Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom

Abstract: Background: Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited. Research design & methods: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (...

Descripción completa

Detalles Bibliográficos
Autores principales: Otero Losada, Matilde, Petrovsky, Nikolai, Alami, Abdallah, Crispo, James A. G., Mattison, Donald, Capani, Francisco, Goetz, Christopher, Krewski, Daniel, Pérez Lloret, Santiago
Formato: Artículo
Lenguaje:Inglés
Publicado: Taylor & Francis 2022
Materias:
Acceso en línea:https://repositorio.uca.edu.ar/handle/123456789/15361
Aporte de:
id I33-R139-123456789-15361
record_format dspace
spelling I33-R139-123456789-153612024-03-21T13:31:12Z Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom Otero Losada, Matilde Petrovsky, Nikolai Alami, Abdallah Crispo, James A. G. Mattison, Donald Capani, Francisco Goetz, Christopher Krewski, Daniel Pérez Lloret, Santiago COVID-19 BNT162b2 VACUNAS ChAdOx1 FARMACOLOGIA NEUROLOGIA PSIQUIATRIA VIGILANCIA EFECTOS ADVERSOS Abstract: Background: Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited. Research design & methods: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) COVID-19 vaccines and recorded in the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. Results: As of 30 June 2021, 46.1 million doses of ChAdOx1 and 30.3 million doses of BNT162b2 had been administered. The most frequently reported AEFI was headache with 1,686 and 575 cases per million doses of ChAdOx1 and BNT162b2, respectively. AEFIs more frequently reported after CHAdOx1 compared with BNT162b2 vaccination were Guillain-Barré syndrome (OR, 95% CI = 2.53, 1.82–3.51), freezing (6.66, 3.12–14.22), cluster headache (1.53, 1.28–1.84), migraine (1.23,1.17–1.30), postural dizziness (1.24,1.13–1.37), tremor (2.86, 2.68–3.05), headache (1.40, 1.38–1.43), paresthesia (1.11, 1.06–1.16), delirium (1.85, 1.45–2.36), hallucination (2.20, 1.82–2.66), poor quality sleep (1.53, 1.26–1.85), and nervousness (1.54, 1.26–1.89) Reactions less frequently reported with ChAdOx1 than with BNT162b2 were Bell’s palsy (0.47, 0.41–0.55), anosmia (0.58, 0.47–0.71), facial paralysis (0.35, 0.29– 0.41), dysgeusia (0.68, 0.62–0.73), presyncope (0.48, 0.42–0.55), syncope (0.63, 0.58–0.67), and anxiety (0.75 (0.67–0.85). Conclusion: Neurological and psychiatric AEFIs were relatively infrequent, but each vaccine was associated with a distinctive toxic profile. Plain Language Summary We examined reports on adverse neurological and psychiatric effects following immunization with BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) for COVID-19 to the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. Adverse effects following immunization (AEFIs) were relatively infrequent. Compared to BNT162b2, Guillain-Barré syndrome, freezing phenomenon, cluster headache, migraine, postural dizziness, tremor, headache, paresthesia, delirium, hallucination, poor quality sleep, and nervousness were more frequently reported for ChAdOx1. Reactions less frequently reported for ChAdOx1 than for BNT162b2 were Bell’s palsy, anosmia, facial paralysis, dysgeusia, presyncope, syncope, and anxiety. 2022-10-31T12:33:45Z 2022-10-31T12:33:45Z 2022 Artículo Otero Losada, M. et al. Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom [en línea]. Expert Opinion on Drug Safety. 2022. doi: 10.1080/14740338.2022.2120607. Disponible en: https://repositorio.uca.edu.ar/handle/123456789/15361 1474-0338 (impreso) 1744-764X (en línea) https://repositorio.uca.edu.ar/handle/123456789/15361 10.1080/14740338.2022.2120607 eng Acceso restringido http://creativecommons.org/licenses/by-nc-sa/4.0/ application/pdf Taylor & Francis Expert Opinion on Drug Safety. 2022
institution Universidad Católica Argentina
institution_str I-33
repository_str R-139
collection Repositorio Institucional de la Universidad Católica Argentina (UCA)
language Inglés
topic COVID-19
BNT162b2
VACUNAS
ChAdOx1
FARMACOLOGIA
NEUROLOGIA
PSIQUIATRIA
VIGILANCIA
EFECTOS ADVERSOS
spellingShingle COVID-19
BNT162b2
VACUNAS
ChAdOx1
FARMACOLOGIA
NEUROLOGIA
PSIQUIATRIA
VIGILANCIA
EFECTOS ADVERSOS
Otero Losada, Matilde
Petrovsky, Nikolai
Alami, Abdallah
Crispo, James A. G.
Mattison, Donald
Capani, Francisco
Goetz, Christopher
Krewski, Daniel
