JAMA
July 18, 2017, Vol 318, No. 3, Pages 215-310
http://jama.jamanetwork.com/issue.aspx

Viewpoint
The Role of Patient Engagement in Addressing Parents’ Perceptions About Immunizations
Mary C. Politi, PhD; Katherine M. Jones, MD; Sydney E. Philpott, BS
JAMA. 2017;318(3):237-238. doi:10.1001/jama.2017.7168
Abstract
Vaccines are frequently cited as one of the greatest successes in the history of public health. The World Health Organization estimates that vaccines for diphtheria, pertussis, tetanus, and measles save between 2 million and 3 million lives annually. However, in recent years, parental resistance toward childhood vaccinations has increased.1 Many parents have become concerned and distrusting of scientific evidence about vaccinations. As a result, cases of vaccine-preventable diseases have reemerged in the United States and other countries. Unvaccinated and undervaccinated individuals are susceptible to disease and increase the risk of transmitting diseases even to those who are fully vaccinated.1

The Lancet
Jul 22, 2017 Volume 390 Number 10092 p333-428
http://www.thelancet.com/journals/lancet/issue/current

Editorial
The global HIV/AIDS epidemic—progress and challenges
The Lancet
[See Featured Journal Content above for full text]

The Lancet
Jul 22, 2017 Volume 390 Number 10092 p333-428
http://www.thelancet.com/journals/lancet/issue/current

Articles
Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects: a cluster-randomised controlled trial
Allen Nsangi, Daniel Semakula, Andrew D Oxman, Astrid Austvoll-Dahlgren, Matt Oxman, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Yunpeng Ding, Nelson K Sewankambo
Summary
Background
Claims about what improves or harms our health are ubiquitous. People need to be able to assess the reliability of these claims. We aimed to evaluate an intervention designed to teach primary school children to assess claims about the effects of treatments (ie, any action intended to maintain or improve health).
Methods
In this cluster-randomised controlled trial, we included primary schools in the central region of Uganda that taught year-5 children (aged 10–12 years). We excluded international schools, special needs schools for children with auditory and visual impairments, schools that had participated in user-testing and piloting of the resources, infant and nursery schools, adult education schools, and schools that were difficult for us to access in terms of travel time. We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books, and a teachers’ guide). Teachers attended a 2 day introductory workshop and gave nine 80 min lessons during one school term. The lessons addressed 12 concepts essential to assessing claims about treatment effects and making informed health choices. We did not intervene in the control schools. The primary outcome, measured at the end of the school term, was the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores on the same test. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201606001679337.
Findings
Between April 11, 2016, and June 8, 2016, 2960 schools were assessed for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n=60, 76 teachers and 6383 children) or control group (n=60, 67 teachers and 4430 children). The mean score in the multiple-choice test for the intervention schools was 62·4% (SD 18·8) compared with 43·1% (15·2) for the control schools (adjusted mean difference 20·0%, 95% CI 17·3–22·7; p<0·00001). In the intervention schools, 3967 (69%) of 5753 children achieved a predetermined passing score (≥13 of 24 correct answers) compared with 1186 (27%) of 4430 children in the control schools (adjusted difference 50%, 95% CI 44–55). The intervention was effective for children with different levels of reading skills, but was more effective for children with better reading skills.
Interpretation
The use of the Informed Health Choices primary school learning resources, after an introductory workshop for the teachers, led to a large improvement in the ability of children to assess claims about the effects of treatments. The results show that it is possible to teach primary school children to think critically in schools with large student to teacher ratios and few resources. Future studies should address how to scale up use of the resources, long-term effects, including effects on actual health choices, transferability to other countries, and how to build on this programme with additional primary and secondary school learning resources.
Funding
Research Council of Norway.

The Lancet
Jul 22, 2017 Volume 390 Number 10092 p333-428
http://www.thelancet.com/journals/lancet/issue/current

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess claims about treatment effects: a randomised controlled trial
Daniel Semakula, Allen Nsangi, Andrew D Oxman, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Doris Tove Kristoffersen, Nelson K Sewankambo
Summary
Background
As part of the Informed Health Choices project, we developed a podcast called The Health Choices Programme to help improve the ability of people to assess claims about the benefits and harms of treatments. We aimed to evaluate the effects of the podcast on the ability of parents of primary school children in Uganda to assess claims about the effects of treatments.
Methods
We did this randomised controlled trial in central Uganda. We recruited parents of children aged 10–12 years who were in their fifth year of school at 35 schools that were participating in a linked trial of the Informed Health Choices primary school resources. The parents were randomly allocated (1:1), via a web-based random number generator with block sizes of four and six, to listen to either the Informed Health Choices podcast (intervention group) or typical public service announcements about health issues (control group). Randomisation was stratified by parents’ highest level of formal education attained (primary school, secondary school, or tertiary education) and the allocation of their children’s school in the trial of the primary school resources (intervention vs control). The primary outcome, measured after listening to the entire podcast, was the mean score and the proportion of parents with passing scores on a test with two multiple choice questions for each of nine key concepts essential to assessing claims about treatments (18 questions in total). We did intention-to-treat analyses. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201606001676150.
Findings
We recruited parents between July 21, 2016, and Oct 7, 2016. We randomly assigned 675 parents to the podcast group (n=334) or the public service announcement group (n=341); 561 (83%) participants completed follow-up. The mean score for parents in the podcast group was 67·8% (SD 19·6) compared with 52·4% (17·6) in the control group (adjusted mean difference 15·5%, 95% CI 12·5–18·6; p<0·0001). In the podcast group, 203 (71%) of 288 parents had a predetermined passing score (≥11 of 18 correct answers) compared with 103 (38%) of 273 parents in the control group (adjusted difference 34%, 95% CI 26–41; p<0·0001). No adverse events were reported.
Interpretation
Listening to the Informed Health Choices podcast led to a large improvement in the ability of parents to assess claims about the effects of treatments. Future studies should assess the long-term effects of use of the podcast, the effects on actual health choices and outcomes, and how transferable our findings are to other countries.
Funding
Research Council of Norway.

The Lancet
Jul 22, 2017 Volume 390 Number 10092 p333-428
http://www.thelancet.com/journals/lancet/issue/current

Review
Progress in evidence-based medicine: a quarter century on
Benjamin Djulbegovic, Gordon H Guyatt
Summary
In response to limitations in the understanding and use of published evidence, evidence-based medicine (EBM) began as a movement in the early 1990s. EBM’s initial focus was on educating clinicians in the understanding and use of published literature to optimise clinical care, including the science of systematic reviews. EBM progressed to recognise limitations of evidence alone, and has increasingly stressed the need to combine critical appraisal of the evidence with patient’s values and preferences through shared decision making. In another progress, EBM incorporated and further developed the science of producing trustworthy clinical practice guidelines pioneered by investigators in the 1980s. EBM’s enduring contributions to clinical medicine include placing the practice of medicine on a solid scientific basis, the development of more sophisticated hierarchies of evidence, the recognition of the crucial role of patient values and preferences in clinical decision making, and the development of the methodology for generating trustworthy recommendations.

New England Journal of Medicine
July 20, 2017  Vol. 377 No. 3
http://www.nejm.org/toc/nejm/medical-journal

Original Articles
Enhanced Prophylaxis plus Antiretroviral Therapy for Advanced HIV Infection in Africa
J. Hakim and Others
High mortality is associated with initiation of antiretroviral therapy for HIV. In this report from sub-Saharan Africa, enhanced prophylaxis with isoniazid, fluconazole, azithromycin, and albendazole was associated with decreased mortality at 24 and 48 weeks.

Editorials
The Enduring Challenge of Advanced HIV Infection
N. Ford and M. Doherty
Until recently, progress in the fight against human immunodeficiency virus (HIV) infection was primarily measured in terms of the number of patients who were started on antiretroviral therapy (ART). Major efforts to increase access to ART in the low- and …

PLOS Currents: Disasters
http://currents.plos.org/disasters/
[Accessed 22 July 2017]

Review
[DIS-17-0023] The Enduring Health Challenges of Afghan Immigrants and Refugees in Iran: A Systematic Review
July 21, 2017 ·
Introduction
Iran is the third country in the world with the highest number of registered refugees with the majority coming from Afghanistan. They suffer major health and social risks yet their health status has never been comprehensively determined.
Methods
This systematic review of the literature highlights major disparities among documented immigrants in health access, communicable and non-communicable diseases and the increasingly desperate plight of undocumented immigrants.
Results
Comparing with Iranian population, the findings suggest the higher prevalence of most diseases among Afghan immigrants and refugees. This highlights the importance of increasing the migrants’ access to health services from both public health as well as human rights perspectives.
Discussion
Although the Iranian government has taken new initiatives to overcome this challenge, certain issues have still remained unaddressed. Potential solutions to improve this process are discussed.

Risk Analysis
June 2017 Volume 37, Issue 6  Pages 1039–1207
http://onlinelibrary.wiley.com/doi/10.1111/risa.2017.37.issue-5/issuetoc

Special Issue: Modeling Measles and Rubella Risks, Part II
Special Series Articles
Modeling and Managing the Risks of Measles and Rubella: A Global Perspective Part II (pages 1041–1051)
Kimberly M. Thompson
Version of Record online: 4 MAY 2017 | DOI: 10.1111/risa.12823

Development of a District-Level Programmatic Assessment Tool for Risk of Measles Virus Transmission (pages 1052–1062)
Eugene Lam, W. William Schluter, Balcha G. Masresha, Nadia Teleb, Pamela Bravo-Alcántara, Abigail Shefer, Dragan Jankovic, Jeffrey McFarland, Eltayeb Elfakki, Yoshihiro Takashima, Robert T. Perry, Alya J. Dabbagh, Kaushik Banerjee, Peter M. Strebel and James L. Goodson
Version of Record online: 15 MAY 2015 | DOI: 10.1111/risa.12409

The World Health Organization Measles Programmatic Risk Assessment Tool—Pilot Testing in India, 2014 (pages 1063–1071)
Kapil Goel, Saroj Naithani, Dheeraj Bhatt, Ajay Khera, Umid M. Sharapov, Jennifer L. Kriss, James L. Goodson, Kayla F. Laserson, Parul Goel, R. Mohan Kumar and L. S. Chauhan
Version of Record online: 18 APR 2016 | DOI: 10.1111/risa.12615

Development of the World Health Organization Measles Programmatic Risk Assessment Tool Using Experience from the 2009 Measles Outbreak in Namibia (pages 1072–1081)
Jennifer L. Kriss, Roselina J. De Wee, Eugene Lam, Reinhard Kaiser, Messeret E. Shibeshi, Emmy-Else Ndevaetela, Clementine Muroua, Nicholaus Shapumba, Balcha G. Masresha and James L. Goodson
Version of Record online: 19 FEB 2016 | DOI: 10.1111/risa.12544

Using the World Health Organization Measles Programmatic Risk Assessment Tool for Monitoring of Supplemental Immunization Activities in the Philippines (pages 1082–1095)
Maria Joyce U. Ducusin, Maricel de Quiroz-Castro, Sigrun Roesel, Luzviminda C. Garcia, Dulce Cecilio-Elfa, W. William Schluter, James L. Goodson and Eugene Lam
Version of Record online: 7 MAY 2015 | DOI: 10.1111/risa.12404

The World Health Organization Measles Programmatic Risk Assessment Tool—Romania, 2015 (pages 1096–1107)
Jennifer L. Kriss, Aurora Stanescu, Adriana Pistol, Cassandra Butu and James L. Goodson
Version of Record online: 20 JUL 2016 | DOI: 10.1111/risa.12669

Modeling the Transmission of Measles and Rubella to Support Global Management Policy Analyses and Eradication Investment Cases (pages 1109–1131)
Kimberly M. Thompson and Nima D. Badizadegan
Version of Record online: 31 MAY 2017 | DOI: 10.1111/risa.12831

Science        
21 July 2017 Vol 357, Issue 6348
http://www.sciencemag.org/current.dtl

In Depth U.S. Biomedical Research
NIH redefines clinical trials, attracting critics
Jocelyn Kaiser
A new National Institutes of Health (NIH) policy aimed at boosting the rigor and transparency of clinical trials is triggering concerns among many behavioral scientists. They are worried that the agency’s widening definition of clinical trials could sweep up a broad array of basic science projects studying the human brain and behavior that do not test treatments. The clinical trials designation would impose a raft of new requirements on work that has already passed ethics review, such as different standards for applications submitted for funding, and a mandate to report results on clinicaltrials.gov, a public database. Critics say that would result in wasted resources and public confusion. NIH officials say they are still determining which behavioral studies will be defined as clinical trials.

