Reporting of Allergic Reactions During Pfizer-BioNTech BNTT162B2 Vaccination in Israel.
Anaphylaxis
COVID-19
SARS-CoV-2
Vaccine allergy
Journal
The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220
Informations de publication
Date de publication:
11 2022
11 2022
Historique:
received:
17
04
2022
revised:
22
06
2022
accepted:
07
07
2022
pubmed:
26
7
2022
medline:
15
11
2022
entrez:
25
7
2022
Statut:
ppublish
Résumé
In December 2020, the Israeli Ministry of Health launched a national vaccination campaign against SARS-CoV-2. Concomitant sporadic reports on anaphylactic responses in other countries raised safety concerns at the outset of this operation. To characterize reports on allergic reactions to coronavirus disease 2019 vaccines. Allergy events were reported by health care professionals throughout the country to Israeli Ministry of Health Division of Epidemiology via a Web-based computerized national vaccine registry. The study period was from December 19, 2020 to September 13, 2021, during which 14,475,979 injections were administered. Allergic reactions were reported in 463 subjects, 99.3% of whom received Pfizer-BioNTech BNTT162B2. The reporting rate was 106 per million in December 2020. From January to May 2021, a reduction was observed to 66, 18, 14, eight, and zero per million, and reporting remained low until September. Mean age of subjects was 48.9 ± 16.7 years (range, 15-96 years) with a female preponderance of 78%. Epinephrine was administered in 34 subjects. Validated immediate allergy was observed in only 37 cases (8%), suggesting 2.5 to 3.3 bona fide reactions per million. In subjects with reactions classified as severe (n = 46), plausible allergy was identified in 36% to 41% of cases. A history of allergy was associated with high false reporting of immediate reactions (83%). Allergic events after the first dose did not compromise adherence to subsequent doses. Excessive reporting of allergy declined over time and did not affect adherence to vaccination. The existence of previous allergy may affect reporting profiles, but not the occurrence of vaccine allergy.
Sections du résumé
BACKGROUND
In December 2020, the Israeli Ministry of Health launched a national vaccination campaign against SARS-CoV-2. Concomitant sporadic reports on anaphylactic responses in other countries raised safety concerns at the outset of this operation.
OBJECTIVE
To characterize reports on allergic reactions to coronavirus disease 2019 vaccines.
METHODS
Allergy events were reported by health care professionals throughout the country to Israeli Ministry of Health Division of Epidemiology via a Web-based computerized national vaccine registry. The study period was from December 19, 2020 to September 13, 2021, during which 14,475,979 injections were administered.
RESULTS
Allergic reactions were reported in 463 subjects, 99.3% of whom received Pfizer-BioNTech BNTT162B2. The reporting rate was 106 per million in December 2020. From January to May 2021, a reduction was observed to 66, 18, 14, eight, and zero per million, and reporting remained low until September. Mean age of subjects was 48.9 ± 16.7 years (range, 15-96 years) with a female preponderance of 78%. Epinephrine was administered in 34 subjects. Validated immediate allergy was observed in only 37 cases (8%), suggesting 2.5 to 3.3 bona fide reactions per million. In subjects with reactions classified as severe (n = 46), plausible allergy was identified in 36% to 41% of cases. A history of allergy was associated with high false reporting of immediate reactions (83%). Allergic events after the first dose did not compromise adherence to subsequent doses.
CONCLUSIONS
Excessive reporting of allergy declined over time and did not affect adherence to vaccination. The existence of previous allergy may affect reporting profiles, but not the occurrence of vaccine allergy.
Identifiants
pubmed: 35872216
pii: S2213-2198(22)00712-7
doi: 10.1016/j.jaip.2022.07.012
pmc: PMC9356746
pii:
doi:
Substances chimiques
Vaccines
0
COVID-19 Vaccines
0
BNT162 Vaccine
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2969-2976Informations de copyright
Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.