To contain Ebola, the United States must fulfil its promise to the World Health Organization

Nature
Volume 571 Issue 7764, 11 July 2019
http://www.nature.com/nature/current_issue.html

 

Editorial | 09 July 2019
To contain Ebola, the United States must fulfil its promise to the World Health Organization
WHO responders are braving bullets to end the outbreak in the Democratic Republic of the Congo, but the virus could cross borders without the pledged funding.

Ethical development of stem-cell-based interventions

Nature Medicine
Volume 25 Issue 7, July 2019
https://www.nature.com/nm/volumes/25/issues/7

 

Perspective | 03 July 2019
Ethical development of stem-cell-based interventions
The clinical translation of stem-cell-based therapeutic interventions has its own ethical and policy challenges requiring collaboration among wide-ranging stakeholders.
Amanda MacPherson  & Jonathan Kimmelman

Ethical development of stem-cell-based interventions

Nature Medicine
Volume 25 Issue 7, July 2019
https://www.nature.com/nm/volumes/25/issues/7

 

Perspective | 03 July 2019
Ethical development of stem-cell-based interventions
The clinical translation of stem-cell-based therapeutic interventions has its own ethical and policy challenges requiring collaboration among wide-ranging stakeholders.
Amanda MacPherson  & Jonathan Kimmelman

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?

New England Journal of Medicine
July 11, 2019 Vol. 381 No. 2
http://www.nejm.org/toc/nejm/medical-journal

 

Perspective
Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?
Ross D. Silverman, J.D., M.P.H., Douglas J. Opel, M.D., M.P.H., and Saad B. Omer, M.B., B.S., M.P.H., Ph.D.
…Such cases raise the question of whether adolescent minors should be able to consent to vaccinations without parental permission. For minors to be able to choose to be vaccinated over parental objections, most states would need to make substantive changes to laws governing medical consent. Since children are generally considered nonautonomous under U.S. law, treatment of a child in a medical setting requires parental permission, typically until a child reaches 18 years of age. Parents are generally given broad discretion in making decisions on behalf of their children, in part because they know their child best, are positioned to weigh competing family interests, and are permitted to raise their child as they choose. Such discretion doesn’t mean that adolescents have no role in decisions that affect them, however. Out of respect for adolescents’ developing autonomy, clinicians routinely explore their understanding of health-related issues, solicit their agreement on care plans, navigate discordance between parental and adolescent preferences, and protect adolescents’ confidentiality interests.2
Both ethical principles and state laws also support independent decision making by adolescents in cases in which failing to grant adolescents autonomy could foreseeably result in substantial risk to the minor or to public health. For instance, all states have laws permitting minors to make independent, confidential clinical decisions regarding certain sensitive or stigmatized health care services, such as those related to sexual health, reproduction, mental health, and substance use disorders. Roughly 20% of jurisdictions require adolescents to be at least 12 or 14 years of age to make such decisions; others don’t designate a minimum age of consent.3 A court may also grant an older adolescent (typically 16 years or older) legal emancipation or deem the adolescent to be a “mature minor” who is able to make certain decisions independently.
Most states, however, don’t authorize adolescents to independently consent to vaccination…

A multilevel analysis of the determinants of missed opportunities for vaccination among children attending primary healthcare facilities in Kano, Nigeria: Findings from the pre-implementation phase of a collaborative quality improvement programme

PLoS One
http://www.plosone.org/
[Accessed 13 Jul 2019]

 

Research Article
A multilevel analysis of the determinants of missed opportunities for vaccination among children attending primary healthcare facilities in Kano, Nigeria: Findings from the pre-implementation phase of a collaborative quality improvement programme
Abdu A. Adamu, Olalekan A. Uthman, Muktar A. Gadanya, Olatunji O. Adetokunboh, Charles S. hu
Published: July 10, 2019 https://doi.org/10.1371/journal.pone.0218572

Global thinking on migration, ethnicity, race and health: why essential and what next?

Public Health
Volume 172, Pages A1-A2, 1-152 (July 2019)
https://www.sciencedirect.com/journal/public-health/vol/172/suppl/C

 

Special issue on Migration, Ethnicity, Race and Health
Edited by Laurence Gruer, Fiona Stanaway, Emma Davidson
Editorial No access
Global thinking on migration, ethnicity, race and health: why essential and what next?
R. Bhopal
Pages 83-84

Polio eradication campaign loses ground

Science
12 July 2019 Vol 365, Issue 6449
http://www.sciencemag.org/current.dtl

 

In Depth
Polio eradication campaign loses ground
By Leslie Roberts
Science12 Jul 2019 : 106-107 Restricted Access
Surging cases in Pakistan and Africa have dashed hopes of defeating the virus this year.
Summary
The global initiative to eradicate polio is badly stuck, battling the virus on two fronts. New figures show the wild polio virus remains entrenched in Afghanistan and Pakistan, its other holdout, where cases are surging. The main problem in both countries is that the massive vaccination campaigns held every few months are still not reaching every child. In Africa, meanwhile, the vaccine itself is spawning virulent strains that are hard to contain. The leaders of the world’s biggest public health program are admitting for the first time that success is not just around the corner—and intensively debating how to break the impasse.

Certify reproducibility with confidential data

Science
12 July 2019 Vol 365, Issue 6449
http://www.sciencemag.org/current.dtl

 

Policy Forum
Certify reproducibility with confidential data
By Christophe Pérignon, Kamel Gadouche, Christophe Hurlin, Roxane Silberman, Eric Debonnel
Science12 Jul 2019 : 127-128 Restricted Access
A trusted third party certifies that results reproduce
Summary
Many government data, such as sensitive information on individuals’ taxes, income, employment, or health, are available only to accredited users within a secure computing environment. Though they can be cumbersome to access, such microdata can allow researchers to pursue questions that could not be addressed with only public data (1). However, researchers using confidential data are inexorably challenged with regard to research reproducibility (2). Empirical results cannot be easily reproduced by peers and journal referees, as access to the underpinning data are restricted. We describe an approach that allows researchers who analyze confidential data to signal the reproducibility of their research. It relies on a certification process conducted by a specialized agency accredited by the confidential-data producers and which can guarantee that the code and the data used by a researcher indeed produce the results reported in a scientific paper.

Enhanced CAR–T cell activity against solid tumors by vaccine boosting through the chimeric receptor

Science
12 July 2019 Vol 365, Issue 6449
http://www.sciencemag.org/current.dtl

 

