Covid-19 Vaccine Trials and Incarcerated People — The Ethics of Inclusion

New England Journal of Medicine
November 12, 2020 Vol. 383 No. 20
http://www.nejm.org/toc/nejm/medical-journal

 

Perspective
Covid-19 Vaccine Trials and Incarcerated People — The Ethics of Inclusion
Camila Strassle, B.A., et al
… There are three arguments for enrolling incarcerated people in vaccine trials. First, it would offer them early access to a potentially efficacious vaccine. Second, it would provide them with a choice to participate in medical research that will be offered to nonincarcerated people. Third, it could shorten the amount of time needed to study vaccine efficacy, if transmission rates continue to be higher in correctional facilities than elsewhere.
Research involving incarcerated populations is ethically, legally, and logistically complex…

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

New England Journal of Medicine
November 12, 2020 Vol. 383 No. 20
http://www.nejm.org/toc/nejm/medical-journal

 

Original Article
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Lisa A. Jackson, M.D., M.P.H., et al.
We conducted a first-in-human phase 1 clinical trial in healthy adults to evaluate the safety and immunogenicity of mRNA-1273. Here we report interim results of the trial.
Abstract
Conclusions
The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461. opens in new tab).
This article was published on July 14, 2020, and updated on August 25, 2020, at NEJM.org.

Decision-making on maternal pertussis vaccination among women in a vaccine-hesitant religious group: Stages and needs

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

 

Research Article
Decision-making on maternal pertussis vaccination among women in a vaccine-hesitant religious group: Stages and needs
Anne C. de Munter, Wilhelmina L. M. Ruijs, Robert A. C. Ruiter, Dagmar J. J. van Nimwegen, Anke J. M. Oerlemans, Rijk van Ginkel, Marlies E. J. L. Hulscher, Jeannine L. A. Hautvast
Research Article | published 12 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0242261

Human Papillomavirus (HPV) and the quadrivalent HPV Vaccine among Brazilian adolescents and parents: Factors associated with and divergences in knowledge and acceptance

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

 

Human Papillomavirus (HPV) and the quadrivalent HPV Vaccine among Brazilian adolescents and parents: Factors associated with and divergences in knowledge and acceptance
Jéssica Menezes Gomes, Beatriz Machado Silva, Edige Felipe de Sousa Santos, Patricia Jane Kelly, Annielson de Souza Costa, Albertina Duarte Takiuti, Luiz Carlos de Abreu, José Maria Soares Júnior, Edmund Chada Baracat, Isabel Cristina Esposito Sorpreso
Research Article | published 12 Nov 2020 PLOS ONE

Repurposing therapeutics for COVID-19: Rapid prediction of commercially available drugs through machine learning and docking

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

 

Repurposing therapeutics for COVID-19: Rapid prediction of commercially available drugs through machine learning and docking
Sovesh Mohapatra, Prathul Nath, Manisha Chatterjee, Neeladrisingha Das, Deepjyoti Kalita, Partha Roy, Soumitra Satapathi
Research Article | published 12 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241543

Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study

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

 

Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study
Analise Nicholl, Kate Evelegh, Kane Evan Deering, Kate Russell, David Lawrence, Philippa Lyons-Wall, Therese Anne O’Sullivan
Research Article | published 09 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241764

Harnessing early life immunity to develop a pediatric HIV vaccine that can protect through adolescence

PLoS Pathogens
http://journals.plos.org/plospathogens/
[Accessed 14 Nov 2020]

 

Pearls
Harnessing early life immunity to develop a pediatric HIV vaccine that can protect through adolescence
Ria Goswami, Stella J. Berendam, Shuk Hang Li, Ashley N. Nelson, Kristina De Paris, Koen K. A. Van Rompay, Sallie R. Permar, Genevieve G. Fouda
| published 12 Nov 2020 PLOS Pathogens
https://doi.org/10.1371/journal.ppat.1008983

Equity, intercultural approaches and access to information on traditional, complementary and integrative medicines in the Americas

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

13 Nov 2020
Equity, intercultural approaches and access to information on traditional, complementary and integrative medicines in the Americas
Current topic | Spanish |
Access to information and intercultural approaches in the field of health are essential for the elimination of inequities in health access and care. Intercultural models such as traditional, complementary and integrative medicine (TCIM) are an important part of health care in most countries and often contribute to expanding access to primary health care. Despite legal recognition and policies to integrate TCIM into health systems, their contribution to health, well-being, and people-centered care to achieve universal health is still underestimated. This article presents the progress (2017-2020) achieved by the Virtual Health Library specialized in the TCIM (VHL TCIM Americas), an initiative created as a tool to reduce the gaps in the production and access to validated information on TCIM. Through collaborative network work, the VHL TCIM Americas contributes to the democratization of health, access to verified scientific data, visibility of non-conventional knowledge, strengthening of research capacities, and exchange of experiences for informed decision-making.

Intentions to Seek Information About the Influenza Vaccine: The Role of Informational Subjective Norms, Anticipated and Experienced Affect, and Information Insufficiency Among Vaccinated and Unvaccinated People

Risk Analysis
Volume 40, Issue 10 Pages: 1887-2111 October 2020
https://onlinelibrary.wiley.com/toc/15396924/current

 

Original Research Articles
Intentions to Seek Information About the Influenza Vaccine: The Role of Informational Subjective Norms, Anticipated and Experienced Affect, and Information Insufficiency Among Vaccinated and Unvaccinated People
Hang Lu, , Kenneth Winneg, Kathleen Hall Jamieson, Dolores Albarracín
Pages: 2040-2056
First Published: 19 February 2020

What’s next for COVID-19 apps? Governance and oversight

Science
13 November 2020 Vol 370, Issue 6518
http://www.sciencemag.org/current.dtl

 

Policy Forum
What’s next for COVID-19 apps? Governance and oversight
By Alessandro Blasimme, Effy Vayena
Science13 Nov 2020 : 760-762 Full Access
Adaptive governance can help earn social license
Summary
Many governments have seen digital health technologies as a promising tool to address coronavirus disease 2019 (COVID-19), particularly digital contact tracing (DCT) apps such as Bluetooth-based exposure notification apps that trace proximity to other devices (1) and GPS-based apps that collect geolocation data. But deploying these systems is fraught with challenges, and most national DCT apps have not yet had the expected rate of uptake. This can be attributed to a number of uncertainties regarding general awareness of DCT apps, privacy risks, and the actual effectiveness of DCT, as well as public attitudes toward a potentially pervasive form of digital surveillance. DCT thus appears to face a typical social control dilemma. On one hand, pending widespread uptake, assessing DCT effectiveness is extremely difficult; on the other hand, until DCT effectiveness is proven, its widespread use at a population scale is hard to justify. Recognizing that technological uptake is an open-ended process reliant upon social learning and the piecemeal creation of public trust, we suggest that policy-makers set up mechanisms to test effectiveness, oversee the use of DCT apps, monitor public attitudes, and adapt technological design to socially perceived risks and expectations.

Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines

Vaccine
Volume 38, Issue 49 Pages 7697-7876 (17 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/49

 

Review article Open access
Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines
Marc Gurwith, Richard C. Condit, Jean-Louis Excler, James S. Robertson, … Sonali Kochhar
Pages 7702-7707

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines

Vaccine
Volume 38, Issue 49 Pages 7697-7876 (17 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/49

 

Review article Open access
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines
Richard C Condit, Denny Kim, James S. Robertson, Jean-Louis Excler, … Sonali Kochhar
Pages 7708-7715

Lessons learned in the implementation of supplementary immunization activity (SIA) field guidelines for injectable vaccines – Experiences from Tanzania

Vaccine
Volume 38, Issue 49 Pages 7697-7876 (17 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/49

 

Research article Abstract only
Lessons learned in the implementation of supplementary immunization activity (SIA) field guidelines for injectable vaccines – Experiences from Tanzania
Nassor Mohamed, Daudi Simba, Alex Mphuru, Dafrossa Lyimo, Furaha Kyesi
Pages 7741-7746

Parents’ and guardians’ views on the acceptability of a future COVID-19 vaccine: A multi-methods study in England

Vaccine
Volume 38, Issue 49 Pages 7697-7876 (17 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/49

 

Research article Open access
Parents’ and guardians’ views on the acceptability of a future COVID-19 vaccine: A multi-methods study in England
Sadie Bell, Richard Clarke, Sandra Mounier-Jack, Jemma L. Walker, Pauline Paterson
Pages 7789-7798

Influenza vaccination: A qualitative study of practice level barriers from medical practitioners caring for children with special risk medical conditions

Vaccine
Volume 38, Issue 49 Pages 7697-7876 (17 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/49

 

Research article Full text access
Influenza vaccination: A qualitative study of practice level barriers from medical practitioners caring for children with special risk medical conditions
Jane L Tuckerman, Jessica Kaufman, Margie Danchin, Helen S Marshall
Pages 7806-7814

Global assessment of national mandatory vaccination policies and consequences of non-compliance

Vaccine
Volume 38, Issue 49 Pages 7697-7876 (17 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/49

 

Research article Open access
Global assessment of national mandatory vaccination policies and consequences of non-compliance
Katie Gravagna, Andy Becker, Robert Valeris-Chacin, Inari Mohammed, … Nicole E. Basta
Pages 7865-7873
Highlights
:: Over 100 countries have a nationwide mandatory vaccination policy requiring one or more vaccines.
:: Of those, 62 countries (59%) also impose one or more penalties against individuals who do not comply.
:: Educational and financial penalties are the most common types of penalties; severity varies.
:: Most educational penalties deny school enrollment until vaccination requirements are met.
Abstract
Background
Declining vaccination coverage and increasing hesitancy is a worldwide concern. Many countries have implemented mandatory vaccination policies to promote vaccination. However, mandatory vaccination policies differ significantly by country. Beyond case studies, no comprehensive study has compared these policies or the penalties for non-compliance on a global scale.
Methods
We conducted extensive keyword, policy, and literature searches to identify mandatory national vaccination policies globally and develop a comprehensive database. A mandatory national vaccination policy was defined as a policy from a national authority that requires individuals to receive at least one vaccination based on age or to access a service. Two reviewers independently evaluated evidence for a mandate and whether non-compliance penalties were incorporated. We categorized penalties into four types, based on the nature of the penalty. These penalties impact an individual’s financial, parental rights, educational (i.e., child’s school entry and access), and liberty status. We rated the severity within each category.
Results
Of 193 countries investigated, 54% (n = 105) had evidence of a nationwide mandate as of December 2018. The frequency, types, and severity of penalties varied widely across all regions. We found that 59% (n = 62) of countries with national mandates defined at least one penalty for non-compliance with a vaccine mandate. Among those, educational penalties (i.e., limiting a child’s entry or ongoing access to school) were the most common (69%; n = 43), with most countries with educational penalties refusing school enrollment until vaccination requirements are met (81%; n = 35).
Conclusion
We undertook a comprehensive assessment of national mandatory vaccination policies and identified a diversity of penalties in place to promote compliance. Our results highlight the need to critically evaluate the implementation of non-compliance penalties in order to determine their effectiveness and to define best practices for sustaining high vaccination uptake worldwide.

Media/Policy Watch

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

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 14 Nov 2020
Ideas
For a Vaccine to Save Lives, Society Has to Make Some Decisions
In distributing a coronavirus vaccine, the U.S. needs to learn from past mistakes.
6:00 AM ET
Thomas J. Bollyky, Director of the Global Health Program at the Council on Foreign Relations

 

BBC
http://www.bbc.co.uk/
Accessed 14 Nov 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 14 Nov 2020
Leaders Nov 14th 2020 edition
Suddenly, hope…The promise of the new covid-19 vaccine is immense
But don’t underestimate the challenge of getting people vaccinated

 

Financial Times
https://www.ft.com/
Accessed 14 Nov 2020
US politics & policy
US vaccine tsar calls on White House to allow contact with Biden
November 13, 2020

 

Forbes
http://www.forbes.com/
Accessed 14 Nov 2020
Breaking  |
5 hours ago
Here’s Why Trump And Cuomo Are Feuding Over A Coronavirus Vaccine
Trump threatened to withhold a vaccine from New York after Cuomo repeatedly declared Trump’s distribution plan and safety measures inadequate.
By Andrew Solender Forbes Staff

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 14 Nov 2020
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 14 Nov 2020
Vaccine Inequality Fuels Suspicion and Division
The world can’t repeat the mistakes of polio, tuberculosis, and measles.
Argument | Oussama Mezoui November 12, 2020, 12:52 PM

 

Kremlin Spin Doctors are Leading Russia’s Vaccine Development
With Sputnik V, the country is conflating good headlines with good health.
Argument | Chris Miller November 12, 2020, 12:23 PM

 

As Vaccine Hopes Grow, Poorer Countries Are Last in Line
A vaccine candidate closely linked with Operation Warp Speed is expected to produce preliminary results similar to the blockbuster Pfizer findings.
Morning Brief | Colm Quinn November 12, 2020, 5:10 AM

 

The Guardian
http://www.guardiannews.com/
Accessed 14 Nov 2020
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 14 Nov 2020
Politics and More Podcast
A Nobel Laureate on the Politics of Fighting the Coronavirus
Dr. Harold E. Varmus, a former director of the National Institutes of Health and winner of a Nobel Prize in Medicine, on combating COVID-19 during the Biden Administration.
By Dorothy Wickenden November 12, 2020

 

New York Times
http://www.nytimes.com/
Accessed 14 Nov 2020
Sunday Review
This Coronavirus Surge Does Not Have to Be So Horrific
America is entering a difficult period. But the outcome is not foregone.
By The Editorial Board

Health
Missing From State Plans to Distribute the Coronavirus Vaccine: Money to Do It
The government has sent billions to drug companies to develop a coronavirus shot but a tiny fraction of that to localities for training, record-keeping and other costs for vaccinating citizens.
By Abby Goodnough and Sheila Kaplan

Health
As the Pandemic Surges, C.D.C. Issues Increasingly Assertive Advice
Agency scientists often contradict the Trump administration now, but critics urge a more public stance.
By Apoorva Mandavilli

 

