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Open AccessArticle

Genomic Transcriptome Benefits and Potential Harms of COVID-19 Vaccines Indicated from Optimized Genomic Biomarkers

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Zhengjun Zhang

Vaccines 2022, 10(11), 1774; https://doi.org/10.3390/vaccines10111774 - 22 Oct 2022

Viewed by 833

Abstract

COVID-19 vaccines can be the tugboats for preventing SARS-CoV-2 infections when they are practical and, more importantly, without adverse effects. However, the reality is that they may result in short-term or long-term impacts on COVID-19-related diseases and even trigger the formation of new [...] Read more.

COVID-19 vaccines can be the tugboats for preventing SARS-CoV-2 infections when they are practical and, more importantly, without adverse effects. However, the reality is that they may result in short-term or long-term impacts on COVID-19-related diseases and even trigger the formation of new variants of SARS-CoV-2. Using published data, we use a set of optimized-performance COVID-19 genomic biomarkers (MND1, CDC6, ZNF282) to study the benefits and adverse effects of the BNT162b2 vaccine. We found that the vaccine lowered the expression values of genes MND1 and CDC6 while heightening the expression values of ZNF282 in individuals who are SARS-CoV-2 naïve, which is expected and satisfies the biological equivalence between the COVID-19 disease and the genomic signature patterns established in the literature. However, we also found that COVID-19-convalescent octogenarians responded reversely. The vaccine heightened the expression values of MND1 and CDC6. In addition, it lowered the expression values of ZNF282. Such adverse effects raise outstanding concerns about whether or not COVID-19-convalescent individuals should take the current vaccine or when they can take it. These findings are new at the genomic level and can provide insights into developing next-generation vaccines, antiviral drugs, and pandemic management guidance. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Prevalence and Assessment of Factors Associated with COVID-19 Vaccine Hesitancy in an Ethnic Minority Oncology Patient Population

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Vaccines 2022, 10(10), 1711; https://doi.org/10.3390/vaccines10101711 - 14 Oct 2022

Viewed by 730

Abstract

Background: Complicating the COVID-19 pandemic are the healthcare disparities experienced by ethnic minorities, especially those with comorbidities including cancer. The introduction of COVID-19 vaccines has been instrumental in blunting the morbidity and mortality from the pandemic; however, vaccine hesitancy, particularly among ethnic minorities, [...] Read more.

Background: Complicating the COVID-19 pandemic are the healthcare disparities experienced by ethnic minorities, especially those with comorbidities including cancer. The introduction of COVID-19 vaccines has been instrumental in blunting the morbidity and mortality from the pandemic; however, vaccine hesitancy, particularly among ethnic minorities, has been a major concern. Thus, we sought to evaluate the knowledge and perspectives of COVID-19 and vaccines among our ethnic minority cancer patient population. Methods: Following an IRB approved protocol, questionnaires were completed by patients in a predominantly ethnic minority population at a single institution between 1 February and 30 June 2021. Included were any adult cancer patients with either a solid or hematologic malignancy. Results: Among the 84 patients that were offered the questionnaires, 52 patients responded, with a median age of 63.5 years. Overall, 36% were non-Hispanic Blacks and 30% were Hispanics; 65% were receiving active treatment for their cancer. Seventy-nine percent believed COVID-19 to be dangerous or harmful to them, 61% were concerned about the side effects, yet 65% considered COVID-19 vaccines as safe. Among the seven patients that refused the vaccine, (71%, n = 5) cited side effects and/or (57%, n = 4) believed that the vaccine was not needed. Overall, there was a significantly higher chance of being vaccinated if patients were receiving active cancer treatment, believed COVID-19 was harmful, or that the vaccine was safe, and knew COVID-19 was a virus. Conclusions: This exploratory study demonstrates that most ethnic minority cancer patients are receptive to vaccines, with a majority being vaccinated. However, we also discovered various reasons why this group of patients may not want be vaccinated, including concerns about side effects and perception that COVID-19 is not harmful. These findings can help us further understand the complex nature of vaccine hesitancy in ethnic minority cancer patients, and aid in developing future vaccine awareness strategies as the COVID-19 pandemic continues to evolve. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Genomic Biomarker Heterogeneities between SARS-CoV-2 and COVID-19

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Zhengjun Zhang

Vaccines 2022, 10(10), 1657; https://doi.org/10.3390/vaccines10101657 - 02 Oct 2022

Cited by 2 | Viewed by 885

Abstract

Genes functionally associated with SARS-CoV-2 infection and genes functionally related to the COVID-19 disease can be different, whose distinction will become the first essential step for successfully fighting against the COVID-19 pandemic. Unfortunately, this first step has not been completed in all biological [...] Read more.

Genes functionally associated with SARS-CoV-2 infection and genes functionally related to the COVID-19 disease can be different, whose distinction will become the first essential step for successfully fighting against the COVID-19 pandemic. Unfortunately, this first step has not been completed in all biological and medical research. Using a newly developed max-competing logistic classifier, two genes, ATP6V1B2 and IFI27, stand out to be critical in the transcriptional response to SARS-CoV-2 infection with differential expressions derived from NP/OP swab PCR. This finding is evidenced by combining these two genes with another gene in predicting disease status to achieve better-indicating accuracy than existing classifiers with the same number of genes. In addition, combining these two genes with three other genes to form a five-gene classifier outperforms existing classifiers with ten or more genes. These two genes can be critical in fighting against the COVID-19 pandemic as a new focus and direction with their exceptional predicting accuracy. Comparing the functional effects of these genes with a five-gene classifier with 100% accuracy identified and tested from blood samples in our earlier work, the genes and their transcriptional response and functional effects on SARS-CoV-2 infection, and the genes and their functional signature patterns on COVID-19 antibodies, are significantly different. We will use a total of fourteen cohort studies (including breakthrough infections and omicron variants) with 1481 samples to justify our results. Such significant findings can help explore the causal and pathological links between SARS-CoV-2 infection and the COVID-19 disease, and fight against the disease with more targeted genes, vaccines, antiviral drugs, and therapies. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Effects of Prior Infection with SARS-CoV-2 on B Cell Receptor Repertoire Response during Vaccination

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Vaccines 2022, 10(9), 1477; https://doi.org/10.3390/vaccines10091477 - 06 Sep 2022

Cited by 1 | Viewed by 1019

Abstract

Understanding the B cell response to SARS-CoV-2 vaccines is a high priority. High-throughput sequencing of the B cell receptor (BCR) repertoire allows for dynamic characterization of B cell response. Here, we sequenced the BCR repertoire of individuals vaccinated by the Pfizer SARS-CoV-2 mRNA [...] Read more.

Understanding the B cell response to SARS-CoV-2 vaccines is a high priority. High-throughput sequencing of the B cell receptor (BCR) repertoire allows for dynamic characterization of B cell response. Here, we sequenced the BCR repertoire of individuals vaccinated by the Pfizer SARS-CoV-2 mRNA vaccine. We compared BCR repertoires of individuals with previous COVID-19 infection (seropositive) to individuals without previous infection (seronegative). We discovered that vaccine-induced expanded IgG clonotypes had shorter heavy-chain complementarity determining region 3 (HCDR3), and for seropositive individuals, these expanded clonotypes had higher somatic hypermutation (SHM) than seronegative individuals. We uncovered shared clonotypes present in multiple individuals, including 28 clonotypes present across all individuals. These 28 shared clonotypes had higher SHM and shorter HCDR3 lengths compared to the rest of the BCR repertoire. Shared clonotypes were present across both serotypes, indicating convergent evolution due to SARS-CoV-2 vaccination independent of prior viral exposure. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Acceptance of Booster COVID-19 Vaccine and Its Association with Components of Vaccination Readiness in the General Population: A Cross-Sectional Survey for Starting Booster Dose in Japan

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Mikiko Tokiya

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Megumi Hara

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Akiko Matsumoto

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Mohammad Said Ashenagar

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Takashi Nakano

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Yoshio Hirota

Vaccines 2022, 10(7), 1102; https://doi.org/10.3390/vaccines10071102 - 08 Jul 2022

Cited by 5 | Viewed by 1728

Abstract

The Japanese government approved COVID-19 vaccine booster doses in November 2021. However, intentions and readiness for booster vaccines among the general population were unknown. This survey measured the intentions for COVID-19 booster vaccination. Among 6172 participants (53.2% female), 4832 (78.3%) accepted booster doses; [...] Read more.

The Japanese government approved COVID-19 vaccine booster doses in November 2021. However, intentions and readiness for booster vaccines among the general population were unknown. This survey measured the intentions for COVID-19 booster vaccination. Among 6172 participants (53.2% female), 4832 (78.3%) accepted booster doses; 415 (6.7%) hesitated. Vaccination intention was associated with higher age, marital status, having children, underlying diseases, and social norms. To evaluate the readiness for vaccination, the seven component (7C) vaccination readiness scale was employed, comprising “Confidence”, “Complacency”, “Constraints”, “Calculation”, “Collective responsibility”, “Compliance”, and “Conspiracy”. Participants with acceptance showed significantly higher 7C scores (p < 0.001) than those who hesitated or were unsure. Multivariable logistic regression analysis revealed that the “social norms” predictor was the strongest predictor of acceptance (adjusted odds ratio (AOR) 4.02, 95% confidence interval (CI): 3.64–4.45). “Constraints” (AOR: 2.27, 95% CI: 2.11–2.45) and “complacency” (AOR: 2.18, 95% CI: 2.03–2.34) were also strongly associated with acceptance, but “compliance” (AOR: 1.24, 95% CI: 1.18–1.31) and “conspiracy” (AOR: 1.42, 95% CI: 1.33–1.52) were weakly associated. The “7C vaccination readiness scale” is useful for measuring vaccine acceptance in the Japanese population. However, “social norms” might be more suitable than “compliance” and “conspiracy” for measuring vaccine acceptance in Japan. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Reactogenicity of mRNA- and Non-mRNA-Based COVID-19 Vaccines among Lactating Mother and Child Dyads

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Beth Jacob-Chow

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Kandarpa Lakshmi Vasundhara

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Vaccines 2022, 10(7), 1094; https://doi.org/10.3390/vaccines10071094 - 08 Jul 2022

Cited by 1 | Viewed by 939

Abstract

The aims of the study are to: (a) Describe the reactogenicity of WHO-approved two mRNA (Pfizer-BioNTech, Moderna) and two non-RNA (Oxford-AstraZeneca, Sinovac) vaccines among lactating mother and child pairs, and (b) Compare and contrast the reactogenicity between mRNA and non-mRNA vaccines. A cross-sectional, [...] Read more.

The aims of the study are to: (a) Describe the reactogenicity of WHO-approved two mRNA (Pfizer-BioNTech, Moderna) and two non-RNA (Oxford-AstraZeneca, Sinovac) vaccines among lactating mother and child pairs, and (b) Compare and contrast the reactogenicity between mRNA and non-mRNA vaccines. A cross-sectional, self-reported survey was conducted amongst 1784 lactating women who received COVID-19 vaccinations. The most common maternal adverse reaction was a local reaction at the injection site, and the largest minority of respondents, 49.6% (780/1571), reported experiencing worse symptoms when receiving the second dose compared to the first dose. Respondents reported no major adverse effects or behavioural changes in the breastfed children for the duration of the study period. Among respondents who received non-mRNA COVID-19 vaccines, a majority reported no change in lactation, but those who did more commonly reported changes in the quantity of milk supply and pain in the breast. The more commonly reported lactation changes (fluctuations in breast milk supply quantity and pain in the breast) for the non-mRNA vaccines were similar to those of respondents who received mRNA vaccines. Our study, with a large, racially diverse cohort, further augments earlier reported findings in that the COVID-19 vaccines tested in this study did not cause any serious adverse events in our population for the duration of our survey period, although long-term effects are yet to be studied. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessArticle

Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study

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Martina Capponi

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Federica Pulvirenti

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Bianca Laura Cinicola

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Cristiana Alessia Guido

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Vaccines 2022, 10(7), 1056; https://doi.org/10.3390/vaccines10071056 - 30 Jun 2022

Cited by 10 | Viewed by 1451

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Vaccination against COVID-19 is the most effective tool to protect both the individual and the community from this potentially life-threatening infectious disease. Data from phase-3 trials showed that two doses of the BNT162b2 vaccine were safe, immunogenic, and effective against COVID-19 in children [...] Read more.

