COVID-19 Vaccination in Patients with Reported Allergic Reactions: Updated Evidence and Suggested Approach

To address this unmet need amidst great uncertainty, in December 2020, we published initial algorithms to help the allergist guide safe vaccination in individuals with allergy histories.2 Since then, more than 46 million individuals have been fully vaccinated and more than 2 million additional Americans receive their vaccinations daily.3 The Centers for Disease Control and Prevention (CDC), using Vaccine Adverse Event Reporting System and V-safe voluntary reporting data, described the rate of anaphylaxis after receipt of the mRNA COVID-19 vaccines as 4.5 cases per million doses administered, with 89% occurring within the 15- to 30-minute observation period.4-6 This is comparable to anaphylaxis rates with other vaccines including the inactivated influenza vaccine (1.4 per million), pneumococcal polysaccharide vaccine (2.5 per million), and the live attenuated herpes zoster vaccine (9.6 per million).4 However, prospective cohort data from more than 60,000 Mass General Brigham (MGB) employees found a higher incidence rate of anaphylaxis to the mRNA COVID-19 vaccines at 2.47 per 10,000 vaccinations.7 The marked difference in observed incidence rates likely relates to incomplete CDC capture of cases, although the MGB cohort may have a higher rate than some US populations because of demographic or geographic effects.Janssen COVID-19 Vaccine On February 27, 2021, the Food and Drug Administration issued EUA approval for a third COVID-19 vaccine from Janssen (Johnson and Johnson) in individuals 18 years or older. Polysorbate 80 as an excipient cause of anaphylaxis is extremely rare, with just 1 case report of vaccine anaphylaxis thought to be related to polysorbate 80 in the literature.10 At the time of publication, updated CDC guidance11 states (1) if you are allergic to PEG, you should not receive an mRNA COVID-19 vaccine and instead speak to your physician about receiving the Janssen COVID-19 vaccine; (2) if you are allergic to polysorbate 80, you should not receive the Janssen COVID-19 vaccine and instead speak to your physician about receiving the mRNA COVID-19 vaccines; (3) a history of polysorbate allergy is a precaution rather than a contraindication to mRNA vaccination12; and (4) vaccination of these individuals (ie, those with PEG or polysorbate allergy histories) should be undertaken only under the supervision of a health care provider experienced in the management of severe allergic reactions.12 Therefore, the CDC suggests that individuals with a contra