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

Vaccines and Global Health: The Week in Review 24 October 2015

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

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

pdf version A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_24 October 2015

blog edition: comprised of the approx. 35+ entries posted below on 13 September 2015..

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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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.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

WHO SAGE Meeting/Malaria Vaccine+

WHO SAGE Meeting/Malaria Vaccine+

WHO – Press Conference on Outcomes of SAGE Immunization Meeting (Geneva, 23 October 2015)
Video
Briefing on outcomes and recommendations of the meeting of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, held this week.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization, which was established to advise WHO on policies and strategies for immunization, met on 20-22 October 20-22 to review the best available scientific evidence on development and use of vaccines including those for use against Ebola virus, poliovirus and malaria. .
Speaker: Professor Jon S. Abramson – Chair of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization

News release
Pilot implementation of first malaria vaccine recommended by WHO advisory groups
Global move to remove type two oral polio vaccine agreed for April
23 October 2015 | GENEVA – The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) jointly recommended pilot projects to understand how to best use a vaccine that protects against malaria in young children.

“This was a historic meeting with two of WHO’s major advisory committees working together to consider current evidence about this vaccine,” said Professor Fred Binka, acting chair of MPAC. “The committees agreed that pilot implementations should be the next step with this vaccine.”

The vaccine, known as RTS,S, is the first vaccine for malaria, but there is one primary question. It requires four doses for a child to be fully protected and therefore requires additional contacts with the health care system. The first three doses are given one month apart followed by an 18-month pause before the fourth dose. Without the fourth dose, children had no overall reduction in severe malaria.

“The question about how the malaria vaccine may best be delivered still need to be answered,” said Professor Jon S. Abramson, chair of SAGE. “After detailed assessment of all the evidence we recommended that this question is best addressed by having 3-5 large pilot implementation projects.”

The malaria vaccine, RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa. It offers no protection against P. vivax malaria, which predominates in many countries outside of Africa. The vaccine is being assessed as a complementary malaria control tool that could potentially be added to—but not replace—the core package of proven malaria preventive, diagnostic and treatment measures.

In other sessions during the SAGE meeting, held from 20-22 October, the group reviewed evidence and offered recommendations on the development and use of vaccines against Ebola virus, poliovirus and measles.

Polio vaccine
Oral polio vaccine (OPV) is the primary tool used to eradicate polio worldwide, thanks to its unique ability to interrupt person-to-person spread of the virus. However, on very rare occasions, the live attenuated vaccine-viruses contained in OPV can be associated with cases of vaccine-associated polio paralysis (VAPP) or circulating vaccine-derived polioviruses (cVDVPs). Withdrawing OPVs is therefore a crucial part of the polio endgame strategy.

The type 2 component of OPV accounts for 40% of VAPP cases, and upwards of 90% of cVDPV cases. By contrast, wild poliovirus type 2 has not been detected anywhere since 1999 and the Global Commission for the Certification of Poliomyelitis Eradication (GCC) declared this strain globally eradicated at its meeting in September 2015. Countries have therefore been preparing to remove the type 2 component from OPV, by switching from trivalent OPV (containing all three serotypes) to bivalent OPV (containing only type 1 and 3 serotypes). All oral polio vaccines will be removed after global eradication of wild poliovirus types 1 and 3 has been certified.

SAGE confirmed that the globally synchronized switch from trivalent oral polio vaccine (tOPV) to bivalent OPV (bOPV) should occur between 17 April and 1 May 2016.

SAGE also concluded that significant progress had been made since its last meeting, in April 2015, with no cases of wild poliovirus in Africa since August and more than a year having passed since the last case was seen in the Middle East, strengthened surveillance and more children being reached with vaccines in key areas of Pakistan and Afghanistan. As a result of these steps, all countries and the partners of the Global Polio Eradication Initiative (GPEI) should intensify their preparations for the global withdrawal of OPV type 2 (OPV2) in April 2016.

SAGE cautioned, however, that more work needs to be done ahead of the switch date. It is critical that countries meet deadlines to protect populations by moving towards destruction of wild poliovirus type 2 stocks or their containment in ‘poliovirus essential’ facilities. Ongoing vaccine-derived type 2 polio outbreaks in Guinea and South Sudan need to be stopped. A global shortage of inactivated polio vaccine needs to be managed ahead of the switch, with available supplies prioritized for the highest-risk areas.

Measles vaccine
Currently 13 percent of measles cases are occurring in children before they reach 9 months – the youngest age at which the first dose is typically given, so SAGE is recommending, in specific circumstances, that a dose may be given earlier to infants as young as 6 months when the risk of contracting measles is high.

Ebola
SAGE also offered provisional recommendations on vaccination in response to an outbreak of Ebola, based on interim trial results suggesting high safety and efficacy. These recommendations are provisional because candidate vaccines are currently being used only in the context of clinical trials, and recommendations for use outside trial settings will depend on the vaccines receiving regulatory approval. The recommendations do not apply to any specific vaccine. Recommendations will be adjusted when more data become available.

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Gavi and Global Fund Statement on Malaria Vaccine Recommendations
23 October 2015
GENEVA – Today’s recommendations by two advisory bodies to the World Health Organization, the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC), for use of the RTS,S malaria vaccine are a step toward making the vaccine available in countries with a heavy malaria burden as well as an opportunity to assess its likely real world impact.

They have called for pilot implementations of the vaccine in three to five settings in sub-Saharan Africa. This follows an earlier four-year trial of the vaccine that found it safe and effective, providing 39 percent efficacy at preventing clinical cases of malaria.

Replicating that success rate in a non-clinical setting poses challenges. The RTS,S vaccine requires four doses and the last dose is critical for sustaining the protective effect of the vaccine. The first three doses of the vaccine will be administered to children between 5 and 9 months of age and the fourth dose is given around the second birthday. This is partially outside the existing immunization schedule in which most vaccines are administered to infants 6 to 14 weeks after birth, potentially posing logistical challenges to health systems in low-income countries. Further assessing the feasibility of providing these vaccinations and the resulting impact is therefore a prudent approach.

While additional studies could demonstrate RTS,S’s utility in the malaria control toolkit, global efforts must continue to expand access to proven methods of malaria control. The RTS,S vaccine could complement – not replace – existing proven and cost-effective methods, such as insecticide-treated mosquito nets and spraying. Tools such as insecticide-treated mosquito nets have significantly reduced the burden of malaria, more than halving the number under-five deaths since 2000. Despite such progress, there are still more than 200 million cases of malaria worldwide each year, resulting in 438,000 deaths, the vast majority of them African children.

It is now for the World Health Organization to confirm its recommendations on the first-ever malaria vaccine based on the recommendations received from SAGE/MPAC. The boards of Gavi and the Global Fund will review the WHO’s recommendation to determine next steps.

Gavi and the Global Fund are continuing to work together to plan for the possible use of a malaria vaccine, if recommended by WHO and if the Gavi and Global Fund boards decide to support the vaccine in conjunction with other proven malaria interventions, as part of an integrated approach towards malaria control. Both organisations are working in close coordination with the Global Malaria Programme at the WHO, other technical and donor partners and implementing countries.

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PATH [to 24 October 2015]
http://www.path.org/news/index.php
GSK and PATH joint statement on WHO advisory group recommendation on use of RTS,S malaria vaccine candidate
October 23, 2015—The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) and Malaria Policy Advisory Committee (MPAC) have today jointly recommended implementation of GlaxoSmithKline’s (GSK) malaria vaccine candidate RTS,S (Mosquirix™) through a number of pilot projects. This is an important step in the process toward making RTS,S available alongside existing tools currently recommended for malaria prevention, diagnosis, treatment, and control. GSK and PATH will now review the SAGE/MPAC advice as we wait for the final policy recommendation from the WHO expected by the end of 2015.

