Clinical Pharmacology & Therapeutics
Volume 108, Issue 4 Pages: 681-895 October 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

Perspectives
Pandemic Best Regulatory Practices: An Urgent Need in the COVID‐19 Pandemic
Murray M. Lumpkin, John C. W. Lim
Pages: 703-705
First Published:04 June 2020
Abstract
As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID‐19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk‐1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight “pandemic best regulatory practices.” These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency—thus contributing to ending this pandemic as quickly, effectively, and safely as possible.

Clinical Pharmacology & Therapeutics
Volume 108, Issue 4 Pages: 681-895 October 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

Mini‐Review Open Access
Leading a Digital Transformation in the Pharmaceutical Industry: Reimagining the Way We Work in Global Drug Development
Luca A. Finelli, Vas Narasimhan
Pages: 756-761
First Published:15 April 2020
Abstract
We are experiencing seminal times in computing that seem to define a fourth industrial revolution. This may fundamentally change the way we live, work, and relate to one another. Embracing data and digital information is a top priority for most industries these days, and Life Sciences is no exception. The pharmaceutical industry in particular is fundamentally a data‐driven business. Inspired by a desire to “Go Big on Data,” we developed a strategic roadmap defining a digital transformation to reimagine the way we work in Novartis Global Drug Development, leveraging data science to generate and inject actionable insights into our best practices. We launched a program called Nerve Live, and built a state‐of‐the‐art data and analytics platform to harness past and present operational data, providing access to decades of drug development “experience” buried across multiple sources. The platform enabled the systematic application of machine learning and predictive analytics to generate “intelligence”: new insights across multiple functional areas. To action the insights and create “value,” we crafted skillfully designed end‐user applications for domain experts to plan, track, predict, compare and monitor domain activities, optimize costs, and maximize quality. Today, the Nerve Live program enables insights‐driven decision making at scale, unlocking productivity, and providing transparency across the Novartis Global Drug Development organization and beyond. We identified three main drivers making the Nerve Live program successful and enabling the associated digital transformation to flourish. We discuss the challenges, highlight the benefits, and see the importance of leading the way to become future proof.

Clinical Therapeutics
August 2020 Volume 42, Issue 8, p1425-1624, e115-e160
http://www.clinicaltherapeutics.com/current

Commentary
COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use
Paul Beninger
p1444–1450
Published online: June 28, 2020
Abstract
Against the backdrop of the COVID pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat, and prevent infection with SARS-CoV-2. These activities may only be legally conducted with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly 12 decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of statutory history have led to the regulatory infrastructure we have in place: (1) standardized processes for routine development of medicinal and medical device products for human use; (2) processes for expedited development to shorten time frames and expand patient populations; (3) mechanisms of Expanded Access to make medicinal products available to patients prior to approval of the US Food and Drug Administration; (4) Emergency Use Authorization during public health emergencies; and (5) the development of pathways for bringing generic drugs and biosimilar biologics to market. These mechanisms are being brought to bear to facilitate the defeat of infection with SARS-CoV-2.

Clinical Therapeutics
August 2020 Volume 42, Issue 8, p1425-1624, e115-e160
http://www.clinicaltherapeutics.com/current

Assessing Participation Burden in Clinical Trials: Introducing the Patient Friction Coefficient
David Cameron, Cara Willoughby, Denise Messer, Marie Lux, Murray Aitken, Kenneth Getz
e150–e159
Published online: July 31, 2020
Abstract
Protocol design complexity, and associated study volunteer burden, negatively impact patient recruitment and retention as well as overall research and development productivity. Complex protocols reduce the willingness of potential clinical trial participants to enroll and reduce retention rates. There have been few systematic assessments of protocol design characteristics to determine the burden placed on study volunteers, although such an assessment would offer a compelling opportunity to optimize trial designs and improve recruitment and retention performance. To be useful, an assessment would need to be patient-centric, and focused on the factors that influence participation throughout the clinical trial. Such an assessment would also need to accommodate the unique cost-value trade-off compared with current treatment patterns that each participant makes when choosing to participate and remain in a clinical trial. This article proposes a new methodology to quantify patient burden: the clinical trial patient friction coefficient (PFC). A case example is provided to illustrate the utility of the PFC. A number of applications for the PFC are envisioned: standardizing patient burden assessment to evaluate clinical trial design feasibility, shedding light on the impact of patient burden on clinical trial economics and performance, and conducting sensitivity analyses to identify factors that most reduce patient burden and improve the performance and efficiency of clinical trials.

