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Safety, Efficacy and Optimization of the COVID-19 Vaccines

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A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Vaccine Efficacy and Safety".

Deadline for manuscript submissions: closed (30 November 2023) | Viewed by 53840

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Special Issue Editor

Dr. Qing Ye

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Guest Editor

1. The Children's Hospital, Zhejiang University School of Medicine, Hangzhou 310052, China
2. National Clinical Research Center for Child Health, Hangzhou 310052, China
3. National Children's Regional Medical Center, Hangzhou 310052, China
Interests: biomarker studies and clinical immunology

Special Issue Information

Dear Colleagues,

To date, the outbreak of coronavirus disease 2019 (COVID-19) has gone on for 3 years and has now spread to more than 200 countries and territories, impacting daily life worldwide at an unprecedented scale. Drug development works side-by-side with vaccine upgrading. Among the means of public health intervention, vaccination is both the most effective and cost-effective, with profound implications. The epidemic situation slows down with the emergency use of multiple COVID-19 vaccines; however, the validity of vaccines is being challenged by the constant emergence of new variants. Meanwhile, the safety in mass vaccination remains to be determined because of the short time-on-market of the vaccines. Therefore, there is still a long way to go to extinguish the COVID-19 epidemic. In this Special Issue, we aim to seek a better vaccine design scheme and optimize vaccination strategies by summarizing the influencing factors that impact the safety and efficacy of the different vaccines (inactivated vaccines, adenovirus-vectored vaccines, and nucleic acid vaccines), including design principle, production flow, storage and transportation, vaccination modalities, vaccinated subjects and so on. Multiple types of paper are included in this issue, including articles, reviews, case reports, letters and so on.

Dr. Qing Ye
Guest Editor

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Keywords

COVID-19 vaccines
safety
efficacy
optimization

Published Papers (14 papers)

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Research

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19 pages, 1433 KiB

Open AccessArticle

Pregnancy Outcomes among Pregnant Persons after COVID-19 Vaccination: Assessing Vaccine Safety in Retrospective Cohort Analysis of U.S. National COVID Cohort Collaborative (N3C)

by Emily A. G. Faherty, Kenneth J. Wilkins, Sara Jones, Anup Challa, Qiuyuan Qin, Lauren E. Chan, Courtney Olson-Chen, Jessica L. Tarleton, Michael N. Liebman, Federico Mariona, Elaine L. Hill, Rena C. Patel and The N3C Consortium

Vaccines 2024, 12(3), 289; https://doi.org/10.3390/vaccines12030289 - 11 Mar 2024

Viewed by 1423

Abstract

COVID-19 vaccines have been shown to be effective in preventing severe illness, including among pregnant persons. The vaccines appear to be safe in pregnancy, supporting a continuously favorable overall risk/benefit profile, though supportive data for the U.S. over different periods of variant predominance are lacking. We sought to analyze the association of adverse pregnancy outcomes with COVID-19 vaccinations in the pre-Delta, Delta, and Omicron SARS-CoV-2 variants’ dominant periods (constituting 50% or more of each pregnancy) for pregnant persons in a large, nationally sampled electronic health record repository in the U.S. Our overall analysis included 311,057 pregnant persons from December 2020 to October 2023 at a time when there were approximately 3.6 million births per year. We compared rates of preterm births and stillbirths among pregnant persons who were vaccinated before or during pregnancy to persons vaccinated after pregnancy or those who were not vaccinated. We performed a multivariable Poisson regression with generalized estimated equations to address data site heterogeneity for preterm births and unadjusted exact models for stillbirths, stratified by the dominant variant period. We found lower rates of preterm birth in the majority of modeled periods (adjusted incidence rate ratio [aIRR] range: 0.42 to 0.85; p-value range: <0.001 to 0.06) and lower rates of stillbirth (IRR range: 0.53 to 1.82; p-value range: <0.001 to 0.976) in most periods among those who were vaccinated before or during pregnancy compared to those who were vaccinated after pregnancy or not vaccinated. We largely found no adverse associations between COVID-19 vaccination and preterm birth or stillbirth; these findings reinforce the safety of COVID-19 vaccination during pregnancy and bolster confidence for pregnant persons, providers, and policymakers in the importance of COVID-19 vaccination for this group despite the end of the public health emergency. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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20 pages, 13243 KiB

