SRFP010: Assessment and management of allergy history with a novel mRNA vaccine

Christina Holt, MD, MSc; Jesse Butler; Katie Sharp, MD; John McDonald

Abstract

Context: Tertiary care hospital provided onsite COVID-19 vaccine roll out as a work benefit for all care team members with medically supervised waiting period at the time of the distribution of the first round of the novel mRNA COVID-19 vaccines. Little was known about the immediate hypersensivity reactions or what might predispose to cross reactivity.
Objective: We developed a working protocol to continuously track the vaccines administered, the patient history of allergy and hypersensistivity, the reactions observed and the care plan developed (determination of allergy to mRNA vaccines or normal vaccine response). Continuous process improvement allowed us to change protocols as the CDC developed guidance. Every patient was observed for at least 15 minutes and every reaction was reviewed by a physician supervising the waiting area. We aimed to determine if there were predictors of adverse, immediate reaction to the vaccine and to assess prevalence of risk factors (history of allergy to polyethylene Glycol or polysorbate; allergy to other injectable medication or vaccines; hypersensitivity to multiple substances).
Study Design: cohort study of all employees who received a first mRNA COVID-19 vaccine between December 16 and January 7th. Descriptive statistics were developed with demographic and medical history recorded, reactions noted and treatment given.
Setting or Dataset: tertiary care hospital in urban area
Population Studied: employees who received an mRNA COVID-19 vaccine
Intervention/Instrument: clinical records from employee vaccine clinic;
Outcome Measures: record of immediate response, determination of allergy;
Results: we served over 7000 individuals with approximately 10% having a history of anaphylactic reaction. We had fewer with history of anaphylaxis to medications or vaccines. We delivered these vaccines safely, and observed three cases of immediate anaphylaxis on first dose of mRNA and over 50 cases of immediate allergic hypersensitivity. We did not see any patterns that predicted these reactions (gender, age or medical history).
Expected Outcomes: We used this data to inform our employee health vaccination campaign and to inform the health system as strategies and safety protocols for vaccination of the population were developed.
Leave a Comment
Jack Westfall
jwestfall@aafp.org 11/21/2021

This is a great topic and research study. Nice work. Thanks

Christina Holt, MD
holtc@mmc.org 11/23/2021

Thanks - we have been working on a publication!

Gillian Bartlett
gillian.bartlett@health.missouri.edu 11/21/2021

Incredibly timely and important research. I hope this helps other institutions to increase the safety and deployment of their vaccine programs for their employees.

Christina Holt, MD
holtc@mmc.org 11/23/2021

Thanks, we are hoping to get this published, Tina Holt

William R. Phillips
wphllps@uw.edu 11/21/2021

How does a primary care perspective or scope of practice inform this impressive immunization safety program? When I attended this type of clinic for my own Covid vaccinations, I asked myself: Who organize this wonder and why don't we put them in charge of more of our health services? (I think your great work might have been better presented in a more traditional poster format, despite current trending as of this format.) Thanks for sharing your work here at NAPCRG - Bill Phillips

Christina Holt, MD
holtc@mmc.org 11/23/2021

Thanks Bill, I appreciate that there might be interest in more visibility for some of our workflows. I got involved because our Preventive Medicine Training program is embedded in the Family Medicine department, and our medical center employee health was undergoing a transition at the time that this work was being stood up. We had a collaborative team including Family Medicine, Infectious Disease, Allergy and Asthma specialists and pharmacists, nurses, managers and members of our hospital HICS team. We were able to share these processes with colleagues in other parts of our health system, and at the health system administered mass vaccination sites, the distributed vaccination processes in our rural communities, and now at the practice and school level where the majority of vaccines are now occurring. thanks for your commentary and we definitely want to have ongoing collaborations with the public health and pandemic response systems. Thanks, Tina Holt, MD

Diane Harper
harperdi@med.umich.edu 11/22/2021

LOVE IT! and love the display. Thank you for sharing your work with NAPCRG!

Christina Holt, MD
holtc@mmc.org 11/23/2021

Thanks! Tina Holt, MD

Andy Pasternak
avpiv711@sbcglobal.net 11/26/2021

Please get this published- some very cool data and a great way to approach this topic

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