Clinical Trials
Volume 17 Issue 5, October 2020
https://journals.sagepub.com/toc/ctja/17/5

Perspective
Clinical trials in the time of a pandemic
Susan S Ellenberg
First Published July 10, 2020; pp. 467–471
Abstract
The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health emergency. By February 2020, cases had been identified in multiple countries, clinical trials of treatments with some biological plausibility had begun in China, and the initial steps of vaccine development were underway. In mid-March, by which time countries around the world were experiencing rapidly increasing numbers of cases and deaths, the World Health Organization categorized the outbreak as a pandemic. This new coronavirus was designated SARS-COV-2 in recognition of its similarity to the coronavirus responsible for the severe acute respiratory syndrome outbreak in 2002–2003. The race is on to develop treatments that can mitigate the severe consequences of infection and vaccines that can prevent infection and/or diminish the severity of disease in those who do get infected. Many challenges face these development efforts. Some are similar to those faced in the past; others are new. The urgency of finding ways to treat, and ultimately prevent, the consequences of this new and potentially deadly infection has led to unprecedented focus on clinical trials.

Clinical Trials
Volume 17 Issue 5, October 2020
https://journals.sagepub.com/toc/ctja/17/5

Research Letter
COVID-19 impact on multi-site recruitment and enrollment
Emma Strujo, Mechelle Sanders, Kevin Fiscella, Marie Thomas, Brent Johnson, Alex Deets, Claudia Sanchez Lucas, Tameir Holder, Nina Johal, Amneris Luque, Andrea Cassells, Stephen Williams, Jonathan N Tobin
First Published August 20, 2020; pp. 501–504

Emerging Infectious Diseases
Volume 26, Number 10—October 2020
http://wwwnc.cdc.gov/eid/

Research
Effectiveness of 23-Valent Pneumococcal Polysaccharide Vaccine against Invasive Pneumococcal Disease in Adults, Japan, 2013–2017

Expert Review of Vaccines
Vol 19 (8) 2020
https://www.tandfonline.com/toc/ierv20/current

Review
Fifteen years of experience with the oral live-attenuated human rotavirus vaccine: reflections on lessons learned
Priya Pereira , Volker Vetter , Baudouin Standaert & Bernd Benninghoff
Pages: 755-769
Published online: 04 Sep 2020

Expert Review of Vaccines
Vol 19 (8) 2020
https://www.tandfonline.com/toc/ierv20/current

Editorial
The potential impact of COVID-19 pandemic on the immunization performance in Indonesia
Auliya A. Suwantika , Cornelis Boersma & Maarten J. Postma
Pages: 687-690
Published online: 06 Aug 2020

Global Health: Science and Practice (GHSP)
Vol. 8, No. 3 October 01, 2020
http://www.ghspjournal.org/content/current

ORIGINAL ARTICLES
The Critical Role and Evaluation of Community Mobilizers in Polio Eradication in Remote Settings in Africa and Asia
Judy Lewis, Karen LeBan, Roma Solomon, Filimona Bisrat, Samuel Usman and Ahmed Arale
Global Health: Science and Practice October 2020, 8(3):396-412; https://doi.org/10.9745/GHSP-D-20-00024
Critical community health worker criteria are important for all community programs, including those focused on a single disease. Areas of importance include community engagement, local adaptation, and linkage with the health system—critical areas for current and future epidemics.

