Industry Watch [to 6 September 2014]

Industry Watch [to 6 September 2014]
Selected media releases and other selected content from industry.
:: Sanofi Pasteur’s Dengue Vaccine Candidate Successfully Completes Final Landmark Phase III Clinical Efficacy Study in Latin America
September 3, 2014
– Second, large-scale phase III study successfully meets primary endpoint with overall vaccine efficacy of 60.8 percent and shows efficacy against each of the four dengue serotypes –
– Additional observation of the results shows a significant reduction of the risk of hospitalization by 80.3 percent confirming the potential public health impact of the vaccine –
– Initial safety data are consistent with the favorable safety profile documented in all previous studies (phase I, II, III) –

:: Johnson & Johnson Responds to Ebola Crisis With Commitment to Accelerate Vaccine Program in Collaboration With the US National Institutes of Health (NIH) and Provide Humanitarian Relief Aid
Sep 04, 2014
Johnson & Johnson (NYSE: JNJ) today announced it will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak…

Reports/Research/Analysis/Commentary+ [to 6 September 2014]

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders
Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Video Commentary: Jon Andrus, Deputy Director of PAHO on Vaccination Development
BioMedox
1 September 2014
Discussion of costs, PAHO revolving fund, import taxes and vaccine price.

Call to Action – HPV Vaccination as a Public Health Priority
NFID
August 2014
Experts gather to discuss importance of HPV vaccination
The recommendations in this document are based upon the proceedings of a May 2014 roundtable convened by the National Foundation for Infectious Diseases (NFID) and the Council of State and Territorial Epidemiologists (CSTE).
NFID and CSTE assembled subject matter experts, including representatives from relevant professional medical associations and organizations, consumer health organizations, and government agencies to discuss the long-term health impact of HPV and the important role of increased immunization…

The Influence of Global Environmental Change on Infectious Disease Dynamics – Workshop
IOM
September 3, 2014
The twentieth century witnessed an era of unprecedented, large-scale, anthropogenic changes to the natural environment. Understanding how environmental factors directly and indirectly affect the emergence and spread of infectious disease has assumed global importance for life on this planet. While the causal links between environmental change and disease emergence are complex, progress in understanding these links, as well as how their impacts may vary across space and time, will require transdisciplinary, transnational, collaborative research. This research may draw upon the expertise, tools, and approaches from a variety of disciplines.
The Forum on Microbial Threats hosted a public workshop on September 24 and 25, 2013, to explore the scientific and policy dimensions of the impacts of global environmental change on infectious disease dynamics. Participants examined and discussed the observed and likely influences of environmental factors, acting both individually and synergistically on infectious disease dynamics. A range of approaches to improve global readiness and capacity for surveillance, detection, and response to emerging microbial threats to plant, animal, and human health in the face of ongoing global environmental change was also discussed.
pdf: https://download.nap.edu/login.php?record_id=18800&page=%2Fdownload.php%3Frecord_id%3D18800

 

A Systematic Review of Mandatory Influenza Vaccination in Healthcare Personnel

American Journal of Preventive Medicine
Volume 47, Issue 3, p233-374 September 2014
http://www.ajpmonline.org/current

A Systematic Review of Mandatory Influenza Vaccination in Healthcare Personnel
Samantha I. Pitts, MD, MPH, Nisa M. Maruthur, MD, MHS, Kathryn R. Millar, MPH, RN, Trish M. Perl, MD, MSc, Jodi Segal, MD, MPH
DOI: http://dx.doi.org/10.1016/j.amepre.2014.05.035
Abstract
Context
Influenza is a major cause of patient morbidity. Mandatory influenza vaccination of healthcare personnel (HCP) is increasingly common yet has uncertain clinical impact. This study systematically examines published evidence of the benefits and harm of influenza vaccine mandates.
Evidence acquisition
MEDLINE, Embase, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Science Citation Index Expanded, and Conference Proceedings Citations Index were searched and analyzed in 2013. Studies must have assessed the effect of a requirement of influenza vaccination among HCP for continued employment or clinical practice. Studies were not limited by comparison group, outcome, language, or study design. Two reviewers independently abstracted data and assessed bias risk.
Evidence synthesis
Twelve observational studies were included in the study from 778 citations. Following implementation of a vaccine mandate, vaccination rates increased in all eight studies reporting this outcome, exceeding 94%. Three studies documented increased vaccination rates in hospitals with mandates compared to those without (p Conclusions
Evidence from observational studies suggests that a vaccine mandate increases vaccination rates, but evidence on clinical outcomes is lacking. Although challenging, large healthcare employers planning to implement a mandate should develop a strategy to evaluate HCP and patient outcomes. Further studies documenting the impact of HCP influenza vaccination on clinical outcomes would inform decisions on the use of mandatory vaccine policies in HCP.

American Journal of Tropical Medicine and Hygiene – September 2014

American Journal of Tropical Medicine and Hygiene
September 2014; 91 (3)
http://www.ajtmh.org/content/current

Editorial
The Ability to Inoculate Purified Malaria Sporozoites Will Accelerate Vaccine and Drug Discovery
Michael F. Good*
Author Affiliations
Institute for Glycomics, Griffith University, Gold Coast, Queensland, Australia
The ability to infect a volunteer with malaria in a controlled and safe manner promises to be of enormous benefit to research programs aimed at developing malaria vaccines1 or novel antimalaria drugs.2 By challenging an individual in early-stage trials with a defined number of parasites of a specific laboratory strain in a controlled clinical environment, it is possible to derive more meaningful data and significantly reduce trial costs, thus facilitating product development. Research presented in this issue shows that it will now be possible for trial volunteers living in both malaria-endemic and non-endemic areas.3…

Current Strategic Thinking for the Development of a Trivalent Alphavirus Vaccine for Human Use
Daniel N. Wolfe*, D. Gray Heppner, Shea N. Gardner, Crystal Jaing, Lesley C. Dupuy, Connie S. Schmaljohn and Kevin Carlton
Author Affiliations
Chemical and Biological Technologies Department, Defense Threat Reduction Agency, Fort Belvoir, Virginia; TASC, Inc., Lorton, Virginia; Computations/Global Security, Lawrence Livermore National Laboratory, Livermore, California; Physical and Life Sciences Directorate, Lawrence Livermore National Laboratory, Livermore, California; US Army Medical Research Institute for Infectious Diseases, Fort Detrick, Maryland; Joint Vaccine Acquisition Program, Medical Countermeasure Systems, Joint Program Executive Office, Fort Detrick, Maryland
Abstract.
Vaccinations against the encephalitic alphaviruses (western, eastern, and Venezuelan equine encephalitis virus) are of significant interest to biological defense, public health, and agricultural communities alike. Although vaccines licensed for veterinary applications are used in the Western Hemisphere and attenuated or inactivated viruses have been used under Investigational New Drug status to protect at-risk personnel, there are currently no licensed vaccines for use in humans. Here, we will discuss the need for a trivalent vaccine that can protect humans against all three viruses, recent progress to such a vaccine, and a strategy to continue development to Food and Drug Administration licensure.

The social value of clinical research

BMC Medical Ethics
(Accessed 6 September 2014)
http://www.biomedcentral.com/bmcmedethics/content

Debate
The social value of clinical research
Michelle GJL Habets, Johannes JM van Delden and Annelien L Bredenoord
Author Affiliations
BMC Medical Ethics 2014, 15:66 doi:10.1186/1472-6939-15-66
Published: 5 September 2014
Abstract (provisional)
Background
International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic.
Discussion
Our analysis and interpretation of the concept social value has led to three proposals. First, as no direct benefits are expected for the research participants in first-in-human trials, we believe it is better to discuss a risk- value assessment instead of a risk – benefit assessment. This will also make explicit the necessity to have a clear and common use for the concept social value. Second, to avoid confusion we propose to limit the concept social value to the intervention tested. It is the expected improvement the intervention can bring to the wellbeing of (future) patients or society that is referred to when we speak about social value. For the sole purpose of gaining knowledge, we should not expose humans to potential harm; the ultimate justification of involving humans in research lies in the anticipated social value of the intervention. Third, at the moment only the validity of the clinical research proposal is a prerequisite for research to take place. We recommend making the anticipated social value a prerequisite as well.

Implementation of a universal rotavirus vaccination program: comparison of two delivery systems

BMC Public Health
(Accessed 6 September 2014)
http://www.biomedcentral.com/bmcpublichealth/content

Research article
Implementation of a universal rotavirus vaccination program: comparison of two delivery systems
Mitchell Zelman, Carolyn Sanford, Anne Neatby, Beth A Halperin, Donna MacDougall, Corinne Rowswell, Joanne M Langley and Scott A Halperin
Author Affiliations
BMC Public Health 2014, 14:908 doi:10.1186/1471-2458-14-908
Published: 2 September 2014
Abstract (provisional)
Background
Rotavirus vaccine is recommended for all infants in Canada. To evaluate the logistics of implementing a universal rotavirus vaccination program, we compared the effectiveness of program implementation in jurisdictions with either a physician-administered or public health nurse-administered program.
Methods
All infants born between October 1, 2010 and September 30, 2012 in Prince Edward Island and Nova Scotia’s Capital District Health Authority were eligible for the vaccination program. A universal rotavirus vaccination program was implemented and delivered in public health clinics in Prince Edward Island and in physicians’ offices in Nova Scotia.
Results
Engagement of vaccinators in delivery of the universal vaccination program was more successful in Prince Edward Island than in Nova Scotia. Vaccine coverage rates rose rapidly in Prince Edward Island, exceeding 90 % for both doses within 3 months and remaining at those levels over the two-year program. In contrast, coverage rates in Nova Scotia rose more slowly and never exceeded 40 % during the two years. Access to coverage data was more timely and accurate in Prince Edward Island than Nova Scotia.
Conclusion
A universal rotavirus vaccination program delivered through public health clinics achieved more rapid and higher levels of coverage than a program administered through physicians’ offices.

The 2030 sustainable development goal for health

British Medical Journal
06 September 2014(vol 349, issue 7973)
http://www.bmj.com/content/349/7973

Editorials
The 2030 sustainable development goal for health
BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g5295 (Published 26 August 2014) Cite this as: BMJ 2014;349:g5295
Gavin Yamey, evidence to policy initiative lead1, Rima Shretta, malaria elimination initiative deputy lead1, Fred Newton Binka, vice chancellor2
Author affiliations
Must balance bold aspiration with technical feasibility
Excerpt
In the year 2000, 193 countries adopted the millennium development goals (MDGs), a milestone in global development. The eight goals were simple to grasp, measurable, and time bound, ending in 2015. Goals 4, 5, and 6 focused on reducing child, maternal, and infectious disease mortality, respectively, raising health to the top of the global agenda and mobilising new health financing.1 Although the three health related goals are unlikely to be met, there has been substantial progress towards their achievement, particularly for infectious diseases.2
As the MDGs come to an end, a new set of sustainable development goals (SDGs) will be debated during the UN General Assembly that starts on 24 September 2014. These goals will have a 2030 end date. They could catalyse further transformations in global health.
An intergovernmental open working group is writing the new goals and has just published its first draft.3 Whereas the MDGs were “‘top-down goals’ formulated by policy elites,”4 the working group deserves credit for drafting the new goals using a bottom-up approach, based on wide ranging consultations. There is much to like in the draft: …

The 2014 Ebola outbreak: ethical use of unregistered interventions

Bulletin of the World Health Organization
Volume 92, Number 9, September 2014, 621-696
http://www.who.int/bulletin/volumes/92/9/en/

Editorials
The 2014 Ebola outbreak: ethical use of unregistered interventions
Ruediger Krech a & Marie-Paule Kieny a
a. World Health Organization, avenue Appia 20, 1211 Geneva 27, Switzerland.
Bulletin of the World Health Organization 2014;92:622. doi: http://dx.doi.org/10.2471/BLT.14.145789
The large number of cases and wide geographical spread distinguish the current 2014 outbreak of Ebola virus disease in west Africa from all known earlier outbreaks.1 In the past, outbreaks of this disease have been stopped by identifying all cases, tracing all contacts and making sure that those caring for patients use correct protective gear at all times. However, the success of such methods depends on the presence of: (i) functional health systems; (ii) health workers who are trained, paid, willing to be deployed and adequately protected in a dangerous work environment; (iii) experts in public health with the skills needed to manage the tracing of people and monitor the evolution of the disease effectively; and (iv) people with solid skills in social engagement and development who are available to work with at-risk communities.2 Such systems and individuals were largely absent from the area where the current outbreak of Ebola virus disease is believed to have begun – a border area between three countries that all have fragile health systems and that are emerging from the traumas of civil war.
Encouragingly, research efforts over the past decade have led to the development, for the first time, of a range of potential treatments and vaccines that could support efforts to control Ebola virus disease. However, although some of these interventions have proven effective in animal models, none has completed clinical testing in humans – a step that is indispensable for the registration of any medical intervention as proven and safe. Why have there been no clinical trials, given that we have known the Ebola virus for 40 years? Why is there no effective registered vaccine or treatment available? At the onset of the current Ebola outbreak – despite some resources provided by the governments of Canada and the United States of America – substantial financial investment was still needed to evaluate and develop several interventions for the control and treatment of Ebola virus disease. Until now – as seen with several other neglected diseases – this disease has received little attention because it was affecting mostly poor people in poor countries.
The above shortcomings aggravate an ethical dilemma. If the treatments for Ebola virus disease that are currently under development could save lives – as the results of animal studies indicate – should they not be used immediately, since far too many people have already died? On the other hand, if there is a possibility that a treatment might cause substantial adverse effects in humans that have not been seen in animal testing, should it not be withheld?3
On 11 August 2014, the World Health Organization (WHO) convened a consultation to consider and assess the ethical implications of the potential use of unregistered interventions, such as drugs, vaccines and passive immunotherapy, in the current Ebola outbreak. The results of this consultation have been widely discussed in the media.4
In summary, the consultation’s panel of experts advised WHO that, in the particular circumstances of the current outbreak – and provided certain conditions are met – it would be ethical to offer unproven interventions – with as yet unknown efficacy and adverse effects – for the potential treatment or prevention of Ebola virus disease. One of the conditions that need to be met is that ethical principles must guide the provision of such interventions. For example, there must be transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity, and involvement of the community.
To understand the safety and efficacy of these interventions, the panel of experts advised that – when and if any of the unregistered interventions is used to treat patients – there is a moral obligation to collect and share all of the data generated, including data arising from any treatment provided for compassionate use – i.e. the use of an unregistered drug outside of a clinical trial.5
What can we learn from this crisis? Robust health systems are key for controlling disease outbreaks. Let us make sure that development efforts are designed to strengthen health systems. Well trained and motivated health workers are indispensable. They should be paid and receive the support they need to carry out their duties. And, finally, increasing investment into research and development for the treatment, control and prevention of diseases that currently mostly affect poor people and poor countries should be a key priority for policy-makers worldwide. Let us not forget these lessons when the current Ebola outbreak no longer appears on the front pages of our newspapers.
References
Ebola virus disease update – west Africa [Disease Outbreak News, 13 August 2014]. Geneva: World Health Organization; 2014. Available from: http://who.int/csr/don/2014_08_13_ebola [cited 2014 Aug 15].
Key components of a well functioning health system. Geneva: World Health Organization; 2014. Available from: http://who.int/healthsystems/EN_HSSkeycomponents.pdf [cited 2014 Aug 15].
International ethical guidelines for biomedical research involving human subjects. Geneva: Council for International Organizations of Medical Sciences; 2002. Available from: http://www.cioms.ch/publications/layout_guide2002.pdf [cited 2014 Aug 15].
Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD): summary of the panel discussion [WHO statement, 12 August 2014]. Geneva: World Health Organization; 2014. Available from: http://who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary [cited 2014 Aug 15].
Ethical considerations for use of unregistered interventions for Ebola virus disease. Report of an advisory panel to WHO. Geneva: World Health Organization; 2014. Available from: http://www.who.int/csr/resources/publications/ebola/ethical-considerations/en/ [cited 2014 Aug 18].

