Digital tools against COVID-19: taxonomy, ethical challenges, and navigation aid

Lancet Digital Health
Aug 2020 Volume 2 Number 8e380-e440
https://www.thelancet.com/journals/landig/issue/current

 

Health Policy
Digital tools against COVID-19: taxonomy, ethical challenges, and navigation aid
Urs Gasser, Marcello Ienca, James Scheibner, Joanna Sleigh, Effy Vayena
Summary
Data collection and processing via digital public health technologies are being promoted worldwide by governments and private companies as strategic remedies for mitigating the COVID-19 pandemic and loosening lockdown measures. However, the ethical and legal boundaries of deploying digital tools for disease surveillance and control purposes are unclear, and a rapidly evolving debate has emerged globally around the promises and risks of mobilising digital tools for public health. To help scientists and policy makers to navigate technological and ethical uncertainty, we present a typology of the primary digital public health applications that are in use. These include proximity and contact tracing, symptom monitoring, quarantine control, and flow modelling. For each, we discuss context-specific risks, cross-sectional issues, and ethical concerns. Finally, recognising the need for practical guidance, we propose a navigation aid for policy makers and other decision makers for the ethical development and use of digital public health tools.

Applications of digital technology in COVID-19 pandemic planning and response

Lancet Digital Health
Aug 2020 Volume 2 Number 8e380-e440
https://www.thelancet.com/journals/landig/issue/current

 

Viewpoint
Applications of digital technology in COVID-19 pandemic planning and response
Sera Whitelaw, Mamas A Mamas, Eric Topol, Harriette G C Van Spall
Summary
With high transmissibility and no effective vaccine or therapy, COVID-19 is now a global pandemic. Government-coordinated efforts across the globe have focused on containment and mitigation, with varying degrees of success. Countries that have maintained low COVID-19 per-capita mortality rates appear to share strategies that include early surveillance, testing, contact tracing, and strict quarantine. The scale of coordination and data management required for effective implementation of these strategies has—in most successful countries—relied on adopting digital technology and integrating it into policy and health care. This Viewpoint provides a framework for the application of digital technologies in pandemic management and response, highlighting ways in which successful countries have adopted these technologies for pandemic planning, surveillance, testing, contact tracing, quarantine, and health care.

Achieving coordinated national immunity and cholera elimination in Haiti through vaccination: a modelling study

Lancet Global Health
Aug 2020 Volume 8 Number 8 e973-e1100
http://www.thelancet.com/journals/langlo/issue/current

 

Articles
Achieving coordinated national immunity and cholera elimination in Haiti through vaccination: a modelling study
Elizabeth C Lee, et al
Summary
Background
Cholera was introduced into Haiti in 2010. Since then, more than 820 000 cases and nearly 10 000 deaths have been reported. Oral cholera vaccine (OCV) is safe and effective, but has not been seen as a primary tool for cholera elimination due to a limited period of protection and constrained supplies. Regionally, epidemic cholera is contained to the island of Hispaniola, and the lowest numbers of cases since the epidemic began were reported in 2019. Hence, Haiti may represent a unique opportunity to eliminate cholera with OCV.
Methods
In this modelling study, we assessed the probability of elimination, time to elimination, and percentage of cases averted with OCV campaign scenarios in Haiti through simulations from four modelling teams. For a 10-year period from January 19, 2019, to Jan 13, 2029, we compared a no vaccination scenario with five OCV campaign scenarios that differed in geographical scope, coverage, and rollout duration. Teams used weekly department-level reports of suspected cholera cases from the Haiti Ministry of Public Health and Population to calibrate the models and used common vaccine-related assumptions, but other model features were determined independently.
Findings
Among campaigns with the same vaccination coverage (70% fully vaccinated), the median probability of elimination after 5 years was 0–18% for no vaccination, 0–33% for 2-year campaigns focused in the two departments with the highest historical incidence, 0–72% for three-department campaigns, and 35–100% for nationwide campaigns. Two-department campaigns averted a median of 12–58% of infections, three-department campaigns averted 29–80% of infections, and national campaigns averted 58–95% of infections. Extending the national campaign to a 5-year rollout (compared to a 2-year rollout), reduced the probability of elimination to 0–95% and the proportion of cases averted to 37–86%.
Interpretation
Models suggest that the probability of achieving zero transmission of Vibrio cholerae in Haiti with current methods of control is low, and that bolder action is needed to promote elimination of cholera from the region. Large-scale cholera vaccination campaigns in Haiti would offer the opportunity to synchronise nationwide immunity, providing near-term population protection while improvements to water and sanitation promote long-term cholera elimination.
Funding
Bill & Melinda Gates Foundation, Global Good Fund, Institute for Disease Modeling, Swiss National Science Foundation, and US National Institutes of Health.

20th Anniversary Update of the Ottawa Decision Support Framework Part 1: A Systematic Review of the Decisional Needs of People Making Health or Social Decisions

Medical Decision Making (MDM)
Volume 40 Issue 5, July 2020
http://mdm.sagepub.com/content/current

 

Reviews
20th Anniversary Update of the Ottawa Decision Support Framework Part 1: A Systematic Review of the Decisional Needs of People Making Health or Social Decisions
Lauren Hoefel, Annette M. O’Connor, Krystina B. Lewis, Laura Boland, Lindsey Sikora, Jiale Hu, Dawn Stacey
First Published July 13, 2020; pp. 555–581
Abstract
Background. The Ottawa Decision Support Framework (ODSF) has been used for 20 years to assess and address people’s decisional needs. The evidence regarding ODSF decisional needs has not been synthesized.
Objectives. To synthesize evidence from ODSF-based decisional needs studies, identify new decisional needs, and validate current ODSF decisional needs.
Methods. A mixed-studies systematic review. Nine electronic databases were searched. Inclusion criteria: studies of people’s decisional needs when making health or social decisions for themselves, a child, or a mentally incapable person, as reported by themselves, families, or practitioners. Two independent authors screened eligibility, extracted data, and quality appraised studies using the Mixed Methods Appraisal Tool. Data were analyzed using narrative synthesis.
Results. Of 4532 citations, 45 studies from 7 countries were eligible. People’s needs for 101 unique decisions (85 health, 16 social) were reported by 2857 patient decision makers (n = 36 studies), 92 parent decision makers (n = 6), 81 family members (n = 5), and 523 practitioners (n = 21). Current ODSF decisional needs were reported in 2 to 40 studies. For 6 decisional needs, there were 11 new (manifestations): 1) information (overload, inadequacy regarding others’ experiences with options), 2) difficult decisional roles (practitioner, family involvement, or deliberations), 3) unrealistic expectations (difficulty believing outcome probabilities apply to them), 4) personal needs (religion/spirituality), 5) difficult decision timing (unpredictable), and 6) unreceptive decisional stage (difficulty accepting condition/need for treatment, powerful emotions limiting information processing, lacking motivation to consider delayed/unpredictable decisions). Limitations. Possible publication bias (only peer-reviewed journals included). Possible missed needs (non-ODSF studies, patient decision aid development studies, 3 ODSF needs added in 2006).
Conclusion. We validated current decisional needs, identified 11 new manifestations of 6 decisional needs, and recommended ODSF revisions.