Science        
21 July 2017 Vol 357, Issue 6348
http://www.sciencemag.org/current.dtl

In Depth
Zika rewrites maternal immunization ethics
By Jon Cohen
Science21 Jul 2017 : 241 Restricted Access
Summary
Pregnant women long have been excluded from vaccine studies because researchers are wary of causing unintended harm to the highly vulnerable developing fetus. But a new report from a group that represents many disciplines contends that ethics demand pregnant women be included in the trial of experimental Zika vaccines, which are designed to protect babies from brain damage and other maladies caused by that mosquito-borne virus. The report is careful to point out that risk/benefit ratios must be weighed for each vaccine and each trial on a case-by-case basis—and indeed the Zika vaccine that has moved furthest in human studies rightly excludes pregnant women, says a co-author of the report. Other experimental maternal immunizations designed to protect babies are also being tested now, and one trial, for a respiratory syncytial virus vaccine, includes pregnant women. A vaccine against group B streptococcus has also moved along the development pipeline and may soon enter trials with pregnant women, too. A second new report on maternal immunizations issued last week explores the challenges of doing safety studies in these women and their babies.

Science        
21 July 2017 Vol 357, Issue 6348
http://www.sciencemag.org/current.dtl

Policy Forum
Promote scientific integrity via journal peer review data
By Carole J. Lee, David Moher
Science21 Jul 2017 : 256-257 Full Access
Publishers must invest, and manage risk
Summary
There is an increasing push by journals to ensure that data and products related to published papers are shared as part of a cultural move to promote transparency, reproducibility, and trust in the scientific literature. Yet few journals commit to evaluating their effectiveness in implementing reporting standards aimed at meeting those goals (1, 2). Similarly, though the vast majority of journals endorse peer review as an approach to ensure trust in the literature, few make their peer review data available to evaluate effectiveness toward achieving concrete measures of quality, including consistency and completeness in meeting reporting standards. Remedying these apparent disconnects is critical for closing the gap between guidance recommendations and actual reporting behavior. We see this as a collective action problem requiring leadership and investment by publishers, who can be incentivized through mechanisms that allow them to manage reputational risk and through continued innovation in journal assessment.

Vaccine
Volume 35, Issue 34, Pages 4295-4450 (3 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/34?sdc=1
Short communication

Persuasive texts for prompting action: Agency assignment in HPV vaccination reminders
Pages 4295-4297
Matthew S. McGlone, Keri K. Stephens, Serena A. Rodriguez, Maria E. Fernandez
Abstract
Vaccination reminders must both inform and persuade, and text messages designed for this purpose must do so in 160 characters or less. We tested a strategy for improving the impact of HPV vaccination text message reminders through strategic wording. In an experiment conducted in community settings, 167 Spanish-speaking Latina mothers reviewed text message reminders that assigned the cause or “agency” for HPV transmission to their daughters or the virus, and assigned protection agency to the mothers or the vaccine. Reminder messages framing transmission as an action of the virus prompted mothers to perceive the threat as more severe than messages describing their daughters as the cause. Assigning transmission agency to the virus also held a persuasive advantage in boosting mothers’ intentions to seek vaccination, particularly when the message cast mothers as agents of protection rather than the vaccine.

Vaccine
Volume 35, Issue 34, Pages 4295-4450 (3 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/34?sdc=1
Short communication

Cost-effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13) in older Australians
Original Research Article
Pages 4307-4314
Dirmesropian, J.G. Wood, C.R. MacIntyre, P. Beutels, P. McIntyre, R. Menzies, J.F. Reyes, C. Chen, A.T. Newall

Abstract
Background
The 23-valent pneumococcal polysaccharide vaccine (PPV23) has been funded under the Australia National Immunisation Program (NIP) since January 2005 for those aged >65 years and other risk groups. In 2016, PCV13 was accepted by the Pharmaceutical Benefits Advisory Committee (PBAC) as a replacement for a single dose of PPV23 in older Australian adults.
Methods
A single-cohort deterministic multi-compartment (Markov) model was developed describing the transition of the population between different invasive and non-invasive pneumococcal disease related health states. We applied a healthcare system perspective with costs (Australian dollars, A$) and health effects (measured in quality adjusted life-years, QALYs) attached to model states and discounted at 5% annually. We explored replacement of PPV23 with PCV13 at 65 years as well as other age based vaccination strategies. Parameter uncertainty was explored using deterministic and probabilistic sensitivity analysis.
Results
In a single cohort, we estimated PCV13 vaccination at the age of 65 years to cost ∼A$11,120,000 and prevent 39 hospitalisations and 6 deaths from invasive pneumococcal disease and 180 hospitalisations and 10 deaths from community acquired pneumonia. The PCV13 program had an incremental cost-effectiveness ratio of ∼A$88,100 per QALY gained when compared to a no-vaccination, whereas PPV23 was ∼A$297,200 per QALY gained. To fall under a cost-effectiveness threshold of A$60,000 per QALY, PCV13 would have to be priced below ∼A$46 per dose. The cost-effectiveness of PCV13 in comparison to PPV23 was ∼A$35,300 per QALY gained.
Conclusion
In comparison to no-vaccination, we found PCV13 use in those aged 65 years was unlikely to be cost-effective unless the vaccine price was below A$46 or a longer duration of protection can be established. However, we found that in comparison to the PPV23, vaccination with PCV13 was cost-effective. This partly reflects the poor value for money estimated for PPV23 use in Australia.

Vaccine
Volume 35, Issue 34, Pages 4295-4450 (3 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/34?sdc=1
Short communication

Shift within age-groups of mumps incidence, hospitalizations and severe complications in a highly vaccinated population. Spain, 1998–2014
Original Research Article
Pages 4339-4345
Noemí López-Perea, Josefa Masa-Calles, María de Viarce Torres de Mier, Aurora Fernández-García, Juan E. Echevarría, Fernando De Ory, María Victoria Martínez de Aragón
Abstract
The mumps vaccine (Jeryl-Lynn-strain) was introduced in Spain in 1981, and a vaccination policy which included a second dose was added in 1995. From 1992–1999, a Rubini-strain based vaccine was administered in many regions but later withdrawn due to lack of effectiveness. Despite high levels of vaccination coverage, epidemics have continued to appear.
We characterized the three epidemic waves of mumps between 1998 and 2014, identifying major changes in susceptible populations using Poisson regression.
For the period 1998–2003 (P1), the most affected group was from 1 to 4 years old (y) [Incidence Rate (IR)=71.7 cases/100,000 population]; in the periods 2004–2009 (P2) and 2010–2014 (P3) IR ratio (IRR) increased among 15–24y (P2=1.46; P3=2.68) and 25–34y (P2=2.17; P3=4.05).
Hospitalization rate (HR), complication rate (CR) and neurological complication rate (NR) among hospitalized subjects decreased across the epidemics, except for 25–34y which increased: HR ratio (HRR) (P2=2.18; P3=2.16), CRR (P3=2.48), NRR (P3=2.41).
In Spain mumps incidence increased, while an overall decrease of hospitalizations and severe complications occurred across the epidemics. Cohorts born during periods of low vaccination coverage and those vaccinated with Rubini-strain were the most affected populations, leading to a shift in mumps cases from children to adolescents and young adults; this also reveals the waning immunity provided by the mumps vaccine. Despite not preventing all mumps cases, the vaccine appears to prevent serious forms of the disease.

Vaccine
Volume 35, Issue 34, Pages 4295-4450 (3 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/34?sdc=1
Short communication

Parents’ concerns about vaccine scheduling in Shanghai, China
Original Research Article
Pages 4362-4367
Abram L. Wagner, Matthew L. Boulton, Xiaodong Sun, Zhuoying Huang, Irene A. Harmsen, Jia Ren, Brian J. Zikmund-Fisher
Abstract
Background
Several new vaccines have been introduced into China in recent years, but some parents in China have shown concerns about the scheduling of vaccinations for young infants. This study explores caregiver concerns about children receiving multiple vaccines during a single visit and about vaccine administration in infants <6 months, and assesses the degree to which these concerns are associated with ratings of the importance of different sources of vaccine information in Shanghai.
Methods
Caregivers of children 8 months to 7 years presenting at immunization clinics in Shanghai completed a survey about vaccine co-administration and vaccine administration <6 months of age. Respondents provided ratings of information from different sources (Internet, family/friends, other parents) and trust in doctors. We analyzed vaccine concerns using linear regression analyses that included these information sources after adjusting for socioeconomic variables.
Results
Among 618 caregivers, 64% were concerned about vaccine co-administration and 31% were concerned about vaccine administration to infants <6 months of age. Higher ratings of Internet as an important source of information were associated with greater concern about co-administration (beta=0.11, 95% CI: 0.00, 0.22) and concern about administration at <6 months of age (beta=0.17, 95% CI: 0.05, 0.28). Higher ratings given to information from other parents corresponded to 0.24 points greater concern about vaccine co-administration (95% CI: 0.04, 0.44). More trust in doctors and ratings of information from friends and family were not associated with vaccine concerns.
Conclusions
Caregiver concerns about vaccine scheduling may limit China’s flexibility to add vaccines to its official immunization schedule. Reporting information about vaccine safety on the Internet and bringing groups of parents together to discuss vaccines might help to ameliorate concerns about vaccine scheduling.