The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level

Bulletin of the World Health Organization
Volume 92, Number 9, September 2014, 621-696
http://www.who.int/bulletin/volumes/92/9/en/

Perspectives
The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level
Christine G Maure a, Alexander N Dodoo b, Jan Bonhoeffer c & Patrick LF Zuber a
a. Department of Essential Medicines and Health Products, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland.
b. Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana, Accra, Ghana.
c. Brighton Collaboration Foundation, Basel, Switzerland.
(Submitted: 19 March 2014 – Accepted: 21 March 2014 – Published online: 31 July 2014.)
Bulletin of the World Health Organization 2014;92:695-696. doi: http://dx.doi.org/10.2471/BLT.14.138875
Excerpt
“…The Decade of Vaccines, which was launched in 2010, aims to increase coordination within the vaccine community worldwide. The Global Vaccine Action Plan1 – the framework endorsed by the World Health Assembly for the Decade of Vaccines – includes a vaccine safety strategy, the Global Vaccine Safety Blueprint.2
The aim of the blueprint is to enhance the safety of vaccines through effective use of pharmacovigilance principles and methods. Its three strategic goals are: to assist LMICs to have at least minimal capacity for vaccine safety activities; to enhance capacity for vaccine safety assessment in countries that introduce newly developed vaccines, that introduce vaccines in settings with novel characteristics, or that manufacture and use prequalified vaccines; and to establish a global support structure for vaccine safety. The blueprint proposes eight complementary strategic objectives. Four of these objectives aim to improve the technical aspects of spontaneous reporting, active surveillance and risk communication; and to ensure the availability of harmonized methods and tools. The remaining four objectives promote the establishment of effective managerial principles to facilitate international collaboration and information exchange relating to vaccine safety monitoring. Implementing the blueprint is a task that requires coordinated participation of vaccine safety stakeholders worldwide. To that end, the World Health Organization (WHO) launched the Global Vaccine Safety Initiative in March 2012.
In its initial phase, the Global Vaccine Safety Initiative is attempting to build a global support structure by linking existing vaccine safety initiatives. Numerous projects are already addressing one or more of the blueprint’s strategic objectives. Some of the top priorities for the initiative are to identify such projects and engage their sponsors in collaboration, and to help disseminate their products and experiences. Therefore, a Global Vaccine Safety Initiative portfolio of activities has been assembled, where activities are prioritized based on their expected impact, geographical relevance, feasibility, usefulness and sustainability.3 For each activity, the portfolio recognizes the roles of initiators, managers and donors. All stakeholders in global pharmacovigilance can use this portfolio to help identify ongoing efforts, allow for better synergies, minimize duplications and enable resource mobilization…

Clinical Infectious Diseases (CID) – September 15, 2014

Clinical Infectious Diseases (CID)
Volume 59 Issue 6 September 15, 2014
http://cid.oxfordjournals.org/content/current

Effectiveness of 7-Valent Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease in HIV-Infected and -Uninfected Children in South Africa: A Matched Case-Control Study
Cheryl Cohen, Claire von Mollendorf, Linda de Gouveia, Nireshni Naidoo, Susan Meiring, Vanessa Quan, Vusi Nokeri, Melony Fortuin-de Smit, Babatyi Malope-Kgokong, David Moore,
Gary Reubenson, Mamokgethi Moshe, Shabir A. Madhi, Brian Eley, Ute Hallbauer, Ranmini Kularatne, Laura Conklin, Katherine L. O’Brien, Elizabeth R. Zell, Keith Klugman, Cynthia G. Whitney, and Anne von Gottberg for the South African Invasive Pneumococcal Disease Case-Control Study Group
Clin Infect Dis. (2014) 59 (6): 808-818 doi:10.1093/cid/ciu431
Abstract
A 2 + 1 seven-valent pneumococcal conjugate vaccine schedule is effective against vaccine-serotype invasive pneumococcal disease (IPD) in HIV-uninfected children and HIV-exposed but -uninfected children and against all-serotype multidrug-resistant IPD in HIV-uninfected children.

Editorial Commentary: Failing Our Patients by Suboptimally Treating Influenza Infections
Michael G. Ison1,2
Author Affiliations
1Division of Infectious Diseases
2Division of Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago, Illinois
(See the Major Article by Havers et al on pages 774–82.)

Influenza is an important cause of morbidity and mortality related to annual epidemics and intermittent pandemics of respiratory viral infections. Whereas most of the 25 million annual cases of influenza result in self-limited infections, influenza is responsible for an excess 31.4 million outpatient visits, 226 000 excess hospitalizations, and up to 48 614 excess deaths annually in the United States [1–5]. Risk factors for serious illness and death include age Antiviral therapy with one of the neuraminidase inhibitors (oseltamivir or zanamivir) is recommended for the treatment of patients who develop influenza infections [7, 8]. Prospective studies in ambulatory adults and children have demonstrated that the neuraminidase inhibitors are associated with shorter time to alleviation of illness and with reductions in severity of illness, duration of fever, time to return to normal activity, and quantity of shed virus [9]. Data also suggest that antiviral therapy is associated with reduction in the frequency of complications leading to antibiotic use, particularly bronchitis, compared with placebo in previously healthy adults [10–12]. In ambulatory adults and children, antiviral therapy is generally effective only if started within the first 48–72 hours after symptom onset [9, 13, 14]. Moreover, earlier initiation of oral oseltamivir therapy is associated with increased therapeutic effects [13].
Data also suggest that antiviral therapy may be associated with fewer hospitalizations, particularly in high-risk patient …

The disease burden of hepatitis B, influenza, measles and salmonellosis in Germany: first results of the Burden of Communicable Diseases in Europe Study

Epidemiology and Infection
Volume 142 – Issue 10 – October 2014
http://journals.cambridge.org/action/displayIssue?jid=HYG&tab=currentissue

Original Papers
Burden of Communicable Diseases in Europe Study
The disease burden of hepatitis B, influenza, measles and salmonellosis in Germany: first results of the Burden of Communicable Diseases in Europe Study
D. PLASSa1 c1, M.-J. J. MANGENa2, A. KRAEMERa1, P. PINHEIROa1, A. GILSDORFa3, G. KRAUSEa3a4, C. L. GIBBONSa5, A. VAN LIERa6, S. A. McDONALDa6, R. J. BROOKEa2, P. KRAMARZa7, A. CASSINIa7 and M. E. E. KRETZSCHMARa2a6
a1 Department of Public Health Medicine, School of Public Health, University of Bielefeld, Bielefeld, Germany
a2 University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands
a3 Robert Koch Institute, Berlin, Germany
a4 Department for Epidemiology, Helmholtz Centre for Infection Research, Braunschweig, Germany
a5 Institute of Evolutionary Biology, University of Edinburgh, Edinburgh, Scotland, UK
a6 National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control, Bilthoven, The Netherlands
a7 European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden
SUMMARY
Setting priorities in the field of infectious diseases requires evidence-based and robust baseline estimates of disease burden. Therefore, the European Centre for Disease Prevention and Control initiated the Burden of Communicable Diseases in Europe (BCoDE) project. The project uses an incidence- and pathogen-based approach to measure the impact of both acute illness and sequelae of infectious diseases expressed in disability-adjusted life years (DALYs). This study presents first estimates of disease burden for four pathogens in Germany. The number of reported incident cases adjusted for underestimation served as model input. For the study period 2005–2007, the average disease burden was estimated at 33,116 DALYs/year for influenza virus, 19,115 DALYs/year for Salmonella spp., 8,708 DALYs/year for hepatitis B virus and 740 DALYs/year for measles virus. This methodology highlights the importance of sequelae, particularly for hepatitis B and salmonellosis, because if omitted, the burden would have been underestimated by 98% and 56%, respectively.

Eurosurveillance – 04 September 2014

Eurosurveillance
Volume 19, Issue 35, 04 September 2014
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Research articles
Association between temperature, humidity and ebolavirus disease outbreaks in Africa, 1976 to 2014
by S Ng, NE Basta, BJ Cowling

Measles virus spread initiated at international mass gatherings in Europe, 2011
by S Santibanez, K Prosenc, D Lohr, G Pfaff , O Jordan, A Mankertz

Is it reasonable to abandon obligatory vaccinations in Italy? A 2013 survey
by CP Pelullo, S Marino, AJ Valdes Abuadili, G Signoriello, F Attena

Learning from developing countries in strengthening health systems: an evaluation of personal and professional impact among global health volunteers at Addis Ababa University’s Tikur Anbessa Specialized Hospital (Ethiopia)

Globalization and Health
[Accessed 6 September 2014]
http://www.globalizationandhealth.com/

Research
Learning from developing countries in strengthening health systems: an evaluation of personal and professional impact among global health volunteers at Addis Ababa University’s Tikur Anbessa Specialized Hospital (Ethiopia)
Heidi Busse1*, Ephrem A Aboneh2 and Girma Tefera1
Author Affiliations
Globalization and Health 2014, 10:64 doi:10.1186/s12992-014-0064-x
Published: 5 September 2014
Abstract (provisional)
Background
The positive impact of global health activities by volunteers from the United States in low-and middle-income countries has been recognized. Most existing global health partnerships evaluate what knowledge, ideas, and activities the US institution transferred to the low- or middle-income country. However, what this fails to capture are what kinds of change happen to US-based partners due to engagement in global health partnerships, both at the individual and institutional levels. ?Reverse innovation? is the term that is used in global health literature to describe this type of impact. The objectives of this study were to identify what kinds of impact global partnerships have on health volunteers from developed countries, advance this emerging body of knowledge, and improve understanding of methods and indicators for assessing reverse innovation.
Methods
The study population consisted of 80 US, Canada, and South Africa-based health care professionals who volunteered at Tikur Anbessa Specialized Hospital in Ethiopia. Surveys were web-based and included multiple choice and open-ended questions to assess global health competencies. The data were analyzed using IBRM SPSS? version 21 for quantitative analysis; the open-ended responses were coded using constant comparative analysis to identify themes.
Results
Of the 80 volunteers, 63 responded (79 percent response rate). Fifty-two percent of the respondents were male, and over 60 percent were 40?years of age and older. Eighty-three percent reported they accomplished their trip objectives, 95 percent would participate in future activities and 96 percent would recommend participation to other colleagues. Eighty-nine percent reported personal impact and 73 percent reported change on their professional development. Previous global health experience, multiple prior trips, and the desire for career advancement were associated with positive impact on professional development.
Conclusion
Professionally and personally meaningful learning happens often during global health outreach. Understanding this impact has important policy, economic, and programmatic implications. With the aid of improved monitoring and evaluation frameworks, the simple act of attempting to measure ?reverse innovation? may represent a shift in how global health partnerships are perceived, drawing attention to the two-way learning and benefits that occur and improving effectiveness in global health partnership spending.

Global health in foreign policy—and foreign policy in health? Evidence from the BRICS

Health Policy and Planning
Volume 29 Issue 6 September 2014
http://heapol.oxfordjournals.org/content/current

Global health in foreign policy—and foreign policy in health? Evidence from the BRICS
Nicola F Watt1,*, Eduardo J Gomez2 and Martin McKee1
1European Centre on Health of Societies in Transition, London School of Hygiene and Tropical Medicine, 15-17, Tavistock Place, London WC1H 9SH, UK and 2King’s International Development Institute, King’s College London, Strand, London, WC2R 2LS, UK
Accepted July 19, 2013.
Abstract
Amidst the growing literature on global health, much has been written recently about the Brazil, Russia, India, China, South Africa (BRICS) countries and their involvement and potential impact in global health, particularly in relation to development assistance. Rather less has been said about countries’ motivations for involvement in global health negotiations, and there is a notable absence of evidence when their motivations are speculated on. This article uses an existing framework linking engagement in global health to foreign policy to explore differing levels of engagement by BRICS countries in the global health arena, with a particular focus on access to medicines. It concludes that countries’ differing and complex motivations reinforce the need for realistic, pragmatic approaches to global health debates and their analysis. It also underlines that these analyses should be informed by analysis from other areas of foreign policy.

Human Vaccines & Immunotherapeutics – September 2014

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
September 2014 Volume 10, Issue 9
http://www.landesbioscience.com/journals/vaccines/toc/volume/10/issue/8/

Special focus: Vaccine acceptance

Commentary
Commentary for Human Vaccines and Immunotherapeutics: The big picture in addressing vaccine hesitancy
Julie Leask, Hal Willaby and Jessica Kaufman
Abstract
Public acceptance of vaccination has never been a given. Today there is a set of societal circumstances that may contribute to a growing parental hesitancy about vaccination. These include: increasingly ‘crowded’ vaccination schedules; lower prevalence of vaccine-preventable diseases; greater access to, and more rapid dissemination of, vaccine-critical messages via digital networks; hyper-vigilance of parents in relation to children and risk; and an increasingly consumerist orientation to healthcare.

Health care professionals and adolescent vaccination: A call for intervention research
Gregory D Zimet
Abstract
In their recently published research study, Gargano et al. found that a physician’s recommendation and parental health beliefs had significant effects on adolescent vaccination rates and on parental intentions to vaccinate. This research replicates the findings of a number of human papillomavirus (HPV) vaccine-focused research studies, but explores new territory by focusing on all recommended adolescent vaccines: meningococcal-conjugate (MCV4), HPV, influenza, and tetanus, diphtheria, and acellular pertussis (Tdap) vaccines. Although Gargano et al.’s study is relatively small in scale and focuses on only one county in Georgia, their results are consistent with many other research reports, suggesting that their findings are robust and replicable. Most published intervention studies have targeted parents and young adults, with little focus on health care professionals. However, given the centrality of physician recommendation in adolescent vaccination, as shown by Gargano et al., it is clear that the time has come to develop and evaluate interventions that help physicians and other health care professionals to more effectively implement strong and routine recommendations for all adolescent platform vaccines.

Commentary
Influenza vaccination of healthcare personnel
Sabine Wicker and Georg Marckmann
Abstract
The thought is terrifying—you are admitted to the hospital and you die of a nosocomial infection. What sounds like a horror scenario, happens every day in hospitals all over the world. Nosocomial influenza is associated with considerable morbidity and mortality among patients with underlying diseases (especially immunocompromised patients), the elderly, and neonates. Although vaccination of healthcare personnel (HCP) is the main measure for preventing nosocomial influenza and is consistently recommended by public-health authorities, vaccine uptake among HCP remains low.1

Review
What are the factors that contribute to parental vaccine-hesitancy and what can we do about it?
Sarah E Williams
Abstract
Parental refusal or delay of childhood vaccines is increasing. Barriers to vaccination among this population have been described, yet less is known regarding motivating factors. Researchers are beginning to evaluate various approaches to address the concerns of “vaccine-hesitant” parents, but few studies have evaluated the effect of interventions on timely vaccine uptake. Several models for communicating with vaccine-hesitant parents have been reported for healthcare providers; however, the effectiveness and utility of these strategies has not been quantified. This article reviews the known barriers to vaccination reported by vaccine-hesitant parents and the current evidence on strategies to address parental vaccine hesitancy.

Commentary
Impact of a physician recommendation
Paul M Darden and Robert M Jacobson
Abstract
HPV vaccination has failed to achieve uptake comparable to the other adolescent-specific vaccines. Gargano et al. conducted a survey of parents of adolescents in a single Georgia county and found uptake similar to national surveys. They also found among the most commonly cited reasons for receiving vaccines a recommendation from a health care provider and among the most commonly cited reasons for not getting any of the adolescent vaccines were concerns for adverse effects. Of note, they found that the recommendation for any one vaccine had a positive effect on the uptake of other vaccines. Their findings for the importance of provider recommendations matched finds from studies of adolescent vaccines, infant vaccines, and adult vaccines. This is despite flaws in their study including a very poor response rate (effectively 4.5%) of those surveyed and in their reporting including a lack of details of survey methods. Local surveys of vaccination have much to offer the national and local discussion about immunization delivery and how delivery should be optimized, but such surveys should use standardized approaches as well as pursue more comprehensive investigations at the local level to address the nuances national complex-cluster surveys cannot.

Research Paper
Attitude toward immunization and risk perception of measles, rubella, mumps, varicella, and pertussis in health care workers working in 6 hospitals of Florence, Italy 2011
Cristina Taddei, Vega Ceccherini, Giuditta Niccolai, Barbara Rita Porchia, Sara Boccalini, Miriam Levi, Emilia Tiscione, Maria Grazia Santini, Simonetta Baretti, Paolo Bonanni and Angela Bechini
Abstract
Background: Health care workers (HCWs) are at risk of infection and transmission of vaccine-preventable infectious diseases. In recent years cases of measles or varicella in health care workers were observed with increasing frequency. The aim of our study was to investigate attitude toward immunization and risk perception of measles, rubella, mumps, varicella, and pertussis in HCWs working in 6 hospitals of Florence (Italy).
Methods: A cross-sectional survey among the physicians, nurses, midwives, and nursing assistants working in selected departments was performed trough a self-administered, anonymous questionnaire. Overall, 600 questionnaires were sent and 436 HCWs’ completed forms were included into the study (Participation rate: 72.7%). Data were analyzed with STATA 11.0® and odds ratio (OR) were calculated in a multivariate analysis.
Results: Among all respondents 74.9% were females. The average age was nearly 43-years-old (42.9 – SD 8.95). The majority of participants (58.6%) were nurses, 21.3% physicians, 12.9% nursing assistants, and 7.2% were midwives. Among those HCWs reporting no history of disease, 52.8% (95% CI: 42.0–63.3%) declared to have been immunized for measles, 46.9% for rubella (95% CI: 39.0–54.9%), 21.6% for mumps (95% CI: 15.1–29.4%), 14.9% for varicella (95% CI: 7.4–25.7%), and 14.5% for pertussis (95% CI: 10.0–20.0%). When considering potentially susceptible HCWs (without history of disease or vaccination and without serological confirmation), less than a half of them feel at risk for the concerned diseases and only less than 30% would undergo immunization. One of the main reasons of the relatively low coverage was indeed lack of active offer of vaccines.
Conclusion: Attitudes toward immunization observed in this study are generally positive for preventing some infectious diseases (i.e., measles and rubella), but relatively poor for others (i.e., varicella). More information should be made available to HCWs on the benefits of vaccination and efforts to encourage vaccination uptake should be performed. Educational program on the risk of being infected working in a hospital should be implemented in order to increase the risk perception toward infectious diseases among HCWs.