GSK and PATH stand ready to work with the WHO on the pilot implementation of the vaccine, in order to provide the additional information needed about how to best deliver the vaccine in a real-world setting, enabling implementation of a wider scale immunisation programme in children in sub-Saharan Africa (SSA). The results of a large scale phase III efficacy and safety trial of RTS,S, have shown that RTS,S could provide a meaningful public health benefit in reducing the burden of malaria when used alongside currently available interventions such as bed nets and insecticides.

The SAGE/MPAC joint recommendation comes after the vaccine candidate received a positive scientific opinion from the European regulators in July 2015 for the prevention of malaria in young children in SSA.

In 2013, there were an estimated 584,000 deaths from malaria with around 90 percent of these occurring in SSA, and 83 percent in children under the age of five.

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Press release | October 20, 2015
Visualize No Malaria campaign to prove malaria elimination possible in Africa
PATH & Tableau Foundation form unique partnership to aid elimination efforts in Zambia using data visualization.

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Global Fund [to 24 October 2015]
http://www.theglobalfund.org/en/news/

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News
Global Fund Statement on Cambodia’s Programs against Malaria
20 October 2015
Cambodia has made impressive progress against malaria, with a 70 percent decline in the number of cases from 2009 to 2014, and a sharp reduction in deaths in the same period.
However, the situation remains critical, and preliminary data on an increase in malaria cases in parts of Cambodia since mid-2014, as well as resistance to artemisinin-based combination therapies, carries serious implications for the broader Mekong region.

The Global Fund is working with key partners, including the Government of Cambodia and the United Nations Office of Project Services and others, to take all possible measures to reverse the recent increase.

The Global Fund implements a framework of accountability that requires transparent reporting on investments in health, so that a maximum of available resources go toward serving people affected by malaria and other diseases.

The Global Fund has a zero tolerance policy for fraud and corruption, and requires a high degree of transparency and accountability from all partners, even in challenging operating environments where governance and accountability systems do not meet international standards.

In Cambodia, the Global Fund is working with the Ministry of Health to address implementation challenges and to support efforts that maximize results and impact and that further strengthen systems for health to serve the people of Cambodia.

EBOLA/EVD [to 24 October 2015]

EBOLA/EVD [to 24 October 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Ebola Situation Report – 21 October 2015
[Excerpts]
SUMMARY
:: Three new confirmed cases of Ebola virus disease (EVD) were reported in the week to 18 October, all of which were reported in Guinea. The country had reported zero cases for the previous 2 weeks. Of the 3 new cases, 1 was reported from the capital, Conakry, and 2 were reported from the subprefecture of Kaliah, Forecariah. Of note, 2 cases were not registered contacts, 1 of whom was identified after post-mortem testing of a community death. There are currently 246 contacts under follow-up in Guinea (70 of whom are high risk), and an additional 253 contacts identified during the past 42 days remain untraced. Therefore there remains a near-term risk of further cases among both registered and untraced contacts. Sierra Leone reported zero cases for a fifth consecutive week.

:: Case incidence has remained at 5 confirmed cases or fewer per week for 12 consecutive weeks. Over the same period, transmission of the virus has been geographically confined to several small areas in western Guinea and Sierra Leone, marking a transition to a distinct, third phase of the epidemic. The phase-3 response coordinated by the Interagency Collaboration on Ebola builds on existing measures to drive case incidence to zero, and ensure a sustained end to EVD transmission. Enhanced capacity to rapidly identify a reintroduction (either from an area of active transmission or from an animal reservoir), or re-emergence of virus from a survivor, and capacity for testing and counselling as part of a comprehensive package to safeguard the welfare of survivors are central to the phase-3 response framework…

POLIO [to 24 October 2015]

POLIO [to 24 October 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week as of 21 October 2015
Global Polio Eradication Initiative
Full report link: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
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:: World Polio Day on 24 October is an opportunity to reflect on how far we have come in the last year and to pay tribute to the countless healthcare workers, volunteers, families, traditional and religious leaders, governments, donors, civil society organizations and partners who work tirelessly to protect children against polio. Join Rotary International and UNICEF for a live streamed global update on 23 October and for updates throughout the week from the partners of the Global Polio Eradication Initiative follow @Vaccines on Twitter.
:: The Independent Monitoring Board met in London in October to assess progress towards polio eradication and to make recommendations for the coming months. The report is expected to be published in the next few weeks.
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[Selected Country Update Information]
Afghanistan
:: Three new positive environmental samples were reported in the past week, two in Hilmand district of Hilmand province with collection dates of 19 and 20 September and one in Nangarhar district of Nangarhar province, collected on 21 September.
:: Mop-up campaigns are planned in October in Gulestan district of Farah using the inactivated polio vaccine (IPV) and bivalent OPV with dates to be confirmed. National Immunization Days (NIDs) will take place on 1 – 3 November using trivalent OPV and Subnational Immunisation Days (SNIDs) are planned from 29 November to 1 December in the south and east of the country using bivalent OPV. Further mop up campaigns will take place in Balabuluk and Khak-E-Safed districts of Farah in November.
Pakistan
:: Three new environmental samples positive for WPV1 were reported in the last week. One was collected in Rawalpindi district of Punjab on 10 September, one in Quetta district of Balochistan on 20 September and one in Karachi-Gadap town, Sindh, on 22 September.
Ukraine
:: No new circulating vaccine-derived poliovirus type 1 (cVDPV1) cases have been reported in the past week. The most recent case had onset of paralysis on 7 July in the Zakarpatskaya oblast, in south-western Ukraine, bordering Romania, Hungary, Slovakia and Poland. The number of cVDPV1 cases reported in 2015 remains 2.
:: Ukraine had been at particular risk of emergence of a cVDPV, due to inadequate vaccination coverage.
:: An outbreak response has started in the last week in Ukraine with supplementary immunization activities taking place in every Oblast. The next few weeks will be critical in terms of continued political support and oversight to ensure all children are reached with the vaccines.

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Nationwide polio immunization campaign under way in Ukraine
After an outbreak of circulating vaccine derived poliovirus was reported in Ukraine in September, a vaccination campaign using the oral polio vaccine has been launched.
Wednesday, October 21, 2015
A nationwide vaccination campaign with oral polio vaccine was launched today in Ukraine in response to a polio outbreak in the country. WHO applauded the decision taken by the Ministry of Health to begin the campaign, which is mandated by international guidelines as part of a comprehensive outbreak response. “With the campaign now under way, we call on health care providers and parents in Ukraine to exercise their right and responsibility to vaccinate all children in the designated age groups urgently to stop transmission of this dreaded virus,” said Dr Zsuzsanna Jakab, WHO Regional Director for Europe.
The first phase of the campaign will target 2.85 million children under the age of 6. At least two additional rounds, with one targeting 4.75 million children up to 10 years, are expected to follow at 1-month intervals. The vaccine is to be given free to all children in the designated age groups…

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Mass polio immunization campaign aims to reach 3 million children in Syria
UNICEF and WHO appeal for improved access to children
DAMASCUS, Syria, 18 October 2015 — A 5-day nationwide immunization campaign began today in Syria aiming to vaccinate 3 million children against polio.
The current campaign is part of a comprehensive response to the polio outbreak in October 2013. 15 mass vaccination campaigns reaching on average 2.9 million children each round have been carried out since. No new cases have been reported since January 2014.
The campaign is jointly organized by the Ministry of Health, UNICEF, the World Health Organization and local partners, including the Syrian Arab Red Crescent. It aims to reach children under the age of 5 across the country, including those who have been displaced. The vaccination will take place at fixed clinics, and in areas where the conflict is heavy vaccinators will go house to house…

