American Journal of Public Health
Volume 107, Issue 1 (January 2017)
http://ajph.aphapublications.org/toc/ajph/current

VACCINES
The Dangerous Curve and The Guardrail: Disease and Vaccination
Robert James Kim-Farley, MD, MPH

AJPH LAW & ETHICS – VACCINES
Parental Refusal of Childhood Vaccines and Medical Neglect Laws
Efthimios Parasidis, Douglas J. Opel
American Journal of Public Health: January 2017, Vol. 107, No. 1: 68–71.
Abstract
Objectives. To examine the relation of vaccine refusal and medical neglect under child welfare laws.
Methods. We used the Westlaw legal database to search court opinions from 1905 to 2016 and identified cases in which vaccine refusal was the sole or a primary reason in a neglect proceeding. We also delineated if religious or philosophical exemptions from required school immunizations were available at the time of adjudication.
Results. Our search yielded 9 cases from 5 states. Most courts (7 of 9) considered vaccine refusal to constitute neglect. In the 4 cases decided in jurisdictions that permitted religious exemptions, courts either found that vaccine refusal did not constitute neglect or considered it neglect only in the absence of a sincere religious objection to vaccination.
Conclusions. Some states have a legal precedent for considering parental vaccine refusal as medical neglect, but this is based on a small number of cases. Each state should clarify whether, under its laws, vaccine refusal constitutes medical neglect.

American Journal of Public Health
Volume 107, Issue 1 (January 2017)
http://ajph.aphapublications.org/toc/ajph/current

AJPH RESEARCH – VACCINES
Trends in Personal Belief Exemption Rates Among Alternative Private Schools: Waldorf, Montessori, and Holistic Kindergartens in California, 2000–2014
Julia M. Brennan, Robert A. Bednarczyk, Jennifer L. Richards, Kristen E. Allen, Gohar J. Warraich, Saad B. Omer
American Journal of Public Health: January 2017, Vol. 107, No. 1: 108–112.
ABSTRACT
Objectives. To evaluate trends in rates of personal belief exemptions (PBEs) to immunization requirements for private kindergartens in California that practice alternative educational methods.
Methods. We used California Department of Public Health data on kindergarten PBE rates from 2000 to 2014 to compare annual average increases in PBE rates between schools.
Results. Alternative schools had an average PBE rate of 8.7%, compared with 2.1% among public schools. Waldorf schools had the highest average PBE rate of 45.1%, which was 19 times higher than in public schools (incidence rate ratio = 19.1; 95% confidence interval = 16.4, 22.2). Montessori and holistic schools had the highest average annual increases in PBE rates, slightly higher than Waldorf schools (Montessori: 8.8%; holistic: 7.1%; Waldorf: 3.6%).
Conclusions. Waldorf schools had exceptionally high average PBE rates, and Montessori and holistic schools had higher annual increases in PBE rates. Children in these schools may be at higher risk for spreading vaccine-preventable diseases if trends are not reversed.

American Journal of Public Health
Volume 107, Issue 1 (January 2017)
http://ajph.aphapublications.org/toc/ajph/current

SYSTEMATIC REVIEWS
Evidence and Health Policy: Using and Regulating Systematic Reviews
Daniel M. Fox
American Journal of Public Health: January 2017, Vol. 107, No. 1: 88–92.

Systematic Review: A Method at Risk for Being Corrupted
Lisa Bero
American Journal of Public Health: January 2017, Vol. 107, No. 1: 93–96.

Systematic Reviews for Policymaking: Muddling Through
Trisha Greenhalgh, Kirsti Malterud
American Journal of Public Health: January 2017, Vol. 107, No. 1: 97–99.

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 7 January 2017)

Research article
Selection of essential medicines for South Africa – an analysis of in-depth interviews with national essential medicines list committee members
The South African (SA) public health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) in the public sector since 1996. To date no studies have reported on the pro…
Velisha Ann Perumal-Pillay and Fatima Suleman
BMC Health Services Research 2017 17:17
Published on: 7 January 2017

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 7 January 2017)

Research article
Outbreak of Middle East respiratory syndrome coronavirus in Saudi Arabia: a retrospective study
The Middle East respiratory syndrome (MERS) is proposed to be a zoonotic disease. Dromedary camels have been implicated due to reports that some confirmed cases were exposed to camels. Risk factors for MERS co…
Fadilah Sfouq Aleanizy, Nahla Mohmed, Fulwah Y. Alqahtani and Rania Ali El Hadi Mohamed
BMC Infectious Diseases 2017 17:23
Published on: 5 January 2017

Research article
Pneumococcal carriage and antibiotic susceptibility patterns from two cross-sectional colonization surveys among children aged <5 years prior to the introduction of 10-valent pneumococcal conjugate vaccine — Kenya, 2009–2010
Pneumococci are spread by persons with nasopharyngeal colonization, a necessary precursor to invasive disease. Pneumococcal conjugate vaccines can prevent colonization with vaccine serotype strains. In 2011, K…
Miwako Kobayashi, Laura M. Conklin, Godfrey Bigogo, Geofrey Jagero, Lee Hampton, Katherine E. Fleming-Dutra, Muthoni Junghae, Maria da Gloria Carvalho, Fabiana Pimenta, Bernard Beall, Thomas Taylor, Kayla F. Laserson, John Vulule, Chris Van Beneden, Lindsay Kim, Daniel R. Feikin…
BMC Infectious Diseases 2017 17:25
Published on: 5 January 2017

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 7 January 2017)

Research article
Characteristics and knowledge synthesis approach for 456 network meta-analyses: a scoping review
Network meta-analysis (NMA) has become a popular method to compare more than two treatments. This scoping review aimed to explore the characteristics and methodological quality of knowledge synthesis approaches underlying the NMA process.
Wasifa Zarin, Areti Angeliki Veroniki, Vera Nincic, Afshin Vafaei, Emily Reynen, Sanober S. Motiwala, Jesmin Antony, Shannon M. Sullivan, Patricia Rios, Caitlin Daly, Joycelyne Ewusie, Maria Petropoulou, Adriani Nikolakopoulou, Anna Chaimani, Georgia Salanti, Sharon E. Straus…
BMC Medicine 2017 15:3
Published on: 5 January 2017

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 7 January 2017)

Study protocol
Sun protection to improve vaccine effectiveness in children in a high ambient ultraviolet radiation and rural environment: an intervention study
Caradee Y. Wright, Patricia N. Albers, Angela Mathee, Zamantimande Kunene, Catherine D’Este, Ashwin Swaminathan and Robyn M. Lucas
BMC Public Health 2017 17:37
Published on: 6 January 2017
Abstract
Background
Vaccination is a mainstay of preventive healthcare, reducing the incidence of serious childhood infections. Ecological studies have demonstrated an inverse association between markers of high ambient ultraviolet (UV) radiation exposure (e.g., sunny season, low latitude of residence) and reduction in the vaccination-associated immune response. Higher sun exposure on the day prior to and spanning the day of vaccination has been associated with a reduced antigen-specific immune response independent of skin pigmentation. The South African Department of Health’s Expanded Programme on Immunisation provides free vaccinations in government primary health care clinics. In some areas, these clinics may have only a small waiting room and patients wait outside in full sun conditions. In rural areas, patients may walk several kilometres to and from the clinic. We hypothesised that providing sun protection advice and equipment to mothers of children (from 18 months) who were waiting to be vaccinated would result in a more robust immune response for those vaccinated.
Methods
We conducted an intervention study among 100 children receiving the booster measles vaccination. We randomised clinics to receive (or not) sun protection advice and equipment. At each clinic we recorded basic demographic data on the child and mother/carer participants, their sun exposure patterns, and the acceptability and uptake of the provided sun protection. At 3–4 weeks post-vaccination, we measured measles IgG levels in all children.
Discussion
This is the first intervention study to assess the effect of sun protection measures on vaccine effectiveness in a rural, real-world setting. The novel design and rural setting of the study can contribute much needed evidence to better understand sun exposure and protection, as well as factors determining vaccine effectiveness in rural Africa, and inform the design of immunisation programmes. (TRN PACTCR201611001881114, 24 November 2016, retrospective registration)

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 7 January 2017)

Research article
Will they lead by example? Assessment of vaccination rates and attitudes to human papilloma virus in millennial medical students
Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. It is also well established that HPV viruses are responsible for a variety of cancers. Little is known about t…
Nelia M. Afonso, Maurice J. Kavanagh, Stephanie M. Swanberg, Jeanne M. Schulte, Tracy Wunderlich and Victoria C. Lucia
BMC Public Health 2017 17:35
Published on: 6 January 2017

Bulletin of the World Health Organization
Volume 95, Number 1, January 2017, 1-84
http://www.who.int/bulletin/volumes/94/11/en/

EDITORIALS
Working as one UN to address the root environmental causes of ill health
Margaret Chan, Erik Solheim & Petteri Taalas
Bulletin of the World Health Organization 2017;95:2. doi: http://dx.doi.org/10.2471/BLT.16.189225
There are many compelling reasons why we need to clean up the global environment. One of the most pressing is that a polluted environment is a deadly one. Every year, almost 12.6 million people die from diseases associated with environmental hazards, such as air, water or soil pollution, and climate change.1 That is one in four deaths worldwide.1

