From Local Action to National Progress on 5 Major Health Challenges: The Bloomberg American Health Initiative

Public Health Reports
Volume 133 Issue 1_suppl, November/December 2018
https://journals.sagepub.com/toc/phrg/133/1_suppl

From Local Action to National Progress on 5 Major Health Challenges: The Bloomberg American Health Initiative
Guest Editor: Joshua M. Sharfstein, Jessica Leighton, Alfred Sommer and Ellen J. MacKenzie
The articles in this supplemental issue of Public Health Reports provide insight into what it will take for the field of public health to tackle 5 of the most complex and difficult health problems of our time: (1) large numbers of adolescents disconnected from work and school; (2) violence (including gun violence), intimate partner and sexual violence, and suicide; (3) opioid addiction and overdose; (4) a dysfunctional food system associated with obesity; and (5) threats to the environment.
These 5 problems are the central focus of the new Bloomberg American Health Initiative, which MacKenzie et al1 describe in their Commentary. “All 5 areas of focus are serious problems facing the nation, with deep connections to economic and social factors,” they write. “None have quick fixes.”1 Yet there is reason to believe that public health can lead the way toward meaningful progress.
From December 2017 to April 2018, the initiative held 5 national symposia to document the state of understanding and to inform a public health perspective on each challenge. This supplement includes these perspectives, as well as commentaries in the cross-cutting areas of evidence, policy, and equity. Together, these articles provide a road map for efforts to bring public health training to frontline organizations, pursue insights through innovative research, and advance effective programs, policies, and strategies for change…

Chronicling the Risk and Risk Communication by Governmental Officials During the Zika Threat

Risk Analysis          
Volume 38, Issue 12  Pages: 2503-2739  December 2018
https://onlinelibrary.wiley.com/toc/15396924/current
Communicating About Zika

Chronicling the Risk and Risk Communication by Governmental Officials During the Zika Threat
Marin Pearson Allen
Pages: 2507-2513
First Published: 12 November 2018
Abstract
The unique circumstances surrounding Zika, including the fact that it is both mosquito‐borne and sexually transmissible, brought to the fore concerns about optimal ways to communicate risk in an environment characterized by rapidly evolving knowledge. The difficulty in doing so is magnified by the fact that science‐based health messages from governmental agencies must be developed in an evidence‐based, audience‐participative, and collaborative manner. A recent reminder in JAMA asserted the importance of preparing now for future threats. Understanding how the knowledge and messaging about Zika changed across time should help public health officials prepare for such challenges.

Comparison between the traditional (1997) and revised (2009) WHO classifications of dengue disease: a retrospective study of 30 670 patients

Tropical Medicine & International Health
Volume 23, Issue 12  Pages: i-iv, 1281-1407  December 2018
https://onlinelibrary.wiley.com/toc/13653156/current

Original Research Papers
Comparison between the traditional (1997) and revised (2009) WHO classifications of dengue disease: a retrospective study of 30 670 patients
Natal Santos da Silva, Eduardo A. Undurraga, Alice Tobal Verro, Maurício Lacerda Nogueira
Pages: 1282-1293
First Published: 03 October 2018
Abstract
Objective
To compare WHO’s traditional (1997) and revised (2009) guidelines for dengue classification, using a large sample of patients of all ages with varying clinical conditions from a dengue‐endemic area in Brazil.
Methods
We compared 30 670 laboratory‐confirmed dengue cases (1998–2012) using both WHO’s dengue classification guidelines. Stereotype ordinal logistic regressions were used to analyse the association between patients’ demographics and signs and symptoms related to dengue infection severity, as defined in the 1997 and 2009 guidelines. We then compared the degree of agreement in dengue classification of both guidelines.
Results
Dengue signs and symptoms in patients were poorly correlated to disease severity as defined by both guidelines (Cramer’s V test <0.2). Hypotensive shock was the exception for both classifications, presenting dependence (Z = 56.42; P < 0.001, and Z = 55.24; P < 0.001) and high agreement (Cramers’s V = 1; P < 0.001, and Cramers’s V = 0.97; P < 0.001) for WHO 1997 and 2009, respectively. Last, we also found substantial agreement in disease classification between both guidelines (Kendall tau‐b = 0.79; P < 0.001), although 2009 guidelines were more sensitive in the detection of severe cases.
Conclusions
We hope our results will inform the debate about dengue classification guidelines, particularly concerning clinical value, study comparability, and ways in which future guidelines can support the clinical management of dengue. Our results suggest that caution should be taken when using WHO guidelines to assess dengue severity to improve clinical management of patients.
Open Access

The health consequences of falsified medicines‐ A study of the published literature

Tropical Medicine & International Health
Volume 23, Issue 12  Pages: i-iv, 1281-1407  December 2018
https://onlinelibrary.wiley.com/toc/13653156/current

The health consequences of falsified medicines‐ A study of the published literature
Mohammad Sofiqur Rahman, Naoko Yoshida, Hirohito Tsuboi, Naoki Tomizu, Jamie Endo, Onishi Miyu, Yoshio Akimoto, Kazuko Kimura
Pages: 1294-1303
First Published: 06 October 2018
Abstract
Objectives
To analyse and present the literature describing the health consequences of falsified medicines, focusing on mortality and morbidity, as well as the scale of the issue, the geographic extent, the medicines affected, and the harm caused at both the individual and population levels.
Methods
We searched for articles in PubMed, using pre‐optimized keywords ‘(counterfeit OR fake OR bogus OR falsified OR spurious) AND (medicine OR drug)’. Searches up to February 2017 yielded 2006 hits, of which 1791 were full‐length articles in English. Among them, we found 81 papers that qualitatively or quantitatively described 48 incidents in which falsified medicines caused patients to suffer serious adverse effects, injury, symptoms or death.
Results
The distribution of incidents was examined according to the economic status of the countries involved, regional location in the world, therapeutic category of the medicines, number of incidents and victims by year, and characteristics of the falsified medicines. Among the 48 reported incidents, 27 (56.3%) occurred in developing countries and 21 (43.7%) in developed countries. These incidents involved a total of approximately 7200 casualties including 3604 deaths.
Conclusions
Despite the poor quality of much of the reported data, the results of this study indicate that all types of medications have been targeted for falsification, and falsified medicines have had a serious impact on the health of both adults and children worldwide, with similar numbers of incidents in developing and developed countries.

Review of the economic evidence presented to the United States Advisory Committee on Immunization Practices, 2012–2016

Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Full text access
Review of the economic evidence presented to the United States Advisory Committee on Immunization Practices, 2012–2016
Jamison Pike, Andrew J. Leidner, Jessica R. MacNeil, Amanda C. Cohn
Pages 7-10

Prioritization of risk groups for influenza vaccination in resource limited settings – A case study from South Africa

Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Open access
Prioritization of risk groups for influenza vaccination in resource limited settings – A case study from South Africa
Meredith L. McMorrow, Stefano Tempia, Sibongile Walaza, Florette K. Treurnicht, … Cheryl Cohen
Pages 25-33

Impact of implementing a technology platform in community pharmacies to increase adult immunizations rates

Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Full text access
Impact of implementing a technology platform in community pharmacies to increase adult immunizations rates
Nizar K. Wehbi, Rajvi J. Wani, Donald G. Klepser, Janice Murry, Ali S. Khan
Pages 56-60

Mandatory policies for influenza vaccination: Views of managers and healthcare workers in England

Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Open access
Mandatory policies for influenza vaccination: Views of managers and healthcare workers in England
Martine Stead, Nathan Critchlow, Douglas Eadie, Fay Sullivan, … Fiona Dobbie
Pages 69-75

The effects of vaccination forecasts and value-based payment on adult immunizations by community pharmacists

Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Full text access
The effects of vaccination forecasts and value-based payment on adult immunizations by community pharmacists
Jennifer L. Bacci, Ryan Hansen, Christina Ree, Marci J. Reynolds, … Peggy S. Odegard
Pages 152-159

An environmental scan to examine stakeholder perspectives on human papillomavirus vaccination: A mixed methods study

Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Full text access
An environmental scan to examine stakeholder perspectives on human papillomavirus vaccination: A mixed methods study
Paige Lake, Monica L. Kasting, Teri Malo, Anna R. Giuliano, Susan T. Vadaparampil
Pages 187-194

