COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic

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

 

Ethics Rounds
COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic
Samantha A. House, Catherine D. Shubkin, Tim Lahey, Jeffrey P. Brosco, John Lantos
Pediatrics, Nov 2020, 146 (5) e2020010728
Abstract
The current coronavirus disease 2019 (COVID-19) pandemic has triggered an intense global research effort to inform the life-saving work of frontline clinicians who need reliable information as soon as possible. Yet research done in pressured circumstances can lead to ethical dilemmas, especially for vulnerable research subjects. We present the case of a child with neurocognitive impairment who is diagnosed with COVID-19 infection after presenting with fever and a seizure. The child lives in a group home and is in the custody of the state; her parents lost parental rights many years ago. Some members of the health care team want to enroll her in a randomized clinical trial evaluating an experimental treatment of COVID-19. For minor patients to enroll in this clinical trial, the institutional review board requires assent of patients and consent of guardians. An ethics consult is called to help identify relevant concerns in enrollment. In the accompanying case discussion, we address historical perspectives on research involving people with disabilities; proper management of research participation for people with disabilities including consent by proxy, therapeutic misconception, and other threats to the ethical validity of clinical trials; and the potentially conflicting obligations of researchers and clinicians.

Revisiting child and adolescent health in the context of the Sustainable Development Goals

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PLoS Medicine
http://www.plosmedicine.org/
(Accessed 7 Nov 2020)

 

Revisiting child and adolescent health in the context of the Sustainable Development Goals
Zulfiqar A. Bhutta, Kathryn M. Yount, Quique Bassat, Artur A. Arikainen
Editorial | published 30 Oct 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003449
[Excerpt]
…As we examine the situation more than 5 years into the SDGs, several concerns emerge. Despite progress, the field remains fragmented, with limited actions in countries to develop integrated strategies for reproductive, maternal, newborn and child health (RMNCH), or inclusion of adolescent health within national plans [5]. Work on the drivers of adolescent health, well being, and empowerment is underway but has yet to translate into a reasonable global strategy. This lag stems from complex, multilevel social influences during adolescence [6], insufficient disaggregation of data on adolescents, suboptimal measurement and a lack of well-defined indicators [7–9], and limited evidence on the differential impacts of social policies and programs [8] within adolescence and between adolescence and adulthood. Within health systems, many nutrition programs remain poorly integrated with other RMNCH programs and few have substantive links with sectors outside health. With the unfinished agenda for maternal, newborn and child deaths, rigorous studies to address mechanisms and hitherto unrecognized causes of excess mortality are just beginning to yield results, albeit with older pediatric age groups remaining significantly understudied, even at the simplest descriptive level [5]. Effort is limited to bring mental-health programming to women and children, especially in conflict settings or emergencies such as the COVID-19 pandemic. These silos in research, planning and policy, and service delivery apply equally to other sectors, and to multi-sectoral planning and implementation at country level. To address the SDGs, we must consider life in the 21st century—including the disruptions of technological change, economic shocks, climate change, and conflict and security…

Informing children citizens efficiently to better engage them in the fight against COVID-19 pandemic

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PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 7 Nov 2020)

 

Viewpoints
Informing children citizens efficiently to better engage them in the fight against COVID-19 pandemic
Jean-Eric Ghia, Sophie Gaulin, Laure Ghia, Laure Garancher, Claude Flamand
| published 04 Nov 2020 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0008828
Abstract
Since the beginning of the year, the world’s attention has rightly been focused on the spread of the Coronavirus Disease 2019 (COVID-19) pandemic and the implementation of drastic mitigation strategies to limit disease transmission. However, public health information campaigns tailored to children are very rare. Now more than ever, at a time when some governments are taking populations out of lockdown and youth are returning to schools, children around the world need to fully grasp the modes of transmission of the disease, the health risks, the scientific notions of the immune system, the value of barrier measures, and the progress of scientific research. In the context of the COVID-19 pandemic, comics can be very useful for communicating quickly and effectively abstract and important information to children who might be under the influence of a large amount of sometimes contradictory information. Conveying precise, reliable, and accessible information to children is key in a world overwhelmingly impacted by the outbreak. This should be the role and the responsibility of world health official leaders and governments in compliance with the United Nations Convention on the Rights of the Child. In partnership with mainstream medias, consortia of scientists, communication experts, and education specialists, it is urgent that world leaders engage children in this worldwide public health fight.
… The use of appropriate governmental communication using comic books, cartoons, appropriate websites, and social media would then make it possible to raise awareness among children about the modes of transmission of the disease, the health risks, the scientific notions of the immune system, the value of barrier measures, and the progress of scientific research. More than texts, comics could be better suited for information campaigns on social media like TikTok [23] and other popular apps. Ideally, they would be tailored by governments, scientific consortium, and educational experts to reach younger citizens….

Scientific quality of COVID-19 and SARS CoV-2 publications in the highest impact medical journals during the early phase of the pandemic: A case control study

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

 

Research Article
Scientific quality of COVID-19 and SARS CoV-2 publications in the highest impact medical journals during the early phase of the pandemic: A case control study
Marko Zdravkovic, Joana Berger-Estilita, Bogdan Zdravkovic, David Berger
Research Article | published 05 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241826

Programmatic assessment of electronic Vaccine Intelligence Network (eVIN)

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

 

Programmatic assessment of electronic Vaccine Intelligence Network (eVIN)
Vandana Gurnani, Prem Singh, Pradeep Haldar, Mahesh Kumar Aggarwal, Kiran Agrahari, Satabdi Kashyap, Shreeparna Ghosh, Mrinal Kar Mohapatra, Ruma Bhargava, Partha Nandi, Pritu Dhalaria
Research Article | published 05 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241369
Abstract
eVIN is a technology system that digitizes vaccine stocks through a smartphone application and builds the capacity of program managers and cold chain handlers to integrate technology in their regular work. To effectively manage the vaccine logistics, in 2015, this technology was rolled-out in 12 states of India. This study assessed the programmatic usefulness of eVIN implementation in the areas of vaccine utilization, vaccine stock and distribution management and documentation across selected cold chain points. A pre-post study design was used, where cold chain points (CCPs) were selected using two-stage sampling technique in eVIN states. Pre-post comparative analysis was carried out on the identified indicators using both primary and secondary data sources. The vaccine utilization data reflects that the utilization had reduced from 305.3 million doses in pre-eVIN period to 215.0 million doses in post-eVIN period across 12 eVIN states, resulting into savings of approximately 90 million doses of vaccines. Number of facilities having stock-out of any vaccine showed a significant reduction by 30.4% in post-eVIN period (p<0.001). There was a 4.0% drop in facilities reporting minimum stock of any vaccine after implementation of eVIN. Facilities with maximum stock of any vaccine had increased from 37.4% in pre-eVIN to 39.2% in post-eVIN. During the pre-eVIN period, only 38.6% facilities updated vaccine stock on a daily basis, while in post-eVIN period, 53.5% facilities updated vaccine stock on daily basis. The completeness of records in the vaccine stock registers, indent form and temperature logbook have been substantially improved in the post-eVIN period (p<0.001). eVIN had helped in streamlining the vaccine flow network and ensured equity through better vaccine management practices. It is a powerful contribution to strengthen the vaccine supply chain and management. Upscaling eVIN in the remaining states of India will be crucial in improving the efficacy of vaccines and cold chain management.

Public attitudes toward allocating scarce resources in the COVID-19 pandemic

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

Public attitudes toward allocating scarce resources in the COVID-19 pandemic
Wesley Buckwalter, Andrew Peterson

Research Article | published 04 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0240651
Abstract
The general public is subject to triage policies that allocate scarce lifesaving resources during the COVID-19 pandemic, one of the worst public health emergencies in the past 100 years. However, public attitudes toward ethical principles underlying triage policies used during this pandemic are not well understood. Three experiments (preregistered; online samples; N = 1,868; U.S. residents) assessed attitudes toward ethical principles underlying triage policies. The experiments evaluated assessments of utilitarian, egalitarian, prioritizing the worst-off, and social usefulness principles in conditions arising during the COVID-19 pandemic, involving resource scarcity, resource reallocation, and bias in resource allocation toward at-risk groups, such as the elderly or people of color. We found that participants agreed with allocation motivated by utilitarian principles and prioritizing the worst-off during initial distribution of resources and disagreed with allocation motivated by egalitarian and social usefulness principles. At reallocation, participants agreed with giving priority to those patients who received the resources first. Lastly, support for utilitarian allocation varied when saving the greatest number of lives resulted in disadvantage for at-risk or historically marginalized groups. Specifically, participants expressed higher levels of agreement with policies that shifted away from maximizing benefits to one that assigned the same priority to members of different groups if this mitigated disadvantage for people of color. Understanding these attitudes can contribute to developing triage policies, increase trust in health systems, and assist physicians in achieving their goals of patient care during the COVID-19 pandemic.

Carrying Out Rapid Qualitative Research During a Pandemic: Emerging Lessons From COVID-19

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Qualitative Health Research
Volume 30 Issue 14, December 2020
http://qhr.sagepub.com/content/current

 

Research Articles
Carrying Out Rapid Qualitative Research During a Pandemic: Emerging Lessons From COVID-19
Cecilia Vindrola-Padros, Georgia Chisnall, Silvie Cooper, Anna Dowrick, Nehla Djellouli, Sophie Mulcahy Symmons, Sam Martin, Georgina Singleton, Samantha Vanderslott, Norha Vera, Ginger A. Johnson
First Published August 31, 2020; pp. 2192–2204

Prospects for a safe COVID-19 vaccine

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Science Translational Medicine
04 November 2020 Vol 12, Issue 568
https://stm.sciencemag.org/

 

Review
Prospects for a safe COVID-19 vaccine
By Barton F. Haynes, Lawrence Corey, Prabhavathi Fernandes, Peter B. Gilbert, Peter J. Hotez, Srinivas Rao, Michael R. Santos, Hanneke Schuitemaker, Michael Watson, Ann Arvin
Science Translational Medicine04 Nov 2020 Full Access
Prior vaccine development experiences do not raise concerns about vaccine-associated enhanced disease for COVID-19 vaccine candidates.

