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

Abstract

Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n [ 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the

Association of Self-reported High-Risk Allergy History With Allergy Symptoms After COVID-19 Vaccination

“…2,3 Since December 2020, the rate of allergy symptoms that have been reported after mRNA COVID-19 vaccination has been approximately 2%, 4 and the incidence of anaphylaxis has been estimated as 0.025 to 2.47 cases per 10 000 vaccinations. [4][5][6][7][8][9] Among individuals with confirmed anaphylaxis to mRNA COVID-19 vaccines, about one-third reported a history of anaphylaxis. 4,7 National and international guidelines on mRNA COVID-19 vaccination have varied and included mixed messages for individuals with a history of anaphylaxis.…”

Serious complications of COVID-19 vaccines: A mini-review

“…Anaphylaxis has been rarely reported after COVID-19 vaccination, with an estimated rate of 11.1 cases per million doses administered [ 11 ], with the mRNA based vaccines (BTN162b2 and mRNA-1273) being the two vaccines with the most frequently reported cases compared to the viral vector vaccines [ [11] , [12] , [13] ]. Although the potential causative allergens within the COVID-19 vaccines have not been identified yet, polyethylene glycol (PEG) and polysorbate might be implicated in severe allergic reactions associated with mRNA and vector-based vaccines, respectively [ 14 ]. The clinical features of severe immediate IgE-mediated hypersensitivity reactions to COVID-19 vaccines do not differ from other anaphylactic reactions; however, other mimicking conditions such as vasovagal episodes or anxiety-related symptoms should be discriminated from true anaphylaxis [ 15 ].…”

COVID-19 vaccines: addressing hesitancy in young people with allergies

“…In fact, for families of individuals with allergies, including those with asthma, one of the major concerns is fear of an allergic reaction to the vaccine. 3,4 This concern is easy to address. It must be emphasised to children and adolescents and their families, including to those with allergic conditions such as asthma, that the risk of having an anaphylactic reaction to a…”

“…A systematic review and meta-analysis noted that the incidence of an allergic reaction to an mRNA-based COVID-19 vaccine is 7•91 cases per million doses (95% CI 4•02-15•59). 4 In a prospective study of health-care employees in Boston, MA, USA, COVID-19 mRNA vaccine anaphylaxis was confirmed in only 16 (0•025%, 95% CI 0•014-0•040) of 64 900 employees, who all completely recovered without any episodes of shock or intubation. 5 No fatalities from COVID-19 vaccine-related anaphylaxis have been reported to date, the allergic reactions resolve rapidly without long-term sequelae, 4 and revaccination after an initial reaction is well tolerated.…”

“…4 In a prospective study of health-care employees in Boston, MA, USA, COVID-19 mRNA vaccine anaphylaxis was confirmed in only 16 (0•025%, 95% CI 0•014-0•040) of 64 900 employees, who all completely recovered without any episodes of shock or intubation. 5 No fatalities from COVID-19 vaccine-related anaphylaxis have been reported to date, the allergic reactions resolve rapidly without long-term sequelae, 4 and revaccination after an initial reaction is well tolerated. 6 Clinicians must reiterate such messaging to families to mitigate vaccine hesitancy due to concerns over anaphylaxis.…”