Open AccessArticle

A Potential Association between Abdominal Obesity and the Efficacy of Humoral Immunity Induced by COVID-19 and by the AZD1222, Convidecia, BNT162b2, Sputnik V, and CoronaVac Vaccines

by Javier Angeles-Martinez, Irma Eloisa Monroy-Muñoz, José Esteban Muñoz-Medina, Larissa Fernandes-Matano, Ángel Gustavo Salas-Lais, Ma De Los Ángeles Hernández-Cueto, Eyerahi Bravo-Flores, Moisés León-Juárez, Clara Esperanza Santacruz-Tinoco and Daniel Montes-Herrera

Vaccines 2024, 12(1), 88; https://doi.org/10.3390/vaccines12010088 - 15 Jan 2024

Viewed by 984

Abstract

Abdominal obesity is highly prevalent in Mexico and has a poor prognosis in terms of the severity of coronavirus disease (COVID-19) and low levels of antibodies induced by infection and vaccination. We evaluated the humoral immune response induced by COVID-19 and five different vaccination schedules in Mexican individuals with abdominal obesity and the effects of other variables. This prospective longitudinal cohort study included 2084 samples from 389 participants. The levels of anti-S1/S2 and anti-RBD IgG antibodies were measured at various time points after vaccination. A high prevalence of hospitalization and oxygen use was observed in individuals with abdominal obesity (AO) who had COVID-19 before vaccination; however, they also had high levels of anti-S1/S2 and anti-RBD-neutralizing IgG antibodies. The same was true for vaccination-induced antibody levels. However, their longevity was low. Interestingly, we did not observe significant differences in vaccine reactogenicity between abdominally obese and abdominally non-obese groups. Finally, individuals with a higher body mass index, older age, and previous COVID-19 had higher levels of antibodies induced by COVID-19 and vaccination. Therefore, it is important to evaluate other immunological and inflammatory factors to better understand the pathogenesis of COVID-19 in the presence of risk factors and to propose effective vaccination schedules for vulnerable populations. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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10 pages, 216 KiB

Open AccessArticle

Humoral Response and Safety after a Fourth Dose of the SARS-CoV-2 BNT162b2 Vaccine in Cancer Patients Undergoing Active Treatment—Results of a Prospective Observational Study

by Chiara Citterio, Claudia Biasini, Camilla Di Nunzio, Giuliana Lo Cascio and Luigi Cavanna

Vaccines 2024, 12(1), 76; https://doi.org/10.3390/vaccines12010076 - 12 Jan 2024

Viewed by 996

Abstract

Only a few studies have been carried out on the efficacy and safety of a fourth dose of the COVID-19 vaccine in patients with cancer. In this prospective observational study, we aimed to assess the serological response and safety of the fourth booster shot of the BNT162b2 vaccine in 79 cancer patients, vaccinated between 1 March and 25 August 2022, under systemic anticancer therapy. The primary endpoint was to assess the increase in the anti-SARS-CoV-2 antibodies; secondary endpoints were the vaccine safety and side effects. Consequently, 40 patients (50.63%) revealed the maximum detection values in their IgG titers before the fourth dose of the vaccine, while 39 patients (49.37%) did not. Primary endpoint: Of 39 patients, 36 (92.31%) showed a significant increase in the anti-SARS-CoV-2 IgG titers, and 32 of them (82.05%) reached the maximum titration values. Secondary endpoints: The most common adverse events were mild in severity and included injection site pain, erythema and tiredness. The majority of the adverse reactions reported were grade 1 and no grade 3 and 4 reactions were detected. Our data provide evidence that a fourth dose of the BNT162b2 anti-SARS-CoV-2 vaccine is effective and safe in patients with solid tumors in active anticancer treatment. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

22 pages, 4789 KiB

Open AccessArticle

Differences in the Evolution of Clinical, Biochemical, and Hematological Indicators in Hospitalized Patients with COVID-19 According to Their Vaccination Scheme: A Cohort Study in One of the World’s Highest Hospital Mortality Populations

by Martha A. Mendoza-Hernandez, Jose Guzman-Esquivel, Marco A. Ramos-Rojas, Vanessa V. Santillan-Luna, Carmen A. Sanchez-Ramirez, Gustavo A. Hernandez-Fuentes, Janet Diaz-Martinez, Valery Melnikov, Fabian Rojas-Larios, Margarita L. Martinez-Fierro, Daniel Tiburcio-Jimenez, Iram P. Rodriguez-Sanchez, Osiris G. Delgado-Enciso, Ariana Cabrera-Licona and Ivan Delgado-Enciso

