FDA [to 31 October2015]

FDA [to 31 October2015]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

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:: Influenza Virus Vaccine for the 2015-2016 Season
Posted: 10/28/2015

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:: Product Development Under the Animal Rule; Guidance for Industry (PDF – 563KB)
Posted: 10/27/2015
INTRODUCTION
This guidance provides information and recommendations on drug and biological product3 development when human efficacy studies are not ethical or feasible. The regulations that set forth the pathway for approval4 of these products under 21 CFR 314.600 through 314.650 (drugs) or 21 CFR 601.90 through 601.95 (biological products) are commonly referred to as the Animal Rule…

Vaxart Awarded $13.98 Million HHS-BARDA Contract to Support Advanced Development of Influenza Tablet Vaccine

Industry Watch
:: Vaxart Awarded $13.98 Million HHS-BARDA Contract to Support Advanced Development of Influenza Tablet Vaccine
Contract to fund series of pre-clinical and clinical studies including a Phase 2 efficacy trial
October 28, 2015
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Vaxart, Inc., a privately held, clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it was awarded a $13.98 million contract by the Office of Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.

The two-year contract was awarded under a Broad Agency Announcement issued to support the advanced development of more effective and universal influenza vaccines to improve seasonal and pandemic influenza preparedness. The contract will primarily fund a Phase 2 challenge study in human volunteers, designed to evaluate whether the Vaxart tablet vaccine offers broader and more durable protection than currently marketed injectable vaccines. Additionally, through a series of preclinical and clinical studies, Vaxart will seek to demonstrate broad cross-protective immunity of its tablet vaccine against drifted and divergent influenza strains…

IVI [to 31 October2015]

IVI [to 31 October2015]
http://www.ivi.org/web/www/home

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IVI Board of Trustees Meeting and Visit by Sida
The week of October 12th was a busy one at IVI with a visit by the Swedish International Development Cooperation Agency (Sida) and the annual gathering of the IVI Board of Trustees (BOT).
Ros Mari Balow, the Sida representative who oversees IVI, visited the IVI headquarters from Oct. 14-16 where she met the Dr. Jerome Kim for the first time since he started his term as Director General and the IVI teams, and participated in the BOT meeting. In addition to being an IVI signatory country, Sweden has been a major contributor of core funds to IVI since 2002. The visit reaffirmed the solid partnership between IVI and Sida.

The BOT meeting took place from Oct. 15-16 at the IVI headquarters and is one of two face-to-face meetings held annually. The meeting is an opportunity for Board members to get institutional updates, and to discuss and make decisions on major issues facing the organization. The major topic at this meeting was IVI’s new strategy and organizational plan to support the strategy. A strategic refresh was initiated since the start of Dr. Kim’s appointment and is currently being supported by the Boston Consulting Group. These organizational changes will make IVI more effective and efficient on delivering in its mission and help ensure the future sustainability of the organization. The new strategic plan will be announced at the end of the year…

UNAIDS 2016–2021 Strategy – On the Fast-Track to end AIDS [by 2030]

UNAIDS 2016–2021 Strategy – On the Fast-Track to end AIDS [by 2030]
Issue date: 27 October 2015 :: 130 pages
UNAIDS PROGRAMME COORDINATING BOARD
UNAIDS/PCB (37)/15.18.rev1
THIRTY-SEVENTH MEETING
Date: 26 – 28 October 2015
WHO, Geneva
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Executive summary [excerpt]
A defining moment
1. The UNAIDS 2016–2021 Strategy comes at a critical moment in the history of the HIV epidemic and response. Evidence demonstrates that if the current, unprecedented level of HIV service coverage is simply maintained, progress will slip backwards with rising numbers of people newly infected, and more people dying from AIDS-related causes. Nevertheless, we have never had more opportunities to leverage our momentum to accelerate the response over the next five years: a new sustainable development agenda; fresh, innovative solutions; and the rise of regional, national and local leadership and institutions – including strong political commitment to the 90–90–90 treatment target. By seizing this moment, we can end the AIDS epidemic as a public health threat by 2030. The next five years provide a fragile window of opportunity to Fast-Track the AIDS response and empower people to lead dignified and rewarding lives….

[excerpt: “vaccine”]
157. The Joint Programme will expand its work on and advocacy for the continued innovation and refinement of HIV-related medicines and technologies, and ensuring their availability, quality and affordability. These efforts will include mobilizing scientific and ethical consensus on efforts towards a vaccine and AIDS cure. UNAIDS will support countries in adopting and using health-related TRIPS flexibilities and in defending their ability to challenge provisions in trade agreements that impede access to affordable medicines and go beyond the international obligations provided under the TRIPS agreement. UNAIDS will join the effort to explore new incentive systems for needed research and development in which research and development costs are delinked from product prices. UNAIDS will also support efforts to overcome regulatory barriers that delay market entry of quality-assured medicines and health technologies, including by strengthening local and regional regulatory capacities. UNAIDS will work with partners in the Diagnostics Access Initiative to fully leverage the potential of laboratory medicine to accelerate progress towards the 90–90–90 treatment target, with particular attention to viral load testing, early infant and other health products amenable to greater market influence…

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Press Release
UNAIDS Board adopts bold and ambitious strategy to end the AIDS epidemic by 2030
GENEVA, 30 October 2015—At its 37th meeting, the UNAIDS Programme Coordinating Board adopted a new strategy to end the AIDS epidemic as a public health threat by 2030. The UNAIDS 2016–2021 Strategy is one of the first in the United Nations system to be aligned to the Sustainable Development Goals, which set the framework for global development policy over the next 15 years, including ending the AIDS epidemic by 2030.

With a universal agenda, firmly grounded in evidence and rights-based approaches, the strategy maps out the UNAIDS Fast-Track approach to accelerate the AIDS response over the next five years to reach critical HIV prevention and treatment targets and achieve zero discrimination. Members of the Board from across all regions called the strategy bold, ambitious, yet achievable, and praised the highly inclusive and consultative process to develop it.

In his opening address, the Executive Director of UNAIDS, Michel Sidibé, described the strategy as an urgent call to front-load investment, to close the testing gap, to increase focus and financing for HIV prevention and to protect the health of the 22 million people living with HIV who are not yet accessing treatment. He said that the strategy would be an instrument for social justice and dignity…

…During the dedicated thematic day, the Board discussed the importance of shared responsibility and global solidarity for an effective, equitable and sustainable HIV response. It was agreed that the most critical next step for achievement of the Sustainable Development Goals will be to have clarity on the means of implementation. Participants emphasized that multisectorality and equitable, transparent and inclusive governance are central bases for effective shared responsibility and global solidarity, and that the AIDS response—and in particular UNAIDS—provides an important model to be replicated for other health, development, gender and rights outcomes…

A NATIONAL BLUEPRINT FOR BIODEFENSE: LEADERSHIP AND MAJOR REFORM NEEDED TO OPTIMIZE EFFORTS

A NATIONAL BLUEPRINT FOR BIODEFENSE: LEADERSHIP AND MAJOR REFORM NEEDED TO OPTIMIZE EFFORTS
BIPARTISAN REPORT OF THE BLUE RIBBON STUDY PANEL
October 2015 :: 100 pages
BACKGROUND
The Blue Ribbon Study Panel on Biodefense was established in 2014 to assess gaps and provide recommendations to improve U.S. biodefense. The Panel – supported by a suite of distinguished ex officio members and staff with deep expertise in science, policy, intelligence, and defense; institutional hosting through Hudson Institute and the Inter-University Center for Terrorism Studies at Potomac Institute for Policy Studies; and funds from academia, foundations, and industry – determined where the United States is falling short…

…CONCLUSIONS
We have reached a critical mass of biological crises. Myriad biological threats, vulnerabilities, and consequences have collectively and dramatically increased the risk to the Nation. They have also, we believe, garnered the attention of enough people who understand the threat is real, want to mobilize and take action, and can provide for effective national biodefense.