Clinical Trials and Administration of Zika Virus Vaccine in Pregnant Women: Lessons (that Should Have Been) Learned from Excluding Immunization with the Ebola Vaccine during Pregnancy and Lactation

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 8 Dec 2018)

Open Access  Perspective
Clinical Trials and Administration of Zika Virus Vaccine in Pregnant Women: Lessons (that Should Have Been) Learned from Excluding Immunization with the Ebola Vaccine during Pregnancy and Lactation
by David A. Schwartz
Vaccines 2018, 6(4), 81; https://doi.org/10.3390/vaccines6040081 – 4 December 2018
Abstract
As evidenced from recent epidemics, both Ebola and Zika virus infection are potentially catastrophic when occurring in pregnant women. Ebola virus causes extremely high rates of mortality in both mothers and infants; Zika virus is a TORCH infection that produces a congenital malformation syndrome and pediatric neurodevelopmental abnormalities. Production of efficacious vaccines has been a public health priority for both infections. Unfortunately, during the clinical trials and subsequent deployment of a vaccine for the Ebola virus, pregnant and lactating women were, and continue to be, excluded from receiving the life-saving vaccine. The most serious consequence of Zika virus infection, congenital Zika syndrome, results from fetal infection during pregnancy. Thus, pregnant women have a major stake in the ongoing development of a vaccine for Zika virus. The exclusion of pregnant women from the development, clinical trials and administration of a potential Zika vaccine unfairly deprives them and their infants of the protection they need against this potentially catastrophic intrauterine infection. When creating policy about these issues, it is important to critically evaluate vaccine safety in pregnancy in the context of the substantial risk of infection for the pregnant woman and her fetus in the absence of immunization.

 

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

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

Medicina
Published: 3 December 2018
Awareness, Attitudes, and Practices Toward Meningococcal B Vaccine among Pediatricians in Italy
P Ferrara, L Stromillo, L Albano
Abstract: Background and objectives: Vaccination against bacterial pathogens is decisive for preventing invasive meningococcal disease and pediatricians play a pivotal role in vaccination compliance and coverage. The aim of this study was to investigate awareness, attitude, and practices toward the vaccine against Meningococcal B serogroup (4CMenB) among a sample of Italian pediatricians.
Materials and Methods: A cross-sectional study was carried out using an online questionnaire from March to May 2015. Three multivariate logistic regression models were built to identify factors associated with the outcomes of interest. Results: The data showed that 95.5% of the interviewees correctly responded about the availability of 4CMenB vaccine in Italy, while only 28.0% knew the vaccination schedule for children aged two years or under. This knowledge was significantly higher in younger pediatricians and in those who worked a higher number of hours per week. Pediatricians self-reported a positive attitude toward the utility and safety of 4CMenB vaccine. Those pediatricians with a strong positive attitude toward the utility of the vaccine, who knew the vaccination schedules for children of two years or under, and who declared a satisfactory or good knowledge about the vaccine were more likely to inform parents about its availability in Italy, recommend the vaccination, and verify patients’ vaccination status, in their daily practice. Conclusions: The study highlights factors that currently influence pediatricians’ practices regarding the 4CMenB vaccine. The results showed the possible actions recommended to improve physicians’ awareness and behaviors in order to improve the vaccination compliance and invasive meningococcal diseases prevention.

Journal of Constitutional Law -University of Pennsylvania
October 2018
Litigating Alternative Facts: School Vaccine Mandates in the Courts
DR Reiss
ABSTRACT
In June 2015, California’s governor signed into law SB277, which removed the personal belief exemption to school immunization requirements, making medical exemptions the only valid way to send an unvaccinated child in the affected categories to school. Naturally, vaccine-hesitant parents opposed the legislation. After their efforts failed in the legislature, they turned to the courts, raising arguments old and new. To date, opponents have filed five lawsuits against the new California law, all of which have failed. This Article explains why courts in the United States, which have consistently upheld school immunization requirements, are correct to do so. These requirements are supported by strong policy reasons and serve a compelling interest, since they dramatically reduce the risk of outbreaks of potentially deadly diseases. These mandates fit with our basic principles of state police power, reasonable limits on individual rights, and protecting children. They are also supported by over a hundred years of  jurisprudence. Using the opponents’ arguments to identify the strongest claims against SB277, the Article explains why those arguments—including claims based in the First Amendment, in parental rights, and in the right to education—cannot stand.

Journal of Experimental Medicine
Published December 3, 2018
Vaccines: An achievement of civilization, a human right, our health insurance for the future
Rino Rappuoli, Angela Santoni, Alberto Mantovani
Abstract
Vaccines have made a key, cost-effective contribution to the prolongation of life expectancy and quality. Here we summarize challenges facing vaccinology and immunology at the level of society, scientific innovation, and technology in a global health perspective. We argue that vaccines represent a safety belt and life insurance for humankind. “…but there was as yet no cause for the sort of alarm that had been displayed by parents, ‘justifiably enough,’ twenty-eight years earlier, during the largest outbreak of the disease ever reported—the 1916 polio epidemic in the northeastern United States, when there had been more than 27,000 cases, with 6,000 deaths. In Newark there had been 1,360 cases and 363 deaths. Now even in a year with an average number of cases…” (Roth, 2010).

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 8 Dec 2018
[No new, unique, relevant content]
 
 
BBC
http://www.bbc.co.uk/
Accessed 8 Dec 2018
[No new, unique, relevant content]
 
 
The Economist
http://www.economist.com/
Accessed 8 Dec 2018
[No new, unique, relevant content]
 
 
Financial Times
http://www.ft.com/home/uk
Accessed 8 Dec 2018
EU warns of bioterror and disease risk as vaccination rates fall
6 December 2018
The EU will face threats from disease epidemics to bioterrorism if it fails to halt anti-vaccination trends driven in part by anti-establishment political movements, the bloc’s health commissioner has warned…
 
 
Forbes
http://www.forbes.com/
Accessed 8 Dec 2018
[No new, unique, relevant content]
 
 
Foreign Affairs
http://www.foreignaffairs.com/
Accessed 8 Dec 2018
[No new, unique, relevant content]
 
 
Foreign Policy
http://foreignpolicy.com/
Accessed 8 Dec 2018
[No new, unique, relevant content]
 
 
The Guardian
http://www.guardiannews.com/
Accessed 8 Dec 2018
The Observer
Interview
Peter Hotez: ‘What happens when the anti-vaccine movement moves into India?’
Andrew Anthony
The American scientist, whose new book explains why vaccines didn’t cause his daughter’s autism, on why conspiracy theorists need to be challenged
 
 
New Yorker
http://www.newyorker.com/
Accessed 8 Dec 2018
[No new, unique, relevant content]
 
 
New York Times
http://www.nytimes.com/
Accessed 8 Dec 2018
Africa
Ebola Spreads to Major Congo City as Vaccines a Concern
By The Associated Press
Dec. 7, 2018  DAKAR, Senegal — The second-largest Ebola outbreak in history has spread to a major city in eastern Congo, as health experts worry whether the stock of an experimental vaccine will stand up to the demands of an epidemic with no end in sight.
Butembo, with more than 1 million residents, is now reporting cases of the deadly hemorrhagic fever. That complicates Ebola containment work already challenged by rebel attacks elsewhere that have made tracking the virus almost impossible in some isolated villages.
“We are very concerned by the epidemiological situation in the Butembo area,” said John Johnson, project coordinator with Medecins Sans Frontieres in the city. New cases are increasing quickly in the eastern suburbs and outlying, isolated districts, the medical charity said…

Europe
WHO Says It Can Fight Ebola Outbreak Despite US Withdrawal
Dec. 3, 2018
The head of the World Health Organization said Monday it can fight the deadly Ebola outbreak in Congo despite the withdrawal of the U.S. Centers for Disease Control and Prevention, insisting: “We can cover it.”
 
 
Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 8 Dec 2018
[No new, unique, relevant content]
 
 
Washington Post
http://www.washingtonpost.com/
Accessed 8 Dec 2018
[No new, unique, relevant content]

Vaccines and Global Health: The Week in Review :: 1 December 2018

.– 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_1 Dec 2018

– 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

Gavi Board starts framing Alliance’s approach to 2021-2025 period

Milestones :: Perspectives
 
 
Gavi Board starts framing Alliance’s approach to 2021-2025 period

Gavi Board approves in principle a set of new and expanded vaccine programmes.
Geneva, 29 November 2018 – The Gavi Board has made a series of decisions that will help shape the Alliance’s approach for the period 2021-2025 during a two-day meeting in Geneva’s Global Health Campus. The Board will adopt the 2021-2025 strategic goals at its next meeting in June 2019.

