Preparing Pandemic Vaccine Capacity

Among the challenges of a pandemic is the need to scale up to billions of doses, at a larger scale than typically needed for vaccines, from raw materials all the way through to the materials for the containers for fill/finish. Having adequate raw materials, building and staffing the facilities, and tech transfer are all keys to success. [...]we can plug into existing infrastructure, including services (gas, water, waste, etc.) as well as analytics and quality labs." Emergent BioSolutions says that its flexible CDMO capacity deployment model can respond quickly to demand fluctuations. The company's facilities in France, Switzerland, and the US are working on the project;at CordenPharma Colorado, unique high-pressure chromatography systems usually used for manufacturing peptides have been reallocated for purifying lipids.

Across time and space: Examiner and candidate experiences of online doctoral vivas

Many countries have doctoral viva examinations, mostly conducted in-person until the COVID-19 pandemic. This article explores the changing processes and experiences of doctoral vivas forced online, from the perspectives of three examiners (two Uk, one NZ) and one recent candidate (UK). It sheds light on remote viva examinations exploring experiences of examination rigour, opportunities to evidence 'doctorateness' and challenges and affordances of remoteness, home location and technology. We use autoethnography, focusing on our experiences including the personal, learning and institutional dimensions. We found virtual spaces had advantages (comfort) and disadvantages (emotional difficulties), and levels of worry were often higher, especially regarding IT. Online formats still enabled examiners to rigorously assess 'doctorateness', but duty of care is needed for candidates with anxiety exacerbated by the pandemic, or technology. Our study offers insiders' insights into the remote online viva itself with recommendations for candidates, examiners and institutions. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Covid-19: Rest and PPE reassurance are needed before NHS services can restart, MPs hear

At a Health and Social Care Select Committee evidence session on 14 May the King's Fund, the Nuffield Trust, and the Health Foundation warned that it would take many more months before core health and care services were able to fully restart. Limited capacity Jennifer Dixon, chief executive officer at the Health Foundation, told the committee that capacity within hospitals would be severely limited because of the need for social distancing, separating out covid and non-covid patients, and more time for deep cleaning of equipment and facilities. Chris Hopson, chief executive officer at NHS Providers, told the committee that NHS staff had worked incredibly hard in the past few months, with leave cancelled, and were very tired as a result.

Covid-19: MPs call on Public Health England to publish evidence for decision to drop community testing

A cross party group of MPs has said that Public Health England's failure to publish the evidence behind its decision to discontinue community testing at the start of the covid-19 outbreak is "unacceptable.” In a 19 page letter to the prime minister, the Science and Technology Committee called for publication of the evidence base and rationale informing Public Health England's decision to concentrate testing for covid-19 in a limited number of its own laboratories and to expand testing capacity gradually, rather than surging capacity through a large number of available laboratories in research institutes, universities, and the public and private sectors.1 This had led to the government announcing on 12 March that testing would stop in the community and would occur principally within hospitals—a decision that was "one of the most consequential made during [the] crisis,” MPs said in the letter. The committee chair, Greg Clark, said, "Greater transparency around scientific advice;putting capacity in place in advance of need, such as in testing and vaccines;collecting more data earlier;and learning from other countries' approaches are some of the early lessons of this pandemic that are relevant to further decisions that will need to be taken during the weeks and months ahead.”

COVID ADVANCES CLINICAL TRIAL TRANSPARENCY

Growing public concerns about politics playing a role in vetting potential vaccines and therapies to combat the COVID-19 pandemic has prompted sponsors of leading clinical trials to make public their study protocols and statistical analysis plans. [...]AstraZeneca's timeframe for enrolling and assessing study participants was delayed by the need to address the report of a serious adverse event in its Phase III study. The disclosure of these usually confidential details on research endpoints, assessment timeframes, and study analysis plans aim to promote information sharing among vaccine developers, and also build public confidence.

