BMJ Global Health
November 2020 – Volume 5 – 11
https://gh.bmj.com/content/5/11

Original research
Enhancing the use of stakeholder analysis for policy implementation research: towards a novel framing and operationalised measures (6 November, 2020)
Marysol Astrea Balane, Benjamin Palafox, Lia M Palileo-Villanueva, Martin McKee, Dina Balabanova

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 7 Nov 2020)

Assessment of immunization data quality of routine reports in Ho municipality of Volta region, Ghana
Immunization has been an important public health intervention for preventing and reducing child morbidity and mortality over the years and coverage has increased in the past decades. However, the validity of t…
Authors: Sorengmen Amos Ziema and Livingstone Asem
Citation: BMC Health Services Research 2020 20:1013
Content type: Research article
Published on: 4 November 2020

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 7 Nov 2020)

Effectiveness of HPV vaccination against the development of high-grade cervical lesions in young Japanese women
Although more than 10 years have passed since HPV vaccination was implemented, first as an interim programme (Emergent vaccine promotion programme) in November 2010, followed by incorporating into the National…
Authors: Yuki Shiko, Ryo Konno, Hiroshi Konishi, Catherine Sauvaget, Yasuo Ohashi and Tadao Kakizoe
Citation: BMC Infectious Diseases 2020 20:808
Content type: Research article
Published on: 5 November 2020

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 7 Nov 2020)

Preventable medication harm across health care settings: a systematic review and meta-analysis
Mitigating or reducing the risk of medication harm is a global policy priority. But evidence reflecting preventable medication harm in medical care and the factors that derive this harm remain unknown. Therefore, we aimed to quantify the prevalence, severity and type of preventable medication harm across medical care settings.,, This is the largest meta-analysis to assess preventable medication harm. We conclude that around one in 30 patients are exposed to preventable medication harm in medical care, and more than a quarter of this harm is considered severe or life-threatening. Our results support the World Health Organisation’s push for the detection and mitigation of medication-related harm as being a top priority, whilst highlighting other key potential targets for remedial intervention that should be a priority focus for future research.
Authors: Alexander Hodkinson, Natasha Tyler, Darren M. Ashcroft, Richard N. Keers, Kanza Khan, Denham Phipps, Aseel Abuzour, Peter Bower, Anthony Avery, Stephen Campbell and Maria Panagioti
Citation: BMC Medicine 2020 18:313
Content type: Research article
Published on: 6 November 2020

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 7 Nov 2020)

Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review
Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined…
Authors: Carolina Graña Possamai, Philippe Ravaud, Lina Ghosn and Viet-Thi Tran
Citation: BMC Medicine 2020 18:310
Content type: Research article
Published on: 6 November 2020

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 7 Nov 2020)

The practice of evaluating epidemic response in humanitarian and low-income settings: a systematic review
Epidemics of infectious disease occur frequently in low-income and humanitarian settings and pose a serious threat to populations. However, relatively little is known about responses to these epidemics. Robust evaluations can generate evidence on response efforts and inform future improvements. This systematic review aimed to (i) identify epidemics reported in low-income and crisis settings, (ii) determine the frequency with which evaluations of responses to these epidemics were conducted, (iii) describe the main typologies of evaluations undertaken and (iv) identify key gaps and strengths of recent evaluation practice.
Authors: Abdihamid Warsame, Jillian Murray, Amy Gimma and Francesco Checchi
Citation: BMC Medicine 2020 18:315
Content type: Research article
Published on: 3 November 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 7 Nov 2020)

Willingness to use HIV prevention methods among vaccine efficacy trial participants in Soweto, South Africa: discretion is important
Despite multiple available HIV prevention methods, the HIV epidemic continues to affect South Africa the most. We sought to understand willingness to use actual and hypothetical HIV prevention methods among pa…
Authors: Fatima Laher, Taibat Salami, Stefanie Hornschuh, Lerato M. Makhale, Mamakiri Khunwane, Michele P. Andrasik, Glenda E. Gray, Hong Van Tieu and Janan J. Dietrich
Citation: BMC Public Health 2020 20:1669
Content type: Research article
Published on: 7 November 2020

