Predictive Role of Blood Cellular Indices and Their Relationship with Endogenous Glycosaminoglycans as Determinants of Inflammatory Biomarkers in Pulmonary Embolism.

INTRODUCTION: In this study, we profiled the levels of blood cellular indices, endogenous glycosaminoglycans (GAGs) and inflammatory biomarkers in a cohort comprised of pulmonary embolism (PE) patients, to determine their inter-relationships. Identification of this relationship may provide insight to the complex pathophysiology of PE and the predictive role of blood cellular indices in acute PE patients. MATERIALS AND METHODS: Plasma samples from PE patients and healthy controls were analyzed for thrombo-inflammatory biomarkers (IL-2, IL-4, IL-6, IL-8, IL-10, VEGF, IFN-É£, TNF-α, IL-1α, IL-1ß, MCP-1, EGF, D-dimer, CRP and MMP-9) using biochip array and ELISA methods. The endogenous GAG levels were quantified using a fluorescence quenching method. The data regarding the blood cellular indices were collected through the review of patient medical records and analyzed to demonstrate their relationship. RESULTS: The levels of inflammatory biomarkers and endogenous GAGs were elevated in acute PE patients compared to controls (P < .05). Most of the blood cellular indices have shown significant differences in acute PE patients compared to controls (P < .05). The levels of inflammatory biomarkers, endogenous GAGs and the blood cellular indices have shown significant associations in correlation and multivariable analysis. While NLR, PLR and SII were significantly predicting the 30-day mortality, PNR, ELR and EMR were not sufficient to predict 30-day mortality in acute PE. CONCLUSION: Our results show that the increased thrombo-inflammatory response is associated with the release of GAGs and the changes in blood cellular indices. The predictive role of the blood cellular indices for mortality is dependent on their relationship with the inflammatory response.

Safety and efficacy of currently used COVID‐19 vaccines: Results of a pilot survey

Introduction After its emergence in China, the COVID‐19 pandemic has spread rapidly around the world, affecting all of our lives. Over the past few months, different vaccines have been issued to the public following FDA approval. Since their release, the number of COVID‐19 cases in the United States have gone down significantly. However, there is a long way to go until the eradication of the virus. There has also been a strong emergence of delta variants across the world, which (for the most part) can still be partially blocked by vaccines. This is why it is so important everyone gets a vaccine for COVID‐19. Purpose The purpose of this project was to determine the public’s opinion of COVID‐19 and the COVID‐19 vaccines, while also determining correlation between different demographics and these opinions. Hypothesis There are many different factors within various demographics that cause a correlation to a certain belief regarding COVID‐19 and COVID‐19 vaccines. Materials and Methods This study was conducted in collaboration with Loyola University Chicago. Survey questions about COVID‐19 and COVID‐19 vaccinations have been sent electronically to the respondents. Initial results based on a pilot study where the answers from 250 respondents were compiled. Basic descriptive statistics were used to characterize the sample and study variables. Univariate analysis of associations between categorical variables and vaccination intent and acceptance were assessed by chi‐square statistics. Multivariate analysis performed by regression analysis to determine significant independent predictors. A p‐value of less than 0.05 was considered to indicate statistical significance;all tests were 2‐tailed. Results In our study population vaccine willingness have been found as 94,4%, the rate of receiving at least one dose of vaccination have been found as 90,8%. In univariate analysis, gender, believing that vaccinations protect others and having enough information about safety and efficacy of vaccines have been found significant factors for vaccine willingness. For receiving at least one dose of vaccination, gender, previous COVID‐19 infection, believing that vaccinations protect others, having enough information about safety and efficacy of vaccines, the degree of COVID‐19 related effects on person’s life, knowledge that COVID‐19 can cause blood clots and the degree of concerns about delta variant have been found significant factors for vaccine willingness. In multivariate analysis only believing that vaccinations protect others have been found as an independent factor for vaccine willingness. For receiving at least one dose of vaccination, believing that vaccinations protect others, the degree of COVID‐19 related effects on person’s life and having enough information about safety and efficacy of vaccines have been found independent factors in multivariate analysis. Conclusion There are several vaccines currently available in the United States. All of these vaccines provide immunity against COVID‐19 and its variants which have been identified in 2020 and 2021. The level of immunity and the reported adverse events vary with each of the vaccines. Despite minor issues the vaccination outweighs the benefits and provides a clear approach to control this pandemic.

Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic.

Pharmacovigilance plays a lifesaving role in the practice of medicine. In 2021, during the Coronavirus Infectious Disease 2019 (COVID-19) pandemic, Loyola University Chicago launched a graduate-level Pharmacovigilance Certificate Program (PV-CERT) and a pre-professional non-graduate Pharmacovigilance Certificate Course (EPEC-PV), to provide students a comprehensive and contemporary understanding of the principles and practices of pharmacovigilance. Formal training in pharmacovigilance through this course provided a structured understanding of how safety data are generated through clinical trials and from real-world evidence as well as the regulatory environment in which data are monitored and interpreted. Pharmacovigilance training is of critical importance, especially during the COVID-19 pandemic, during which several drugs were re-purposed for the management of various stages of COVID-19 without conventional safety data. Moreover, the safety of currently-used vaccines is of concern in some populations. Although anticoagulants and antithrombotic medications are crucial in the management of COVID-19, a clear pharmacovigilance program on their use in this indication is not established. As the century progresses, new diseases and infectious agents will require novel therapies for which the evaluation of benefits versus risks will be as essential as it has been for the current COVID-19 pandemic. As such, the Loyola course and accompanying programs on pharmacovigilance will play a key role in educating the next generation of professionals in pursuing careers in the development of therapies that ultimately improve patient outcomes while maintaining rigorous safety standards.

The Relevance of Anti-PF4 Antibody Isotypes and Endogenous Glycosaminoglycans and their Relationship with Inflammatory Biomarkers in Pulmonary Embolism Patients.

INTRODUCTION: Previous studies have shown that inflammation may contribute to the interplay of endogenous glycosaminoglycans (GAGs) and anti-PF4 antibodies. In this study, we quantified the levels of anti-PF4 antibody isotypes and endogenous GAGs together with inflammatory biomarkers in pulmonary embolism (PE) patients to determine whether there is a relationship in between. Identification of this relationship may provide insight to the complex pathophysiology of PE and HIT and may also be useful for development of potential prognostic, diagnostic and therapeutic interventions. MATERIALS AND METHODS: Plasma samples from PE patients (n: 210) were analyzed for anti-PF4 antibody isotypes and various thrombo-inflammatory cytokines utilizing commercially available biochip array and ELISA methods. The endogenous GAG levels in PE patients' plasma were quantified using a fluorescence quenching method. The collected data analyzed to demonstrate the relationship between various parameters. RESULTS: The endogenous GAG levels were increased in the PE group (P < .05). The levels of anti-PF4 antibody isotypes were higher in varying levels in comparison to the normal group (P < .05). Inflammatory cytokines have shown varying levels of increase with IL-6, IL-8 and IL-10 showing the most pronounced values. Mortality outcome was related to increased GAGs and some of the cytokines. CONCLUSION: In this study, we demonstrated increased levels of anti-PF4 antibody isotypes, endogenous GAGs, and inflammatory biomarkers in a large patient cohort in PE. The levels of the endogenous GAGs and inflammatory biomarkers were associated with PE severity and mortality. More studies are needed to understand this complex pathophysiology.

An Update on the Status of Vaccine Development for SARS-CoV-2 Including Variants. Practical Considerations for COVID-19 Special Populations.

The progress in the development of various vaccine platforms against SARS-CoV-2 have been rather remarkable owing to advancement in molecular and biologic sciences. Most of the current vaccines and those in development focus on targeting the viral spike proteins by generating antibodies of varying spectrum. These vaccines represent a variety of platforms including whole virus vaccines, viral vector vaccines, nucleic acid vaccines representing RNA, DNA, and their hybrid forms.The therapeutic efficacy of these vaccines varies owing to their pharmacodynamic individualities. COVID-19 variants are capable of inducing different pathologic responses and some of which may be resistant to antibodies generated by current vaccines. The current clinical use of these vaccines has been through emergency use authorization until recently. Moreover, the efficacy and safety of these vaccines have been tested in substantial numbers of individuals but studies in special populations that better reflect the global population are pending results. These specialized populations include young children, immunocompromised patients, pregnant individuals, and other specialized groups. Combination approaches, molecularly modified vaccination approaches, and vaccines conferring longer periods of immunity are being currently being investigated, as well as pharmacovigilance studies.The continual transformation of SARS-CoV-2 and its variants are of concern along with the breakthrough infections. These considerations pose new challenges for the development of vaccination platforms. For this purpose, booster doses, combination vaccine approaches, and other modalities are being discussed. This review provides an updated account of currently available vaccines and those in advanced development with reference to their composition and mechanisms of action.A discussion on the use of vaccines in special populations including immunocompromised patients, pregnant women and other specialized populations are also included.

