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Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study

BACKGROUND: Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk o...

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Autores principales: Wan, Eric Yuk Fai, Chui, Celine Sze Ling, Lai, Francisco Tsz Tsun, Chan, Esther Wai Yin, Li, Xue, Yan, Vincent Ka Chun, Gao, Le, Yu, Qiuyan, Lam, Ivan Chun Hang, Chun, Raccoon Ka Cheong, Cowling, Benjamin John, Fong, Wing Chi, Lau, Alexander Yuk Lun, Mok, Vincent Chung Tong, Chan, Frank Ling Fung, Lee, Cheuk Kwong, Chan, Lot Sze Tao, Lo, Dawin, Lau, Kui Kai, Hung, Ivan Fan Ngai, Leung, Gabriel Matthew, Wong, Ian Chi Kei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8367195/
https://www.ncbi.nlm.nih.gov/pubmed/34411532
http://dx.doi.org/10.1016/S1473-3099(21)00451-5
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author Wan, Eric Yuk Fai
Chui, Celine Sze Ling
Lai, Francisco Tsz Tsun
Chan, Esther Wai Yin
Li, Xue
Yan, Vincent Ka Chun
Gao, Le
Yu, Qiuyan
Lam, Ivan Chun Hang
Chun, Raccoon Ka Cheong
Cowling, Benjamin John
Fong, Wing Chi
Lau, Alexander Yuk Lun
Mok, Vincent Chung Tong
Chan, Frank Ling Fung
Lee, Cheuk Kwong
Chan, Lot Sze Tao
Lo, Dawin
Lau, Kui Kai
Hung, Ivan Fan Ngai
Leung, Gabriel Matthew
Wong, Ian Chi Kei
author_facet Wan, Eric Yuk Fai
Chui, Celine Sze Ling
Lai, Francisco Tsz Tsun
Chan, Esther Wai Yin
Li, Xue
Yan, Vincent Ka Chun
Gao, Le
Yu, Qiuyan
Lam, Ivan Chun Hang
Chun, Raccoon Ka Cheong
Cowling, Benjamin John
Fong, Wing Chi
Lau, Alexander Yuk Lun
Mok, Vincent Chung Tong
Chan, Frank Ling Fung
Lee, Cheuk Kwong
Chan, Lot Sze Tao
Lo, Dawin
Lau, Kui Kai
Hung, Ivan Fan Ngai
Leung, Gabriel Matthew
Wong, Ian Chi Kei
author_sort Wan, Eric Yuk Fai
collection PubMed
description BACKGROUND: Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell's palsy after BNT162b2 and CoronaVac vaccination. METHODS: In this case series and nested case-control study done in Hong Kong, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun–BioNTech [equivalent to Pfizer–BioNTech]) or CoronaVac (from Sinovac Biotech, Hong Kong) using data from voluntary surveillance reporting with the Hospital Authority, the COVID-19 Vaccine Adverse Event Online Reporting system for all health-care professionals, and the Hospital Authority's territory-wide electronic health records from the Clinical Data Analysis and Reporting System. We described reported cases of Bell's palsy among vaccine recipients (aged 18–110 years for CoronaVac and aged 16–110 years for BNT162b2). We compared the estimated age-standardised incidence of clinically confirmed cases among individuals who had received the CoronaVac or BNT162b2 vaccination (up to 42 days before presentation) with the background incidence in the population. A nested case-control study was also done using conditional logistic regression to estimate the odds ratio (OR) for risk of Bell's palsy and vaccination. Cases and controls were matched (1:4) by age, sex, admission setting, and admission date. FINDINGS: Between February 23 and May 4, 2021, 451 939 individuals received the first dose of CoronaVac and 537 205 individuals received the first dose of BNT162b2. 28 clinically confirmed cases of Bell's palsy were reported following CoronaVac and 16 cases were reported following BNT162b2. The age-standardised incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac vaccination and 42·8 per 100 000 person-years (19·4 to 66·1) for BNT162b2 vaccination. The age-standardised difference for the incidence compared with the background population was 41·5 (95% CI 11·7 to 71·4) for CoronaVac and 17·0 (−6·6 to 40·6) for BNT162b2, equivalent to an additional 4·8 cases per 100 000 people vaccinated for CoronaVac and 2·0 cases per 100 000 people vaccinated for BNT162b2. In the nested case-control analysis, 298 cases were matched to 1181 controls, and the adjusted ORs were 2·385 (95% CI 1·415 to 4·022) for CoronaVac and 1·755 (0·886 to 3·477) for BNT162b2. INTERPRETATION: Our findings suggest an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event. Additional studies are needed in other regions to confirm our findings. FUNDING: The Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, China. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.
