Diagnostic accuracy of vaccine and vaccine excipient testing in the setting of allergic reactions to COVID‐19 vaccines: A systematic review and meta‐analysis

Abstract

For persons with immediate allergic reactions to mRNA COVID-19 vaccines, skin testing (ST) to the vaccine/excipients (polyethylene glycol[PEG] and polysorbate 80 [PS]) has been recommended, but has unknown accuracy. To assess vaccine/excipient ST accuracy in predicting all-severity immediate allergic reactions upon re-vaccination, systematic review was performed searching Medline, EMBASE, Web of Science, and the WHO global coronavirus database (inception-Oct 4, 2021) for studies addressing immediate (≤4 h post-vaccination) all-severity allergic reactions to 2nd mRNA COVID-19 vaccination in persons with 1st dose immediate allergic reactions. Cases evaluating delayed reactions, change of vaccine platform, or revaccination without vaccine/excipient ST were excluded. Meta-analysis of diagnostic testing accuracy was performed using Bayesian methods. The GRADE approach evaluated certainty of the evidence, and QUADAS-2 assessed risk of bias. Among 20 studies of mRNA

Pearls for practice from the 2022 joint task force drug allergy practice parameter

“…In addition, the sensitivity and specificity of skin testing with SARS-CoV-2 vaccines or excipients in individuals with prior reactions to the vaccine is low. In a third meta-analysis and systematic review, the sensitivity of skin testing to either mRNA SARS-CoV-2 vaccine (or related excipient) was 0.03 (95% credible interval, 0.00–0.08) [50 ▪▪ ].…”

Value of vaccine and vaccine excipient skin testing to COVID‐19 vaccines

“…The vast majority of patients reacting to the vaccine have negative ST. 1,2 This argues against an allergic mechanism. Only a minority of these non-allergic patients also react to a the subsequent COVID-19 mRNA vaccination, which explains the low sensitivity of ST.…”

Safety of COVID‐19 vaccination in children with prior allergic reactions or mast cell disorders

“…A systematic review revealed that skin testing has low sensitivity but high specificity in predicting repeat immediate hypersensitivity reactions, but it is noteworthy that all re-vaccinations were performed in adults. 2 Given the high degrees of parental anxiety around childhood immunisation and the likelihood of seasonal vaccine boosters against emerging strains of COVID-19, there is a need for more research on reported adverse reactions in children together with guidance on testing, management and public health messaging.…”