Risk of Second Allergic Reaction to SARS-CoV-2 Vaccines

Abstract

IMPORTANCEVaccination against SARS-CoV-2 is a highly effective strategy to prevent infection and severe COVID-19 outcomes. The best strategy for a second dose of vaccine among persons who had an immediate allergic reaction to their first SARS CoV-2 vaccination is unclear.OBJECTIVE To assess the risk of severe immediate allergic reactions (eg, anaphylaxis) to a second dose of SARS-CoV-2 mRNA vaccine among persons with immediate allergic reactions to their first vaccine dose.DATA SOURCES MEDLINE, Embase, Web of Science, and the World Health Organization Global Coronavirus database were searched from inception through October 4, 2021.STUDY SELECTION Included studies addressed immediate allergic reactions of any severity to a second SARS-CoV-2 vaccine dose in persons with a known or suspected immediate allergic reaction (<4 hours after vaccination) after their first SARS-CoV-2 vaccine dose. Studies describing a second vaccine dose among persons reporting delayed reactions (>4 hours after vaccination) were excluded.DATA EXTRACTION AND SYNTHESIS Paired reviewers independently selected studies, extracted data, and assessed risk of bias. Random-effects models were used for meta-analysis. The GRADE (Grading of Recommendation, Assessment, Development, and Evaluation) approach evaluated certainty of the evidence. MAIN OUTCOMES AND MEASURESRisk of severe immediate allergic reaction and repeated severe immediate allergic reactions with a second vaccine dose. Reaction severity was defined by the reporting investigator, using Brighton Collaboration Criteria, Ring and Messmer criteria, World Allergy Organization criteria, or National Institute of Allergy and Infectious Diseases criteria. RESULTS Among 22 studies of SARS-CoV-2 mRNA vaccines, 1366 individuals (87.8% women; mean age, 46.1 years) had immediate allergic reactions to their first vaccination. Analysis using the pooled random-effects model found that 6 patients developed severe immediate allergic reactions after their second vaccination (absolute risk, 0.16% [95% CI, 0.01%-2.94%]), 232 developed mild symptoms (13.65% [95% CI, 7.76%-22.9%]), and, conversely, 1360 tolerated the dose (99.84% [95% CI, 97.09%-99.99%]). Among 78 persons with severe immediate allergic reactions to their first SARS-CoV-2 mRNA vaccination, 4 people (4.94% [95% CI, 0.93%-22.28%]) had a second severe immediate reaction, and 15 had nonsevere symptoms (9.54% [95% CI, 2.18%-33.34%]). There were no deaths. Graded vaccine dosing, skin testing, and premedication as risk-stratification strategies did not alter the findings. Certainty of evidence was moderate for those with any allergic reaction to the first dose and low for those with severe allergic reactions to the first dose. CONCLUSIONS AND RELEVANCEIn this systematic review and meta-analysis of case studies and case reports, the risk of immediate allergic reactions and severe immediate reactions or anaphylaxis associated with a second dose of an SARS-CoV-2 mRNA vaccine was low among persons who experienced an immediate allergic reaction to their fir...

Immediate Hypersensitivity Reactions Induced by COVID-19 Vaccines: Current Trends, Potential Mechanisms and Prevention Strategies

“…Chu, DK. et al performed a meta-analysis of 22 studies, including 1366 patients, and found a low incidence (0.16%) of immediate severe allergic reactions associated with the second dose of the mRNA COVID-19 vaccine among individuals who had an allergic history of their first dose [ 33 ]. In a separate study, the incidence rates of anaphylaxis were lower for the viral COVID-19 vaccine (odds ratio [OR], 0.47; 95% CI, 0.33–0.68) and the inactivated COVID-19 (OR, 0.31; 95% CI, 0.18–0.53) vaccine [ 34 ].…”

“…In addition, Shavit et al further reported that a higher rate of allergic reactions to the BNT162b2 vaccine was identified among patients with a history of sensitivity to aeroallergens, insect bites, food, latex, or drugs [ 109 ]. Recently, Chu et al performed a systematic review and meta-analysis of case studies and found that the risk of immediate hypersensitivity reactions or anaphylaxis related to the second dose of an mRNA COVID-19 vaccine was lower among persons who experienced an immediate allergic reaction to their first dose (absolute risk, 0.16% [95% CI, 0.01–2.94%]) [ 33 ].…”

Adverse Reactions to Anti-Infective Vaccines: an Emerging Problem in the COVID-19 Era

“…Patients with mild reactions (erythema, self-limiting acute urticaria, and subjective mild spontaneously resolving airway symptoms) do not generally have to be evaluated. Most can tolerate a second dose [ 82 , 88 , 89 ]. In these patients, the vaccine should be administered in a controlled environment, and patient should be kept under observation for 30 min.…”

Reply to “Variability of eliciting thresholds in PEG allergy limits prediction of tolerance to PEG-containing mRNA COVID vaccines”

“…In conclusion, given the high benefits of COVID-19 vaccination, especially with mRNA vaccines, and the reassuring data on their safety, 5 , 6 even in patients with a documented PEG allergy, 2 , 3 , 7 we would encourage allergists to offer supervised administration of mRNA vaccines to PEG-allergic patients either in a single or divided doses.…”