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1.
Topics in Antiviral Medicine ; 30(1 SUPPL):18, 2022.
Article in English | EMBASE | ID: covidwho-1880294

ABSTRACT

Background: The Sisonke Phase IIIB open-label implementation study vaccinated health care workers (HCWs) with the single dose Ad26.COV2.S vaccine during two phases of the South African Covid-19 epidemic, dominated first by the Beta followed by the Delta variant of concern. Methods: HCWs were vaccinated over 3 months (17 February-17 May 2021). Safety was monitored by self-reporting, facility reporting and linkage to national databases. Vaccine effectiveness (VE) against Covid-19 related hospitalisation, hospitalisation requiring critical or intensive care and death, ascertained 28 days or more post vaccination was assessed up until 17 July 2021. Nested sub-cohorts (A and B) from two national medical schemes were evaluated to assess VE using a matched retrospective cohort design. Results: Over the 3-month period, 477234 HCWs were vaccinated in 122 vaccination sites across South Africa. VE derived from the sub-cohorts comprising 215 813 HCWs was 83% (95% CI 75-89) to prevent Covid-19 deaths, 75% (95% CI 69-82) to prevent hospital admissions requiring critical or intensive care and 67% (95% CI 62-71) to prevent Covid-19 related hospitalisations. The VE was maintained in older HCWs and those with comorbidities including HIV infection. VE remained consistent throughout the Beta and Delta dominant phases of the study. 10279 adverse events were reported and 139 (1.4%) were serious, including two cases of thrombosis with thrombocytopenia syndrome and four cases of Guillain-Barré syndrome who recovered. Conclusion: The single dose Ad26.COV2.S was safe and effective against severe Covid-19 disease and death post-vaccination, and against both Beta and Delta variants providing real-world evidence for its use globally.

2.
Am Surg ; 88(7): 1522-1525, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1784956

ABSTRACT

BACKGROUND: The SARS-Cov-2 coronavirus has varying clinical effects-from asymptomatic patients to life-threatening illness and death. At the only Level 1 Trauma Center in a rural state, outcomes appeared worse in trauma patients who tested positive for COVID despite these patients presumably being asymptomatic or only mildly affected before their traumatic event. This study compares all trauma admissions that were COVID-positive to those who were not. METHODS: The institutional database was queried for all level 1 and 2 trauma activations from March 2020-July 2021. The analysis consisted of a multivariate regression between COVID-negative and the COVID-positive group controlling for age, injury severity score (ISS), and Glasgow Coma Score (GCS). Outcomes compared were hospital length-of-stay (LOS), ICU LOS, ventilator days, days to discharge to a facility, and in-hospital mortality. RESULTS: Hospital LOS was 2.7 days longer in the COVID-positive group (P < .0005). ICU LOS was 2.9 days longer for patients admitted to the ICU in the COVID positive-group (P = .017). Ventilator days were 4.7 days longer for patients requiring mechanical ventilation in the COVID-positive group (P = .002). Discharge to a post-acute facility required 6.1 more days in the COVID-positive group (P = .005). CONCLUSION: Trauma patients presenting positive for COVID-19 are presumed to be asymptomatic before their traumatic event. Despite this, the physiologic toll of trauma combined with the COVID infection causes significantly worse clinical outcomes, including increasing hospital days in this patient population, which continues to tax the already burdened healthcare system.


Subject(s)
COVID-19 , COVID-19/therapy , Humans , Intensive Care Units , Length of Stay , Retrospective Studies , SARS-CoV-2 , Trauma Centers , Ventilators, Mechanical
3.
South African Medical Journal ; 112(2 b), 2022.
Article in English | EMBASE | ID: covidwho-1706330

ABSTRACT

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID-19, including hospitalisations and deaths. The Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies: (i) consistently advocate for vaccination to reduce public hesitancy;(ii) an electronic vaccination data system (EVDS) is critical;(iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres;(iv) let digitally literate people help elderly and marginalised people to register for vaccination;(v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators;(vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres;(vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks;(viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system;(ix) develop efficient systems to monitor and investigate COVID-19 breakthrough infections;and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.