ENCODE

Nature
Volume 583 Issue 7818, 30 July 2020
http://www.nature.com/nature/current_issue.html

 

ENCODE
This week marks the publication of results from phase three of the Encyclopedia of DNA Elements (ENCODE) project. Nine articles in this issue of Nature, along with papers published online and in several other journals, examine the most comprehensive catalogue yet of the candidate functional elements in the human and mouse genomes. In an overview paper, the ENCODE Project Consortium offers a summary of the new elements in the encyclopedia, which have been compiled with data sets from some 6,000 experiments. Much of the work published in this issue examines DNA regions called candidate cis-regulatory elements (cCREs), which may regulate gene transcription. Three papers — from Joseph Ecker, Bing Ren, Barbara Wold and their colleagues — look at cCREs during embryonic development in the mouse. Two papers from Wouter Meuleman, Jeff Vierstra, John Stamatoyannopoulos and colleagues map cCREs and transcription factor footprints in hundreds of human cell and tissue types. Michael Snyder and colleagues map chromatin loops in 24 human cell types; Eric Mendenhall and co-workers map the genome-wide binding of almost one-quarter of all chromatin-associated proteins active in a human liver cell line; and Brenton Graveley and colleagues integrate multiple assays to produce a comprehensive analysis of RNA-binding proteins and their functional elements. Finally, in a Perspective article, the project team puts the multiple phases of ENCODE in context

Electronic health records and polygenic risk scores for predicting disease risk

Nature Reviews Genetics
Volume 21 Issue 8, August 2020
https://www.nature.com/nrg/volumes/21/issues/8

 

Review Article | 31 March 2020
Electronic health records and polygenic risk scores for predicting disease risk
Electronic health records (EHRs) linked to biobanks provide new opportunities for developing and applying polygenic risk scores in the clinic. The authors review the opportunities and challenges that arise when using EHR data for the systematic evaluation of patient disease susceptibilities.
Ruowang Li, Yong Chen[…] & Jason H. Moore

A call to arms: helping family, friends and communities navigate the COVID-19 infodemic

Nature Reviews Immunology
Volume 20 Issue 8, August 2020
https://www.nature.com/nri/volumes/20/issues/8

 

Comment | 02 July 2020
A call to arms: helping family, friends and communities navigate the COVID-19 infodemic
In this Comment, Heidi Larson discusses the COVID-19 ‘infodemic’ and suggests the ways in which scientists can help to mitigate the spread of misinformation.
Heidi J. Larson

Optimizing safety surveillance for COVID-19 vaccines

Nature Reviews Immunology
Volume 20 Issue 8, August 2020
https://www.nature.com/nri/volumes/20/issues/8

 

Comment | 17 June 2020
Optimizing safety surveillance for COVID-19 vaccines
Rebecca Chandler from the Uppsala Monitoring Centre discusses how the COVID-19 pandemic could be the catalyst that propels vaccine safety surveillance into the twenty-first century.
Rebecca E. Chandler

The non-specific and sex-differential effects of vaccines

Nature Reviews Immunology
Volume 20 Issue 8, August 2020
https://www.nature.com/nri/volumes/20/issues/8

 

Viewpoint | 27 May 2020
The non-specific and sex-differential effects of vaccines
In this Viewpoint article, members of the Optimmunize consortium discuss the evidence for non-specific and sex-differential effects of vaccines and how this information might inform vaccine design and policy, including in relation to the COVID-19 pandemic.
Peter Aaby, Christine Stabell Benn[…] & Frank Shann

Boosting delivery of rare disease therapies: the IRDiRC Orphan Drug Development Guidebook

Nature Reviews Drug Discovery
Volume 19 Issue 8, August 2020
https://www.nature.com/nrd/volumes/19/issues/8

 

Comment | 20 April 2020
Boosting delivery of rare disease therapies: the IRDiRC Orphan Drug Development Guidebook
The International Rare Diseases Research Consortium (IRDiRC) has created a Guidebook to facilitate drug development for rare diseases by organizing available tools into a standardized framework.
Anneliene Hechtelt Jonker, Virginie Hivert[…] & Diego Ardigo

Developing a low-cost and accessible COVID-19 vaccine for global health

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 1 Aug 2020)

 

Viewpoints
Developing a low-cost and accessible COVID-19 vaccine for global health
Peter J. Hotez, Maria Elena Bottazzi
| published 29 Jul 2020 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0008548
Overview
There is an urgent need to advance safe and affordable COVID-19 vaccines for low- and middle-income countries of Asia, Africa, and Latin America. Such vaccines rely on proven technologies such as recombinant protein–based vaccines to facilitate its transfer for emerging market vaccine manufacturers. Our group is developing a two-pronged approach to advance recombinant protein–based vaccines to prevent COVID-19 caused by SARS-CoV-2 and other coronavirus infections. One vaccine is based on a yeast-derived (Pichia pastoris) recombinant protein comprised of the receptor-binding domain (RBD) of the SARS-CoV formulated on alum and referred to as the CoV RBD219-N1 Vaccine. Potentially, this vaccine could be used as a heterologous vaccine against COVID-19. A second vaccine specific for COVID-19 is also being advanced using the corresponding RBD of SARS-CoV-2. The first antigen has already undergone current Good Manufacturing Practices (cGMP) manufacture and is therefore “shovel ready” for advancing into clinical trials, following vialing and required Good Laboratory Practice (GLP) toxicology testing. Evidence for its potential efficacy to cross-protect against SARS-CoV-2 includes cross-neutralization and binding studies using polyclonal and monoclonal antibodies. Evidence in support of its safety profile include our internal assessments in a mouse challenge model using a lethal mouse-adapted SARS strain, which shows that SARS-CoV RBD219-N1 (when adsorbed to aluminum hydroxide) does not elicit eosinophilic lung pathology. Together, these findings suggest that recombinant protein–based vaccines based on the RBD warrant further development to prevent SARS, COVID-19, or other coronaviruses of pandemic potential.

Determinants of pregnant women’s knowledge about influenza and the influenza vaccine: A large, single-centre cohort study

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

 

Research Article
Determinants of pregnant women’s knowledge about influenza and the influenza vaccine: A large, single-centre cohort study
Stéphanie Bartolo, Ophélie Mancel, Emilie Deliege, Sophie Carpentier, Rodrigue Dessein, Karine Faure, Damien Subtil
| published 31 Jul 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0236793

Trait reactance and trust in doctors as predictors of vaccination behavior, vaccine attitudes, and use of complementary and alternative medicine in parents of young children

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

 

Trait reactance and trust in doctors as predictors of vaccination behavior, vaccine attitudes, and use of complementary and alternative medicine in parents of young children
Anna Soveri, Linda C. Karlsson, Otto Mäki, Jan Antfolk, Otto Waris, Hasse Karlsson, Linnea Karlsson, Mikael Lindfelt, Stephan Lewandowsky
Research Article | published 27 Jul 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0236527

Eco-evolutionary control of pathogens

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

 

Eco-evolutionary control of pathogens
Michael Lässig and Ville Mustonen
PNAS first published July 31, 2020. https://doi.org/10.1073/pnas.1920263117
Significance
Vaccinations and therapies targeting evolving pathogens aim to curb the pathogen and to steer it toward a controlled evolutionary state. Control is leveraged against the pathogen’s intrinsic evolutionary forces, which in turn, can drive an escape from control. Here, we analyze a simple model of control, in which a host produces antibodies that bind the pathogen. We show that the leverages of host (or external intervention) and pathogen are often highly imbalanced: an error threshold separates parameter regions of efficient control from regions of compromised control, where the pathogen retains the upper hand. Because control efficiency can be predicted from few measurable fitness parameters, our results establish a proof of principle how control theory can guide interventions against evolving pathogens.

Interdependence and the cost of uncoordinated responses to COVID-19

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

 

Interdependence and the cost of uncoordinated responses to COVID-19
David Holtz, Michael Zhao, Seth G. Benzell, Cathy Y. Cao, Mohammad Amin Rahimian, Jeremy Yang, Jennifer Allen, Avinash Collis, Alex Moehring, Tara Sowrirajan, Dipayan Ghosh, Yunhao Zhang, Paramveer S. Dhillon, Christos Nicolaides, Dean Eckles, and Sinan Aral
PNAS first published July 30, 2020. https://doi.org/10.1073/pnas.2009522117
Significance
As local governments relax shelter-in-place orders worldwide, policy makers lack evidence on how policies in one region affect mobility and social distancing in other regions and the consequences of uncoordinated regional policies adopted in the presence of such spillovers. Our analysis suggests the contact patterns of people in one region are significantly influenced by the policies and behaviors of people in other, sometimes distant, regions. When just one-third of a state’s social and geographic peer states adopt shelter-in-place policies, it creates a reduction in mobility equal to the state’s own policy decisions, highlighting the need for national coordination. The paper gives governors a roadmap for coordination in the absence of national leadership and applies globally to other regions lacking coordination.

