Bangkok Principles for the implementation of the health aspects of the Sendai Framework for Disaster Risk Reduction 2015-2030
11 March 2016 :: 3 pages

The International Conference on the Implementation of the Health Aspect of the Sendai Framework for Disaster Risk Reduction 2015-2030, held on 10-11 March 2016, in Bangkok, Thailand, adopted the “Bangkok Principles” which articulates measures that could assist countries in implementing the health aspects of the Sendai Framework for Disaster Risk Reduction.

The Bangkok Principles are organized under seven recommendation themes:
1. Promote systematic integration of health into national and sub-national disaster risk reduction policies and plans and the inclusion of emergency and disaster risk management programmes in national and sub-national health strategies.

2. Enhance cooperation between health authorities and other relevant stakeholders to strengthen country capacity for disaster risk management for health, the implementation of the International Health Regulations (2005) and building of resilient health systems.

3. Stimulate people-centered public and private investment in emergency and disaster risk reduction, including in health facilities and infrastructure.

4. Integrate disaster risk reduction into health education and training and strengthen capacity building of health workers in disaster risk reduction.

5. Incorporate disaster-related mortality, morbidity and disability data into multi-hazards early warning system, health core indicators and national risk assessments

6. Advocate for, and support cross-sectoral, transboundary collaboration including information sharing, and science and technology for all hazards, including biological hazards.

7. Promote coherence and further development of local and national policies and strategies, legal frameworks, regulations, and institutional arrangements.
Full text: http://www.preventionweb.net/files/47606_bangkokprinciples.pdf

UN Secretary General’s High-Level Panel on Access to Medicines
http://www.unsgaccessmeds.org/#homepage-1

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GLOBAL DIALOGUE LIVE FROM JOHANNESBURG
When: 10:00 – 17:00 (London time)
Location: Johannesburg, South Africa

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WHO submission
Submission in response to request for a written contribution by the World Health Organization to the UN SG High-Level Panel on Access to Medicines.
7 March 2016 :: 20 pages
…The mandate of the High-Level Panel focuses on the current innovation model and its impact on access to health products. It does not include the many other complex challenges countries are facing in designing robust health systems and ensuring delivery of primary care. The Panel is looking both for possibilities for incremental improvements of the current system and for alternative or complementary models through which to research and develop new medical treatments, vaccines and diagnostics.
This submission thus briefly summarizes relevant WHO experience in access to medicines that relate to the current innovation system, and presents in more detail a number of WHO-led projects that implement alternative models of innovation. These will foster the development of health products that address priority health needs, to ensure these products will be affordable and available to those who need them….

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 12 March 2016)

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Research article
Scoping review of complexity theory in health services research
There are calls for better application of theory in health services research. Research exploring knowledge translation and interprofessional collaboration are two examples, and in both areas, complexity theory…
David S. Thompson, Xavier Fazio, Erika Kustra, Linda Patrick and Darren Stanley
BMC Health Services Research 2016 16:87
Published on: 12 March 2016

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Research article
Examining the role of a decision aid in reducing decisional conflict amongst hospital healthcare workers towards receiving the influenza vaccine
Currently the uptake of the influenza vaccine amongst Australian hospital staff remains low. While some staff members choose not to receive the vaccine, others may feel decisional conflict around whether to…
Holly Seale, Rajneesh Kaur, Kerryn Lajoie, Julie Dixon and Julie Gallard
BMC Health Services Research 2016 16:84
Published on: 9 March 2016

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 12 March 2016)

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Review
Does tuberculosis threaten our ageing populations?
The global population is ageing quickly and our understanding of age-related changes in the immune system suggest that the elderly will have less immunological protection from active tuberculosis (TB).
Rachel Byng-Maddick and Mahdad Noursadeghi
BMC Infectious Diseases 2016 16:119
Published on: 11 March 2016

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Study protocol
Clinical evaluation of dengue and identification of risk factors for severe disease: protocol for a multicentre study in 8 countries
The burden of dengue continues to increase globally, with an estimated 100 million clinically apparent infections occurring each year…
Thomas Jaenisch, Dong Thi Hoai Tam, Nguyen Tan Thanh Kieu, Tran Van Ngoc, Nguyen Tran Nam, Nguyen Van Kinh, Sophie Yacoub, Ngoun Chanpheaktra, Varun Kumar, Lucy Lum Chai See, Jameela Sathar, Ernesto Pleités Sandoval, Gabriela Maria Marón Alfaro, Ida Safitri Laksono, Yodi Mahendradhata, Malabika Sarker…
BMC Infectious Diseases 2016 16:120
Published on: 11 March 2016

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 12 March 2016)

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Research article
A survey of the governance capacity of national public health associations to enhance population health
James Chauvin, Mahesh Shukla, James Rice and Laetitia Rispel
BMC Public Health 2016 16:251
Published on: 11 March 2016
Abstract
Background
National public health associations (PHAs) are key partners with governments and communities to improve, protect and promote the public’s health. Governance and organizational capacity are among the key determinants of a PHA’s effectiveness as an advocate for appropriate public health policies and practice.
Methods
During 2014, the World Federation of Public Health Associations (WFPHA) conducted an on-line survey of its 82 PHA members, to identify the state of organizational governance of national public health associations, as well as the factors that influence optimal organizational governance. The survey consisted of 13 questions and focused on the main elements of organizational governance: cultivating accountability; engaging stakeholders; setting shared direction; stewarding resources; and, continuous governance enhancement. Four questions included a qualitative open-ended response for additional comments. The survey data were analyzed using Microsoft Excel. The qualitative data was analyzed using thematic content analysis
Results
Responses were received from 62 PHAs, constituting a 75.6 % response rate. The two most important factors that support governance effectiveness were a high degree of integrity and ethical behavior of the PHA’s leaders (77 %) and the competence of people serving on the PHA’s governing body (76 %). The lack of financial resources was considered as the most important factor that negatively affected organizational governance effectiveness (73 %). The lack of mentoring for future PHA leaders; ineffective or incompetent leadership; lack of understanding about good governance practices; and lack of accurate information for strategic planning were identified as factors influencing PHA governance effectiveness. Critical elements for PHA sustainability included diversity, gender-responsiveness and inclusive governance practices, and strategies to build the future generation of public health leaders.
Conclusion
National PHA have a responsibility to put into place the practices and infrastructure that enhance organizational governance. This will enhance their ability to be effective advocates for policies and practices that enhance, protect and promote the public’s health. The WFPHA has an important role to play in providing the technical assistance and financial resources to assist PHAs in attaining and sustaining a higher level of governance capacity.

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 12 March 2016]

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Research
Retrospective analysis of reproductive health indicators in the United Nations High Commissioner for Refugees post-emergency camps 2007–2013
Jennifer Whitmill, Curtis Blanton, Sathyanarayanan Doraiswamy, Nadine Cornier, Marian Schilperood, Paul Spiegel and Barbara Tomczyk
Published on: 9 March 2016
Abstract
Background
The United Nations Refugee Agency’s Health Information System issues analytical reports on the current camp conditions and trends for priority reproductive health issues. The goal was to assess the status of reproductive health by analyzing seven indicators and comparing them to standards and host country estimates.
Methods
Data on seven indicators were extracted from the database during a seven-year period (2007 through 2013). A standardized country inclusion criterion was created based on the year of country implementation and the percentage of missing reports per camp and year. The unit of analysis was monthly camp reports by year within a country. To account for the lack of independence of monthly camp reports, the variance was computed using Taylor Series Linearization methods in SAS.
Results
Ten of the 23 eligible countries met the inclusion criterion. The mean camp maternal and neonatal mortality rates, except for two country years, were lower than the host country estimates for all countries and years. There was a significant increase in the percent of births attended by a skilled birth attendant (p <0.0001), and 8 of 10 countries did not meet the standard of 100 % for all reporting years. The percent of births performed by Caesarian section (p<0.001), were below the recommended minimum standard for nearly half of the countries every year. There was a significant increase in the percent of women screened for syphilis across years (p<0.0001) and the percent of women who received post HIV exposure prophylaxis (p<0.0001) and 10 % reached the standard for all reporting years, respectively.
Conclusion
Comprehensive, consistent and comparable statistics on reproductive health provides an opportunity to assess progress towards indicator standards. Despite some improvements over time, this analysis confirms that most countries did not meet standards and that there were differences in reproductive health indicators between countries and across years. Consequently, the HIS periodic monitoring of key reproductive health indicators at the camp level should continue. Data should be used to improve intervention strategies.

Emerging Infectious Diseases
Volume 22, Number 3—March 2016
http://wwwnc.cdc.gov/eid/

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Expedited Ahead-of-Print Articles
Zika Virus in a Traveler Returning to China from Caracas, Venezuela, February 2016 J. Li et al. June 2016
Perspectives on West Africa Ebola Virus Disease Outbreak, 2013–2016 J. R. Spengler et al. June 2016
Projecting Month of Birth for At-Risk Infants after Zika Virus Disease Outbreaks J. Reefhuis et al. May 2016

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Research
Mortality Rates during Cholera Epidemic, Haiti, 2010–2011
F. J. Luquero et al.
Summary
Actual rates were higher than rates calculated from healthcare facility reports.

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Effects of Response to 2014–2015 Ebola Outbreak on Deaths from Malaria, HIV/AIDS, and Tuberculosis, West Africa
A. S. Parpia et al.
Abstract
Response to the 2014–2015 Ebola outbreak in West Africa overwhelmed the healthcare systems of Guinea, Liberia, and Sierra Leone, reducing access to health services for diagnosis and treatment for the major diseases that are endemic to the region: malaria, HIV/AIDS, and tuberculosis. To estimate the repercussions of the Ebola outbreak on the populations at risk for these diseases, we developed computational models for disease transmission and infection progression. We estimated that a 50% reduction in access to healthcare services during the Ebola outbreak exacerbated malaria, HIV/AIDS, and tuberculosis mortality rates by additional death counts of 6,269 (2,564–12,407) in Guinea; 1,535 (522–2,8780) in Liberia; and 2,819 (844–4,844) in Sierra Leone. The 2014–2015 Ebola outbreak was catastrophic in these countries, and its indirect impact of increasing the mortality rates of other diseases was also substantial.

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Faster Detection of Poliomyelitis Outbreaks to Support Polio Eradication
I. M. Blake et al.
Abstract
As the global eradication of poliomyelitis approaches the final stages, prompt detection of new outbreaks is critical to enable a fast and effective outbreak response. Surveillance relies on reporting of acute flaccid paralysis (AFP) cases and laboratory confirmation through isolation of poliovirus from stool. However, delayed sample collection and testing can delay outbreak detection. We investigated whether weekly testing for clusters of AFP by location and time, using the Kulldorff scan statistic, could provide an early warning for outbreaks in 20 countries. A mixed-effects regression model was used to predict background rates of nonpolio AFP at the district level. In Tajikistan and Congo, testing for AFP clusters would have resulted in an outbreak warning 39 and 11 days, respectively, before official confirmation of large outbreaks. This method has relatively high specificity and could be integrated into the current polio information system to support rapid outbreak response activities.

Eurosurveillance
Volume 21, Issue 10, 10 March 2016
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

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Rapid communications
Isolation of infectious Zika virus from saliva and prolonged viral RNA shedding in a traveller returning from the Dominican Republic to Italy, January 2016
by L Barzon, M Pacenti, A Berto, A Sinigaglia, E Franchin, E Lavezzo, P Brugnaro, G Palù

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Profile of illness in Syrian refugees: A GeoSentinel analysis, 2013 to 2015
by F Mockenhaupt, K Barbre, M Jensenius, C Larsen, E Barnett, W Stauffer, C Rothe, H Asgeirsson, D Hamer, D Esposito, P Gautret, P Schlagenhauf
Abstract
Screening of 488 Syrian unaccompanied minor refugees (< 18 years-old) in Berlin showed low prevalence of intestinal parasites (Giardia, 7%), positive schistosomiasis serology (1.4%) and absence of hepatitis B. Among 44 ill adult Syrian refugees examined at GeoSentinel clinics worldwide, cutaneous leishmaniasis affected one in three patients; other noteworthy infections were active tuberculosis (11%) and chronic hepatitis B or C (9%). These data can contribute to evidence-based guidelines for infectious disease screening of Syrian refugees.

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Research Articles
Waning immunity against mumps in vaccinated young adults, France 2013
by S Vygen, A Fischer, L Meurice, I Mounchetrou Njoya, M Gregoris, B Ndiaye, A Ghenassia, I Poujol, J Stahl, D Antona, Y Le Strat, D Levy-Bruhl, P Rolland

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Children and young people with perinatal HIV in Europe: epidemiological situation in 2014 and implications for the future
by Writing group for the Kids to Adults Working Group and Data Management and Harmonisation Group in EuroCoord

International Journal of Infectious Diseases
March 2016 Volume 44, p1-74
http://www.ijidonline.com/current

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Editorial
HIV in the MENA Region: Cultural and Political Challenges
Seif Al-Abri, Jacques E. Mokhbat
p64–65
Published online: February 9 2016
Preview
Over the last few years, our knowledge of the HIV epidemic and its drivers in the Middle East and North Africa (MENA) region have improved markedly, thanks to many recently conducted studies.1 While the annual number of new HIV infections in sub-Saharan Africa has declined by 33% since 2005, new HIV infections in the MENA region have increased by 31% since 2001, the greatest increase in all regions in the world. There are growing HIV epidemics in key populations (KPs) including people who inject drugs, men who have sex with men, and to a lesser extent, female sex workers.