Leadership moves America forward. A central and authoritative leader – who, by recommendation of this report, is the Vice President – can foster substantial progress in biodefense, much of it in the near term. Once installed as this leader, the Vice President (and the interagency team of experts who will work to realize the strategic vision of the Executive and Legislative Branches) can foster substantial progress, much of it in the near term. This is especially true for coordinating federal activities, forging intersectoral partnerships, and revolutionizing the ways in which we approach this mission space.

Dramatic improvements are within our reach if we follow a national blueprint for biodefense, establish leadership, and engage in major reform efforts that build on the good work that is already in place.

American Journal of Infection Control – November 2015

American Journal of Infection Control
November 2015 Volume 43, Issue 11, p1147-1268, e67-e81
http://www.ajicjournal.org/current

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Influenza vaccination of health care personnel: Experiences with the first year of a national data collection effort
Elizabeth J. Kalayil, Samantha B. Dolan, Megan C. Lindley, Faruque Ahmed
p1154–1160
Published online: July 30 2015
Preview
The purpose of this project was to evaluate a standardized measure of health care personnel (HCP) influenza vaccination during the first year of implementation. The measure requires acute care hospitals to gather vaccination status data from employees, licensed independent practitioners (LIPs), and adult students/trainees and volunteers. The evaluation included a hospital sampling frame stratified by 4 United States Census Bureau Regions and hospital bed count. The hospitals were selected within strata using simple random sampling and the probability proportional to size method, without replacement.

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Social and political determinants of vaccine hesitancy: Lessons learned from the H1N1 pandemic of 2009-2010
Gustavo S. Mesch, Kent P. Schwirian
p1161–1165
Preview
Public acceptance of vaccination programs is essential for vaccine preventable diseases. However, increasing sectors of the population have expressed hesitancy about participating in such programs, leading to the re-emergence of vaccine preventable diseases. In this study we rely on a recreancy hypothesis to test the association between confidence in the government and local hospitals and the willingness to take the vaccine.

Measles, Mumps, and Rubella Titers in Air Force Recruits: Below Herd Immunity Thresholds?

American Journal of Preventive Medicine
November 2015 Volume 49, Issue 5, p661-810, e53-e88
http://www.ajpmonline.org/current

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Brief Reports
Measles, Mumps, and Rubella Titers in Air Force Recruits: Below Herd Immunity Thresholds?
Paul E. Lewis, Daniel G. Burnett, Amy A. Costello, Cara H. Olsen, Juste N. Tchandja, Bryant J. Webber
p757–760
Published online: July 6 2015
Preview
Preventable diseases like measles and mumps are occurring with increasing frequency in the U.S. despite the availability of an effective vaccine. Given concern that an outbreak may occur among military recruits, we compared serologic evidence of immunity to measles, mumps, and rubella among military recruits with known herd immunity thresholds and determined whether the current Department of Defense policy of presuming mumps immunity based on measles and rubella titers is reliable.

Universal Health Coverage: A Political Struggle and Governance Challenge

American Journal of Public Health
Volume 105, Issue S5 (November 2015)
http://ajph.aphapublications.org/toc/ajph/current

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Universal Health Coverage: A Political Struggle and Governance Challenge
Scott L. Greer, Claudio A. Méndez
American Journal of Public Health: November 2015, Vol. 105, No. S5: S637–S639
Abstract
Universal health coverage has become a rallying cry in health policy, but it is often presented as a consensual, technical project. It is not.
A review of the broader international literature on the origins of universal coverage shows that it is intrinsically political and cannot be achieved without recognition of its dependence on, and consequences for, both governance and politics.

On one hand, a variety of comparative research has shown that health coverage is associated with democratic political accountability. Democratization, and in particular left-wing parties, gives governments particular cause to expand health coverage. On the other hand, governance, the ways states make and implement decisions, shapes any decision to strive for universal health coverage and the shape of its implementation.

Cost-effectiveness evaluation of quadrivalent influenza vaccines for seasonal influenza prevention: a dynamic modeling study of Canada and the United Kingdom

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 31 October2015)

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Research article
Cost-effectiveness evaluation of quadrivalent influenza vaccines for seasonal influenza prevention: a dynamic modeling study of Canada and the United Kingdom
Edward Thommes, Afisi Ismaila, Ayman Chit, Genevieve Meier, Christopher Bauch
BMC Infectious Diseases 2015, 15:465 (27 October 2015)

Evaluation of fotonovela to increase human papillomavirus vaccine knowledge, attitudes, and intentions in a low-income Hispanic community

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 31 October2015)

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Research article
Evaluation of fotonovela to increase human papillomavirus vaccine knowledge, attitudes, and intentions in a low-income Hispanic community
Alvin Chan, Brandon Brown, Enedina Sepulveda, Lorena Teran-Clayton BMC Research Notes 2015, 8:615 (29 October 2015)
Abstract
Background
It has nearly been a decade since the introduction of the vaccine against human papillomavirus (HPV), yet vaccination rates in the United States have remained suboptimal, particularly among Hispanics. Culturally and linguistically relevant health education tools targeting Hispanics are needed to increase the current rate of HPV vaccination. This article evaluates a theory-informed, evidence-guided fotonovela (photographic short story) intervention to improve HPV vaccination knowledge, attitudes, and intention among young adults.
Methods
Young adults (N = 41, aged 18–26 years) in a low-income primary care clinic in Southern California were administered pre- and post-intervention surveys to measure changes in perceived susceptibility to HPV, perceived benefit of vaccination in committed relationship, intention to vaccinate, intention to encourage social networks to vaccinate, and attitude towards vaccination. Post-intervention survey also examined attitudes towards fotonovela. Relationships between attitudes towards fotonovela and demographic characteristics were assessed with Fisher’s exact test. Self-reported gains in knowledge were categorized and tabulated. Changes in perceptions and intentions were analyzed with the marginal homogeneity test.
Results
The majority of participants were female (78.0 %), Latino/Hispanic (92.7 %), single (70.7 %), and had at least a college education (61.0 %). The mean age was 21.9 years (SD 0.4). The fotonovela was viewed as entertaining (95.1 %), educational (97.6 %), and easy to read (100 %). Following the intervention, Hispanic participants improved in all five variables of interest measured in the survey, including perceived susceptibility (+10.5 %, p = 0.03), benefit of vaccination (+7.8 %, p = 0.25), intent to vaccinate (+18.4 %, p = 0.06), intent to encourage others to vaccinate (+10.5 %, p = 0.14) and attitude towards vaccination (+13.1 %, p = 0.05). Improvements in perceived susceptibility and attitude towards vaccination reached statistical significance (p < 0.05). The most frequent gains in knowledge were the risk of HPV infection despite condom use (N = 16) and relationship status (N = 8), three-dose vaccine administration schedule (N = 13), and burden of HPV infection among males (N = 9).
Conclusion
Results are promising because they demonstrate that health messages delivered through a narrative format can promote positive changes in knowledge, attitudes, and intentions. The fotonovela may be a powerful vehicle for HPV education, particularly among Hispanics.