A real options approach to growth opportunities and resilience aftermath of the COVID-19 pandemic

PurposeFacing the challenges posed by the pandemic of COVID-19, this paper aims to contribute to the resilience of businesses through the development of a real options approach (ROA) that provides alternatives and opportunities for a decision process under situations when future events and outcomes are unknown and not capable of being known from current information.Design/methodology/approachThis paper involves a stochastic modelling process in generating a set of absolute option values, using available data and scenarios from the COVID-19 pandemic event. The modelling and simulations using ROA suggest how strategic portfolios resolve the growing problem during the endemic to all but in the most isolated societies.FindingsThis study finds the emergent correlation between circuit breakers and lockdowns, which have brought about a "distorted gravity” effect (inverse growth of global businesses and trades). However, "time-to-build” real options (i.e. deferral, expand, switch and compound exchange) start to function in the adaptive-transformative capabilities for growth opportunities of both government and corporate sectors. Significantly, some sectors grow faster than others while the compound exchange remains primarily challenging. Clearly, the government and corporate sectors are entangled, inevitably, the decoherence allows for the former to change uncertainty in the latter;therefore, government sector options change option values in the corporate sector.Originality/valueThe ROA by empirically focusing on both government and corporate sectors demonstrates under conditions of uncertainty how options in decision-making generate opportunities that hitherto have not been recognised and exercised upon by research in the immediate context of the COVID-19 pandemic. Importantly, the ROA provides an insightful concatenation (capability–behaviour approach) that drives resilience.

THE PREVALENCE AND INCIDENCE OF PSORIASIS AND PSORIATIC ARTHRITIS IN ENGLAND FROM 2009-2019: AN OBSERVATIONAL STUDY USING PRIMARY CARE DATA

BackgroundPsoriasis (PsO) and psoriatic arthritis (PsA) can greatly impact quality of life and result in substantial personal and societal costs. Complete and up to date data on the prevalence and incidence of these conditions and whether these change over time and vary by age is important for healthcare service planning so that specialist care and funding can be appropriately allocated.ObjectivesTo determine the prevalence and incidence of PsO and PsA in males and females from 2009-2019 across all age groups in England.MethodsWe used Clinical Practice Research Datalink AURUM, a primary care electronic health record database, including 20% of the English population. The codes used to identify patients with PsO and PsA were selected by rheumatologists and dermatologists and cross-checked with published code lists from other studies to ensure inclusion of all relevant codes. All included patients must have data for at least 1 year before their diagnosis. The annual incidence and point prevalence were calculated from 2009-2019 and stratified by age/sex. The study period ended in 2019 to avoid COVID-19 pandemic affecting results.ResultsThe prevalence of PsO and PsA in males and females increased annually, peaking in 2019 (PsO males 2.41% [95% confidence interval (CI) 2.40, 2.42];PsO females 2.60% [95% CI 2.59-2.61];PsA males 0.20% [95% CI 0.20-0.20];PsA females 0.21% [95% CI 0.21- 0.22]), as illustrated in Table 1. In 2019, the prevalence of PsO and PsA was highest in the over 65 years age group;PsO 4.25% [95% CI 4.22-4.28] and PsA 0.38% [95% CI 0.37-0.38]. The annual incidence (per 100,000 person years) of PsO has gradually decreased in males (from 168 (164-171) in 2009 to 148 (145-151) in 2019) but in females it has been stable with a slight annual decrease (from 180 (177-184) in 2009 to 173 (170-176) in 2019). The annual incidence for PsA has increased in both males and females (13 (12-14) in 2009 and 15 (14-16) in 2019 for males and 12 (11-13) in 2009 and 18 (17-19) in 2019 for females).ConclusionThe increasing prevalence of PsO and PsA highlights the importance of organising healthcare services to meet this need, particularly in the elderly population.ReferencesNIL.Table 1.Prevalence of PsO and PsA from 2009-2019 in EnglandYear20092010201120122013201420152016201720182019Population (n)1073383110910802110318501118036711343299112249341137842211657996119336261223432512420998PsO (n)216841229106239819250667259988268032276804286499295712304568311104PsO prevalence (%, 95%CI)-Male1.98 (1.96-1.99)2.06 (2.05- 2.07)2.13 (2.12-2.14)2.19 (2.18-2.20)2.24 (2.23- 2.25)2.33 (2.32- 2.34)2.37 (2.36- 2.38)2.39 (2.38- 2.40)2.40 (2.39- 2.41)2.40 (2.39- 2.42)2.41 (2.40- 2.42)-Female2.07 (2.05- 2.08)2.14 (2.13- 2.16)2.22 (2.21- 2.23)2.29 (2.28- 2.31)2.35 (2.33- 2.36)2.45 (2.43- 2.46)2.50 (2.49- 2.51)2.53 (2.52- 2.54)2.56 (2.54- 2.57)2.58 (2.56- 2.59)2.60 (2.59- 2.61)PsO incidence (100,000 person years)-Male168 (164-171)158 (155- 162)161 (158-165)153 (150-157)161 (157- 164)156 (153- 159)155 (152- 159)154 (151- 157)153 (150-156)150 (147-153)148 (145-151)-Female180 (177-184)176 (172-179)181 (177-184)171 (167-174)175 (171-178)176 (172-180)179 (176-183)178 (174-181)177 (174-181)174 (170-177)173 (170-176)PsA (n)1444515443164681752218545196182072021994232572451425683PsA prevalence (%, 95%CI)-Male0.14 (0.14- 0.14)0.15 (0.14- 0.15)0.15 (0.15- 0.16)0.16 (0.16- 0.16)0.17 (0.16- 0.17)0.18 (0.17- 0.18)0.18 (0.18- 0.19)0.19 (0.18- 0.19)0.19 (0.19- 0.20)0.20 (0.19- 0.20)0.20 (0.20- 0.20)-Female0.13 (0.13- 0.13)0.14 (0.13- 0.14)0.15 (0.14- 0.15)0.15 (0.15- 0.16)0.16 (0.16- 0.16)0.17 (0.17- 0.18)0.18 (0.18- 0.18)0.19 (0.19- 0.19)0.20 (0.19- 0.20)0.20 (0.20- 0.21)0.21 (0.21- 0.22)PsA incidence (100,000 person years)-Male13 (12- 14)12 (11- 13)13 (12- 14)12 (11- 13)13 (12-14)14 (13- 15)14 (13- 15)14 (13-15)1514-16)14(13- 15)15 (14-16)-Female12 (11- 13)13 (12- 14)13 (12- 14)14 (13-15)14 (13-15)15 (14-16)17 (16- 18)16 (15- 17)17 (16- 18)18 (17-19)18 (17-19)Acknowledgements:NIL.Disclosure of InterestsArani Vivekanantham: None declared, Edward Burn: None dec ared, Marta Pineda-Moncusí: None declared, Sara Khalid Grant/research support from: SK has received research grant funding from the UKRI and Alan Turing Institute outside this work. SK's research group has received grant support from Amgen and UCB Biopharma., Daniel Prieto-Alhambra Grant/research support from: DPA's department has received grant/s from Amgen, Chiesi-Taylor, Lilly, Janssen, Novartis, and UCB Biopharma. His research group has received consultancy fees from Astra Zeneca and UCB Biopharma. Amgen, Astellas, Janssen, Synapse Management Partners and UCB Biopharma have funded or supported training programmes organised by DPA's department., Laura Coates Speakers bureau: LC has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Novartis, Pfizer and UCB., Consultant of: LC has worked as a paid consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer and UCB., Grant/research support from: LC has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Novartis and Pfizer.