Investigating spatial variation and change (2006–2017) in childhood immunisation coverage in New Zealand

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Social Science & Medicine
Volume 263 October 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/262/suppl/C

 

Research article Abstract only
Investigating spatial variation and change (2006–2017) in childhood immunisation coverage in New Zealand
Lukas Marek, Matthew Hobbs, John McCarthy, Jesse Wiki, … Simon Kingham
Article 113292

Elevating the uses of storytelling approaches within Indigenous health research: a critical and participatory scoping review protocol involving Indigenous people and settlers

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 7 Nov 2020]

 

https://stm.sciencemag.org/
Elevating the uses of storytelling approaches within Indigenous health research: a critical and participatory scoping review protocol involving Indigenous people and settlers
There is a complicated and exploitative history of research with Indigenous peoples and accompanying calls to meaningfully and respectfully include Indigenous knowledge in healthcare. Storytelling approaches t…
Authors: Kendra L. Rieger, Sarah Gazan, Marlyn Bennett, Mandy Buss, Anna M. Chudyk, Lillian Cook, Sherry Copenace, Cindy Garson, Thomas F. Hack, Bobbie Hornan, Tara Horrill, Mabel Horton, Sandra Howard, Janice Linton, Donna Martin, Kim McPherson…
Citation: Systematic Reviews 2020 9:257
Content type: Protocol
Published on: 4 November 2020

A QuESt for speed: rapid qualitative evidence syntheses as a response to the COVID-19 pandemic

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 7 Nov 2020]

 

A QuESt for speed: rapid qualitative evidence syntheses as a response to the COVID-19 pandemic
The COVID-19 pandemic has created a sense of urgency in the research community in their bid to contribute to the evidence required for healthcare policy decisions. With such urgency, researchers experience met…
Authors: Linda Biesty, Pauline Meskell, Claire Glenton, Hannah Delaney, Mike Smalle, Andrew Booth, Xin Hui S. Chan, Declan Devane and Catherine Houghton
Citation: Systematic Reviews 2020 9:256
Content type: Methodology
Published on: 4 November 2020

Exploring uncertainty and risk in the accelerated response to a COVID-19 vaccine: Perspective from the pharmaceutical industry

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Open access
Exploring uncertainty and risk in the accelerated response to a COVID-19 vaccine: Perspective from the pharmaceutical industry
L. Coudeville, G.B. Gomez, O. Jollivet, R.C. Harris, … C. Mahé
Pages 7588-7595

Rural, urban, and suburban differences in influenza vaccination coverage among children

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Abstract only
Rural, urban, and suburban differences in influenza vaccination coverage among children
Yusheng Zhai, Tammy A. Santibanez, Katherine E. Kahn, Anup Srivastav, … James A. Singleton
Pages 7596-7602

Assessment of missed opportunities for vaccination (MOV) in Burkina Faso using the World Health Organization’s revised MOV strategy: Findings and strategic considerations to improve routine childhood immunization coverage

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Open access
Assessment of missed opportunities for vaccination (MOV) in Burkina Faso using the World Health Organization’s revised MOV strategy: Findings and strategic considerations to improve routine childhood immunization coverage
Lassané Kaboré, Bertrand Meda, Isaie Médah, Stephanie Shendale, … Ikechukwu U. Ogbuanu
Pages 7603-7611

Knowledge, attitudes and practices about vaccine-preventable diseases and vaccinations of children among pregnant women in Greece

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Abstract only
Knowledge, attitudes and practices about vaccine-preventable diseases and vaccinations of children among pregnant women in Greece
Helena C. Maltezou, Marianna Theodora, Theodore Lytras, Aikaterini Fotiou, … Alexandros Rodolakis
Pages 7654-7658

Immunization costs, from evidence to policy: Findings from a nationally representative costing study and policy translation effort in Tanzania

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Open access
Immunization costs, from evidence to policy: Findings from a nationally representative costing study and policy translation effort in Tanzania
Kelsey Vaughan, Emma Clarke-Deelder, Kassimu Tani, Dafrossa Lyimo, … Annette Ozaltin
Pages 7659-7667

Influenza Vaccination Hesitancy among Healthcare Workers in South Al Batinah Governorate in Oman: A Cross-Sectional Study

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 7 Nov 2020)

 

Open Access Article
Influenza Vaccination Hesitancy among Healthcare Workers in South Al Batinah Governorate in Oman: A Cross-Sectional Study
by Salah T. Al Awaidy, Zayid K. Al Mayahi, Malak Kaddoura, Ozayr Mahomed, Nathalie Lahoud, Abdinasir Abubakar and Hassan Zaraket
Vaccines 2020, 8(4), 661; https://doi.org/10.3390/vaccines8040661 – 06 Nov 2020
Abstract
Background: Seasonal influenza infections are a major cause of morbidity and mortality worldwide. Healthcare workers (HCWs) are an important target group for vaccination against influenza due to their increased risk of infection and their potential to transmit the infection to their patients, families […]

Vaccine Hesitancy in China: A Qualitative Study of Stakeholders’ Perspectives

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 7 Nov 2020)

 

Open Access Communication
Vaccine Hesitancy in China: A Qualitative Study of Stakeholders’ Perspectives
by Ronghui Yang, Bart Penders and Klasien Horstman
Vaccines 2020, 8(4), 650; https://doi.org/10.3390/vaccines8040650 – 03 Nov 2020
Viewed by 213
Abstract
A series of vaccine incidents have stimulated vaccine hesitance in China over the last decade. Many scholars have studied the institutional management of these incidents, but a qualitative study of stakeholders’ perspectives on vaccine hesitancy in China is missing. To address this lacuna, […]

Media/Policy Watch

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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 7 Nov 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

Financial Times
https://www.ft.com/
Accessed 7 Nov 2020
US presidential election 2020
Biden plans to name Covid task force on Monday
November 7, 2020
Top of Form
Bottom of Form

Coronavirus treatment
Covid-19 vaccine market worth $10bn a year, analysts say
…The future Covid-19 vaccine market could be worth more than $10bn a year, generating bumper revenues for pharmaceutical companies that have funded large parts of their research with government money…
November 5, 2020

 

Forbes
http://www.forbes.com/
Accessed 7 Nov 2020
Nov 6, 2020
A More Transparent And Trusted Covid Vaccine
A new article highlights the need to increase transparency around Covid-19 vaccines.
By William A. Haseltine Contributor

Nov 6, 2020
More Than 200 People Catch Mink-Related Covid-19 In Denmark Since June, Prompting World Health Organization To Investigate
Denmark ordered the culling of 17 million mink, its entire herd, after a dangerous new Covid-19 strain spread to humans.
By Robert Hart Forbes Staff

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 7 Nov 2020
Snapshot November 5, 2020
China Is Winning the Vaccine Race
How Beijing positioned itself as the savior of the developing world.
Eyck Freymann and Justin Stebbing

 

Foreign Policy
http://foreignpolicy.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

The Guardian
http://www.guardiannews.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 7 Nov 2020
World
In Hunt for Virus Source, W.H.O. Let China Take Charge
As it praised Beijing, the World Health Organization concealed concessions to China and may have sacrificed the best chance to unravel the virus’s origins.
Nov. 2

 

Washington Post
https://www.washingtonpost.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

Think Tanks et al

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Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 7 Nov 2020
[No new relevant content]
 
 
Center for Global Development [to 7 Nov 2020]
http://www.cgdev.org/page/press-center
Report
November 2, 2020
Bridging the Gap Between Need and Innovation: The Case of Vaccines
To attain and sustain universal health coverage, we must harness the power of healthcare innovation. But how can we do so when in many settings, these innovations do not align with local priorities?
Rachel Archer, Yot Teerawattananon and Francis Ruiz
 
 
Chatham House [to 7 Nov 2020]
https://www.chathamhouse.org/
Event
Members Event The Virus, the Vaccine and Violence
23 November 2020 — 4:00PM TO 5:15PM
This webinar assesses the potential for conflict-sensitive approaches to COVID-19 with a focus on vaccines.

 
 

CSIS
https://www.csis.org/
Accessed 7 Nov 2020
Podcast Episode
Coronavirus Crisis Update: Helene Gayle – How to Allocate a Covid-19 Vaccine Equitably?
November 3, 2020 | By J. Stephen Morrison, H. Andrew Schwartz

 
 
Council on Foreign Relations
http://www.cfr.org/
Accessed 7 Nov 2020
[No new relevant content]

 
 
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 7 Nov 2020
November 2, 2020 News Release
Wide Variations in Flu Vaccination Rates Across States Highlight Challenges as State and Local Authorities Plan to Distribute a COVID-19 Vaccine
When a COVID-19 vaccine becomes available, all or most people living in the country will need to get vaccinated in order to maximize its benefits and provide adequate immunity nationwide. That could present a daunting challenge for state and local health officials, as a new KFF analysis shows vaccination rates…

Vaccines and Global Health: The Week in Review :: 31 October 2020

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Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here: 

vaccines-and-global-health_the-week-in-review_31-oct-2020-1Download

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

.
David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Funding for COVID-19 Vaccines, Treatments Fastest Way to Save Lives, Economy, Secretary-General Tells World Health Summit, Urging Global Solidarity

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Milestones :: Perspectives :: Research

 

Funding for COVID-19 Vaccines, Treatments Fastest Way to Save Lives, Economy, Secretary-General Tells World Health Summit, Urging Global Solidarity
25 October 2020 SG/SM/20364
Following is UN SecretaryGeneral António Guterres’ message to the virtual World Health Summit, in New York today:
The COVID-19 pandemic is the greatest crisis of our age.  Just seven months since it was declared, over 1 million people have died, and tens of millions have been infected.  Cases are still rising, and new spikes and waves are occurring in places that had suppressed the virus for many months.