We now know that the single greatest environmental risk to human health is through our most basic need – the air that we breathe.1 For years, governments have struggled to improve access to energy so they can promote economic development. But the largely unsustainable energy path that the world has followed has come at an unacceptable cost. Air pollution, overwhelmingly resulting from energy production and use, causes heart and lung diseases and cancer, resulting in approximately 6.5 million deaths each year.2

The energy sources that cause the release of deadly air pollutants, such as black carbon, also release greenhouse gases, including methane and carbon dioxide. Together, these drive climate change, which threatens to undermine all of the environmental conditions on which human lives depend – food, water, and shelter.3

By 2050, 66% of the world’s population will live in urban areas, which are often characterized by pollution as well as heavy traffic, poor housing, limited access to water and sanitation services and other health risks.4

Environmental risks to health, like many of the challenges facing our world, are too complex and interconnected to be dealt with by simplistic, short-term solutions or by individual actors. That’s why the 2030 agenda for sustainable development, adopted by all countries, is so important. This, the world’s first ever global development plan, offers a unique opportunity for coherent, long-term action by all of society for all of society.5

Many governments are now bringing several ministries and departments together, for example linking up environment, climate and health sectors, to take joint action. We saw this recently at the Conference of the Parties to the United Nations Framework Convention on Climate Change when ministers of health and environment answered a call by the Government of Morocco to sign the Marrakech Ministerial Declaration on Health, Environment and Climate Change.6 The declaration recognizes that there is currently no global mechanism to bring the environment and health sectors together to work on saving lives and protecting the planet, and calls on the relevant United Nations (UN) agencies to put a mechanism in place.6

The challenge now is to follow up this declaration with actions.

Simple interventions, such as reducing vehicle emissions and investments in rapid transit systems, will save lives. Benin, Côte d’Ivoire, Ghana, Nigeria and Togo have committed to introduce low sulphur fuels by July 2017. Athens, Madrid, Mexico City and Paris plan to ban diesel vehicles by 2025. Implementing proven interventions to address short-lived climate pollutants could save over 2.4 million lives a year, and reduce global warming by approximately 0.5 C, by 2050.7 In many cases the benefits will more than cover the cost of intervention.
Failure to take into account the health impacts of air pollution and other environmental damages is estimated to amount to a US$ 5.3 trillion dollar subsidy to polluting energy sources.8 Failure to protect populations from environmental risks is not just a human cost, but places an additional strain on health services. Health service-related cost is among the largest financial burdens for governments and individuals.

Just as it is in both the individual and the collective interest of countries and ministries to work together to address complex problems, it is essential for all UN agencies to work more closely together to support them.

The United Nations Environment Programme (UNEP), the World Meteorological Organization (WMO) and the World Health Organization (WHO) are working together to support countries to follow through on the aims of the Marrakech Declaration. We are committed to joining our technical and financial resources behind a single environment and health plan. Air pollution will be our first priority due to the huge health impacts that it causes, as well as its close links with other risks, such as climate change and chemical contamination.

Each of us will bring our wealth of expertise in either climate, health or environment. WMO, through national meteorological agencies and their network of ground and remote-sensing stations, provides the essential data on climate, and air quality conditions, and facilitates the delivery of related weather and climate services. UNEP works with Member States’ Ministries of Environment and other key policy-makers to help prevent and reverse environmental degradation, thereby supporting individuals and communities. WHO, with national Ministries of Health, monitors and assesses health exposures and health impacts, and provides guidance on how to reduce them.

By June 2017 our agencies will have developed a joint plan, seeking wider engagement from other agencies and from the scientific, environment and health communities at large. In the words of the African proverb: “If you want to go fast, go alone. If you want to go far, go together.”

References
Prüss-Ustün A, Wolf J, Corvalán C, Neira M, editors. Preventing disease through healthy environments. A global assessment of the burden of disease from environmental risks. Geneva: World Health Organization; 2016. Available from: http://apps.who.int/iris/bitstream/10665/204585/1/9789241565196_eng.pdf?ua=1 [cited 2016 Dec 5].

Ambient air pollution: A global assessment of exposure and burden of disease. Geneva: World Health Organization; 2016. Available from: http://www.who.int/iris/bitstream/10665/250141/1/9789241511353-eng.pdf?ua=1 [cited 2016 Dec 5].

Reducing global health risks through mitigation of short-lived climate pollutants. Scoping report for policy-makers. Geneva: World Health Organization; 2015. Available from: http://apps.who.int/iris/bitstream/10665/189524/1/9789241565080_eng.pdf?ua=1 [cited 2016 Dec 5].

World urbanization prospects. The 2014 revision. Highlights (ST/ESA/SER.A/352). New York: United Nations; 2014. Available from: https://esa.un.org/unpd/wup/Publications/Files/WUP2014-Highlights.pdf [cited 2016 Dec 5].

Transforming our world: the 2030 agenda for sustainable development. New York: United Nations; 2015.
Marrakech ministerial declaration on health, environment and climate change. In: Conference of the parties to the United Nations framework convention on climate change. (UNFCCC COP22), 15 November 2016. Marrakesh: Morocco; 2016. Available from: http://www.who.int/globalchange/mediacentre/events/Ministerial-declaration-EN.pdf?ua=1 [cited 2016 Dec 5].

Shindell D, Kuylenstierna JC, Vignati E, van Dingenen R, Amann M, Klimont Z, et al. Simultaneously mitigating near-term climate change and improving human health and food security. Science. 2012 Jan 13;335(6065):183–9. http://dx.doi.org/10.1126/science.1210026 pmid: 22246768

Coady D, Parry I, Sears L, Shang B. How large are global energy subsidies? IMF working paper (WP/15/105). Washington: International Monetary Fund; 2015. Available from: https://www.imf.org/external/pubs/ft/wp/2015/wp15105.pdf [cited 2016 Dec 5].

Bulletin of the World Health Organization
Volume 95, Number 1, January 2017, 1-84
http://www.who.int/bulletin/volumes/94/11/en/

RESEARCH
Countries’ response to WHO’s travel recommendations during the 2013–2016 Ebola outbreak
Wendy Rhymer & Rick Speare
http://dx.doi.org/10.2471/BLT.16.171579
Abstract
Objective
To determine how, during the 2013–2016 Ebola outbreak in western Africa, States Parties to the World Health Organization’s (WHO) 2005 International Health Regulations (IHR) followed the IHR’s international travel recommendations.
Methods
In 2015, we used the Google search engine to investigate the 196 States Parties to the 2005 IHR. Information detailing Ebola-related travel regulations or restrictions of each State Party was sourced first from official government websites and then from travel and news websites. When limited, conflicting or no relevant information was found on a government website, an email inquiry was sent to a corresponding embassy in an Anglophone country.
Findings
We collected relevant and non-conflicting data for each of 187 States Parties. Of these, 43 (23.0%) prohibited the entry of foreigners who had recently visited a country with widespread Ebola transmission and another 15 (8.0%) imposed other substantial restrictions on such travellers: the requirement to produce a medical certificate documenting no infection with Ebola (n = 8), mandatory quarantine (n = 6) or other restrictions (n = 1).
Conclusion
In responding to the 2013–2016 Ebola outbreak, countries had variable levels of adoption of the 2005 IHR’s international travel recommendations. We identified 58 (31.0%) States Parties that exceeded or disregarded the recommendations. There is a need for more research to understand and minimize deviations from such recommendations.

Bulletin of the World Health Organization
Volume 95, Number 1, January 2017, 1-84
http://www.who.int/bulletin/volumes/94/11/en/

PERSPECTIVES
Improving health-care quality in resource-poor settings
Bejoy Nambiar, Dougal S Hargreaves, Chelsea Morroni, Michelle Heys, Sonya Crowe, Christina Pagel, Felicity Fitzgerald, Susana Frazao Pinheiro, Delan Devakumar, Sue Mann, Monica Lakhanpaul, Martin Marshall & Tim Colbourn
http://dx.doi.org/10.2471/BLT.16.170803
Excerpt
Elements to consider when improving health-care quality in resource-poor settings:
Systems thinking
Health systems are dynamic complex adaptive systems, where all parts need to be considered. These parts are (i) the inter-relationships between the patient, clinical and nonclinical workers in the health system; (ii) the different levels of the health system ranging from the community to tertiary referral system; and (iii) the required human and material resources and training, supervision and management structures.
Participatory approach
Participatory, grounded and bottom-up approaches involving health-care professionals, patients and communities as well as researchers-in-residence are important to understand health systems. Participation also increases buy-in to quality improvement efforts and enables design and implementation of interventions that are effective in specific contexts, consider sociocultural beliefs and build accountability.
Accountability
The people involved in making health systems work must be accountable to the individuals and local communities the health system is serving. Data for decision-making is important as it can be used to encourage and track quality improvements and, when useful metrics are chosen, can also be a mechanism by which the health system can be held accountable.
Evidence-based
Evidence on what works to improve quality of care in low-resource settings is scarce. We propose an evidence-based approach that supports data harmonization while at the same time maintaining the highest standards of scientific and academic rigor.
Innovative evaluation
Both plausibility and probability evaluation designs should be used as part of a research strategy to rigorously determine whether quality improvement interventions can work and how, why and in what circumstances they work. Using a range of research strategies from theory-based evaluation to cluster randomized controlled trials is important.