‘You Took me Back to the sea:' Using Narrative to Explore and Inform the Practice of Social Work with Dying People

This article centres on a qualitative interview extract, the ‘Story of the Pebble', in which a West African Hospital Social Worker Ado, working in a UK context, and identifying as a Shaman, describes successfully trusting his instincts to create a symbol for a dying patient. Despite criticisms from colleagues, Ado's capacity to understand his patients needs are justified both before and after her death.The article discusses significant themes from the interview extract, including the meaning of professionalism, practice wisdom and cultural influences in a UK social work context, as well as through Ado's heritage and identification as a Shaman. The article considers holistic patient care in a medical context and suggests this has some useful lessons for social workers, particularly those involved with dying people. Although the extract, and wider research study from which it is drawn, pre-date the Covid 19 pandemic, this is referenced throughout, linking the interview extract to ways of helping practitioners and educators to consider people holistically at end of life. AD -, Chichester, UK ;, Chichester, UK

Life after ICU: five minutes with . . . Ron Daniels

The consultant in intensive care and anaesthesia and UK Sepsis Trust founder talks about life after intensive care for covid-19 patients

Trial Decline

According to the Association of the British Pharmaceutical Industry (ABPI) there has been a significant decline in the number of industry clinical trials nitiated in the UK. "The COVID-19 pandemic has accelerated the decline in ate-stage industry clinical research in the UK, compared to its global peers," said Richard Torbett, chief executive of the ABPI in a press release (3). Findings from an ABPI report into the state of clinical trials in the UK has shown that consistently slow and variable set up times for clinical trials encountered in the NHS are causing some pharmaceutical companies to look elsewhere for clinical research (4). [...]a close relationship is needed between government and the life sciences sector now more than ever to ensure the country does not fall too far behind its global competitors.