 

The indirect impact of the pandemic is wreaking havoc on societies and economies.  Travel restrictions and lockdowns have resulted in the loss of 500 million jobs so far and are costing the global economy some $375 billion every month.

Reports of gender-based violence are skyrocketing.  Mental illness is a crisis within a crisis.  Deaths from other health conditions are likely to increase, as resources are redirected towards COVID-19.  Some 24 million children could drop out of school, with lifelong impact.  COVID-19 is driving us even farther off course from achieving the vision and promise of the 2030 Agenda for Sustainable Development.

The first hard lesson of this crisis is that we were not prepared.  Global health and emergency response systems have been tested and found wanting.  Access to health is a human right denied to billions of people around the world.

Universal health coverage is the path to high-quality, equitable, affordable health care.  Strong public health systems and emergency preparedness are essential steps to greater resilience.  All countries have signed up to universal health coverage by 2030.  But, we cannot wait 10 years.  We need health systems that work, before we face an outbreak of something more contagious than COVID-19, more deadly or both.

The second lesson is that we are not powerless.  If we follow the science, and demonstrate unity and solidarity, we can overcome the pandemic.  Public health measures, including masks, physical distancing and handwashing, are proven means of keeping the virus at bay.

We need to protect the vulnerable – older people and those with pre-existing conditions.  We must stop holding and attending events that amplify the spread of the virus; and we must work with communities on sharing information and building trust.

Numerous Governments have demonstrated that taking targeted, local measures immediately outbreaks occur can stamp them out.  At the same time, we must persevere with comprehensive public health measures that the World Health Organization (WHO) identified on day one:  find, isolate, test and care for cases, and trace and quarantine their contacts.

Third, we need global solidarity every step of the way.  Developed countries must support health systems in countries that are short of resources.  And we must join together as Governments, the private sector, civil society and all partners, to make sure vaccines, tests and treatments are available to everyone, everywhere.  A vaccine must be a global public good.

Fully funding the ACT-Accelerator is the fastest way to end the pandemic.  Vaccines, tests and therapies are more than life savers.  They are economy savers and society savers.

There is no choice between saving people’s lives and saving jobs.  Protecting people from the virus is the best way to keep schools open and businesses running.  It will prevent the virus from spreading even more widely and returning in wave after wave.

But, as I have said before, there is no panacea during a pandemic.  Relief will come not through one single step, but through smartly combining cutting-edge research with basic public health.

The fourth lesson is that misinformation and disinformation are deadly allies of the virus.  They are contributing to deaths and infections, and to social tensions that have led to violence.  Unless we counter rumours, conspiracy theories and lies, they will negate our other efforts.

The United Nations “Verified” campaign aims to ensure people have access to accurate advice that protects and promotes health.  I welcome efforts by social media platforms and others to prevent the spread of false stories and advice, and promote scientific, fact-based analysis — although more needs to be done.

The World Health Summit and the M8 Alliance are important platforms to champion and work together for global health.  This gathering, bringing together science, politics, business and civil society, is the place to build new partnerships, share best practices and take decisions that could save lives.  Let us use this opportunity to confront the COVID-19 crisis together, with the urgency and integrity it requires.  Thank you.

IFFIm Prices US$500 Million 3-year Benchmark Vaccine Bonds

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Milestones :: Perspectives :: Research

 

IFFIm Prices US$500 Million 3-year Benchmark Vaccine Bonds
London, 29 October 2020 – The International Finance Facility for Immunisation Company (IFFIm) today priced US$500 million, 3-year fixed rate benchmark Vaccine Bonds that will provide Gavi, the Vaccine Alliance, flexible funding for its core immunisation programmes and efforts to develop and distribute eventual COVID-19 vaccines to countries around the world, particularly the poorest.

The transaction will mature on 6 November 2023, has a re-offer price of 99.821%, and carries a semi-annual coupon of 0.375%. This is IFFIm’s first US$ benchmark bond since its US$300 million 3-year floating rate bond in November 2017. Citi, Crédit Agricole CIB, and TD Securities are lead managers of the transaction.

“As the world confronts a devastating pandemic, this latest Vaccine Bond issuance is giving Gavi the financing it needs to act quickly, boldly and flexibly,” said IFFIm Board Chair Cyrus Ardalan. “These bonds enable private sector investors to directly contribute to a critical effort to address one of the biggest global challenges we face.”

“IFFIm’s Vaccine Bonds have long been an indispensable tool that allows Gavi to do what is necessary to ensure the availability of vaccines to the world’s poorest children,” said Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance. “This latest issuance will give Gavi the financial headroom to continue that core work, which has been complicated by the COVID-19 pandemic, as well as to play an essential role in the global collaboration to develop and equitably distribute eventual COVID-19 vaccines around the world.”

“We are pleased to see a robust response from investors for IFFIm and Gavi to support vaccine development and distribution in response to COVID-19,” said Jingdong Hua, Vice President and Treasurer of the World Bank, IFFIm’s Treasury Manager. “Investors are making a critical contribution to vaccine availability in the poorest countries, while benefitting from a uniquely impactful investment opportunity and the strong credit quality of the issuer.”

The diversified and high-quality orderbook reflects the appeal of the IFFIm mission with global investors. Geographic placement was 52% for Europe, Middle East and Africa and 40% for the Americas with the remaining 8% placed with Asian investors. Central banks and official institutions took 60%, asset managers, pension funds and insurance funds made up 26% and banks, bank treasuries and corporates rounded out the book with 14%…

COVAX welcomes appointment of civil society representatives

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Milestones :: Perspectives :: Research

 

COVAX welcomes appointment of civil society representatives
Geneva, 30 October 2020 – As part of the global response to the COVID-19 pandemic, COVAX – the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) – welcomes the appointment of civil society organisation (CSO) representatives to key COVAX working groups. The involvement of civil society has been crucial in public health campaigns in recent years – in promoting access to health products, engaging with the public, and expanding the reach of public health organisations in rolling out programmes around the world.

The representatives were selected by a civil society selection committee made up of members from 10 civil society organisations from 7 countries and 4 continents. The ten nominees were selected from a pool of 159 candidates based on a range of criteria: technical expertise, CSO experience and connectedness, knowledge of immunization and engagement of CSOs in the immunization space, and the detailed technical criteria outlined in the call for applications for each workstream. Gender and geographical diversity were also taken into consideration. In addition, all candidates were thoroughly assessed by the COVAX workstream leads and leadership.

The selected representatives will be involved in a number of key groups working contributing to the only global solution for equitable access to COVID-19 vaccines for the most vulnerable groups around the world. The ten civil society and community representatives will provide valuable technical expertise and use their experiences to play an important role in the success of COVAX.

COVID-19 Vaccines: World Bank Country Financing/Oversight

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Milestones :: Perspectives :: Research

 

COVID-19 Vaccines: World Bank Country Financing/Oversight

 

Editor’s Note:
In our edition of 17 October 2020, we reported on a World Bank Group [WBG] announcement of a USD$12 billion “envelope for developing countries to finance the purchase and distribution of COVID-19 vaccines, tests, and treatments for their citizens.”

In a supporting document – WBG VACCINE ANNOUNCEMENT– KEY FACTS – the World Band noted that it “will help client countries develop appropriate criteria for making the selected vaccine available to all their citizens.” This document references a “consensus to first target health workers, other essential workers, and priority groups such as the elderly, people with co-morbidities, and others at high risk from COVID-19” and added that “the Bank will ensure that the allocation mechanisms within countries are fair and equitable.”

Given the number of active COVID-19 vaccine allocation frameworks and guidance documents, the role of multilateral collaborations such as COVAX, and varying regulatory and recommending bodies, we found this stated role ensuring that allocation is fair and equitable to be quite interesting.

 

The Center for Vaccine Ethics and Policy [CVEP] raised five questions about this oversight role with the World Bank. The questions and the WBG answers are presented below:

[1] [CVEP] Will WBG be using any specific “active” normative guidance [WHO Values Framework; COVAX allocation framework, NSAEM Framework, country-level allocation strategies, etc.] to define/guide what ” fair and equitable” will mean in a country’s allocation mechanisms? If not, will WBG create its own guidance?
[WBG] Country allocation strategies will be appraised for their alignment with the WHO Fair Allocation Framework before Bank financing for vaccine purchase will be committed.
 
[2] [CVEP] Would the vaccine allocation “formula/strategy” be specified in the financing terms of the World Bank “grants, credits, and loans” that might be employed in any given country situation?
[WBG] There is no predetermined allocation of financing to countries.   Countries will decide the amounts within their IBRD/IDA allocations, and will access the financing on their applicable country specific IDA or IBRD financing terms.
[International Bank for Reconstruction and Development/International Development Association]

[3] [CVEP] What WBG governance/review mechanism will be employed to assess/confirm that the allocation approach proposed by the country is, indeed, fair and equitable? What monitoring mechanism will ensure that the allocation plan is executed adequately in that regard?
[WBG] The Bank will appraise the client’s overall vaccination strategy, including its specific allocation approach, before committing financing for vaccine purchases. The appraisal of the allocation framework will consider alignment with the WHO Fair Allocation Framework as well compliance with Bank risk management frameworks and policies as applicable, such as the Environmental and Social Framework. Bank teams will supervise implementation of the project and provide implementation support to the client as in any Bank-financed operation, including to monitor compliance with the agreed allocation plan.