Bulletin of the World Health Organization
Volume 95, Number 1, January 2017, 1-84
http://www.who.int/bulletin/volumes/94/11/en/

PERSPECTIVES
Documenting attacks on health workers and facilities in armed conflicts
Preeti Patel, Fawzia Gibson-Fall, Richard Sullivan & Rachel Irwin
http://dx.doi.org/10.2471/BLT.15.168328
[Initial text]
During armed conflicts, international humanitarian law (which regulates the conduct of parties engaged in war) protects health-care workers and health facilities, the wounded and the sick. In the first half of 2016, however, the international medical charity Médecins Sans Frontières (MSF) reported several attacks on health facilities and workers in Afghanistan, the Central African Republic, South Sudan, the Syrian Arab Republic and Yemen.1 These events have attracted media attention to a phenomenon of contemporary armed conflict that has important ramifications for the health, humanitarian, legal and security sectors.2 In December 2015, the Stockholm Peace Research Institute and the Conflict and Health Research Group at King’s College London convened a workshop in London on Eliminating violence against health workers: from theory to practice. Participants from MSF, the International Committee of the Red Cross (ICRC), Medical Aid for Palestinians and academic organizations discussed current trends in violence against health workers and attacks on health facilities, presented research findings and highlighted key debates and research gaps in evidence.
Some important lessons can be drawn from ICRC’s Health Care in Danger campaign, MSF’s Medical Care Under Fire campaign, as well as other organizations such as Physicians for Human Rights, which has recently documented mass atrocities in the Syrian Arab Republic as well as the impact of the Syrian conflict on the health sector.3–5 There is a perception of an increase in the number of health workers being killed and facilities being accidentally destroyed (so-called collateral damage) or deliberated targeted during armed conflicts. Comprehensive databases have been set up by independent research organizations to record major incidents of violence against aid workers, such as the Aid Worker Security Database of Humanitarian Outcomes and the Security in Numbers Database from Insecurity Insight.6 However, even these do not currently provide health-specific data. The absence of baseline and routine data relating to attacks on health workers and health facilities makes it difficult to identify actual rising trends. Most of the available data sources do not capture violence on local health workers, who seem to bear the brunt of most attacks. Data disaggregated by sex are also lacking…6

Clinical Therapeutics
December 2016 Volume 38, Issue 12, p2509-2710
http://www.clinicaltherapeutics.com/issue/S0149-2918(16)X0012-4

Pharmacovigilance Update: Pharmacovigilance in the New Millemium
Pharmacovigilance in the New Millennium
Paul Beninger, MD, MBA
Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts

Modern pharmacovigilance (PV) is very much a creature of the new millennium. Yes, we usually recognize the thalidomide tragedy as it unfolded in the 1950s as the pivotal event on both sides of the Atlantic that triggered the development of an international systematic approach to managing drug safety issues. (The reader is referred to an excellent detailed chronology of this subject up to and including the thalidomide tragedy by Myles Stephens, The Dawn of Drug Safety.1) This led to the World Health Organization-led consensus document International Drug Monitoring: The Role of National Centres.2 There was traction and “drug safety” took off, evolving over several decades as a discipline and as an organizational structure.

The larger trans-national infrastructure of PV, including its definitions and activities, was gradually shaped by the ground-breaking activities of CIOMS (The Council for International Organizations of Medical Sciences) and ICH (The International Conference on Harmonisation). These can be viewed as dyadic “content and process”—CIOMS creating much of the content through consensus, and ICH working through the various governmental jurisdictions to create the regulatory processes that implemented the content created by CIOMS.

Yet, to return to the New Millennium, to meet the needs of wholly new areas of PV, the full spectrum of the modern professional landscape has only taken shape since the beginning of this millennium: case management, signal management, and benefit risk management, each with two dimensions of medical and operational activities. In larger companies, these are distinct professional areas. They are complemented with experts in database management, periodic report preparation, and tracking activities that have all become their own specialties. In many, if not most, regions of the world, there is also the Qualified Person for Pharmacovigilance (QPPV), a role that evolved into its own discipline. Thus, departments in large companies now have hundreds of professionals employed in PV.

In recognition of the substantive evolution and growth in the field of PV, Clinical Therapeutics is presenting two Specialty Updates, this month and in April 2017, to highlight some of the advances and challenges in present-day PV. This month, we are publishing “Pharmacovigilance and Biomedical Informatics: A Model for Future Development,” which examines how the ad hoc interactions between these two disciplines have advanced PV processes over the past decade and also shows how a systematic approach can facilitate many new opportunities for potential advances in PV.3 The article “What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?” emphasizes that new technologies cannot be applied carte blanche but require more subtle consideration. Finally, the article “The US FDA’s Risk Evaluation and Mitigation Strategy (REMS) Program – current status and future directions” shows that the introduction of new regulatory disciplines can benefit from mid-course correction as new information becomes available.4, 5 We hope you enjoy these articles.

Clinical Therapeutics
December 2016 Volume 38, Issue 12, p2509-2710
http://www.clinicaltherapeutics.com/issue/S0149-2918(16)X0012-4

Commentaries
Pharmacovigilance and Biomedical Informatics: A Model for Future Development
Paul Beninger, Michael A. Ibara
p2514–2525
Published online: November 29, 2016

The US Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) Program – Current Status and Future Direction
Jasmanda Wu, Juhaeri Juhaeri
p2526–2532
Published online: December 1, 2016

What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?
John Price
p2533–2545
Published online: December 1, 2016

Contemporary Clinical Trials
Volume 52, Pages 1-100 (January 2017)
http://www.sciencedirect.com/science/journal/15517144/52

Study Design, Statistical Design, Study Protocols
Design of a long-term follow-up effectiveness, immunogenicity and safety study of women who received the 9-valent human papillomavirus vaccine
Original Research Article
Pages 54-61
Alain Luxembourg, Susanne K. Kjaer, Mari Nygard, Misoo C. Ellison, Thomas Group, J. Brooke Marshall, David Radley, Alfred Saah
Abstract
The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets four HPV types (6/11/16/18) also covered by the quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). Vaccine efficacy to prevent HPV infection and disease was established in a Phase III clinical study in women 16–26 years of age. A long-term follow-up (LTFU) study has been initiated as an extension of the Phase III clinical study to assess effectiveness of the 9vHPV vaccine up to at least 14 years after the start of vaccination. It includes participants from Denmark, Norway and Sweden and uses national health registries from these countries to assess incidence of cervical pre-cancers and cancers due to the 7 oncogenic types in the vaccine (HPV 16/18/31/33/45/52/58). Incidences will be compared to the estimated incidence rate in an unvaccinated cohort of similar age and risk level. This LTFU study uses a unique design: it is an extension of a Phase III clinical study and also has elements of an epidemiological study (i.e., endpoints based on standard clinical practice; surveillance using searches from health registries); it uses a control chart method to determine whether vaccine effectiveness may be waning. Control chart methods which were developed in industrial and manufacturing settings for process and production monitoring, can be used to monitor disease incidence in real-time and promptly detect a decrease in vaccine effectiveness. Experience from this innovative study design may be applicable to other medicinal products when long-term outcomes need to be assessed, there is no control group, or outcomes are rare.

Current Opinion in Infectious Diseases
February 2017 – Volume 30 – Issue 1 pp: v-vi,1-142
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx

SEXUALLY TRANSMITTED DISEASES
Future prospects for new vaccines against sexually transmitted infections
Gottlieb, Sami L.; Johnston, Christine
Abstract
Purpose of review: This review provides an update on the need, development status, and important next steps for advancing development of vaccines against sexually transmitted infections (STIs), including herpes simplex virus (HSV), Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), and Treponema pallidum (syphilis).
Recent findings: Global estimates suggest that more than a million STIs are acquired every day, and many new and emerging challenges to STI control highlight the critical need for development of new STI vaccines. Several therapeutic HSV-2 vaccine candidates are in Phase I/II clinical trials, and one subunit vaccine has shown sustained reductions in genital lesions and viral shedding, providing hope that an effective HSV vaccine is on the horizon. The first vaccine candidate for genital chlamydia infection has entered Phase I trials, and several more are in the pipeline. Use of novel technological approaches will likely see viable vaccine candidates for gonorrhea and syphilis in the future. The global STI vaccine roadmap outlines key activities to further advance STI vaccine development.
Summary: Major progress is being made in addressing the large global unmet need for STI vaccines. With continued collaboration and support, these critically important vaccines for global sexual and reproductive health can become a reality.

