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Open AccessArticle

Comparative Safety and Effectiveness of Heterologous CoronaVac–ChAdOx1 versus Homologous CoronaVac Vaccination in a Real-World Setting: A Retrospective Cohort Study

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Vaccines 2023, 11(9), 1458; https://doi.org/10.3390/vaccines11091458 - 05 Sep 2023

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Abstract

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has outpaced vaccine availability and delivery from vaccine manufacturers, and thus, a scarcity of vaccines happened to many countries around the world. In Thailand, the mixing of different types of vaccines was [...] Read more.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has outpaced vaccine availability and delivery from vaccine manufacturers, and thus, a scarcity of vaccines happened to many countries around the world. In Thailand, the mixing of different types of vaccines was approved and clinically implemented partially due to concerns about the availability and efficacy of one vaccine. Objective: This study aimed to investigate the effectiveness and safety of heterologous CoronaVac–ChAdOx1 nCoV-19 vaccines compared with the usual regimen of homologous CoronaVac–CoronaVac. A retrospective cohort study was conducted by dividing patients into the CoronaVac–CoronaVac group and the CoronaVac–ChAdOx1 group. Results: A total of 875 patients received vaccinations at Srisangwan Hospital between April to October 2021 and were included for analysis. The patients in both homologous and heterologous groups had low rates of COVID-19 infection. In addition, the hospitalization rates in the 40 days after the second vaccination were low in both regimens. Minimal adverse events (AE) were reported in both groups, including local AE (e.g., discomfort at the injection site, rash, soreness, swelling, and redness) and systemic AE (e.g., fever, headache, weariness, nausea, vomiting, diarrhoea, and myalgia). Moreover, several factors were associated with lower adverse events following immunization (AEFIs), including age ≥ 50 years, male, and body weight ≥ 50 kg. In contrast, thyroid disease, diabetes mellitus, allergic rhinitis, and psychiatric disorders were independent risk factors associated with an increase in AEFIs. Conclusions: The heterologous CoronaVac–ChAdOx1 and homologous CoronaVac–CoronaVac regimens were promising vaccination strategies for the prevention of SARS-CoV-2 infection. However, the heterologous CoronaVac–ChAdOx1 potentially caused fewer AEFIs compared with the homologous CoronaVac–CoronaVac regimen. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

Association between the COVID-19 Vaccine and Preventive Behaviors: Panel Data Analysis from Japan

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Vaccines 2023, 11(4), 810; https://doi.org/10.3390/vaccines11040810 - 06 Apr 2023

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Abstract

The coronavirus (COVID-19) vaccine is key to reducing the probability of contracting COVID-19. The vaccine is generally known to prevent severe illness, death, and hospitalization as a result of the disease and for considerably reduce COVID-19 infection risk. Accordingly, this might significantly change [...] Read more.

The coronavirus (COVID-19) vaccine is key to reducing the probability of contracting COVID-19. The vaccine is generally known to prevent severe illness, death, and hospitalization as a result of the disease and for considerably reduce COVID-19 infection risk. Accordingly, this might significantly change an individual’s perceived risk of altering everyday behaviors. For instance, the proliferation of vaccination is anticipated to reduce preventive behaviors such as staying at home, handwashing, and wearing a mask. We corresponded with the same individuals monthly for 18 months from March 2020 (early stage of COVID-19) to September 2021 in Japan to independently construct large sample panel data (N = 54,007), with a participation rate of 54.7%. We used a fixed effects model, controlling for key confounders, to determine whether vaccination was associated with a change in preventive behaviors. The major findings are as follows. Contrary to the prediction, (1) based on the whole sample, being vaccinated against COVID-19 led people to stay at home; however, it did not change the habit of handwashing and wearing a mask. Especially after the second shot, respondents were likelier to stay at home by 0.107 (95% CIs: 0.059–0.154) points on a 5-point scale compared to before the vaccination. Dividing the entire sample into young and old, (2) those aged ≤ 40 years were more likely to go out after being vaccinated, and (3) people over 40 years of age were more likely to stay at home (similar to the first result). Preventive behaviors impact all individuals during the current pandemic. Informal social norms motivate people to increase or maintain preventive behaviors even after being vaccinated in societies where these behaviors are not enforced. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

Is SARS-CoV-2 Vaccination of Subjects with a Prior History of Allergies Dangerous? Experiences in the Veneto Region of Italy

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Vaccines 2023, 11(3), 574; https://doi.org/10.3390/vaccines11030574 - 02 Mar 2023

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Abstract

Adverse events after SARS-CoV-2 vaccinations have caused alarm to some individuals with previously diagnosed allergies. The aim of this study was to investigate whether the risk of adverse reactions was actually higher in this subgroup. To this end, we carried out an observational [...] Read more.