[4] [CVEP] Does WBG intend to take a position on COVID-19 vaccine program elements beyond “fairness and equitable access”? Such elements would include requirements for a consent process [at least where a vaccine is still investigational [EUA without Phase III data/not yet licensed by any major reg authority]], ad mandates [where a government may require immunization with a vaccine which still may be EUA, for example]?
[WBG] Given the unprecedented pace of vaccine development, the Bank will accept as the threshold for eligibility of IBRD/IDA resources for vaccine purchase either (i) approval by Stringent Regulatory Authorities (SRAs) in three regions or (ii) WHO prequalification and approval by 1 SRA*.

[5] [CVEP] Does the WBG program anticipate that multiple COVID-19 vaccines — with varying profiles [EUA vs major reg approval; safety; efficacy; durability of protection; etc.] — will be in play in the same country at the same time, with varying constellations over time? This complexity suggests a very dynamic allocation scenario that will change, perhaps continuously, over 2+ years at least…
[WBG] We are working in complexity and a high degree of uncertainty and have developed the programmatic framework with the best available information.  As the vaccine landscape continues to develop we take a dynamic view in supporting countries to ensure their programs are  adapted to help maximize impact for their populations.

*List of Stringent Regulatory Authorities (SRAs) [WHO]
…The interim definition of an SRA includes the same elements as the current definition, each qualified by the wording “as before 23 October 2015”, as follows:
“A regulatory authority which is:
[a] a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or
[b] an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or
[c] a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).”
Currently there are 35 country NRAs [National Regulatory Authorities]which are designated as SRAs: Australia Austria Belgium Bulgaria Canada Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Japan Latvia Liechtenstein
Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia
Slovenia Spain Sweden Switzerland United Kingdom United States of America

COVID 19 Vaccine Development/Regulatory/Distribution Programs Update

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Milestones :: Perspectives :: Research

 

COVID 19 Vaccine Development/Regulatory/Distribution Programs Update

Dr. Reddy’s partners with Department of Biotechnology – Biotechnology Industry Research Assistance Council for Sputnik V vaccine clinical trials in India
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announced its partnership with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), Government of India, for advisory support on clinical trials of Sputnik V vaccine in India.
“We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.”
The partnership will allow Dr. Reddy’s to identify and use some of BIRAC’s clinical trial centres for the vaccine, which are funded under the National Biopharma Mission (NBM), implemented by Project Management Unit-NBM at BIRAC. Further, the Company will have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine.
Satish Reddy, Chairman, Dr. Reddy’s Laboratories said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.”…

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Moderna Partners with Takeda and the Government of Japan to Supply 50 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) to Japan
MHLW and Takeda will import and distribute mRNA-1273 in Japan starting in the first half of 2021
October 28, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., Ltd (NYSE: TAK) have agreed to purchase and distribute 50 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the Japanese public as soon as possible, subject to necessary regulatory approvals. Moderna is responsible for the manufacture and supply of Moderna’s vaccine candidate, and Takeda, with the support of the MHLW, the Japan Agency for Medical Research and Development (AMED) and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan to ensure timely access starting during the first half of 2021…

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UK Medicines and Healthcare products Regulatory Agency Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
Moderna completed enrollment of its Phase 3 COVE study of mRNA-1273 on October 22
Rolling review based on preclinical, CMC, and clinical data available to date
October 27, 2020

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has started the rolling review process of mRNA-1273, the Company’s vaccine candidate against COVID-19. This announcement follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine…

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Moderna Announces Supply Agreement with the Ministry of Public Health to Supply Qatar with mRNA Vaccine Against COVID-19 (mRNA-1273)
Supply agreement reflects Moderna’s commitment to make its vaccine available in Qatar
October 26, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support the Ministry’s ongoing efforts to secure early access to a safe and effective COVID-19 vaccine for the people of Qatar…

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

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EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 8 October 2020, 20:00 GMT-4
Confirmed cases :: 45 428 731 [week ago: 42 055 863] [two weeks ago: 39 023 292]
Confirmed deaths :: 1 185 721 [week ago: 1 141 567] [two weeks ago: 1 099 586]
Countries, areas or territories with cases :: 219

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Statement on the fifth meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic
30 October 2020 Statement
The fifth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) (2005) regarding the coronavirus disease (COVID-19) took place on Thursday, 29 October 2020 from 12:30 to 16:05 Geneva time (CEST).

Proceedings of the meeting
Members and advisors of the Emergency Committee were convened by videoconference…

The Secretariat turned the meeting over to the Chair, Professor Didier Houssin. Professor Houssin also welcomed the Committee and reviewed the objectives and agenda of the meeting.

The WHO Assistant Directors-General for Emergency Response and for Emergency Preparedness and International Health Regulations provided an overview of the current context and an update on the implementation of the 1 August 2020 Temporary Recommendation. WHO continues to assess the global risk level of the COVID-19 pandemic as very high.

The Committee expressed strong appreciation for WHO’s leadership and activities throughout the global response. In particular, the Committee appreciated WHO’s critical role in developing evidence-based guidance and recommendations; providing countries with technical assistance and operational support; communicating clear information and addressing misinformation; and convening the Solidarity Trials and the Access to COVID-19 Tools (ACT) Accelerator. The Committee commended WHO’s sustained efforts to strengthen national, regional, and global responses to the COVID-19 pandemic.

After ensuing discussion, the Committee unanimously agreed that the pandemic still constitutes an extraordinary event, a public health risk to other States through international spread, and continues to require a coordinated international response. As such, the Committee considered the COVID-19 pandemic to remain a public health emergency of international concern and offered advice to the Director-General.

The Director-General determined that the COVID-19 pandemic continues to constitute a PHEIC. He accepted the advice of the Committee to WHO and issued the Committee’s advice to States Parties as Temporary Recommendations under the IHR (2005).

The Emergency Committee will be reconvened within three months, at the discretion of the Director-General. The Director-General thanked the Committee for its work.

 

Advice to the WHO Secretariat
Leadership and Coordination
1. Continue to coordinate global and regional multilateral organizations, partners, and networks and share best practices for responding to the pandemic.
2. Provide States Parties with a mechanism including templates and processes to report on national progress in implementing the temporary recommendations; collect, analyze, and provide regular updates to the Committee on this progress.

Evidence-Based Response Strategies
3. Continue to provide evidence-based guidance for COVID-19 readiness and response. This guidance should include sustainable long-term response strategies, mitigation approaches for different levels of transmission, refined indicators for risk management and pandemic response, a meta-analysis of the effectiveness of public health and social measures for COVID-19 response, and lessons learned including from intra-action reviews.

Research 
4. Continue to convene multi-disciplinary experts to agree on consistent language for and to further explain: all potential modes of transmission and virulence of SARS-CoV-2; severity risk factors and epidemiology of COVID-19; and the striking diversity of the pandemic dynamics globally.
5. Continue intersectoral collaborations to understand the origin of SARS-CoV-2, the role/impact of animals, and provide regular updates on international research findings.
6. Continue to work with partners to refine mathematical models that can inform policy decisions on how best to mitigate the effects of the pandemic.

Surveillance and Contact Tracing
7. Continue to work with partners and networks to provide guidance, tools, and trainings to support countries in strengthening their robust public health surveillance, comprehensive contact tracing, and cluster investigation.
8. Encourage and support countries to understand and report on their epidemiological situation and relevant indicators including through leveraging existing influenza sentinel surveillance systems for COVID-19.

Risk communications and community engagement
9. Continue to work with partners to counter the ongoing infodemic and provide guidance on community mobilization to support effective public health and social measures.

Diagnostics, therapeutics, and vaccines
10. Continue to support development of and equitable access to diagnostics, safe and effective therapeutics and vaccines, through the Access to COVID-19 Tools (ACT) Accelerator; continue to work with all ACT Accelerator partners to provide countries with additional clarity on the processes to enable equitable and timely access to diagnostics, therapeutics, and vaccines, including in humanitarian settings.
11. Accelerate support to enhance countries’ readiness for COVID-19 vaccine introduction by providing guidance, tools, and technical assistance for critical areas such as vaccination strategies, vaccine acceptance and demand, training, supply and logistics with a focus on cold chain, and monitoring uptake and vaccine safety.

Health Measures in Relation to International Traffic
12. Continue to work with partners to update and review evidence-based guidance for international travel consistent with IHR (2005) provisions. This guidance should focus on effective, risk-based, and coherent approaches (including targeted use of diagnostics and quarantine) that consider transmission levels, response capacities in origin and destination countries, and relevant travel-specific considerations.

Essential Health Services
13. Work with partners to support countries in strengthening their essential health services, with a particular focus on mental health, public health prevention and control systems, and other societal impacts, as well as preparing for and responding to concurrent outbreaks, such as seasonal influenza. Special attention should continue to be provided to vulnerable settings.

Temporary Recommendations to State Parties
Leadership and coordination
1. Continue to share with WHO best practices, including from intra-action reviews, and apply lessons learned for mitigating resurgence of COVID-19; invest in implementing National Action Plans for sustainable preparedness and response capacities in compliance with the IHR requirements.
2. Report to WHO on progress in implementing the Temporary Recommendations, particularly major achievements, milestones, and obstacles. This information will empower countries, WHO, partners, and the Committee to continue to make informed decisions as the pandemic evolves.

Evidence-Based Response Strategies
3. Avoid politicization or complacency with regards to the pandemic response which negatively impact local, national, regional, and global response efforts. National strategies and localized readiness and response activities should be driven by science, data, and experience and should engage and enable all sectors using a whole-of-society approach.
4. Implement a dynamic risk management approach using appropriate indicators to inform time-limited, evidence-based public health and social measures.