Vaccine Volume 35, Issue 34, Pages 4295-4450 (3 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/34?sdc=1
Short communication

Improving hepatitis B birth dose coverage through village health volunteer training and pregnant women education
Original Research Article
Pages 4396-4401
Xi Li, James Heffelfinger, Eric Wiesen, Sergey Diorditsa, Jayaprakash Valiakolleri, Agnes Bauro Nikuata, Ezekial Nukuro, Beia Tabwaia, Joseph Woodring
Abstract
Hepatitis B is highly endemic in the Republic of Kiribati, while the coverage of timely birth dose vaccination, the primary method shown to prevent mother-to-child transmission of hepatitis B virus, was only 66% in 2014. Children born at home are especially at high risk, as they have limited access to timely birth dose (i.e. within 24 h) vaccination. To improve birth dose coverage, a project to improve linkages between village health volunteers and health workers and educate pregnant women on hepatitis B vaccination was carried out in 16 communities with low birth dose coverage in Kiribati from November 2014 to May 2015. After project completion, the coverage of timely birth dose administration increased significantly both in the densely populated capital region of South Tarawa (from 89% to 95%, p=0.001) and the Outer Islands (from 57% to 83%, p<0.001). The coverage of timely birth dose administration among infants born at home increased significantly from 70% to 84% in South Tarawa (p=0.001) and from 49% to 75% in the Outer Islands (p<0.001). Timely birth dose was associated with being born in a hospital, being born during the study period and caregivers having developed an antenatal birth dose plan. The project demonstrates a successful model for improving hepatitis B vaccine birth dose coverage that could be adopted in other areas in Kiribati as well as other similar settings.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 22 July 2017)

Review
Egg-Independent Influenza Vaccines and Vaccine Candidates
by Ilaria Manini, Claudia Maria Trombetta, Giacomo Lazzeri, Teresa Pozzi, Stefania Rossi and Emanuele Montomoli
Vaccines 2017, 5(3), 18; doi:10.3390/vaccines5030018 – 18 July 2017
Abstract
Vaccination remains the principal way to control seasonal infections and is the most effective method of reducing influenza-associated morbidity and mortality. Since the 1940s, the main method of producing influenza vaccines has been an egg-based production process. However, in the event of a pandemic, this method has a significant limitation, as the time lag from strain isolation to final dose formulation and validation is six months. Indeed, production in eggs is a relatively slow process and production yields are both unpredictable and highly variable from strain to strain. In particular, if the next influenza pandemic were to arise from an avian influenza virus, and thus reduce the egg-laying hen population, there would be a shortage of embryonated eggs available for vaccine manufacturing. Although the production of egg-derived vaccines will continue, new technological developments have generated a cell-culture-based influenza vaccine and other more recent platforms, such as synthetic influenza vaccines

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

International Journal of Health Governance
Volume 22 Issue 2 2017
http://www.emeraldinsight.com/toc/ijhg/22/2
Articles
A review of policy, practices, and players governing and involved in the United States vaccine and immunization enterprise
Angela K Shen, Alice Y. Tsai, Gus Birkhead
Abstract:
Purpose
This paper outlines the organization and governance of the U.S. vaccine and immunization enterprise. It describes the major components of the U.S. system including the various relationships between major federal government entities, stakeholders, and advisory committees that inform government policymaking at various points in the system.
Design/methodology/approach
We describe the complex interdependent network of partners that engage in a wide range of activities such as disease surveillance, research, vaccine development, regulatory licensure, practice recommendations, financing, service delivery, communications and post-licensure monitoring.
Findings
The U.S. system of governance is highly participatory and focuses on a transparent and open engagement, with input from a wide range of partners to inform decision-making. This collaborative framework allows many inputs to be heard and helps support the U.S. vaccine and immunization system as it evolves to meet the continued public health needs in the U.S. through the optimal use of safe and effective vaccines.
Originality/value
Invited article on the US vaccine and immunization enterprise. The development and availability of vaccines in the United States has had profound impact on mortality and morbidity and public health (Centers for Disease Control & Prevention, 2011). The success of this enterprise is a result of a blended public and private sector system with partnerships at the federal, state and local levels of government to optimize the use of safe and effective vaccines. Governance structures have been established to support the interaction and decision-making among the federal and non-federal actors toward the common goal of controlling and preventing infectious diseases.

Open Forum Infectious Diseases
Published: 18 July 2017
Vaccine rejection and hesitancy: a review and call to action
TC Smith –
Abstract
Vaccine refusal has been a recurring story in the media for well over a decade. Though there is scant evidence that refusal is genuinely increasing in the population, multiple studies have demonstrated concerning patterns of decline of confidence in vaccines, the medical professionals who administer vaccines, and the scientists who study and develop vaccines. As specialists in microbiology, immunology, and infectious diseases, scientists are content experts but often lack the direct contact with individuals considering vaccination for themselves or their children that healthcare professionals have daily. This review examines the arguments and players in the United States anti-vaccination scene, and discusses ways that experts in infectious diseases can become more active in promoting vaccination to friends, family, and the public at large.

Current Opinion in Infectious Diseases
Post Author Corrections: July 14, 2017
Dengue vaccines: implications for dengue control
Robinson, Matthew L.; Durbin, Anna P.
Abstract
Purpose of review: Dengue, the most common arbovirus, is an increasingly significant cause of morbidity worldwide. After decades of research, an approved tetravalent dengue vaccine is finally available. Models constructed using recently available vaccine efficacy data allow for a data-driven discussion of the potential impact of dengue vaccine deployment on global control.
Recent findings: Phase 3 efficacy trials demonstrated that the approved dengue vaccine, chimeric yellow fever-dengue-tetravalent dengue vaccine, has an efficacy of 60% against dengue illness of any severity. However, among dengue unexposed recipients, vaccination offers limited efficacy and may increase dengue severity. The WHO consequently recommends dengue vaccination for populations in which 70% of intended recipients are dengue seropositive. Models predict that routine childhood dengue vaccine may reduce dengue burden, but over time, population-level impact may be limited. Additional vaccine candidates in late-stage development may not suffer from the same limitations as chimeric yellow fever-dengue-tetravalent dengue vaccine.
Summary: The efficacy and safety profile of the recently approved dengue vaccine is favorable only in previously dengue exposed recipients, which limits its potential for global control. Future work must evaluate the approved vaccine’s long-term durability, efficacy of other late phase vaccine candidates, and potential for vector control efforts to work synergistically with vaccine deployment.

Cold Spring Harbor Perspectives in Biology
http://cshperspectives.cshlp.org/content/early/recent
Early Release Articles Last updated July 17, 2017
Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: The Path to a Dengue Vaccine: Learning from Human Natural Dengue Infection Studies and Vaccine Trials
Aravinda M. de Silva and Eva Harris
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a029371
Abstract
Dengue virus (DENV) is the most common arthropod-borne viral disease of humans. Although effective vaccines exist against other flaviviral diseases like yellow fever and Japanese encephalitis, dengue vaccine development is complicated by the presence of four virus serotypes and the possibility of partial immunity enhancing dengue disease severity. Several live attenuated dengue vaccines are being tested in human clinical trials. Initial results are mixed, with variable efficacy depending on DENV serotype and previous DENV exposure. Here, we highlight recent discoveries about the human antibody response to DENV and propose guidelines for advancing development of safe and effective dengue vaccines.
 
Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: Questions Raised by the Development and Implementation of Dengue Vaccines: Example of the Sanofi Pasteur Tetravalent Dengue Vaccine
Bruno Guy
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a029462
Abstract
Dengue is a still-growing public health concern in many tropical and subtropical regions of the world. The development and implementation of an effective dengue vaccine in these regions is a high priority. This insight focuses on the expected characteristics of a safe and efficacious vaccine, referring to the clinical experience obtained during the development of the first tetravalent dengue vaccine from Sanofi Pasteur, now licensed in several endemic countries. Safety and efficacy data from both short- and long-term follow-up of large-scale efficacy studies will be discussed, as well as the next steps following vaccine introduction.

Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: There Is Only One True Winner
Scott B. Halstead
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a030700
Abstract
The scientific community now possesses information obtained directly from human beings that makes it possible to understand why breakthrough-enhanced dengue virus (DENV) infections occurred in children receiving Sanofi Pasteur’s Dengvaxia tetravalent live attenuated vaccine and to predict the possibility of breakthrough-enhanced DENV infections following immunization with two other tetravalent live attenuated vaccines now in phase III testing. Based upon recent research, Dengvaxia, lacking DENV nonstructural protein antigens, did not protect seronegatives because it failed to raise a competent T-cell response and/or antibodies to NS1. It is also possible that chimeric structure does not present the correct virion conformation permitting the development of protective neutralizing antibodies. A premonitory signal shared by the Sanofi Pasteur and the Takeda vaccines was the failure of fully immunized subhuman primates to prevent low-level viremia and/or anamnestic antibody responses to live DENV challenge. The vaccine developed by the National Institute of Allergy and Infectious Diseases (National Institutes of Health [NIH]) has met virtually all of the goals needed to demonstrate preclinical efficacy and safety for humans. Each monovalent vaccine was comprehensively studied for reactogenicity and immunogenicity in human volunteers. Protective immunity in subjects receiving tetravalent candidate vaccines was evidenced by the fact that when vaccinated subjects were given further doses of vaccine or different strains of DENV the result was “solid immunity,” a nonviremic and nonanamnestic immune response.

Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: The Risks of Incomplete Immunity to Dengue Virus Revealed by Vaccination
Stephen S. Whitehead and Kanta Subbarao
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a028811
Abstract
Immune enhancement of dengue disease continues to be a concern for those with incomplete immunity in endemic areas. Advanced testing and follow-up of a newly available live attenuated dengue vaccine has recently shown the ability of vaccination to predispose some recipients for a severe outcome on subsequent infection. To improve safety, recommendations have been made to restrict use of the vaccine to those who are likely to have had prior exposure to dengue virus (DENV). Researchers continue to investigate dengue immunity and seek evidence that dengue vaccines can be safely administered to all populations needing protection.

Immune Memory and Vaccines: Great Debates – Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination?: The Challenges of a Dengue Vaccine
Gavin Screaton and Juthathip Mongkolsapaya
Cold Spring Harb Perspect Biol doi:10.1101/cshperspect.a029520
Abstract
A dengue vaccine has been pursued for more than 50 years and, unlike other flaviviral vaccines such as that against yellow fever, progress has been slow. In this review, we describe progress toward the first licensed dengue vaccine Dengvaxia, which does not give complete protection against disease. The antibody response to the dengue virion is reviewed, highlighting immunodominant yet poorly neutralizing responses in the context of a highly dynamic structurally flexible dengue virus particle. Finally, we review recent evidence for cross-reactivity between antibody responses to Zika and dengue viruses, which may further complicate the development of broadly protective dengue virus vaccines.

Media/Policy Watch

This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations 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.
 
Forbes
http://www.forbes.com/
Accessed 22 July 2017
When The Drug You Need Doesn’t Make Money
Jul 18, 2017
Alison Bateman-House, Contributor
What do we do when there is no market incentive to create a drug that benefits patients?

New York Times
http://www.nytimes.com/
Accessed 22 July 2017
U.N. Hopes for Lull in Syria Battles With Islamic State for Polio Campaign
19 July 2017
GENEVA — The United Nations is hoping that battles against Islamic State in Syria will calm sufficiently for it to carry out a vaccination drive against polio, starting on Saturday, U.N. agencies said on Wednesday.
The World Health Organization is trying to eradicate polio globally, so the 27 cases of the crippling childhood disease that have surfaced around the Syrian battlefields of Deir al-Zor and Raqqa represent a small but crucial setback.
The United Nations is “in communication with all parties in Deir al-Zor and Raqqa regarding ceasefire days” to allow the vaccination campaign to go ahead, the United Nations’ children’s agency UNICEF said in a polio situation report.
It did not say whether the United Nations was talking directly to Islamic State fighters, who are under assault by U.S.-backed forces in Raqqa city and besieging Syrian government forces in Deir al-Zor, nor did it say if any party had agreed to observe a ceasefire on any part of the battlefield.
Other U.N. agencies confirmed the hope of carrying out vaccinations…

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 22 July 2017
New CDC Chief Lays Out Priorities as Agency Faces Cuts
By Betsy McKay
July 16, 2017 4:25 pm ET
Brenda Fitzgerald, the new director of the Centers for Disease Control and Prevention said she will prioritize a wide range of public health issues, from fighting infectious disease to strengthening early-childhood development.

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_15 July 2017

– blog edition: comprised of the approx. 35+ entries posted below.