Social distancing responses to COVID-19 emergency declarations strongly differentiated by income

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

 

Social distancing responses to COVID-19 emergency declarations strongly differentiated by income
Joakim A. Weill, Matthieu Stigler, Olivier Deschenes, and Michael R. Springborn
PNAS first published July 29, 2020. https://doi.org/10.1073/pnas.2009412117

Noninvasive wearable electroactive pharmaceutical monitoring for personalized therapeutics

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

 

Noninvasive wearable electroactive pharmaceutical monitoring for personalized therapeutics
Shuyu Lin, Wenzhuo Yu, Bo Wang, Yichao Zhao, Ke En, Jialun Zhu, Xuanbing Cheng, Crystal Zhou, Haisong Lin, Zhaoqing Wang, Hannaneh Hojaiji, Christopher Yeung, Carlos Milla, Ronald W. Davis, and Sam Emaminejad
PNAS first published July 27, 2020. https://doi.org/10.1073/pnas.2009979117
Significance
To achieve the mission of personalized medicine, centering on delivering the right drug to the right patient at the right dose, therapeutic drug monitoring solutions are necessary. By devising a surface engineering strategy, we created a voltammetric sensing interface, featuring an “undistorted potential window,” within which the target electroactive drug’s voltammetric response is dominant and interference is eliminated, rendering reliable target quantification in noninvasively retrievable biofluids (sweat and saliva). Leveraging this sensing interface, a fully integrated, wearable solution was constructed to seamlessly render drug readouts with minute-level temporal resolution. To inform its clinical utility, the solution was utilized to demonstrate noninvasive pharmacokinetic monitoring of a pharmaceutical (here, acetaminophen, a widely used analgesic and antipyretic) in a wearable format.

Law, Ethics, and Politics in the Face of a Global Pandemic

Public Health Ethics
IN PROGRESS

 

Volume 13, Issue 1, April 2020
http://phe.oxfordjournals.org/content/current
Editorial
Law, Ethics, and Politics in the Face of a Global Pandemic
Angus Dawson, Marcel Verweij
Public Health Ethics, Volume 13, Issue 1, April 2020, Pages 1–3, https://doi.org/10.1093/phe/phaa023
Extract
We are in the midst of a global pandemic caused by the novel SARS-CoV-2 virus. Millions of people have been infected, hundreds of thousands have died and health care systems have been stretched to breaking point. Unprecedented work is going on around the world to discover effective treatments and vaccines. In their absence, we are reliant upon traditional public health measures that aim to both prevent transmission (through the use of isolation, quarantine, physical distancing, restrictions on movement, shutting of borders, etc.) and detect infected individuals and those possibly exposed to infection (through testing and contact tracing, etc.). The implementation of such actions, particularly physical distancing, has caused massive disruption to social life and economic activity,…

The Factors That Promote Vaccine Hesitancy, Rejection, or Delay in Parents

Qualitative Health Research
Volume 30 Issue 11, September 2020
http://qhr.sagepub.com/content/current

 

Special Issue: International Health
Research Articles
The Factors That Promote Vaccine Hesitancy, Rejection, or Delay in Parents
Umair Majid, Mobeen Ahmad
First Published June 29, 2020; pp. 1762–1776
Preview
Vaccines are some of the most cost-effective public health interventions for reducing disease burden and mortality. However, in recent years, health systems have faced a growing challenge with increasing number of parents who choose not to vaccinate their children. This decision has important implications for the health of communities worldwide, and despite a considerable amount of research that reinforces vaccine effectiveness and safety, there is uncertainty surrounding the factors that may encourage vaccine hesitancy in parents. In this interpretive review of 34 qualitative studies, we examine the factors that bolster vaccine hesitancy, rejection, and delay, and identify the overlaps and relationships between these factors. We depict our findings using the metaphor of a gear train where each gear represents one of seven factors: previous experiences; “natural” and “organic” living; perceptions of other parents; experiences interacting with health care providers; information sources, challenges, and preferences; distrust in health system players; and mandatory vaccine policies.

Perinatal COVID-19 in Latin America

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

 

Latest articles
Perinatal COVID-19 in Latin America
Sola et al. 31 Jul 2020
Objective.
To evaluate and report the clinical characteristics and outcomes of SARS-CoV-2 infection in pregnant women and newborns in Latin America.
Methods.
Descriptive study based on the prospective report of the units of the Ibero-American Society of Neonatology Network.
Results.
Of 86 pregnant women with COVID-19 confirmed by RT-PCR in seven countries (6 from Latin America, and Equatorial Guinea) 68% (59) were asymptomatic. Of 32% of symptomatic women, 89% (24) had mild symptoms and 3.5% (3) had severe respiratory symptoms. No women died. The cesarean section rate was 38%; gestational age was < 37 weeks in 6% of cases. RT-PCR was performed on all newborns between 16 and 36 hours of age; 6 (7%) were positive. All of them presented mild and transient respiratory distress; none died. Two newborns with negative RT-PCR died from other causes. Breastfeeding was authorized in only 24% of mothers; in 13% milk was expressed and 63% of newborns were fed with formula. In 76% of cases the motherchild pair was separated, and in 95% of cases the mother could not be accompanied at delivery or during the postpartum period.
Conclusions.
The lack of maternal accompaniment, the low rate of breastfeeding and the frequent separation of the mother-child dyad are of concern. The health care team must reflect on the need to defend humanized and family-centered care during this pandemic.

Cautious optimism

Science
31 July 2020 Vol 369, Issue 6503
http://www.sciencemag.org/current.dtl

 

Editorial
Cautious optimism
By H. Holden Thorp
Science31 Jul 2020 : 483
Summary
The first half of 2020 has seen extraordinary accomplishments in science. The international scientific community has described the genomic sequence of the virus that causes coronavirus disease 2019 (COVID-19) and structures of its important proteins, elucidated principal aspects of the immune response, identified neutralizing antibodies that can serve as therapeutics, and developed promising vaccines. There is much more to learn about COVID-19 and its cause, but the achievements so far are remarkable. So why doesn’t this progress feel like the triumph that it is?

Using influenza surveillance networks to estimate state-specific prevalence of SARS-CoV-2 in the United States

Science Translational Medicine
29 July 2020 Vol 12, Issue 554
https://stm.sciencemag.org/

 

Report
Using influenza surveillance networks to estimate state-specific prevalence of SARS-CoV-2 in the United States
By Justin D. Silverman, Nathaniel Hupert, Alex D. Washburne
Science Translational Medicine29 Jul 2020 Open Access
Analysis of influenza-like illness surveillance data estimates that most SARS-CoV-2 infections in the United States went undetected in March 2020.

 

Scientific considerations for global drug development

Science Translational Medicine
29 July 2020 Vol 12, Issue 554
https://stm.sciencemag.org/

Perspective
Scientific considerations for global drug development
By Jennifer L. Wilson, Kit Wun Kathy Cheung, Lawrence Lin, Elizabeth A. E. Green, Analia I. Porrás, Ling Zou, David Mukanga, Paul A. Akpa, Delese Mimi Darko, Rae Yuan, Sheng Ding, Wiltshire C. N. Johnson, Howard A. Lee, Emer Cooke, Carl C. Peck, Steven E. Kern, Dan Hartman, Yoshikazu Hayashi, Peter W. Marks, Russ B. Altman, Murray M. Lumpkin, Kathleen M. Giacomini, Terrence F. Blaschke
Science Translational Medicine29 Jul 2020 Restricted Access
Abstract
Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

Stigma in African genomics research: Gendered blame, polygamy, ancestry and disease causal beliefs impact on the risk of harm

Social Science & Medicine
Volume 258 August 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/258/suppl/C

 

Discussion Open access
Stigma in African genomics research: Gendered blame, polygamy, ancestry and disease causal beliefs impact on the risk of harm
Jantina de Vries, Guida Landouré, Ambroise Wonkam
Article 113091
Highlights
:: Gendered blame, polygamy and supernatural causal beliefs relate to stigma.
:: African genomics research intersects with pre-existing stigma and may cause harm.
:: Genomics can reveal sensitive information about group ancestry.
: Genomics researchers need to be culturally competent to minimize risk of harm.
Abstract
A recurring concern in genomics research is the possibility that it could lead to stigma for participants, their families and the population groups they belong to. Little evidence exists to explain how and when this ought to be a concern in genomics research in Africa whilst there is growing international evidence drawing into question the direct link between stigma and genetics. In this paper, we interrogate practical instances from African genomics research where stigma was identified as a concern in an attempt to nuance and refine accounts of when stigma should be considered as an ethical issue. The paper describes examples involving gendered blame, polygamy, beliefs in supernatural disease causation and sensitive information about group lineage. We propose that the concern may not be about stigma so much as broader research-related harm, including for instance reputational harm to population groups. Furthermore, we propose to shift the analytical gaze from establishing causal relationships to exploring the intersection of genomics with pre-existing stigma. Finally, we emphasize the importance of ensuring genomics researchers are culturally competent, meaning able to recognise when cultural factors impact on the possibility that genomics research could cause harm.