Research 
5. Conduct research and share information on transmission, including role of aerosols; presence and potential impact of SARS-CoV-2 in animal populations; and potential sources of contamination (such as frozen products) to mitigate potential risks through preventative measures and international cooperation.

Surveillance and Contact Tracing
6. Sustain efforts to strengthen public health surveillance systems and investments in a trained workforce for active case finding, comprehensive contact tracing, and cluster investigations.
7. Continue timely and consistent reporting to WHO, including through platforms such as GISRS, on all recommended indicators for COVID-19 epidemiology and severity, response measures, and concurrent outbreaks, to enhance global understanding of the pandemic’s evolution.

Risk Communications and Community Engagement
8. Engage and empower individuals and communities to strengthen confidence in the COVID-19 response and promote sustained adherence to public health and social measures underpinned by the principles of solidarity and human rights; monitor and address rumours and misinformation.

Diagnostics, Therapeutics, and Vaccines
9. Establish a national multi-disciplinary taskforce, assess progress using the COVID-19 Vaccine Introduction Readiness Assessment Tool (VIRAT), and prepare the National Deployment and Vaccination Plan, which can serve as the holistic operational plan for COVID-19 vaccine introduction. A strong emphasis should be placed on communication with communities to prepare for COVID-19 vaccination.

Health Measures in Relation to International Traffic
10. Regularly re-consider measures applied to international travel in compliance with Article 43 of the IHR (2005) and continue to provide information and rationales to WHO on measures that significantly interfere with international traffic. Ensure that measures affecting international traffic (including targeted use of diagnostics and quarantine) are risk-based, evidence-based, coherent, proportionate and time limited.
11. Continue to strengthen capacity at points of entry to manage potential risks of cross-border transmission and to facilitate international contact tracing.

Essential Health Services
12. Maintain essential health services with sufficient funding, supplies, and human resources; strengthen health systems to cope with mental health impacts of the pandemic, concurrent disease outbreaks, and other emergencies.

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WHO Director-General’s opening remarks at the media briefing on COVID-19 – 26 October 2020
26 October 2020
:: Last week saw the highest number of COVID-19 cases reported so far. Many countries in the northern hemisphere are seeing a concerning rise in cases and hospitalisations. And intensive care units are filling up to capacity in some places, particularly in Europe and North America.
We must do all we can to protect health workers, and the best way to do that is for all of us to take every precaution we can to reduce the risk of transmission, for ourselves and others. No one wants more so-called lockdowns. But if we want to avoid them, we all have to play our part.

:: The fight back against this pandemic is everyone’s business. We cannot have the economic recovery we want and live our lives the way we did before the pandemic. We can keep our kids in school, we can keep businesses open, we can preserve lives and livelihoods. We can do it! But we must all make trade-offs, compromises and sacrifices.

:: When leaders act quickly and deliberately, the virus can be suppressed. But, where there has been political division at the national level; where there has been blatant disrespect for science and health professionals, confusion has spread and cases and deaths have mounted. This is why I have said repeatedly: stop the politicisation of COVID-19.

:: Last week WHO conducted its first global e-learning course on health and migration, addressing a critical and often neglected topic of global health. It’s vital that all countries include refugees and migrants in their national policies as part of their commitment to universal health coverage.

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Weekly epidemiological update – 27 October 2020
Global epidemiological situation
In the past week the highest number of new COVID-19 cases have been reported globally, amounting to over 2 million new cases in the past 7 days (Figure 1), the shortest intervals for this exponential increase since the start of the pandemic, while the number of new deaths is comparable to previous weeks. As of 25 October, over 42 million cases and 1.1 million deaths have been reported globally, with over 2.8 million new cases and nearly 40 000 new deaths reported over the past week.

For the second consecutive week the European Region accounts for the greatest proportion of reported new cases, with over 1.3 million new cases reported this past week – a 33% increase in cases compared to the previous week – contributing nearly half of all new cases reported worldwide this week (46%) (Table 1). Similarly, the number of deaths continues to increase in the region with a 35% increase from last week and accounting for nearly one third of all new deaths globally. Although not as substantial, increases in reported new cases were also observed in the Region of the Americas, Eastern-Mediterranean and African regions. Declines in cases and deaths continued to be reported in the South-East Asia region while the Western Pacific region has shown a slight decline in new cases and deaths in the past 7 days.

Despite regional variations the countries reporting the highest number of cases in the past week remain the same as the previous 3 weeks: India, the United States of America, France, Brazil and the United Kingdom.

Key weekly updates
:: “We are at a critical juncture in this pandemic…We urge leaders to take immediate action, to prevent further unnecessary deaths, essential health services from collapsing and schools shutting again.” stressed the WHO Director-General Dr Tedros as part of the regular press briefing on COVID-19 on 23 October. Dr Tedros expanded that as the northern hemisphere enters winter, cases are accelerating, particularly in Europe and North America. The next few months are going to be very tough and some countries are on a dangerous track. WHO is calling on governments to carry out five key actions:
1. Assess the current outbreak situation in your country based on the latest data
2. For those countries where cases, hospitalizations and ICU rates are rising, make the necessary adjustments and course correct as quickly as possible.
3. Be clear and honest with the public about the status of the pandemic in your country and what is needed from every citizen to get through this pandemic together.
4. Put systems in place to make it easier for citizens to comply with the measures that are advised.
5. Improve contact tracing systems and focus on isolating all cases and quarantining contacts, to avoid mandatory stay at home orders for everyone.

:: WHO has updated its draft landscape of COVID-19 candidate vaccines, which lists 44 candidate vaccines in clinical evaluation. At a press briefing last week, Dr Soumya Swaminathan, WHO Chief Scientist, said “We’re looking at the beginning of next year really to start seeing data for many of the trials though we may see one or two before the end of the year but the majority will start reporting in early 2021.Manycompanies are already manufacturing several million doses so as soon as the results are out, if it’s promising, companies will be able to start providing those doses to the COVAX facility which will then distribute based on the fair allocation framework that we have developed…”

:: WHO has published an assessment tool for laboratories implementing SARS-CoV-2 testing to assess the capacity of laboratories that have implemented or intend to implement testing for SARS-CoV-2, the virus that causes coronavirus disease (COVID-19)…

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POLIO Public Health Emergency of International Concern (PHEIC)

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 28 October 2020
:: Acknowledging the critical role of leadership in gender mainstreaming, the GPEI launched a Gender Champion for Polio Eradication  Our Champions commit to supporting the GPEI Gender Equality Strategy, highlighting the role of gender in achieving eradication and advocating for its full implementation.
:: In our latest edition of Coffee with Polio Experts, we get to hear from Dr Zubair Wadood on the impact of COVID-19 on the global polio eradication effort, and how the polio infrastructure is supporting COVID response.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: two WPV1 positive environmental samples and one cVDPV2 positive environmental sample
:: Pakistan: 18 WPV1 positive environmental samples and 16 cVDPV2 cases
:: Cameroon: two cVDPV2 cases
:: Chad: eight cVDPV2 cases
:: Côte d’Ivoire: three cVDPV2 cases
:: Democratic Republic of the Congo (DR Congo): four cVDPV2 cases
:: Mali: 15 cVDPV2 cases
:: Nigeria: one cVDPV2 positive environmental sample
:: South Sudan: 9 cVDPV2 cases

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WHO Grade 3 Emergencies [to 31 Oct 2020]

Syrian Arab Republic
:: WHO Regional Director for the Eastern Mediterranean hands-over medical supplies during his visit to Syria
24 October 2020, Damascus, Syria – A chartered aircraft has landed in Damascus International Airport from the WHO’s logistics hub in Dubai, carrying WHO supplies to support the health response in Syria. The 8.8-ton shipment includes medical kits and medicines for almost 2000 beneficiaries and enough personal protective equipment to protect more than 4000 health care workers.

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
Yemen – No new digest announcements identified

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WHO Grade 2 Emergencies [to 31 Oct 2020]
Burkina Faso
:: Préparation pour une réponse efficace aux situations sanitaires exceptionnelles : Le…
30 octobre 2020

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
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – 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

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WHO Grade 1 Emergencies [to 31 Oct 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
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 20 As of 29 October 2020

Yemen – No new digest announcements identified

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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.
COVID-19
::    Coronavirus disease 2019 (COVID-19) Situation Report 50: occupied Palestinian territory, issued 29 October 2020, information for period: 5 March – 29 October 2020

East Africa Locust Infestation
:: Desert Locust situation update – 26 October 2020
Another generation of breeding starts in the Horn of Africa
As expected, the situation remains very critical as more swarms form and a new generation of breeding has now started in Ethiopia and Somalia, which will cause new swarms to form by mid-December that are likely to move southwards and threaten Kenya. Although countries are better prepared compared to a year ago, survey and control operations need to continue to detect and reduce as many infestations as possible. In addition, locusts are increasing along both sides of the southern Red Sea.