BMJ Open
October 2020 – Volume 10 – 11
https://bmjopen.bmj.com/content/10/11

Health policy
Original research
Original research: Advancing a health equity agenda across multiple policy domains: a qualitative policy analysis of social, trade and welfare policy (6 November, 2020)
While there is urgent need for policymaking that prioritises health equity, successful strategies for advancing such an agenda across multiple policy sectors are not well known. This study aims to address this gap by identifying successful strategies to advance a health equity agenda across multiple policy domains.
Belinda Townsend, Sharon Friel, Toby Freeman, Ashley Schram, Lyndall Strazdins, Ronald Labonte, Tamara Mackean, Fran Baum

Bulletin of the World Health Organization
Volume 98, Number 11, November 2020, 725-820
https://www.who.int/bulletin/volumes/98/11/en/

EDITORIALS
Strengthening our resolve for primary health care
— Tedros Adhanom Ghebreyesus
http://dx.doi.org/10.2471/BLT.20.279489

Clinical Pharmacology & Therapeutics
Volume 108, Issue 5 Pages: 897-1106 November 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

Reviews
State of the Art
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop
Ni A. Khin et al
Pages: 949-963
First Published:20 January 2020

Clinical Trials
Volume 17 Issue 6, December 2020
https://journals.sagepub.com/toc/ctja/17/5

Ethics
When and how to include vulnerable subjects in clinical trials
David Wendler
First Published August 17, 2020; pp. 696–702
Abstract
There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem for trials covered by the US regulations, which mandate strict requirements on the inclusion of three groups: pregnant women/fetuses, prisoners, and children. For the past 30 years, funders, investigators, and institutional review boards have frequently responded to these regulations by excluding pregnant women/fetuses, prisoners, and children from clinical trials. More recent work has emphasized the extent to which a default of exclusion can undermine the value of clinical trials, especially pragmatic trials. A default of exclusion also has the potential to undermine the interests of vulnerable groups, in both the short and the long term. These concerns raise the need for guidance on how to satisfy existing US regulations, while minimizing their negative impact on the value of clinical trials and the interests of vulnerable groups. The present manuscript thus describes a six-step decision procedure that institutional review boards can use to determine when and how to include vulnerable subjects in clinical trials, including pragmatic trials, that are covered by US regulations.

Current Opinion in Infectious Diseases
December 2020 – Volume 33 – Issue 6
https://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx

PAEDIATRIC AND NEONATAL INFECTIONS
The current state of immunization against Gram-negative bacteria in children: a review of the literature
Broad, Jonathan; Le Doare, Kirsty; Heath, Paul T.; More
Current Opinion in Infectious Diseases. 33(6):517-529, December 2020.

EMBO Reports
Volume 21 Issue 11 5 November 2020
https://www.embopress.org/toc/14693178/current

Opinion 20 October 2020 Free Access
If you promise, you have to deliver
Frank Gannon
COVID‐19 highlighted the importance of science and scientists to produce vaccines, cures and diagnostics. But scientists need to be careful not to overpromise on what they can deliver.

EMBO Reports
Volume 21 Issue 11 5 November 2020
https://www.embopress.org/toc/14693178/current

Science & Society 26 October 2020 Open Access
COVID‐19 and misinformation : Is censorship of social media a remedy to the spread of medical misinformation?
Emilia Niemiec
Social media companies have resorted to censorship to suppress misinformation about the COVID‐19 pandemic. This is not the most prudent solution though given the uncertainties about the disease.

EMBO Reports
Volume 21 Issue 11 5 November 2020
https://www.embopress.org/toc/14693178/current

Science & Society 5 November 2020 Open Access
Health disinformation & social media: The crucial role of information hygiene in mitigating conspiracy theory and infodemics
David Robert Grimes
Social media has been an effective vector for spreading disinformation about medicine and science. Informational hygiene can reduce the severity of falsehoods about health.
Science & Society21 October 2020 Open Access

EMBO Reports

Volume 21 Issue 11 5 November 2020
https://www.embopress.org/toc/14693178/current

COVID‐19 and the boundaries of open science and innovation : Lessons of traceability from genomic data sharing and biosecurity
Jusaku Minari, Go Yoshizawa, Nariyoshi Shinomiya

The COVID‐19 crisis has further highlighted the challenges for open science and data sharing in biomedical research and the need for more traceability and transparency.