Adverse events after SARS-CoV-2 vaccinations have caused alarm to some individuals with previously diagnosed allergies. The aim of this study was to investigate whether the risk of adverse reactions was actually higher in this subgroup. To this end, we carried out an observational descriptive analysis of vaccines administered in a “protected setting” in the Veneto region of Italy between December 2020 and December 2022. Reactions were classified using systemic organic classification (SOC), and their severity was assessed using the criteria of the Italian Drug Agency (AIFA). A total of 421 subjects were vaccinated with 1050 doses, 95.0% of which were administered without adverse events. In all, 53 subjects reported 87 SOC reactions (1.6 reactions/person), and 18.3% of these reactions were severe. One person was hospitalized, but all subjects enjoyed complete remission. Reporting rates were 9.0%, 3.1%, and 1.2% for first, second, and third doses, respectively. The most frequent reactions involved the respiratory system (2.3%), the cutaneous and subcutaneous systems (2.1%), and the nervous system (1.7%). Multivariate analyses (adjOR (95% CI)) revealed that the probability of experiencing at least one reaction significantly declined with increases in age [0.95 (0.94–0.97)] and in the number of doses received, i.e., 75% [0.25 (0.13–0.49)] for second doses and 88% [0.12 (0.04–0.39)] for third doses. These results indicated that vaccinations could be safely administered; few reactions were reported, and there were no permanent adverse outcomes. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

Widening Disparities in Teen HPV Vaccinations during COVID-19 Pandemic: A Case Study from Veneto Region (Italy)

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Vaccines 2022, 10(12), 2120; https://doi.org/10.3390/vaccines10122120 - 11 Dec 2022

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Abstract

Introduction: In Local Health Unit 7, human papilloma virus (HPV) vaccination campaigns for 12-year-olds have long been implemented by the vaccination services of the Department of Prevention. Due to the pressure of the COVID-19 pandemic on these services, an emergency vaccination campaign was [...] Read more.

Introduction: In Local Health Unit 7, human papilloma virus (HPV) vaccination campaigns for 12-year-olds have long been implemented by the vaccination services of the Department of Prevention. Due to the pressure of the COVID-19 pandemic on these services, an emergency vaccination campaign was directly managed by primary care pediatricians (PCPs). An initial evaluation of this experience was conducted. Materials and methods: Data on 12-year-olds assisted by PCPs belonging to the 2006 (pre-pandemic) and 2008 (pandemic) birth cohorts were extracted, along with HPV vaccination data. Health district, gender, citizenship, socioeconomic status, and PCPs were evaluated as possible influencing factors in a two-level logistic regression (second level: single PCP). Results: The HPV vaccination gap between males and females increased significantly for the 2008 birth cohort compared to the 2006 birth cohort (11 vs. 4 percentage points). As for PCPs, the vaccination uptake range was 4–71% for the 2008 birth cohort vs. 32–85% for the 2006 cohort. The proportion of variance explained at the second level was overall equal to 9.7% for the 2008 cohort vs. 3.6% for the 2006 cohort. Conclusions: The vaccination campaign carried out during the peak of the COVID-19 pandemic increased the HPV vaccination gaps among Health Districts, genders, and individual PCPs, probably due to a lack of homogeneity in professional practices and attitudes toward HPV vaccination. Catch-up interventions are required in the immediate term, while an equity-lens approach should be taken for reprogramming the vaccination campaign. Greater involvement of schools and families could ensure a more equitable approach and a better uptake. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

Estimation of mRNA COVID-19 Vaccination Effectiveness in Tokyo for Omicron Variants BA.2 and BA.5: Effect of Social Behavior

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Vaccines 2022, 10(11), 1820; https://doi.org/10.3390/vaccines10111820 - 28 Oct 2022

Cited by 2 | Viewed by 1052

Abstract

The variability of the COVID-19 vaccination effectiveness (VE) should be assessed with a resolution of a few days, assuming that the VE is influenced by public behavior and social activity. Here, the VE for the Omicron variants (BA.2 and BA.5) is numerically derived [...] Read more.