Bulletin of the World Health Organization – Volume 93, Number 11, November 2015, 741-816

Bulletin of the World Health Organization
Volume 93, Number 11, November 2015, 741-816
http://www.who.int/bulletin/volumes/93/11/en/

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EDITORIALS
Gender, health and the Sustainable Development Goals
Veronica Magar

RESEARCH
An insecticide-treated bed-net campaign and childhood malaria in Burkina Faso
Valérie R Louis, Anja Schoeps, Justin Tiendrebéogo, Claudia Beiersmann, Maurice Yé, Marie R Damiba, Guang Y Lu, André H Mbayiha, Manuela De Allegri, Albrecht Jahn, Ali Sié, Heiko Becher & Olaf Müller
doi: 10.2471/BLT.14.147702

POLICY & PRACTICE
Evidence on global medical travel
Kai Ruggeri, Ladislav Záliš, Christopher R Meurice, Ian Hilton, Terry-Lisa Ly, Zorana Zupan & Saba Hinrichs
doi: 10.2471/BLT.14.146027
Abstract
The potential benefits of travelling across national borders to obtain medical treatment include improved care, decreased costs and reduced waiting times. However, medical travel involves additional risks, compared to obtaining treatment domestically. We review the publicly-available evidence on medical travel. We suggest that medical travel needs to be understood in terms of its potential risks and benefits so that it can be evaluated against alternatives by patients who are seeking care. We propose three domains –quality standards, informed decision-making, economic and legal protection – in which better evidence could support the development of medical travel policies.

Coincident polio and Ebola crises expose similar fault lines in the current global health regime

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 7 November 2015]

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Debate
Coincident polio and Ebola crises expose similar fault lines in the current global health regime
Philippe Calain, Caroline Abu Sa’Da
Conflict and Health 2015, 9:29 (16 Sept 2015)
Abstract
Background
In 2014, the World Health Organization (WHO) declared two “public health emergencies of international concern”, in response to the worldwide polio situation and the Ebola epidemic in West Africa respectively. Both emergencies can be seen as testing moments, challenging the current model of epidemic governance, where two worldviews co-exist: global health security and humanitarian biomedicine.
Discussion
The resurgence of polio and the spread of Ebola in 2014 have not only exposed the weaknesses of national health systems, but also the shortcomings of the current global health regime in dealing with transnational epidemic threats. These shortcomings are of three sorts. Firstly, the global health regime is fragmented and dominated by the domestic security priorities of industrialised nations. Secondly, the WHO has been constrained by constitutional country allegiances, crippling reforms and the limited impact of the (2005) International Health Regulations (IHR) framework. Thirdly, the securitization of infectious diseases and the militarization of humanitarian aid undermine the establishment of credible public health surveillance networks and the capacity to control epidemic threats.
Summary
The securitization of communicable diseases has so far led foreign aid policies to sideline health systems. It has also been the source of ongoing misperceptions over the aims of global health initiatives. With its strict allegiance to Member States, the WHO mandate is problematic, particularly when it comes to controlling epidemic diseases. In this context, humanitarian medical organizations are expected to palliate the absence of public health services in the most destitute areas, particularly in conflict zones. The militarization of humanitarian aid itself threatens this fragile and imperfect equilibrium. None of the reforms announced by the WHO in the wake of the 68 th World Health Assembly address these fundamental issues.

Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

Eurosurveillance
Volume 20, Issue 43, 29 October 2015
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

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Rapid communications
Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015
by A Pillsbury, P Cashman, A Leeb, A Regan, D Westphal, T Snelling, C Blyth, N Crawford, N Wood, K Macartney

lobal governmentality: Biosecurity in the era of infectious diseases

Global Public Health
Volume 10, Issue 10, 2015
http://www.tandfonline.com/toc/rgph20/current

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Global governmentality: Biosecurity in the era of infectious diseases
Jlateh Vincent Jappah & Danielle Taana Smith
pages 1139-1156
DOI:10.1080/17441692.2015.1038843
Abstract
This paper uses Foucault’s concept of governmentality to examine relationships between globalisation, the threat of infectious diseases and biosecurity. It draws attention to forms of calculated practices which Foucault notes as technologies of power that aim to foster positive demographic and economic trends in societies through the apparatus of security. These practices are employed at the global level with similar ambitions; hence, we adopt the term global governmentality. We discuss the applications of global governmentality by actors in the global core through the apparatus of security and (neo)liberal economic practices. We then provide examples of resistance/contestation from actors mainly in the global periphery through discussions of viral sovereignty; access to essential medicines, including HIV drugs; and health for all as a human right. We conclude that despite the core-periphery power asymmetry and competing paradigms, these developments tend to complement and/or regulate the phenomenon termed global governmentality, which is made evident by the tremendous successes in global health.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines) – Volume 11, Issue 10, 2015

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 11, Issue 10, 2015
http://www.tandfonline.com/toc/khvi20/current

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Review
Protection of young children from influenza through universal vaccination
Nicola Principi, Laura Senatore & Susanna Esposito
pages 2350-2358
DOI:10.1080/21645515.2015.1055428
Abstract
Influenza is a very common disease among infants and young children, with a considerable clinical and socioeconomic impact. A significant number of health authorities presently recommend universal influenza vaccination for the pediatric population, but a large number of European health authorities is still reluctant to include influenza vaccination in their national vaccination programs. The reasons for this reluctance include the fact that the protection offered by the currently available vaccines is considered poor. This review shows that although future research could lead to an increase in the immunogenicity and potential efficacy of influenza vaccines, the available vaccines, even with their limits, assure sufficient protection in most subjects aged ≥ 6 months, thus reducing the total burden of influenza in young children and justifying the recommendation for the universal vaccination of the whole pediatric population. For younger subjects, the vaccination of their mother during pregnancy represents an efficacious strategy.

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Commentary
Apps for immunization: Leveraging mobile devices to place the individual at the center of care
Kumanan Wilson, Katherine M Atkinson & Jacqueline Westeinde
pages 2395-2399
Open access
DOI:10.1080/21645515.2015.1057362
Abstract
Mobile technology and applications (apps) have disrupted several industries including healthcare. The advantage of apps, being personally focused and permitting bidirectional communication, make them well suited to address many immunization challenges. As of April 25, 2015 searching the Android app store with the words ‘immunize app’ and ‘immunization app’ in Canada yielded 225 apps. On the Apple App Store a similar search produced 98 results. These include apps that provide immunization related information, permit vaccine tracking both for individuals and for animals, assist with the creation of customized schedules and identification of vaccine clinics and serve as sources of education. The diverse functionality of mobile apps creates the potential for transformation of immunization practice both at a personal level and a system level. For individuals, mobile apps offer the opportunity for better record keeping, assistance with the logistics of vaccination, and novel ways of communicating with and receiving information from public health officials. For the system, mobile apps offer the potential to improve the quality of information residing in immunization information systems and program evaluation, facilitate harmonization of immunization information between individuals, health care providers and public health as well as reduce vaccine hesitancy. As mobile technology continues to rapidly evolve there will emerge new ways in which apps can enhance immunization practice.

