2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "COVID-19 Vaccines and Vaccination".

Deadline for manuscript submissions: 31 October 2024 | Viewed by 33207

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Guest Editor
Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan
Interests: PET/CT; COVID-19; vaccine; vaccination
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Special Issue Information

Dear Colleagues,

COVID-19 is a global public health crisis. There are two main treatment options available for COVID-19—antiviral drugs that help prevent viral replication and immunomodulatory/anti-inflammatory medications that help prevent tissue damage. However, most of these treatments only provide symptomatic relief, and none of them are ideal. Therefore, vaccination is extremely important in the fight against COVID-19. In addition to vaccine efficacy, safety data are crucial to approving vaccine use. Despite the introduction and widespread use of SARS-CoV-2 vaccinations, various adverse effects and complications have been reported. Although essential post-marketing surveillance of vaccines is ongoing, SARS-CoV-2 vaccines are considered highly effective and safe despite several indications of adverse events following immunization. These transient symptoms have been reported to include cerebral venous sinus thrombosis, demyelinating episodes, lymphadenopathy, cognitive decline, and myalgia/arthralgia.

We invite you to contribute your work to this Special Issue titled “Safety and Autoimmune Response to SARS-CoV-2 Vaccination”. This Special Issue aims to publish high-quality reviews, regular research papers, communications, case reports on the safety of the SARS-CoV-2 vaccine in the general population and special groups, proposals of different schedules and their effects on vaccine safety, security of neurological adverse events following immunization, and other aspects that may be proposed.

We look forward to receiving your contributions.

Dr. Minghui Yang
Guest Editor

Manuscript Submission Information

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Keywords

  • COVID-19 vaccine
  • vaccine efficacy
  • vaccine safety
  • adverse events following immunization

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Related Special Issue

Published Papers (7 papers)