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WHO & Regional Offices [to 31 Oct 2020]

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WHO & Regional Offices [to 31 Oct 2020]

30 October 2020 News release
As COVID-19 spread accelerates, IHR Emergency Committee urges focus on measures that work

30 October 2020 Statement
Statement on the fifth meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic

30 October 2020 Departmental news
Start of 1st WHO infodemic management training

29 October 2020 Departmental news
Young people and digital health interventions: working together to design better

29 October 2020 Country mission
Launch of the NCD Investment Case for the Russian Federation: Prevention and control of non-communicable diseases as a catalyst of economic growth and social well-being in Russia

27 October 2020 Departmental news
Beijing+25: where are we now, and where do we go next?

 

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Weekly Epidemiological Record, 30 October 2020, vol. 95, 44 (pp. 525–544)
:: Antigenic and genetic characteristics of zoonotic influenza A viruses and development of candidate vaccine viruses for pandemic preparedness
:: WHO seasonal influenza vaccination recommendations during the COVID-19 pandemic

 

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified

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
:: The challenge of winter during COVID-19 for poor families 30-10-2020
:: Cities against COVID-19: citizens seek a “better normal” of urban life 30-10-2020
:: COVID-19: Taking stock and moving forward together 29-10-2020
:: Roadmap sets direction of Pan-European Commission on Health and Sustainable Development 29-10-2020
:: WHO delivers emergency medical supplies in response to conflict in and around Nagorno-Karabakh 27-10-2020

WHO Eastern Mediterranean Region EMRO
:: WHO and partners affirm support to end polio in Pakistan 25 October 2020
:: Regional Director arrives in Syria, hands-over medical supplies during his visit to Syria
24 October 2020
:: Health workers celebrated on World Polio Day in Somalia 24 October 2020

WHO Western Pacific Region
:: Investing in mental health during the COVID-19 pandemic 29 October 2020

CDC Issues Framework for Resuming Safe and Responsible Cruise Ship Passenger Operations

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CDC/ACIP [to 31 Oct 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC Issues Framework for Resuming Safe and Responsible Cruise Ship Passenger Operations
Friday, October 30, 2020
Today the Centers for Disease Control and Prevention (CDC) issued a Framework for Conditional Sailing Order that introduces a phased approach for the safe and responsible resumption of passenger cruises.  The Order establishes a framework of actionable items for the cruise line industry to follow so they can resume passenger operations with an emphasis on preventing the further spread of COVID-19 on cruise ships and from cruise ships into communities, and to protect public health and safety. The Order applies to passenger operations on cruise ships with the capacity to carry at least 250 passengers in waters subject to U.S. jurisdiction…

CDC Opens New South America Regional Office in Brazil
Friday, October 30, 2020

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: Wear Face Masks on Public Transportation Conveyances and at Transportation Hubs Thursday, October 29, 2020
:: “Excess Death” Data Point to Pandemic’s True Toll Tuesday, October 27, 2020

MMWR News Synopsis Friday, October 30, 2020
:: COVID-19 in a Correctional Facility Employee Following Multiple Brief Exposures to Persons with COVID-19 — Vermont, July–August 2020 (Early release October 21, 2020)
:: Adoption of Strategies to Mitigate Transmission of COVID-19 During a Statewide Primary Election — Delaware, September 2020 (Early release October 23, 2020)
:: COVID-19–Associated Hospitalizations Among Health Care Personnel — COVID-NET, 13 States, March 1–May 31, 2020 (Early release October 26, 2020)
:: COVID-19 Mitigation Behaviors by Age Group — United States, April–June 2020 (Early release October 27, 2020)
:: COVID-19 Outbreak Among a University’s Men’s and Women’s Soccer Teams — Chicago, Illinois, July–August 2020 (Early release October 27, 2020)
:: Trends in the Use of Telehealth During the Emergence of the COVID-19 Pandemic — United States, January–March 2020
:: COVID-19 Outbreak at an Overnight Summer School Retreat ― Wisconsin, July–August 2020
:: SARS-CoV-2 Exposure and Infection Among Health Care Personnel — Minnesota, March 6–July 11, 2020

China CDC

Posted on by

China CDC
http://www.chinacdc.cn/en/
No new digest content identified.

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Oct 31: Daily briefing on novel coronavirus cases in China
On Oct 30, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 33 new cases of confirmed infections.

Vaccine makers might need insurance
2020-10-30
Experts have welcomed a draft regulation on compulsory insurance for Chinese vaccine manufacturers, saying it will better protect the legal rights of vaccine recipients and strengthen oversight of the industry.
The draft regulation, released by the National Medical Products Administration for a month’s public consultation earlier this month, includes mandatory liability insurance for all licensed vaccine suppliers on the Chinese mainland to ensure they can provide compensation for recipients injured or killed by substandard vaccines.
It mandates the establishment of a nationwide minimum liability limit, with at least 500,000 yuan ($74,800) in compensation for a death and indemnities for injuries determined by appraisal results.
“The overall safety and quality of domestic vaccines is well guaranteed. But vaccine products, from China or overseas, always carry inevitable risks, so devising an adequate compensation mechanism in advance is necessary,” said Du Yifang, a law professor at Fudan University in Shanghai.
By enlisting insurance firms’ mediation in disputes arising from inoculations, people will be able to obtain adequate compensation more quickly and cheaply, she added.
China’s Drug Administration Law, which also applies to vaccines, already stipulates that people harmed by substandard drugs are entitled to compensation. However, Yang Yue, a professor at Shenyang Pharmaceutical University in Shenyang, Liaoning province, who specializes in administration of the sector, said vaccine makers would likely struggle to afford such payouts.
“Vaccines are administered to a large number of healthy people, so defective products will result in severe harm and cause large-scale incidents,” she said. “In addition to seeking accountability, it is equally significant to deliver assistance to vaccine recipients and protect their legal rights.
“Compulsory insurance of vaccines is thus a crucial tool to spread risks traditionally borne by vaccine makers and add an additional layer of protection for consumers.”..

Announcements

Posted on by

Announcements

 

Paul G. Allen Frontiers Group [to 31 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 31 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
October 28, 2020: HHS, DOD Collaborate on Plans to Purchase of Lilly Investigational Therapeutic to Treat COVID-19
…the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today announced an agreement with Eli Lilly and Company to purchase the first doses of the company’s COVID-19 investigational antibody therapeutic bamlanivimab, also known as LY-CoV555. These doses will be available for patient care if the U.S. Food and Drug Administration (FDA) authorizes use of the therapeutic, as outlined in agency guidance…

 

BMGF – Gates Foundation [to 31 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 31 Oct 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 31 Oct 2020]
https://carb-x.org/
News
No new digest content identified.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 31 Oct 2020]
http://cepi.net/
Latest News
COVAX welcomes appointment of civil society representatives
Those selected will provide valuable technical expertise and use their experiences in a number of key COVAX groups working to ensure equitable access to COVID-19 vaccines.
COVAX
30 Oct 2020
[See Milestones above for detail]

Italy pledges first EUR 5 million funding to CEPI to advance COVID-19 vaccine development efforts
Financial contribution is part of a larger donation to support CEPI’s work.
COVAX
28 Oct 2020

 

EDCTP [to 31 Oct 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.

 

Emory Vaccine Center [to 31 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 31 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
Extra transparency measures for COVID-19 vaccines and therapeutics
News 30/10/2020
Today the European Medicines Agency (EMA) has implemented two further extra transparency measures for COVID-19 medicines, by publishing both the clinical data in support of the authorisation of Veklury (remdesivir) and information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF).
These are the latest measures in EMA’s drive to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19…

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 October 2020
News 30/10/2020
PRAC reviews EMA guidance on risk management plan requirements for COVID-19 vaccines
EMA’s safety committee (PRAC) has reviewed the guidance developed by EMA for pharmaceutical companies on how to prepare risk management plans (RMPs) for COVID-19 vaccines.
As for any medicine, companies are required to submit an RMP for COVID-19 vaccines when they apply for a marketing authorisation. Such a plan explains how the company that markets the vaccine must monitor and report on its safety, and what measures they must put in place to manage any risks. Importantly, RMPs are continually updated throughout the lifetime of the vaccine as new information becomes available.
The guidance is for COVID-19 vaccines only and complements the already existing guidelines on the RMP format in the EU, which apply to all medicines.
The guidance will now be sent for adoption to EMA’s human medicines committee (CHMP) and will be made public once it is adopted by the CHMP…

 

European Vaccine Initiative [to 31 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 31 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
October 30, 2020 – Coronavirus (COVID-19) Update: October 30, 2020

October 30, 2020 – FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency. A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.
The goal of this work is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological and nuclear threats. To accomplish this goal, the executive order seeks to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on foreign manufacturers of these products…

October 28, 2020 – Coronavirus (COVID-19) Update: October 28, 2020

October 26, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 26, 2020

 

FDA – COVID-19 Vaccines [to 31 Oct 2020]
www.fda.gov/covid19vaccines
Upcoming Events
10/27/2020
I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.
FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks
10/27/2020

FDA Commissioner Stephen Hahn on the Radio: COVID-19 & FDA
FDA Commissioner Stephen Hahn joins a radio morning show to discuss the FDA’s role in the fight against COVID-19.
10/27/2020

 

Fondation Merieux [to 31 Oct 2020]
http://www.fondation-merieux.org/
News, Events
Project
The REDISSE project in West Africa, for the improvement of disease surveillance in ECOWAS countries continues with a second phase
October 29, 2020, Benin, Niger, Nigeria, Mali and Mauritania
The Mérieux Foundation starts the second phase of its mandate as part of the REDISSE project aiming at strengthening disease …

Publication
HINTT project team publishes results of its multicentered cohort study on tuberculosis
October 26, 2020, Lyon (France)
High white blood cell counts and low lymphocyte proportions before treatment are significantly associated with the risk of tuberculosis treatment …

 

Gavi [to 31 Oct 2020]
https://www.gavi.org/
News releases
30 October 2020
COVAX welcomes appointment of civil society representatives
[See Milestones above for detail]