Vaccines 2024, 12(1), 72; https://doi.org/10.3390/vaccines12010072 - 11 Jan 2024

Cited by 1 | Viewed by 1388

Abstract

COVID-19 vaccines primarily prevent severe illnesses or hospitalization, but there is limited data on their impact during hospitalization for seriously ill patients. In a Mexican cohort with high COVID-19 mortality, a study assessed vaccination’s effects. From 2021 to 2022, 462 patients with 4455 hospital days were analyzed. The generalized multivariate linear mixed model (GENLINMIXED) with binary logistic regression link, survival analysis and ROC curves were used to identify risk factors for death. The results showed that the vaccinated individuals were almost half as likely to die (adRR = 0.54, 95% CI = 0.30–0.97, p = 0.041). When stratifying by vaccine, the Pfizer group (BNT162b2) had a 2.4-times lower risk of death (adRR = 0.41, 95% CI = 0.2–0.8, p = 0.008), while the AstraZeneca group (ChAdOx1-S) group did not significantly differ from the non-vaccinated (adRR = 1.04, 95% CI = 0.5–2.3, p = 0.915). The Pfizer group exhibited a higher survival, the unvaccinated showed increasing mortality, and the AstraZeneca group remained intermediate (p = 0.003, multigroup log-rank test). Additionally, BNT162b2-vaccinated individuals had lower values for markers, such as ferritin and D-dimer. Biochemical and hematological indicators suggested a protective effect of both types of vaccines, possibly linked to higher lymphocyte counts and lower platelet-to-lymphocyte ratio (PLR). It is imperative to highlight that these results reinforce the efficacy of COVID-19 vaccines. However, further studies are warranted for a comprehensive understanding of these findings. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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23 pages, 6881 KiB

Open AccessArticle

Co-Delivery of Novel Synthetic TLR4 and TLR7/8 Ligands Adsorbed to Aluminum Salts Promotes Th1-Mediated Immunity against Poorly Immunogenic SARS-CoV-2 RBD

by Karthik Siram, Stephanie K. Lathrop, Walid M. Abdelwahab, Rebekah Tee, Clara J. Davison, Haley A. Partlow, Jay T. Evans and David J. Burkhart

Vaccines 2024, 12(1), 21; https://doi.org/10.3390/vaccines12010021 - 23 Dec 2023

Viewed by 1176

Abstract

Despite the availability of effective vaccines against COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide, pressing the need for new vaccines with improved breadth and durability. We developed an adjuvanted subunit vaccine against SARS-CoV-2 using the recombinant receptor–binding domain (RBD) of spikes with synthetic adjuvants targeting TLR7/8 (INI-4001) and TLR4 (INI-2002), co-delivered with aluminum hydroxide (AH) or aluminum phosphate (AP). The formulations were characterized for the quantities of RBD, INI-4001, and INI-2002 adsorbed onto the respective aluminum salts. Results indicated that at pH 6, the uncharged RBD (5.73 ± 4.2 mV) did not efficiently adsorb to the positively charged AH (22.68 ± 7.01 mV), whereas it adsorbed efficiently to the negatively charged AP (−31.87 ± 0.33 mV). Alternatively, pre-adsorption of the TLR ligands to AH converted it to a negatively charged particle, allowing for the efficient adsorption of RBD. RBD could also be directly adsorbed to AH at a pH of 8.1, which changed the charge of the RBD to negative. INI-4001 and INI-2002 efficiently to AH. Following vaccination in C57BL/6 mice, both aluminum salts promoted Th2-mediated immunity when used as the sole adjuvant. Co-delivery with TLR4 and/or TLR7/8 ligands efficiently promoted a switch to Th1-mediated immunity instead. Measurements of viral neutralization by serum antibodies demonstrated that the addition of TLR ligands to alum also greatly improved the neutralizing antibody response. These results indicate that the addition of a TLR7/8 and/or TLR4 agonist to a subunit vaccine containing RBD antigen and alum is a promising strategy for driving a Th1 response and neutralizing antibody titers targeting SARS-CoV-2. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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19 pages, 5000 KiB