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Research

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17 pages, 1932 KiB  
Article
Vaccination with Tozimameran Induces T-Cell Activation, but Not Senescent or Exhaustive Alterations, in Kidney Transplant Recipients
by Stamatia Stai, Georgios Lioulios, Aliki Xochelli, Anastasia Papadopoulou, Evangelia Yannaki, Efstratios Kasimatis, Michalis Christodoulou, Eleni Moysidou, Margarita Samali, Theodolinda Testa, Artemis Maria Iosifidou, Myrto Aikaterini Iosifidou, Georgios Tsoulfas, Maria Stangou and Asimina Fylaktou
Vaccines 2024, 12(8), 877; https://doi.org/10.3390/vaccines12080877 - 2 Aug 2024
Viewed by 682
Abstract
Background: Multiple vaccinations have potential inimical effects on the immune system aging process. We examined whether response to SARS-CoV-2 vaccination with Tozinameran is associated with immunosenescence and immunoexhaustion in kidney transplant recipients (KTRs). Methods: In this prospective observational study, we observed 39 adult [...] Read more.
Background: Multiple vaccinations have potential inimical effects on the immune system aging process. We examined whether response to SARS-CoV-2 vaccination with Tozinameran is associated with immunosenescence and immunoexhaustion in kidney transplant recipients (KTRs). Methods: In this prospective observational study, we observed 39 adult kidney transplant recipients (KTRs) who had no pre-existing anti-SARS-CoV-2 antibodies and were on stable immunosuppression. CD4+ and CD8+ T-cell subpopulations [comprising CD45RA+CCR7+ (naïve), CD45RA−CCR7+ (T-central memory, TCM), CD45RA−CCR7− (T-effector memory, TEM) and CD45RA+CCR7− (T-effector memory re-expressing CD45RA, TEMRA, senescent), CD28− (senescent) and PD1+ (exhausted)] were evaluated at 2 time points: T1 (48 h prior to the 3rd), and T2 (3 weeks following the 3rd Tozinameran dose administration). At each time point, patients were separated into Humoral and/or Cellular Responders and Non-Responders. Results: From T1 to T2, CD4+TCM and CD8+TEM were increased, while naïve CD4+ and CD8+ proportions were reduced in the whole cohort of patients, more prominently among responders. At T2, responders compared to non-responders had higher CD8+CD28+ [227.15 (166) vs. 131.44 (121) cells/µL, p: 0.036], lower CD4+CD28− T-lymphocyte numbers [59.65 (66) cells/µL vs. 161.19 (92) cells/µL, p: 0.026] and percentages [6.1 (5.5)% vs. 20.7 (25)%, p: 0.04]. Conclusion: In KTRs, response to vaccination is not associated with an expansion of senescent and exhausted T-cell concentrations, but rather with a switch from naïve to differentiated-activated T-cell forms. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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20 pages, 1200 KiB  
Article
Effectiveness and Safety of the COVID-19 Vaccine in Patients with Rheumatoid Arthritis in a Real-World Setting
by María Torres-Rufas, Esther F. Vicente-Rabaneda, Laura Cardeñoso, Ainhoa Gutierrez, David A. Bong, Cristina Valero-Martínez, José M. Serra López-Matencio, Rosario García-Vicuña, Miguel A. González-Gay, Isidoro González-Álvaro and Santos Castañeda
Vaccines 2024, 12(6), 672; https://doi.org/10.3390/vaccines12060672 - 18 Jun 2024
Viewed by 1121
Abstract
Novel mechanisms of COVID-19 vaccines raised concern about their potential immunogenicity in patients with rheumatoid arthritis (RA) undergoing immunomodulatory treatments. We designed a retrospective single-center study to investigate their effectiveness and safety in this population, analyzing data from the first vaccination program (December [...] Read more.
Novel mechanisms of COVID-19 vaccines raised concern about their potential immunogenicity in patients with rheumatoid arthritis (RA) undergoing immunomodulatory treatments. We designed a retrospective single-center study to investigate their effectiveness and safety in this population, analyzing data from the first vaccination program (December 2020–October 2021). Inclusion criteria were availability of post-vaccination serology and a minimum subsequent follow-up of 6 months. Binding antibody units (BAU/mL) ≥ 7.1 defined an adequate serological response. Post-vaccine COVID-19 incidence and its timing since vaccination, adverse events (AEs), and RA flares were recorded. Adjusted logistic and linear multivariate regression analyses were carried out to identify factors associated with vaccine response. We included 118 patients (87.2% women, age 65.4 ± 11.6 years, evolution 12.0 ± 9.6 years), of whom 95.8% had a complete vaccination schedule. Adequate humoral immunogenicity was achieved in 88.1% of patients and was associated with previous COVID-19 and mRNA vaccines, whereas smoking, aCCP, age, and DMARDs exerted a negative impact. Post-vaccine COVID-19 occurred in 18.6% of patients, a median of 6.5 months after vaccination. Vaccine AE (19.5%) and RA flares (1.7%) were mostly mild and inversely associated with age. Our results suggest that COVID-19 vaccines induce adequate humoral immunogenicity, with an acceptable safety profile in RA patients. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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12 pages, 1791 KiB  
Article
Spike-Specific Memory B Cell Response in Hematopoietic Cell Transplantation Recipients following Multiple mRNA-1273 Vaccinations: A Longitudinal Observational Study
by Elena Pettini, Annalisa Ciabattini, Fabio Fiorino, Jacopo Polvere, Gabiria Pastore, Monica Tozzi, Francesca Montagnani, Giuseppe Marotta, Alessandro Bucalossi and Donata Medaglini
Vaccines 2024, 12(4), 368; https://doi.org/10.3390/vaccines12040368 - 29 Mar 2024
Viewed by 1187
Abstract
Preventing SARS-CoV-2 infection is of utmost importance in allogeneic hematopoietic cell transplantation patients (allo-HCT), given their heightened susceptibility to adverse outcomes associated with SARS-CoV-2 infection. However, limited data are available regarding the immune response to COVID-19 vaccines in these subjects, particularly concerning the [...] Read more.
Preventing SARS-CoV-2 infection is of utmost importance in allogeneic hematopoietic cell transplantation patients (allo-HCT), given their heightened susceptibility to adverse outcomes associated with SARS-CoV-2 infection. However, limited data are available regarding the immune response to COVID-19 vaccines in these subjects, particularly concerning the generation and persistence of spike-specific memory response. Here, we analyzed the spike-specific memory B cells in a cohort of allo-HCT recipients vaccinated with multiple doses of the mRNA-1273 vaccine and monitored the spike-specific antibody response from baseline up to one month after the fourth dose. After the primary vaccine series, the frequency of spike-specific B cells, detected within the pool of Ig-switched CD19+ cells, significantly increased. The booster dose further induced a significant expansion, reaching up to 0.28% of spike-specific B cells. The kinetics of this expansion were slower in the allo-HCT recipients compared to healthy controls. Spike-specific IgG and ACE2/RBD binding inhibition activity were observed in 80% of the allo-HCT recipients after the first two doses, with a significant increase after the third and fourth booster doses, including in the subjects who did not respond to the primary vaccine series. Additionally, 87% of the allo-HCT recipients exhibited positive cross-inhibition activity against the BA.1 variant. Our findings provide evidence that allo-HCT recipients need repeated doses of the mRNA-1273 vaccine to induceSARS-CoV-2 specific immune response similar to that observed in healthy individuals. This is particularly crucial for vulnerable individuals who may exhibit a limited response to the primary series of SARS-CoV-2 vaccination. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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20 pages, 3282 KiB  
Article
Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study
by Francesco Ciccimarra, Nicoletta Luxi, Chiara Bellitto, Luca L’Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Caroline Dureau-Pournin, Andreea Farcas, Francisco Batel Marques, Kathryn Morton, Debabrata Roy, Simona Sonderlichová, Nicolas H. Thurin, Felipe Villalobos, Miriam C. Sturkenboom and Gianluca Trifirò
Vaccines 2024, 12(3), 241; https://doi.org/10.3390/vaccines12030241 - 26 Feb 2024
Cited by 4 | Viewed by 3422
Abstract
In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the [...] Read more.
In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021–February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee’s characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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Review