Research Paper
Knowledge, attitude, and uptake related to human papillomavirus vaccination among young women in Germany recruited via a social media site
Cornelius Remschmidt, Dietmar Walter, Patrick Schmich, Matthias Wetzstein, Yvonne Deleré and Ole Wichmann
Abstract
Background: Many industrialized countries have introduced human papillomavirus (HPV) vaccination of young women, but vaccine uptake often remains suboptimal. This study aimed to investigate whether a social media site like Facebook is an appropriate tool to assess knowledge, attitude and uptake related to HPV vaccination in young women in Germany. Methods: Between December 2012 and January 2013 two different targeting strategies were implemented on Facebook, providing a link to an online questionnaire. Advertisements were displayed to female Facebook users aged 18–25 years living in Germany. During the simple targeting strategy, advertisements comprised health-related images along with various short titles and text messages. During the focused strategy, advertisements were targeted to users who in addition had certain fashion brands or pop stars listed on their profiles. The targeting strategies were compared with respect to participant characteristics. Univariate and multivariate analyses were used to identify factors associated with HPV vaccine uptake.
Results: A total of 1161 women participated. The two targeting strategies resulted in significant differences regarding educational status and migrant background. Overall, awareness of HPV was high, but only 53% received at least one vaccine dose. In multivariate analysis, HPV vaccine uptake was independently associated with a physician’s recommendation and trust in vaccine effectiveness. Concerns of adverse effects were negatively associated with vaccine uptake.
Discussion: Social network recruitment permits fast and convenient access to young people. Sample characteristics can be manipulated by adjusting targeting strategies. There is further need for promoting knowledge of HPV vaccination among young women. Physicians have a major role in the vaccination decision-making process of young women.

Review
Maternal immunization: Clinical experiences, challenges, and opportunities in vaccine acceptance
Michelle H Moniz and Richard H Beigi
Abstract
Maternal immunization holds tremendous promise to improve maternal and neonatal health for a number of infectious conditions. The unique susceptibilities of pregnant women to infectious conditions, as well as the ability of maternally-derived antibody to offer vital neonatal protection (via placental transfer), together have produced the recent increased attention on maternal immunization. The Advisory Committee on Immunization Practices (ACIP) currently recommends 2 immunizations for all pregnant women lacking contraindication, inactivated Influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). Given ongoing research the number of vaccines recommended during pregnancy is likely to increase. Thus, achieving high vaccination coverage of pregnant women for all recommended immunizations is a key public health enterprise. This review will focus on the present state of vaccine acceptance in pregnancy, with attention to currently identified barriers and determinants of vaccine acceptance. Additionally, opportunities for improvement will be considered.

Research Paper
Vaccination against human papilloma virus infection in male adolescents: Knowledge, attitudes, and acceptability among parents in Italy
Aida Bianco, Claudia Pileggi, Francesca Iozzo, Carmelo Giuseppe Nobile and Maria Pavia
Abstract
Objectives: To elicit information about parents’ knowledge, attitudes, and acceptability towards HPV infection and vaccination of male adolescents in Italy; to identify subgroups of this population who exhibit poor knowledge about prevention of HPV infection and reveal negative attitudes towards HPV vaccination in relation to their male sons. Study design: Data were collected via self-administered anonymous questionnaire from 1021 parents of males aged 10 to 14 years who were recruited from a random sample of public secondary schools in the South of Italy. Results: Three-quarters (72.6%) reported that the vaccine is a preventive measure for HPV infection and 55.8% that condom use reduces the risk of HPV infection. A high education level, abundant sources of information about HPV infection received from physicians, and knowledge about HPV infection were factors significantly associated with high level of knowledge about preventive measures for HPV infection. 71% revealed their intentions to vaccinate their sons, and this intention was significantly associated with perceived benefits both for HPV vaccination for girls and for childhood recommended vaccinations as well as a need for additional information about HPV vaccination. 53.7% of the eligible parents reported that their daughters had been vaccinated against HPV. Conclusion: Results of the study suggest that the risk of acquiring HPV infection and HPV-related diseases is sorely underestimated. Knowledge on the benefits of adolescents’ HPV vaccination in cancer prevention in both sexes should be improved to maximize uptake of HPV vaccination.

Commentary
Social media targeting of health messages: A promising approach for research and practice
Cornelia Betsch
Abstract
In their contribution, Remschmidt and colleagues1 put forward an innovative approach for recruiting female, German study participants from diverse social and ethnical backgrounds to assess their knowledge, attitudes, and behaviors regarding HPV vaccination. The approach involves placing advertisements on the social media platform Facebook that specify tags for not only the sought after socio-demographic characteristics (age, gender) but also self-relevant aspects of the target group. These tags determine which Facebook users will see the ad. By sequentially adjusting the tags, the researchers were able to recruit different sub-populations, resulting in a final sample similar to a representative German sample for a particular age group.

Research Paper
Factors Associated with Maternal Influenza Immunization Decision-Making: Evidence of Immunization History and Message Framing Effects
Paula M Frew, Lauren E Owens, Diane S Saint-Victor, Samantha Benedict, Siyu Zhang and Saad B Omer
Abstract
Objective
We examined pregnant women’s intention to obtain the seasonal influenza vaccine via a randomized controlled study examining the effects of immunization history, message exposure, and sociodemographic correlates.
Methods
Pregnant women ages 18–50 participated in a randomized message framing study from September 2011 through May 2012. Venue-based sampling was used to recruit racial and ethnic minority women throughout Atlanta, Georgia. Key outcomes were evaluated using bivariate and multivariate analyses.
Results
History of influenza immunization was positively associated with intent to immunize during pregnancy [OR = 2.31, 90%CI: (1.06, 5.00)]. Significant correlates of intention to immunize included perceived susceptibility to influenza during pregnancy [OR = 3.8, 90% CI: (1.75, 8.36)] and vaccine efficacy [OR = 10.53, 90% CI: (4.34, 25.50)]. Single message exposure did not influence a woman’s intent to vaccinate.
Conclusions
Prior immunization, perceived flu susceptibility and perceived vaccine effectiveness promoted immunization intent among this population of pregnant minority women. Vaccine efficacy and disease susceptibility are critical to promoting immunization among women with no history of seasonal influenza immunization, while those who received the vaccine are likely to do so again. These findings provide evidence for the promotion of repeated exposure to vaccine messages emphasizing vaccine efficacy, normative support, and susceptibility to influenza.

Research Paper
Parental concern about vaccine safety in Canadian children partially immunized at age two: A multivariable model including system level factors
Donald Schopflocher, Wendy Vaudry and Shannon MacDonald
Abstract
Children who begin but do not fully complete the recommended series of childhood vaccines by two years of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of ‘partially’ immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized two year old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138- 13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151 – 6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017 – 10.625), residential mobility (aOR 3.908, 95% CI 2.075 – 7.358), daycare use (aOR 0.310, 95% CI 0.144 – 0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598 – 23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057 – 0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

Commentary
Protecting a New Generation against HPV: Are We Willing to be Bold?
Richard Crosby, Lindsay Stradtman and Robin Vanderpool
Abstract
Despite the advent of a novel human papillomavirus (HPV) vaccine to prevent associated cancers, HPV vaccination rates in the United States (US) remain well below national goals. Two recent reports by the Centers for Disease Control and Prevention (CDC) and the President’s Cancer Panel (PCP) have identified missed clinical opportunities as an intervention point for increasing HPV vaccination rates, including the provision of immunization in alternative venues by varying healthcare providers. In this paper, we specifically comment on the idea of offering HPV vaccination in emergency departments (ED) by emergency medicine (EM) physicians as posited by Hill and Okugo (2014), identifying both strengths and limitations to this strategy. We also offer ideas for additional research, suggest provider and healthcare systems changes, and discuss needed policy changes to improve HPV vaccination rates in the US.

Commentary
Comprehensive Efforts to Increase Healthcare Personnel Immunization
Samuel B Graitcer, David Kim and Megan Lindley
Abstract
Vaccination of healthcare personnel (HCP) is an important component of worker and patient safety, yet vaccination rates are lagging. The findings from Taddei et al.’s study of healthcare personnel immunization attitudes and practices in Florence, Italy provides further data of the importance of routine assessment of and recommendations for vaccines for HCP in order to improve coverage.
Does Intention to Recommend HPV Vaccines Impact HPV Vaccination Rates?
Maria Middleton, Alexander Fiks, Sarah Winters, Sara Kinsman, Jessica Kahn and Kristen Feemster
Abstract
Despite recommendations for routine vaccination, HPV vaccination rates among adolescent females have remained low. The objective of this prospective cohort study was to determine whether clinician intention to recommend HPV vaccines predicts HPV vaccine series initiation among previously unvaccinated 11 to 18 year-old girls (N=18,083) who were seen by a pediatric clinician (N=105) from a large primary care network within three years of vaccine introduction. We used multivariable logistic regression with generalized estimating equations, Cox Regression and standardized survival curves to measure the association between clinician intention and time to and rate of first HPV vaccine receipt among eligible females. All models adjusted for patient age, race / ethnicity, payor category, visit type, and practice location. Eighty-five percent of eligible 11 to 12 year-old and 95% of 13 to 18 year-old girls were seen by a provider reporting high intention to recommend HPV vaccines. However, only 30% of the cohort initiated the HPV vaccine series and the mean number of days from first eligible visit to series initiation was 190 (95% C.I. 184.2, 195.4). After adjusting for covariates, high clinician intention was modestly associated with girls’ likelihood of HPV vaccine series initiation (OR 1.36; 95 % C.I. 1.07, 1.71) and time to first HPV vaccination (HR 1.22; 95% 1.06, 1.40). Despite high intention to vaccinate among this cohort of pediatric clinicians, overall vaccination rates for adolescent girls remained low. These findings support ongoing efforts to develop effective strategies to translate clinician intention into timely HPV vaccine receipt.

Commentary
Making evidence-based selections of influenza vaccines
Billy-Clyde Childress, Joshua D Montney and Elise A Albro
Abstract
Years ago, intramuscular influenza vaccines were the only option for those who wanted to arm themselves against the flu. Today there are alternatives, including intradermal injections and intranasal sprays. In order to select the right influenza vaccine for their patients, pharmacists, and other healthcare professionals must have a basic understanding of the immune system. Influenza vaccines elicit different levels of immune response involving innate and adaptive immunity, which are critical to fighting infection. For the 2013–2014 flu season, there were 13 different formulations of influenza vaccines on the market with vast differences in indications, contraindications, and effectiveness. The CDC does not recommend one vaccine over another, but recommends that all patients be vaccinated against the flu. Preventing the spread of influenza is no simple task; however, the most recent evidence on influenza vaccines and sufficient knowledge of the immune system will allow pharmacists and other healthcare providers to better advocate for vaccines, determine which are most appropriate, and ensure their proper administration.

Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers

International Journal of Infectious Diseases
Vol 26 Complete | September 2014 | Pages 1-172
http://www.ijidonline.com/current

Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers
Miguel Tregnaghi, Pio Lopez, Daniel Stamboulian, Gabriela Graña, Tatjana Odrljin, Lisa Bedell, Peter M. Dull
Received 20 December 2013; received in revised form 7 March 2014; accepted 27 March 2014. published online 30 June 2014.
Corresponding Editor: Eskild Petersen, Aarhus, Denmark
Summary
Objectives
This phase III study assessed the safety and immunogenicity of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, administered with routine vaccines starting at 2 months of age.
Methods
Healthy infants received MenACWY-CRM in a two- or three-dose primary infant series plus a single toddler dose. In addition, a two-dose toddler catch-up series was evaluated. Immune responses to MenACWY-CRM were assessed for serum bactericidal activity with human complement (hSBA). Reactogenicity and safety results were collected systematically.
Results
After a full infant/toddler series or two-dose toddler catch-up series, MenACWY-CRM elicited immune responses against the four serogroups in 94–100% of subjects. Noninferiority of the two- versus three-dose MenACWY-CRM infant dosing regimen was established for geometric mean titers for all serogroups. Following the three-dose infant primary series, 89–98% of subjects achieved an hSBA ≥8 across all serogroups. Immune responses to concomitant routine vaccines given with MenACWY-CRM were noninferior to responses to routine vaccines alone, except for pertactin after the two-dose infant series. Noninferiority criteria were met for all concomitant antigens after the three-dose infant series.
Conclusions
MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated. No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed.

An outbreak of adult measles by nosocomial transmission in a high vaccination coverage community

International Journal of Infectious Diseases
Vol 26 Complete | September 2014 | Pages 1-172
http://www.ijidonline.com/current

An outbreak of adult measles by nosocomial transmission in a high vaccination coverage community
Fen-juan Wang, Xiang-jue Sun, Fu-liang Wang, Long-fang Jiang, Er-ping Xu, Jian-feng Guo
Received 3 March 2014; received in revised form 4 May 2014; accepted 6 May 2014. published online 07 July 2014.
Corresponding Editor: Eskild Petersen, Aarhus, Denmark
Abstract
Highlights
:: With the implementation of hastened measles elimination strategies, the susceptible populations now have moved to the infants under 8 months who are too young to receive the MCV vaccination and the adults over 20 year old.
:: Hospital exposure 1∼2 weeks before infected with measles was the main cause of the community-based measles outbreak, there is a link between them.
:: Controlling nosocomial infections is a vital link in propagation of measles prevention and control.
Summary
Objectives
The aims of this study were to determine the mechanism of an outbreak of measles in adults and to provide scientific measures for putting forward a measles elimination program.
Methods
We performed a cross-sectional investigation during the measles outbreak to identify a possible communication link.
Results
From November 1, 2011 to January 26, 2012, the town reported 11 cases of measles in total. The case study identified an obvious propagation chain, which showed ordered and intimate exposure between cases.
Conclusions
Hospital exposure 1–2 weeks before infection with measles was the main cause of the measles outbreak. We must be fully aware of the possibility of nosocomial infection in an outbreak of measles; controlling nosocomial infections is a vital step in the prevention and control of the propagation of measles.

Screening and Vaccines in an Urban Primary Care Practice: A Retrospective Chart Review

Journal of Immigrant and Minority Health
Volume 16, Issue 5, October 2014
http://link.springer.com/journal/10903/16/4/page/1

Screening and Vaccines in an Urban Primary Care Practice: A Retrospective Chart Review
Barbara Waldorf, Christopher Gill, Sondra S. Crosby
Abstract
In the United States, 38.5 million people are foreign-born, one in three arriving since 2000. Health issues include high rates of hepatitis B, human immunodeficiency virus infection, parasitic infections, and M. tuberculosis. We sought to determine rates of provider adherence to accepted national guidelines for immigrant and refugee health screening and vaccines done at the primary care clinics at Boston Medical Center. Randomized, retrospective chart review of foreign born patients in the primary care clinics. We found low screening and immunization rates that do not conform to CDC/ACIP guidelines. Only 43 % of immigrant patients had tuberculosis screening, 36 % were screened for HIV and hepatitis B, and 33 % received tetanus vaccinations. Organizational changes incorporating multi-disciplinary approaches such as creative use of nursing staff, protocols, standing orders, EMR reminders, and web based educational tools can contribute to better outcomes by identifying patients and improving utilization of guidelines.

Influenza Vaccination of Pregnant Women and Protection of Their Infants

New England Journal of Medicine
August 28, 2014 Vol. 371 No. 9
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Influenza Vaccination of Pregnant Women and Protection of Their Infants
Shabir A. Madhi, M.D., Ph.D., Clare L. Cutland, M.D., Locadiah Kuwanda, M.Sc., Adriana Weinberg, M.D., Andrea Hugo, M.D., Stephanie Jones, M.D., Peter V. Adrian, Ph.D., Nadia van Niekerk, B.Tech., Florette Treurnicht, Ph.D., Justin R. Ortiz, M.D., Marietjie Venter, Ph.D., Avy Violari, M.D., Kathleen M. Neuzil, M.D., Eric A.F. Simões, M.D., Keith P. Klugman, M.D., Ph.D., and Marta C. Nunes, Ph.D. for the Maternal Flu Trial (Matflu) Team
N Engl J Med 2014; 371:918-931September 4, 2014DOI: 10.1056/NEJMoa1401480
Background
There are limited data on the efficacy of vaccination against confirmed influenza in pregnant women with and those without human immunodeficiency virus (HIV) infection and protection of their infants.
Methods
We conducted two double-blind, randomized, placebo-controlled trials of trivalent inactivated influenza vaccine (IIV3) in South Africa during 2011 in pregnant women infected with HIV and during 2011 and 2012 in pregnant women who were not infected. The immunogenicity, safety, and efficacy of IIV3 in pregnant women and their infants were evaluated until 24 weeks after birth. Immune responses were measured with a hemagglutination inhibition (HAI) assay, and influenza was diagnosed by means of reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assays of respiratory samples.
Results
The study cohorts included 2116 pregnant women who were not infected with HIV and 194 pregnant women who were infected with HIV. At 1 month after vaccination, seroconversion rates and the proportion of participants with HAI titers of 1:40 or more were higher among IIV3 recipients than among placebo recipients in both cohorts. Newborns of IIV3 recipients also had higher HAI titers than newborns of placebo recipients. The attack rate for RT-PCR–confirmed influenza among both HIV-uninfected placebo recipients and their infants was 3.6%. The attack rates among HIV-uninfected IIV3 recipients and their infants were 1.8% and 1.9%, respectively, and the respective vaccine-efficacy rates were 50.4% (95% confidence interval [CI], 14.5 to 71.2) and 48.8% (95% CI, 11.6 to 70.4). Among HIV-infected women, the attack rate for placebo recipients was 17.0% and the rate for IIV3 recipients was 7.0%; the vaccine-efficacy rate for these IIV3 recipients was 57.7% (95% CI, 0.2 to 82.1).
Conclusions
Influenza vaccine was immunogenic in HIV-uninfected and HIV-infected pregnant women and provided partial protection against confirmed influenza in both groups of women and in infants who were not exposed to HIV. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov numbers, NCT01306669 and NCT01306682.)