4.
Embase;
Preprint in English | EMBASE | ID: ppcovidwho-327037

ABSTRACT

Following the results of the ENSEMBLE 2 study, which demonstrated improved vaccine efficacy of a two-dose regimen of Ad26.COV.2 vaccine given 2 months apart, we expanded the Sisonke study which had provided single dose Ad26.COV.2 vaccine to almost 500 000 health care workers (HCW) in South Africa to include a booster dose of the Ad26.COV.2. Sisonke 2 enrolled 227 310 HCW from the 8 November to the 17 December 2021. Enrolment commenced before the onset of the Omicron driven fourth wave in South Africa affording us an opportunity to evaluate early VE in preventing hospital admissions of a homologous boost of the Ad26.COV.2 vaccine given 6-9 months after the initial vaccination in HCW. We estimated vaccine effectiveness (VE) of the Ad26.COV2.S vaccine booster in 69 092 HCW as compared to unvaccinated individuals enrolled in the same managed care organization using a test negative design. We compared VE against COVID19 admission for omicron during the period 15 November to 20 December 2021. After adjusting for confounders, we observed that VE for hospitalisation increased over time since booster dose, from 63% (95%CI 31-81%);to 84% (95% CI 67-92%) and then 85% (95% CI: 54-95%), 0-13 days, 14-27 days, and 1-2 months post-boost. We provide the first evidence of the effectiveness of a homologous Ad26.COV.2 vaccine boost given 6-9 months after the initial single vaccination series during a period of omicron variant circulation. This data is important given the increased reliance on the Ad26.COV.2 vaccine in Africa.

5.
Embase;
Preprint in English | EMBASE | ID: ppcovidwho-326920

ABSTRACT

Background: The Sisonke open-label phase 3b implementation study aimed to assess the safety and effectiveness of the Janssen Ad26.CoV2.S vaccine among health care workers (HCWs) in South Africa. Here, we present the safety data. Methods: We monitored adverse events (AEs) at vaccination sites, through self-reporting triggered by text messages after vaccination, health care provider reports and by active case finding. The frequency and incidence rate of non-serious and serious AEs were evaluated from day of first vaccination (17 February 2021) until 28 days after the final vaccination (15 June 2021). COVID-19 breakthrough infections, hospitalisations and deaths were ascertained via linkage of the electronic vaccination register with existing national databases. Findings: Of 477,234 participants, 10,279 (2.2%) reported AEs, of which 139 (1.4%) were serious. Women reported more AEs than men (2.3% vs. 1.6%). AE reports decreased with increasing age (3.2% for 18–30, 2.1% for 31-45, 1.8% for 46-55 and 1.5% in >55-year-olds). Participants with previous COVID-19 infection reported slightly more AEs (2.6% vs. 2.1%). The commonest reactogenicity events were headache and body aches, followed by injection site pain and fever, and most occurred within 48 hours of vaccination. Two cases of Thrombosis with Thrombocytopenia Syndrome and four cases of Guillain-Barre Syndrome were reported post-vaccination. Serious AEs and AEs of special interest including vascular and nervous system events, immune system disorders and deaths occurred at lower than the expected population rates. Interpretation: The single-dose Ad26.CoV2.S vaccine had an acceptable safety profile supporting the continued use of this vaccine in our setting.

6.
S Afr Med J ; 112(2b): 13486, 2021 12 24.
Article in English | MEDLINE | ID: covidwho-1678836

ABSTRACT

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID­19, including hospitalisations and deaths. The  Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies:(i) consistently advocate for vaccination to reduce public hesitancy; (ii) an electronic vaccination data system (EVDS) is critical; (iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres; (iv) let digitally literate people help elderly and marginalised people to register for vaccination; (v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators; (vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres; (vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks; (viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system; (ix) develop efficient systems to monitor and investigate COVID­19 breakthrough infections; and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Health Personnel , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Mass Vaccination , Humans , Prospective Studies , SARS-CoV-2 , South Africa/epidemiology
7.
Frontiers in Education ; 6:14, 2021.
Article in English | Web of Science | ID: covidwho-1512022

ABSTRACT

The COVID-19 pandemic and related lock downs have accelerated the need for online and remote teaching within university settings. However, due to the abrupt nature of the pandemic, many academic staff were not prepared for this forced transition. This study aimed to understand how the pandemic affected academics at a New Zealand university, with regards to their transition to emergency remote teaching. Specifically, it explores the challenges as well as benefits academics experienced during this transition. Recommendations for future online learning are also made. Academic staff (N = 67) at a New Zealand University completed an anonymous online survey. Quantitative data were analyzed statistically using descriptive and inferential statistics, while qualitative data were analyzed thematically. Major challenges experienced included miscommunication from the university, concerns about student access to technology, finding a quiet space to work, lack of digital competence skills, too much screen-time, managing work hours, and work/life balance. Benefits included enhanced flexibility, enhanced teacher creativity, increasing autonomy of learners, and reduced commute time. Looking forward, academic staff desired future teaching to include blended learning and virtual immersion. New strategies of working remotely are being explored to facilitate teaching and learning while catering to the preferences and skills of both educators and students. Our findings honor the considerable agility of academic staff who sought to sustain and enhance excellence in remote education. At an institutional level our findings point to the need for staff to be supported by their institutions as they further refine their work within new-found spaces.