Reports
Enhanced CAR–T cell activity against solid tumors by vaccine boosting through the chimeric receptor
By Leyuan Ma, Tanmay Dichwalkar, Jason Y. H. Chang, Benjamin Cossette, Daniel Garafola, Angela Q. Zhang, Michael Fichter, Chensu Wang, Simon Liang, Murillo Silva, Sudha Kumari, Naveen K. Mehta, Wuhbet Abraham, Nikki Thai, Na Li, K. Dane Wittrup, Darrell J. Irvine
Science12 Jul 2019 : 162-168 Restricted Access
Vaccine boosting enhances chimeric antigen receptor–T cell immunotherapy for cancer.
A boost for CAR–T cells
Editor’s Summary
Chimeric antigen receptor (CAR)–T cell immunotherapy has been highly successful for treating certain blood cancers. Yet this approach has been a challenge for solid tumors, in part because it is difficult to target functional engineered T cells to the tumor site. Ma et al. designed a vaccine strategy to improve the efficacy of CAR–T cells by restimulating the CAR directly within the native lymph node microenvironment (see the Perspective by Singh and June). Injected “amph-ligand” vaccines promoted synthetic antigen presentation and led to CAR–T cell activation, expansion, and increased tumor killing. The system could potentially be applied to boost any CAR–T cell.
Abstract
Chimeric antigen receptor–T cell (CAR-T) therapy has been effective in the treatment of hematologic malignancies, but it has shown limited efficacy against solid tumors. Here we demonstrate an approach to enhancing CAR-T function in solid tumors by directly vaccine-boosting donor cells through their chimeric receptor in vivo. We designed amphiphile CAR-T ligands (amph-ligands) that, upon injection, trafficked to lymph nodes and decorated the surfaces of antigen-presenting cells, thereby priming CAR-Ts in the native lymph node microenvironment. Amph-ligand boosting triggered massive CAR-T expansion, increased donor cell polyfunctionality, and enhanced antitumor efficacy in multiple immunocompetent mouse tumor models. We demonstrate two approaches to generalizing this strategy to any chimeric antigen receptor, enabling this simple non–human leukocyte antigen–restricted approach to enhanced CAR-T functionality to be applied to existing CAR-T designs.

Influence of health interventions on quality of life in seriously ill children at the end of life: a systematic review protocol

Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 13 Jul 2019]

 

Protocol
Influence of health interventions on quality of life in seriously ill children at the end of life: a systematic review protocol
Seriously ill children suffer from numerous symptoms at the end of their lives, including pain, anxiety, and restricted communication. There are currently no comprehensive overviews of which health interventions.
Authors: Veerle E. Piette, Joachim Cohen, Luc Deliens, Nele Pauwels, Jutte van der Werff ten Bosch and Kim Beernaert
Citation: Systematic Reviews 2019 8:165
Published on: 11 July 2019

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Gynecologic Oncology
June 2019 Volume 154, Supplement 1, Page 225
Abandoning the HPV vaccine in Japan due to safety concerns-where is the evidence?
CI Liao, DA Klein, AK Mann, DS Kapp, JK Chan –
Objective: The reported HPV vaccine rates in Japan have dropped from 70% to near zero because of concerns of safety. We proposed to compare the regional and systemic safety profiles of HPV vaccine in Japanese versus whites in a meta-analysis to address these beliefs.

 

Cancer Treatment Reviews
Volume 78, August 2019, Pages 8-16
Anti-Tumour Treatment
The Promise of Combining Cancer Vaccine and Checkpoint Blockade for Treating HPV-Related Cancer
T Shibata, BJ Lieblong, T Sasagawa, M Nakagawa – 2019
Highlights
:: HPV have ingenious immune suppressive mechanisms.
:: Checkpoint inhibitors have little efficacy against HPV-associated cancers.
:: HPV therapeutic vaccines have little efficacy against HPV-associated cancers.
:: However, combining these two therapeutic modalities is starting to show promise.
:: Epitope spreading may play a critical role mechanistically in this combination.

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 13 Jul 2019
Health
What the Measles Epidemic Really Says About America
The return of a vanquished disease reflects historical amnesia, declining faith in institutions, and a troubling lack of concern for the public good.
Peter Beinart
August 2019 Issue

 

BBC
http://www.bbc.co.uk/
Accessed 13 Jul 2019
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 13 Jul 2019
Global
Are social media to blame for a decline in vaccine uptake?
July 03, 2019 Professor David Salisbury
England’s health minister thinks that social media companies should be forced to remove false information about vaccines, but Professor David Salisbury, associate fellow at the Centre on Global Health Security, Chatham House, London, says other factors are at play around vaccine uptake

 

Financial Times
http://www.ft.com/home/uk
Accessed 13 Jul 2019
[No new, unique, relevant content]

 

Forbes
http://www.forbes.com/
Accessed 13 Jul 2019
[No new, unique, relevant content]

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 13 Jul 2019
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 13 Jul 2019
[No new, unique, relevant content]

 

The Guardian
http://www.guardiannews.com/
Accessed 13 Jul 2019
Vaccines and immunisation
‘Worry is contagious’: the vaccine-hesitant parents putting children at risk
More than committed anti-vaxxers, parents who are unsure about vaccination are one of the top 10 threats to global health this year. What’s behind this crisis of confidence?
Hattie Garlick Sat 13 Jul 2019 05.01 EDT

 

New Yorker
http://www.newyorker.com/
Accessed 13 Jul 2019
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 13 Jul 2019
Business
Johnson & Johnson to Test Experimental HIV Vaccine in U.S., Europe
Johnson & Johnson said on Friday it plans to conduct a late-stage study of its investigational vaccine for Human Immunodeficiency Virus (HIV) in several countries across the Americas and Europe, including the United States.
By Reuters
July 12

 

Washington Post
http://www.washingtonpost.com/
[No new, unique, relevant content]

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 13 Jul 2019
[No new relevant content]

 

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

 

CSIS
https://www.csis.org/
Accessed 13 Jul 2019
[No new relevant content]

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 13 Jul 2019
[No new relevant content]

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 13 Jul 2019
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 06 July 2019

.– 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_6 Jul 2019

– 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

Immunization Agenda 2030 – WHO

Milestones :: Perspectives :: Research

 

Immunization Agenda 2030 – WHO
As we approach the end of the Decade of Vaccines and with just a couple of years remaining on the Global Vaccine Action Plan (GVAP 2011-2020) a new global strategy for immunization is needed for the entire health and development community – one that reflects the collective inputs of people, communities, governments, civil society, health professionals, academia, development agencies, and the private sector.

A consortium of immunization stakeholders, together with World Health Organization, took the lead in sketching some ideas on post 2020.

In May 2019, an initial draft (“Draft Zero”) assembling ideas, thoughts and content on a new vision and strategic framework for 2030 was disseminated broadly for public consultation. Over 2800+ specific comments were received from over 250+ stakeholders on the “Draft Zero” – including stakeholders from the global, regional, national and sub-national levels.

“Draft One” incorporates this stakeholder feedback and is now available for a consultations up until August 5. Over the course of July, consultations will be held with country stakeholders to get in-depth feedback and finalize the document.

The final document will be submitted to SAGE for review in October 2019, and will be endorsed by WHO Member States at the 73rd World Health Assembly in May 2020.
Draft one:
English pdf, 1.05Mb
French pdf, 1.24Mb
Spanish pdf, 1.04Mb

To ensure the inputs and voices of everyone is heard, we encourage everyone to review the document and share comments and feedback no later than August 5, 2019 by email to: immunizationagenda2030@who.int

Tackling misinformation & building trust to achieve universal health coverage: A UN high-level event to champion children’s right to immunization

Milestones :: Perspectives :: Research

 

Tackling misinformation & building trust to achieve universal health coverage: A UN high-level event to champion children’s right to immunization
[UN Web TV [1:16: 12]
28 Jun 2019 –  UNICEF and the Permanent Mission of Japan to the United Nations are holding a high-level event to bring together decision makers, the global health community, governments, civil society actors, and the private sector, including technology companies to take action in combating misinformation on vaccination, building trust and confidence on vaccines and improving quality of care to ensure children worldwide have access to vaccination. This will be the first event of its kind, focusing on misinformation and vaccination, to take place at the UN.