Pediatrics – September 2014

Pediatrics
September 2014, VOLUME 134 / ISSUE 3
http://pediatrics.aappublications.org/current.shtml

Article
Long-term Study of a Quadrivalent Human Papillomavirus Vaccine
Daron Ferris, MDa, Rudiwilai Samakoses, MDb, Stan L. Block, MDc, Eduardo Lazcano-Ponce, Dd,
Jaime Alberto Restrepo, MDe, Keith S. Reisinger, MD, MPHf, Jesper Mehlsen, MDg, Archana Chatterjee, MD, PhDh, Ole-Erik Iversen, MDi, Heather L. Sings, PhDj, Qiong Shou, PhDj, Timothy A. Sausser, BSj, and Alfred Saah, MDj
Author Affiliations
aDepartment of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia;
bDepartment of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand;
cKentucky Pediatric and Adult Research, Inc, Bardstown, Kentucky;
dCenter for Research in Population Health, National Institute of Public Health, Cuernavaca Morelos, Mexico;
eClinical Research Center, Medellín, Colombia;
fPrimary Physicians Research, Pittsburgh, Pennsylvania;
gCoordinating Research Centre, Frederiksberg Hospital, Frederiksberg, Denmark;
hDepartment of Pediatrics, University of South Dakota Sanford School of Medicine, Sanford Children’s Specialty Clinics, Sioux Falls, South Dakota;
iDepartment of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway; and
jMerck & Co., Inc, Whitehouse Station, New Jersey
Abstract
BACKGROUND: We present a long-term safety, immunogenicity, and effectiveness study of a quadrivalent human papillomavirus (HPV4) vaccine.
METHODS: Sexually naive boys and girls aged 9 to 15 years (N = 1781) were assigned (2:1) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6. At month 30, the placebo group (n = 482) received HPV4 vaccine following the same regimen and both cohorts were followed through month 96. Subjects ≥16 years were eligible for effectiveness evaluations. The primary objective was to evaluate the long-term anti-HPV6/11/16/18 serological levels. The secondary objective was to estimate vaccine effectiveness against HPV6/11/16/18-related persistent infection or disease.
RESULTS: For each of the HPV4 vaccine types, vaccination-induced anti-HPV response persisted through month 96. Among 429 subjects who received HPV4 vaccine at a mean age of 12, none developed HPV6/11/16/18-related disease or persistent infection of ≥12 months’ duration. Acquisition of new sexual partners (among those ≥16 years) was ∼1 per year. Subjects receiving HPV4 vaccine at month 30 (mean age 15 years) had a similar baseline rate of seropositivity to ≥1 of the 4 HPV types to those vaccinated at day 1 (mean age 12 years; 1.9% [9 of 474] vs 1.7% [20 of 1157]); however, 4 of the 9 subjects vaccinated at the later age were seropositive to 3 vaccine types, indicating previous HPV exposure. No new significant serious adverse events were observed for 8 years postvaccination in both genders.
CONCLUSIONS: When administered to adolescents, the HPV4 vaccine demonstrated durability in clinically effective protection and sustained antibody titers over 8 years.

Article
Missed Opportunities for HPV Vaccination in Adolescent Girls: A Qualitative Study
Rebecca B. Perkins, MD, MSca, Jack A. Clark, PhDb,c, Gauri Apte, MB, BS, MPHc, Jessica L. Vercruysse, MAa, Justen J. Sumner, MD, MPHa, Constance L. Wall-Haas, DNP, PPCNP-BCd,
Anna W. Rosenquist, MDe, and Natalie Pierre-Joseph, MD, MPHa
Author Affiliations
aBoston University School of Medicine, Boston, Massachusetts;
bEdith Nourse Rogers Memorial Veterans Hospital–Bedford, Bedford, Massachusetts;
cBoston University School of Public Health, Boston, Massachusetts;
dHarvard Vanguard Medical Associates, Chelsmford, Massachusetts; and
eHarvard Vanguard Medical Associates, Burlington, Massachusetts
Abstract
OBJECTIVE: The goal of this study was to identify the rationale by parents/guardians and providers for delaying or administering human papillomavirus (HPV) vaccination to girls.
METHODS: Qualitative interviews were conducted with parents/guardians accompanying their vaccine-eligible 11- to 17-year-old daughters to medical visits. Interviews were conducted in 1 public clinic and 3 private practice settings to ascertain why girls did or did not receive HPV vaccination. Questions probed vaccine decision-making from the point of view of parents/guardians and providers.
RESULTS: A total of 124 parents/guardians and 37 providers participated. The most common reasons parents reported for not vaccinating their daughters was the lack of a physician recommendation (44%). Both parents and providers believed that HPV vaccination provided important health benefits, but the timing of vaccination with relation to sexual activity was an important theme related to vaccine delay. Providers with lower self-reported vaccination rates delayed vaccine recommendations in girls perceived to be at low risk for sexual activity, and several parents reported that their providers suggested or supported delaying vaccination until their daughters were older. However, parents/guardians and providers agreed that predicting the timing of sexual debut was extremely difficult. In contrast, providers with high vaccination rates presented HPV vaccination as a routine vaccine with proven safety to prevent cancer, and parents responded positively to these messages.
CONCLUSIONS: Although most parents and providers believe that HPV vaccination is important, missed opportunities result from assumptions about the timing of vaccination relative to sexual activity. Routinely recommending HPV vaccination as cancer prevention to be coadministered with other vaccines at age 11 years can improve vaccination rates

Article
Vaccine Message Framing and Parents’ Intent to Immunize Their Infants for MMR
Kristin S. Hendrix, PhDa,b, S. Maria E. Finnell, MD, MSa,b,c, Gregory D. Zimet, PhDa, Lynne A. Sturm, PhDa, Kathleen A. Lane, MSd, and Stephen M. Downs, MD, MSa,b
Author Affiliations
aDepartments of Pediatrics, and
dBiostatistics, Indiana University School of Medicine, Indianapolis, Indiana;
bRegenstrief Institute, Inc, Indianapolis, Indiana; and
cRyan White Center for Pediatric Infectious Disease, Riley Hospital for Children, Indianapolis, Indiana
Abstract
BACKGROUND AND OBJECTIVE: Emphasizing societal benefits of vaccines has been linked to increased vaccination intentions in adults. It is unclear if this pattern holds for parents deciding whether to vaccinate their children. The objective was to determine whether emphasizing the benefits of measles-mumps-rubella (MMR) vaccination directly to the vaccine recipient or to society differentially impacts parents’ vaccine intentions for their infants.
METHODS: In a national online survey, parents (N = 802) of infants RESULTS: Compared with the VIS-only group (mean intention = 86.3), parents reported increased vaccine intentions for their infants when receiving additional information emphasizing the MMR vaccine’s benefits either directly to the child (mean intention = 91.6, P = .01) or to both the child and society (mean intention = 90.8, P = .03). Emphasizing the MMR vaccine’s benefits only to society did not increase intentions (mean intention = 86.4, P = .97).
CONCLUSIONS: We did not see increases in parents’ MMR vaccine intentions for their infants when societal benefits were emphasized without mention of benefits directly to the child. This finding suggests that providers should emphasize benefits directly to the child. Mentioning societal benefits seems to neither add value to, nor interfere with, information highlighting benefits directly to the child.

Article
Impact of a Pertussis Epidemic on Infant Vaccination in Washington State
Elizabeth R. Wolf, MD, MPHa,b, Douglas Opel, MD, MPHa,b, M. Patricia DeHart, ScDc,
Jodi Warren, BSNd, and Ali Rowhani-Rahbar, MD, MPH, PhDe
Author Affiliations
aSeattle Children’s Research Institute, Seattle, Washington;
Departments of bPediatrics, and
eEpidemiology, University of Washington, Seattle, Washington;
cWashington State Department of Health, Olympia, Washington; and
dWashington State Immunization Information System, Seattle, Washington
Abstract
BACKGROUND AND OBJECTIVES: Washington State experienced a pertussis epidemic from October 2011 to December 2012. There was wide variation in incidence by county. The objectives of this study were to determine how the pertussis epidemic affected infant vaccination in Washington State and whether the incidence in counties modified this effect.
METHODS: We conducted an ecologic before–after study to compare the proportion of infants up to date (UTD) with a pertussis-containing vaccine at time points before (September 30, 2011), during (September 30, 2012), and after (September 30, 2013) the epidemic. Children aged 3 to 8 months enrolled in the Washington State Immunization Information System with documented county of residence were included. UTD status was determined as ≥1, ≥2, or ≥3 doses of a pertussis-containing vaccine at ages 3, 5, and 7 months, respectively. Generalized linear models with extension to the binomial family and clustered robust standard errors were used to examine differences in the proportion of UTD infants between preepidemic and either epidemic or postepidemic points. The potential modifying effect of pertussis incidence by county was examined.
RESULTS: We found no significant difference in statewide UTD status with a pertussis-containing vaccine between preepidemic and either epidemic (absolute difference 2.1%; 95% confidence interval, −1.6 to 5.9) or postepidemic (absolute difference 0.2%; 95% confidence interval, −4.0 to 4.5) time points. There was no significant modification by county pertussis incidence. There was wide variation in the absolute difference in UTD status across counties.
CONCLUSIONS: A statewide pertussis epidemic does not appear to have significantly changed the proportion of infants who were UTD with a pertussis-containing vaccine.

Commentary
Pertussis Resurgence and Vaccine Uptake: Implications for Reducing Vaccine Hesitancy
Jessica E. Atwell, MPHa,b and Daniel A. Salmon, PhD, MPHa,b,c,d
Author Affiliations
aGlobal Disease Epidemiology and Control,
cHealth, Behavior, and Society,
bDepartment of International Health, and
dInstitute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland
Previously controlled vaccine preventable diseases (VPDs) are in resurgence.1,2 To date, there have been 477 confirmed measles cases in the United States in 2014, the most in 18 years.3 In 2013 there were ∼25 000 pertussis cases in the United States. Vaccine refusal has been associated with outbreaks of invasive Haemophilus influenzae type b disease,4 varicella,5 pneumococcal disease,6 measles,7 and pertussis.8–12
Even while national and statewide immunization coverage remain high, rates of parents who refuse vaccines via nonmedical exemptions (NMEs) to school immunization requirements have been increasing.13,14 Furthermore, NMEs cluster geographically,9,10 leading to critical reductions in herd immunity and a perfect storm for sustained transmission, outbreaks, and increased risk of VPDs to both unvaccinated and vaccinated individuals.7,9,10,15,16
Beyond active refusal, many parents are delaying vaccines and using “alternative immunization schedules” to spread out the number of vaccines given per visit or in infancy.17 Seventy-seven percent of parents of young children report concerns about vaccines, such as the number of vaccines or doses given simultaneously or before age two, what ingredients are contained in vaccines, or if there are associations with adverse outcomes such as autism and other chronic diseases.18 Some have gone so far as to identify a “vaccine crisis in confidence…”19–21

Oral Cholera Vaccine Development and Use in Vietnam

PLoS Medicine
(Accessed 6 September 2014)
http://www.plosmedicine.org/

Oral Cholera Vaccine Development and Use in Vietnam
Dang Duc Anh, Anna Lena Lopez mail, Hung Thi Mai Tran, Nguyen Van Cuong, Vu Dinh Thiem,
Mohammad Ali, Jacqueline L. Deen, Lorenz von Seidlein, David A. Sack
Published: September 02, 2014
DOI: 10.1371/journal.pmed.1001712
Summary Points
:: Vietnam is the first and only country in the world to regularly use oral cholera vaccines (OCVs) in their cholera control program.
:: From 1998 to 2012, more than 10.9 million doses of the locally produced OCV were deployed in the country through its public health system.
:: We present an overview of cholera epidemiology in Vietnam and the development and deployment of the OCV.
:: Since 1997, the number of cholera cases in Vietnam has declined, in association with increased OCV use as well as improvements in socioeconomic and water and sanitation conditions. It is not possible to establish the relative contributions of each of these to the reduction in cholera rates.
:: Hue, the only province to use OCVs consistently every year, has not reported any cholera case since 2003.
:: As WHO organizes a stockpile of OCV for use in emergencies and recommends the use of OCVs together with traditional means of control, the experience in Vietnam will be helpful to other at-risk countries as they look towards adopting the vaccine in their cholera control programs.

Cholera: A Continuing Public Health Threat
The emergence of cholera in Haiti highlighted the difficulties in containing cholera outbreaks with only safe water, sanitation, hygiene, and appropriate case management. In less developed settings where cholera occurs, these basic needs are often not met or are rapidly overwhelmed during man-made or natural disasters. Prior to the Haitian outbreak, countries in Africa and Asia had borne most of the cholera burden, with an estimated 1.4 billion people at risk, 2.8 million cases, and 100,000 to 200,000 deaths occurring annually [1],[2]; however, because of difficulties in surveillance and differences in reporting systems, only 245,393 cases with 3,034 deaths were reported to the World Health Organization (WHO) in 2012 [1]. This figure does not include the large number of acute watery diarrhoea cases reported in Asia, of which a significant proportion is caused by Vibrio cholerae. As cholera continues to be a global public health problem, in 2011, the World Health Assembly called for an integrated and comprehensive approach to cholera control, including oral cholera vaccines (OCVs) [3].
OCVs have been available for more than 20 years, but public health use has been limited. Vietnam is the first and currently the only country in the world to use killed OCVs routinely in its public health program. This article describes the cholera problem in Vietnam and how an oral cholera vaccine was developed and used as a component of a public health strategy against the disease…

From Google Scholar [ to 6 September 2014]

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

International Health
Volume 6, Issue 3 Pp. 160-161.
Vaccination in humanitarian crises: satisficing should no longer suffice
Rebecca F. Graisa, and Aitana Juan-Ginera,b
Author Affiliations
aEpicentre, 8 rue Saint Sabin, Paris 75011, France
bInternational Vaccination Working Group, Médecins Sans Frontières, Paris, France
Received May 22, 2014.
Revision received July 9, 2014.
Accepted July 9, 2014. doi: 10.1093/inthealth/ihu051
Abstract
There are more possible vaccination interventions to mitigate the adverse health consequences of populations in crises than ever before, but recent reviews suggest delivering these vaccines has been fraught with difficulty. The decision to implement vaccination interventions in crises remains, more often than not, an exercise in satisficing. The sparse credible epidemiologic and effectiveness data in populations affected by crises contributes greatly to decision-making difficulty, as do the limits of vaccine presentations, formulations and storage. Political considerations and lack of decision-making guidance contribute further. Moving forward requires sound effectiveness studies to help ensure that decision-making is based to the degree possible on substance.