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Rotary gives US$40.4 million to end polio worldwide
Oct 23, 2015
On the heels of historic success against polio in Nigeria and across the continent of Africa, the global effort to end polio is receiving an additional US$40.4 million boost from Rotary to support immunization activities and surveillance spearheaded by the Global Polio Eradication Initiative….
… Following Nigeria’s polio-free milestone, and no cases of wild polio in all of Africa in more than a year, Rotary is contributing $26.8 million to African countries to ensure the disease never returns to the continent: Burkina Faso ($1.6 million), Cameroon ($2.7 million), Chad ($2.6 million), Democratic Republic of Congo ($499,579), Equatorial Guinea ($685,000), Kenya ($750,102), Madagascar ($562,820), Mali ($1.5 million), Niger ($3 million), Nigeria ($6.9 million), Somalia ($4.9 million) and South Sudan ($1.5 million).
Rotary has earmarked $6.7 million to polio-endemic Pakistan, $400,000 to Iraq and $5.3 million to India. The remaining $990,542 will support immunization activities and surveillance…

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WHO: World Polio Day: Thanking the health worker for the progress
24 October 2015 — World Polio Day marks the milestones that have been reached in the past year towards a polio-free world, and most importantly, recognises the incredible contributions made by healthcare workers, volunteers, families, and partners. WHO and partners are marking this day by celebrating progress towards eradication and planning for what still needs to be done to achieve a polio-free world.
Video message from the WHO Director-General

MERS-CoV [to 24 October 2015]

MERS-CoV [to 24 October 2015]
Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 22 October 2015
Between 10 and 13 October 2015, the National IHR Focal Point for the Kingdom of Saudi Arabia notified WHO of 4 additional cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection. The four cases are from the same compound in Riyadh city…

…The National IHR Focal Point for the Kingdom of Saudi Arabia also notified WHO of the death of 3 MERS-CoV cases that were reported in previous DONs on 27 September (case no. 13), on 17 September (case no. 9) and on 2 September (case no. 1).

Globally, since September 2012, WHO has been notified of 1,599 laboratory-confirmed cases of infection with MERS-CoV, including at least 574 related deaths….

WHO & Regionals [to 24 October2015]

WHO & Regionals [to 24 October2015]
Disease Outbreak News (DONs)
:: Zika virus infection – Brazil and Colombia 21 October 2015
:: Cholera – United Republic of Tanzania 21 October 2015
:: Human infection with avian influenza A(H7N9) virus – China 19 October 2015

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Weekly Epidemiological Record (WER) 23 October 2015, vol. 90, 43 (pp. 577–588):
577 Progress towards eliminating onchocerciasis in the WHO Region of the Americas: verification of elimination of transmission in Mexico
581 Progress towards poliomyelitis eradication: Afghanistan, January 2014–August 2015

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:: WHO Regional Offices
WHO African Region AFRO
:: Statement by the WHO Regional Director for Africa on World Polio Day 2015: A tribute to polio successes in Africa
Brazzaville, 24 October 2015 – Today, we celebrate a very special World Polio Day and a historic moment in the WHO African Region, one without a case of wild polio virus in over a year. The day comes just days before the official ceremony with the President of Nigeria to take the country off the polio endemic list. The day is a true testament of what political will, government leadership and the collective efforts of partners can achieve when united behind a global public health good. The successes in Africa demonstrate that strategies for eradication of vaccine preventable diseases work…
:: WHO ramps up response to cholera outbreak in two regions – 22 October 2015
:: WHO scales up efforts to detect and control the spread of influenza viruses in Africa – 19 October 2015

WHO Region of the Americas PAHO
No new digest content identified.

WHO South-East Asia Region SEARO
:: Act tough against tobacco 20 October 2015

WHO European Region EURO
:: Towards domestic funding of HIV and TB response in eastern Europe and central Asia 23-10-2015
:: Day 2 of Life-course Conference: Minsk Declaration signed 23-10-2015
:: World Polio Day highlights progress and concerns in the final stretch to polio eradication 23-10-2015
:: Day 1 of Life-course Conference: synergies between Health 2020 and sustainable development goals 21-10-2015
:: Nationwide polio immunization campaign under way in Ukraine 21-10-2015

WHO Eastern Mediterranean Region EMRO
:: WHO responds to deteriorating health situation in Taiz, Yemen
20 October 2015, Sana’a, Yemen – Ongoing violence and insecurity continue to limit the delivery of aid in Taiz, Yemen, where more than 3.3 million people, including 300,585 internally displaced persons, are in critical need of health assistance. WHO has provided 30 metric tonnes of medicines and medical supplies to Taiz and is distributing almost one million litres of water. It urgently needs US$ 60 million to continue life-saving response operations across the country until the end of 2015.
:: Mass polio immunization campaign aims to reach 3 million children in Syria
18 October 2015

WHO Western Pacific Region
:: World Polio Day: Fewer children than ever with polio

IDRI AND SANOFI PASTEUR TEAM WITH PHILANTHROPY TO DEVELOP NEW MODEL FOR VACCINE DEVELOPMENT

IDRI AND SANOFI PASTEUR TEAM WITH PHILANTHROPY TO DEVELOP NEW MODEL FOR VACCINE DEVELOPMENT
Seattle, WA | October 15, 2015
In an effort to accelerate timelines and decrease development costs of life-saving vaccines, the Infectious Disease Research Institute (IDRI) and Sanofi Pasteur today announced the establishment of the Global Health Vaccine Center of Innovation (GHVCI), to be headquartered at IDRI in Seattle. This project is funded in part by a grant from the Bill & Melinda Gates Foundation. The GHVCI represents an alliance among the three organizations, focused on accelerating the development of vaccines and associated technologies to fight a wide range of global infectious diseases, and ensuring that these critical vaccines are accessible globally, especially to people in need within developing countries.

Each partner will bring its respective world-leading expertise and technologies to the GHVCI and, collectively, the parties will collaborate with a wide range of other vaccine development organizations. Funding for the establishment, operation and growth of the GHVCI will come from Sanofi and the Gates Foundation, and additional funding will be sought to support collaborative research activities with respect to specific vaccines to be developed at the GHVCI.

This distinctive collaboration leverages the potential power of the partners’ collective expertise, combining IDRI’s vaccine design, formulation and production technologies; Sanofi’s position as a leading multi-national vaccine developer, manufacturer and seller; and the Gates Foundation’s knowledge, influence and financial support regarding the discovery and development of global health interventions, including vaccines. A key component is the application of IDRI’s vaccine adjuvant technologies and formulation expertise, which have been developed over the past few years with strong financial support from the Gates Foundation. These adjuvant technologies are uniquely designed to improve immune responses, broaden vaccine protection and significantly save costs by reducing the amount of vaccine needed…

…A Joint Steering Committee, comprised of representatives from each of the three partners, will mutually identify areas of research to discover, evaluate and develop novel human vaccines, as well as adjuvant/formulation platforms for the rapid response to emerging pathogens, that can prevent or treat infectious diseases.

