Safety of COVID-19 Vaccines among Patients with Type 2 Diabetes Mellitus: Real-World Data Analysis.

BACKGROUND: Little is known about the adverse events (AEs) associated with coronavirus disease 2019 (COVID-19) vaccination in patients with type 2 diabetes mellitus (T2DM). METHODS: This study used vaccine AE reporting system data to investigate severe AEs among vaccinated patients with T2DM. A natural language processing algorithm was applied to identify people with and without diabetes. After 1:3 matching, we collected data for 6,829 patients with T2DM and 20,487 healthy controls. Multiple logistic regression analysis was used to calculate the odds ratio for severe AEs. RESULTS: After COVID-19 vaccination, patients with T2DM were more likely to experience eight severe AEs than controls: cerebral venous sinus thrombosis, encephalitis myelitis encephalomyelitis, Bell's palsy, lymphadenopathy, ischemic stroke, deep vein thrombosis (DVT), thrombocytopenia (TP), and pulmonary embolism (PE). Moreover, patients with T2DM vaccinated with BNT162b2 and mRNA-1273 were more vulnerable to DVT and TP than those vaccinated with JNJ-78436735. Among patients with T2DM administered mRNA vaccines, mRNA-1273 was safer than BNT162b2 in terms of the risk of DVT and PE. CONCLUSION: Careful monitoring of severe AEs in patients with T2DM may be necessary, especially for those related to thrombotic events and neurological dysfunctions after COVID-19 vaccination.

Application of Minimal Physiologically-Based Pharmacokinetic Model to Simulate Lung and Trachea Exposure of Pyronaridine and Artesunate in Hamsters.

A fixed-dose combination of pyronaridine and artesunate, one of the artemisinin-based combination therapies, has been used as a potent antimalarial treatment regimen. Recently, several studies have reported the antiviral effects of both drugs against severe acute respiratory syndrome coronavirus two (SARS-CoV-2). However, there are limited data on the pharmacokinetics (PKs), lung, and trachea exposures that could be correlated with the antiviral effects of pyronaridine and artesunate. The purpose of this study was to evaluate the pharmacokinetics, lung, and trachea distribution of pyronaridine, artesunate, and dihydroartemisinin (an active metabolite of artesunate) using a minimal physiologically-based pharmacokinetic (PBPK) model. The major target tissues for evaluating dose metrics are blood, lung, and trachea, and the nontarget tissues were lumped together into the rest of the body. The predictive performance of the minimal PBPK model was evaluated using visual inspection between observations and model predictions, (average) fold error, and sensitivity analysis. The developed PBPK models were applied for the multiple-dosing simulation of daily oral pyronaridine and artesunate. A steady state was reached about three to four days after the first dosing of pyronaridine and an accumulation ratio was calculated to be 1.8. However, the accumulation ratio of artesunate and dihydroartemisinin could not be calculated since the steady state of both compounds was not achieved by daily multiple dosing. The elimination half-life of pyronaridine and artesunate was estimated to be 19.8 and 0.4 h, respectively. Pyronaridine was extensively distributed to the lung and trachea with the lung-to-blood and trachea-to-blood concentration ratios (=Cavg,tissue/Cavg,blood) of 25.83 and 12.41 at the steady state, respectively. Also, the lung-to-blood and trachea-to-blood AUC ratios for artesunate (dihydroartemisinin) were calculated to be 3.34 (1.51) and 0.34 (0.15). The results of this study could provide a scientific basis for interpreting the dose-exposure-response relationship of pyronaridine and artesunate for COVID-19 drug repurposing.

Formative Usability Evaluation of a Three-Way Digital Healthcare System for the People with Disabilities and Their Caregivers: A Cross-Sectional Study.

During the COVID-19 pandemic, there was a growing awareness about the importance of building a health and safety net based on digital healthcare systems, such as ICT-based local community online services and patient monitoring technology. This study was conducted with the aim of evaluating the formative usability of a three-way digital healthcare system, which had been developed to build a health and safety net for people with disabilities and deriving the directions for system improvement in order for them to be used as basic data for further system enhancement. A formative usability evaluation of a three-way digital healthcare system was performed with the participation of 43 healthcare professionals, using the 10-item System Usability Scale (SUS) and five items for satisfaction evaluation. Each item was rated on a five-point Likert scale, with the result converted to a scale of 100. Analysis was performed using the average score and the acceptable system usability level. The overall mean SUS score was 62.4, which corresponds to Grade D according to the SUS grading scale, and the below-average items were complexity (Q2), convenience (Q8), simplicity (Q3), professionalism (technician support, prior learning) (Q4, Q10), and learnability (Q7). The overall mean user satisfaction was 71.2 points, where overall satisfaction, system architecture and understandability, and continuous use intention were marked with below-average scores. The SUS D grade is interpreted as "fair" and the water solubility is "almost acceptable". For the usability enhancement of the newly developed a three-way digital healthcare system, the overall direction for system architecture improvement was analyzed centering on complexity (Q2), convenience (Q8), professionalism (technician support, prior learning) (Q4, Q10), learnability (Q7), and simplicity (Q3). Efforts need to be directed at enhancing system satisfaction and continuance rate by deriving detailed system improvement strategies and achieving system enhancement to reflect the opinions of not only experts but also users.