Over the last three decades, the world has seen significant improvements in health and well- being of children.  Access to vaccination has contributed to a dramatic decrease in under-five deaths. The world is on the brink of eradicating deadly diseases that were, until recently, affecting millions of children. But more important challenges remain. Despite clear evidence around the power of vaccines to save lives and control disease, millions of young children around the world are missing out, putting them and their communities at risk of diseases and deadly outbreaks.   Access to quality primary health care, including immunization, which is critical to achieving Universal Health Coverage, is greatly undermined by weak health systems, poverty and conflict.

New challenges are also emerging. A combination of complacency and skepticism on the safety and effectiveness of vaccines, fueled by the proliferation of online misinformation, is increasing public uncertainty about the necessity and importance of immunization, threatening gains made so far.

 

Objectives of the event
:: Build commitment and leadership by countries to acknowledge that despite considerable progress in increasing global vaccine coverage, some countries struggle to provide quality immunization services and affordable vaccines. Countries need to invest domestic resources and provide political commitment to invest in immunization, an entry point to strengthen primary health care, which is central to ensuring universal health coverage.

:: Provide a platform for informed dialogue on ways to address stagnation and reverse declining vaccination rates, build broad-based public trust and demand for immunization, counter misinformation and misunderstandings about vaccine effectiveness and safety, and reinvigorate global efforts to achieve SDG 3.8’s target of access to “safe, effective, quality and affordable essential medicines and vaccines for all.

:: Provide a platform for informed dialogue on ways to address stagnation and reverse declining vaccination rates, build broad-based public trust and demand for immunization, counter misinformation and misunderstandings about vaccine effectiveness and safety, and reinvigorate global efforts to achieve SDG 3.8’s target of access to “safe, effective, quality and
affordable essential medicines and vaccines for all.”

vaccines for all.
Remarks by Henrietta Fore, UNICEF Executive Director, at the opening of a UN high-level event to tackle misinformation and champion children’s right to immunization, New York,
01/07/2019 Press Release
[Excerpt]
“…As a global community, we need new tactics to build public trust in vaccines and break down not only the barriers of hesitancy, but of availability, cost and access.

We call on governments and donors to invest in quality health systems that deliver quality and affordable immunizations to all children. No matter who they are or where they live. This includes support for health professionals and community workers to give concerned parents accurate information about why vaccines work, and why they’re so important.

We call on technology companies — like the ones represented here today — to do more to promote credible, quality and scientifically proven content about vaccines. This could include modifying search and recommendation algorithms to combat misinformation, and prioritize true, verified information at the top of any search result. Let’s work on this together.

And we call on all parents, everywhere, to vaccinate their children.

UNICEF’s own experience shows that we can make a difference across all these areas. In the Philippines, we worked closely with the government to ensure that vaccination services reach all children. We’re also running “Community for Immunity” — a social media campaign to encourage parents to vaccinate their children using scientifically accurate information on measles.

The result? The measles outbreak is now contained, with 30 per cent fewer cases by May of this year compared to the same period in 2018.

The lesson is clear. If we combine stronger programmes and greater access to vaccines with scientifically accurate information to build trust, we can break down the many barriers between children and the vaccinations they need and deserve.

And along the way, we strengthen basic health services in the communities that most need these improvements. A key step in our goal of universal health coverage — in which every person, no matter where they live, has access to the primary health services they need. Including immunizations.

Vaccines work. But that doesn’t mean that our work is over.

Let’s continue improving access to these lifesaving vaccinations. Everywhere. Let’s push back against the rising tide of misinformation and mistrust. Let’s make sure we leave no one behind.”

G20 Osaka Leaders’ Declaration

Milestones :: Perspectives :: Research

G20 Osaka Leaders’ Declaration
G20 Summit, Osaka, Japan June 28 to 29, 2019
[Excerpt]
…Global Health
30. Health is a prerequisite for sustainable and inclusive economic growth. We recall our commitment to moving towards achieving universal health coverage according to national contexts and priorities. We look forward to the United Nations General Assembly High Level Meeting on Universal Health Coverage (UHC). Primary health care including access to medicines, vaccination, nutrition, water and sanitation, health promotion and disease prevention is a cornerstone for advancing health and inclusion. We will strengthen health systems with a focus on quality including through enhancing health workforce and human resources for policy development and promoting public and private sector innovation, such as cost-effective and appropriate digital and other innovative technologies. Recognizing the importance of sustainable financing for health, we will call for greater collaboration between health and finance authorities in accordance with the G20 Shared Understanding on the Importance of UHC Financing in Developing Countries, to which our commitment was affirmed by our Finance and Health Ministers at their Joint Session. We encourage international organizations and all stakeholders to collaborate effectively and we look forward to the upcoming presentation of the global action plan for healthy lives and well-being for all.

31. We will promote healthy and active ageing through policy measures to address health promotion, prevention and control of communicable and non-communicable diseases, and through people-centered, multi-sectoral, community-based integrated health and long-term care over the life course in accordance with national context including demographic trends. We will implement comprehensive set of policies to address dementia, including promoting risk reduction and sustainable provision of long-term care as well as inclusive societies aiming to improve quality of lives of people with dementia and caregivers.

32. We are committed to improving public health preparedness and response including strengthening our own core capacities and supporting capacities of other countries in compliance with the World Health Organization (WHO) International Health Regulations (2005). We will support countries suffering from the current Ebola outbreak in Africa, through both timely financial and technical assistance and in line with the central coordination responsibility that WHO has for international responses to health emergencies. We will work for the sustainability and efficiency of global health emergency financing mechanisms. We reaffirm our commitment to eradicate polio as well as to end the epidemics of AIDS, tuberculosis and malaria and look forward to the success of the sixth replenishment of the Global Fund to fight AIDS, Tuberculosis, and Malaria.

33. We will accelerate efforts based on the One-Health approach to tackle antimicrobial resistance (AMR). Recognizing the UN Secretary-General’s report on AMR, which was informed by the recommendations of the UN Interagency Coordination Group on AMR and other relevant initiatives, we encourage all stakeholders including international organizations to act and coordinate on those items relevant to their missions that contribute to global efforts to combat AMR. We recognize the need for policy measures for infection prevention and reduction of excessive antimicrobial usage. Further action should be taken to promote stewardship of and access to antimicrobials. Noting the ongoing work done by Global AMR R&D Hub, we will promote R&D to tackle AMR. We call on interested G20 members and Global AMR R&D Hub to analyze push and pull mechanisms to identify best models for AMR R&D and to report back to relevant G20 Ministers…

WHO launches five-year plan to improve the quality and safety of health products

Milestones :: Perspectives :: Research

 

WHO launches five-year plan to improve the quality and safety of health products
1 July 2019 | News release
…Despite global progress, serious problems with health product quality and safety persist, particularly in lower- and middle-income countries. These problems threaten the health of people every day and waste resources. Quality and safety of medicines, vaccines and other products are compromised when manufacturers, whether by accident or intent, produce substandard products, when the supply chain allows unsafe medical products through, and when systems (usually due to lack of resources) are too slow to respond to adverse events.

Current regulatory capacity and enforcement are insufficient in most developing countries. WHO estimates that only 3 out of 10 regulatory authorities globally function according to acceptable standards. To compound that, manufacturing of health products has become increasingly globalized, with products and the materials that go into them crossing several borders before they reach patients, requiring even greater global vigilance. And with the rise of non-communicable diseases, such as cancer, cardiovascular conditions and diabetes, regulatory authorities in developing countries are facing greater workloads and new demands to regulate innovative products.

