key: cord-0812885-4falo1i9 authors: Rush, Cassandra; Faulk, Kelly E.; Bradley, Zanette Kanani; Turner, Aubree; Krumins, Maija; Greenhawt, Matthew title: The Safety Of SARS-Cov-2 Vaccines in Persons with a Known History of Pegaspargase Allergy: A Single Institution Experience date: 2021-12-06 journal: J Allergy Clin Immunol Pract DOI: 10.1016/j.jaip.2021.11.025 sha: e4695d29df0013ffdbca57ba74efd5a16afff744 doc_id: 812885 cord_uid: 4falo1i9 nan (1) Pharmacy Department, Children's Hospital Colorado 9 (2) Center for Cancer and Blood Disorders, Children's Hospital Colorado, Department of 10 Pediatrics, University of Colorado School of Medicine 11 (3) Section of Allergy and Immunology, Children's Hospital Colorado, Department of Pediatrics, 12 University MedLearningGroup. 40 The rest of the authors report no conflicts of interest. allergist supervision, few were even observed more than the standard 15 minutes common for 106 COVID-19 vaccines, and none underwent either excipient or vaccine skin testing or received 107 pre-medication prior to vaccination. Interestingly, few patients were aware the pegaspargase 108 allergy was a vaccination contraindication, and in the cases where the vaccine was given without 109 allergist supervision, it remains uncertain if either the pegaspargase allergy was disclosed (when 110 it was known by the patient) and/or the clinicians administering the vaccine were aware of the 111 contraindication with this allergy. To date, no evidence supports PEG as an allergen causing 112 administering these vaccines to PEG allergic individuals persists, and emerging data may support 114 a non-IgE mediated pathway (complement activation related pseudoallergy [CARPA] , which 115 also may be the primary mechanism for allergic reactions to pegaspargase). 7 116 117 These data help to provide evidence in support that the contraindication to administering PEG-118 containing COVID-19 vaccines to pegaspargase allergic individuals may be unnecessary and a 119 potential barrier to vaccination for some patients, and that pegaspargase allergic individuals can 120 be safely vaccinated with mRNA COVID-19 vaccines without allergist supervision or risk-121 stratification measures. Our data reflect similar findings from the recent study from Mark et al, 122 who vaccinated 32 patients with a history of pegaspargase allergy under the supervision of an 123 allergist, without premedication, with no allergic reactions occurring. 8 As well, our findings 124 both supplement and help further evolve the findings in the recently published work by Koo et 125 al, who demonstrated similar safety data in 19 pegaspargase allergic patients; however, in their 126 study, 14 patients underwent skin testing to PEG3350, and all vaccination was supervised by an 127 allergist. 9 The key differentiating features of our report are that we did not perform skin testing 128 in any patients prior to vaccination, not all subject were PEG3350 tolerant, and that the majority 129 of patients received their initial mRNA COVID-19 vaccine dose without allergist supervision. 130 A limitation of our report is that it does not have a large sample size, nor was designed as a 131 powered trial to provide a robustly narrow confidence interval that would provide high-level 132 evidence of definitive safety of the concept, a limitation common to the other two 133 aforementioned studies. Predicting 147 success of desensitization after pegaspargase allergy Predict Pegaspargase Allergic Reactions and Failure of Rechallenge The Risk of 154 Allergic Reaction to SARS-CoV-2 Vaccines and Recommended Evaluation and 155 Management: A Systematic Review, Meta-Analysis, GRADE Assessment, and 156 International Consensus Approach Immediate 159 Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We 160 Have Recognized Adverse reactions to vaccines practice parameter 162 2012 update Assessment of 164 Allergic and Anaphylactic Reactions to mRNA COVID-19 Vaccines With Confirmatory 165 Testing in a US Regional Health System Safety of administration 168 of BNT162b2 mRNA (Pfizer-BioNTech) COVID-19 vaccine in youths and young adults 169 with a history of acute lymphoblastic leukemia and allergy to PEG-asparaginase. Pediatr 170 Blood Cancer 172 mRNA COVID-19 Vaccine Safety in Patients with Previous Immediate Hypersensitivity 173 to Pegaspargase