Vaccination against COVID-19 is the most effective tool to protect both the individual and the community from this potentially life-threatening infectious disease. Data from phase-3 trials showed that two doses of the BNT162b2 vaccine were safe, immunogenic, and effective against COVID-19 in children aged 5–11 years. However, no surveys in real-life settings have been carried out in this age range. Here, we conducted a cross-sectional study to evaluate the short-term adverse reactions (ARs) and the rate of protection against infection of the BNT162b2 vaccine in children aged 5–11 years by the compilation of two surveillance questionnaires conceived using Google Forms. Five-hundred and ninety one children were included in the analysis. ARs were reported by 68.9% of the children, being mainly local. The incidence of systemic ARs, especially fever, was higher after the second dose. The incidence of infection after completing the immunization accounted for 13.6% of the children. COVID-19 symptoms reported were mild, with the exception of one case of pneumonia. Only 40% of infected participants needed to take medication to relieve symptoms, mostly paracetamol and NSAIDs, and none reported persistent symptoms. The Pfizer–BioNTech vaccine in children aged 5–11 years is safe and well tolerated. The mild clinical course of COVID-19 in immunized children confirmed the favorable risk–benefit ratio, encouraging parents to immunize their children. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Anti-SARS-CoV-2S Antibody Levels in Healthcare Workers 10 Months after the Administration of Two BNT162b2 Vaccine Doses in View of Demographic Characteristic and Previous COVID-19 Infection

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Blanka Wolszczak-Biedrzycka

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Anna Bieńkowska

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Joanna Ewa Zaborowska

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Elwira Smolińska-Fijołek

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Grzegorz Biedrzycki

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Justyna Dorf

Vaccines 2022, 10(5), 741; https://doi.org/10.3390/vaccines10050741 - 09 May 2022

Cited by 3 | Viewed by 914

Abstract

Antibody levels that confer full protection against SARS-CoV-2 infection after the administration of different vaccine brands as well as the factors influencing the humoral immune response have been analyzed extensively ever since the vaccination program was launched in late 2020. The aim of [...] Read more.

Antibody levels that confer full protection against SARS-CoV-2 infection after the administration of different vaccine brands as well as the factors influencing the humoral immune response have been analyzed extensively ever since the vaccination program was launched in late 2020. The aim of this study was to determine anti-SARS-CoV-2S antibody titers in 100 healthcare workers 10 months after the administration of two BNT162b2 vaccine doses, and to investigate the influence of demographic characteristics, the presence of comorbidities and history of COVID-19 infection. The results were compared with antibody levels that were determined eight months after the administration of two BNT162b2 vaccine doses in our previous study. Antibody levels in venous blood serum were measured by the ECLIA method with the use of the Roche Cobas e411 analyzer. In all tested subjects, antibody titers remained high 10 months after vaccination, particularly in recovered COVID-19 patients, and only a minor decrease was observed relative to the values noted two months earlier. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Development and Testing of a Low-Cost Inactivation Buffer That Allows for Direct SARS-CoV-2 Detection in Saliva

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Brandon Bustos-Garcia

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Sylvia Garza-Manero

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Nallely Cano-Dominguez

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Dulce Maria Lopez-Sanchez

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Gonzalo Salgado-Montes de Oca

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Alfonso Salgado-Aguayo

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Felix Recillas-Targa

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Santiago Avila-Rios

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Victor Julian Valdes

Vaccines 2022, 10(5), 730; https://doi.org/10.3390/vaccines10050730 - 06 May 2022

Cited by 1 | Viewed by 1224

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Massive testing is a cornerstone in efforts to effectively track infections and stop COVID-19 transmission, including places with good vaccination coverage. However, SARS-CoV-2 testing by RT-qPCR requires specialized personnel, protection equipment, commercial kits, and dedicated facilities, which represent significant challenges for massive testing [...] Read more.

Massive testing is a cornerstone in efforts to effectively track infections and stop COVID-19 transmission, including places with good vaccination coverage. However, SARS-CoV-2 testing by RT-qPCR requires specialized personnel, protection equipment, commercial kits, and dedicated facilities, which represent significant challenges for massive testing in resource-limited settings. It is therefore important to develop testing protocols that are inexpensive, fast, and sufficiently sensitive. Here, we optimized the composition of a buffer (PKTP), containing a protease, a detergent, and an RNase inhibitor, which is compatible with the RT-qPCR chemistry, allowing for direct SARS-CoV-2 detection from saliva without extracting RNA. PKTP is compatible with heat inactivation, reducing the biohazard risk of handling samples. We assessed the PKTP buffer performance in comparison to the RNA-extraction-based protocol of the US Centers for Disease Control and Prevention in saliva samples from 70 COVID-19 patients finding a good sensitivity (85.7% for the N1 and 87.1% for the N2 target) and correlations (R = 0.77, p < 0.001 for N1, and R = 0.78, p < 0.001 for N2). We also propose an auto-collection protocol for saliva samples and a multiplex reaction to minimize the PCR reaction number per patient and further reduce costs and processing time of several samples, while maintaining diagnostic standards in favor of massive testing. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Vaccination Is Reasonably Effective in Limiting the Spread of COVID-19 Infections, Hospitalizations and Deaths with COVID-19

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Jože P. Damijan

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Sandra Damijan

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Črt Kostevc

Vaccines 2022, 10(5), 678; https://doi.org/10.3390/vaccines10050678 - 24 Apr 2022

Cited by 3 | Viewed by 1907

Abstract

This paper uses large cross-country data for 110 countries to examine the effectiveness of COVID vaccination coverage during the delta variant outbreak. Our results confirm that vaccines are reasonably effective in both limiting the spread of infections and containing more severe disease progression [...] Read more.

This paper uses large cross-country data for 110 countries to examine the effectiveness of COVID vaccination coverage during the delta variant outbreak. Our results confirm that vaccines are reasonably effective in both limiting the spread of infections and containing more severe disease progression in symptomatic patients. First, the results show that full vaccination rate is consistently negatively correlated with the number of new COVID cases, whereby a 10 percent increase in vaccination rate is associated with a 1.3 to 1.7 percent decrease in new COVID cases. Second, the magnitude of vaccination is shown to contribute significantly to moderating severe disease progression. On average, a 10 percent increase in the rate of vaccination leads to a reduction of about 5 percent in the number of new hospitalizations, 12 percent decrease in the number of new intensive care patients and 2 percent reduction in the number of new deaths. Finally, by comparing the data for the same period between 2020 and 2021, we also check how well vaccination performs as a substitute for lockdowns or other stringent government protection measures. Results suggest that vaccination appears to be an effective substitute for more stringent government safety measures to contain the spread of COVID infections only at a sufficiently high vaccination coverage threshold (more than 70 percent). On the other hand, vaccination is shown to be quite effective in limiting the more severe course of the disease in symptomatic patients already at moderate vaccination coverage (between 40 and 70 percent). This suggests that vaccination can also help to reduce pressure on the health system and thus benefit the overall public health of society. On the other hand, the efficient rollout of vaccines could explain the favourable economic performance in the second half of 2021 despite the severe outbreak of the delta variant. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

A Rapid and Consistent Method to Identify Four SARS-CoV-2 Variants during the First Half of 2021 by RT-PCR

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Vaccines 2022, 10(3), 483; https://doi.org/10.3390/vaccines10030483 - 21 Mar 2022

Cited by 2 | Viewed by 1320

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Since 2020, the COVID-19 pandemic has spread worldwide, causing health, economic, and social distress. Containment strategies rely on rapid and consistent methodology for molecular detection and characterization. Emerging variants of concern (VOCs) are currently associated with increased infectivity and immune escape (natural defence [...] Read more.

Since 2020, the COVID-19 pandemic has spread worldwide, causing health, economic, and social distress. Containment strategies rely on rapid and consistent methodology for molecular detection and characterization. Emerging variants of concern (VOCs) are currently associated with increased infectivity and immune escape (natural defence mechanisms and vaccine). Several VOCs have been detected, including Alpha variant (B.1.1.7), Beta variant (B.1.351), Gamma variant (P.1/B.1.1.28.1) and Delta variant (B.1.617.2), first identified in the UK, South Africa, Brazil and India, respectively. Here, a rapid and low-cost technique was validated to distinguish the Alpha, Beta, Gamma, and Delta SARS-CoV-2 variants by detecting spike gene mutations using a real-time reverse transcription polymerase chain reaction methodology (RT-PCR). A total of 132 positive patients affected by coronavirus disease-19 (COVID-19) were analysed by employing RT-PCR to target single-nucleotide polymorphisms (SNPs) to screen spike protein mutations. All data were validated by the next-generation sequencing (NGS) methodology and using sequences from a public database. Among 132 COVID-19-positive samples, we were able to discriminate all of the investigated SARS-CoV-2 variants with 100% concordance when compared with the NGS method. RT-PCR -based assays for identifying circulating VOCs of SARS-CoV-2 resulted in a rapid method used to identify specific SARS-CoV-2 variants, allowing for a better survey of the spread of the virus and its transmissibility in the pandemic phase. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Evaluating COVID-19 Booster Vaccination Strategies in a Partially Vaccinated Population: A Modeling Study

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Clément R. Massonnaud

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Jonathan Roux

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Vittoria Colizza

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Pascal Crépey

Vaccines 2022, 10(3), 479; https://doi.org/10.3390/vaccines10030479 - 19 Mar 2022

Cited by 2 | Viewed by 1664

Abstract

Background: Several countries are implementing COVID-19 booster vaccination campaigns. The objective of this study was to model the impact of different primary and booster vaccination strategies. Methods: We used a compartmental model fitted to hospital admission data in France to analyze the impact [...] Read more.

Background: Several countries are implementing COVID-19 booster vaccination campaigns. The objective of this study was to model the impact of different primary and booster vaccination strategies. Methods: We used a compartmental model fitted to hospital admission data in France to analyze the impact of primary and booster vaccination strategies on morbidity and mortality, assuming waning of immunity and various levels of virus transmissibility during winter. Results: Strategies prioritizing primary vaccinations were systematically more effective than strategies prioritizing boosters. Regarding booster strategies targeting different age groups, their effectiveness varied with immunity and virus transmissibility levels. If the waning of immunity affects all adults, people aged 30 to 49 years should be boosted in priority, even for low transmissibility levels. Conclusions: Increasing the primary vaccination coverage should remain a priority. If a plateau has been reached, boosting the immunity of younger adults could be the most effective strategy, especially if SARS-CoV-2 transmissibility is high. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Durability of Humoral Responses after the Second Dose of mRNA BNT162b2 Vaccine in Residents of a Long Term Care Facility

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Vaccines 2022, 10(3), 446; https://doi.org/10.3390/vaccines10030446 - 14 Mar 2022

Cited by 4 | Viewed by 1226

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Residents of long-term care facilities (LTCFs) have been dramatically hit by the COVID-19 pandemic on a global scale as older age and comorbidities pose an increased risk of severe disease and death. The aim of the study was to assess the quantity and [...] Read more.

Residents of long-term care facilities (LTCFs) have been dramatically hit by the COVID-19 pandemic on a global scale as older age and comorbidities pose an increased risk of severe disease and death. The aim of the study was to assess the quantity and durability of specific antibody responses to SARS-CoV-2 after the first cycle (two doses) of BNT162b2 vaccine. To achieve this, SARS-CoV-2 Spike-specific IgG (S-IgG) titers was evaluated in 432 residents of the largest Italian LTCF at months 2 and 6 after vaccination. By stratifying levels of humoral responses as high, medium, low and null, we did not find any difference when comparing the two time points; however, the median levels of antibodies halved overtime. As positive nucleocapsid serology was associated with a reduced risk of a suboptimal response at both time points, we conducted separate analyses accordingly. In subjects with positive serology, the median level of anti-S IgG slightly increased at the second time point, while a significant reduction was observed in patients without previous exposure to the virus. At month 6, diabetes alone was associated with an increased risk of impaired response. Our data provide additional insights into the longitudinal dynamics of the immune response to BNT162b2 vaccination in the elderly, highlighting the need for SARS-CoV-2 antibody monitoring following third-dose administration. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

The Influence of Time of Day of Vaccination with BNT162b2 on the Adverse Drug Reactions and Efficacy of Humoral Response against SARS-CoV-2 in an Observational Study of Young Adults

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Zbigniew Bartoszewicz

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Jacek Sienko

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Urszula Ambroziak

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Karolina Malesa-Tarasiuk

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Anna Staniszewska

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Jakub Golab

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Rafał Krenke

Vaccines 2022, 10(3), 443; https://doi.org/10.3390/vaccines10030443 - 14 Mar 2022

Cited by 3 | Viewed by 1577

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An increasing body of evidence from both academic and clinical studies shows that time-of-day exposure to antigens might significantly alter and modulate the development of adaptive immune responses. Considering the immense impact of the COVID-19 pandemic on global health and the diminished efficacy [...] Read more.

An increasing body of evidence from both academic and clinical studies shows that time-of-day exposure to antigens might significantly alter and modulate the development of adaptive immune responses. Considering the immense impact of the COVID-19 pandemic on global health and the diminished efficacy of vaccination in selected populations, such as older and immunocompromised patients, it is critical to search for the most optimal conditions for mounting immune responses against SARS-CoV-2. Hence, we conducted an observational study on 435 healthy young adults vaccinated with two doses of BNT162b2 (Pfizer-BioNTech) vaccine to determine whether time-of-day of vaccination influences either the magnitude of humoral response or number of adverse drug reactions (ADR) being reported. We found no significant differences between morning and afternoon vaccination in terms of both titers of anti-Spike antibodies and frequency of ADR in the studied population. In addition, our analysis of data on the occurrence of ADR in 1324 subjects demonstrated that the second administration of vaccine in those with previous SARS-CoV-2 infection was associated with lower incidence of ADR. In aggregate, vaccination against COVID-19 with two doses of BNT162b2 mRNA vaccine is presumed to generate an equally efficient anti-Spike humoral response. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Pre-Vaccination Stress, Post-Vaccination Adverse Reactions, and Attitudes towards Vaccination after Receiving the COVID-19 Vaccine among Health Care Workers

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Izabela Grzegorczyk-Karolak

Vaccines 2022, 10(3), 401; https://doi.org/10.3390/vaccines10030401 - 06 Mar 2022

Cited by 6 | Viewed by 1999

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The vaccines against COVID-19 are the best treatment for limiting the spread of the epidemic, and from an individual point of view, for avoiding getting sick. A cross-sectional retrospective survey was conducted from 15 May to 15 July 2021 among healthcare workers, including [...] Read more.