– 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.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Milestones :: Perspectives
 
Gavi Board reappoints Chair and CEO
Dr Ngozi Okonjo-Iweala and Dr Seth Berkley to help further protect millions of children from vaccine-preventable diseases
Geneva, 10 July 2017 – Dr Ngozi Okonjo-Iweala and Dr Seth Berkley have been unanimously reappointed Chair of the Gavi Alliance Board and Chief Executive Officer of Gavi, the Vaccine Alliance for three and four year terms, respectively.
Since her appointment in 2016, Dr Ngozi Okonjo-Iweala’s leadership has enabled the Alliance to further its engagement with developing countries and for partners to scale-up and finance immunisation programmes, while fostering public-private initiatives to improve access to healthcare for those most in need. Dr Okonjo-Iweala has also been an instrumental advocate for the positive economic benefits of vaccination. The direction she has provided to the Gavi Board has been critical in the implementation of the Gavi 2016-2020 strategy, which aims to support the vaccination of a further 300 million children against life-threatening diseases, preventing 5 to 6 million deaths.
“I am greatly honoured by the confidence the Gavi Alliance Board has placed in me and as Chair of the Board I am excited to be given the opportunity to continue to dedicate my work to that greatest purpose of protecting the lives of millions of the poorest children in the world with life-saving vaccines,” said Dr Ngozi Okonjo-Iweala. “Universal access to immunisation will play a fundamental role in bringing about healthy, resilient populations and in ensuring that we develop stronger economies as we face the challenges of the next century.”…
“I am extremely humbled and proud to have received the support of the entire Gavi Board,” said Dr Seth Berkley. “We are now entering a critical period for Gavi as we approach the mid-point of the 2016-2020 strategic period and as programme implementation reaches its peak. At the same time, Gavi is launching its mid-term review (MTR) process, the first milestone towards the next replenishment. I look forward to working together with partners to define our next strategy and achieve Gavi’s goal of providing equal access to life-saving vaccines.”
These reappointments follow an extensive performance review which drew on the excellent results of both individuals, as well as, in the case of the CEO, the performance of the Gavi Alliance since his appointment.
Appointment of Gunilla Carlsson as Vice-Chair of the Gavi Board
The Gavi Board has also appointed Gunilla Carlsson, former Swedish Minister for International Development Cooperation, as the new Vice-Chair of the Board. Ms Carlsson replaces Dr Flavia Bustreo, World Health Organization Assistant Director-General for Family, Women’s and Children’s Health.
Ms Carlsson joined the Gavi Board before the 2015 replenishment meeting in Berlin after playing a major role in supporting the Gavi replenishment event in London in 2011. Her extensive experience in domestic, European Union and international politics and negotiations, as well as in policy reform implementation and in mechanisms for ensuring both efficiency and accountability in complex organisations, will be crucial for the Gavi in the coming years.
Dr Flavia Bustreo who remains a Board member, was appointed Vice-Chair in January 2015…
 
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Editor’s Note:
We include the full text of the G20 speech by Dr Tedros Adhanom Ghebreyesus. To our understanding, this is the first major international address by the new WHO DG.
 
Health emergencies represent some of the greatest risks to the global economy and security
Remarks delivered by Dr Tedros Adhanom Ghebreyesus to G20 8 July 2017
Hamburg, Germany
…
It’s really a great privilege for me to be with you today to discuss the critical health threats facing our world today. And I thank you, Chancellor Merkel for your leadership in putting health on the G20 agenda and for the successful emergency simulation exercise which we have seen with health ministers in Berlin in May.

I think the exercise, as has been said, highlighted two major things among others: number one is that pandemics of infectious diseases and other threats to health, such as anti-microbial resistance, transcend borders and national interests, so vulnerability for one is vulnerability for all of us. And viruses actually do not know or do not respect borders.

And the second thing from the exercise that we found out is that we are not well prepared. That we are very often reactive rather than proactive. Therefore we require a strong global response- that we need to remain connected in our inter-connected world.

The reason we ask you to support global health is because we want to support you, you the leaders, to achieve your goals. Because pandemics, health emergencies and weak health systems not only cost lives but represent some of the greatest risks to the global economy and security that we face today.

And we know what happened as has been said with Spanish flu in 1918: more than 50 million people died.

And the SARS outbreak cost the world economy around US$ 60billion.

We have seen bird flu, MERS, Zika. Now. Cholera, Yellow Fever are back in force. WHO detects around 3000 signals a month but the world actually knows very few of them.

We do not know where the next global pandemic will occur, we don’t know when it will occur, but it will be costly in lives and dollars. With airline travel (3 billion travellers every year) global spread of any new pathogen would occur in hours. As well as untold human suffering, the economic losses would be measured in trillions,-including the losses of tourism, trade, consumer confidence and also including political problems and challenges. There will be 2 epidemics – one caused by the virus, and the other one caused by fear.

During the Ebola outbreak of 2014 in West Africa, WHO and the global community had to confront a tough reality that had left the world unprepared-what Jim Kim, the President of the World Bank calls the cycle of panic and neglect. At the height of outbreaks, we are galvanized but we quickly lose focus. Our world cannot afford this vicious cycle to continue.

The Ebola outbreak has also taught us another lesson. Our global system is only as strong as its weakest link. We must address the root causes of this problem: the lack of access of the most vulnerable people to health care, especially primary health care.

Universal health coverage and health security are the two sides of the same coin. This year, 400 million people, that is 1 out of 17, mostly poor people, women and children, around the world remain without access to health care. Strong health systems will not only be our best defence but will also be critical for attaining the SDGs.

So we propose 4 ways forward which we actually all know.
Number one is sustainably financing the global health security system to prevent, detect and respond to emerging threats, whether natural or man-made. Ensuring a guaranteed level of contingency financing for outbreaks and emergencies would be a great start.

And the second is mapping all the capacities we have can help us to move forward, mapping all capacities in countries and use them in a coordinated manner, based on their comparative advantage to strengthen preparedness.

And the third recommendation is to support the goal of Universal Health Coverage in line with the SDGs. This is the strategic solution actually, to prevent epidemics and provide quality care to our people by strengthening health systems of countries, especially in the most fragile and vulnerable parts of our world.

And number four, prioritize research and development of new medical counter-measures through the Research and Development Blueprint of the World Health Organization. WHO strongly supports the German proposal to establish the Global Collaboration Hub on Antimicrobial resistance research and development.

Delivering on these priorities will cost money but only a fraction of what remaining unprepared will cost.

WHO is prepared to fully play its leadership role. And together we need to take the responsibility of making the world a healthier and safer place. It’s possible and it’s in our hands.
Thank you.

::::::
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Announcement on the passing of Olga Popova
12 July2017
by Johan Van Hoof, Global Head, Infectious Diseases & Vaccines, Janssen; Managing Director, Janssen Vaccines & Prevention B.V.
Dear all,
I am sorry to have to share some very sad news today. Olga Popova, Janssen’s Head of Global Vaccine Policy & Partnerships and member of the company’s Vaccines Leadership Team, passed away on Monday after fighting a brave battle with cancer.

Olga joined Janssen Vaccines in 2007 to lead the Government Affairs group. Since then, she directed international policy development for Janssen and was a true thought leader, helping to shape Janssen’s public policy priorities, perspectives and contributions on vaccine development and pandemic preparedness issues. Olga oversaw our relationships and ongoing dialogue with numerous international stakeholders, such as the WHO and GAVI Alliance, major philanthropic foundations, and many industry associations such as IFPMA.

Olga was always very committed to the development and implementation of life-saving vaccination programs, especially for children. She provided expert ongoing counsel to the Board of GAVI, including to support the organization’s replenishment campaign with the goal of immunizing an additional 300 million children in developing countries by 2020. And she was one of the leaders of Janssen’s Quinvaxem program, for which we are immensely grateful for her invaluable contribution.

Perhaps most notably, Olga was a driving force when Johnson & Johnson, through its Janssen Pharmaceutical Companies, accelerated the development of our Ebola vaccine at the height of the 2014 Ebola outbreak. She played an instrumental role in forging and maintaining our relationships with key global partners, including WHO, the European Commission and the Innovative Medicines Initiative. These partnerships, and Olga’s tireless work in support of them, were critical in accelerating the development of our Ebola vaccine.

Beyond these many professional achievements, Olga was a true public champion for vaccines. She shared – proudly and with pictures – that she had her daughter vaccinated. Her dedication to the public health value of vaccines was inspiring.

Above all, we will remember Olga as a very positive, warm person and a great person. She was widely esteemed as a passionate, energetic leader and champion for people in developing nations. Her vibrant embrace of every opportunity and challenge made her a joy to work with, and she will be sorely missed by all of us who had that privilege.

Olga’s funeral was held yesterday in Calabria, Italy. Our deepest condolences and thoughts go out to her family and young daughter.

If you would like to express your own personal condolences, you may reply to me ta-tibbe-frthdejvh1@its.jnj.com and we will be sure to include your thoughts in a condolence book from Janssen that we will ultimately share with Olga’s family.

Olga was an exceptional colleague with many talents, a great ambassador for us at many international organizations and a great human being. She will be missed dearly.

Emergencies
 
Yemen – Cholera – OCV
Editor’s Note:
   We have been monitoring the cholera outbreak in Yemen [currently the globe’s largest] for some time, with particular focus on the recent decision to allocate 1 million doses of OCV from the global stockpile for deployment in country. It has been unclear what the status of that deployment might be, and what review and decision processes might be underway as the volume of suspected cases and fatalities have continued to mount.
  We provide below a chronological sample of information and characterizations from WHO, other agencies, and the media on the status of the cholera epidemic and the OCV allocated to help address it. 
  We will continue to monitor this, noting the shifting narratives below, the absence of any posted information or announcement about the OCV decisions, and that no mention of the OCV intervention was included in the new WHO DG’s presentation on Yemen to the Security Council [see below].
 
10 July 2017
UN OCHA – L3 Emergencies Yemen
:: Key messages on cholera (10 July 2017)
Yemen, the world’s largest food security crisis, is now facing the world’s worst cholera outbreak which in the span of two months has spread to the entire country except for one governorate….
[No mention of OCV]
10 July 2017
WHO and partners, including UNICEF, scale up efforts to minimize spread of acute watery diarrhoea/cholera in the Eastern Mediterranean Region
10 July 2017 – With increasing numbers of people in some countries of the World Health Organization’s Eastern Mediterranean Region affected by acute watery diarrhoea and cholera, WHO in the Region is working with partners, including UNICEF, to save lives in areas where outbreaks are active, and reduce the risk of these diseases crossing into unaffected areas and neighbouring countries.
“The situation has reached a critical point. The number of people with acute watery diarrhoea/cholera in countries in the Region in 2017 alone is higher than the number of people affected worldwide in 2016. Infectious diseases know no borders, and can quickly spread if they are not effectively contained. As the numbers of cases grow day by day, it is imperative that we exert all efforts to make sure populations in cholera-endemic countries and neighbouring countries are protected,” said Dr Mahmoud Fikri, WHO Regional Director for the Eastern Mediterranean.
Population movement is increasing the risk of epidemic-prone diseases crossing into unaffected areas. In Somalia, the cholera outbreak has spread to the northern region, which had previously been cholera-free for more than 10 years. In Sudan, cases of acute watery diarrhoea have appeared for the first time in camps hosting internally displaced Sudanese in Darfur. Increasing numbers of people are expected to be affected during the current high season for transmission of waterborne disease due to deteriorating humanitarian conditions and lack of access to safe water and sanitation.  Acute watery diarrhoea/cholera are easily treatable, but can be life-threatening without immediate medical care. National health authorities in affected countries, supported by WHO and partners, are responding to the current outbreaks through disease surveillance for the early detection of cases, improving case management and infection control through the establishment of treatment centres, improving and monitoring water quality, providing medicines and supplies, introducing the oral cholera vaccine, and promoting safe hygiene practices in communities.
WHO and UNICEF co-hosted a sub-regional meeting region from 8 to 9 July 2017 in Beirut, Lebanon, on scaling up preparedness and response to acute watery diarrhoea/cholera in the Region. The meeting was attended by health officials from affected and neighbouring countries, as well as key partners involved in the health response.
A regional roadmap was developed during the meeting focusing on the areas of (a) strengthening coordination at sub-national level; (b) enhancing integrated, multi-sector rapid response teams in affected areas; (c) decentralising and expanding laboratory testing; (d) reinforcing guidelines for case management and infection prevention and control; (e) scaling up water and sanitation activities at household level; and
(f) enhancing risk communications at community level.