Washington Post
https://www.washingtonpost.com/
World · Nov 12, 2020
Analysis
Vaccines have never been distributed equally. A coronavirus vaccine would be no different, history suggests
Ruby Mellen ·

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 14 Nov 2020
[No new relevant content]
 
 
Center for Global Development [to 14 Nov 2020]
http://www.cgdev.org/page/press-center
November 12, 2020
Beyond the Rhetoric of Equity: Will the Frontline Healthcare Workers Who Serve the Poor Be Prioritized for the COVID Vaccine?
Healthcare providers, particularly in low- and middle-income countries, are a diverse, fragmented, and loosely regulated population. Will the COVID vaccine plans prioritize them?
Asif Saleh, Maria Khan and Richard A. Cash
 
 
Chatham House [to 14 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 14 Nov 2020
[No new relevant content]

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 14 Nov 2020
[No new relevant content]

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 14 Nov 2020
November 11, 2020 News Release
New Brief Examines COVID-19 Risks and Impacts for Health Care Workers by Race and Ethnicity
New coronavirus cases in the United States have hit daily records multiple times in the past week and hospitalizations are rising in several areas of the country. Health care workers face some of the greatest risk of exposure to the coronavirus and a new KFF brief examines the composition of…

Vaccines and Global Health: The Week in Review :: 07 November 2020

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: 

– 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

UNICEF and WHO call for emergency action to avert major measles and polio epidemics

Milestones :: Perspectives :: Research

 

UNICEF and WHO call for emergency action to avert major measles and polio epidemics
As COVID-19 disrupts immunizations, urgent action needed to protect most vulnerable children from deadly and debilitating diseases

GENEVA/ NEW YORK, 6 November 2020 – UNICEF and the World Health Organization (WHO) today issued an urgent call to action to avert major measles and polio epidemics as COVID-19 continues to disrupt immunization services worldwide, leaving millions of vulnerable children at heightened risk of preventable childhood diseases.

The two organizations estimate that US$655 million (US$400 million for polio and US$255 million for measles) are needed to address dangerous immunity gaps in non-Gavi eligible countries and target age groups.

“COVID-19 has had a devastating effect on health services and in particular immunization services, worldwide,” commented Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “But unlike with COVID, we have the tools and knowledge to stop diseases such as polio and measles. What we need are the resources and commitments to put these tools and knowledge into action. If we do that, children’s lives will be saved.”

“We cannot allow the fight against one deadly disease to cause us to lose ground in the fight against other diseases,” said Henrietta Fore, UNICEF Executive Director. “Addressing the global COVID-19 pandemic is critical. However, other deadly diseases also threaten the lives of millions of children in some of the poorest areas of the world. That is why today we are urgently calling for global action from country leaders, donors and partners. We need additional financial resources to safely resume vaccination campaigns and prioritize immunization systems that are critical to protect children and avert other epidemics besides COVID-19.”

In recent years, there has been a global resurgence of measles with ongoing outbreaks in all parts of the world.  Vaccination coverage gaps have been further exacerbated in 2020 by COVID-19. In 2019, measles climbed to the highest number of new infections in more than two decades. Annual measles mortality data for 2019 to be released next week will show the continued negative toll that sustained outbreaks are having in many countries around the world.
At the same time, poliovirus transmission is expected to increase in Pakistan and  Afghanistan and in many under-immunized areas of Africa. Failure to eradicate polio now would lead to global resurgence of the disease, resulting in as many as 200,000 new cases annually, within 10 years.

New tools, including a next-generation novel oral polio vaccine and the forthcoming Measles Outbreak Strategic Response Plan are expected to be deployed over the coming months to help tackle these growing threats in a more effective and sustainable manner, and ultimately save lives. The Plan is a worldwide strategy to quickly and effectively prevent, detect and respond to measles outbreaks.

World Health Assembly charts course for COVID-19 response and global health priorities // Strengthening preparedness for health emergencies: implementation of the International Health Regulations (2005)

Milestones :: Perspectives :: Research

 

World Health Assembly charts course for COVID-19 response and global health priorities
5 November 2020 News release
The WHA usually takes place in May. This year, given the COVID-19 pandemic, a reduced (de minimis) WHA took place on 18-19 May. The resumed WHA73 will take place virtually from 9-14 November 2020.

As health leaders prepare to gather for a virtual session of the resumed 73rd World Health Assembly (WHA), WHO has three messages to share.

 

First, we can beat COVID-19 with science, solutions and solidarity.

More than 47 million COVID-19 cases have now been reported to WHO, and more than 1.2 million people have lost their lives.

Although this is a global crisis, many countries and cities have successfully prevented or controlled transmission with a comprehensive, evidence-based approach.

For the first time, the world has rallied behind a plan to accelerate the development of the vaccines, diagnostics and therapeutics we need, and to ensure they are available to all countries on the basis of equity. The Access to COVID-19 Tools (ACT) Accelerator is delivering real results.

 

Second, we must not backslide on our critical health goals.

The COVID-19 pandemic is a sobering reminder that health is the foundation of social, economic and political stability.

It reminds us why WHO’s ‘triple billion’ targets are so important, and why countries must pursue them with even more determination, collaboration and innovation.

 

Since May, Member States have adopted a number of decisions – the Immunization Agenda 2030, the Decade of Healthy Ageing 2020-2030, as well as initiatives to tackle cervical cancer, tuberculosis, eye care, food safety, intellectual property and influenza preparedness.

The resumed session will discuss a 10-year-plan for addressing neglected tropical diseases, as well as efforts to address meningitis, epilepsy and other neurological disorders, maternal infant and young child nutrition, digital health, and the WHO Global Code of Practice on the International Recruitment of Health Personnel, adopted in 2010.

 

Third, we must prepare for the next pandemic now.

We’ve seen this past year that countries with robust health emergency preparedness infrastructure have been able to act quickly to contain and control the spread of the SARS-CoV-2 virus.

 

The WHA will consider a draft resolution (EB146.R10) that strengthens Member States’ preparedness for health emergencies, such as COVID-19, through more robust compliance with the International Health Regulations (2005).

This resolution calls on the global health community to ensure that all countries are better equipped to detect and respond to cases of COVID-19 and other dangerous infectious diseases.

 

::::::

Strengthening preparedness for health emergencies: implementation of the International Health Regulations (2005)
WHA 146th session
EB146.R10 Draft Resolution Agenda item 15.2 8 February 2020
[Excerpt] p.4
1. URGES Member States:1
(1) to fully comply with the International Health Regulations (2005), to take actions to implement the unmet obligations thereof, and to continue to build core capacities to detect, assess, report on and respond to public health events as set out in the International Health Regulations (2005), while mindful of the purpose and scope of the regulations to prevent, protect against, control, and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade…

COVAX Facility convenes first meeting of COVAX Shareholders Council

Milestones :: Perspectives :: Research

 

COVAX Facility convenes first meeting of COVAX Shareholders Council
3 November 2020
:: The COVAX Shareholders Council, composed of all self-financing participants, forms a key component of Facility governance
:: The AMC Engagement Group, a second governance body comprising economies that are eligible for COVID-19 vaccines through the Gavi COVAX Advance Market Commitment (AMC) will also meet in November
:: Seth Berkley: “Ensuring all participating economies’ perspectives are part of the solution will be critical to shaping and implementing a COVAX Facility that works for everyone, everywhere.”