Pérez Lloret, Santiago
Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom
topic_facet COVID-19
BNT162b2
VACUNAS
ChAdOx1
FARMACOLOGIA
NEUROLOGIA
PSIQUIATRIA
VIGILANCIA
EFECTOS ADVERSOS
description Abstract: Background: Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited. Research design & methods: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) COVID-19 vaccines and recorded in the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. Results: As of 30 June 2021, 46.1 million doses of ChAdOx1 and 30.3 million doses of BNT162b2 had been administered. The most frequently reported AEFI was headache with 1,686 and 575 cases per million doses of ChAdOx1 and BNT162b2, respectively. AEFIs more frequently reported after CHAdOx1 compared with BNT162b2 vaccination were Guillain-Barré syndrome (OR, 95% CI = 2.53, 1.82–3.51), freezing (6.66, 3.12–14.22), cluster headache (1.53, 1.28–1.84), migraine (1.23,1.17–1.30), postural dizziness (1.24,1.13–1.37), tremor (2.86, 2.68–3.05), headache (1.40, 1.38–1.43), paresthesia (1.11, 1.06–1.16), delirium (1.85, 1.45–2.36), hallucination (2.20, 1.82–2.66), poor quality sleep (1.53, 1.26–1.85), and nervousness (1.54, 1.26–1.89) Reactions less frequently reported with ChAdOx1 than with BNT162b2 were Bell’s palsy (0.47, 0.41–0.55), anosmia (0.58, 0.47–0.71), facial paralysis (0.35, 0.29– 0.41), dysgeusia (0.68, 0.62–0.73), presyncope (0.48, 0.42–0.55), syncope (0.63, 0.58–0.67), and anxiety (0.75 (0.67–0.85). Conclusion: Neurological and psychiatric AEFIs were relatively infrequent, but each vaccine was associated with a distinctive toxic profile. Plain Language Summary We examined reports on adverse neurological and psychiatric effects following immunization with BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) for COVID-19 to the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. Adverse effects following immunization (AEFIs) were relatively infrequent. Compared to BNT162b2, Guillain-Barré syndrome, freezing phenomenon, cluster headache, migraine, postural dizziness, tremor, headache, paresthesia, delirium, hallucination, poor quality sleep, and nervousness were more frequently reported for ChAdOx1. Reactions less frequently reported for ChAdOx1 than for BNT162b2 were Bell’s palsy, anosmia, facial paralysis, dysgeusia, presyncope, syncope, and anxiety.
format Artículo
author Otero Losada, Matilde
Petrovsky, Nikolai
Alami, Abdallah
Crispo, James A. G.
Mattison, Donald
Capani, Francisco
Goetz, Christopher
Krewski, Daniel
Pérez Lloret, Santiago
author_facet Otero Losada, Matilde
Petrovsky, Nikolai
Alami, Abdallah
Crispo, James A. G.
Mattison, Donald
Capani, Francisco
Goetz, Christopher
Krewski, Daniel
Pérez Lloret, Santiago
author_sort Otero Losada, Matilde
title Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom
title_short Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom
title_full Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom
title_fullStr Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom
title_full_unstemmed Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1(Oxford-AstraZeneca) and BNT162b2 (Pfizer- BioNTech) COVID-19 vaccines in the United Kingdom
title_sort disproportionality analysis of adverse neurological and psychiatric reactions with the chadox1(oxford-astrazeneca) and bnt162b2 (pfizer- biontech) covid-19 vaccines in the united kingdom
publisher Taylor & Francis
publishDate 2022
url https://repositorio.uca.edu.ar/handle/123456789/15361
work_keys_str_mv AT oterolosadamatilde disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT petrovskynikolai disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT alamiabdallah disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT crispojamesag disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT mattisondonald disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT capanifrancisco disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT goetzchristopher disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT krewskidaniel disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
AT perezlloretsantiago disproportionalityanalysisofadverseneurologicalandpsychiatricreactionswiththechadox1oxfordastrazenecaandbnt162b2pfizerbiontechcovid19vaccinesintheunitedkingdom
_version_ 1807949152047333376