“The Board had extensive discussions on Gavi’s future direction which will lead to intense work over the coming months to develop a strategy for the 2021-2025 period – the fifth in Gavi’s existence,” said Dr Ngozi Okonjo-Iweala, Gavi Board Chair. “The global landscape has changed fundamentally since Gavi was created in 2000 and the Alliance is changing with it. While for Gavi the core focus remains on its current mission of accelerating access to vaccines and increasing equitable coverage in the world’s poorest countries, Gavi is also adapting to meet the challenges of the future.”

As part of its Vaccine Investment Strategy (VIS), the Gavi Board approved a future investment in six new and expanded vaccine programmes, contingent on the final parameters of Gavi’s 2021-2025 strategy (Gavi 5.0) and sufficient funding being made available after Gavi’s next replenishment. Following a thorough evaluation of current and future vaccines, the final VIS prioritised:

:: hepatitis B birth dose – to prevent chronic hepatitis B virus (HBV) infection, which develops in as many as 90% of infants infected with HBV at birth or in the first year of life and can lead to liver cancer,

:: diphtheria, pertussis & tetanus containing boosters – given at 12-24 months, 4-7 years and 9-15 years, these three boosters offer continued protection from those diseases beyond the primary series administered in the first year,

:: oral cholera vaccine (OCV) – to proactively reduce incidence of a disease that mainly affects poor and marginalised people,

:: human rabies vaccine for post-exposure prophylaxis – to provide equitable access to human rabies prevention following a suspected dog bite,

:: meningococcal conjugate vaccine – multivalent A,C,W-containing vaccine to expand serogroups protection beyond meningitis A,

:: and respiratory syncytial virus (RSV) – to prevent one of the most common causes of bronchiolitis and pneumonia in children under 1 year of age.

“Unlike previous vaccine investment strategies, these vaccines will involve building new delivery platforms which will strengthen primary healthcare as a whole,” said Dr Berkley. “This life-course immunisation approach can help lay the foundation for strengthening primary healthcare as a whole by providing more moments in which a child, adolescent or adult is in contact with health workers.”…

Measles cases spike globally due to gaps in vaccination coverage: New report

Milestones :: Perspectives

Measles cases spike globally due to gaps in vaccination coverage: New report

Press release
GENEVA/ATLANTA/NEW YORK, 29 November 2018: Reported measles cases spiked in 2017, as multiple countries experienced severe and protracted outbreaks of the disease. This is according to a new report published today by leading health organizations:
Weekly Epidemiological Record, 30 November 2018, vol. 93, 48 (pp. 649–660)
Progress towards regional measles elimination – worldwide, 2000–2017

Because of gaps in vaccination coverage, measles outbreaks occurred in all regions, while there were an estimated 110,000 deaths related to the disease.

Using updated disease modelling data, the report provides the most comprehensive estimates of measles trends over the last 17 years. It shows that since 2000, over 21 million lives have been saved through measles immunizations. However, reported cases increased by more than 30 percent worldwide from 2016.

The Americas, the Eastern Mediterranean Region, and Europe experienced the greatest upsurges in cases in 2017, with the Western Pacific the only World Health Organization (WHO) region where measles incidence fell.

“The resurgence of measles is of serious concern, with extended outbreaks occurring across regions, and particularly in countries that had achieved, or were close to achieving measles elimination,” said Dr Soumya Swaminathan, Deputy Director General for Programmes at WHO. “Without urgent efforts to increase vaccination coverage and identify populations with unacceptable levels of under-, or unimmunized children, we risk losing decades of progress in protecting children and communities against this devastating, but entirely preventable disease.”…

“The increase in measles cases is deeply concerning, but not surprising,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “Complacency about the disease and the spread of falsehoods about the vaccine in Europe, a collapsing health system in Venezuela and pockets of fragility and low immunization coverage in Africa are combining to bring about a global resurgence of measles after years of progress. Existing strategies need to change: more effort needs to go into increasing routine immunization coverage and strengthening health systems. Otherwise we will continue chasing one outbreak after another.”

Responding to the recent outbreaks, health agencies are calling for sustained investment in immunization systems, alongside efforts to strengthen routine vaccination services. These efforts must focus especially on reaching the poorest, most marginalized communities, including people affected by conflict and displacement.

The agencies also call for actions to build broad-based public support for immunizations, while tackling misinformation and hesitancy around vaccines where these exist…

Ebola – Democratic Republic of the Congo

Milestones :: Perspectives

Ebola – Democratic Republic of the Congo

 
Clinical trial of investigational Ebola treatments begins in the Democratic Republic of the Congo [NIH]
November 27, 2018
— Study is enrolling patients of any age with confirmed Ebola virus disease.
An international research team has begun patient enrollment in a clinical trial testing multiple investigational Ebola therapies in the Democratic Republic of the Congo (DRC). The randomized, controlled trial is enrolling patients of any age with confirmed Ebola virus disease (EVD) at a treatment unit in the city of Beni operated by ALIMA (link is external) (The Alliance for International Medical Action), a medical humanitarian organization.

The trial, which will expand to additional DRC districts, is organized through an international research consortium coordinated by the World Health Organization (WHO). It is led and funded by the National Institute for Biomedical Research (INRB) (link is external), part of the DRC Ministry of Health (link is external), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and also involves several additional international partners.

“Combatting Ebola requires a comprehensive response that draws on the strengths of all areas of public health. Biomedical research can lead to critical new tools, such as potentially life-saving therapies,” said NIAID Director Anthony S. Fauci., M.D. “Through scientifically and ethically sound clinical trials, we hope to efficiently and definitively establish the safety and efficacy of these investigational Ebola treatments, offering new ways to save lives.”

On Aug. 1, 2018, the DRC Ministry of Health declared the country’s 10th outbreak of EVD. As of Nov. 25, 2018, 240 deaths out of 419 confirmed and probable cases of EVD have been reported in the northeastern provinces of North Kivu and Ituri. Under the leadership of the DRC Ministry of Health, the WHO has coordinated the outbreak response with several international partners. NIAID, along with the U.S. Centers for Disease Control and Prevention, the U.S. Agency for International Development (USAID), and other U.S. government partners, have provided guidance and support to the multi-sectoral outbreak response.

“We urgently need a safe and effective treatment for this deadly disease,” said DRC Minister of Health Oly Ilunga Kalenga, M.D., Ph.D. “As we face a 10th outbreak of Ebola, we hope this clinical trial will give us more information about how best to treat patients.”

The trial aims to compare mortality among patients who receive one of three investigational Ebola drugs with a control group of patients who receive the investigational monoclonal antibody cocktail treatment ZMapp, developed by Mapp Biopharmaceutical, Inc. The therapies being tested include: mAb114, a single monoclonal antibody developed by NIAID, with early support from the INRB; and remdesivir (also known as GS-5734), an antiviral drug developed by Gilead Sciences, Inc. The trial has been approved to begin enrolling patients in these three groups, and plans are underway to amend the trial to include REGN-EB3 (also known as REGN3470-3471-3479), a monoclonal antibody cocktail developed by Regeneron Pharmaceuticals, Inc.

The participating Ebola treatment units will continue to provide all participants with supportive care for EVD. Ebola care includes supportive oral and/or intravenous fluids, electrolyte replacement, maintaining oxygen status and blood pressure, and pain management.

The investigational treatments have varying levels of data to support their use from testing in the laboratory, animals, and humans. However, none has been approved for treating EVD.

ZMapp is the only investigational treatment previously tested in a randomized, controlled efficacy trial. Results from that study, conducted in the U.S. and West Africa during the 2014 to 2016 outbreak, suggested that ZMapp appeared to be beneficial, but as the outbreak waned, the trial ultimately could not enroll enough participants to definitively establish the drug’s efficacy.

The investigational treatments also have been administered to most of the Ebola patients in the current outbreak in the DRC under an ethical framework developed by the WHO called Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) (link is external). However, this emergency-use mechanism cannot yield generalizable evidence on how well the treatments work.