Universal health coverage will bring about greater access to medical products, but we must ensure that those products are quality-assured, safe and effective so that they do what they are supposed to do – prevent illness and improve people’s health. That is why today’s launch of WHO’s five-year plan ‘Delivering Quality-assured Medical Products for All 2019–2023’ is important.

 

The plan outlines work and activities to reach four main objectives:
[1] Strengthen country and regional regulatory systems – improving the functioning of regulatory authorities but also speeding up product registration timelines so that patients can get the product sooner, and facilitating cross-border collaboration;
[2] Increase regulatory preparedness for public health emergencies – equipping regulators with the knowhow to deal with emergencies, including by fast-tracking product approval processes and improving crisis communication;
[3] Strengthen and expand WHO prequalification – WHO prequalification of priority health products has contributed to treating millions of people with quality, cost-effective HIV medicines, as well as to the vaccination of millions of children through Gavi, the Vaccine Alliance. It is now expanding to include cancer medicines as the cancer burden grows in low- and middle-income countries;
[4] Increase the impact of WHO’s Regulatory Support activities – by aligning work across all levels of the organization, with particular attention given to countries’ needs.

Providing oversight of health products throughout their lifecycle – from laboratory to health facility – is the linchpin of effective prevention, diagnosis and treatment and an essential part of WHO’s drive towards universal health coverage. While WHO has worked to improve the quality and safety of health products for many years, this is the first time we are aligning goals and activities with global partners (Bill and Melinda Gates Foundation, UNITAID, The Global Fund to Fight AIDS, TB and Malaria, GAVI and UNICEF) to ensure full coordination and work towards a common goal – to deliver a safe and quality-assured supply of medicines, vaccines, medical devices and other health products for all populations.

 

External assessment report of the programmes, prequalification and regulatory supporting activities
WHO makes available the outcomes of an external assessment report of the programmes, prequalification and regulatory supporting activities. The review aims to increase a fact-based understanding of the impact and value of WHO’s work on prequalification of medicines, vaccines and in-vitro diagnostics and supporting regulatory activities, including norms and standards setting, regulatory systems strengthening, safety monitoring and vigilance.

 

Key findings:
:: WHO Prequalification (PQ) programme enables a core market of approximately US$3.5 billion with the majority coming from vaccines
:: WHO PQ has a Return on Investment of 30-40 to 1 for the PQ-enabled donor-funded market (US$ million)
:: Most donors and procurers and implementing partners view PQ approval as equivalent to approvals by stringent regulatory authorities
:: 340-400 million more patients have access thanks to resources freed up by PQ
:: National regulatory authorities (NRAs) relying on Collaborative Registration Procedure (CRP) have achieved significant acceleration of approval timelines vs pre-CRP registrations

 

Impact on countries:
:: Since 1997, WHO trained more than 8’000 NRA staff worldwide and number of functional NRAs increased by 70%
:: Four types of inspection-related capacity building activities are held to support local NRAs
:: A positive correlation is observed between the number of substandard and falsified medical products reported and the number of trained focal points
:: Number of reports on adverse events in medicines has increased in regions with extensive training activities
:: Number of countries with basic vaccine safety monitoring system has increased with workshops held in the regions

 

Opportunities for improvement:
:: Improve external communication and operational efficiency
:: Strengthen cross-functional collaboration and communication
:: Increase cooperation with entities outside of the department, e.g. emergencies, procurement
:: Continue efforts to expand existing PQ-product list with a more end-to-end lifecycle view
:: Increase awareness of WHO support provided during the early development phase of a product

The truth about PHEICs

Featured Journal Content

 

The Lancet
Correspondence | Online First
The truth about PHEICs
Johan Giesecke on behalf of STAG-IH
Published: July 05, 2019 DOI:https://doi.org/10.1016/S0140-6736(19)31566-1

The recent decision by the WHO Director-General that the Ebola virus outbreak in DR Congo does not constitute a Public Health Emergency of International Concern (PHEIC)1 has generated controversy, as articulated by the Editors2 of The Lancet. Members of the WHO Strategic and Technical Advisory Group for Infectious Hazards (STAG-IH) have discussed this Editorial and would like to clarify the role of the International Health Regulations (IHR) and the designation of a PHEIC.

The predecessor to the IHR, the International Sanitary Regulations (ISR), were agreed upon in 1851 by diplomats from 12 European countries to protect against cross-border transmission of disease (mainly cholera) in a way that minimised interference with international trade and travel. In 1969, the World Health Assembly (WHA) adapted and renamed the ISR as the IHR.3 Until its most recent revision in 2005, the IHR considered only cholera, plague, and yellow fever, with smallpox—after its eradication—having been removed from the original IHR by a minor revision in the 1980s.

In 2003, the emergence of severe acute respiratory syndrome, followed shortly thereafter by the avian influenza (H5N1) outbreak, underlined the need for rapidly concluding the IHR revision that had been requested by the WHA in a 1995 resolution. IHR (2005) represents a consensus among all WHO Member States to cooperate for global health security. It shifts the focus from quarantine and embargoes at borders to containment at source, increases the emphasis on preparedness by requiring all countries to maintain necessary core capacities in surveillance and response, and widens the scope from reporting of a predefined disease list to reporting of a public health event based on a decision tree analysis.

Through its legal framework, IHR (2005) ensures rapid collection of information, availability of international support to affected countries, and a common understanding of what constitutes a PHEIC: “an extraordinary event which is determined…to constitute a public health risk to other States through the international spread of disease”. Trade and traffic remain as important to the IHR as they did in 1969—the regulations are meant to prevent unwarranted restrictions on travel and trade that do not rest on a science-based risk analysis.

The decision to declare a PHEIC lies with the WHO Director-General and requires the input of a committee of experts—the IHR emergency committee. By declaring a PHEIC, the Director-General requires state parties to share critical information for risk assessment, adjust response plans if deemed necessary, and implement temporary recommendations formulated by the emergency committee. As the Acting Chair of the emergency committee for Ebola stated on June 14, 2019,1 the declaration of a PHEIC for the current Ebola outbreak would add no clear benefit in any of these three areas. Both DR Congo and Uganda are providing information in a timely manner, and 10 months into the outbreak (with innumerable daily border crossings of inhabitants in the area), the recent event in Uganda is confined to close family members. Members of the emergency committee cited potential disadvantages of a PHEIC declaration (effects on travel and trade that could impede support to affected regions and hinder outbreak control) and provided technical advice that the STAG-IH supports fully.

Since 2005, WHO has declared four PHEICs: the H1N1 influenza virus pandemic (2009), the resurgence of wild poliovirus (2014), the west Africa Ebola virus outbreak (2014), and the Zika virus outbreak (2018). As international public health emergencies evolve into more complex forms, it becomes necessary to identify gaps in the alarm and response mechanisms, and the WHA has called for two reviews of IHR (2005): one in 2010, after the H1N1 influenza virus pandemic, and a second in 2015, to examine the response to the west Africa Ebola virus outbreak. Citing the difficulties and potential risks in opening an accepted international agreement to revision, Member States requested a mechanism to independently monitor WHO’s ongoing risk assessment. STAG-IH has its origin in this request, and has since its first meeting in 2018 reviewed WHO’s risk assessments and responses before and between the emergency committee’s three meetings about the current Ebola virus outbreak.