Initial funding will be used to establish and operate the GHVCI, build capacity as the collaboration grows, and provide management and scientific recruitment as well as training…

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Sanofi Pasteur and the Infectious Disease Research Institute Partner on a Global-Health, Open-Innovation, Vaccine Research & Development Center
The GHVCI will address a range of infectious diseases
SWIFTWATER, Pennsylvania, October 15, 2015 /PRNewswire/ —
Sanofi Pasteur, the vaccines division of Sanofi, announced today the creation of a Global Health Vaccine Center of Innovation (GHVCI) with the Infectious Disease Research Institute (IDRI)… This project is also funded in part by a grant from the Bill & Melinda Gates Foundation, as the proposed R&D alliance is related to the Gates Foundation and Sanofi Pasteur’s strategic agreement on a Vaccine Discovery Partnership signed in 2013.

The addition of IDRI will enable vaccine adjuvant/formulation platforms and a pipeline of vaccine candidates to be discovered, evaluated and developed to address a range of infectious diseases under the center of innovation based at IDRI. The GHVCI will be co-funded by the Gates Foundation and Sanofi Pasteur under a tripartite agreement…

…”IDRI is a partner of choice as they are a world-leader in the development and evaluation of adjuvant formulations, using a broad portfolio of adjuvants with different immune-stimulating properties,” commented Jim Tartaglia, PhD, R&D VP for new vaccine projects at Sanofi Pasteur. “The Institute has a world-class staff and capabilities in immunology and GMP production”.

“There are a number of diseases that are of great global-health significance, where Sanofi Pasteur could significantly contribute,” according to John Shiver, PhD, Sr. VP for R&D at Sanofi Pasteur; “however, commercial realities provide a challenge to investment. The establishment of this Global Health Vaccines Center of Innovation represents a new opportunity–operating within the open innovation R&D model–to provide antigens, adjuvanted formulations, funding, and expertise to allow development of needed vaccines.”…

IAVI International AIDS Vaccine Initiative [to 24 October2015] :: Human Vaccines Project Welcomes Janssen as Newest Partner

IAVI International AIDS Vaccine Initiative [to 24 October2015]
http://www.iavi.org/press-releases/2015

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Human Vaccines Project Welcomes Janssen as Newest Partner
October 23, 2015
The Human Vaccines Project welcomes Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), as the newest industry partner in its effort to accelerate the research and development of vaccines and immunotherapies for infectious diseases and cancer.

Incubated at the International AIDS Vaccine Initiative (IAVI), the Human Vaccines Project is an ambitious new public-private partnership seeking to transform the future of global disease prevention and treatment by solving the primary scientific obstacles impeding the research and development of new vaccines and immunotherapies. Endorsed by 35 leading vaccine scientists, the Project brings together top academic research centers, and government, non-profit and industry research and development efforts into a global consortium.

“The Human Vaccines Project offers an unprecedented opportunity to merge cutting-edge academic science with industrial product development capabilities to elucidate how the human immune system confers effective immunity, and thus accelerate the development of new interventions for a broad range of critical diseases,” said Johan van Hoof, Global Head, Infectious Diseases and Vaccines, Janssen. “Collaborative partnerships such as this, which bring together key expertise to solve complex scientific problems, are essential to deliver the transformational medical innovations needed to advance human health.”…

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Research and Development of New Biomedical HIV Prevention Tools for Women and Girls: Combating the Global AIDS Epidemic Through a More Empowered Response in Sub-Saharan Africa
IAVI Policy Brief
September 2015 :: 8 pages
High HIV prevalence and incidence puts a disproportionate burden on girls and women in Sub-Saharan Africa and threatens to reverse current success in combating the global AIDS epidemic. Programs to fight HIV/AIDS among women and girls can be bolstered by new biomedical prevention tools including pre-exposure prophylaxis, microbicides and vaccines that enhance women and girls’ ability to protect themselves. Better aligning research and development efforts with the needs of women and girls can accelerate the introduction of a wider, more effective array of HIV prevention tools to enhance the health of girls and women, as well as the global response to HIV/AIDS.

First oncolytic immunotherapy medicine recommended for approval

European Medicines Agency [to 24 October2015]
http://www.ema.europa.eu/ema/

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First oncolytic immunotherapy medicine recommended for approval
Advanced therapy medicine Imlygic indicated to treat certain stages of melanoma
23/10/2015
The European Medicines Agency (EMA) has recommended authorising Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma that cannot be removed by surgery and that has spread either to the surrounding area or to other areas of the body (regionally or distantly metastatic) without affecting the bones, brain, lung or other internal organs.
Imlygic is a first-in-class advanced therapy medicinal product (ATMP) derived from a virus, that has been genetically engineered to infect and kill cancer cells. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP) based on an assessment carried out by the Committee for Advanced Therapies (CAT), the Agency’s expert committee for ATMPs…

Lions and Bil Gates commit to vaccinations – Gavi

Gavi [to 24 October2015]

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Lions and Bill Gates commit to vaccinations
21 October 2015
The Lions Clubs International Foundation (LCIF) has committed to raising US$30 million by 2017 to improve access to vaccines through Gavi, The Vaccine Alliance. The funds raised will be matched by the United Kingdom’s Department for International Development and the Bill & Melinda Gates Foundation, bringing the total to US$60 million.

Malawi and Global Fund Deepen Partnership

Global Fund [to 24 October2015]
http://www.theglobalfund.org/en/news/
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News
Malawi and Global Fund Deepen Partnership
22 October 2015
LILONGWE, Malawi – Malawi and the Global Fund are strengthening their partnership by signing grants worth more than US$332 million, to expand treatment and prevention for HIV, TB and malaria and build resilient and sustainable systems for health. This brings the total Global Fund commitment to Malawi to US$616 million from 2014-2017.
The financial resources provided through the Global Fund come from many sources and partners, represented at the signing ceremony today by the United States, the European Union, the United Kingdom, Germany, Japan, Ireland and Norway, as well as technical partners such as UNAIDS and WHO…

New prize competition seeks innovative ideas to advance open science

NIH [to 24 October2015]
http://www.nih.gov/news/releases.htm

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New prize competition seeks innovative ideas to advance open science
Applicants asked to develop new products or services to harness the power of “big data” to improve health

October 20, 2015 — The National Institutes of Health has partnered with London-based Wellcome Trust to launch a global science competition for new products or services to advance “open science,” a movement to make scientific research data broadly accessible to the public. Up to six teams of technology experts and researchers stand to win $80,000 each to develop their ideas into a prototype or to advance an existing early stage prototype. The prototype judged to have the greatest potential to further open science will receive $230,000.

“Research is a global, data-driven enterprise and our ability to improve health increasingly hinges on our ability to manage and make sense of the enormous amounts of data being produced by scientific research,” said NIH Director Francis S. Collins, M.D., Ph.D. “I expect the Open Science Prize to generate innovative ideas to improve data access and establish new international collaborations that will illustrate the transformative power of sharing research data.”…

FAO Food & Agriculture Organization [to 24 October2015]

FAO Food & Agriculture Organization [to 24 October2015]
http://www.fao.org/news/archive/news-by-date/2015/en/
U.S. backs FAO efforts to combat global animal disease threats with $87 million
Ebola, MERS-CoV and H5N1 avian influenza among diseases with human health implications and pandemic potential being targeted in Africa, Middle East and Asia
20 October 2015, Rome – The United States Agency for International Development (USAID) is backing FAO’s efforts to combat pandemic animal disease threats in Asia, Africa and the Middle East with an additional $87 million in funding covering the 2015-19 period.

USAID and FAO have worked in partnership on controlling animal diseases and managing related human health threats for over a decade. USAID financial backing for this work now amounts to $320 million since 2004.