“A randomized, controlled clinical trial is necessary to obtain reliable data about the safety and efficacy of investigational Ebola treatments,” said H. Clifford Lane, M.D., director of NIAID’s Division of Clinical Research. “It is possible to conduct rigorous clinical research in an outbreak setting, and we anticipate this trial will provide useful data.”

Professor Jean-Jacques Muyembe-Tamfum, M.D., Ph.D., director-general of the INRB, and Richard T. Davey, Jr., M.D., deputy director of NIAID’s Division of Clinical Research, are co-principal investigators for the study.

Trial participants will be randomly assigned to receive one of the investigational treatments by intravenous infusion. Site clinicians will monitor patients’ symptoms and take blood samples for laboratory tests. Patients will remain in the Ebola treatment unit until they fully recover from the disease. They will be asked to return to the clinic approximately two months after receiving treatment for a check-up and to provide additional blood samples for laboratory tests.

Plans are underway to expand the trial beyond the ALIMA site in Beni to additional Ebola treatment units operated by medical humanitarian organizations, including International Medical Corps. The trial also may be adapted to continue across more than one outbreak and in several countries. The number of participants enrolled in the trial ultimately will depend on the evolution of Ebola outbreaks. The study is designed to enroll 112 patients per arm, potentially over multiple outbreaks.

“This clinical trial marks a significant and important step forward for the DRC and our international partners,” said Dr. Muyembe. “We are eager to learn more about each of these investigational treatments as we continue to work tirelessly to identify new cases, trace contacts and control the spread of disease.”

An independent data and safety monitoring board will regularly review the study data. For more information, visit ClinicalTrials.gov and search identifier NCT03719586.

 
::::::
 

17: Situation report on the Ebola outbreak in North Kivu 
28 November 2018
[Excerpt]
…Case Management
The ETCs continue to provide therapeutics under the monitored emergency use of unregistered and experimental interventions (MEURI) protocol, in collaboration with the MoH and the Institut National de Recherche Biomédicale (INRB) together with supportive care measures. WHO is providing technical clinical expertise on-site and is assisting with the creation of a data safety management board…

DONs Ebola virus disease – Democratic Republic of the Congo   
29 November 2018
[Excerpt]
…The risk of the outbreak spreading to other provinces in the Democratic Republic of the Congo, as well as to neighbouring countries, remains very high. Over the course of the past week, alerts have been reported from South Sudan and Uganda; EVD has been ruled out for all alerts to date…

 

Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 27 November 2018 [GPEI]
Summary of new viruses this week:
Afghanistan – advance notification of one wild poliovirus type 1 (WPV1) case and six positive WPV 1 environmental samples
Pakistan – two WPV1 positive environmental samples.
Niger – one case of circulating vaccine-derived poliovirus type 2 (cVDPV2).

Statement of the Nineteenth IHR Emergency Committee Regarding the International Spread of Poliovirus
30 November 2018
[Excerpts; Editor’s text bolding]
The nineteenth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) regarding the international spread of poliovirus was convened by the Director General on 27 November 2018 at WHO headquarters with members, advisers and invited Member States attending via teleconference.

The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV).  The Secretariat presented a report of progress for affected IHR States Parties subject to Temporary Recommendations.  The following IHR States Parties provided an update on the current situation and the implementation of the WHO Temporary Recommendations since the Committee last met on 15 August 2018: Afghanistan, Democratic Republic of the Congo (DR Congo), Nigeria, Niger, Papua New Guinea (PNG), and Somalia…

Conclusion
The Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC), and recommended the extension of Temporary Recommendations for a further three months. The Committee considered the following factors in reaching this conclusion:

:: Although the declaration of the PHEIC and issuance of Temporary Recommendations has reduced the risk of international spread of WPV, progress is fragile, and should international spread now occur, the impact on WPV eradication would be even more grave in terms of delaying certification and prolonging requirements for dedicated human and financial resources in support of the eradication effort. The reversal in progress in Afghanistan and the stagnation in Pakistan with exportation of WPV continuing between the two countries, heighten concerns.

:: There is a risk of global complacency as the numbers of WPV cases remains low and eradication becomes a tangible reality, and a concern that removal of the PHEIC now could contribute to greater complacency.

:: Many countries remain vulnerable to WPV importation. Gaps in population immunity in several key high-risk areas is evidenced by the current number of cVDPV outbreaks of all serotypes, which only emerge and circulate when polio population immunity is low as a result of deficient routine immunization programmes.

:: The international outbreak of cVDPV2 affecting Somalia and Kenya, with a highly diverged cVDPV2 that appears to have circulated undetected for up to four years, highlights that there are still high-risk populations in South and Central zones of Somalia where population immunity and surveillance are compromised by conflict.

:: Similarly the new spread of cVDPV2 between Nigeria and Niger highlights the significant risk of persisting type 2 outbreaks two years after OPV2 withdrawal, and the inability so far to prevent further spread within and outside Nigeria through application of consistently high quality mOPV2 SIAs is a concern.

:: The difficulty in controlling spread of cVDPV2 in DR Congo heightens these concerns and demonstrates significant gaps in population immunity at a critical time in the polio endgame; the low coverage with routine IPV vaccination in several countries neighboring DR Congo heightens the risk of international spread, as population immunity is rapidly waning.

:: Inaccessibility continues to be a major risk, particularly in several countries currently infected with WPV or cVDPV, i.e. Afghanistan, Nigeria and Somalia, which all have sizable populations that have been unreached with polio vaccine for prolonged periods.

:: The increasing number of countries in which immunization systems have been weakened or disrupted by conflict and complex emergencies pose another risk. Populations in these fragile states are vulnerable to outbreaks of polio.

:: The risk is amplified by population movement, whether for family, social, economic or cultural reasons, or in the context of populations displaced by insecurity and returning refugees. There is a need for international coordination to address these risks. A regional approach and strong cross ­border cooperation is required to respond to these risks, as much international spread of polio occurs over land borders.

…Based on the current situation regarding WPV1 and cVDPV, and the reports provided by Afghanistan, DR Congo, Nigeria, Niger, Papua New Guinea and Somalia, the Director-General accepted the Committee’s assessment and on 27 November 2018 determined that the situation relating to poliovirus continues to constitute a PHEIC, with respect to WPV1 and cVDPV…

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

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 1 Dec 2018]
Democratic Republic of the Congo
:: Malaria control campaign launched in Democratic Republic of the Congo to save lives and aid Ebola response
28 November 2018 | BENI: A spike in malaria cases is threatening the health of people in parts of the eastern Democratic Republic of the Congo (DRC) where health workers are also battling an Ebola outbreak.  In response, a four-day mass drug administration (MDA) campaign was launched today in the Northern Kivu province town of Beni, with a target to reach up to 450 000 people with anti-malarial drugs combined with the distribution of insecticide-treated mosquito nets…
:: 17: Situation report on the Ebola outbreak in North Kivu  28 November 2018
:: DONs Ebola virus disease – Democratic Republic of the Congo   29 November 2018
[See Milestones above for more detail]

Bangladesh – Rohingya crisis
:: Weekly Situation Report 52 -22 November 2018
Key Highlights
… The fourth round of oral cholera campaign was launched on 17 November 2018 under the leadership of DGHS in collaboration WHO, UNICEF and other health sector partners.
 
Syrian Arab Republic
:: WHO update on reported chemical event in Aleppo, Syria   29 November 2018

Myanmar – No new announcements identified
Nigeria – No new announcements identified
Somalia – No new announcements identified
South Sudan – No new announcements identified
Yemen – No new announcements identified
 

::::::

 
WHO Grade 2 Emergencies  [to 1 Dec 2018]
Iraq
:: WHO and health partners step up efforts to provide urgent support for victims of flooding in Iraq   26 November 2018
Brazil (in Portugese) – No new announcements identified
Cameroon  – No new announcements identified
Central African Republic  – No new announcements identified
Ethiopia – No new announcements identified
Hurricane Irma and Maria in the Caribbean – No new announcements identified
occupied Palestinian territory – No new announcements identified
Libya – No new announcements identified
MERS-CoV – No new announcements identified
Niger – No new announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new announcements identified
Sudan – No new announcements identified
Ukraine – No new announcements identified
Zimbabwe – No new announcements identified

WHO-AFRO: Outbreaks and Emergencies Bulletin, Week 46: 1- 23 November 2018
The WHO Health Emergencies Programme is currently monitoring 53 events in the region. This week’s edition covers key ongoing events, including:
:: Ebola virus disease in the Democratic Republic of the Congo
:: Anthrax (suspected) in Namibia
:: Measles in Madagascar
:: Typhoid fever in Zimbabwe
:: Humanitarian crisis in Mali.