28 October 2020
Gavi signs statement of intent to procure 200 million doses of Sanofi-GSK COVID-19 vaccine candidate for the COVAX Facility
Geneva, 28 October 2020 – Gavi, the Vaccine Alliance announced today that it had signed a Statement of Intent with Sanofi and GSK to provide 200 million doses of the companies’ adjuvanted recombinant protein COVID-19 vaccine to the COVAX Facility. The non-binding statement is a critical step toward making sure doses of the vaccine, if approved and licensed, will be made available to all countries and economies participating in the COVAX Facility.
“The signing of this statement of intent is an important step forward in our partnership, and I welcome Sanofi and GSK’s commitment to the COVAX goal of equitable access to COVID-19 vaccines,” said Seth Berkley, CEO of Gavi. “Gavi is seeking to secure doses of the most promising vaccine candidates – so that the 184 participants involved in the COVAX Facility can make sure their most at-risk groups, such as healthcare workers, have rapid access to doses of a safe and effective vaccine. That is the world’s best chance to end the acute stage of this pandemic, and we encourage other vaccine manufacturers to work with us towards that shared global goal.”…

27 October 2020
Myanmar introduces cervical cancer vaccine nationally, despite COVID-19 challenges
:: Around 450,000 girls aged 9-101 will receive the human papillomavirus (HPV) vaccine, which protects against the leading cause of cervical cancer
:: Myanmar currently has the second-highest incidence of cervical cancer in Southeast Asia
:: The vaccine will be rolled out with stringent COVID-19 safety measures in place, including physical distancing and catch-up immunisations for the 73 “stay-at-home townships” currently under tighter restrictions

 

GHIT Fund [to 31 Oct 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 31 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
Strategy Development Open Consultation: First Round of Input
30 October 2020
Approximately 250 individuals and groups have contributed to the first round of input into the Open Consultation on the development of the next Global Fund Strategy, a multiyear road map for our partnership’s future. Input is synthesized in a new presentation:
Strategy Development Open Consultation Synthesis of First Round of Input
download in Français | English
This synthesis covers the responses contributed as of 1 September 2020, which comes from civil society, communities, technical experts, County Coordinating Mechanisms, multilateral partners, bilateral partners, implementers and a range of other stakeholders across regions globally…

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 31 Oct 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 31 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 31 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 31 Oct 2020]
https://www.iavi.org/newsroom
PRESS RELEASES
October 27, 2020
Support from the U.S. Department of Defense Will Accelerate Progress on Vaccine Candidate for COVID-19, IAVI Says
NEW YORK — OCTOBER 27, 2020 — IAVI announced today the award of US$26.7M from the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DoD) to support IAVI’s recombinant vesicular stomatitis virus (rVSV) vectored SARS-CoV-2 vaccine candidate. DTRA’s commitment will enable critical nonclinical development on the vaccine candidate that IAVI is developing in partnership with Merck (known as MSD outside the United States and Canada).
DTRA’s award will facilitate the vaccine candidate’s clinical development path to licensure by supporting work at IAVI’s Vaccine Design and Development Laboratory (DDL) in Brooklyn, New York, to characterize immune responses in animals and demonstrate the safety and efficacy profile of rVSVΔG-SARS-CoV-2 vaccination in animals. These nonclinical data will be essential to supplement the clinical data package and to inform the most effective use of the vaccine in an ongoing pandemic. The award from DTRA comes from its Science and Technology New Initiatives, under the topic area Chemical/Biological…

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

 

 

IFFIm
http://www.iffim.org/
Announcements
IFFIm Appoints Kenneth Lay as Chair of its Board of Directors
29 Oct 2020
Lay succeeds Cyrus Ardalan, who introduced CEPI programme and led successful replenishment raising over US$ 926 million London, 29 October 2020 – The Board of Directors of the International Finance Facility for Immunisation (IFFIm) has selected Kenneth Lay, a former World Bank executive with extensive capital markets experience, as its next Chair….

IFFIm Prices US$500 Million 3-year Benchmark Vaccine Bonds
29 Oct 2020
IFFIm today priced US$ 500 million, 3-year fixed rate benchmark Vaccine Bonds that will provide Gavi, the Vaccine Alliance, flexible funding for its core immunisation programmes and efforts to develop and distribute eventual COVID-19 vaccines to countries around the world, particularly the poorest.
[See Milestones above for detail]

 

IFRC [to 31 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Azerbaijan
Azerbaijan Red Crescent Society and IFRC mourn death of volunteer
The Azerbaijan Red Crescent Society and IFRC have today condemned the death of a Red Crescent volunteer who was providing humanitarian assistance in the town of Barda, Azerbaijan.
29 October 2020

Vietnam
Major typhoon devastates areas of central Viet Nam
Kuala Lumpur/Hanoi/Geneva, 29 October 2020 – A major typhoon has devastated areas of central Vietnam, with dozens of people feared dead in tragic landslides in Quang Nam.  There are 53 people buried and feared dead in two landslides caused by the storm …
29 October 2020

Vietnam
Homes of 1 million people in ruin as major typhoon hits Viet Nam
Kuala Lumpur/Hanoi/Geneva, 28 October, 2020 – Catastrophic floods across central Vietnam have already ruined the homes of more than one million people as yet another major storm takes aim for the battered region. In excess of 310,000 homes have been da …
28 October 2020

Global
Nuclear ban: “Today is an historic day. We call on world leaders to act with courage and join the right side of history”
Geneva/New York, 24 October 2020 – The International Red Cross and Red Crescent Movement welcomes the coming into force of the UN Treaty on the Prohibition of Nuclear Weapons (TPNW). Fifty States have now ratified the Treaty, meaning that it will enter …
24 October 2020

 

IRC International Rescue Committee [to 31 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
The Trump Administration sets new all-time low number for refugee admissions at 15,000 for fiscal year 2021
October 28, 2020

Press Release
The International Rescue Committee warns against worrying rise of misinformation in crisis-affected states, imperiling fight against COVID-19
October 28, 2020

 

IVAC [to 31 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 31 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
International Vaccine Institute honored with Minister of Health and Welfare Award for achievements in biosafety
October 28, 2020, SEOUL, Korea —  The International Vaccine Institute (IVI) received an award by the Minister of Health and Welfare of the Republic of Korea for achievements in biosafety management…

 

JEE Alliance [to 31 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 31 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
MSF responds as COVID-19 arrives in Jordan’s largest refugee camp
Project Update 28 Oct 2020

Mali
Prevention is better than cure – vaccinating against measles in Timbuktu
Project Update 27 Oct 2020
… Despite the official end of the war in 2015, Timbuktu region in northern Mali remains tense, and security incidents and criminality have had a significant impact on people’s ability to access healthcare. This in turn has led to low rates of vaccination coverage, especially among children.
Since February, a number of measles cases have been reported in the area and in September Médecins Sans Frontières (MSF), alongside the Ministry of Health, decided to launch a vaccination campaign. The campaign reached over 50,000 children aged between six months and 14 years…

Greece
Negligent and dangerous COVID-19 response in Vathy camp, Samos
Project Update 26 Oct 2020
Médecins Sans Frontières (MSF) is urging the Greek authorities to immediately scale up their response to COVID-19 in Vathy camp on Samos island and transfer people at high risk to safe accommodation on Greece’s mainland or in other EU states.
Vathy camp, which hosts 4,300 people, has registered more than 100 positive cases of COVID-19, yet the authorities have so far failed to put an appropriate medical response in place. Forty asylum seekers in the camp are at risk of developing severe symptoms and at least 10 people have serious medical conditions that cannot be addressed at Samos hospital. Only one army doctor and three nurses are available at the camp…

 

National Vaccine Program Office – U.S. HHS [to 31 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 31 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH scientists discover key pathway in lysosomes that coronaviruses use to exit cells
October 28, 2020 — Targeting cells’ ‘trash compactor’ could lead to new antiviral strategy to fight COVID-19.

Scientists use clues in the human genome to discover new inflammatory syndrome
October 27, 2020 — Study used a “search the genome” approach to reveal how mutations in a gene called UBA1 are associated with inflammatory diseases.

 

PATH [to 31 Oct 2020]
https://www.path.org/media-center/
Press Release
South American countries meet to discuss rollout of new innovations for malaria elimination
October 30, 2020
Experts and policymakers met to review research and plan for the pilot introduction of a new treatment protocol for P. vivax malaria in the Americas, against the backdrop of the COVID-19 pandemic.
…“The new tools open a new horizon to eliminate malaria in Brazil, Peru, and Colombia. The feasibility study will be conducted to inform if health services can implement the new treatment scheme. If the results are as expected then we will be able to expand radical cure through these new tools,” said Alejandro Llanos-Cuentas, professor at Universidad Peruana Cayetano Heredia.
Brazil, Colombia, and Peru have embraced PAHO’s malaria elimination goals but face the challenges of advancing malaria control among ​hard-to-reach populations in the Amazon and other territories with limited coverage of services. In light of these challenges, there is a desire to explore new tools that may help to increase treatment effectiveness.
As of October 2020, tafenoquine has been approved by the US Food and Drug Administration; Australia’s Therapeutic Goods Administration; the Thai Food and Drug Administration; and the Brazilian Regulatory agency (ANVISA). The SD Biosensor STANDARD™ G6PD Test has already been approved in Brazil…

Press Release
PATH and Wondfo partner to develop a point-of-care rapid diagnostic test for G6PD deficiency
Point-of-care diagnostics for G6PD deficiency, a common hereditary condition, play a critical role in supporting the appropriate treatment of Plasmodium vivax malaria

 