Indirect costs associated with deaths from the Ebola virus disease in West Africa

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 31 October2015]

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Research Article
Indirect costs associated with deaths from the Ebola virus disease in West Africa
Joses Kirigia, Felix Masiye, Doris Kirigia, Patricia Akweongo Infectious Diseases of Poverty 2015, 4:45 (29 October 2015)
Editor’s summary
Deaths associated with Ebola Virus Disease have been shown to impose a significant economic burden on the affected West African countries. The team did this study to complement the projection by the World Bank in 2014; and made a plea for increased domestic and external investments to enable Guinea, Liberia and Sierra Leone (and other vulnerable African countries) to develop resilient health systems. Image: Ebola v?rus disease treatment centre in Monrovia, Sierra Leone.

Abstract
Background
By 28 June 2015, there were a total of 11,234 deaths from the Ebola virus disease (EVD) in five West African countries (Guinea, Liberia, Mali, Nigeria and Sierra Leone). The objective of this study was to estimate the future productivity losses associated with EVD deaths in these West African countries, in order to encourage increased investments in national health systems.
Methods
A cost-of-illness method was employed to calculate future non-health (NH) gross domestic product (GDP) (NHGDP) losses associated with EVD deaths. The future non-health GDP loss (NHGDPLoss) was discounted at 3 %. Separate analyses were done for three different age groups (< =14 years, 15–44 years and = >45 years) for the five countries (Guinea, Liberia, Mali, Nigeria, and Sierra Leone) affected by EVD. We also conducted a one-way sensitivity analysis at 5 and 10 % discount rates to gauge their impacts on expected NHGDPLoss.
Results
The discounted value of future NHGDPLoss due to the 11,234 deaths associated with EVD was estimated to be Int$ (international dollars) 155,663,244. About 27.86 % of the loss would be borne by Guinea, 34.84 % by Liberia, 0.10 % by Mali, 0.24 % by Nigeria and 36.96 % by Sierra Leone. About 27.27 % of the loss is attributed to those aged under 14 years, 66.27 % to those aged 15–44 years and 6.46 % to those aged over 45 years. The average NHGDPLoss per EVD death was estimated to be Int$ 17,473 for Guinea, Int$ 11,283 for Liberia, Int$ 25,126 for Mali, Int$ 47,364 for Nigeria and Int$ 14,633 for Sierra Leone.
Conclusion
In spite of alluded limitations, the estimates of human and economic losses reported in this paper, in addition to those projected by the World Bank, show that EVD imposes a significant economic burden on the affected West African countries. That heavy burden, coupled with human rights and global security concerns, underscores the urgent need for increased domestic and external investments to enable Guinea, Liberia and Sierra Leone (and other vulnerable African countries) to develop resilient health systems, including core capacities to detect, assess, notify, verify and report events, and to respond to public health risks and emergencies.

The Journal of Law, Medicine & Ethics – Fall 2015

The Journal of Law, Medicine & Ethics
Fall 2015 Volume 43, Issue 3 Pages 437–666
http://onlinelibrary.wiley.com/doi/10.1111/jlme.2015.43.issue-2/issuetoc

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Special Issue: SYMPOSIUM: Should We Offer Genomic Research Results to a Participant’s Family, Including After the Participant’s Death?

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Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice (pages 594–609)
Leslie E. Wolf, Mayank J. Patel, Brett A. Williams Tarver, Jeffrey L. Austin, Lauren A. Dame and Laura M. Beskow
Article first published online: 19 OCT 2015 | DOI: 10.1111/jlme.12302
Abstract
The federal Certificate of Confidentiality plays an important role in research on sensitive topics by authorizing researchers to refuse to disclose identifiable research data in response to subpoenas in any legal setting. However, there is little known about how effective Certificates are in practice. This article draws on our legal and empirical research on this topic to fill this information gap. It includes a description of the purpose of Certificates, their legislative and regulatory history, and a summary of the few reported and unreported cases that have dealt with Certificates. In addition, we outline other statutory confidentiality protections, compare them to the Certificate’s protections, and analyze some of the vulnerabilities of a Certificate’s protections. This analysis allows us to make specific recommendations for strengthening the protections afforded to research data.

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Funding the Costs of Disease Outbreaks Caused by Non-Vaccination (pages 633–647)
Charlotte A. Moser, Dorit Reiss and Robert L. Schwartz
Article first published online: 19 OCT 2015 | DOI: 10.1111/jlme.12305
Abstract
While vaccination rates in the United States are high — generally over 90 percent — rates of exemptions have been going up, and preventable diseases coming back. Aside from their human cost and the financial cost of treatment imposed on those who become ill, outbreaks impose financial costs on an already burdened public health system, diverting resources from other areas. This article examines the financial costs of non-vaccination, showing how high they can be and what they include. It makes a case for requiring those who do not vaccinate to cover the costs of outbreak caused by their choice. Such recouping is justified because the choice not to vaccinate can easily be seen as negligent. But even if it is not, that choice involves imposing costs on others, and there are good reasons to require the actors to internalize those costs.
The article proposes alternative statutory and regulatory schemes to cover the costs imposed on the public purse, focusing on no-fault mechanisms. We consider both ex ante mechanisms like a tax or a fee that will go into a no-fault fund to cover the costs and ex post mechanisms like a statutory authorization for recoupment of those costs by health officials.

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Physician Dismissal of Families Who Refuse Vaccination: An Ethical Assessment (pages 654–660)
Douglas S. Diekema
Article first published online: 19 OCT 2015 | DOI: 10.1111/jlme.12307
Abstract
Thousands of U.S. parents choose to refuse or delay the administration of selected vaccines to their children each year, and some choose not to vaccinate their children at all. While most physicians continue to provide care to these families over time, using each visit as an opportunity to educate and encourage vaccination, an increasing number of physicians are choosing to dismiss these families from their practice unless they agree to vaccinate their children. This paper will examine this emerging trend along with the reasons given by those who advocate such an approach. I will argue that the strategy of refusing to allow families into a clinic unless they agree to vaccinate their children is misguided, and the arguments for doing so fail to stand up to close scrutiny. Such a strategy does not benefit the child or the health of the community, and may have a negative impact on both. Furthermore, some of the arguments in support of dismissal policies ignore the importance of professional obligation and appear to favor self-interest over the interest of the patient.

What next for the malaria RTS,S vaccine candidate?

The Lancet
Oct 31, 2015 Volume 386 Number 10005 p1707-1794 e22-e26
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
What next for the malaria RTS,S vaccine candidate?
The Lancet
DOI: http://dx.doi.org/10.1016/S0140-6736(15)00733-3
Summary
On Oct 23, the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) announced their much-anticipated recommendations for the world’s first malaria vaccine candidate known as RTS,S/AS01. Their decision is not to recommend widespread deployment of the vaccine based on existing evidence, but instead to assess the feasibility of delivering the vaccine and its impact in real-world settings. This decision was perhaps unexpected given the fact that earlier this year the European Medicines Agency reviewed the same safety and efficacy data, and approved the vaccine’s use in young children.