Geneva, 3 November 2020 – Gavi, the Vaccine Alliance, in its capacity as the legal administrator of the COVAX Facility, yesterday convened the first meeting of the COVAX Shareholders Council. The COVAX Shareholders Council, which is comprised of all self-financing participants and will be self-organising, is a key component of Facility governance. More than 200 participants from 67 countries joined the half-day virtual meeting.

The meeting, which was exceptionally co-chaired by Ngozi Okonjo-Iweala and Andrew Witty pending appointments made by the self-financing participants, discussed, among other things, updates on Facility progress, possible terms of reference (ToRs) for the Council, as well as the process for finalising ToRs and appointments – anticipated to occur over the next few weeks.

“This is a significant milestone for the COVAX Facility,” said Seth Berkley, CEO of Gavi. “In just a few short months we have moved from design to implementation, thanks to unprecedented collaboration from countries and organisations around the world. Reflecting that same spirit of co-creation in governance – ensuring all participating economies’ perspectives are part of the solution – will be critical to shaping and implementing a COVAX Facility that works for everyone, everywhere. We are only safe if we are all safe.”

Following on from a series of briefings for AMC-eligible economies hosted by Gavi and partners last week, the first meeting of the COVAX AMC Engagement Group is anticipated to take place in the coming weeks. The AMC Engagement Group is the Facility governance body comprised of participants and stakeholders in the Gavi COVAX AMC…

WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines

Milestones :: Perspectives :: Research

 

WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines
6 November 2020 – Statement
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have committed to working together to ensure that patients have access to safe and effective health products against COVID-19 as early as possible, while the existing rigorous scientific standards for the evaluation and safety monitoring of treatments and vaccines are maintained at all times.

In their joint statement, international medicines regulators and WHO reiterate that therapeutics and vaccines against COVID-19 can only be rapidly approved if applications are supported by robust and sound scientific evidence that allows medicine regulators to conclude on a positive benefit-risk balance for these products. ICMRA and WHO also pledge to take concrete actions to ensure equitable access to safe, effective and quality-assured medicines for the treatment or prevention of COVID-19 around the world.

In view of the large number of COVID-19 vaccines and treatments under development, and their potentially imminent roll-out, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) have joined forces to uphold and promote the most rigorous, evidence-based regulatory practices by supporting the alignment of regulatory processes across all countries. As in other areas of the pandemic response, multilateral cooperation between regulatory authorities will be critical in ensuring there is a level playing field, that COVID-19 vaccines and medicines are safe, effective and quality-assured, and that all countries may benefit from such products equitably and at the same time.

This joint statement commits each organization to a series of actions to make this happen.

:: ICMRA and WHO continue to join forces in collaborating to address the unprecedented global health challenges related to COVID-19 pandemic, affecting so many people in the world.

:: These challenges are best addressed by working together to ensure existing rigorous scientific standards of review and oversight are maintained, while still giving patients access to safe and effective medical products at the earliest time possible

 

:: Regulatory authorities for medical products, including medicines and vaccines, have the responsibility to approve quality assured, safe and effective products based on robust and reliable data.

:: The regulatory approval should be based on an independent scientific assessment of the balance of benefits and risks.

:: Robust and reliable data on efficacy and safety to support market approval of medicines and vaccines are best collected through randomized controlled clinical trials which control for bias, meet Good Clinical Practice standards, respect the rights, autonomy and safety of clinical trial participants, and can be audited.

:: To ensure patients have fast access to safe and effective medicines and vaccines, WHO and ICMRA, together with other stakeholders including public health institutions, are committed to the following actions:
…Working to prioritise well-designed clinical trials that will provide robust and reliable results.
Ensuring that there are meaningful and scientifically sound endpoints and safety data of sufficient duration in clinical trials;
…Sharing data between regulators in real time to facilitate multi-country approvals;
…Putting in place processes and policies utilizing the principles of regulatory agility by ICMRA members and WHO member states, providing an agile and rapid response to the global emergency;
…Committing to full transparency of clinical trial results to support regulatory decisions, as well as ensuring public trust in authorities and confidence in vaccines
…Working together to prevent and/or mitigate shortages of critical medicines and vaccines;
…Continue working together once these COVID-19 therapies and vaccines are authorized and used to monitor their use, and identify, communicate and mitigate any safety or efficacy issues which may arise;
…Reduce the risks associated with unproven treatments, potentially fraudulent and false claims, which endanger patients’ lives.

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

EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 7 November 2020, 10:30 GMT-4
Confirmed cases :: 49 106 931 [week ago: 45 428 731] [two weeks ago: 42 055 863]
Confirmed deaths :: 1 239 157 [week ago: 1 185 721} [two weeks ago: 1 141 567]
Countries, areas or territories with cases :: 219

::::::

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 6 November 2020
6 November 2020
:: Today, WHO and UNICEF are jointly launching an emergency appeal to rapidly boost measles and polio vaccination. We estimate that $655 million US dollars is needed to address dangerous immunisation gaps in children in non-Gavi eligible countries.
:: As the pandemic unfolds, as countries have reflected, they have used intra action reviews to make their responses stronger.  An Intra-Action Review uses a whole-of-society, multi-sectoral approach, acknowledging the contributions of all relevant stakeholders involved in COVID-19 preparedness and response at the national and sub-national levels.
:: Intra-Action Reviews not only help countries improve their COVID-19 response but also contribute towards their long-term health security. To date, 21 countries have completed them and others are in pipeline.
:: Today we are happy to welcome the Ministers of Health from Indonesia, the Kingdom of Thailand and South Africa to share their experience and lessons from COVID-19.

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

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

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 04 November 2020
:: The Independent Monitoring Board (IMB) for polio eradication will host its 19th meeting via video conference from 17 – 19 November 2020 to discuss overall situation report; ongoing COVID-19 impact, outbreaks and vaccine deployment among other issues. In preparation for the meeting, we have made the necessary meeting documents available here.
:: Fahima Ahmed Hassan is a 25-year-old community mobilizer who goes the extra mile to ensure parents of children under the age of five are well informed of the polio vaccination campaign and ready to vaccinate their children in Somalia. Take a look at this photo essay showing Fahima and other mobilisers lay the groundwork for vaccinators.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: 20 cVDPV2 cases
:: Pakistan: one WPV1 case and one WPV1 positive environmental sample
:: Burkina Faso: three cVDPV2 cases
:: Cameroon: one cVDPV2 positive environmental sample
:: Central African Republic: one cVDPV2 case
:: Chad: two cVDPV2 cases
:: Congo: one cVDPV2 case
:: Côte d’Ivoire: one cVDPV2 case
:: Somalia: one cVDPV2 positive environmental sample
:: South Sudan: three cVDPV2 cases

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

WHO Grade 3 Emergencies [to 7 Nov 2020]

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

::::::

WHO Grade 2 Emergencies [to 7 Nov 2020]
Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso – 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

::::::

WHO Grade 1 Emergencies [to 7 Nov 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

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

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 – No new digest announcements identified
Yemen – No new digest announcements identified

::::::