The variability of the COVID-19 vaccination effectiveness (VE) should be assessed with a resolution of a few days, assuming that the VE is influenced by public behavior and social activity. Here, the VE for the Omicron variants (BA.2 and BA.5) is numerically derived for Japan’s population for the second and third vaccination doses. We then evaluated the daily VE variation due to social behavior from the daily data reports in Tokyo. The VE for the Omicron variants (BA.1, BA.2, and BA.5) are derived from the data of Japan and Tokyo with a computational approach. In addition, the effect of the different parameters regarding human behavior on VE was assessed using daily data in Tokyo. The individual VE for the Omicron BA.2 in Japan was 61% (95% CI: 57–65%) for the second dose of the vaccination from our computation, whereas that for the third dose was 86% (95% CI: 84–88%). The individual BA.5 VE for the second and third doses are 37% (95% CI: 33–40%) and 63% (95% CI: 61–65%). The reduction in the daily VE from the estimated value was closely correlated to the number of tweets related to social gatherings on Twitter. The number of tweets considered here would be one of the new candidates for VE evaluation and surveillance affecting the viral transmission. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

Third BNT162b2 Vaccine Booster Dose against SARS-CoV-2-Induced Antibody Response among Healthcare Workers

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Khetam Hussein

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Halima Dabaja-Younis

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Moran Szwarcwort-Cohen

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Yael Shachor-Meyouhas

Vaccines 2022, 10(10), 1741; https://doi.org/10.3390/vaccines10101741 - 18 Oct 2022

Cited by 3 | Viewed by 1116

Abstract

This study assessed humoral response to the third BNT162b2 dose among healthcare workers (HCW). This prospective cohort study of HCW tested for anti-spike antibodies (LIAISON SARS-CoV-2 S1/S2 IgG assay) at 1, 3, 6, 9, and 12 months after receiving the second BNT162b2 vaccine [...] Read more.

This study assessed humoral response to the third BNT162b2 dose among healthcare workers (HCW). This prospective cohort study of HCW tested for anti-spike antibodies (LIAISON SARS-CoV-2 S1/S2 IgG assay) at 1, 3, 6, 9, and 12 months after receiving the second BNT162b2 vaccine dose (tests 1, 2, 3, 4, and 5, respectively). A third (booster) vaccination dose was introduced before test 4. Linear regression model was used to determine the humoral response following vaccine doses. For each serology test, changes in log-transformed antibody concentrations over time, adjusted for age, sex, underlying diseases, steroid treatment, and smoking were described using the general linear mix model. Serology tests were performed at 3, 6, 9, and 12 months after the second vaccine dose in 1113, 1058, 986, and 939 participants, respectively. The third dose was received by 964 participants before the 9-month tests, 797 of whom participated in the 9- and 12-month serology tests. A significant inverse correlation was noted between time from third dose and antibody concentrations (Spearman correlation −0.395; p < 0.001). Age (p < 0.0001; CI 95% −0.005–−0.004), heart disease (p < 0.0001; CI 95% −0.177–−0.052), immunodeficiency (p < 0.0001; CI 95% 0.251–−0.106), and smoking (p < 0.0001; CI 95% −0.122–−0.040) were significantly associated with decreased antibody concentrations. Female sex (p = 0.03; CI 95% 0.013–0.066) was associated with increased antibody concentrations. The third booster dose had a better effect on immunogenicity, with higher antibody concentrations among tested HCW. Heart disease, smoking, and other known risk factors were associated with decreased antibody concentrations. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

Vaccination Status and Number of Vaccine Doses Are Independently Associated with the PaO₂/FiO₂ Ratio on Admission in Hospitalized COVID-19 Patients

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Vaccines 2022, 10(9), 1424; https://doi.org/10.3390/vaccines10091424 - 29 Aug 2022

Cited by 1 | Viewed by 1010

Abstract

Introduction: Coronavirus Disease-19 (COVID-19) vaccines reduce the risk of severe disease and mortality. However, the association between vaccination status and number of doses and the PaO₂/FiO₂ ratio, a clinical measure of hypoxemia associated with an increased risk of intensive care [...] Read more.