Logistical challenges for potential SARS-CoV-2 vaccine and a call to research institutions, developers and manufacturers

Vaccine
Volume 38, Issue 34 Pages 5389-5562 (22 July 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/34

 

Discussion Full text access
Logistical challenges for potential SARS-CoV-2 vaccine and a call to research institutions, developers and manufacturers
Umit H. Kartoglu, Kelly L. Moore, John S. Lloyd

Use of seasonal influenza and pneumococcal polysaccharide vaccines in older adults to reduce COVID-19 mortality

Vaccine
Volume 38, Issue 34 Pages 5389-5562 (22 July 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/34

 

Discussion Full text access
Use of seasonal influenza and pneumococcal polysaccharide vaccines in older adults to reduce COVID-19 mortality
Deus Thindwa, Maria Garcia Quesada, Yang Liu, Julia Bennett, … Stefan Flasche
Pages 5398-5401

Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countries

Vaccine
Volume 38, Issue 34 Pages 5389-5562 (22 July 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/34

 

Research article Open access
Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countries
Katharina Hartmann, Sonia Pagliusi, Alexander Precioso
Pages 5490-5497

Pneumococcal Vaccination for Children in Asian Countries: A Systematic Review of Economic Evaluation Studies

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 1 Aug 2020)

 

Open Access Review
Pneumococcal Vaccination for Children in Asian Countries: A Systematic Review of Economic Evaluation Studies
by Neily Zakiyah , Widya N. Insani , Auliya A. Suwantika , Jurjen van der Schans and Maarten J. Postma
Vaccines 2020, 8(3), 426; https://doi.org/10.3390/vaccines8030426 (registering DOI) – 30 Jul 2020
Background: Evidence on costs and health benefits of pneumococcal conjugate vaccine (PCV) for children in Asian countries is limited but growing. As a region with a considerably high burden of pneumococcal disease, it is prominent to have a comprehensive overview on the cost-effectiveness […]

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 1 Aug 2020
Ideas
When a Vaccine Arrives, People Will Ignore the Anti-Vaxxers
Even if some Americans opt out, the country will still reach herd immunity against COVID-19.
July 31, 2020

 

BBC
http://www.bbc.co.uk/
Accessed 1 Aug 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 1 Aug 2020
[No new, unique, relevant content]

 

Financial Times
http://www.ft.com/home/uk
Accessed 1 Aug 2020
Global Insight
A coronavirus vaccine could split America
In the battle between public science and anti-vaxxer sentiment, science is heavily outgunned
Edward Luce July 30 2020

Pfizer chief says Trump price threats distract from vaccine progress
July 28, 2020

 

Forbes
http://www.forbes.com/
Accessed 1 Aug 2020
Aug 1, 2020
Trust Is The Vaccine Infrastructure We Need
The promise of a vaccine is the failsafe for millions of Americans nostalgic for normalcy but will communities trust us enough to take it?
By Lisa Fitzpatrick Contributor

Jul 31, 2020
Scientists Sequence DNA From Civil War Era Smallpox Vaccines
DNA sequenced from 150-year-old smallpox vaccination kits sheds some light on the evolutionary history of the viral strains used in smallpox vaccines.
By Kiona N. Smith Contributor

Jul 31, 2020
CDC Director: White House Stripped Agency Of Covid-19 Data With No Warning
The CDC director says he wasn’t told hospitals must now report directly toTrump administration until the decision was made.
By Jemima McEvoy Contributor

Jul 30, 2020
FDA Chief: We’ll Consider Emergency Use Authorization For Covid-19 Vaccines
The head of the U. S Food and Drug Administration said he would consider an “emergency use authorization” to expedite getting a vaccine against the Coronavirus strain Covid-19 to Americans.
By Bruce Japsen Senior Contributor

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 1 Aug 2020
Essay July 27, 2020
The Tragedy of Vaccine Nationalism
Global cooperation on vaccine allocation would be the most efficient way to disrupt the spread of the virus
Thomas J. Bollyky and Chad P. Bown

 

Foreign Policy
http://foreignpolicy.com/
Accessed 1 Aug 2020 |
Document of The Week: Global Plan for Sharing Vaccines [COVAX]
An alliance of international health organizations are competing with the United States and other rich countries in an effort to secure vaccines for the world’s neediest.
Colum Lynch

 

The Guardian
http://www.guardiannews.com/
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 1 Aug 2020
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 1 Aug 2020
Asia Pacific
Indian Billionaires Bet Big on Head Start in Coronavirus Vaccine Race
The world’s largest vaccine producer, the Serum Institute, announced a plan to make hundreds of millions of doses of an unproven inoculation. It’s a gamble with a huge upside. And huge risks.
By Jeffrey Gettleman
PRINT EDITION August 2, 2020

Europe
Russia Preparing Mass Vaccination Against Coronavirus for October
Russia’s health minister is preparing a mass vaccination campaign against the novel coronavirus for October, local news agencies reported on Saturday, after a vaccine completed clinical trials.
By Reuters Aug. 1

Europe
Sanofi, Glaxo Advance Talks to Supply Up to 300 Million COVID-19 Vaccine Doses to Europe: Companies
Sanofi SA and GlaxoSmithKline Plc on Friday said they are in advanced discussions with the European Commission to supply up to 300 million doses of the drugmakers’s experimental COVID-19 vaccine.
By Reuters July 31

Asia Pacific
Impact of Coronavirus Will Be Felt for Decades to Come, WHO Says
The global coronavirus outbreak is the sort of disaster whose effects will last far into the future, World Health Organization Director General Tedros Adhanom Ghebreyesus said on Friday.
By Reuters July 31

U.S.
Trump Planning for U.S. Rollout of Coronavirus Vaccine Falling Short, Officials Warn
As scientists and pharmaceutical companies work at breakneck speed to develop a vaccine for the novel coronavirus, public health officials and senior U.S. lawmakers are sounding alarms about the Trump administration’s lack of planning for its nationwide distribution.
By Reuters July 31

Europe
Large U.S. COVID-19 Vaccine Trials Will Exclude Pregnant Women for Now
The first two COVID-19 vaccines to enter large-scale U.S. trials will not be tested in pregnant women this year, raising questions about how this vulnerable population will be protected from the coronavirus, researchers told Reuters.
By Reuters July 31

Europe
Pfizer, BioNTech to Supply 120 Million Doses of Coronavirus Vaccine to Japan
Pfizer Inc and BioNTech SE have agreed to supply Japan with 120 million doses of their experimental coronavirus vaccine in the first half of 2021, the companies said on Friday.
By Reuters July 31

 

Washington Post
https://www.washingtonpost.com/
Accessed 1 Aug 2020
[No new, unique, relevant content]

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 1 Aug 2020
[No new relevant content]

Center for Global Development [to 1 Aug 2020]
http://www.cgdev.org/page/press-center
Accessed 1 Aug 2020
[No new relevant content]

Chatham House [to 1 Aug 2020]
https://www.chathamhouse.org/
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 1 Aug 2020
Report
Covid-19 Reshapes the Future
July 28, 2020 | By Samuel Brannen

Commentary
Digital in the Time of the Coronavirus: Data Science and Technology as a Force for Inclusion
July 28, 2020 | By Aleem Walji

Commentary
Co-Chairs’ Statement: Vaccine Confidence, Social Media Misinformation, and National Security within the Covid-19 Crisis
July 27, 2020 | By Katherine E. Bliss, J. Stephen Morrison

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 1 Aug 2020
[No new relevant content]

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 1 Aug 2020
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 25 July 2020

Our response to COVID-19 will help define the 21st century

Milestones :: Perspectives :: Research

Wellcome Trust [to 25 July 2020]
https://wellcome.ac.uk/news
Opinion | 24 July 2020
Our response to COVID-19 will help define the 21st century
Jeremy Farrar, Director Wellcome
The true impact of the COVID-19 pandemic will be felt beyond its immediate effects. Jeremy Farrar explains why the choices leaders make now will help define the 21st century.
[This article was first published in the Financial Times (opens in a new tab).]