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 51: occupied Palestinian territory, issued 5 November 2020, information for period: 5 March – 5 November 2020

East Africa Locust Infestation – No new digest announcements identified

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

WHO & Regional Offices [to 7 Nov 2020]

WHO & Regional Offices [to 7 Nov 2020]
6 November 2020 News release
UNICEF and WHO call for emergency action to avert major measles and polio epidemics
[See Milestones above for detail]

6 November 2020 Statement
WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines
[See Milestones above for detail]

5 November 2020 News release
World Health Assembly charts course for COVID-19 response and global health priorities
[See Milestones above for detail]

5 November 2020 Departmental news
Neglected tropical diseases and One Health: gearing up against antimicrobial resistance to secure the safety of future generations

4 November 2020 Departmental news
Message from Director SRH/HRP

4 November 2020 Departmental news
WHO publishes series of profiles on climate change and health in island states

2 November 2020 Departmental news
Ensuring medicines work safely for everyone

 

::::::

Weekly Epidemiological Record, 6 November 2020, vol. 95, 45 (pp. 545–556)
:: Elimination of human onchocerciasis: progress report, 2019–2020
:: Monthly report on dracunculiasis cases, January-August 2020

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Reinforcing key health services amid COVID-19 05 November 2020
Thousands of vaccinators fanned through villages and towns across 73 districts in Ghana, immunizing more than 4.6 million children against vaccine-derived poliovirus. Mass immunization campaigns, like many key health services, have suffered a heavy jolt dealt by the COVID-19 pandemic.
:: Talk radio, teletherapy expands mental health services in Ethiopia 05 November 2020
The Erq Ma’ed – or ‘reconciliation table’ – social enterprise has mixed talk radio, communications and counselling to boost the mental health and wellbeing of Ethiopians for nearly a decade. With the added pressure due to the COVID-19 pandemic, their journey of innovation to meet people’s mental health needs amid unprecedented times has been further spurred on.
:: Easing COVID-19 impact on key health services 05 November 2020
The COVID-19 pandemic has strained health systems and disrupted essential health services in Africa. Countries are working to restore and strengthen key services to better withstand shocks and ensure quality care. Regina Kamoga, the Executive Director of Uganda’s Community Health and Information Network and Chairperson of the Uganda Alliance of Patients Organizations, speaks about the impact of COVID-19 and solutions to restore essential health services.

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
:: Mink-strain of COVID-19 virus in Denmark 07-11-2020
:: Albania needs to expand population coverage to move towards universal health coverage 06-11-2020
:: Helicopter paramedic nurse Jacqueline Zbären – providing emergency care in inhospitable terrain 06-11-2020
:: WHO/Europe and Ukrainian government sign Biennial Collaborative Agreement 05-11-2020
:: Regional Director visits newly opened GDO in Istanbul and speaks at Turkic Council on country visit 05-11-2020

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
No new digest content identified

CDC/ACIP [to 7 Nov 2020]

CDC/ACIP [to 7 Nov 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
[No new digest content identified]

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: COVID-19 Science Update released: November 6, 2020 Friday, November 06, 2020
:: Vaccines Wednesday, November 04, 2020
:: Health Equity Monday, November 02, 2020

:: Operational Considerations for Immunization Services during COVID-19 in Non-US Settings Focusing on Low-Middle Income Countries Friday, November 06, 2020
Background
Immunization services have been disrupted significantly during the COVID-19 pandemic, threatening the achievements in the eradication and elimination of major vaccine preventable diseases (VPDs) like polio and measles. More than 80 million children under the age of one are estimated to be affected by disruptions in routine immunization services in more than 68 countries and are at risk of polio, measles, diphtheria, pertussis, tetanus, hepatitis B, Hemophilus influenza type b, pneumococcus, and rotavirus infections 1. As of June 1, 2020, approximately 125 mass vaccination campaigns against polio, measles, meningitis A, yellow fever, typhoid, cholera, and tetanus had been postponed.
In many countries, immunization services have been disrupted as a result of:
:: Unavailability of healthcare workers as a result of their deployment to the COVID-19 response.
:: Lack of personal protective equipment (PPE) to conduct immunization activities during COVID-19.
:: Healthcare workers’ fear about contracting COVID-19.
:: Lack of vaccines due to closure of country borders as a result of COVID-19.
:: Reduced demand for immunization services due to unwillingness or inability of parents to leave their homes due to fear of COVID-19.

Purpose
The purpose of this document is to provide operational considerations for the implementation of immunization services during the COVID-19 pandemic in non-US settings. Its intended users are CDC country offices, immunization program managers, and staff from partner immunization programs. These considerations are meant to supplement—not replace—any local health and safety laws, rules, and regulations.
This document provides a summary of global guidance on immunization services during COVID-19 as of June 12, 2020. It complements and provides reference to more detailed technical guidance from the World Health Organization, UNICEF, and the Global Polio Eradication Initiative including the following:
:: Guiding principles for immunization activities during the COVID-19 pandemic: Interim guidancepdf iconexternal icon
:: Frequently Asked Questions: Immunization in the context of COVID-19 pandemicpdf iconexternal icon
:: Framework for decision-making: implementation of mass vaccination campaigns in the context of COVID-19: Interim guidanceexternal icon
:: Polio eradication programme continuity: implementation in the context of the COVID-19 pandemicpdf iconexternal icon

MMWR News Synopsis Friday, November 6, 2020
:: Network Characteristics and Visualization of COVID-19 Outbreak in a Large Detention Facility in the United States — Cook County, Illinois, 2020
:: Transmission of SARS-COV-2 Infections in Households — Tennessee and Wisconsin, April–September 2020 (Early release October 30, 2020)
:: Birth and Infant Outcomes Following Laboratory-Confirmed SARS-CoV-2 Infection in Pregnancy — SET-NET, 16 Jurisdictions, March 29–October 14, 2020 (Early release November 2, 2020)
:: Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confird SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020 (Early release November 2, 2020)
:: Telework Before Illness Onset Among Symptomatic Adults Aged ≥18 Years With and Without COVID-19 in 11 Outpatient Health Care Facilities — United States, July 2020
:: A SARS-CoV-2 Outbreak Illustrating the Challenges in Limiting the Spread of the Virus — Hopi Tribe, May–June 2020

Outbreak Brief 42: Coronavirus Disease 2019 (COVID-19) Pandemic

Africa CDC [to 7 Nov 2020]
http://www.africacdc.org/
Press Releases
Outbreak Brief 42: Coronavirus Disease 2019 (COVID-19) Pandemic
3 November 2020
… s of 9 am East African Time (EAT) 2 November 2020, a total of 1,803,464 COVID-19 cases and 43,389 deaths (CFR: 2.4%) have been reported in 55 African Union (AU) Member States. This is 4% of all cases reported globally. The majority of countries (41, 75%) are still reporting community transmission. Of the countries actively reporting COVID-19 epidemiologic data, fifteen countries are reporting case fatality rates higher than the global case fatality rate of 2.6%, these include Sahrawi Arab Democratic Republic (7.1%), Chad (6.5%), Sudan (6.0%), Egypt (5.8), Liberia (5.7%), Niger (5.6%), Mali (3.8%), Algeria (3.4%), Gambia (3.2%), Sierra Leone (3.1%), Malawi (3.1%), Zimbabwe (2.9%), Democratic Republic of Congo (2.7%), Burkina Faso (2.7%) and South Africa (2.7%).