Emerging Infectious Diseases
Volume 23, Number 1—January 2017
http://wwwnc.cdc.gov/eid/

Perspective
A Framework for Modeling Emerging Diseases to Inform Management PDF Version [PDF – 424 KB – 6 pages]
R. E. Russell et al.
Abstract
The rapid emergence and reemergence of zoonotic diseases requires the ability to rapidly evaluate and implement optimal management decisions. Actions to control or mitigate the effects of emerging pathogens are commonly delayed because of uncertainty in the estimates and the predicted outcomes of the control tactics. The development of models that describe the best-known information regarding the disease system at the early stages of disease emergence is an essential step for optimal decision-making. Models can predict the potential effects of the pathogen, provide guidance for assessing the likelihood of success of different proposed management actions, quantify the uncertainty surrounding the choice of the optimal decision, and highlight critical areas for immediate research. We demonstrate how to develop models that can be used as a part of a decision-making framework to determine the likelihood of success of different management actions given current knowledge.

Emerging Infectious Diseases
Volume 23, Number 1—January 2017
http://wwwnc.cdc.gov/eid/

Research
Oral Cholera Vaccine Coverage during an Outbreak and Humanitarian Crisis, Iraq, 2015 PDF Version [PDF – 757 KB – 8 pages]
E. Lam et al.
Abstract
During November–December 2015, as part of the 2015 cholera outbreak response in Iraq, the Iraqi Ministry of Health targeted ≈255,000 displaced persons >1 year of age with 2 doses of oral cholera vaccine (OCV). All persons who received vaccines were living in selected refugee camps, internally displaced persons camps, and collective centers. We conducted a multistage cluster survey to obtain OCV coverage estimates in 10 governorates that were targeted during the campaign. In total, 1,226 household and 5,007 individual interviews were conducted. Overall, 2-dose OCV coverage in the targeted camps was 87% (95% CI 85%–89%). Two-dose OCV coverage in the 3 northern governorates (91%; 95% CI 87%–94%) was higher than that in the 7 southern and central governorates (80%; 95% CI 77%–82%). The experience in Iraq demonstrates that OCV campaigns can be successfully implemented as part of a comprehensive response to cholera outbreaks among high-risk populations in conflict settings.

Global Health: Science and Practice (GHSP)
December 2016 | Volume 4 | Issue 4
http://www.ghspjournal.org/content/current

VIEWPOINTS
Improving the Safety and Security of Those Engaged in Global Health Traveling Abroad
We need to improve the safety and security of global health students, faculty, residents, and workers who travel abroad, particularly those affiliated with smaller organizations or educational programs that lack resources and protocols. We offer a checklist covering 6 core elements: (1) institutional commitment, (2) trainee and faculty participation, (3) safety and security assessment and analysis, (4) risk and hazard prevention, (5) safety training, and (6) program evaluation.
Ranit Mishori, Andrew Eastman, Jessica Evert
Glob Health Sci Pract 2016;4(4):522-528. http://dx.doi.org/10.9745/GHSP-D-16-00203

Global Health: Science and Practice (GHSP)
December 2016 | Volume 4 | Issue 4
http://www.ghspjournal.org/content/current

VIEWPOINTS
Social Mobilization and Community Engagement Central to the Ebola Response in West Africa: Lessons for Future Public Health Emergencies
Key lessons for the crucial components of social mobilization and community engagement in this context:
:: Invest in trusted local community members to facilitate community entrance and engagement.
:: Use key communication networks and channels with wide reach and relevance to the community, such as radio in low-resource settings or faith-based organizations.
:: Invest in strategic partnerships to tap relevant capacities and resources.
: Support a network of communication professionals who can deploy rapidly for lengthy periods.
Balance centralized mechanisms to promote consistency and quality with decentralized programming for flexibility and adaptation to local needs.
:: Evolve communication approaches and messaging over time with the changing outbreak patterns, e.g., from halting disease transmission to integration and support of survivors.
:: Establish clear communication indicators and analyze and share data in real time.
Amaya M Gillespie, Rafael Obregon, Rania El Asawi, Catherine Richey, Erma Manoncourt, Kshiitij Joshi, Savita Naqvi, Ade Pouye, Naqibullah Safi, Ketan Chitnis, Sabeeha Quereshi
Glob Health Sci Pract 2016;4(4):626-646. http://dx.doi.org/10.9745/GHSP-D-16-00226
ABSTRACT
Following the World Health Organization (WHO) declaration of a Public Health Emergency of International Concern regarding the Ebola outbreak in West Africa in July 2014, UNICEF was asked to co-lead, in coordination with WHO and the ministries of health of affected countries, the communication and social mobilization component—which UNICEF refers to as communication for development (C4D)—of the Ebola response. For the first time in an emergency setting, C4D was formally incorporated into each country’s national response, alongside more typical components such as supplies and logistics, surveillance, and clinical care. This article describes the lessons learned about social mobilization and community engagement in the emergency response to the Ebola outbreak, with a particular focus on UNICEF’s C4D work in Guinea, Liberia, and Sierra Leone. The lessons emerged through an assessment conducted by UNICEF using 4 methods: a literature review of key documents, meeting reports, and other articles; structured discussions conducted in June 2015 and October 2015 with UNICEF and civil society experts; an electronic survey, launched in October and November 2015, with staff from government, the UN, or any partner organization who worked on Ebola (N = 53); and key informant interviews (N = 5). After triangulating the findings from all data sources, we distilled lessons under 7 major domains: (1) strategy and decentralization: develop a comprehensive C4D strategy with communities at the center and decentralized programming to facilitate flexibility and adaptation to the local context; (2) coordination: establish C4D leadership with the necessary authority to coordinate between partners and enforce use of standard operating procedures as a central coordination and quality assurance tool; (3) entering and engaging communities: invest in key communication channels (such as radio) and trusted local community members; (4) messaging: adapt messages and strategies continually as patterns of the epidemic change over time; (5) partnerships: invest in strategic partnerships with community, religious leaders, journalists, radio stations, and partner organizations; (6) capacity building: support a network of local and international professionals with capacity for C4D who can be deployed rapidly; (7) data and performance monitoring: establish clear C4D process and impact indicators and strive for real-time data analysis and rapid feedback to communities and authorities to inform decision making. Ultimately, communication, community engagement, and social mobilization need to be formally placed within the global humanitarian response architecture with proper funding to effectively support future public health.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 7 January 2017]

Review
The link between the West African Ebola outbreak and health systems in Guinea, Liberia and Sierra Leone: a systematic review
Haitham Shoman, Emilie Karafillakis and Salman Rawaf
Published on: 4 January 2017
Abstract
Background
An Ebola outbreak started in December 2013 in Guinea and spread to Liberia and Sierra Leone in 2014. The health systems in place in the three countries lacked the infrastructure and the preparation to respond to the outbreak quickly and the World Health Organisation (WHO) declared a public health emergency of international concern on August 8 2014.
Objective
The aim of this study was to determine the effects of health systems’ organisation and performance on the West African Ebola outbreak in Guinea, Liberia and Sierra Leone and lessons learned. The WHO health system building blocks were used to evaluate the performance of the health systems in these countries.
Methods
A systematic review of articles published from inception until July 2015 was conducted following the PRISMA guidelines. Electronic databases including Medline, Embase, Global Health, and the Cochrane library were searched for relevant literature. Grey literature was also searched through Google Scholar and Scopus. Articles were exported and selected based on a set of inclusion and exclusion criteria. Data was then extracted into a spreadsheet and a descriptive analysis was performed. Each study was critically appraised using the Crowe Critical Appraisal Tool. The review was supplemented with expert interviews where participants were identified from reference lists and using the snowball method.
Findings
Thirteen articles were included in the study and six experts from different organisations were interviewed. Findings were analysed based on the WHO health system building blocks. Shortage of health workforce had an important effect on the control of Ebola but also suffered the most from the outbreak. This was followed by information and research, medical products and technologies, health financing and leadership and governance. Poor surveillance and lack of proper communication also contributed to the outbreak. Lack of available funds jeopardised payments and purchase of essential resources and medicines. Leadership and governance had least findings but an overarching consensus that they would have helped prompt response, adequate coordination and management of resources.
Conclusion
Ensuring an adequate and efficient health workforce is of the utmost importance to ensure a strong health system and a quick response to new outbreaks. Adequate service delivery results from a collective success of the other blocks. Health financing and its management is crucial to ensure availability of medical products, fund payments to staff and purchase necessary equipment. However, leadership and governance needs to be rigorously explored on their main defects to control the outbreak.