Journal of Medical Internet Research
2014;16(9):e198)
Original Paper
Estimation of Geographic Variation in Human Papillomavirus Vaccine Uptake in Men and Women: An Online Survey Using Facebook Recruitment
Erik J Nelson1, MPH, PhD; John Hughes2, PhD; J Michael Oakes1, PhD; James S Pankow1, MPH, PhD; Shalini L Kulasingam1, PhD
1School of Public Health, Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, United States
2School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, United States
ABSTRACT
Background: Federally funded surveys of human papillomavirus (HPV) vaccine uptake are important for pinpointing geographically based health disparities. Although national and state level data are available, local (ie, county and postal code level) data are not due to small sample sizes, confidentiality concerns, and cost. Local level HPV vaccine uptake data may be feasible to obtain by targeting specific geographic areas through social media advertising and recruitment strategies, in combination with online surveys.
Objective: Our goal was to use Facebook-based recruitment and online surveys to estimate local variation in HPV vaccine uptake among young men and women in Minnesota.
Methods: From November 2012 to January 2013, men and women were recruited via a targeted Facebook advertisement campaign to complete an online survey about HPV vaccination practices. The Facebook advertisements were targeted to recruit men and women by location (25 mile radius of Minneapolis, Minnesota, United States), age (18-30 years), and language (English).
Results: Of the 2079 men and women who responded to the Facebook advertisements and visited the study website, 1003 (48.2%) enrolled in the study and completed the survey. The average advertising cost per completed survey was US $1.36. Among those who reported their postal code, 90.6% (881/972) of the participants lived within the previously defined geographic study area. Receipt of 1 dose or more of HPV vaccine was reported by 65.6% women (351/535), and 13.0% (45/347) of men. These results differ from previously reported Minnesota state level estimates (53.8% for young women and 20.8% for young men) and from national estimates (34.5% for women and 2.3% for men).
Conclusions: This study shows that recruiting a representative sample of young men and women based on county and postal code location to complete a survey on HPV vaccination uptake via the Internet is a cost-effective and feasible strategy. This study also highlights the need for local estimates to assess the variation in HPV vaccine uptake, as these estimates differ considerably from those obtained using survey data that are aggregated to the state or federal level.

British Journal of Cancer
(2 September 2014) | doi:10.1038/bjc.2014.479
Reduction of low-and high-grade cervical abnormalities associated with high uptake of the HPV bivalent vaccine in Scotland
K G J Pollock, K Kavanagh, A Potts, J Love, K Cuschieri, H Cubie, C Robertson, M Cruickshank, T J Palmer, S Nicoll and M Donaghy
Abstract
Background:
In Scotland, a national HPV immunisation programme began in 2008 for 12- to 13-year olds, with a catch-up campaign from 2008 to 2011 for those under the age of 18. To monitor the impact of HPV immunisation on cervical disease at the population level, a programme of national surveillance was established.
Methods:
We analysed colposcopy data from a cohort of women born between 1988 and 1992 who entered the Scottish Cervical Screening Programme (SCSP) and were aged 20–21 in 2008–2012.
Results:
By linking datasets from the SCSP and colposcopy services, we observed a significant reduction in diagnoses of cervical intraepithelial neoplasia 1 (CIN 1; RR 0.71, 95% CI 0.58 to 0.87; P=0.0008), CIN 2 (RR 0.5, 95% CI 0.4 to 0.63; P<0.0001) and CIN 3 (RR 0.45, 95% CI 0.35 to 0.58; P<0.0001) for women who received three doses of vaccine compared with unvaccinated women.
Conclusions:
To our knowledge, this is one of the first studies to show a reduction of low- and high-grade CIN associated with high uptake of the HPV bivalent vaccine at the population level. These data are very encouraging for countries that have achieved high HPV vaccine uptake.

Cuts at W.H.O. Hurt Response to Ebola Crisis

New York Times
http://www.nytimes.com/
Accessed 6 September 2014

Cuts at W.H.O. Hurt Response to Ebola Crisis
SHERI FINK
3 September 2014

With treatment centers overflowing, and alarmingly little being done to stop Ebola from sweeping through West African villages and towns, Dr. Joanne Liu, the president of Doctors Without Borders, knew that the epidemic had spun out of control.

The only person she could think of with the authority to intensify the global effort was Dr. Margaret Chan, the director general of the World Health Organization, which has a long history of fighting outbreaks. If the W.H.O., the main United Nations health agency, could not quickly muster an army of experts and health workers to combat an outbreak overtaking some of the world’s poorest countries, then what entity in the world would do it?

“I wish I could do that,” Dr. Chan said when the two met at the W.H.O.’s headquarters in Geneva this summer, months after the outbreak burgeoned in a Guinean rain forest and spilled into packed capital cities. The W.H.O. simply did not have the staffing or ability to flood the Ebola zone with help, said Dr. Chan, who recounted the conversation. It was a fantasy, she argued, to think of the W.H.O. as a first responder ready to lead the fight against deadly outbreaks around the world.

The Ebola epidemic has exposed gaping holes in the ability to tackle outbreaks in an increasingly interconnected world, where diseases can quickly spread from remote villages to cities housing millions of people.

The W.H.O., the United Nations agency assigned in its constitution to direct international health efforts, tackle epidemics and help in emergencies, has been badly weakened by budget cuts in recent years, hobbling its ability to respond in parts of the world that need it most. Its outbreak and emergency response units have been slashed, veterans who led previous fights against Ebola and other diseases have left, and scores of positions have been eliminated — precisely the kind of people and efforts that might have helped blunt the outbreak in West Africa before it ballooned into the worst Ebola epidemic ever recorded…

What’s missing in the Ebola fight in West Africa: Jim Yong Kim and Paul Farmer

Washington Post
http://www.washingtonpost.com/
Accessed 6 September 2014

What’s missing in the Ebola fight in West Africa: Jim Yong Kim and Paul Farmer
By Jim Yong Kim and Paul Farmer August 31
Jim Yong Kim is president of the World Bank. Paul Farmer is the Kolokotrones University professor at Harvard University. Farmer and Kim, who are infectious disease physicians, co-founded the nonprofit organization Partners in Health.

If the Ebola epidemic devastating the countries of Guinea, Liberia and Sierra Leone had instead struck Washington, New York or Boston, there is no doubt that the health systems in place could contain and then eliminate the disease.

Hospitals would isolate suspected cases. Health workers would be outfitted with proper protective clothing and equipment. Doctors and nurses would administer effective supportive care, including comprehensive management of dehydration, impaired kidney and liver function, bleeding disorders and electrolyte disturbance. Labs would dispose of hazardous materials properly. And a public health command center would both direct the response and communicate clearly to the public about the outbreak.
Ebola is spread by direct physical contact with infected bodily fluids, making it less transmissible than an airborne disease such as tuberculosis. A functioning health system can stop Ebola transmission and, we believe, save the lives of a majority of those who are afflicted.

So why isn’t this happening in West Africa, where more than 1,500 people have already died?

As international groups pull staff from the three countries, airlines suspend commercial flights and neighboring countries close their borders, some have argued that it will be next to impossible to contain the outbreak — that public health systems are too weak, the cost of providing effective care too high and health workers too scarce.

But Ebola has been stopped in every other outbreak to date, and it can be stopped in West Africa, too. The crisis we are watching unfold derives less from the virus itself and more from deadly and misinformed biases that have led to a disastrously inadequate response to the outbreak.

These biases, tragically, live on, despite evidence that disproves them again and again.

Just 15 years ago, Western experts said confidently that there was little that rich countries could do to stop the global AIDS crisis, which was killing millions of people in Africa and elsewhere.

Today, thanks to leadership and advocacy from President George W. Bush, a bipartisan coalition of members in Congress, courageous faith-based organizations and U.S. government researchers such as Tony Fauci and Mark Dybul, more than 10 million Africans are getting life-saving treatment.

The take-no-action argument has been used over the years as an excuse not to mount an effort to control drug-resistant tuberculosis, malaria and many other diseases that afflict primarily the poor.

But the reality is this: The Ebola crisis today is a reflection of long-standing and growing inequalities of access to basic health care. Guinea, Liberia and Sierra Leone do not have the staff, stuff and systems required to halt the outbreak on their own. According to its ministry of health, before the outbreak Liberia had just 50 doctors working in public health facilities serving a population of 4.3 million.

To halt this epidemic, we need an emergency response that is equal to the challenge. We need international organizations and wealthy countries that possess the required resources and knowledge to step forward and partner with West African governments to mount a serious, coordinated response as laid out in the World Health Organization’s Ebola response roadmap.

Many are dying needlessly. Historically, in the absence of effective care, common acute infections have been characterized by high mortality rates. What’s happening with Ebola in Africa has been no different.

A 1967 outbreak in Germany and Yugoslavia of Marburg hemorrhagic fever — a disease similar to Ebola — had a 23 percent fatality rate. Compare that with an 86 percent rate for cases across sub-Saharan Africa in the years since. The difference is that Germany and Yugoslavia had functioning health systems and the resources to treat patients effectively. The West African countries coping with Ebola today have neither.

With a strong public health response led by the United Nations, the World Health Organization, the United States, Britain, France and other wealthy nations, the virus could be contained and the fatality rate — which, based on the most conservative estimates, exceeds 50 percent in the present outbreak — would drop dramatically, perhaps to below 20 percent.

We are at a dangerous moment in these three West African countries, all fragile states that have had strong economic growth in recent years after decades of wars and poor governance. It would be scandalous to let this crisis escalate further when we have the knowledge, tools and resources to stop it. Tens of thousands of lives, the future of the region and hard-won economic and health gains for millions hang in the balance.

Vaccines and Global Health: The Week in Review 30 August 2014

Vaccines and Global Health: The Week in Review

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.
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pdf versionA pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_30 August 2014

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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Support:  If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…
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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
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

EBOLA [to 30 August 2014]

EBOLA [to 30 August 2014]

WHO issues roadmap to scale up international response to the Ebola outbreak in West Africa
Statement
28 August 2014
[Full text]
WHO is issuing today a roadmap to guide and coordinate the international response to the outbreak of Ebola virus disease in west Africa.

The aim is to stop ongoing Ebola transmission worldwide within 6–9 months, while rapidly managing the consequences of any further international spread. It also recognizes the need to address, in parallel, the outbreak’s broader socioeconomic impact.

It responds to the urgent need to dramatically scale up the international response. Nearly 40% of the total number of reported cases have occurred within the past three weeks.

The roadmap was informed by comments received from a large number of partners, including health officials in the affected countries, the African Union, development banks, other UN agencies, Médecins Sans Frontières (MSF), and countries providing direct financial support.

It will serve as a framework for updating detailed operational plans. Priority is being given to needs for treatment and management centres, social mobilization, and safe burials. These plans will be based on site-specific data that are being set out in regular situation reports, which will begin this week.

The situation reports map the hotspots and hot zones, present epidemiological data showing how the outbreak is evolving over time, and communicate what is known about the location of treatment facilities and laboratories, together with data needed to support other elements of the roadmap.
The roadmap covers the health dimensions of the international response. These dimensions include key potential bottlenecks requiring international coordination, such as the supply of personal protective equipment, disinfectants, and body bags.
The WHO roadmap will be complemented by the development of a separate UN-wide operational platform that brings in the skills and capacities of other agencies, including assets in the areas of logistics and transportation. The UN-wide platform aims to facilitate the delivery of essential services, such as food and other provisions, water supply and sanitation, and primary health care.

Resource flows to implement the roadmap will be tracked separately, with support from the World Bank.

Ebola response roadmap
WHO
28 August 2014 :: 27 pages pdf: http://apps.who.int/iris/bitstream/10665/131596/1/EbolaResponseRoadmap.pdf?ua=1
[Excerpt from introduction]
GOAL
To stop Ebola transmission in affected countries within 6-9 months and prevent international spread.

CONTEXT
… National authorities in the affected countries have been working with WHO and partners to scale-up control measures. However, the EVD outbreak remains grave and transmission is still increasing in a substantial number of localities, aggravating fragile social, political and economic conditions in the sub-region and posing increasingly serious global health security challenges and risks.

The Ebola response activities to date have generated significant knowledge on the effectiveness and limitations of current approaches, highlighting key areas for course corrections. Clearly, a massively scaled and coordinated international response is needed to support affected and at-risk countries in intensifying response activities and strengthening national capacities. Response activities must be adapted in areas of very intense transmission and particular attention must be given to stopping transmission in capital cities and major ports, thereby facilitating the larger response and relief effort.

This updated and more comprehensive roadmap builds on current, country-specific realities to guide response efforts and align implementation activities across different sectors of government and international partners.

PURPOSE OF DOCUMENT
To assist governments and partners in the revision and resourcing of country-specific operational plans for Ebola response, and the coordination of international support for their full implementation.

OBJECTIVES
1. To achieve full geographic coverage with complementary Ebola response activities in countries with widespread and intense transmission
2. To ensure emergency and immediate application of comprehensive Ebola response interventions in countries with an initial case(s) or with localized transmission
3. To strengthen preparedness of all countries to rapidly detect and respond to an Ebola exposure, especially those sharing land borders with an intense transmission area and those with international transportation hubs

WHO: Global Alert and Response (GAR) – Disease Outbreak News [to 30 August 2014]
http://www.who.int/csr/don/en/
:: Ebola virus disease update – west Africa 28 August 2014
Excerpt
Epidemiology and surveillance
:: The total number of probable and confirmed cases in the current outbreak of Ebola virus disease (EVD) in the four affected countries as reported by the respective Ministries of Health of Guinea, Liberia, Nigeria, and Sierra Leone is 3069, with 1552 deaths.
:: The outbreak continues to accelerate. More than 40% of the total number of cases have occurred within the past 21 days. However, most cases are concentrated in only a few localities.
:: The overall case fatality rate is 52%. It ranges from 42% in Sierra Leone to 66% in Guinea.
:: A separate outbreak of Ebola virus disease, which is not related to the outbreak in West Africa, was laboratory-confirmed on 26 August by the Democratic Republic of Congo (DRC) and is detailed in a separate edition of the Disease Outbreak News.
Health sector response
…WHO does not recommend any travel or trade restrictions be applied except in cases where individuals have been confirmed or are suspected of being infected with EVD or where individuals have had contact with cases of EVD. (Contacts do not include properly-protected health-care workers and laboratory staff.) Temporary recommendations from the Emergency Committee with regard to actions to be taken by countries can be found at:
HR Emergency Committee on Ebola outbreak in west Africa
:: Ebola virus disease – Democratic Republic of Congo 27 August 2014

NIH: Ebola
:: Single animal to human transmission event responsible for 2014 Ebola outbreak
August 29, 2014 — Scientists used advanced genomic sequencing technology to identify a single point of infection from an animal reservoir to a human in the current Ebola outbreak in West Africa. This research has also revealed the dynamics of how the Ebola virus has been transmitted from human to human, and traces how the genetic code of the virus is changing over time to adapt to human hosts. Pardis Sabeti, M.D., Ph.D, a 2009 National Institutes of Health Director’s New Innovator awardee and her team carried out the research…
…Joined by an international team of scientists, Dr. Sabeti used advanced technology to analyze the genetics of the Ebola samples extremely rapidly and with high levels of accuracy. Using this technology, the researchers pinpointed a single late 2013 introduction from an unspecified animal reservoir into humans. Their study showed that the strain responsible for the West African outbreak separated from a closely related strain found in Central Africa as early as 2004, indicating movement from Central to West Africa over the span of a decade. Studying RNA changes occurring over the span of the outbreak suggests that the first human infection of the outbreak was followed by exclusive human to human transmissions….
…While analyzing the genetic makeup of the Ebola samples, Dr. Sabeti and colleagues discovered a number of mutations that arose as the outbreak spread. Some of these mutations, termed nonsynonymous mutations, alter the biological state of the virus and may allow it to continually and rapidly adapt to human immune defenses as the outbreak continues. This feature points to the need for improved methods that will allow for close monitoring of changes in the viral genome and the impact on vaccine targets. Such monitoring, called genomic surveillance, can provide important insights into the biology of how the Ebola virus spreads and evolves. It may also allow scientists to develop improved methods to detect infection, and point the way to new and improved drug and vaccines….
:: NIH to Launch Human Safety Study of Ebola Vaccine Candidate
Trial is First in Series of Accelerated Safety Studies of Ebola Vaccines
August 28, 2014
Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland.

The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.

In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.

Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country….

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Ebola vaccine trials fast-tracked by international consortium
Unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine
GSK Media Release
28 August 2014
Excerpt
A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of a series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in west Africa.

Human trials of this candidate vaccine, being co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline, are to be accelerated with funding from an international consortium in response to the Ebola epidemic…

A £2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID) will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, to start safety tests of the vaccine alongside similar trials in the USA run by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).

The phase 1 trials will begin as soon as they receive ethical and regulatory approvals, which will be considered on an expedited basis. If approvals are granted, the UK research teams could start vaccinating volunteers from mid-September.

The consortium’s funding will also enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, so that if the trials are successful stocks could then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities.
The candidate vaccine is against the Zaire species of Ebola, which is the one circulating in west Africa, and uses a single Ebola virus protein to generate an immune response. As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with Ebola. Pre-clinical research by the NIH and Okairos, a biotechnology company acquired last year by GSK, has indicated that it provides promising protection in non-human primates exposed to Ebola without significant adverse effects….