China CDC

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
Nov 7: Daily briefing on novel coronavirus cases in China
On Nov 6, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 33 new cases of confirmed infections.

Chinese vice premier demands efforts to curb epidemic spread
Updated: 2020-11-06 | Xinhua
KASHGAR — Chinese Vice Premier Sun Chunlan has stressed a science-based and targeted approach, as well as resolute measures to curb the spread of the COVID-19 epidemic in northwest China’s Xinjiang Uygur Autonomous Region to safeguard the lives and health of people of all ethnic groups.
Sun made the remarks during her visit to Kashgar and Kirgiz Autonomous Prefecture of Kizilsu in southern Xinjiang on Wednesday and Thursday.
The cluster cases in Kashgar were discovered at an early stage, Sun said, adding that with a timely emergency response mechanism and decisive measures, major progress was achieved in containing the outbreak, and the epidemic situation is on the whole manageable…

One more Chinese COVID-19 vaccine ready for phase-3 clinical trials
Updated: 2020-11-02 | Xinhua
BEIJING — A COVID-19 vaccine candidate developed by the Institute of Microbiology under the Chinese Academy of Sciences has shown to be safe in early-stage trials, suggesting potential for further clinical tests.
The results of phase-1 and phase-2 trials support the safety and immunogenicity of this recombinant subunit vaccine in healthy participants, and no serious adverse events have been found so far, the institute said in a statement on Oct 30.
Jointly developed by the institute and Chongqing Zhifei Biological Products Co Ltd, the vaccine was issued with a clinical research permit from the National Medical Products Administration on June 19…

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 7 Nov 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 7 Nov 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 7 Nov 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 7 Nov 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 7 Nov 2020]
https://carb-x.org/
News
No new digest content identified.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 7 Nov 2020]
http://cepi.net/
Latest News
CEPI extends partnership with Clover to fund COVID-19 vaccine candidate through global Phase 2/3 study to licensure
:: CEPI to fund the development of Clover’s protein-based S-Trimer vaccine candidate through to licensure, including a global pivotal Phase 2/3 efficacy clinical study beginning before the end of 2020.
:: Agreement between CEPI and Clover anticipates that the vaccine – if proven to be safe and effective – will be made available for procurement and allocation through the COVAX Facility to those who need it most around the world.
:: CEPI’s total investment in S-Trimer will be up to $328 million, including $69.5 million previously announced.
OSLO, Norway and CHENGDU, China,  Nov 03, 2020— CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will fund the development of the protein-based S-Trimer COVID-19 vaccine candidate by Sichuan Clover Biopharmaceuticals, Inc (China) (“Clover”) through a global pivotal Phase 2/3 efficacy clinical trial and to licensure in China and globally, if the vaccine is proven to be safe and effective…

 

EDCTP [to 7 Nov 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 7 Nov 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 7 Nov 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: International regulators and WHO join forces to address COVID-19 challenges
Last updated: 06/11/2020
[See COVID above for detail]

 

European Vaccine Initiative [to 7 Nov 2020]
http://www.euvaccine.eu/
Latest News
EVI, Oct 29, 2020
Open call for Vaccine R&D services
Developing a vaccine is a time-consuming and complex process, requiring a combination of specialized skills and technical capacities not readily available at a single organization. To facilitate access to these skills and capacities, TRANSVAC2 offers high-quality technical services to support the development of prophylactic and therapeutic vaccines for both human and animal use. These services are not restricted to any disease area. Services will be offered free of charge, with few exceptions! Academic and non-academic research groups, SMEs and industries can apply!
Submit your application by December 15th, 2020! For further information on services available and how to apply please visit www.transvac.org

 

FDA [to 7 Nov 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
November 6, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

November 3, 2020 – Coronavirus (COVID-19) Update: November 3, 2020

 

FDA – COVID-19 Vaccines [to 7 Nov 2020]
www.fda.gov/covid19vaccines
Upcoming Events
No new digest content identified.

 

Fondation Merieux [to 7 Nov 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 7 Nov 2020]
https://www.gavi.org/
News releases
COVAX Facility convenes first meeting of COVAX Shareholders Council
3 November 2020
[See COVAX above for detail]

 

GHIT Fund [to 7 Nov 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 7 Nov 2020]
https://www.theglobalfund.org/en/news/
News/Updates
Removing Human Rights Barriers to Health: Findings and Lessons
04 November 2020
Programs to remove human rights barriers to HIV, TB and malaria services are essential to increasing the effectiveness of Global Fund grants. Such programs help to ensure health services reach those most affected by the three diseases. The Global Fund Strategy 2017-2022 recognizes and reaffirms this through its human rights objective.
Breaking Down Barriers initiative
As part of attaining this objective, the Global Fund’s Breaking Down Barriers initiative aims to dramatically scale up programs to remove these obstacles. The Global Fund has now published a summary of key findings of the baseline assessments undertaken as part of the initiative:
Breaking Down Barriers Initiative: Summary of Key Findings of the Baseline Assessments in 20 Countries [download in English]

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 7 Nov 2020]
https://www.glopid-r.org/news/
News
GloPID-R appoints new Chair and Vice Chairs to lead the network’s Board
05/11/2020
GloPID-R is delighted to announce that Dr. Charu Kaushic has been appointed Chair of the network following the excellent work carried out by Prof. Yazdan Yazdanpanah over the past two years. Prof. Yazdanpanah will continue to serve GloPID-R as a Vice Chair.

BMC Medicine publishes ‘Ending COVID-19: progress and gaps in research – highlights of the July 2020 GloPID-R COVID-19 Research Synergies Meetings’
03/11/2020

 

Hilleman Laboratories [to 7 Nov 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 7 Nov 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
HVP COVID Report
What a COVID-19 Vaccine may Mean for Ageing Adults 
Interview with Wayne Koff, Ph.D., President and CEO
HVP Editor Kristen Jill Abboud recently discussed the state of COVID-19 vaccine research with Koff and asked him about the priorities for evaluating and deploying eventual vaccines in various populations, including the elderly.

 

IAVI [to 7 Nov 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
November 6, 2020
Participant Enrollment Begins for Phase I Trial of IAVI-Merck COVID-19 Vaccine Candidate
A Phase I clinical trial of the IAVI-Merck (known as MSD outside the United States and Canada) SARS-CoV-2 vaccine candidate V590 has begun enrolling participants. The randomized, placebo-controlled double-blinded trial is being conducted at seven sites in the U.S. and will include up to 252 participants ages 18 and up, including seniors. This vaccine candidate uses the recombinant vesicular stomatitis virus (rVSV) technology that IAVI has developed through its long-standing research program on an rVSV-based HIV vaccine candidate as well as rVSV-based vaccines for other emerging infectious diseases such as Lassa fever and Marburg virus disease.