The vaccines against COVID-19 are the best treatment for limiting the spread of the epidemic, and from an individual point of view, for avoiding getting sick. A cross-sectional retrospective survey was conducted from 15 May to 15 July 2021 among healthcare workers, including doctors, nurses, midwives, and students at the Medical University of Lodz (nursing, midwifery and medical students) in Poland. Data were obtained from 1080 participants. The aim of the study was to evaluate vaccination coverage against COVID-19 among healthcare workers (HCWs) in Poland, and to analyze their attitude towards the available vaccines, stress before taking, and side effects after administrating them, and motivation towards continuing vaccination in the future (if necessary). The survey also estimated the frequency and quality of adverse post-vaccination reactions after two doses of BioNTech/Pfizer and two doses of AstraZeneca vaccines. The present study revealed that the vaccination ratio after 6 months from the start of vaccination against COVID-19 in Poland among HCWs was very high at 91.2%. However, doctors and medical students were more likely to be vaccinated than nurses and midwives, and nursing and midwifery students (94.8%, 98.3% vs. 78.9% and 86.3%, respectively). The main reasons that HCWs reported receiving a vaccination were to protect the health of themselves and their families, while the main reasons for avoiding a vaccination were fear of side effects, doubts about effectiveness, and an expedited clinical trial process of vaccines. Furthermore, more than two-thirds of those vaccinated reported side effects after receiving at least one dose of the vaccine. Most of the side effects were short-term symptoms with only slight and moderate intensification. The univariate and multivariate logistic regressions showed that the type of vaccine used had a significant impact on the occurrence of adverse post-vaccination effects and the severity and duration of vaccination symptoms. In addition, chronic disease and fear of vaccination also had some influence. Despite this, most participants (more often older than younger participants; p < 0.001) were in favor of compulsory vaccination against COVID-19 for HCWs. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessArticle

Humoral and Cellular Responses to COVID-19 Vaccines in SARS-CoV-2 Infection-Naïve and -Recovered Korean Individuals

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Vaccines 2022, 10(2), 332; https://doi.org/10.3390/vaccines10020332 - 18 Feb 2022

Cited by 4 | Viewed by 1887

Abstract

In the face of a global COVID-19 vaccine shortage, an efficient vaccination strategy is required. Therefore, the immunogenicity of single or double COVID-19 vaccination doses (ChAdOX1, BNT162b2, or mRNA-1273) of SARS-CoV-2-recovered individuals was compared to that of unvaccinated individuals with SARS-CoV-2 infection at [...] Read more.

In the face of a global COVID-19 vaccine shortage, an efficient vaccination strategy is required. Therefore, the immunogenicity of single or double COVID-19 vaccination doses (ChAdOX1, BNT162b2, or mRNA-1273) of SARS-CoV-2-recovered individuals was compared to that of unvaccinated individuals with SARS-CoV-2 infection at least one year post-convalescence. Moreover, the immunogenicity of SARS-CoV-2-naïve individuals vaccinated with a complete schedule of Ad26.CoV2.S, ChAdOX1, BNT162b2, mRNA-1273, or ChAdOX1/BNT162b2 vaccines was evaluated. Anti-SARS-CoV-2 S1 IgG antibody (S1-IgG), pseudotyped virus-neutralizing antibody titer (pVNT₅₀), and IFN-γ ELISpot counts were measured. Humoral immune responses were significantly higher in vaccinated than in unvaccinated recovered individuals, with a 43-fold increase in the mean pVNT₅₀ values. However, there was no significant difference in the pVNT₅₀ and IFN-γ ELISpot values between the single- and double-dose regimens. In SARS-CoV-2-naïve individuals, antibody responses varied according to the vaccine type: BNT162b2 and mRNA-1273 induced similar levels of S1-IgG to those observed in vaccinated, convalescent individuals; in contrast, pVNT₅₀ was much lower in SARS-CoV-2-naïve vaccinees than in vaccinated recovered individuals. Therefore, a single dose of ChAdOX1, BNT162b2, or mRNA-1273 vaccines would be a good alternative for recovered individuals instead of a double-dose regimen. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Human Milk Antibodies after BNT162b2 Vaccination Exhibit Reduced Binding against SARS-CoV-2 Variants of Concern

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Vaccines 2022, 10(2), 225; https://doi.org/10.3390/vaccines10020225 - 31 Jan 2022

Cited by 2 | Viewed by 2413

Abstract

SARS-CoV-2-specific antibody responses are engendered in human milk after BNT162b2 vaccination. However, the emergence of variants of concern (VOCs) raises concerns about the specificity of and potential cross-protection mediated by milk antibody responses, which are crucial for passive immunity transferred from breastfeeding mothers [...] Read more.

SARS-CoV-2-specific antibody responses are engendered in human milk after BNT162b2 vaccination. However, the emergence of variants of concern (VOCs) raises concerns about the specificity of and potential cross-protection mediated by milk antibody responses, which are crucial for passive immunity transferred from breastfeeding mothers to their infants. In this study, we collected milk samples at three different time points pre- and post-vaccination, and measured milk IgA antibody binding to the receptor binding domain (RBD) of the original Wuhan-Hu-1 strain, and the four VOCs, namely Alpha, Beta, Gamma and Delta. We report a significant level of anti-RBD IgA in milk collected at 4–6 weeks after the second dose of vaccination compared to pre-vaccination. We observed around a 30% reduction in binding to most VOCs, including the major circulating Delta variant, compared to the original Wuhan-Hu-1 strain. As COVID-19 vaccines may take some time to be approved for infants, these individuals remain at risk for severe disease and rely mainly on transferred passive immunity. Our findings support the current recommendations for vaccinating lactating women with the aim of transferring mucosal immunity to breastfeeding infants. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Side Effects and Efficacy of COVID-19 Vaccines among the Egyptian Population

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Mohamed E. A. Abdelrahim

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Ahmed M. Sayed

Vaccines 2022, 10(1), 109; https://doi.org/10.3390/vaccines10010109 - 12 Jan 2022

Cited by 17 | Viewed by 2958

Abstract

Background: Knowledge about a vaccine’s side effects and efficacy is important to improving public vaccine acceptance. This study aimed to detect the safety and efficacy of vaccines among the Egyptian population. Methodology and Results: Data was collected using an online survey from participants [...] Read more.

Background: Knowledge about a vaccine’s side effects and efficacy is important to improving public vaccine acceptance. This study aimed to detect the safety and efficacy of vaccines among the Egyptian population. Methodology and Results: Data was collected using an online survey from participants who took two doses of the BBIBP-CorV, ChAdOx1, or BNT162 vaccines. Pain at the vaccine injection site, muscle pain, fatigue, dizziness, fever, and headache were the most common side effects after the first and second doses. The number pf side effects was higher in ChAdOx1 than in BNT162 and BBIBP-CorV. Most of the side effects started on the first day after vaccination and persisted for 1–2 days. Vaccinated people with past coronavirus infections before vaccination developed better antibodies than those who were only vaccinated. The side-effect severity was greater after the first dose of BBIBP-CorV and ChAdOx1 than after the second dose, but in contrast, the side-effect severity was greater after the second dose of BNT162 vaccine than after the first dose. ChAdOx1 was more effective than BBIBP-CorV, and one dose of ChAdOx1 produced an immune response similar to that of two doses of BBIBP-CorV. Conclusions: Coronavirus vaccines were well-tolerated, safe, and produced an immune response against the virus in most cases. Most postvaccine side effects were mild to moderate, which indicated the building of immunity by the body for protection. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessArticle

Vaccine Breakthrough Infections by SARS-CoV-2 Variants after ChAdOx1 nCoV-19 Vaccination in Healthcare Workers

Vaccines 2022, 10(1), 54; https://doi.org/10.3390/vaccines10010054 - 31 Dec 2021

Cited by 3 | Viewed by 1544

Abstract

This study elucidated the clinical, humoral immune response and genomic analysis of vaccine breakthrough (VBT) infections after ChAdOx1 nCoV-19/Covishield vaccine in healthcare workers (HCWs). Amongst 1858 HCWs, 1639 had received either two doses (1346) or a single dose (293) of ChAdOx1 nCoV-19 vaccine. [...] Read more.

This study elucidated the clinical, humoral immune response and genomic analysis of vaccine breakthrough (VBT) infections after ChAdOx1 nCoV-19/Covishield vaccine in healthcare workers (HCWs). Amongst 1858 HCWs, 1639 had received either two doses (1346) or a single dose (293) of ChAdOx1 nCoV-19 vaccine. SARS-CoV-2 IgG antibodies and neutralizing antibodies were measured in the vaccinated group and the development of SARS-CoV-2 infection was monitored.Forty-six RT-PCR positive samples from the 203 positive samples were subjected to whole genome sequencing (WGS). Of the 203 (10.92%) infected HCWs, 21.46% (47/219) were non-vaccinated, which was significantly more than 9.52% (156/1639) who were vaccinated and infection was higher in doctors and nurses. Unvaccinated HCWs had 1.57 times higher risk compared to partially vaccinated HCWs and 2.49 times higher risk than those who were fully vaccinated.The partially vaccinated were at higher risk than the fully vaccinated (RR 1.58). Antibody non-response was seen in 3.44% (4/116), low antibody levels in 15.51% (18/116) and medium levels were found in 81.03% (94/116). Fully vaccinated HCWs had a higher antibody response at day 42 than those who were partially vaccinated (8.96 + 4.00 vs. 7.17 + 3.82). Whole genome sequencing of 46 samples revealed that the Delta variant (B.1.617.2) was predominant (69.5%). HCWs who had received two doses of vaccine showed better protection from mild, moderate, or severe infection, with a higher humoral immune response than those who had received a single dose. The genomic analysis revealed the predominance of the Delta variant (B.1.617.2) in the VBT infections. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

SARS-CoV-2 Post Vaccinated Adverse Effects and Efficacy in the Egyptian Population

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Marwa O. Elgendy

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Ahmed O. El-Gendy

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Abdulaziz Ibrahim Alzarea

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Mohamed E. A. Abdelrahim

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Abdullah S. Alanazi

Vaccines 2022, 10(1), 18; https://doi.org/10.3390/vaccines10010018 - 24 Dec 2021

Cited by 10 | Viewed by 2476

Abstract

Vaccines are the solution to overcome SARS-CoV-2. This study aimed to determine the post-Sinopharm vaccine safety-profile and immunity through antibody titers. Data were collected using a structured questionnaire from Egyptian participants who received two doses of Sinopharm vaccine. Data were divided into three [...] Read more.

Vaccines are the solution to overcome SARS-CoV-2. This study aimed to determine the post-Sinopharm vaccine safety-profile and immunity through antibody titers. Data were collected using a structured questionnaire from Egyptian participants who received two doses of Sinopharm vaccine. Data were divided into three parts, the first and second parts were to detect participants’ post-first and second dose symptoms and practices, and the third for the results of IgG anti spike protein antibodies test and laboratory tests. Pain, redness, swelling at the injection site, headache, fatigue, and lethargy were the most common post-vaccine symptoms for both first and second doses. Most of the participants felt mild or no symptoms after vaccination. The symptoms started mostly during the first day post-vaccination and lasted for no more than two days. Forty-nine percent of the participants resulted in positive antibodies tests on day 18 post-vaccination. The average antibody level for vaccinated participants with past SARS-CoV-2 infection was much higher than that for non-past infected participants. These vaccines’ administration methods need to be reevaluated by changing the dose, dose interval, adding a third dose, or mixing it with other vaccines with different techniques to improve their protection rates. Further studies are required to validate this finding. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessArticle

Evaluation of Antibody Response to Heterologous Prime–Boost Vaccination with ChAdOx1 nCoV-19 and BNT162b2: An Observational Study

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Vaccines 2021, 9(12), 1478; https://doi.org/10.3390/vaccines9121478 - 14 Dec 2021

Cited by 5 | Viewed by 2515

Abstract

In several countries, thrombotic events after vaccination with ChAdOx1 nCoV-19 have led to heterologous messenger RNA (mRNA) boosting. We tested the antibody response to SARS-CoV-2 spike protein four weeks after heterologous priming with the ChAdOx1 (ChAd) vector vaccine followed by boosting with BNT162b2(ChAd/BNT), [...] Read more.

