Real Life Experience of the COVID-19 Vaccine: What Do You Need to Know?

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

Deadline for manuscript submissions: closed (31 January 2024) | Viewed by 24929

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Guest Editor
Department of Cardiologic, Vascular and Thoracic Sciences, and Public Health, University of Padova, 35128 Padova, Italy
Interests: vaccine; epidemiology; immunogenicity; safety; public health; infection diseases

Special Issue Information

Dear Colleagues,

It has been two years since the first reports of the SARS-CoV2 pandemic from Wuhan. In that time we have seen 250 million people worldwide infected and, over 5 million deaths and we have learnt that science and a strong public health system can make the difference to our lives.

The current increase of infections due to the spreading of the “omicrom” variant is putting the world under pressure once again. That is why today, in the middle of the fourth wave, it is time to look back and see what has been done in terms of prevention.

The quick development of several types of COVID-19 vaccines, based on mRNA technology and viral vectors, should be considered the biggest goal the scientific community has reached in recent decades. Once the evidence of efficacy and safety was clearly demonstrated in clinical trials, the most important challenge was finding evidence of effectiveness in a wider population. This is what real life studies intended to demonstrate during the mass vaccination campaign. Now, based on almost one year of mass vaccinations and data collection, evidence suggests the vaccines are effective (at least one dose) in preventing infections, hospitalizations, and deaths and in reducing the average hospital stay. On the other hand, unvaccinated individuals are significantly more likely to become infected, need hospitalization and die of COVID-19.

In conclusion, scientific community shares an important social responsibility by analyzing data and communicating the evidence in order to sustain equity in the vaccination campaign.

To achieve a more extensive understanding of recent scientific knowledge and current trends in the SARS-CoV-2 vaccines, this Special Issue is focused on the recent scientific, strategies and results in real life. Based on your extensive knowledge and experience, we invite you to contribute with an original report, original observation or review, to highlight:

  1. strategies of vaccination;
  2. safety, immunogenicity and efficacy of SARS-CoV-2 vaccines;
  3. effectiveness in real-world;
  4. advances in vaccines development.

Prof. Dr. Vincenzo Baldo
Guest Editor

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Keywords

  • COVID-19
  • SARS-CoV-2
  • COVID-19 vaccines
  • vaccine effectiveness
  • immunogenicity
  • safety

Published Papers (10 papers)