It is discomfiting but true that most people still underestimate the true impact of the COVID-19 pandemic. Its immediate effects are so shocking that we are all caught up in them. But the longer-term implications may be more profound still. If we are not careful, they will shake the world order to its foundations.

To understand the crisis fully, imagine the concentric ripples generated by a stone thrown into a pond.

The innermost circle is the immediate impact of the virus: fear, illness and death. The second, larger circle describes COVID-19’s indirect health effects, such as missed cancer screenings. In the 2014 Ebola outbreak, more people died of malaria in west Africa than of the virus itself. It can take years for people to regain trust in healthcare systems.

The third circle, the social and economic impact of rising joblessness and shrinking economies, is larger still. Like every crisis, the pandemic will amplify existing social fractures and inequalities. This will have political consequences. Some governments may fall as a result of COVID-19.

That leads to the fourth and biggest circle: geopolitics. How world powers choose to look after themselves versus the rest of the world will define global politics over the coming decades.

For example, as many governments come to face rising criticism for their perceived or actual failure to protect their citizens, one natural response will be to blame others.

In the UK, there have been increased attacks on minority groups (opens in a new tab). In the US, President Donald Trump has referred to the “China virus” and threatened to withdraw the US from the World Health Organization (WHO).

In stark contrast, China’s President Xi Jinping has sought to position his country (opens in a new tab) as Africa’s friend, promising the continent vaccines as soon as any Chinese citizens get them. Only time will tell if Mr Xi’s promise was true altruism, or merely diplomatic powerplay. But it deliberately differentiated China from Europe and the US. It also underlined the accelerating shift of global power from west to east.

Still, none of the above ripple effects are inevitable.

Of the first two circles, it is not too late to improve disease-surveillance measures, public health and clinical care to reduce the impact of COVID-19’s first wave, and to prepare for potential second waves. We must invest the $31 billion needed in diagnostics, treatments and vaccines (opens in a new tab) to build health systems for all, regardless of ability to pay. This is the only true exit strategy from the pandemic.

The social and political impacts of the third circle can also be mitigated. Among the most vitally needed responses are: debt relief for poorer countries; investment to help the digital transition; support for green technologies to build a carbon neutral world; better education for the young; anti-corruption fighting; and enhanced democratic structures and institutions.

Lastly, there is the fourth circle, where we also face a choice. We can choose nationalistic routes that blame others for our problems. Or we can work together to forge a better, shared future.

There are historical parallels. The international institutions such as the UN, World Bank and WHO that were established after the second world war were born of a moment of enlightened self-interest by leading nations. These institutions have been central to the world’s largely peaceful order of the last 75 years.

Today, they require reform. But they are also needed more than ever. The giant social, scientific and technological advances that humanity saw during the later half of the 20th century grew out of a global commitment to sharing. This did not happen by chance. It happened as a result of choices that were made.

The effects of COVID-19 have been and will continue to be devastating. But infectious disease and pandemics are not the only global challenges that we face. We urgently need to address other issues, including climate change, access to clean water, antimicrobial resistance and mental health.

Like coronavirus, these problems transcend borders. They will not be defeated by insular nationalism, blaming others or drifting into a more polarised world – all this only leaves everyone more vulnerable. Rather, they can be solved by enhancing international cooperation and developing a sense of shared destiny.

It is not inevitable that COVID-19 ripples out these four circles of ruinous effects. But avoiding this outcome requires leaders who lay out honestly the challenges that we face and then, equally honestly, how to deal with them.

The choices we make today will help define the 21st century.

Continue reading

A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus

Milestones :: Perspectives :: Research

 

A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus
National Academies of Sciences, Engineering, Medicine [U.S.]
An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will develop an overarching framework for vaccine allocation to assist policymakers in the domestic and global health communities in planning for equitable allocation of vaccines against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

The expectation is that such a framework would inform the decisions by health authorities, including the Advisory Committee on Immunization Practices (ACIP), as they create and implement national and/or local guidelines for SARS-CoV-2 vaccine allocation. As part of this effort, the committee will consider the following:
What criteria should be used in setting priorities for equitable allocation of vaccine?
How should the criteria be applied in determining the first tier of vaccine recipients? As more vaccine becomes available, what populations should be added successively to the priority list of recipients? How do we take into account factors such as:
Health disparities and other health access issues
Individuals at higher risk (e.g., elderly, underlying health conditions)
Occupations at higher risk (e.g., health care workers, essential industries, meat packing plants, military)
Populations at higher risk (e.g., racial and ethnic groups, incarcerated individuals, residents of nursing homes, individuals who are homeless)
Geographic distribution of active virus spread
Countries/populations involved in clinical trials
How will the framework apply in various scenarios (e.g., different characteristics of vaccines and differing available doses)?
If multiple vaccine candidates are available, how should we ensure equity?
How can countries ensure equity in allocation of COVID-19 vaccines?
For the US, how can communities of color be assured access to vaccination?
How can we communicate to the American public about vaccine allocation to minimize perceptions of lack of equity?
What steps should be taken to mitigate vaccine hesitancy, especially among high-priority populations?
As part of the overall study, the committee will produce a discussion draft of the framework for public comment, and hold a public workshop to solicit feedback from external stakeholders.
National Academies Launch Study on Equitable Allocation of a COVID-19 Vaccine – First Meeting July 24
Friday, July 24, 4:30 p.m. – 5:30 p.m. EDT
Virtual – Zoom webinar
Agenda

 

Confusion spreads over system to determine priority access to Covid-19 vaccines

Milestones :: Perspectives :: Research

 

Confusion spreads over system to determine priority access to Covid-19 vaccines
STAT 22 July 2020
By Helen Branswell @HelenBranswell
As manufacturers around the world race to develop Covid-19 vaccines, a parallel effort has begun to figure out who in the United States should get them first — and how those doses should be distributed.
But already the effort is being complicated by tensions over who gets to make those critical decisions, with some groups feeling sidelined and multiple new actors crowding the stage.
On Tuesday, the National Academy of Medicine, tasked by top U.S. health officials, named an expert panel to develop a framework to determine who should be vaccinated first, when available doses are expected to be scarce. But that panel is ostensibly encroaching on the role of the Advisory Committee on Immunization Practices, a panel that has made recommendations on vaccination policy to the Centers for Disease Control and Prevention for decades, including drawing up the vaccination priority list during the 2009 H1N1 flu pandemic.
There is also the matter of Operation Warp Speed, the government’s vaccine fast-tracking program that has claimed authority over, among other things, distribution decisions when it comes to Covid-19 vaccines.
Amid so many players, public health experts are expressing concern and confusion.
“It seems to me like we’ve just assigned four different air traffic control towers to land the same plane,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “Between ACIP, and this new committee, the group working within Operation Warp Speed and just in terms of input from the general community, it’s not clear to me who will make the final decision and how that process will unfold.”
The health of untold numbers could hang in the balance, given that initial batches of vaccine are likely to be available only for a sliver of the population. Additionally, most vaccines will probably be given in two-dose regimens, meaning any figure of available doses would have to be divided in half to see how many people could be vaccinated.
There is no doubt that health care workers will be offered vaccines first. But after that, tough decisions will have to be made about the order in which other frontline workers — which? how many? — are offered priority access to vaccine and who will follow, in what order.
Normally, such decisions would fall to ACIP, which months ago set up a working group to monitor the evolving science on Covid-19 and the vaccines being developed to protect against it. But it’s not clear what task ACIP will be handed here.
“We haven’t been given a firm answer as to what our role will be. We are continuing with our routine planning and discussion, and we will come up with what we think are appropriate guidelines for prioritization. But that we’ve not been given assurances that we will actually be contributing to that,” said José Romero, the panel’s chairman…

 

Statement on COVID-19 Immunization

Milestones :: Perspectives :: Research

WFPHA: World Federation of Public Health Associations [to 25 July 2020]
https://www.wfpha.org/
Taskforce on Immunization
Statement on COVID-19 Immunization
Introduction
Immunization is one of the most successful public health measures of modern times. In fact, according to a recent World Health Organization (WHO) report on the prevention of infectious diseases, it is second only to clean water (WHO 2008). Annually immunization prevents an estimated 2.5 million deaths globally and reduces disease-specific treatment costs (WHO 2018).