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16 pages, 1408 KiB  
Review
A Comprehensive Review on the Intricate Interplay between COVID-19 Immunization and the New Onset of Pemphigus Foliaceus
by Beatrice Bălăceanu-Gurău, Adrian Dumitrascu, Călin Giurcăneanu, Raluca Tatar, Cristian-Dorin Gurău and Olguța Anca Orzan
Vaccines 2024, 12(8), 857; https://doi.org/10.3390/vaccines12080857 - 30 Jul 2024
Viewed by 871
Abstract
Autoimmune bullous diseases (AIBDs) are characterized by the formation of vesicles, bullous lesions, and mucosal erosions. The autoantibodies target the cellular anchoring structures from the surface of epidermal keratinocyte named desmosomes, leading to a loss of cellular cohesion named acantholysis. AIBDs are classified [...] Read more.
Autoimmune bullous diseases (AIBDs) are characterized by the formation of vesicles, bullous lesions, and mucosal erosions. The autoantibodies target the cellular anchoring structures from the surface of epidermal keratinocyte named desmosomes, leading to a loss of cellular cohesion named acantholysis. AIBDs are classified into intraepidermal or subepidermal types based on clinical features, histological characteristics, and immunofluorescence patterns. Pemphigus foliaceus (PF) is an acquired, rare, autoimmune skin condition associated with autoantibodies that specifically target desmoglein-1, leading to a clinical presentation characterized by delicate cutaneous blisters, typically sparing the mucous membranes. Several factors, including genetic predisposition, environmental triggers, malignancies, medication use, and vaccination (for influenza, hepatitis B, rabies, tetanus, and more recently, severe acute respiratory syndrome Coronavirus 2 known as SARS-CoV-2), can potentially trigger the onset of pemphigus. With the advent of vaccines playing a pivotal role in combatting the 2019 coronavirus disease (COVID-19), extensive research has been conducted globally to ascertain their efficacy and potential cutaneous adverse effects. While reports of AIBDs post-COVID-19 vaccination exist in the medical literature, instances of PF following vaccination have been less commonly reported worldwide. The disease’s pathophysiology is likely attributed to the resemblance between the ribonucleic acid (RNA) antigen present in these vaccines and cellular nuclear matter. The protein produced by the BNT-162b2 messenger ribonucleic acid (mRNA) vaccine includes immunogenic epitopes that could potentially trigger autoimmune phenomena in predisposed individuals through several mechanisms, including molecular mimicry, the activation of pattern recognition receptors, the polyclonal stimulation of B cells, type I interferon production, and autoinflammation. In this review, we present a comprehensive examination of the existing literature regarding the relationship between COVID-19 and PF, delving into their intricate interactions. This exploration improves the understanding of both pemphigus and mRNA vaccine mechanisms, highlighting the importance of close monitoring for PF post-immunization. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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Other