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 7 January 2017]

Editorial
Building health research systems: WHO is generating global perspectives, and who’s celebrating national successes?
Stephen R. Hanney and Miguel A. González-Block
Published on: 28 December 2016
Abstract
In 2016, England’s National Institute for Health Research (NIHR) celebrated its tenth anniversary as an innovative national health research system with a focus on meeting patients’ needs. This provides a good opportunity to reflect on how the creation of the NIHR has greatly enhanced important work, started in 1991, to develop a health research system in England that is embedded in the National Health Service.
In 2004, WHO identified a range of functions that a national health research system should undertake to improve the health of populations. Health Research Policy and Systems (HRPS) has taken particular interest in the pioneering developments in the English health research system, where the comprehensive approach has covered most, if not all, of the functions identified by WHO. Furthermore, several significant recent developments in thinking about health research are relevant for the NIHR and have informed accounts of its achievements. These include recognition of the need to combat waste in health research, which had been identified as a global problem in successive papers in the Lancet, and an increasing emphasis on demonstrating impact. Here, pioneering evaluation of United Kingdom research, conducted through the impact case studies of the Research Excellence Framework, is particularly important. Analyses informed by these and other approaches identified many aspects of NIHR’s progress in combating waste, building and sustaining research capacity, creating centres of research excellence linked to leading healthcare institutions, developing research networks, involving patients and others in identifying research needs, and producing and adopting research findings that are improving health outcomes.
The NIHR’s overall success, and an analysis of the remaining problems, might have lessons for other systems, notwithstanding important advances in many countries, as described in papers in HRPS and elsewhere. WHO’s recently established Global Observatory for Health Research and Development provides an opportunity to promote some of these lessons. To inform its work, the Observatory is sponsoring a thematic series of papers in HRPS focusing on health research issues such as funding flows, priority setting, capacity building, utilisation and equity. While important papers on these have been published, this series is still open to new submissions.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 12, Issue 12, 2016
http://www.tandfonline.com/toc/khvi20/current

Review article
Comparison of dual influenza and pneumococcal polysaccharide vaccination with influenza vaccination alone for preventing pneumonia and reducing mortality among the elderly: A meta-analysis
Pages: 3056-3064
Published online: 14 Sep 2016
Yan-Yang Zhang, Xue-Feng Tang, Chang-Hui Du, Bin-Bing Wang, Zhen-Wang Bi & Bi-Rong Dong

Review
Influenza immunization during pregnancy: Benefits for mother and infant
Pages: 3065-3071
Published online: 05 Aug 2016
Isaac G. Sakala, Yoshikazu Honda-Okubo, Johnson Fung & Nikolai Petrovsky Director

Commentary
The safety of maternal immunization
Pages: 3132-3136
Published online: 19 Aug 2016
Annette K. Regan

Research Paper
How do parents and pediatricians arrive at the decision to immunize their children in the private sector? Insights from a qualitative study on rotavirus vaccination across select Indian cities
Pages: 3139-3145
Published online: 23 Nov 2016
Mathew Sunil George, Preeti Negandhi, Habib Hassan Farooqui, Anjali Sharma & Sanjay Zodpey

Reviews
Community pharmacies as sites of adult vaccination: A systematic review
Pages: 3146-3159
Published online: 15 Aug 2016
Randall C. Burson, Alison M. Buttenheim, Allison Armstrong & Kristen A. Feemster

Infectious Agents and Cancer

[Accessed 7 January 2017]

Research Article
Multiple HPV infections in female sex workers in Western Kenya: implications for prophylactic vaccines within this sub population
Whilst the imputed role of High Risk (HR) HPV infection in the development of cervical lesions and cancer has been established, the high number of HPV genotypes that Female Sex workers (FSW) harbour warrants that the synergistic effects of potential HR (pHR) and HR HPV genotypes be elucidated to assess the potential impact of prophylactic vaccines. This population in Kenya also harbours a number of other vaginal infections and STIs, including bacterial vaginosis (BV), trichomonas vaginalis (TV) and candida spp.
Sonia Menon, Davy van den Broeck, Rodolfo Rossi, Emilomo Ogbe and Hillary Mabeya
Infectious Agents and Cancer 2017 12:2
Published on: 6 January 2017

International Journal of Infectious Diseases
December 2016 Volume 53, p1-68
http://www.ijidonline.com/issue/S1201-9712(16)X0011-2
Reviews
Drivers of earlier infectious disease outbreak detection: a systematic literature review
Lindsay Steele, Emma Orefuwa, Petra Dickmann
p15–20
Published online: October 21, 2016
Highlights
Early detection of infectious disease outbreaks can lead to a decreased impact on populations. Numerous approaches to the earlier detection of outbreaks exist, and methods have been developed to measure progress on timeliness. Understanding why these surveillance approaches work and do not work will elucidate key drivers of early detection, and could guide interventions to achieve earlier detection. Without clarity about necessary conditions for earlier detection and their influencing factors, attempts to improve surveillance will be ad hoc and unsystematic.
This systematic literature review revealed that despite significant investment in early outbreak detection, there is very little evidence with respect to factors that influence earlier detection. More research is needed to guide intervention planning.

International Journal of Infectious Diseases
December 2016 Volume 53, p1-68
http://www.ijidonline.com/issue/S1201-9712(16)X0011-2

Original Reports
Clinical profile and containment of the Ebola virus disease outbreak in two large West African cities, Nigeria, July–September 2014
Chima Ohuabunwo, Celestine Ameh, Oyin Oduyebo, Anthony Ahumibe, Bamidele Mutiu, Adebola Olayinka, Wasiu Gbadamosi, Erika Garcia, Carolina Nanclares, Wale Famiyesin, Abdulaziz Mohammed, Patrick Nguku, Richard I. Koko, Joshua Obasanya, Durojaye Adebayo, Yemi Gbadegesin, Oni Idigbe, Olukayode Oguntimehin, Sara Nyanti, Charles Nzuki, Ismail Abdus-Salam, Joseph Adeyemi, Nnanna Onyekwere, Emmanuel Musa, David Brett-Major, Faisal Shuaib, Abdulsalami Nasidi
p23–29
Published online: August 27, 2016

JAMA Pediatrics
January 1, 2017, Vol 171, No. 1, Pages 3-100
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Association Between Influenza Infection and Vaccination During Pregnancy and Risk of Autism Spectrum Disorder
Ousseny Zerbo, PhD; Yinge Qian, MS; Cathleen Yoshida, MA; et al.
online only
JAMA Pediatr. 2017;171(1):e163609. doi:10.1001/jamapediatrics.2016.3609
Key Points
Question  Is there an association between maternal influenza infection and vaccination and autism risk?
Findings  In a cohort study of 196,929 children, of whom 3103 had austism spectrum disorder, maternal influenza infection during pregnancy was not associated with increased autism risk. There was a suggestion of increased risk of autism spectrum disorders among children whose mothers received an influenza vaccination during their first trimester, but the association was statistically insignificant after adjusting for multiple comparisons, indicating that the finding could be due to chance.
Meaning  Our findings do not call for vaccine policy or practice changes but do suggest the need for additional studies.
Abstract
Importance
Maternal infections and fever during pregnancy are associated with increased risk for autism spectrum disorders (ASDs). To our knowledge, no study has investigated the association between influenza vaccination during pregnancy and ASD.
Objective
To investigate the association between influenza infection and vaccination during pregnancy and ASD risk.
Design, Setting, and Participants
This cohort study included 196 929 children born at Kaiser Permanente Northern California from January 1, 2000 to December 31, 2010, at a gestational age of at least 24 weeks.
Exposures
Data on maternal influenza infection and vaccination from conception date to delivery date, obtained from Kaiser Permanente Northern California inpatient and outpatient databases. Influenza infection was defined by the International Classification of Diseases, Ninth Revision, Clinical Modification codes or positive influenza laboratory test results.
Main Outcomes and Measures
Clinical diagnoses of ASDs identified by International Classification of Diseases, Ninth Revision, Clinical Modification codes 299.0, 299.8, or 299.9 recorded in Kaiser Permanente Northern California electronic medical records on at least 2 occasions any time from birth through June 2015.
Results
Within this cohort of 196 929 children, influenza was diagnosed in 1400 (0.7%) mothers and 45 231 (23%) received an influenza vaccination during pregnancy. The mean (SD) ages of vaccinated and unvaccinated women were 31.6 (5.2) and 30.4 (5.6) years, respectively. A total number of 3101 (1.6%) children were diagnosed with ASD. After adjusting for covariates, we found that maternal influenza infection (adjusted hazard ratio, 1.04; 95% CI, 0.68-1.58) or influenza vaccination (adjusted hazard ratio, 1.10; 95% CI, 1.00-1.21) anytime during pregnancy was not associated with increased ASD risk. In trimester-specific analyses, first-trimester influenza vaccination was the only period associated with increased ASD risk (adjusted hazard ratio, 1.20; 95% CI, 1.04-1.39). However, this association could be due to chance (P = 0.1) if Bonferroni corrected for the multiplicity of hypotheses tested (n = 8). Maternal influenza vaccination in the second or third trimester was not associated with increased ASD risk.
Conclusions and Relevance
There was no association between maternal influenza infection anytime during pregnancy and increased ASD risk. There was a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester, but the association was not statistically significant after adjusting for multiple comparisons, indicating that the finding could be due to chance. These findings do not call for changes in vaccine policy or practice, but do suggest the need for additional studies on maternal influenza vaccination and autism.