Global Health: Science and Practice (GHSP)
Vol. 8, No. 3 October 01, 2020
http://www.ghspjournal.org/content/current

Open Access
Determinants of Facility-Level Use of Electronic Immunization Registries in Tanzania and Zambia: An Observational Analysis
Emily Carnahan, Ellen Ferriss, Emily Beylerian, Francis Dien Mwansa, Ngwegwe Bulula, Dafrossa Lyimo, Anna Kalbarczyk, Alain B. Labrique, Laurie Werner and Jessica C. Shearer
Global Health: Science and Practice October 2020, 8(3):488-504; https://doi.org/10.9745/GHSP-D-20-00134
We provide a framework to quantify the use of electronic immunization registry systems at the facility level and results show the importance of behavioral and organizational factors in explaining their sustained use in Tanzania and Zambia.

Global Health: Science and Practice (GHSP)
Vol. 8, No. 3 October 01, 2020
http://www.ghspjournal.org/content/current

REVIEWS
Open Access
Factors That Influence Data Use to Improve Health Service Delivery in Low- and Middle-Income Countries
Nicole Rendell, Kamalini Lokuge, Alexander Rosewell and Emma Field
Global Health: Science and Practice October 2020, 8(3):566-581; https://doi.org/10.9745/GHSP-D-19-00388
We identified factors that may influence the relationship between information generation and improvement of health service delivery: governance (leadership, participatory monitoring, regular review of data); production of information (presentation of findings, data quality, qualitative data); and health information system resources (electronic health management information systems, organizational structure, training).

Global Public Health
Volume 15, 2020 Issue 10
http://www.tandfonline.com/toc/rgph20/current

Article
Medical populism and the COVID-19 pandemic
Gideon Lasco
Pages: 1417-1429
Published online: 11 Aug 2020
ABSTRACT
This paper uses the vocabulary of ‘medical populism’ to identify and analyse the political constructions of (and responses to) the COVID-19 pandemic in Brazil, the Philippines, and the United States from January to mid-July 2020, particularly by the countries’ heads of state: Jair Bolsonaro, Rodrigo Duterte, and Donald Trump. In all three countries, the leaders’ responses to the outbreak can be characterised by the following features: simplifying the pandemic by downplaying its impacts or touting easy solutions or treatments, spectacularizing their responses to crisis, forging divisions between the ‘people’ and dangerous ‘others’, and making medical knowledge claims to support the above. Taken together, the case studies illuminate the role of individual political actors in defining public health crises, suggesting that medical populism is not an exceptional, but a familiar response to them. This paper concludes by offering recommendations for global health in anticipating and responding to pandemics and infectious disease outbreaks.

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/7

Original Articles
Budget line items for immunization in 33 African countries
Ulla K Griffiths, Jennifer Asman, Alex Adjagba, Marina Yo, James O Oguta …
Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 753–764, https://doi.org/10.1093/heapol/czaa040

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/7

The development of a new accountability measurement framework and tool for global health initiatives
Adriane Martin Hilber, Patricia Doherty, Andrea Nove, Rachel Cullen, Tunde Segun …

Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 765–774, https://doi.org/10.1093/heapol/czz170
Abstract
The Global Strategy for Women’s Children’s and Adolescents’ Health emphasizes accountability as essential to ensure that decision-makers have the information required to meet the health needs of their populations and stresses the importance of tracking resources, results, and rights to see ‘what works, what needs improvement and what requires increased attention’. However, results from accountability initiatives are mixed and there is a lack of broadly applicable, validated tools for planning, monitoring and evaluating accountability interventions. This article documents an effort to transform accountability markers—including political will, leadership and the monitor–review–act cycle—into a measurement tool that can be used prospectively or retrospectively to plan, monitor and evaluate accountability initiatives. It describes the development process behind the tool including the literature review, framework development and subsequent building of the measurement tool itself. It also examines feedback on the tool from a panel of global experts and the results of a pilot test conducted in Bauchi and Gombe states in Nigeria. The results demonstrate that the tool is an effective aid for accountability initiatives to reflect on their own progress and provides a useful structure for future planning, monitoring and evaluation. The tool can be applied and adapted to other accountability mechanisms working in global health.

