Monthly Archives: October 2020

Fifteen years of experience with the oral live-attenuated human rotavirus vaccine: reflections on lessons learned

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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

The Critical Role and Evaluation of Community Mobilizers in Polio Eradication in Remote Settings in Africa and Asia

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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.

Determinants of Facility-Level Use of Electronic Immunization Registries in Tanzania and Zambia: An Observational Analysis

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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.

Factors That Influence Data Use to Improve Health Service Delivery in Low- and Middle-Income Countries

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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).

Medical populism and the COVID-19 pandemic

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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.

Budget line items for immunization in 33 African countries

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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

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 …

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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.

Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?

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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

Seeking Normalcy as the Curve Flattens: Ethical Considerations for Pediatricians Managing Collateral Damage of Coronavirus Disease-2019

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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

Assessing US traveller vaccination access: an evaluation of US requirements for healthcare payer coverage of recommended travel vaccines

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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

Safety of yellow fever vaccination in pregnancy: findings from a cohort of active duty US military women

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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

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

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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 NCDI Poverty Commission: bridging a gap in universal health coverage for the poorest billion

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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

Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension

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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.

Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

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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.

A historic achievement in a year of turmoil

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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…

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

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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.

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

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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

Certifying the interruption of wild poliovirus transmission in the WHO African region on the turbulent journey to a polio-free world

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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.

Curing COVID-19

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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…

Vaccinology: time to change the paradigm?

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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.

COVID vaccine confidence requires radical transparency

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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.

Exploring the coronavirus pandemic with the WashU Virus Genome Browser

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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

The UCSC SARS-CoV-2 Genome Browser

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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

Exploring the structural distribution of genetic variation in SARS-CoV-2 with the COVID-3D online resource

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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

Treating medical data as a durable asset

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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.

The Human Genome Project changed everything

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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

The road ahead in genetics and genomics

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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

Responsible, practical genomic data sharing that accelerates research

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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

Immunological considerations for COVID-19 vaccine strategies

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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

COVID-19 must catalyse changes to clinical development

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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

Ensuring Uptake of Vaccines against SARS-CoV-2

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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).

HPV Vaccination and the Risk of Invasive Cervical Cancer

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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.

Ensuring Uptake of Vaccines against SARS-CoV-2

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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).

We believe that six substantive criteria should be met before a state imposes a SARS-CoV-2 vaccine mandate (see box). The first is the existence of evidence that Covid-19 is inadequately controlled in the state by other measures, such as testing, contact tracing, and isolation and quarantine — as indicated by sustained, troubling trends in new cases, hospitalizations, or deaths. Principles of public health law and ethics require that interventions that impinge on autonomy be reasonable and necessary; therefore, Covid-19 must present an ongoing threat. By the time a vaccine is available, more will be known about natural immunity in the population, the consequences of relaxing community mitigation measures, and the feasibility of scaling up test-and-trace strategies. There should be a reasonable indication as to whether further measures are needed.

Six Trigger Criteria for State Covid-19 Vaccination Mandates.

:: Covid-19 is not adequately contained in the state.

:: The Advisory Committee on Immunization Practices has recommended vaccination for the groups for which a mandate is being considered.

:: The supply of vaccine is sufficient to cover the population groups for which a mandate is being considered.

:: Available evidence about the safety and efficacy of the vaccine has been transparently communicated.

:: The state has created infrastructure to provide access to vaccination without financial or logistic barriers, compensation to workers who have adverse effects from a required vaccine, and real-time surveillance of vaccine side effects.

:: In a time-limited evaluation, voluntary uptake of the vaccine among high-priority groups has fallen short of the level required to prevent epidemic spread.

The second criterion is that the Advisory Committee on Immunization Practices (ACIP), after reviewing the safety and efficacy evidence, has recommended vaccination for the persons who would be covered by a mandate. Currently available evidence suggests that the elderly, health professionals working in high-risk situations or working with high-risk patients (e.g., nursing home residents and patients with severe respiratory symptoms), and persons with certain underlying medical conditions may be high-priority groups for the ACIP’s consideration, along with other workers with frequent, close, on-the-job contacts and persons living in high-density settings such as prisons and dormitories. When a vaccine nears approval, the ACIP should review the updated evidence and develop recommendations. Only recommended groups should be considered for a vaccination mandate, though health officials can encourage voluntary uptake for others, using means such as public education campaigns and free vaccination.

The fact that a vaccine has received Food and Drug Administration (FDA) approval — whether under an Emergency Use Authorization (EUA) or ordinary review processes — is an insufficient basis on which to conclude that it should be required. FDA approval reflects a determination that clinical trial evidence shows that the benefits of a vaccine outweigh its risks. ACIP recommendations reflect broader considerations, including values and preferences of affected groups, implementation issues, and health economic analyses. Overweighting FDA decisions would be particularly problematic for SARS-CoV-2 vaccines because EUAs may be based on very limited evidence and consciously or unconsciously influenced by the intense pressure to speed countermeasures to market.2

The third criterion is that there is an adequate supply of vaccine to cover the groups for which a mandate is being considered. Initially, global demand for SARS-CoV-2 vaccines will outstrip supply, making the salient question not who must get them but who will be granted access to them. New York State’s unsuccessful attempt to mandate H1N1 influenza vaccination for health care workers demonstrates that imposing requirements before adequate supply has been secured needlessly provokes controversy and alienates people who have already made sacrifices to fight an epidemic.3

The fourth criterion is that there has been transparent communication of the best available evidence about the vaccine’s safety and efficacy.4 Particularly given the possibility that the evidence underlying FDA approval of SARS-CoV-2 vaccines may be more modest than usual, policymakers and the public will need to understand the limits of what is known. Public trust has already been compromised by federal officials’ endorsement of hydroxychloroquine as a Covid-19 treatment without evidentiary support; the same must not occur for vaccines.

