Updated Evidence, Suggested Approach for Safe COVID-19 Vaccination in People With High-Risk Allergies

April 20, 2021

By Denise Baez

Severe allergic reactions to coronavirus disease 2019 (COVID-19) vaccines remain exceedingly rare, but researchers have updated guidance on safe vaccination approaches among people with a history of high-risk allergies.

Aleena Banerji, MD, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, and colleagues updated their pre-vaccine risk stratification algorithm, which can be used in conjunction with previously published skin testing guidance.

The algorithm is published in the Journal of Allergy and Clinical Immunology: In Practice.

“All vaccine sites should continue to observe higher risk individuals following CDC [Centers for Disease Control and Prevention] guidelines and have staff trained in recognising and managing anaphylaxis,” the authors wrote. “The vast majority of individuals with high-risk allergy histories will not need excipient skin testing prior to vaccination, but as our experience and knowledge with COVID-19 variants vaccines increases, we must continue to remain flexible with our approach.”

Since vaccination efforts were initiated at Massachusetts General Hospital, 472 employees with high-risk allergy histories had allergist guidance prior to vaccination, and the researchers recommended 15 minute (n = 209) and 30 minute (n = 241) observations after COVID-19 mRNA vaccination.

Of 22 (5%) referred for pre-mRNA vaccination excipient skin testing, 16 completed skin testing to date. Referral reasons included a history of a severe allergic reaction to a vaccine or injectable with polyethylene glycol (PEG)/polysorbate (n = 8), oral PEG (n = 4), other vaccine or injectable (n = 3), and food, drug, venom, or latex (n = 1). Only 1 employee, with a history of oral PEG allergy, was skin test positive to methylprednisolone acetate (4 mg/mL intradermal, 10 × 30 mm), which contains PEG as an excipient. This employee subsequently tolerated the Janssen adenovirus vector COVID-19 vaccine (Ad26COV2.S). Among the skin test negative individuals (n = 15) who received the first dose (n = 13), no allergic reactions were observed (9 Pfizer-BioNTech, 2 Moderna, 2 Janssen). At the time of publication, 2 employees with negative skin testing await COVID-19 vaccination.

“Similar to our initial algorithm, individuals with any history of anaphylaxis should continue to be monitored for 30 minutes after receiving an mRNA COVID-19 vaccine,” the authors wrote. “Following current CDC guidance, individuals who self-report a PEG-allergy only can be considered for Janssen COVID-19 vaccine if available, whereas individuals who self-report a polysorbate-only allergy can be considered for mRNA COVID-19 vaccines after shared decision making with their physician. For COVID-19 vaccine-naïve individuals, clarification of polysorbate allergy can be easily assessed by asking about tolerance of other common vaccines with polysorbate 80. In patients with a history of PEG anaphylaxis, cross-reactivity to polysorbate 80 and other PEG derivatives may be a significant problem and more data are needed to assess whether these individuals will tolerate the low concentrations of polysorbate 80 present in the Janssen vaccine.”

“Pending the CDC’s ongoing evaluation of the Janssen vaccine, our algorithms may require additional modifications,” they added.

Reference: https://www.sciencedirect.com/science/article/pii/S2213219821004396

SOURCE: Journal of Allergy and Clinical Immunology: In Practice