Myocarditis and Pericarditis following COVID-19 Vaccination: Inequalities in Age and Vaccine Types.

An increasing number of myocarditis/pericarditis incidences has been reported after coronavirus disease-19 (COVID-19) vaccination in adolescents and young adults. This study was designed to investigate the incidence rate of-and risk for-myocarditis and pericarditis following COVID-19 vaccination in the United States according to age and vaccine type. This study used the Vaccine Adverse Events Reporting System (VAERS) from 11 December 2020 to 13 August 2021. A population-based data mining approach was performed based on the reporting odds ratio (ROR). Adverse events of myocarditis and pericarditis following COVID-19 vaccination were rare, with an incidence rate of 5.98 (95% CI = 5.73-6.24) cases per million doses administered. The incidence rate was higher in adolescents and after the administration of the second dose of messenger RNA (mRNA) vaccines. Overall, two mRNA vaccines were significantly associated with increased risks for myocarditis/pericarditis (mRNA-1273 (Moderna): ROR = 2.91, 95% CI = 2.21-3.83; BNT162b2 (Pfizer-BioNTech): ROR = 5.37, 95% CI = 4.10-7.04) compared to all other vaccines from VAERS. The viral vector vaccine of Ad26.COV2.S (Janssen) was not associated with signals of myocarditis/pericarditis (ROR = 1.39; 95% CI = 0.99-1.97). This study found increased risks for myocarditis/pericarditis following mRNA COVID-19 vaccines. For patients at high risk for myocarditis/pericarditis or with myocardial injuries, the viral vector vaccine may be an alternative for consideration.

Monitoring transmissibility and mortality of COVID-19 in Europe

Objectives: As a global pandemic is inevitable, real-time monitoring of transmission is vital for containing the spread of COVID-19. The main objective of this study was to report the real-time effective reproduction numbers (R(t)) and case fatality rates (CFR) in Europe.

Pandemic Worry and Preventive Health Behaviors During the COVID-19 Outbreak.

Objective: As schools are preparing for onsite learning, it is urgently needed to characterize the extent of pandemic worry and to examine predictors of adopting preventive health behaviors of hand washing, face mask wearing, and maintaining social distance among student pharmacists. Methods: An online survey was sent to 326 student pharmacists in the United States. Pandemic worry was measured using a seven-point Likert scale ranging from extremely not afraid of, to extremely afraid of getting COVID-19. The health belief model (HBM) was the theoretical framework of this study. Preventive health behaviors and components of the HBM were also measured using seven-point Likert scales (one indicated extremely unlikely; seven indicated extremely likely). Multivariable linear regression models were used to identify predictors of each behavior. Results: A medium level of pandemic worry (M = 4.2, SD = 1.92) was identified and females reported a higher pandemic worry. Respondents reported that they were extremely likely to wash their hands (M = 6.8, SD = 0.48) and maintain social distance (M = 6.6, SD = 0.92), but were moderately unlikely to wear face masks (M = 2.2, SD = 1.51). Determinants of face mask wearing included pandemic worry, perceived benefits, cue to action, self-efficacy, and being of an Asian American. Perceived barriers were negatively associated with face mask wearing. Conclusion: Strategies should be implemented to reduce the psychological impact of COVID-19 pandemic among student pharmacists. Predictors identified in this study should be incorporated in efforts to improve face mask wearing. Continued monitoring of pandemic worry and preventive health behaviors is of great significance when universities and colleges are for onsite learning.

Knowledge and Determinants of Behavioral Responses to the Pandemic of COVID-19.