Full media release: http://www.gsk.com/en-gb/media/press-releases/2014/ebola-vaccine-trials-fast-tracked-by-international-consortium/

POLIO [to 30 August 2014]

POLIO [to 30 August 2014]
GPEI Update: Polio this week – As of 27 August 2014
Global Polio Eradication Initiative
Editor’s Excerpt and text bolding
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: Continued transmission in Kano: wild poliovirus 1 transmission continues in a geographically limited area of southern Kano state, Nigeria, indicating pockets where vaccination campaigns and social mobilization are still too weak to assure sufficient coverage during campaigns. Kano is the only state in Nigeria reporting cases of wild poliovirus since April.
:: Protecting west Africa: Even as polio programme staff across west Africa support efforts to control the Ebola outbreak affecting the region, preparations are going ahead for large scale multi-country vaccination campaigns in those countries not affected by Ebola, in mid-September.
Afghanistan
:: Vaccination activities have resumed in parts of Helmand Province, Southern Region, where no vaccination had taken place for 5 months.
Nigeria
:: One new case of WPV1 was reported in the past week. This most recent case, which had onset of paralysis in Sumaila Local Government Area (LGA), southern Kano, on 24 July, is the second to be reported in the LGA this year. Nigeria’s total case count for 2014 is now six. Kano is the only state with cases of WPV since April.
:: One new case of type 2 circulating vaccine-derived poliovirus (cVDPV2) was reported in the past week. The total number of cVDPV2 cases for 2014 is 19. The most recent cVDPV2 case had onset of paralysis on 22 June, also in Kano.
Pakistan
:: Two new WPV1 cases were reported in the past week, one from Khyber Agency in the Federally Administered Tribal Areas (FATA) and one from Karachi in Sindh, bringing the total number of WPV1 cases for 2014 to 117. The FATA case is the most recent WPV1 case in the country, with onset of paralysis on 30 July.

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The Weekly Epidemiological Record (WER) 29 August 2014, vol. 89, 35 (pp. 377–388)
Includes:
:: Assessing and mitigating the risks of outbreaks due to wild poliovirus in polio-free African countries, 2013–2014
:: Monthly report on dracunculiasis cases, January– July 2014
http://www.who.int/entity/wer/2014/wer8935.pdf?ua=1

EuBiologics and IVI announce OCV Milestones

Media Release: Major Milestones for Development of Korea’s First Cholera Vaccine for the World’s Poor
-Global Access Agreement between EuBiologics Co., Ltd. and International Vaccine Institute
– Investments by Global Health Investment Fund I, LLC (GHIF) and domestic investors to EuBiologics
– Milestones pave the way to make an oral cholera vaccine available for developing countries
Excerpt
SEOUL, KOREA – EuBiologics Co., Ltd. (EuBiologics) and the International Vaccine Institute (IVI) announced today that major milestones have been met in their collaborative efforts to develop an oral cholera vaccine (OCV) for use in developing countries. EuBiologics has entered into a Global Access Agreement with IVI to ensure that the cholera vaccine will be made available and accessible at an affordable price for the public sector. Furthermore, Global Health Investment Fund I, LLC (GHIF), a new $108 million USD fund developed by the Bill & Melinda Gates Foundation, Lion’s Head Global Partners and JPMorgan Chase & Co., has committed 2.5 million USD of equity capital and made a 2.5 million USD loan to support EuBiologics in the development and production of the OCV. In addition, Korea-Seoul Life Science Fund (KSLSF) and Korea Investment Global Frontier Fund (KIGFF) have each invested 1.25 million USD of equity capital alongside the GHIF in this financing.

“We are thankful to receive the OCV technology from IVI and are very much delighted to have an opportunity to work with GHIF,” said Mr. Yeong-Ok Baik, CEO of EuBiologics, “We are confident that our vaccine, Euvichol will achieve WHO prequalification with IVI’s support and assistance. We are pleased to supply Euvichol worldwide as per the Global Access Agreement made with IVI, and we are committed to contribute to global efforts to prevent and control cholera in poor communities around the world.”

The OCV was specifically developed for use in developing countries through a public-private partnership led by IVI with support from the Republic of Korea, Sweden, and the Bill & Melinda Gates Foundation. The partnership initially involved Shantha Biotechnics (part of the Sanofi group) in Hyderabad, India; Vabiotech, a state-owned vaccine manufacturer in Hanoi, Vietnam; and the University of Gothenburg in Sweden. IVI transferred the OCV production technology to Shantha, and the vaccine, licensed as Shancholin India, was prequalified by the World Health Organization (WHO) in September 2011.

“Through a phase III clinical trial in Kolkata, India, IVI has shown that the vaccine provides sustained protection against cholera at an efficacy of 65% for at least five years, the longest duration of protection conferred by an oral cholera vaccine to date,” said Dr. Thomas F. Wierzba, Deputy Director General for IVI’s Development and Delivery, “The vaccine is safe and it clearly works. IVI is gratified to be working with a partner like EuBiologics who share IVI’s mission of discovering, developing and delivering safe, effective and affordable vaccines for developing nations.”…

Aeras announces Phase IIb trial for novel vaccine candidate

Aeras announced the initiation of a large, multi-country Phase IIb clinical trial to evaluate the ability of a novel vaccine candidate to prevent tuberculosis in adults. Aeras and GSK will jointly conduct the double-blind, randomised, placebo-controlled study (ClinicalTrials.gov Identifier: NCT01755598) to evaluate the efficacy, safety and immunogenicity of GSK’s proprietary vaccine candidate M72/AS01E*. The trial will enroll more than 3500 healthy adults, with latent (asymptomatic) TB infection (LTBI), ages 18-50, in TB-endemic sub-Saharan African countries, starting in South Africa. Subjects will be enrolled in 2014 and 2015, with a 36-month follow-up, yielding study results in 2018.
August 28, 2014 – full press release.

CDC/MMWR Watch [to 30 August 2014]

CDC/MMWR Watch [to 30 August 2014]
http://www.cdc.gov/mmwr/mmwr_wk.html

MMWR Weekly – :: August 29, 2014 / Vol. 63 / No. 34
:: National, State, and Selected Local Area Vaccination Coverage Among Children Aged 19–35 Months — United States, 2013
Excerpt
…This report describes national, regional, state, and selected local area vaccination coverage estimates for children born January 2010–May 2012, based on results from the 2013 NIS. In 2013, vaccination coverage achieved the 90% national Healthy People 2020 target* for ≥1 dose of measles, mumps, and rubella vaccine (MMR) (91.9%); ≥3 doses of hepatitis B vaccine (HepB) (90.8%); ≥3 doses of poliovirus vaccine (92.7%); and ≥1 dose of varicella vaccine (91.2%).

Coverage was below the Healthy People 2020 targets for ≥4 doses of diphtheria, tetanus, and pertussis vaccine (DTaP) (83.1%; target 90%); ≥4 doses of pneumococcal conjugate vaccine (PCV) (82.0%; target 90%); the full series of Haemophilus influenzae type b vaccine (Hib) (82.0%; target 90%); ≥2 doses of hepatitis A vaccine (HepA) (54.7%; target 85%); rotavirus vaccine (72.6%; target 80%); and the HepB birth dose (74.2%; target 85%).

Coverage remained stable relative to 2012 for all of the vaccinations with Healthy People 2020 objectives except for increases in the HepB birth dose (by 2.6 percentage points) and rotavirus vaccination (by 4.0 percentage points).

The percentage of children who received no vaccinations remained below 1.0% (0.7%). Children living below the federal poverty level had lower vaccination coverage compared with children living at or above the poverty level for many vaccines, with the largest disparities for ≥4 doses of DTaP (by 8.2 percentage points), full series of Hib (by 9.5 percentage points), ≥4 doses of PCV (by 11.6 percentage points), and rotavirus (by 12.6 percentage points). MMR coverage was below 90% for 17 states. Reaching and maintaining high coverage across states and socioeconomic groups is needed to prevent resurgence of vaccine-preventable diseases….

Industry Watch [to 30 August 2014]

Industry Watch [to 30 August 2014]
Selected media releases and other selected content from industry.
:: Pfizer’s Investigational Vaccine Candidate for Clostridium difficile Receives U.S. Food and Drug Administration Fast Track Designation
August 28, 2014
:: GSK commits to improving access to vaccines – Business Day, Kemi Ajumobi
August 29, 2014
GlaxoSmithKline “…has announced that it will freeze the prices of its vaccines for five years for developing countries that graduate from GAVI Alliance support….”

Harris Poll [U.S.]: Over Three-Fourths of Americans Believe Childhood Vaccinations Should be Mandatory

Harris Poll [U.S.]: Over Three-Fourths of Americans Believe Childhood Vaccinations Should be Mandatory
Younger Americans more likely than their elder counterparts to question vaccine safety
Excerpt from media release
NEW YORK, Aug. 26, 2014 /PRNewswire/ — With incidents on the rise for many diseases once considered dangers of the past, the subject of vaccinations has been a frequent topic of conversation in recent days. In fact, strong majorities of U.S. adults favor childhood vaccinations being mandatory for all children (77%), while seven in ten don’t think unvaccinated children should be allowed to attend either public or private schools (69%). What’s more, nine in ten feel it’s important that children be vaccinated (89%) and believe vaccinations should be provided for free to children whose families cannot afford them (90%).
These are some of the results of The Harris Poll® of 2,306 adults surveyed online between July 16 and 21, 2014…

Timely measles vaccination in Tianjin, China: a cross-sectional study of immunization records and mothers

BMC Public Health
(Accessed 30 August 2014)
http://www.biomedcentral.com/bmcpublichealth/content

Research article
Timely measles vaccination in Tianjin, China: a cross-sectional study of immunization records and mothers
Abram L Wagner, Ying Zhang, JoLynn P Montgomery, Yaxing Ding, Bradley F Carlson and Matthew L Boulton
Author Affiliations
BMC Public Health 2014, 14:888 doi:10.1186/1471-2458-14-888
Published: 29 August 2014
Abstract (provisional)
Background
Measles is a highly infectious disease, and timely administration of two doses of vaccine can ensure adequate protection against measles for all ages in a population. This study aims to estimate the proportion of children aged 8 months to 6 years vaccinated on time with measles-containing vaccines (MCV) and vaccinated during the 2008 and 2010 measles supplementary immunization activities. This study also characterizes differences in mean age at vaccination and vaccination timeliness by demographic characteristics, and describes maternal knowledge of measles vaccination.
Methods
Immunization records were selected from a convenience sample of immunization clinics in Tianjin, China. From the records, overall vaccination coverage and timely vaccination coverage were calculated for different demographic groups. Mothers were also interviewed at these clinics to ascertain their knowledge of measles vaccination.
Results
Within the 329 immunization clinic records, child’s birth year and district of residence were found to be significant predictors of different measures of vaccine timeliness. Children born in 2009 had a lower age at MCV dose 2 administration (17.96 months) than children born in 2005 (22.00 months). Children living in Hebei, a district in the urban center of Tianjin were less likely to be vaccinated late than children living in districts further from the urban core of Tianjin. From the 31 interviews with mothers, most women believed that timely vaccination was very important and more than one dose was very necessary; most did not know whether their child needed another dose.
Conclusions
When reviewing MCV coverage in China, most studies do not consider timeliness. However, this study shows that overall vaccination coverage can greatly overestimate vaccination coverage within certain segments of the population, such as young infants.

The prevalence of underweight, overweight, obesity and associated risk factors among school-going adolescents in seven African countries

BMC Public Health
(Accessed 30 August 2014)
http://www.biomedcentral.com/bmcpublichealth/content

Research article
The prevalence of underweight, overweight, obesity and associated risk factors among school-going adolescents in seven African countries
Taru Manyanga, Hesham El-Sayed, David Teye Doku and Jason R Randall
Author Affiliations
BMC Public Health 2014, 14:887 doi:10.1186/1471-2458-14-887
Published: 28 August 2014
Abstract (provisional)
Background
The burden caused by the coexistence of obesity and underweight in Low and Middle Income Countries is a challenge to public health. While prevalence of underweight among youth has been well documented in these countries, overweight, obesity and their associated risk factors are not well understood unlike in high income countries.
Methods
Cross-sectional data from the Global School-based Student Health Survey (GSHS) conducted in seven African countries were used for this study. The survey used a clustered design to obtain a representative sample (n = 23496) from randomly selected schools. 53.6% of the sample was male, and participants ranged in age from 11-17 years old. Body Mass Index (BMI) was calculated using age and sex adjusted self-reported heights and weights. Classification of weight status was based on the 2007 World Health Organization growth charts (BMI-for-age and sex). Multivariable Logistic Regression reporting Odds Ratios was used to assess potential risk factors on BMI, adjusting for age, sex, and country. Statistical analyses were performed with Stata with an alpha of 0.05 and reporting 95% confidence intervals.
Results
Unadjusted rates of being underweight varied from 12.6% (Egypt) to 31.9% (Djibouti), while being overweight ranged from 8.7% (Ghana) to 31.4% (Egypt). Obesity rates ranged from 0.6% (Benin) to 9.3% (Egypt). Females had a higher overweight prevalence for every age group in five of the countries, exceptions being Egypt and Malawi. Overall, being overweight was more prevalent among younger (<=12) adolescents and decreased with age. Males had a higher prevalence of being underweight than females for every country. There was a tendency for the prevalence of being underweight to increase starting in the early teens and decrease between ages 15 and 16. Most of the potential risk factors captured by the GSHS were not significantly associated with weight status.
Conclusions
The prevalence of both overweight and underweight was relatively high, demonstrating the existence of the double burden of malnutrition among adolescents in developing countries. Several factors were not associated with weight status suggesting the need to explore other potential risk factors for overweight and underweight, including genetic factors and socioeconomic status.

Including mental health among the new sustainable development goals

British Medical Journal
23 August 2014(vol 349, issue 7972)
http://www.bmj.com/content/349/7972

Editorials
Including mental health among the new sustainable development goals
BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g5189 (Published 20 August 2014) Cite this as: BMJ 2014;349:g5189
Graham Thornicroft, professor 1, Vikram Patel, professor23
Author affiliations
Excerpt
The United Nations will soon decide what will follow its millennium development goals, which expire in 2015. The case for including mental health among the new sustainable development goals is compelling, both because it cuts across most of the suggested new goals and because of the unmet needs of the 450 million people in the world with mental illness.1

Poorer mental health is a precursor to reduced resilience to conflict. It’s also a barrier to achieving the suggested goal of promoting peaceful and inclusive societies for sustainable development, providing access to justice for all, and building effective, accountable, and inclusive institutions at all levels. In addition, conflict is itself a risk factor for adverse mental health consequences,2 and in the aftermath of conflict the needs of vulnerable groups such as people with mental illness are often accorded the lowest priority (as documented by photojournalist Robin Hammond, http://www.robinhammond.co.uk).

The improvement of mental health systems will also have a decisive role in making cities and human settlements inclusive, safe, resilient, and sustainable, and this is especially important given the global trend towards urbanisation with its associated risk factors for mental illness. Moreover, individual adversity—for example, complications of pregnancy, such as miscarriage—is associated with worse mental health.

A third suggested goal is to promote sustained, inclusive, and sustainable economic growth, full and productive employment, and decent …

Guidance on priority setting in health care (GPS-Health): the inclusion of equity criteria not captured by cost-effectiveness analysis

Cost Effectiveness and Resource Allocation
(Accessed 30 August 2014)
http://www.resource-allocation.com/

Methodology
Guidance on priority setting in health care (GPS-Health): the inclusion of equity criteria not captured by cost-effectiveness analysis
Ole F Norheim, Rob Baltussen, Mira Johri, Dan Chisholm, Erik Nord, DanW Brock, Per Carlsson, Richard Cookson, Norman Daniels, Marion Danis, Marc Fleurbaey, Kjell A Johansson, Lydia Kapiriri, Peter Littlejohns, Thomas Mbeeli, Krishna D Rao, Tessa Tan-Torres Edejer and Dan Wikler
Author Affiliations
Cost Effectiveness and Resource Allocation 2014, 12:18 doi:10.1186/1478-7547-12-18
Published: 29 August 2014
Abstract (provisional)
This Guidance for Priority Setting in Health Care (GPS-Health), initiated by the World Health Organization, offers a comprehensive map of equity criteria that are relevant to health care priority setting and should be considered in addition to cost-effectiveness analysis. The guidance, in the form of a checklist, is especially targeted at decision makers who set priorities at national and sub-national levels, and those who interpret findings from cost-effectiveness analysis. It is also targeted at researchers conducting cost-effectiveness analysis to improve reporting of their results in the light of these other criteria. The guidance was develop through a series of expert consultation meetings and involved three steps: i) methods and normative concepts were identified through a systematic review; ii) the review findings were critically assessed in the expert consultation meetings which resulted in a draft checklist of normative criteria; iii) the checklist was validated though an extensive hearing process with input from a range of relevant stakeholders. The GPS-Health incorporates criteria related to the disease an intervention targets (severity of disease, capacity to benefit, and past health loss); characteristics of social groups an intervention targets (socioeconomic status, area of living, gender; race, ethnicity, religion and sexual orientation); and non-health consequences of an intervention (financial protection, economic productivity, and care for others).

The Lancet – Aug 30, 2014

The Lancet
Aug 30, 2014 Volume 384 Number 9945 p715 – 828
http://www.thelancet.com/journals/lancet/issue/current

Comment
Africa’s child demographics and the world’s future
Jeffrey O’Malley, Tessa Wardlaw, Danzhen You, Lucia Hug, David Anthony
Preview
In 1950, only about a tenth of the world’s children lived in Africa.1 Within 50 years, that proportion almost doubled, and it is set to double again by the middle of the 21st century, leaving Africa with nearly a billion children younger than 18 years by 2050—37% of the worldwide total. By the end of the century, based on present trends, almost half of all children will live in Africa.