JAMA Network
COVID-19 Update October 3, 2020

These articles on COVID-19 were published across the JAMA Network in the last week.

Journal of Adolescent Health
October 2020 Volume 67, Issue 4, p461-622
https://www.jahonline.org/issue/S1054-139X(20)X0008-5

Original Articles
Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?
One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear.
Seema K. Shah, Zaynab Essack, Katherine Byron, Catherine Slack, Daniel Reirden, Heidi van Rooyen, Nathan R. Jones, David S. Wendler
p495–501
Published online: July 5, 2020

Journal of Pediatrics
October 2020 Volume 225, p1-288
http://www.jpeds.com/current

Commentary
Seeking Normalcy as the Curve Flattens: Ethical Considerations for Pediatricians Managing Collateral Damage of Coronavirus Disease-2019
Dalia M. Feltman, Gregory P. Moore, Andrew F. Beck, Emily Siffermann, Carlo Bellieni, John Lantos
p233–238
Published online: June 26, 2020

Journal of Travel Medicine
Volume 27, Issue 6, August 2020
https://academic.oup.com/jtm/issue/27/6

Perspectives
Assessing US traveller vaccination access: an evaluation of US requirements for healthcare payer coverage of recommended travel vaccines
Richard Hughes IV, Zach Klein
Journal of Travel Medicine, Volume 27, Issue 6, August 2020, taaa118, https://doi.org/10.1093/jtm/taaa118

Journal of Travel Medicine
Volume 27, Issue 6, August 2020
https://academic.oup.com/jtm/issue/27/6

Original Article
Safety of yellow fever vaccination in pregnancy: findings from a cohort of active duty US military women
Clinton Hall, PhD, Zeina G Khodr, PhD, Richard N Chang, MPH, Anna T Bukowinski, MPH, Gia R Gumbs, MPH …
Journal of Travel Medicine, Volume 27, Issue 6, August 2020, taaa138, https://doi.org/10.1093/jtm/taaa138

The Lancet
Oct 03, 2020 Volume 396 Number 10256 p935-1044, e53-e56
https://www.thelancet.com/journals/lancet/issue/current

Comment
Offline: Science and the breakdown of trust
Richard Horton

The Lancet
Oct 03, 2020 Volume 396 Number 10256 p935-1044, e53-e56
https://www.thelancet.com/journals/lancet/issue/current

Articles
Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial
Remo H M Furtado, et al for the COALITION COVID-19 Brazil II Investigators
The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19…
In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19.

The Lancet
Oct 03, 2020 Volume 396 Number 10256 p935-1044, e53-e56
https://www.thelancet.com/journals/lancet/issue/current

The Lancet Commissions
The Lancet NCDI Poverty Commission: bridging a gap in universal health coverage for the poorest billion
Gene Bukhman, et al for the Lancet NCDI Poverty Commission Study Group
Key messages
:: For the poorest of our world, non-communicable diseases and injuries (NCDIs) account for more than a third of their burden of disease; this burden includes almost 800 000 deaths annually among those aged younger than 40 years, more than HIV, tuberculosis, and maternal deaths combined
:: Despite already living in abject poverty, between 19 million and 50 million of the poorest billion spend a catastrophic amount of money each year in direct out-of-pocket costs on health care as a :: :: :: Progressive implementation of affordable, cost-effective, and equitable NCDI interventions between 2020 and 2030 could save the lives of more than 4·6 million of the world’s poorest, including 1·3 million who would otherwise die before the age of 40 years
:: To avoid needless death and suffering, and to reduce the risk of catastrophic health spending, essential NCDI services must be financed through pooled, public resources, either from increased domestic funding or external funds
:: National governments should set and adjust priorities based on the best available local data on NCDIs and the specific needs of the worst off
:: International development assistance for health should be augmented and targeted to ensure that the poorest families affected by NCDIs are included in progress towards universal health care