JAMA Pediatrics
January 1, 2017, Vol 171, No. 1, Pages 3-100
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
The Complexities of Conducting Research on Child Trafficking
Jonathan Todres, JD; Leslie E. Wolf, JD, MPH
JAMA Pediatr. 2017;171(1):9-10. doi:10.1001/jamapediatrics.2016.3532
Child trafficking is a significant public health problem in the United States and globally.1 Despite substantial efforts to respond to human trafficking over the past 15 years, there is still relatively little known about its prevalence and effective ways to prevent, identify, and respond to it.2

Journal of Epidemiology & Community Health
January 2017, Volume 71, Issue 1
http://jech.bmj.com/content/current
Review
Interventions to reduce inequalities in vaccine uptake in children and adolescents aged Tim Crocker-Buque, Michael Edelstein, Sandra Mounier-Jack
J Epidemiol Community Health 2017;71:87-97 Published Online First: 17 August 2016 doi:10.1136/jech-2016-207572
Abstract
Background
In high-income countries, substantial differences exist in vaccine uptake relating to socioeconomic status, gender, ethnic group, geographic location and religious belief. This paper updates a 2009 systematic review on effective interventions to decrease vaccine uptake inequalities in light of new technologies applied to vaccination and new vaccine programmes (eg, human papillomavirus in adolescents).
Methods
We searched MEDLINE, Embase, ASSIA, The Campbell Collaboration, CINAHL, The Cochrane Database of Systematic Reviews, Eppi Centre, Eric and PsychINFO for intervention, cohort or ecological studies conducted at primary/community care level in children and young people from birth to 19 years in OECD countries, with vaccine uptake or coverage as outcomes, published between 2008 and 2015.
Results
The 41 included studies evaluated complex multicomponent interventions (n=16), reminder/recall systems (n=18), outreach programmes (n=3) or computer-based interventions (n=2). Complex, locally designed interventions demonstrated the best evidence for effectiveness in reducing inequalities in deprived, urban, ethnically diverse communities. There is some evidence that postal and telephone reminders are effective, however, evidence remains mixed for text-message reminders, although these may be more effective in adolescents. Interventions that escalated in intensity appeared particularly effective. Computer-based interventions were not effective. Few studies targeted an inequality specifically, although several reported differential effects by the ethnic group.
Conclusions
Locally designed, multicomponent interventions should be used in urban, ethnically diverse, deprived populations. Some evidence is emerging for text-message reminders, particularly in adolescents. Further research should be conducted in the UK and Europe with a focus on reducing specific inequalities.

Journal of Infectious Diseases
Volume 214 Issue 12 December 15, 2016
http://jid.oxfordjournals.org/content/current

PERSPECTIVES
Editor’s choice:
Critique of World Health Organization Recommendation of a Dengue Vaccine
Scott B. Halstead
J Infect Dis. (2016) 214 (12): 1793-1795 doi:10.1093/infdis/jiw340

Journal of Infectious Diseases
Volume 214 Issue 12 December 15, 2016
http://jid.oxfordjournals.org/content/current

VIRUSES
Risk of Delayed Human Papillomavirus Vaccination in Inner-City Adolescent Women
J Infect Dis. (2016) 214 (12): 1952-1960 doi:10.1093/infdis/jiw486
Nicolas F. Schlecht, Angela Diaz, Viswanathan Shankar, Arnold H. Szporn, Maoxin Wu,
Anne Nucci-Sack, Ken Peake, Howard D. Strickler, and Robert D. Burk
Abstract
Background.
Uptake of human papillomavirus (HPV) vaccine in the United States is slow, and the effectiveness of the vaccine has not been assessed in high-risk adolescent populations.
Methods.
We conducted a longitudinal study of 1139 sexually active, inner-city adolescent women receiving the 3-dose quadrivalent (4vHPV) vaccine. Cervical and anal specimens collected semiannually were tested using an L1-specific polymerase chain reaction assay. Postvaccination incidence of 4vHPV vaccine and nonvaccine HPV types, and risk of cervical cytological abnormalities, were assessed in relation to time to completion of all 3 vaccine doses.
Results.
Compared to vaccine naive women at enrollment, vaccinated women had significantly lower incidence rate ratios of cervical infection with HPV6/11/16/18 (0.2; 95% confidence interval [CI], .1–.4) and the related types HPV31 and HPV45 (0.4 [95% CI, .2–1.0] and 0.3 [95% CI, .1–.6], respectively), as well as significantly lower incidence rate ratios of anal infection with HPV6/11/16/18 (0.4; 95% CI, .2–.7). Notably, we observed higher risks of cervical HPV6/11/16/18 infection (hazards ratio [HR], 2.9; 95% CI, 1.0–8.0) and associated cytological abnormalities (HR, 4.5; 95% CI, .7–26.0) among women immunized at ≥15 years of age who took ≥12 months (vs Conclusions.
Among adolescents immunized at ≥15 years of age, a longer time to complete the 3-dose schedule was associated with an increased risk of anogenital HPV6/11/16/18 infection and an increased incidence of associated cervical cytological abnormalities.

Journal of Infectious Diseases
Volume 214 Issue 12 December 15, 2016
http://jid.oxfordjournals.org/content/current

Reduction in Vaccine-Type Human Papillomavirus Prevalence Among Women in the United States, 2009–2012
J Infect Dis. (2016) 214 (12): 1961-1964 doi:10.1093/infdis/jiw515
Abbey B. Berenson, Tabassum Haque Laz, and Mahbubur Rahman

Journal of Infectious Diseases
Volume 214 Issue 12 December 15, 2016
http://jid.oxfordjournals.org/content/current

Measles Outbreak Among Previously Immunized Healthcare Workers, the Netherlands, 2014
J Infect Dis. (2016) 214 (12): 1980-1986 doi:10.1093/infdis/jiw480
Susan J. M. Hahné, Laura M. Nic Lochlainn, Nathalie D. van Burgel, Jeroen Kerkhof, Jussi Sane,
Kioe Bing Yap, and Rob S. van Binnendijk

Journal of Medical Ethics
January 2017, Volume 43, Issue 1
http://jme.bmj.com/content/current

Law, ethics and medicine
Paper: Towards a European code of medical ethics. Ethical and legal issues
Sara Patuzzo, Elisabetta Pulice
J Med Ethics 2017;43:41-46 Published Online First: 8 October 2016 doi:10.1136/medethics-2015-102963
Abstract
The feasibility of a common European code of medical ethics is discussed, with consideration and evaluation of the difficulties such a project is going to face, from both the legal and ethical points of view. On the one hand, the analysis will underline the limits of a common European code of medical ethics as an instrument for harmonising national professional rules in the European context; on the other hand, we will highlight some of the potentials of this project, which could be increased and strengthened through a proper rulemaking process and through adequate and careful choice of content. We will also stress specific elements and devices that should be taken into consideration during the establishment of the code, from both procedural and content perspectives. Regarding methodological issues, the limits and potentialities of a common European code of medical ethics will be analysed from an ethical point of view and then from a legal perspective. The aim of this paper is to clarify the framework for the potential but controversial role of the code in the European context, showing the difficulties in enforcing and harmonising national ethical rules into a European code of medical ethics.

Journal of Medical Microbiology
Volume 65, Issue 12, December 2016
http://jmm.microbiologyresearch.org/content/journal/jmm/65/12

Review
Prevention of herpes zoster and its complications: from the clinic to the real-life experience with the vaccine
Gabutti Giovanni, Valente Nicoletta, Kuhdari Parvanè, Lupi Silvia, Stefanati Armando
J. Med. Microbiol., December 2016 65: 1363-1369, doi: 10.1099/jmm.0.000386
Abstract
The herpes zoster is an acute viral illness characterized by a vesicular rash of unilateral distribution, which can eventually cause severe complications, such as post-herpetic neuralgia, ophthalmic zoster, stroke or other neurological complications. In Europe, an incidence of between 2.0 and 4.6 cases per 1000 person-years is estimated, with an increase after 50 years of age. Currently, the therapeutic options for are only partially effective in limiting the acute phase, while the management of complications is frequently complex and not satisfactory. The overall burden of the disease and the elevated costs associated with diagnosis and clinical and therapeutic management led to the development of a new preventive approach through a live attenuated virus vaccine. The vaccine now available decreases the incidence of the disease, post-herpetic neuralgia and the burden of illness. Moreover, the vaccine is safe and well tolerated and it seems to confer long-term protection. Based on the clinical results and evidence provided by the Health Technology Assessment, several countries introduced immunization although with different recommendations and methods of funding.