Emerging Infectious Diseases
Volume 26, Number 11—November 2020
http://wwwnc.cdc.gov/eid/

Synopses
Measuring Timeliness of Outbreak Response in the World Health Organization African Region, 2017–2019 [PDF – 2.49 MB – 10 pages]
B. Impouma et al.
Large-scale protracted outbreaks can be prevented through early detection, notification, and rapid control. We assessed trends in timeliness of detecting and responding to outbreaks in the African Region reported to the World Health Organization during 2017–2019. We computed the median time to each outbreak milestone and assessed the rates of change over time using univariable and multivariable Cox proportional hazard regression analyses. We selected 296 outbreaks from 348 public reported health events and evaluated 184 for time to detection, 232 for time to notification, and 201 for time to end. Time to detection and end decreased over time, whereas time to notification increased. Multiple factors can account for these findings, including scaling up support to member states after the World Health Organization established its Health Emergencies Programme and support given to countries from donors and partners to strengthen their core capacities for meeting International Health Regulations.

Ethics & Human Research
Volume 42, Issue 6 Pages: 1-40 November–December 2020
https://onlinelibrary.wiley.com/toc/25782363/current

Video‐capture studies • Benefit sharing and genomics research
Articles
Benefit Sharing for Human Genomics Research: Awareness and Expectations of Genomics Researchers in Sub‐Saharan Africa
Nchangwi Syntia Munung, Jantina de Vries
Pages: 14-20
First Published: 02 November 2020
ABSTRACT
Benefit sharing is an ethical issue that underscores the need to find a balance between access to genetic resources and the provision of fair benefits in exchange for access. The Human Genome Organisation (HUGO) is one of the few initiatives to have engaged with the topic of benefit sharing in human genomics. However, there is a lack of clarity on what benefit sharing entails in human genomics research and how it could be implemented in practice. This paper reports on a qualitative study that explored the views and expectations of benefit sharing by a group of genomics researchers in sub‐Saharan Africa. Overall, while there was little awareness of benefit sharing among the researchers, there was support for benefit sharing in human genetics, and this was based on principles of fairness, solidarity, and reciprocity. This in‐depth explorative study demonstrates the need for genomics research consortia in Africa to have open discussions on benefit sharing and to develop ethics frameworks for benefit sharing in population genomics studies in Africa. HUGO’s statement on benefit sharing and the Nagoya Protocol could provide guidance.

Ethics & Human Research
Volume 42, Issue 6 Pages: 1-40 November–December 2020
https://onlinelibrary.wiley.com/toc/25782363/current

Loopholes in the Research Ethics System? Informed Consent Waivers in Cluster Randomized Trials with Individual‐Level Intervention
Alex John London, Monica Taljaard, Charles Weijer

Pages: 21-28
First Published: 02 November 2020
ABSTRACT
Individual‐cluster trials randomize groups of individuals but deliver study interventions directly to individual participants. We examine three arguments that might justify the perception that the bar for a waiver of consent should be lower in such trials than for individually randomized trials. We contend that if these arguments are treated as sufficient to grant a waiver of consent, then a loophole emerges in research oversight. Such loopholes are morally hazardous for study participants, the integrity of science, and public trust in the research enterprise. We conclude by articulating the standards that research ethics committees should use to evaluate requests for waivers of consent in individual‐cluster trials.

Global Public Health
Volume 15, 2020 Issue 12
http://www.tandfonline.com/toc/rgph20/current

Report
Political distrust and the spread of COVID-19 in Nigeria
While studies have explored how health sector corruption, weak healthcare system, large-scale immune compromised population, misinformation and prevalence of highly congested slums contribute to the spread of COVID-19 in Nigeria, they have glossed over the impact of political distrust on the spread of the virus. This study explores the impact of political distrust on the spread of COVID-19 pandemic in Nigeria
Christian C. Ezeibe , Chukwudi Ilo , Ezinwanne N. Ezeibe , Chika N. Oguonu , Nnamdi A. Nwankwo , Chukwuedozie K. Ajaero & Nnabuike Osadebe
Pages: 1753-1766
Published online: 06 Oct 2020