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Reviews
Rapid Spread of Zika Virus in The Americas – Implications for Public Health Preparedness for Mass Gatherings at the 2016 Brazil Olympic Games
Eskild Petersen, Mary E. Wilson, Sok Touch, Brian McCloskey, Peter Mwaba, Matthew Bates, Osman Dar, Frank Mattes, Mike Kidd, Giuseppe Ippolito, Esam I. Azhar, Alimuddin Zumla
p11–15
Published online: February 4 2016
Highlights
:: We discuss the global spread of the Zika virus (ZIKV) since its first discovery in 1947 in Uganda to the current outbreak in the Americas which has been declared a ‘Global emergency’ by the World Health Organization.
:: We highlight that ZIKV and other arboviruses may pose a threat to the attendees of the 2016 Rio De Janeiro Olympic and Paralympic games and to residents of Brazil.
:: We review clinical features and highlight the need for more accurate and rapid screening tests for ZIKV
:: We discuss the recent possible linkage of microcephaly in babies exposed to ZIKV in utero, and highlight knowledge gaps in the epidemiology and pathogenesis of ZIKV.
:: We review the public health implications of the current ZIKV outbreak and highlight the need for enhanced preparedness and proactive surveillance for all infectious diseases before, during and after the 2016 Olympic games.
:: We stress that there is no specific treatment available or preventive vaccines and that that the emergence of ZIKV soon after the Ebola outbreak, is yet another wake up call for the urgent need for a coordinated global response for prevention and spread of infectious diseases with epidemic potential at mass gatherings events
Summary
Mass gatherings at major international sporting events put millions of international travelers and local host-country residents at risk of acquiring infectious diseases, including locally endemic infectious diseases. The mosquito-borne Zika virus (ZIKV) has recently aroused global attention due to its rapid spread since its first detection in May 2015 in Brazil to 22 other countries and other territories in the Americas. The ZIKV outbreak in Brazil, has also been associated with a significant rise in the number of babies born with microcephaly and neurological disorders, and has been declared a ‘Global Emergency by the World Health Organization. This explosive spread of ZIKV in Brazil poses challenges for public health preparedness and surveillance for the Olympics and Paralympics which are due to be held in Rio De Janeiro in August, 2016. We review the epidemiology and clinical features of the current ZIKV outbreak in Brazil, highlight knowledge gaps, and review the public health implications of the current ZIKV outbreak in the Americas. We highlight the urgent need for a coordinated collaborative response for prevention and spread of infectious diseases with epidemic potential at mass gatherings events.

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Reviews
HIV/AIDS: trends in the Middle East and North Africa region
Deniz Gökengin, Fardad Doroudi, Johnny Tohme, Ben Collins, Navid Madani
p66–73
Published in issue: March 2016
Highlights
:: New HIV infections have been on the rise in the Middle East and North Africa (MENA) region in recent years.
:: There is substantial heterogeneity in HIV epidemic dynamics across MENA, and different risk contexts are present throughout the region.
:: Overall, the major route of infection in the MENA region seems to be sexual transmission, but a range of challenges limit interventions to determine the actual sexual trends.
:: Despite unfavorable conditions, many countries in the region have put significant efforts into scaling up their response to this growing epidemic.
Summary
Objectives
To give an overview of the HIV epidemic in the Middle East and North Africa (MENA) region.
Methods
Articles on the MENA region were reviewed.
Results
The MENA region comprises a geographically defined group of countries including both high-income, well-developed nations and low- and middle-income countries. While the annual number of new HIV infections in Sub-Saharan Africa has declined by 33% since 2005, new HIV infections in the MENA region have increased by 31% since 2001, which is the highest increase among all regions in the world. Moreover, the number of AIDS-related deaths in 2013 was estimated to be 15 000, representing a 66% increase since 2005. However, the current prevalence of 0.1% is still among the lowest rates globally. There is substantial heterogeneity in HIV epidemic dynamics across MENA, and different risk contexts are present throughout the region. Despite unfavorable conditions, many countries in the region have put significant effort into scaling up their response to this growing epidemic, while in others the response to HIV is proving slower due to denial, stigma, and reluctance to address sensitive issues.
Conclusions
The HIV epidemic in the MENA region is still at a controllable level, and this opportunity should not be missed.

JAMA
March 8, 2016, Vol 315, No. 10
http://jama.jamanetwork.com/issue.aspx

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Viewpoint | March 8, 2016
The Ethical Challenges of Compassionate Use
FREE
Arthur L. Caplan, PhD; Amrit Ray, MD, MBA

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Viewpoint | March 8, 2016
Immunization Policy and the Importance of Sustainable Vaccine Pricing
H. Cody Meissner, MD1
[Initial text]
This Viewpoint discusses vaccine costs and policy and explains the importance of balancing these factors to provide optimal care while restricting spending on costly interventions with limited benefit.

The individual, societal, and economic benefits of disease prevention resulting from childhood and adult immunization programs in the United States are without question. A report from the Centers for Disease Control and Prevention (CDC) describing the benefits of vaccination of the 2009 birth cohort through 18 years of age estimated that 20 million cases of vaccine-preventable disease will not occur, 42 000 early deaths related to these diseases will be avoided, and $76 billion in direct and indirect costs will be averted.1 This economic benefit stands in stark contrast to the comparatively small cost for vaccine purchases. The estimated vaccine purchasing cost for a similar birth cohort based on 2015 pricing is $7.8 billion, based on CDC costs, and $11.6 billion at private sector pricing (eTable in the Supplement).2…

JAMA Pediatrics
March 2016, Vol 170, No. 3
http://archpedi.jamanetwork.com/issue.aspx

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Editorial | March 2016
The Grand Divergence in Global Child Health Confronting Data Requirements in Areas of Conflict and Chronic Political Instability
FREE
Paul H. Wise, MD, MPH1,2; Gary L. Darmstadt, MD, MS1,2
Author Affiliations
1Division of Neonatology, Department of Pediatrics, Stanford University School of Medicine, Stanford, California
2Freeman Spogli Institute for International Studies, Stanford University, Stanford, California
[Initial text]
There is something deeply troubling about a death that goes unnoticed. Beyond the humane impulse to provide solace through collective acknowledgment and community support lies the recognition that an unnoticed death implies an unnoticed life. There can be no doubt that the accurate counting and causal attribution of morbidity and mortality provide technical information that is essential for public health planning, evaluation, and improvement in program performance. However, there is also a justice imperative inherent in counting and attribution—an imperative that transcends the practical and touches on the moral basis of global health and its commitment to the rights and societal claims of those whose health and well-being have for too long gone unnoticed.

At a global level, available data demonstrate that dramatic reductions in child mortality have occurred in many low- and middle-income countries. Moreover, long-standing disparities in survival between materially wealthy and poorer regions of the world are dissipating. If sustained, this historic record of reduced mortality inequality could drive a “grand convergence” in life expectancy during the next 2 decades.1 This prospect has been used constructively to advocate for a continued global commitment to economic development and the provision of effective health interventions.

On closer examination, however, it is apparent that the trends toward convergence have not been universal. Some countries are being left behind. These countries have experienced stagnant or, in some arenas, worsening child health outcomes. Indeed, these countries could be described as contributing to a “grand divergence” in life expectancies, in which their health indicators fall increasingly behind those of other low- and middle-income countries.2

The article by the Global Burden of Disease (GBD) Pediatrics Collaboration in this issue of JAMA Pediatrics represents an important contribution to the field of global health and provides troubling evidence of the diverging trends in child health and well-being.3 What is now evident from even a cursory examination of presented child mortality trends is that the countries making the least progress in child survival and well-being, particularly since 2000, are those most likely to be plagued by chronic civil conflict, political instability, and weak governance. Nigeria and the Democratic Republic of the Congo, which together account for more than a third of all child deaths in sub-Saharan Africa, experienced annual child mortality declines of 2.2% and 1.8%, respectively (eTable 9 in their Supplement). It is useful to note that during this same period among the most rapid annual declines were those recorded in China (6.01%), Iran (5.97%), and Bangladesh (5.24%).

Using data from the GBD 2013 study, the article presents detailed child mortality and morbidity trends for the 50 countries with the largest child and adolescent populations in the world, information that will prove essential for programmatic evaluation and planning…

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Special Communication
Global and National Burden of Diseases and Injuries Among Children and Adolescents Between 1990 and 2013: Findings From the Global Burden of Disease 2013 Study
FREE
Global Burden of Disease Pediatrics Collaboration
Includes: Supplemental Content
Abstract
Importance
The literature focuses on mortality among children younger than 5 years. Comparable information on nonfatal health outcomes among these children and the fatal and nonfatal burden of diseases and injuries among older children and adolescents is scarce.
Objective
To determine levels and trends in the fatal and nonfatal burden of diseases and injuries among younger children (aged Evidence Review
Data from vital registration, verbal autopsy studies, maternal and child death surveillance, and other sources covering 14,244 site-years (ie, years of cause of death data by geography) from 1980 through 2013 were used to estimate cause-specific mortality. Data from 35,620 epidemiological sources were used to estimate the prevalence of the diseases and sequelae in the GBD 2013 study. Cause-specific mortality for most causes was estimated using the Cause of Death Ensemble Model strategy. For some infectious diseases (eg, HIV infection/AIDS, measles, hepatitis B) where the disease process is complex or the cause of death data were insufficient or unavailable, we used natural history models. For most nonfatal health outcomes, DisMod-MR 2.0, a Bayesian metaregression tool, was used to meta-analyze the epidemiological data to generate prevalence estimates.
Findings
Of the 7.7 (95% uncertainty interval [UI], 7.4-8.1) million deaths among children and adolescents globally in 2013, 6.28 million occurred among younger children, 0.48 million among older children, and 0.97 million among adolescents. In 2013, the leading causes of death were lower respiratory tract infections among younger children (905,059 deaths; 95% UI, 810 304-998,125), diarrheal diseases among older children (38,325 deaths; 95% UI, 30,365-47,678), and road injuries among adolescents (115186 deaths; 95% UI, 105 185-124870). Iron deficiency anemia was the leading cause of years lived with disability among children and adolescents, affecting 619 (95% UI, 618-621) million in 2013. Large between-country variations exist in mortality from leading causes among children and adolescents. Countries with rapid declines in all-cause mortality between 1990 and 2013 also experienced large declines in most leading causes of death, whereas countries with the slowest declines had stagnant or increasing trends in the leading causes of death. In 2013, Nigeria had a 12% global share of deaths from lower respiratory tract infections and a 38% global share of deaths from malaria. India had 33% of the world’s deaths from neonatal encephalopathy. Half of the world’s diarrheal deaths among children and adolescents occurred in just 5 countries: India, Democratic Republic of the Congo, Pakistan, Nigeria, and Ethiopia.
Conclusions and Relevance
Understanding the levels and trends of the leading causes of death and disability among children and adolescents is critical to guide investment and inform policies. Monitoring these trends over time is also key to understanding where interventions are having an impact. Proven interventions exist to prevent or treat the leading causes of unnecessary death and disability among children and adolescents. The findings presented here show that these are underused and give guidance to policy makers in countries where more attention is needed.

The Lancet
Mar 12, 2016 Volume 387 Number 10023 p1027-1132
http://www.thelancet.com/journals/lancet/issue/current
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Comment
NextGen HIV prevention: new possibilities and questions
Kenneth H Mayer
Published Online: 04 March 2016
Summary
In less than a decade, HIV prevention has evolved from a reliance on education, behavioural interventions, and use of condoms to focusing on the optimum use of antiretrovirals to suppress infectiousness and for primary prophylaxis. Landmark studies have shown the efficacy of the early initiation of treatment for people infected with HIV,1 and the use of oral pre-exposure prophylaxis (PrEP) for those at highest risk to decrease HIV transmission.2 Despite PrEP being shown to be efficacious in most trials in which it was assessed, the paramount importance of consistent use of preventive medication was shown when oral and topical tenofovir-based regimens did not show efficacy in three studies involving young African women, primarily because of suboptimum adherence.

New England Journal of Medicine
March 10, 2016 Vol. 374 No. 10
http://www.nejm.org/toc/nejm/medical-journal

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Brief Report
Zika Virus Associated with Microcephaly
Jernej Mlakar, M.D., Misa Korva, Ph.D., Nataša Tul, M.D., Ph.D., Mara Popović, M.D., Ph.D., Mateja Poljšak-Prijatelj, Ph.D., Jerica Mraz, M.Sc., Marko Kolenc, M.Sc., Katarina Resman Rus, M.Sc., Tina Vesnaver Vipotnik, M.D., Vesna Fabjan Vodušek, M.D., Alenka Vizjak, Ph.D., Joze Pizem, M.D., Ph.D., Miroslav Petrovec, M.D., Ph.D., and Tatjana Avsic Zupanc, Ph.D.
Abstract
A widespread epidemic of Zika virus (ZIKV) infection was reported in 2015 in South and Central America and the Caribbean. A major concern associated with this infection is the apparent increased incidence of microcephaly in fetuses born to mothers infected with ZIKV. In this report, we describe the case of an expectant mother who had a febrile illness with rash at the end of the first trimester of pregnancy while she was living in Brazil. Ultrasonography performed at 29 weeks of gestation revealed microcephaly with calcifications in the fetal brain and placenta. After the mother requested termination of the pregnancy, a fetal autopsy was performed. Micrencephaly (an abnormally small brain) was observed, with almost complete agyria, hydrocephalus, and multifocal dystrophic calcifications in the cortex and subcortical white matter, with associated cortical displacement and mild focal inflammation. ZIKV was found in the fetal brain tissue on reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay, with consistent findings on electron microscopy. The complete genome of ZIKV was recovered from the fetal brain.

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Editorial
Zika Virus and Microcephaly
Eric J. Rubin, M.D., Ph.D., Michael F. Greene, M.D., and Lindsey R. Baden, M.D.
DOI: 10.1056/NEJMe1601862
[Extract]
…Zika virus has spread explosively since its introduction into South America and has now been found throughout Central America and the Caribbean. The full extent of disease is not clear — most infections are asymptomatic and many are associated with only mild disease.6 But the apparent risk of microcephaly was enough for the World Health Organization to declare a public health emergency of international concern on February 1.

What more do we need to know to help us manage and control this outbreak? Certainly, understanding the disease better could have long-term benefits, including the development of protective vaccines. However, it is the information that we do not yet have that has potential immediate applications.