The Lancet
Jan 07, 2017 Volume 389 Number 10064 p1-126 e1
http://www.thelancet.com/journals/lancet/issue/current

Series
Advancing Early Childhood Development: from Science to Scale
Early childhood development coming of age: science through the life course
Maureen M Black, Susan P Walker, Lia C H Fernald, Christopher T Andersen, Ann M DiGirolamo, Chunling Lu, Dana C McCoy, Günther Fink, Yusra R Shawar, Jeremy Shiffman, Amanda E Devercelli, Quentin T Wodon, Emily Vargas-Barón, Sally Grantham-McGregor, Lancet Early Childhood Development Series Steering Committee

Advancing Early Childhood Development: from Science to Scale
Nurturing care: promoting early childhood development
Pia R Britto, Stephen J Lye, Kerrie Proulx, Aisha K Yousafzai, Stephen G Matthews, Tyler Vaivada, Rafael Perez-Escamilla, Nirmala Rao, Patrick Ip, Lia C H Fernald, Harriet MacMillan, Mark Hanson, Theodore D Wachs, Haogen Yao, Hirokazu Yoshikawa, Adrian Cerezo, James F Leckman, Zulfiqar A Bhutta, Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee

Advancing Early Childhood Development: from Science to Scale
Investing in the foundation of sustainable development: pathways to scale up for early childhood development
Linda M Richter, Bernadette Daelmans, Joan Lombardi, Jody Heymann, Florencia Lopez Boo, Jere R Behrman, Chunling Lu, Jane E Lucas, Rafael Perez-Escamilla, Tarun Dua, Zulfiqar A Bhutta, Karin Stenberg, Paul Gertler, Gary L Darmstadt, Paper 3 Working Group and the Lancet Early Childhood Development Series Steering Committee

Health Policy
Generation of global political priority for early childhood development: the challenges of framing and governance
Yusra Ribhi Shawar, Jeremy Shiffman

Lancet Global Health
Jan 2017 Volume 5 Number 1 e1-e114
http://www.thelancet.com/journals/langlo/issue/current

Editorial
Precision global health: beyond prevention and control
The Lancet Global Health
As we step into 2017 and look back at the past year, Zika undoubtedly stands out. 2016 saw the rise and fall of the epidemic in the Americas and worldwide spread of cases, until WHO declared on Nov 18 that the virus and associated consequences no longer constituted a Public Health Emergency of International Concern, but represented a “significant enduring public health challenge requiring intense action”. As such, Zika joined other “enduring public health challenges” to which “intense action” has been directed for a long time, particularly other communicable and vector-borne diseases, on the list of health priorities. With Zika we are almost in uncharted territory: the heterogeneity in the natural history of the disease and transmission pathways still blur the picture of what is likely to be a long-term global health issue. Yet with some other diseases, a wealth of knowledge and seemingly defined course of action have not enabled us to close the chapter.

Much has been achieved on malaria, for example, but progress is fragile and we are still scrambling in areas where the burden persists despite decades of interventions. One major concern is resistance to pyrethroids used in long-lasting insecticidal nets (LLIN), a cornerstone of malaria control. During the 65th American Society for Tropical Medicine and Hygiene (ASTMH) meeting in Atlanta in November, WHO released the results of a study that shows that LLINs provide protection against malaria even in areas with resistance. However, in this issue of The Lancet Global Health, Laura Steinhardt and colleagues report contrasting results of a case control study in Haiti that raises doubts on the usefulness of nets in a low transmission setting, hinting that their mass distribution is not a panacea everywhere. In fact, a session at ASTMH explored key knowledge gaps in malaria interventions and raised thought-provoking questions on what is needed to finally get rid of the disease, given issues of resistance, uncertainties about newer strategies such as seasonal malaria chemoprevention or intermittent preventive treatment for pregnant women, and potential impact of the RTS,S vaccine. As highlighted during the session, there is no silver bullet, and success may only be found by putting multiple axes of pressure on the vector through combinations of interventions. The trick is figuring out what combination works in what setting, and that seems to be the next big question around malaria elimination: how do we develop decision tools to tailor interventions to a set of biological and social determinants—in other words, how do we move on to a more customised approach, through what could be called “precision global health”?

The idea of a “precision” approach to global health is not limited to malaria. Prevention strategies against soil-transmitted helminths (STH) for example have included water, sanitation, and hygiene interventions and mass drug administration, another imperfect and controversial intervention as highlighted in an Article by Vivian Welch and colleagues and two Comments in this issue. In their network meta-analysis, Welch and colleagues found little to no effect of mass deworming on children’s growth, cognition, and school attendance. Eliminating the last pockets of STH incidence and prevalence will therefore require another precision approach, maybe one that combines controlling the parasites with working on more distal determinants of infection such as poverty.

A tailored approach will also help in reaching broader global health targets. The decrease in child mortality during the Millennium Development Goals era has been real but insufficient, and unequal. In some areas progress could be accelerated with more refined targeting of causes of death. Knowing where to target interventions to reduce mortality, by analysing the variability in the distribution of health outcomes for different causes would optimise efforts to reduce child mortality. A study by Marshall Burke and colleagues published in the last issue provides such valuable input, by identifying subnational mortality hotspots across sub-Saharan Africa in which the mortality decline is not on target to reach the Sustainable Development Goals (SDG) by 2030, as well as potential drivers for the difference in mortality. Spatial analyses of this kind provide crucial granular information—in line with a precision approach to global health—that could contribute to the progress towards the SDGs.

So beyond the essential steps of event surveillance and case management, on which the prevention and control of diseases are based, if we are to truly advance health and eliminate diseases, a case can be made for a tailored approach and the advent of precision-style global health.

Lancet Global Health
Jan 2017 Volume 5 Number 1 e1-e114
http://www.thelancet.com/journals/langlo/issue/current

Articles
Indirect effects of childhood pneumococcal conjugate vaccination on invasive pneumococcal disease: a systematic review and meta-analysis
Tinevimbo Shiri, Samik Datta, Jason Madan, Alexander Tsertsvadze, Pamela Royle, Matt J Keeling, Noel D McCarthy, Stavros Petrou

The Lancet Infectious Diseases
Jan 2017 Volume 17 Number 1 p1-116 e1-e29
http://www.thelancet.com/journals/laninf/issue/current

Articles
Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial
Helen S Marshall, Peter C Richmond, Johannes Beeslaar, Qin Jiang, Kathrin U Jansen, Maria Garcés-Sánchez, Federico Martinón-Torres, Leszek Szenborn, Jacek Wysocki, Joseph Eiden, Shannon L Harris, Thomas R Jones, Su-San Lee, John L Perez, 6108A12001 Study Investigators

The Lancet Infectious Diseases
Jan 2017 Volume 17 Number 1 p1-116 e1-e29
http://www.thelancet.com/journals/laninf/issue/current

Articles
Quadrivalent vaccine-targeted human papillomavirus genotypes in heterosexual men after the Australian female human papillomavirus vaccination programme: a retrospective observational study
Eric P F Chow, Dorothy A Machalek, Sepehr N Tabrizi, Jennifer A Danielewski, Glenda Fehler, Catriona S Bradshaw, Suzanne M Garland, Marcus Y Chen, Christopher K Fairley

Nature Medicine
January 2017, Volume 23 No 1 pp1-135
http://www.nature.com/nm/journal/v23/n1/index.html

Editorial
Safeguarding science
doi:10.1038/nm.4270
Changing political and funding landscapes in the US create an uncertain environment for biomedical research. The research community must insist that scientific policy follow from science, not political partisanship.

Nature Reviews Immunology
January 2017 Vol 17 No 1
http://www.nature.com/nri/journal/v16/n12/index.html

Reviews
Human immune system variation
Petter Brodin & Mark M. Davis
p21 | doi:10.1038/nri.2016.125
Abstract
The human immune system is highly variable between individuals but relatively stable over time within a given person. Recent conceptual and technological advances have enabled systems immunology analyses, which reveal the composition of immune cells and proteins in populations of healthy individuals. The range of variation and some specific influences that shape an individual’s immune system is now becoming clearer. Human immune systems vary as a consequence of heritable and non-heritable influences, but symbiotic and pathogenic microbes and other non-heritable influences explain most of this variation. Understanding when and how such influences shape the human immune system is key for defining metrics of immunological health and understanding the risk of immune-mediated and infectious diseases.

New England Journal of Medicine
January 5, 2017  Vol. 376 No. 1
http://www.nejm.org/toc/nejm/medical-journal

Review Article
The Changing Face of Clinical Trials
Jeffrey M. Drazen, M.D., David P. Harrington, Ph.D., John J.V. McMurray, M.D., James H. Ware, Ph.D., Janet Woodcock, M.D., Editors
The Large Pharmaceutical Company Perspective
Michael Rosenblatt, M.D.
N Engl J Med 2017; 376:52-60 January 5, 2017 DOI: 10.1056/NEJMra1510069
Large pharmaceutical companies conduct clinical trials to evaluate efficacy and identify safety issues for candidate drugs as effectively, efficiently, and expeditiously as possible, while addressing simultaneously the requirements of regulatory authorities across the globe. To put the fewest people at risk and to learn the most, these trials often are configured to provide evidence for health care providers, regulatory approval, and reimbursement from health agencies. Because there are so many unknowns, pharmaceutical research and development is a high-risk business with the highest failure rate for new product candidates of any industry.

