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      Risk and characteristics of Bell’s palsy in adults as an adverse event following COVID-19 vaccination: a retrospective study

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          Abstract

          Background

          Although an association between COVID-19 vaccination and Bell’s palsy (BP) has been reported, a clear causal relationship has not been elucidated. We investigated the risk and clinical characteristics of BP after COVID-19 vaccination.

          Methods

          This retrospective chart review evaluated the association between COVID-19 vaccination and BP by comparing the number of patients diagnosed with BP during the pre-COVID-19 vaccination period (March 2018–February 2021) and the COVID-19 mass vaccination period (March 2021–February 2022). We then compared vaccine-related (time between vaccination and BP onset < 42 days) and -unrelated (time interval ≥ 42 days or non-vaccination) clinical characteristics in newly diagnosed patients with BP.

          Results

          BP occurred more during the COVID-19 vaccination period than in the previous three pre-vaccination years. Thirteen patients developed BP within 42 days of vaccination. All patients, except one, developed BP after mRNA-based vaccination, with most cases (9/13, 69.2%) occurring after the second or third dose. Thirteen patients with vaccine-related BP were younger (age 43.92 ± 13.14 vs. 54.32 ± 16.01 years; p = 0.033) and more frequently experienced taste changes (58.8% vs. 10.9%; p = 0.002) than 52 patients with vaccine-unrelated BP. Patients with vaccine-related BP had a greater likelihood of good and faster ( p = 0.042) facial nerve function recovery than those with vaccine-unrelated BP (100% vs. 78%).

          Conclusion

          COVID-19 vaccines, especially mRNA-based vaccines, may be associated with BP cases with distinctive clinical characteristics, which occur more frequently in young individuals, are frequently accompanied by taste changes, and have fast and good recovery.

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          Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

          Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
          Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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            Global impact of the first year of COVID-19 vaccination: a mathematical modelling study

            Oliver J Watson, Gregory Barnsley, Jaspreet Toor … (2022)
            Background The first COVID-19 vaccine outside a clinical trial setting was administered on Dec 8, 2020. To ensure global vaccine equity, vaccine targets were set by the COVID-19 Vaccines Global Access (COVAX) Facility and WHO. However, due to vaccine shortfalls, these targets were not achieved by the end of 2021. We aimed to quantify the global impact of the first year of COVID-19 vaccination programmes. Methods A mathematical model of COVID-19 transmission and vaccination was separately fit to reported COVID-19 mortality and all-cause excess mortality in 185 countries and territories. The impact of COVID-19 vaccination programmes was determined by estimating the additional lives lost if no vaccines had been distributed. We also estimated the additional deaths that would have been averted had the vaccination coverage targets of 20% set by COVAX and 40% set by WHO been achieved by the end of 2021. Findings Based on official reported COVID-19 deaths, we estimated that vaccinations prevented 14·4 million (95% credible interval [Crl] 13·7–15·9) deaths from COVID-19 in 185 countries and territories between Dec 8, 2020, and Dec 8, 2021. This estimate rose to 19·8 million (95% Crl 19·1–20·4) deaths from COVID-19 averted when we used excess deaths as an estimate of the true extent of the pandemic, representing a global reduction of 63% in total deaths (19·8 million of 31·4 million) during the first year of COVID-19 vaccination. In COVAX Advance Market Commitment countries, we estimated that 41% of excess mortality (7·4 million [95% Crl 6·8–7·7] of 17·9 million deaths) was averted. In low-income countries, we estimated that an additional 45% (95% CrI 42–49) of deaths could have been averted had the 20% vaccination coverage target set by COVAX been met by each country, and that an additional 111% (105–118) of deaths could have been averted had the 40% target set by WHO been met by each country by the end of 2021. Interpretation COVID-19 vaccination has substantially altered the course of the pandemic, saving tens of millions of lives globally. However, inadequate access to vaccines in low-income countries has limited the impact in these settings, reinforcing the need for global vaccine equity and coverage. Funding Schmidt Science Fellowship in partnership with the Rhodes Trust; WHO; UK Medical Research Council; Gavi, the Vaccine Alliance; Bill & Melinda Gates Foundation; National Institute for Health Research; and Community Jameel.
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              Surveillance for Adverse Events After COVID-19 mRNA Vaccination

              Nicola Klein, Ned Lewis, Kristin Goddard … (2021)
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                Author and article information

                Contributors
                Jin-Sung Park: neurojspark@gmail.com
                Hung Youl Seok:
                ORCID: http://orcid.org/0000-0002-9938-5355
                shy2354@gmail.com
                Journal
                Journal ID (nlm-ta): Acta Neurol Belg
                Journal ID (iso-abbrev): Acta Neurol Belg
                Title: Acta Neurologica Belgica
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 0300-9009
                ISSN (Electronic): 2240-2993
                Publication date (Electronic): 12 February 2023
                Pages: 1-9
                Affiliations
                [1 ]GRID grid.412091.f, ISNI 0000 0001 0669 3109, Department of Neurology, , Dongsan Hospital, Keimyung University School of Medicine, ; 1035 Dalgubeol-Daero, Dalseo-Gu, Daegu, 42601 Republic of Korea
                [2 ]GRID grid.258803.4, ISNI 0000 0001 0661 1556, Department of Neurology, School of Medicine, , Kyungpook National University, Kyungpook National University Chilgok Hospital, ; 807 Hoguk-Ro, Buk-Gu, Daegu, 41404 Korea
                [3 ]GRID grid.222754.4, ISNI 0000 0001 0840 2678, Department of Neurology, , Korea University College of Medicine, ; Seoul, Republic of Korea
                Author information
                http://orcid.org/0000-0002-9938-5355
                Article
                Publisher ID: 2204
                DOI: 10.1007/s13760-023-02204-2
                PMC ID: 9924857
                PubMed ID: 36781626
                SO-VID: 3bc1669b-524d-429f-b7f2-864667fcda3c
                Copyright © © The Author(s) under exclusive licence to Belgian Neurological Society 2023, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
                License:

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                Date received : 24 August 2022
                Date accepted : 30 January 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100014188, Ministry of Science and ICT, South Korea;
                Award ID: NRF-2022R1C1C1009723
                Award Recipient :
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Neurosciences
                Keywords: bell’s palsy,covid-19,covid-19 vaccines,sars-cov-2,vaccination
                Data availability:
                ScienceOpen disciplines: Neurosciences
                Keywords: bell’s palsy, covid-19, covid-19 vaccines, sars-cov-2, vaccination

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