Cold Comfort for Bio/Pharma

The COVID-19 pandemic highlighted how vital cold chain is for the pharmaceutical industry, particularly as some vaccines needed to be produced, transported, and stored at -70 °C. Market projections for cold chain logistics of pharmaceuticals are projected to grow at a compound annual growth rate of 9.03% by 2025, which is reported to be driven by greater global demand for pharmaceuticals, increasing initiatives to promote cold chain, and more demand for reefer containers from the pharma industry (1). Gilmore (Tower Cold Chain): Putting the European success of the COVID-19 vaccine rollout to one side, the demand for effective temperature-controlled packaging solutions in the pharmaceutical supply chain has increased significantly in recent years. Today, the cold chain is grappling with additional challenges: serving a global market, driving out costs and waste, addressing capacity and resource constraints, and dealing with continually mounting regulations-all whilst handling valuable pharmaceutical cargo. Cold chain logistics providers must invest in the latest on-board equipment built into containers to track temperature and location, and to make data available to partners and customers in real time, to prevent or mitigate loss.

Building Up to a Bright Future

Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. [...]there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. Novel formulations can pose challenges when using standard apparatus;nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. [...]modification of the instrumentation, such as that found in Agilent's NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.

The Outlook for a Year of Change

"The coronavirus pandemic has highlighted the vital need to strengthen our health systems," said Ursula von der Leyen, president of the European Commission (EC) in a press release on the strategy's publication (1). [...]O'Sullivan continues, many pharma companies have already started taking steps to localize supply chains, which is a trend he believes will become permanent. According to Coleman, industry has not only survived but has thrived in this aspect, demonstrating the ability to audit sites from different continents, collaborating effectively with partners from all over the world, and trusting the workforce to get the job done in a remote capacity. [...]online learning tools have surged in popularity, Raposo continues.

A Bright Outlook

Bolstered by the increased public awareness of healthcare, expanding government activity-particularly in the vaccine sector-and rapid actions taken by bio/pharma companies in reaction to the pandemic, the pharma industry is expected to experience continued growth in 2021. "The industry will continue to benefit from favourable demographic and lifestyle factors, innovations, and a diminishing threat from expiring patents in addition to the shot in the arm for the whole sector from the COVID-19 pandemic, whose impact goes beyond the vaccines," said Olaf Tblke, head of corporate ratings at Scope and lead healthcare-sector analyst, in a press release (1). According to recent insight from McKinsey, M&A is a critical aspect to a pharmaceutical company's recovery within the new normal (3).

A Little More Respect

According to research from GlobeScan, stakeholders have a tendency to believe that the pharma industry's reputation is poor, with a particularly negative environment seen in Canada and the United Kingdom caused by campaigns from nongovernmental organizations or films (2). Great effort required As pharma companies continue to forge ahead, collaborating with others that may be considered as competitors in a 'normal' situation, there is a chance that the overall reputation of the industry can be further improved. PatientView, "Pharma Reputation in 2018Among UK Patient Groups-Falls Due to Brexit and Other Factors," Press Release, 16 July 2019.

Leader of the Pack?

AstraZeneca has potentially taken poll position in the race to develop a novel coronavirus vaccine, but will AZD1222 be ready in 2020? "The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type," said Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial, in a press release (1). [...]AstraZeneca and the European Commission recently concluded an agreement for the supply of up to 400 million doses (3), which adds to a prior arrangement the company had formed with the Inclusive Vaccines Alliance (4).

The COVID-19 Vaccine Blind Spot

According to a global survey undertaken by Ipsos, the number of people who would be vaccinated with a COVID-19 vaccine outweighs the number who wouldn't in most countries, but some European countries ranked quite low in terms of public confidence in vaccine safety (5). [...]overcoming misgivings and improving confidence in vaccination programmes are of critical importance to ensure overall success. [...]this complacency may be a result of the eradication of certain diseases, such as polio and smallpox, which could lead to forgetfulness as to how vaccines are effective tools in epidemics.