mRNA COVID-19 vaccine safety in patients with previous immediate hypersensitivity to pegaspargase

The safety of SARS-CoV-2 vaccines in persons with a known history of pegaspargase allergy: A single institution experience

“…Our data reflect similar findings from the recent study from Mark et al, 9 who vaccinated 32 patients with a history of pegaspargase allergy under the supervision of an allergist, without premedication, with no allergic reactions occurring. As well, our findings both supplement and help further evolve the findings in the recently published work by Koo et al, 10 who demonstrated similar safety data in 19 pegaspargaseallergic patients; however, in their study, 14 patients underwent skin testing to PEG3350, and all vaccination was supervised by an allergist. The key differentiating features of our report are that we did not perform skin testing in any patient before vaccination, not all subjects were PEG3350 tolerant, and most patients received their initial mRNA COVID-19 vaccine dose without allergist supervision.…”

“…A limitation of our report is that it does not have a large sample size, nor was it designed as a powered trial to provide a robustly narrow CI that would provide high-level evidence of definitive safety of the concept, a limitation common to the other 2 aforementioned studies. 9,10 Although further research is needed, a preference-sensitive approach to offering mRNA COVID-19 vaccination to pegaspargase-allergic individuals, either under the supervision of an allergist or in any other general health care setting where anaphylaxis could be assessed and treated, should be considered. This approach may not have to involve negative skin testing results to PEG3350.…”

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

“…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.…”

Consensus on COVID-19 Vaccination in Pediatric Oncohematological Patients, on Behalf of Infectious Working Group of Italian Association of Pediatric Hematology Oncology

“…The type of PEG used in mRNA vaccines is different from that used in other drugs and preparations, and therefore, cross-reactivity is uncertain. In two studies, in which 32 and 19 patients with a history of PEG-L-Asparaginase allergy were vaccinated with two doses of BNT162b vaccines (Pfizer–BioNTech), no patients developed any allergy-related signs or symptoms [ 45 , 46 ]. In these cases, it is recommended to proceed after consulting the allergist and carry out a more prolonged observation of the subject (30–60 min instead of the standard 15 min).…”