The fifth criterion is that the government has put in place certain support mechanisms for persons required to receive the vaccine. Lessons from past vaccination campaigns suggest that a generous compensation program for people who have serious vaccine side effects should be a centerpiece of these efforts. A federal compensation fund like the Smallpox Vaccine Injury Compensation Program is one attractive model, although identifying compensable injuries may be challenging with a novel vaccine. States will also have to create distribution systems to provide SARS-CoV-2 vaccine to high-priority groups with near-zero financial and logistic barriers — for example, bringing free vaccine to points of care, pharmacies, and work sites. It is equally critical to have a safety-assessment plan in place before vaccines are widely distributed to enable health officials to evaluate safety evidence in real time. States should work with health systems to ensure that reporting systems for vaccine-related adverse events are consistently used and specify a process for reconsidering mandate decisions as evidence evolves.

The last criterion is that vaccination mandates are imposed only after a time-limited trial of voluntary vaccine provision has proved unsuccessful. Principles of public health ethics support trying less burdensome policies before moving to more burdensome ones whenever possible. In this case, the costs of a failed voluntary scheme are sufficiently high that the attempt should be limited to a matter of weeks. States should implement a system for measuring vaccine uptake within each high-priority group against a set of coverage targets. Ensuring that the economic and logistic supports described above are in place will maximize the chances for success.

If the proposed trigger criteria were met, what might a vaccination mandate look like? Because the constitutional power to protect public health rests primarily with states, each state will need to adopt its own legislation. Proposed legislation should be supported by attestations from the state health officer, the ACIP, or another expert committee that all trigger criteria have been met. Targeted SARS-CoV-2 vaccination mandate policies may also be appropriate in certain federal contexts, including high-risk groups in active-duty military environments, Veterans Affairs facilities, federal prisons, and immigration detention centers.

Although state vaccination mandates are usually tied to school and day care entry, that approach is not appropriate for SARS-CoV-2 because children won’t be a high-priority group. In addition, state mandates should not be structured as compulsory vaccination (absolute requirements); instead, noncompliance should incur a penalty. Nevertheless, because of the infectiousness and dangerousness of the virus, relatively substantive penalties could be justified, including employment suspension or stay-at-home orders for persons in designated high-priority groups who refuse vaccination. Neither fines nor criminal penalties should be used, however; fines disadvantage the poor, and criminal penalties invite legal challenges on procedural due-process grounds. Both are bad public health policy for a Covid-19 vaccine because they may stoke distrust without improving uptake.

The need to build public trust requires that state officials implement vaccination policy through a transparent and inclusive process, working closely with stakeholder groups such as local health officers, health professional and hospital associations, representatives of high-risk population groups, and groups concerned about vaccine safety. States’ experience with HPV vaccination mandates offers another process tip: vaccine manufacturers should stay on the sidelines. The HPV vaccine manufacturer’s direct involvement in crafting and lobbying for mandate legislation raised suspicion that profit rather than public health motives lay behind such proposals, undercutting support for vaccination even without a mandatory regime.5

As with social distancing orders, we can expect that the advent of SARS-CoV-2 vaccines will spark intense clashes of feeling about what people owe to one another in the fight against the pandemic. In contrast to earlier phases of the pandemic, though, we currently have some time on our side. Careful deliberation now about state vaccination policy can help ensure that we have a strategy when the breakthrough comes.

Trend and determinants of complete vaccination coverage among children aged 12-23 months in Ghana: Analysis of data from the 1998 to 2014 Ghana Demographic and Health Surveys

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PLoS One
http://www.plosone.org/

 

Research Article
Trend and determinants of complete vaccination coverage among children aged 12-23 months in Ghana: Analysis of data from the 1998 to 2014 Ghana Demographic and Health Surveys
Eugene Budu, Eugene Kofuor Maafo Darteh, Bright Opoku Ahinkorah, Abdul-Aziz Seidu, Kwamena Sekyi Dickson
| published 01 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0239754

Incidence of invasive pneumococcal disease after introduction of the 13-valent conjugate pneumococcal vaccine in British Columbia: A retrospective cohort study

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PLoS One
http://www.plosone.org/

 

Incidence of invasive pneumococcal disease after introduction of the 13-valent conjugate pneumococcal vaccine in British Columbia: A retrospective cohort study
Nirma Khatri Vadlamudi, David M. Patrick, Linda Hoang, Manish Sadarangani, Fawziah Marra
Research Article | published 30 Sep 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0239848

Translational Research in the Time of COVID-19—Dissolving Boundaries

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PLoS Pathogens
http://journals.plos.org/plospathogens/
[Accessed 3 Oct 2020]

 

Opinion
Translational Research in the Time of COVID-19—Dissolving Boundaries
Jonathan D. Edgeworth, Rahul Batra, Gaia Nebbia, Karen Bisnauthsing, Eithne MacMahon, Malur Sudhanva, Sam Douthwaite, Simon Goldenberg, Geraldine O’Hara, Manu Shankar-Hari, Katie J. Doores, Rocio Martinez-Nunez, Carolyn Hemsley, Nicholas M. Price, Jill Lockett, Robert I. Lechler, Stuart J. D. Neil, Michael H. Malim
| published 30 Sep 2020 PLOS Pathogens
https://doi.org/10.1371/journal.ppat.1008898