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17 pages, 3069 KiB  
Article
Dynamic Profiling and Prediction of Antibody Response to SARS-CoV-2 Booster-Inactivated Vaccines by Microsample-Driven Biosensor and Machine Learning
by Sumin Bian, Min Shang, Ying Tao, Pengbo Wang, Yankun Xu, Yao Wang, Zhida Shen and Mahamad Sawan
Vaccines 2024, 12(4), 352; https://doi.org/10.3390/vaccines12040352 - 25 Mar 2024
Cited by 1 | Viewed by 1032
Abstract
Knowledge of the antibody response to the third dose of inactivated SARS-CoV-2 vaccines is crucial because it is the subject of one of the largest global vaccination programs. This study integrated microsampling with optical biosensors to profile neutralizing antibodies (NAbs) in fifteen vaccinated [...] Read more.
Knowledge of the antibody response to the third dose of inactivated SARS-CoV-2 vaccines is crucial because it is the subject of one of the largest global vaccination programs. This study integrated microsampling with optical biosensors to profile neutralizing antibodies (NAbs) in fifteen vaccinated healthy donors, followed by the application of machine learning to predict antibody response at given timepoints. Over a nine-month duration, microsampling and venipuncture were conducted at seven individual timepoints. A refined iteration of a fiber optic biolayer interferometry (FO-BLI) biosensor was designed, enabling rapid multiplexed biosensing of the NAbs of both wild-type and Omicron SARS-CoV-2 variants in minutes. Findings revealed a strong correlation (Pearson r of 0.919, specificity of 100%) between wild-type variant NAb levels in microsamples and sera. Following the third dose, sera NAb levels of the wild-type variant increased 2.9-fold after seven days and 3.3-fold within a month, subsequently waning and becoming undetectable after three months. Considerable but incomplete evasion of the latest Omicron subvariants from booster vaccine-elicited NAbs was confirmed, although a higher number of binding antibodies (BAbs) was identified by another rapid FO-BLI biosensor in minutes. Significantly, FO-BLI highly correlated with a pseudovirus neutralization assay in identifying neutralizing capacities (Pearson r of 0.983). Additionally, machine learning demonstrated exceptional accuracy in predicting antibody levels, with an error level of <5% for both NAbs and BAbs across multiple timepoints. Microsample-driven biosensing enables individuals to access their results within hours of self-collection, while precise models could guide personalized vaccination strategies. The technology’s innate adaptability means it has the potential for effective translation in disease prevention and vaccine development. Full article
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14 pages, 1995 KiB  
Article
Comparative Safety and Effectiveness of Heterologous CoronaVac–ChAdOx1 versus Homologous CoronaVac Vaccination in a Real-World Setting: A Retrospective Cohort Study
by Ayakarn Ruenkham, Suriyon Uitrakul, Peninnah Oberdorfer, Siriporn Okonogi and Wasan Katip
Vaccines 2023, 11(9), 1458; https://doi.org/10.3390/vaccines11091458 - 5 Sep 2023
Cited by 3 | Viewed by 1478
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
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20 pages, 667 KiB  
Article
Association between the COVID-19 Vaccine and Preventive Behaviors: Panel Data Analysis from Japan
by Eiji Yamamura, Youki Kohsaka, Yoshiro Tsutsui and Fumio Ohtake
Vaccines 2023, 11(4), 810; https://doi.org/10.3390/vaccines11040810 - 6 Apr 2023
Cited by 1 | Viewed by 1427
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
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10 pages, 945 KiB  
Article
Is SARS-CoV-2 Vaccination of Subjects with a Prior History of Allergies Dangerous? Experiences in the Veneto Region of Italy
by Silvia Cocchio, Gloria Girolametto, Alice Pierobon, Patrizia Furlan, Emanuela Destefani, Lorenzo Bulegato, Antonio Stano, Silvia Fietta, Annachiara Poletto and Vincenzo Baldo
Vaccines 2023, 11(3), 574; https://doi.org/10.3390/vaccines11030574 - 2 Mar 2023
Cited by 1 | Viewed by 1141
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
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12 pages, 3112 KiB  
Article
Estimation of mRNA COVID-19 Vaccination Effectiveness in Tokyo for Omicron Variants BA.2 and BA.5: Effect of Social Behavior
by Sachiko Kodera, Yuki Niimi, Essam A. Rashed, Naoki Yoshinaga, Masashi Toyoda and Akimasa Hirata
Vaccines 2022, 10(11), 1820; https://doi.org/10.3390/vaccines10111820 - 28 Oct 2022
Cited by 3 | Viewed by 1436
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
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8 pages, 954 KiB  
Article
Third BNT162b2 Vaccine Booster Dose against SARS-CoV-2-Induced Antibody Response among Healthcare Workers
by Khetam Hussein, Halima Dabaja-Younis, Moran Szwarcwort-Cohen, Ronit Almog, Ronit Leiba, Avi Weissman, Michal Mekel, Gila Hyams, Nethanel A. Horowitz, Vardit Gepstein, Hagar Cohen Saban, Jalal Tarabeia, Michael Halberthal and Yael Shachor-Meyouhas
Vaccines 2022, 10(10), 1741; https://doi.org/10.3390/vaccines10101741 - 18 Oct 2022
Cited by 5 | Viewed by 1640
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
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11 pages, 673 KiB  
Article
Vaccination Status and Number of Vaccine Doses Are Independently Associated with the PaO2/FiO2 Ratio on Admission in Hospitalized COVID-19 Patients
by Elisabetta Zinellu, Angelo Zinellu, Michela Merella, Arduino A. Mangoni, Maria Carmina Pau, Sara S. Fois, Alessandro G. Fois, Ciriaco Carru and Pietro Pirina
Vaccines 2022, 10(9), 1424; https://doi.org/10.3390/vaccines10091424 - 29 Aug 2022
Cited by 4 | Viewed by 1367
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
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15 pages, 1694 KiB  
Article
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
by Silvia Cocchio, Federico Zabeo, Giacomo Facchin, Nicolò Piva, Patrizia Furlan, Michele Nicoletti, Mario Saia, Michele Tonon, Michele Mongillo, Francesca Russo and Vincenzo Baldo
Vaccines 2022, 10(1), 107; https://doi.org/10.3390/vaccines10010107 - 11 Jan 2022
Cited by 10 | Viewed by 3275
Abstract
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
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38 pages, 4235 KiB  
Systematic Review
The Occurrence of Acute Disseminated Encephalomyelitis in SARS-CoV-2 Infection/Vaccination: Our Experience and a Systematic Review of the Literature
by Adina Stoian, Zoltan Bajko, Mircea Stoian, Roxana Adriana Cioflinc, Raluca Niculescu, Emil Marian Arbănași, Eliza Russu, Marian Botoncea and Rodica Bălașa
Vaccines 2023, 11(7), 1225; https://doi.org/10.3390/vaccines11071225 - 10 Jul 2023
Cited by 9 | Viewed by 4241
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
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9 pages, 886 KiB  
Brief 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
by Luigi Cari, Mahdieh Naghavi Alhosseini, Antonella Mencacci, Graziella Migliorati and Giuseppe Nocentini
Vaccines 2023, 11(4), 879; https://doi.org/10.3390/vaccines11040879 - 21 Apr 2023
Cited by 5 | Viewed by 6166
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
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