In several countries, thrombotic events after vaccination with ChAdOx1 nCoV-19 have led to heterologous messenger RNA (mRNA) boosting. We tested the antibody response to SARS-CoV-2 spike protein four weeks after heterologous priming with the ChAdOx1 (ChAd) vector vaccine followed by boosting with BNT162b2(ChAd/BNT), comparing data of homologous regimen (BNT/BNT, ChAd/ChAd) subjects positive for SARS-CoV-2 after the first dose of BNT162b2 (BNT1dose/CoV2) and convalescent COVID-19. Methods: healthy subjects naïve for SARS-CoV-2 infection were assessed for serum IgG anti-S-RBD response 21 days after priming (T1), 4 (T_FULL) and 15 (T_15W) weeks after booster dose. Results: The median IgG anti-S-RBD levels at T_FULL of Chad/BNT group were significantly higher than the BNT/BNT group and ChAd/ChAd. Those of BNT/BNT group were significantly higher than ChAd/ChAd. IgG anti-S-RBD of BNT1dose/CoV2 group were similar to BNT/BNT, ChAd/BNT and ChAd/Chad group. The levels among COVID-19 convalescents were significantly lower than ChAd/BNT, BNT/BNT, ChAd/Chad and BNT1dose/CoV2. The proportion of subjects reaching an anti-S-RBD titer >75 AU/mL, correlated with high neutralizing titer, was 94% in ChAd/BNT and BNT/BNT, 60% in BNT1dose/CoV2, 25% in ChAd/ChAd and 4.2% in convalescents. At T_15W the titer of ChAd/BNT was still significantly higher than other vaccine schedules, while the anti-S-RBD decline was reduced for ChAd/ChAd and similar for other combinations. Conclusion: Our data highlight the magnitude of IgG anti-S-RBD response in ChAd/BNT dosing, supporting the current national guidelines for heterologous boosting Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Immunogenicity after Second ChAdOx1 nCoV-19 (AZD1222) Vaccination According to the Individual Reactogenicity, Health Status and Lifestyle

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Vaccines 2021, 9(12), 1473; https://doi.org/10.3390/vaccines9121473 - 13 Dec 2021

Cited by 2 | Viewed by 2249

Abstract

The immune-acquired responses after vaccination vary depending on the type of vaccine and the individual. The purpose of this study was to investigate the relationship between the acquisition of immunity and the side effects, health status, and lifestyle after completion of the second [...] Read more.

The immune-acquired responses after vaccination vary depending on the type of vaccine and the individual. The purpose of this study was to investigate the relationship between the acquisition of immunity and the side effects, health status, and lifestyle after completion of the second dose of AZD1222. Blood samples were collected after a second dose of AZD1222. The Euroimmun Anti-SARS-CoV-2 ELISA (IgG) for anti-S1 antibody, the cPASS SARS-CoV-2 neutralizing antibody detection kit for the surrogate virus neutralization test, and the T-spot Discovery SARS-CoV-2 kit were used to identify cellular immunogenicity. Patient experience of adverse effects was investigated using questionnaires. Information on health status and lifestyle were collected from the most recent health checkup data. Generally, females experience more reactogenicity in both intensity and duration. The rash of the first shot and chills of the second shot were associated with humoral immunity. However, comprehensive adverse effects had no correlation with humoral and cellular immunity. The T-spot-positive group had a higher creatinine level, which reflects muscle mass, than the T-spot-negative group. Males presented a higher level of T-spot assays. Body mass index and age were negatively correlated with the T-spot assay and anti-S1 antibody, respectively. Immune acquisition after the second AZD1222 shot was not associated with reactogenicity. However, individuals’ sex, age, and BMI were found to be associated with immunogenicity after vaccination. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Questionnaire Survey of Possible Association of Allergic Diseases with Adverse Reactions to SARS-CoV-2 Vaccination

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Vaccines 2021, 9(12), 1421; https://doi.org/10.3390/vaccines9121421 - 01 Dec 2021

Cited by 1 | Viewed by 1360

Abstract

To protect against COVID-19, SARS-CoV-2 vaccines have been widely used. Besides anaphylaxis, some less severe adverse effects may occur at higher frequencies. It remains unclear whether present or past histories of allergic diseases exert effects on local and systemic reactions. We conducted a [...] Read more.

To protect against COVID-19, SARS-CoV-2 vaccines have been widely used. Besides anaphylaxis, some less severe adverse effects may occur at higher frequencies. It remains unclear whether present or past histories of allergic diseases exert effects on local and systemic reactions. We conducted a questionnaire survey among workers in our hospital. We analyzed the adverse effects occurring after the first and second doses of the Pfizer–BioNTech vaccine in 955 subjects. The presence or absence of local injection reactions and systemic reactions (headache, fatigability, fever, muscle pain, and joint pain) was questioned. The intensities of these reactions were graded on a scale of 0–4 (except fever) or 0–2 (fever). The allergic diseases that we focused on were bronchial asthma, atopic dermatitis, food allergy, pollinosis, and hand eczema. For the systemic reactions, fatigability after the first dose tended to be more severe in the bronchial asthma than in the non-allergic group. Headache, joint pain, and fever tended to be more severe in the food allergy than in the non-allergic group after the second dose. For the local skin reactions, atopic dermatitis subjects tended to show rather less severe local skin reactions after the second dose. The results contribute to the guidelines for the care of individuals with different allergy histories, so that they may safely receive their vaccine. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

PICK-ing Malaysia’s Epidemic Apart: Effectiveness of a Diverse COVID-19 Vaccine Portfolio

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Maheshwara Rao Appannan

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Hishamshah Mohd Ibrahim

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Noor Hisham Abdullah

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Kalaiarasu M. Peariasamy

Vaccines 2021, 9(12), 1381; https://doi.org/10.3390/vaccines9121381 - 24 Nov 2021

Cited by 16 | Viewed by 6914

Abstract

Malaysia rolled out a diverse portfolio of predominantly three COVID-19 vaccines (AZD1222, BNT162b2, and CoronaVac) beginning 24 February 2021. We evaluated vaccine effectiveness with two methods, covering 1 April to 15 September 2021: (1) the screening method for COVID-19 (SARS-CoV-2) infection and symptomatic [...] Read more.

Malaysia rolled out a diverse portfolio of predominantly three COVID-19 vaccines (AZD1222, BNT162b2, and CoronaVac) beginning 24 February 2021. We evaluated vaccine effectiveness with two methods, covering 1 April to 15 September 2021: (1) the screening method for COVID-19 (SARS-CoV-2) infection and symptomatic COVID-19; and (2) a retrospective cohort of confirmed COVID-19 cases for COVID-19 related ICU admission and death using logistic regression. The screening method estimated partial vaccination to be 48.8% effective (95% CI: 46.8, 50.7) against COVID-19 infection and 33.5% effective (95% CI: 31.6, 35.5) against symptomatic COVID-19. Full vaccination is estimated at 87.8% effective (95% CI: 85.8, 89.7) against COVID-19 infection and 85.4% effective (95% CI: 83.4, 87.3) against symptomatic COVID-19. Among the cohort of confirmed COVID-19 cases, partial vaccination with any of the three vaccines is estimated at 31.3% effective (95% CI: 28.5, 34.1) in preventing ICU admission, and 45.1% effective (95% CI: 42.6, 47.5) in preventing death. Full vaccination with any of the three vaccines is estimated at 79.1% effective (95% CI: 77.7, 80.4) in preventing ICU admission and 86.7% effective (95% CI: 85.7, 87.6) in preventing deaths. Our findings suggest that full vaccination with any of the three predominant vaccines (AZD1222, BNT162b2, and CoronaVac) in Malaysia has been highly effective in preventing COVID-19 infection, symptomatic COVID-19, COVID-19-related ICU admission, and death. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Clinical Phenotype and Contagiousness of Early Breakthrough SARS-CoV-2 Infections after BNT162b2 COVID-19 mRNA Vaccine: A Parallel Cohort Study in Healthcare Workers

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Vaccines 2021, 9(12), 1377; https://doi.org/10.3390/vaccines9121377 - 23 Nov 2021

Cited by 4 | Viewed by 1490

Abstract

We evaluated the clinical protection of BNT162b2 mRNA vaccine in healthcare workers (HCWs) and how COVID-19 manifestations and contagiousness change as the time since first dose increases. A matched (1:2 ratio) parallel cohort study was performed. During the first three months of vaccination [...] Read more.

We evaluated the clinical protection of BNT162b2 mRNA vaccine in healthcare workers (HCWs) and how COVID-19 manifestations and contagiousness change as the time since first dose increases. A matched (1:2 ratio) parallel cohort study was performed. During the first three months of vaccination campaign, HCWs of the entire health district ASL Città di Torino (Turin, Italy) were classified according to SARS-CoV-2-positivity in respect of the vaccination schedule: post-first-dose (fHCWs, <12 days), partially (PHCWs, ≥12 from first dose to ≤7 days after the second), and totally vaccinated (THCWs, ≥8 days after the second dose). Age-/sex-matched unvaccinated controls were randomly selected from all the SARS-CoV-2-positivity detected in the same district and period. Previous infections were excluded. Clinical and virologic data (ORF1ab gene cycle threshold values, Ct) were recorded. In total, 6800 HCWs received at least one dose, and 55 tested positive subsequently: 20 fHCWs, 25 PHCWs, 10 THCWs. Furthermore, 21.8% of breakthrough infections were in male, with a median age of 49 years (32–56), and 51.4% occurred while SARS-CoV-2 B.1.1.7 variant was predominant. The incident relative risk was 0.13 (0.12–0.15) for PHCWs and 0.06 (0.05–0.07) for THCWs. Compared to controls (n = 110), no difference was observed in fHCWs, while PHCWs and THCWs showed higher prevalence of asymptomatic infections, fewer signs/symptoms with a milder systemic involvement, and significantly higher Ct values (PHCWs 30.3 (24.1–35.5) vs. 22.3 (19.6–30.6), p = 0.023; THCWs 35.0 (31.3–35.9) vs. 22.5 (18.2–30.6), p = 0.024). Duration of symptoms was also shorter in THCWs (5 days (3–6) vs. 9 (7–14), p = 0.028). A linear increase of 3.81 points in Ct values was observed across the groups by vaccination status (p = 0.001) after adjusting for age, sex, comorbidities, and time between COVID-19 onset and swab collection. BNT162b2 decreased the risk of PCR-confirmed infections and severe disease, and was associated with a virologic picture of lesser epidemiologic concern as soon as 12 days after the first vaccine dose. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Immunogenicity and Safety of an Intradermal BNT162b2 mRNA Vaccine Booster after Two Doses of Inactivated SARS-CoV-2 Vaccine in Healthy Population

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Porntip Intapiboon

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Purilap Seepathomnarong

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Jomkwan Ongarj

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Smonrapat Surasombatpattana

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Supattra Uppanisakorn

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Surakameth Mahasirimongkol

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Waritta Sawaengdee

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Supaporn Phumiamorn

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Sompong Sapsutthipas

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Pasuree Sangsupawanich

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Sarunyou Chusri

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Nawamin Pinpathomrat

Vaccines 2021, 9(12), 1375; https://doi.org/10.3390/vaccines9121375 - 23 Nov 2021

Cited by 19 | Viewed by 3937

Abstract

Effective vaccine coverage is urgently needed to tackle the COVID-19 pandemic. Inactivated vaccines have been introduced in many countries for emergency usage, but have only provided limited protection. Heterologous vaccination is a promising strategy to maximise vaccine immunogenicity. Here, we conducted a phase [...] Read more.

Effective vaccine coverage is urgently needed to tackle the COVID-19 pandemic. Inactivated vaccines have been introduced in many countries for emergency usage, but have only provided limited protection. Heterologous vaccination is a promising strategy to maximise vaccine immunogenicity. Here, we conducted a phase I, randomised control trial to observe the safety and immunogenicity after an intradermal boost, using a fractional dosage (1:5) of BNT162b2 mRNA vaccine in healthy participants in Songkhla, Thailand. In total, 91 volunteers who had been administered with two doses of inactivated SARS-CoV-2 (CoronaVac) were recruited into the study, and then randomised (1:1:1) to received different regimens of the third dose. An intramuscular booster with a full dose of BNT162b2 was included as a conventional control, and a half dose group was included as reciprocal comparator. Both, immediate and delayed adverse events following immunisation (AEFI) were monitored. Humoral and cellular immune responses were examined to observe the booster effects. The intradermal booster provided significantly fewer systemic side effects, from 70% down to 19.4% (p < 0.001); however, they were comparable to local reactions with the conventional intramuscular booster. In the intradermal group after receiving only one fifth of the conventional dosage, serum Anti-RBD IgG was halved compared to the full dose of an intramuscular injection. However, the neutralising function against the Delta strain remained intact. T cell responses were also less effective in the intradermal group compared to the intramuscular booster. Together, the intradermal booster, using a fractional dose of BNT162b2, can reduce systemic reactions and provides a good level and function of antibody responses compared to the conventional booster. This favourable intradermal boosting strategy provides a suitable alternative for vaccines and effective vaccine management to increase the coverage during the vaccine shortage. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database

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Vaccines 2021, 9(11), 1326; https://doi.org/10.3390/vaccines9111326 - 15 Nov 2021

Cited by 25 | Viewed by 4736

Abstract

Vaccination against COVID-19 is the cornerstone of controlling and mitigating the ongoing pandemic. Thrombotic adverse events linked to Moderna, Pfizer and the Oxford-AstraZeneca vaccine have been documented and described as extremely rare. While the Oxford-AstraZeneca vaccine has received much of the attention, the [...] Read more.