In line with the International Health Regulations (IHR 2005), WHO will also work closely with neighbouring countries to reinforce disease surveillance, laboratory and preparedness capacity, including at Points of Entry, to rapidly detect potential cases and ensure that all suspected acute watery diarrhoea/cholera cases are referred to appropriate health facilities.

11 July 2017
Geneva Press Briefing: UNHCR, OCHA, UNICEF, ITU, ILO, IOM, WHO,  TUESDAY, 11 JULY 2017
[Video: 01:09:01]
WHO – Christian Lindmeier [at approx.. 59:00 – 01:09; Editor’s excerpts as no transcript of the press briefing has been posted]
Reporter: Follow up on [OCV] vaccines for Yemen, what is status?
Response: Government still deciding…likelihood that OCV will not be used…OCV will likely be re-routed to other settings where they might be used more effectively…

Reporter: Wait…A number of agencies had been working on this…it was clear from you [WHO] and other agencies that these vaccines were going there…vaccines are staged…what has changed?
Response: Yemen a “complex situation” with regard to cholera…outbreak is at different stages in different districts…it’s a race against the clock…can’t plan a campaign like a normal country…security situation difficult…also, huge volume of vaccines…cold chain issues right to point of use…also now in middle of an outbreak…need to get ahead of the curve…makes no sense now…must get ahead of the situation to make best use of OCV…logistically a huge effort…

Reporter: Follow-up – We are talking about 300,000 cases…many deaths…what might you have done differently…
Response:  Too early to speculate…volatile situation…
 
11 July 2017
U.N. Suspending Plan for Cholera Vaccination in Yemen
New York Times, July 11, 2017 – By NICK CUMMING-BRUCE and RICK GLADSTONE
United Nations officials said a cholera vaccination campaign no longer made sense in Yemen because the war would make the effort difficult.
GENEVA — The United Nations said on Tuesday that it was suspending plans for a cholera vaccination campaign in Yemen — reversing a decision made a month ago — because the disease’s rampant spread and the ravages of war there would make such an effort ineffective.
Jamie McGoldrick, the United Nations aid coordinator in Yemen, said plans for preventive vaccination were being “set aside.” He attributed the change to obstacles in delivering vaccines in the middle of a conflict that has crippled the country’s health system and hampered access to some areas threatened by the contagious disease.
Christian Lindmeier, a spokesman for the World Health Organization, told reporters the vaccine doses originally designated for shipment to Yemen would probably be sent to other countries threatened by cholera, where they could be used more effectively.
The surprise disclosure, made at a regular news briefing at the United Nations headquarters in Geneva, came as the number of Yemenis afflicted with cholera reached 313,000 and the death toll exceeded 1,700…
… A vaccination effort in Yemen, Mr. Lindmeier said, is a “difficult approach because you can’t plan a campaign like you would do in a normal country” where war and insecurity are absent…
 
 
12 July 2017
The situation in the Middle East (Yemen) – Security Council, 7999th meeting – 12 Jul 2017 – 
[Video: 1:09:43]
WHO DG Tedros Report [at approx. 24:00 – 30:00]
No mention of OCV

Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, Stephen O’Brien: Statement to the Security Council on Yemen, 12 July 2017
[Excerpts]
… Nearly 16 million people do not have access to adequate water, sanitation and hygiene, and more than 320,000 suspected cholera cases have been reported in all of the country’s governorates bar one. At least 1,740 people already are known to have died from this entirely preventable disease – probably many more in the many very remote areas of Yemen we can’t reach….
…This cholera scandal is entirely manmade by the conflicting parties and those beyond Yemen’s borders who are leading, supplying, fighting and perpetuating the fear and fighting…
…Just for the sake of reaching all the millions of Yemenis with cholera vaccines, so desperately needed, the people of Yemen need stability. Failure to do so renders their fate, and our – and your – ability to intervene useless and hopeless. We should all feel deeply guilty about that – and especially the conflicting parties in Yemen should do so and those who drive them from outside Yemen. Our joint – your –top common priority should be always to save civilian lives and protect them. The Yemeni people deserve this equally to any other citizen of the world – be it one of you around this table or someone cowering in fear somewhere in Sana’a or Taizz in Yemen…
 
 
14 July 2017
Geneva Press Briefing: WHO, OHCHR, UNHCR, IOM – 14 Jul 2017 
Biweekly Geneva Press Briefing Chaired by Alessandra Vellucci, Director of the United Nations Information Service in Geneva
[Video: 1:09:03]
Dominic LeGros, WHO focal point for cholera [at approx 04:40 to 22:00; Editor’s excerpts as no transcript of the press briefing has been posted]
:: Began by relating the status of a number of other cholera outbreaks underway globally.
:: Referenced October 2017 meeting as call for action to address recurring cholera outbreaks…notes that solution is not a technical issue…a matter of engagement/political will by countries and development donors.

Reporter: Could you elaborate on thinking behind not proceeding with selected OCV vaccinations?
Response: Decisions made by Yemeni authorities to delay. We understand that decision… outbreak is so mature in Yemen…difficult to find districts where OCV could make maximum contribution. 43 OCV campaigns since formation of stockpile. Also, need resources for classic response strategies [WASH]…

Reporter: Follow up…so, effectively, was the window of opportunity to use the vaccine [OCV] missed at some point in the past?
Response: Dealing with a country that so far did not choose the vaccine…[OCV] is a new strategy, new tool…we have seen this kind of delay in decision to use. The other fact is that epidemic is moving very fast there so difficult to project course…

14 July 2017
Vaccine deployment for cholera suspended in Yemen
By Daniella Emanuel, CNN
Updated 9:29 AM ET, Fri July 14, 2017
(CNN)The cholera outbreak in Yemen is spreading so quickly that plans have been suspended to deploy one million doses of vaccines to the country, according to the World Health Organization.
The number of suspected cases affected by the outbreak is now more than 325,000. Cholera is an acute diarrheal illness which kills thousands of people worldwide each year.
“The situation has evolved so rapidly that vaccines are not the priority tool to use right now,” Tarik Jasarevic, WHO spokesperson, said in an email.
“Now that cholera has spread to 91% of Yemen’s governorates, the focus will instead be on scaling up other interventions that will have a greater effect on the evolution of the outbreak and save lives.”
Those interventions include scaling up access to clean water and sanitation, treatment to people affected and working with communities to promote hygiene, sanitation and cholera prevention, explained Jasarevic.
The one million doses of vaccine were initially approved by the International Coordinating Group, an organization established in 1997 with the purpose of managing and coordinating the use of emergency vaccine supplies and antibiotics to countries in the midst of major outbreaks, according to WHO.
The one million doses of vaccine were initially approved by the International Coordinating Group, an organization established in 1997 with the purpose of managing and coordinating the use of emergency vaccine supplies and antibiotics to countries in the midst of major outbreaks, according to WHO.
Five hundred thousand doses were shipped to Djibouti in East Africa because of the country’s close proximity to Yemen, Jasarevic said. The country is across the Bab al-Mandab Strait from Yemen.
The vaccines are still there, and they may be shipped to another country for use, he said.
“The decision to suspend was taken by the Yemeni authorities in consultation with the technical teams that are working on cholera from the United Nations side,” said George Khoury, Head of Office at the UN Office for the Coordination of Humanitarian Affairs in Yemen.
WHO confirmed that they and other partners were consulted on the decision. They serve as advisers to the Yemen health authorities on vaccines and other interventions related to the ongoing cholera outbreak in the country, Jasarevic said.
“It was decided by the professionals that all the risks and the potential problems may outweigh the benefits of administering the vaccine,” Khoury said. “Given the limited number of vaccines, administering the vaccines in some areas and not others may create disputes on who gets and who doesn’t get the vaccine…

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POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 12 July 2017 [GPEI]
:: At the G20 Head of State Summit in Hamburg, Germany, last weekend, leaders acknowledged the efforts to eradicate and committed to completing the job of polio eradication.  More.

:: Journal of Infectious Diseases publishes supplement of articles on polio endgame and legacy implementation lessons learned and best practices. [see below]

:: The Global Certification Commission for the Eradication of Poliomyelitis (GCC) met on 4-5 July in Paris, France.  This was the 16th meeting of the GCC, and the first under the group’s new Chair, Professor David Salisbury from the UK, following the retirement of the previous Chair Professor Tony Adams from Australia.  The meeting was attended by all six Regional Certification Committee (RCC) Chairs, along with partners of the Global Polio Eradication Initiative (GPEI).

:: In Syria, one of the previously-reported cases from Raqua, on re-testing, has been confirmed as negative for circulating vaccine-derived poliovirus type 2 (cVDPV2), and has been removed from the list of cases.  The total number of cVDPV2 cases is now 23 (22 from Deir-Al-Zour and one from Raqua).

:: The Pakistan and Afghanistan National Emergency Operation Centre teams convened a coordination meeting in Amman, Jordan, on 10–11 July.  A joint response plan was put together for new wild poliovirus type 1 (WPV1) cases / isolates in the southern corridor (comprising Quetta Block / Greater Kandahar). The teams also reviewed the situation in the greater Peshawar / Nangarhar and South East Afghanistan / Southern KP-FATA Corridors and agreed on further actions to improve the quality of immunization activities and surveillance with special focus on high-risk mobile populations.

:: Summary of newly-reported viruses this week:  Pakistan – one new wild poliovirus type 1 (WPV1) isolated from an acute flaccid paralysis case; Afghanistan – one new WPV1-positive environmental sample.  See country-specific section below, for more details.

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Journal of Infectious Disease
Volume 216, Issue suppl_1  1 July 2017
https://academic.oup.com/jid/issue/216/suppl_1
Polio Endgame & Legacy-Implementation, Best Practices, and Lessons Learned
49 articles focused on themes including:
:: STRATEGY AND COORDINATION
:: IPV INTRODUCTION AND THE SWITCH
:: STRENGTHENING IMMUNIZATION SERVICES
:: POLIO TRANSITION
EDITORS’ INTRODUCTION
Addressing the Challenges and Opportunities of the Polio Endgame: Lessons for the Future
Manish Patel; Stephen Cochi
Abstract
The Global Commission for the Certification of the Eradication of Poliomyelitis certified the eradication of type 2 poliovirus in September 2015, making type 2 poliovirus the first human pathogen to be eradicated since smallpox. The eradication of type 2 poliovirus, the absence of detection of type 3 poliovirus worldwide since November 2012, and cornering type 1 poliovirus to only a few geographic areas of 3 countries has enabled implementation of the endgame of polio eradication which calls for a phased withdrawal of oral polio vaccine beginning with the type 2 component, introduction of inactivated poliovirus vaccine, strengthening of routine immunization in countries with extensive polio resources, and initiating activities to transition polio resources, program experience, and lessons learned to other global health initiatives. This supplement focuses on efforts by global partners to successfully launch polio endgame activities to permanently secure and sustain the enormous gains of polio eradication forever.
 
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WHO Grade 3 Emergencies  [to 15 July 2017]
Yemen –
::  YEMEN: cholera outbreak – Daily epidemiology update: 15 July 2017
Highlights
From 27 April to 14 July 2017, 338 969 suspected cholera cases and 1 770 deaths (CFR: 0.5%)
have been reported in 91.3% (21/23) of Yemen governorates, and 87.7% (292/333) of the
districts.

Iraq  – No new announcements identified.
Nigeria – No new announcements identified.
South Sudan – No new announcements identified.
The Syrian Arab Republic – No new announcements identified.
 