The public health community must recognise the close link between disease and trade inherent in IHR (2005) and the risks and benefits of using this strong instrument of international law to raise awareness and resources—a policy that could jeopardise the future effectiveness of these regulations in sectors of society other than health.

References
1. WHO
Statement on the meeting of the International Health Regulations (2005) Emergency Committee for Ebola virus disease in the Democratic Republic of the Congo.
https://www.who.int/news-room/detail/14-06-2019-statement-on-the-meeting-of-the-international-health-regulations-(2005)-emergency-committee-for-ebola-virus-disease-in-the-democratic-republic-of-the-congo
Date: June 14, 2019
Date accessed: June 23, 2019
View in Article
Google Scholar

2. The Lancet
The politics of PHEIC.
Lancet. 2019; 3932470
View in Article
Google Scholar

3. WHO
Strengthening health security by implementing the International Health Regulations.
https://www.who.int/ihr/current/en/
Date: 2005
Date accessed: June 23, 2019

DRC – Ebola/Cholera/Polio/Measles

Featured Journal Content

 

DRC – Ebola/Cholera/Polio/Measles

Disease Outbreak News (DONs}
Ebola virus disease – Democratic Republic of the Congo
4 July 2019
The outbreak of Ebola virus disease (EVD) in North Kivu and Ituri provinces, Democratic Republic of the Congo continued with a steady transmission intensity this week. Indicators demonstrated the early signs of transmission easing in intensity in some major hotspots, such as Butembo and Katwa. The current hotspots are the health zones of Beni, Mabalako, and Mandima, with some cases being exported from these hotspot areas into unaffected health zones. There is a slight but notable increase in the number of new cases occurring in areas that previously had lower rates of transmission, such as the Komanda, Lubero, and Rwampara/ Bunia health zones…
…No new EVD cases or deaths have been reported in the Republic of Uganda since the previous EVD Disease Outbreak News publication on 13 June 2019. As of 26 June, 108 exposed contacts were identified, and they are in the process of completing the 21-day follow-up period…
WHO risk assessment
WHO continuously monitors changes to the epidemiological situation and context of the outbreak to ensure that support to the response is adapted to the evolving circumstances. The last assessment concluded that the national and regional risk levels remain very high, while global risk levels remain low…

 

::::::

More than a million people to be vaccinated in phase 2 of a huge cholera vaccination campaign in the Democratic Republic of the Congo
MBUJI-MAYI / GENEVA, 3 JULY 2019 — Phase 2 of the biggest ever oral vaccination campaign against cholera is scheduled to take place from 3-8 July 2019 in 15 health districts in the four central provinces of the Democratic Republic of the Congo (DRC) – Kasaï, Kasaï Oriental, Lomami et Sankuru. The second dose of vaccine confers lasting immunity against cholera, and is being targeted at 1,235,972 people over 1 year of age. The 5-day, door-to-door campaign will involve 2632 vaccinators recruited mainly from local communities, whose job it is to administer the oral cholera vaccine, fill in vaccination cards and tally sheets, and compile a daily summary of the teams’ progress.

In parallel, 583 community mobilizers have been selected – 1 mobilizer for every 3 teams in urban areas and 1 mobilizer for every 2 teams in rural districts. Their job is to alert local people that vaccinators will visit their homes. They will use loudspeakers to spread the message, particularly in the early evening. The campaign is organized by the Ministry of Health with technical, logistic and financial support from WHO, Gavi, the Vaccine Alliance and the Global Task Force on Cholera Control (GTFCC). It is the second such campaign in this central region of the DRC. 1,224,331 people over 1 year of age were vaccinated during the first round in late December 2018. The purpose of the vaccination campaign is to contain the serious epidemic which resulted in 9154 presumed cases and 458 deaths (case-fatality rate of 5%) in the 5 affected provinces in Kasaï region between January and December 2018.

This cholera vaccination campaign marks the intensification of our response in the DRC,” said Dr Matshidiso Moeti, WHO Regional Director for Africa, “WHO and our partners are working with national authorities to rollout the vaccine, which comes in addition to multiple interventions introduced since the beginning of the cholera epidemic, including sanitation and water quality control in the affected areas, many of which have little access to a safe water supply.”

Right now, with the second dose, the preventive campaign for which 1,235,972 doses of oral vaccine have been laid in will ensure coverage of all at-risk areas in this central region of the DRC. The vaccines have been provided from global cholera vaccine stocks managed by Gavi, the Vaccine Alliance. “This vaccination campaign will play a key role in bringing this cholera outbreak under control,” said Dr Seth Berkley, CEO of Gavi. “The DRC is currently going through an unprecedented combination of deadly epidemics, with Ebola and measles outbreaks also causing untold misery across the country. It is vital that the global effort to control these outbreaks continues to receive support: we cannot allow this needless suffering to continue.”…

 

::::::

Polio – Democratic Republic of Congo (DR Congo) 3 July 2019
:: One case of circulating vaccine-derived poliovirus type 2 (cVDPV2) has been reported this week in the Democratic Republic of the Congo (DR Congo) in Kasai province, Kamonia district, with onset of paralysis on 28 May 2019 bringing the total number of cVDPV2 cases to six.  The total number of cVDPV2 cases reported in 2018 is 20.  DRC is currently affected by six separate cVDPV2 outbreaks, in the provinces of Haut Katanga; Mongala; Haut Lomami/Tanganika/Haut Katanga/Ituri, Sankuru and Kasai (2).
:: Read our Democratic Republic of the Congo country page to see information on surveillance and vaccination campaigns

Emergencies

Emergencies

 

POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 3 July 2019
:: G20 Leaders met on 28-29 June 2019 in Osaka, Japan, and discussed major challenges facing the world and the importance of eradicating polio. The G20 declaration states, “We reaffirm our commitment to eradicate polio as well as to end the epidemics of AIDS, tuberculosis and malaria and look forward to the success of the sixth replenishment of the Global Fund to fight AIDS, Tuberculosis, and Malaria.” Read more here.
:: A second cVDPV2 outbreak has been reported in Angola this year; the earlier outbreak was detected in Lunda Norte province; for which an outbreak response is in progress (in close coordination with DRC). The Global Polio Eradication Initiative (GPEI) Outbreak Preparedness and Response Task Team (OPRTT) is also supporting the Angola polio eradication team on planning the response to the new outbreak in Huila.
:: The World Health Organization is seeking Expressions of Interest from public- and private-sector vaccine manufacturers and other institutions on development and manufacture of affordable poliovirus virus-like-particle vaccine.  Read more here

 

Summary of new viruses this week:
:: Afghanistan —two wild poliovirus type 1 (WPV1)-positive environmental samples;
:: Pakistan — five WPV1 cases and 18 WPV1-positive environmental samples;
:: Nigeria — five circulating vaccine-derived poliovirus type 2 (cVDPV2)-positive environmental samples case;
:: DR Congo —  one cVDPV2 case;
:: Angola—  one cVDPV2 case and four cVDPV2 isolated from healthy community contacts.

 

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

Editor’s Note:
WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below.