Background: Understanding knowledge and behavioral responses to the pandemic of coronavirus disease 2019 (COVID-19) is important for appropriate public health interventions. Objectives: To assess knowledge of COVID-19 and to examine determinants associated with the adoption of preventive health behaviors among future health care providers. Methods: An anonymous online survey was sent out to pharmacy students in high and low-endemic areas of COVID-19 in China. Based on recommendations from the Chinese Center for Disease Control and Prevention, preventive health behaviors examined in this study included washing hands, wearing a face mask, and maintaining social distancing. The Health Belief Model (HBM) was used and measured by a seven-point Likert scale (one as extremely unlikely; seven as extremely likely). Multivariate linear regression models were used to examine predictors of preventive health behaviors. Results: Among 203 respondents who finished the survey, a medium level of knowledge (4.41 ± 0.95) of COVID-19 was reported. Respondents were extremely likely to wear a face mask (6.85 ± 0.60), but only moderately likely to engage in washing hands (5.95 ± 1.38) and maintaining social distancing (6.19 ± 1.60). Determinants of washing hands were cue to action, self-efficacy, knowledge, and gender; wearing a face mask were cue to action, self-efficacy, knowledge, and ethnicity; and maintaining social distancing were cue to action and self-efficacy. Conclusions: Public health interventions should consider incorporating cue to action, self-efficacy, and knowledge as factors to potentially improve the adoption of face mask-wearing, hand washing, and social distancing as appropriate individual preventive measures, especially if local and regional authorities are considering reopening schools sometime in future.

Mortality Rate and Characteristics of Deaths Following COVID-19 Vaccination.

Background: The emergency use authorization for coronavirus disease 2019 (COVID-19) vaccines brought both hopes and concerns to the Americans and others. We aimed to estimate the mortality rate of COVID-19 vaccination and presented characteristics of deaths following COVID-19 vaccination. Methods: Data on deaths following COVID-19 vaccination were obtained from the Vaccine Adverse Event Reporting System (VAERS) from December 11, 2020 through January 8, 2021. The Centers for Disease Control and Prevention (CDC) COVID Data Tracker was used to identify the total number of people receiving COVID-19 vaccines during the same period to estimate the mortality rate. Stratified analysis was conducted by the location of vaccination. Results: As of January 8, 2021, 55 deaths were reported, and the mortality rate of COVID-19 vaccination was 8.2 per million population. A total of 37 deaths were reported among long-term care facility residents, and the mortality rate was 53.4 per million population. Top reported comorbidities associated with deaths included hypertension, dementia, chronic obstructive pulmonary disease (COPD), diabetes, and heart failure. In addition, dementia was more likely to be associated with deaths vaccinated at long-term care facilities than at other locations. Conclusion: The benefits of COVID-19 vaccines outweigh the potential risks in older frail populations, and our findings do not support actions to exclude older adults from being vaccinated. However, continued monitoring of COVID-19 vaccination is still warranted.

Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).

BACKGROUND: Several pharmacological agents, such as chloroquine/hydroxychloroquine, have been promoted for COVID-19 treatment or pre-exposure prophylaxis. However, no comprehensive evaluation of the safety of these possible agents is available, and is urgently needed. OBJECTIVE: The purpose of this study was to investigate the risks of cardiac adverse events associated with the possible pharmacotherapies for COVID-19, including certain antimalarial, antiviral, and antibiotic drugs. PATIENTS AND METHODS: We conduced retrospective pharmacovigilance analyses of the US Food and Drug Administration Adverse Event Reporting System database. The reporting odds ratio (ROR), a data mining algorithm commonly used in pharmacovigilance assessment, was generated to quantify the detection signal of adverse events. RESULTS: Among individuals without coronavirus infection from 2015 Q1 to 2020 Q1, increased risks for cardiac disorders were found for antiviral agents such as chloroquine/hydroxychloroquine (ROR: 1.68; 95% confidence interval [CI] 1.66-1.70), lopinavir/ritonavir (ROR: 1.52; 95% CI 1.39-1.66), and antibiotics such as azithromycin (ROR: 1.37; 95% CI 1.30-1.44) and ceftriaxone (ROR: 1.92; 95% CI 1.80-2.05). Increased serious cardiac adverse events, including myocardial infarction, arrhythmia, and cardiac arrest, were also reported for these drugs. Further analyses of individuals with coronavirus infections revealed that 40% of individuals receiving chloroquine/hydroxychloroquine reported serious cardiac adverse events. Two cases resulted in QT prolongations and one case resulted in cardiac arrest. Chloroquine/hydroxychloroquine and azithromycin contributed to all the QT prolongation and cardiac arrest cases. CONCLUSIONS: The current pharmacotherapies for COVID-19 are associated with increased risks of cardiac adverse events. Variations in the cardiac safety profiles of these pharmacotherapies were also observed. Clinicians should closely monitor patients with COVID-19, especially those at high risk, using chloroquine/hydroxychloroquine and azithromycin.