 
WHO Grade 2 Emergencies  [to 15 July 2017]
Cameroon  – No new announcements identified
Central African Republic  – No new announcements identified. 
Democratic Republic of the Congo – No new announcements identified
Ethiopia – No new announcements identified.
Libya – No new announcements identified.
Myanmar – No new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
 
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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Iraq: Mosul Humanitarian Response Situation Report No. 39 (29 June to 11 July 2017)
:: Humanitarian funding is urgently required to assist 700,000 civilians displaced from Mosul [EN/AR/KU]
(Baghdad, 9 July 2017) – Since the military campaign to retake Mosul began on 17 October 2016, 920,000 civilians have fled their homes. Close to 700,000 people are still displaced, nearly half of whom are living in 19 emergency camps.
“It’s a relief to know that the military campaign in Mosul is ending. The fighting may be over, but the humanitarian crisis is not,” said the Humanitarian Coordinator for Iraq, Ms. Lise Grande.
“Many of the people who have fled have lost everything. They need shelter, food, health care, water, sanitation and emergency kits. The levels of trauma we are seeing are some of the highest anywhere. What people have experienced is nearly unimaginable,” said Ms. Grande.
“We’ve been working around the clock for months. Enormous efforts have been made by the Government and front-line partners to stay one step ahead of the crisis. We’ve done our best to protect and assist the people who need it the most.”
“There’s a lot to do in the weeks and months ahead. Of the 54 residential neighborhoods in western Mosul, 15 are heavily damaged and at least 23 are moderately damaged.”
“The civilians who are trapped in the areas where fighting is likely to occur, including Tel Afar, Hawija and western Anbar, will be at extreme risk. We have to make sure we are ready to help them,” said Ms. Grande.
Only 43 percent of the USD 985 million Humanitarian Response Plan for Iraq has been received. Partners urgently require US$562 million to meet the needs of millions of Iraqis who need help.

Syrian Arab Republic
:: 14 Jul 2017  Syrian Arab Republic: CCCM Whole of Syria Ar-Raqqa Displacement Map as of July 5, 2017

Yemen
:: Key messages on cholera (10 July 2017)
Current situation
Yemen, the world’s largest food security crisis, is now facing the world’s worst cholera outbreak which in the span of two months has spread to the entire country except for one governorate (Socotra island)….

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Ethiopia
:: 10 Jul 2017 Ethiopia Weekly Humanitarian Bulletin, 10 July 2017

DRC
:: DRC: Number of internally displaced people rises to 3.8 million – the highest in Africa
7 July, 2017  The Democratic Republic of the Congo (DRC) is experiencing a significant change in conflict patterns, with growing intercommunal tensions and violence affecting new parts of the country. DRC is now one of the world’s most complex humanitarian crises, in which 7.3 million people need humanitarian assistance.
The relentlessly acute nature of the crisis, the lack of basic social services throughout the country and the persistent armed conflict have led to the internal displacement of 3.8 million people. This is the highest number of displaced people in the African continent…

WHO & Regional Offices [to 15 July 2017]

Extending health coverage in the Democratic Republic of the Congo
13 July 2017 – In the Tanganyika province of the Democratic Republic of the Congo, going to a health centre often means traveling long distances over poor roads, while carrying a sick child and supplies. WHO’s Rapid Access Expansion Programme (RAcE) is bringing diagnosis and treatment for malaria, pneumonia, and diarrhoea – the three deadliest childhood diseases – into remote communities.

Highlights
Trachoma: 85 million people treated through expanded access to medicine
2017 – New WHO data show a remarkable increase of 63% in the number of people treated with an antibiotic for trachoma from 2014–2016, considerably improving prospects for the global elimination of the disease. The surge is mainly due to expanded access to azithromycin.

Measles continues to spread and take lives in Europe
July 2017 – Ongoing measles outbreaks in the Europe have caused 35 deaths in the past year. The most recent fatality was a 6-year-old boy in Italy, where over 3300 measles cases and 2 deaths have occurred since June 2016. Several other countries have also reported outbreaks, according to national public health authorities.

Scaling up efforts to minimize spread of acute watery diarrhoea/cholera in the Eastern Mediterranean Region
July 2017 – With increasing numbers of people in some countries of WHO’s Eastern Mediterranean Region affected by acute watery diarrhoea and cholera, WHO is working with partners, including UNICEF, to save lives in areas where outbreaks are active, and reduce the risk of these diseases crossing into unaffected areas and neighbouring countries.

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Weekly Epidemiological Record, 14 July 2017, vol. 92, 28 (pp. 393–404)
:: Meeting of the Global Advisory Committee on Vaccine Safety, 7–8 June 2017
:: Monthly report on dracunculiasis cases, January– May 2017

::::::
 
Disease outbreak news
:: Cholera – Nigeria – 12 July 2017
:: Acute hepatitis E – Nigeria  – 12 July 2017
 
::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Mobile teams deliver healthcare to more than 400 000 in remote areas of north-eastern Nigeria  13 July 2017 – Among many women who brought their children to the WHO-supported…
:: 5 places where WHO needs more emergencies funding to help people now
12 July 2017 – To help people living in some of the world’s most dire emergency…
:: WHO in collaboration with the Ministry of Health and health partners strategizes efforts to combat cholera in South Sudan  10 July 2017 – Cholera contributes substantially to the disease burden in South…
:: Paramount rulers in the Northern Nigeria recommit to improving health indicators in the region.  10 July 2017 – Sokoto, 10 July 2017 – Paramount rulers under the umbrella body,…

WHO European Region EURO
:: Using experience and lessons learned to help countries combat tobacco industry tactics 13-07-2017
:: Public health advice as heatwave continues across southern and central Europe 13-07-2017
:: Measles continues to spread and take lives in Europe 11-07-2017
:: Collaboration among immunization programmes aims to bring Europe closer to stopping HPV 10-07-2017
:: Minister of Health of Lithuania visits WHO/Europe to discuss key priorities and collaboration 10-07-2017

WHO Eastern Mediterranean Region EMRO
:: WHO and partners, including UNICEF, scale up efforts to minimize spread of acute watery diarrhoea/cholera in the Eastern Mediterranean Region  10 July 2017

CDC/ACIP [to 15 July 2017]
http://www.cdc.gov/media/index.html

MMWR News Synopsis for July 13, 2017

Measles Outbreak — Minnesota, April–May 2017
Recent U.S. and international measles cases are concerning and serve as a reminder of the seriousness of the disease and the importance of vaccination. Addressing parents’ questions and concerns and correcting misinformation about childhood vaccines through healthcare professionals and other trusted community leaders is critical in protecting children and communities from vaccine-preventable diseases. Since April 2017, a measles outbreak in Minnesota has been demonstrating the importance of maintaining high vaccination rates to protect communities from measles. Measles quickly spread in an under-vaccinated population, resulting in a large-scale and intensive public health response to prevent further illnesses and possible deaths. The outbreak also highlighted the importance of building trust with communities and identifying effective, culturally appropriate ways to address questions, concerns, and misinformation about the MMR vaccine.

Pneumococcal Vaccination Among Medicare Beneficiaries Following the Advisory Committee on Immunization Practices Recommendation for Routine Use of 13-valent Pneumococcal Conjugate Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine for Adults Aged ≥65 Years
Providers should ensure that older adults initiate and complete the recommended pneumococcal vaccination series to reduce their risk of contracting pneumococcal disease. To reduce the burden of pneumococcal disease, providers should ensure that older adults initiate and complete the recommended pneumococcal vaccination series. CDC analyzed claims for vaccination submitted for reimbursement to the Centers for Medicare & Medicaid Services (CMS) to help measure PCV13 and PPSV23 vaccination uptake among adults aged ≥65 years before and after implementation of revised recommendations in September 2014. By September 18, 2016, 43.2 percent of Medicare Parts A and B beneficiaries aged ≥65 years had claims for at least one dose of PPSV23 (regardless of PCV13 status), 31.5 percent had claims for at least one dose of PCV13 (regardless of PPSV23 status), and 18.3 percent had claims for at least one dose each of PCV13 and PPSV23.

Announcements
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 15 July 2017]
http://cepi.net/
08 July 2017
Norway strengthens its commitment to CEPI
CEPI welcomes global leadership shown by government of Norway
CEPI welcomes the vital contribution of additional funding from the government of Norway, which today announced it is increasing its original investment in CEPI by $70m. The government of Norway is a founding investor in CEPI, which will create new vaccines against epidemic threats through an innovative partnership between public, private, philanthropic and civil organizations.
Together with the governments of Germany and Japan, the Bill & Melinda Gates Foundation and Wellcome, the founding investors contributed a total of $540m to launch CEPI in January 2017. CEPI’s mission is to outsmart epidemics by developing safe and effective vaccines against known infectious diseases that can be deployed rapidly to contain outbreaks, before they become global health emergencies.
Responding to the announcement by the Prime Minister of Norway, Erna Solberg, at the G20 summit, Richard Hatchett, CEO of CEPI said:
“Norway was at the forefront of the world’s response to Ebola. Its far-sightedness helped facilitate the clinical evaluation of an Ebola vaccine that showed 100% effectiveness. It demonstrated that same spirit when it became a founding investor in CEPI. And today, we thank the government of Norway for this additional vital investment. This is a wonderful example of global leadership that will strengthen our defenses against the diseases that threaten the health, prosperity and security of us all. It is further proof of the momentum within the G20 to support collective action against future epidemics.”…

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The Vaccine Confidence Project  [to 15 July 2017]
http://www.vaccineconfidence.org/
12 Jul, 2017
EU judgment on vaccine claims: Vaccine confidence breaker or trust builder?
Confidence Commentary – Heidi Larson With Shalini Anand reporting from India
A recent landmark judgment by the European Court of Justice (ECJ) has shaken the global health community. Scientists from all over the world have voiced dissent, as the ruling threatens to undermine science-based evidence and impact on vaccine confidence….
 
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NIH  [to 15 July 2017]
http://www.nih.gov/news-events/news-releases
July 13, 2017
Experimental Zika virus vaccines restrict in utero virus transmission in mice
— Vaccines protect against Zika-related congenital damage.

July 12, 2017
HIV hijacks surface molecule to invade cell
— NIH discovery could lead to new drugs to prevent HIV infection.

July 10, 2017
NIH launches prospective study of Zika and HIV co-infection during pregnancy
— Study to determine potential risks that infection with Zika may pose for pregnancies in which the mother is also has HIV.
 
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UNAIDS  [to 15 July 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update
Review of Global Commission on HIV and the Law identifies progress and challenges
“Laws that criminalize HIV are anti-science, unjust and unconstructive”
14 July 2017
Five years ago, a landmark report published by the Global Commission on HIV and the Law urged governments to promote laws and policies grounded in evidence and human rights in order to turn the tide against AIDS. On 12 and 13 July, members of the commission and other experts came together to assess the progress made in advancing the report’s recommendations, look at the barriers that remain and discuss opportunities for further progress.
The participants recognized the role of the commission as a catalyst for social justice and human rights in the HIV response. Since the release of the commission’s report in 2012, efforts to advance the report’s recommendations have been documented in 88 countries. Several countries have conducted comprehensive assessments of laws, policies and practices affecting people living with HIV and have changed legislation as a result. National conversations on the rights of people living with and vulnerable to HIV have led countries to reform discriminatory practices against people living with HIV. Judges, civil society organizations and partners have been instrumental in helping to overturn discriminatory legislation and counter HIV stigma…

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European Medicines Agency  [to 15 July 2017]
http://www.ema.europa.eu/ema/
13/07/2017
Call for independent scientific experts to join EMA’s Pharmacovigilance Risk Assessment Committee (PRAC)
Expressions of interest to be submitted to European Commission by 30 September 2017
 
::::::
 
Wellcome Trust  [to 15 July 2017]
https://wellcome.ac.uk/news
11 July 2017
Researchers establish key mechanism controlling cell division
Researchers at the Francis Crick and Gurdon Institutes have pinpointed the mechanism that activates a key point in embryonic development. This could help scientists develop new treatments for diseases where the cell cycle is disrupted, such as cancer.
 
