This is a summary, written by members of the CITF Secretariat, of:
Greenhawt M, Abrams EM, Shaker M, Chu DK, Kahn D, Akin C, Alqurashi W, Arkwright P, Baldwin JL, Ben-Shoshan M, Bernstein J, Bingeman T, Blumchen K, Byrne A, Bognanni A, Campbell D, Campbell R, Chagla Z, Chan ES, Chan J, Comberiatti P, Dribin TE, Ellis AK, Fleischer DM, Fox A, Frischmeyer-Guerrerio PA, Gagnon R, Grayson MH, Horner CC, Hourihane J, Katelaris CH, Kim H, Kelso JM, Lang D, Ledford D, Levin M, Lieberman J, Loh R, Mack D, Mazer B, Mosnaim G, Munblit D, Mustafa SS, Nanda A, Oppenheimer J, Perrett KP, Ramsey A, Rank M, Robertson K, Shiek J, Spergel JM, Stukus D, Tang ML, Tracy JM, Turner PJ, Whalen-Browne A, Wallace D, Wang J, Wasserman S, Witty JK, Worm M, Vander Leek TK, Golden DB. The risk of allergic reaction to SARS-CoV-2 vaccines and recommended evaluation and management: A systematic review, meta-analysis, GRADE assessment, and international consensus approach. J Allergy Clin Immunol Pract. 2021 Jun 18:S2213-2198(21)00671-1. doi: 10.1016/j.jaip.2021.06.006.
The results and/or conclusions contained in the research do not necessarily reflect the views of all CITF members.
An ad hoc panel of clinical experts from the US, Canada, UK, Ireland, Germany, Italy, South Africa, and Australia, including CITF Associate Scientific Director Dr. Bruce Mazer, was formed to synthesize the current evidence regarding severe allergic reactions to the SARS-CoV-2 vaccines, and provide consensus on recommendations regarding risk factors and management of patients at possible risk for severe allergic reactions. The group, whose manuscript was published in The Journal of Allergy and Clinical Immunology: In Practice, included infectious disease clinicians, front-line clinicians administering vaccines, and allergy specialists with prior expertise in policy related to adverse reactions to vaccines.
After reviewing data from 26 studies encompassing data from the administration of 41 million vaccinations, the team of experts reported that allergies to SARS-CoV-2 vaccines were rare, with less than eight cases of allergic reactions observed per million vaccines administered. Given the low risk observed, experts recommended vaccination and did not think that performing pre-emptive allergy testing was necessary for people without a history of severe allergic reactions to the first dose of SARS-CoV-2 vaccines or its individual components.
- What is the risk of a severe allergic reaction to a SARS-CoV-2 vaccine in people without a history of a severe allergic reaction to the first dose of this vaccine or its individual components? Potential allergic reactions have been reported but have occurred very rarely. The experts recommended receiving a vaccine based on this risk.
- Should SARS-CoV-2 vaccines be administered to an individual who had an immediate allergic reaction to the first dose of the vaccine? The experts recommended consulting with an allergy specialist, potentially changing vaccine platforms, and receiving the vaccine in facilities with the capacity to treat a systemic allergic reaction.
- What are the potential allergies to the SARS-CoV-2 vaccine’s non-active components (such as polyethylene glycol or PEG from the Pfizer mRNA vaccine)? PEG has been suggested as a potential culprit in allergic reactions to SARS-CoV-2 mRNA vaccines. This is an ubiquitous compound, found in many health and beauty products, as well as in foods and beverages. It is widely used and well tolerated. Therefore, even if individuals have a known PEG allergy through positive PEG skin testing (which only suggests a local skin reaction), they will likely tolerate a SARS-CoV-2 mRNA vaccine well, assuming no systemic allergic reaction occurred during skin testing. Nevertheless, consultation with an allergy specialist is warranted for people with known allergies to any non-active ingredients.