Effect of a community-led sanitation intervention on child diarrhoea and child growth in rural Mali: a cluster-randomised controlled trial

The Lancet Global Health
Nov 2015 Volume 3 Number 11 e654-e724
http://www.thelancet.com/journals/langlo/issue/current

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Effect of a community-led sanitation intervention on child diarrhoea and child growth in rural Mali: a cluster-randomised controlled trial
Amy J Pickering, Habiba Djebbari, Carolina Lopez, Massa Coulibaly, Maria Laura Alzua
Summary
Background
Community-led total sanitation (CLTS) uses participatory approaches to mobilise communities to build their own toilets and stop open defecation. Our aim was to undertake the first randomised trial of CLTS to assess its effect on child health in Koulikoro, Mali.
Methods
We did a cluster-randomised trial to assess a CLTS programme implemented by the Government of Mali. The study population included households in rural villages (clusters) from the Koulikoro district of Mali; every household had to have at least one child aged younger than 10 years. Villages were randomly assigned (1:1) with a computer-generated sequence by a study investigator to receive CLTS or no programme. Health outcomes included diarrhoea (primary outcome), height for age, weight for age, stunting, and underweight. Outcomes were measured 1·5 years after intervention delivery (2 years after enrolment) among children younger than 5 years. Participants were not masked to intervention assignment. The trial is registered with ClinicalTrials.gov, number NCT01900912.
Findings
We recruited participants between April 12, and June 23, 2011. We assigned 60 villages (2365 households) to receive the CLTS intervention and 61 villages (2167 households) to the control group. No differences were observed in terms of diarrhoeal prevalence among children in CLTS and control villages (706 [22%] of 3140 CLTS children vs 693 [24%] of 2872 control children; prevalence ratio [PR] 0·93, 95% CI 0·76–1·14). Access to private latrines was almost twice as high in intervention villages (1373 [65%] of 2120 vs 661 [35%] of 1911 households) and reported open defecation was reduced in female (198 [9%] of 2086 vs 608 [33%] of 1869 households) and in male (195 [10%] of 2004 vs 602 [33%] of 1813 households) adults. Children in CLTS villages were taller (0·18 increase in height-for-age Z score, 95% CI 0·03–0·32; 2415 children) and less likely to be stunted (35% vs 41%, PR 0·86, 95% CI 0·74–1·0) than children in control villages. 22% of children were underweight in CLTS compared with 26% in control villages (PR 0·88, 95% CI 0·71–1·08), and the difference in mean weight-for-age Z score was 0·09 (95% CI –0·04 to 0·22) between groups. In CLTS villages, younger children at enrolment (<2 years) showed greater improvements in height and weight than older children.
Interpretation
In villages that received a behavioural sanitation intervention with no monetary subsidies, diarrhoeal prevalence remained similar to control villages. However, access to toilets substantially increased and child growth improved, particularly in children <2 years. CLTS might have prevented growth faltering through pathways other than reducing diarrhoea.
Funding
Bill & Melinda Gates Foundation.

The Lancet Infectious Diseases – Nov 2015

The Lancet Infectious Diseases
Nov 2015 Volume 15 Number 11 p1243-1360
http://www.thelancet.com/journals/laninf/issue/current

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Comment
Polio eradication: inching forward, with safety nets
Beth D Kirkpatrick, Josyf C Mychaleckyj
Summary
By mid-2015, WHO-reported cases of paralytic disease caused by polioviruses had reached a new low: only 34 cases were caused by wild polioviruses and nine cases were due to circulating vaccine-derived poliovirus (cVDPV).1 In light of this progress, WHO’s Polio Endgame Strategy is moving into a pivotal new stage, focusing on global withdrawal of a vaccine component from primary immunisation schedules. This plan will minimise the time to reach eradication, while maintaining the protection of children in case of disease re-emergence.

Comment
Near full control of human papillomavirus vaccine types
Joakim Dillner
Published Online: 19 July 2015
The Lancet Infectious Diseases, Eric Chow and colleagues1 report on the near elimination of the major human papillomavirus (HPV) types 6, 11, 16, and 18 after introduction of vaccination against these types in Australia when analysed in high-risk women. The authors use the innovative strategy of establishing HPV prevalence in women who are chlamydia positive. Traditional monitoring strategies would typically enrol from the general population, which is both cumbersome and expensive, and potentially biased because volunteering women would tend to be low risk, therefore possibly missing HPV circulation in high-risk core groups.

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Ebola: missed opportunities for Europe–Africa research
Giuseppe Ippolito, Simone Lanini, Philippe Brouqui, Antonino Di Caro, Francesco Vairo, Salim Abdulla, Francesco Maria Fusco, Sanjeev Krishna, Maria Rosaria Capobianchi, Henry Kyobe-Bosa, David J M Lewis, Vincenzo Puro, Roman Wolfel, Tatjana Avsic-Zupanc, Osman Dar, Peter Mwaba, Matthew Bates, David Heymann, Alimuddin Zumla
Summary
The current unprecedented Ebola virus disease outbreak in parts of west Africa, which has caused more than 11 200 deaths, has emphasised how the medical and scientific communities lack specific pathways for tackling relevant logistical, design, and ethical issues for assessment of novel diagnostics, treatments, and vaccines through implementation of appropriate clinical trials.1,2 The phenomenal outbreak arose because of several weaknesses in local, regional, and international public health responses, which delayed provision and implementation of effective intervention.

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Post-exposure prophylaxis against Ebola virus disease with experimental antiviral agents: a case-series of health-care workers
Michael Jacobs, Emma Aarons, Sanjay Bhagani, Ruaridh Buchanan, Ian Cropley, Susan Hopkins, Rebecca Lester, Daniel Martin, Neal Marshall, Stephen Mepham, Simon Warren, Alison Rodger
Summary
Background
Although a few international health-care workers who have assisted in the current Ebola outbreak in west Africa have been medically evacuated for treatment of Ebola virus disease, more commonly they were evacuated after potential accidental exposure to Ebola virus. An urgent need exists for a consensus about the risk assessment of Ebola virus transmission after accidental exposure, and to investigate the use of post-exposure prophylaxis (PEP). Experimental vaccines have occasionally been used for Ebola PEP, but newly developed experimental antiviral agents have potential advantages. Here, we describe a new method for risk assessment and management of health-care workers potentially exposed to Ebola virus and report the use of experimental antiviral therapies for Ebola PEP in people.
Methods
We devised a risk assessment and management algorithm for health-care workers potentially exposed to Ebola virus and applied this to eight consecutive individuals who were medically evacuated to the UK from west Africa between January, and March, 2015. PEP with antiviral agents was given to health-care workers assessed to have had substantial risk exposures to Ebola virus. Participants were followed up for 42 days after potential exposure.
Findings
Four of eight health-care workers were classified as having had low risk exposures and managed by watchful waiting in the community. None of these health-care workers developed Ebola virus disease. The other four health-care workers had intermediate or maximum risk exposures and were given PEP with antiviral agents. PEP was well tolerated with no serious adverse effects. None of these four health-care workers, including two with maximum risk exposures from penetrating injuries with freshly used hollow-bore needles, developed Ebola virus disease.
Interpretation
Standardised risk assessment should be adopted and consensus guidelines developed to systematically study the efficacy and safety of PEP with experimental agents. New experimental antiviral treatments are a viable option for PEP against Ebola.
Funding
Royal Free London NHS Foundation Trust.