For all the devastation caused by COVID-19, an important lesson is that the balance needs to shift from treating disease to preventing it. The WHO states that immunization has an important role to play in prevention not only for infants but throughout life as a key component of healthy ageing. Further, investing in vaccines specifically, and immunization generally, saves time, money and lives, and leads to healthier, sustainable healthcare systems and communities (UK Chief Medical Officers’ Guidelines 2011).

Specific to COVID-19, almost everyone is at risk and may require vaccination if given the opportunity. Hence, it is likely that demand will surpass supply. The concern of the WFPHA Immunisation Taskforce is the tendency for the rich to acquire and pay for the limited supply of available efficacious vaccines to the detriment of the at-risk populations in low income settings.

Not surprisingly, the race to produce an efficacious and cost-effective vaccine for COVID-19 has been on-going and there are indications that success may not be too far away. There are important lessons, unfortunately, that experience has taught us from previous immunization programs. Even when effective vaccines are available, vulnerable persons in low income settings usually do not have access to these vaccines for some time, if at all. There is a myriad of reasons for this state of affairs. These include (among others) high cost of vaccination programs for countries, health systems, families and individual, individual’s poor geographical access to vaccination centres, and inadequate supply of available vaccines due to competition. To worsen matters, GAVI (The Vaccine Alliance) indicated (prior to COVID-19) its intention to wean itself off such funding support.

Therefore, the WFPHA Immunisation Taskforce recommends
1. The international community should widen the process of coming together to support research and development of cost-effective COVID-19 vaccines from multiple centres.
2. The International community should establish a COVID-19 vaccination fund to support needy but resource-constrained countries
3. Supporting the efforts of the World Health Organization in efforts to coordinate the response to COVID-19 and in particular the coordination of efforts to develop an appropriate vaccine
4. National authorities should financially support the WHO and invest in strengthening national health systems with a particular focus on sustainable immunization programs
5. GAVI should continue to work for equitable distribution of any effective vaccine against COVID-19 and postpone any plans of withdrawing funding support to developing countries.

References
GAVI (2020) COVID-19: massive impact on lower-income countries threatens more disease outbreaks https://www.gavi.org/news/media-room/covid-19-massive-impact-lower-income-countries-threatens-more-disease-outbreaks

WHO (2008) Vaccination greatly reduces disease, disability, death and inequity worldwide. Available at: https://www.who.int/bulletin/volumes/86/2/07-040089/en/ Last accessed: June 2019.

WHO (2018) Vaccines: the powerful innovations bringing WHO’s mission to life every day. Available at: https://www.who.int/news-room/commentaries/detail/vaccines-the-powerful-innovations-bringing-who-s-mission-to-life-every-day Last accessed: May 2019.

UK Chief Medical Officers’ Guidelines (2011) Physical activity benefits for adults and older adults. Available at: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/physical-activity-info.pdf Last accessed: June 2019.

 

Statement on COVID-19 Immunization

Milestones :: Perspectives :: Research

 

WFPHA: World Federation of Public Health Associations [to 25 July 2020]
https://www.wfpha.org/
Taskforce on Immunization
Statement on COVID-19 Immunization
Introduction
Immunization is one of the most successful public health measures of modern times. In fact, according to a recent World Health Organization (WHO) report on the prevention of infectious diseases, it is second only to clean water (WHO 2008). Annually immunization prevents an estimated 2.5 million deaths globally and reduces disease-specific treatment costs (WHO 2018).

For all the devastation caused by COVID-19, an important lesson is that the balance needs to shift from treating disease to preventing it. The WHO states that immunization has an important role to play in prevention not only for infants but throughout life as a key component of healthy ageing. Further, investing in vaccines specifically, and immunization generally, saves time, money and lives, and leads to healthier, sustainable healthcare systems and communities (UK Chief Medical Officers’ Guidelines 2011).

Specific to COVID-19, almost everyone is at risk and may require vaccination if given the opportunity. Hence, it is likely that demand will surpass supply. The concern of the WFPHA Immunisation Taskforce is the tendency for the rich to acquire and pay for the limited supply of available efficacious vaccines to the detriment of the at-risk populations in low income settings.

Not surprisingly, the race to produce an efficacious and cost-effective vaccine for COVID-19 has been on-going and there are indications that success may not be too far away. There are important lessons, unfortunately, that experience has taught us from previous immunization programs. Even when effective vaccines are available, vulnerable persons in low income settings usually do not have access to these vaccines for some time, if at all. There is a myriad of reasons for this state of affairs. These include (among others) high cost of vaccination programs for countries, health systems, families and individual, individual’s poor geographical access to vaccination centres, and inadequate supply of available vaccines due to competition. To worsen matters, GAVI (The Vaccine Alliance) indicated (prior to COVID-19) its intention to wean itself off such funding support.

 

Therefore, the WFPHA Immunisation Taskforce recommends
1. The international community should widen the process of coming together to support research and development of cost-effective COVID-19 vaccines from multiple centres.
2. The International community should establish a COVID-19 vaccination fund to support needy but resource-constrained countries
3. Supporting the efforts of the World Health Organization in efforts to coordinate the response to COVID-19 and in particular the coordination of efforts to develop an appropriate vaccine
4. National authorities should financially support the WHO and invest in strengthening national health systems with a particular focus on sustainable immunization programs
5. GAVI should continue to work for equitable distribution of any effective vaccine against COVID-19 and postpone any plans of withdrawing funding support to developing countries.

References
GAVI (2020) COVID-19: massive impact on lower-income countries threatens more disease outbreaks https://www.gavi.org/news/media-room/covid-19-massive-impact-lower-income-countries-threatens-more-disease-outbreaks

WHO (2008) Vaccination greatly reduces disease, disability, death and inequity worldwide. Available at: https://www.who.int/bulletin/volumes/86/2/07-040089/en/ Last accessed: June 2019.

WHO (2018) Vaccines: the powerful innovations bringing WHO’s mission to life every day. Available at: https://www.who.int/news-room/commentaries/detail/vaccines-the-powerful-innovations-bringing-who-s-mission-to-life-every-day Last accessed: May 2019.

UK Chief Medical Officers’ Guidelines (2011) Physical activity benefits for adults and older adults. Available at: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/physical-activity-info.pdf Last accessed: June 2019.

 

Rich country vaccine rush threatens supply security

Milestones :: Perspectives :: Research

 

Coronavirus treatment
Rich country vaccine rush threatens supply security
Spending spree stokes wrangles over pricing and risks leaving behind poorer nations
Financial Times reporters July 23 2020 | Free to read

A multibillion-dollar flurry of coronavirus vaccine dealmaking between rich countries and companies has exposed a lack of international co-ordination and threatens to leave poor nations out.

The resulting patchwork of agreements has raised big questions about global vaccine access and stoked wrangles over pricing, supply security and liability for possible side-effects.

“On the positive side, bilateral deals between countries and companies can drive forward the science and clinical development — and expand the world’s manufacturing capacity,” said Seth Berkley, chief executive of Gavi, a UN-backed alliance that buys and distributes vaccines in more than 50 of the world’s poorest countries.

“But . . . you [also] end up with unnecessary competition, shortages of supplies and a failure to optimise a pipeline that should make the best vaccines available at scale as quickly as possible.”

Every government scrambling to secure inoculations has faced similar difficulties in deciding what to back and how much to pay for products that could prove revolutionary but do not yet exist.

The accords struck range widely in nature. They include commitments to buy specified numbers of doses, production licensing agreements, and the acquisition of direct stakes in manufacturers.

The vaccine rush accelerated this week with the announcement that the UK had agreed to buy 60m doses from Valneva of France and 30m doses over the next two years of a candidate developed by Germany’s BioNTech with the US pharma giant Pfizer.

Two days later, the US unveiled a deal to spend $1.95bn on 100m doses of the same inoculation to distribute free of charge to American citizens. The agreement also included the option for Washington to purchase a further 500m doses, subject to the product receiving regulatory approval

The recent deals add to a growing list being struck for the scores of candidate vaccines being developed worldwide. The US Biomedical Advanced Research and Development Authority has spent billions of dollars securing supplies. The EU has allocated billions of euros and has been in talks with companies including Johnson & Johnson of the US and France’s Sanofi.