::::::

 
WHO Grade 1 Emergencies  [to 1 Dec 2018]
Afghanistan
Chad
Indonesia – Sulawesi earthquake 2018
Kenya
Lao People’s Democratic Republic
Mali
Namibia – viral hepatitis
Peru
Philippines – Tyhpoon Mangkhut
Tanzania
 
::::::
 
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. 
YemenNo new announcements identified.
Syrian Arab Republic   No new 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.
Ethiopia 
:: Ethiopia: Humanitarian Response Situation Report No.19 (November 2018) 26 Nov 2018

Somalia  – No new announcements identified.
 
::::::

“Other Emergencies”
Indonesia: Central Sulawesi EarthquakeNo new announcements identified.
 
::::::
::::::
 

Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.

EBOLA/EVD  [to 1 Dec 2018]
http://www.who.int/ebola/en/
:: 16: Situation report on the Ebola outbreak in North Kivu  21 November 2018
:: DONs Ebola virus disease – Democratic Republic of the Congo   22 November 2018
 [See Milestones above for more detail]

MERS-CoV [to 1 Dec 2018]
http://who.int/emergencies/mers-cov/en/
No new announcements identified.

Yellow Fever  [to 1 Dec 2018]
http://www.who.int/csr/disease/yellowfev/en/
No new announcements identified.

Zika virus  [to 1 Dec 2018]
http://www.who.int/csr/disease/zika/en/
No new announcements identified.

WHO & Regional Offices [to 1 Dec 2018]

WHO & Regional Offices [to 1 Dec 2018]

1 December 2018
Why the HIV epidemic is not over
1 December 2018 marks the 30th anniversary of World AIDS Day – a day created to raise awareness about HIV and the resulting AIDS epidemics. Since the beginning of the epidemic, more than 70 million people have acquired the infection, and about 35 million people have died. Today, around 37 million worldwide live with HIV, of whom 22 million are on treatment…
 

29 November 2018
News Release
Measles cases spike globally due to gaps in vaccination coverage
[See Milestones above for more detail]

26 November 2018
News Release
Democratic Republic of the Congo begins first-ever multi-drug Ebola trial
[See Milestones above for more detail]

::::::

 
Weekly Epidemiological Record, 30 November 2018, vol. 93, 48 (pp. 649–660)
Progress towards regional measles elimination – worldwide, 2000–2017
Monthly report on dracunculiasis cases, January-October 2018

::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: Tailoring services to people at higher risk of HIV in Nigeria  30 November 2018
:: Self-testing for HIV is getting high marks in Zimbabwe  30 November 2018
:: South Sudan declares Yellow fever outbreak in Sakure, Nzara County, Gbudue State  29 November 2018
:: With WHO support, South Sudan enhances meningitis preparedness and response  28 November 2018

WHO Region of the Americas PAHO
:: PAHO and Ministers of Health from the Americas identified a series of actions that seek to improve the health of migrants in the Region (11/30/2018)
:: PAHO urges testing as the first step towards preventing HIV and halting the AIDS epidemic (11/30/2018)
:: Violence against women affects almost 60% of women in some countries of the Americas (11/29/2018)
:: PAHO launches campaign to prevent cervical cancer (11/27/2018)
:: Countries in the Americas commit to continuing to collaborate in strengthening regulatory systems to ensure safe, effective and quality medicines (11/26/2018)

 
WHO South-East Asia Region SEARO
– No new announcement identified

 

WHO European Region EURO
:: New HIV diagnoses at alarmingly high levels in the European Region despite progress in EU/EEA 28-11-2018
:: Countries of eastern Europe and central Asia improve access to HIV, TB and viral hepatitis diagnostic technologies and medicines 27-11-2018
:: WHO and EU commit to work together to accelerate progress on health 27-11-2018

WHO Eastern Mediterranean Region EMRO

:: Twentieth polio case reported in Afghanistan: the highest number since 2015  29 November 2018
:: Lifesaving medical supplies reach Shirqat for Iraqi flood victims  28 November 2018
:: Strengthening the health system response to gender-based violence in the Region  25 November 2018

WHO Western Pacific Region
– No new announcement identified

 

CDC/ACIP [to 1 Dec 2018]

CDC/ACIP [to 1 Dec 2018]

http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for Friday November 30, 2018
Implementation of the Treat All Policy Among Persons Living with HIV Enrolled in Care but Not on Antiretroviral Therapy — India, May 2017–June 2018
This report describes India’s implementation of the Treat All policy, which recommends that all people living with HIV (PLHIV) begin antiretroviral treatment as soon as possible after diagnosis. India’s experience suggests that active tracking and tracing of people with HIV infection who are enrolled in HIV care but not on ART, combined with education about the benefits of early HIV treatment, can facilitate ART initiation. India, which has the world’s third largest burden of HIV infection (2.1 million people), adopted Treat All on April 28, 2017. From May 1, 2017, through June 30, 2018, India’s National AIDS Control Organization (NACO), CDC, and other partners conducted activities to facilitate ART initiation among people enrolled in care (but not on ART because of ineligibility based on previous guidelines) at 46 ART centers supported by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) in the six most populated districts in two states. Among 25,007 people enrolled, 9,898 (40%) initiated ART after the Treat All policy adoption. Of those, 6,315 (64%), including 1,635 (17%) people lost to follow-up while awaiting ART initiation, initiated ART only after they were reached and educated about ART benefits. Active tracking and tracing of people with HIV infection who are enrolled in HIV care but not on ART, combined with education about the benefits of early HIV treatment, can facilitate ART initiation.

Multistate Infestation with an Exotic Disease-Vector Tick Haemaphysalis longicornis — United States, August 2017–September 2018
The Asian longhorned tick (Haemaphysalis longicornis) is new to the United States and can transmit pathogens found in the United States. In August 2017, a tick common to eastern Asia was discovered on a sheep in New Jersey. This tick, known as the Asian longhorned tick or Haemaphysalis longicornis, is not native to the United States. As of October 2, 2018, Asian longhorned ticks have been found in nine states: Arkansas, Connecticut, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Virginia, and West Virginia. While ticks collected in the United States have not been found infected with any pathogens, in other parts of the world the tick can spread viruses, bacteria, and parasites known to infect people and animals, causing severe disease and death. To date, there is no evidence that the tick has spread pathogens to people or animals in the United States. A single female tick can reproduce offspring without mating. As a result, hundreds to thousands of ticks may be found on a single animal or in the surrounding environment.

Outbreak of Dengue Virus Type 2 — American Samoa, November 1, 2016 – October 31, 2018
Dengue continues to be a public health burden throughout the tropics. After recent outbreaks of dengue, chikungunya, and Zika viruses in the U.S. territory of American Samoa, another dengue outbreak occurred starting in late 2016 and lasted through October 2018. During this outbreak, more than 1,000 dengue cases were confirmed, and more than one-third of people with dengue were hospitalized. This outbreak further demonstrates that additional approaches to the control of mosquito-transmitted diseases are urgently needed.

Progress Toward Regional Measles Elimination — Worldwide, 2000–2017
During 2000-2017, increased vaccination coverage with measles-containing vaccine administered through routine immunization programs, supplementary immunization activities, and other global measles elimination efforts contributed to an 83 percent drop in reported measles incidence and an 80 percent reduction in estimated measles mortality. The increasing number of countries verified as having achieved measles elimination indicates progress toward interruption of measles virus transmission globally. Continuing to increase coverage with first dose of measles-containing vaccine (MCV1) and second dose of measles-containing vaccine (MCV2) is critical to both the achievement and sustainability of global and regional measles goals. During 2000-2017, MCV1 coverage increased globally from 72 percent to 85 percent due to routine immunization programs, supplemental immunization activities (SIAs), and other global measles-elimination efforts. Measles vaccination prevented an estimated 21.1 million deaths during this period, with the majority of deaths averted in the WHO African region and among Gavi, the Vaccine Alliance-eligible countries. Estimated MCV2 coverage increased globally from 15 percent in 2000 to 67 percent in 2017, largely due to an increase in the number of countries providing MCV2 nationally from 98 (51%) in 2000 to 167 (86%) in 2017. Despite progress made, global milestones have not been achieved: MCV1 coverage has stagnated for nearly a decade; global MCV2 coverage is only at 67 percent despite steady increases in coverage; and several regions are experiencing a measles resurgence.