 

PLOS Currents: Disasters [Accessed 31 October2015]

PLOS Currents: Disasters
http://currents.plos.org/disasters/
[Accessed 31 October2015]

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An Analysis of the Relationship Between the Heat Index and Arrivals in the Emergency Department
October 29, 2015 · Research article
Background: Heatwaves are one of the most deadly weather-related events in the United States and account for more deaths annually than hurricanes, tornadoes, floods, and earthquakes combined. However, there are few statistically rigorous studies of the effect of heatwaves on emergency department (ED) arrivals. A better understanding of this relationship can help hospitals plan better and provide better care for patients during these types of events.
Methods: A retrospective review of all ED patient arrivals that occurred from April 15 through August 15 for the years 2008 through 2013 was performed. Daily patient arrival data were combined with weather data (temperature and humidity) to examine the potential relationships between the heat index and ED arrivals as well as the length of time patients spend in the ED using generalized additive models. In particular the effect the 2012 heat wave that swept across the United States, and which was hypothesized to increase arrivals was examined.
Results: While there was no relationship found between the heat index and arrivals on a single day, a non-linear relationship was found between the mean three-day heat index and the number of daily arrivals. As the mean three-day heat index initially increased, the number of arrivals significantly declined. However, as the heat index continued to increase, the number of arrivals increased. It was estimated that there was approximately a 2% increase in arrivals when the mean heat index for three days approached 100°F. This relationship was strongest for adults aged 18-64, as well as for patients arriving with lower acuity. Additionally, a positive relationship was noted between the mean three-day heat index and the length of stay (LOS) for patients in the ED, but no relationship was found for the time from which a patient was first seen to when a disposition decision was made. No significant relationship was found for the effect of the 2012 heat wave on ED arrivals, though it did have an effect on patient LOS.
Conclusion: A single hot day has only a limited effect on ED arrivals, but continued hot weather has a cumulative effect. When the heat index is high (~90°F) for a number of days in a row, this curtails peoples activities, but if the heat index is very hot (~100°F) this likely results in an exacerbation of underlying conditions as well as heat-related events that drives an increase in ED arrivals. Periods of high heat also affects the length of stay of patients either by complicating care or by making it more difficult to discharge patients.

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2011 Joplin, Missouri Tornado Experience, Mental Health Reactions, and Service Utilization: Cross-Sectional Assessments at Approximately 6 Months and 2.5 Years Post-Event
October 26, 2015 · Research article
Introduction. On May 22, 2011 the deadliest tornado in the United States since 1947 struck Joplin, Missouri killing 161 people, injuring approximately 1,150 individuals, and causing approximately $2.8 billion in economic losses.
Methods. This study examined the mental health effects of this event through a random digit dialing sample (N = 380) of Joplin adults at approximately 6 months post-disaster (Survey 1) and a purposive convenience sample (N = 438) of Joplin adults at approximately 2.5 years post-disaster (Survey 2). For both surveys we assessed tornado experience, posttraumatic stress, depression, mental health service utilization, and sociodemographics. For Survey 2 we also assessed social support and parent report of child strengths and difficulties.
Results. Probable PTSD relevance was 12.63% at Survey 1 and 26.74% at Survey 2, while current depression prevalence was 20.82% at Survey 1 and 13.33% at Survey 2. Less education and more tornado experience was generally related to greater likelihood of experiencing probable PTSD and current depression for both surveys. Men and younger participants were more likely to report current depression at Survey 1. Low levels of social support (assessed only at Survey 2) were related to more probable PTSD and current depression. For both surveys, we observed low rates of mental health service utilization, and these rates were also low for participants reporting probable PTSD and current depression. At Survey 2 we assessed parent report of child (ages 4 to 17) strengths and difficulties and found that child difficulties were more frequent for younger children (ages 4 to 10) than older children (ages 11 to 17), and that parents reporting probable PTSD reported a greater frequency of children with borderline or abnormal difficulties.
Discussion. Overall our results indicate that long-term (multi-year) community disaster mental health monitoring, assessment, referral, outreach, and services are needed following a major disaster like the 2011 Joplin tornado

Using Qualitative Evidence in Decision Making for Health and Social Interventions: An Approach to Assess Confidence in Findings from Qualitative Evidence Syntheses (GRADE-CERQual)

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 31 October2015)

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Using Qualitative Evidence in Decision Making for Health and Social Interventions: An Approach to Assess Confidence in Findings from Qualitative Evidence Syntheses (GRADE-CERQual)
Simon Lewin, Claire Glenton, Heather Munthe-Kaas, Benedicte Carlsen, Christopher J. Colvin, Metin Gülmezoglu, Jane Noyes, Andrew Booth, Ruth Garside, Arash Rashidian
Guidelines and Guidance | published 27 Oct 2015 | PLOS Medicine
10.1371/journal.pmed.1001895
Summary Points
:: Qualitative evidence syntheses are increasingly used, but methods to assess how much confidence to place in synthesis findings are poorly developed.
:: The Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach helps assess how much confidence to place in findings from a qualitative evidence synthesis.
:: CERQual’s assessment of confidence for individual review findings from qualitative evidence syntheses is based on four components: the methodological limitations of the qualitative studies contributing to a review finding, the relevance to the review question of the studies contributing to a review finding, the coherence of the review finding, and the adequacy of data supporting a review finding.
:: CERQual provides a transparent method for assessing confidence in qualitative evidence syntheses findings. Like the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach for evidence of effectiveness, CERQual may facilitate the use of qualitative evidence to inform decisions and shape policies.
:: The CERQual approach is being developed by a subgroup of the GRADE Working Group.

PLoS One [Accessed 31 October2015]

PLoS One
http://www.plosone.org/
[Accessed 31 October2015]

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Modeling the Impact of Alternative Immunization Strategies: Using Matrices as Memory Lanes
Wladimir J. Alonso, Maia A. Rabaa, Ricardo Giglio, Mark A. Miller, Cynthia Schuck-Paim
Research Article | published 28 Oct 2015 | PLOS ONE
10.1371/journal.pone.0141147

The Impact of Hepatitis B Vaccination Status on the Risk of Diabetes, Implicating Diabetes Risk Reduction by Successful Vaccination
Jean Huang, Horng-Yih Ou, James Lin, Rudruidee Karnchanasorn, Wei Feng, Raynald Samoa, Lee-Ming Chuang, Ken C. Chiu
Research Article | published 28 Oct 2015 | PLOS ONE
10.1371/journal.pone.0139730

Missed Opportunities for Measles, Mumps, and Rubella (MMR) Immunization in Mesoamerica: Potential Impact on Coverage and Days at Risk
Ali H. Mokdad, Marielle C. Gagnier, K. Ellicott Colson, Emily Dansereau, Paola Zúñiga-Brenes, Diego Ríos-Zertuche, Annie Haakenstad, Casey K. Johanns, Erin B. Palmisano, Bernardo Hernandez, Emma Iriarte
Research Article | published 27 Oct 2015 | PLOS ONE
10.1371/journal.pone.0139680

Effectively Communicating the Uncertainties Surrounding Ebola Virus Transmission

PLoS Pathogens
http://journals.plos.org/plospathogens/
(Accessed 31 October2015)