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 7 Nov 2020]

Moving from rhetoric to action: how Africa can use scientific evidence to halt the COVID-19 pandemic
The ongoing pandemic of the coronavirus disease 2019 has spread rapidly to all countries of the world. Africa is particularly predisposed to an escalation of the pandemic and its negative impact given its weak economy and health systems. In addition, inadequate access to the social determinants of health such as water and sanitation and socio-cultural attributes may constrain the implementation of critical preventive measures such as hand washing and social distancing on the continent.
Authors: Olushayo Oluseun Olu, Joy Luba Lomole Waya, Sylvester Maleghemi, John Rumunu, David Ameh and Joseph Francis Wamala
Content type: Commentary
28 October 2020

JAMA
November 3, 2020, Vol 324, No. 17, Pages 1699-1798
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Protecting the Editorial Independence of the CDC From Politics
Sonja A. Rasmussen, MD, MS; John W. Ward, MD; Richard A. Goodman, MD, MPH
JAMA. 2020;324(17):1729-1730. doi:10.1001/jama.2020.19646
Beginning September 11, 2020, media sources reported that political appointees within the US Department of Health and Human Services (HHS) have demanded the ability to review and revise scientific reports on the coronavirus disease 2019 (COVID-19) pandemic published in Morbidity and Mortality Weekly Report (MMWR), published by the Centers for Disease Control and Prevention (CDC).^1,2 According to these sources, reviews by political appointees have sometimes led to delays in publication and changes in language in certain reports. Whether this is true is unclear, but these reports are consistent with other reports of the actions of political appointees and their attempts to influence the scientific process.³ As former editors in chief of MMWR, we believe these media reports raise serious concerns that in the midst of the COVID-19 pandemic, scientific reports published in MMWR might have been delayed or altered for political purposes. These concerns threaten the credibility of MMWR, an essential source of information to help counteract the pandemic.

JAMA Network
COVID-19 Update November 7, 2020

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

JAMA Pediatrics
November 2020, Vol 174, No. 11, Pages 1017-1124
http://archpedi.jamanetwork.com/issue.aspx

Review
HIV Preexposure Prophylaxis Among Adolescents in the USA Review
Hasiya Yusuf, MBBS, MPH; Errol Fields, MD, PhD, MPH; Renata Arrington-Sanders, MD, MPH, ScM; et al.
JAMA Pediatr. 2020;174(11):1102-1108. doi:10.1001/jamapediatrics.2020.0824
This narrative review assesses the use of preexposure prophylaxis in adolescents of sexual and gender minority groups who are at risk for HIV acquisition.

Journal of Empirical Research on Human Research Ethics
Volume 15 Issue 5, December 2020
http://journals.sagepub.com/toc/jre/current

Motives and Willingness for Research Participation
Communities and Clinical Trials: A Case Study from the RTS,S Malaria Vaccine Trials in Eastern Africa
Machteld Wyss-van den Berg, Bernhards Ogutu, Nelson K. Sewankambo, Sonja Merten, Nikola Biller-Andorno, Marcel Tanner
First Published August 26, 2020; pp. 465–477

Journal of Empirical Research on Human Research Ethics
Volume 15 Issue 5, December 2020
http://journals.sagepub.com/toc/jre/current

Book Review: Health research ethics: Safeguarding the interests of research participants
Ali Joseph

First Published September 18, 2020; pp. 494–495

Journal of Epidemiology & Community Health
November 2020 – Volume 74 – 11
https://jech.bmj.com/content/74/11

Essay
The COVID-19 pandemic and health inequalities (13 June, 2020) Free
Clare Bambra, Ryan Riordan, John Ford, Fiona Matthews

Journal of Medical Ethics
November 2020 – Volume 46 – 11
http://jme.bmj.com/content/current

Guest editorial
COVID-19 and beyond: the ethical challenges of resetting health services during and after public health emergencies (16 October, 2020)
Paul Baines, Heather Draper, Anna Chiumento, Sara Fovargue, Lucy Frith

Journal of Medical Ethics
November 2020 – Volume 46 – 11
http://jme.bmj.com/content/current

Original research
Uncovering social structures and informational prejudices to reduce inequity in delivery and uptake of new molecular technologies
Sara Filoche¹, et al
Abstract
Advances in molecular technologies have the potential to help remedy health inequities through earlier detection and prevention; if, however, their delivery and uptake (and therefore any benefits associated with such testing) are not more carefully considered, there is a very real risk that existing inequities in access and use will be further exacerbated. We argue this risk relates to the way that information and knowledge about the technology is both acquired and shared, or not, between health practitioners and their patients.

