American College of Allergy, Asthma, and Immunology (ACAAI) Guidance on Risk of Allergic Reactions to the Pfizer-BioNTech COVID-19 Vaccine

Allergic reactions to vaccines, in general, are rare with the incidence of anaphylaxis estimated at 1.31 in 1 million doses given. With the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine by the FDA on December 11, 2020, the ACAAI COVID-19 Vaccine Task Force recommends the following guidance for physicians and other providers related to risk of an allergic reaction on vaccination. These recommendations are based on best knowledge to date but could change at any time, pending new information and further guidance from the FDA or CDC. 
 
1. The Pfizer-BioNTech COVID-19 vaccine should be administered in a health care setting where anaphylaxis can be treated. All individuals must be observed for at least 20-30 minutes after injection to monitor for any adverse reaction. All anaphylactic reactions should be managed immediately with IM epinephrine as the first line treatment.
 
2. The Pfizer-BioNTech COVID-19 vaccine should not be administered to individuals with a known history of a severe allergic reaction to polyethylene glycol as it is a component of this vaccine known to cause anaphylaxis.
 
3. Data related to risk in individuals with a history of allergic reactions to previous vaccinations and/or mast cell activation syndrome/idiopathic anaphylaxis is very limited and evolving. A clinical decision to administer the Pfizer-BioNTech COVID-19 vaccine should be undertaken by the physician or other provider administering the vaccine using their professional judgment and in consultation with the patient, balancing the benefits and risks associated with taking the vaccine.
 
4. Individuals with common allergies to medications, foods, inhalants, insects and latex are no more likely than the general public to have an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine. Those patients should be informed of the benefits of the vaccine versus its risks.
 
5. The Pfizer-BioNTech COVID-19 vaccine is not a live vaccine and can be administered to immunocompromised patients. Physicians and other providers should inform such immunocompromised patients of the possibility of a diminished immune response to the vaccine.
 
6. Anyone with questions related to the risk of an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine should contact their local board-certified allergist/immunologist.
 
 
References
 
McNeil MM, Weintraub ES, Duffy J, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol. 2016;137(3):868-878.
 
Dreskin et al. International Consensus (ICON): allergic reactions to vaccines
World Allergy Organization Journal (2016) 9:32.
 
Wylon, K., Dölle, S. & Worm, M. Polyethylene glycol as a cause of anaphylaxis. Allergy Asthma Clin Immunol 12, 67 (2016).

Stone CA, Liu Y, et al. Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized.  J Allergy Clin Immunol Pract. 2019; 7(5): 1533–1540.

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