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      Vaccine-associated uveitis following SARS-CoV-2 vaccination: A CDC-VAERS database analysis

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          Abstract

          Purpose

          To assess the risk of vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination and evaluate uveitis onset interval and clinical presentations in the patients.

          Design

          A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS).

          Participants

          Patients diagnosed with VAU following administration of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccine, worldwide.

          Methods

          A descriptive analysis of the demographics, clinical history and presentation was performed. We evaluated the correlation between the three vaccines and continuous and categorical variables. A post-hoc analysis was performed between uveitis onset-interval after vaccination, and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset post-vaccination was performed.

          Main Outcome Measures

          The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.

          Results

          A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU for the cases reports from the United States was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n=853, 77.97%). The mean age of patients with VAU was 46.24±16.93 years, and 68.65% (n=751) were women. Most cases were reported after the first dose (n=452, 41.32%) and within the first week (n=591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22± 42.74 days) compared to BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (p<0.0001). The post-hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (p<0.0001) and the first dose compared to the second dose (p=0.0021). The 30-day risk analysis showed a significant difference between the three vaccines (p<0.0001).

          Conclusions

          The low crude reporting rate and observed-expected ratio suggests a low safety concern for VAU. This study provides insights into possible temporal association between reported VAU events and SARS-CoV-2 vaccines, however further investigations are required to delineate the associated immunological mechanisms.

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          Most cited references43

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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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            Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19

            Jerald Sadoff, Glenda Gray, An Vandebosch … (2021)
            Background The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. Methods In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×10 10 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe–critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. Results The per-protocol population included 19,630 SARS-CoV-2–negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe–critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe–critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe–critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe–critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19–related), and 16 in the placebo group (5 were Covid-19–related). Conclusions A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722 .)
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              mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants

              Zijun Wang, Fabian Schmidt, Yiska Weisblum … (2021)
              Here we report on the antibody and memory B cell responses of a cohort of 20 volunteers who received the Moderna (mRNA-1273) or Pfizer-BioNTech (BNT162b2) vaccine against SARS-CoV-21-4. Eight weeks after the second injection of vaccine, volunteers showed high levels of IgM and IgG anti-SARS-CoV-2 spike protein (S) and receptor-binding-domain (RBD) binding titre. Moreover, the plasma neutralizing activity and relative numbers of RBD-specific memory B cells of vaccinated volunteers were equivalent to those of individuals who had recovered from natural infection5,6. However, activity against SARS-CoV-2 variants that encode E484K-, N501Y- or K417N/E484K/N501-mutant S was reduced by a small-but significant-margin. The monoclonal antibodies elicited by the vaccines potently neutralize SARS-CoV-2, and target a number of different RBD epitopes in common with monoclonal antibodies isolated from infected donors5-8. However, neutralization by 14 of the 17 most-potent monoclonal antibodies that we tested was reduced or abolished by the K417N, E484K or N501Y mutation. Notably, these mutations were selected when we cultured recombinant vesicular stomatitis virus expressing SARS-CoV-2 S in the presence of the monoclonal antibodies elicited by the vaccines. Together, these results suggest that the monoclonal antibodies in clinical use should be tested against newly arising variants, and that mRNA vaccines may need to be updated periodically to avoid a potential loss of clinical efficacy.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Ophthalmology
                Journal ID (iso-abbrev): Ophthalmology
                Title: Ophthalmology
                Publisher: Published by Elsevier Inc. on behalf of the American Academy of Ophthalmology
                ISSN (Print): 0161-6420
                ISSN (Electronic): 1549-4713
                Publication date PMC-release: 31 August 2022
                Publication date (Electronic): 31 August 2022
                Affiliations
                [1 ]Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, USA
                [2 ]Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands
                [3 ]Discipline of Ophthalmology and Visual Sciences, Faculty of Health and Medical Sciences, Adelaide Medical School, University of Adelaide, Australia
                [4 ]Department of Ophthalmology, Government Medical College and Hospital, Chandigarh, India
                [5 ]Eye Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
                [6 ]Department of Ophthalmology, University of Maastricht, Maastricht, the Netherlands
                [7 ]Stein Eye Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, USA
                Author notes
                [∗ ]Corresponding author(s): Edmund Tsui, MD, Assistant Professor of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, USA
                [∗∗ ]Corresponding author(s): Aniruddha Agarwal, MD, Associate Professor of Ophthalmology, Eye Institute, Cleveland Clinic Abu Dhabi, Jazeerat Al-Maryah, Abu Dhabi, UAE
                Article
                Publisher Item ID: S0161-6420(22)00672-8
                DOI: 10.1016/j.ophtha.2022.08.027
                PMC ID: 9428109
                PubMed ID: 36055601
                SO-VID: 59be006f-4036-4164-83a5-95a205caa68f
                Copyright © © 2022 Published by Elsevier Inc. on behalf of the American Academy of Ophthalmology.
                License:

                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.

                History
                Date received : 1 July 2022
                Date revision received : 11 August 2022
                Date accepted : 24 August 2022
                Categories
                Subject: Article

                ScienceOpen disciplines: Ophthalmology & Optometry
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry

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