Long-term immune persistence induced by two-dose BBIBP-CorV vaccine with different intervals, and immunogenicity and safety of a homologous booster dose in high-risk occupational population. Secondary Study Based on a Randomized Clinical Trial (preprint)

Background BBIBP-CorV vaccine with two doses and an interval of 3-4 weeks had been proved to have good immunogenicity and efficacy as well as an acceptable safety profile according to our initial research and other similar studies. Maintaining adequate neutralizing antibody levels is also necessary for long-term protection, especially in the midst of the COVID-19 pandemic. Our aim was to evaluate the immune persistence of neutralizing antibody elicited by BBIBP-CorV vaccines with day 0-14, 0-21 and 0-28 schedule, and assess the immunogenicity and safety of a homologous booster dose in the high-risk occupational population aged 18-59 years. Methods A total of 809 eligible participants, aged 18-59 years, were recruited and randomly allocated to receive BBIBP-CorV vaccine with day 0-14, 0-21 or 0-28 schedule respectively between January and May 2021 in Taiyuan City, Shanxi Province, China among the public security officers and the airport ground staff in initial study. In this secondary study, the responders (GMT [≥] 16) at day 28 after priming two-dose vaccine were followed up at months 3, 6 and 10 to evaluate the immune persistence of three two-dose schedules. At month 10, eligible participants of three two-dose schedules were received a homologous booster dose respectively (hereafter abbreviated as 0-14d-10m group, 0-21d-10m group and 0-28d-10m group), and followed up at day 28 post-booster to assess the safety and immunogenicity of the booster dose. The contents of follow-up included the blood samples, oropharyngeal/nasal swabs, and adverse reactions collection. The main outcomes of the study included geometric mean titers (GMT) of neutralizing antibody to live SARS-CoV-2, the positive rates of different criteria and the constituent ratio of GMT of neutralizing antibodies at different follow-up point. Meanwhile, we explored the kinetics of antibody levels of different vaccination regimens by generalized estimating equations (GEE) and used exponent curve model to predict the duration of maintaining protected antibody after the booster dose. We also determined predictors of maintaining protected antibody level within 10 months after the second dose by Cox proportional hazards regression model and nomogram. The trial was registered with ChiCTR.org.cn (ChiCTR2100041705, ChiCTR2100041706). Results The number of 241, 247 and 256 responders (GMT [≥] 16) at day 28 after two-dose BBIBP-CorV vaccine in 0-14d, 0-21d and 0-28d schedule were followed-up at months 3, 6, and 10 for immune persistence evaluation. At month 10, a total of 390 participants were eligible and received a booster dose with 130 participants in the 0-14d-10m, 0-21d-10m and 0-28d-10m group respectively, of whom 74.1% (289/390) were male, with a mean age of 37.1{+/-}10.3 years. The GMT of neutralizing antibody in 0-28d-10m and 0-21d-10m group were significantly higher than 0-14d-10m group at month 3 (GMT: 71.6 & 64.2 vs 46.4, P<0.0001 ), month 6 (GMT: 47.1 & 42.8 vs 30.5, P<0.0001) and month 10 (GMT: 32.4 vs 20.3, P<0.0001; 28.8 vs 20.3, P=0.0004) after the second dose. A sharply decrease by 4.85-fold (GMT: 94.4-20.3), 4.67-fold (GMT: 134.4-28.8) and 4.49-fold (GMT: 145.5-32.4) was observed from day 28 to month 10 after the second dose in 0-14d-10m, 0-21d-10m and 0-28d-10m group, respectively, and they had similar decline kinetics (P=0.67). At 28 days after booster dose, a remarkable rebound in neutralizing antibody (GMT: 246.2, 277.5 and 288.6) were observed in three groups, respectively. Notably, the GMT after booster dose was not affected by priming two-dose schedule. The predictive duration of neutralizing antibody declining to the cutoff level of positive antibody response may be 18.08 months, 18.83 months and 19.08 months after booster dose in three groups, respectively. Long-term immune persistence within 10 months after the second dose was associated with age<40, female, and history of influenza vaccination. All adverse reactions were mild after the booster injection. None of the participants were infected SARS-CoV-2 during the trial period. Conclusions The priming two-dose BBIBP-CorV vaccine with 0-28 days and 0-21 days schedule could lead a longer persistence of neutralizing antibody than 0-14 days schedule. Maintaining long-term immune persistence was also associated with age<40, female, and history of influenza vaccination. Regardless of priming two-doses vaccination regimens, a homologous booster dose led to a strong rebound in neutralizing antibody and might elicit satisfactory persistent immunity.