The new funds will support monitoring and surveillance, epidemiological studies, prevention and control activities as well as improving veterinary capacities in Asia, Africa and the Middle East and promoting links between animal health specialists and the public health sector.

FAO Director-General José Graziano da Silva thanked the U.S. for its support and longstanding partnership. “This shows how important transboundary diseases are for FAO and the UN system, and how much more important they will be in in the future if we want to achieve the Sustainable Development Goals,” he said. “Millions of people rely on livestock for survival, income and nutrition, and their livelihoods must be protected,” he said…

The Selection and Use of Essential Medicines – Report of the WHO Expert Committee, 2015

The Selection and Use of Essential Medicines
WHO Technical Report Series
Report of the WHO Expert Committee, 2015
(including the 19th WHO Model List of Essential Medicines and the 5th WHO Model List of Essential Medicines for Children)
Executive summary
The 20th meeting of the WHO Expert Committee on the Selection and Use of Essential medicines took place in Geneva, Switzerland, from 20 to 24 April 2015. The goal of the meeting was to review and update the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc).
In accordance with approved procedures,1 the Expert Committee evaluated the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines. Both lists went through major revisions this year, as the Committee considered 77 applications, including 29 treatment regimens for cancer, and innovative hepatitis C and tuberculosis (TB) medicines.
The Expert Committee –
:: recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list); and
:: recommended the addition of 16 new medicines to the EMLc (four to the core list and 12 to the complementary list).

Section 19: Immunologicals [p. 313]
19.3: Vaccines (review) – EML and EMLc
The EML Secretariat, with input from the WHO Immunization, Vaccines and Biologicals Department, proposed a slightly revised approach to the listing of vaccines on the EML and EMLc for consideration by the Expert Committee.

The revised approach involves the full alignment of vaccines on the Model Lists with current WHO immunization policy recommendations as published in vaccine position papers on the basis of recommendations made by the Strategic Advisory Group of Experts on Immunization (SAGE).

SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development to delivery of immunization and its linkages with other health interventions in accordance with its mandate to provide guidance to Member States on health policy matters (http://www.who.int/immunization/policy/sage/en). SAGE consists of 15 internationally renowned independent experts in the field of immunization and is concerned not just with childhood vaccines and immunization but with all vaccine-preventable diseases. SAGE meets twice a year, generally in April and October. Working groups are established for detailed review of specific topics in advance of discussion by SAGE. Members of working groups review the evidence and prepare options for recommendations for discussion by the full SAGE group in an open forum. In developing recommendations, SAGE follows an evidence-based review process and applies GRADE. Processes follow the critical elements required by WHO’s Guideline Review Committee in the development of WHO guidelines.

SAGE may decide to recommend specific vaccines to be used universally or to be used conditionally or to not use specific vaccines at a given point in time. These recommendations translate into WHO policy recommendations. WHO publishes its global vaccine policy recommendations as vaccine position papers within the Weekly Epidemiological Record, available on the WHO website at http://www.who.int/immunization/documents/positionpapers/en/index.html. The position papers summarize essential background information on diseases and vaccines, and conclude with the current WHO position concerning vaccine use in the global context. The papers are designed for use by national public health officials and immunization programme managers. They may also be of interest to international funding agencies, the vaccine manufacturing industry, the medical community, and the scientific media.

WHO position papers undergo a formal review process both internally and externally before publication. Processes for managing potential conflicts of interest and ensuring careful and critical appraisal of the best scientific evidence have become more rigorous in recent years. The need for updating vaccine position papers is reviewed periodically and depends primarily on the availability of new scientific evidence and public health priorities. A brief update concerning a specific recommendation in a paper is released when warranted.

The Expert Committee agreed that the EML and EMLc should include those vaccines for which a WHO position paper exists (as at a specific publication date), with reference to the WHO immunization website for up-to-date recommendations at any point in time. The Committee also agreed that the EML and EMLc should specify whether vaccines are recommended for universal or conditional use (e.g. only in certain regions, populations, or in other specified circumstances), with reference to relevant WHO vaccine position papers for detail.

Key factors in children’s competence to consent to clinical research

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 24 October2015)

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Research article
Key factors in children’s competence to consent to clinical research
Irma Hein, Pieter Troost, Robert Lindeboom, Marc Benninga, C. Zwaan, Johannes van Goudoever, Ramón Lindauer
BMC Medical Ethics 2015, 16:74 (24 October 2015)
Abstract
Background
Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children’s consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children’s competence to consent to clinical research and to what extent they explain the variation in competence judgments.
Methods
From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children’s competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child’s or parents decision to participate.
Results
Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P < 0.05). Total explained variance in competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05).
Conclusions
Age is the factor that explaines most of to the variance in children’s competence to consent, followed by intelligence. Experience with disease did not affect competence in this study, nor did other variables.

Role of healthcare workers in early epidemic spread of Ebola: policy implications of prophylactic compared to reactive vaccination policy in outbreak prevention and control

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 24 October2015)

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Correspondence
Role of healthcare workers in early epidemic spread of Ebola: policy implications of prophylactic compared to reactive vaccination policy in outbreak prevention and control
Cordelia Coltart, Anne Johnson, Christopher Whitty BMC Medicine 2015, 13:271 (19 October 2015)
Abstract
Ebola causes severe illness in humans and has epidemic potential. How to deploy vaccines most effectively is a central policy question since different strategies have implications for ideal vaccine profile. More than one vaccine may be needed. A vaccine optimised for prophylactic vaccination in high-risk areas but when the virus is not actively circulating should be safe, well tolerated, and provide long-lasting protection; a two- or three-dose strategy would be realistic. Conversely, a reactive vaccine deployed in an outbreak context for ring-vaccination strategies should have rapid onset of protection with one dose, but longevity of protection is less important.

In initial cases, before an outbreak is recognised, healthcare workers (HCWs) are at particular risk of acquiring and transmitting infection, thus potentially augmenting early epidemics. We hypothesise that many early outbreak cases could be averted, or epidemics aborted, by prophylactic vaccination of HCWs. This paper explores the potential impact of prophylactic versus reactive vaccination strategies of HCWs in preventing early epidemic transmissions. To do this, we use the limited data available from Ebola epidemics (current and historic) to reconstruct transmission trees and illustrate the theoretical impact of these vaccination strategies. Our data suggest a substantial potential benefit of prophylactic versus reactive vaccination of HCWs in preventing early transmissions. We estimate that prophylactic vaccination with a coverage >99 % and theoretical 100 % efficacy could avert nearly two-thirds of cases studied; 75 % coverage would still confer clear benefit (40 % cases averted), but reactive vaccination would be of less value in the early epidemic.

A prophylactic vaccination campaign for front-line HCWs is not a trivial undertaking; whether to prioritise long-lasting vaccines and provide prophylaxis to HCWs is a live policy question. Prophylactic vaccination is likely to have a greater impact on the mitigation of future epidemics than reactive strategies and, in some cases, might prevent them. However, in a confirmed outbreak, reactive vaccination would be an essential humanitarian priority.

The value of HCW Ebola vaccination is often only seen in terms of personal protection of the HCW workforce. A prophylactic vaccination strategy is likely to bring substantial additional benefit by preventing early transmission and might abort some epidemics. This has implications both for policy and for the optimum product profile for vaccines currently in development.