Lancet Digital Health
Oct 2020 Volume 2 Number 10 e493-e560
https://www.thelancet.com/journals/landig/issue/current

Editorial
Guiding better design and reporting of AI-intervention trials
The Lancet Digital Health

Lancet Digital Health
Oct 2020 Volume 2 Number 10 e493-e560
https://www.thelancet.com/journals/landig/issue/current

Review
Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension
Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, Melanie J Calvert, Alastair K Denniston and the SPIRIT-AI and CONSORT-AI Working Group
Summary
The CONSORT 2010 statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders), and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human–AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret, and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

Lancet Digital Health
Oct 2020 Volume 2 Number 10 e493-e560
https://www.thelancet.com/journals/landig/issue/current

Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension
Samantha Cruz Rivera, Xiaoxuan Liu, An-Wen Chan, Alastair K Denniston, Melanie J Calvert and The SPIRIT-AI and CONSORT-AI Working Group
Summary
The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human–AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret, and critically appraise the design and risk of bias for a planned clinical trial.

Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

Editorial
A historic achievement in a year of turmoil
The Lancet Global Health
On World Polio Day 6 years ago, we wrote in an Editorial that “2014 has not felt like a good year for infectious disease control”. Little did we know what lay ahead. Yet in 2020—a year of unprecedented disruption at the hands of a new human pathogen—the transmission of an old and more deadly and disabling virus was formally declared over on a continent with some of the weakest health systems in the world.
The certification on Aug 25 that the African region is now free of wild poliovirus was a truly historic moment. Back in 2014, WHO declared a Public Health Emergency of International Concern over markedly increased international spread, including from Africa, and in 2016 WHO revoked Nigeria’s recently achieved polio-free status after several cases of wild poliovirus were discovered in Borno state. Genetic analysis pointed to long-term undetected transmission—a devastating setback borne of prolonged conflict that had destroyed health-care delivery infrastructure and severely restricted surveillance…

Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

Comment
Launching the Kofi Annan Global Health Leadership Programme
John N Nkengasong, Edem Adzogenu, Amira E M Elfadil, Kwesi T Quartey

Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

Leadership training to accelerate progress in public health in sub-Saharan Africa: time for action
Yukari C Manabe, Yohana Mashalla, Carey Farquhar, Nelson K Sewankambo

Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

The SickleGenAfrica Network
Solomon F Ofori-Acquah on behalf of the SickleGenAfrica Network

Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

Articles
Routine childhood immunisation during the COVID-19 pandemic in Africa: a benefit–risk analysis of health benefits versus excess risk of SARS-CoV-2 infection
Kaja Abbas, et al LSHTM CMMID COVID-19 Working Group
National immunisation programmes globally are at risk of suspension due to the severe health system constraints and physical distancing measures in place to mitigate the ongoing COVID-19 pandemic. We aimed to compare the health benefits of sustaining routine childhood immunisation in Africa with the risk of acquiring severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection through visiting routine vaccination service delivery points.

Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

The allocation of US$105 billion in global funding from G20 countries for infectious disease research between 2000 and 2017: a content analysis of investments
Michael G Head, et al

Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

Domestic HPV vaccine price and economic returns for cervical cancer prevention in China: a cost-effectiveness analysis
Zhuoru Zou, et al.

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Lancet Global Health
Oct 2020 Volume 8 Number 10 e1242-e1351
http://www.thelancet.com/journals/langlo/issue/current

Health Policy
Certifying the interruption of wild poliovirus transmission in the WHO African region on the turbulent journey to a polio-free world
The Africa Regional Commission for the Certification of Poliomyelitis Eradication
Summary
On Aug 25 2020, the Africa Regional Commission for the Certification of Poliomyelitis Eradication declared that the WHO African region had interrupted transmission of all indigenous wild polioviruses. This declaration marks the African region as the fifth of the six WHO regions to celebrate this extraordinary achievement. Following the Yaoundé Declaration on Polio Eradication in Africa by heads of state and governments in 1996, Nelson Mandela launched the Kick Polio out of Africa campaign. In this Health Policy paper, we describe the long and turbulent journey to the certification of the interruption of wild poliovirus transmission, focusing on 2016–20, lessons learned, and the strategies and analyses that convinced the Regional Commission that the African region is free of wild polioviruses. This certification of the WHO African region shows the feasibility of polio eradication in countries with chronic insecurity, inaccessible and hard-to-reach populations, and weak health systems. Challenges have been daunting and the sacrifices enormous—dozens of health workers and volunteers have lost their lives in the pursuit of a polio-free Africa.