Vaccination against COVID-19 is the cornerstone of controlling and mitigating the ongoing pandemic. Thrombotic adverse events linked to Moderna, Pfizer and the Oxford-AstraZeneca vaccine have been documented and described as extremely rare. While the Oxford-AstraZeneca vaccine has received much of the attention, the other vaccines should not go unchallenged. This study aimed to determine the frequency of reported thrombotic adverse events and clinical outcomes for these three COVID-19 vaccines, namely, Moderna, Pfizer and Oxford-AstraZeneca. A retrospective descriptive analysis was conducted of spontaneous reports for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines submitted to the EudraVigilance database in the period from 17 February to 14 June 2021. There were 729,496 adverse events for the three vaccines, of which 3420 were thrombotic, mainly Oxford-AstraZeneca (n = 1988; 58.1%) followed by Pfizer (n = 1096; 32.0%) and Moderna (n = 336; 9.8%). As serious adverse events, there were 705 reports of pulmonary embolism for the three vaccines, of which 130 reports (18.4%) were for Moderna, 226 reports (32.1%) for Pfizer and 349 (49.5%) for Oxford-AstraZeneca vaccines. The occurrence of pulmonary embolism is significantly associated with a fatal outcome (p ≤ 0.001). Sixty-three fatalities were recorded (n = 63/3420; 1.8%), of which Moderna (n = 6), Pfizer (n = 25) and Oxford-AstraZeneca (n = 32). Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessArticle

Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA

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Vaccines 2021, 9(11), 1310; https://doi.org/10.3390/vaccines9111310 - 11 Nov 2021

Cited by 2 | Viewed by 1389

Abstract

Robust assay development for SARS-CoV-2 serological testing requires assessment of asymptomatic and non-hospitalised individuals to determine if assays are sensitive to mild antibody responses. Our study evaluated the performance characteristics of two high-throughput SARS-CoV-2 IgG nucleocapsid assays (Abbott Architect and Roche) and The [...] Read more.

Robust assay development for SARS-CoV-2 serological testing requires assessment of asymptomatic and non-hospitalised individuals to determine if assays are sensitive to mild antibody responses. Our study evaluated the performance characteristics of two high-throughput SARS-CoV-2 IgG nucleocapsid assays (Abbott Architect and Roche) and The Binding Site (TBS) Anti-Spike IgG/A/M ELISA kit in samples from healthcare workers (HCWs). The 252 samples were collected from multi-site NHS trusts and analysed for SARS-CoV-2 serology. Assay performance was evaluated between these three platforms and ROC curves were used to redefine the Abbott threshold. Concordance between Abbott and TBS was 66%. Any discrepant results were analysed using Roche, which showed 100% concordance with TBS. Analysis conducted in HCWs within 58 days post-PCR result demonstrated 100% sensitivity for both Abbott and Roche. Longitudinal analysis for >100 days post-PCR led to sensitivity of 77.2% and 100% for Abbott and Roche, respectively. A redefined Abbott threshold (0.64) increased sensitivity to 90%, producing results comparable to TBS and Roche. The manufacturer’s threshold set by Abbott contributes to lower sensitivity and elevated false-negative occurrences. Abbott performance improved upon re-optimisation of the cut-off threshold. Our findings provided evidence that TBS can be used as bespoke alternative for SARS-CoV-2 serology analysis where high-throughput platforms are not feasible on site. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessFeature PaperArticle

Estimating Vaccine Confidence Levels among Healthcare Staff and Students of a Tertiary Institution in South Africa

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Vaccines 2021, 9(11), 1246; https://doi.org/10.3390/vaccines9111246 - 27 Oct 2021

Cited by 6 | Viewed by 1440

Abstract

Healthcare workers were the first group scheduled to receive COVID-19 vaccines when they became available in South Africa. Therefore, estimating vaccine confidence levels and intention to receive COVID-19 vaccines among healthcare workers ahead of the national vaccination roll-out was imperative. We conducted an [...] Read more.

Healthcare workers were the first group scheduled to receive COVID-19 vaccines when they became available in South Africa. Therefore, estimating vaccine confidence levels and intention to receive COVID-19 vaccines among healthcare workers ahead of the national vaccination roll-out was imperative. We conducted an online survey from 4 February to 7 March 2021, to assess vaccine sentiments and COVID-19 vaccine intentions among healthcare staff and students at a tertiary institution in South Africa. We enrolled 1015 participants (74.7% female). Among the participants, 89.5% (confidence interval (CI) 87.2–91.4) were willing to accept a COVID-19 vaccine, 95.4% (CI 93.9–96.6) agreed that vaccines are important for them, 95.4% (CI 93.8–96.6) that vaccines are safe, 97.4% (CI 96.2–98.3) that vaccines are effective, and 96.1% (CI 94.6–97.2) that vaccines are compatible with religion. Log binomial regression revealed statistically significant positive associations between COVID-19 vaccine acceptance and the belief that vaccines are safe (relative risk (RR) 32.2, CI 4.67–221.89), effective (RR 21.4, CI 3.16–145.82), important for children (RR 3.5, CI 1.78–6.99), important for self (RR 18.5, CI 4.78–71.12), or compatible with religion (RR 2.2, CI 1.46–3.78). The vaccine confidence levels of the study respondents were highly positive. Nevertheless, this could be further enhanced by targeted interventions. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessCommunication

Characterization of Individuals Interested in Participating in a Phase I SARS-CoV-2 Vaccine Trial

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Parichehr Shamsrizi

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Frederik Johannes Kramer

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Marylyn Martina Addo

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Anahita Fathi

Vaccines 2021, 9(10), 1208; https://doi.org/10.3390/vaccines9101208 - 19 Oct 2021

Cited by 1 | Viewed by 1492

Abstract

The development of an effective vaccine against SARS-CoV-2 marks one of the highest priorities during the ongoing pandemic. However, recruitment of participants for clinical trials can be challenging, and recruitment failure is among the most common reasons for discontinuation in clinical trials. From [...] Read more.

The development of an effective vaccine against SARS-CoV-2 marks one of the highest priorities during the ongoing pandemic. However, recruitment of participants for clinical trials can be challenging, and recruitment failure is among the most common reasons for discontinuation in clinical trials. From 20 May 2020, public announcements about a planned phase I trial of the vaccine candidate MVA-SARS-2-S against SARS-CoV-2 began, and interested individuals started contacting the study team via designated e-mail. All emails received from these individuals between 20 May 2020–30 September 2020 were assessed. Of the 2541 interested volunteers, 62% contacted the study team within three days after the first media announcement. The average age was 61 years (range 16–100), 48% of volunteers were female and 52% male. A total of 274, 186, and 53 individuals, respectively, reported medical pre-conditions, were health-care workers, or had frequent inter-person contacts. In conclusion, we report a high number of volunteers, with a considerable percentage stating factors for an elevated risk to acquire COVID-19 or develop severe disease. Factors such as media coverage and the perception of a disease as an acute threat may influence the individual’s choice to volunteer for a vaccine trial. Our data provide first important insights to better understand reasons to participate in such trials to facilitate trial implementation and recruitment. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessFeature PaperArticle

Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients

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Vaccines 2021, 9(10), 1186; https://doi.org/10.3390/vaccines9101186 - 15 Oct 2021

Cited by 38 | Viewed by 24215

Abstract

Myocarditis and pericarditis have been linked recently to COVID-19 vaccines without exploring the underlying mechanisms, or compared to cardiac adverse events post-non-COVID-19 vaccines. We introduce an informatics approach to study post-vaccine adverse events on the systems biology level to aid the prioritization of [...] Read more.

Myocarditis and pericarditis have been linked recently to COVID-19 vaccines without exploring the underlying mechanisms, or compared to cardiac adverse events post-non-COVID-19 vaccines. We introduce an informatics approach to study post-vaccine adverse events on the systems biology level to aid the prioritization of effective preventive measures and mechanism-based pharmacotherapy by integrating the analysis of adverse event reports from the Vaccine Adverse Event Reporting System (VAERS) with systems biology methods. Our results indicated that post-vaccine myocarditis and pericarditis were associated most frequently with mRNA COVID-19 vaccines followed by live or live-attenuated non-COVID-19 vaccines such as smallpox and anthrax vaccines. The frequencies of cardiac adverse events were affected by vaccine, vaccine type, vaccine dose, sex, and age of the vaccinated individuals. Systems biology results suggested a central role of interferon-gamma (INF-gamma) in the biological processes leading to cardiac adverse events, by impacting MAPK and JAK-STAT signaling pathways. We suggest that increasing the time interval between vaccine doses minimizes the risks of developing inflammatory adverse reactions. We also propose glucocorticoids as preferred treatments based on system biology evidence. Our informatics workflow provides an invaluable tool to study post-vaccine adverse events on the systems biology level to suggest effective mechanism-based pharmacotherapy and/or suitable preventive measures. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Course and Lethality of SARS-CoV-2 Epidemic in Nursing Homes after Vaccination in Florence, Italy

Vaccines 2021, 9(10), 1174; https://doi.org/10.3390/vaccines9101174 - 13 Oct 2021

Cited by 7 | Viewed by 2015

Abstract

Evidence on the effectiveness of SARS-CoV-2 vaccines in nursing home (NHs) residents is limited. We examined the impact of the BNT162b2 mRNA SARS-CoV-2 vaccine on the course of the epidemic in NHs in the Florence Health District, Italy, before and after vaccination. Moreover, [...] Read more.

Evidence on the effectiveness of SARS-CoV-2 vaccines in nursing home (NHs) residents is limited. We examined the impact of the BNT162b2 mRNA SARS-CoV-2 vaccine on the course of the epidemic in NHs in the Florence Health District, Italy, before and after vaccination. Moreover, we assessed survival and hospitalization by vaccination status in SARS-CoV-2-positive cases occurring during the post-vaccination period. We calculated the weekly infection rates during the pre-vaccination (1 October–26 December 2020) and post-vaccination period (27 December 2020–31 March 2021). Cox analysis was used to analyze survival by vaccination status. The study involved 3730 residents (mean age 84, 69% female). Weekly infection rates fluctuated during the pre-vaccination period (1.8%–6.5%) and dropped to zero during the post-vaccination period. Nine unvaccinated (UN), 56 partially vaccinated (PV) and 35 fully vaccinated (FV) residents tested SARS-CoV-2+ during the post-vaccination period. FV showed significantly lower hospitalization and mortality rates than PV and UV (hospitalization: FV 3%, PV 14%, UV 33%; mortality: FV 6%, PV 18%, UV 56%). The death risk was 84% and 96% lower in PV (HR 0.157, 95%CI 0.049–0.491) and FV (HR 0.037, 95%CI 0.006–0.223) versus UV. SARS-CoV-2 vaccination was followed by a marked decline in infection rates and was associated with lower morbidity and mortality among infected NH residents. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessFeature PaperArticle

The Rise and Fall of a Local SARS-CoV-2 Variant with the Spike Protein Mutation L452R

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, Israel National Consortium for SARS-CoV-2 Sequencing,

Ella S. Mendelson

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Neta S. Zuckerman

Vaccines 2021, 9(8), 937; https://doi.org/10.3390/vaccines9080937 - 23 Aug 2021

Cited by 8 | Viewed by 2148

Abstract

Emerging SARS-CoV-2 variants may threaten global vaccination efforts and the awaited reduction in outbreak burden. In this study, we report a novel variant carrying the L452R mutation that emerged from a local B.1.362 lineage, B.1.362+L452R. The L452R mutation is associated with the Delta [...] Read more.

Emerging SARS-CoV-2 variants may threaten global vaccination efforts and the awaited reduction in outbreak burden. In this study, we report a novel variant carrying the L452R mutation that emerged from a local B.1.362 lineage, B.1.362+L452R. The L452R mutation is associated with the Delta and Epsilon variants and was shown to cause increased infection and reduction in neutralization in pseudoviruses. Indeed, the B.1.362+L452R variant demonstrated a X4-fold reduction in neutralization capacity of sera from BNT162b2-vaccinated individuals compared to a wild-type strain. The variant infected 270 individuals in Israel between December 2020 and March 2021, until diminishing due to the gain in dominance of the Alpha variant in February 2021. This study demonstrates an independent, local emergence of a variant carrying a critical mutation, L452R, which may have the potential of becoming a variant of concern and emphasizes the importance of routine surveillance and detection of novel variants among efforts undertaken to prevent further disease spread. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Adverse Effects on Work and Daily Life Interference among Healthcare Workers after the First and Second ChAdOx1 and BNT162b2 COVID-19 Vaccine Doses

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Vaccines 2021, 9(8), 926; https://doi.org/10.3390/vaccines9080926 - 19 Aug 2021

Cited by 4 | Viewed by 1866

Abstract

In this study, we assessed the adverse effects and the work and daily life interference associated with each dose of the ChAdOx1 and BNT162b2 COVID-19 vaccines. Questionnaires were distributed to workers after they received both doses; only those who worked the day after [...] Read more.