Open AccessArticle

Immune Response after SARS-CoV-2 Infection with Residual Post-COVID Symptoms

by Tanyaporn Pongkunakorn, Thamonwan Manosan, Apinya Surawit, Suphawan Ophakas, Pichanun Mongkolsucharitkul, Sureeporn Pumeiam, Sophida Suta, Bonggochpass Pinsawas, Nitat Sookrung, Nawannaporn Saelim, Kodchakorn Mahasongkram, Pannathee Prangtaworn, Anchalee Tungtrongchitr, Watip Tangjittipokin, Suthee Mangmee, Kobporn Boonnak, Tassanee Narkdontri, Nipaporn Teerawattanapong, Rungsima Wanitphadeedecha and Korapat Mayurasakorn

Vaccines 2023, 11(9), 1413; https://doi.org/10.3390/vaccines11091413 - 24 Aug 2023

Cited by 1 | Viewed by 1663

Abstract

Many patients develop post-acute COVID syndrome (long COVID (LC)). We compared the immune response of LC and individuals with post-COVID full recovery (HC) during the Omicron pandemic. Two hundred ninety-two patients with confirmed COVID infections from January to May 2022 were enrolled. We observed anti-SARS-CoV-2 receptor-binding domain immunoglobulin G, surrogate virus neutralization test, T cell subsets, and neutralizing antibodies against Wuhan, BA.1, and BA.5 viruses (NeuT). NeuT was markedly reduced against BA.1 and BA.5 in HC and LC groups, while antibodies were more sustained with three doses and an updated booster shot than ≤2-dose vaccinations. The viral neutralization ability declined at >84-days after COVID-19 onset (PC) in both groups. PD1-expressed central and effector memory CD4⁺ T cells, and central memory CD8⁺ T cells were reduced in the first months PC in LC. Therefore, booster vaccines may be required sooner after the most recent infection to rescue T cell function for people with symptomatic LC. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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13 pages, 557 KiB

Open AccessArticle

COVID-19 Breakthrough Infections in Vaccinated Kidney Transplant Recipients

by Xiaojing Zhang, Ruopeng Weng, Fei Liu, Yi Xie, Yanyan Jin, Qiuyu Li, Guoping Huang, Junyi Chen, Jingjing Wang, Huijun Shen, Haidong Fu and Jianhua Mao

Vaccines 2022, 10(11), 1911; https://doi.org/10.3390/vaccines10111911 - 11 Nov 2022

Cited by 2 | Viewed by 2173

Abstract

Coronavirus disease 2019 (COVID-19) is associated with increased morbidity and mortality among kidney transplant recipients (KTRs). The administration of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination is the only reliable strategy to prevent COVID-19 and alleviate the severity of COVID-19 in this particular population. The aim of this article was to evaluate the clinical protection by vaccines (breakthrough infections, deaths, and hospitalizations) in KTRs. There were 135 KTRs with COVID-19 breakthrough infections for whom patient-level data were available in PubMed and Web of Science. There was a male predominance (61.4%), 97 were given the standard vaccination regimen, and 38 received three or four doses of the vaccine. The median age was 59.0 (IQR: 49.0–69.0) years. A total of 67 patients were hospitalized, and 10 patients died. In 72.6% of cases, triple-maintenance immunosuppression was employed. The deceased patients were older than the survivors (p < 0.05); an age over 60 years was a risk factor for death (p < 0.05). The KTRs with booster vaccines had a longer time interval from the last vaccine to COVID-19 infection and lower hospitalization rates than the individuals who received the standard vaccination regimen (33.3% vs. 54.8%, p < 0.05). The hospitalized patients were older than the outpatients (p < 0.05). Among 16,820 fully vaccinated or boosted KTRs from 14 centers, there were 633 breakthrough infections (3.58%) and 73 associated deaths (0.41%). The center-level breakthrough infection rates varied from 0.21% to 9.29%. These findings highlight the need for booster doses for KTRs. However, more research is needed to define the long-term effectiveness and immunogenicity of booster doses and to identify methods to boost the protective response to vaccination in these immunocompromised patients. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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14 pages, 2056 KiB

Open AccessArticle

Neutralizing Antibody Response, Safety, and Efficacy of mRNA COVID-19 Vaccines in Pediatric Patients with Inflammatory Bowel Disease: A Prospective Multicenter Case—Control Study

by Kyung Jae Lee, So Yoon Choi, Yoo Min Lee and Han Wool Kim

Vaccines 2022, 10(8), 1265; https://doi.org/10.3390/vaccines10081265 - 6 Aug 2022