Although many authorities are counseling women who are pregnant or could become pregnant to avoid travel to affected areas, the millions of women who live in these places are faced with enormous uncertainty, and as the virus spreads, many more will be affected. For example, assuming the association between Zika virus and microcephaly exists, we do not know whether the timing of the infection during pregnancy has an effect on the risk of fetal abnormalities, nor do we have any idea of the magnitude of that risk. The development of rapid, scalable diagnostic tests is needed, since the current polymerase-chain-reaction assay detects viral RNA and thus should be positive only during the period of viremia, which may be relatively short.

Current serologic assays have considerable cross-reactivity with other flaviviruses, including those that are endemic in the same areas (as in the case now being reported), and serologic assays specific for Zika virus are not easily available. Thus, it may be difficult to determine retrospectively whether a woman has been infected. This will be particularly difficult in areas where dengue virus and other pathogens can cause symptoms similar to those of the Zika virus.
In addition, it is unclear whether asymptomatic or minimally symptomatic disease poses a risk to the fetus. It is possible that as is the case with mumps, early infection could result in fetal loss rather than malformations. And, as in this case report, ultrasonography may detect severe fetal abnormalities only very late in gestation — in many cases, too late to terminate the pregnancy. Is there a sensitive test that can be applied earlier? And is previous infection protective?

Although we need a good deal of research to define critical aspects of infection, there is much to do immediately. A vulnerable point for Zika virus transmission is the mosquito vector. Unfortunately, mosquito-control efforts have failed to curtail the spread of many similar pathogens, including dengue and chikungunya viruses, which are carried by the same aedes species and are spreading in the same communities currently affected by the Zika virus. Perhaps this new threat will help boost such control efforts with the use of both old and new approaches. Women need to have access to relevant health care services, including contraception, diagnostics, and pregnancy-termination services. And the many affected children need to have care. Coming shortly after the global response to the Ebola virus, the rapid spread of the Zika virus reminds us how connected we all are.7 Once again, an outbreak is going to challenge our public health infrastructure and require a substantial response.

Pediatrics
March 2016, VOLUME 137 / ISSUE
http://pediatrics.aappublications.org/content/137/3?current-issue=y

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Articles
Prevalence of HPV After Introduction of the Vaccination Program in the United States
Lauri E. Markowitz, Gui Liu, Susan Hariri, Martin Steinau, Eileen F. Dunne, Elizabeth R. Unger
Pediatrics Mar 2016, 137 (3) 1-9; DOI: 10.1542/peds.2015-1968

Vaccination and 30-Day Mortality Risk in Children, Adolescents, and Young Adults
Natalie L. McCarthy, Julianne Gee, Lakshmi Sukumaran, Eric Weintraub, Jonathan Duffy, Elyse O. Kharbanda, Roger Baxter, Stephanie Irving, Jennifer King, Matthew F. Daley, Rulin Hechter, Michael M. McNeil
Pediatrics Mar 2016, 137 (3) 1-8; DOI: 10.1542/peds.2015-2970

Waning Tdap Effectiveness in Adolescents
Nicola P. Klein, Joan Bartlett, Bruce Fireman, Roger Baxter
Pediatrics Mar 2016, 137 (3) 1-9; DOI: 10.1542/peds.2015-3326

Parental Choice of Recall Method for HPV Vaccination: A Pragmatic Trial
Allison Kempe, Sean T. O’Leary, Jo Ann Shoup, Shannon Stokley, Steven Lockhart, Anna Furniss, L. Miriam Dickinson, Juliana Barnard, Matthew F. Daley
Pediatrics Mar 2016, 137 (3) 1-10; DOI: 10.1542/peds.2015-2857

Complete Influenza Vaccination Trends for Children Six to Twenty-Three Months
Tammy A. Santibanez, Lisa A. Grohskopf, Yusheng Zhai, Katherine E. Kahn
Pediatrics Mar 2016, 137 (3) 1-10; DOI: 10.1542/peds.2015-3280

Review Article
Global Varicella Vaccine Effectiveness: A Meta-analysis
Mona Marin, Melanie Marti, Anita Kambhampati, Stanley M. Jeram, Jane F. Seward
Pediatrics Mar 2016, 137 (3) 1-10; DOI: 10.1542/peds.2015-3741

Quality Reports
Improving HPV Vaccination Rates Using Maintenance-of-Certification Requirements
Alexander G. Fiks, Xianqun Luan, Stephanie L. Mayne
Pediatrics Mar 2016, 137 (3) 1-11; DOI: 10.1542/peds.2015-0675

PharmacoEconomics
Volume 34, Issue 3, March 2016
http://link.springer.com/journal/40273/34/3/page/1

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Commentary
Economic Evidence of Pneumococcal Vaccination in Older Adults: Uncertain Modelling or Competitive Tendering?
Livio Garattini, Anna Padula, Milene Rangel Da Costa
[No abstract]

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Consensus Statement
Methods for Health Economic Evaluation of Vaccines and Immunization Decision Frameworks: A Consensus Framework from a European Vaccine Economics Community
Bernhard Ultsch , Oliver Damm, Philippe Beutels, Joke Bilcke, Bernd Brüggenjürgen, Andreas Gerber-Grote, Wolfgang Greiner, Germaine Hanquet, Raymond Hutubessy
and 11 more
Open Access pdf: http://link.springer.com/content/pdf/10.1007%2Fs40273-015-0335-2.pdf
Abstract
Background
Incremental cost-effectiveness and cost-utility analyses [health economic evaluations (HEEs)] of vaccines are routinely considered in decision making on immunization in various industrialized countries. While guidelines advocating more standardization of such HEEs (mainly for curative drugs) exist, several immunization-specific aspects (e.g. indirect effects or discounting approach) are still a subject of debate within the scientific community.
Objective
The objective of this study was to develop a consensus framework for HEEs of vaccines to support the development of national guidelines in Europe.
Methods
A systematic literature review was conducted to identify prevailing issues related to HEEs of vaccines. Furthermore, European experts in the field of health economics and immunization decision making were nominated and asked to select relevant aspects for discussion. Based on this, a workshop was held with these experts. Aspects on ‘mathematical modelling’, ‘health economics’ and ‘decision making’ were debated in group-work sessions (GWS) to formulate recommendations and/or—if applicable—to state ‘pros’ and ‘contras’.
Results
A total of 13 different aspects were identified for modelling and HEE: model selection, time horizon of models, natural disease history, measures of vaccine-induced protection, duration of vaccine-induced protection, indirect effects apart from herd protection, target population, model calibration and validation, handling uncertainty, discounting, health-related quality of life, cost components, and perspectives. For decision making, there were four aspects regarding the purpose and the integration of HEEs of vaccines in decision making as well as the variation of parameters within uncertainty analyses and the reporting of results from HEEs. For each aspect, background information and an expert consensus were formulated.
Conclusions
There was consensus that when HEEs are used to prioritize healthcare funding, this should be done in a consistent way across all interventions, including vaccines. However, proper evaluation of vaccines implies using tools that are not commonly used for therapeutic drugs. Due to the complexity of and uncertainties around vaccination, transparency in the documentation of HEEs and during subsequent decision making is essential.

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
(Accessed 12 March 2016)

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Parental Vaccine Hesitancy in Quebec (Canada)
March 7, 2016 · Research Article
Abstract
Introduction: “Vaccine hesitancy” is a concept frequently used in the discourse around vaccine acceptance. This study aims to contribute to the ongoing reflections on tools and indicators of vaccine hesitancy by providing results of a knowledge, attitudes and beliefs (KAB) survey conducted among parents.
Methods: Data were collected in 2014 through a computer-assisted telephone interview survey administered to a sample of parents of children aged between 2 months and 17 years of age.
Results: The majority of the 589 parents included in the analyses agreed on the importance of vaccination to protect their children’s health and to prevent the spread of diseases in the community. The majority of the parents (81%) reported that their child had received all doses of recommended vaccines and 40% of parents indicated having hesitated to have their child vaccinated. Fear of adverse events and low perceived vulnerability of the child or severity of the disease were the most frequent reasons mentioned by these vaccine-hesitant parents. In multivariate analyses, KAB items remaining significantly associated both with an incomplete vaccination status of the child and parents’ vaccine hesitancy were: not thinking that it is important to have the child vaccinated to prevent the spreading of diseases in the community; not trusting the received vaccination information and having felt pressure to have the child vaccinated.
Discussion: Further researches will be needed to better understand when, how and why these beliefs are formed in order to prevent the onset of vaccine hesitancy.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 12 March 2016)

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Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere
Brook K. Baker
Essay | published 08 Mar 2016 | PLOS Medicine
10.1371/journal.pmed.1001970
Summary Points
:: The recently negotiated Trans Pacific Partnership Agreement (TPP) contains provisions that would dramatically and negatively impact access to affordable medicines in the United States and elsewhere if it is ratified.
:: Provisions in the Intellectual Property (IP) Chapter of TPP lengthen, broaden, and strengthen patent-related monopolies on medicine and erect new monopoly protections on regulatory data as well. IP Chapter enforcement provisions also mandate injunctions preventing medicines sales, increase damage awards, and expand confiscation of medicines at the border.
:: IP rightholders gain new powers in the Investment Chapter to bring private, IP-related investor-state-dispute-settlement (ISDS) damage claims directly against foreign governments before unreviewable, three-person arbitration panels. Unrestricted IP-investor damage claims deter countries’ willingness to render adverse IP decisions and to adopt IP policy flexibilities designed to increase access to affordable medicines.
:: The Transparency Chapter contains provisions that allow pharmaceutical companies more access to government decisions listing medicines and medical devices for reimbursement.
At the very least, these multiple TPP provisions that extend pharmaceutical powers should be scaled back to the minimum consensus standards reached in the 1994 World Trade Organization (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Health advocates should convince the US Congress and opponents in other countries to reject an agreement that could so adversely impact access to medicines.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 12 March 2016)

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Successful Control of Ebola Virus Disease: Analysis of Service Based Data from Rural Sierra Leone
Kamalini Lokuge, Grazia Caleo, Jane Greig, Jennifer Duncombe, Nicholas McWilliam, James Squire, Manjo Lamin, Emily Veltus, Anja Wolz, Gary Kobinger, Marc-Antoine de la Vega, Osman Gbabai, Sao Nabieu, Mohammed Lamin, Ronald Kremer, Kostas Danis, Emily Banks, Kathryn Glass
Research Article | published 09 Mar 2016 | PLOS Neglected Tropical Diseases
10.1371/journal.pntd.0004498
Abstract
Introduction
The scale and geographical distribution of the current outbreak in West Africa raised doubts as to the effectiveness of established methods of control. Ebola Virus Disease (EVD) was first detected in Sierra Leone in May 2014 in Kailahun district. Despite high case numbers elsewhere in the country, transmission was eliminated in the district by December 2014. We describe interventions underpinning successful EVD control in Kailahun and implications for EVD control in other areas.
Methods
Internal service data and published reports from response agencies were analysed to describe the structure and type of response activities, EVD case numbers and epidemic characteristics. This included daily national situation reports and District-level data and reports of the Sierra Leone Ministry of Health and Sanitation, and Médecins Sans Frontières (MSF) patient data and internal epidemiological reports. We used EVD case definitions provided by the World Health Organisation over the course of the outbreak. Characteristics assessed included level of response activities and epidemiological features such as reported exposure (funeral-related or not), time interval between onset of illness and admission to the EVD Management Centre (EMC), work-related exposures (health worker or not) and mortality. We compared these characteristics between two time periods—June to July (the early period of response), and August to December (when coverage and quality of response had improved). A stochastic model was used to predict case numbers per generation with different numbers of beds and a varying percentage of community cases detected.
Results
There were 652 probable/confirmed EVD cases from June-December 2014 in Kailahun. An EMC providing patient care opened in June. By August 2014 an integrated detection, treatment, and prevention strategy was in place across the district catchment zone. From June-July to August-December 2014 surveillance and contact tracing staff increased from 1.0 to 8.8 per confirmed EVD case, EMC capacity increased from 32 to 100 beds, the number of burial teams doubled, and health promotion activities increased in coverage. These improvements in response were associated with the following changes between the same periods: the proportion of confirmed/probable cases admitted to the EMC increased from 35% to 83% (χ2 p-value<0·001), the proportion of confirmed patients admitted to the EMC
Discussion
Our findings demonstrate that control of EVD can be achieved using established interventions based on identification and appropriate management of those who are at risk of and develop EVD, including in the context of ongoing transmission in surrounding regions. Key attributes in achieving control were sufficient patient care capacity (including admission to specialist facilities of suspect and probable cases for assessment), integrated with adequate staffing and resourcing of community-based case detection and prevention activities. The response structure and coverage targets we present are of value in informing effective control in current and future EVD outbreaks.

Author Summary
Ebola Virus Disease (EVD) is a severe illness that is usually spread from person to person through caring for someone who is sick, or if they die, contact with their body during their funeral. The recent EVD outbreak in West Africa caused illness and death in many thousands in Guinea, Sierra Leone and Liberia. It has been the largest and most difficult to control of any EVD outbreak in history, and this led to doubts as to the effectiveness of established control measures. Our study describes the successful control of EVD in a rural district of Sierra Leone. As in previous outbreaks, we found that control was achieved by working with communities to identify people who may have been exposed to EVD; if they then became sick, their early admission for testing and care to specialised centres that have equipment and procedures to prevent EVD passing on to staff or other patients, and safe burial of those who die of EVD by trained workers with appropriate protective equipment. We describe the resources and response structure needed to implement such measures effectively, information that will assist in controlling future outbreaks.