::::::
 
Industry Watch
:: Sanofi to acquire Protein Sciences 
Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio
Paris, France – July 11, 2017 – Sanofi announced today it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States. Under the terms of the agreement, Sanofi will make an upfront payment of $650 million and pay up to $100 million upon achievement of certain milestones.
Protein Sciences received approval from the US Food and Drug Administration (FDA) in October 2016 for their Flublok® Quadrivalent Influenza Vaccine (QIV). Flublok® is the only recombinant protein-based influenza vaccine approved by the FDA.
“The acquisition of Protein Sciences will allow us to broaden our flu portfolio with the addition of a non-egg based vaccine,” said David Loew, Sanofi Executive Vice President and Head of Sanofi Pasteur, Sanofi’s vaccines division.
“Protein Sciences was actively looking for an opportunity to grow its business, particularly in the US,” said Manon M.J. Cox, President and Chief Executive Officer, Protein Sciences. “As part of Sanofi Pasteur, we expect our Flublok influenza vaccine to benefit from Sanofi Pasteur’s expertise in the field of influenza vaccines.”
The acquisition, which has been unanimously approved by the board of directors of Protein Sciences and a majority of Protein Sciences shareholders, is expected to close in the third quarter of 2017, subject to customary regulatory approvals.

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BIO    [to 15 July 2017]
https://www.bio.org/insights/press-release
Jul 13 2017
Jennifer Dent (BIO Ventures for Global Health) at the 2017 BIO International Convention
Mike Huckman interviews Jennifer Dent (BIO Ventures for Global Health) at the 2017 BIO International Convention Buzz Center

Jul 13 2017
Nima Farzan (PaxVax) at the 2017 BIO International Convention
Mike Huckman interviews Nima Farzan (PaxVax) at the 2017 BIO International Convention Buzz Center.

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PhRMA    [to 15 July 2017]
http://www.phrma.org/press-room
July 12, 2017
PhRMA Statement on House Passage of PDUFA VI Reauthorization
PhRMA president and CEO Stephen J. Ubl issued the following statement on the House passage of PDUFA reauthorization.

July 12, 2017
New “Let’s Talk About Cost” campaign convenes national dialogue on medicine costs
Discussions about costs are important. We recognize that many are struggling to access their medicine and have important questions about their medicine costs.

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

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

UNICEF – WHO
Progress on Drinking Water, Sanitation and Hygiene: 2017 Update and SDG Baselines
UNICEF
July 2017 :: 110 pages
PDF: https://www.unicef.org/publications/index_96611.html#
Overview
This report presents the first ever estimates of the population using ‘safely managed’ drinking water and sanitation services – meaning drinking water free from contamination that is available at home when needed, and toilets whereby excreta are treated and disposed of safely. It also documents progress towards ending open defecation and achieving universal access to basic services. The report identifies a number of critical data gaps that will need to be addressed in order to enable systematic monitoring of Sustainable Development Goal (SDG) targets and to realize the commitment to ‘leave no one behind’.

Joint press release
2.1 billion people lack safe drinking water at home, more than twice as many lack safe sanitation
WHO, UNICEF release first global estimates for water, sanitation and hygiene for the Sustainable Development Goals
12 JULY 2017 GENEVA/ NEW YORK – Some 3 in 10 people worldwide, or 2.1 billion, lack access to safe, readily available water at home, and 6 in 10, or 4.5 billion, lack safely managed sanitation, according to a new report by the World Health Organization (WHO) and UNICEF.
The Joint Monitoring Programme report, Progress on Drinking Water, Sanitation and Hygiene: 2017 Update and Sustainable Development Goal Baselines, presents the first global assessment of “safely managed” drinking water and sanitation services. The overriding conclusion is that too many people still lack access, particularly in rural areas.

“Safe water, sanitation and hygiene at home should not be a privilege of only those who are rich or live in urban centres,” says Dr Tedros Adhanom Ghebreyesus, Director-General, World Health Organization. “These are some of the most basic requirements for human health, and all countries have a responsibility to ensure that everyone can access them.”

Billions of people have gained access to basic drinking water and sanitation services since 2000, but these services do not necessarily provide safe water and sanitation. Many homes, healthcare facilities and schools also still lack soap and water for handwashing.  This puts the health of all people – but especially young children – at risk for diseases, such as diarrhoea.
As a result, every year, 361 000 children under 5 years die due to diarrhoea. Poor sanitation and contaminated water are also linked to transmission of diseases such as cholera, dysentery, hepatitis A, and typhoid.

“Safe water, effective sanitation and hygiene are critical to the health of every child and every community – and thus are essential to building stronger, healthier, and more equitable societies,” said UNICEF Executive Director Anthony Lake. “As we improve these services in the most disadvantaged communities and for the most disadvantaged children today, we give them a fairer chance at a better tomorrow.”

Significant inequalities persist
In order to decrease global inequalities, the new SDGs call for ending open defecation and achieving universal access to basic services by 2030.
Of the 2.1 billion people who do not have safely managed water, 844 million do not have even a basic drinking water service. This includes 263 million people who have to spend over 30 minutes per trip collecting water from sources outside the home, and 159 million who still drink untreated water from surface water sources, such as streams or lakes.

In 90 countries, progress towards basic sanitation is too slow, meaning they will not reach universal coverage by 2030.

Of the 4.5 billion people who do not have safely managed sanitation, 2.3 billion still do not have basic sanitation services. This includes 600 million people who share a toilet or latrine with other households, and 892 million people – mostly in rural areas – who defecate in the open. Due to population growth, open defecation is increasing in sub-Saharan Africa and Oceania.

Good hygiene is one of the simplest and most effective ways to prevent the spread of disease. For the first time, the SDGs are monitoring the percentage of people who have facilities to wash their hands at home with soap and water.  According to the new report, access to water and soap for handwashing varies immensely in the 70 countries with available data, from 15 per cent of the population in sub-Saharan Africa to 76 per cent in western Asia and northern Africa.

Additional key findings from the report include::: Many countries lack data on the quality of water and sanitation services. The report includes estimates for 96 countries on safely managed drinking water and 84 countries on safely managed sanitation.
:: In countries experiencing conflict or unrest, children are 4 times less likely to use basic water services, and 2 times less likely to use basic sanitation services than children in other countries.
:: There are big gaps in service between urban and rural areas. Two out of three people with safely managed drinking water and three out of five people with safely managed sanitation services live in urban areas. Of the 161 million people using untreated surface water (from lakes, rivers or irrigation channels), 150 million live in rural areas.

Featured Journal Content

PATH  [to 15 July 2017]
http://www.path.org/news/index.php
Press release | July 13, 2017
Now is the time to eliminate cervical cancer for all women
Experts agree it is feasible, including in low-resource countries
SEATTLE, July 13, 2017 – The International Journal of Obstetrics and Gynecology this week released a series of papers with recommendations on state-of-the-art cervical cancer prevention tools and strategies that could lead to elimination of the disease in low- and middle-income countries as well as in wealthier nations.
In a call to action published in the journal, 14 global health leaders highlight the impact that human papillomavirus (HPV) vaccination has had in recent years in high-income countries, with dramatic decreases in HPV infection and associated cervical disease.
They urge the health community to increase HPV vaccination everywhere and to accelerate cervical precancer screening and treatment for women who are beyond vaccination age to reduce incidence and mortality worldwide…
 
International Journal of Obstetrics and Gynecology
Volume 138, Issue Supplement S1   July 2017  Pages 1–73
http://obgyn.onlinelibrary.wiley.com/hub/issue/10.1111/ijgo.2017.138.issue-S1/
Special Issue: Cervical Cancer Prevention: Recent Progress and the Unfinished Agenda in Low‐ and Middle‐Income Countries
Guest Editor: Vivien Davis Tsu. IJGO Supplement Editor: Claudio Sosa. Publication of this supplement was supported by the Bill & Melinda Gates Foundation.

EDITORIAL
Cervical cancer prevention for all women: Why now?
In the past 25 years, the view of cervical cancer has changed from resigned acceptance of a seemingly inevitable and inequitable blight to guarded optimism that we are on the brink of eliminating this dreaded disease that has taken so many women in the prime of their lives. The projections in GLOBOCAN 2012 that the estimated 285 000 annual deaths in 2015 would grow to nearly 385 000 by 2030, with 95% of those deaths in lower-income countries, were based on the assumption that incidence and mortality rates would continue unchanged.[1] That assumption is now being called into question on both scientific and social justice grounds.[2]

Much of the recent change is due to stunning advances in our understanding of the role of human papillomavirus (HPV) in the development of cervical (and other) cancer and of the virus itself and related biomarkers, which enabled the creation of HPV vaccines and screening tests. But these technologies alone do not tell the whole story, since they would be meaningless without the programmatic knowledge of how best to deploy them in the low-resource settings that need them most. Also essential has been the parallel development of a growing contingent of global and national advocates calling for allocation of adequate financial and human resources and implementation at scale of evidence-based strategies for prevention and effective management of cervical cancer. Multilateral agencies such as WHO and UNFPA, international and national nongovernmental organizations (NGOs), coalitions such as Cervical Cancer Action, federations such as the Union for International Cancer Control and FIGO, and donors such as the Bill & Melinda Gates Foundation have joined forces to set norms, strengthen capacities, generate knowledge, and build community demand and political support.

An effort to make screening for cervical cancer available in low-resource settings was started in 1991 by PATH, an international nonprofit NGO devoted to improving the health of women and children through innovation. The modest goal was to identify a screening method that was more feasible than the Papanicolaou test that had become standard in high-income countries and had dramatically reduced previously high rates of cervical cancer through organized, regularly repeated screening.[3] Over the next decade and a half, several organizations, including PATH, generated persuasive clinical and operational evidence that visual inspection with acetic acid (VIA) could be an effective screening modality, despite its shortcomings of user variability and moderate sensitivity.[4]

In the past 5–8 years, the pace of scientific discovery has accelerated, and the body of programmatic experience with cervical cancer prevention in Africa, Asia, and Latin America has grown dramatically. More than 20 low- and middle-income countries (LMICs) have introduced HPV vaccine in either pilot or national programs.[5] Three LMICs in Central America are introducing HPV testing using self-collected specimens in their routine national screening programs,[6] while others in Africa and elsewhere are conducting pilot programs with this method. Countries in Africa and Asia are building service platforms using VIA for screening and cryotherapy for managing precancerous lesions, in line with recent WHO recommendations.[7] As best practices emerge through systematic evaluation, new challenges and remaining gaps are also more clearly delineated.

This Supplement to the International Journal of Gynecology and Obstetrics (IJGO) comes at a critical juncture for cervical cancer prevention. Decisions that are made (or not made) now will affect several generations of women.
:: Will the current inequitable distribution of cervical cancer incidence and mortality be perpetuated or even exacerbated by slow rollout of HPV vaccination in LMICs?
:: Will women in their 30s and 40s, who were too old to benefit from HPV vaccine when it became available, or younger women who missed the opportunity to be vaccinated fully, be offered the life-saving chance to be screened at least once by a qualified provider using an effective screening test followed by treatment when indicated?
:: Will countries heed the call to invest national resources now to prevent the oncoming tidal wave of noncommunicable diseases such as cervical cancer?
:: Will donors expand their funding agendas to support national governments and NGOs with start-up costs and capacity building?

