Allergic reactions to the Ad26.COV2.S vaccine in South Africa.
Allergic reaction
Janssen-Ad26.COV2.S vaccine
anaphylaxis
urticaria
Journal
The journal of allergy and clinical immunology. Global
ISSN: 2772-8293
Titre abrégé: J Allergy Clin Immunol Glob
Pays: United States
ID NLM: 9918453488706676
Informations de publication
Date de publication:
Feb 2022
Feb 2022
Historique:
received:
27
10
2021
revised:
03
12
2021
accepted:
03
12
2021
medline:
9
12
2021
pubmed:
9
12
2021
entrez:
2
10
2023
Statut:
epublish
Résumé
The Janssen-Ad26.COV2.S vaccine is authorized for use in several countries, with more than 30 million doses administered. Mild and severe allergic adverse events following immunization (AEFI) have been reported. We sought to detail allergic reactions reported during the Sisonke phase 3B study in South Africa. A single dose of the Ad26.COV2.S vaccine was administered to 4,77,234 South African health care workers between February 17 and May 17, 2021. Monitoring of adverse events used a combination of passive reporting and active case finding. Telephonic contact was attempted for all adverse events reported as "allergy." Anaphylaxis adjudication was performed using the Brighton Collaboration and National Institute of Allergy and Infectious Disease case definitions. Only 251 (0.052%) patients reported any allergic-type reaction (<1 in 2000), with 4 cases of adjudicated anaphylaxis (Brighton Collaboration level 1, n = 3) (prevalence of 8.4 per million doses). All anaphylaxis cases had a previous history of drug or vaccine-associated anaphylaxis. Cutaneous allergic reactions were the commonest nonanaphylatic reactions and included self-limiting, transient/localized rashes requiring no health care contact (n = 92) or isolated urticaria and/or angioedema (n = 70; median onset, 48 [interquartile range, 11.5-120] hours postvaccination) that necessitated health care contact (81%), antihistamine (63%), and/or systemic/topical corticosteroid (16%). All immediate (including adjudicated anaphylaxis) and most delayed AEFI (65 of 69) cases resolved completely. Allergic AEFI are rare following a single dose of Ad26.COV, with complete resolution in all cases of anaphylaxis. Although rare, isolated, delayed-onset urticaria and/or angioedema was the commonest allergic AEFI requiring treatment, with nearly half occurring in participants without known atopic disease.
Sections du résumé
Background
UNASSIGNED
The Janssen-Ad26.COV2.S vaccine is authorized for use in several countries, with more than 30 million doses administered. Mild and severe allergic adverse events following immunization (AEFI) have been reported.
Objective
UNASSIGNED
We sought to detail allergic reactions reported during the Sisonke phase 3B study in South Africa.
Methods
UNASSIGNED
A single dose of the Ad26.COV2.S vaccine was administered to 4,77,234 South African health care workers between February 17 and May 17, 2021. Monitoring of adverse events used a combination of passive reporting and active case finding. Telephonic contact was attempted for all adverse events reported as "allergy." Anaphylaxis adjudication was performed using the Brighton Collaboration and National Institute of Allergy and Infectious Disease case definitions.
Results
UNASSIGNED
Only 251 (0.052%) patients reported any allergic-type reaction (<1 in 2000), with 4 cases of adjudicated anaphylaxis (Brighton Collaboration level 1, n = 3) (prevalence of 8.4 per million doses). All anaphylaxis cases had a previous history of drug or vaccine-associated anaphylaxis. Cutaneous allergic reactions were the commonest nonanaphylatic reactions and included self-limiting, transient/localized rashes requiring no health care contact (n = 92) or isolated urticaria and/or angioedema (n = 70; median onset, 48 [interquartile range, 11.5-120] hours postvaccination) that necessitated health care contact (81%), antihistamine (63%), and/or systemic/topical corticosteroid (16%). All immediate (including adjudicated anaphylaxis) and most delayed AEFI (65 of 69) cases resolved completely.
Conclusions
UNASSIGNED
Allergic AEFI are rare following a single dose of Ad26.COV, with complete resolution in all cases of anaphylaxis. Although rare, isolated, delayed-onset urticaria and/or angioedema was the commonest allergic AEFI requiring treatment, with nearly half occurring in participants without known atopic disease.
Identifiants
pubmed: 37780073
doi: 10.1016/j.jacig.2021.12.002
pii: S2772-8293(21)00003-5
pmc: PMC10509997
doi:
Types de publication
Journal Article
Langues
eng
Pagination
2-8Informations de copyright
© 2021 Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.
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