PLoS One
http://www.plosone.org/
[Accessed 12 March 2016]

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Using Seroprevalence and Immunisation Coverage Data to Estimate the Global Burden of Congenital Rubella Syndrome, 1996-2010: A Systematic Review
Emilia Vynnycky, Elisabeth J. Adams, Felicity T. Cutts, Susan E. Reef, Ann Marie Navar, Emily Simons, Lay-Myint Yoshida, David W. J. Brown, Charlotte Jackson, Peter M. Strebel, Alya J. Dabbagh
Research Article | published 10 Mar 2016 | PLOS ONE
10.1371/journal.pone.0149160

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Research Article
Influenza Vaccine Manufacturing: Effect of Inactivation, Splitting and Site of Manufacturing. Comparison of Influenza Vaccine Production Processes
Theone C. Kon, Adrian Onu, Laurentiu Berbecila, Emilia Lupulescu, Alina Ghiorgisor, Gideon F. Kersten, Yi-Qing Cui, Jean-Pierre Amorij, Leo Van der Pol
Published: March 9, 2016
DOI: 10.1371/journal.pone.0150700
Abstract
The aim of this study was to evaluate the impact of different inactivation and splitting procedures on influenza vaccine product composition, stability and recovery to support transfer of process technology. Four split and two whole inactivated virus (WIV) influenza vaccine bulks were produced and compared with respect to release criteria, stability of the bulk and haemagglutinin recovery. One clarified harvest of influenza H3N2 A/Uruguay virus prepared on 25.000 fertilized eggs was divided equally over six downstream processes. The main unit operation for purification was sucrose gradient zonal ultracentrifugation. The inactivation of the virus was performed with either formaldehyde in phosphate buffer or with beta-propiolactone in citrate buffer. For splitting of the viral products in presence of Tween®, either Triton™ X-100 or di-ethyl-ether was used. Removal of ether was established by centrifugation and evaporation, whereas removal of Triton-X100 was performed by hydrophobic interaction chromatography. All products were sterile filtered and subjected to a 5 months real time stability study. In all processes, major product losses were measured after sterile filtration; with larger losses for split virus than for WIV. The beta-propiolactone inactivation on average resulted in higher recoveries compared to processes using formaldehyde inactivation. Especially ether split formaldehyde product showed low recovery and least stability over a period of five months.

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HPV Serology Testing Confirms High HPV Immunisation Coverage in England
David Mesher, Elaine Stanford, Joanne White, Jamie Findlow, Rosalind Warrington, Sukamal Das, Richard Pebody, Ray Borrow, Kate Soldan
Research Article | published 09 Mar 2016 | PLOS ONE
10.1371/journal.pone.0150107

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Crippling Violence: Conflict and Incident Polio in Afghanistan
Alison Norris, Kevin Hachey, Andrew Curtis, Margaret Bourdeaux
Research Article | published 09 Mar 2016 | PLOS ONE
10.1371/journal.pone.0149074
Abstract
Background
Designing effective public health campaigns in areas of armed conflict requires a nuanced understanding of how violence impacts the epidemiology of the disease in question.
Methods
We examine the geographical relationship between violence (represented by the location of detonated Improvised Explosive Devices) and polio incidence by generating maps of IEDs and polio incidence during 2010, and by comparing the mean number of IED detonations in polio high-risk districts with non polio high-risk districts during 2004–2009.
Results
We demonstrate a geographic relationship between IED violence and incident polio. Districts that have high-risk for polio have highly statistically significantly greater mean numbers of IEDs than non polio high-risk districts (p-values 0.0010–0.0404).
Conclusions
The geographic relationship between armed conflict and polio incidence provides valuable insights as to how to plan a vaccination campaign in violent contexts, and allows us to anticipate incident polio in the regions of armed conflict. Such information permits vaccination planners to engage interested armed combatants to co-develop strategies to mitigate the effects of violence on polio.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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Conference report
Global Vaccine and Immunization Research Forum: Opportunities and challenges in vaccine discovery, development, and delivery
Pages 1489-1495
Andrew Q. Ford, Nancy Touchette, B. Fenton Hall, Angela Hwang, Joachim Hombach
Abstract
The World Health Organization, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Bill & Melinda Gates Foundation convened the first Global Vaccine and Immunization Research Forum (GVIRF) in March 2014. This first GVIRF aimed to track recent progress of the Global Vaccine Action Plan research and development agenda, identify opportunities and challenges, promote partnerships in vaccine research, and facilitate the inclusion of all stakeholders in vaccine research and development. Leading scientists, vaccine developers, and public health officials from around the world discussed scientific and technical challenges in vaccine development, research to improve the impact of immunization, and regulatory issues. This report summarizes the discussions and conclusions from the forum participants.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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Efficacy of 23-valent pneumococcal polysaccharide vaccine in preventing community-acquired pneumonia among immunocompetent adults: A systematic review and meta-analysis of randomized trials
Review Article
Pages 1496-1503
Wen-qi Diao, Ning Shen, Pan-xi Yu, Bei-bei Liu, Bei He
Abstract
Background
Data on the efficacy of the 23-valent pneumococcal polysaccharide vaccine (PPV-23) in preventing adult community-acquired pneumonia (CAP) among the target population of individuals aged over 65 years and high-risk individuals aged 19–64 years are conflicting. As the Advisory Committee on Immunization Practices (ACIP) has recently demonstrated PPV-23 is likely beneficial to immunocompromised adults by the Grading, Assessment, Development, and Evaluation (GRADE) framework, we conducted meta-analysis to examine its efficacy in an immunocompetent population.
Methods
We searched the PUBMED, EMBASE, and Cochrane Library databases for randomized trials. Overall relative risks (RRs) with 95% confidential intervals (CIs) were calculated, and the Cochrane Q test (p, I2) was performed. Outcomes were assessed by the GRADE framework.
Results
Seven randomized trials involving 156,010 participants were included in this meta-analysis. High-quality evidence revealed that PPV-23 was weakly associated with the prevention of all-cause pneumonia ([RR] 0.87, [95%CI] 0.76–0.98, p=0.11, I2=43%), especially among the target population ([RR] 0.72, [95%CI] 0.69–0.94, p = 0.58 I2=0%), the elderly group aged over 40 years ([RR] 0.80, [95%CI] 0.69–0.94) and the Japanese population ([RR] 0.72, [95%CI] 0.59–0.88, p=0.24, I2=30%). The target population included adults aged over 65 years and patients at high risk of pneumonia due to chronic lung disease, chronic obstructive pulmonary disease or living in a nursing home. Protective trends of PPV-23 in the outcomes of pneumococcal pneumonia ([RR] 0.54, [95%CI] 0.18–1.65, p=0.01, I2=77%) and mortality due to pneumonia ([RR] 0.67, [95%CI] 0.43–1.04, p = 0.67, I2=0%) were observed, although the results were statistically insignificant, possibly due to the small number of trials included. PPV-23 did not prevent all-cause mortality ([RR] 1.04, [95%CI] 0.87–1.24, p=0.95, I2=0%).
Conclusions
PPV-23 provided weak protection against all-cause pneumonia in an immunocompetent population, especially among the target population. The additional benefit of PPV-23 in preventing CAP further supports its application in the target population.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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Cost-effectiveness analysis of universal maternal immunization with tetanus-diphtheria-acellular pertussis (Tdap) vaccine in Brazil
Original Research Article
Pages 1531-1539
Ana Marli Christovam Sartori, Patrícia Coelho de Soárez, Eder Gatti Fernandes, Ligia Castellon Figueiredo Gryninger, Juliana Yukari Kodaira Viscondi, Hillegonda Maria Dutilh Novaes
Abstract
Background
Pertussis incidence has increased significantly in Brazil since 2011, despite high coverage of whole-cell pertussis containing vaccines in childhood. Infants Methods
Economic evaluation using a decision tree model comparing two strategies: (1) universal vaccination with one dose of Tdap in the third trimester of pregnancy and (2) current practice (no pertussis maternal vaccination), from the perspective of the health system and society. An annual cohort of newborns representing the number of vaccinated pregnant women were followed for one year. Vaccine efficacy were based on literature review. Epidemiological, healthcare resource utilization and cost estimates were based on local data retrieved from Brazilian Health Information Systems. Costs of epidemiological investigation and treatment of contacts of cases were included in the analysis. No discount rate was applied to costs and benefits, as the temporal horizon was one year. Primary outcome was cost per life year saved (LYS). Univariate and best- and worst-case scenarios sensitivity analysis were performed.
Results
Maternal vaccination of one annual cohort, with vaccine effectiveness of 78%, and vaccine cost of USD$12.39 per dose, would avoid 661 cases and 24 infant deaths of pertussis, save 1800 years of life and cost USD$28,942,808 and USD$29,002,947, respectively, from the health system and societal perspective. The universal immunization would result in ICERs of USD$15,608 and USD$15,590 per LYS, from the health system and societal perspective, respectively. In sensitivity analysis, the ICER was most sensitive to discounting of life years saved, variation in case-fatality, disease incidence, vaccine cost, and vaccine effectiveness.
Conclusion
The results indicate that universal maternal immunization with Tdap is a cost-effective intervention for preventing pertussis cases and deaths in infants in Brazil.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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The effectiveness of pneumococcal polysaccharide vaccine 23 (PPV23) in the general population of 50 years of age and older: A systematic review and meta-analysis
Original Research Article
Pages 1540-1550
Hannah Kraicer-Melamed, Shauna O’Donnell, Caroline Quach
Abstract
Two pneumococcal vaccines currently exist and have been recommended for the prevention of pneumococcal infection in adults 65 years of age and older: the 23-valent polysaccharide (PPV23) and the conjugate 13-valent (PCV13) vaccine.
Objective
To evaluate and summarize the results from all studies reporting on the vaccine effectiveness of PPV23 in preventing invasive pneumococcal disease (IPD) and community-acquired pneumonia (CAP) in individuals over the age of 50.
Methods
Systematic database searches were completed in PubMed, Medline, Embase, CINAHL, Web of Science, and Cochrane. Google Scholar and hand searches of seminal articles and past systematic reviews were employed. Studies were included if they independently evaluated the effect of PPV23 on IPD and/or CAP in adults (50+). Data extraction and quality assessment were both completed independently by two researchers. Quality was assessed using the National Advisory Committee on Immunization methodology for quality assessment. All conflicts were resolved by consensus.
Results
The vaccine effectiveness for PPV23 in preventing IPD was 50% (95% CI: 21%–69%) for cohort studies and 54% (95% CI: 32%–69%) for case-control studies. The VE estimates for CAP were 4% (95% CI: -26%–26%) for trials, 17% (95% CI: -26%–45%) for cohort studies, and 7% (95% CI: -10%–21%) for case-control studies.
Conclusions
The vaccine effectiveness of PPV23 in preventing IPD and all-cause CAP was consistent with past systematic reviews and similar to the estimates that were reported in the CAPiTA trial evaluating the vaccine effectiveness of PCV13. Consistent benefits were also reported across ecological studies and reports of surveillance data for the general population 50 years and older. The results suggests that the current practice of vaccinating the adults 65 years of age and older with PPV23 would have similar benefits to PCV13 in preventing potential cases of all-serotype IPD and all-cause CAP.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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The oral cholera vaccine Shanchol™ when stored at elevated temperatures maintains the safety and immunogenicity profile in Bangladeshi participants
Original Research Article
Pages 1551-1558
Amit Saha, Arifuzzaman Khan, Umme Salma, Nusrat Jahan, Taufiqur Rahman Bhuiyan, Fahima Chowdhury, Ashraful Islam Khan, Farhana Khanam, Sundaram Muruganandham, Sreeramulu Reddy Kandukuri, Mandeep Singh Dhingra, John D. Clemens, Alejandro Cravioto, Firdausi Qadri
Abstract
Background
The oral cholera vaccine (OCV), Shanchol™ has shown protective efficacy lasting up to 5 years, however, requirement for a cold chain limits its use in resource poor settings. The study was conducted to determine the safety and immunogenicity of Shanchol in adult participants in Bangladesh when stored at elevated temperatures.
Methods
The study was conducted in Mirpur, Dhaka. Four groups of healthy adult participants received two doses of Shanchol™, kept under standard storage temperature (Group A; 2–8 °C) or at elevated temperatures (Group B, 25 °C; Group C, 37 °C; Group D, 42 °C) for 14 days, respectively. Vaccine specific antibody responses were determined.
Findings
145 participants were assigned to each group. Adverse events were mild not differing among groups. Vaccine stored at elevated temperatures remained stable with cumulative LPS content within admissible limits.
Vibriocidal antibody responses were observed in all groups after each dose of vaccine at day 7 and 21 compared to pre-immune levels (P < 0.001). Four-fold increases to Vibrio cholerae O1 Ogawa were observed at day 7 and/or day 21 after vaccination in the standard temperature and the three elevated temperature groups, with responder rates of; 76% (95% CI LB; 70%), 80% (95% CI LB; 74%), 69% (95% CI LB; 63%), and 74% (95% CI LB; 68%) in Groups A–D, respectively (P = 0.240). Responses were also seen in all groups to V. cholerae O1 Inaba and V. cholerae O139 and in LPS specific IgA response to V. cholerae O1 antigens.
Interpretation
This is the first report to show that the OCV is stable at elevated temperatures, and the safety and immunogenicity profiles are not altered. This information will help formulate global policies for use of the vaccine at higher temperatures, resulting in easier distribution and vaccination costs and decrease logistical challenges to vaccine delivery.
Funding
Bill & Melinda Gates Foundation.
Trial registration
Clinical Trials.gov number NCT01762930.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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Trends in reasons for non-receipt of influenza vaccination during pregnancy in Georgia, 2004–2011
Original Research Article
Pages 1597-1603
Allison T. Chamberlain, Ruth L. Berkelman, Kevin A. Ault, Eli S. Rosenberg, Walter A. Orenstein, Saad B. Omer
Abstract
Background
Considerable research has identified barriers to antenatal influenza vaccination, yet no research has explored temporal trends in reasons for non-receipt.
Purpose
To examine trends in reasons for non-receipt of influenza vaccination during pregnancy.
Methods
Serial cross-sectional analyses using 8 years of Georgia Pregnancy Risk Assessment Monitoring Survey (PRAMS) data were conducted. Weighted logistic regression was used to examine trends in the prevalence of citing reasons for non-receipt over time.
Results
Between 2004 and 2011, 8300 women reported no influenza vaccination during or immediately before pregnancy. Proportions of women citing “doctor didn’t mention vaccination,” “in first trimester during influenza season,” and “not pregnant during influenza season” decreased significantly over time (Doctor didn’t mention: 48.0% vs. 27.1%, test for trend p < 0.001; in first trimester: 26.8% vs. 16.3%, test for trend p<0.001; not influenza season: 24.2% vs. 12.7%, test for trend p=0.001). Safety concerns increased over 2004 proportions in 2010 (concern about side effects for me: 40.2% vs. 28.5%, prevalence ratio (PR): 1.41, 95% confidence interval (CI): 1.16, 1.71; concern about harming my baby: 38.9% vs. 31.0%, PR=1.26, 95% CI: 1.04, 1.53) and 2011 (concern about side effects for me: 39.0% vs. 28.5%, PR=1.37, 95% CI: 1.13, 1.65; concern about harming my baby: 38.8% vs. 31.0%, PR=1.25, 95% CI: 1.04, 1.50). Following the 2009/2010 H1N1 pandemic, more Hispanic women cited concern about vaccination harming their baby than other women; in 2011, their concern remained elevated relative to non-Hispanic white women (63% vs. 35%; adjusted PR=1.79, 95% CI: 1.23, 2.61).
Conclusion
Examining trends in reasons for non-receipt of antenatal influenza vaccination can reflect successes related to vaccine promotion and areas for improvement. By highlighting differential impacts of the 2009/2010 H1N1 pandemic, we reveal opportunities for additional research on tailoring vaccine promotion efforts to specific types of women.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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HPV vaccination coverage of teen girls: The influence of health care providers
Original Research Article
Pages 1604-1610
Philip J. Smith, Shannon Stokley, Robert A. Bednarczyk, Walter A. Orenstein, Saad B. Omer
Abstract
Background
Between 2010 and 2014, the percentage of 13–17 year-old girls administered ≥3 doses of the human papilloma virus (HPV) vaccine (“fully vaccinated”) increased by 7.7 percentage points to 39.7%, and the percentage not administered any doses of the HPV vaccine (“not immunized”) decreased by 11.3 percentage points to 40.0%.
Objective
To evaluate the complex interactions between parents’ vaccine-related beliefs, demographic factors, and HPV immunization status.
Methods
Vaccine-related parental beliefs and sociodemographic data collected by the 2010 National Immunization Survey-Teen among teen girls (n=8490) were analyzed. HPV vaccination status was determined from teens’ health care provider (HCP) records.
Results
Among teen girls either unvaccinated or fully vaccinated against HPV, teen girls whose parent was positively influenced to vaccinate their teen daughter against HPV were 48.2 percentage points more likely to be fully vaccinated. Parents who reported being positively influenced to vaccinate against HPV were 28.9 percentage points more likely to report that their daughter’s HCP talked about the HPV vaccine, 27.2 percentage points more likely to report that their daughter’s HCP gave enough time to discuss the HPV shot, and 43.4 percentage points more likely to report that their daughter’s HCP recommended the HPV vaccine (p < 0.05). Among teen girls administered 1–2 doses of the HPV vaccine, 87.0% had missed opportunities for HPV vaccine administration.
Conclusion
Results suggest that an important pathway to achieving higher ≥3 dose HPV vaccine coverage is by increasing HPV vaccination series initiation though HCP talking to parents about the HPV vaccine, giving parents time to discuss the vaccine, and by making a strong recommendation for the HPV. Also, HPV vaccination series completion rates may be increased by eliminating missed opportunities to vaccinate against HPV and scheduling additional follow-up visits to administer missing HPV vaccine doses.

