Protocol of safe vaccination against COVID‐19 in patients with high risk of allergic reactions

Abstract

Background Sars‐CoV‐2 infections are hazardous, especially to the elderly and patients with comorbidities. With no efficient treatment available, newly developed vaccines are the only way to change the course of the pandemic. However, reports of allergic reactions resulted in some patients and practicing physicians being concerned about the safety of vaccine administration, particularly in people with severe anaphylactic reactions to multiple or unknown factors in their medical history. This study aimed to develop an allergic work‐up protocol based on skin prick tests (SPT), intradermal testing (IDT) and intramuscular provocations, and desensitisation which may contribute to diagnosis and management of anti‐COVID‐19 vaccine allergy. Methods Two hundred and eighty‐five patients were enrolled. Two hundred and five of them entered the study based on severe anaphylactic reaction to unknown or multiple factors in their medical history which disqualified them for standard treatment. Another 80 patients were enrolled after developing an allergic reaction to the first dose of one such vaccine. In all subjects, SPT and IDT were performed. Serum tryptase was assessed in 79 patients randomly chosen from the study group. Results Two hundred and seventy‐seven patients with negative tests were given a vaccine without complications. Seven patients had positive skin tests. In two cases, tests confirmed Comirnaty allergy, while the other five confirmed solely skin sensitisation with no exposure prior to the study. Six patients with positive tests received titrated challenge using desensitisation protocol with a reasonable tolerance. One patient did not consent to desensitisation and one patient resigned despite negative tests. Overall, 283 (99%) patients were vaccinated using this newly developed protocol. Patients with adverse reactions to the first dose of the vaccine before the study had a significantly lower basal serum tryptase concentration (p = 0.001). Conclusion Skin tests with anti‐COVID‐19 vaccines are a useful tool in the vaccination protocol. This protocol enables safe immunisation of high‐allergy‐risk patients even in cases of positive skin tests.

Desensitization Protocols for Anti-SARS-CoV-2 Vaccines in Patients with High Risk of Allergic Reactions

“…Recently, Iemoli et al described two patients who experienced bronchospasm after vaccination with the BNT162b2 vaccine and for whom gradual administration of incremental doses of vaccine was not sufficient to prevent the recurrence of symptoms [ 21 ]. Other experiences, on the other hand, are reassuring of the efficacy of desensitization protocols with the BNT162b2 vaccine [ 22 , 23 ]. As regards the other vaccines (mRNA-1273 and ChAdOx1-S), the desensitization protocols used were designed according to the international recommendations for desensitization to drugs and vaccines [ 9 , 25 , 26 ], proving to be safe and effective.…”

“…A single standardized scheme for desensitization to anti-SARS-CoV-2 vaccines has not been established; however, new promising approaches are being considered, and few publications reported case reports or small case series of patients receiving an anti-SARS-CoV-2 vaccine with a desensitization protocol [ 9 , 18 , 19 , 20 , 21 , 22 , 23 ].…”

Successful mRNA COVID-19 Vaccination and Colonoscopy After Oral Desensitization in a Patient With Polyethylene Glycol Allergy

“…It has also been reported that vaccination occurred safely after titrated challenge to six patients with positive skin tests to the vaccine, and desensitization using the BNT162b2 was effective in a patient sensitized to PS80. 16 17 In all of these cases, desensitization was a graded challenge that started with 0.005–0.05 mL of undiluted vaccine and was increased in 4–5 steps. However, the safety and efficacy of graded challenges for COVID-19 vaccines have not been established.…”

From Immunogen to COVID-19 vaccines: Prospects for the post-pandemic era

“…The excipients of the vaccine may also induce IgE/ non-IgE allergic reactions. dermatosis Ref [144] , Ref [145] , Ref [146] , Ref [147] , Ref [148] , Ref [149] , Ref [150] , Ref [151] . Immune thrombotic thrombocytopenia It is characterized by thrombocytopenia, systemic activation of coagulation, and extensive venous thrombosis and platelet factor 4(PF4) antibody.…”

“…COV2. S and also useful tools in a COVID-19 vaccination regimen that enables safe immunization of patients at high allergy risk [148] . Guidance from the Centers for Disease Control and Prevention (USA) recommends that individuals who have an allergic reaction or are allergic to the component of COVID-19 vaccines should avoid the same vaccination [149] .…”