The Lancet
Nov 07, 2020 Volume 396 Number 10261 p1463-1534, e73-e82
https://www.thelancet.com/journals/lancet/issue/current

Editorial
COVID-19 in Latin America: a humanitarian crisis
The Lancet
Latin America has some of the highest COVID-19 death rates in the world. Why? For outsiders, much of the discussion of COVID-19 in Latin America has focused on Brazil and the errors of President Jair Bolsonaro. But the region as a whole is facing a humanitarian crisis borne out of political instability, corruption, social unrest, fragile health systems, and perhaps most importantly, longstanding and pervasive inequality—in income, health care, and education—which has been woven into the social and economic fabric of the region…

The Lancet
Nov 07, 2020 Volume 396 Number 10261 p1463-1534, e73-e82
https://www.thelancet.com/journals/lancet/issue/current

Comment
First human efficacy study of a plant-derived influenza vaccine
John S Tregoning

The Lancet
Nov 07, 2020 Volume 396 Number 10261 p1463-1534, e73-e82
https://www.thelancet.com/journals/lancet/issue/current

Offline: Managing the COVID-19 vaccine infodemic
Richard Horton

The Lancet
Nov 07, 2020 Volume 396 Number 10261 p1463-1534, e73-e82
https://www.thelancet.com/journals/lancet/issue/current

Articles
Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18–64 years) and older adults (≥65 years): two multicentre, randomised phase 3 trials
Brian J Ward, et al

The Lancet
Nov 07, 2020 Volume 396 Number 10261 p1463-1534, e73-e82
https://www.thelancet.com/journals/lancet/issue/current

Health Policy
Lessons learnt from easing COVID-19 restrictions: an analysis of countries and regions in Asia Pacific and Europe
Emeline Han, et al
Summary
The COVID-19 pandemic is an unprecedented global crisis. Many countries have implemented restrictions on population movement to slow the spread of severe acute respiratory syndrome coronavirus 2 and prevent health systems from becoming overwhelmed; some have instituted full or partial lockdowns. However, lockdowns and other extreme restrictions cannot be sustained for the long term in the hope that there will be an effective vaccine or treatment for COVID-19. Governments worldwide now face the common challenge of easing lockdowns and restrictions while balancing various health, social, and economic concerns. To facilitate cross-country learning, this Health Policy paper uses an adapted framework to examine the approaches taken by nine high-income countries and regions that have started to ease COVID-19 restrictions: five in the Asia Pacific region (ie, Hong Kong [Special Administrative Region], Japan, New Zealand, Singapore, and South Korea) and four in Europe (ie, Germany, Norway, Spain, and the UK). This comparative analysis presents important lessons to be learnt from the experiences of these countries and regions. Although the future of the virus is unknown at present, countries should continue to share their experiences, shield populations who are at risk, and suppress transmission to save lives.

Lancet Digital Health
Nov 2020 Volume 2 Number 11 e561-e628
https://www.thelancet.com/journals/landig/issue/current

Comment
The International Hundred Thousand Plus Cohort Consortium: integrating large-scale cohorts to address global scientific challenges
Teri A Manolio, Peter Goodhand, Geoffrey Ginsburg
…Leaders of large-scale cohorts, with support from the National Institutes of Health and the Wellcome Trust, and in collaboration with the Global Alliance for Genomics and Health (GA4GH) and the Global Genomic Medicine Collaborative (G2MC), have come together to form the International Hundred Thousand Plus Cohort Consortium (IHCC). As of May, 2020, IHCC comprises 103 cohorts in 43 countries involving nearly 50 million participants (figure, appendix). Collaborative efforts to date have focused on developing a queryable cohort registry and data sharing platform, identifying and piloting high-priority scientific projects, and developing a charter and governance structure to foster collaborations…

Lancet Global Health
Nov 2020 Volume 8 Number 11 e1352-e1443
http://www.thelancet.com/journals/langlo/issue/current

Comment
COVID-19 vaccination: returning to WHO’s Health For All
Irene Torres, et al.