Vaccine
Volume 34, Issue 13, Pages 1489-1642 (18 March 2016)
http://www.sciencedirect.com/science/journal/0264410X/34/13

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Successful introduction of an underutilized elderly pneumococcal vaccine in a national immunization program by integrating the pre-existing public health infrastructure
Original Research Article
Pages 1623-1629
Tae Un Yang, Eunsung Kim, Young-Joon Park, Dongwook Kim, Yoon Hyung Kwon, Jae Kyong Shin, Ok Park
Abstract
Background
Although pneumococcal vaccines had been recommended for the elderly population in South Korea for a considerable period of time, the coverage has been well below the optimal level. To increase the vaccination rate with integrating the pre-existing public health infrastructure and governmental funding, the Korean government introduced an elderly pneumococcal vaccination into the national immunization program with a 23-valent pneumococcal polysaccharide vaccine in May 2013.
Objective
The aim of this study was to assess the performance of the program in increasing the vaccine coverage rate and maintaining stable vaccine supply and safe vaccination during the 20 months of the program.
Methods
We qualitatively and quantitatively analyzed the process of introducing and the outcomes of the program in terms of the systematic organization, efficiency, and stability at the national level.
Results
A staggered introduction during the first year utilizing the public sector, with a target coverage of 60%, was implemented based on the public demand for an elderly pneumococcal vaccination, vaccine supply capacity, vaccine delivery capacity, safety, and sustainability. During the 20-month program period, the pneumococcal vaccine coverage rate among the population aged ≥65 years increased from 5.0% to 57.3% without a noticeable vaccine shortage or safety issues. A web-based integrated immunization information system, which includes the immunization registry, vaccine supply chain management, and surveillance of adverse events following immunization, reduced programmatic errors and harmonized the overall performance of the program.
Conclusion
Introduction of an elderly pneumococcal vaccination in the national immunization program based on strong government commitment, meticulous preparation, financial support, and the pre-existing public health infrastructure resulted in an efficient, stable, and sustainable increase in vaccination coverage.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 March 2016)

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Review:
Hepatitis Vaccines
by Sina Ogholikhan and Kathleen B. Schwarz
Vaccines 2016, 4(1), 6; doi:10.3390/vaccines4010006 (registering DOI) – published 11 March 2016
Abstract:
Viral hepatitis is a serious health problem all over the world. However, the reduction of the morbidity and mortality due to vaccinations against hepatitis A and hepatitis B has been a major component in the overall reduction in vaccine preventable diseases. We will discuss the epidemiology, vaccine development, and post-vaccination effects of the hepatitis A and B virus. In addition, we discuss attempts to provide hepatitis D vaccine for the 350 million individuals infected with hepatitis B globally. Given the lack of a hepatitis C vaccine, the many challenges facing the production of a hepatitis C vaccine will be shown, along with current and former vaccination trials. As there is no current FDA-approved hepatitis E vaccine, we will present vaccination data that is available in the rest of the world. Finally, we will discuss the existing challenges and questions facing future endeavors for each of the hepatitis viruses, with efforts continuing to focus on dramatically reducing the morbidity and mortality associated with these serious infections of the liver.

Advanced Drug Delivery Reviews
Available online 4 March 2016 – In Press, Uncorrected Proof

Role of nanotechnology in HIV/AIDS vaccine development
Y Liu, C Chen
Abstract
HIV/AIDS is one of the worst crises affecting global health and influencing economic development and social stability. Preventing and treating HIV infection is a crucial task. However, there is still no effective HIV vaccine for clinical application. Nanotechnology has the potential to solve the problems associated with traditional HIV vaccines. At present, various nano-architectures and nanomaterials can function as potential HIV vaccine carriers or adjuvants, including inorganic nanomaterials, liposomes, micelles and polymer nanomaterials. In this review, we summarize the current progress in the use of nanotechnology for the development of an HIV/AIDS vaccine and discuss its potential to greatly improve the solubility, permeability, stability and pharmacokinetics of HIV vaccines.

Although nanotechnology holds great promise for applications in HIV/AIDS vaccines, there are still many inadequacies that result in a variety of risks and challenges. The potential hazards to the human body and environment associated with some nano-carriers, and their underlying mechanisms require in-depth study. Non-toxic or low-toxic nanomaterials with adjuvant activity have been identified. However, studying the confluence of factors that affect the adjuvant activity of nanomaterials may be more important for the optimization of the dosage and immunization strategy and investigations into the exact mechanism of action. Moreover, there are no uniform standards for investigations of nanomaterials as potential vaccine adjuvants. These limitations make it harder to analyze and deduce rules from the existing data. Developing vaccine nano-carriers or adjuvants with high benefit–cost ratios is important to ensure their broad usage. Despite some shortcomings, nanomaterials have great potential and application prospects in the fields of AIDS treatment and prevention.

Current Opinion in Biotechnology
Volume 42, December 2016, Pages 24–29

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Pharmaceutical biotechnology • Chemical biotechnology
Enhancing vaccine effectiveness with delivery technology
M Beitelshees, Y Li, BA Pfeifer
Highlights
:: Vaccine potency can be influenced by antigen delivery technology.
:: Chemical vectors covered include microneedle devices and liposomes.
:: Biological vectors covered include attenuated bacterial hosts.
:: A diverse set of properties and tools enable vaccine delivery vector impact.

Vaccines stand as a very powerful means of disease prevention and treatment. Fundamental to the success of vaccination is the efficient delivery of antigenic cargo needed to trigger an effective immune response. In this article, we will review recent advances in delivery technology with a focus on devices designed to optimally maximize responses to antigen cargo. Included with the review is an overview of traditional vaccine applications and how these approaches can benefit by well-designed delivery methods

BMC Malaria Journal
2016 15:143

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Case Study
Policy analysis for deciding on a malaria vaccine RTS,S in Tanzania
Idda Romore, Ritha J. A. Njau, Innocent Semali, Aziza Mwisongo, Antoinette Ba Nguz, Hassan Mshinda, Marcel Tanner and Salim Abdulla
DOI: 10.1186/s12936-016-1197-6
Published: 8 March 2016
Abstract
Background
Traditionally, it has taken decades to introduce new interventions in low-income countries. Several factors account for these delays, one of which is the absence of a framework to facilitate comprehensive understanding of policy process to inform policy makers and stimulate the decision-making process. In the case of the proposed introduction of malaria vaccines in Tanzania, a specific framework for decision-making will speed up the administrative process and shorten the time until the vaccine is made available to the target population.
Methods
Qualitative research was used as a basis for developing the Policy Framework. Interviews were conducted with government officials, bilateral and multilateral partners and other stakeholders in Tanzania to assess malaria treatment policy changes and to draw lessons for malaria vaccine adoption.
Results
The decision-making process for adopting malaria interventions and new vaccines in general takes years, involving several processes: meetings and presentations of scientific data from different studies with consistent results, packaging and disseminating evidence and getting approval for use by the Ministry of Health and Social Welfare (MOHSW). It is influenced by contextual factors; Promoting factors include; epidemiological and intervention characteristics, country experiences of malaria treatment policy change, presentation and dissemination of evidence, coordination and harmonization of the process, use of international scientific evidence. Barriers factors includes; financial sustainability, competing health and other priorities, political will and bureaucratic procedures, costs related to the adoption and implementations of interventions, supply and distribution and professional compliance with anti-malarial drugs.
Conclusion
The framework facilitates the synthesis of information in a coherent way, enabling a clearer understanding of the policy process, thereby speeding up the policy decision-making process and shortening the time for a malaria vaccine to become available.

Papillomavirus Research
Volume 2, December 2016, Pages 38–40
Examining maternal beliefs and human papillomavirus vaccine uptake among male and female children in low-income families
EL Fuchs, M Rahman, AB Berenson
doi:10.1016/j.pvr.2016.02.002
Abstract
Purpose
This study examines within-family differences in the uptake of the HPV vaccine and HPV-related beliefs by children׳s sex.
Methods
From a 2011–2013 survey of mothers of children aged 9–17 years in Texas, mothers with both male and female children (n=350) were selected.
Results
Mothers were more likely to report having initiated and completed HPV vaccination for their daughters than sons. Mothers did not express differences by children׳s sex in HPV-related beliefs. Among those who had not completely vaccinated either child, mothers were more likely to report they wanted their daughters compared to sons vaccinated and were more likely to report feeling confident they could get their daughters vaccinated than their sons.
Conclusion
In this population, mothers were more likely to report HPV vaccination of and motivation to vaccinate daughters compared to sons, although maternal beliefs about HPV did not differ by children׳s sex.

Media/Policy Watch
This section is intended to alert readers to substantive news, analysis and opinion from the general media on vaccines, immunization, global; public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 12 March 2016
The Rare Super-Antibodies That Destroy HIV
A recent study sheds new light on a rare immune response to the virus—and could bring researchers a step closer to developing a vaccine.
Diana Crow – Mar 10, 2016

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BBC
http://www.bbc.co.uk/
Accessed 12 March 2016
Would you take a dose of hookworms?
13 Mar 2016
…Scientists in Washington are infecting healthy volunteers with hookworms to help the development of a vaccine against the parasite that can cause severe disability and anaemia. Lizzie Crouch reports…

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Financial Times
http://www.ft.com/home/uk
Accessed 12 March 2016
WHO chief wants help for drug industry to fight global pandemics
7 March 2016
…Pharmaceuticals companies cannot be expected to keep picking up the bill for tackling global pandemics, the head of the World Health Organisation has warned, urging the creation of a new funding mechanism for emergency drugs and vaccines. Margaret Chan, WHO director-general, said the pharma industry had spent almost $1bn developing Ebola vaccines in the past two years without any return on investment. … “We need a funding mechanism in place allowing countries and industry to prepare for high-impact events.” …

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The Guardian
http://www.guardiannews.com/
Accessed 12 March 2016
Ebola vaccine trial in Sierra Leone battles against fear and logistics
Health workers face suspicion and a lack of cold storage as they test the Ebola vaccine and also try to reach children who have missed inoculations against other diseases
10 March 2016

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New York Times
http://www.nytimes.com/
Accessed 12 March 2016
MSF Challenges Pfizer’s India Vaccine Patent Application
NEW DELHI — Doctors Without Borders has challenged Pfizer’s application for an Indian patent for its pneumonia vaccine so cheaper versions can be available to children in poor countries and to humanitarian organizations.
March 12, 2016 – By THE ASSOCIATED PRESS –

Brazil Giving $2.8 Million for Zika Research
Health Minister Marcelo Castro said over a $1 million would help finance a study to find a vaccine for the virus, which Brazilian researchers have tentatively linked to a surge in cases of microcephaly,
March 10, 2016 – By THE ASSOCIATED PRESS – World –

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 12 March 2016
Mind and Matter: Susan Pinker
The Peril of Ignoring Vaccines—and a Solution

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

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

– pdf version:  A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_5 March 2016

– blog edition: comprised of the approx. 35+ entries posted below on 6 March 2016.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

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

Zika virus [to 5 March 2016]
Public Health Emergency of International Concern (PHEIC)
http://www.who.int/emergencies/zika-virus/en/

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WHO – Press Conference: update on global response to Microcephaly (Geneva, 4 March 2016)
[Video: 00:53:18]
WHO update on global response to microcephaly, neurological disorders and Zika virus
Dr Bruce Aylward, Executive Director, Outbreaks and Health Emergencies (ai), WHO, provided a broad overview and noted important Geneva meetings on Zika to be held next week including:
:: 7-9 March – Consultation on continuing research a link between the Zika virus and the neurological disorders Guillain-Barre syndrome and microcephaly, and review on new products including rapid diagnostics, vaccines, rapid control measures, etc.
:: Emergency Committee on Zika under IHR to review evolving information, review the current PHEIC designation, and review recommendations around travel and trade, and around coordinated international action.

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WHO: Zika Virus, Microcephaly and Guillain–Barré syndrome situation report – 4 March 2016
Read the full situation report
Summary
:: Between 1 January 2007 and 3 March 2016, a total of 52 countries and territories have reported autochthonous (local) transmission or indication of transmission of Zika virus (41 since 1 January 2015). Five of these countries and territories reported a Zika virus outbreak that is now over. In addition, three countries and territories have reported locally acquired infection, probably through sexual transmission.

:: Among the 52 countries and territories, Lao People’s Democratic Republic is the latest to report autochthonous transmission of Zika virus. France, Italy and the United States of America have reported locally acquired Zika virus infection in the absence of any known mosquito vectors.

:: The geographical distribution of Zika virus has steadily widened since the virus was first detected in the Americas in 2015. Autochthonous Zika virus transmission has been reported in 31 countries and territories of this region. Zika virus is likely to be transmitted and detected in other countries within the geographical range of competent mosquito vectors, especially Aedes aegypti.

:: So far an increase in microcephaly cases and other neonatal malformations has only been reported in Brazil and French Polynesia, although two cases linked to a stay in Brazil were detected in the United States of America and Slovenia.

:: During 2015 and 2016, 8 countries and territories have reported an increased incidence of Guillain-Barré syndrome (GBS) and/or laboratory confirmation of a Zika virus infection among GBS cases.

:: A recently published case control study in French Polynesia provides further evidence of a causal relationship between Zika virus infection and GBS.

:: The global prevention and control strategy launched by WHO as a Strategic Response Framework encompasses surveillance, response activities and research, and this situation report is organized under those headings. Following consultation with partners and taking changes in caseload into account, the framework will be updated at the end of March 2016 to reflect epidemiological evidence coming to light and the evolving division of roles and responsibilities for tackling this emergency.

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WHO: Pregnancy management in the context of Zika
2 March 2016 — WHO releases new guidance, today, on pregnancy management during the Zika virus epidemic. The guidance aims to reduce the risk of maternal Zika infection and to help manage potential complications during pregnancy to give both mothers and their babies the best possible health outcomes.
:: Read the guidance on pregnancy management

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Disease Outbreak News (DONs)
:: Zika virus infection – Netherlands – Sint Maarten 4 March 2016
:: Zika virus infection – Saint Vincent and the Grenadines 1 March 2016
:: Zika virus infection – Trinidad and Tobago 29 February 2016

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WHO fact sheets
:: Microcephaly 2 March 2016

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Zika Open
[Bulletin of the World Health Organization]
:: All papers available here
No new papers posted.

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CDC/ACIP [to 5 March 2016]
http://www.cdc.gov/media/index.html
FRIDAY, MARCH 4, 2016
Zika Action Plan Summit – April 1, 2016
CDC is hosting a one-day Zika Action Plan Summit as the nation faces likely local mosquito-borne transmission of Zika virus in some places in the continental United States. The Commonwealth of Puerto Rico, U.S. Virgin Islands, and American Samoa are already experiencing active mosquito-borne transmission. The U.S. government has planned this Summit to provide state and local senior officials with the information and tools needed to improve Zika preparedness and response within their states and jurisdictions.
Participants will hear the latest scientific knowledge about Zika, including implications for pregnant women and strategies for mosquito control. This meeting will also provide an opportunity to increase knowledge of best communications practices and identify possible gaps in preparedness and response at the federal, state, and local levels and help begin to address possible gaps.
The anticipated outcome of the summit is to arm state and local leaders with the necessary knowledge and technical support to have a comprehensive Zika Readiness Action Plan for their jurisdiction, including plans for preparedness and response activities.
Who
:: State and local senior officials
:: Representatives from multiple federal departments involved in Zika response
:: Representatives from non-government organizations
:: CDC experts
When
Save the Date, Friday, April 1, 2016
Where
CDC Headquarters 1600 Clifton Road, Atlanta GA 30329; sessions may be available by video conference.

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MONDAY, FEBRUARY 29, 2016
CDC adds 2 destinations to interim travel guidance related to Zika virus – Media Statement
CDC is working with other public health officials to monitor for ongoing Zika virus‎ transmission. Today, CDC added the following destinations to the Zika virus travel notices: St. Vincent and the Grenadines & Sint Maarten

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MMWR March 4, 2016 / Vol. 65 / No. 8
:: Zika Virus Infection Among U.S. Pregnant Travelers — August 2015–February 2016
:: Transmission of Zika Virus Through Sexual Contact with Travelers to Areas of Ongoing Transmission — Continental United States, 2016

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FDA [to 5 March 2016]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
March 01, 2016
FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue products
As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration today issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues.

The new guidance is a part of the FDA’s ongoing efforts to protect HCT/Ps and blood products from Zika virus transmission. On Feb. 16, the FDA issued recommendations for reducing the risk of Zika virus via blood transfusion in the U.S.

“Though there is more to be learned about the transmission of Zika virus, given what we know about the virus at this point, which also is informed by our understanding of similar viruses, we must address the potential risk of Zika virus transmission by human cells and tissues,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Providing HCT/P establishments with donor eligibility recommendations will help reduce that potential risk.”

There is a potential risk that the Zika virus can be transmitted by HCT/Ps used as part of a medical, surgical, or reproductive procedure. HCT/Ps include products such as corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells (HPCs), gestational tissues such as amniotic membrane, and reproductive tissues such as semen and oocytes…

According to the Centers for Disease Control and Prevention, Zika virus can be spread by a man to his sexual partners. And to date, there have been several cases of sexual transmission in the U.S. Current information about Zika virus detection in semen suggests that a period of ineligibility longer than the waiting period that has been recommended for donors of Whole Blood and blood components is necessary for HCT/P donors.

Recommendations for living donors of HCT/Ps: Donors should be considered ineligible if they were diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of those risk factors, within the past six months. Donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if they have had any of the above risk factors at any point during their pregnancy.

Recommendations for deceased (non-heart-beating) donors: Donors should be considered ineligible if they were diagnosed with Zika virus infection in the past six months.
A deferral period of six months was chosen because of the limited data available on the length of time the virus can persist in all tissues. Zika virus has been detected in tissues and body fluids after the virus is no longer detectable in the blood stream, and has been detected in semen possibly up to 10 weeks after the onset of symptoms. Given the uncertainty, six months was determined to provide the appropriate level of caution.

Less evidence exists regarding the potential for transmission of Zika virus by HCT/Ps typically recovered from deceased donors. As more information becomes available, the understanding of the risks to recipients of HCT/Ps, including HCT/Ps recovered from deceased donors, may evolve. The FDA will continue to monitor the situation, and will carefully evaluate new information regarding the associated risks as it becomes available.

In addition to the guidance documents addressing the nation’s blood supply and HCT/Ps, the FDA continues to prioritize the development of blood donor screening and diagnostic tests that may be useful for identifying the presence of or recent infection with the virus, prepare to evaluate the safety and efficacy of investigational vaccines and therapeutics that might be developed, and review technology that may help suppress populations of the mosquitoes that can spread the virus…

Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry (PDF – 76KB)
Posted: 3/1/2016

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Sabin Vaccine Institute [to 5 March 2016]
http://www.sabin.org/updates/ressreleases
Friday, March 4, 2016
Sabin President Peter Hotez Testifies at House Hearings on Zika, Infectious Diseases
Peter Hotez, M.D., Ph.D., president of the Sabin Vaccine Institute (Sabin) and director of the Sabin Product Development Partnership (Sabin PDP), testified this week at two congressional hearings: the House Energy and Commerce Subcommittee on Oversight and Investigations hearing, “Examining the U.S. Public Health Response to the Zika Virus”; and the House Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations on “The Growing Threat of Cholera and Other Diseases in the Middle East.”

During the hearing on the Zika virus, Chairman Tim Murphy (R-PA) and other members of the subcommittee sought greater clarity on the U.S. government’s response to the outbreak in Latin America. The first panel included witnesses from the federal government, including Thomas Frieden, M.D., director of the Centers for Disease Control and Prevention, and Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases at the National Institutes of Health. Dr. Hotez, who served on the second panel of NGO witnesses, shared his concerns that the Zika virus could spread to the Gulf Coast as early as this spring. “I am particularly concerned about the U.S. Gulf Coast because it represents the perfect storm of key factors that promote the spread of Zika, including extreme poverty and the unique presence of the Aedes aegypti mosquito,” said Dr. Hotez. Video of the full hearing is available here.

“To fight Zika, the U.S. government needs to coordinate with our global health partners on a two-pronged approach towards controlling the spread of Zika: aggressive mosquito control with insecticides, and source reduction to remove standing water that breeds mosquitoes,” Dr. Hotez said in his prepared testimony. “In addition to coordination on mosquito control and source reduction within the federal government, there needs to be similar coordination between the federal, state, and local governments.”

At the hearing on cholera and other diseases in the Middle East, Chairman Chris Smith addressed the conflicts in places such as Iraq, Syria and Lebanon and the resulting threat of cholera and other emerging viral and neglected diseases in the region. Video of the full hearing is available here.

EBOLA/EVD [to 5 March 2016]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

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Ebola Situation Reports
[While no announcement of a change in reporting cycle is evident, we deduce that Ebola Situation Reports have been reduced to a bi-weekly cycle given the spacing of the last few reports – previous update at 17 February 2016]
Ebola Situation Report – 2 March 2016
[No new Ebola cases reported. Liberia, Sierra Leone and Guinea are each moving through enhanced surveillance periods following their last, respective confirmed EVD cases and associated contact clusters.]

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WHO: Clinical care for survivors of Ebola virus disease
Interim guidance
February 2016 :: 31 pages
Languages: English
WHO reference number: WHO Ref: WHO/EVD/OHE/PED/16.1.rev1
Downloads: Clinical care for survivors of Ebola virus disease: interim guidance
Overview
Today, there are over 10 000 survivors of Ebola virus disease. A number of medical problems have been reported in survivors, including mental health issues. Ebola virus may persist in some body fluids, including semen. Ebola survivors need comprehensive support for the medical and psychosocial challenges they face and also to minimize the risk of continued Ebola virus transmission.

WHO has developed this document to guide health services on how to provide quality care to survivors of Ebola virus disease. Table of contents include:
:: Introduction
:: Planning follow-up of the Ebola survivor
:: Common sequelae of Ebola virus disease and recommended evaluation and clinical management
:: Considerations for special populations
:: Monitoring for persistent Ebola virus infection in survivors: guidelines for testing and counselling
:: Infection prevention and control considerations in survivors
:: Risk communication considerations.

POLIO [to 5 March 2016]
Public Health Emergency of International Concern (PHEIC)

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Polio this week as of 2 March 2016
:: The Director General of WHO, Dr Margaret Chan, upon the advice of the Emergency Committee, concluded that poliovirus continues to constitute a Public Health Emergency of International Concern (PHEIC). Read the statement here [and below]
:: The Journal of Infectious Diseases has published a supplemental journal on Nigeria’s polio eradication effort. Read more here.
:: A new method to administer the inactivated poliovirus vaccine (IPV), developed by a collaboration of Australian institutions, has had promising results in animal trials. The Nanopatch may enable unprecedented levels of dose reduction.
:: There are seven weeks to go until the globally synchronized switch from the trivalent to bivalent oral polio vaccine

Selected Country Levels Updates [excerpted]
Pakistan
:: Three new cases of wild poliovirus type 1 (WPV1) were reported in the last week, in Quetta, Balochistan, and the districts of Hangu and Peshawar in Khyber Pakhtunkhwa, with onset of paralysis between 1 and 12 February. The total number of WPV1 cases for 2016 is now 5, compared to 13 reported for 2015 at this point last year.
:: Four new WPV1 environmental positive samples were reported in the past week; one in Faisalabad, Punjab; two in Karachi Gadap, Sindh; and one in Peshawar, Khyber Pakhtunkhwa; with collection dates between 3 and 10 February.

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Statement on the 8th IHR Emergency Committee meeting regarding the international spread of poliovirus
WHO statement
1 March 2016
[Excerpts; Editor’s text bolding]

The eighth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) regarding the international spread of poliovirus was convened via teleconference by the Director-General on 12 February 2016. As with the seventh meeting, the Emergency Committee reviewed the data on circulating wild poliovirus as well as circulating vaccine-derived polioviruses (cVDPV). The latter is particularly important as cVDPVs reflect serious gaps in immunity to poliovirus due to weaknesses in routine immunization coverage in otherwise polio-free countries. In addition, it is essential to stop type 2 cVDPVs in advance of the globally synchronized withdrawal of type 2 OPV in April 2016.

The following IHR States Parties submitted an update on the implementation of the Temporary Recommendations since the Committee last met on 10 November 2015: Afghanistan, Pakistan and Guinea.

Wild polio
The Committee noted that since the declaration that the international spread of polio constituted a Public Health Emergency of International Concern (PHEIC) in May 2014, strong progress has been made by countries toward interruption of wild poliovirus transmission and implementation of Temporary Recommendations issued by the Director-General. There has been an overall decline in the occurrence of international spread of wild poliovirus. The Committee was particularly encouraged by the intensified efforts and progress toward interruption of poliovirus transmission in Pakistan and Afghanistan despite challenging circumstances, and the renewed emphasis on cooperation along the long international border between the two countries.

The Committee noted however that the international spread of wild poliovirus has continued, with two new recent reports of exportations from Pakistan into Afghanistan which occurred in October and November 2015. These cases occurred in Nangarhar and Kunar Provinces, in the eastern region, adjoining the Pakistan border. While there has been no new exportation from Afghanistan to Pakistan, ongoing transmission particularly in inaccessible parts of the Eastern Region of Afghanistan close to the international border presents an ongoing risk.

The Committee noted that while Pakistan and Afghanistan have historically shared a vast common zone of poliovirus transmission, the ongoing spread between the two countries is occurring from discrete zones of persistent transmission in each country. Strong programmatic action in these zones should interrupt such cross-border transmission, as illustrated by the experience in regions that were previously polio-endemic.

The committee re-emphasized that under the IHR, spread of poliovirus between two Member States can constitute international spread. The Committee acknowledged that cross border collaboration efforts have continued to be strengthened. Whilst border vaccination between these two countries is limited to children under ten years of age, efforts are being made to vaccinate departing travellers of all age groups from airports when leaving this epidemiological block formed by the two countries. The committee was particularly pleased that the Temporary Recommendations for international travellers of all ages are now being implemented in Afghanistan at the international airport in Kabul. In this respect, it noted that all countries, and particularly those with embassies in Afghanistan and Pakistan, should facilitate implementation of Temporary Recommendations through adopting procedures that include proof of polio vaccination as part of visa application processes for travellers departing from Afghanistan or Pakistan.

The committee noted that globally there are still significant vulnerable areas and populations that are inadequately immunized due to conflict, insecurity and poor coverage associated with weak immunization programmes. Such vulnerable areas include countries in the Middle East, the Horn of Africa, central Africa and parts of Europe. The hard-earned gains of the GPEI can be quickly lost if there is re-introduction of poliovirus in settings of disrupted health systems and complex humanitarian emergencies. The large population movements across the Middle East and from Afghanistan and Pakistan create a heightened risk of international spread of polio. There is a risk of missing polio vaccination among refugee and mobile populations, adding to missed and under vaccinated populations in Europe, the Middle East and Africa. An estimated three to four million people have been displaced to Turkey, Lebanon, and Jordan and are at the centre of a mass migration across Europe.

The committee was very concerned by the weakening of AFP surveillance in Equatorial Guinea, and urged renewed efforts to strengthen surveillance and routine immunization there. Insecurity in Africa, notably in parts of Cameroon and Somalia, continues to pose a threat to polio eradication in that continent.

Vaccine derived poliovirus
The current circulating vaccine-derived poliovirus (cVDPV) outbreaks across four WHO regions illustrate serious gaps in routine immunization programs, leading to significant pockets of vulnerability to polio outbreaks. In 2015, six outbreaks of circulating vaccine derived poliovirus have occurred – three cVDPV type 1 outbreaks (Ukraine, Madagascar and Lao People’s Democratic Republic) and three cVDPV type 2 outbreaks (Myanmar, Nigeria and Guinea).

Six additional cases of cVDPV type 2 have been reported in Guinea since the last meeting. This increases the threat of international spread, particularly to neighbouring countries, where the Ebola epidemic has weakened health systems including routine immunization. This is of particular concern given the imminent global withdrawal of type 2 oral polio vaccine (OPV2) in April 2016. The committee noted with concern that AFP surveillance does not meet international standards in parts of Guinea, heightening concern about whether circulation could be missed. Post-Ebola there was a new community reluctance to accept vaccination, and this needs to be urgently addressed. The committee acknowledged the efforts to improve the quality of supplementary immunization activities (SIAs), and urged that this continue.

The committee noted that in Lao People’s Democratic Republic and Myanmar there was ongoing circulation of vaccine derived polioviruses, particularly in hard to reach populations in both countries, underlining the importance of communication to counteract vaccine hesitancy.

While there have been no new cases of cVDPV in Ukraine, Madagascar, South Sudan or Nigeria since the last committee meeting, threats remain. More needs to be done in each of these countries to improve routine coverage and AFP surveillance. In Ukraine, the committee was concerned by the restricted availability of polio vaccines (including non-availability to persons >10 years of age) and suboptimal routine immunization, and reports of lack of community acceptance of polio vaccines. This reluctance to be vaccinated needs to be addressed through well-crafted communications. In South Sudan and Nigeria, there was heightened risk of further circulation in areas affected by conflict and insecurity. Complacency is another risk in Nigeria, and as the number of SIAs decreases, the strengthening of routine immunization needs to be a high priority.

Conclusion
The Committee unanimously agreed that the international spread of polio remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of the Temporary Recommendations for a further three months. The Committee considered the factors expressed in reaching this conclusion at the seventh meeting still applied:
:: The continued international spread of wild poliovirus during 2015 involving Pakistan and Afghanistan.
:: The risk and consequent costs of failure to eradicate globally one of the world’s most serious vaccine preventable diseases.
:: The continued necessity of a coordinated international response to improve immunization and surveillance for wild poliovirus, stop its international spread and reduce the risk of new spread.
:: The serious consequences of further international spread for the increasing number of countries in which immunization systems have been weakened or disrupted by conflict and complex emergencies. Populations in these fragile states are vulnerable to outbreaks of polio. Outbreaks in fragile states are exceedingly difficult to control and threaten the completion of global polio eradication during its end stage.
:: The importance of a regional approach and strong cross-border cooperation, as much international spread of polio occurs over land borders, while recognizing that the risk of distant international spread remains from zones with active poliovirus transmission.
:: Additionally with respect to cVDPV:
::: cVDPVs also pose a risk for international spread, and if there is no urgent response with appropriate measures, particularly threaten vulnerable populations as noted above;
::: The emergence and circulation of VDPVs in four WHO regions demonstrates significant gaps in population immunity at a critical time in the polio endgame;
::: There is a particular urgency of stopping type 2 cVDPVs in advance of the globally synchronized withdrawal of type 2 component of the oral poliovirus vaccine in April 2016.

WHO & Regionals [to 5 March 2016]

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Weekly Epidemiological Record (WER) 4 March 2016, vol. 91, 9 (pp. 105–120)
Contents:
105 Progress towards measles elimination in Nepal, 2007–2014
112 Integrated Disease Surveillance and Response in Liberia: national expert group meeting, 15–19 September 2015

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Disease Outbreak News (DONs)
:: Zika virus infection – Saint Vincent and the Grenadines 1 March 2016
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 29 February 2016
:: Zika virus infection – Trinidad and Tobago 29 February 2016

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:: WHO Regional Offices
WHO African Region AFRO
:: WHO Regional Director for Africa, Dr Moeti concludes official visit to Cote d’Ivoire
Abidjan, 3 March 2016 – The WHO Regional Director for Africa, Dr Matshidiso Moeti concluded a three day official visit to Cote d’Ivoire yesterday. The visit began on Monday 29 February and was aimed at further strengthening collaboration between WHO and the Government of Cote d’Ivoire…

WHO Region of the Americas PAHO
:: PAHO/WHO calls on countries to strengthen surveillance of birth defects, including microcephaly (03/03/2016)

WHO South-East Asia Region SEARO
:: Media Statement on World Birth Defects Day 03 March 2016

WHO European Region EURO
No new digest content identified.

WHO Eastern Mediterranean Region EMRO
:: Countries urged to enhance preparedness and readiness measures for Zika virus infection in the Region 3 March 2016
:: Life-saving medical supplies reach besieged city in Syria
2 March 2016 – Today, WHO delivered urgently needed medicines, including antibiotics and painkillers, to the besieged city of Mouadamieh, 10 km south of Damascus. Since January 2016, WHO has delivered medicines, medical supplies and vaccines to a number of hard-to-reach areas in Syria, but at times has faced the challenge of having vital medicines removed from shipments depriving people of vital medical support.

WHO Western Pacific Region
:: WHO and partners reflect on the outcomes of the Conference of Parties on climate change
MANILA, 2 March 2016 – From 30 November to 11 December 2015, world leaders, climate change experts, representatives from the private sector and civil society organizations met in Paris to set a new standard for dealing with complex global problems posed by climate change. In all, 195 countries committed to limit the temperature increase to well below two degrees Celsius. This United Nations Conference of Parties on climate change, (COP 21) resulted in a major agreement and “a huge flame of hope.”

Secretary-General Appoints Commission on Health Employment and Economic Growth
2 March 2016
Secretary-General SG/A/1639
Press Release
United Nations Secretary-General Ban Ki-moon today announced the appointment of a Commission on Health Employment and Economic Growth.

The global economy is projected to create around 40 million new health sector jobs by 2030, mostly in middle- and high-income countries. Despite this growth, there is a projected shortage of 18 million health workers in low- and lower-middle-income countries. The Commission is tasked with proposing actions to redress these inequities, and stimulate and guide the creation of health and social sector jobs for inclusive economic growth.

“Having a sufficient number of health workers responsive to population needs and well-distributed across the world will be critical to the achievement of the Sustainable Development Goals and to addressing the growing challenges to global public health security,” said Secretary-General Ban Ki-moon. “I expect this Commission to make an important contribution towards the achievement of Universal Health Coverage, the creation of decent jobs, and to inclusive and transformative economic growth.”

The Commission had been established following United Nations General Assembly resolution A/RES/70/183, which recognized that “investing in new health workforce employment opportunities may also add broader socioeconomic value to the economy and contribute to the implementation for the 2030 Agenda for Sustainable Development” and requested the Secretary-General to “explore steps to meet the global shortfall of trained health workers”.

The Commission will be co-chaired by François Hollande, President of France, and Jacob Zuma, President of South Africa.

Approximately 25 Commissioners will soon be appointed to provide a balance of policy, technical and geographical expertise, from the education, employment, health and foreign affairs sectors of government, as well as representation from international organizations, academia, health-care professional associations, civil society and trade unions.

The Commission will hold its first meeting on 23 March, and will deliver its final report in the margin of the seventy-first regular session of the United Nations General Assembly in September.

Commission website: http://www.who.int/hrh/com-heeg/.

AERAS [to 5 March 2016]
http://www.aeras.org/pressreleases

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March 1, 2016
Danilo Casimiro Joins Aeras as Chief Scientific Officer
Rockville, MD,– Aeras today announced that Danilo Casimiro, Ph.D., has joined the organization as Chief Scientific Officer (CSO) effective February 29. Dr. Casimiro joins Aeras from the Merck Research Laboratories, where he was Executive Director in the Department of Infectious Diseases and Vaccine Research.

“Danilo Casimiro has dedicated his career to developing vaccines to combat many major human health issues and we are delighted he will be leading Aeras’s scientific strategy to develop a new, effective tuberculosis (TB) vaccine,” said Jacqueline E. Shea, Ph.D., Aeras Chief Executive Officer. “As a prominent and highly respected scientific leader, Dr. Casimiro brings a broad-ranging wealth of vaccine discovery and development experience and shares our passion and commitment to TB vaccine development and to global health.”

Dr. Casimiro will be filling the position recently vacated by Thomas G. Evans, M.D., who was formerly Aeras CEO and has been serving as Acting Chief Scientific Officer during the search for a permanent CSO…

Global Fund [to 5 March 2016]
http://www.theglobalfund.org/en/news/

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News
Major Pledge by European Commission Signals Strong Replenishment for the Global Fund
03 March 2016
BRUSSELS – The European Commission announced a pledge of €470 million for the Global Fund to Fight AIDS, Tuberculosis and Malaria for the three-year period beginning in 2017, an increase of €100 million, or 27 percent, over their previous contribution.

The pledge signals the European Commission’s strong leadership in global health, and marked the first pledge for the Global Fund’s Fifth Replenishment, a funding cycle covering the years 2017 through 2019.

“One of the lessons of the Ebola outbreak in West Africa is the clear need to strengthen health systems in developing countries, so that infectious diseases can be controlled for good,” said Neven Mimica, EU Commissioner for International Cooperation and Development.

“With €470 million, the EU’s contribution to the Global Fund will contribute to achieve our shared ambition to save 8 million more lives and avert up to 300 million infections,” Commissioner Mimica said. “I call on others to raise their contributions so that more resilient systems can be built, and the special needs of women and girls and those of key affected populations be better served.”…

PATH [to 5 March 2016]
http://www.path.org/news/index.php

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Press release | March 03, 2016
Woman’s Condom achieves WHO/UNFPA prequalification
An important step toward increasing global access to next-generation female condom
February 2016

Press release | February 26, 2016
Leading health innovator PATH partners with Johnson & Johnson Vietnam to reduce childhood tuberculosis
New initiative builds on PATH’s longstanding commitment to support Vietnam’s tuberculosis control efforts

European Medicines Agency [to 5 March 2016]
http://www.ema.europa.eu/

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03/03/2016
Guidance for the publication of clinical data
Requirements for industry now available on submission of clinical data for publication

The European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.
EMA’s pioneering policy entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The first reports are currently foreseen to be publicly available in September 2016.

“With this guidance, the Agency is moving towards the operational implementation of its proactive publication policy, which launched a new era of transparency,” says Noël Wathion, EMA’s Deputy Executive Director. “The guidance will ensure that companies are aware of what is expected of them and are ready for the publication of these critical data.”…

Defeating Meningitis in Africa
Chris Elias, President of Global Development at the Bill & Melinda Gates Foundation.
Project Syndicate | 2 March 2016

SEATTLE – Africa’s progress in fighting meningitis A is one of the best-kept secrets in global health. Thanks to the development and deployment of a low-cost vaccine, the lives of hundreds of thousands of children have been saved, and communities that might otherwise have been devastated by the illness are thriving….

…The MVP stands as a powerful example of what is possible when African leaders and experts from across the spectrum of global health work together. Strong, temporary partnerships, with a focused goal, can have truly catalytic effects. But the work is far from over. Last year, the WHO approved MenAfriVac for use in regular vaccine schedules, making it possible for millions more to be protected.
The stakes are high. Universal access to immunization is a cornerstone of health, development, and economic growth. Recognizing this, several African countries are already making plans to roll out meningitis – and other – vaccines into routine immunization systems this year. The task before African leaders is to ensure a smooth and full transition from mass vaccination campaigns to routine immunization.

Last week, government officials assembled in Ethiopia for the first-ever Ministerial Conference on Immunization in Africa, where they re-committed to ensuring that everyone on the continent has access to the vaccines they need. This will require further investment in immunization, improved data collection and analytics, new tools and approaches, and most importantly, strong partnerships.
We must build on the legacy of the MVP and work toward a world in which every child receives the life-saving vaccines they need to survive and thrive.

American Journal of Tropical Medicine and Hygiene
March 2016; 94 (3)
http://www.ajtmh.org/content/current

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Perspective Piece
Travel Vaccines Enter the Digital Age: Creating a Virtual Immunization Record
Kumanan Wilson, Katherine M. Atkinson, and Cameron P. Bell
Am J Trop Med Hyg 2016 94:485-488; Published online December 28, 2015, doi:10.4269/ajtmh.15-0510
Abstract
At present, proof of immunization against diseases such as yellow fever is required at some international borders in concordance with the International Health Regulations. The current standard, the International Certificate of Vaccination or Prophylaxis (ICVP), has limitations as a paper record including the possibility of being illegible, misplaced, or damaged. We believe that a complementary, digital record would offer advantages to public health and travelers alike. These include enhanced availability and reliability, potential to include lot specific information, and integration with immunization information systems. Challenges exist in implementation, particularly pertaining to verification at border crossings. We describe a potential course for the development and implementation of a digital ICVP record.

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Articles
Community Attitudes Toward Mass Drug Administration for Control and Elimination of Neglected Tropical Diseases After the 2014 Outbreak of Ebola Virus Disease in Lofa County, Liberia
Joshua Bogus, Lincoln Gankpala, Kerstin Fischer, Alison Krentel, Gary J. Weil, Peter U. Fischer,
Karsor Kollie, and Fatorma K. Bolay
Am J Trop Med Hyg 2016 94:497-503; Published online December 14, 2015, doi:10.4269/ajtmh.15-0591
Abstract
The recent outbreak of Ebola virus disease (EVD) interrupted mass drug administration (MDA) programs to control and eliminate neglected tropical diseases in Liberia. MDA programs treat entire communities with medication regardless of infection status to interrupt transmission and eliminate lymphatic filariasis and onchocerciasis. Following reports of hostilities toward health workers and fear that they might be spreading EVD, it was important to determine whether attitudes toward MDA might have changed after the outbreak. We surveyed 140 community leaders from 32 villages in Lofa County, Liberia, that had previously participated in MDA and are located in an area that was an early epicenter of the EVD outbreak. Survey respondents reported a high degree of community trust in the MDA program, and 97% thought their communities were ready to resume MDA. However, respondents predicted that fewer people would comply with MDA after the EVD epidemic than before. The survey also uncovered fears in the community that EVD and MDA might be linked. Respondents suggested that MDA programs emphasize to people that the medications are identical to those previously distributed and that MDA programs have nothing to do with EVD.

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Articles
Diarrhea Prevalence, Care, and Risk Factors Among Poor Children Under 5 Years of Age in Mesoamerica
Danny V. Colombara, Bernardo Hernández, Claire R. McNellan, Sima S. Desai, Marielle C. Gagnier, Annie Haakenstad, Casey Johanns, Erin B. Palmisano, Diego Ríos-Zertuche, Alexandra Schaefer, Paola Zúñiga-Brenes, Nicholas Zyznieuski, Emma Iriarte, and Ali H. Mokdad
Am J Trop Med Hyg 2016 94:544-552; Published online January 19, 2016, doi:10.4269/ajtmh.15-0750
Abstract
Care practices and risk factors for diarrhea among impoverished communities across Mesoamerica are unknown. Using Salud Mesoamérica Initiative baseline data, collected 2011–2013, we assessed the prevalence of diarrhea, adherence to evidence-based treatment guidelines, and potential diarrhea correlates in poor and indigenous communities across Mesoamerica. This study surveyed 14,500 children under 5 years of age in poor areas of El Salvador, Guatemala, Mexico (Chiapas State), Nicaragua, and Panama. We compared diarrhea prevalence and treatment modalities using χ2 tests and used multivariable Poisson regression models to calculate adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) for potential correlates of diarrhea. The 2-week point prevalence of diarrhea was 13% overall, with significant differences between countries (P < 0.05). Approximately one-third of diarrheal children were given oral rehydration solution and less than 3% were given zinc. Approximately 18% were given much less to drink than usual or nothing to drink at all. Antimotility medication was given to 17% of diarrheal children, while antibiotics were inappropriately given to 36%. In a multivariable regression model, compared with children 0–5 months, those 6–23 months had a 49% increased risk for diarrhea (aRR = 1.49, 95% CI = 1.15, 1.95). Our results call for programs to examine and remedy low adherence to evidence-based treatment guidelines.

Annals of Internal Medicine
1 March 2016, Vol. 164. No. 5
http://annals.org/issue.aspx

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Original Research
Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial
FREE
Lindsey R. Baden, MD; Etienne Karita, MD; Gaudensia Mutua, MBChB; Linda-Gail Bekker, MD; Glenda Gray, MBBCh; Liesl Page-Shipp, MD; Stephen R. Walsh, MD; Julien Nyombayire, MD; Omu Anzala, MBChB, PhD; Surita Roux, MD; Fatima Laher, MBBCh; Craig Innes, MD; Michael S. Seaman, PhD; Yehuda Z. Cohen, MD; Lauren Peter; Nicole Frahm, PhD; M. Juliana McElrath, MD, PhD; Peter Hayes, PhD; Edith Swann, PhD; Nicole Grunenberg, MD; Maria Grazia-Pau, MSc; Mo Weijtens, PhD; Jerry Sadoff, MD; Len Dally, MSc; Angela Lombardo, PhD; Jill Gilmour, PhD; Josephine Cox, PhD; Raphael Dolin, MD; Patricia Fast, MD, PhD; Dan H. Barouch, MD, PhD; Dagna S. Laufer, MD, for the B003-IPCAVD004-HVTN091 Study Group
Abstract
Background: A prophylactic HIV-1 vaccine is a global health priority.
Objective: To assess a novel vaccine platform as a prophylactic HIV-1 regimen.
Design: Randomized, double-blind, placebo-controlled trial. Both participants and study personnel were blinded to treatment allocation. (ClinicalTrials.gov: NCT01215149)
Setting: United States, East Africa, and South Africa.
Patients: Healthy adults without HIV infection.
Intervention: 2 HIV-1 vaccines (adenovirus serotype 26 with an HIV-1 envelope A insert [Ad26.EnvA] and adenovirus serotype 35 with an HIV-1 envelope A insert [Ad35.Env], both administered at a dose of 5 × 1010 viral particles) in homologous and heterologous combinations.
Measurements: Safety and immunogenicity and the effect of baseline vector immunity.
Results: 217 participants received at least 1 vaccination, and 210 (>96%) completed follow-up. No vaccine-associated serious adverse events occurred. All regimens were generally well-tolerated. All regimens elicited humoral and cellular immune responses in nearly all participants. Preexisting Ad26- or Ad35-neutralizing antibody titers had no effect on vaccine safety and little effect on immunogenicity. In both homologous and heterologous regimens, the second vaccination significantly increased EnvA antibody titers (approximately 20-fold from the median enzyme-linked immunosorbent assay titers of 30–300 to 3000). The heterologous regimen of Ad26–Ad35 elicited significantly higher EnvA antibody titers than Ad35–Ad26. T-cell responses were modest and lower in East Africa than in South Africa and the United States.
Limitations: Because the 2 envelope inserts were not identical, the boosting responses were complex to interpret. Durability of the immune responses elicited beyond 1 year is unknown.
Conclusion: Both vaccines elicited significant immune responses in all populations. Baseline vector immunity did not significantly affect responses. Second vaccinations in all regimens significantly boosted EnvA antibody titers, although vaccine order in the heterologous regimen had a modest effect on the immune response.
Primary Funding Source: International AIDS Vaccine Initiative, National Institutes of Health, Ragon Institute, Crucell Holland.

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Ideas and Opinions
Interrupting Ebola Transmission in Liberia Through Community-Based Initiatives
Mosoka Fallah, PhD, MPH; Bernice Dahn, MD, MPH; Tolbert G. Nyenswah, Esq, MPH; Moses Massaquoi, MD, MPH; Laura A. Skrip, MPH; Dan Yamin, PhD; Martial Ndeffo Mbah, PhD; Netty Joe, MD; Siedoh Freeman, MD; Thomas Harris, BA; Zinnah Benson, BBA; and Alison P. Galvani, PhD
In Liberia, programs based on community engagement were effective in controlling the Ebola virus disease epidemic. This article details the community-based initiative that was instrumental to the shift in transmission dynamics.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 5 March 2016)

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Debate
Implications of prioritizing HIV cure: new momentum to overcome old challenges in HIV

Curing HIV is a new strategic priority for several major AIDS organizations. In step with this new priority, HIV cure research and related programs are advancing in low, middle, and high-income country settings…
Joseph D. Tucker, Adam Gilbertson, Ying-Ru Lo and Marco Vitória
BMC Infectious Diseases 2016 16:109
Published on: 3 March 2016

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 5 March 2016)

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Research article
Qualitative study on custodianship of human biological material and data stored in biobanks
Michiel Verlinden, Herman Nys, Nadine Ectors and Isabelle Huys
Published on: 1 March 2016
Abstract
Background
Balancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials (HBM) and data.
Methods
Twenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and applicants with respect to access to HBM and data.
Results
There was no consensus among the informants on whether the custodian of a biobank should decide upon the scientific merits and the utility of an access request. Nearly all informants agreed that a new request or an amendment to the initial request has to be submitted when an applicant wants to use leftover HBM in a new or follow-up project. Several informants felt that it might be justified to charge higher access fees to external or industrial applicants that did not contribute (directly or indirectly) to the collection of HBM and data. Most informants agreed that a custodian of a biobank could request the sharing and return of research results. It was furthermore argued that some of the benefits of research projects should be fed back into biobanks.
Conclusions
The interviews revealed a rather complex web of rights and obligations allocated to the custodian and the applicant in relation to access to HBM and data stored in biobanks. Some rights and obligations are negotiated on a case-by-case basis, while others are stipulated in access arrangements. We did find a consensus on the attribution of certain general rights to the custodians and the applicant.

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 5 March 2016)

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Research article
Awareness and knowledge about human papillomavirus vaccination and its acceptance in China: a meta-analysis of 58 observational studies

The human papillomavirus (HPV) vaccines have been widely introduced in immunization programs worldwide, however, it is not accepted in mainland China…Low HPV vaccine awareness and knowledge was observed among the Chinese population. HPV vaccine awareness differed across sexes, ethnicities, and regions. Given the limited quality and number of studies included, further research with improved study design is necessary.
Yanru Zhang, Ying Wang, Li Liu, Yunzhou Fan, Zhihua Liu, Yueyun Wang and Shaofa Nie
BMC Public Health 2016 16:216
Published on: 3 March 2016

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 5 March 2016)

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Research Article
Factors influencing willingness to participate in new drug trial studies: a study among parents whose children were recruited into these trials in northern Ghana
James Akazili, Samuel Chatio, Fabian Sebastian Achana, Abraham Oduro, Edmund W. Kanmiki and Frank Baiden
BMC Research Notes 2016 9:139
Published on: 3 March 2016
Abstract
Background
During the last decade, the number of clinical trials conducted in sub-Saharan Africa has increased significantly which has helped to address priority health problems in the region. Navrongo health research centre since it was established in 1989, has conducted several trial studies including rectal artesunate trial in the Kassena-Nankana districts. However, there is little evidence-based for assessing the impact of new drug trials. This study explored factors that motivate parents to allow their children to participate in new drug trials in northern Ghana.
Method
The study used both quantitative and qualitative methods. The participants were randomly selected from among parents whose children were enrolled in a new drug trial conducted in the Kassena-Nankana districts between 2000 and 2003. QSR Nvivo 9 software was used to code the qualitative data into themes before analysis while STATA software Version 11.2© was used to analyze the quantitative data.
Results
The results showed that majority (95.9 %) of the parents were willing to allow their children to be enrolled in future new drug trials. The main factors motivating their willingness to allow their children to be enrolled in these trials were quality of health care services offered to trial participants (92.9 %), detail medical examination (90.8 %), promptness of care provided (94.4 %) and quality of drugs (91.9 %). Other factors mentioned included disease prevention (99.5 %) and improved living standard (96.1 %). Parents reported that the conduct of these trials had reduced the frequency of disease occurrences in the communities because of the quality of health care services provided to the children recruited into these trial studies.
Conclusion
Though the implementation of clinical trials in the study area is believed to have positive impact on health status of people particularly trial participants, measures should however be taken to address safety and likely side effects of new drugs given to trial participants during these trial studies.