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spelling pubmed-83671952021-08-17 Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study Wan, Eric Yuk Fai Chui, Celine Sze Ling Lai, Francisco Tsz Tsun Chan, Esther Wai Yin Li, Xue Yan, Vincent Ka Chun Gao, Le Yu, Qiuyan Lam, Ivan Chun Hang Chun, Raccoon Ka Cheong Cowling, Benjamin John Fong, Wing Chi Lau, Alexander Yuk Lun Mok, Vincent Chung Tong Chan, Frank Ling Fung Lee, Cheuk Kwong Chan, Lot Sze Tao Lo, Dawin Lau, Kui Kai Hung, Ivan Fan Ngai Leung, Gabriel Matthew Wong, Ian Chi Kei Lancet Infect Dis Articles BACKGROUND: Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell's palsy after BNT162b2 and CoronaVac vaccination. METHODS: In this case series and nested case-control study done in Hong Kong, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun–BioNTech [equivalent to Pfizer–BioNTech]) or CoronaVac (from Sinovac Biotech, Hong Kong) using data from voluntary surveillance reporting with the Hospital Authority, the COVID-19 Vaccine Adverse Event Online Reporting system for all health-care professionals, and the Hospital Authority's territory-wide electronic health records from the Clinical Data Analysis and Reporting System. We described reported cases of Bell's palsy among vaccine recipients (aged 18–110 years for CoronaVac and aged 16–110 years for BNT162b2). We compared the estimated age-standardised incidence of clinically confirmed cases among individuals who had received the CoronaVac or BNT162b2 vaccination (up to 42 days before presentation) with the background incidence in the population. A nested case-control study was also done using conditional logistic regression to estimate the odds ratio (OR) for risk of Bell's palsy and vaccination. Cases and controls were matched (1:4) by age, sex, admission setting, and admission date. FINDINGS: Between February 23 and May 4, 2021, 451 939 individuals received the first dose of CoronaVac and 537 205 individuals received the first dose of BNT162b2. 28 clinically confirmed cases of Bell's palsy were reported following CoronaVac and 16 cases were reported following BNT162b2. The age-standardised incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac vaccination and 42·8 per 100 000 person-years (19·4 to 66·1) for BNT162b2 vaccination. The age-standardised difference for the incidence compared with the background population was 41·5 (95% CI 11·7 to 71·4) for CoronaVac and 17·0 (−6·6 to 40·6) for BNT162b2, equivalent to an additional 4·8 cases per 100 000 people vaccinated for CoronaVac and 2·0 cases per 100 000 people vaccinated for BNT162b2. In the nested case-control analysis, 298 cases were matched to 1181 controls, and the adjusted ORs were 2·385 (95% CI 1·415 to 4·022) for CoronaVac and 1·755 (0·886 to 3·477) for BNT162b2. INTERPRETATION: Our findings suggest an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event. Additional studies are needed in other regions to confirm our findings. FUNDING: The Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, China. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section. Elsevier Ltd. 2022-01 2021-08-16 /pmc/articles/PMC8367195/ /pubmed/34411532 http://dx.doi.org/10.1016/S1473-3099(21)00451-5 Text en © 2021 Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Articles
Wan, Eric Yuk Fai
Chui, Celine Sze Ling
Lai, Francisco Tsz Tsun
Chan, Esther Wai Yin
Li, Xue
Yan, Vincent Ka Chun
Gao, Le
Yu, Qiuyan
Lam, Ivan Chun Hang
Chun, Raccoon Ka Cheong
Cowling, Benjamin John
Fong, Wing Chi
Lau, Alexander Yuk Lun
Mok, Vincent Chung Tong
Chan, Frank Ling Fung
Lee, Cheuk Kwong
Chan, Lot Sze Tao
Lo, Dawin
Lau, Kui Kai
Hung, Ivan Fan Ngai
Leung, Gabriel Matthew
Wong, Ian Chi Kei
Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study
title Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study
title_full Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study
title_fullStr Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study
title_full_unstemmed Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study
title_short Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study
title_sort bell's palsy following vaccination with mrna (bnt162b2) and inactivated (coronavac) sars-cov-2 vaccines: a case series and nested case-control study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8367195/
https://www.ncbi.nlm.nih.gov/pubmed/34411532
http://dx.doi.org/10.1016/S1473-3099(21)00451-5
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