19 pandemic, and future perspectives

Sampath

Rabinowitz

Shah

et al. 2021

Allergy

123

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The rapid development and the launch of several novel COVID-19 vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an extraordinary and remarkable accomplishment of modern science. The Pfizer-BioNTech BNT162b2 was the first vaccine to be granted temporary authorization for emergency use by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K for the treatment of COVID-19 on 2 December 2020. 1 Soon after, on 11 December 2020, it also received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). 2 EUA is a mechanism to facilitate the availability of vaccines during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products (including vaccines) to prevent serious or life-threatening disease when certain statutory criteria have been met and no adequate and/or approved alternatives are available. The authorization of BNT162b2 was followed by an EUA for a second COVID-19 vaccine, the Moderna mRNA-1273 on 18 December 2020. 3 This was followed by the authorization of mRNA-1273 for use by other regulatory agencies such as the European Commission, UK MHRA, Israel Ministry of

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“…152,163 What is especially troubling is that anti-PEG antibodies have not only been detected in patients receiving a PEGylated drug, but also in naïve patients. 152,164 This growth of anti-PEG immune responses is thought to stem from enhanced exposure to PEGylated products used in a broad variety of applications, including cosmetics and processed foods. As such, the growing frequency of anti-PEG immune responses, and concerns of how these may impact therapeutic efficacy and induce adverse effects, has resulted in a need to find safer options for future drug development.…”

Section: Influence Of Structural Modifications On Protein Stability and Aggregationmentioning

confidence: 99%

Aggregation of protein therapeutics enhances their immunogenicity: causes and mitigation strategies

Lundahl

Fogli²,

Colavita

et al. 2021

RSC Chem. Biol.

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Antibodies against polyethylene glycol in human blood: A literature review

Cited by 71 publications

References 51 publications

Pseudo-Anaphylactic Reactions to Pfizer BNT162b2 Vaccine: Report of 3 Cases of Anaphylaxis Post Pfizer BNT162b2 Vaccination

Pseudo-Anaphylactic Reactions to Pfizer BNT162b2 Vaccine: Report of 3 Cases of Anaphylaxis Post Pfizer BNT162b2 Vaccination

Vaccines and allergic reactions: The past, the current COVID‐19 pandemic, and future perspectives

Aggregation of protein therapeutics enhances their immunogenicity: causes and mitigation strategies

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