WHO Grade 3 Emergencies [to 6 Jul 2019]

Democratic Republic of the Congo
:: More than a million people to be vaccinated in phase 2 of a huge cholera vaccination campaign in the Democratic Republic of the Congo 3 July 2019
:: 48: Situation report on the Ebola outbreak in North Kivu 2 July 2019
:: Disease Outbreak News (DONs} Ebola virus disease – Democratic Republic of the Congo
4 July 2019
[See DRC Ebola+ above for detail]

Syrian Arab Republic
:: WHO delivers healthcare to displaced people in north-west Syrian Arab Republic
2 July 2019

Yemen
:: WHO supports emergency medical care in Al Thawra Hospital, Sana’a, Yemen
2 July 2019

Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Myanmar – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified

 

::::::

WHO Grade 2 Emergencies [to 6 Jul 2019]

Ethiopia
:: Ethiopia sets new standards for the management of acute malnutrition 26 June 2019

Afghanistan – No new digest announcements identified
Bangladesh – Rakhine conflict – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Cyclone Idai – 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
MERS-CoV – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – 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 6 Jul 2019]

Angola – No new digest announcements identified
Chad – No new digest announcements identified
Djibouti – No new digest announcements identified
Indonesia – Sulawesi earthquake 2018 – No new digest announcements identified
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
:: Syria: Humanitarian Response in Al Hol camp, Situation Report No. 5 – As of 5 July 2019
Published on 05 Jul 2019
HIGHLIGHTS
:: The camp population is at 70,097 individuals or 19,824 households, as of 26 June; more than 90% are children and women. The decrease in numbers from 73,782 four weeks ago, is the result of updated distribution figures, a slight increase in repatriation of 3rd country nationals and the return of hundreds of internally displaced Syrians to Raqqa governorate.
:: A total of 35 humanitarian partners; UN agencies and other humanitarian organisations, are delivering a range of services and activities in the camp. Needs remain considerable across all sectors; such as in protection, health, water, sanitation and hygiene, shelter and education. Water quantity and quality, poor hygiene conditions, inadequate feeding habits and limited health services pose challenges.
:: Past month has seen a slight increase in acute malnutrition, and a sharp increase in acute diarrhea. However, overall emergency thresholds have not been breached and assistance efforts remain within SPHERE standards…
:: Humanitarian access to the annexes hosting some 11,000 foreign nationals, who are not Iraqi nor Syrian, has slightly improved although it remains restricted, particularly in the evening and during night time – and continues to impact and prevent delivery of services 24/7. More approvals are being granted to humanitarian actors to access the annexes and one INGO already has a static health center in an annex.

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.
Editor’s Note:
Ebola in the DRC has bene added as a OCHA “Corporate Emergency” this week:
CYCLONE IDAI and Kenneth – No new digest announcements identified
EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

 

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

WHO & Regional Offices [to 6 Jul 2019]

WHO & Regional Offices [to 6 Jul 2019]
5 July 2019
Developing the Immunization Agenda 2030
[See Milestones above for detail]

3 July 2019 News release
More than a million people to be vaccinated in phase 2 of a huge cholera vaccination campaign in the Democratic Republic of the Congo
[See DRC – Ebola + above for detail]

1 July 2019 | News release
WHO launches five-year plan to improve the quality and safety of health products
[See Milestones above for detail]

 

::::::

GIN June 2019 pdf, 1.59Mb
1 July 2019

 

::::::

Weekly Epidemiological Record, 5 July 2019, vol. 94, 27 (pp. 301–308)
:: Genetic characterization of measles and rubella viruses detected through surveillance for global measles and rubella elimination, 2016–2018
:: Monthly report on dracunculiasis cases, January- April 2019

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO celebrates big step forward in improving health security in the African region
06 July 2019
WHO reached an important milestone globally today with the completion of the 100th Joint External Evaluation —a voluntary assessment of a country’s ability to prevent, detect and respond to public health threats.
:: Restoring essential health services after Cyclone Idai in Mozambique 05 July 2019
Communities and coordination are crucial in fighting Ebola 04 July 2019
Close to the border with the Ebola-hit Democratic Republic of Congo (DRC), over 100 volunteer health workers are busily planning surveillance actions to detect potential Ebola cases and defend against the virus.
More than a million people to be vaccinated in phase 2 of a huge cholera vaccination campaign in the Democratic Republic of the Congo 03 July 2019

WHO Region of the Americas PAHO
– No new digest announcements identified

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

WHO European Region EURO
:: Major step towards control of noncommunicable diseases in the WHO European Region 05-07-2019
:: WHO delivers health care to displaced people in north-west Syria 02-07-2019

WHO Eastern Mediterranean Region EMRO
– No new digest announcements identified

WHO Western Pacific Region
– No new digest announcements identified

Announcements

Announcements

Paul G. Allen Frontiers Group [to 6 Jul 2019]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
No new digest content identified.

BMGF – Gates Foundation [to 6 Jul 2019]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 6 Jul 2019]
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 6 Jul 2019]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 6 Jul 2019]
http://cepi.net/
No new digest content identified.

Clinton Health Access Initiative, Inc. (CHAI) [to 6 Jul 2019]
https://clintonhealthaccess.org/about/
No new digest content identified.

EDCTP [to 6 Jul 2019]
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
No new digest content identified.

Emory Vaccine Center [to 6 Jul 2019]
http://www.vaccines.emory.edu/
No new digest content identified.

European Medicines Agency [to 6 Jul 2019]
http://www.ema.europa.eu/ema/
News and press releases
No new digest content identified.

European Vaccine Initiative [to 6 Jul 2019]
http://www.euvaccine.eu/news-events
No new digest content identified.

FDA [to 6 Jul 2019]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.

Fondation Merieux [to 6 Jul 2019]
http://www.fondation-merieux.org/
No new digest content identified.

Gavi [to 6 Jul 2019]
https://www.gavi.org/
No new digest content identified.

GHIT Fund [to 6 Jul 2019]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical
No new digest content identified.

Global Fund [to 6 Jul 2019]
https://www.theglobalfund.org/en/news/
No new digest content identified.

Hilleman Laboratories [to 6 Jul 2019]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 6 Jul 2019]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.

IAVI [to 6 Jul 2019]
https://www.iavi.org/newsroom
July 1, 2019
University of Oslo, IAVI, and THSTI to Develop HIV Broadly Neutralizing Antibodies as a Prevention Product for Affordable Global Access
NEW YORK – July 1, 2019 – The University of Oslo (UiO), IAVI, and the Translational Health Science and Technology Institute (THSTI) today announced an award from the Research Council of Norway through the GLOBVAC (Global Health Vaccination and Research) program for the development of broadly neutralizing antibodies (bNAbs) as HIV prevention products. Teams on three continents will work to engineer and optimize antibodies to extend their half-life, an improvement designed to increase the duration of antibody activity and potentially lead to longer intervals between protective doses. The consortium led by UiO received a research grant of 19.09M Norwegian kroner (about U.S. $2.2M) for a period of three years…
… Devin Sok, Ph.D., IAVI’s Director of Antibody Discovery and Development, said, “We know that having different prevention options for young women in low- and middle-income countries is important, so the availability of a product that provides long-term protection, is well tolerated, and could potentially be used discreetly will be a major addition to the suite of different prevention options.”…

 

IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.

IFRC [to 6 Jul 2019]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

IVAC [to 6 Jul 2019]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.

IVI [to 6 Jul 2019]
http://www.ivi.int/
IVI News & Announcements
No new digest content identified.