Pediatrics
January 2017, VOLUME 139 / ISSUE
http://pediatrics.aappublications.org/content/139/1?current-issue=y

Articles
Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds
Hung-Fu Tseng, Lina S. Sy, Bradley K. Ackerson, Rulin C. Hechter, Sara Y. Tartof, Mendel Haag, Jeffrey M. Slezak, Yi Luo, Christine A. Fischetti, Harp S. Takhar, Yan Miao, Marianne Cunnington, Zendi Solano, Steven J. Jacobsen
Pediatrics Jan 2017, 139 (1) e20162084; DOI: 10.1542/peds.2016-2084

Pediatrics
January 2017, VOLUME 139 / ISSUE
http://pediatrics.aappublications.org/content/139/1?current-issue=y

Articles
Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial
Noel T. Brewer, Megan E. Hall, Teri L. Malo, Melissa B. Gilkey, Beth Quinn, Christine Lathren
Pediatrics Jan 2017, 139 (1) e20161764; DOI: 10.1542/peds.2016-1764

PharmacoEconomics
Volume 35, Issue 1, January 2017
http://link.springer.com/journal/40273/35/1/page/1

Leading Article
Discounting the Recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine
Mike Paulden, James F. O’Mahony, Christopher McCabe

PharmacoEconomics
Volume 35, Issue 1, January 2017
http://link.springer.com/journal/40273/35/1/page/1

Systematic Review
Challenges in Cost-Effectiveness Analysis Modelling of HPV Vaccines in Low- and Middle-Income Countries: A Systematic Review and Practice Recommendations
Obinna I. Ekwunife, James F. O’Mahony, Andreas Gerber Grote…
Abstract
Background
Low- and middle-income countries (LMICs) face a number of challenges in implementing cervical cancer prevention programmes that do not apply in high-income countries.
Objective
This review assessed how context-specific challenges of implementing cervical cancer prevention strategies in LMICs were accounted for in existing cost-effectiveness analysis (CEA) models of human papillomavirus (HPV) vaccination.
Methods
The databases of MEDLINE, EMBASE, NHS Economic Evaluation Database, EconLit, Web of Science, and the Center for the Evaluation of Value and Risk in Health (CEA) Registry were searched for studies published from 2006 to 2015. A descriptive, narrative, and interpretative synthesis of data was undertaken.
Results
Of the 33 studies included in the review, the majority acknowledged cost per vaccinated girl (CVG) (26 studies) and vaccine coverage rate (21 studies) as particular challenges for LMICs, while nine studies identified screening coverage rate as a challenge. Most of the studies estimated CVG as a composite of different cost items. However, the basis for the items within this composite cost was unclear. The majority used an assumption rather than an observed rate to represent screening and vaccination coverage rates. CVG, vaccine coverage and screening coverage were shown by some studies through sensitivity analyses to reverse the conclusions regarding cost-effectiveness, thereby significantly affecting policy recommendations.
Conclusions
While many studies recognized aspects of the particular challenges of HPV vaccination in LMICs, greater efforts need to be made in adapting models to account for these challenges. These include adapting costings of HPV vaccine delivery from other countries, learning from the outcomes of cervical cancer screening programmes in the same geographical region, and taking into account the country’s previous experience with other vaccination programmes.
Key Points for Decision Makers
:: Cost per vaccinated girl, vaccine coverage and screening coverage are highly uncertain parameters in model-based cost-effectiveness analysis (CEA) of human papillomavirus (HPV) vaccines in low- and middle-income countries.
:: These uncertain parameters matter as they can reverse the conclusions regarding cost-effectiveness made by a CEA, thereby altering the resulting policy choice.
:: More precise parameters could be obtained by adapting costings of HPV vaccine delivery conducted for other countries, observing the outcomes of cervical cancer screening programmes in the same geographical region, and taking into account the country’s previous experience with other vaccination programmes.

PLOS Currents: Disasters
http://currents.plos.org/disasters/
[Accessed 7 January 2017]

Research Article
Reducing Disaster Exacerbated Non-communicable Diseases Through Public Health Infrastructure Resilience: Perspectives of Australian Disaster Service Providers
December 21, 2016 ·
Background: The exposure of people and infrastructure to flood and storm related disasters across the world is increasing faster than vulnerability is decreasing. For people with non-communicable diseases this presents a significant risk as traditionally the focus of disaster management systems has been on immediate trauma and communicable diseases. This focus must now be expanded to include the management of non-communicable diseases because these conditions are generating the bulk of ill health, disability and premature death around the globe. When public health service infrastructure is destroyed or damaged access to treatment and care is severely jeopardised, resulting in an increased risk of non-communicable disease exacerbation or even death. This research proposes disaster responders, coordinators and government officials are vital assets to mitigate and eventually prevent these problems from being exacerbated during a disaster. This is due to their role in supporting the public health service infrastructure required to maximise treatment and care for people with non-communicable diseases. By focusing on the disaster cycle as a template, and on mitigation and prevention phases in particular, these actions and activities performed by disaster service responders will lead to overall improved preparedness, response, recovery and rehabilitation phases.
Methods: Data were collected via 32 interviews and one focus group (eight participants) between March 2014 and August 2015 (total of 40 participants). The research was conducted in the State of Queensland, Australia, with disaster service providers. The analysis included the phases of: organizing data; data description; data classification; and interpretation.
Results: The research found a relationship between the impact of a disaster on public health service infrastructure, and increased health risks for people with non-communicable diseases. Mitigation strategies were described for all phases of the disaster cycle impacting public health service infrastructure. Specific measures include: increasing the use of telemedicine; preplanning with medical suppliers; effective town planning; health professionals visiting evacuation centers; evacuation centers having power for medical equipment; hubs for treatment and care after a disaster; evacuation of high risk people prior to disaster; mapping people at risk by non-communicable disease; and a mechanism for sharing information between agencies. A common theme from the participants was that having accurate and easily accessible data on people with non-communicable diseases would allow disaster service providers to adequately prepare for and respond to a disaster.
Conclusions: Disaster service providers can play a vital role in reducing the risk of disaster exacerbated non-communicable diseases through public health service infrastructure resilience. They are often employed in communities where disasters occur and are therefore best-placed to lead implementation of the mitigation strategies identified in this research. To sustainably implement the mitigation strategies they will need to become integrated into effective performance and monitoring of the disaster response and health sector during non-disaster periods. For this to occur, the strategies should be integrated into business and strategic plans. Achieving this will help implement the Sendia Framework for Disaster Risk Reduction 2015-2030 and, most importantly, help protect the health of people with non-communicable diseases before, during and after a disaster.

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 7 January 2017]

Research Article
Exploring the Continuum of Vaccine Hesitancy Between African American and White Adults: Results of a Qualitative Study
December 29, 2016 ·
Vaccine delay and refusal present very real threats to public health. Since even a slight reduction in vaccination rates could produce major consequences as herd immunity is eroded, it is imperative to understand the factors that contribute to decision-making about vaccines. Recent scholarship on the concept of “vaccine hesitancy” emphasizes that vaccine behaviors and beliefs tend fall along a continuum from refusal to acceptance. Most research on hesitancy has focused on parental decision-making about childhood vaccines, but could be extended to explore decision-making related to adult immunization against seasonal influenza. In particular, vaccine hesitancy could be a useful approach to understand the persistence of racial/ethnic disparities between African American and White adults. This study relied on a thematic content analysis of qualitative data, including 12 semi-structured interviews, 9 focus groups (N=90), and 16 in-depth interviews, for a total sample of 118 (N=118) African American and White adults. All data were transcribed and analyzed with Atlas.ti. A coding scheme combining both inductive and deductive codes was utilized to identify themes related to vaccine hesitancy. The study found a continuum of vaccine behavior from never-takers, sometimes-takers, and always-takers, with significant differences between African Americans and Whites.  We compared our findings to the Three Cs: Complacency, Convenience, and Confidence framework. Complacency contributed to low vaccine acceptance with both races.  Among sometimes-takers and always-takers, convenience was often cited as a reason for their behavior, while never-takers of both races were more likely to describe other reasons for non-vaccination, with convenience only a secondary explanation.  However, for African Americans, cost was a barrier.  There were racial differences in trust and confidence that impacted the decision-making process. The framework, though not a natural fit for the data, does provide some insight into the differential sources of hesitancy between these two populations. Complacency and confidence clearly impact vaccine behavior, often more profoundly than convenience, which can contribute either negatively or positively to vaccine acceptance. The Three Cs framework is a useful, but limited tool to understanding racial disparities. Understanding the distinctions in those cultural factors that drive lower vaccine confidence and greater hesitancy among African Americans could lead to more effective communication strategies as well as changes in the delivery of vaccines to increase convenience and passive acceptance.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 7 January 2017)

Research Article
Zika Virus Infection as a Cause of Congenital Brain Abnormalities and Guillain–Barré Syndrome: Systematic Review
Fabienne Krauer, Maurane Riesen, Ludovic Reveiz, Olufemi T. Oladapo, Ruth Martínez-Vega, Teegwendé V. Porgo, Anina Haefliger, Nathalie J. Broutet, Nicola Low, WHO Zika Causality Working Group
| published 03 Jan 2017 PLOS Medicine
http://dx.doi.org/10.1371/journal.pmed.1002203

Research Article
Priority-Setting for Novel Drug Regimens to Treat Tuberculosis: An Epidemiologic Model
Emily A. Kendall, Sourya Shrestha, Ted Cohen, Eric Nuermberger, Kelly E. Dooley, Lice Gonzalez-Angulo, Gavin J. Churchyard, Payam Nahid, Michael L. Rich, Cathy Bansbach, Thomas Forissier, Christian Lienhardt, David W. Dowdy
| published 03 Jan 2017 PLOS Medicine
http://dx.doi.org/10.1371/journal.pmed.1002202