In this study, we assessed the adverse effects and the work and daily life interference associated with each dose of the ChAdOx1 and BNT162b2 COVID-19 vaccines. Questionnaires were distributed to workers after they received both doses; only those who worked the day after receiving the vaccine were included in the analysis. Overall, 368 ChAdOx1-vaccinated and 27 BNT162b2-vaccinated participants were included. Among the ChAdOx1-vaccinated participants, the incidence of adverse effects was significantly lower after the second dose than after the first dose. Among the BNT162b2-vaccinated participants, however, no differences in adverse effects or work and daily life interference were found between the doses. After the first and second dose, the numeric scale score (0–10) for interference with work was 3.9 ± 2.9 and 1.6 ± 1.9 for the ChAdOx1 and 3.2 ± 2.5 and 3.6 ± 3.0 for the BNT162b2 vaccine, respectively. A similar trend was observed for interference with daily life. Factors associated with work and daily life interference in the multivariate model were age, vaccine dose (first or second), and the interaction term of vaccine type and dose. These results could be used to inform the general population of the adverse effects associated with these vaccinations. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessArticle

Prevalence and Factors of the Performed or Scheduled COVID-19 Vaccination in a Chinese Adult General Population in Hong Kong

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Vaccines 2021, 9(8), 847; https://doi.org/10.3390/vaccines9080847 - 02 Aug 2021

Cited by 9 | Viewed by 2417

Abstract

Background: Globally, COVID-19 vaccination programs have been rolled out. To inform health promotion, this study investigated the prevalence and associated factors of performance or being scheduled to perform at least one dose of COVID-19 vaccination (PSCV) in a Chinese adult general population. Methods: [...] Read more.

Background: Globally, COVID-19 vaccination programs have been rolled out. To inform health promotion, this study investigated the prevalence and associated factors of performance or being scheduled to perform at least one dose of COVID-19 vaccination (PSCV) in a Chinese adult general population. Methods: An anonymous, random telephone survey interviewed 500 adults aged 18–75 in Hong Kong, China from 14–27 May 2021. Results: The prevalence of PSCV was 21.0%, which was significantly lower among females and those aged ≤30. Positively associated factors of PSCV included perceived protection effect of vaccination, self-perceived physical fitness for vaccination, compulsory COVID-19 testing experience, perceived need to travel, general trust toward the government, and trust toward the governmental vaccination program, while negatively associated factors included perceived low efficacy of vaccination, concerns about side effects, and chronic disease status. Furthermore, the association between sex and PSCV was fully mediated by stronger concern about side effects and lower levels of self-perceived physical fitness for COVID-19 vaccination among females than males. Conclusion: Moderately low prevalence of COVID-19 vaccination was observed in Hong Kong, where there was no shortage of vaccine supply. To achieve herd immunity, health promotion is greatly warranted and may incorporate messages based on the findings of this study. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessArticle

Intranasal Administration of RBD Nanoparticles Confers Induction of Mucosal and Systemic Immunity against SARS-CoV-2

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Tuksin Jearanaiwitayakul

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Mathurin Seesen

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Runglawan Chawengkirttikul

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Jitra Limthongkul

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Suttikarn Apichirapokey

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Vaccines 2021, 9(7), 768; https://doi.org/10.3390/vaccines9070768 - 09 Jul 2021

Cited by 24 | Viewed by 3283

Abstract

Mucosal immunity plays a significant role in host defense against viruses in the respiratory tract. Because the upper respiratory airway is a primary site of SARS-CoV-2 entry, immunization at the mucosa via the intranasal route could potentially lead to induction of local sterilizing [...] Read more.

Mucosal immunity plays a significant role in host defense against viruses in the respiratory tract. Because the upper respiratory airway is a primary site of SARS-CoV-2 entry, immunization at the mucosa via the intranasal route could potentially lead to induction of local sterilizing immunity that protects against SARS-CoV-2 infection. In this study, we evaluated the immunogenicity of a receptor-binding domain (RBD) of SARS-CoV-2 spike glycoprotein loaded into N,N,N-trimethyl chitosan nanoparticles (RBD-TMC NPs). We showed that intranasal delivery of RBD-TMC NPs into mice induced robust local mucosal immunity, as evidenced by the presence of IgG and IgA responses in BALs and the lungs of immunized mice. Furthermore, mice intranasally administered with this platform of immunogens developed robust systemic antibody responses including serum IgG, IgG1, IgG2a, IgA and neutralizing antibodies. In addition, these immunized mice had significantly higher levels of activated splenic CD4⁺ and CD8⁺ cells compared with those that were administered with soluble RBD immunogen. Collectively, these findings shed light on an alternative route of vaccination that mimics the natural route of SARS-CoV-2 infection. This route of administration stimulated not only local mucosal responses but also the systemic compartment of the immune system. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessArticle

Efficacy and Safety of COVID-19 Vaccines in Phase III Trials: A Meta-Analysis

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Vaccines 2021, 9(6), 582; https://doi.org/10.3390/vaccines9060582 - 01 Jun 2021

Cited by 41 | Viewed by 7770

Abstract

Nowadays, the vaccination with COVID-19 vaccines is being promoted worldwide, professionals and common people are very concerned about the efficacy and safety of COVID-19 vaccines. No published systematic review and meta-analysis has assessed the efficacy and safety of the COVID-19 vaccines based on [...] Read more.

Nowadays, the vaccination with COVID-19 vaccines is being promoted worldwide, professionals and common people are very concerned about the efficacy and safety of COVID-19 vaccines. No published systematic review and meta-analysis has assessed the efficacy and safety of the COVID-19 vaccines based on data from phase III clinical trials. Therefore, this study has estimated the efficacy and safety of COVID-19 vaccines and the differences between vaccine types. PubMed, Embase, the Cochrane Library, CNKI, Wanfang, medRxiv databases and two websites were used to retrieve the studies. Random-effects models were used to estimate the pooled efficacy and safety with risk ratio (RR). A total of eight studies, seven COVID-19 vaccines and 158,204 subjects were included in the meta-analysis. All the vaccines had a good preventive effect on COVID-19 (RR = 0.17, 95% CI: 0.09–0.32), and the mRNA vaccine (RR = 0.05, 95% CI: 0.03–0.09) was the most effective against COVID-19, while the inactivated vaccine (RR = 0.32, 95% CI: 0.19–0.54) was the least. In terms of safety, the risk of overall adverse events showed an increase in the vaccine group after the first (RR = 1.46, 95% CI: 1.03–2.05) or second (RR = 1.52, 95% CI: 1.04–2.20) injection. However, compared with the first injection, the risk of local (RR = 2.64, 95% CI: 1.02–6.83 vs. RR = 2.25, 95% CI: 0.52–9.75) and systemic (RR = 1.33, 95% CI: 1.21–1.46 vs. RR = 1.59, 95% CI: 0.84–3.01) adverse events decreased after the second injection. As for the mRNA vaccine, the risk of overall adverse events increased significantly, compared with the placebo, no matter whether it was the first (RR = 1.83, 95% CI = 1.80–1.86) or the second (RR = 2.16, 95% CI = 2.11–2.20) injection. All the COVID-19 vaccines that have published the data of phase III clinical trials have excellent efficacy, and the risk of adverse events is acceptable. The mRNA vaccines were the most effective against COVID-19, meanwhile the risk and grade of adverse events was minimal, compared to that of severe symptoms induced by COVID-19. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessCommunication

Mice Immunized with the Vaccine Candidate HexaPro Spike Produce Neutralizing Antibodies against SARS-CoV-2

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Suwimon Manopwisedjaroen

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Sirawat Srichatrapimuk

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Suppachok Kirdlarp

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Somnuek Sungkanuparph

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Somchai Chutipongtanate

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Arunee Thitithanyanont

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Suradej Hongeng

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Patompon Wongtrakoongate

Vaccines 2021, 9(5), 498; https://doi.org/10.3390/vaccines9050498 - 12 May 2021

Cited by 9 | Viewed by 3960

Abstract

Updated and revised versions of COVID-19 vaccines are vital due to genetic variations of the SARS-CoV-2 spike antigen. Furthermore, vaccines that are safe, cost-effective, and logistic-friendly are critically needed for global equity, especially for middle- to low-income countries. Recombinant protein-based subunit vaccines against [...] Read more.

Updated and revised versions of COVID-19 vaccines are vital due to genetic variations of the SARS-CoV-2 spike antigen. Furthermore, vaccines that are safe, cost-effective, and logistic-friendly are critically needed for global equity, especially for middle- to low-income countries. Recombinant protein-based subunit vaccines against SARS-CoV-2 have been reported using the receptor-binding domain (RBD) and the prefusion spike trimers (S-2P). Recently, a new version of prefusion spike trimers, named HexaPro, has been shown to possess two RBD in the “up” conformation, due to its physical property, as opposed to just one exposed RBD found in S-2P. Importantly, this HexaPro spike antigen is more stable than S-2P, raising its feasibility for global logistics and supply chain. Here, we report that the spike protein HexaPro offers a promising candidate for the SARS-CoV-2 vaccine. Mice immunized by the recombinant HexaPro adjuvanted with aluminum hydroxide using a prime-boost regimen produced high-titer neutralizing antibodies for up to 56 days after initial immunization against live SARS-CoV-2 infection. Also, the level of neutralization activity is comparable to that of convalescence sera. Our results indicate that the HexaPro subunit vaccine confers neutralization activity in sera collected from mice receiving the prime-boost regimen. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Review

Jump to: Research, Other

Open AccessReview

Racial and Ethnic Diversity in SARS-CoV-2 Vaccine Clinical Trials Conducted in the United States

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Vaccines 2022, 10(2), 290; https://doi.org/10.3390/vaccines10020290 - 14 Feb 2022

Cited by 10 | Viewed by 1515

Abstract

Evidence shows that White and non-Hispanic individuals are overrepresented in clinical trials. The development of new vaccines and drugs, however, necessitates that clinical research trials include representative participants, particularly in light of evidence showing that underrepresented minorities may have a different response to [...] Read more.

Evidence shows that White and non-Hispanic individuals are overrepresented in clinical trials. The development of new vaccines and drugs, however, necessitates that clinical research trials include representative participants, particularly in light of evidence showing that underrepresented minorities may have a different response to certain medications and vaccines. Racial and ethnic disparities among clinical trials are multilayered and complex, and this requires action. The results of this study indicate that significant racial and ethnic disparities consistently exist among the most recent early SARS-CoV-2 vaccine clinical trials as compared to the pandemic H1N1 vaccine clinical trials of 2009. New strategies, policies, training programs, and reforms are required to address these disparities among clinical trials. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessReview

Effectiveness and Efficacy of Vaccine on Mutated SARS-CoV-2 Virus and Post Vaccination Surveillance: A Narrative Review

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Ihsanul Hafiz

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Didi Nurhadi Illian

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Okpri Meila

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Ahmad Rusdan Handoyo Utomo

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Arida Susilowati

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Ipanna Enggar Susetya

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Desrita Desrita

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Gontar Alamsyah Siregar

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Mohammad Basyuni

Vaccines 2022, 10(1), 82; https://doi.org/10.3390/vaccines10010082 - 06 Jan 2022

Cited by 8 | Viewed by 1895

Abstract

The ongoing COVID-19 pandemic, as a result of the SARS-CoV-2 virus, since December 2019, is a major health problem and concern worldwide. The pandemic has impacted various fields, from the social to the development of health science and technology. The virus has been [...] Read more.

The ongoing COVID-19 pandemic, as a result of the SARS-CoV-2 virus, since December 2019, is a major health problem and concern worldwide. The pandemic has impacted various fields, from the social to the development of health science and technology. The virus has been mutating and thus producing several new variants, rushing research in the field of molecular biology to develop rapidly to overcome the problems that occur. Vaccine clinical studies are developing promptly with the aim of obtaining vaccines that are effective in suppressing the spread of the virus; however, the development of viral mutations raises concerns about the decreasing effectiveness of the resulting vaccine, which also results in the need for more in-depth studies. There have been 330 vaccines developed, including 136 clinical developments and 194 pre-clinical developments. The SARS-CoV-2 variant continues to evolve today, and it poses a challenge in testing the effectiveness of existing vaccines. This is a narrative review describing the emergence of the COVID-19 pandemic, development of vaccine platforms, identification of concerning mutations and virus variants in various countries of the world, and real-world monitoring of post-vaccination effectiveness and surveillance. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessReview

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

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Mohammad Hossein Razizadeh

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Diana L. Turner

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Raymond J. Turner

Vaccines 2021, 9(5), 467; https://doi.org/10.3390/vaccines9050467 - 06 May 2021

Cited by 151 | Viewed by 26263

Abstract

The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 [...] Read more.