Cited by 7 | Viewed by 2704

Abstract

The vaccination of immunocompromised children against coronavirus disease 2019 is an important public health issue. We evaluated the serological response, safety, and efficacy of the BNT162b2 vaccine in children with and without inflammatory bowel disease (IBD). A prospective, multicenter, case–control study was conducted in a pediatric population, including patients with IBD, aged 12–18 years. Clinical characteristics, safety profile, and serum samples for surrogate virus-neutralizing antibody testing pre- and post-BNT162b2 vaccination were assessed. The breakthrough infection rate during the Omicron outbreak was calculated to evaluate efficacy. Fifteen controls and twenty-three patients with IBD were enrolled. After two vaccine doses, the median level of percentage inhibition was highly increased, without significant differences between the groups (control 96.9 and IBD 96.3). However, it was significantly reduced in IBD patients receiving combination therapy (anti-tumor necrosis factor-α + immunomodulators) relative to those in other therapies and controls. Serious adverse events were not observed. The breakthrough infection rate was 42.1%, without statistical differences between the groups. Immunization with BNT162b2 in patients with IBD was comparable with that in healthy adolescents in terms of immunogenicity and safety. Nevertheless, the efficacy of BNT162b2 in preventing infection caused by the Omicron variant in the pediatric population was insufficient. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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Review

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17 pages, 826 KiB

Open AccessReview

Neurological Disorders following COVID-19 Vaccination

by Ying Yang and Lisu Huang

Vaccines 2023, 11(6), 1114; https://doi.org/10.3390/vaccines11061114 - 19 Jun 2023

Cited by 4 | Viewed by 16989

Abstract

Nowadays, people all over the world have been receiving different types of coronavirus disease 2019 (COVID-19) vaccines. While their effectiveness has been well recognized, various post-vaccination disorders are not fully understood. In this review, we discuss neurological disorders related to vascular, immune, infectious, and functional factors following COVID-19 vaccination, and attempt to provide neuroscientists, psychiatrists, and vaccination staff with a reference for the diagnosis and treatment of these diseases. These disorders may present as a recurrence of previous neurological disorders or new-onset diseases. Their incidence rate, host and vaccine characteristics, clinical manifestations, treatment, and prognosis differ significantly. The pathogenesis of many of them remains unclear, and further studies are needed to provide more evidence. The incidence rate of severe neurological disorders is relatively low, most of which are reversible or treatable. Therefore, the benefits of vaccination outweigh the risk of COVID-19 infection, especially among fragile populations. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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18 pages, 697 KiB

Open AccessReview

A Review of Inactivated COVID-19 Vaccine Development in China: Focusing on Safety and Efficacy in Special Populations

by Lidan Hu, Jingmiao Sun, Yan Wang, Danny Tan, Zhongkai Cao, Langping Gao, Yuelin Guan, Xiuwei Jia and Jianhua Mao

Vaccines 2023, 11(6), 1045; https://doi.org/10.3390/vaccines11061045 - 31 May 2023

Cited by 5 | Viewed by 3235

Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been widespread globally, and vaccination is critical for preventing further spread or resurgence of the outbreak. Inactivated vaccines made from whole inactivated SARS-CoV-2 virus particles generated in Vero cells are currently the most widely used COVID-19 vaccines, with China being the largest producer of inactivated vaccines. As a result, the focus of this review is on inactivated vaccines, with a multidimensional analysis of the development process, platforms, safety, and efficacy in special populations. Overall, inactivated vaccines are a safe option, and we hope that the review will serve as a foundation for further development of COVID-19 vaccines, thus strengthening the defense against the pandemic caused by SARS-CoV-2. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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18 pages, 931 KiB

Open AccessReview

Renal Side Effects of COVID-19 Vaccination

by Junfeng Zhang, Jiajia Cao and Qing Ye

Vaccines 2022, 10(11), 1783; https://doi.org/10.3390/vaccines10111783 - 23 Oct 2022

