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      Ocular motility disorders following coronavirus disease-19 vaccination

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          Abstract

          Purpose

          To describe clinical manifestations and short-term prognosis of ocular motility disorders following coronavirus disease-2019 (COVID-19) vaccination.

          Methods

          Ocular motility disorders were diagnosed by clinical assessment, high-resolution magnetic resonance imaging, and laboratory testing. Clinical manifestations, short-term prognosis, and rate of complete recovery were analyzed.

          Results

          Sixty-three patients (37 males, 26 females) with a mean age of 61.6 ± 13.3 years (range, 22–81 years) were included in this study. Among 61 applicable patients with sufficient information regarding medical histories, 38 (62.3%) had one or more significant underlying past medical histories including vasculopathic risk factors. The interval between initial symptoms and vaccination was 8.6 ± 8.2 (range, 0–28) days. Forty-two (66.7%), 14 (22.2%), and 7 (11.1%) patients developed symptoms after the first, second, and third vaccinations, respectively. One case of internuclear ophthalmoplegia, 52 cases of cranial nerve palsy, two cases of myasthenia gravis, six cases of orbital diseases (such as myositis, thyroid eye disease, and IgG-related orbital myopathy), and two cases of comitant vertical strabismus with acute onset diplopia were found. Among 42 patients with follow-up data (duration: 62.1 ± 40.3 days), complete improvement, partial improvement, no improvement, and exacerbation were shown in 20, 15, 3, and 4 patients, respectively.

          Conclusion

          This study provided various clinical features of ocular motility disorders following COVID-19 vaccination. The majority of cases had a mild clinical course while some cases showed a progressive nature. Close follow-up and further studies are needed to elucidate the underlying mechanisms and long-term prognosis.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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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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              Is Open Access

              Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

              Merryn Voysey, Sue Ann Costa Clemens, Shabir Madhi … (2022)
              Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
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                Author and article information

                Contributors
                Dong Gyu Choi:
                ORCID: http://orcid.org/0000-0002-1614-9534
                eyechoi602@gmail.com
                Journal
                Journal ID (nlm-ta): Graefes Arch Clin Exp Ophthalmol
                Journal ID (iso-abbrev): Graefes Arch Clin Exp Ophthalmol
                Title: Graefe's Archive for Clinical and Experimental Ophthalmology
                Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )
                ISSN (Print): 0721-832X
                ISSN (Electronic): 1435-702X
                Publication date (Electronic): 16 November 2022
                Pages: 1-13
                Affiliations
                [1 ]GRID grid.414964.a, ISNI 0000 0001 0640 5613, Department of Ophthalmology, , Samsung Medical Center, Sungkyunkwan University School of Medicine, ; Seoul, Korea
                [2 ]GRID grid.262229.f, ISNI 0000 0001 0719 8572, Department of Ophthalmology, , Pusan National University Collage of Medicine and Biomedical Research Institute, ; Busan, Korea
                [3 ]GRID grid.256753.0, ISNI 0000 0004 0470 5964, Department of Ophthalmology, Kangnam Sacred Heart Hospital, , College of Medicine Hallym University, ; Seoul, Korea
                [4 ]GRID grid.31501.36, ISNI 0000 0004 0470 5905, Department of Ophthalmology, , Seoul National University College of Medicine, ; Seoul, Korea
                [5 ]GRID grid.411120.7, ISNI 0000 0004 0371 843X, Department of Ophthalmology, , Konkuk University Hospital, ; Seoul, Korea
                [6 ]GRID grid.267370.7, ISNI 0000 0004 0533 4667, Department of Ophthalmology, Asan Medical Center, , University of Ulsan College of Medicine, ; Seoul, Korea
                [7 ]GRID grid.412091.f, ISNI 0000 0001 0669 3109, Department of Ophthalmology, , Keimyung University School of Medicine, ; Daegu, Korea
                [8 ]GRID grid.411625.5, ISNI 0000 0004 0647 1102, Department of Ophthalmology, , Inje University College of Medicine, Busan Paik Hospital, ; Busan, Korea
                [9 ]GRID grid.264381.a, ISNI 0000 0001 2181 989X, Department of Ophthalmology, Samsung Changwon Hospital, , Sungkyunkwan University School of Medicine, ; Seoul, Korea
                [10 ]GRID grid.490241.a, ISNI 0000 0004 0504 511X, Department of Ophthalmology, , Kim’s Eye Hospital, ; Seoul, Korea
                [11 ]GRID grid.254229.a, ISNI 0000 0000 9611 0917, Department of Ophthalmology, , Chungbuk National University College of Medicine, ; Cheongju, Korea
                [12 ]GRID grid.413028.c, ISNI 0000 0001 0674 4447, Department of Ophthalmology, , Yeungnam University College of Medicine, ; Daegu, Korea
                [13 ]GRID grid.254224.7, ISNI 0000 0001 0789 9563, Department of Ophthalmology, , Chung-Ang University, Gwangmyeong Hospital, ; Gwangmyeong, Korea
                [14 ]GRID grid.411545.0, ISNI 0000 0004 0470 4320, Department of Ophthalmology, , Jeonbuk National University College of Medicine, ; Jeonju, Korea
                [15 ]GRID grid.264381.a, ISNI 0000 0001 2181 989X, Department of Radiology, Samsung Medical Center, , Sungkyunkwan University School of Medicine, ; Seoul, Korea
                Author information
                http://orcid.org/0000-0002-1614-9534
                Article
                Publisher ID: 5888
                DOI: 10.1007/s00417-022-05888-z
                PMC ID: 9667443
                PubMed ID: 36383278
                SO-VID: 51d8fad8-ccb1-451d-98a1-30ec61dd40dd
                Copyright © © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2022, 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 : 27 June 2022
                Date revision received : 31 August 2022
                Date accepted : 25 October 2022
                Categories
                Subject: Neurophthalmology

                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: coronavirus disease 2019 (covid-19),ocular motility disorders,severe acute respiratory syndrome coronavirus 2 (sars-cov-2),ophthalmoplegia
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: coronavirus disease 2019 (covid-19), ocular motility disorders, severe acute respiratory syndrome coronavirus 2 (sars-cov-2), ophthalmoplegia

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