ABSTRACT
BackgroundCovid-19 vaccines are urgently needed, especially against emerging variants. NVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 rS) nanoparticle vaccine containing trimeric full-length SARS-CoV-2 spike glycoprotein and Matrix-M adjuvant. MethodsA phase 3, randomized, observer-blinded, placebo-controlled trial was conducted in adults 18-84 years old who received two intramuscular 5-{micro}g doses, 21 days apart, of NVX-CoV2373 or placebo (1:1) across 33 sites in the United Kingdom. The primary efficacy endpoint was virologically confirmed symptomatic Covid-19 with onset 7 days after second vaccination in serologically negative participants. ResultsA total of 15,187 participants were randomized, of whom 7569 received NVX-CoV2373 and 7570 received placebo; 27.2% were 65 years or older, 44.7% had comorbidities and 4.2% had baseline serological evidence of SARS-CoV-2. There were 10 cases of Covid-19 among NVX-CoV2373 recipients and 96 cases among placebo recipients, with symptom onset at least 7 days after second vaccination; NVX-CoV2373 was 89.7% (95% confidence interval, 80.2 to 94.6) effective in preventing Covid-19, with no hospitalizations or deaths reported. There were five cases of severe Covid-19, all in the placebo group. Post hoc analysis revealed efficacies of 96.4% (73.8 to 99.5) and 86.3% (71.3 to 93.5) against the prototype strain and B.1.1.7 variant, respectively. Vaccine efficacy was similar across subgroups, including participants with comorbidities and those [≥]65 years old. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups. ConclusionA two-dose regimen of NVX-CoV2373 conferred 89.7% protection against a blend of prototype and variant Covid-19, demonstrated high efficacy against the B.1.1.7 variant, and had a reassuring safety profile. (Funded by Novavax, Inc. EudraCT number, 2020-004123-16).
Subject(s)
COVID-19ABSTRACT
This study aims to contribute to the critical discourse on project management processes within the vein of institutional theory. Specifically, the study will focus on the dynamics between disruptive elements and agility which lead to process and organisational change. This empirical research will focus on how project professionals have had to adapt and adopt new organisational routines, particularly following COVID-19. The global coronavirus pandemic has had a profound and dramatic impact on working practices, especially in professional occupations who rapidly shifted to home-based working. Individuals, industries, and organisations of all sizes have had to re-evaluate their management processes and project priorities as a result of the disruptive impact of the pandemic crisis.
Subject(s)
COVID-19ABSTRACT
The COVID-19 global pandemic crisis has had a deep and profound impact on fundamental elements of society, the economy, and the environment as a whole. Key organisations, businesses, sectors and industries vital for delivering crucial projects have been affected by the relatively fast onset of COVID-19 on a global scale. As a result, organisational routines and project management processes that would have focused on established methods and practices have incurred dramatic changes leading to a greater emphasis on agility as part of a more exhaustive strategic COVID-19 world, where new routines and processes become embedded as the new normal. This research focuses on the increased demand in Homeworking Project Management (HPM) and more significant agility requirements across dispersed virtual project management teams. Initial insights from semi-structured interviews with a cross-section of 12 high-level project professionals suggest that; (i) Transitional homeworking project management processes have a direct impact on collaborative and operational routines; (ii) There is a greater level of demand on agility with HPM teams which do not necessarily have the organisational infrastructure to support these, (iii) Technological resources are becoming a primary concern with inequality of information across HPM teams, and (iv) Increasing critical bottlenecks across dispersed HPM teams is adversely affecting tenable project outcomes.