Lancet Global Health
Nov 2020 Volume 8 Number 11 e1352-e1443
http://www.thelancet.com/journals/langlo/issue/current

Articles
Projected health-care resource needs for an effective response to COVID-19 in 73 low-income and middle-income countries: a modelling study
Tessa Tan-Torres Edejer, et al.
Since WHO declared the COVID-19 pandemic a Public Health Emergency of International Concern, more than 20 million cases have been reported, as of Aug 24, 2020. This study aimed to identify what the additional health-care costs of a strategic preparedness and response plan (SPRP) would be if current transmission levels are maintained in a status quo scenario, or under scenarios where transmission is increased or decreased by 50%.

Lancet Infectious Diseases
Nov 2020 Volume 20 Number 11 p1217-1348, e275-e297
http://www.thelancet.com/journals/laninf/issue/current

Articles
Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study
Maja Jahnmatz, and the BPZE1 study team

Lancet Infectious Diseases
Nov 2020 Volume 20 Number 11 p1217-1348, e275-e297
http://www.thelancet.com/journals/laninf/issue/current

Clinical and epidemiological performance of WHO Ebola case definitions: a systematic review and meta-analysis
Grazia Caleo, et al

Lancet Public Health
Nov 2020 Volume 5 Number 11 e568-e627
https://www.thelancet.com/journals/lanpub/issue/current

Articles
The cost-effectiveness profile of sex-neutral HPV immunisation in European tender-based settings: a model-based assessment
Venetia Qendri, et al

Nature
Volume 587 Issue 7832, 5 November 2020
http://www.nature.com/nature/current_issue.html

Comment | 03 November 2020
Redesign open science for Asia, Africa and Latin America
Researchers in many countries need custom-built systems to do robust and transparent science.
Sandersan Onie

Nature Biotechnology
Volume 38 Issue 11, November 2020
https://www.nature.com/nbt/volumes/38/issues/11

Editorial | 27 October 2020
Preparing for the vaccine
Clear and consistent messaging on COVID-19 vaccine rollout will be key to building public trust and managing expectations.
As approval of the first COVID-19 vaccine draws closer, attention is shifting to how to manufacture and distribute sufficient shots to supply national or global immunization programs. The challenge is unprecedented: to make enough vaccine not for a few million people, but for hundreds of millions of people. Ironically, the RNA and viral vector vaccines that are furthest along in clinical development are the least suitable for large-scale manufacture, storage and distribution. Until conventional vaccines become available that can capitalize on the existing immunization and distribution infrastructure, it seems likely that a large proportion of the world’s population will remain unvaccinated in 2021. In this context, clear and consistent public health communication to manage expectations about vaccine distribution, who gets the vaccine first, and full transparency as to the benefits as well as the risks will be key to building trust.

Thus far, public health messaging during the epidemic has been anything but clear and consistent.

Part of the problem is that new research has regularly upended expert advice, with inconsistent messaging on masks, testing and social distancing that has confused public understanding and compliance.

Vaccines represent an intervention where effective and consistent messaging will be critical to success because in recent decades scientific consensus on their value has been recast as controversy (or even conspiracy) in the public sphere. Social media have reinforced vaccine hesitancy, with religious leaders, family members or other trusted sources often perpetuating myths and misinformation.

According to a September report from Pew Research, only 51% of US adults say they definitely or probably would get vaccinated with a COVID-19 vaccine — a 21% percentage point drop from May. A survey of Europeans by the Vaccine Confidence Project found that 20% of Swiss and 18% of French respondents would refuse a vaccine; similarly, a recent YouGov survey found that one in six British adults would definitely or probably turn down a shot.

But ironically, it may be the unrealistic expectations of vaccine proponents that turns out to be as much as a problem: 55% of them would, apparently, be somewhat dissuaded if the vaccine was “only” 60% effective. And yet a vaccine that halves the risk of infection for an individual would be sufficient for a US Food and Drug Administration Emergency Use Authorization (EUA). For a public that expected 100% efficacy, 50% might feel like failure.