Meanwhile, UK-based AstraZeneca has announced agreements to supply Britain, an alliance of four continental European countries, the US, Brazil and low-income nations.

Pricing is a particularly fraught question. People involved on all sides say there are many unknowns, including manufacturing costs, yields of end products and dosage sizes needed. Some companies such as Johnson & Johnson have said they will manufacture on a “not for profit” basis, while others, including Pfizer, have made no such commitment. Latest coronavirus news Follow FT’s live coverage and analysis of the global pandemic and the rapidly evolving economic crisis here.

Many of the agreements do not disclose price, while the variation in those that do is large. The US deal for the BioNTech-Pfizer inoculation works out at $19.50 a dose. This is several times higher than estimates for an AstraZeneca supply agreement with the Netherlands, Germany, France and Italy that the Dutch government described as “at cost”, according to Geoffrey Porges, a pharma and biotech analyst at SVB Leerink.

Without access to full confidential details of agreements, it is hard for outsiders to make firm judgments on pricing. But Peter Pitts, former associate commissioner of the US Food and Drug Administration, said he believed the terms would be such that pharmaceutical companies would benefit one way or another.

“I think at the end of the day what we’ll see is everybody is going to recoup their costs and make some profit,” he said. “I suspect they are all saying different things that mean the same thing.”

The complexity of the dealmaking has been increased by the variety of different vaccine types that are in development.

Kate Bingham, head of the UK’s vaccines taskforce, said London was hoping to expand its three deals to give it a “broad and diverse portfolio”. The aim is to have two agreements in place for each of the four main vaccine technologies — mRNA, viral vectors, inactivated whole virus and adjuvanted proteins.

The terms of agreements also vary depending on the size and type of company. “Smaller companies need a lot more funding upfront than larger companies, [such as] contributions to scale up manufacturing and help to fund clinical trials,” Ms Bingham said.

While any new pharmaceutical product poses potential safety risks, the hazards may be higher with Covid-19 because of the gaps in scientific knowledge of the disease and the accelerated development of candidate vaccines.

“[Liability] is an issue that comes up all the time and with Covid-19 the risk is unknown,” said Melanie Saville, head of vaccines at the Coalition for Epidemic Preparedness Innovations (Cepi), a partnership of governments, industry and charities.

“The usual types of insurance policies that companies take out just aren’t available. It will have to be sorted out and we’re looking at how to do it.”

Cepi is one of the organisations leading efforts to secure supplies for poorer countries by funding nine Covid-19 vaccine projects. A condition of the financing is that recipients participate in the joint Cepi, Gavi and World Health Organization Covax programme, which aims to enable equitable access to a inoculation for all countries, rich and poor.

But efforts to ensure equitable worldwide distribution of any successful vaccine are the exception to the wider deal-making free-for-all.

As rich countries pour rising sums into ad-hoc bets on products they hope will provide an escape hatch out of the pandemic, an official at one vaccine manufacturer observed: “In the future, we need a better system.”

Reporting by Michael Peel in Brussels, Clive Cookson in London, Hannah Kuchler in New York, Joe Miller in Frankfurt and Donato Paolo Mancini in Rome

 

Coronavirus [COVID-19] Public Health Emergency of International Concern (PHEIC)

EMERGENCIES

Coronavirus [COVID-19]
Public Health Emergency of International Concern (PHEIC)

Situation report – 187
Coronavirus disease 2019 (COVID-19)
25 July 2020

Confirmed cases :: 15 581 009 [week ago: 13 876 441]
Confirmed deaths :: 635 173 [week ago: 593 087]

Highlights [selected]
:: The COVID-19 pandemic has affected older people disproportionately, especially those living in long-term care facilities. WHO has published a policy brief on preventing and managing COVID-19 across long-term care services.

:: WHO has released a set of practical steps for implementing the prescriptions of the WHO Manifesto for a healthy recovery from COVID-19. These prescriptions aim to create a healthier, fairer and greener world while investing to maintain and resuscitate the economy hit by the effects of the pandemic.

::::::
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New COVID-19 Law Lab to provide vital legal information and support for the global COVID-19 response
22 July 2020 News release New York/Geneva
Launching today, the COVID-19 Law Lab initiative gathers and shares legal documents from over 190 countries across the world to help states establish and implement strong legal frameworks to manage the pandemic. The goal is to ensure that laws protect the health and wellbeing of individuals and communities and that they adhere to international human rights standards.
The new Lab (at www.COVIDLawLab.org) is a joint project of United Nations Development Programme (UNDP), the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the O’Neill Institute for National and Global Health Law at Georgetown University.
Well-designed laws can help build strong health systems; evaluate and approve safe and effective drugs and vaccines; and enforce actions to create healthier and safer public spaces and workplaces. Critically, they are key to effective implementation of the WHO International Health Regulations: surveillance; infection prevention and control; management of travel and trade; and implementation of measures to maintain essential health services.
“Laws and policies that are grounded in science, evidence and human rights can enable people to access health services, protect themselves from COVID-19 and live free from stigma, discrimination and violence,” says Achim Steiner, UNDP Administrator. “The COVID-19 Law Lab is an important tool for sharing good practices on laws and policies.”…

::::::
::::::

Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
July 22, 2020
:: U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses
:: Americans to receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines
:: Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021

Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data
July 20, 2020
:: The data further demonstrated the ability of BNT162b1 to elicit high SARS-CoV-2 neutralizing titers
:: BNT162b1 elicited strong CD4+ and CD8+ T cell responses against SARS-CoV-2- receptor binding domain (RBD), compared to baseline
:: The RBD-specific, interferon-γ+, IL-2+, CD8+ T cells elicited by BNT162b1 in immunized participants indicate a strong potential for cell mediated anti-viral activity
:: T cell cytokine profile shows vaccine elicited T cells exhibit a Th1 phenotype, which is associated with antiviral properties
:: BNT162b1 induced antibodies had broadly neutralizing activity in pseudovirus neutralization assays across a panel of sixteen SARS-CoV-2 RBD variants identified in published SARS-CoV-2 sequences and against the newly dominant D614G strain
:: Robust specific antibody and T cell responses, (both of which are considered by experts as key to a vaccine ensuring protection against disease) elicited by the BNT162b1 mRNA vaccine against RBD suggest a potential for multiple beneficial protective mechanisms against COVID-19
:: Local reactions and systemic events after immunization with BNT162b1 were dose-dependent, generally mild to moderate and transient, with occasional severe adverse events (Grade 3, e.g. flu-like symptoms and injection site reactions) that resolved spontaneously or could be managed with simple measures – no serious adverse events were reported

Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2
July 19, 2020
:: Thirty million doses expected to be delivered in 2020 and 2021, subject to regulatory approval or authorization
:: Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020 and manufacture globally up to 100 million doses by the end of 2020 and more than 1.3 billion doses by the end of 2021
:: Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic

Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate
Jul 23, 2020

COVID-19 Vaccines Test Safe & Effective by China & UK teams: the Lancet
Jul 23, 2020,

 

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POLIO – Public Health Emergency of International Concern (PHEIC); WHO/OCHA Emergencies

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 21 July 2020
:: In response to donor and stakeholder feedback, as well as the programme’s evolving needs and challenges, in December 2019, GPEI launched an internal governance review process to evaluate how to improve the partnership’s operations and structures at the leadership level (Polio Oversight Board, Finance & Accountability Committee and Strategy Committee). The result of a series of surveys, workshops, interviews and stakeholder consultations conducted over a six-month period, this report outlines key issues with recommendations aimed at strengthening the programme’s governance [see below].

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: five WPV1 cases and five WPV1 positive environmental samples
:: Pakistan: two WPV1 cases and eight WPV1 positive environmental samples
:: Cameroon: one cVDPV2 positive environmental sample
:: Chad: three cVDPV2 cases

::::::

GPEI – Governance Review Final Report
July 2020 :: 25 pages
EXECUTIVE SUMMARY
In response to donor and stakeholder feedback, as well as the programme’s evolving needs
and challenges, the Global Polio Eradication Initiative (GPEI) undertook an internal review process to evaluate how to improve the partnership’s operations, structures and culture in order to more efficiently and effectively progress towards the endgame strategy’s goals and objectives. The result of a series of surveys, workshops, interviews and stakeholder consultations, this report sets forth key issues and recommendations aimed at strengthening
the programme’s structure and operations.