Cited by 13 | Viewed by 15183

Abstract

Background: The COVID-19 pandemic has imposed a challenge on global healthcare and has tremendously impacted everyone’s lives. Vaccination is one of the most effective and vital strategies to halt the pandemic. However, new-onset and relapsed kidney diseases have been reported after COVID-19 vaccination. This narrative review was conducted to collect published data and generalize some hypotheses for the pathogenesis of renal side effects of COVID-19 vaccines. Methods: A systematic literature search of articles reporting renal adverse reactions, including in adults and children, in the PubMed and Web of Science databases until August 2022 was performed. Results: A total of 130 cases reporting a renal adverse reaction following COVID-19 vaccination from 90 articles were included in this review, of which 90 (69%) were new-onset kidney diseases, while 40 (31%) were relapsed kidney diseases. The most frequent renal side effects of COVID-19 vaccination were minimal change disease (52 cases), IgA nephropathy (48 cases), antineutrophil cytoplasmic autoantibody vasculitis (16 cases), and acute interstitial nephritis (12 cases). Other renal side effects occurred at a much lower frequency. Follow-up data were available for 105 patients, and 100 patients (95%) responded to the treatments. Conclusions: The number of reported cases is far less than the hundreds of millions of vaccinations, and the benefit of COVID-19 vaccination far outweighs its risks. This review will assist healthcare professionals, particularly nephrologists, who should be aware of these side effects and recognize them early and treat them efficiently. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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9 pages, 775 KiB

Open AccessReview

The Epidemiological Features of the SARS-CoV-2 Omicron Subvariant BA.5 and Its Evasion of the Neutralizing Activity of Vaccination and Prior Infection

by Dandan Tian, Wenjian Nie, Yanhong Sun and Qing Ye

Vaccines 2022, 10(10), 1699; https://doi.org/10.3390/vaccines10101699 - 11 Oct 2022

Cited by 16 | Viewed by 1989

Abstract

From December 2021 to May 2022, the Omicron BA.1 and BA.2 subvariants successively became the most dominant strains in many countries around the world. Subsequently, Omicron subvariants have emerged, and Omicron has been classified into five main lineages, including BA.1, BA.2, BA.3, BA.4, BA.5, and some sublineages (BA.1.1, BA.2.12.1, BA.2.11, BA.2.75, BA.4.6, BA.5.1, and BA.5.2). The recent emergence of several Omicron subvariants has generated new concerns about further escape from immunity induced by prior infection and vaccination and the creation of new COVID-19 waves globally. In particular, BA.5 (first found in southern Africa, February 2022) displays a higher transmissibility than other Omicron subvariants and is replacing the previously circulating BA.1 and BA.2 in several countries. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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10 pages, 940 KiB

Open AccessCase Report

Tip Lesion Most Frequent FSGS Variant Related to COVID-19 Vaccine: Two Case Reports and Literature Review

by Emmy Marjorie Carvalho de Araújo, Marcos Adriano Garcia Campos, Andressa Monteiro Sodré, Maria Izabel de Holanda, Rodrigo Hagemann, Antonio Augusto Lima Teixeira Júnior, Natalino Salgado Filho, Precil Diego Miranda de Menezes Neves and Gyl Eanes Barros Silva

Vaccines 2024, 12(1), 62; https://doi.org/10.3390/vaccines12010062 - 8 Jan 2024

Cited by 1 | Viewed by 1345

Abstract

Large-scale COVID-19 vaccination has been one of the most effective strategies to control the spread of the SARS-CoV-2 virus. However, several cases of glomerular injury related to the COVID-19 vaccine have been described in the literature. We report two cases of a tip lesion variant of focal segmental glomerulosclerosis (FSGS), which presented with significant proteinuria and improved after immunosuppression. In our literature review, the tip lesion variant of FSGS is currently the most frequent variant associated with vaccination against COVID-19. Prognosis is favorable and without significant alterations in the tubulointerstitial or vascular compartments. Adverse effects of vaccines need to be recognized early and will help us to understand the immune and pathological mechanisms of kidney damage. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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6 pages, 234 KiB

Open AccessCommentary

Considerations in Understanding Vaccine Effectiveness

by Chin Shern Lau and Tar Choon Aw

Vaccines 2023, 11(1), 20; https://doi.org/10.3390/vaccines11010020 - 22 Dec 2022

Viewed by 1296

Abstract

Although vaccine effectiveness reports are essential to assessing policies on SARS-CoV-2 vaccination, several factors can affect our interpretation of the results. These include the waning of antibodies, the prevailing viral variants at the time of the study, and COVID-19 disease prevalence in the population. Disease prevalence significantly impacts absolute risk reduction and could skew expected efficacy when increased disease prevalence inflates the absolute risk reduction in the face of a constant relative risk reduction. These factors must be considered in the interpretation of vaccine effectiveness to better understand how vaccines can improve disease prevention among the population. We highlight the impact of various factors on vaccine effectiveness. Full article

(This article belongs to the Special Issue Safety, Efficacy and Optimization of the COVID-19 Vaccines)

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