Lancet Infectious Diseases
Sep 2020 Volume 20 Number 9 p993-1100, e215-e249
http://www.thelancet.com/journals/laninf/issue/current

Editorial
Curing COVID-19
The Lancet Infectious Diseases
As the COVID-19 pandemic moves into its 10th month, greater patient survival suggests that treatment of severe disease has improved. How much of this improvement is due to better supportive care and how much to pharmaceuticals is a matter of debate. Given the huge effort that the biomedical community has put into finding drugs to treat COVID-19, with thousands of trials completed and ongoing, it’s worth taking stock of the evidence for what has worked and what has not…

Lancet Infectious Diseases
Sep 2020 Volume 20 Number 9 p993-1100, e215-e249
http://www.thelancet.com/journals/laninf/issue/current

Personal View
Need for sustainable biobanking networks for COVID-19 and other diseases of epidemic potential
Rosanna W Peeling, Debrah Boeras, Annelies Wilder-Smith, Amadou Sall, John Nkengasong

Lancet Infectious Diseases
Sep 2020 Volume 20 Number 9 p993-1100, e215-e249
http://www.thelancet.com/journals/laninf/issue/current

Vaccinology: time to change the paradigm?
Christine Stabell Benn, Ane B Fisker, Andreas Rieckmann, Signe Sørup, Peter Aaby
Summary
The existing vaccine paradigm assumes that vaccines only protect against the target infection, that effective vaccines reduce mortality corresponding to the target infection’s share of total mortality, and that the effects of vaccines are similar for males and females. However, epidemiological vaccine research has generated observations that contradict these assumptions and suggest that vaccines have important non-specific effects on overall health in populations. These include the observations that several live vaccines reduce the incidence of all-cause mortality in vaccinated compared with unvaccinated populations far more than can be explained by protection against the target infections, and that several non-live vaccines are associated with increased all-cause mortality in females. In this Personal View we describe current observations and contradictions and define six emerging principles that might explain them. First, that live vaccines enhance resistance towards unrelated infections. Second, non-live vaccines enhance the susceptibility of girls to unrelated infections. Third, the most recently administered vaccination has the strongest non-specific effects. Fourth, combinations of live and non-live vaccines given together have variable non-specific health effects. Fifth, vaccinating children with live vaccines in the presence of maternal immunity enhances beneficial non-specific effects and reduces mortality. Finally, vaccines might interact with other co-administered health interventions, for example vitamin A supplementation. The potential implications for child health are substantial. For example, if BCG vaccination was given to children at birth, if higher measles vaccination coverage could be obtained, if diphtheria, tetanus, and pertussis-containing vaccines were not given with or after measles vaccine, or if the BCG strain with the best non-specific effects could be used consistently, then child mortality could be considerably lower. Pursuing these emerging principles could improve our understanding and use of vaccines globally.

Lancet Public Health
Oct 2020 Volume 5 Number 10 e512-e567
https://www.thelancet.com/journals/lanpub/issue/current

Editorial
Public health must be a priority in the 2020 US election
The Lancet Public Health

Nature
Volume 585 Issue 7826, 24 September 2020
http://www.nature.com/nature/current_issue.html

Editorial | 29 September 2020
COVID vaccine confidence requires radical transparency
Public trust in a potential vaccine is under threat. Drug companies and their academic partners must disclose protocols and results data.
…History has shown that once public trust in vaccines has been compromised it is difficult to win back — and that distrust in one vaccine can fuel concerns about others. People wary of a COVID-19 vaccine might be less likely to get vaccinated against other ailments, fuelling the vaccine-hesitancy movement that has already led to dangerous resurgences of diseases such as measles that were once largely contained. The causes of vaccine hesitancy are complex. But delays and reluctance in communicating results, or outright secrecy, do not help. Researchers, publishers, regulators, policymakers — and especially pharmaceutical companies — need to accept this if we are to succeed in quickly disrupting the path of the pandemic.