Effects of meteorological factors and air pollutants on the incidence of COVID-19 in South Korea.

Air pollution and meteorological factors can exacerbate susceptibility to respiratory viral infections. To establish appropriate prevention and intervention strategies, it is important to determine whether these factors affect the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therefore, this study examined the effects of sunshine, temperature, wind, and air pollutants including sulfur dioxide (SO2), carbon monoxide (CO), ozone (O3), nitrogen dioxide (NO2), particulate matter ≤2.5 µm (PM2.5), and particulate matter ≤10 µm (PM10) on the age-standardized incidence ratio of coronavirus disease (COVID-19) in South Korea between January 2020 and April 2020. Propensity score weighting was used to randomly select observations into groups according to whether the case was cluster-related, to reduce selection bias. Multivariable logistic regression analyses were used to identify factors associated with COVID-19 incidence. Age 60 years or over (odds ratio [OR], 1.29; 95% CI, 1.24-1.35), exposure to ambient air pollutants, especially SO2 (OR, 5.19; 95% CI, 1.13-23.9) and CO (OR, 1.17; 95% CI, 1.07-1.27), and non-cluster infection (OR, 1.28; 95% CI, 1.24-1.32) were associated with SARS-CoV-2 infection. To manage and control COVID-19 effectively, further studies are warranted to confirm these findings and to develop appropriate guidelines to minimize SARS-CoV-2 transmission.

The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data.

Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are authorized in the US to hinder COVID-19 infections. We analyzed severe and common adverse events in response to COVID-19 vaccines using real-world, Vaccine Adverse Effect Reporting System (VAERS) data. From 14 December 2020 to 30 September 2021, 481,172 (50.7 ± 17.5 years, males 27.89%, 12.35 per 100,000 people) individuals reported adverse events (AEs). The median time to severe AEs was 2 days after injection. The risk of severe AEs following the one viral vector vaccine (OR = 1.044, 95% CI = 1.005-1.086) was significantly higher than that after the two mRNA vaccines, and the risk among males (OR = 1.374, 95% CI = 1.342-1.406) was higher than among females, except for anaphylaxis. For common AEs, however, the risk to males (OR = 0.621, 95% CI = 0.612-0.63) was lower than to females. In conclusion, we provided medical insight and clinical guidance about vaccine types by characterizing AEs using real-world data. In particular, COVID-19 mRNA vaccines are safer than viral vector vaccines with regard to coagulation disorders, whereas inflammation-related AEs are lower in the viral vaccine. The risk-benefit ratio of vaccines should be carefully considered, and close monitoring and management of severe AEs is needed.

Impact analysis of virtual ambulatory transplant pharmacists during COVID-19.

INTRODUCTION: During the coronavirus disease 2019 (COVID-19) pandemic, transplant centers were challenged to meet the demand for new telemedicine strategies. The ability of lung transplant providers (LTP) to conduct face-to-face clinic visits for high-risk immunocompromised patients, such as lung transplant recipients (LTR), was limited. Through the implementation of comprehensive medication management visits, pharmacists were able to assist LTP in the transition to telemedicine. METHODS: A retrospective chart review of telephone encounters from cardiothoracic (CT) transplant pharmacists at our center from March to September 2020 was completed. LTR scheduled for clinic visits with LTP were called prior to the visit by CT transplant pharmacists who conducted medication list reviews, adherence assessments, and medication access assistance. Clinical recommendations were communicated directly to the LTP and documented in patient electronic medical records. The primary outcome was the number of pharmacist-driven clinical interventions. Secondary endpoints included the clinical severity and value of service of each intervention, percentage of accepted recommendations, patient cost savings interventions, prevention of adverse events, and avoidance of inappropriate doses. RESULTS: From March to September 2020, the CT transplant pharmacists conducted 385 virtual visits on 157 LTR with a median of 20 minutes spent per visit. There were 891 total interventions made by CT transplant pharmacists, including 778 medication discrepancies identified. Over 60% of encounters demonstrated some form of medication error and over 55% of encounters exhibited value of pharmacy services. CONCLUSION: Implementation of CT transplant pharmacist telehealth visits has potential for increased patient access to pharmacy care and improved accuracy of medication lists. When focusing on the severity of errors and value of services, most demonstrated a level of significance. Further investigation is needed to analyze the impact of this service on patient outcomes as well as cost-effectiveness.