Safety of BNT162b2 or CoronaVac COVID-19 vaccines in patients with heart failure: A self-controlled case series study

Background: COVID-19 vaccines are important for patients with heart failure (HF) to prevent severe outcomes but the safety concerns could lead to vaccine hesitancy. This study aimed to investigate the safety of two COVID-19 vaccines, BNT162b2 and CoronaVac, in patients with HF. Methods: We conducted a self-controlled case series analysis using the data from the Hong Kong Hospital Authority and the Department of Health. The primary outcome was hospitalization for HF and the secondary outcomes were major adverse cardiovascular events (MACE) and all hospitalization. We identified patients with a history of HF before February 23, 2021 and developed the outcome event between February 23, 2021 and March 31, 2022 in Hong Kong. Incidence rate ratios (IRR) were estimated using conditional Poisson regression to evaluate the risks following the first three doses of BNT162b2 or CoronaVac. Findings: We identified 32,490 patients with HF, of which 3035 were vaccinated and had a hospitalization for HF during the observation period (BNT162b2 = 755;CoronaVac = 2280). There were no increased risks during the 0–13 days (IRR 0.64 [95% confidence interval 0.33–1.26];0.94 [0.50–1.78];0.82 [0.17–3.98]) and 14–27 days (0.73 [0.35–1.52];0.95 [0.49–1.84];0.60 [0.06–5.76]) after the first, second and third doses of BNT162b2. No increased risks were observed for CoronaVac during the 0–13 days (IRR 0.60 [0.41–0.88];0.71 [0.45–1.12];1.64 [0.40–6.77]) and 14–27 days (0.91 [0.63–1.32];0.79 [0.46–1.35];1.71 [0.44–6.62]) after the first, second and third doses. We also found no increased risk of MACE or all hospitalization after vaccination. Interpretation: Our results showed no increased risk of hospitalization for HF, MACE or all hospitalization after receiving BNT162b2 or CoronaVac vaccines in patients with HF. Funding: The project was funded by a Research Grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (Ref. No. COVID19F01). F.T.T.L. (Francisco T.T. Lai) and I.C.K.W. (Ian C.K. Wong)'s posts were partly funded by the D24H;hence this work was partly supported by AIR@InnoHK administered by Innovation and Technology Commission. © 2022 The Authors

Safety of Inactivated and mRNA COVID-19 Vaccination among Patients Treated for Hypothyroidism: a Population-based Cohort Study

Background: Thyroiditis and Graves’ disease have been reported after COVID-19 vaccination. Patients with hypothyroidism due to various etiologies may be at risk of thyroid-specific outcomes. We aimed to evaluate the risks of thyroid-specific outcomes and adverse events after COVID-19 vaccination among patients treated for hypothyroidism. Methods: In this population-based cohort from Hong Kong Hospital Authority electronic health records with Department of Health vaccination records linkage, levothyroxine users were categorized into unvaccinated, vaccinated with BNT162b2 (mRNA vaccine) or CoronaVac (inactivated vaccine) between 23 February and 9 September 2021. Propensity score (PS) weighting with inverse probability of treatment weighting (IPTW) was applied to balance the baseline characteristics among the three groups, which included age, sex, history of COVID-19, health care utilization, comorbidities, baseline thyroid-stimulating hormone (TSH) level (within the 6 months before the index date), and recent use of medications including anti-hypertensive, anti-diabetic and lipid-lowering agents. Study outcomes were dosage reduction or escalation in levothyroxine, emergency department visit, unscheduled hospitalization, adverse events of special interest (AESI) according to World Health Organization's Global Advisory Committee on Vaccine Safety, and all-cause mortality. Results: In total, 47,086 levothyroxine users were identified (BNT162b2: n=12,310;CoronaVac: n=11,353;unvaccinated: n=23,423). After PS weighting, all baseline characteristics had standardised differences of less than 0.2, implying a balance of covariates among the three groups. COVID-19 vaccination was not associated with increased risks of levothyroxine dosage reduction (BNT162b2: HR=0.971, 95% CI 0.892–1. 058;CoronaVac: HR=0.968, 95% CI 0.904–1. 037) or escalation (BNT162b2: HR=0.779, 95% CI 0.519–1.169;CoronaVac: HR=0.715, 95% CI 0.481–1. 062). Besides, COVID-19 vaccination was not associated with a higher risk of emergency department visits (BNT162b2: HR=0.944, 95% CI 0.700-1.273;CoronaVac: HR=0.851, 95% CI 0.647-1.120) or unscheduled hospitalization (BNT162b2: HR=0.905, 95% CI 0.539-1.520;CoronaVac: HR=0.735, 95% CI 0.448-1.207). There were two (0. 016%) deaths and six (0. 062%) AESI recorded for BNT162b2 recipients, and one (0. 009%) and three (0. 035%) for CoronaVac recipients, respectively. Sensitivity analyses were performed by stratifying the groups according to age, sex and pre-vaccination thyroid status. The results were largely consistent with the main analysis. Conclusion: BNT162b2 or CoronaVac vaccination is not associated with unstable thyroid status or an increased risk of adverse outcomes among patients treated for hypothyroidism. These reassuring data should encourage them to get vaccinated against COVID-19 for protection from potentially worse COVID-19-related outcomes.Presentation: No date and time listed