Stakeholders also emphasized the importance of integration activities and – while not a primary focus of this report – we acknowledge that work remains to be done to strengthen efforts toward GPEI’s integration goal. Incorporating these recommendations through deliberate and concerted actions – while simultaneously strengthening efforts towards integration and fostering a culture of change – GPEI can achieve greater accountability for decisions and
implementation, increase transparency around its decision-making and financial processes,
enhance country engagement and ownership, and reinforce continuous improvement. These outcomes will help GPEI reach its goals: eradication, integration, containment and certification.

GPEI has achieved significant and important successes. There are, however, obstacles that GPEI must address in order to realize its goals. The programme must rise to meet significant
challenges, including GPEI’s work in the remaining endemic countries, contending with
circulating vaccine-derived polioviruses, vaccine supply issues and the impact of COVID-19 on
GPEI operations and vaccination efforts.

Donors have questioned whether GPEI’s structure and governance remain fit for purpose to eradicate polio. This report outlines proposed changes that stakeholders feel will reinforce the partnership’s fitness moving forward. These recommendations do not address questions of
programme strategy and are not intended to be the sum total of the governance review process. They are, however, important steps in GPEI’s ongoing improvement to ensure the partnership is fit for purpose and provide important substrate for the larger revision of the endgame strategy. The GPEI Strategy Committee should actively manage and monitor implementation of the recommendations and any required follow-ups.

While the need for this review was identified and the exercise itself began before the onset of COVID-19, the challenges confronting GPEI as a result of the pandemic have reinforced

CONCLUSION AND NEXT STEPS
The donor community is supportive of GPEI and its work. Though this review explored the possibility, no one suggested that GPEI should be dismantled and rebuilt from the ground up. The history, momentum, institutional knowledge and capabilities of the partnership are unparalleled, and stakeholders are eager to see the partnership succeed. However, stakeholders want substantive changes within the partnership related to role clarity, accountability, and considering new perspectives.

This review emphasizes stakeholders’ concerns with some of GPEI’s operations and structures across all levels of the programme and presents some ways forward to address them. GPEI must commit to a strong culture of change to implement these recommendations and improve the programme’s accountability, transparency, country engagement and ownership, as well as the ability to continuously improve. GPEI must also refocus its integration efforts, which will allow GPEI to support immunization, health systems and emergency response in the near term, particularly in the wake of COVID-19, as well as in the long-term, cementing its legacy in a post-polio world.

GPEI’s donors, stakeholders and partners are rooting for its success, and seeing demonstrable progress on these recommendations will strengthen their commitment and resolve to achieve a polio-free world.

As immediate next steps, the Strategy Committee needs to:
reflect on recommendations and determine how to move forward;
consult with the POB on its conclusions and course of action;
develop an implementation workplan;
follow up (as soon as possible) with donors and other stakeholders, outlining which steps are to be taken and what the implementation workplan (and timeline) looks like; and
provide regular updates to the programme and stakeholders on the progress of the implementation workplan.

It is critical that GPEI leadership follow through on the steps listed above to ensure that this is
a substantial, serious effort – and demonstrate that change is welcome within the partnership
because eradication goals may be at risk with the partnership’s current structure and practices

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WHO Grade 3 Emergencies [to 25 July 2020]

Democratic Republic of the Congo – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

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WHO Grade 2 Emergencies [to 25 July 2020]
Burkina Faso [in French]
:: Combattre la peur et la stigmatisation liées à la COVID-19
23 juillet 2020
Hésitation à se faire dépister, éviter les personnes chargées de la recherche des contacts ou se méfier de ce que diront les voisins : la pandémie de COVID-19 a déclenché chez certains habitants de Ouagadougou des réactions diverses qui ont rendu la riposte plus difficile.

Iraq
:: WHO mobile clinics serving the vulnerable in Mosul amid COVID-19 outbreak 20 July 2020

Niger
:: Continuité des services de santé en contexte de COVID19 : l’OMS accompagne le Gouver… 19 juillet 2020
Le Niger a lancé officiellement le 13 juillet l’édition 2020 de la campagne de chimio prévention du paludisme saisonnier. Cette campagne couplée au dépistage de la malnutrition, entre dans le cadre de la lutte contre le paludisme au Niger qui reste une des principales préoccupations de santé pour le pays. La cérémonie de lancement a eu lieu à Niamey dans la salle de conférence de l’hôtel Bravia sous le patronage du Ministre de la Santé Publique, Dr Idi Illiassou Mainassara en présence de la Représentante de l’OMS au Niger Dr Anya Blanche, et des autres partenaires du Programme.

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Libya – No new digest announcements identified
Malawi – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Myanmar – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 25 July 2020]

Chad – No new digest announcements identified
Djibouti – Page not responding at inquiry
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: 23 Jul 2020 Daily Noon Briefing Highlights: Nigeria – Syria

Yemen
:: 22 Jul 2020 UN report: Yemen sees return to alarming levels of food insecurity
:: 20 Jul 2020 Daily Noon Briefing Highlights: India – Nepal – Sudan – Yemen

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
East Africa Locust Infestation
:: Desert Locust situation update – 21 July 2020

COVID-19
:: Coronavirus disease 2019 (COVID-19) Situation Report 37: occupied Palestinian territory, issued 16 July 2020, information for period: 5 March – 23 July 2020

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WHO & Regional Offices [to 25 July 2020]

WHO & Regional Offices [to 25 July 2020]

 

New COVID-19 Law Lab to provide vital legal information and support for the global COVID-19 response
22 July 2020 News release New York/Geneva
[See COVID-19 above for detail]
::::::

Weekly Epidemiological Record, 24 July 2020, vol. 95, 30 (pp. 349–360)
WHO Alliance for the Global Elimination of Trachoma by 2020: progress report, 2019

 

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Over 10 000 health workers in Africa infected with COVID-19 23 July 2020
The World Health Organization (WHO) today warned of the threat posed by COVID-19 to health workers across Africa. More than 10 000 health workers in the 40 countries which have reported on such infections have been infected with COVID-19 so far, a sign of the challenges medical staff on the frontlines of the outbreak face.
:: WHO, Africa CDC in joint push for COVID-19 traditional medicine research in Africa
22 July 2020

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
No new digest content identified

WHO European Region EURO
:: Prison nurse Deanna Mezen guarantees continuity of care for detainees 24-07-2020
:: Countries commit to meeting SDGs in face of pandemic 23-07-2020
:: WHO Regional Director for Europe signs agreement for new centre of excellence and visits Gaziantep, marking 60 years of cooperation with Turkey 22-07-2020
:: Altynai Karakhoishiyeva: helping women give birth during the COVID-19 pandemic 21-07-2020

WHO Eastern Mediterranean Region EMRO
:: Confronting outbreaks in Somalia 22 July 2020
:: WHO delivers 16 CT scan machines to Islamic Republic of Iran 21 July 2020
:: Essential polio vaccination campaigns resume  20 July 2020

WHO Western Pacific Region
No new digest content identified

 

CDC/ACIP [to 25 July 2020]

CDC/ACIP [to 25 July 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases
Transcript for CDC Telebriefing on New Resources and Tools to Support Opening Schools Friday, July 24, 2020

CDC releases new resources and tools to support opening schools Thursday, July 23, 2020

Dr. Robert R. Redfield Statement on SARS-CoV-2 infections Wednesday, July 22, 2020

MMWR News Synopsis Friday, July 24, 2020
Estimated County-Level Prevalence of Select Underlying Medical Conditions Associated with Increased Risk of Severe COVID-19 Illness: United States 2018

Evaluation of an Online Risk Assessment To Identify Rabies Exposures Among Health Care Workers — Utah, 2019

Population Point Prevalence of SARS-CoV-2 Infection Based on a Statewide Random Sample — Indiana, April 25–29, 2020 (Early release July 21, 2020)

Estimated Community Seroprevalence of SARS-CoV-2 Antibodies — Two Georgia Counties, April 28–May 3, 2020 (Early release, July 21, 2020)