Public Perceptions of Current COVID-19 Vaccinations. Results of a Pilot Survey.

INTRODUCTION: We conducted a cross-sectional survey as a part of an educational program in collaboration with the Global Thrombosis Forum (GTF), an affiliate of North American Thrombosis Forum (NATF), and Loyola University about public perceptions of COVID-19 and COVID-19 vaccinations in the US. In this study, we are reporting the results of this survey. MATERIALS AND METHODS: The survey, in the form of a questionnaire, has been developed by GTF and faculty members. A prepared questionnaire was sent to the members of the Georgia and Illinois communities. RESULTS: In our current study, the COVID-19 vaccine willingness rate was 94.5% and vaccination rate was 90.9%. In multivariate analysis believing to have enough information about the safety and efficacy of COVID-19 vaccines (OR: 3.730, 95% CI: 1.199-11.603, p: 0.023) and gender (OR: 0.123, 95% CI: 0.016-0.967, p: 0.046) were significant predictors for vaccine willingness. Previous COVID-19 infection (OR: 0.215, 95% CI: 0.061-0.758, p: 0.017), moderate and severe effects of COVID-19 pandemic on participant's life (OR: 4.631, 95% CI 1.681-12.760, p: 0.003) and believing to have enough information about the safety and efficacy of COVID-19 vaccines (OR: 4.119, 95% CI: 1.508-11.253, p: 0.006) were significant predictors for final vaccination status. CONCLUSION: In conclusion, currently vaccination remains one of the most effective tools in the fight against the COVID-19 pandemic. The vaccine hesitancy is a complex phenomenon that is driven by individuals' perceptions of safety, and efficiency of the vaccines. We must continue to educate the public and communities that vaccines are safe, that they are effective and that they are still required even after a COVID-19 infection.

The COVID-19 Pandemic and the Need for an Integrated and Equitable Approach: An International Expert Consensus Paper.

BACKGROUND: One year after the declaration of the coronavirus disease 2019 (COVID-19) pandemic by the World Health Organization (WHO) and despite the implementation of mandatory physical barriers and social distancing, humanity remains challenged by a long-lasting and devastating public health crisis. MANAGEMENT: Non-pharmacological interventions (NPIs) are efficient mitigation strategies. The success of these NPIs is dependent on the approval and commitment of the population. The launch of a mass vaccination program in many countries in late December 2020 with mRNA vaccines, adenovirus-based vaccines, and inactivated virus vaccines has generated hope for the end of the pandemic. CURRENT ISSUES: The continuous appearance of new pathogenic viral strains and the ability of vaccines to prevent infection and transmission raise important concerns as we try to achieve community immunity against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) and its variants. The need of a second and even third generation of vaccines has already been acknowledged by the WHO and governments. PERSPECTIVES: There is a critical and urgent need for a balanced and integrated strategy for the management of the COVID-19 outbreaks organized on three axes: (1) Prevention of the SARS-CoV-2 infection, (2) Detection and early diagnosis of patients at risk of disease worsening, and (3) Anticipation of medical care (PDA). CONCLUSION: The "PDA strategy" integrated into state policy for the support and expansion of health systems and introduction of digital organizations (i.e., telemedicine, e-Health, artificial intelligence, and machine-learning technology) is of major importance for the preservation of citizens' health and life world-wide.

An Update on the Pathogenesis of COVID-19 and the Reportedly Rare Thrombotic Events Following Vaccination.

Today the coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has become a global health problem. After more than a year with the pandemic, although our knowledge has progressed on COVID-19, there are still many unknowns in virological, pathophysiological and immunological aspects. It is obvious that the most efficient solution to end this pandemic are safe and efficient vaccines. This manuscript summarizes the pathophysiological and thrombotic features of COVID-19 and the safety and efficacy of currently approved COVID-19 vaccines with an aim to clarify the recent concerns of thromboembolic events after COVID-19 vaccination. The influx of newer information is rapid, requiring periodic updates and objective assessment of the data on the pathogenesis of COVID-19 variants and the safety and efficacy of currently available vaccines.