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13 pages, 2085 KiB  
Brief Report
Association between Gut Microbiota Composition and Long-Term Vaccine Immunogenicity following Three Doses of CoronaVac
by Li-Na Zhang, Jing-Tong Tan, Ho-Yu Ng, Yun-Shi Liao, Rui-Qi Zhang, Kwok-Hung Chan, Ivan Fan-Ngai Hung, Tommy Tsan-Yuk Lam and Ka-Shing Cheung
Vaccines 2024, 12(4), 365; https://doi.org/10.3390/vaccines12040365 - 27 Mar 2024
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Abstract
Background: Neutralizing antibody level wanes with time after COVID-19 vaccination. We aimed to study the relationship between baseline gut microbiota and immunogenicity after three doses of CoronaVac. Methods: This was a prospective cohort study recruiting three-dose CoronaVac recipients from two centers in Hong [...] Read more.
Background: Neutralizing antibody level wanes with time after COVID-19 vaccination. We aimed to study the relationship between baseline gut microbiota and immunogenicity after three doses of CoronaVac. Methods: This was a prospective cohort study recruiting three-dose CoronaVac recipients from two centers in Hong Kong. Blood samples were collected at baseline and one year post-first dose for virus microneutralization (vMN) assays to determine neutralization titers. The primary outcome was high immune response (defined as with vMN titer ≥ 40). Shotgun DNA metagenomic sequencing of baseline fecal samples identified potential bacterial species and metabolic pathways using Linear Discriminant Analysis Effect Size (LEfSe) analysis. Univariate and multivariable logistic regression models were used to identify high response predictors. Results: In total, 36 subjects were recruited (median age: 52.7 years [IQR: 47.9–56.4]; male: 14 [38.9%]), and 18 had low immune response at one year post-first dose vaccination. Eubacterium rectale (log10LDA score = 4.15, p = 0.001; relative abundance of 1.4% vs. 0, p = 0.002), Collinsella aerofaciens (log10LDA score = 3.31, p = 0.037; 0.39% vs. 0.18%, p = 0.038), and Streptococcus salivarius (log10LDA score = 2.79, p = 0.021; 0.05% vs. 0.02%, p = 0.022) were enriched in low responders. The aOR of high immune response with E. rectale, C. aerofaciens, and S. salivarius was 0.03 (95% CI: 9.56 × 10−4–0.32), 0.03 (95% CI: 4.47 × 10−4–0.59), and 10.19 (95% CI: 0.81–323.88), respectively. S. salivarius had a positive correlation with pathways enriched in high responders like incomplete reductive TCA cycle (log10LDA score = 2.23). C. aerofaciens similarly correlated with amino acid biosynthesis-related pathways. These pathways all showed anti-inflammation functions. Conclusion: E. rectale,C. aerofaciens, and S. salivarius correlated with poorer long-term immunogenicity following three doses of CoronaVac. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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10 pages, 1343 KiB  
Case Report
Fatal Myocarditis following COVID-19 mRNA Immunization: A Case Report and Differential Diagnosis Review
by Pedro Manuel Barros de Sousa, Elon Almeida Silva, Marcos Adriano Garcia Campos, Joyce Santos Lages, Rita da Graça Carvalhal Frazão Corrêa and Gyl Eanes Barros Silva
Vaccines 2024, 12(2), 194; https://doi.org/10.3390/vaccines12020194 - 13 Feb 2024
Viewed by 23785
Abstract
Carditis in childhood is a rare disease with several etiologies. We report a case of infant death due to pericarditis and myocarditis after the mRNA vaccine against COVID-19 (COVIDmRNAV). A 7-year-old male child received the first dose of the COVIDmRNAV and presented with [...] Read more.
Carditis in childhood is a rare disease with several etiologies. We report a case of infant death due to pericarditis and myocarditis after the mRNA vaccine against COVID-19 (COVIDmRNAV). A 7-year-old male child received the first dose of the COVIDmRNAV and presented with monoarthritis and a fever non-responsive to oral antibiotics. The laboratory investigation showed signs of infection (leukocytosis, high levels of c-reactive protein). His condition rapidly deteriorated, and the patient died. The autopsy identified pericardial fibrin deposits, hemorrhagic areas in the myocardium, and normal valves. A diffuse intermyocardial inflammatory infiltrate composed of T CD8+ lymphocytes and histiocytes was identified. An antistreptolysin O (ASO) dosage showed high titers. The presence of arthritis, elevated ASO, and carditis fulfills the criteria for rheumatic fever. However, valve disease and Aschoff’s nodules, present in 90% of rheumatic carditis cases, were absent in this case. The temporal correlation with mRNA vaccination prompted its inclusion as one of the etiologies. In cases of myocardial damage related to COVID-19mRNAV, it appears to be related to the expression of exosomes and lipid nanoparticles, leading to a cytokine storm. The potential effects of the COVID-19mRNAV must be considered in the pathogenesis of this disease, whether as an etiology or a contributing factor to a previously initiated myocardial injury. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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