Association between COVID-19 related elective surgery cancellations and pediatric inguinal hernia complications: A nationwide multicenter cohort study.

BACKGROUND: Optimal inguinal hernia repair timing remains controversial. It remains unclear how COVID-19 related elective surgery cancellations impacted timing of inguinal hernia repair and whether any delays led to complications. This study aims to determine whether elective surgery cancellations are safe in pediatric inguinal hernia. METHODS: This multicenter retrospective cohort study at 14 children's hospitals included patients ≤18 years who underwent inguinal hernia repair between September 13, 2019, through September 13, 2020. Patients were categorized by whether their inguinal hernia repair occurred before or after their hospital's COVID-19 elective surgery cancellation date. Incarceration and emergency department encounters were compared between pre and postcancellation. RESULTS: Of 1,404 patients, 604 (43.0%) underwent inguinal hernia repair during the postcancellation period, 92 (6.6%) experienced incarceration, and 213 (15.2%) had an emergency department encounter. The postcancellation period was not associated with incarceration (odds ratio 1.54; 95% confidence interval 0.88-2.71; P = .13) or emergency department encounters (odds ratio 1.53; 95% confidence interval 0.94-2.48; P = .09) despite longer median times to inguinal hernia repair (precancellation 29 days [interquartile range 13-55 days] versus postcancellation 31 days [interquartile range 14-73 days], P = .01). Infants were more likely to have the emergency department be their index presentation in the postcancellation period (odds ratio 1.69; 95% confidence interval 1.24-2.31; P < .01). CONCLUSION: Overall, COVID-19 elective surgery cancellations do not appear to increase the likelihood of incarceration or emergency department encounters despite delays in inguinal hernia repair, suggesting that cancellations are safe in children with inguinal hernia. Assessment of elective surgery cancellation safety has important implications for health policy.

Closure of Anchor Businesses Reduced COVID-19 Transmission During the Early Months of the Pandemic.

OBJECTIVES: To investigate the relationship between the closure of "anchor businesses" - manufacturing plants and distribution centers employing >1000 workers - and the daily, county-level COVID-19 rate between March 1, 2020 and May 31, 2020. METHODS: We conducted a comparative, interrupted time series analysis of publicly available county-level data. Our main variable of interest was closure, indicating whether one or more of the anchor businesses within the county experienced a full or partial closure of at least 22 days (main analysis) or at least 1 day (sensitivity analyses). RESULTS: Closure of an anchor business was associated with 142 fewer positive COVID-19 tests per 100,000 population over a 40-day period. Even short-term and partial closures were associated with reduced spread. CONCLUSIONS: Temporary closure of anchor businesses appears to have slowed, but not completely contained, the spread of COVID-19.

Impact of high-quality-development strategy on energy demand of East China

As one of the most important economic zones in China, the energy demand of East China accounts for approximately 20% of the whole country. However, with limited reserves of fossil energy, the energy supply in East China mainly depends on imports. The energy demand in East China plays an important role in the future energy planning of the whole country. In 2017, the high-quality-development strategy was proposed, and in 2020, COVID-19 outbroke, which will influence the development of energy demand in East China considerably. It is essential to analyze the energy demand of East China for the energy planning of the whole country. Meanwhile, suggestions for high-quality-development can also be obtained in this work.

Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine in High-Risk Occupational Population: a randomized, parallel, controlled clinical trial (preprint)

Vaccination is urgently needed to prevent the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here, we conducted a randomized, parallel, controlled clinical trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval for high-risk occupational population. Participants were randomly assigned to receive two doses of inactivated SARS-CoV-2 vaccine (4 {micro}g per dose) at an interval of either 14 days, 21 days or 28 days. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Our results showed that the seroconversion rates (GMT [≥] 16) were all 100% in the three groups and the 0-21 and 0-28 groups elicited significantly higher SARS-CoV-2 neutralizing antibody level. All reported adverse reactions were mild. (Chinese Clinical Trial Registry: ChiCTR2100041705, ChiCTR2100041706)

Effect of the COVID-19 pandemic on presentation and severity of traumatic injury due to physical child abuse across US children's hospitals.

BACKGROUND: Physical child abuse affects 9 in every 1,000 children in the United States and associated traumatic injuries are often identified by the healthcare system. The COVID-19 pandemic has intensified risk factors for physical child abuse and increased avoidance of the healthcare system. This study examined the effect of the COVID-19 pandemic on presentation and severity of physical child abuse. METHODS: A retrospective, cross-sectional study utilizing the Pediatric Health Information System was performed. An interrupted time series analysis estimated the effect of the COVID-19 pandemic on the number of children <15 years old presenting with physical child abuse to children's hospitals from March 1st to June 30th of 2020 by comparing to those presenting during the same period for years 2016-2019. Hierarchical regression models estimated the effect of the pandemic on likelihood of operative intervention, ICU admission, traumatic brain injury, and mortality. RESULTS: Over the study period, 20,346 physical child abuse encounters were reported by 47 children's hospitals. An interrupted times series model predicted a significant decline in cases due to the effect of the COVID-19 pandemic, representing a deficit of 2,645 cases (p = 0.001). Children presenting during the pandemic had increased odds of requiring ICU admission (p = 0.03) and having a traumatic brain injury in those under 5 years of age (p=<0.001). CONCLUSIONS: The number of children with physical child abuse presenting to children's hospitals significantly declined during the COVID-19 pandemic, but those that did were more likely to be severe. The pandemic may be a risk factor for worse outcomes associated with physical child abuse.

Impact of Population Emigration from Wuhan and Medical Support on COVID-19 Infection in China.

BACKGROUND: The novel Coronavirus Disease 2019 (COVID-19) infection broken out in Wuhan. We aimed to analyse the impact of medical support and population emigration from Wuhan on the cure rate and mortality of COVID-19 infection in China and to provide early warning on the developmental trend of the epidemic. METHODS: Data were obtained from The National Health Commission of People's Republic of China, Chinese Center for Disease Control and Prevention and The National Health Commission of People's Republic of Hubei Province. The Poisson distribution and normal approximate were used to analyse the relationship between population emigration from Wuhan and the probability of outbreaks and to predict the developmental trend of the epidemic situation. RESULTS: The outbreak were related to population emigration from Wuhan in 87% of the cities in Hubei. The result of developmental trend indicated that 95% confidence intervals of confirmed case in Xiaogan and HuangGang were 3301.678-3526.042 and 3201.189-3422.17, respectively. For province outside of Hubei, the outbreak in 76% of the provinces were related to population emigration from Wuhan. Hot spot provinces for epidemic prevention included GuangDong and HeNan. Medical support significantly improved the cure rate of patients with COVID-19 (r = 0.852, p < 0.001). CONCLUSION: Population emigration from Wuhan has a certain impact on the probability of outbreaks COVID-19 in Hubei and the whole country, medical support improved the cure rate of patients with COVID-19.

Psychological Status and Influencing Factors of Hospital Medical Staff During the COVID-19 Outbreak.

