Tolerability of polysorbate 80–containing COVID-19 vaccines in confirmed polyethylene glycol–allergic patients

Ieven, Toon; Weyenbergh, Thomas Van; Vandebotermet, Martijn; Devolder, David; Breynaert, Christine; Schrijvers, R.

doi:10.1016/j.jaip.2021.09.039

Cited by 16 publications

(28 citation statements)

References 9 publications

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“…This finding is in line with prior reports of patients with PEG-asparaginase reactions who tolerated mRNA COVID-19 vaccines and PEG-allergic patients who tolerated both polysorbate-containing vaccines and PEG-containing COVID-19 vaccines. [20][21][22][23][24] This suggests that patients do not need to be screened for PEG/polysorbate allergy prior to receiving COVID-19 vaccines.…”

Section: Discussionmentioning

confidence: 99%

Coronavirus disease 2019 vaccine administration in patients with reported reactions to polyethylene glycol- and polysorbate-containing therapeutics

Otani

Tsao

Tang

2022

Annals of Allergy, Asthma & Immunology

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Section: Discussionmentioning

confidence: 99%

Coronavirus disease 2019 vaccine administration in patients with reported reactions to polyethylene glycol- and polysorbate-containing therapeutics

Otani

Tsao

Tang

2022

Annals of Allergy, Asthma & Immunology

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“…In patients with a possible or confirmed excipient allergy, an additional workup was performed prior to vaccination as previously described to decide on the selection of either a PEG-containing (BNT162b2) or PS80-containing vaccine (Ad26.COV2-S) [15].…”

Section: Vaccine Selectionmentioning

confidence: 99%

“…A miscellaneous group, consisting of (a) patients with a history of immediate reactions to other vaccines; (b) patients with (non)-anaphylactic reactions to the first dose of any COVID-19 vaccine; (c) patients with a proven PEG allergy of whom 10/11 were reported in a previous study [15]; and (d) others, amongst which patients with a history of isolated anaphylaxis-like or poorly circumscribed severe reactions to drug(s) or unclear trigger(s) not fulfilling the criteria for IA.…”

mentioning

confidence: 99%

COVID-19 Vaccination Safety and Tolerability in Patients Allegedly at High Risk for Immediate Hypersensitivity Reactions

et al. 2022

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The reported incidence of immediate hypersensitivity reactions (IHR) including anaphylaxis after COVID-19 vaccination is 10-fold higher than for other vaccines. Several patient groups are theorized to be at particular risk. Since specific vaccination guidelines for these patients are based on expert opinion, we performed a retrospective monocentric analysis of the tolerability of adenoviral vector and mRNA-based COVID-19 vaccines in a cohort of patients allegedly at high risk of IHR. Reactions were assessed immediately on-site by allergists during a monitored vaccination protocol and after 3–7 days through telephone interviews. The cohort included 196 patients (aged 12–84 years) with primary mast cell disease (pMCD, 50.5%), idiopathic anaphylaxis (IA, 19.9%), hereditary angioedema (HAE, 5.1%) or miscellaneous indications (24.5%). Twenty-five immediate reactions were observed in 221 vaccine doses (11.3%). Most occurred in IA or miscellaneous patients. None fulfilled anaphylaxis criteria and most were mild and self-limiting. Reaction occurrence was significantly associated with female sex. In total, 13.5% of pMCD patients reported mast cell activation-like symptoms within 72 h post-vaccination. All pediatric pMCD patients (n = 9, 12–18 years) tolerated both mRNA-based vaccine doses. In summary, adenoviral vector and mRNA-based COVID-19 vaccines were safe and well-tolerated in patients with pMCD, HAE, and IA. No anaphylaxis was observed. The mild and subjective nature of most reactions suggests a nocebo effect associated with vaccination in a medicalized setting. Patients with pMCD could experience mild flare-ups of mast cell activation-like symptoms, supporting antihistamine premedication.

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“…Both ChAdOx1 nCov-19 and Ad26.COV2 vaccines contain polysorbate 80, a synthetic nonionic surfactant additive that may convey severe allergic reactions and vascular thrombosis. Of clinical concern, polysorbate 80 also breaks the blood-brain barrier, enhances membrane permeability, and facilitates the migration of drugs or other substances from the blood compartment into the brain [2,78,79].…”

Section: Allergic Reactionsmentioning

confidence: 99%

“…It is a recognized notion that inflammation can be triggered even by small substances derived from injured, post-traumatic and/or post-vaccine, targeted cells (either infected or non-infected). These pathogen-like substances can lead to unusual clinical pictures such as the multisystem inflammatory syndrome in children or multisite thrombogenic syndrome in adults [79,80].…”

Section: Other Hypothesesmentioning

confidence: 99%

Cerebral Venous Sinus Thrombosis following COVID-19 Vaccination: Analysis of 552 Worldwide Cases

et al. 2022

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To date, billions of vaccine doses have been administered to restrain the current COVID-19 pandemic worldwide. Rare side effects, including intravascular blood clots, were reported in the general population after vaccination. Among these, cerebral venous sinus thrombosis (CVST) has been considered the most serious one. To shed further light on such an event, we conducted a literature search for case descriptions of CVST in vaccinated people. Findings were analyzed with emphasis on demographic characteristics, type of vaccine, site of thrombosis, clinical and histopathological findings. From 258 potential articles published till September 2021, 41 studies were retrieved for a total of 552 patients. Of these, 492 patients (89.1%) had received AZD1222/Vaxzevria, 45 (8.2%) BNT162b2/CX-024414 Spikevax, 15 (2.7%) JNJ-78436735, and 2 (0.3%) Covishield vaccine. CVST occurred in 382 women and 170 men (mean aged 44 years), and the median timing from the shot was 9 days (range 2–45). Thrombi were predominantly seen in transverse (84%), sigmoid (66%), and/or superior sagittal (56%) sinuses. Brain injury (chiefly intracranial bleeding) occurred in 32% of cases. Of 426 patients with detailed clinical course, 63% were discharged in good clinical conditions, at times with variable neurological sequelae, whereas 37% deceased, largely due to brain injury. This narrative review confirmed CVST as a rare event after (adenoviral vector) COVID-19 vaccination, with a women/men rate ratio of 2.25. Though the pathogenesis of thrombosis is still under discussion, currently available histopathological findings likely indicate an underlying immune vasculitis.

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Tolerability of polysorbate 80–containing COVID-19 vaccines in confirmed polyethylene glycol–allergic patients

Cited by 16 publications

References 9 publications

Coronavirus disease 2019 vaccine administration in patients with reported reactions to polyethylene glycol- and polysorbate-containing therapeutics

Coronavirus disease 2019 vaccine administration in patients with reported reactions to polyethylene glycol- and polysorbate-containing therapeutics

COVID-19 Vaccination Safety and Tolerability in Patients Allegedly at High Risk for Immediate Hypersensitivity Reactions

Cerebral Venous Sinus Thrombosis following COVID-19 Vaccination: Analysis of 552 Worldwide Cases

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