Merck is the sponsor of the trial, which is called V590-001. IAVI has partnered with Merck on trial design and site selection, and the IAVI Human Immunology Laboratory at Imperial College London is conducting a panel of immunogenicity assays to assess certain aspects of immune responses to the vaccine.
The study will assess the safety, tolerability, and immunogenicity (the level of antibodies that target the virus) of V590 compared to placebo…

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines
6 November 2020 – Statement
[See Milestones above for detail]

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
Global Biosimilars Week: Message of the IGBA Chair (November 2020) [Video]

 

 

IFFIm
http://www.iffim.org/
Press Releases/Announcements
No new digest content identified.

 

IFRC [to 7 Nov 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

 

IRC International Rescue Committee [to 7 Nov 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
No new digest content identified.

 

IVAC [to 7 Nov 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 7 Nov 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
Webinar on AMR – Evidence to Action: Advancing the Antimicrobial Resistance agenda during a pandemic
Invitation for Webinar on “Evidence to Action: Advancing the Antimicrobial Resistance agenda during a pandemic”
You are invited to the Webinar on “Evidence to Action: Advancing the Antimicrobial Resistance agenda during a pandemic” on the 3rd of December 2020.

 

JEE Alliance [to 7 Nov 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 7 Nov 2020]
http://www.msf.org/
Latest [Selected Announcements]
DRC Ebola outbreaks
New strategies at work in eleventh Ebola outbreak in DRC
Interview 4 Nov 2020

Mozambique
Urgent assistance needed for hundreds of thousands of people displaced by viol…
Press Release 3 Nov 2020

South Sudan
Urgent vaccination campaign needed to stop spread of measles in Pibor
Press Release 3 Nov 2020
Juba, South Sudan ─ Two months into a measles outbreak in Pibor town in the Greater Pibor Administrative Area, the spread of the highly contagious and life-threatening illness is a severe growing crisis. Médecins Sans Frontières (MSF) calls on all health organisations to urgently launch a reactive vaccination campaign to curb the outbreak.
On 18 August 2020, MSF treated the first patient for suspected measles in Pibor town, eastern South Sudan. By the end of October, teams had treated over 250 children.
“We believe measles is now widespread and getting out of control. It is especially concerning that the Greater Pibor Administrative Area is flooded and in emergency. We started with four, then six and then 18 isolation beds,” says MSF’s Dr Adelard Shyaka. “At the moment we have 30 children with severe measles receiving treatment in our health facility.”…

 

National Vaccine Program Office – U.S. HHS [to 7 Nov 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 7 Nov 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
No new digest content identified.

 

PATH [to 7 Nov 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

 

Sabin Vaccine Institute [to 7 Nov 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 7 Nov 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
6 November 2020
20–50–80 to reach 100 in Ukraine

3 November 2020
A tale of two Jamaican clinics during COVID-19

2 November 2020
Highly effective HIV prevention option not reaching those who need it

 

UNICEF [to 7 Nov 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
11/06/2020
UNICEF alarmed by spike in school attacks in Cameroon
UNICEF calls on all parties to protect all children, at school or in their communities and to uphold the principles of the Safe Schools Declaration, which calls for stopping attacks on schools, education facilities and personnel

Press release
11/06/2020
UNICEF and WHO call for emergency action to avert major measles and polio epidemics
As COVID-19 disrupts immunizations, urgent action needed to protect most vulnerable children from deadly and debilitating diseases
[See Milestones above for detail]

Press release
11/05/2020
More than 1.5 million children at risk due to the impact of Tropical Storm ETA in Honduras- UNICEF

Statement
11/05/2020
At least five children and two aid workers killed in a renewed wave of violence in north-west Syria
Statement from Ted Chaiban, UNICEF Regional Director for the Middle East and North Africa

Press release
11/05/2020
UNICEF and WHO sound the alarm over 250 000 children at risk of vaccine-preventable diseases in Libya
TRIPOLI, Libya, 5 November 2020 – UNICEF and WHO are extremely concerned over severe shortages of critical vaccines in Libya that threaten the health of the country’s children. Over the past 7 months, unprecedented vaccine shortages in the country have disrupted children’s immunization schedules and put them at risk of disease and death.
There has been an alarming decline in the number of children receiving life-saving vaccines globally. In Libya, this decline is a direct result of the COVID-19 pandemic, which has led to the closure of international borders, movement restrictions, and delays procuring and distributing vaccines. Many vaccination centres have been forced to close due to shortages of personal protective equipment for health workers.
A recent assessment of 200 of Libya’s 700 vaccine sites, carried out by the National Centre of Disease Control with the support of UNICEF and WHO, showed that all 200 sites had stockouts of BCG vaccine and extremely limited quantities of hexavalent vaccine…

Press release
11/03/2020
Nearly half a million children in Nicaragua at risk from Hurricane Eta

 

Unitaid [to 7 Nov 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 7 Nov 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 7 Nov 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 7 Nov 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 7 Nov 2020]
https://wellcome.ac.uk/news
Opinion | 4 November 2020
Science can give us the tools to end the pandemic, but it needs funding
Jeremy Farrar, Director, Wellcome
Vaccines, tests and treatments, alongside well-equipped health systems, are the solutions to bringing the Covid-19 pandemic under control. But this won’t happen without urgent investment, explains Jeremy Farrar.  

 

The Wistar Institute [to 7 Nov 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 7 Nov 2020]
https://www.wfpha.org/
Latest News
Major National Barriers to Climate Change Adaptation for Public Health
Nov 6, 2020
Major National Barriers to Climate Change Adaptation for Public Health – What are the major government constraints to enactment and implementation of public health-targeted climate change adaptation (CCA) strategies? According to a recent study…

Call for Case Studies on Responses to COVID-19 Aimed at Improving and Sustaining Health Equity
Nov 6, 2020
Call for Case Studies on Responses to COVID-19 Aimed at Improving and Sustaining Health Equity – World Health Organisation (WHO) in collaboration with the Sustainable Health Equity Movement (SHEM) initiative is seeking submissions of case studies that…

Oral Health for Children: A Human Right
Nov 2, 2020
Oral Health for Children: A Human Right – Every child should have good oral health as a basic human right. The World Federation of Public Health Associations (WFPHA) has produced 1 webinar to pinpoint: The global challenge of child oral health Why is…

 

World Organisation for Animal Health (OIE) [to 7 Nov 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

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ARM [Alliance for Regenerative Medicine] [to 7 Nov 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 7 Nov 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 7 Nov 2020]
http://www.dcvmn.org/
News; Upcoming events
DCVMN manufacturers trigger successful Collaborative Registration Procedure (CRP) for WHO Prequalified Vaccines in Developing Countries
Geneva, 03nd November 2020 – Encouraged by open dialogue between WHO and DCVMN, vaccine manufacturers are actively pursuing the WHO Collaborative Registration Procedure: three companies – Biological E Ldt., Bharat Biotech International Ltd. and Serum Institute of India Pvt. Ltd.- were successful in registering their respective new WHO pre-qualified vaccines in eight developing countries: Democratic Republic of Congo, Eritrea, Ghana, Malaysia, Malawi, Nigeria, Sierra Leone, and Zambia.