Introduction: Coronavirus Disease-19 (COVID-19) vaccines reduce the risk of severe disease and mortality. However, the association between vaccination status and number of doses and the PaO₂/FiO₂ ratio, a clinical measure of hypoxemia associated with an increased risk of intensive care treatment and mortality, has not been investigated. Methods: We retrospectively assessed a consecutive series of 116 patients admitted to hospital with a primary diagnosis of COVID-19 between January and April 2022. Demographic, clinical, and laboratory data were collected within 24 h from admission. Results: There was a significant positive relationship between the number of vaccine doses and the PaO₂/FiO₂ ratio (r = 0.223, p = 0.012). This association remained significant after adjusting for confounders. Vaccinated patients had significantly higher PaO₂/FiO₂ ratios than the unvaccinated (median: 250; IQR: 195–309 vs. 200; IQR: 156–257, p = 0.013). Conclusion: These results highlight the importance of the number of vaccine doses received in reducing the degree of hypoxia on admission in hospitalized COVID-19 patients. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

COVID-19 Vaccine Effectiveness against Omicron Variant among Underage Subjects: The Veneto Region’s Experience

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Vaccines 2022, 10(8), 1362; https://doi.org/10.3390/vaccines10081362 - 20 Aug 2022

Cited by 4 | Viewed by 1933

Abstract

Even if most of the complications due to COVID-19 are observed in the elderly, in Italy the impact of COVID-19 among young people has not been negligible. Furthermore, their contribution to SARS-CoV-2 circulation is still unclear. These reasons have driven policy makers to [...] Read more.

Even if most of the complications due to COVID-19 are observed in the elderly, in Italy the impact of COVID-19 among young people has not been negligible. Furthermore, their contribution to SARS-CoV-2 circulation is still unclear. These reasons have driven policy makers to involve subjects aged 5 to 17 years in the COVID-19 vaccination campaign. However, the trade-off of vaccinating this age-group should be further investigated, especially in view of the rise of new immunologically evasive variants of concern (VOCs). We used regional databases to retrospectively estimate vaccine effectiveness over time of each approved vaccination schedule among children (5–11) and adolescents (12–17). Our findings suggest that COVID-19 vaccines were highly effective and their protection levels lasted longer during a period of Delta variant predominance, whereas they offered just mild to moderate levels of protection—apparently affected by a rapid waning effect—in a period of Omicron variant predominance. Considering these results, it is plausible to evaluate a reformulation of possible future COVID-19 vaccination campaigns among underage subjects. However, effectiveness against serious complications due to COVID-19, as well as indirect benefits of underage vaccinations, should first be addressed. Furthermore, vaccine effectiveness should be kept monitored, as new VOCs may arise, but also new adapted vaccines may start being administered. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessArticle

The Effectiveness of a Diverse COVID-19 Vaccine Portfolio and Its Impact on the Persistence of Positivity and Length of Hospital Stays: The Veneto Region’s Experience

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Vaccines 2022, 10(1), 107; https://doi.org/10.3390/vaccines10010107 - 11 Jan 2022

Cited by 8 | Viewed by 2615

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The vaccination campaign for the Veneto region (northeastern Italy) started on 27 December 2020. As of early December 2021, 75.1% of the whole Veneto population has been fully vaccinated. Vaccine efficacy has been demonstrated in many clinical trials, but reports on real-world contexts [...] Read more.

The vaccination campaign for the Veneto region (northeastern Italy) started on 27 December 2020. As of early December 2021, 75.1% of the whole Veneto population has been fully vaccinated. Vaccine efficacy has been demonstrated in many clinical trials, but reports on real-world contexts are still necessary. We conducted a retrospective cohort study on 2,233,399 residents in the Veneto region to assess the reduction in the COVID-19 burden, taking different outcomes into consideration. First, we adopted a non-brand-specific approach borrowed from survival analysis to estimate the effectiveness of vaccination against SARS-CoV-2 in preventing infections, hospitalizations, and deaths. We used t-tests and multivariate regressions to examine vaccine impact on breakthrough infections, in terms of the persistence of positivity and the length of hospital stays. Evidence emerging from this study suggests that unvaccinated individuals are significantly more likely to become infected, need hospitalization, and are at a higher risk of death from COVID-19 than those given at least one dose of vaccine. Cox models indicate that the effectiveness of full vaccination is 88% against infection, 94% against hospitalization, and 95% against death. Multivariate regressions suggest that vaccination is significantly correlated with a shorter period of positivity and shorter hospital stays, with each step toward completion of the vaccination cycle coinciding with a reduction of 3.3 days in the persistence of positivity and 2.3 days in the length of hospital stay. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessSystematic Review

The Occurrence of Acute Disseminated Encephalomyelitis in SARS-CoV-2 Infection/Vaccination: Our Experience and a Systematic Review of the Literature

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Adina Stoian

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Zoltan Bajko

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Mircea Stoian

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Roxana Adriana Cioflinc

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Vaccines 2023, 11(7), 1225; https://doi.org/10.3390/vaccines11071225 - 10 Jul 2023

Cited by 1 | Viewed by 1885

Abstract

Background: The neurological complications of coronavirus disease 2019 (COVID-19) infection and the side effects of vaccination include immune-mediated diseases of the central nervous system (CNS) such as acute disseminated encephalomyelitis (ADEM). It is an acute-onset demyelinating disease that involves a rapid evolution and [...] Read more.