Safety, pharmacokinetics, and antiviral activity of the S-antigen Transport Inhibiting Oligonucleotide Polymers (STOPS) drug candidate ALG-010133 in subjects with chronic hepatitis B

Background and aims: To evaluate the safety, pharmacokinetics (PK) and antiviral activity of ALG-010133, a STOPS molecule designed to reduce hepatitis B S-antigen (HBsAg) in chronic hepatitis B (CHB) patients. Method: This was a 3-part, multicenter, double-blind, randomized, placebo-controlled study. In Parts 1 and 2, single and multiple subcutaneous (SC) doses of ALG-010133were generallywell tolerated in healthy volunteers (Gane et al, EASL 2021). Part 3 evaluatedweekly SC doses of ALG-010133 or placebo × 12 weeks in virologically suppressed Hepatitis B e-antigen (HBeAg) negative CHB subjects (N = 10/cohort;8 active:2 placebo). Reported here are preliminary blinded Part 3 safety, PK, and antiviral data;unblinded data will be presented at the conference. Results: 31 CHB subjects completed dosing and follow-up in Cohorts 1 (120 mg;N = 10), 2. (200 mg;N = 10), and 3 (400 mg;N = 11). Most subjects were male (61%) and 48% were white, with mean age 48 years, mean BMI 26.1 kg/m2 and baseline HBsAg across cohorts of 3.6 to 3.7 log10 IU/ ml. Therewas 1 unrelated serious treatment emergent adverse event (TEAE) (hospitalization for orchitis) and 1 unrelated TEAE (COVID-19 infection) resulting in premature study drug discontinuation. All TEAEs were Grade 1 or 2 in severity, except for 1 Grade 3 TEAE of injection site erythema (severity based only on surface area criteria of ≥100 cm2;required no treatment and resolved despite continued study drug dosing) and the aforementioned TEAE of orchitis (Grade 3). There was no dose relationship to severity or frequency for any TEAE. The most common (≥3 subjects) TEAEs were injection site erythema (n = 5), increased ALT (n = 4), injection site bruising (n = 4), increased AST (n = 3), and injection site pruritus (n = 3);none were assessed as clinically concerning. Although treatment-emergent ALT and AST elevations (n = 13) were observed, all were Grade 1 (<2.5x upper limit of normal [ULN]) or 2 (≥2.5 to <5x ULN) and none led to premature study drug discontinuation or were associated with symptoms or evidence of liver dysfunction. There were no other clinically significant lab abnormalities. No clinically significant physical examinations, vital signs, or ECG abnormalities were reported. Plasma ALG-010133 exposures increased more than dose proportionally between the 120 to 400 mg dose levels, with moderate variability and minimal accumulation. Compared to baseline, the magnitude of HBsAg decline at Week 12 was <0.1 log10 IU/ml for placebo and across all ALG-010133 dose levels, including the projected efficacious dose level of 400 mg (estimated to maintain total liver exposures >3x EC90 for HBsAg inhibition). Conclusion: ALG-010133 was safe and well tolerated with predictable PK properties when given to CHB subjects as multiple SC doses of up to 400 mg. No meaningful HBsAg reduction was observed across all cohorts. Further clinical development of ALG-010133 has been discontinued.

Economic burden of public health care and hospitalisation associated with COVID-19 in China.