Nature Genetics
Volume 52 Issue 10, October 2020
https://www.nature.com/ng/volumes/52/issues/10

Comment | 09 September 2020
Exploring the coronavirus pandemic with the WashU Virus Genome Browser
The WashU Virus Genome Browser is a web-based portal for efficient visualization of viral ‘omics’ data in the context of a variety of annotation tracks and host infection responses. The browser features both a phylogenetic-tree-based view and a genomic-coordinate, track-based view in which users can analyze the sequence features of viral genomes, sequence diversity among viral strains, genomic sites of diagnostic tests, predicted immunogenic epitopes and a continuously updated repository of publicly available genomic datasets.
Jennifer A. Flynn, Deepak Purushotham[…] & Ting Wang

Nature Genetics
Volume 52 Issue 10, October 2020
https://www.nature.com/ng/volumes/52/issues/10

Comment | 09 September 2020
The UCSC SARS-CoV-2 Genome Browser
The UCSC SARS-CoV-2 Genome Browser ( https://genome.ucsc.edu/covid19.html ) is an adaptation of our popular genome-browser visualization tool for this virus, containing many annotation tracks and new features, including conservation with similar viruses, immune epitopes, RT–PCR and sequencing primers and CRISPR guides. We invite all investigators to contribute to this resource to accelerate research and development activities globally.
Jason D. Fernandes, Angie S. Hinrichs[…] & Maximilian Haeussler

Nature Genetics
Volume 52 Issue 10, October 2020
https://www.nature.com/ng/volumes/52/issues/10

Comment | 09 September 2020
Exploring the structural distribution of genetic variation in SARS-CoV-2 with the COVID-3D online resource
The emergence of the COVID-19 pandemic has spurred a global rush to uncover basic biological mechanisms to inform effective vaccine and drug development. Despite the novelty of the virus, global sequencing efforts have already identified genomic variation across isolates. To enable easy exploration and spatial visualization of the potential implications of SARS-CoV-2 mutations in infection, host immunity and drug development, we have developed COVID-3D ( http://biosig.unimelb.edu.au/covid3d/ ).
Stephanie Portelli, Moshe Olshansky[…] & David B. Ascher

Nature Genetics
Volume 52 Issue 10, October 2020
https://www.nature.com/ng/volumes/52/issues/10

Perspective | 14 September 2020
Treating medical data as a durable asset
This Perspective discusses important aspects of data generation, infrastructure and management that affect how the research community uses medical data, including genetic and genomic information.
Amalio Telenti & Xiaoqian Jiang
Abstract
Access to medical data is central for conducting research on genomics. However, to tap these metadata (observable traits and phenotypes, diagnoses and medication, and labels), researchers must grapple with the complex and sensitive nature of the information. In this Perspective, we argue that, at this exciting time for genomics and artificial intelligence, several critical aspects of data generation, infrastructure and management are pillars of a modern data ecosystem. Many risks to privacy and many obstacles to medical research can be eliminated or mitigated by new secure data analytics. Finally, we discuss the potential consequences of medical data exiting the institutions and being managed by individuals. These shifts in data ownership have the potential for profound disruption and opportunity across many fields.