Background: The neurological complications of coronavirus disease 2019 (COVID-19) infection and the side effects of vaccination include immune-mediated diseases of the central nervous system (CNS) such as acute disseminated encephalomyelitis (ADEM). It is an acute-onset demyelinating disease that involves a rapid evolution and multifocal neurological deficits that develops following a viral or bacterial infection or, less frequently, following vaccination. Acute hemorrhagic leukoencephalitis (AHLE) is the hemorrhagic variant of ADEM that presents a more severe evolution which can be followed by coma and death. The objectives of this study consist in evaluating the diagnosis, clinical characteristics, imaging and laboratory features, evolution, and treatment of ADEM and AHLE following COVID-19 infection or vaccination. Methods: We performed a systematic review of the medical literature according to PRISMA guidelines that included ADEM cases published between 1 January 2020 and 30 November 2022 following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and vaccination and also included our own clinical experience regarding this pathology. Results: A total number of 74 patients were diagnosed with ADEM, 45 following COVID-19 infection and 29 after a SARS-CoV-2 vaccine. A total of 13 patients (17.33%) presented AHLE. The moderate form of COVID-19 presented a positive correlation with AHLE (r = 0.691, p < 0.001). The existence of coma and AHLE was correlated with poor outcomes. The following more aggressive immunomodulatory therapies applied in severe cases were correlated with poor outcomes (major sequelae and death): therapeutic plasma exchange (TPE) treatment (r = 382, p = 0.01) and combined therapy with corticosteroids and TPE (r = 0.337, p = 0.03). Conclusions: Vaccinations are essential to reduce the spread of the COVID-19 pandemic, and the monitoring of adverse events is an important part of the strategic fight against SARS-CoV-2. The general benefits and the overall good evolution outweigh the risks, and prompt diagnosis is associated with a better prognosis in these patients. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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Open AccessBrief Report

Differences in the Expression Levels of SARS-CoV-2 Spike Protein in Cells Treated with mRNA-Based COVID-19 Vaccines: A Study on Vaccines from the Real World

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Luigi Cari

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Mahdieh Naghavi Alhosseini

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Antonella Mencacci

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Graziella Migliorati

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Giuseppe Nocentini

Vaccines 2023, 11(4), 879; https://doi.org/10.3390/vaccines11040879 - 21 Apr 2023

Cited by 1 | Viewed by 4566

Abstract

Comirnaty (BNT162b2) and Spikevax (mRNA-1273) COVID-19 vaccines encode a full-length SARS-CoV-2 Spike (S) protein. To evaluate whether the S-protein expressed following treatment with the two vaccines differs in the real-world context, two cell lines were treated for 24 h with two concentrations of [...] Read more.

Comirnaty (BNT162b2) and Spikevax (mRNA-1273) COVID-19 vaccines encode a full-length SARS-CoV-2 Spike (S) protein. To evaluate whether the S-protein expressed following treatment with the two vaccines differs in the real-world context, two cell lines were treated for 24 h with two concentrations of each vaccine, and the expression of the S-protein was evaluated using flow cytometry and ELISA. Vaccines were obtained from three vaccination centers in Perugia (Italy) that provided us with residual vaccines present in vials after administration. Interestingly, the S-protein was detected not only on the cell membrane but also in the supernatant. The expression was dose-dependent only in Spikevax-treated cells. Furthermore, the S-protein expression levels in both cells and supernatant were much higher in Spikewax-than in Comirnaty-treated cells. Differences in S-protein expression levels following vaccine treatment may be attributed to variations in the efficacy of lipid nanoparticles, differences in mRNA translation rates and/or loss of some lipid nanoparticles’ properties and mRNA integrity during transport, storage, or dilution, and may contribute to explaining the slight differences in the efficacy and safety observed between the Comirnaty and Spikevax vaccines. Full article

(This article belongs to the Special Issue Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?)

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