Global, regional, and national prevalence of overweight and obesity in children and adults during 1980—2013: a systematic analysis for the Global Burden of Disease Study 2013
Marie Ng PhD a, et al
Summary
Background
In 2010, overweight and obesity were estimated to cause 3•4 million deaths, 3•9% of years of life lost, and 3•8% of disability-adjusted life-years (DALYs) worldwide. The rise in obesity has led to widespread calls for regular monitoring of changes in overweight and obesity prevalence in all populations. Comparable, up-to-date information about levels and trends is essential to quantify population health effects and to prompt decision makers to prioritise action. We estimate the global, regional, and national prevalence of overweight and obesity in children and adults during 1980—2013.
Methods
We systematically identified surveys, reports, and published studies (n=1769) that included data for height and weight, both through physical measurements and self-reports. We used mixed effects linear regression to correct for bias in self-reports. We obtained data for prevalence of obesity and overweight by age, sex, country, and year (n=19 244) with a spatiotemporal Gaussian process regression model to estimate prevalence with 95% uncertainty intervals (UIs).
Findings
Worldwide, the proportion of adults with a body-mass index (BMI) of 25 kg/m2 or greater increased between 1980 and 2013 from 28•8% (95% UI 28•4—29•3) to 36•9% (36•3—37•4) in men, and from 29•8% (29•3—30•2) to 38•0% (37•5—38•5) in women. Prevalence has increased substantially in children and adolescents in developed countries; 23•8% (22•9—24•7) of boys and 22•6% (21•7—23•6) of girls were overweight or obese in 2013. The prevalence of overweight and obesity has also increased in children and adolescents in developing countries, from 8•1% (7•7—8•6) to 12•9% (12•3—13•5) in 2013 for boys and from 8•4% (8•1—8•8) to 13•4% (13•0—13•9) in girls. In adults, estimated prevalence of obesity exceeded 50% in men in Tonga and in women in Kuwait, Kiribati, Federated States of Micronesia, Libya, Qatar, Tonga, and Samoa. Since 2006, the increase in adult obesity in developed countries has slowed down.
Interpretation
Because of the established health risks and substantial increases in prevalence, obesity has become a major global health challenge. Not only is obesity increasing, but no national success stories have been reported in the past 33 years. Urgent global action and leadership is needed to help countries to more effectively intervene.
Funding
Bill & Melinda Gates Foundation.

The Lancet Global Health – Sep 2014

The Lancet Global Health
Sep 2014 Volume 2 Number 9 e488 – 549
http://www.thelancet.com/journals/langlo/issue/current

Comment
Excess female mortality in infants and children
Shams El Arifeen
Preview |
The sex ratio of mortality in children younger than 5 years (under-5s) has always been regarded as an important indicator for child health and survival, especially in the context of sex preference and discrimination in many cultures such as those in south Asia.1 However, the effective use of this indicator to improve child health and survival has been constrained by the absence of a clear understanding of what the ideal ratio should be.

National, regional, and global sex ratios of infant, child, and under-5 mortality and identification of countries with outlying ratios: a systematic assessment
Leontine Alkema, Fengqing Chao, Danzhen You, Jon Pedersen, Cheryl C Sawyer

Cost-effectiveness of HIV prevention for high-risk groups at scale: an economic evaluation of the Avahan programme in south India
Anna Vassall, Michael Pickles, Sudhashree Chandrashekar, Marie-Claude Boily, Govindraj Shetty, Lorna Guinness, Catherine M Lowndes, Janet Bradley, Stephen Moses, Michel Alary, Charme India Group , Peter Vickerman

Effect of preventive and curative interventions on hepatitis C virus transmission in Egypt (ANRS 1211): a modelling study
Romulus Breban, Naglaa Arafa, Sandrine Leroy, Aya Mostafa, Iman Bakr, Laura Tondeur, Mohamed Abdel-Hamid, Wahid Doss, Gamal Esmat, Mostafa K Mohamed, Arnaud Fontanet

The Lancet Infectious Diseases – Sep 2014

The Lancet Infectious Diseases
Sep 2014 Volume 14 Number 9 p779 – 898
http://www.thelancet.com/journals/laninf/issue/current

Editorial
Ebola in west Africa
The Lancet Infectious Diseases

Comment
Pneumococcal conjugate vaccination: correlates of protection
Angel Vila-Corcoles, Olga Ochoa-Gondar
Preview |
Infections caused by Streptococcus pneumoniae are a major health problem worldwide. Susceptibility to pneumococcal infections varies with age, and is highest in young infants and older adults. Death from pneumococcus is the most common vaccine-preventable illness in infants younger than 5 years, with an estimated 700 000 to 1 million deaths occurring yearly throughout the world in this age group.1

What can rotavirus vaccines teach us about rotavirus?
Jim P Buttery, Carl D Kirkwood
Preview
Suspected and unexpected clinical features of pathogens might only become apparent during clinical trials to test vaccines or after implementation of vaccination programmes. For example, the role of Haemophilus influenzae type b (Hib) in early childhood pneumonia was not evident until findings of a clinical vaccine trial in The Gambia showed that—after 3 years of follow-up—Hib caused more than 20% of radiologically defined pneumonia in infants.1,2 Moreover, the ability of different pneumococcal serotypes, but not meningococcal serogroups, to replace competing strains in nasopharyngeal carriage and invasive disease was only noted after implementation of pneumococcal and group C meningococcal glycoconjugate vaccines.

Islam and polio
Fatima Riaz, Yasir Waheed
Preview
Public health interventions and policies do not have a uniform response worldwide. Medical anthropologists appreciate the role of cultural epidemiology in establishing the community response and, concomitantly, the disease’s fate.1 In the case of polio, which has a viable vaccine, social misconceptions and religious misinterpretations receive the most media attention as the barriers preventing the disease from tipping over into complete eradication.2

Epidemiology of invasive meningococcal disease in the Netherlands, 1960–2012: an analysis of national surveillance data
Merijn W Bijlsma, Vincent Bekker, Matthijs C Brouwer, Lodewijk Spanjaard, Diederik van de Beek, Arie van der Ende

Epidemiology of bacterial meningitis in the USA from 1997 to 2010: a population-based observational study
Rodrigo Lopez Castelblanco, MinJae Lee, Rodrigo Hasbun

Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study
Jorge E Osorio, Ivan D Velez, Cynthia Thomson, Liliana Lopez, Alejandra Jimenez, Aurelia A Haller, Shawn Silengo, Jaclyn Scott, Karen L Boroughs, Janae L Stovall, Betty E Luy, John Arguello, Mark E Beatty, Joseph Santangelo, Gilad S Gordon, Claire Y-H Huang, Dan T Stinchcomb

Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study
Nick J Andrews, Pauline A Waight, Polly Burbidge, Emma Pearce, Lucy Roalfe, Marta Zancolli, Mary Slack, Shamez N Ladhani, Elizabeth Miller, David Goldblatt

Distribution of rotavirus strains and strain-specific effectiveness of the rotavirus vaccine after its introduction: a systematic review and meta-analysis
Eyal Leshem, Ben Lopman, Roger Glass, Jon Gentsch, Krisztián Bányai, Umesh Parashar, Manish Patel

Updating Cost-Effectiveness — The Curious Resilience of the $50,000-per-QALY Threshold

New England Journal of Medicine
August 28, 2014 Vol. 371 No. 9
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Updating Cost-Effectiveness — The Curious Resilience of the $50,000-per-QALY Threshold
Peter J. Neumann, Sc.D., Joshua T. Cohen, Ph.D., and Milton C. Weinstein, Ph.D.
N Engl J Med 2014; 371:796-797August 28, 2014
DOI: 10.1056/NEJMp1405158

For more than two decades, the ratio of $50,000 per quality-adjusted life-year (QALY) gained by using a given health care intervention has played an important if enigmatic role in health policy circles as a benchmark for the value of care. Researchers have summoned this cost-effectiveness ratio in order to champion or denounce particular investments in medical technologies and health programs. Critics, meanwhile, have argued that the ratio is misunderstood and misused.

The fact that the $50,000-per-QALY yardstick has persisted attests to the medical community’s need for a value threshold and to the advantages enjoyed by incumbents. It has endured even as the United States has legislated against the explicit use of cost-per-QALY thresholds, and it has held its own even though common sense might dictate that it should be updated to reflect inflation and economic growth. Like the 4-minute mile in running, which has withstood threats to its relevance (the current record is 3:43, and the sport long ago switched championship races to 1500 m, the “metric mile”), $50,000-per-QALY retains its place in the imagination. As the United States debates anew how much to spend on medical care — a question that has been highlighted by high-priced drugs for cancer and hepatitis C — it is useful to reexamine what the ratio means, why it persists, and how it might be applied more reasonably to inform resource-prioritization discussions in today’s health care and economic climate.

The $50,000-per-QALY ratio has murky origins. It is often attributed to the U.S. decision to mandate Medicare coverage for patients with end-stage renal disease (ESRD) in the 1970s: because the cost-effectiveness ratio for dialysis at the time was roughly $50,000 per QALY, the government’s decision arguably endorsed that cutoff point implicitly.1 However, the link to dialysis is inexact — and even something of an urban legend, given that the cost-effectiveness ratio for dialysis was probably more like $25,000 to $30,000 per QALY, the ESRD decision was controversial, and even at the time Medicare was covering some treatments costing more than $50,000 per QALY.1
Furthermore, the $50,000-per-QALY standard did not gain widespread use until the mid-1990s, long after the ESRD decision, and seems to stem more from a series of articles that proposed rough ranges ($20,000 to $100,000 per QALY) for defining cost-effective care. The field settled on $50,000 per QALY as an arbitrary but convenient round number, after several prominent cost-effectiveness analyses in the mid-1990s referenced that threshold and helped to congeal it into conventional wisdom.1 Researchers continue to cite the threshold regularly, although in recent years more have been referencing $100,000 per QALY (see table Cost-Effectiveness Thresholds Referenced by Authors of U.S.-Based Cost-Utility Analyses, 1990–2012.).

A society’s cost-effectiveness threshold — which indicates its willingness to pay for improvements in health — can also be inferred from its budget for health care expenditures. In theory, if all interventions could be measured in similar terms and ranked by the favorability of their incremental cost-effectiveness ratios, decision makers with a fixed budget could maximize health gains by choosing interventions with the lowest (most favorable) ratios and working their way down the list until the available resources were consumed. The cost-effectiveness of the last (least favorable) technology covered would represent society’s willingness-to-pay threshold — the highest price society is willing to pay for health gains.

In practice, cost-effectiveness information is spotty, and U.S. decision makers do not face rigidly fixed budgets. Instead, thresholds are used as rough guides to help determine whether particular investments constitute reasonable value.1 Referencing a $50,000-per-QALY threshold has in practice implied adding new “favorable” interventions (with ratios below $50,000 per QALY), but without displacing any “unfavorable” interventions (with ratios of $50,000 per QALY or above).

Researchers have attempted in various ways to deduce what constitutes a reasonable threshold on the basis of economic theory or empirical estimates.1 Some economists as well as the World Health Organization have argued, on the basis of plausible assumptions about people’s values and attitudes toward risk, for a threshold of two to three times the per capita annual income, which would imply a U.S. threshold of $110,000 to $160,000 per QALY today (given that the per capita income is roughly $54,000). Others have inferred a threshold of $200,000 to $300,000 per QALY on the basis of increases in health care spending over time and the health gains that have been associated with those increases, surveys that ask people how much they would be willing to pay for health gains, or the trade-offs that people make in the workplace between pay and safety risks.2,3

All this research suggests that $50,000 per QALY is too low, although in truth it is impossible to find a single threshold to represent society’s willingness to pay for QALYs gained, because different approaches yield different values, each of which is based on different assumptions, inferences, and contexts. Searching for a single benchmark is at best a quixotic exercise because there is no threshold that is appropriate in all decision contexts.4 In principle, the threshold should depend on the budget available to a decision maker and the costs and benefits of alternative uses of that budget. In the United States, no single decision maker knows the opportunity costs of alternative health investments and issues health care decisions under a single budget.4 Moreover, U.S. policymakers, who are already averse to explicit rationing, would balk at such a rigid exercise.

Still, we face a powerful need to assess comparative value. The effective but costly hepatitis C drug sofosbuvir (Sovaldi, Gilead Sciences) is only the most recent example to remind us that society cannot avoid difficult trade-offs in choosing among health-improving technologies. Despite its problems, the threshold is a useful tool for organizing evidence and informing decisions. It should, however, be used with greater thoughtfulness and consistency. For example, it is useful to know that sofosbuvir may in fact be cost-effective in certain populations according to traditional cost-per-QALY thresholds, but its widespread use at its current price raises critical questions about its affordability and about what services will not be provided in order to pay for it.

Rather than settling on a single threshold, we believe it would be preferable to use multiple thresholds, ideally ones based on the available resources for the relevant decision maker and possible alternative uses of those resources. For example, decision makers in resource-poor settings would have a more stringent (lower) ceiling.
Given the evidence suggesting that $50,000 per QALY is too low in the United States, it might best be thought of as an implied lower boundary.4 Instead, we would recommend that analysts use $50,000, $100,000, and $200,000 per QALY. If one had to select a single threshold outside the context of an explicit resource constraint or opportunity cost, we suggest using either $100,000 or $150,000.

Invoking thresholds, however, means acknowledging limits — and thus in some cases displacing currently provided interventions that have cost-effectiveness ratios exceeding the threshold. It also suggests that more of our spending should focus on underutilized interventions with ratios below the threshold; substituting more cost-effective interventions for less cost-effective ones could improve health outcomes and save money.5 Finally, much more work is needed to elucidate the comparative effectiveness and cost-effectiveness of existing care and to establish systemwide incentives to encourage cost-conscious decisions.

The Immune System in Children with Malnutrition—A Systematic Review

PLoS One
[Accessed 30 August 2014]
http://www.plosone.org/

Research Article
The Immune System in Children with Malnutrition—A Systematic Review
Maren Johanne Heilskov Rytter, Lilian Kolte, André Briend, Henrik Friis, Vibeke Brix Christensen
Published: August 25, 2014
DOI: 10.1371/journal.pone.0105017
Abstract
Background
Malnourished children have increased risk of dying, with most deaths caused by infectious diseases. One mechanism behind this may be impaired immune function. However, this immune deficiency of malnutrition has not previously been systematically reviewed.
Objectives
To review the scientific literature about immune function in children with malnutrition.
Methods
A systematic literature search was done in PubMed, and additional articles identified in reference lists and by correspondence with experts in the field. The inclusion criteria were studies investigating immune parameters in children aged 1–60 months, in relation to malnutrition, defined as wasting, underweight, stunting, or oedematous malnutrition.
Results
The literature search yielded 3402 articles, of which 245 met the inclusion criteria. Most were published between 1970 and 1990, and only 33 after 2003. Malnutrition is associated with impaired gut-barrier function, reduced exocrine secretion of protective substances, and low levels of plasma complement. Lymphatic tissue, particularly the thymus, undergoes atrophy, and delayed-type hypersensitivity responses are reduced. Levels of antibodies produced after vaccination are reduced in severely malnourished children, but intact in moderate malnutrition. Cytokine patterns are skewed towards a Th2-response. Other immune parameters seem intact or elevated: leukocyte and lymphocyte counts are unaffected, and levels of immunoglobulins, particularly immunoglobulin A, are high. The acute phase response appears intact, and sometimes present in the absence of clinical infection. Limitations to the studies include their observational and often cross-sectional design and frequent confounding by infections in the children studied.
Conclusion
The immunological alterations associated with malnutrition in children may contribute to increased mortality. However, the underlying mechanisms are still inadequately understood, as well as why different types of malnutrition are associated with different immunological alterations. Better designed prospective studies are needed, based on current understanding of immunology and with state-of-the-art methods.

A Scenario-Based Evaluation of the Middle East Respiratory Syndrome Coronavirus and the Hajj

Risk Analysis
August 2014 Volume 34, Issue 8 Pages 1359–1579
http://onlinelibrary.wiley.com/doi/10.1111/risa.2014.34.issue-8/issuetoc

Original Research Article
A Scenario-Based Evaluation of the Middle East Respiratory Syndrome Coronavirus and the Hajj
Lauren M. Gardner1,2,*, David Rey1, Anita E. Heywood3, Renin Toms3, James Wood3, S. Travis Waller1,2 andC. Raina MacIntyre3
Article first published online: 14 JUL 2014
DOI: 10.1111/risa.12253
Abstract
Between April 2012 and June 2014, 820 laboratory-confirmed cases of the Middle East respiratory syndrome coronavirus (MERS-CoV) have been reported in the Arabian Peninsula, Europe, North Africa, Southeast Asia, the Middle East, and the United States. The observed epidemiology is different to SARS, which showed a classic epidemic curve and was over in eight months. The much longer persistence of MERS-CoV in the population, with a lower reproductive number, some evidence of human-to-human transmission but an otherwise sporadic pattern, is difficult to explain. Using available epidemiological data, we implemented mathematical models to explore the transmission dynamics of MERS-CoV in the context of mass gatherings such as the Hajj pilgrimage, and found a discrepancy between the observed and expected epidemiology. The fact that no epidemic occurred in returning Hajj pilgrims in either 2012 or 2013 contradicts the long persistence of the virus in human populations. The explanations for this discrepancy include an ongoing, repeated nonhuman/sporadic source, a large proportion of undetected or unreported human-to-human cases, or a combination of the two. Furthermore, MERS-CoV is occurring in a region that is a major global transport hub and hosts significant mass gatherings, making it imperative to understand the source and means of the yet unexplained and puzzling ongoing persistence of the virus in the human population.