Chinese medicine treatment of mastitis in COVID-19 patients: A protocol for systematic review.

BACKGROUND: Assessing the effectiveness and safety of Chinese medicine for the mastitis in COVID-19 patients is the main purpose of this systematic review protocol. METHODS: The following electronic databases will be searched from inception to April 2020: MEDLINE, Ovid, EMBASE, the Cochrane Library, the Allied and Complementary Medicine Database (AMED), Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), VIP Database and Wanfang Database. In addition, Clinical trial registries, like the Chinese Clinical Trial Registry (ChiCTR), the Netherlands National Trial Register (NTR) and ClinicalTrials.gov, will be searched for ongoing trials with unpublished data. No language restrictions will be applied. The primary outcome will be the time of disappearance of main symptoms (including fever, asthenia, cough disappearance rate, and temperature recovery time), and serum cytokine levels. The secondary outcome will be the accompanying symptoms (such as myalgia, expectoration, stuffiness, runny nose, pharyngalgia, anhelation, chest distress, dyspnea, crackles, headache, nausea, vomiting, anorexia, diarrhea) disappear rate, negative COVID-19 results rate on 2 consecutive occasions (not on the same day), CT image improvement, average hospitalization time, occurrence rate of common type to severe form, clinical cure rate, and mortality. Two independent reviewers will conduct the study selection, data extraction and assessment. RevMan V.5.3 will be used for the assessment of risk of bias and data synthesis. RESULTS: The results will provide a high-quality synthesis of current evidence for researchers in this subject area. CONCLUSION: The conclusion of the study will provide an evidence to judge whether Chinese medicine is effective and safe for mastitis in COVID-19 patients. PROSPERO REGISTRATION NUMBER: CRD42020189924.

Monitoring transmissibility and mortality of COVID-19 in Europe.

OBJECTIVES: As a global pandemic is inevitable, real-time monitoring of transmission is vital for containing the spread of COVID-19. The main objective of this study was to report the real-time effective reproduction numbers (R(t)) and case fatality rates (CFR) in Europe. METHODS: Data for this study were obtained mainly from the World Health Organization website, up to March 9, 2020. R(t) were estimated by exponential growth rate (EG) and time-dependent (TD) methods. 'R0' package in R was employed to estimate R(t) by fitting the existing epidemic curve. Both the naïve CFR (nCFR) and adjusted CFR (aCFR) were estimated. RESULTS: With the EG method, R(t) was 3.27 (95% confidence interval (CI) 3.17-3.38) for Italy, 6.32 (95% CI 5.72-6.99) for France, 6.07 (95% CI 5.51-6.69) for Germany, and 5.08 (95% CI 4.51-5.74) for Spain. With the TD method, the R value for March 9 was 3.10 (95% CI 2.21-4.11) for Italy, 6.56 (95% CI 2.04-12.26) for France, 4.43 (95% CI 1.83-7.92) for Germany, and 3.95 (95% CI 0-10.19) for Spain. CONCLUSIONS: This study provides important findings on the early outbreak of COVID-19 in Europe. Due to the recent rapid increase in new cases of COVID-19, real-time monitoring of the transmissibility and mortality in Spain and France is a priority.