8.
Am Surg ; 88(3): 356-359, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1501889

ABSTRACT

BACKGROUND: The COVID-19 pandemic caused an abrupt change to societal norms. We anecdotally noticed an increase in penetrating and violent trauma during the period of stay-at-home orders. Studying these changes will allow trauma centers to better prepare for future waves of COVID-19 or other global catastrophes. METHODS: We queried our institutional database for all level 1 and 2 trauma activations presenting from the scene within our local county from March 18 to May 21, 2020 and matched time periods from 2016 to 2019. Primary outcomes were overall trauma volume, rates of penetrating trauma, rates of violent trauma, and transfusion requirements. RESULTS: The number of penetrating and violent traumas at our trauma center during the period of societal quarantine for the COVID-19 pandemic was more than any historical total. During the COVID-19 time period, we saw 39 penetrating traumas, while the mean value for the same time period from 2016 to 2019 was 26 (P = .03). We saw 45 violent traumas during COVID; the mean value from 2016 to 2019 was 32 (P = .05). There was also a higher rate of trauma patients requiring transfusion in the COVID cohort (6.7% vs 12.2%). DISCUSSION: Societal quarantine increased the number of penetrating and violent traumas, with a concurrent increased percentage of patients transfused. Despite this, there was no change in outcomes. Given the continuation of the COVID-19 pandemic, quarantine measures could be re-implemented. Data from this study can help guide expectations and utilization of hospital resources in the future.


Subject(s)
Blood Transfusion/statistics & numerical data , COVID-19/epidemiology , Pandemics , Trauma Centers/statistics & numerical data , Wounds, Nonpenetrating/epidemiology , Wounds, Penetrating/epidemiology , Adolescent , Adult , Age Distribution , Aged , Arkansas/epidemiology , COVID-19/prevention & control , Female , Hospitalization , Humans , Male , Middle Aged , Quarantine , Sex Distribution , Time Factors , Violence/statistics & numerical data , Young Adult
9.
Ann Med Surg (Lond) ; 65: 102285, 2021 May.
Article in English | MEDLINE | ID: covidwho-1188262

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) has had a widespread impact on graduate medical education. This survey aims to assess how general surgery residency programs adapted to the initial wave of the COVID-19 pandemic in the United States (US). MATERIALS AND METHODS: General surgery program directors (PDs) in the US were invited to partake in a 16-question survey between April 17 and May 1, 2020. The survey included questions about basic program information, clinical practice changes, changes to education structure, surgery resident clinical duties, and perceived impact on resident operative experience and future career choices. RESULTS: Forty-eight PDs completed the survey in the designated two-week period. Almost all (44/48, 91.7%) programs changed their didactic education to an online video conference-based format. Thirteen programs (27.1%) decreased the amount/frequency of formal education, and 13 (27.1%) reported canceling didactic education for some period of time. The majority of PDs (26/48, 54.2%) felt these changes had no impact on resident didactic participation, 14 (29.2%) reported an increase in participation, and 8 (16.7%) reported decreased participation. Ten programs (20.8%) redeployed residents to non-surgical services at the time of this survey, 30 (62.5%) have not redeployed residents but plan to if needed, and 8 (16.7%) did not have any plans to redeploy residents. CONCLUSIONS: The outbreak of COVID-19 has required general surgery residency PDs to change numerous aspects of resident education and clinical roles. Future inquiry is needed to assess if these changes lead to appreciable differences in resident preparedness and career selection.

10.
J Card Surg ; 35(12): 3443-3448, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-717315

ABSTRACT

OBJECTIVE: The coronavirus disease 2019 (COVID-19) has altered how the current generation of thoracic surgery residents are being trained. The aim of this survey was to determine how thoracic surgery program directors (PDs) are adapting to educating residents during the COVID-19 pandemic. METHODS: Thoracic surgery PDs of integrated, traditional (2 or 3 year), and combined 4 + 3 general/thoracic surgery training programs in the United States were surveyed between 17th April and 1st May 2020 during the peak of the COVID-19 pandemic in much of the United States. The 15-question electronic survey queried program status, changes to the baseline surgical practice, changes to didactic education, deployment/scheduling of residents, and effect of the pandemic on case logs and preparedness for resident graduation. RESULTS: All 23 institutions responding had ceased elective procedures, and most had switched to telemedicine clinic visits. Online virtual didactic sessions were implemented by 91% of programs, with most (69.6%) observing same or increased attendance. PDs reported that 82.7% of residents were on a non-standard schedule, with most being deployed in a 1 to 2 week on, 1 to 2 week off block schedule. Case volumes were affected for both junior and graduating trainees, but a majority of PDs report that graduating residents will graduate on time without perceived negative effect on first career/fellowship position. CONCLUSIONS: The COVID-19 pandemic has radically changed the educational approach of thoracic surgery programs. PDs are adapting educational delivery to optimize training and safety during the pandemic. Long-term effects remain uncertain and require additional study.


Subject(s)
COVID-19/epidemiology , Education, Medical, Graduate/methods , Internship and Residency/methods , Pandemics , Thoracic Surgery/education , Thoracic Surgical Procedures/education , Female , Humans , Male , Surveys and Questionnaires , United States
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