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Effectively Communicating the Uncertainties Surrounding Ebola Virus Transmission
Andy Kilianski, Nicholas G. Evans
Opinion | published 29 Oct 2015 | PLOS Pathogens
10.1371/journal.ppat.1005097
Abstract
The current Ebola virus outbreak has highlighted the uncertainties surrounding many aspects of Ebola virus virology, including routes of transmission. The scientific community played a leading role during the outbreak—potentially, the largest of its kind—as many of the questions surrounding ebolaviruses have only been interrogated in the laboratory. Scientists provided an invaluable resource for clinicians, public health officials, policy makers, and the lay public in understanding the progress of Ebola virus disease and the continuing outbreak. Not all of the scientific communication, however, was accurate or effective. There were multiple instances of published articles during the height of the outbreak containing potentially misleading scientific language that spurred media overreaction and potentially jeopardized preparedness and policy decisions at critical points. Here, we use articles declaring the potential for airborne transmission of Ebola virus as a case study in the inaccurate reporting of basic science, and we provide recommendations for improving the communication about unknown aspects of disease during public health crises.
Author Summary
Basic scientific research is now considered an integral component of the fight against emerging infectious diseases like Ebola virus. The recent Ebola outbreak, however, demonstrates how the ineffective communication of basic science can stoke public panic more than it provides helpful tools to responders; basic science trades in probabilities and uncertainty, while public communication tends to favor more categorical claims. Here, we discuss the ethics of communicating scientific results, using, as a case study, the recent controversy over whether basic life sciences research demonstrates that Ebola could become transmissible via airborne respiratory droplet nuclei—popularly known as a virus becoming “airborne.” We show how the science does not demonstrate this possibility, despite claims made in the popular and scientific press. We then recommend that uncertain scientific results in the context of public health crises ought to be communicated with humility, an emphasis on what is unknown, and a clear outline of the kinds of evidence that would give proof to controversial claims.

Commentary: Impact of bed capacity on spatiotemporal shifts in Ebola transmission

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/
(Accessed 7 November 2015)

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Social Sciences – Economic Sciences:
Commentary: Impact of bed capacity on spatiotemporal shifts in Ebola transmission
Jeffrey P. Townsend,
Laura A. Skrip,
and Alison P. Galvani
PNAS 2015 ; published ahead of print October 30, 2015, doi:10.1073/pnas.1518484112
Extract
The unprecedentedly devastating Ebola epidemic in West Africa brought international attention to the challenges faced by resource-constrained nations in curtailing outbreaks. As the epidemic tapers in Sierra Leone and Guinea, the focus of epidemiologists has shifted from emergency response toward retrospection. Lessons learned from this outbreak will be fundamental for establishing preparedness strategies and for averting future epidemics. In a masterful data-driven modeling study in PNAS, Kucharski et al. (1) quantified the extent to which the international effort to provide more treatment beds prevented new infections across the 12 districts of Sierra Leone, as well as the incremental benefit that could have been achieved if the provision had been earlier in the epidemic.

Risk Communication, Values Clarification, and Vaccination Decisions

Risk Analysis
October 2015 Volume 35, Issue 10 Pages 1765–1956
http://onlinelibrary.wiley.com/doi/10.1111/risa.2015.35.issue-10/issuetoc

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Introduction to the Special Series on Risk, Perception, and Response (pages 1766–1769)
Lisa A. Robinson and James K. Hammitt
Article first published online: 22 OCT 2015 | DOI: 10.1111/risa.12520

Risk Communication, Values Clarification, and Vaccination Decisions (pages 1801–1819)
Holly O. Witteman, Selma Chipenda Dansokho, Nicole Exe, Audrey Dupuis, Thierry Provencher and Brian J. Zikmund-Fisher
Article first published online: 20 MAY 2015 | DOI: 10.1111/risa.12418
Abstract
Many health-related decisions require choosing between two options, each with risks and benefits. When presented with such tradeoffs, people often make choices that fail to align with scientific evidence or with their own values. This study tested whether risk communication and values clarification methods could help parents and guardians make evidence-based, values-congruent decisions about children’s influenza vaccinations. In 2013–2014 we conducted an online 2×2 factorial experiment in which a diverse sample of U.S. parents and guardians (n = 407) were randomly assigned to view either standard information about influenza vaccines or risk communication using absolute and incremental risk formats. Participants were then either presented or not presented with an interactive values clarification interface with constrained sliders and dynamic visual feedback. Participants randomized to the risk communication condition combined with the values clarification interface were more likely to indicate intentions to vaccinate (β = 2.10, t(399) = 2.63, p < 0.01). The effect was particularly notable among participants who had previously demonstrated less interest in having their children vaccinated against influenza (β = –2.14, t(399) = –2.06, p < 0.05). When assessing vaccination status reported by participants who agreed to participate in a follow-up study six months later (n = 116), vaccination intentions significantly predicted vaccination status (OR = 1.66, 95%CI (1.13, 2.44), p < 0.05) and rates of informed choice (OR = 1.51, 95%CI (1.07, 2.13), p < 0.012), although there were no direct effects of experimental factors on vaccination rates. Qualitative analysis suggested that logistical barriers impeded immunization rates. Risk communication and values clarification methods may contribute to increased vaccination intentions, which may, in turn, predict vaccination status if logistical barriers are also addressed.

The realities of risk-cost-benefit analysis

Science
30 October 2015 vol 350, issue 6260, pages 481-596
http://www.sciencemag.org/current.dtl

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Review
The realities of risk-cost-benefit analysis
Baruch Fischhoff
BACKGROUND
Synthetic biology, nanotechnology, geoengineering, and other innovative technologies share a property: Their effects must often be inferred long before they are experienced. If those inferences are sound, then informed decisions are possible. If not, then decision-makers may incur risks and costs far greater than any expected benefits. Risk, cost, and benefit analysis can offer transparent ways to assemble and integrate relevant evidence to support complex decision-making All forms of analysis have the same logic: Decompose complex systems into manageable components and then calculate how they might perform together. All require scientific judgment to bound the set of components and assess the limits to those bounds. All require ethical judgment to determine which outcomes to predict and to extract the policy implications of the results. The usefulness of any analysis depends on how well its underlying assumptions and their implications are understood by those hoping to use its results. The present review uses historical examples to illustrate the roles of judgment in analyses that address four basic questions: (i) How large are the risks from a single technology?(ii) Which risks merit the greatest attention? (iii) Which technology produces the least risk per unit of benefit? (iv) Are a technology’s expected benefits acceptable, given its risks and other expected costs?
ADVANCES
Analyses are always incomplete. They neglect concerns that are hard to quantify. They define terms in ways that serve some interests more than others. They consider some sources of uncertainty but not others. Advances in the science of analysis have often occurred after critics unhappy with the results of an analysis challenged the legitimacy of its assumptions. Awareness of the role of judgment in analysis has grown over time, in parallel with improvements in the sophistication of analytical calculations. Progress has been made in some areas, but more is needed, to include developing better ways to model human behavior, elicit expert judgments, articulate decision-makers’ preferences, characterize the robustness of conclusions, and communicate with decision-makers. The practice of analysis draws on the sciences of public participation and science communication, both shaped by the challenges faced in securing a fair hearing for science in issues where it plays a central role.
OUTLOOK
The pace of advances will depend on the degree of collaboration among the sciences relevant to these problems, including not only the sciences underlying the technology in question but social, behavioral, and economic science as well. How well the science of analysis aids its practice will depend on how well analysts collaborate with decision-makers so as to produce the estimates that decision-makers need and ensure that analytical results are properly understood. Over time, those interactions will help decision-makers understand the capabilities and limitations of analysis while helping analysts become trusted allies, dedicated to producing relevant, properly qualified estimates of cost, risk, and benefit.