JEE Alliance [to 6 Jul 2019]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 6 Jul 2019]
http://www.msf.org/
Selected News; Project Updates, Reports
Lebanon
Treating Syrian children suffering from thalassemia
Project Update 5 Jul 2019

Haiti
People’s healthcare in danger amidst worsening anger and d…
Project Update 5 Jul 2019

Central American Migration
Northern Mexican city too dangerous to send back people seeking as…
Press Release 3 Jul 2019

DRC Ebola outbreaks
Crisis update – July 2019
Crisis Update 2 Jul 2019

NIH [to 6 Jul 2019]
http://www.nih.gov/news-events/news-releases
No new digest content identified.

PATH [to 6 Jul 2019]
https://www.path.org/media-center/
No new digest content identified.

Sabin Vaccine Institute [to 6 Jul 2019]
http://www.sabin.org/updates/pressreleases
No new digest content identified.

UNAIDS [to 6 Jul 2019]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
3 July 2019
Pakistan: bringing services closer to communities affected by the HIV outbreak
A newly refurbished paediatric centre is to open in Ratodero, Pakistan, to serve families affected by the recent HIV outbreak in the district of Larkana. It is expected that the centre will be operational by mid-July.

UNICEF [to 6 Jul 2019]
https://www.unicef.org/media/press-releases
Selected Statements, Press Releases, Reports
Press release
Venezuela: more than 2.8 million people will gain access to safe drinking water with UNICEF support
05/07/2019

Press release
Millions of people risk being cut off from safe water as hostilities escalate in Eastern Ukraine – UNICEF
Volatile shelling affects vital water infrastructure five times during the last week of June
04/07/2019

Press release
Remarks by Henrietta Fore, UNICEF Executive Director, at the opening of a UN high-level event to tackle misinformation and champion children’s right to immunization, New York,
01/07/2019
[See Milestones above for detail]

Vaccine Confidence Project [to 6 Jul 2019]
http://www.vaccineconfidence.org/
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 6 Jul 2019]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

Wellcome Trust [to 6 Jul 2019]
https://wellcome.ac.uk/news
News | 3 July 2019
Prizewinning photos give eye-opening perspectives on health
The Wellcome Photography Prize 2019 overall winner is Erin Lefevre for her picture of her young brother, who lives with autism.

The Wistar Institute [to 6 Jul 2019]
https://www.wistar.org/news/press-releases
Press Release
Jul. 3, 2019
The Wistar Institute Secures More Than $4.2M in Philanthropic Support
PHILADELPHIA — (July 3, 2019) —The Wistar Institute, an international leader in biomedical research on cancer, immunology and infectious disease, has received more than $4.2 million in non-federal funding awarded by private foundations.

Press Release
Jul. 2, 2019
Wistar Appoints Dr. Rahul Shinde as Inaugural Caspar Wistar Fellow
Caspar Wistar Fellows Program is a springboard to launch the careers of promising innovative biomedical researchers as next generation scientific leaders.

World Organisation for Animal Health (OIE) [to 6 Jul 2019]
http://www.oie.int/en/for-the-media/press-releases/2019/
No new digest content identified.

 

::::::

BIO [to 6 Jul 2019]
https://www.bio.org/insights/press-release
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 6 Jul 2019]
http://www.dcvmn.org/
No new digest content identified.

IFPMA [to 6 Jul 2019]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.

PhRMA [to 6 Jul 2019]
http://www.phrma.org/press-room
No new digest content identified.

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 focus 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

Advancing measurement and monitoring of reproductive, maternal, newborn and child health and nutrition: global and country perspectives (24 June, 2019)

BMJ Global Health
May 2019 – Volume 4 – Suppl 4
https://gh.bmj.com/content/4/Suppl_4

 

Measurement of reproductive, maternal, newborn and child health and nutrition
Editorial
Advancing measurement and monitoring of reproductive, maternal, newborn and child health and nutrition: global and country perspectives (24 June, 2019)
Tanya Marchant, Zulfiqar A Bhutta, Robert Black, John Grove, Catherine Kyobutungi, Stefan Peterson
Introduction
Aligned with the Sustainable Development Goals, the Global Strategy for Women’s, Children’s and Adolescents’ Health (2016–2030) represents an essential shift in prioritisation for actions designed to help families live healthy, secure lives and fulfil their economic potential.1 The reproductive, maternal, newborn, child and adolescent health and nutrition (RMNCAH-N) agenda is now both broader and more complex than was the case during the Millennium Development Goal era, creating a need for new data. To contribute to this need, Countdown to 2030 for Women’s, Children’s and Adolescents’ Health (Countdown), a multi-institutional network of academics from institutions around the world and representatives from United Nations agencies and civil society, aims to enhance monitoring and measurement of women’s, children’s and adolescents’ health globally and in countries.2 In 2018, Countdown organised a measurement conference in Stellenbosch, South Africa, that brought together 100 experts in multiple areas of RMNCAH-N, which resulted in the six papers in this supplement and an overall research agenda.
The manuscripts in this collection represent the first developments of Countdown’s work to enhance measurement. They identify some of the persistent measurement and monitoring gaps in RMNCAH-N, for example, by reviewing the evidence on methods for generating effective coverage estimates and presenting actionable analytical methods to identify inequalities within and between countries. The collection also considers measurement advances for early childhood development and for nutrition. Further, it expands to analyse new priority issues, including using national surveys to analyse the impact of armed conflicts on RMNCAH-N;3 and describing the new data needed to better understand the social, political and contextual complexity of health system governance.
Countdown will continue to extend this measurement improvement agenda. In some aspects, however, the measurement and monitoring of RMNCAH-N is more advanced than other health areas, such as infectious diseases, non-communicable diseases, injuries and mental health…

Armed conflicts and national trends in reproductive, maternal, newborn and child health in sub-Saharan Africa: what can national health surveys tell us? (24 June, 2019)

BMJ Global Health
May 2019 – Volume 4 – Suppl 4
https://gh.bmj.com/content/4/Suppl_4

 

 

Armed conflicts and national trends in reproductive, maternal, newborn and child health in sub-Saharan Africa: what can national health surveys tell us? (24 June, 2019)
Ties Boerma, Hannah Tappis, Ghada Saad-Haddad, Jai Das, Dessalegn Y Melesse, Jocelyn DeJong, Paul Spiegel, Robert Black, Cesar Victora, Zulfiqar A Bhutta, Aluisio J D Barros

Early childhood development: an imperative for action and measurement at scale (24 June, 2019)

BMJ Global Health
May 2019 – Volume 4 – Suppl 4
https://gh.bmj.com/content/4/Suppl_4

 

Early childhood development: an imperative for action and measurement at scale (24 June, 2019)
Linda Richter, Maureen Black, Pia Britto, Bernadette Daelmans, Chris Desmond, Amanda Devercelli, Tarun Dua, Günther Fink, Jody Heymann, Joan Lombardi, Chunling Lu, Sara Naicker, Emily Vargas-Barón

 

Lenses and levels: the why, what and how of measuring health system drivers of women’s, children’s and adolescents’ health with a governance focus (24 June, 2019)

BMJ Global Health
May 2019 – Volume 4 – Suppl 4
https://gh.bmj.com/content/4/Suppl_4

 