OBJECTIVES: This study aimed to evaluate the socio-economic burden imposed on the Chinese healthcare system during the coronavirus disease 2019 (COVID-19) pandemic. STUDY DESIGN: A cross-sectional study was used to investigate how COVID-19 impacted health and medical costs in China. Data were derived from a subdivision of the Centers for Disease control and Prevention of China. METHODS: We prospectively collected information from the Centers for Disease Control and Prevention and the designated hospitals to determine the cost of public health care and hospitalisation due to COVID-19. We estimated the resource use and direct medical costs associated with public health. RESULTS: The average costs, per case, for specimen collection and nucleic acid testing (NAT [specifically, polymerase chain reaction {PCR}]) in low-risk populations were $29.49 and $53.44, respectively; however, the average cost of NAT in high-risk populations was $297.94 per capita. The average costs per 1000 population for epidemiological surveys, disinfectant, health education and centralised isolation were $49.54, $247.01, $90.22 and $543.72, respectively. A single hospitalisation for COVID-19 in China cost a median of $2158.06 ($1961.13-$2325.65) in direct medical costs incurred only during hospitalisation, whereas the total costs associated with hospitalisation of patients with COVID-19 were estimated to have reached nearly $373.20 million in China as of 20, May, 2020. The cost of public health care associated with COVID-19 as of 20, May, 2020 ($6.83 billion) was 18.31 times that of hospitalisation. CONCLUSIONS: This study highlights the magnitude of resources needed to treat patients with COVID-19 and control the COVID-19 pandemic. Public health measures implemented by the Chinese government have been valuable in reducing the infection rate and may be cost-effective ways to control emerging infectious diseases.

Stock market reactions to favorable and unfavorable information security events: A systematic literature review

The rapid digital transformations across every industry sector, accelerated partly due to the COVID-19 pandemic, have increased organizations’ use of information systems for operational and strategic purposes. These organizational responses have led to a confluence of digital, biological, and physical technologies that are revolutionizing business practices and workflows. But accompanying the pervasive use of digital technologies and the evolutionary nature of digital assets, is a shifting world of cyberattacks and information security (ISec) cybercrimes. Dynamic cybercrimes make it increasingly difficult for managers and researchers to anticipate the types, magnitude, and severity of future information security (ISec) breaches. Thus, we perform a systematic literature review (SLR) that explores, gathers, and categorizes event studies to examine the influence of favorable and unfavorable ISec events on stock markets. We extend the research conducted by Spanos and Angelis (2016) and provide a comprehensive understanding of the market's efficiency to process public information released about ISec events, ISec contingency factors, and the influence of ISec events on stock prices and factors other than price. Our systematic search reveals 58 relevant papers that include 80 studies. We find that in 75% of the studies ISec events can significantly affect a company's stock market performance, and that such effects are primarily exhibited within two days before and after the event day. Further, the magnitude of abnormal returns is higher in studies examining unfavorable ISec events, such as ISec breaches, compared to abnormal returns from favorable events, such as ISec investments and ISec certifications. In the end, our SLR serves as a foundation for ISec and management communities to build upon to keep industry and academia apprised of continually developing trends, new attack vectors and types of data breaches, protective ISec behaviors and programs, and their subsequent influences on stock market values and returns. © 2021 Elsevier Ltd

The Connectedness of the Coronavirus Disease Pandemic in the World: A Study Based on Complex Network Analysis

Since the coronavirus disease (COVID-19) pandemic started at the beginning of 2020, it has seriously affected various countries’ economic and social development and accelerated the economic recession worldwide. Therefore, the connectedness of the global COVID-19 network across countries is studied in this article. Based on COVID-19 correlations in 122 countries, we construct a complex network of COVID-19 from January 19, 2020, to August 15, 2020. We then deconstruct the overall global network connectedness and analyze the connectedness characteristics. Moreover, we empirically investigate the network connectedness influencing factors by using various countries’ macroeconomic and social data. We find that the global COVID-19 pandemic network has some prominent complex network properties, such as low path length, high clustering, and good community structure. Furthermore, population density, economic size, trade, government spending, and quality of medical treatment are significant macrofactors affecting COVID-19 connectedness in different countries. © Copyright © 2021 Zhu, Kou, Lai, Feng and Du.

Prevention and control management standard of COVID-19 in the medical station of the medical team supporting for Hubei province from Sichuan province

To prevent and control 2019 novel coronavirus pneumonia diseases (COVID-19), hundreds of medical teams and tens of thousands of medical professionals throughout the nation were transferred to Hubei to assist COVID-19 control efforts. Medical professionals were at high risk of novel coronavirus pneumonia infections. To ensure the prevention and control of infection in medical teams and prevent cross-infection among medical staff at the medical station, this management standard includes routine management standards, resident disinfection, personnel entry and exit process, and logistics support management, so as to provide reference for medical teams combating COVID-19 in the future.