Providers’ beliefs about the effectiveness of the HPV vaccine in preventing cancer and their recommended age groups for vaccination: Findings from a provider survey, 2012

Preventive Medicine
Available online 24 October 2015
Providers’ beliefs about the effectiveness of the HPV vaccine in preventing cancer and their recommended age groups for vaccination: Findings from a provider survey, 2012
Z Berkowitz, M Malone, J Rodriguez, M Saraiya
Abstract
Background
The human papillomavirus (HPV) vaccine was recommended in 2007 by the Advisory Committee on Immunization Practices (ACIP) to preadolescent and adolescent girls. Vaccination initiation was recommended at age 11–12 years with the option to start at age 9. Catchup vaccination was recommended to females aged 13–26 previously not vaccinated. However, vaccination coverage remains low. Studies show that the HPV vaccine can prevent cervical, vulvar, vaginal, anal and some oropharyngeal cancers and that provider recommendation of vaccines can improve low vaccination rates.
Methods
Using data from 2012 DocStyles, an annual, web-based survey of U.S. healthcare professionals including physicians and nurse practitioners (n = 1753), we examined providers’ knowledge about the effectiveness of the HPV vaccine in preventing cancer and their vaccine recommendation to all age-eligible females (9–26 years). Descriptive statistics and Chi-square tests were used to assess differences across specialties.
Results
Knowledge about HPV vaccine effectiveness in preventing cervical cancer was highly prevalent (96.9%), but less so for anal, vaginal, vulvar and oropharyngeal cancers. Only 14.5% of providers recommended the vaccine to all age-eligible females and 20.2% recommended it to females aged 11–26 years. Knowledge assessment of cancers associated with HPV and vaccination recommendations varied significantly among providers (p < 0.01). Providers more frequently recommended the vaccine to girls older than 11–12 years.
Conclusions
Improving providers’ knowledge about HPV-associated cancers and the age for vaccination initiation, communicating messages focusing on the vaccine safety and benefits in cancer prevention and on the importance of its delivery prior to sexual onset, may improve HPV vaccine coverage.

Vaccine coverage in Italy and assessment of the 2012-2014 National Immunization Prevention Plan

Epidemiol Prev

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Vaccine coverage in Italy and assessment of the 2012-2014 National Immunization Prevention Plan
Paolo Bonanni,1 Antonio Ferro,1 Raniero Guerra,2 Stefania Iannazzo,2 Anna Odone,1Maria Grazia Pompa,2Elvira Rizzuto,2 Carlo Signorelli1
Abstract
Background. In 2012, the Italian Ministry of Health issued the National Immunization Prevention Plan (Piano Nazionale Prevenzione Vaccinale, or PNPV 2012-2014), with the aim of harmonizing immunization strategies across the country and ensuring equitable access to infectious disease prevention to all citizens. The Plan defines the immunization standards all regions should comply with.
Objective and methods. As new evidence has accumulated in the field of immunization, and the new National Immunization Prevention Plan is about to be launched, the aim of the current study is to: i. present immunization coverage data (2000-2014) for 14 vaccines included in the PNPV to be offered to the general population, ii. assess to what extent the PNPV coverage targets and objectives have been met, and iii. report on how the PNPV was transposed into regional immunization programs. Data are also available for the eight regions that piloted varicella immunization.
Results. The 2012-2014 PNPV first introduced a “lifecourse” approach to vaccination at the institutional level, and has been a milestone for prevention in the Italian health policy agenda. However, infant vaccine coverage rates have been decreasing over the last years, as has influenza immunization in the elderly. HPV vaccine coverage has been increasing for all birth cohorts, but is still far below the targets set in the Plan. Promising preliminary data show that pneumococcal and meningococcal C conjugate vaccines were well introduced in regional immunization schedules.
Conclusion. The 2012-2014 PNPV objectives have only been partially met, due to several factors, in particular increase in vaccine hesitancy. Strengthened efforts are needed to promote immunization. The new National Immunization Prevention Plan should introduce new vaccines and extend immunization programs to other target populations on the basis of the most recent scientific evidence available. It is of crucial importance that interventions of proven efficacy be planned and implemented to contrast the growing phenomenon of vaccine hesitancy and ultimately increase immunization uptake.

Immunization Coverage in Migrant School Children Along the Thailand-Myanmar Border

Journal of Immigrant and Minority Health

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Immunization Coverage in Migrant School Children Along the Thailand-Myanmar Border
Kaji A, Parker DM, Chu CS, Thayatkawin W, Suelaor J, Charatrueangrongkun R, Salathibuppha K, Nosten FH, McGready R
Abstract
The objective of this project was to document and increase vaccine coverage in migrant school children on the Thailand-Myanmar border. Migrant school children (n = 12,277) were enrolled in a school-based immunization program in four Thai border districts. The children were evaluated for vaccination completion and timing, for six different vaccines: Bacille Calmette-Guerin (BCG); Oral Polio vaccine (OPV); Hepatitis B vaccine (HepB); Diphtheria, Pertussis and Tetanus vaccine (DTP); Measles Containing Vaccine or Measles, Mumps and Rubella vaccine (MMR); Tetanus and Diphtheria containing vaccine (Td). Vaccine coverage proportions for BCG, OPV3, DTP3, HepB3 and measles containing vaccine were 92.3, 85.3, 63.8, 72.2, and 90.9 % respectively. Most children were able to receive vaccines in a time appropriate manner. School-based immunization programs offer a suitable vaccine delivery mechanism for hard-to-reach populations. However, these data suggest overall low vaccine coverage in migrant populations. Further efforts toward improving appropriate vaccine coverage and methods of retaining documentation of vaccination in mobile migrant populations are necessary for improved health.

Media/Policy Watch [to 31 October 2015]

Media/Policy Watch
This section is intended to alert readers to substantive news, analysis and opinion from the general media 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.

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Forbes
http://www.forbes.com/
Accessed 31 October2015
FluMist Shortage Shouldn’t Delay Flu Shots — Yes, Even If You Hate Needles
Yes, you have to get your flu shot approximately yesterday if you want to be protected from this year’s flu season — even if that means getting a painful jab.
Sarah Hedgecock, Forbes Staff, Oct 30, 2015

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Foreign Policy
http://foreignpolicy.com/
Accessed 31 October2015
The Polio Capital of the World
Pakistan’s Army and Lady Health Workers are at the center of the global effort to eradicate polio. How successful have they been?
Arsla Jawaid | October 22, 2015

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New York Times
http://www.nytimes.com/
Accessed 31 October2015
It’s Not Brain Surgery, Ben Carson
…He has hedged on the question of childhood vaccine safety to suggest that “a multitude of vaccines” backed by decades of conclusive research ought to be considered with “discretion.”
November 01, 2015 – By ISHANI GANGULI – Opinion

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 31 October2015
NY to mandate meningitis vaccines for 7th, 12th-graders
Oct. 29, 2015 4:38 pm ET