For SARS-CoV-2, many unanswered questions remain about natural immunity to the virus, let alone the nature and length of immune protection afforded by a vaccine. As long as doubts remain about the frequency of repeated infections, the capacity of reinfected individuals to spread or shed virus as well as develop symptomatic or even serious disease, and the length of protection afforded by neutralizing antibody titers, doubts will linger about COVID-19 vaccines. If immunized individuals still have to wear masks, vaccine uptake will be further disincentivized.

For those vaccines that receive an EUA, the coming challenge will be to meet demand. The United States, Britain, France and Germany have already grabbed hundreds of millions of doses via advance purchase agreements, but COVAX — a global initiative coordinated by Gavi, the Coalition for Epidemic Preparedness Initiative (CEPI) and the World Health Organization, which now includes China as well as another 170 nations — aims to obtain two billion doses of vaccines by the end of 2021 for low-to-middle income countries.

A CEPI survey estimates that global manufacturing capacity could produce two to four billion doses next year. As different facilities ramp up production, supply-chain bottlenecks for glass vials, pressure on fill and finish facilities and shortages of materials like bioreactors or adjuvants are likely to arise.

The public may also be surprised to find that all vaccines are not equal. It may not realize that RNA and viral vector vaccines — those most advanced in clinical development — are the least suitable for large-scale manufacture, storage and distribution and that they carry a greater technology risk. As no one has ever manufactured RNA vaccines with liposomal nanoparticles at this scale before — nor a viral vector vaccine — rollout might hit snags that tried and tested platforms (like inactivated or recombinant subunit vaccines) can avoid. The RNA vaccines also have onerous storage requirements (Pfizer/BioNtech’s product must be kept at–70 °C, Moderna’s at –20 °C). They are unlikely to be suitable for doctor’s offices or pharmacies in developed nations, let alone in developing countries. Why not get that message out there now to offset disappointment later?

Perhaps the trickiest dilemma, however, will be prioritizing who receives the vaccine first. A recent US National Academy of Medicine report suggests that personal vulnerabilities (comorbidities and age) and social vulnerabilities (high-risk work settings, use of public transportation, and crowding or multiple generations at home) should determine allotment. Vaccine distribution would proceed in distinct phases: first, healthcare workers, care workers, first responders and those with pre-existing conditions; then essential workers, school teachers and people in prison (because of close quarters); and then everyone else. This is likely to be controversial. During the 2009 H1N1 influenza pandemic, for example, an association of bread makers argued that its workers were essential. We should expect wrangling about who qualifies to be in what phase.

The global distribution of coronavirus vaccines will be the defining public health challenge of 2021. There will be snafus. There will be delays. But whatever happens, an early and coordinated health communication campaign on various media is needed to drive uptake in vulnerable groups and engage diverse stakeholders in ethnic communities. Vaccines should be positioned alongside hand-washing, social distancing, masking and isolation as part of the pandemic solution, not a panacea to immediately end it. Governments need to start informing the public now by being transparent and open about where vaccines actually are — and effectively communicating their plans for distributing them.

Nature Reviews Genetics
Volume 21 Issue 11, November 2020
https://www.nature.com/nrg/volumes/21/issues/11

Comment | 16 September 2020
African ancient DNA research requires robust ethics and permission protocols
In Africa, there is a disparity in ethics and permission requirements for molecular research on samples from living people versus ancient DNA. At the precipice of the archaeogenomics revolution, heritage agencies require updated policies and procedures for genetic and genomic research on African ancient DNA.
Victoria E. Gibbon

Nature Reviews Immunology
Volume 20 Issue 11, November 2020
https://www.nature.com/nri/volumes/20/issues/11

Review Article | 20 May 2020
A guide to cancer immunotherapy: from T cell basic science to clinical practice
T cells play a central role in immune responses to cancer. In this guide to cancer immunotherapy, the authors provide a comprehensive historical and biological perspective on cancer immunotherapy, with a focus on current and emerging therapeutic approaches that harness T cells to fight cancer.
Alex D. Waldman, Jill M. Fritz & Michael J. Lenardo