Clinical Infectious Diseases (CID) = Volume 61 Issue 10 November 15, 2015

Clinical Infectious Diseases (CID)
Volume 61 Issue 10 November 15, 2015
http://cid.oxfordjournals.org/content/current

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Association of Influenza Vaccination Coverage in Younger Adults With Influenza-Related Illness in the Elderly
Glen B. Taksler, Michael B. Rothberg, and David M. Cutler
Clin Infect Dis. (2015) 61 (10): 1495-1503 doi:10.1093/cid/civ630
Abstract
Background.
Older adults have the highest influenza-related morbidity and mortality risk, but the influenza vaccine is less effective in the elderly. It is unknown whether influenza vaccination of nonelderly adults confers additional disease protection on the elderly population.
Methods.
We examined the association between county-wide influenza vaccination coverage among 520 229 younger adults (aged 18–64 years) in the Behavioral Risk Factors Surveillance System Survey and illnesses related to influenza in 3 317 709 elderly Medicare beneficiaries aged ≥65 years, between 2002 and 2010 (13 267 786 person-years). Results were stratified by documented receipt of a seasonal influenza vaccine in each Medicare beneficiary.
Results.
Increases in county-wide vaccine coverage among younger adults were associated with lower adjusted odds of illnesses related to influenza in the elderly. Compared with elderly residents of counties with ≤15% of younger adults vaccinated, the adjusted odds ratio for a principal diagnosis of influenza among elderly residents was 0.91 (95% confidence interval, .88–.94) for counties with 16%–20% of younger adults vaccinated, 0.87 (.84–.90) for counties with 21%–25% vaccinated, 0.80 (.77–.83) for counties with 26%–30% vaccinated, and 0.79 (.76–.83) for counties with ≥31% vaccinated (P for trend <.001). Stronger associations were observed among vaccinated elderly adults, in peak months of influenza season, in more severe influenza seasons, in influenza seasons with greater antigenic match to influenza vaccine, and for more specific definitions of influenza-related illness.
Conclusions.
In a large, nationwide sample of Medicare beneficiaries, influenza vaccination among adults aged 18–64 years was inversely associated with illnesses related to influenza in the elderly.

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The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial
Najaaraq Lund, Andreas Andersen, Anna Sofie K. Hansen, Frida S. Jepsen, Amarildo Barbosa,
Sofie Biering-Sørensen, Amabelia Rodrigues, Henrik Ravn, Peter Aaby, and Christine Stabell Benn
Clin Infect Dis. (2015) 61 (10): 1504-1511 doi:10.1093/cid/civ617
Abstract
Background.
Routine vaccines may have nonspecific effects on mortality. An observational study found that OPV given at birth (OPV0) was associated with increased male infant mortality. We investigated the effect of OPV0 on infant mortality in a randomized trial in Guinea-Bissau.
Methods.
A total of 7012 healthy normal-birth-weight neonates were randomized to BCG only (intervention group) or OPV0 with BCG (usual practice). All children were to receive OPV with pentavalent vaccine (diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and hepatitis B) at 6, 10, and 14 weeks of age. Seven national OPV campaigns were also conducted during the trial period. Children were followed to age 12 months. We used Cox regression to calculate hazard ratios (HRs) for mortality.
Results.
The trial contradicted the original hypothesis about OPV0 increasing male infant mortality. Within 12 months, 73 children in the BCG + OPV group and 87 children in the BCG-only group died, all from infectious diseases. Comparing BCG + OPV0 vs BCG only, the HR was 0.83 (95% confidence interval [CI], .61–1.13): 0.72 (95% CI, .47–1.10) in boys and 0.97 (95% CI, .61–1.54) in girls. For children enrolled within the first 2 days of life, the HR for BCG + OPV0 vs BCG only was 0.58 (95% CI, .38–.90). From enrollment until the time of OPV campaigns, the HR was 0.68 (95% CI, .45–1.00), the beneficial effect being separately significant for males (0.55 [95% CI, .32–.95]).
Conclusions.
This is the only randomized trial of the effect of OPV0 on mortality. OPV0 may be associated with nonspecific protection against infectious disease mortality, particularly when given early in life. There are reasons to monitor mortality when OPV is being phased out.

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Editorial Commentary: Oral Polio Vaccine at Birth
Lawrence D. Frenkel
Clin Infect Dis. (2015) 61 (10): 1512-1513 doi:10.1093/cid/civ619
Extract
The carefully done randomized study by Lund and colleagues, published in this issue of Clinical Infectious Diseases [1], is reassuring, after a previous observational study reported an increase in male infant mortality following oral poliovirus vaccine (OPV) given at birth [2]. That article by Benn and colleagues was disconcerting to vaccine advocates around the world, both for the possible detrimental effect on the control of polio disease in the few remaining endemic countries and because it could give additional fodder to antivaccine groups. The study by Lund et al reports the opposite—namely, a protective effect of OPV given within 2–3 days of birth, and an overall (uncensored) reduction in mortality of 16% by specifically decreasing male infant mortality. The specific causes of mortality are unfortunately not documented in this article, although the statement is made that they were all related to infectious diseases.
It is important to note that none of the studies of nonspecific effects of live viral vaccines given at birth show the same protective or detrimental effects in female infants as is seen in males. It is generally hypothesized that females have an extra …

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Chicago Ebola Response Network (CERN): A Citywide Cross-hospital Collaborative for Infectious Disease Preparedness
Omar Lateef, Bala Hota, Emily Landon, Larry K. Kociolek, Julie Morita, Stephanie Black, Gary Noskin, Michael Kelleher, Krista Curell, Amy Galat, David Ansell, John Segreti, and Stephen G. Weber
Clin Infect Dis. (2015) 61 (10): 1554-1557 doi:10.1093/cid/civ510
Abstract
The Chicago Ebola Response Network, a hospital and public health collaboration, was formed in response to the 2014–2015 Ebola virus epidemic and is a roadmap for how a region can prepare to respond to public health emergencies.

Emerging Infectious Diseases – Volume 21, Number 11—November 2015 :: Ebola

Emerging Infectious Diseases
Volume 21, Number 11—November 2015
http://wwwnc.cdc.gov/eid/

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Perspective
Ebola in West Africa—CDC’s Role in Epidemic Detection, Control, and Prevention
T. R. Frieden and I. K. Damon
Abstract
Since Ebola virus disease was identified in West Africa on March 23, 2014, the Centers for Disease Control and Prevention (CDC) has undertaken the most intensive response in the agency’s history; >3,000 staff have been involved, including >1,200 deployed to West Africa for >50,000 person workdays. Efforts have included supporting incident management systems in affected countries; mobilizing partners; and strengthening laboratory, epidemiology, contact investigation, health care infection control, communication, and border screening in West Africa, Nigeria, Mali, Senegal, and the United States. All efforts were undertaken as part of national and global response activities with many partner organizations. CDC was able to support community, national, and international health and public health staff to prevent an even worse event. The Ebola virus disease epidemic highlights the need to strengthen national and international systems to detect, respond to, and prevent the spread of future health threats.

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Contact Tracing Activities during the Ebola Virus Disease Epidemic in Kindia and Faranah, Guinea, 2014
M. G. Dixon et al.
Summary
Thorough case identification and contact tracing are necessary to end this epidemic.