Lenses and levels: the why, what and how of measuring health system drivers of women’s, children’s and adolescents’ health with a governance focus (24 June, 2019)
Asha George, Amnesty Elizabeth LeFevre, Tanya Jacobs, Mary Kinney, Kent Buse, Mickey Chopra, Bernadette Daelmans, Annie Haakenstad, Luis Huicho, Rajat Khosla, Kumanan Rasanathan, David Sanders, Neha S Singh, Nicki Tiffin, Rajani Ved, Shehla Abbas Zaidi, Helen Schneider

 

Measuring the coverage of nutrition interventions along the continuum of care: time to act at scale (24 June, 2019)

BMJ Global Health
May 2019 – Volume 4 – Suppl 4
https://gh.bmj.com/content/4/Suppl_4

 

Measuring the coverage of nutrition interventions along the continuum of care: time to act at scale (24 June, 2019)
Stuart Gillespie, Purnima Menon, Rebecca Heidkamp, Ellen Piwoz, Rahul Rawat, Melinda Munos, Robert Black, Chika Hayashi, Kuntal Kumar Saha, Jennifer Requejo

 

Analyses of inequalities in RMNCH: rising to the challenge of the SDGs (24 June, 2019)

BMJ Global Health
May 2019 – Volume 4 – Suppl 4
https://gh.bmj.com/content/4/Suppl_4

 

Analyses of inequalities in RMNCH: rising to the challenge of the SDGs (24 June, 2019)
Cesar Victora, Ties Boerma, Jennifer Requejo, Marilia Arndt Mesenburg, Gary Joseph, Janaína Calu Costa, Luis Paulo Vidaletti, Leonardo Zanini Ferreira, Ahmad Reza Hosseinpoor, Aluisio J D Barros

 

Advances in the measurement of coverage for RMNCH and nutrition: from contact to effective coverage (24 June, 2019)

BMJ Global Health
May 2019 – Volume 4 – Suppl 4
https://gh.bmj.com/content/4/Suppl_4

 

Analysis papers
Advances in the measurement of coverage for RMNCH and nutrition: from contact to effective coverage (24 June, 2019)
Agbessi Amouzou, Hannah Hogan Leslie, Malathi Ram, Monica Fox, Safia S Jiwani, Jennifer Requejo, Tanya Marchant, Melinda Kay Munos, Lara M E Vaz, William Weiss, Chika Hayashi, Ties Boerma

 

Seroprevalence of Transplacentally acquired Measles antibodies in unvaccinated infants at nine months of age and its relation to the feeding practices

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 6 Jul 2019)

 

Research article
Seroprevalence of Transplacentally acquired Measles antibodies in unvaccinated infants at nine months of age and its relation to the feeding practices
In recent years Pakistan has faced frequent measles outbreaks killing hundreds of children despite the availability of vaccine for decades. This study was undertaken to determine the persistence of maternal tr…
Authors: Najma Javed, Muhammad Arif Nadeem Saqib, Mir. Muhammad Hassan Bullo and Rana Jawad Asghar
Citation: BMC Infectious Diseases 2019 19:587
Published on: 5 July 2019

Influenza vaccination effectiveness for people aged under 65 years in Japan, 2013/2014 season: application of a doubly robust method to a large-scale, real-world dataset

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 6 Jul 2019)

 

Research article
Influenza vaccination effectiveness for people aged under 65 years in Japan, 2013/2014 season: application of a doubly robust method to a large-scale, real-world dataset
Influenza vaccination is recognized as a primary public health intervention which prevents the illness of patients and relieves the societal burdens of influenza for medical community as well as the economy. T…
Authors: Natsumi Shibata, Shinya Kimura, Takahiro Hoshino and Hisashi Urushihara
Citation: BMC Infectious Diseases 2019 19:586
Published on: 5 July 2019

The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 6 Jul 2019)

 

Research article
The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study
There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot …
Authors: Joseph Mumba Zulu, Ingvild Fossgard Sandøy, Karen Marie Moland, Patrick Musonda, Ecloss Munsaka and Astrid Blystad
Citation: BMC Medical Ethics 2019 20:45
Published on: 4 July 2019

Bioethical reflexivity and requirements of valid consent: conceptual tools

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 6 Jul 2019)

 

Debate
Bioethical reflexivity and requirements of valid consent: conceptual tools
Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists…
Authors: John Barugahare
Citation: BMC Medical Ethics 2019 20:44
Published on: 4 July 2019

The global impact and cost-effectiveness of a melioidosis vaccine

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 6 Jul 2019)

 

Research article
The global impact and cost-effectiveness of a melioidosis vaccine
Every year, 90,000 people may die from melioidosis. Vaccine candidates have not proceeded past animal studies, partly due to uncertainty around the potential market size. This study aims to estimate the potent…
Authors: Nantasit Luangasanatip, Stefan Flasche, David A. B. Dance, Direk Limmathurotsakul, Bart J. Currie, Chiranjay Mukhopadhyay, Tim Atkins, Richard Titball and Mark Jit
Citation: BMC Medicine 2019 17:129
Published on: 5 July 2019

Coverage and determinants of influenza vaccine among pregnant women: a cross-sectional study

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 6 Jul 2019)

 

Research article
Coverage and determinants of influenza vaccine among pregnant women: a cross-sectional study
Pregnant women are at increased risk of influenza-related complications. The World Health Organisation recommends influenza vaccination to this high-risk population as highest priority. However, achieving high…
Authors: Vittoria Offeddu, Clarence C. Tam, Tze Tein Yong, Lay Kok Tan, Koh Cheng Thoon, Nicole Lee, Thiam Chye Tan, George S. H. Yeo and Chee Fu Yung
Citation: BMC Public Health 2019 19:890
Published on: 5 July 2019

Effects of vaccines in protecting against Ebola virus disease: protocol for a systematic review

BMJ Open
July 2019 – Volume 9 – 7
http://bmjopen.bmj.com/content/current

 

Infectious diseases
Protocol
Effects of vaccines in protecting against Ebola virus disease: protocol for a systematic review
(3 July, 2019)
Lindi Mathebula, Duduzile Edith Ndwandwe, Elizabeth Pienaar, Charles Shey Wiysonge
Abstract
Introduction
Ebola virus disease is one of the most devastating infectious diseases in the world with up to 90% case fatality observed. There are at least 13 candidate vaccines developed and being tested to prevent the occurrence of the Ebola virus disease. While none of these candidate vaccines has received regulatory approval for use, one candidate vaccine (rVSVΔG-ZEBOV-GP) has been granted access for emergency use. Two other candidate vaccines (GamEvac-Combi and Ad5-EBOV) have been licensed for emergency use in their countries of origin. The objective of this systematic review is to summarise the effects of the Ebola candidate vaccines in humans.
Methods and analysis
We will search for potentially eligible studies, with no language or date restrictions, in the Cochrane Central Register of Controlled Trials, PubMed, Scopus, the WHO International Clinical Trial Registry Platform, and reference lists of relevant publications. The Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effect (DARE) will be searched for related reviews. Two review authors will independently screen search records, assess study eligibility, perform data extraction, and assess the risk of bias; and reconcile their findings. We will pool data from similar studies using Mantel-Haenszel’s fixed-effect model.
Ethics and dissemination
This study is exempted from ethical consideration since the data collected are publicly available and at no point will confidential information from human participants be used. We will disseminate our results through publications in peer-reviewed journals and relevant conferences.
PROSPERO registration number CRD42018110505.