Nature Reviews Drug Discovery
Volume 19 Issue 11, November 2020
https://www.nature.com/nrd/volumes/19/issues/11

Comment | 29 April 2020
What makes a drug discovery consortium successful?
Consortia are enabling drug discovery in areas that individual organizations are unable to support alone because of the high risk or the need to pool information. This article discusses desirable features that can underpin the success of such consortia.
Peter B. Simpson & Graeme F. Wilkinson

Nature Reviews Drug Discovery
Volume 19 Issue 11, November 2020
https://www.nature.com/nrd/volumes/19/issues/11

Review Article | 05 October 2020
Modulating gene regulation to treat genetic disorders
cis-Regulation therapy (CRT) — modifying the activity of gene-regulatory elements — is emerging as a potential approach to treat genetic diseases. Here, Matharu and Ahituv assess emerging CRT technologies and present proof-of-concept studies in cell and animal models. Key factors to be considered for the translation of CRT into the clinic are discussed.
Navneet Matharu & Nadav Ahituv

New England Journal of Medicine
November 5, 2020 Vol. 383 No. 19
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations P.R. Krause and M.F. Gruber
… Use of an investigational vaccine under an EUA would not be subject to the usual informed consent requirements for clinical investigations; nevertheless, vaccine recipients will be provided a fact sheet that describes the investigational nature of the product, the known and potential benefits and risks, available alternatives, and the option to refuse vaccination. To minimize the risk that use of a vaccine under an EUA will interfere with long-term assessment of safety and efficacy in ongoing trials, it will be essential to continue to gather data about the vaccine even after it is made available under the EUA. Continued follow-up of clinical trial participants to further refine efficacy estimates, further evaluate the potential for enhanced disease and waning of immunity, and obtain additional active safety follow-up will be essential in order to ensure public confidence in a broadly administered vaccine. The quality of the data available to inform ongoing assessment of a vaccine’s benefits and risks will depend on the ability to continue evaluating the vaccine against a placebo comparator in clinical trials for as long as feasible. Moreover, evaluation of other potentially superior vaccines will depend on the ability to continue to maintain placebo controls in ongoing trials. Thus, issuance of an EUA should not, in and of itself, require unblinding of a Covid-19 vaccine trial and immediate vaccination of placebo recipients, since doing so may jeopardize approval of these products.
In setting criteria for EUAs, regulators determine the amount of data that could support a positive benefit–risk assessment, providing people who wish to receive an investigational vaccine the opportunity to realize that benefit while also providing confidence that a vaccine is unlikely to cause net harm when used in this manner.
From a safety perspective, a 2-month median follow-up (meaning that at least half of vaccine recipients in clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen will allow identification of potential adverse events that were not apparent in the immediate postvaccination period and will also provide greater confidence in their absence, if none are observed…

Pediatrics
Vol. 146, Issue 5 1 Nov 2020
https://pediatrics.aappublications.org/

Articles
Vaccine Effectiveness Against Pediatric Influenza Hospitalizations and Emergency Visits
Angela P. Campbell, Constance Ogokeh, Joana Y. Lively, Mary A. Staat, Rangaraj Selvarangan, Natasha B. Halasa, Janet A. Englund, Julie A. Boom, Geoffrey A. Weinberg, John V. Williams, Monica McNeal, Christopher J. Harrison, Laura S. Stewart, Eileen J. Klein, Leila C. Sahni, Peter G. Szilagyi, Marian G. Michaels, Robert W. Hickey, Mary E. Moffat, Barbara A. Pahud, Jennifer E. Schuster, Gina M. Weddle, Brian Rha, Alicia M. Fry, Manish Patel
Pediatrics, Nov 2020, 146 (5) e20201368

Pediatrics
Vol. 146, Issue 5 1 Nov 2020
https://pediatrics.aappublications.org/

Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial
Jason M. Glanz, Nicole M. Wagner, Komal J. Narwaney, Jennifer Pyrzanowski, Bethany M. Kwan, Carter Sevick, Kenneth Resnicow, Amanda F. Dempsey
Pediatrics, Nov 2020, 146 (5) e20200669