The Collaborative Registration Procedure (CRP) was launched in 2013 to facilitate and accelerate the registration process for WHO-prequalified medicines and vaccines in 43 CRP-adopting countries [1]. It is based on information sharing between WHO prequalification services and National Regulatory Authorities (NRAs) by leveraging assessment and inspection reports of WHO prequalification, and thereby eliminating duplicative regulatory tasks, for in-country registration of quality-assured products, contributing to their wider availability. This procedure helps harmonize submissions and streamline the licensure process in many developing countries.

There has been a positive change in the registration process for WHO Prequalified vaccines during past few months [2]. The overall process has proceeded well within the stipulated 90 days period, likely due to the active consultation between NRA’s and WHO-CRP team, although the greater success of achieving maximum registrations through CRP is yet to come.
DCVMN calls for further support from governments to increase the value of WHO-Prequalification of vaccines towards accelerated global access goals.

1https://extranet.who.int/pqweb/medicines/collaborative-registration-faster-registration
[2https://www.who.int/pq-vector-control/resources/orient_crp.pdf?ua=1

 

ICBA – International Council of Biotechnology Associations [to 7 Nov 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 7 Nov 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

PhRMA [to 7 Nov 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
U.S. trade policy must prioritize American biopharmaceutical innovation and patient access
November 2, 2020
As the United States biopharmaceutical industry works around the clock to develop vaccines and treatments for COVID-19, it’s more important than ever that countries’ international trade policies facilitate patient access to innovative medicines. The pandemic has shed additional light on various countries’ unsustainable barriers that threaten availability, research and development of much-needed treatments and cures…

Journal Watch

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

What makes people intend to take protective measures against influenza? Perceived risk, efficacy, or trust in authorities

American Journal of Infection Control
November 2020 Volume 48 Issue 11 p1287-1414
http://www.ajicjournal.org/current

 

Major Articles
What makes people intend to take protective measures against influenza? Perceived risk, efficacy, or trust in authorities
Zepeng Gong, Justin Veuthey, Ziqiang Han
Published online: July 30, 2020
p1298-1304

A scoping review on the influential cognitive constructs informing public AMR behavior compliance and the attribution of personal responsibility

American Journal of Infection Control
November 2020 Volume 48 Issue 11 p1287-1414
http://www.ajicjournal.org/current

 

State of the Science Review
A scoping review on the influential cognitive constructs informing public AMR behavior compliance and the attribution of personal responsibility
Hayley Fletcher-Miles, John Gammon
Published online: February 14, 2020
p1381-1386

Variations in Hepatitis B Vaccine Series Completion by Setting Among Adults at Risk in West Virginia

American Journal of Preventive Medicine
November 2020 Volume 5 9Issue 5 p621-772
http://www.ajpmonline.org/current

 

Variations in Hepatitis B Vaccine Series Completion by Setting Among Adults at Risk in West Virginia
Stacy Tressler, Christa Lilly, Diane Gross, Thomas Hulsey, Judith Feinberg
Published online: October 01, 2020
e189-e196

A Timely History: Examining the History of the World Health Organization to Frame the Future of Global Health Governance

American Journal of Public Health
November 2020 110(11)
http://ajph.aphapublications.org/toc/ajph/current

 

WORLD HEALTH ORGANIZATION
A Timely History: Examining the History of the World Health Organization to Frame the Future of Global Health Governance
Global Health, History, Human Rights, Social Science, Health Law, Health Policy
Benjamin Mason Meier and Lawrence O. Gostin
110(11), pp. 1592–1594

ENOUGH: COVID-19, Structural Racism, Police Brutality, Plutocracy, Climate Change—and Time for Health Justice, Democratic Governance, and an Equitable, Sustainable Future

American Journal of Public Health
November 2020 110(11)
http://ajph.aphapublications.org/toc/ajph/current

 

DEMOCRATIC GOVERNANCE
ENOUGH: COVID-19, Structural Racism, Police Brutality, Plutocracy, Climate Change—and Time for Health Justice, Democratic Governance, and an Equitable, Sustainable Future
Other Race/Ethnicity, Socioeconomic Factors, Race/Ethnicity
Nancy Krieger
110(11), pp. 1620–1623

Measles Immunization: The Need for Evidence-Based School Entry Laws

American Journal of Public Health
November 2020 110(11)
http://ajph.aphapublications.org/toc/ajph/current

 

MEASLES
Measles Immunization: The Need for Evidence-Based School Entry Laws
Immunization/Vaccines, Infections, Child and Adolescent Health, Public Health Practice, Health Law, School Health
Gina M. Phillipi and Judith A. Guzman-Cottrill
110(11), pp. 1648–1649

Living Systematic Reviews and Other Approaches for Updating Evidence

American Journal of Public Health
November 2020 110(11)
http://ajph.aphapublications.org/toc/ajph/current

 

SYSTEMATIC REVIEWS
Living Systematic Reviews and Other Approaches for Updating Evidence
Public Health Practice, Statistics/Evaluation/Research, Community Health, Other Statistics/Evaluation/Research
Amy Lansky and Holly R. Wethington
110(11), pp. 1687–1688

What COVID-19 Reveals about the Neglect of WASH within Infection Prevention in Low-Resource Healthcare Facilities

American Journal of Tropical Medicine and Hygiene
Volume 103, Issue 5, November 2020
http://www.ajtmh.org/content/journals/14761645/103/5

 

Perspective Piece
oa What COVID-19 Reveals about the Neglect of WASH within Infection Prevention in Low-Resource Healthcare Facilities
Joanne A. McGriff and Lindsay Denny
Pages: 1762–1764
https://doi.org/10.4269/ajtmh.20-0638

Bringing a health systems modelling approach to complex evaluations: multicountry applications in HIV, TB and malaria

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

 

Bringing a health systems modelling approach to complex evaluations: multicountry applications in HIV, TB and malaria (3 November, 2020)
David E Phillips, Guillermo Ambrosio, Audrey Batzel, Carmen Cerezo, Herbert Duber, Adama Faye, Ibrahima Gaye, Bernardo Hernández Prado, Bethany Huntley, Edgar Kestler, Constant Kingongo, Stephen S Lim, Emily Linebarger, Jorge Matute, Godefroid Mpanya, Salva Mulongo, Caitlin O’Brien-Carelli, Erin Palmisano, Francisco Rios Casas, Katharine Shelley, Roger Tine, Daniel Whitaker, Jennifer M Ross

Availability and affordability of medicines and cardiovascular outcomes in 21 high-income, middle-income and low-income countries

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

 

Availability and affordability of medicines and cardiovascular outcomes in 21 high-income, middle-income and low-income countries (3 November, 2020)
Clara Kayei Chow, Tu Ngoc Nguyen, Simone Marschner, Rafael Diaz, Omar Rahman, Alvaro Avezum, Scott A Lear, Koon Teo, Karen E Yeates, Fernando Lanas, Wei Li, Bo Hu, Patricio Lopez-Jaramillo, Rajeev Gupta, Rajesh Kumar, Prem K Mony, Ahmad Bahonar, Khalid Yusoff, Rasha Khatib, Khawar Kazmi, Antonio L Dans, Katarzyna Zatonska, Khalid F Alhabib, Iolanthe Marike Kruger, Annika Rosengren, Sadi Gulec, Afzalhussein Yusufali, Jephat Chifamba, Sumathy Rangarajan, Martin McKee, Salim Yusuf