 

China CDC  :: National Health Commission of the People’s Republic of China

China CDC 
http://www.chinacdc.cn/en/
New website launched…no “news” or “announcements” page identified.

National Health Commission of the People’s Republic of China
http://en.nhfpc.gov.cn/
Selected Updates/ Press Releases/ Notices
Updated: 2018-12-01
Gene-edited babies: Chinese Academy of Medical Sciences’ response and action
(The Lancet )

Researcher who edited human gene suspended

National Health Commission of the People’s Republic of China
http://en.nhfpc.gov.cn/
Selected Updates/ Press Releases/ Notices

Updated: 2018-11-30
Researcher who edited human gene suspended
(China Daily)
He Jiankui, the Chinese researcher who claimed to have created the world’s first gene-edited babies, has been suspended from any scientific activities amid mounting questions from government agencies and academicians about the experiment.
Using a fertilized human egg cell, He sought to disable a gene that forms a protein doorway that allows the HIV to enter, intending to make the resulting person resistant to the virus.
“The case, as media have reported, is a blatant violation of China’s laws and regulations, and it breaks the bottom line of academic morality and ethics,” Xu Nanping, vice-minister of science and technology, said on Thursday in an interview with China Central Television. “It’s shocking and unacceptable.”
Xu said the ministry has ordered relevant authorities to suspend all scientific activity of people involved with the case, and will mete out punishments together with other authorities based on the results of the investigation…

Announcements

Announcements
 
 
BMGF – Gates Foundation  [to 1 Dec 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 1 Dec 2018]
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 1 Dec 2018]
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 1 Dec 2018]
http://cepi.net/
No new digest content identified.
 
 
EDCTP    [to 1 Dec 2018]
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
30 November 2018
World AIDS Day 2018: Supporting R&D partnerships to tackle HIV
World AIDS Day 2018 marks its 30th anniversary. Significant progress has been made in the fight against the disease during these three decades. However, the Global AIDS Update 2018
report shows that much needs to be done to reach the…
 
 
26 November 2018
National health research systems in Africa: developing a collaborative approach
EDCTP published the report on the EDCTP high-level meeting Engaging African governments to strengthen national health research systems with complementary international cooperation. The meeting took place in Dakar, Senegal, on 30 August 2018. It was organised as a side meeting…
 
 
Emory Vaccine Center    [to 1 Dec 2018]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 1 Dec 2018]
http://www.ema.europa.eu/ema/
News and press releases
No new digest content identified.
 
 
European Vaccine Initiative  [to 1 Dec 2018]
http://www.euvaccine.eu/news-events
No new digest content identified.
 
 
FDA [to 1 Dec 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.
November 28, 2018 –
FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation
 
 
November 26, 2018 –
 FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
 
 
November 26, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
 
 
Fondation Merieux  [to 1 Dec 2018]
http://www.fondation-merieux.org/
Mérieux Foundation co-organized event
OCV working group / Global Task Force on Cholera Control (GTFCC)
December 5 – 6, 2018 – Les Pensieres Center for Global Health, Veyrier-du-Lac (France)
 
Partner event
ASLM 2018 – Preventing and controlling the next pandemic: the role of laboratory
December 10 – 13, 2018 – Abuja (Nigeria)
 
Mérieux Foundation co-organized event
Dengue pre-vaccination screening based on serostatus: rapid tests and implementation strategies
January 14 – 16, 2019 – Les Pensières Center for Global Helath, Veyrier du Lac (France)
 
 
Gavi [to 1 Dec 2018]
https://www.gavi.org/
29 November 2018
Measles cases spike globally due to gaps in vaccination coverage: New report
 
Gavi Board starts framing Alliance’s approach to 2021-2025 period
29 November 2018
[See Milestones above for detail]
 
Gavi recognised as an equal salary employer
26 November 2018
 
 
GHIT Fund   [to 1 Dec 2018]
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 1 Dec 2018]
https://www.theglobalfund.org/en/news/
30 November 2018
Global Fund Marks World AIDS Day

Feature Story
Young Women at the Epicenter of HIV
29 November 2018

Global Fund Applauds UNAIDS Report on HIV Testing
27 November 2018
The Global Fund to Fight AIDS, Tuberculosis and Malaria welcomed a new report by UNAIDS that shows great gains in HIV testing, and getting people to know their HIV status. Knowledge is Power, the report released just prior to World AIDs Day on 1 December, shows that 75 percent of people living with HIV aware of their status in 2017, compared with 67 percent in 2015…
 
 
Hilleman Laboratories   [to 1 Dec 2018]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 1 Dec 2018]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 1 Dec 2018]
https://www.iavi.org/newsroom
November 29, 2018
IAVI Report Vol. 22, No. 3, 2018
Scientists are more optimistic than ever about developing HIV vaccines and antibody-based products.
 
IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.
 
IVAC  [to 1 Dec 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 1 Dec 2018]
http://www.ivi.int/
IVI News & Announcements
BOT meets face-to-face and visits KCDC & LG Chem’s vaccine plant
On Nov. 19, 2018, IVI’s Board of Trustees convened at IVI headquarters in Seoul for their second face-to-face meeting of the year. This was followed by a visit to the Korea Center for Disease Control (KCDC) on Nov. 20 to exchange information on new initiatives, discuss matters of mutual interest, and to explore opportunities to further expand their partnership, as well as a site tour to LG Chem’s vaccine plant in Osong, North Chungcheong Province…
 
Scientific Advisory Group (SAG) gathers for 17th meeting
IVI’s Scientific Advisory Group (SAG) convened at IVI headquarters in Seoul on November 15 for their 17th annual two-day-long meeting. This event brings together IVI scientists and members of the SAG. The SAG consists of 16 members, including distinguished vaccinologists and public health leaders, who have been helping the Institute to chart the direction of vaccine research and development, and to explore future opportunities. During this meeting they shared an overview of the latest in IVI projects and exchanged new information and ideas…
 
 
JEE Alliance  [to 1 Dec 2018]
https://www.jeealliance.org/
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 1 Dec 2018]
http://www.msf.org/
Selected News; Project Updates, Reports
World AIDS Day
UNAIDS report overlooks significant aspects of the global HIV response
Statement 29 Nov 2018
UNAIDS’ World AIDS Day 2018 report is selectively silent on persistently high AIDS mortality and looming treatment rationing in light of donor disengagement.
This year’s UNAIDS report highlights the importance of viral load testing, a critical indicator of the effectiveness of HIV treatment in people living with HIV.
Yet the focus on HIV testing and regular viral load monitoring overlooks fundamental aspects of today’s HIV epidemic and continued high numbers of AIDS-related deaths.
The report also fails to profile the significant shortfalls in international support to effectively fight the HIV/AIDS epidemic…

HIV/AIDS
Pharmaceutical corporations are failing children with HIV
Press Release 29 Nov 2018
:: Kids living with HIV need to be on antiretroviral (ARV) treatment for life to stay healthy
:: One year ago, pharmaceutical corporations committed to improving access to paediatric versions of HIV drugs for children, but very little progress has been made
:: MSF urges pharmaceutical corporations including Viiv and Merck to immediately register paediatric ARVs and improve access for kids.
 
 
NIH  [to 1 Dec 2018]
http://www.nih.gov/news-events/news-releases
November 30, 2018
NIH Statement on World AIDS Day December 1, 2018
— We now have life-saving antiretroviral drugs to treat and greatly extend the lives of men and women living with HIV.

November 27, 2018
Clinical trial of investigational Ebola treatments begins in the Democratic Republic of the Congo
— Study is enrolling patients of any age with confirmed Ebola virus disease.
[See Milestones above for detail]
 
 
PATH  [to 1 Dec 2018]
https://www.path.org/media-center/
Nov. 30, 2018
Vietnam launches national program for pre-exposure prophylaxis for HIV
PATH, USAID, and Vietnam’s Ministry of Health launch PrEP program to substantially reduce new HIV infections as total PrEP service enrollment passes 2,000.
 