SDH-NET: a South–North-South collaboration to build sustainable research capacities on social determinants of health in low- and middle-income countries

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 24 October2015]

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Research
SDH-NET: a South–North-South collaboration to build sustainable research capacities on social determinants of health in low- and middle-income countries
Lucinda Cash-Gibson, German Guerra, V Salgado-de-Snyder Health Research Policy and Systems 2015, 13:45 (22 October 2015)
Abstract
Background
It is desirable that health researchers have the ability to conduct research on health equity and contribute to the development of their national health system and policymaking processes. However, in low- and middle-income countries (LMICs), there is a limited capacity to conduct this type of research due to reasons mostly associated with the status of national (health) research systems. Building sustainable research capacity in LMICs through the triangulation of South–North-South (S-N-S) collaborative networks seems to be an effective way to maximize limited national resources to strengthen these capacities. This article describes how a collaborative project (SDH-Net), funded by the European Commission, has successfully designed a study protocol and a S-N-S collaborative network to effectively support research capacity building in LMICs, specifically in the area of social determinants of health (SDH); this project seeks to elaborate on the vital role of global collaborative networks in strengthening this practice.
Methods
The implementation of SDH-Net comprised diverse activities developed in three phases. Phase 1: national level mapping exercises were conducted to assess the needs for SDH capacity building or strengthening in local research systems. Four strategic areas were defined, namely research implementation and system performance, social appropriation of knowledge, institutional and national research infrastructure, and research skills and training/networks. Phase 2: development of tools to address the identified capacity building needs, as well as knowledge management and network strengthening activities. Phase 3: identifying lessons learned in terms of research ethics, and how policies can support the capacity building process in SDH research.
Results
The implementation of the protocol has led the network to design innovative tools for strengthening SDH research capacities, under a successful S-N-S collaboration that included national mapping reports, a global open-access learning platform with tools and resources, ethical guidelines for research, policy recommendations, and academic contributions to the global SDH discourse.
Conclusions
The effective triangulation of S-N-S partnerships can be of high value in building sustainable research capacity in LMICs. If designed appropriately, these multicultural, multi-institutional, and multidisciplinary collaborations can enable southern and northern academics to contextualize global research according to their national realities.

JAMA – October 20, 2015

JAMA
October 20, 2015, Vol 314, No. 15
http://jama.jamanetwork.com/issue.aspx

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The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines
Jing Luo, MD; Aaron S. Kesselheim, MD, JD, MPH
[Initial text]
This Viewpoint discusses the importance of patent protection and its role in the Trans-Pacific Partnership (TPP) Agreement.

After a difficult legislative battle, President Obama signed into law Trade Promotion Authority on June 29, 2015. The legislation allows for an up-or-down vote with no amendments in Congress for international trade agreements such as the Trans-Pacific Partnership (TPP) Agreement. The TPP Agreement includes 12 Asia-Pacific countries (United States, Canada, Mexico, Peru, Chile, Japan, Vietnam, Malaysia, Singapore, Brunei, Australia, and New Zealand) with a collective trading power amounting to 40% of the global gross domestic product. The TPP Agreement is still being negotiated; recently, in a meeting of trade ministers in Maui, Hawaii, negotiators failed to finalize the text of the Agreement due in large part to disagreement regarding intellectual property protections for pharmaceutical products.1

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Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations
Lakshmi Sukumaran, MD, MPH; Natalie L. McCarthy, MPH; Elyse O. Kharbanda, MD, MPH; Michael M. McNeil, MD, MPH; Allison L. Naleway, PhD; Nicola P. Klein, MD, PhD; Michael L. Jackson, MPH, PhD; Simon J. Hambidge, MD, PhD; Marlene M. Lugg, DrPH; Rongxia Li, PhD; Eric S. Weintraub, MPH; Robert A. Bednarczyk, PhD; Jennifer P. King, MPH; Frank DeStefano, MD, MPH; Walter A. Orenstein, MD; Saad B. Omer, MBBS, MPH, PhD
Abstract
Importance
The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking.
Objective
To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates.
Design, Setting, and Participants
A retrospective cohort study in 29 155 pregnant women aged 14 through 49 years from January 1, 2007, through November 15, 2013, using data from 7 Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.
Exposures
Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before.
Main Outcomes and Measures
Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls.
Results
There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. For example, local reactions occurred at a rate (per 10 000 women) of 4.2 in those who received Tdap in pregnancy less than 2 years before (adjusted risk ratio [RR], 0.49 [95% CI, 0.11-2.20]; P = .35) and 7.0 two to 5 years before (adjusted RR, 0.77 [95% CI, 0.31-1.95]; P  = .59) a prior tetanus-containing vaccine compared with 11.2 in controls. Preterm delivery occurred in 6.6% of women receiving Tdap in pregnancy less than 2 years before (adjusted RR, 1.15 [95% CI, 0.98-1.34]; P = .08) and 6.4% two to 5 years before (adjusted RR, 1.06 [95% CI, 0.94-1.19]; P  = .33) a prior tetanus-containing vaccine compared with 6.8% of controls. Small for gestational age delivery occurred in 9.0% of women less than 2 years before (adjusted RR, 0.99 [95% CI, 0.87-1.13]; P = .88) and 8.7% of women 2 to 5 years before (adjusted RR, 0.96 [95% CI, 0.87-1.06]; P = .45) a prior tetanus-containing vaccine compared with 9.1% of controls.
Conclusions and Relevance
Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.

Journal of Public Health Policy – Volume 36, Issue 4 (November 2015)

Journal of Public Health Policy
Volume 36, Issue 4 (November 2015)
http://www.palgrave-journals.com/jphp/journal/v36/n4/index.html

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Climate change: Assessing effects on health and wealth of populations
Anthony Robbins
Excerpt
Can the health consequences of climate change be at the center of discussions at this year’s climate summit in Paris? Very possibly. Pope Francis’ encyclical letter and The Lancet’s excellent report on the topic give us hope.1, 2 Now the World Federation of Public Health Associations (whose Federation’s Pages we publish in JPHP) is preparing to participate in the twenty-first Conference of the Parties, United Nations Framework Convention on Climate Change. The Federation and its Environmental Health Working Group have developed a strategy to put population health front and center in the Paris discussions. We commend them…

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Viewpoint: Counterfeit medicines and substandard medicines: Different problems requiring different solutions
Ellen ‘t Hoen and Fernando Pascual
J Public Health Pol 36: 384-389; advance online publication, July 16, 2015; doi:10.1057/jphp.2015.22
Ensuring that all effective and necessary medicines are affordable, available, and of assured quality will combat falsified and substandard medicines. The authors explain how and why this will protect consumers.

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Global prevention and control of NCDs: Limitations of the standard approach
Neil Pearce, Shah Ebrahim, Martin McKee, Peter Lamptey, Mauricio L Barreto, Don Matheson, Helen Walls, Sunia Foliaki, J Jaime Miranda, Oyun Chimeddamba, Luis Garcia-Marcos, Andy Haines, and Paolo Vineis
J Public Health Pol 36: 408-425; advance online publication, September 17, 2015; doi:10.1057/jphp.2015.29
The standard approach to prevention and control of non-communicable disease, called ‘25×25’ has the benefit of simplicity, but also has major weaknesses described herein.