Nature Reviews Genetics
Volume 21 Issue 10, October 2020
https://www.nature.com/nrg/volumes/21/issues/9

Comment | 07 August 2020
The Human Genome Project changed everything
Thirty years on from the launch of the Human Genome Project, Richard Gibbs reflects on the promisesthat this voyage of discovery bore. Its success should be measured by how this project transformed the rules of research, the way of practising biological discovery and the ubiquitous digitization of biological science.
Richard A. Gibbs

Nature Reviews Genetics
Volume 21 Issue 10, October 2020
https://www.nature.com/nrg/volumes/21/issues/9

Viewpoint | 24 August 2020
The road ahead in genetics and genomics
To celebrate the first 20 years of Nature Reviews Genetics, we asked 12 leading scientists to reflect on the key challenges and opportunities faced by the field of genetics and genomics.
Amy L. McGuire, Stacey Gabriel[…] & Jin-Soo Kim

Nature Reviews Genetics
Volume 21 Issue 10, October 2020
https://www.nature.com/nrg/volumes/21/issues/9

Review Article | 21 July 2020
Responsible, practical genomic data sharing that accelerates research
Data sharing can maximize the benefit and reach of genomics research. However, sharing must occur in a responsible manner, particularly when there are privacy risks to human participants. In this Review, the authors discuss the principles of data sharing, strategies for assessing and mitigating privacy risks, as well as practical guidelines for researchers and wider stakeholders.
James Brian Byrd, Anna C. Greene[…] & Casey S. Greene

Nature Reviews Immunology
Volume 20 Issue 10, October 2020
https://www.nature.com/nri/volumes/20/issues/10

Review Article | 04 September 2020
Immunological considerations for COVID-19 vaccine strategies
This Review outlines the guiding immunological principles for the design of coronavirus disease 2019 (COVID-19) vaccine strategies and analyses the current COVID-19 vaccine landscape and the challenges ahead.
Mangalakumari Jeyanathan, Sam Afkhami[…] & Zhou Xing

Nature Reviews Drug Discovery
Volume 19 Issue 10, October 2020
https://www.nature.com/nrd/volumes/19/issues/10

Comment | 03 September 2020
COVID-19 must catalyse changes to clinical development
The response to the COVID-19 pandemic has shown that exceptional efforts can dramatically accelerate the clinical development of vaccines. We propose that it is time to also take immediate actions to improve clinical trials in other areas to better serve all patients.
Rod MacKenzie, Peter Honig[…] & Marie-Pierre Hellio

New England Journal of Medicine
October 1, 2020 Vol. 383 No. 14
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Ensuring Uptake of Vaccines against SARS-CoV-2
Michelle M. Mello, J.D., Ph.D., Ross D. Silverman, J.D., M.P.H., and Saad B. Omer, M.B., B.S., M.P.H., Ph.D.
As Covid-19 continues to exact a heavy toll, development of a vaccine appears the most promising means of restoring normalcy to civil life. Perhaps no scientific breakthrough is more eagerly anticipated. But bringing a vaccine to market is only half the challenge; also critical is ensuring a high enough vaccination rate to achieve herd immunity. Concerningly, a recent poll found that only 49% of Americans planned to get vaccinated against SARS-CoV-2.¹

One option for increasing vaccine uptake is to require it. Mandatory vaccination has proven effective in ensuring high childhood immunization rates in many high-income countries. However, except for influenza vaccination of health care workers, mandates have not been widely used for adults.

Although a vaccine remains months to years away, developing a policy strategy to ensure uptake takes time. We offer a framework that states can apply now to help ensure uptake of the vaccine when it becomes available — including consideration of when a mandate might become appropriate. Our approach is guided by lessons from U.S. experiences with vaccines for the 1976 “swine flu,” H1N1 influenza, smallpox, and human papillomavirus (HPV).

New England Journal of Medicine
October 1, 2020 Vol. 383 No. 14
http://www.nejm.org/toc/nejm/medical-journal

Original Article Free Preview
HPV Vaccination and the Risk of Invasive Cervical Cancer
Jiayao Lei, Ph.D., et al.
The efficacy and effectiveness of the quadrivalent human papillomavirus (HPV) vaccine in preventing high-grade cervical lesions have been shown. However, data to inform the relationship between quadrivalent HPV vaccination and the subsequent risk of invasive cervical cancer are lacking.