 
Sabin Vaccine Institute  [to 1 Dec 2018]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 1 Dec 2018]
http://www.unaids.org/en
27 November 2018
Call for minimum standards of PrEP provision and monitoring in Europe

26 November 2018
Countries in eastern Europe and central Asia agree to expand access to a range of medicines
 
 
UNICEF  [to 1 Dec 2018]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Press release
Around 80 adolescents will die of AIDS every day by 2030, at current trends – UNICEF
UNICEF calls for urgent scale-up of treatment and prevention programmes among adolescents as data shows slow reduction of HIV infections and AIDS-related deaths
29/11/2018
 
 
Press release
2018 Global Nutrition Report reveals malnutrition is unacceptably high and affects every country in the world, but there is also an unprecedented opportunity to end it.
28/11/2018
 
 
Press release
Measles cases spike globally due to gaps in vaccination coverage: New report
29/11/2018
[See Milestones above for detail]
 
 
Press release
UNICEF strengthens support for women and children in Venezuela
Supplies for 350,000 women and children flown in since August
…Working with the Ministry of Health, UNICEF has also provided 30 tons of medicines and health supplies to help stop the spread of infectious diseases and to improve health outcomes for children and women in vulnerable communities. These supplies will be used in the treatment and care for 25,000 pregnant women, 10,000 newborns in neonatal wards and more than 2,300 children living with HIV. Through UNICEF’s expanded programme, 40,000 pregnant women now have access to rapid HIV and syphilis tests, while 100,000 children and pregnant women have access to malaria treatment.
UNICEF, present in Venezuela since 1991, has over the past two years strengthened its work with partners to provide vulnerable children affected by the economic crisis with support in education, health, nutrition and protection. So far this year, UNICEF has also supported the vaccination of children with 2.5 million doses of measles vaccines and provided antiretrovirals for 2,334 children and antimalarial treatment for 150,000 children.
 
 
Vaccine Confidence Project  [to 1 Dec 2018]
http://www.vaccineconfidence.org/
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 1 Dec 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 1 Dec 2018]
https://wellcome.ac.uk/news
29 November 2018
How should Wellcome best support science to achieve our mission of improving health?
We’re launching a review of how Wellcome supports science. Jeremy Farrar explains why it’s necessary and what we hope to achieve.
Wellcome’s mission is to improve health for everyone by helping great ideas to thrive. We achieve this in large part through our support for science, where we spend almost £630 million a year through many different mechanisms. But while the way we support science has varied little over several decades, science and the way it is done have changed.
With this in mind, it is timely for Wellcome to review the way we support research to ensure we get the best possible advances in scientific knowledge and health. How do we know, as technologies and ways of working change, that our current approach is the right one?
To answer these questions, we have decided to review how Wellcome supports science. Director of Science Jim Smith will lead a small group that will explore questions such as:
:: What disciplines and areas of science should Wellcome support?
:: What career stages should Wellcome focus on?
:: Where should Wellcome fund?
:: With whom should Wellcome partner?…
 
 
The Wistar Institute   [to 1 Dec 2018]
https://www.wistar.org/news/press-releases
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 1 Dec 2018]
http://www.oie.int/en/for-the-media/press-releases/2018/
No new digest content identified.

::::::

BIO    [to 1 Dec 2018]
https://www.bio.org/insights/press-release
Nov 30 2018
BIO Commends Signing of the United States-Mexico-Canada Agreement
Washington, D.C. (November 30, 2018) – Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the United States-Mexico-Canada…
 
 
BIO Statement on Unsubstantiated Reports of Heritable Human Genome Editing Experiments in China
Nov 28 2018
The Biotechnology Innovation Organization (BIO) issued the following statement regarding unsubstantiated reports this week of experiments involving heritable human genome editing in China.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 1 Dec 2018]
http://www.dcvmn.org/
No new digest content identified.
 
 
IFPMA   [to 1 Dec 2018]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.
 
 
PhRMA    [to 1 Dec 2018]
http://www.phrma.org/press-room
Latest News
PhRMA Statement on Signing the U.S.-Mexico-Canada Agreement (USMCA)
WASHINGTON, D.C. (November 30, 2018) – Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement:
“We congratulate the United States, Mexico and Canada on signing the U.S.-Mexico-Canada Agreement (USMCA). This is an important step in the process to modernize North American trade, including by improving critical intellectual property (IP) protections and other standards in Canada and Mexico that will help to usher in the next generation of medical treatments and cures. When countries protect and value innovation, America’s biopharmaceutical companies can continue bringing new medicines to patients around the world. The IP standards in the USMCA far exceed those in any other international trade agreement. We look forward to continuing to assist efforts by the Administration and Congress to pass the USMCA.”…

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

 

Tweeting about measles during stages of an outbreak: A semantic network approach to the framing of an emerging infectious disease

American Journal of Infection Control
December 2018 Volume 46, Issue 12, p1319-1424, e75-e90
http://www.ajicjournal.org/current

Major Articles
Tweeting about measles during stages of an outbreak: A semantic network approach to the framing of an emerging infectious disease
Lu Tang, Bijie Bie, Degui Zhi
p1375–1380
Published online: June 18, 2018
Highlights
:: Semantic networks based on word frequencies and co-occurrences can be used to induce the frames used in Twitter discussion about infectious diseases such as measles.
:: The public used four different frames in discussing the 2015 measles outbreak: news update, public health, vaccination, and political.
:: The public health frame is the most dominant frame in the initial and resolution stages. The vaccine frame is the most dominant frame in the maintenance stage.
:: The political frame is used least frequently during all stages of the outbreak.
:: Understanding how the public discuss measles on Twitter during a break allows public health professionals to create effective messages in communicating with the public.

Impact of Electronic Point-of-Care Prompts on Human Papillomavirus Vaccine Uptake in Retail Clinics

American Journal of Preventive Medicine
December 2018 Volume 55, Issue 6, p759-944
http://www.ajpmonline.org/current

Research Articles
Impact of Electronic Point-of-Care Prompts on Human Papillomavirus Vaccine Uptake in Retail Clinics
Amanda F. Meyer, Nicole L. Borkovskiy, Jennifer L. Brickley, Rajeev Chaudhry, Andrew Franqueira, Joseph W. Furst, Donna M. Hinsch, Margaret R. McDonah, Jane F. Myers, Randi E. Petersen, Lila J. Finney Rutten, Patrick M. Wilson, Robert M. Jacobson
p822–829
Published online: October 18, 2018

 

 

Consent requirements for research with human tissue: Swiss ethics committee members disagree

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 1 Dec 2018)

Research article
|   26 November 2018
Consent requirements for research with human tissue: Swiss ethics committee members disagree
Authors: Flora Colledge, Sophie De Massougnes and Bernice Elger
Background
In Switzerland, research with identifiable human tissue samples, and/or its accompanying data, must be approved by a research ethics committee (REC) before it can be allowed to take place. However, as the demand for such tissue has rapidly increased in recent years, and biobanks have been created to meet these needs, committees have had to deal with a growing number of such demands. Detailed instructions for evaluating every kind of tissue request are scarce. Committees charged with evaluating research protocols therefore sometimes face uncertainty in their decision-making.