The Lancet – Oct 24, 2015

The Lancet
Oct 24, 2015 Volume 386 Number 10004 p1599-1706
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Ebola: forgotten but not gone?
The Lancet
On Oct 16, two new Ebola cases were reported in Guinea, indicating the continuing danger of Ebola virus even after progress in bringing the west African Ebola outbreak under control. The outbreak in Guinea, Liberia, and Sierra Leone caught the world badly unprepared during 2013–14, resulting in more than 11 000 deaths. WHO responded slowly to this major challenge in countries with sparse health provision, and disease control measures worked imperfectly. During 2015, lost ground has been made up by provision of care for those infected and at risk of infection, yet recent developments illustrate the continuing health risks for those who have been infected.
Despite previous outbreaks in sub-Saharan Africa, limited understanding of the physiological effects of Ebola virus has compromised preventive and therapeutic efforts. However, a recent study on 100 Ebola survivors in Sierra Leone has shown the importance of continuing research by indicating that viral RNA can be detected in semen up to 9 months after overt recovery from infection. A study in The Lancet Infectious Diseases on 49 survivors of a 2007 Ebola outbreak in Uganda reported ocular deficits and hearing loss, among other health problems, which persisted for 2 years. On Oct 6, Pauline Cafferkey, a Scottish nurse who contracted Ebola early in 2015 and was thought to have made a full recovery after treatment, was rehospitalised with severe health problems. At the time of writing, Ms Cafferkey’s condition was reported to be serious but stable, with disease transmission unlikely. Post-Ebola discharge criteria are discussed by Nazaria Bevilacqua and colleagues in The Lancet Global Health.
Salutary lessons are still being learned from the west African Ebola outbreak—opportunities for and benefits of research will be greatest in the communities most affected. WHO’s Director-General Margaret Chan believes the world is “dangerously ill-prepared” for further infectious disease outbreaks spread through the air or contagious during an incubation period. Strengthening of and investment in health systems in countries most at risk of infectious disease outbreaks are key to prevention, and in the worst case scenarios control, of health emergencies.

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Comment
Essential medicines are still essential
Andy L Gray, Veronika J Wirtz, Ellen F M ‘t Hoen, Michael R Reich, Hans V Hogerzeil
DOI: http://dx.doi.org/10.1016/S0140-6736(15)00514-0
On Oct 21, WHO published the full report of the 20th Expert Committee on the Selection and Use of Essential Medicines,1 with its new WHO Model List of Essential Medicines (EML).2 The new list includes recently developed medicines for drug-resistant tuberculosis (bedaquiline and delamanid), a number of new cancer treatments (such as imatinib, rituximab, and trastuzumab), and, perhaps most controversially, new direct-acting antiviral drugs (DAA) for the treatment of hepatitis C (sofosbuvir, simeprevir, daclatasvir, ledipasvir, and ombitasvir).

New England Journal of Medicine – October 22, 2015

New England Journal of Medicine
October 22, 2015 Vol. 373 No. 17
http://www.nejm.org/toc/nejm/medical-journal

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Perspective
Caring for the Wave of Refugees in Munich
Thomas Nicolai, M.D., Oliver Fuchs, M.D., and Erika von Mutius, M.D.
N Engl J Med 2015; 373:1593-1595 October 22, 2015 DOI: 10.1056/NEJMp1512139
[No abstract]

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Editorial
Declining Malaria Transmission and Pregnancy Outcomes in Southern Mozambique
Nicholas J. White, F.R.S.
N Engl J Med 2015; 373:1670-1671 October 22, 2015 DOI: 10.1056/NEJMe1511278
Free Full Text

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Changing Trends in P. falciparum Burden, Immunity, and Disease in Pregnancy
Mayor and Others
N Engl J Med 2015; 373:1607-1617 October 22, 2015 DOI: 10.1056/NEJMoa1406459
Free Full Text

Validating the Use of Google Trends to Enhance Pertussis Surveillance in California

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
(Accessed 24 October2015)

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Validating the Use of Google Trends to Enhance Pertussis Surveillance in California
October 19, 2015 · Research
Introduction and Methods: Pertussis has recently re-emerged in the United States. Timely surveillance is vital to estimate the burden of this disease accurately and to guide public health response. However, the surveillance of pertussis is limited by delays in reporting, consolidation and dissemination of data to relevant stakeholders. We fit and assessed a real-time predictive Google model for pertussis in California using weekly incidence data from 2009-2014.
Results and Discussion: The linear model was moderately accurate (r = 0.88). Our findings cautiously offer a complementary, real-time signal to enhance pertussis surveillance in California and help to further define the limitations and potential of Google-based epidemic prediction in the rapidly evolving field of digital disease detection.

Cholera Transmission in Ouest Department of Haiti: Dynamic Modeling and the Future of the Epidemic

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 24 October2015)

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Cholera Transmission in Ouest Department of Haiti: Dynamic Modeling and the Future of the Epidemic
Alexander Kirpich, Thomas A. Weppelmann, Yang Yang, Afsar Ali, J. Glenn Morris, Ira M. Longini
Research Article | published 21 Oct 2015 | PLOS Neglected Tropical Diseases
10.1371/journal.pntd.0004153

Community Participation in Health Systems Research: A Systematic Review Assessing the State of Research, the Nature of Interventions Involved and the Features of Engagement with Communities

PLoS One
http://www.plosone.org/
[Accessed 24 October2015]

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Community Participation in Health Systems Research: A Systematic Review Assessing the State of Research, the Nature of Interventions Involved and the Features of Engagement with Communities
Asha S. George, Vrinda Mehra, Kerry Scott, Veena Sriram
Research Article | published 23 Oct 2015 | PLOS ONE
10.1371/journal.pone.0141091
Abstract
Background
Community participation is a major principle of people centered health systems, with considerable research highlighting its intrinsic value and strategic importance. Existing reviews largely focus on the effectiveness of community participation with less attention to how community participation is supported in health systems intervention research.
Objective
To explore the extent, nature and quality of community participation in health systems intervention research in low- and middle-income countries.
Methodology
We searched for peer-reviewed, English language literature published between January 2000 and May 2012 through four electronic databases. Search terms combined the concepts of community, capability/participation, health systems research and low- and middle-income countries. The initial search yielded 3,092 articles, of which 260 articles with more than nominal community participation were identified and included. We further excluded 104 articles due to lower levels of community participation across the research cycle and poor description of the process of community participation. Out of the remaining 160 articles with rich community participation, we further examined 64 articles focused on service delivery and governance within health systems research.
Results
Most articles were led by authors in high income countries and many did not consistently list critical aspects of study quality. Articles were most likely to describe community participation in health promotion interventions (78%, 202/260), even though they were less participatory than other health systems areas. Community involvement in governance and supply chain management was less common (12%, 30/260 and 9%, 24/260 respectively), but more participatory. Articles cut across all health conditions and varied by scale and duration, with those that were implemented at national scale or over more than five years being mainstreamed by government. Most articles detailed improvements in service availability, accessibility and acceptability, with fewer efforts focused on quality, and few designs able to measure impact on health outcomes. With regards to participation, most articles supported community’s in implementing interventions (95%, n = 247/260), in contrast to involving communities in identifying and defining problems (18%, n = 46/260). Many articles did not discuss who in communities participated, with just over a half of the articles disaggregating any information by sex. Articles were largely under theorized, and only five mentioned power or control. Majority of the articles (57/64) described community participation processes as being collaborative with fewer describing either community mobilization or community empowerment. Intrinsic individual motivations, community-level trust, strong external linkages, and supportive institutional processes facilitated community participation, while lack of training, interest and information, along with weak financial sustainability were challenges. Supportive contextual factors included decentralization reforms and engagement with social movements.
Conclusion
Despite positive examples, community participation in health systems interventions was variable, with few being truly community directed. Future research should more thoroughly engage with community participation theory, recognize the power relations inherent in community participation, and be more realistic as to how much communities can participate and cognizant of who decides that.

A Mumps Outbreak in Vojvodina, Serbia, in 2012 Underlines the Need for Additional Vaccination Opportunities for Young Adults
Jasminka Nedeljković, Vesna Kovačević-Jovanović, Vesna Milošević, Zorica Šeguljev, Vladimir Petrovic, Claude P. Muller, Judith M. Hübschen
Research Article | published 23 Oct 2015 | PLOS ONE
10.1371/journal.pone.0139815