Global vaccine supply: The increasing role of manufacturers from middle income countries

Vaccine
Volume 32, Issue 41, Pages 5259-5370 (15 September 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/41

Global vaccine supply. The increasing role of manufacturers from middle income countries
Pages 5259-5265
Donald P. Francis, Yu-Ping Du, Alexander R. Precioso
Abstract
Hallmarks in the remarkable evolution of vaccines and their application include the eradication of smallpox, the development and delivery of the early childhood vaccines and the emergence of recombinant vaccines initiated by the hepatitis B vaccine. Now we enter a most exciting era as vaccines are increasingly produced and delivered in less developed countries. The results are dramatic decreases in childhood morbidity and mortality around the world.

Experiences with provider and parental attitudes and practices regarding the administration of multiple injections during infant vaccination visits: Lessons for vaccine introduction

Vaccine
Volume 32, Issue 41, Pages 5259-5370 (15 September 2014)
http://www.sciencedirect.com/science/journal/0264410X/32/41

Experiences with provider and parental attitudes and practices regarding the administration of multiple injections during infant vaccination visits: Lessons for vaccine introduction
Original Research Article
Pages 5301-5310
Aaron S. Wallace, Carsten Mantel, Gill Mayers, Osman Mansoor, Jacqueline S. Gindler, Terri B. Hyde
Abstract
Introduction
An increasing proportion of childhood immunization visits include administration of multiple injections. Future introduction of vaccines to protect against multiple diseases will further increase the number of injections at routine immunization childhood visits, particularly in developing countries that are still scaling up introductions. Parental and healthcare provider attitudes toward multiple injections may affect acceptance of recommended vaccines, and understanding these attitudes may help to inform critical decisions about vaccine introduction.
Methods
We conducted a systematic review of the literature to examine factors underlying reported parental and healthcare provider concerns and practices related to administration of multiple injections during childhood vaccination visits.
Results
Forty-four articles were identified; 42 (95%) were from high income countries, including 27 (61%) from the USA. Providers and parents report concerns about multiple injections, which tend to increase with increasing numbers of injections. Common parental and provider concerns included apprehension about the pain experienced by the child, worry about potential side effects, and uncertainty about vaccine effectiveness. Multiple studies reported that a positive provider recommendation to the parent and a high level of concern about the severity of the target disease were significantly associated with parental acceptance of all injections. Providers often significantly overestimated parental concerns about multiple injections.
Discussion
Providers may play a critical role in the decision for a child to receive all recommended injections. Their overestimation of parental concerns may lead them to postpone recommended vaccinations, which may result in extra visits and delayed vaccination. More research is needed on interventions to overcome provider and parental concern about multiple injections, particularly in developing countries.

From Google Scholar+ [to 30 August 2014]

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

Epidemiology and Infection
Volume 142 – Issue 10 – October 2014
http://journals.cambridge.org/action/displayIssue?jid=HYG&tab=currentissue
FirstView Articles Published online: 22 August 2014
A probability model for evaluating the bias and precision of influenza vaccine effectiveness estimates from case-control studies.
M. HABER, Q. AN, I. M. FOPPA, D. K. SHAY, J. M. FERDINANDS and W. A. ORENSTEIN
DOI: http://dx.doi.org/10.1017/S0950268814002179
SUMMARY
As influenza vaccination is now widely recommended, randomized clinical trials are no longer ethical in many populations. Therefore, observational studies on patients seeking medical care for acute respiratory illnesses (ARIs) are a popular option for estimating influenza vaccine effectiveness (VE). We developed a probability model for evaluating and comparing bias and precision of estimates of VE against symptomatic influenza from two commonly used case-control study designs: the test-negative design and the traditional case-control design. We show that when vaccination does not affect the probability of developing non-influenza ARI then VE estimates from test-negative design studies are unbiased even if vaccinees and non-vaccinees have different probabilities of seeking medical care against ARI, as long as the ratio of these probabilities is the same for illnesses resulting from influenza and non-influenza infections. Our numerical results suggest that in general, estimates from the test-negative design have smaller bias compared to estimates from the traditional case-control design as long as the probability of non-influenza ARI is similar among vaccinated and unvaccinated individuals. We did not find consistent differences between the standard errors of the estimates from the two study designs.

Epidemics
Available online 27 August 2014
Seven challenges in Modelling Vaccine Preventable Diseases
C.J.E. Metcalfa, O.N. Bjørnstadc, K. Eamesd, W.J. Edmundsd, S. Funkd, T.D. Hollingsworthe, f, J. Lesslerg, C. Viboudh, B.T. Grenfella, h
Highlights
:: Mathematical models have informed vaccination from the underlying science to program design.
:: This is an exciting time as novel challenges are emerging from changing biology and advancing vaccine technology.
:: Population scale challenges range from modeling immune heterogeneity to dynamics near elimination.
:: Within host challenges include modeling immune memory, evolution of escape, and new vaccine biology.
Abstract
Vaccination has been one of the most successful public health measures since the introduction of basic sanitation. Substantial mortality and morbidity reductions have been achieved via vaccination against many infections, and the list of diseases that are potentially controllable by vaccines is growing steadily. We introduce key challenges for modeling in shaping our understanding and guiding policy decisions related to vaccine preventable diseases.

Clinical Infectious Diseases
Volume 59, Issue suppl 2 Pp. S80-S84
Ending the Global HIV/AIDS Pandemic: The Critical Role of an HIV Vaccine
Anthony S. Fauci, Gregory K. Folkers, and Hilary D. Marston
Author Affiliations
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
Abstract
While the human immunodeficiency virus (HIV)/AIDS pandemic continues, the incidence of HIV infections has fallen because of the deployment of antiretroviral drugs and multiple prevention modalities. To achieve a durable end to the pandemic, a vaccine remains essential. Recent advances in vaccinology offer new promise for an effective HIV vaccine.

Current Gene Therapy
Volume 14, No. 2, 2014
http://benthamscience.com/journal/contents.php?journalID=cgt&issueID=124005
Editorial (Thematic Issue: The Coming of Age of DNA Vaccines)
ANikolai Petrovsky
Affiliation: Director, Department of Diabetes and Endocrinology, Flinders Medical Centre, Adelaide, SA 5042 Australia.
Abstract
Conventional immunization approaches utilize live attenuated pathogens, inactivated organisms, recombinant proteins or polysaccharide antigens to induce protective immunity. Twenty years ago in a major breakthrough it was shown that immune responses could instead be elicited by injecting plasmid DNA encoding relevant vaccine antigens [1-3]. This heralded the start of DNA vaccination. DNA vaccines offer many potential advantages; including speed and simplicity of manufacture. Despite early hype, this technology has yet to yield approved human products although there are already a number of approved veterinary DNA vaccines suggesting human applications are only a matter of time [4]. It should be remembered that monoclonal antibodies took over 2 decades from initial discovery to final successful human application. By these standards DNA vaccine technology is still in its relatively infancy. Hence this special edition on DNA vaccines is timely to examine the state of the art in DNA vaccine technology. It is hoped this collections of papers will help address the perennial question asked on all long journeys, “are we there yet?” These papers convey a sense of the tremendous distance that DNA vaccine technology has come over the 20 years since its initial discovery. In particular, issues of DNA vaccine safety have by and large been satisfactorily addressed, leaving vaccine efficacy as the only real remaining challenge [5]. Despite the passage of time there is still a sense of excitement that surrounds the DNA vaccine field. These papers convey a willingness of those in the field to press on to solve the remaining challenges to bring DNA vaccines to the human market. This augurs well for the eventual success of DNA vaccine technology. A variety of key topics are covered by this collection. The excellent review by Jim Williams describes the state of the art in DNA plasmid design. It highlights just how far plasmid design has been advanced and explores how plasmids can be fine-tuned for maximal protein expression. Kwilas et al., describe a novel delivery approach that uses a jet injector device to deliver the plasmid intramuscularly without the need for a needle. Interestingly this form of administration appears to also enhance plasmid expression and vaccine immunogenicity. Another area where there have been major advances is the area of DNA vaccine adjuvants. Capitani et al. demonstrate that plasmids encoding aggregation-promoting domains act as DNA vaccine adjuvants by triggering frustrated autophagy leading to caspase activation and apoptotic cell death. The induction of cell death is common to traditional vaccine adjuvants including alum and squalene oil emulsions [6], but poses safety risks as excess cell death may trigger unwanted side effects and even autoimmunity in susceptible individuals [7, 8]. No discussion of DNA vaccines would be complete without including electroporation as a method of enhancing plasmid expression. Davtyan et al. describe studies on electroporation settings to maximize delivery of an Alzheimer’s disease DNA vaccine encoding a β-amyloid epitope. Electroporation remains a potent tool for maximizing DNA delivery but with the downsides of inconvenience, cost and discomfort. Finally, Lucyna Cova examines the history of hepatitis B DNA vaccine development, describing the many challenges encountered along the way. This is a story that could easily be repeated for the many other DNA vaccines under development. I trust this collection of papers on current DNA vaccine research will convince the reader that the field of DNA vaccines is not dead, and in fact under the surface vigorous research and development efforts continue towards a key milestone which will be approval of the first human DNA vaccine. Considering the more than 20 years that monoclonal antibody technology had to spend in the wilderness before all their problems were solved and they became the pharmaceutical industry’s biggest success story, DNA vaccines may yet have their time in the sun.

Vaccines and Global Health: The Week in Review is a service of the Center for Vaccines Ethics and Policy (CVEP) which is solely responsible for its content. Support for this service is provided by its governing institutions – Department of Medical Ethics, NYU Medical School; The Wistar Institute Vaccine Center and the Children’s Hospital of Philadelphia Vaccine Education Center. Additional support is provided by the PATH Vaccine Development Program; the International Vaccine Institute (IVI); the Bill & Melinda Gates Foundation; industry resource members Janssen, Pfizer, and Sanofi Pasteur U.S. (list in formation), and the Developing Countries Vaccine Manufacturers Network (DCVMN). Support is also provided by a growing list of individuals who use this membership service to support their roles in public health, clinical practice, government, NGOs and other international institutions, academia and research organizations, and industry.

Vaccines and Global Health: The Week in Review 23 August 2014

Vaccines and Global Health: The Week in Review

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.
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pdf versionA pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_23 August 2014

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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
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

Ebola [to 23 August 2014]

WHO: Global Alert and Response (GAR) – Disease Outbreak News [to 23 August 2014]
http://www.who.int/csr/don/en/
:: Ebola virus disease update – west Africa 22 August 2014
Epidemiology and surveillance
Between 19 and 20 August 2014, a total of 142 new cases of Ebola virus disease (laboratory-confirmed, probable, and suspect cases) as well as 77 deaths were reported from Guinea, Liberia, Nigeria, and Sierra Leone.

Health sector response
Questions have been received in WHO Headquarters about the original proposed budget for the response and the new draft budget, which is being reviewed by partners. The increase in needed resources is based on improved data and understanding of the situation on the ground in the affected countries. The new estimation of costs is derived using a unit-cost model, built for the most intense transmission areas and reflects the average operational costs based on the current situation in the affected countries. The major assumptions for the cost estimates will be announced towards the end of next week.

WHO continues to receive reports of rumoured or suspected cases from countries around the world and systematic verification of these cases is ongoing. Countries are encouraged to continue engaging in active surveillance and preparedness activities. As of today, no new cases have been confirmed outside of Guinea, Liberia, Nigeria, or Sierra Leone.

WHO does not recommend any travel or trade restrictions be applied except in cases where individuals have been confirmed or are suspected of being infected with EVD or where individuals have had contact with cases of EVD. (Contacts do not include properly-protected health-care workers and laboratory staff.) Temporary recommendations from the Emergency Committee with regard to actions to be taken by countries can be found at:
IHR Emergency Committee on Ebola outbreak in west Africa

:: WHO Director-General briefs Geneva UN missions on the Ebola outbreak – 12 August 2014

:: Statement on travel and transport in relation to Ebola virus disease (EVD) outbreak – 18 August 2014

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Ethical considerations for use of unregistered interventions for Ebola virus disease
Report of an advisory panel to WHO
2014 :: 10 pages :: WHO reference number: WHO/HIS/KER/GHE/14.1
Overview
West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation to consider and assess the ethical implications for clinical decision-¬making of use of unregistered interventions that have shown promising results in the laboratory and in animal models but that have not yet been evaluated for safety and efficacy in humans.

Conclusion [full text from report p.7]
In the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to offer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluated for safety and efficacy in humans as potential treatment or prevention.

Ethical, scientific and pragmatic criteria must guide the provision of such interventions. The ethical criteria include transparency about all aspects of care, so that the maximum information is obtained about the effects of the interventions, fairness, promotion of cosmopolitan solidarity, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity, involvement of the community and risk–benefit assessment.

If and when unproven interventions that have not yet been evaluated for safety and efficacy in humans but have shown promising results in the laboratory and in animal models are used to treat patients, those involved have a moral obligation to collect and share all the scientifically relevant data generated, including from treatments provided for “compassionate use”.

Researchers have a moral duty to evaluate these interventions (for treatment or prevention) in clinical trials that are of the best possible design in the current exceptional circumstances of the West African Ebola outbreak, in order to establish the safety and efficacy of the interventions or to provide evidence to stop their use. Continuous evaluation should guide future interventions.

POLIO [to 23 August 2014]

POLIO [to 23 August 2014]

GPEI Update: Polio this week – As of 20 August 2014
Global Polio Eradication Initiative
Editor’s Excerpt and text bolding
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: The Horn of Africa Technical Advisory Group (TAG) met last week to review the current epidemiological situation, the impact of outbreak response and to determine additional strategies needed to rapidly interrupt residual transmission in the region. Plans were developed to increase access to mobile populations, to improve community surveillance and to strengthen campaign quality. Read more in the Horn of Africa section below.
:: China, India and Australia have joined Saudi Arabia in requiring proof of polio vaccination for visa applications for travellers coming from polio endemic and outbreak countries to mitigate the risk of international spread of polio.
:: In Cameroon, genetic sequencing of the recently-reported cases confirms continued wild poliovirus circulation, gaps in surveillance resulting in undetected transmission and geographic expansion to new areas of the country. See ‘central Africa’ section below for further information.
Pakistan
:: Seven new WPV1 cases were reported in the past week, all from Federally Administered Tribal Areas (FATA), from North Waziristan, South Waziristan and Khyber, bringing the total number of WPV1 cases for 2014 to 115. One of the newly-reported cases from North Waziristan is the most recent WPV1 case in the country, with onset of paralysis on 27 July.
Horn of Africa
:: The Horn of Africa TAG met from 12-14 August to review the current epidemiological situation and the impact of the outbreak response and to determine additional strategies needed to rapidly interrupt residual transmission in the region.
:: Strategies were proposed to improve operations and strengthen surveillance including targeted tactics for reaching mobile populations in Somalia and Ethiopia, considering new communication channels and opportunities to reach these groups. The need to sustain the sense of urgency until the outbreak is stopped was highlighted
Middle East
:: In the Middle East, the second phase of the comprehensive outbreak response is being implemented across the region.
:: WHO and UNICEF are committed to working with all organizations and agencies providing humanitarian assistance to Syrians affected by the conflict. This includes vaccination of all children no matter where they are, whether in government or contested areas of the country, or outside Syria.
:: SNIDs will start on 31 August in high-risk governorates of Syria where over the past several SIAs coverage has been lower than in other areas. Technical support is being maximized to these areas.
:: On 6-7 September, there will be a review of the Phase 2 outbreak response in the Middle East so far.
West Africa
:: Polio staff across West Africa are supporting efforts to control the Ebola outbreak affecting the region. The Ebola outbreak will impact the planned multi-country polio campaigns in September in the Ebola affected countries with campaigns in Liberia, Sierra Leone, and Guinea being postponed until the Ebola outbreak is brought under control. Preparations for large scale multi-country campaigns in countries across the rest of West Africa in mid-September are proceeding as planned.

UNICEF Watch [to 23 August 2014]
http://www.unicef.org/media/media_71724.html
Mass Polio Vaccination Campaign Supported by WHO and UNICEF Kicks Off in Iraq
ERBIL/AMMMAN, 11 August 2014 – Iraq has launched a polio immunization campaign aiming to protect over four million children under the age of 5 throughout the country against the crippling disease.