The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 March 2021. A total of 25 RCTs (123 datasets), 58,889 cases that received the COVID-19 vaccine and 46,638 controls who received placebo were included in the meta-analysis. In total, mRNA-based and adenovirus-vectored COVID-19 vaccines had 94.6% (95% CI 0.936–0.954) and 80.2% (95% CI 0.56–0.93) efficacy in phase II/III RCTs, respectively. Efficacy of the adenovirus-vectored vaccine after the first (97.6%; 95% CI 0.939–0.997) and second (98.2%; 95% CI 0.980–0.984) doses was the highest against receptor-binding domain (RBD) antigen after 3 weeks of injections. The mRNA-based vaccines had the highest level of side effects reported except for diarrhea and arthralgia. Aluminum-adjuvanted vaccines had the lowest systemic and local side effects between vaccines’ adjuvant or without adjuvant, except for injection site redness. The adenovirus-vectored and mRNA-based vaccines for COVID-19 showed the highest efficacy after first and second doses, respectively. The mRNA-based vaccines had higher side effects. Remarkably few experienced extreme adverse effects and all stimulated robust immune responses. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Other

Jump to: Research, Review

Open AccessCase Report

Cytomegalovirus Proctitis Developed after COVID-19 Vaccine: A Case Report and Literature Review

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Yuqing Lv

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Ying Chang

Vaccines 2022, 10(9), 1417; https://doi.org/10.3390/vaccines10091417 - 29 Aug 2022

Cited by 1 | Viewed by 1929

Abstract

(1) Background: We describe a case of a 58-year-old Chinese woman, without obvious cause of immunosuppression, who developed cytomegalovirus (CMV) proctitis three days after a second COVID-19 vaccination. Electronic colonoscopy revealed a new lesion that was circumferential at the anorectal junction, with an [...] Read more.

(1) Background: We describe a case of a 58-year-old Chinese woman, without obvious cause of immunosuppression, who developed cytomegalovirus (CMV) proctitis three days after a second COVID-19 vaccination. Electronic colonoscopy revealed a new lesion that was circumferential at the anorectal junction, with an uneven surface and ulceration, which mimicked rectal carcinoma. This is the first case of CMV proctitis following vaccination since the invention of the COVID-19 vaccine, suggesting that the COVID-19 vaccine may cause disorders of immune homeostasis, including not only immune hyperactivity but also immune deficiency. We report this case to increase readers’ awareness of the risks after COVID-19 vaccination and to provide new ideas for the diagnosis and treatment of similar cases. (2) Methods: In this case, we used laboratory biochemical examinations, colonoscopy, immunohistochemistry, and a biochemical index to confirm the existence of CMV proctitis. (3) Results: In this case, the vaccine-induced CMV proctitis had a similar endoscopic appearance to rectal neoplastic lesions, which could be confirmed by biopsy and quickly relieved by ganciclovir treatment. Ganciclovir was used to treat the patient, and a good effect was observed. (4) Conclusions: COVID-19 vaccination may cause immune disorders, not just immune hyperactivity as previously reported, but also immune deficiency, such as CMV proctitis in this case. The clinical course of CMV proctitis secondary to COVID-19 vaccination was favorable with ganciclovir therapy. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessBrief Report

Promising Efficacy of a Third Dose of mRNA SARS-CoV-2 Vaccination in Patients Treated with Anti-CD20 Antibody Who Failed 2-Dose Vaccination

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Vaccines 2022, 10(6), 965; https://doi.org/10.3390/vaccines10060965 - 17 Jun 2022

Cited by 3 | Viewed by 1291

Abstract

Anti-CD20 antibodies react with CD20 expressed not only on malignant B cells, but also on normal B cells. It has been reported that patients treated with anti-CD20 antibodies had an insufficient response to two-dose mRNA SARS-CoV-2 vaccination. To investigate the efficacy of a [...] Read more.

Anti-CD20 antibodies react with CD20 expressed not only on malignant B cells, but also on normal B cells. It has been reported that patients treated with anti-CD20 antibodies had an insufficient response to two-dose mRNA SARS-CoV-2 vaccination. To investigate the efficacy of a third dose in these patients, we investigated serum IgG antibody titers for the S1 protein after a third vaccination in 22 patients treated with the anti-CD20 antibody who failed two-dose vaccination. Results showed that overall, 50% of patients seroconverted. Although no patient who received the third dose within 1 year of the last anti-CD20 antibody administration showed an increase in S1 antibody titer, 69% of patients who received the third dose more than 1 year after the last anti-CD20 antibody administration seroconverted. Our data show that a third dose of vaccination is effective in improving the seroconversion rate in patients treated with the anti-CD20 antibody who failed standard two-dose vaccination. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessBrief Report

Identification of Potential SARS-CoV-2 CD8⁺ T Cell Escape Mutants

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Syed Faraz Ahmed

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Muhammad Saqib Sohail

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Ahmed Abdul Quadeer

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Matthew R. McKay

Vaccines 2022, 10(4), 542; https://doi.org/10.3390/vaccines10040542 - 31 Mar 2022

Cited by 3 | Viewed by 1485

Abstract

Memory SARS-CoV-2-specific CD8⁺ T cell responses induced upon infection or COVID-19 vaccination have been important for protecting against severe COVID-19 disease while being largely robust against variants of concern (VOCs) observed so far. However, T cell immunity may be weakened by genetic [...] Read more.

Memory SARS-CoV-2-specific CD8⁺ T cell responses induced upon infection or COVID-19 vaccination have been important for protecting against severe COVID-19 disease while being largely robust against variants of concern (VOCs) observed so far. However, T cell immunity may be weakened by genetic mutations in future SARS-CoV-2 variants that lead to widespread T cell escape. The capacity for SARS-CoV-2 mutations to escape memory T cell responses requires comprehensive experimental investigation, though this is prohibited by the large number of SARS-CoV-2 mutations that have been observed. To guide targeted experimental studies, here we provide a screened list of potential SARS-CoV-2 T cell escape mutants. These mutants are identified as candidates for T cell escape as they lie within CD8⁺ T cell epitopes that are commonly targeted in individuals and are predicted to abrogate HLA–peptide binding. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessCommentary

COVID-19 Vaccines and Hyperglycemia—Is There a Need for Postvaccination Surveillance?

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Samson Mathews Samuel

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Elizabeth Varghese

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Chris R. Triggle

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Dietrich Büsselberg

Vaccines 2022, 10(3), 454; https://doi.org/10.3390/vaccines10030454 - 16 Mar 2022

Cited by 8 | Viewed by 4630

Abstract

The COVID-19 vaccines currently in use have undoubtedly played the most significant role in combating the SARS-CoV-2 virus and reducing disease severity and the risk of death among those affected, especially among those with pre-existing conditions, such as diabetes. The management of blood [...] Read more.

The COVID-19 vaccines currently in use have undoubtedly played the most significant role in combating the SARS-CoV-2 virus and reducing disease severity and the risk of death among those affected, especially among those with pre-existing conditions, such as diabetes. The management of blood glucose levels has become critical in the context of the COVID-19 pandemic, where data show two- to threefold higher intensive care hospital admissions and more than twice the mortality rate among diabetic COVID-19 patients when compared with their nondiabetic counterparts. Furthermore, new-onset diabetes and severe hyperglycemia-related complications, such as hyperosmolar hyperglycemic syndrome (HHS) and diabetic ketoacidosis (DKA), were reported in COVID-19 patients. However, irrespective of the kind of vaccine and dosage number, possible vaccination-induced hyperglycemia and associated complications were reported among vaccinated individuals. The current article summarizes the available case reports on COVID-19 vaccination-induced hyperglycemia, the possible molecular mechanism responsible for this phenomenon, and the outstanding questions that need to be addressed and discusses the need to identify at-risk individuals and promote postvaccination monitoring/surveillance among at-risk individuals. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessBrief Report

Effect of Heterologous Vaccination Regimen with Ad5-nCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG Antibodies Titers

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Maria Elena Romero-Ibarguengoitia

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Diego Rivera-Salinas

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Yodira Guadalupe Hernández-Ruíz

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Ana Gabriela Armendariz-Vázquez

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Arnulfo González-Cantú

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Irene Antonieta Barco-Flores

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Rosalinda González-Facio

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Laura Patricia Montelongo-Cruz

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Gerardo Francisco Del Rio-Parra

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Miguel Ángel Sanz-Sánchez

Vaccines 2022, 10(3), 392; https://doi.org/10.3390/vaccines10030392 - 03 Mar 2022

Cited by 3 | Viewed by 1363

Abstract

The efficacy of one dose Ad5-nCoV has been concerning. This study aimed to evaluate the effect of a single dose BNT162b2 in individuals after a completed Ad5-nCoV vaccination regiment compared to a group without this boost measuring SARS-CoV-2 Spike 1–2 IgG antibodies in [...] Read more.

The efficacy of one dose Ad5-nCoV has been concerning. This study aimed to evaluate the effect of a single dose BNT162b2 in individuals after a completed Ad5-nCoV vaccination regiment compared to a group without this boost measuring SARS-CoV-2 Spike 1–2 IgG antibodies in plasma. This observational study included a subgroup analysis of patients who were immunized with Ad5-nCoV in a northern city of Mexico. During follow-up, some patients self-reported having received a BNT162b2 booster. We report baseline IgG levels, 21–28 days after the Ad5-nCoV dose, three months, and an additional 21–28 days after BNT162b2 (four months after Ad5-nCoV). Seventeen patients, age 40 (16), 52.9% men, were analyzed. We created four groups: G1 and G2 refer to patients without a history of SARS-CoV-2 infection, vaccinated with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 4 and n = 6), respectively; G3 and G4 included patients with a history of SARS-CoV-2 infection and immunized with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 5 and n = 2), respectively. The Ad5-nCoV/BNT162b2 protocol reported higher antibody titers after 21–28 days. Median (IQR) values were: G1 46.7 (-), G2 1077.5 (1901), G3 1158.5 (2673.5), and G4 2090 (-) (p < 0.05). Headache and pain at injection site were the most frequent adverse reactions associated with Ad5-nCoV (n = 10, 83%) and BNT162b2 (n = 5, 83.3%), respectively. Patients receiving BNT162b2 after Ad5-nCoV had higher SARS-CoV-2 spike 1–2 IgG antibody titers and had no severe adverse reactions. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessSystematic Review

Effectiveness of Vaccination against SARS-CoV-2 Infection in the Pre-Delta Era: A Systematic Review and Meta-Analysis

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Angela Meggiolaro

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Monica Sane Schepisi

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Georgios F. Nikolaidis

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Daniele Mipatrini

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Andrea Siddu

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Giovanni Rezza

Vaccines 2022, 10(2), 157; https://doi.org/10.3390/vaccines10020157 - 21 Jan 2022

Cited by 6 | Viewed by 1914

Abstract

(1) Background: The objective of this study was to assess the effectiveness of SARS-CoV-2 vaccines in terms of prevention of disease and transmission in the pre-Delta era. The evaluation was narrowed to two mRNA vaccines and two modified adenovirus-vectored vaccines. (2) Methods: The [...] Read more.

(1) Background: The objective of this study was to assess the effectiveness of SARS-CoV-2 vaccines in terms of prevention of disease and transmission in the pre-Delta era. The evaluation was narrowed to two mRNA vaccines and two modified adenovirus-vectored vaccines. (2) Methods: The overall risk of any SARS-CoV-2 infection confirmed by positive real-time Polymerase Chain Reaction (PCR) test was estimated in partially and fully vaccinated individuals. The evidence synthesis was pursued through a random-effects meta-analysis. The effect size was expressed as relative risk (RR) and RRR (RR reduction) of SARS-CoV-2 infection following vaccination. Heterogeneity was investigated through a between-study heterogeneity analysis and a subgroup meta-analysis. (3) Results: The systematic review identified 27 studies eligible for the quantitative synthesis. Partially vaccinated individuals presented a RRR = 73% (95%CI = 59–83%) for positive SARS-CoV-2 PCR (RR = 0.27) and a RRR=79% (95%CI = 30–93%) for symptomatic SARS-CoV-2 PCR (RR = 0.21). Fully vaccinated individuals showed a RRR = 94% (95%CI = 88–98%) for SARS-CoV-2 positive PCR (RR = 0.06) compared to unvaccinated individuals. The full BNT162b2 vaccination protocol achieved a RRR = 84–94% against any SARS-CoV-2-positive PCR and a RRR = 68–84% against symptomatic positive PCR. (4) Conclusions: The meta-analysis results suggest that full vaccination might block transmission. In particular, the risk of SARS-CoV-2 infection appeared higher for non-B.1.1.7 variants and individuals aged ≥69 years. Considering the high level of heterogeneity, these findings must be taken with caution. Further research on SARS-CoV-2 vaccine effectiveness against emerging SARS-CoV-2 variants is encouraged. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessBrief Report

Effect of SARS-CoV-2 Vaccination on Symptoms from Post-Acute Sequelae of COVID-19: Results from the Nationwide VAXILONG Study

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Jacques-Eric Gottenberg

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Jean Sibilia

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Renaud Felten

Vaccines 2022, 10(1), 46; https://doi.org/10.3390/vaccines10010046 - 30 Dec 2021

Cited by 17 | Viewed by 4070

Abstract

Introduction: Few data are available concerning the effect of SARS-CoV-2 vaccination on the persistent symptoms associated with COVID-19, also called long-COVID or post-acute sequelae of COVID-19 (PASC). Patients and methods: We conducted a nationwide online study among adult patients with PASC as defined [...] Read more.