BACKGROUND: The aim of this study was to analyze the psychological status of and its influencing factors in health care workers (HCWs) during the coronavirus disease 2019 (COVID-19) outbreak so as to provide sufficient theory and scientific basis for the formulation and implementation of relevant policies and measures in improving the psychological status of HCWs. METHOD: During February 1 to February 20, 2020, 1,002 members of the HCWs from Xi'an and Wuhan completed a 12-item questionnaire regarding pressure about the COVID-19 influenza pandemic, along with the 12-item General Health Questionnaire (GHQ-12). The GHQ-12 scale was divided by three points. The positive group was scored more than 3. All data were analyzed by SPSS. RESULTS: More than half of the participants (61.1%) reported psychological distress. The HCWs have sufficient information about the COVID-19 symptoms, prognosis, treatment, infection route, and preventive measures (medians ranged from 6/9 to 8/9). Female, engaged in clinic work less than 7 years, married person, and working in Wuhan were risk factors affecting the psychological status of HCWs (P < 0.05). CONCLUSION: Psychological distress is common in HCWs during the COVID-19 outbreak. Hospitals and relevant departments should provide psychological support to HCWs, and strict infection control measures should be developed.

COVID-19-Related Abnormal Liver Enzymes Levels: A Retrospective Study (preprint)

Background: A new disease called Coronavirus disease (COVID-19) related to SARS-CoV-2 has brought serious attacks to the world. It causes damage to multiple organ systems of the body include liver. Here we intend to shed light on the clinical features its mechanism related to liver damage which caused by COVID-19.Methods: Clinical records and laboratory results were obtained from 138 patients with laboratory-confirmed COVID-19 who were admitted to Tongji hospital, Wuhan, China from February 8, 2020 to February 18, 2020. Information on clinical features of patients with abnormal liver tests were collected for analysis.Results: Fifty-four (39.1%) and eighty-three (60.1%) patients had abnormal liver enzyme levels on admission and during the course of disease. Hepatocyte type was more common than cholestatic type abnormal. 24(17.4%) patients reached the liver injury standard in the course of disease. Patients with abnormal liver enzyme levels were more likely to be male, had higher levels of inflammation indicators, lower pulse oxygen saturation and lymphocyte count. There is a significantly higher proportion of abnormal liver enzymes levels in the patients which administrated antibiotics during hospitalization, compared with that in the ones without antibiotics therapy (56.6% vs 32.7%). Patients with liver injury was an independent predictor of a poor prognosis (p<0.0001, OR 7.774, 95%CI 2.674-22.599).Conclusions: Liver injury in COVID-19 patients was an independent predictor of a poor prognosis. The COVID-19-related abnormal liver enzymes levels may be considered as the result of secondary liver damage caused mainly by several factors. Hypoxia and disease severity account for the largest proportion.

A Survey Analysis of Psychological Impact on Chinese during Quarantine against COVID-19 (preprint)

Objective: Few studies have investigated the psychological impact throughout a major epidemic, such as COVID-19. This study aimed to evaluate the psychological state of individuals experienced quarantine and to provide evidence to reduce the impact of quarantine after COVID-19.Methods: A questionnaire-based survey conducted by using an internet site using 631 individuals who lived in China in the year 2020. Spearman rank correlation analysis was used for the data analysis.Results: Approximately 9.97% of the study participants reported that they did not feel good about his or her health condition. Approximately 50.16% of participants had experienced various levels of anxious and nervous feelings. Approximately 5.91% of participants reported anxious or nervous feelings almost every day. By using the spearman rank correlation analysis, we observed that anxious and nervous feelings appeared to be correlated with the frequency of receiving negative news, current health situation and time spent on receiving information related to COVID-19.Conclusion: A long-term quarantine is likely to have some level of impact on health conditions among relatively healthy individuals. The survey study may suggest that government and hospital workers should pay close attention to the psychological change experienced by quarantined individuals.