key: cord-0754715-isrcyelr
authors: Dages, Kelley N.; Pitlick, Mitchell M.; Joshi, Avni Y.; Park, Miguel A.
title: Risk of allergic reaction in patients with atopic disease and recent COVID-19 vaccination
date: 2021-05-05
journal: Ann Allergy Asthma Immunol
DOI: 10.1016/j.anai.2021.04.024
sha: 8fb2863b9dbfb67c7514c2bd25ae6ec8e7504e93
doc_id: 754715
cord_uid: isrcyelr

nan

The number of cases of Coronavirus disease 2019 (COVID-19) has exceeded 20 million in the United States as of January 3, 2021. 1 On December 11, 2020 an Emergency Use Authorization (EUA) was issued by the Food and Drug Administration (FDA) for the use of the Pfizer-BioNTech vaccine for the prevention of COVID-19. 1 The Moderna COVID-19 vaccine became available via EUA one week later on December 18, 2021. 1 The Centers for Disease Control (CDC) has since issued interim clinical considerations for the use of mRNA COVID-19 vaccines authorized in the US and for potential management of anaphylaxis following vaccination for COVID-19. 2, 3 Vaccines are highly effective public health interventions, but carry the risk of potentially serious adverse reactions. 4 Vaccine-associated hypersensitivity has been well-reported in the literature. 4, 5 All vaccines have the potential to trigger anaphylaxis, a life-threatening allergic reaction. 5, 6 Fortunately, severe allergic reaction, including anaphylaxis, to vaccines is rare. 7 In a recent vaccine safety update from the CDC COVID-19 Vaccine Task Force, data through January 18, 2021 reported 50 cases of anaphylaxis. 8 There was a total of 9,943,247 administered doses of the Pfizer-BioNTech vaccine (61% females, 36% males, and unknown gender in 3%). Of the 50 reported cases of anaphylaxis, most cases occurred in females (n=47, 94%), and most occurred within 30 minutes of vaccination (n=45, 90%). Additionally, most cases occurred after the first dose of the vaccine (n=42, 84%), and a majority of patients had a documented history of allergies or allergic reactions to drugs and/or foods (n=40, 80%). 8 From December 14 to January 18, 2021, the estimated rate of anaphylaxis reported to the Vaccine Adverse Event Reporting System (VAERS) following administration of Pfizer-BioNTech COVID-19 vaccines was 5.0 per million doses. 8 This is in contrast to the previously reported rate of 11.1 per million doses administered during the period of December 14 to December 23, 2021, where 90% of cases occurred in females. 1, 9 In this single-center retrospective cohort study, we describe a cohort of patients receiving medical care at a large tertiary medical center with a known history of atopic disease on subcutaneous immunotherapy (SCIT) who received at least one dose of the Pfizer-BioNTech or Moderna COVID-19

vaccine. The aim of this study was to identify whether patients with a history of atopic disease on SCIT are at increased risk of allergic reaction to COVID-19 vaccine. Patients were selected from an internal database of consecutive patients on SCIT at Mayo Clinic, Rochester, Minnesota. We identified all patients with a history of atopic disease on maintenance or building SCIT, followed by an allergist within the Division of Allergic Diseases, and who had received at least one dose of either COVID-19 vaccine.

Medical records were reviewed for each patient for collection of baseline demographic and clinical data.

Allergy lists of all patients were reviewed, and all patients were asked about allergy to polyethylene glycol (PEG) or vaccine allergy prior to receiving their first dose of the COVID-19 vaccine. The study protocol was approved by the Mayo Clinic Institutional Review Board.

Our cohort included 68 patients (68% female) with a mean age of 44.1 years and known history of atopic disease who were on either maintenance or building SCIT at the time of this study (Table 1) .

Most patients had a history of allergic rhinitis (91%) and were receiving maintenance SCIT (87%) for animal allergens (75%), aeroallergens (71%), and/or stinging insect venom (12%). 47% of patients had a and their SCIT dose on the same day, only if the COVID-19 vaccine is administered before SCIT. If a patient receives his/her SCIT dose first, then he/she must wait at least 48 hours before receiving the COVID-19 vaccine.

As previously reported, anaphylaxis to the COVID-19 vaccine is rare, and most cases occur in patients with a documented history of atopy. In our sample of highly atopic patients as demonstrated by being treated with SCIT, zero had an allergic reaction. Although limited by a small sample size, atopy may not be a significant risk factor for an immediate allergic reaction to the mRNA COVID-19 vaccines.

Our current protocol at Mayo Clinic allows for patients to receive the COVID-19 vaccine and IT on the same day if the vaccine is administered before an IT dose. Recent data show that 74% of cases of anaphylaxis occurred within 15 minutes of vaccine administration. 8, 9 The CDC recommends a 30 minute observation period for any person with a history of immediate allergic reaction to a vaccine or other injectable therapy, or history of anaphylaxis due to any cause. 2 Recommendations regarding timing of administration of COVID-19 vaccination and SCIT requires further research. Although the three patients in our study received same day administration of COVID-19 vaccine and maintenance SCIT without complication, this small sample size limits any generalizations. Our initial findings suggest that the two can potentially be given safely on the same day based on our current protocol (COVID-19 vaccine followed by SCIT), but whether a patient can safely receive his/her SCIT dose followed by COVID-19 vaccine on the same day requires further evaluation and a larger sample size. Alternatively, a 24-hour waiting period between COVID-19 vaccination and SCIT dose may be a reasonable next step. 

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine -United States

COVID-19 vaccination: clinical considerations. Interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccination

COVID-19 vaccination: clinical considerations. Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States

Protecting the public's health: critical functions of the Section 317 Immunization Program-a report of the National Vaccine Advisory Committee

Vaccine-associated hypersensitivity

Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Risk of anaphylaxis after vaccination in children and adults

COVID-19 vaccine safety update. In: (ACIP) ACoIP, ed: CDC COVID 19 Vaccine Task Force

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine