Incidence of Pneumococcal Pneumonia Among Adults in Rural Thailand, 2006–2011: Implications for Pneumococcal Vaccine Considerations

American Journal of Tropical Medicine and Hygiene
December 2015; 93 (6)
http://www.ajtmh.org/content/current

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Incidence of Pneumococcal Pneumonia Among Adults in Rural Thailand, 2006–2011: Implications for Pneumococcal Vaccine Considerations
Barameht Piralam, Sara M. Tomczyk, Julia C. Rhodes, Somsak Thamthitiwat, Christopher J. Gregory, Sonja J. Olsen, Prabda Praphasiri, Pongpun Sawatwong, Sathapana Naorat, Somrak Chantra, Peera Areerat, Cameron P. Hurst, Matthew R. Moore, Charung Muangchana, and Henry C. Baggett
Am J Trop Med Hyg 2015 93:1140-1147; Published online October 26, 2015, doi:10.4269/ajtmh.15-0429
Abstract
The incidence of pneumococcal pneumonia among adults is a key driver for the cost-effectiveness of pneumococcal conjugate vaccine used among children. We sought to obtain more accurate incidence estimates among adults by including results of pneumococcal urine antigen testing (UAT) from population-based pneumonia surveillance in two Thai provinces. Active surveillance from 2006 to 2011 identified acute lower respiratory infection (ALRI)–related hospital admissions. Adult cases of pneumococcal pneumonia were defined as hospitalized ALRI patients aged ≥ 18 years with isolation of Streptococcus pneumoniae from blood or with positive UAT. Among 39,525 adult ALRI patients, we identified 481 pneumococcal pneumonia cases (105 by blood culture, 376 by UAT only). Estimated incidence of pneumococcal pneumonia hospitalizations was 30.5 cases per 100,000 persons per year (2.2 and 28.3 cases per 100,000 persons per year by blood culture and UAT, respectively). Incidence varied between 22.7 in 2007 and 43.5 in 2010, and increased with age to over 150 per 100,000 persons per year among persons aged ≥ 70 years. Viral coinfections including influenza A/B, respiratory syncytial virus (RSV), and adenovirus occurred in 11% (44/409) of pneumococcal pneumonia cases tested. Use of UAT to identify cases of pneumococcal pneumonia among adults in rural Thailand substantially increases estimates of pneumococcal pneumonia burden, thereby informing cost-effectiveness analyses and vaccine policy decisions.

A systematic review of factors that affect uptake of community-based health insurance in low-income and middle-income countries

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 12 December 2015)

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Research article
A systematic review of factors that affect uptake of community-based health insurance in low-income and middle-income countries
Esther Adebayo, Olalekan Uthman, Charles Wiysonge, Erin Stern, Kim Lamont, John Ataguba BMC Health Services Research 2015, 15:543 (8 December 2015)

Cost-effectiveness analysis of human papillomavirus vaccination in South Africa accounting for human immunodeficiency virus prevalence

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 12 December 2015)

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Research article
Cost-effectiveness analysis of human papillomavirus vaccination in South Africa accounting for human immunodeficiency virus prevalence
Xiao Li, Martinus Stander, Georges Van Kriekinge, Nadia Demarteau
BMC Infectious Diseases 2015, 15:566 (11 December 2015)
Abstract
Background
This study aims at evaluating the cost-effectiveness of a 2-dose schedule human papillomavirus (HPV) vaccination programme of HPV and human immunodeficiency virus (HIV) naïve 12-year-old girls, in addition to cervical cancer (CC) screening alone, in South Africa. The study aims to account for both the impact of the vaccine among girls who are HIV-positive (HIV+) as well as HIV-negative (HIV-) population.
Methods
A previously published Markov cohort model was adapted to assess the impact and cost-effectiveness of a HPV vaccination programme in girls aged 12 years (N = 527 900) using the AS04-adjuvanted HPV-16/18 vaccine from a public payer perspective. Two subpopulations were considered: HIV- and HIV+ women. Each population followed the HPV natural history with different transition probabilities. Model input data were obtained from the literature, local databases and Delphi panel. Costs and outcomes were discounted at 5 %. Extensive sensitivity analyses were conducted to assess the robustness of the evaluation.
Results
Implementation of the AS04-adjuvanted HPV-16/18 vaccine in combination with current cytological screening in South African girls could prevent up to 8 869 CC cases and 5 436 CC deaths over the lifetime of a single cohort. Without discounting, this HPV vaccine is dominant over screening alone; with discounting, the incremental cost-effectiveness ratio is ZAR 81 978 (South African Rand) per quality-adjusted life years (QALY) gained. HPV vaccination can be considered cost-effective based on World Health Organization (WHO) recommended threshold (3 x gross domestic product/capita = ZAR 200 293). In a scenario with a hypothetical targeted vaccination in a HIV+ subpopulation alone, the modelled outcomes suggest that HPV vaccination is still cost-effective, although the incremental cost-effectiveness ratio increases to ZAR 102 479. Results were sensitive to discount rate, vaccine efficacy, HIV incidence and mortality rates, and HPV-related disease transition probabilities.
Conclusions
The AS04-adjuvanted HPV-16/18 vaccine can be considered cost-effective in a South African context although the cost-effectiveness is expected to be lower in the HIV+ subpopulation than in the overall female population. With improved access to HIV treatment, the HIV mortality and incidence rates are likely to be reduced, which could improve cost-effectiveness of the vaccination programme in South Africa.

BMC Public Health (Accessed 12 December 2015)

BMC Public Health
http://www.biomedcentral.com/bmcpublichealth/content
(Accessed 12 December 2015)

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Research article
The use of reimbursement data for timely monitoring of vaccination coverage: the example of human papillomavirus vaccine following public concerns about vaccine safety
Laure Fonteneau, Marine Ragot, Isabelle Parent du Châtelet, Jean-Paul Guthmann, Daniel Lévy-Bruhl BMC Public Health 2015, 1
Abstract
Background
Since 2011 public concerns about Human Papillomavirus (HPV) vaccination safety and efficacy arose in France. We explored the relevance of using vaccines reimbursement data to assess the impact of those public concerns on vaccination coverage.
Methods
We used the Permanent Sample of Beneficiaries which was, at the time of the study, a representative sample of 1/97 th health insurance beneficiaries of the main Social Security scheme, the General Health Insurance Scheme, covering approximately 77 % of the French resident population. We estimated HPV vaccination coverage among girls born between 1995 and 1999 at their 15th, 16th and 17th birthday.
Results
The coverage for complete vaccination among 16 years old girls decreased from 26.5 % in the first semester of 2011 to 18.6 % in the first semester of 2014.
Conclusions
HPV vaccination coverage was already low in 2011 and continued to decrease thereafter. Vaccines reimbursement data allowed us to reactively monitor the impact of the controversy on vaccination coverage and design counteracting measures.

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Research article
Vaccination decision-making of immigrant parents in the Netherlands; a focus group study
Irene Harmsen, Helien Bos, Robert Ruiter, Theo Paulussen, Gerjo Kok, Hester de Melker, Liesbeth Mollema
BMC Public Health 2015, 1
Abstract
Background
Although the vaccination coverage in most high income countries is high, variations in coverage rates on the national level among different ethnic backgrounds are reported. A qualitative study was performed to explore factors that influence decision-making among parents with different ethnic backgrounds in the Netherlands.
Methods
Six focus groups were conducted with 33 mothers of Moroccan, Turkish and other ethnic backgrounds with at least one child aged 0–4 years. Data were analysed using thematic analysis.
Results
Parents had a positive attitude towards childhood vaccination and a high confidence in the advices of Child Vaccine Providers (CVPs). Vaccinating their children was perceived as self-evident and important. Parents do perceive a language barrier in understanding the provided NIP-information, and they had a need for more NIP- information, particularly about the targeted diseases. Another barrier parents perceived was the distance to the Child Welfare Center (CWC), especially when the weather was bad and when they had no access to a car.
Conclusion
More information about targeted diseases and complete information regarding benefits and drawbacks of the NIP should be provided to the parents. To fulfill parents’ information needs, NIP information meetings can be organized at CWCs in different languages. Providing NIP information material in Turkish, Arabic and Berber language with easy access is also recommended. Providing information tailored to these parents’ needs is important to sustain high vaccination participation, and to ensure acceptance of future vaccinations.

Special Issue: Evidence of the Impact of Human Rights-Based Approaches to Health

Health and Human Rights
Volume 17, Issue 2 December 2015
http://www.hhrjournal.org/

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Special Issue: Evidence of the Impact of Human Rights-Based Approaches to Health

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Editorial
Making the Case: What Is the Evidence of Impact of Applying Human Rights-Based Approaches to Health?
Paul Hunt, Alicia Ely Yamin, and Flavia Bustreo, Guest Editors

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Framing the Issues
Assessing the Impact of a Human Rights-Based Approach Across a Spectrum of Change for Women’s, Children’s, and Adolescents’ Health
Rebekah Thomas, Shyama Kuruvilla, Rachael Hinton, Steven L. B. Jensen, Veronica Magar, and Flavia Bustreo

Ethical and Human Rights Foundations of Health Policy: Lessons from Comprehensive Reform in Mexico
Julio Frenk and Octavio Gómez-Dantés

What Constitutes Evidence in Human Rights-Based Approaches to Health? Learning from Lived Experiences of Maternal and Sexual Reproductive Health
Maya Unnithan

Measuring the Impact of the Human Rights on Health in Global Health Financing
Sara L.M. Davis

The Universal Periodic Review: A Platform for Dialogue, Accountability, and Change on Sexual and Reproductive Health and Rights
Kate Gilmore, Luis Mora, Alfonso Barragues, Ida Krogh Mikkelsen

Assessing Ebola-related web search behaviour: insights and implications from an analytical study of Google Trends-based query volumes

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 12 December 2015]

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Research Article
Assessing Ebola-related web search behaviour: insights and implications from an analytical study of Google Trends-based query volumes
Cristiano Alicino, Nicola Bragazzi, Valeria Faccio, Daniela Amicizia, Donatella Panatto, Roberto Gasparini, Giancarlo Icardi, Andrea Orsi Infectious Diseases of Poverty 2015, 4:54 (10 December 2015)
Abstract
Background
The 2014 Ebola epidemic in West Africa has attracted public interest worldwide, leading to millions of Ebola-related Internet searches being performed during the period of the epidemic. This study aimed to evaluate and interpret Google search queries for terms related to the Ebola outbreak both at the global level and in all countries where primary cases of Ebola occurred. The study also endeavoured to look at the correlation between the number of overall and weekly web searches and the number of overall and weekly new cases of Ebola.
Methods
Google Trends (GT) was used to explore Internet activity related to Ebola. The study period was from 29 December 2013 to 14 June 2015. Pearson’s correlation was performed to correlate Ebola-related relative search volumes (RSVs) with the number of weekly and overall Ebola cases. Multivariate regression was performed using Ebola-related RSV as a dependent variable, and the overall number of Ebola cases and the Human Development Index were used as predictor variables.
Results
The greatest RSV was registered in the three West African countries mainly affected by the Ebola epidemic. The queries varied in the different countries. Both quantitative and qualitative differences between the affected African countries and other Western countries with primary cases were noted, in relation to the different flux volumes and different time courses. In the affected African countries, web query search volumes were mostly concentrated in the capital areas. However, in Western countries, web queries were uniformly distributed over the national territory. In terms of the three countries mainly affected by the Ebola epidemic, the correlation between the number of new weekly cases of Ebola and the weekly GT index varied from weak to moderate. The correlation between the number of Ebola cases registered in all countries during the study period and the GT index was very high.
Conclusion
Google Trends showed a coarse-grained nature, strongly correlating with global epidemiological data, but was weaker at country level, as it was prone to distortions induced by unbalanced media coverage and the digital divide. Global and local health agencies could usefully exploit GT data to identify disease-related information needs and plan proper communication strategies, particularly in the case of health-threatening events.

Addressing contact tracing challenges—critical to halting Ebola virus disease transmission

International Journal of Infectious Diseases
December 2015 Volume 41, In Progress
http://www.ijidonline.com/issue/S1201-9712%2815%29X0012-9

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Addressing contact tracing challenges—critical to halting Ebola virus disease transmission
Ashley L. Greiner, Kristina M. Angelo, Andrea M. McCollum, Kelsey Mirkovic, Ray Arthur, Frederick J. Angulo
p53–55
Published online: November 4 2015
Open Access
Abstract
The 2014–2015 Ebola virus disease (EVD) outbreak is the largest in history and the first in West Africa. Many factors underlie the extensive transmission of EVD, particularly delayed and ineffective contact tracing. Contact tracing is a key component to halting the epidemic and getting to zero cases; it includes identifying, locating, and assessing people (known as contact-persons) who have been exposed to a symptomatic EVD case patient.1 Contact-persons are then systematically followed during the maximum Ebola virus incubation period of 21 days, to allow for immediate identification and prompt isolation if they become symptomatic, preventing onward transmission.

Journal of Epidemiology & Community Health – January 2016

Journal of Epidemiology & Community Health
January 2016, Volume 70, Issue 1
http://jech.bmj.com/content/current

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Editorial
The 2014–2015 Ebola saga: lessons for the future
James A Ayukekbong
Author Affiliations
Section of Clinical Virology, Redeem Biomedical System, Buea, Cameroon
Extract
The duration and characteristics of the current devastating and unprecedented Ebola epidemic highlight the need for global public health surveillance to establish preparedness mechanisms for future outbreaks. Since the discovery of the virus in 1976, at least 25 Ebola outbreaks have been recorded, on average occurring every 1.5 years with case fatality rate (CFR) between 30% and 90%.1 ,2 The largest interval between two outbreaks is 15 years, that is, from the 1979 outbreak in Sudan due to the Sudan Ebola virus and the subsequent 1994 outbreak in Gabon caused by the Zaire Ebola virus.
Remarkably, only six previous outbreaks generated >100 deaths but the approximately 11 222 deaths (as of 30 June 2015) in the ongoing epidemic is already more than seven times the number of deaths reported for all previous outbreaks combined, which is estimated to be about 1580 deaths.3 ,4 Obviously, the present epidemic is the longest, largest and most complex Ebola outbreak since the virus was first discovered about 40 years ago. The outbreak started in December 2013 in Guinea,2 spread across land borders to Sierra Leone and Liberia, and then subsequently, by some infected persons, to seven other countries (Mali, Nigeria, Senegal, Spain, the UK, Germany and the USA). In some of these countries, individuals were only diagnosed as Ebola virus disease (EVD) cases after their arrival (eg, the USA), while other countries received known patients for treatment (eg, Spain). However, in these countries, the disease was rapidly contained, thanks to improved healthcare facilities, timely patient isolation and treatment. Meanwhile, the outbreak in Guinea, Liberia and Sierra Leone continued on …

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Ebola, viewed through a lens of African epidemiology
Musa Abubakar Kana, Olufunmilayo Y Elegba, Jackie Obey, Faina Linkov, Eugene Shubnikov
J Epidemiol Community Health 2016;70:6-8 Published Online First: 5 August 2015 doi:10.1136/jech-2015-205874

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Reaching the poor with health interventions: programme-incidence analysis of seven randomised trials of women’s groups to reduce newborn mortality in Asia and Africa
Tanja A J Houweling, Joanna Morrison, Glyn Alcock, Kishwar Azad, Sushmita Das, Munir Hossen, Abdul Kuddus, Sonia Lewycka, Caspar W Looman, Bharat Budhathoki Magar, Dharma S Manandhar, Mahfuza Akter, Albert Lazarous Nkhata Dube, Shibanand Rath, Naomi Saville, Aman Sen, Prasanta Tripathy, Anthony Costello, for the EquiNaM group
J Epidemiol Community Health 2016;70:31-41 Published Online First: 5 August 2015 doi:10.1136/jech-2014-204685
Abstract
Background
Efforts to end preventable newborn deaths will fail if the poor are not reached with effective interventions. To understand what works to reach vulnerable groups, we describe and explain the uptake of a highly effective community-based newborn health intervention across social strata in Asia and Africa.
Methods
We conducted a secondary analysis of seven randomised trials of participatory women’s groups to reduce newborn mortality in India, Bangladesh, Nepal and Malawi. We analysed data on 70 574 pregnancies. Socioeconomic and sociodemographic differences in group attendance were tested using logistic regression. Qualitative data were collected at each trial site (225 focus groups, 20 interviews) to understand our results.
Results
Socioeconomic differences in women’s group attendance were small, except for occasional lower attendance by elites. Sociodemographic differences were large, with lower attendance by young primigravid women in African as well as in South Asian sites. The intervention was considered relevant and interesting to all socioeconomic groups. Local facilitators ensured inclusion of poorer women. Embarrassment and family constraints on movement outside the home restricted attendance among primigravid women. Reproductive health discussions were perceived as inappropriate for them.
Conclusions
Community-based women’s groups can help to reach every newborn with effective interventions. Equitable intervention uptake is enhanced when facilitators actively encourage all women to attend, organise meetings at the participants’ convenience and use approaches that are easily understandable for the less educated. Focused efforts to include primigravid women are necessary, working with families and communities to decrease social taboos.

Journal of Global Ethics – Volume 11, Issue 3, 2015

Journal of Global Ethics
Volume 11, Issue 3, 2015
http://www.tandfonline.com/toc/rjge20/.U2V-Elf4L0l#.VAJEj2N4WF8

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Forum: The Sustainable Development Goals
Introduction: The 2030 Agenda
Eric Palmer*
DOI: 10.1080/17449626.2015.1119928
pages 262-269
Abstract
This introduction notes the contributions of authors to the second (final) issue of the Journal of Global Ethics 2015 Sustainable Development Goals Forum. It briefly explains the process through which the Sustainable Development Goals (SDGs) have developed from their receipt in 2014 to their passage in September 2015 by the UN General Assembly, and it considers their development in prospect. The Millennium Development Goals, which spanned 1990–2015, present a case study that reveals the changeability of such long-term multilateral commitments. They were enmeshed in overlapping and inconsistent national and intergovernmental commitments reaching from 1995 to 2005, and the text of those goals also evolved, stabilizing for the last time in 2007. The SDGs and attendant commitments should be expected to evolve similarly over their 15-year run. This presents a concern, for among the three committees established by the UN to create the goals, the two committees charged with public consultation were retired as planned in 2014. The process evident thereafter has displayed a shift towards a strategy of enrolling broad public endorsement that leaves such consultation and specific responsibility to those consulted in doubt. This bodes ill for public deliberation on the goals and for public accountability as the agenda proceeds towards 2030.

The Lancet – Dec 12, 2015

The Lancet
Dec 12, 2015 Volume 386 Number 10011 p2365-2444 e56-e60
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Remembering the right to health
The Lancet
Summary
Dec 10 marks Human Rights Day. This year, the day is devoted to the launch of a year-long UN campaign to celebrate the 50th anniversary of two landmark international covenants on human rights: the International Covenant on Economic, Social and Cultural Rights and the International Covenant on Civil and Political Rights, which were adopted by the UN General Assembly on Dec 16, 1966.

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Comment
Women’s, children’s, and adolescents’ health needs universal health coverage
Robin Gorna, Nicole Klingen, Kunio Senga, Agnes Soucat, Keizo Takemi
2371

A worldwide shift in polio vaccines for routine immunisation
Julie R Garon, Walter A Orenstein
2375

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Articles
Immunogenicity of a new routine vaccination schedule for global poliomyelitis prevention: an open-label, randomised controlled trial
Roland W Sutter, Sunil Bahl, Jagadish M Deshpande, Harish Verma, Mohammad Ahmad, P Venugopal, J Venkateswara Rao, Sharad Agarkhedkar, Sanjay K Lalwani, Abhishek Kunwar, Raman Sethi, Marina Takane, Lalitendu Mohanty, Arani Chatterjee, T Jacob John, Hamid Jafari, R Bruce Aylward
Summary
Background
Polio eradication needs a new routine immunisation schedule—three or four doses of bivalent type 1 and type 3 oral poliovirus vaccine (bOPV) and one dose of inactivated poliovirus vaccine (IPV), but no immunogenicity data are available for this schedule. We aimed to assess immunogenicity of this vaccine schedule.
Methods
We did an open-label, randomised controlled trial in four centres in India. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of five groups: trivalent OPV (tOPV); tOPV plus IPV; bOPV; bOPV plus IPV; or bOPV plus two doses of IPV (2IPV). The key eligibility criteria were: full-term birth (≥37 weeks of gestation); birthweight ≥2·5 kg; and Apgar score of 9 or more. OPV was administered at birth, 6 weeks, 10 weeks, and 14 weeks; IPV was administered intramuscularly at 14 weeks. The primary study objective was to investigate immunogenicity of the new vaccine schedule, assessed by seroconversion against poliovirus types 1, 2, and 3 between birth and 18 weeks in the per-protocol population (all participants with valid serology results on cord blood and at 18 weeks). Neutralisation assays tested cord blood and sera collected at 14 weeks, 18 weeks, 19 weeks, and 22 weeks by investigators masked to group allocation. This trial was registered with the India Clinical Trials Registry, number CTRI/2013/06/003722.
Findings
Of 900 newborn babies enrolled between June 13 and Aug 29, 2013, 782 (87%) completed the per-protocol requirements. Between birth and age 18 weeks, seroconversion against poliovirus type 1 in the tOPV group occurred in 162 of 163 (99·4%, 95% CI 96·6–100), in 150 (98·0%, 94·4–99·6) of 153 in the tOPV plus IPV group, in 153 (98·7%, 95·4–99·8) of 155 in the bOPV group, in 155 (99·4%, 96·5–100) of 156 in the bOPV plus IPV group, and in 154 (99·4%, 96·5–100) of 155 in the bOPV plus 2IPV group. Seroconversion against poliovirus type 2 occurred in 157 (96·3%, 92·2–98·6) of 163 in the tOPV group, 153 (100%, 97·6–100·0) of 153 in the tOPV plus IPV group, 29 (18·7%, 12·9–25·7) of 155 in the bOPV group, 107 (68·6%, 60·7–75·8) of 156 in the bOPV plus IPV group, and in 121 (78·1%, 70·7–84·3) of 155 in the bOPV plus 2IPV group. Seroconversion against poliovirus type 3 was achieved in 147 (90·2%, 84·5–94·3) of 163 in the tOPV group, 152 (99·3%, 96·4–100) of 153 in the tOPV plus IPV group, 151 (97·4%, 93·5–99·3) of 155 in the bOPV group, 155 (99·4%, 96·5–100) of 156 in the bOPV plus IPV group, and 153 (98·7%, 95·4–99·8) of 155 in the bOPV plus 2IPV group. Superiority was achieved for vaccine regimens including IPV against poliovirus type 3 compared with those not including IPV (tOPV plus IPV vs tOPV alone, p=0·0008; and bOPV plus IPV vs bOPV alone, p=0·0153). 12 serious adverse events occurred (six in the tOPV group, one in the tOPV plus IPV group, three in the bOPV group, zero in the bOPV plus IPV group, and two in the bOPV plus 2IPV group), none of which was attributed to the trial intervention.
Interpretation
The new vaccination schedule improves immunogenicity against polioviruses, especially against poliovirus type 3.
Funding
WHO, through a grant from Rotary International ( grant number 59735 ).

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Review
Assuring health coverage for all in India
Vikram Patel, Rachana Parikh, Sunil Nandraj, Priya Balasubramaniam, Kavita Narayan, Vinod K Paul, A K Shiva Kumar, Mirai Chatterjee, K Srinath Reddy

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Health Policy
How much donor financing for health is channelled to global versus country-specific aid functions?
Marco Schäferhoff, Sara Fewer, Jessica Kraus, Emil Richter, Lawrence H Summers, Jesper Sundewall, Gavin Yamey, Dean T Jamison

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Viewpoint
The health gap: the challenge of an unequal world
Michael Marmot

Bringing the Common Rule into the 21st Century

New England Journal of Medicine
December 10, 2015 Vol. 373 No. 24
http://www.nejm.org/toc/nejm/medical-journal

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Perspective
Bringing the Common Rule into the 21st Century
Kathy L. Hudson, Ph.D., and Francis S. Collins, M.D., Ph.D.
N Engl J Med 2015; 373:2293-2296
December 10, 2015
DOI: 10.1056/NEJMp1512205

On September 8, 2015, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a proposal to revise the regulations governing the ethical conduct of research involving humans.1 The current regulations were adopted by HHS in 1981 to implement the landmark 1979 Belmont Report. Adopted by other agencies throughout government in 1991, the regulations, informally known as the Common Rule, have changed little since their inception, while the research landscape has changed radically.

In addition to revolutionary advances in scientific knowledge and technologies, society has undergone tremendous shifts in recent decades that are highly relevant to the conduct of research. Today’s studies are more likely to include multiple research sites and large numbers of participants. Research is moving toward a more participatory model, as volunteers increasingly expect to be partners in research — as exemplified by such studies as the President’s Precision Medicine Initiative (www.nih.gov/precisionmedicine). Sharing data and biospecimens can accelerate discoveries, and increasingly sophisticated information can be obtained from biospecimens. The controversy that followed the 2013 publication of the genome sequence of the HeLa cell line (derived from tumor cells from Henrietta Lacks) underscores the need for greater involvement of and respect for research participants.2

The two central goals of the proposed revisions to the Common Rule are to enhance respect and safeguards for research participants and to increase research efficiency by reducing unnecessary burdens and calibrating oversight to the level of risk. If they are ultimately adopted, the key changes will require consent for research involving biospecimens, allow participants to grant broad consent for future use of data and biospecimens, strengthen privacy and security safeguards to prevent unauthorized disclosure and use of data and biospecimens, streamline institutional review board (IRB) operations by requiring reliance on a single IRB for multisite studies conducted in the United States, and exclude some nonresearch activities and low-risk research from the rule, while exempting other low-risk research from certain requirements (see Table 1Table 1Major Proposed Changes in the Common Rule Notice of Proposed Rulemaking (NPRM).). The proposals reflect careful consideration of the public comments on proposals published in 20113 and a deeper understanding of participants’ preferences and risks4 that has been developed over the past 4 years.

One of the most significant changes will be requiring consent for the use of all biospecimens in research, whether or not they are deidentified (see Table 2Table 2Major Changes to Requirements by Research Type.). A growing body of literature indicates that prospective research participants want to decide whether their biospecimens are used in research; they want researchers to ask their permission — it is the respectful thing to do. Moreover, given the available tools and technologies, we know that biospecimens can be used to generate information unique to individuals and therefore cannot be truly deidentified4; there is thus an ethical obligation to seek permission and inform participants of risks to their privacy. The proposed change allows consent to be broad, enabling participants to grant permission for researchers to use their biospecimens and data for all kinds of downstream research questions.
No doubt, requiring consent for the use of deidentified biospecimens and allowing broad consent will pose challenges for the research community. But the proposed rule allows continued use of deidentified biospecimens collected in the past, and the new policy will be phased in over 3 years. In the beginning, there will be additional costs and effort needed to make the consent process work and to track the consent status of stored biospecimens. Enormous benefits, however, will be realized as biospecimens become more available for secondary research.

The Common Rule proposal also tackles some long-standing complaints about informed-consent documents — namely, that they are too long, too complicated, and filled with legal text designed more to protect institutions than participants. Under the proposal, the content of these forms will be limited to specific elements outlined in the rule, with nonessential information moved into a separate appendix. Furthermore, the proposed regulations strengthen privacy and security safeguards for all research involving biospecimens or identifiable information, as well as for certain research that may be exempt from other provisions of the rule. The proposal brings under the Common Rule umbrella currently unregulated clinical trials (e.g., trials of surgical procedures that do not involve devices regulated by the Food and Drug Administration [FDA] and are not funded by one of the Common Rule agencies), if they are conducted in the United States at institutions that receive human-subjects research funding from a Common Rule agency. This extension of the rule will not apply to clinical trials that are subject to regulation by the FDA or that are conducted at institutions that receive funding only for exempt research.

Multisite research now accounts for nearly half the studies funded by the National Institutes of Health (NIH). The proposal addresses inefficiencies created by the current process of redundant IRB review of multisite studies, by requiring participating U.S. institutions to rely on a single IRB of record, unless local IRB review is required by law or the federal department or agency supporting or conducting the research determines that use of a single IRB is not appropriate for the particular study. This change will help speed the initiation of research and save considerable resources.5 One concern that institutions have expressed regarding relying on single IRBs is uncertainty over whether an outside IRB or the institution would be held responsible for regulatory violations by the IRB, and the proposal addresses this concern by establishing that the IRB of record, rather than the institution relying on the IRB, will be held responsible for any IRB regulatory violations.

Several other changes will, collectively, reduce the burden on IRBs, allowing them to focus on higher-risk research. Continuing IRB review will be eliminated for studies that qualify for expedited IRB review and for most studies that have completed the interventional stages and involve only data analysis, unless on initial review it was determined that continuing review was appropriate. In addition, publication of a list of activities considered to pose minimal risk will reduce the burden on IRBs in making minimal-risk determinations. Finally, IRBs will no longer be required to review grant applications or contract proposals.

Another set of proposed changes aims to match the level of oversight to the level of risk the research poses to participants, by defining categories of research that are excluded from the Common Rule or are exempt from one or more of its requirements (e.g., IRB review). The excluded categories are activities that are deemed not to meet the rule’s definition of research (such as public health surveillance and some quality-assurance activities), to be very low-risk social science research (such as surveys, focus groups, and interviews), or to be subject to other rules with appropriate requirements (such as research involving medical records and Medicare claims data that is subject to the privacy rule of the Health Insurance Portability and Accountability Act).

Determinations of whether specific research proposals are exempt from the rule can be made with a Web-based decision tool. For example, one category of research that will be exempt from nearly all requirements includes certain types of studies involving standard educational practices, public program evaluations, or benign interventions (such as interactions that are temporary and painless with no lasting negative effects). Another category includes certain uses of sensitive information from which individuals are identifiable, if proper privacy and security safeguards are in place. Establishment of biospecimen and data repositories will be exempted from full IRB review if initial broad consent has been obtained, safeguards are in place, and to ensure that both these requirements are met, a limited IRB review is conducted. Secondary research using these repositories will be required only to have safeguards in place, and no IRB review will be necessary.

These long-overdue reforms will bring the Common Rule into the 21st century. They should help the scientific community take a giant leap forward in showing respect for research participants, without whom the biomedical research enterprise would cease to exist. Just as the Lacks family’s experience helped clarify how research needed to change, the perspectives of researchers, the public, and patients should be heard as these reforms are finalized. The NIH urges all stakeholders to closely review the proposed changes and participate in the comment process by the deadline of December 7, 2015.
Editor’s note: HHS has extended the comment period by 30 days, to January 6, 2016.

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Perspective
Reform of Clinical Research Regulations, Finally
Ezekiel J. Emanuel, M.D., Ph.D.
N Engl J Med 2015; 373:2296-2299
December 10, 2015
DOI: 10.1056/NEJMp1512463

PLoS One [Accessed 12 December 2015]

PLoS One
http://www.plosone.org/
[Accessed 12 December 2015]

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The Global Health Impact Index: Promoting Global Health
Nicole Hassoun
Research Article | published 11 Dec 2015 | PLOS ONE
10.1371/journal.pone.0141374
Abstract
Millions of people cannot access essential medicines they need for deadly diseases like malaria, tuberculosis (TB) and HIV/AIDS. There is good information on the need for drugs for these diseases but until now, no global estimate of the impact drugs are having on this burden. This paper presents a model measuring companies’ key malaria, TB and HIV/AIDS drugs’ consequences for global health (global-health-impact.org). It aggregates drugs’ impacts in several ways–by disease, country and originator-company. The methodology can be extended across diseases as well as drugs to provide a more extensive picture of the impact companies’ drugs are having on the global burden of disease. The study suggests that key malaria, TB and HIV/AIDS drugs are, together, ameliorating about 37% of the global burden of these diseases and Sanofi, Novartis, and Pfizer’s drugs are having the largest effect on this burden. Moreover, drug impacts vary widely across countries. This index provides important information for policy makers, pharmaceutical companies, countries, and other stake-holders that can help increase access to essential medicines.

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Health Gains and Financial Protection from Pneumococcal Vaccination and Pneumonia Treatment in Ethiopia: Results from an Extended Cost-Effectiveness Analysis
Kjell Arne Johansson, Solomon Tessema Memirie, Clint Pecenka, Dean T. Jamison, Stéphane Verguet
Research Article | published 09 Dec 2015 | PLOS ONE
10.1371/journal.pone.0142691
Abstract
Background
Pneumonia and pneumococcal disease cause a large disease burden in resource-constrained settings. We pursue an extended cost-effectiveness analysis (ECEA) of two fully publicly financed interventions in Ethiopia: pneumococcal vaccination for newborns and pneumonia treatment for under-five children in Ethiopia.
Methods
We apply ECEA methods and estimate the program impact on: (1) government program costs; (2) pneumonia and pneumococcal deaths averted; (3) household expenses related to pneumonia/pneumococcal disease treatment averted; (4) prevention of household medical impoverishment measured by an imputed money-metric value of financial risk protection; and (5) distributional consequences across the wealth strata of the country population. Available epidemiological and cost data from Ethiopia are applied and the two interventions are assessed separately at various incremental coverage levels.
Results
Scaling-up pneumococcal vaccines at around 40% coverage would cost about $11.5 million and avert about 2090 child deaths annually, while a 10% increase of pneumonia treatment to all children under 5 years of age would cost about $13.9 million and avert 2610 deaths annually. Health benefits of the two interventions publicly financed would be concentrated among the bottom income quintile, where 30–40% of all deaths averted would be expected to occur in the poorest quintile. In sum, the two interventions would eliminate a total of $2.4 million of private household expenditures annually, where the richest quintile benefits from around 30% of the total private expenditures averted. The financial risk protection benefits would be largely concentrated among the bottom income quintile. The results are most sensitive to variations in vaccine price, population size, number of deaths due to pneumonia, efficacy of interventions and out-of-pocket copayment share.
Conclusions
Vaccine and treatment interventions for children, as shown with the illustrative examples of pneumococcal vaccine and pneumonia treatment, can bring large health and financial benefits to households in Ethiopia, most particularly among the poorest socio-economic groups.

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The Willingness to Pay for Vaccination against Tick-Borne Encephalitis and Implications for Public Health Policy: Evidence from Sweden
Daniel Slunge
Research Article | published 07 Dec 2015 | PLOS ONE
10.1371/journal.pone.0143875

Value in Health – December 2015

Value in Health
December 2015 Volume 18, Issue 8, p941-1162
http://www.valueinhealthjournal.com/current

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Impact and Cost-Effectiveness of Hypothetical Strategies to Enhance Retention in Care within HIV Treatment Programs in East Africa
Jason Kessler, Kimberly Nucifora, Lingfeng Li, Lauren Uhler, Scott Braithwaite
p946–955
Published online: November 16 2015
Preview
Attrition from care among HIV infected patients can lead to poor clinical outcomes. Our objective was to evaluate hypothetical interventions seeking to improve retention-in-care (RIC) for HIV-infected patients in East Africa, asking whether they could offer favorable value compared to earlier ART initiation.

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Cost-Effectiveness Analysis of Universal Human Papillomavirus Vaccination Using a Dynamic Bayesian Methodology: The BEST II Study
Katrin Haeussler, Andrea Marcellusi, Francesco Saverio Mennini, Giampiero Favato, Mauro Picardo, Giorgia Garganese, Marco Bononi, Silvano Costa, Giovanni Scambia, Peter Zweifel, Alessandro Capone, Gianluca Baio
p956–968
Published online: October 16 2015
Preview
Human papillomavirus (HPV) plays a role in the development of benign and malign neoplasms in both sexes. The Italian recommendations for HPV vaccines consider only females. The BEST II study (Bayesian modelling to assess the Effectiveness of a vaccination Strategy to prevent HPV-related diseases) evaluates 1) the cost-effectiveness of immunization strategies targeting universal vaccination compared with cervical cancer screening and female-only vaccination and 2) the economic impact of immunization on various HPV-induced diseases.

Media/Policy Watch [to 12 December 2015]

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

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

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Foreign Policy
http://foreignpolicy.com/
Accessed 12 December 2015
Ebola Is Now Killing People Who Aren’t Even Infected
The epidemic has waned, but the virus still threatens the lives of women and children in West Africa.
By Matt Hongoltz-Hetling
December 7, 2015

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New York Times
http://www.nytimes.com/
Accessed 12 December 2015
They Helped Erase Ebola in Liberia. Now Liberia Is Erasing Them.
By HELENE COOPER
DEC. 9, 2015

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 12 December 2015
Fresh Ebola Cases Damp Liberia Hopes of Eliminating Deadly Disease
New cases serve notice that the fight against the disease will take months, even years
By Drew Hinshaw in Monrovia, Liberia, and Betsy McKay in Atlanta
Updated Dec. 10, 2015

Vaccines and Global Health: The Week in Review :: 5 December 2015

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

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

pdf version A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_5 December 2015

blog edition: comprised of the approx. 35+ entries posted below on 6 December 2015.

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

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

EBOLA/EVD [to 5 December 2015]

EBOLA/EVD [to 5 December 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

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Ebola Situation Report – 2 December 2015
No confirmed cases were reported in the week to 29 November. Investigations are ongoing into the origin of infection of the cluster of 3 confirmed cases of Ebola virus disease (EVD) reported from Liberia in the week to 22 November. The first-reported case in that cluster was a 15-year-old boy who tested positive for EVD after admission to a health facility in the Greater Monrovia area on 19 November. He was then transferred to an Ebola treatment centre along with the 5 other members of his family. Two other members of the family – the boy’s 8-year old brother and his 40-year-old father – subsequently tested positive for EVD whilst in isolation. The 15-year-old boy died on 23 November. In addition to the family of the first-reported case, 165 contacts have been identified so far, including 34 high-risk contacts. Liberia was previously declared free of Ebola transmission on 3 September 2015.

On 7 November WHO declared that Sierra Leone had achieved objective 1 of the phase 3 framework, and the country has now entered a 90-day period of enhanced surveillance scheduled to conclude on 5 February 2016. As of 29 November it had been 13 days since the last EVD patient in Guinea received a second consecutive EVD-negative blood test. The last case in Guinea was reported on 29 October 2015…

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Editorial: Learning from Ebola: readiness for outbreaks and emergencies
Margaret Chan, DG, World Health Organization
Bulletin of the World Health Organization 2015;93:818-818A.
doi: http://dx.doi.org/10.2471/BLT.15.165720
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For almost 70 years, the World Health Organization (WHO) has coordinated the norms and technical standards required to improve global health. This is the role people most often associate with WHO. However, the organization’s constitution also calls on it to “furnish technical assistance and, in emergencies, necessary aid” to governments, a role WHO has played on countless occasions. Examples include eradicating smallpox, bringing polio and guinea-worm disease to the brink of eradication and responding to health threats posed by humanitarian crises worldwide.

Despite initial delays in the western Africa Ebola outbreak response, the tide of this unprecedented health crisis has now been turned. While still requiring intense and focused action to bring new cases to zero, the outbreak is now limited to only a few cases per week. Deficiencies in capacity, expertise and approach revealed by WHO’s response to Ebola suggest that organization-wide change is needed:1 WHO must ensure it can prepare for and respond to outbreaks and emergencies in a way that genuinely supports national efforts and fully integrates with international partners.

WHO must do more than provide support in emergencies. It must become a fully operational emergency organization. This distinction may sound subtle – but the new course that WHO is charting marks one of the most profound shifts in its history. WHO must enable countries to strengthen their outbreak and emergency preparedness, while ensuring that its own experts and those of its partners can rapidly roll out the required response within the first 24–72 hours. Subsequently, WHO must support countries in the recovery phase after an outbreak or emergency and help them “build back better” when health systems have been damaged. To succeed, this will require stronger, more functional linkages and partnerships to allow WHO to prepare and respond more predictably to infectious disease outbreaks and other emergencies.

WHO has established a high-level advisory group,2 chaired by Dr David Nabarro, the United Nations Secretary-General’s Special Envoy for Ebola. The advisory group is mandated to provide WHO with clear, actionable advice on developing the capacities needed to coordinate governments, national responders, United Nations (UN) agencies, funds and programmes and operational partners in outbreaks and emergencies.

The Ebola outbreak has taught us many lessons, among them that the response to outbreaks and emergencies must start and end at ground level – which means that certain key capacities have to be in place before launching a response, including leadership and coordination, technical support, logistics, management of human resources and communications. It has also shown that the organizations working to contain outbreaks and emergencies must collaborate closely. Following the 68th World Health Assembly decision on the Ebola virus disease outbreak and the Special Session of the Executive Board on Ebola,3,4 WHO has begun reviewing systems and capacities throughout the organization to streamline the way it works in outbreaks and emergencies.

These changes focus on six key areas:5 (i) a unified WHO platform for outbreaks and emergencies with health and humanitarian consequences; (ii) a global health emergency workforce, to be effectively deployed in support of countries; (iii) core capacities at country-level under the International Health Regulations; (iv) functioning, transparency, effectiveness and efficiency of the International Health Regulations; (v) a framework for research and development preparedness and capacity during outbreaks or emergencies; and (vi) adequate international financing for pandemics and other health emergencies, including a 100 million United States dollars contingency fund and a pandemic emergency financing facility.

By the end of 2015, a structure will be finalized for a new operations platform, which will lead to a major transformation of WHO. The platform will improve and align the strengths and capacities of the country, regional and headquarters’ levels of the organization into a single team. There will be an emphasis on overcoming managerial, administrative and logistic constraints, improving performance and leveraging strategic partnerships in outbreak and humanitarian emergency preparedness and response.
A clear incident management system will be developed and understood by all inside and outside the organization. For this purpose, WHO has been sounding out all relevant constituencies on the steps it must take. These include operational humanitarian and disease outbreak control partners from global health cluster and Global Outbreak Alert and Response Network partners. Member States are closely following and guiding the process, providing support to ensure that WHO can deliver the services governments need in emergencies.

No single organization can deliver the wide range of services and systems needed for a truly global mechanism that prepares for and responds to outbreaks and emergencies. This is why WHO will continue seeking advice from our partners inside and outside the UN system to make needed change. With their collaboration and support, WHO will be well positioned to deliver what the world needs when outbreaks and emergencies occur: a timely response that rapidly contains the consequences – for economies and societies as well as for human health.

References
1..Report of the Ebola Interim Assessment Panel. Geneva: World Health Organization; 2015. Available from: http://who.int/csr/resources/publications/ebola/report-by-panel.pdf [cited 2015 Nov 2].
2..Terms of reference for the advisory group on reform of WHO’s work in outbreaks and emergencies with health and humanitarian consequences. Geneva: World Health Organization; 2015. Available from: http://who.int/about/who_reform/emergency-capacities/advisory-group/tor/en/ [cited 2015 Nov 2].
3..Resolution WHA68(10). 2014 Ebola virus disease outbreak and follow-up to the Special Session of the Executive Board on Ebola. In: Sixty-eighth World Health Assembly, Geneva, 5 June 2015. Decisions and list of resolutions. Geneva: World Health Organization; 2015. Available from: http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_DIV3-en.pdf?ua=1 [cited 2015 Nov 2].
4..WHO Executive Board Special Session on the Ebola emergency. Geneva: World Health Organization; 25 January 2015. Available from: http://apps.who.int/gb/e/e_ebss3.html [cited 2015 Nov 2].
5..Follow up to World Health Assembly decision on Ebola virus disease outbreak and the Executive Board Special Session on Ebola: a roadmap for action. Geneva: World Health Organization; 2015. Available from: http://who.int/about/who_reform/emergency-capacities/WHO-outbreasks-emergencies-Roadmap.pdf?ua=1 [cited 2015 Nov 2].

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Live Webcast: “Ebola and Ethics – The Unfinished Agenda” – 8 December
WHO – Global Health Ethics Unit in collaboration with the University of York and the Wellcome Trust
Tuesday, December 8, 2015 12:30pm [Europe Time (Paris, GMT+01:00)]
External participants: https://who-meeting.webex.com/who-meeting/j.php?MTID=m367091d30deacef3cfceea8d29ec4cf4
Meeting Number: 841 281 566
Meeting Password: this meeting does not require a password.

Panel discussion (featuring Dr Melba Gomes (Chair of the WHO Research Ethics Review Committee), Dr Annick Antierens (Manager, Investigational Platform for Experimental Ebola Products, MSF) & Dr Philippe Calain (Chair of Ethics Panel established by WHO; Senior Researcher, MSF)).
Overview
One year ago the world witnessed the worst Ebola outbreak in history. In response, a panel of 12 members was invited by the WHO Director General to advise on the ethical implications of the potential use of unregistered interventions during an epidemic. More than a year later, as the epidemic wanes, it is time to reflect on the effect of the panel’s advice on the various stakeholders involved in research during the outbreak response, the challenges they faced, and the implications of these recommendations for research conducted during future epidemics

POLIO [to 5 December 2015]

POLIO [to 5 December 2015]
Public Health Emergency of International Concern (PHEIC)

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GPEI Update: Polio this week as of 2 December 2015
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: The Organisation of Islamic Cooperation (OIC) reaffirmed their commitment to poliovirus eradication, urged all countries affected by polio to implement their National Emergency Action Plans, and called for the necessary financial resources to finish the job, at the Fifth Session of the Islamic Conference of Health Ministers.

:: Commonwealth leaders united in Malta to recommit to ending polio. The theme of this year’s Commonwealth meeting was ‘Adding Global Value’. Eradicating polio will not only be a major public health success, it will also mean global savings of more than US$50 billion over the next 20 years.

:: Polio surveillance continues to improve in Afghanistan. Strengthening the surveillance networks to ensure that any poliovirus transmission is detected remains vital to the success of the polio endgame.

:: In Afghanistan in the year 2015, until 21 November, stool specimens from a total 2,399 children were tested. By then, 16 of these children had been found to be infected with wild poliovirus.

:: In 2015, wild poliovirus transmission is at the lowest levels ever, with fewer cases reported from fewer areas of fewer countries than ever before. In 2015 so far, 60 wild poliovirus cases have been reported from two countries (Pakistan and Afghanistan), compared to 316 cases from nine countries during the same period in 2014

[Selected elements from Country-level reports]
Afghanistan
:: One new wild poliovirus type 1 (WPV1) case was reported in the past week, in Kunar province, with onset of paralysis on 3 November. This is the first case in Kunar province since January 2014. The total number of WPV1 cases for 2015 is 17.
:: One new WPV1 environmental positive sample was reported in the past week, collected on 25 October from Mandacool district of Asadabad province.

Pakistan
:: Two new wild poliovirus type 1 (WPV1) cases were reported in the past week, the first with onset of paralysis on 30 October in the Federally Administered Tribal Areas (FATA) and the second with onset on 2 November in Sindh province. The total number of WPV1 cases for 2015 is now 43.
:: Three new environmental samples positive for WPV1 were reported in the last week, one each from Jacobabad, Peshawar and Karachi, from samples collected on 4, 11 and 15 November respectively.

Lao People’s Democratic Republic
:: One new case of circulating vaccine-derived poliovirus type 1 (cVDPV1) was reported in the past week. The case was reported from Saysomboun district in Xaysomboune province, and had onset of paralysis on 28 October. This is the most recent date of onset. The total number of cVDPV1 cases in 2015 is now five. Outbreaks of cVDPVs can arise in areas with low population immunity, emphasizing the importance of maintaining strong vaccination coverage. Learn more about VDPVs.
:: An emergency outbreak response is continuing in the country, with particular focus on three high-risk provinces. The first Subnational Immunization Days (SNIDs) using trivalent oral polio vaccine (OPV) targeted an expanded age group of children under the age of fifteen in the three most high risk districts, and children under the age of ten elsewhere. According to independent monitoring conducted in the high-risk areas, coverage of 85-95% was achieved, with 5-15%…
:: In neighbouring countries, notably Thailand and Vietnam, both surveillance and immunization activities have been stepped up, particularly in border areas.

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UN: Polio Outbreak in Ukraine Is a State of Emergency
By The Associated Press
KIEV, Ukraine — Dec 1, 2015, 11:24 AM ET
The World Health Organization is urging Ukraine’s health ministry to declare a state of emergency due to a polio outbreak, a move meant to prompt more action from the government in Kiev.
In September, Ukraine announced two polio cases — the first in Europe since 2010.
The U.N. health agency recommended that Ukraine declare a state of emergency and “respond to the polio outbreak as quickly and effectively as possible,” Dorit Nitzan, head of the WHO’s office in Ukraine, told journalists.
Half of Ukraine’s children have not been vaccinated against polio…

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Building Bridges for Healthier Ummah
Draft Resolution No. 2/5-ICHM – On Healthy Life Style, Prevention and Control of Communicable and Non-Communicable Diseases, and Health Emergencies and Disasters
The Fifth Session of the Islamic Conference of Health Ministers held in Istanbul, Republic of Turkey, from 17 to19 November, 2015;

[Excerpt from Resolution]
Communicable Diseases
3. Reaffirms the support of all OIC Member States for the goal of global polio eradication and the full implementation of the Polio Eradication and Endgame Strategic Plan 2013-18 to protect all children from life-long polio paralysis;

4. Calls upon the polio affected countries to fully implement their National Emergency Action Plans for polio eradication and ensure that all children are consistently reached and vaccinated; effective implementation of vaccination campaigns will require regular oversight of polio eradication efforts by Government leaders, and a “whole of Government” approach to raise community awareness, address concerns, and successfully and safely access and vaccinate all children;

5. Reiterates its support for the religious injunctions (Fatwas) of the International Islamic Fiqh Academy regarding the safety and acceptability in Islam of polio vaccination and declaring it a duty of all parents and communities to protect children and to allow health workers to carry out their duty in safety;

6. Calls on the International Islamic Fiqh Academy and the Islamic Advisory Group (IAG) on polio eradication to continue to work closely with the Global Polio Eradication Initiative, polio-affected Members States and religious and community leaders to help address challenges regarding community perceptions on vaccinations, on the safety and acceptance of vaccines, and to help secure access to all children for immunization;

7. Calls upon all Member States and international development partners, including the Islamic Development Bank (IDB), the Saudi Fund for Development, and philanthropic organizations, in particular those in the Islamic world, to provide the necessary financial support to eradicate polio from the remaining OIC Member States and to help strengthen routine immunization efforts;

8. Further calls upon the Member States to work towards the SDG target of ending, by 2030, the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases…

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First doses of Injectable Polio Vaccine ShanIPV™ soon available for Indian infants
November 30, 2015
– This new polio vaccine is manufactured by Shantha in Hyderabad, India –
– Both Sanofi Pasteur and Shantha are to provide the majority of doses for the introduction of IPV in India, a key step towards polio eradication

Lyon, France – November 30, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first shipment of ShanIPV™, a brand new injectable, inactivated polio vaccine (IPV) manufactured by its affiliate Shantha Biotechnics, in Hyderabad, India, will occur in a couple of days. These first vaccine doses will be available to implement one dose of IPV in India’s immunization schedule for all infants.

Today, India is officially introducing IPV in their national immunization schedule, to supplement the iconic “drops on sugar” of oral polio vaccine (OPV). Over 20 million newborns will eventually benefit from this new vaccine every year. This is a critical step towards a polio-free future, a prospect that is now very close. India’s 2014 certification as polio-free reassured experts that the decades-long global fight against polio was finally drawing to an end. Sanofi Pasteur and its affiliate Shantha Biotechnics will together produce most of India’s IPV supply.

“With the introduction of IPV in their immunization schedule, India moves the world much closer to being polio-free”, said Olivier Charmeil, President and CEO of Sanofi Pasteur. “As a company deeply rooted in India, we are very proud that vaccines produced by both Sanofi Pasteur and Shantha will be used in this vital step towards a polio-free world. We have worked as partners of the government of India for many years, with this day in mind.”

Only two countries in the world are still classified as polio endemic, meaning that wild polio virus passes routinely between members of the community. However, great progress has been made in both countries and the last case of polio in the world may possibly be only months away. “Ours will be the last generation to see the horror of children paralyzed or killed by polio. I am sure,” said Pr Jacob John (Former Christian Medical College, Vellore, Tamil Nadu, India). “Maybe we will remember 2015 as the year we took the final step to eradicate this disease forever.”…

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Introduction Of Inactivated Polio Vaccine (IPV) In Nepal
A PUBLIC HEALTH MILESTONE FOR POLIO FREE NEPAL
UNICEF, WHO
DECEMBER, 2015 :: 48 pages
Pdf: http://reliefweb.int/sites/reliefweb.int/files/resources/748913046413035946-documentation-on-ipv-introduction-in-nepal-final.pdf
Overview
This publication has been jointly authored by Child Health Division, Department of Health Services, UNICEF and WHO. It captures a comprehensive process of Inactivated Polio Vaccine (IPV) introduction in Nepal. In September 2014, Nepal introduced one dose of Inactivated Poliomyelitis Vaccine (IPV) at 14 weeks of age into its national routine immunization schedule. In doing so, Nepal became the first country in South Asia – and the first GAVI-supported country in the world to do so.
This document describes the process leading to the introduction of IPV in Nepal. Introduction of a new vaccine into a country consists of numerous steps and support/endorsement from multiple stakeholders at the policy level. In addition to lessons from previous introductions, Nepal utilized a policy framework developed by Orin, et al. (2010) which is based on the existing set of WHO guidelines for new vaccine introduction and the experience with acceleration the introduction of Hib, pneumococcal and rota virus vaccine. The proposed framework is based on observations of the process and drivers of new vaccine adoption in GAVI-eligible countries such as Nepal.

WHO & Regionals [to 5 December 2015]

WHO & Regionals [to 5 December 2015]

Improving the quality of care at birth
4 December 2015 — Worldwide, the majority of maternal and newborn deaths occur around the time of birth, typically within the first 24 hours after childbirth. Most of these deaths are preventable. WHO’s new “Safe Childbirth Checklist and Implementation Guide” targets the major causes of maternal and newborn complications and deaths, including post-partum haemorrhage, infection, obstructed labour, preeclampsia and birth asphyxia.
Press release on the safe child birth checklist

First ever global estimates of foodborne diseases
3 December 2015 — Almost one third (30%) of all deaths from foodborne diseases are in children under the age of 5 years, despite the fact that they make up only 9% of the global population. This is among the findings of WHO’s “Estimates of the global burden of foodborne diseases” – the most comprehensive report to date on the impact of contaminated food on health and wellbeing. The report estimates the burden of foodborne diseases caused by 31 agents – bacteria, viruses, parasites, toxins and chemicals.
Read the press release
Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: 4 December 2015 Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia
:: 3 December 2015 Zika virus infection – Venezuela
:: 3 December 2015 Zika virus infection – Mexico
:: 3 December 2015 Zika virus infection – Paraguay
Weekly Epidemiological Record (WER) 04 December 2015, vol. 90, 49 (pp. 661–680) includes;
661 African Programme for Onchocerciasis Control: progress report, 2014–2015
675 Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2015

IVB
:: Request for proposals Develop Design and Budget for Pilot Implementation of Malaria Vaccine
3 December 2015 Information and submission of proposals pdf, 101kb
Application deadline: 31 December 2015

:: Request for proposals: Group B streptococcus briefing document
2 December 2015 Information and submission of proposals pdf, 100kb
Deadline for application: 30 December 2015

:: GIN November 2015 pdf, 2.09Mb
30 November 2015
:: WHO Regional Offices
WHO African Region AFRO
No new digest content identified.

WHO Region of the Americas PAHO
:: The health challenges posed by urbanization must be addressed through cross-sector policies, experts say (12/03/2015)
:: PAHO/WHO and Foreign Medical Teams Examine How to Strengthen Emergency Response to Outbreaks and Disasters (12/01/2015)
:: Data from 17 countries and territories in the Americas point to elimination of mother-to-child transmission of HIV and syphilis (11/30/2015)

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
:: More than 23 million people in the WHO European Region fall ill from unsafe food every year 03-12-2015
:: Papers invited for Public Health Panorama 30-11-2015

WHO Eastern Mediterranean Region EMRO
No new digest content identified.

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 5 December 2015]

CDC/ACIP [to 5 December 2015]
http://www.cdc.gov/media/index.html

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Transcript for CDC Telebriefing: Daily Pill Prevents HIV
WEDNESDAY, NOVEMBER 25, 2015
New CDC estimates underscore the need to increase awareness of a daily pill that can prevent HIV infection

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MMWR Weekly – December 4, 2015 / No. 47/ Volume (64) No. 47
http://www.cdc.gov/mmwr/index2015.html
:: Announcement: National Influenza Vaccination Week — December 6–12, 2015

UNICEF [to 5 December 2015]

UNICEF [to 5 December 2015]
http://www.unicef.org/media/media_78364.html

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Nepal: Serious shortage of essential supplies threatens millions of children this winter – UNICEF
KATHMANDU, Nepal, 30 November 2015 – More than 3 million children under the age of 5 in Nepal are at risk of death or disease during the harsh winter months due to a severe shortage of fuel, food, medicines and vaccines, UNICEF warns.

In the past 10 weeks, vital imports of essential commodities have been severely restricted at Nepal’s southern border due to unrest over the country’s new constitution.
The government’s regional medical stores have already run out of BCG vaccines against tuberculosis. Stocks of other vaccines and antibiotics are critically low…

…”The risks of hypothermia and malnutrition, and the shortfall in life-saving medicines and vaccines, could be a potentially deadly combination for children this winter,” said UNICEF

…Fears are also growing that the rising dependence on firewood because of the fuel crisis is increasing indoor pollution, which in turn could lead to a spike in cases of pneumonia. Last year more than 800,000 children under five suffered from the condition in Nepal and around 5,000 died.

Gavi [to 5 December 2015]

Gavi [to 5 December 2015]
http://www.gavialliance.org/library/news/press-releases/

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New support for measles vaccine to help save more than one million lives
Gavi Board approves ambitious package to tackle highly-infectious disease
Geneva, 3 December 2015 – A new package of support for measles and rubella immunisation, approved today by the Board of Gavi, the Vaccine Alliance, will contribute towards saving more than a million lives. The decision marks a significant step forward in the approach to tackling measles and rubella in developing countries.

Despite progress over the past decade, global targets to eliminate measles are significantly off-track. The disease still claims the lives of more than 100,000 people worldwide every year, most of them children under 5 years of age. The disease is so infectious that an unvaccinated person could catch measles in a doctor’s waiting room hours after an infected person has left the building. Communities with measles vaccination coverage rates lower than 90-95% are at risk of fast-spreading outbreaks, leading to numerous fatalities.

Gavi’s revised strategy will help consolidate the currently fragmented approach to tackling measles in developing countries, underpinned by strong routine immunisation programmes with high coverage. This will put countries firmly on the road towards controlling the disease; they will also be able to take advantage of children’s visits to health facilities for measles vaccinations to increase coverage rates of other vaccines.

Gavi will support periodic, data-driven measles and rubella campaigns to ensure children who have not been reached through routine immunisation are protected, as well as supporting parts of the Measles & Rubella Initiative’s (M&RI) work to tackle any outbreaks. Under the new approach, these campaigns will be better planned and synchronised with other immunisation activities and be more targeted at the hardest to reach children. They will also be independently monitored.

Countries will be required to have a five-year rolling measles and rubella plan, as part of their long term routine immunisation plans, which will be updated annually…

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Gavi Board thanks Dagfinn Høybråten for inspirational leadership
03 December 2015
Gavi Board Chair steps down after five years of unparalleled achievement.

Nepal research has lessons for global vaccination efforts

Nepal research has lessons for global vaccination efforts
3 Dec 2015
Oxford University researchers are making important progress evaluating the impact of an important new programme to save the lives of children in Nepal, which is being discussed in Geneva this week.

Gavi – the Global Alliance for Vaccines and Immunization – is meeting in Geneva to discuss progress on its plans to vaccinate an additional 300 million children by 2020. The Oxford team are working on assessment of the introduction of new vaccines in one of the world’s poorest countries.

The latest work is built on ten years’ partnership between Oxford University’s Oxford Vaccine Group, Kathmandu’s Patan Academy of Health Sciences and New Zealand’s Otago University. Together they have studied the spread and prevention of serious bacterial infections in Nepali children. Nepal is one of the world’s least economically developed countries in the world and infection-related illness imposes a high burden on its society and economy. Infections are particularly an issue for children less than five years of age, with pneumonia the leading cause of death for the age group.

Oxford’s Professor Andrew Pollard explained: ‘Vaccination is key to preventing fatal and serious infectious diseases in childhood – and throughout life. With limited resources, Nepal needs to make sure that any vaccines it introduces will be effective. We have worked with the Nepali doctors to assess a vaccine against Hib, an important cause of meningitis and pneumonia, and that vaccine is now part of Nepal’s expanded programme of immunisations.

‘We also looked at different ways to use a pneumonia vaccine that protects against ten types of pneumococcus, a common bacteria that can also cause pneumonia and meningitis. Our study with the team in Nepal showed that a programme of two doses of the vaccine in early life and one at nine months was a more effective way to prevent infections. The Nepalese Government adopted that programme last year.’

The team are now carrying out a four year evaluation to assess the impact of the pneumonia vaccine programme, funded by Gavi. This important follow-up impact study will look at the number of children hospitalised with meningitis and pneumonia as well as the number of children in Kathmandu carrying the pneumococcal bacteria.

The funding has also enabled the team to provide extra training to microbiology technicians at Patan hospital, enabling them to identify different strains of pneumococcus to improve monitoring of the bug and so strengthen efforts to limit its impact.

Professor Pollard said: ‘Gavi aims to reach 300 million more children with vaccines between 2016 and 2020, preventing a further five to six million more deaths. The information from Nepal regularly feeds into a global database, allowing researchers to spot emerging trends and perhaps identify weaknesses in the bacteria that we can target. The four-year study will also provide in-depth understanding of the effectiveness of vaccination in Nepal. That can provide lessons for vaccination efforts worldwide and ensure we meet the 300 million target.’

Global Fund [to 5 December 2015]

Global Fund [to 5 December 2015]
http://www.theglobalfund.org/en/news/

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New Toolkit for Differentiated Care in HIV and TB Programs
04 December 2015
HARARE, Zimbabwe – The Global Fund presented a toolkit to help partners implement differentiated care approaches in HIV and TB investments with the aim of maximizing cost efficiency and better serving the different needs of various communities most affected by diseases.

Unveiled at the International Conference on AIDS and sexually transmitted diseases in Africa (ICASA), the toolkit is intended to support country program managers and managers of health facilities by gathering examples of good practices at health facilities that seek to increase the quality and efficiency of service delivery.

The toolkit includes a section on how to best use data to emphasize the importance of supporting differentiated care with accurate data collection and analysis for planning and modifying approaches. It also provides information and practical steps on how health centres can develop differentiated approaches from testing and counselling to treatment and care to drug delivery.

The tool kit was based on innovative work from health facilities in Senegal, Uganda, Kenya and elsewhere, and also based on models of care pioneered by Médecins Sans Frontières and The AIDS Support Organisation in Uganda. It was developed in collaboration with a wide range of in-country and global partners, including Ministry of Health officials, the Bill & Melinda Gates Foundation, World Health Organization, the President’s Emergency Program for AIDS Relief, UNAIDS, the StopTB Partnership, and the International AIDS Society…

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Global Fund Embraces Fast-Track Approach on AIDS
30 November 2015
GENEVA – To mark World AIDS Day on 1 December, the Global Fund to Fight AIDS, Tuberculosis and Malaria declared its strong support for Fast-Track, the smart approach by UNAIDS to end the epidemic by 2030.

In a new report, “On the Fast-Track to end AIDS by 2030: Focus on location and population,” UNAIDS identifies all the most critical factors: the need to front-load investments; to focus on the locations, populations and programs that deliver the greatest impact; to catalyze innovation; engage local leadership; to creates new partnerships, to stand firm on human rights, and to deliver results that leave no one behind.

UNAIDS and the Global Fund work together closely, and are achieving impressive results in partnership. Antiretroviral therapy has grown from 4 percent coverage in 2005 in countries where the Global Fund invests to 21 percent in 2010 and 40 percent in 2014…

IAVI International AIDS Vaccine Initiative [to 5 December 2015]

IAVI International AIDS Vaccine Initiative [to 5 December 2015]
http://www.iavi.org/press-releases/2015

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IAVI Marks World AIDS Day with Expert Panel Discussion in New York City
December 4, 2015
NEW YORK — Expert leaders from five diverse local, national and international organizations underscored the urgent need to work together to end AIDS, during a lively panel discussion Tuesday evening.

The panelists represented a broad cross-section from the frontlines of the battle against HIV/AIDS: Mary T. Bassett, Commissioner of the New York City Department of Health and Mental Hygiene; Mark Feinberg, President & CEO, the International AIDS Vaccine Initiative (IAVI); Charles King, President & CEO, Housing Works and Co-Chair of Governor Cuomo’s New York State End-AIDS Task Force; Kelsey Louie, CEO, GMHC and Member, Governor Cuomo’s New York State End-AIDS Task Force; and Chase Strangio, Staff Attorney, ACLU LGBT & AIDS Project.

They gathered at the Housing Works Bookstore Café in Manhattan for “It’s About Time: Together We Can End AIDS,” a World AIDS Day event that drew about 200 attendees. It was moderated by Mo Rocca, correspondent for CBS Sunday Morning…

Johnson & Johnson Marks World AIDS Day with Major New Global Commitments to End HIV Infection in Adolescent Girls and Women

Johnson & Johnson Marks World AIDS Day with Major New Global Commitments to End HIV Infection in Adolescent Girls and Women
NEW BRUNSWICK, N.J., Dec. 1, 2015 /PRNewswire/ — Building on its 25-year legacy in the fight against HIV/AIDS, Johnson & Johnson (NYSE: JNJ) today announced four new public-private partnerships through its Janssen Pharmaceutical Companies to significantly reduce the burden of HIV incidence, especially among adolescent girls, who make up 74 percent of new HIV infections among adolescents in sub-Saharan Africa1. Announced on World AIDS Day, these new initiatives include collaborations with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Clinton Health Access Initiative (CHAI) and the International Partnership for Microbicides (IPM), all focused on efforts to stem the tide of HIV infection and empower women and girls in HIV prevention…

Organization of Islamic Cooperation (OIC) [to 5 December 2015]

Organization of Islamic Cooperation (OIC) [to 5 December 2015]
http://www.oic-oci.org/oicv2/news/
Selected Press Releases

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First Expert Meeting of the OIC Network on Population and Reproductive, Maternal, New-born and Child Health
The First Expert Meeting of the OIC Network on Population and Reproductive, Maternal, New-born and Child Health (OIC MHNet) was held in Ankara, Turkey, on 2-4 December 2015…
…The meeting is participated by a group of interdisciplinary experts in this area from OIC region who engage in collective efforts to share information and knowledge in an endeavor to improve OIC MHNet…
The meeting is the first step in the establishment of the OIC Network, which will serve as a deposit of innovative ideas, problem solving and best practices as well as a platform for disseminating knowledge to OIC countries. Members of the Network engaged in joint activities and discussions, and disseminate and exchange innovative ideas, best practices and viable means of addressing challenges to improve the health of mothers and children in OIC member countries.
04/12/2015

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International coalition on vaccines approved as member of OIC health committee
An international coalition of partners committed to saving children’s lives and protecting people’s health by increasing access to immunization [Gavi] has been officially approved as a member of the OIC’s Steering Committee on Health…
01/12/2015

Sabin Vaccine Institute [to 5 December 2015]

Sabin Vaccine Institute [to 5 December 2015]
http://www.sabin.org/updates/pressreleases

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UK Government Allocates £1 billion to Combat Malaria, Other Infectious Diseases
Wednesday, November 25, 2015
The Sabin Vaccine Institute (Sabin) and its UK sister organization Sabin Foundation Europe, released the following statement on the UK government’s allocation of £1 billion for malaria and other infectious diseases. This funding will be distributed through the newly-developed Ross Fund, created by the Department for International Development (DFID) in collaboration with the Bill and Melinda Gates Foundation.
The £1 billion fund will include a £300 million package focused on malaria and other infectious diseases, including:
:: A £90 million eradication of malaria implementation fund;
: £100 million support for research and development into products for infectious diseases; and
:: £115 million to develop new drugs, diagnostics and insecticides for malaria, TB and other infectious disease resistance.
In addition, the Ross Fund will be used to target neglected tropical diseases (NTDs) and diseases with epidemic potential and emerging resistance.

Sabin and Sabin Foundation Europe are encouraged by the UK government’s investment in global health programs, despite austerity measures taking place across UK government departments and an increasing international focus on emerging humanitarian threats. The allocation of these funds demonstrates the government’s commitment to improving health worldwide and fighting diseases that primarily plague the world’s poorest populations.

The Ross Fund is an important development for global efforts to combat malaria, and will have positive implications for research and development for infectious and neglected diseases. DFID is doing remarkable work, supporting NTD programs to treat lymphatic filariasis (elephantiasis), onchocerciasis (river blindness), schistosomiasis and Guinea worm. The case for continuing to use and scale-up currently-available high-impact treatments remains clear; however, there is a need to consider future needs by investing in novel technologies, including the development of new affordable drugs, vaccines and point-of care technologies, if we are to achieve elimination of some of these diseases…

American Journal of Infection Control – December 2015

American Journal of Infection Control
December 2015 Volume 43, Issue 12, p1269-1382, e83-e106
http://www.ajicjournal.org/current

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Personal protective equipment for the Ebola virus disease: A comparison of 2 training programs
Enrique Casalino, Eugenio Astocondor, Juan Carlos Sanchez, David Enrique Díaz-Santana, Carlos del Aguila, Juan Pablo Carrillo
p1281–1287
Published online: August 12 2015

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Current vaccination status regarding measles among university students in Dresden, Germany
Henna Riemenschneider, Jeannine Schübel, Antje Bergmann, Joachim Kugler, Karen Voigt
p1363–1365
Published in issue: December 01 2015

Knowledge and attitudes towards rotavirus diarrhea and the vaccine amongst healthcare providers in Yogyakarta Indonesia

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 5 December 2015)

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Research article
Knowledge and attitudes towards rotavirus diarrhea and the vaccine amongst healthcare providers in Yogyakarta Indonesia
Holly Seale, Mei Sitaresmi, Jarir Atthobari, Anita Heywood, Rajneesh Kaur, Raina MacIntyre, Yati Soenarto, Retna Padmawati
BMC Health Services Research 2015, 15:528 (30 November 2015)

BMC Medical Ethics (Accessed 5 December 2015)

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 5 December 2015)

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Research article
Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda
Agnes Ssali, Fiona Poland, Janet Seeley
BMC Medical Ethics 2015, 1
Abstract
Background
Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team.
Methods
Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.
Results
Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.
Conclusion
Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.

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Debate
Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi
Randy Mungwira, Wongani Nyangulu, James Misiri, Steven Iphani, Ruby Ng’ong’ola, Chawanangwa Chirambo, Francis Masiye, Joseph Mfutso-Bengo
BMC Medical Ethics 2015, 16:83 (2 December 2015)

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Research article
Readiness of ethics review systems for a changing public health landscape in the WHO African Region
Marion Motari, Martin Ota, Joses Kirigia BMC Medical Ethics 2015, 16:82 (2 December 2015)
Abstract
Background
The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer.
Methods
This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries.
Results
Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support.
Conclusions
Despite the existing training initiatives, the Region still experiences a shortage of professionals trained in health research ethics/ethicists. Committees continue to face various capacity needs especially for evaluating clinical trials, for monitoring ongoing research, database management and for accrediting institutional ethics committees. Given the growing number of clinical trials involving human participants in the African Region, there is urgent need for supporting countries without NECs to establish them; capacity strengthening where they exist; and creation of a regional network and joint ethical review mechanisms, whose membership would be open to all NECs of the Region.

Benchmarking health system performance across regions in Uganda: a systematic analysis of levels and trends in key maternal and child health interventions, 1990–2011

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 5 December 2015)

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Research article
Benchmarking health system performance across regions in Uganda: a systematic analysis of levels and trends in key maternal and child health interventions, 1990–2011
D. Roberts, Marie Ng, Gloria Ikilezi, Anne Gasasira, Laura Dwyer-Lindgren, Nancy Fullman, Talemwa Nalugwa, Moses Kamya, Emmanuela Gakidou
BMC Medicine 2015, 13:285 (3 December 2015)

BMC Public Health (Accessed 5 December 2015)

BMC Public Health
http://www.biomedcentral.com/bmcpublichealth/content
(Accessed 5 December 2015)

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Research article
The burden of hypertension in sub-Saharan Africa: a four-country cross sectional study
David Guwatudde, Joan Nankya-Mutyoba, Robert Kalyesubula, Carien Laurence, Clement Adebamowo, IkeOluwapo Ajayi, Francis Bajunirwe, Marina Njelekela, Faraja Chiwanga, Todd Reid, Jimmy Volmink, Hans-Olov Adami, Michelle Holmes, Shona Dalal
BMC Public Health 2015, 15:1211 (5 December 2015)

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Research article
Charting the evolution of approaches employed by the Global Alliance for Vaccines and Immunizations (GAVI) to address inequities in access to immunization: a systematic qualitative review of GAVI policies, strategies and resource allocation mechanisms through an equity lens (1999–2014)
Gian Gandhi
BMC Public Health 2015, 15:1198 (30 November 2015)
Abstract
Background
GAVI’s focus on reducing inequities in access to vaccines, immunization, and GAVI funds, − both between and within countries – has changed over time. This paper charts that evolution.
Methods
A systematic qualitative review was conducted by searching PubMed, Google Scholar and direct review of available GAVI Board papers, policies, and program guidelines. Documents were included if they described or evaluated GAVI policies, strategies, or programs and discussed equity of access to vaccines, utilization of immunization services, or GAVI funds in countries currently or previously eligible for GAVI support. Findings were grouped thematically, categorized into time periods covering GAVI’s phases of operations, and assessed depending on whether the approaches mediated equity of opportunity or equity of outcomes between or within countries.
Results
Serches yielded 2816 documents for assessment. After pre-screening and removal of duplicates, 552 documents underwent detailed evaluation and pertinent information was extracted from 188 unique documents. As a global funding mechanism, GAVI responded rationally to a semi-fixed funding constraint by focusing on between-country equity in allocation of resources. GAVI’s predominant focus and documented successes have been in addressing between-country inequities in access to vaccines comparing lower income (GAVI-eligible) countries with higher income (ineligible) countries. GAVI has had mixed results at addressing between-country inequities in utilization of immunization services, and has only more recently put greater emphasis and resources towards addressing within-country inequities in utilization to immunization services. Over time, GAVI has progressively added vaccines to its portfolio. This expansion should have addressed inter-country, inter-regional, inter-generational and gender inequities in disease burden, however, evidence is scant with respect to final outcomes.
Conclusion
In its next phase of operations, the Alliance can continue to demonstrate its strength as a highly effective multi-partner enterprise, capable of learning and innovating in a world that has changed much since its inception. By building on its successes, developing more coherent and consistent approaches to address inequities between and within countries and by monitoring progress and outcomes, GAVI is well-positioned to bring the benefits of vaccination to previously unreached and underserved communities towards provision of universal health coverage.

Characteristics of users of a tailored, interactive website for parents and its impact on adolescent vaccination attitudes and uptake

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 5 December 2015)

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Research article
Characteristics of users of a tailored, interactive website for parents and its impact on adolescent vaccination attitudes and uptake
Amanda Dempsey, Julie Maertens, Brenda Beaty, Sean O’Leary BMC Research Notes 2015, 8:739 (1 December 2015)
Abstract
Background
We examined the characteristics of parents using an iPad-based intervention about vaccines, and its impact on vaccination attitudes and behavior.
Methods
Interventions were implemented in three primary care clinics from June 2012–September 2013. Baseline and follow up surveys assessed vaccination attitudes and intentions. Medical records were used to examine adolescent vaccine uptake.
Results
During the study, 42 parents viewed tailored educational content. Users were generally positive about vaccines, though one out of five worried that vaccines caused more harm than good. Among the 16 parents completing the post-intervention survey, there was a slightly higher, non-statistically significant, mean vaccination intention after viewing the website than prior to viewing it for three of the four adolescent vaccines (all except tetanus–diphtheria–acellular pertussis). Using the intervention did not increase the likelihood of adolescent vaccination.
Conclusions
Providing educational material via iPads in clinic waiting rooms does not appear to be an effective strategy for engaging parents about vaccines. Overall, parents’ interaction with TeenVaxScene was low, and had little impact on their vaccination attitudes and beliefs. However, use of TeenVaxScene did not appear to worsen parents’ attitudes about vaccines. New and creative ideas for engaging parents to use such educational materials are needed.

Incorporating research evidence into decision-making processes: researcher and decision-maker perceptions from five low- and middle-income countries

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 5 December 2015]

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Research
Incorporating research evidence into decision-making processes: researcher and decision-maker perceptions from five low- and middle-income countries
Zubin Shroff, Bhupinder Aulakh, Lucy Gilson, Irene Agyepong, Fadi El-Jardali, Abdul Ghaffar Health Research Policy and Systems 2015, 13:70 (30 November 2015)
Abstract
Background
The ‘Sponsoring National Processes for Evidence-Informed Policy Making in the Health Sector of Developing Countries’ program was launched by the Alliance for Health Policy and Systems Research, WHO, in July 2008. The program aimed to catalyse the use of evidence generated through health policy and systems research in policymaking processes through (1) promoting researchers and policy advocates to present their evidence in a manner that is easy for policymakers to understand and use, (2) creating mechanisms to spur the demand for and application of research evidence in policymaking, and (3) increased interaction between researchers, policy advocates, and policymakers. Grants ran for three years and five projects were supported in Argentina, Bangladesh, Cameroon, Nigeria and Zambia. This paper seeks to understand why projects in some settings were perceived by the key stakeholders involved to have made progress towards their goals, whereas others were perceived to have not done so well. Additionally, by comparing experiences across five countries, we seek to illustrate general learnings to inform future evidence-to-policy efforts in low- and middle-income countries.
Methods
We adopted the theory of knowledge translation developed by Jacobson et al. (J Health Serv Res Policy 8(2):94–9, 2003) as a framing device to reflect on project experiences across the five cases. Using data from the projects’ external evaluation reports, which included information from semi-structured interviews and quantitative evaluation surveys of those involved in projects, and supplemented by information from the projects’ individual technical reports, we applied the theoretical framework with a partially grounded approach to analyse each of the cases and make comparisons.
Results and conclusion
There was wide variation across projects in the type of activities carried out as well as their intensity. Based on our findings, we can conclude that projects perceived as having made progress towards their goals were characterized by the coming together of a number of domains identified by the theory. The domains of Jacobson’s theoretical framework, initially developed for high-income settings, are of relevance to the low- and middle-income country context, but may need modification to be fully applicable to these settings. Specifically, the relative fragility of institutions and the concomitantly more significant role of individual leaders point to the need to look at leadership as an additional domain influencing the evidence-to-policy process.

The Ebola outbreak of 2014-2015: From coordinated multilateral action to effective disease containment, vaccine development, and beyond

Journal of Global Infectious Diseases (JGID)
October-December 2015 Volume 7 | Issue 4 Page Nos. 125-174
http://www.jgid.org/currentissue.asp?sabs=n

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The Ebola outbreak of 2014-2015: From coordinated multilateral action to effective disease containment, vaccine development, and beyond
Thomas R Wojda1, Pamela L Valenza2, Kristine Cornejo2, Thomas McGinley2, Sagar C Galwankar3, Dhanashree Kelkar3, Richard P Sharpe1, Thomas J Papadimos4, Stanislaw P Stawicki1
1 Department of Surgery, St. Luke’s University Health Network, Bethlehem, Pennsylvania and Phillipsburg, New Jersey, USA
2 Department of Family Medicine, St. Luke’s University Health Network, Bethlehem, Pennsylvania and Phillipsburg, New Jersey, USA
3 Department of Emergency Medicine, University of Florida, Jacksonville, Florida, USA
4 Department of Anesthesiology, The Ohio State University College of Medicine, Columbus, Ohio, USA
Abstract
The Ebola outbreak of 2014-2015 exacted a terrible toll on major countries of West Africa. Latest estimates from the World Health Organization indicate that over 11,000 lives were lost to the deadly virus since the first documented case was officially recorded. However, significant progress in the fight against Ebola was made thanks to a combination of globally-supported containment efforts, dissemination of key information to the public, the use of modern information technology resources to better track the spread of the outbreak, as well as more effective use of active surveillance, targeted travel restrictions, and quarantine procedures. This article will outline the progress made by the global public health community toward containing and eventually extinguishing this latest outbreak of Ebola. Economic consequences of the outbreak will be discussed. The authors will emphasize policies and procedures thought to be effective in containing the outbreak. In addition, we will outline selected episodes that threatened inter-continental spread of the disease. The emerging topic of post-Ebola syndrome will also be presented. Finally, we will touch on some of the diagnostic (e.g., point-of-care [POC] testing) and therapeutic (e.g., new vaccines and pharmaceuticals) developments in the fight against Ebola, and how these developments may help the global public health community fight future epidemics.

BCG Vaccination Enhances the Immunogenicity of Subsequent Influenza Vaccination in Healthy Volunteers: A Randomized, Placebo-Controlled Pilot Study

Journal of Infectious Diseases
Volume 212 Issue 12 December 15, 2015
http://jid.oxfordjournals.org/content/current

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BCG Vaccination Enhances the Immunogenicity of Subsequent Influenza Vaccination in Healthy Volunteers: A Randomized, Placebo-Controlled Pilot Study
Jenneke Leentjens, Matthijs Kox, Robin Stokman, Jelle Gerretsen, Dimitri A. Diavatopoulos, Reinout van Crevel, Guus F. Rimmelzwaan, Peter Pickkers, and Mihai G. Netea
J Infect Dis. (2015) 212 (12): 1930-1938 doi:10.1093/infdis/jiv332
Abstract
Background.  Influenza-related morbidity and mortality remain high. Seasonal vaccination is the backbone of influenza management but does not always result in protective antibody titers. Nonspecific effects of BCG vaccination related to enhanced function of myeloid antigen-presenting cells have been reported. We hypothesized that BCG vaccination could also enhance immune responses to influenza vaccination.
Methods. Healthy volunteers received either live attenuated BCG vaccine (n = 20) or placebo (n = 20) in a randomized fashion, followed by intramuscular injection of trivalent influenza vaccine 14 days later. Hemagglutination-inhibiting (HI) antibodies and cellular immunity measured by ex vivo leukocyte responses were assessed.
Results. In BCG-vaccinated subjects, HI antibody responses against the 2009 pandemic influenza A(H1N1) vaccine strain were significantly enhanced, compared with the placebo group, and there was a trend toward more-rapid seroconversion. Additionally, apart from enhanced proinflammatory leukocyte responses following BCG vaccination, nonspecific effects of influenza vaccination were also observed, with modulation of cytokine responses against unrelated pathogens.
Conclusions. BCG vaccination prior to influenza vaccination results in a more pronounced increase and accelerated induction of functional antibody responses against the 2009 pandemic influenza A(H1N1) vaccine strain. These results may have implications for the design of vaccination strategies and could lead to improvement of vaccination efficacy.

The Lancet – Dec 05, 2015

The Lancet
Dec 05, 2015 Volume 386 Number 10010 p2227-2364 e46-e55
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Adolescent health: boys matter too
The Lancet
Summary
It has been a good year for adolescents. Many global health reports and initiatives now mention adolescents. So also does the latest UN Population Fund’s State of the World Population 2015 report, released on Dec 3. Shelter from the Storm: a transformative agenda for women and girls in a crisis-prone world reminds us that there are 26 million women and adolescent girls in their childbearing years in need of humanitarian assistance worldwide. During the past 2 years or so, adolescents have been increasingly included in the women’s and child health agenda, culminating in UN Secretary-General Ban Ki-moon’s updated Global Strategy for Women’s and Children’s Health into the Global Strategy for Women’s, Children’s and Adolescents’ Health (2016–2030), presented on Sept 26 at the General Assembly.

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Articles
Global, regional, and national levels and trends in under-5 mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Inter-agency Group for Child Mortality Estimation
Dr Danzhen You, PhD, Lucia Hug, MA, Simon Ejdemyr, MA, Priscila Idele, PhD, Daniel Hogan, PhD, Colin Mathers, PhD, Patrick Gerland, PhD, Jin Rou New, MA, Leontine Alkema, PhD
for the United Nations Inter-agency Group for Child Mortality Estimation (UN IGME)
Summary
Background
In 2000, world leaders agreed on the Millennium Development Goals (MDGs). MDG 4 called for a two-thirds reduction in the under-5 mortality rate between 1990 and 2015. We aimed to estimate levels and trends in under-5 mortality for 195 countries from 1990 to 2015 to assess MDG 4 achievement and then intended to project how various post-2015 targets and observed rates of change will affect the burden of under-5 deaths from 2016 to 2030.
Methods
We updated the UN Inter-agency Group for Child Mortality Estimation (UN IGME) database with 5700 country-year datapoints. As of July, 2015, the database contains about 17 000 country-year datapoints for mortality of children younger than 5 years for 195 countries, and includes all available nationally-representative data from vital registration systems, population censuses, household surveys, and sample registration systems. We used these data to generate estimates, with uncertainty intervals, of under-5 (age 0–4 years) mortality using a Bayesian B-spline bias-reduction model (B3 model). This model includes a data model to adjust for systematic biases associated with different types of data sources. To provide insights into the global and regional burden of under-5 deaths associated with post-2015 targets, we constructed five scenario-based projections for under-5 mortality from 2016 to 2030 and estimated national, regional, and global under-5 mortality rates up to 2030 for each scenario.
Results
The global under-5 mortality rate has fallen from 90·6 deaths per 1000 livebirths (90% uncertainty interval 89·3–92·2) in 1990 to 42·5 (40·9–45·6) in 2015. During the same period, the annual number of under-5 deaths worldwide dropped from 12·7 million (12·6 million–13·0 million) to 5·9 million (5·7 million–6·4 million). The global under-5 mortality rate reduced by 53% (50–55%) in the past 25 years and therefore missed the MDG 4 target. Based on point estimates, two regions—east Asia and the Pacific, and Latin America and the Caribbean—achieved the MDG 4 target. 62 countries achieved the MDG 4 target, of which 24 were low-income and lower-middle income countries. Between 2016 and 2030, 94·4 million children are projected to die before the age of 5 years if the 2015 mortality rate remains constant in each country, and 68·8 million would die if each country continues to reduce its mortality rate at the pace estimated from 2000 to 2015. If all countries achieve the Sustainable Development Goal of an under-5 mortality rate of 25 or fewer deaths per 1000 livebirths by 2030, we project 56·0 million deaths by 2030. About two-thirds of all sub-Saharan African countries need to accelerate progress to achieve this target.
Interpretation
Despite substantial progress in reducing child mortality, concerted efforts remain necessary to avoid preventable under-5 deaths in the coming years and to accelerate progress in improving child survival further. Urgent actions are needed most in the regions and countries with high under-5 mortality rates, particularly those in sub-Saharan Africa and south Asia.
Funding
None.

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Articles
Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013
GBD 2013 Risk Factors Collaborators*
Summary
Background
The Global Burden of Disease, Injuries, and Risk Factor study 2013 (GBD 2013) is the first of a series of annual updates of the GBD. Risk factor quantification, particularly of modifiable risk factors, can help to identify emerging threats to population health and opportunities for prevention. The GBD 2013 provides a timely opportunity to update the comparative risk assessment with new data for exposure, relative risks, and evidence on the appropriate counterfactual risk distribution.
Methods
Attributable deaths, years of life lost, years lived with disability, and disability-adjusted life-years (DALYs) have been estimated for 79 risks or clusters of risks using the GBD 2010 methods. Risk–outcome pairs meeting explicit evidence criteria were assessed for 188 countries for the period 1990–2013 by age and sex using three inputs: risk exposure, relative risks, and the theoretical minimum risk exposure level (TMREL). Risks are organised into a hierarchy with blocks of behavioural, environmental and occupational, and metabolic risks at the first level of the hierarchy. The next level in the hierarchy includes nine clusters of related risks and two individual risks, with more detail provided at levels 3 and 4 of the hierarchy. Compared with GBD 2010, six new risk factors have been added: handwashing practices, occupational exposure to trichloroethylene, childhood wasting, childhood stunting, unsafe sex, and low glomerular filtration rate. For most risks, data for exposure were synthesised with a Bayesian meta-regression method, DisMod-MR 2.0, or spatial-temporal Gaussian process regression. Relative risks were based on meta-regressions of published cohort and intervention studies. Attributable burden for clusters of risks and all risks combined took into account evidence on the mediation of some risks such as high body-mass index (BMI) through other risks such as high systolic blood pressure and high cholesterol.
Findings
All risks combined account for 57·2% (95% uncertainty interval [UI] 55·8–58·5) of deaths and 41·6% (40·1–43·0) of DALYs. Risks quantified account for 87·9% (86·5–89·3) of cardiovascular disease DALYs, ranging to a low of 0% for neonatal disorders and neglected tropical diseases and malaria. In terms of global DALYs in 2013, six risks or clusters of risks each caused more than 5% of DALYs: dietary risks accounting for 11·3 million deaths and 241·4 million DALYs, high systolic blood pressure for 10·4 million deaths and 208·1 million DALYs, child and maternal malnutrition for 1·7 million deaths and 176·9 million DALYs, tobacco smoke for 6·1 million deaths and 143·5 million DALYs, air pollution for 5·5 million deaths and 141·5 million DALYs, and high BMI for 4·4 million deaths and 134·0 million DALYs. Risk factor patterns vary across regions and countries and with time. In sub-Saharan Africa, the leading risk factors are child and maternal malnutrition, unsafe sex, and unsafe water, sanitation, and handwashing. In women, in nearly all countries in the Americas, north Africa, and the Middle East, and in many other high-income countries, high BMI is the leading risk factor, with high systolic blood pressure as the leading risk in most of Central and Eastern Europe and south and east Asia. For men, high systolic blood pressure or tobacco use are the leading risks in nearly all high-income countries, in north Africa and the Middle East, Europe, and Asia. For men and women, unsafe sex is the leading risk in a corridor from Kenya to South Africa.
Interpretation
Behavioural, environmental and occupational, and metabolic risks can explain half of global mortality and more than one-third of global DALYs providing many opportunities for prevention. Of the larger risks, the attributable burden of high BMI has increased in the past 23 years. In view of the prominence of behavioural risk factors, behavioural and social science research on interventions for these risks should be strengthened. Many prevention and primary care policy options are available now to act on key risks.
Funding
Bill & Melinda Gates Foundation.

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Series
How to eliminate tuberculosis
Data for action: collection and use of local data to end tuberculosis
Grant Theron, Helen E Jenkins, Frank Cobelens, Ibrahim Abubakar, Aamir J Khan, Ted Cohen, David W Dowdy
2324

How to eliminate tuberculosis
Turning off the tap: stopping tuberculosis transmission through active case-finding and prompt effective treatment
Courtney M Yuen, Farhana Amanullah, Ashwin Dharmadhikari, Edward A Nardell, James A Seddon, Irina Vasilyeva, Yanlin Zhao, Salmaan Keshavjee, Mercedes C Becerra
2334

How to eliminate tuberculosis
Controlling the seedbeds of tuberculosis: diagnosis and treatment of tuberculosis infection
Molebogeng X Rangaka, Solange C Cavalcante, Ben J Marais, Sok Thim, Neil A Martinson, Soumya Swaminathan, Richard E Chaisson
2344

How to eliminate tuberculosis
Stopping tuberculosis: a biosocial model for sustainable development
Katrina F Ortblad, Joshua A Salomon, Till Bärnighausen, Rifat Atun
2354

The Lancet Infectious Diseases – Dec 2015

The Lancet Infectious Diseases
Dec 2015 Volume 15 Number 12 p1361-1498
http://www.thelancet.com/journals/laninf/issue/current

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Editorial
Tuberculosis reaches new milestones, good and bad
The Lancet Infectious Diseases
DOI: http://dx.doi.org/10.1016/S1473-3099(15)00431-4
Summary
The 20th instalment of WHO’s Global tuberculosis report was published on Oct 28, 2015, heralded by the headline that tuberculosis mortality had nearly halved over the past 25 years. This positive news was closely followed by the sobering announcement that tuberculosis now ranks alongside HIV among the leading infectious causes of death, with the deaths of 1·5 million people being attributable to the disease. Most of these deaths could have been prevented; in fact, tuberculosis has been a curable disease since the 1950s.

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Comment
Neonatal rotavirus vaccination making headway
Timo Vesikari
Published Online: 26 August 2015
Summary
The randomised trial reported by Julie Bines and colleagues1 in The Lancet Infectious Diseases is a clear step forward in the long history of the Australian neonatal rotavirus vaccine. In 1983, Bishop and colleagues2,3 noted that children who had acquired a rotavirus infection in the neonatal period were protected against severe (but not mild) rotavirus diarrhoea later in life. The study had been made possible because a so-called nursery strain of rotavirus was circulating in a hospital in Melbourne, which was later identified as G3P2A[6] rotavirus and is the origin of the present vaccine designated as RV3-BB.

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Articles
Safety and immunogenicity of RV3-BB human neonatal rotavirus vaccine administered at birth or in infancy: a randomised, double-blind, placebo-controlled trial
Julie E Bines, Margaret Danchin, Pamela Jackson, Amanda Handley, Emma Watts, Katherine J Lee, Amanda West, Daniel Cowley, Mee-Yew Chen, Graeme L Barnes, Frances Justice, Jim P Buttery, John B Carlin, Ruth F Bishop, Barry Taylor, Carl D Kirkwood, RV3 Rotavirus Vaccine Program
Summary
Background
Despite the success of rotavirus vaccines, suboptimal vaccine efficacy in regions with a high burden of disease continues to present a challenge to worldwide implementation. A birth dose strategy with a vaccine developed from an asymptomatic neonatal rotavirus strain has the potential to address this challenge and provide protection from severe rotavirus disease from birth.
Methods
This phase 2a randomised, double-blind, three-arm, placebo-controlled safety and immunogenicity trial was undertaken at a single centre in New Zealand between Jan 13, 2012, and April 17, 2014. Healthy, full-term (≥36 weeks gestation) babies, who weighed at least 2500 g, and were 0–5 days old at the time of randomisation were randomly assigned (1:1:1; computer-generated; telephone central allocation) according to a concealed block randomisation schedule to oral RV3-BB vaccine with the first dose given at 0–5 days after birth (neonatal schedule), to vaccine with the first dose given at about 8 weeks after birth (infant schedule), or to placebo. The primary endpoint was cumulative vaccine take (serum immune response or stool shedding of vaccine virus after any dose) after three doses. The immunogenicity analysis included all randomised participants with available outcome data. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611001212943.
Findings
95 eligible participants were randomised, of whom 89 were included in the primary analysis. A cumulative vaccine take was detected in 27 (90%) of 30 participants in the neonatal schedule group after three doses of RV3-BB vaccine compared with four (13%) of 32 participants in the placebo group (difference in proportions 0·78, 95% CI 0·55–0·88; p<0·0001). 25 (93%) of 27 participants in the infant schedule group had a cumulative vaccine take after three doses compared with eight (25%) of 32 participants in the placebo group (difference in proportions 0·68, 0·44–0·81; p<0·0001). A serum IgA response was detected in 19 (63%) of 30 participants and 20 (74%) of 27 participants, and stool shedding of RV3-BB was detected in 21 (70%) of 30 participants and 21 (78%) of 27 participants in the neonatal and infant schedule groups, respectively. The frequency of solicited and unsolicited adverse events was similar across the treatment groups. RV3-BB vaccine was not associated with an increased frequency of fever or gastrointestinal symptoms compared with placebo.
Interpretation
RV3-BB vaccine was immunogenic and well tolerated when given as a three-dose neonatal or infant schedule. A birth dose strategy of RV3-BB vaccine has the potential to improve the effectiveness and implementation of rotavirus vaccines.
Funding
Australian National Health and Medical Research Council, the New Zealand Health Research Council, and the Murdoch Childrens Research Institute.

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Immunogenicity of the RTS,S/AS01 malaria vaccine and implications for duration of vaccine efficacy: secondary analysis of data from a phase 3 randomised controlled trial
Michael T White, Robert Verity, Jamie T Griffin, Kwaku Poku Asante, Seth Owusu-Agyei, Brian Greenwood, Chris Drakeley, Samwel Gesase, John Lusingu, Daniel Ansong, Samuel Adjei, Tsiri Agbenyega, Bernhards Ogutu, Lucas Otieno, Walter Otieno, Selidji T Agnandji, Bertrand Lell, Peter Kremsner, Irving Hoffman, Francis Martinson, Portia Kamthunzu, Halidou Tinto, Innocent Valea, Hermann Sorgho, Martina Oneko, Kephas Otieno, Mary J Hamel, Nahya Salim, Ali Mtoro, Salim Abdulla, Pedro Aide, Jahit Sacarlal, John J Aponte, Patricia Njuguna, Kevin Marsh, Philip Bejon, Eleanor M Riley, Azra C Ghani
1450
Open Access
Summary
Background
The RTS,S/AS01 malaria vaccine targets the circumsporozoite protein, inducing antibodies associated with the prevention of Plasmodium falciparum infection. We assessed the association between anti-circumsporozoite antibody titres and the magnitude and duration of vaccine efficacy using data from a phase 3 trial done between 2009 and 2014.
Methods
Using data from 8922 African children aged 5–17 months and 6537 African infants aged 6–12 weeks at first vaccination, we analysed the determinants of immunogenicity after RTS,S/AS01 vaccination with or without a booster dose. We assessed the association between the incidence of clinical malaria and anti-circumsporozoite antibody titres using a model of anti-circumsporozoite antibody dynamics and the natural acquisition of protective immunity over time.
Findings
RTS,S/AS01-induced anti-circumsporozoite antibody titres were greater in children aged 5–17 months than in those aged 6–12 weeks. Pre-vaccination anti-circumsporozoite titres were associated with lower immunogenicity in children aged 6–12 weeks and higher immunogenicity in those aged 5–17 months. The immunogenicity of the booster dose was strongly associated with immunogenicity after primary vaccination. Anti-circumsporozoite titres wane according to a biphasic exponential distribution. In participants aged 5–17 months, the half-life of the short-lived component of the antibody response was 45 days (95% credible interval 42–48) and that of the long-lived component was 591 days (557–632). After primary vaccination 12% (11–13) of the response was estimated to be long-lived, rising to 30% (28–32%) after a booster dose. An anti-circumsporozoite antibody titre of 121 EU/mL (98–153) was estimated to prevent 50% of infections. Waning anti-circumsporozoite antibody titres predict the duration of efficacy against clinical malaria across different age categories and transmission intensities, and efficacy wanes more rapidly at higher transmission intensity.
Interpretation
Anti-circumsporozoite antibody titres are a surrogate of protection for the magnitude and duration of RTS,S/AS01 efficacy, with or without a booster dose, providing a valuable surrogate of effectiveness for new RTS,S formulations in the age groups considered.
Funding
UK Medical Research Council.

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Cost-effectiveness of high-dose versus standard-dose inactivated influenza vaccine in adults aged 65 years and older: an economic evaluation of data from a randomised controlled trial
Ayman Chit, Debbie L Becker, Carlos A DiazGranados, Michael Maschio, Eddy Yau, Michael Drummond
Summary
Background
Adults aged 65 years and older account for most seasonal influenza-related hospital admissions and deaths. Findings from the randomised controlled FIM12 study showed that high-dose inactivated influenza vaccine is more effective than standard-dose vaccine for prevention of laboratory-confirmed influenza in this age group. We aimed to assess the economic impact of high-dose versus standard-dose influenza vaccine in participants in the FIM12 study population.
Methods
The FIM12 study was a head-to-head randomised controlled trial in which 31 989 participants aged 65 years and older were randomly assigned (1:1) to receive either high-dose or standard-dose trivalent inactivated influenza vaccine over two influenza seasons (2011–12 and 2012–13). Data for health-care resource consumption obtained in the FIM12 study were summarised across vaccine groups. Unit costs obtained from standard US cost sources were applied to each resource item, including to the vaccines (high dose US$31·82, standard dose $12·04). Clinical illness data were mapped to existing quality-of-life data. The time horizon was one influenza season; however, quality-adjusted life-years (QALYs) lost due to death during the study were calculated over a lifetime. We calculated incremental cost-effectiveness ratios (ICERs) for high-dose versus standard-dose vaccine and used QALYs as an outcome in the cost-utility analysis. We undertook a probabilistic sensitivity analysis using bootstrapping to explore the effect of statistical uncertainty on the study results.
Findings
Mean per-participant medical costs were lower in the high-dose vaccine group ($1376·72 [SD 6857·59]) than in the standard-dose group ($1492·64 [7447·14]; difference –$115·92 [95% CI −264·18 to 35·48]). Mean societal costs were likewise lower in the high-dose versus the standard-dose group ($1506·48 [SD 7305·19] vs $1634·50 [7952·99]; difference −$128·02 [95% CI −286·89 to 33·30]). Hospital admissions contributed 95% of the total health-care-payer cost and 87% of the total societal costs. The mean per-participant number of hospital admissions was 0·0937 (SD 0·3644) in the high-dose group and 0·1017 (0·3708) in the standard-dose group (difference −0·0080, 95% CI −0·0160 to −0·0003). The high-dose vaccine provided a gain in QALYs (mean 8·1502 QALYs gained per participant [SD 0·5693]) compared with the standard-dose vaccine (8·1499 QALYs [0·5697]) and, due to cost savings, dominated standard-dose vaccine in the cost-utility analysis. The probabilistic sensitivity analysis showed that the high-dose vaccine is 93% likely to be cost saving.
Interpretation
High-dose trivalent inactivated influenza vaccine is a less costly and more effective alternative to the standard-dose vaccine, driven by a reduction in the number of hospital admissions. These findings are relevant to US health-care beneficiaries, providers, payers, and recommending bodies, especially those seeking to improve outcomes while containing costs.
Funding
Sanofi Pasteur.

An Intervention to Enhance Obstetric and Newborn Care in India: A Cluster Randomized-Trial

Maternal and Child Health Journal
Volume 19, Issue 12, December 2015
http://link.springer.com/journal/10995/19/12/page/1

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Original Paper
An Intervention to Enhance Obstetric and Newborn Care in India: A Cluster Randomized-Trial
Shivaprasad S. Goudar, Richard J. Derman
Abstract
Objectives
This study assessed whether community mobilization and interventions to improve emergency obstetric and newborn care reduced perinatal mortality (PMR) and neonatal mortality rates (NMR) in Belgaum, India.
Methods
The cluster-randomised controlled trial was conducted in Belgaum District, Karnataka State, India. Twenty geographic clusters were randomized to control or the intervention. The intervention engaged and mobilized community and health authorities to leverage support; strengthened community-based stabilization, referral, and transportation; and aimed to improve quality of care at facilities.
Results
17,754 Intervention births and 15,954 control births weighing ≥1000 g, respectively, were enrolled and analysed. Comparing the baseline period to the last 6 months period, the NMR was lower in the intervention versus control clusters (OR 0.60, 95 % CI 0.34–1.06, p = 0.076) as was the PMR (OR 0.74, 95 % CI 0.46–1.19, p = 0.20) although neither reached statistical significance. Rates of facility birth and caesarean section increased among both groups. There was limited influence on quality of care measures.
Conclusions for Practice
The intervention had large but not statistically significant effects on neonatal and perinatal mortality. Community mobilization and increased facility care may ultimately improve neonatal and perinatal survival, and are important in the context of the global transition towards institutional delivery.

Expanding the role of diagnostic and prognostic tools for infectious diseases in resource-poor settings

Nature
Volume 528 Number 7580 pp7-158 3 December 2015
http://www.nature.com/nature/current_issue.html

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World View
The world must accept that the HPV vaccine is safe
But the science alone will not be enough to build public and political confidence, says Heidi Larson.
01 December 2015

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Supplement: Infectious disease control and elimination: Modelling the impact of improved diagnostics
Diagnostic technologies play a pivotal part in understanding and addressing the burden of infectious diseases. The Diagnostics Modelling Consortium was established in 2013 to facilitate the integration of diagnostic data into models of disease transmission dynamics. In this supplement, the Consortium and its partners report on the latest research outcomes across several major diseases. The outputs demonstrate that improved, well-considered diagnostics could support the elimination of multiple diseases in the field.
Free full access

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Introduction
Expanding the role of diagnostic and prognostic tools for infectious diseases in resource-poor settings
Open Access
Azra C. Ghani, Deborah Hay Burgess, Alison Reynolds & Christine Rousseau
Nature 528, S50-S52 (03 December 2015)

Pediatrics – December 2015

Pediatrics
December 2015, VOLUME 136 / ISSUE 6
http://pediatrics.aappublications.org/content/136/6?current-issue=y

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Characteristics of Physicians Who Dismiss Families for Refusing Vaccines
Sean T. O’Leary, Mandy A. Allison, Allison Fisher, Lori Crane, Brenda Beaty, Laura Hurley, Michaela Brtnikova, Andrea Jimenez-Zambrano, Shannon Stokley, Allison Kempe
Abstract
BACKGROUND AND OBJECTIVES: Physicians dismissing families who refuse vaccines from their practices is controversial. We assessed the following among pediatricians (Peds) and family physicians (FPs): (1) reported prevalence of parental refusal of 1 or more vaccines in the infant series; (2) physician response to refusal; and (3) the association between often/always dismissing families and provider/practice characteristics and state exemption laws.
METHODS: Nationally representative survey conducted June to October 2012. A multivariable analysis assessed association of often/always dismissing families with physician/practice characteristics, state philosophical exemption policy, and degree of difficulty obtaining nonmedical exemptions.
RESULTS: The response rate was 66% (534/815). Overall, 83% of physicians reported that in a typical month, ≥1% of parents refused 1 or more infant vaccines, and 20% reported that >5% of parents refused. Fifty-one percent reported always/often requiring parents to sign a form if they refused (Peds 64%, FP 29%, P < .0001); 21% of Peds and 4% of FPs reported always/often dismissing families if they refused ≥1 vaccine. Peds only were further analyzed because few FPs dismissed families. Peds who dismissed families were more likely to be in private practice (adjusted odds ratio [aOR] 4.90, 95% confidence interval [CI] 1.40–17.19), from the South (aOR 4.07, 95% CI 1.08–15.31), and reside in a state without a philosophical exemption law (aOR 3.70, 95% CI 1.74–7.85).
CONCLUSIONS: Almost all physicians encounter parents who refuse infant vaccines. One-fifth of Peds report dismissing families who refuse, but there is substantial variation in this practice. Given the frequency of dismissal, the impact of this practice on vaccine refusers and on pediatric practices should be studied.

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FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007–2013
Judith U. Cope, Geoffrey L. Rosenthal, Pamela Weinel, Amy Odegaard, Dianne M. Murphy
Abstract
BACKGROUND AND OBJECTIVES: In 2002, Congress mandated that the US Food and Drug Administration (FDA) monitor postmarketing pediatric adverse events and present safety reports to the FDA’s Pediatric Advisory Committee (PAC). These safety reviews play a critical role in the postmarketing surveillance and identification of pediatric safety issues. This article follows a previous review ending in 2007 and summarizes 6 years of recent pediatric safety reporting, recommendations by the PAC, and actions by the FDA, including labeling changes.
METHODS: An analysis of the FDA’s PAC safety reviews performed from November 2007 through September 2013 was conducted. PAC recommendations for subsequent labeling changes, future studies, or other safety issues were reviewed.
RESULTS: There were 6930 serious adverse event reports in 181 reviews. These findings resulted in 33 (18%) recommended labeling changes, and 21 (64%) of these changes were adopted. For 10 products, information was added to the Warning and Precautions section of the label. The PAC also discussed or recommended additional studies for certain products.
CONCLUSIONS: This article highlights the importance of the FDA’s ongoing pediatric postmarketing safety reviews of regulated products, advice from the PAC, and FDA actions in the best interest of pediatric patients. This mandated process facilitates detection of safety concerns that may not be identified in prelicensure clinical trials. It continues to identify critical safety concerns, including unlabeled adverse events, frequent off-label use, product misuse, and secondary exposures in children.

Dealing with Time in Health Economic Evaluation: Methodological Issues and Recommendations for Practice

PharmacoEconomics
Volume 33, Issue 12, December 2015
http://link.springer.com/journal/40273/33/12/page/1

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Dealing with Time in Health Economic Evaluation: Methodological Issues and Recommendations for Practice
James F. O’Mahony, Anthony T. Newall, Joost van Rosmalen
Abstract
Time is an important aspect of health economic evaluation, as the timing and duration of clinical events, healthcare interventions and their consequences all affect estimated costs and effects. These issues should be reflected in the design of health economic models. This article considers three important aspects of time in modelling: (1) which cohorts to simulate and how far into the future to extend the analysis; (2) the simulation of time, including the difference between discrete-time and continuous-time models, cycle lengths, and converting rates and probabilities; and (3) discounting future costs and effects to their present values. We provide a methodological overview of these issues and make recommendations to help inform both the conduct of cost-effectiveness analyses and the interpretation of their results. For choosing which cohorts to simulate and how many, we suggest analysts carefully assess potential reasons for variation in cost effectiveness between cohorts and the feasibility of subgroup-specific recommendations. For the simulation of time, we recommend using short cycles or continuous-time models to avoid biases and the need for half-cycle corrections, and provide advice on the correct conversion of transition probabilities in state transition models. Finally, for discounting, analysts should not only follow current guidance and report how discounting was conducted, especially in the case of differential discounting, but also seek to develop an understanding of its rationale. Our overall recommendations are that analysts explicitly state and justify their modelling choices regarding time and consider how alternative choices may impact on results.

The Ebola Vaccine, Iatrogenic Injuries, and Legal Liability

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 5 December 2015)

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The Ebola Vaccine, Iatrogenic Injuries, and Legal Liability
Amir Attaran, Kumanan Wilson
Policy Forum | published 01 Dec 2015 | PLOS Medicine
10.1371/journal.pmed.1001911
Summary Points
:: The development and eventual deployment of an Ebola vaccine was delayed for various technical and financial reasons, but with the apparent success of a vaccine candidate in a recently reported clinical trial, an urgent problem is the lack of any system to protect vaccine firms from the risks of legal liability caused by vaccine-related injuries.
:: Without indemnity or security against the legal risks, vaccine firms are less likely to engage in research and development of vaccines, particularly for rare diseases of poor countries such as Ebola.
:: WHO’s traditional method of mitigating the legal risks through indemnification agreements with countries appears too slow to implement in urgent pandemic situations. Also, the enforceability of any WHO-backed legal agreement is placed in doubt because the United Nations has the option to claim immunity from lawsuits.
:: Creating a compensation system for vaccine injuries, based on no-fault principles and, most likely, overseen by the World Bank, could address the liability concerns and facilitate getting novel vaccines into clinical trials and to the market. This system would also ensure that recipients of these vaccines are fairly compensated in the rare instances that they are harmed.

Frameworks for Disaster Research and Evaluation

Prehospital & Disaster Medicine
Volume 30 – Issue 06 – December 2015
https://journals.cambridge.org/action/displayIssue?jid=PDM&tab=currentissue
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Frameworks for Disaster Research and Evaluation
Samuel J. Stratton
DOI: http://dx.doi.org/10.1017/S1049023X15005397 (About DOI), Published online: 11 November 2015

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Special Reports
Research and Evaluations of the Health Aspects of Disasters, Part III: Framework for the Temporal Phases of Disasters
Marvin L. Birnbaum, Elaine K. Daily and Ann P. O’Rourke

Research and Evaluations of the Health Aspects of Disasters, Part IV: Framework for Societal Structures: the Societal Systems
Marvin L. Birnbaum, Elaine K. Daily and Ann P. O’Rourke

Research and Evaluations of the Health Aspects of Disasters, Part V: Epidemiological Disaster Research
Marvin L. Birnbaum, Elaine K. Daily and Ann P. O’Rourke

Science Special Issue – Toward Healthy Aging

Science
4 December 2015 vol 350, issue 6265, pages 1125-1288
http://www.sciencemag.org/current.dtl

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Introduction to Special Issue – Toward Healthy Aging
Putting Off the Inevitable
Stella Hurtley, Leslie Roberts, L. Bryan Ray, Beverly A. Purnell, Caroline Ash
The dream of cheating death has evolved into a scientific quest to extend healthy life span. Scientists and doctors are looking for ways to maximize the number of years that we live free of chronic diseases, cancer, and cognitive decline. But before we can intervene, we have to understand the cellular and molecular mechanisms that drive aging and senescence. Some clues reside in our telomeres, the tips of our chromosomes that shrink with age. Others lie in our stem cells, which can only go on for so long repairing our tissues. Our mitochondria, too, the so-called powerhouses of the cell, may hold some answers to prolonging youthfulness. Other research points to changes in the gut microbiota associated with frailty in the aged. At a mechanistic level, the modulation of coenzyme NAD+ usage or production can prolong both health span and life span. Current geroscience initiatives aim to harness basic insights in aging research to promote general advances in healthy aging.

Questions remain throughout the aging field. By tweaking everything from genes to diets to environmental temperature and mating, scientists have created Methuselah flies and other remarkably long-lived animals while garnering fundamental insights into the biology of aging. Still, researchers puzzle over the most basic questions, such as what determines the life spans of animals. Meanwhile, a handful of molecular biologists are searching for ways to measure a person’s biological, as opposed to chronological, age, but that quest, too, has proved elusive.

An ever-growing literature addresses both theoretical and pragmatic approaches to the challenge of aging. In this special issue, we have focused mainly on the cellular aspects of mammalian aging, with the goal of spurring future developments in promoting health span, if not life span.

Social Science & Medicine – Volume 145, Pages 1-248 (November 2015)

Social Science & Medicine
Volume 145, Pages 1-248 (November 2015)
http://www.sciencedirect.com/science/journal/02779536/145

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Special issue section Health Systems in Asia 2013; Edited by Kai Hong Phua, Shenglan Tang and Kabir Sheikh
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Editorial – Health Systems of Asia: Equity, Governance and Social Impact
Pages 141-144
Kai Hong Phua, Kabir Sheikh, Sheng-Lan Tang, Vivian Lin
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District-level variations in childhood immunizations in India: The role of socio-economic factors and health infrastructure
Original Research Article
Pages 163-172
Anu Rammohan, Niyi Awofeso
Abstract
Routine childhood immunizations against measles and DPT are part of the World Health Organization’s (WHO) Expanded Program on Immunization (EPI) set up in 1974, with the aim of reducing childhood morbidity and mortality. Despite this, immunization rates are sub-optimal in developing countries such as India, with wide heterogeneity observed across districts and socio-economic characteristics. The aim of this paper is to examine district-level variations in the propensity to vaccinate a child in India for measles and DPT3, and analyse the extent to which these immunizations are given age-inappropriately, either prematurely or delayed. The present study uses data from the Indian District Level Household Survey (DLHS-3) collected in 2008, and the final sample contains detailed information on 42157 children aged between 12 and 60 months, across 549 Indian districts for whom we have complete information on immunization history. Our empirical study analyses: (i) the district-level average immunization rates for measles and DPT3, and (ii) the extent to which these immunizations have been given age-appropriately. A key contribution of this paper is that we link the household-level data at the district level to data on availability and proximity to health infrastructure and district-level socio-economic factors. Our results show that after controlling for an array of socio-economic characteristics, across all our models, the district’s income per capita is a strong predictor of better immunization outcomes for children. Mother’s education level at the district-level has a statistically significant and positive influence on immunization outcomes across all our models.
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Emerging challenges in implementing universal health coverage in Asia
Original Research Article
Pages 243-248
Caryn Bredenkamp, Timothy Evans, Leizel Lagrada, John Langenbrunner, Stefan Nachuk, Toomas Palu
Abstract
As countries in Asia converge on the goal of universal health coverage (UHC), some common challenges are emerging. One is how to ensure coverage of the informal sector so as to make UHC truly universal; a second is how to design a benefit package that is responsive and appropriate to current health challenges, yet fiscally sustainable; and a third is how to ensure “supply-side readiness”, i.e. the availability and quality of services, which is a necessary condition for translating coverage into improvements in health outcomes. Using examples from the Asia region, this paper discusses these three challenges and how they are being addressed.
On the first challenge, two promising approaches emerge: using general revenues to fully cover the informal sector, or employing a combination of tax subsidies, non-financial incentives and contributory requirements. The former can produce fast results, but places pressure on government budgets and may induce informality, while the latter will require a strong administrative mandate and systems to track the ability-to-pay. With respect to benefit packages, we find considerable variation in the nature and rigor of processes underlying the selection and updating of the services included. Also, in general, packages do not yet focus sufficiently on non-communicable diseases (NCDs) and related preventive outpatient care. Finally, there are large variations and inequities in the supply-side readiness, in terms of availability of infrastructure, equipment, essential drugs and staffing, to deliver on the promises of UHC. Health worker competencies are also a constraint.
While the UHC challenges are common, experience in overcoming these challenges is varied and many of the successes appear to be highly context-specific. This implies that researchers and policymakers need to rigorously, and regularly, assess different approaches, and share these findings across countries in Asia – and across the world.

Tropical Medicine & International Health – December 2015

Tropical Medicine & International Health
December 2015 Volume 20, Issue 12 Pages 1591–1854
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2015.20.issue-12/issuetoc

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Systematic Reviews
Acute respiratory infection case definitions for young children: a systematic review of community-based epidemiologic studies in South Asia (pages 1607–1620)
Daniel E. Roth, Michelle F. Gaffey, Evelyn Smith-Romero, Tiffany Fitzpatrick and Shaun K. Morris
Article first published online: 20 SEP 2015 | DOI: 10.1111/tmi.12592

Systematic Reviews
Who, What, Where: an analysis of private sector family planning provision in 57 low- and middle-income countries (pages 1639–1656)
Oona M. R. Campbell, Lenka Benova, David Macleod, Catherine Goodman, Katharine Footman, Audrey L. Pereira and Caroline A. Lynch
Article first published online: 28 SEP 2015 | DOI: 10.1111/tmi.12597

Role of the private sector in childbirth care: cross-sectional survey evidence from 57 low- and middle-income countries using Demographic and Health Surveys (pages 1657–1673)
Lenka Benova, David Macleod, Katharine Footman, Francesca Cavallaro, Caroline A. Lynch and Oona M. R. Campbell
Article first published online: 28 SEP 2015 | DOI: 10.1111/tmi.12598

Report on the second WHO integrated meeting on development and clinical trials of influenza vaccines that induce broadly protective and long-lasting immune responses: Geneva, Switzerland, 5–7 May 2014

Vaccine
Volume 33, Issue 48, Pages 6503-6946 (27 November 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/48
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Report on the second WHO integrated meeting on development and clinical trials of influenza vaccines that induce broadly protective and long-lasting immune responses: Geneva, Switzerland, 5–7 May 2014
Pages 6503-6510
Nancy J. Cox, Julian Hickling, Rebecca Jones, Guus F. Rimmelzwaan, Linda C. Lambert, John Boslego, Larisa Rudenko, Leena Yeolekar, James S. Robertson, Joachim Hombach, Justin R. Ortiz
Abstract
On 5–7 May 2014, the World Health Organization (WHO) convened the second integrated meeting on “influenza vaccines that induce broadly protective and long-lasting immune responses”. Around 100 invited experts from academia, the vaccine industry, research and development funders, and regulatory and public health agencies attended the meeting. Areas covered included mechanisms of protection in natural influenza-virus infection and vaccine-induced immunity, new approaches to influenza-vaccine design and production, and novel routes of vaccine administration. A timely focus was on how this knowledge could be applied to both seasonal influenza and emerging viruses with pandemic potential such as influenza A (H7N9), currently circulating in China. Special attention was given to the development of possible universal influenza vaccines, given that the Global Vaccine Action Plan calls for at least one licensed universal influenza vaccine by 2020. This report highlights some of the topics discussed and provides an update on studies published since the report of the previous meeting.

The current situation of meningococcal disease in Latin America and updated Global Meningococcal Initiative (GMI) recommendations

Vaccine
Volume 33, Issue 48, Pages 6503-6946 (27 November 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/48
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The current situation of meningococcal disease in Latin America and updated Global Meningococcal Initiative (GMI) recommendations
Review Article
Pages 6529-6536
Marco Aurélio P. Sáfadi, Miguel O’Ryan, Maria Teresa Valenzuela Bravo, Maria Cristina C. Brandileone, Maria Cecília O. Gorla, Ana Paula S. de Lemos, Gabriela Moreno, Julio A. Vazquez, Eduardo L. López, Muhamed-Kheir Taha, Ray Borrow, Global Meningococcal Initiative
Abstract
The Global Meningococcal Initiative (GMI) was established in 2009 and comprises an international team of scientists, clinicians, and public health officials with expertise in meningococcal disease (MD). Its primary goal is to promote global prevention of MD through education, research, international cooperation, and developing recommendations that include decreasing the burden of severe disease. The group held its first roundtable meeting with experts from Latin American countries in 2011, and subsequently proposed several recommendations to reduce the regional burden of MD. A second roundtable meeting was convened with Latin American representatives in June 2013 to reassess MD epidemiology, vaccination strategies, and unmet needs in the region, as well as to update the earlier recommendations. Special emphasis was placed on the emergence and spread of serogroup W disease in Argentina and Chile, and the control measures put in place in Chile were a particular focus of discussions. The impact of routine meningococcal vaccination programs, notably in Brazil, was also evaluated. There have been considerable improvements in MD surveillance systems and diagnostic techniques in some countries (e.g., Brazil and Chile), but the lack of adequate infrastructure, trained personnel, and equipment/reagents remains a major barrier to progress in resource-poor countries. The Pan American Health Organization’s Revolving Fund is likely to play an important role in improving access to meningococcal vaccines in Latin America. Additional innovative approaches are needed to redress the imbalance in expertise and resources between countries, and thereby improve the control of MD. In Latin America, the GMI recommends establishment of a detailed and comprehensive national/regional surveillance system, standardization of laboratory procedures, adoption of a uniform MD case definition, maintaining laboratory-based surveillance, replacement of polysaccharide vaccines with conjugate formulations (wherever possible), monitoring and evaluating implemented vaccination strategies, conducting cost-effectiveness studies, and developing specific recommendations for vaccination of high-risk groups.