Availability and affordability of priority life-saving medicines for under-five children in health facilities of Tigray region, northern Ethiopia

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 1 Dec 2018)

Research article
Availability and affordability of priority life-saving medicines for under-five children in health facilities of Tigray region, northern Ethiopia
In developing countries, child health outcomes are influenced by the non-availability of priority life-saving medicines at public sector health facilities and non-affordability of medicines at private medicine…
Authors: Solomon Abrha, Ebisa Tadesse, Tesfay Mehari Atey, Fantahun Molla, Wondim Melkam, Birhanetensay Masresha, Solomon Gashaw and Abrham Wondimu
Citation: BMC Pregnancy and Childbirth 2018 18:464
Published on: 29 November 2018

Measles vaccination coverage, determinants of delayed vaccination and reasons for non-vaccination among children aged 24–35 months in Zhejiang province, China

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 1 Dec 2018)

Research article
Measles vaccination coverage, determinants of delayed vaccination and reasons for non-vaccination among children aged 24–35 months in Zhejiang province, China
This study was aimed to assess the coverage of two doses of measles vaccine and identify the determinants of the delayed vaccination.
Authors: Yu Hu, Ying Wang, Yaping Chen, Hui Liang and Zhiping Chen
Citation: BMC Public Health 2018 18:1298
Published on: 27 November 2018

Oral cholera vaccination in hard-to-reach communities, Lake Chilwa, Malawi

Bulletin of the World Health Organization
Volume 96, Number 12, December 2018, 797-864
http://www.who.int/bulletin/volumes/96/12/en/

RESEARCH
Oral cholera vaccination in hard-to-reach communities, Lake Chilwa, Malawi
To evaluate vaccination coverage, identify reasons for non-vaccination and assess satisfaction with two innovative strategies for distributing second doses in an oral cholera vaccine campaign in 2016 in Lake Chilwa, Malawi, in response to a cholera outbreak.
– Francesco Grandesso, Florentina Rafael, Sikhona Chipeta, Ian Alley, Christel Saussier, Francisco Nogareda, Monica Burns, Pauline Lechevalier, Anne-Laure Page, Leon Salumu, Lorenzo Pezzoli, Maurice Mwesawina, Philippe Cavailler, Martin Mengel, Francisco Javier Luquero & Sandra Cohuet
http://dx.doi.org/10.2471/BLT.17.206417

Cost of a human papillomavirus vaccination project, Zimbabwe

Bulletin of the World Health Organization
Volume 96, Number 12, December 2018, 797-864
http://www.who.int/bulletin/volumes/96/12/en/

Cost of a human papillomavirus vaccination project, Zimbabwe
The government of Zimbabwe conducted the project from 2014–2015, delivering two doses of HPV vaccine to 10-year-old girls in two districts. School delivery was the primary vaccination strategy, with health facilities and outreach as secondary strategies. A retrospective cost analysis was conducted from the provider perspective. Financial costs (government expenditure) and economic costs (financial plus the value of existing or donated resources including vaccines) were calculated by activity, per dose and per fully immunized girl.
– Anna Hidle, Gwati Gwati, Taiwo Abimbola, Sarah W Pallas, Terri Hyde, Amos Petu, Deborah McFarland & Portia Manangazira
http://dx.doi.org/10.2471/BLT.18.211904

Implementing large Foot and Mouth Disease vaccination programmes for smallholder farmers: lessons from Lao PDR

Epidemiology and Infection
Volume 146 – Issue 16 – December 2018
https://www.cambridge.org/core/journals/epidemiology-and-infection/latest-issue

Original Paper
Implementing large Foot and Mouth Disease vaccination programmes for smallholder farmers: lessons from Lao PDR
Nampanya, S. Khounsy, R. Abila, P. A. Windsor
https://doi.org/10.1017/S0950268818002443
Published online: 23 August 2018, pp. 2086-2095

The financial sustainability of the World Health Organization and the political economy of global health governance: a review of funding proposals

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 1 Dec 2018]

Review
The financial sustainability of the World Health Organization and the political economy of global health governance: a review of funding proposals
The World Health Organization (WHO) continues to experience immense financial stress. The precarious financial situation of the WHO has given rise to extensive dialogue and debate. This dialogue has generated …
Authors: Srikanth K. Reddy, Sumaira Mazhar and Raphael Lencucha
Citation: Globalization and Health 2018 14:119
Published on: 29 November 2018

 

Developing more participatory and accountable institutions for health: identifying health system research priorities for the Sustainable Development Goal-era

Health Policy and Planning
Volume 33, Issue 9, 1 November 2018
https://academic.oup.com/heapol/issue/33/9

Editor’s Choice
Developing more participatory and accountable institutions for health: identifying health system research priorities for the Sustainable Development Goal-era
K Scott; N Jessani; M Qiu; S Bennett
Health Policy and Planning, Volume 33, Issue 9, 1 November 2018, Pages 975–987, https://doi.org/10.1093/heapol/czy079

An analysis of research priority-setting at the World Health Organization – how mapping to a standard template allows for comparison between research priority-setting approaches

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 1 Dec 2018]

Research
An analysis of research priority-setting at the World Health Organization – how mapping to a standard template allows for comparison between research priority-setting approaches
A review of research priorities completed by WHO technical units was undertaken. Results of the mapping were recorded in a database that was used to generate analysis and compare research priorities and the di…
Authors: R. F. Terry, E. Charles, B. Purdy and A. Sanford
Citation: Health Research Policy and Systems 2018 16:116
Published on: 29 November 2018

Rohingya refugees in Bangladesh: the humanitarian response

Humanitarian Exchange Magazine
Number 73,  October 2018
https://odihpn.org/magazine/mental-health-and-psychosocial-support-in-humanitarian-crises/
Rohingya refugees in Bangladesh: the humanitarian response
More than 700,000 Rohingya refugees have arrived in Bangladesh since 25 August 2017 fleeing violence and persecution in Rakhine State, Myanmar. Over a million are sheltering in overcrowded camps without adequate assistance or protection. Stateless in Myanmar and denied refugee status in Bangladesh, the Rohingya have few rights or freedoms. Monsoons and cyclones are causing landslides, destroying shelters and infrastructure and disrupting services.

This edition of Humanitarian Exchange focuses on the humanitarian response to the Rohingya crisis. In the lead article, Mark Bowden outlines the historical, local and national political context in Bangladesh, and its operational implications. Amal de Chickera highlights the links between statelessness and displacement, and the international community’s failure to prioritise human rights in its dealings both with Bangladesh and with Myanmar. Puttanee Kangkun and John Quinley document the persistent persecution and denial of rights the Rohingya have faced for decades. Jeff Crisp reflects on the premature, involuntary and unsafe return of Rohingya refugees to Myanmar in the 1970s and 1990s, and asks whether this could happen again.

Sally Shevach and colleagues explore how the ‘localisation’ agenda has influenced the operational response, and Kerrie Holloway draws on research by the Humanitarian Policy Group to test the common assumption that local actors necessarily have a better understanding of people’s needs. Nasif Rashad Khan and colleagues and Ashish Banik reflect on their experiences of engaging with the international humanitarian response system. Margie Buchanan-Smith and Marian Casey-Maslen discuss evaluation findings relating to communication and community engagement, a theme taken up by Nick Van Praag and Kai Hopkins, who report on a Ground Truth survey on refugees’ perceptions of assistance. Julia Brothwell discusses the British Red Cross/Bangladesh Red Crescent involvement in disaster preparedness and risk reduction during the monsoon season, and Gina Bark, Kate White and Amelie Janon outline the consequences of long-term exclusion from basic healthcare services in increasing vulnerability to preventable diseases. Matthew Wencel and colleagues round off the issue with reflections on data collection coordination and other challenges associated with monitoring large concentrations of refugees.

 

Improving immunization capacity in Ethiopia through continuous quality improvement interventions: a prospective quasi-experimental study

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 1 Dec 2018]

Research Article
Improving immunization capacity in Ethiopia through continuous quality improvement interventions: a prospective quasi-experimental study
Strong scientific evidence is needed to support low-income countries in building effective and sustainable immunization programs and proactively engaging in global vaccine development and implementation initiatives. This study aimed to implement and evaluate the effectiveness of system-wide continuous quality improvement (CQI) interventions to improve national immunization programme performance in Ethiopia.
Authors: Tsegahun Manyazewal, Alemayehu Mekonnen, Tesfa Demelew, Semegnew Mengestu, Yusuf Abdu, Dereje Mammo, Workeabeba Abebe, Belay Haffa, Daniel Zenebe, Bogale Worku, Amir Aman and Setegn Tigabu
Citation: Infectious Diseases of Poverty 2018 7:119
Published on: 30 November 2018

Evaluating the frequency of operational research conducted during the 2014–2016 West Africa Ebola epidemic

International Journal of Infectious Diseases
December 2018 Volume 77, p1-118
https://www.ijidonline.com/issue/S1201-9712(18)X0012-5

Original Reports
Evaluating the frequency of operational research conducted during the 2014–2016 West Africa Ebola epidemic
Christopher Hurtado, Diane Meyer, Michael Snyder, Jennifer B. Nuzzo
p29–33
Published online: October 5, 2018