Sabin Vaccine Institute [to 31 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Skoll Foundation Funds Sabin Vaccine Institute, Dalberg and JSI Research & Training Institute, Inc. to Establish COVID-19 Vaccine Equity Project
October 28, 2020
As COVID-19 vaccine developers generate clinical evidence of safety and effectiveness needed for vaccine approval, this project will help prepare for the efficient and equitable distribution of vaccines globally by ensuring that national immunization programs have the resources and health systems in place to achieve sustainable global protection from COVID-19 by 2022 and strengthen capacity for vaccination across the life span…
The COVID-19 Vaccine Equity Project will comprise three phases designed to rapidly assess vaccine distribution landscape, maximize learnings and scale a successful pilot to enable equitable global delivery of vaccines. The Skoll Foundation is funding Phases 1 and 2. In Phase 1 (“Plan”), the group will collaborate with Sabin’s Boost Community members to coordinate with ACT-A and select the four countries in which to pilot the project. In Phase 2 (“Pilot”), all three partners will work hand-in-hand with national and subnational immunization professionals to analyze the pilot countries’ needs regarding vaccine financing, procurement and distribution; leading to the creation of tailored action plans for equitable delivery of COVID-19 vaccines. As additional funders join the project, these action plans will serve as a blueprint for Phase 3, in which a successful pilot will be scaled to more than 40 countries and expanded beyond COVID-19 vaccines to strengthen life-course immunization; an approach that prioritizes timely and effective vaccination throughout the lifespan…

 

UNAIDS [to 31 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
30 October 2020
UNAIDS saddened by the death of Valentin Pokrovsky, a Russian leader on HIV, medicine and pandemic preparedness

30 October 2020
Bringing HIV and COVID-19 testing services to hard-to-reach areas in Uzbekistan

29 October 2020
Working with allies to keep comprehensive sexuality education alive

27 October 2020
COVID-19’s impact on HIV vertical transmission services reversed

26 October 2020
Key populations have suboptimal knowledge of their HIV status

 

UNICEF [to 31 Oct 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
10/29/2020
UNICEF Executive Director Henrietta Fore’s remarks at Indiana University on “Access to Learning for the World’s Children: Reimagining Education for the Post-COVID World”
Checked against delivery

Press release
10/28/2020
Children in the poorest countries have lost nearly four months of schooling since start of pandemic – UNESCO, UNICEF and World Bank report finds
New report looks at national education responses to COVID-19 including lost learning; remote learning support for students, parents and teachers; school reopening plans; health protocols; and financing

Statement
10/27/2020
UNICEF Executive Director Henrietta Fore’s remarks at the World Health Summit Panel “Accelerating the SDG-3 Global Action Plan for Health and Wellbeing”
As prepared for delivery

Press release
10/27/2020
Malnutrition surges among young children in Yemen as conditions worsen
One in five children under the age of five in parts of Yemen are estimated to be acutely malnourished and in urgent need of treatment as malnutrition cases increase across the south, UN agencies warn

 

Unitaid [to 31 Oct 2020]
https://unitaid.org/
Featured News
27 October 2020
Delivering innovation for children
A technology landscape by Unitaid and WHO
Children continue to suffer disproportionately from preventable and treatable diseases such as tuberculosis, malaria, HIV and co-morbidities in low- and middle-income countries.
One of the reasons behind this is the lack of availability of child-friendly health products, despite recent progress in tackling these diseases.
The new technology landscape released by Unitaid, in collaboration with WHO, provides an overview of existing and pipeline technologies that could better allow for more effective administration of essential medicines to children.  The report highlights potential opportunities to apply innovation to critical formulations that meet the unique needs of children.
“The landscape shows the untapped potential to innovate and tackle the challenges facing millions of children needing to take medicine and affected by the deadliest infectious diseases,” said Dr Philippe Duneton, Unitaid Executive Director. “Unitaid, WHO and its partners are exploring which innovative delivery systems could enable faster access to better-tailored treatments for children”.

26 October 2020
UnitaidExplore keeps seeking!
26 October 2020
UnitaidExplore is looking to improve child health outcomes by developing better delivery systems for children’s medicines for use in low resource settings. Delivery and formulation solutions of interest may include—but are not limited to! —micro-needles, supportive technologies such as taste-masking, enhancement of bioavailability, and others described in the Unitaid landscape Innovative Delivery Systems for Paediatrics Medicines. UnitaidExplore aims to support transformative solutions and we are open to diverse technologies; surprise us!

Press Release on the appointment of Dr Philippe Duneton as Unitaid’s new Executive Director
26 October 2020
Geneva – The Unitaid Executive Board is delighted to announce the appointment of Dr Philippe Duneton as Executive Director.
Dr Duneton played an essential role in the founding of Unitaid as well as in the numerous successes achieved by the organization since then. He has been acting Executive Director since March 2020 and has been instrumental in leading Unitaid’s response to the COVID-19 pandemic…

 

Vaccination Acceptance Research Network (VARN) [to 31 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 31 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 31 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
Vaccine Update for Providers
October 2020
:: December 2020 event Registration is now open for the Dec. 9, 2020, Current Issues in Vaccines webinar. Dr. Offit’s presentation will be an Update on SARS-CoV-2 vaccines
The event will start at noon ET, and free continuing education credits will be offered for the live and archived event (CME, CEU, and CPE).

 

Wellcome Trust [to 31 Oct 2020]
https://wellcome.ac.uk/news
Opinion | 29 October 2020
A look inside the global partnership that’s working to find and deliver Covid-19 treatments
Paul Schreier, Chief Operating Officer, Wellcome
Finding and delivering Covid-19 treatments worldwide requires global collaboration at an unprecedented scale. Paul Schreier describes how the ACT-Accelerator Therapeutics Partnership works and what it needs to achieve its mission.

 

The Wistar Institute [to 31 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
Oct. 29, 2020
Wistar Creates a New Synthetic DNA Vaccine Against Powassan Virus
Vaccine protects animals against tick-borne Powassan virus, an emerging infectious disease.

 

WFPHA: World Federation of Public Health Associations [to 31 Oct 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 31 Oct 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
26/10/20
OIE and FAO kickstart global initiative to stop spread of deadly pig disease

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 31 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 31 Oct 2020]
https://www.bio.org/press-releases
Press Releases
New Strategic Vision for Biotechnology Innovation Organization
October 27, 2020
The Biotechnology Innovation Organization (BIO) today announced a new, strategic direction that will help guide it to achieving long-term goals while maintaining responsiveness to changing political headwinds…

After at least 106 one-on-one conversations with member companies, extensive strategic planning sessions, a broad membership survey and several focus groups, BIO outlined the new direction through
:: a new mission – to drive a bio revolution through education, collaboration, and advocacy,
:: a new purpose – to cure patients, protect our climate and to nourish humanity; and
:: a new vision – a world of rapid biotech innovation that is equitably harnessed for health, sustainability and justice.

BIO plans to execute on the strategic direction though five different pillars:
[1] Be a voice of science and for science.
[2] Unite and empower biotech innovators and their ecosystem to improve lives.
[3] Remove barriers to innovation.
[4] Champion broad access to biotech breakthroughs and scientific quality.
[5] Catalyze resilient and sustainable bio-based economies.

The Board and staff of the nearly 1000-member organization plan to operationalize the five pillars beginning immediately. For more information on BIO’s new strategic direction, visit www.bio.org/strategic-vision.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 31 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
DCVMN Annual General Meeting (Virtual): Vaccines, a healthy future
3 November 2020 to 5 November 2020

 

ICBA – International Council of Biotechnology Associations [to 31 Oct 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 31 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

PhRMA [to 31 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
The latest: What they are saying: Intellectual property protections vital to incentivize ongoing COVID-19 research and development
Tom Wilbur   |     October 28, 2020

Journal Watch

Posted on by

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

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BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 31 Oct 2020)

 

Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?
In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes.
Authors: Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. van Thiel, Nancy S. Breekveldt, Christine C. Gispen and Johannes J. M. van Delden
Content type: Research article
27 October 2020

The first 10 000 COVID-19 papers in perspective: are we publishing what we should be publishing?

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The European Journal of Public Health
Volume 30, Issue 5, October 2020
https://academic.oup.com/eurpub/issue/30/5

 

Viewpoints
The first 10 000 COVID-19 papers in perspective: are we publishing what we should be publishing?
Anna Odone, Sandro Galea, David Stuckler, Carlo Signorelli, the University Vita-Salute San Raffaele COVID-19 literature monitoring working group
European Journal of Public Health, Volume 30, Issue 5, October 2020, Pages 849–850, https://doi.org/10.1093/eurpub/ckaa170

COVID-19 and human rights—why should the public health community be concerned?

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The European Journal of Public Health
Volume 30, Issue 5, October 2020
https://academic.oup.com/eurpub/issue/30/5

 

COVID-19 and human rights—why should the public health community be concerned?
David Patterson, Dineke Zeegers Paget
European Journal of Public Health, Volume 30, Issue 5, October 2020, Pages 852–853, https://doi.org/10.1093/eurpub/ckaa174

Measles outbreak in Romania: understanding factors related to suboptimal vaccination uptake

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The European Journal of Public Health
Volume 30, Issue 5, October 2020
https://academic.oup.com/eurpub/issue/30/5

 

Vaccination
Measles outbreak in Romania: understanding factors related to suboptimal vaccination uptake
Katrine Bach Habersaat, Adriana Pistol, Aurora Stanescu, Catherine Hewitt, Miljana Grbic …
European Journal of Public Health, Volume 30, Issue 5, October 2020, Pages 986–992, https://doi.org/10.1093/eurpub/ckaa079

Examining vaccination coverage in Germany: spatiotemporal clustering of MMR coverage, 2008–14

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The European Journal of Public Health
Volume 30, Issue 5, October 2020
https://academic.oup.com/eurpub/issue/30/5

 

Examining vaccination coverage in Germany: spatiotemporal clustering of MMR coverage, 2008–14
Cory N Spencer, Paul L Delamater
European Journal of Public Health, Volume 30, Issue 5, October 2020, Pages 993–995, https://doi.org/10.1093/eurpub/ckaa120

Disability inclusion in humanitarian action

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

 

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

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

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

Moving from rhetoric to action: how Africa can use scientific evidence to halt the COVID-19 pandemic

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Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 31 Oct 2020]

 

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