Introduction: Few data are available concerning the effect of SARS-CoV-2 vaccination on the persistent symptoms associated with COVID-19, also called long-COVID or post-acute sequelae of COVID-19 (PASC). Patients and methods: We conducted a nationwide online study among adult patients with PASC as defined by symptoms persisting over 4 weeks following a confirmed or probable COVID-19, without any identified alternative diagnosis. Information concerning PASC symptoms, vaccine type and scheme and its effect on PASC symptoms were studied. Results: 620 questionnaires were completed and 567 satisfied the inclusion criteria and were analyzed. The respondents’ median age was 44 (IQR 25–75: 37–50) and 83.4% were women. The initial infection was proven in 365 patients (64%) and 5.1% had been hospitalized to receive oxygen. A total of 396 patients had received at least one injection of SARS-CoV-2 vaccine at the time of the survey, after a median of 357 (198–431) days following the initially-reported SARS-CoV-2 infection. Among the 380 patients who reported persistent symptoms at the time of SARS-CoV-2 vaccination, 201 (52.8%) reported a global effect on symptoms following the injection, corresponding to an improvement in 21.8% and a worsening in 31%. There were no differences based on the type of vaccine used. After a complete vaccination scheme, 93.3% (28/30) of initially seronegative patients reported a positive anti-SARS-CoV-2 IgG. A total of 170 PASC patients had not been vaccinated. The most common reasons for postponing the SARS-CoV-2 vaccine were fear of worsening PASC symptoms (55.9%) and the belief that vaccination was contraindicated because of PASC (15.6%). Conclusion: Our study suggests that SARS-CoV-2 vaccination is well tolerated in the majority of PASC patients and has good immunogenicity. Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with PASC. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessCase Report

Chronic Inflammatory Demyelinating Polyneuropathy after ChAdOx1 nCoV-19 Vaccination

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Caterina Francesca Bagella

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Davide G. Corda

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Pietro Zara

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Antonio Emanuele Elia

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Elisa Ruiu

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Elia Sechi

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Paolo Solla

Vaccines 2021, 9(12), 1502; https://doi.org/10.3390/vaccines9121502 - 19 Dec 2021

Cited by 8 | Viewed by 3830

Abstract

Recently several patients, who developed Guillain–Barré syndrome characterized by prominent bifacial weakness after ChAdOx1 nCoV-19 vaccination, were described from different centers. We recently observed a patient who developed a similar syndrome, later in the follow up he showed worsening of the neuropathy two [...] Read more.

Recently several patients, who developed Guillain–Barré syndrome characterized by prominent bifacial weakness after ChAdOx1 nCoV-19 vaccination, were described from different centers. We recently observed a patient who developed a similar syndrome, later in the follow up he showed worsening of the neuropathy two months after the initial presentation. Repeat EMG showed reduced nerve sensory and motor conduction velocities of both upper and lower limbs, and a diagnosis of chronic inflammatory demyelinating polyneuropathy (typical CIDP) was made according to established criteria. Our report expands on the possible outcomes in patients who develop Guillain–Barrè syndrome after COVID-19 vaccinations and suggest that close monitoring after the acute phase is needed in these patients to exclude a chronic evolution of the disease, which has important implications for long-term treatment. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessProtocol

Detection and Quantification of SARS-CoV-2 Receptor Binding Domain Neutralization by a Sensitive Competitive ELISA Assay

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Alexander A. Khromykh

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Vaccines 2021, 9(12), 1493; https://doi.org/10.3390/vaccines9121493 - 16 Dec 2021

Cited by 5 | Viewed by 2504

Abstract

This protocol describes an ELISA-based procedure for accurate measurement of SARS-CoV-2 spike protein-receptor binding domain (RBD) neutralization efficacy by murine immune serum. The procedure requires a small amount of S-protein/RBD and angiotensin converting enzyme-2 (ACE2). A high-throughput, simple ELISA technique is employed. Plate-coated-RBDs [...] Read more.

This protocol describes an ELISA-based procedure for accurate measurement of SARS-CoV-2 spike protein-receptor binding domain (RBD) neutralization efficacy by murine immune serum. The procedure requires a small amount of S-protein/RBD and angiotensin converting enzyme-2 (ACE2). A high-throughput, simple ELISA technique is employed. Plate-coated-RBDs are allowed to interact with the serum, then soluble ACE2 is added, followed by secondary antibodies and substrate. The key steps in this procedure include (1) serum heat treatment to prevent non-specific interactions, (2) proper use of blank controls to detect side reactions and eliminate secondary antibody cross-reactivity, (3) the addition of an optimal amount of saturating ACE2 to maximize sensitivity and prevent non-competitive co-occurrence of RBD-ACE2 binding and neutralization, and (4) mechanistically derived neutralization calculation using a calibration curve. Even manually, the protocol can be completed in 16 h for >30 serum samples; this includes the 7.5 h of incubation time. This automatable, high-throughput, competitive ELISA assay can screen a large number of sera, and does not require sterile conditions or special containment measures, as live viruses are not employed. In comparison to the ‘gold standard’ assays (virus neutralization titers (VNT) or plaque reduction neutralization titers (PRNT)), which are laborious and time consuming and require special containment measures due to their use of live viruses. This simple, alternative neutralization efficacy assay can be a great asset for initial vaccine development stages. The assay successfully passed conventional validation parameters (sensitivity, specificity, precision, and accuracy) and results with moderately neutralizing murine sera correlated with VNT assay results (R² = 0.975, n = 25), demonstrating high sensitivity. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Graphical abstract

Open AccessSystematic Review

Effectiveness of the WHO-Authorized COVID-19 Vaccines: A Rapid Review of Global Reports till 30 June 2021

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Vaccines 2021, 9(12), 1489; https://doi.org/10.3390/vaccines9121489 - 16 Dec 2021

Cited by 14 | Viewed by 2771

Abstract

Large clinical trials have proven the efficacy of the COVID-19 vaccine, and the number of studies about the effectiveness rapidly grew in the first half of the year after mass vaccination was administrated globally. This rapid review aims to provide evidence syntheses as [...] Read more.

Large clinical trials have proven the efficacy of the COVID-19 vaccine, and the number of studies about the effectiveness rapidly grew in the first half of the year after mass vaccination was administrated globally. This rapid review aims to provide evidence syntheses as a means to complement the current evidence on the vaccine effectiveness (VE) against various outcomes in real-world settings. Databases (PubMed, EMBASE, and MedRxiv) were searched up to 30 June 2021, (PROSPERO ID: 266866). A total of 39 studies were included, covering over 15 million participants from 11 nations. Among the general population being fully vaccinated, the VE against symptomatic SARS-CoV-2 infection was estimated at 89–97%, 92% (95% CI, 78–97%), and 94% (95% CI, 86–97%) for BNT162b2, ChAdOx1, and mRNA-1273, respectively. As for the protective effects against B.1.617.2-related symptomatic infection, the VE was 88% (95% CI, 85.3–90.1%) by BNT162b2 and 67.0% (95% CI, 61.3–71.8%) by ChAdOx1 after full vaccination. This review revealed a consistently high effectiveness of certain vaccines among the general population in real-world settings. However, scarce data on the major variants of SARS-CoV-2 and the shortness of the study time may limit the conclusions to the mRNA vaccines and ChAdOx1. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessCase Report

Dual Corneal-Graft Rejection after mRNA Vaccine (BNT162b2) for COVID-19 during the First Six Months of Follow-Up: Case Report, State of the Art and Ethical Concerns

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Matteo Nioi

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Ernesto d’Aloja

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Maurizio Fossarello

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Pietro Emanuele Napoli

Vaccines 2021, 9(11), 1274; https://doi.org/10.3390/vaccines9111274 - 03 Nov 2021

Cited by 21 | Viewed by 2653

Abstract

Present mass vaccination against Coronavirus Disease-19 (COVID-19) is the most widely used health policy and the most promising approach to curb the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic globally. However, new side effects are emerging from the mass vaccination not described [...] Read more.

Present mass vaccination against Coronavirus Disease-19 (COVID-19) is the most widely used health policy and the most promising approach to curb the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic globally. However, new side effects are emerging from the mass vaccination not described during the experimental stages. In the present study, we discuss a case of acute corneal graft rejection, which has occurred 25 years after transplantation and 13 days after the administration of the BNT162b2 vaccine (Comirnaty, BioNTech/Pfizer), which was followed-up for a period of six months. In this period, the corneal inflammation appeared twice but was successfully managed with topical therapy and supplementation of Vitamin D. A risk of corneal graft rejection must be included in the list of potential vaccine complications, in order to inform the transplanted patient to undergo a preliminary and a follow-up ocular examination, and eventually to include corneal graft in the list of contraindications to vaccination. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessCase Report

Humoral Response Induced by Prime-Boost Vaccination with the ChAdOx1 nCoV-19 and mRNA BNT162b2 Vaccines in a Teriflunomide-Treated Multiple Sclerosis Patient

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Yves Michiels

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Nadhira Houhou-Fidouh

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Gilles Collin

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Jérôme Berger

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Evelyne Kohli

Vaccines 2021, 9(10), 1140; https://doi.org/10.3390/vaccines9101140 - 06 Oct 2021

Cited by 3 | Viewed by 1740

Abstract

Patients with multiple sclerosis (MS) are treated with drugs that may impact immune responses to SARS-CoV-2 vaccination. Evaluation of “prime-boost” (heterologous) vaccination regimens including a first administration of a viral vector-based vaccine and a second one of an mRNA-based vaccine in such patients [...] Read more.

Patients with multiple sclerosis (MS) are treated with drugs that may impact immune responses to SARS-CoV-2 vaccination. Evaluation of “prime-boost” (heterologous) vaccination regimens including a first administration of a viral vector-based vaccine and a second one of an mRNA-based vaccine in such patients has not yet been completed. Here, we present the anti-spike protein S humoral response, including the neutralizing antibody response, in a 54-year-old MS patient who had been treated with teriflunomide for the past 2 years and who received a heterologous ChAdOx1 nCoV-19/ BNT162b2 vaccination regimen. The results showed a very strong anti-S IgG response and a good neutralizing antibody response. These results show that teriflunomide did not prevent the development of a satisfactory humoral response in this MS patient after vaccination with a ChAdOx1 nCoV-19/ BNT162b2 prime-boost protocol. Full article

(This article belongs to the Special Issue The COVID Vaccine)

Open AccessCase Report

A Case of Exacerbation of Subclinical Hyperthyroidism after First Administration of BNT162b2 mRNA COVID-19 Vaccine

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Vaccines 2021, 9(10), 1108; https://doi.org/10.3390/vaccines9101108 - 29 Sep 2021

Cited by 13 | Viewed by 5650

Abstract

COVID-19 vaccines are the most critical measure for controlling the COVID-19 pandemic; however, we have little information on their complications. We experienced a case of a patient who developed hyperthyroidism complicated with atrial fibrillation and heart failure on the sixth day after the [...] Read more.

COVID-19 vaccines are the most critical measure for controlling the COVID-19 pandemic; however, we have little information on their complications. We experienced a case of a patient who developed hyperthyroidism complicated with atrial fibrillation and heart failure on the sixth day after the first dose of COVID-19 vaccination. This case report shows the importance of considering hyperthyroidism as a possible complication after COVID-19 vaccination. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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Open AccessBrief Report

BNT162b2 Vaccine Encoding the SARS-CoV-2 P2 S Protects Transgenic hACE2 Mice against COVID-19

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Vaccines 2021, 9(4), 324; https://doi.org/10.3390/vaccines9040324 - 01 Apr 2021

Cited by 11 | Viewed by 4523

Abstract

BNT162b2 is a highly efficacious mRNA vaccine approved to prevent COVID-19. This brief report describes the immunogenicity and anti-viral protective effect of BNT162b2 in hACE2 transgenic mice. Prime-boost immunization with BNT162b2 elicited high titers in neutralizing antibodies against SARS-CoV-2, which correlated with viral [...] Read more.

BNT162b2 is a highly efficacious mRNA vaccine approved to prevent COVID-19. This brief report describes the immunogenicity and anti-viral protective effect of BNT162b2 in hACE2 transgenic mice. Prime-boost immunization with BNT162b2 elicited high titers in neutralizing antibodies against SARS-CoV-2, which correlated with viral clearance and alleviated lung lesions in these mice after viral challenge. Full article

(This article belongs to the Special Issue The COVID Vaccine)

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