In this Supplement we focus on cervical cancer prevention and gather the latest information on the progress that has been made in recent years, the challenges that remain, and the priorities for action and investment in the next 5–10 years.

In the first paper, a group of world leaders in cancer and reproductive health make an urgent appeal for action to accelerate and expand prevention efforts, building on what is already in place.[8] Next, LaMontagne et al.[9] review the surprisingly rapid initial uptake of HPV vaccine among LMICs, while acknowledging the daunting challenges faced by countries wanting to transform their pilot efforts into sustainable nationwide programs. For secondary prevention, there is a widening set of options for screening, with a growing consensus that all programs eventually will need to move to HPV testing, which includes opportunities associated with self-collected samples.[10] New technology opportunities are emerging in the field of outpatient ablative treatments for precancerous cervical lesions.[11] Basu et al.[12] share the latest thinking on how to combine screening and preventive treatment methods for the optimal balance of effectiveness, acceptability, safety, and feasibility in low-resource settings.

In addition to new options for the screening process itself, several aspects of programmatic structures and strategies are addressed. Drummond et al.[13] discuss how recent advances in health information technology can address some of the challenges that beset data systems needed for both patient care and program monitoring. White et al.[14] draw on their experience integrating cervical cancer screening into existing family planning and HIV/AIDS services to delineate the potential opportunities such integration can create, as well as the challenges that must be overcome to reap the full benefits of this approach. Using their extensive modeling capabilities, Campos et al.[15] estimate the level of investment needed for vaccination and screening over the next 10 years and the potential health and economic impact of such investment in the 50 poorest countries. Wittet et al.[16] emphasize the importance of clear communication and strategic partnerships in strengthening advocacy for cervical cancer prevention. Holme et al.[17] capture the experience of five countries that have embarked on the process of scaling-up their screening programs, identifying challenges they have encountered and insights garnered that could be useful for other countries.

The final paper makes the argument that we now have sufficient tools and knowledge to deliver HPV vaccination, screening, and preventive treatment to even the most resource-constrained settings.[18] There is a limited window of opportunity over the next 10 years to prevent more than 5 million cervical cancer cases with very cost-effective interventions.[15] In 2011, cervical cancer screening and HPV vaccination were identified as “best buys” in the fight against noncommunicable diseases.[19] These efforts are timelier than ever, as the health and well-being of women and girls are considered essential to ending extreme poverty, promoting development and resilience, and achieving the Sustainable Development Goals.[20]

What Dr Mahmoud Fathalla said about maternal mortality is equally true of cervical cancer: “Women are not dying because of untreatable diseases. They are dying because societies have yet to make the decision that their lives are worth saving.”[21] Preventing cervical cancer has been largely accomplished in wealthier countries; failing to use the tools and knowledge we now have at hand to accord women in low-resource settings the same life-saving opportunity is unthinkable. This Supplement describes the major achievements of the past decade and points out the way forward.
ACKNOWLEDGMENTS
This paper and publication of the entire Supplemental issue were supported by funding from the Bill & Melinda Gates Foundation. We are grateful for their support, but the funder has had no role in selecting the authors or reviewing the papers. The findings and conclusions contained within this publication are those of the authors and do not necessarily reflect positions or policies of the Bill & Melinda Gates Foundation.
CONFLICTS OF INTEREST
The author has no conflicts of interest to declare.
This Supplement focuses on cervical cancer prevention—recent progress, remaining challenges, and priorities for action and investment in the next 5–10 years.

CALL TO ACTION
Ending cervical cancer: A call to action
Sanchia Aranda, Seth Berkley, Sally Cowal, Mark Dybul, Tim Evans, Katja Iversen, Matshidiso Moeti, Babatunde Osotimehin, Stefan Peterson, Peter Piot, et al
First Published: 9 July 2017
Elimination of cervical cancer is now on the horizon if we rapidly scale up prevention in the low‐ and middle‐income countries that bear the highest burden of disease.

SUPPLEMENT ARTICLES
Progress in HPV vaccination in low‐ and lower‐middle‐income countries
Scott LaMontagne, Paul J.N. Bloem, Julia M.L. Brotherton, Katherine E. Gallagher, Ousseynou Badiane, Cathy Ndiaye
As of December 2016, 11 low‐ and lower‐middle‐income countries (LLMICs) have introduced or will soon introduce HPV vaccine nationally; another 32 LLMICs have conducted pilot or demonstration programs.

Optimizing secondary prevention of cervical cancer: Recent advances and future challenges
Gina Ogilvie, Carolyn Nakisige, Warner K. Huh, Ravi Mehrotra, Eduardo L. Franco, Jose Jeronimo
HPV‐based cervical cancer screening offers enormous promise toward the global elimination of cervical cancer, but key challenges need to be addressed to ensure women across the world benefit from this new technology.

Treatment of cervical intraepithelial lesions
Philip E. Castle, Dan Murokora, Carlos Perez, Manuel Alvarez, Swee Chong Quek, Christine Campbell
Treatment of precancerous cervical lesions has evolved and newer ablative options for low‐resource settings are being implemented. We review the evolution of treatments, current status, and future directions.

Management algorithms for cervical cancer screening and precancer treatment for resource‐limited settings
Partha Basu, Filip Meheus, Youssef Chami, Roopa Hariprasad, Fanghui Zhao, Rengaswamy Sankaranarayanan
Management algorithms for screen‐positive women in resource‐limited settings need to be pragmatically selected to ensure strong linkage between screening and treatment. Approaches based on limited number of visits are most efficient and cost‐effective.

Cervical cancer data and data systems in limited‐resource settings: Challenges and opportunities
Jennifer L. Drummond, Martin C. Were, Silvina Arrossi, Kara Wools‐Kaloustian
This article draws on authors’ experiences and current literature to describe outstanding challenges and recent advances in implementation of cervical cancer data systems, and to offer recommendations for next steps.

Integrating cervical cancer screening and preventive treatment with family planning and HIV‐related services
Heather L. White, Alejandra Meglioli, Raveena Chowdhury, Olivia Nuccio
Integrating cervical cancer prevention services into existing sexual and reproductive health programs can improve “screen and treat” coverage in countries with high cervical cancer burden.

The health and economic impact of scaling cervical cancer prevention in 50 low‐ and lower‐middle‐income countries
Nicole G. Campos, Monisha Sharma, Andrew Clark, Kyueun Lee, Fangli Geng, Catherine Regan, Jane Kim, Stephen Resch
A 10‐year roll‐out of HPV vaccination for girls and cervical cancer screening for women in 50 low‐ and lower‐middle‐income countries could prevent 5.2 million cancer cases, and is estimated to be very cost‐effective.

Advocacy, communication, and partnerships: Mobilizing for effective, widespread cervical cancer prevention
Scott Wittet, Jenny Aylward, Sally Cowal, Jacqui Drope, Etienne Franca, Sarah Goltz, Taona Kuo, Heidi Larson, Silvana Luciani, Emmanuel Mugisha, et al
Advocacy and communications interventions can help overcome current low levels of access to cervical prevention services in low‐resource settings, especially when implemented through strong partnerships speaking with a common voice.

Scaling up proven innovative cervical cancer screening strategies: Challenges and opportunities in implementation at the population level in low‐ and lower‐middle‐income countries
Francesca Holme, Sharon Kapambwe, Ashrafun Nessa, Partha Basu, Raul Murillo, Jose Jeronimo
Governments in low‐ and lower‐middle‐income countries should consider implementing population‐based cervical cancer screening as soon as possible following a successful pilot program. We discuss these efforts in five countries, including progress, remaining challenges, and recommendations.

The investment case for cervical cancer elimination
Vivien Davis Tsu, Ophira Ginsburg
The inequitable burden of cervical cancer could be eliminated with solutions already available. Sustained political commitment and strategic investments in the next few years could make this a reality.

Journal Watch

   Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 15 July 2017)

Research
Cost effectiveness of pre-referral antimalarial treatment in severe malaria among children in sub-Saharan Africa
In 2013, 78% of malaria deaths occurred in children aged 5 years and below, in sub-Saharan Africa. Treatment of severe malaria requires a health facility with inpatient care. However, in most sub-Sahara Africa…
Vivian Rakuomi, Faith Okalebo, Stanley Ndwigah and Levi Mbugua
Cost Effectiveness and Resource Allocation 2017 15:14
Published on: 14 July 2017

Research
Cost-effectiveness analysis of the nine-valent HPV vaccine in Italy
In Italy HPV vaccination with the quadrivalent vaccine (Gardasil®) is offered actively and free of charge to girls aged 12 since 2007. A nine-valent vaccine (Gardasil 9®) received the European market authorizatio…
Francesco Saverio Mennini, Paolo Bonanni, Florence Bianic, Chiara de Waure, Gianluca Baio, Giacomo Plazzotta, Mathieu Uhart, Alessandro Rinaldi and Nathalie Largeron
Cost Effectiveness and Resource Allocation 2017 15:11
Published on: 11 July 2017

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 15 July 2017)

Research article
Area-based socioeconomic factors and Human Papillomavirus (HPV) vaccination among teen boys in the United States
This study is the first to examine associations between several area-based socioeconomic factors and human papillomavirus (HPV) vaccine uptake among boys in the United States (U.S.).
Kevin A. Henry, Allison L. Swiecki-Sikora, Antoinette M. Stroup, Echo L. Warner and Deanna Kepka
BMC Public Health 2017 18:19
Published on: 14 July 2017

BMJ Open
July 2017 – Volume 7 – 7
http://bmjopen.bmj.com/content/current

Research
Research: A systematic review of the worldwide prevalence of survivors of poliomyelitis reported in 31 studies
Kelly M Jones, Shivanthi Balalla, Alice Theadom, Gordon Jackman, Valery L Feigin
Abstract
Background Accurate prevalence figures estimating the number of survivors of poliomyelitis (disease causing acute flaccid paralysis) following poliovirus infection are not available. We aim to undertake a systematic review of all literature concerning the prevalence of survivors of poliomyelitis.
Methods Electronic databases were searched from 1900 up to May 2016 for peer-reviewed studies using a population-based approach witha defined denominator and some form of diagnostic or clinical verification of polio. Exclusion criteria were any prevalence data that were unable to be extracted or calculated and studies reporting on incidence only. The quality of each included study was assessed using an existing tool modified for use in prevalence studies. Average crude prevalence rates were used to calculate worldwide estimates.
Results Thirty-one studies met criteria with 90% of studies conducted in low-income to lower middle-income countries. Significant variability in the prevalence of survivors of poliomyelitis was revealed, in low- income to lower middle-income (15 per 100 000 in Nigeria to 1733 in India) and upper-middle to high-income countries (24 (Japan) to 380 per 100 000 (Brazil). The total combined prevalence of survivors of poliomyelitis for those studies at low to moderate risk of bias ranged from 165 (high-income countries) to 425 (low-income to lower middle-income countries) per 100 000 person-years. Historical lameness surveys of children predominated, with wide variation in case definition and assessment criteria, and limited relevance to current prevalence given the lack of incidence of poliovirus infection in the ensuing years.
Conclusions These results highlight the need for future epidemiological studies of poliomyelitis to examine nationally representative samples, including all ages and greater focus on high-income countries. Such efforts will improve capacity to provide reliable and more robust worldwide prevalence estimates.

Health policy – Research
Evaluating the importance of policy amenable factors in explaining influenza vaccination: a cross-sectional multinational study
Ana Wheelock, Marisa Miraldo, Angus Thomson, Charles Vincent, Nick Sevdalis

Developing World Bioethics
August 2017  Volume 17, Issue 2  Pages 61–140
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2017.17.issue-2/issuetoc

The Saudi Law of Ethics of Research on Living Creatures and its Implementing Regulations (pages 63–69)
Ghiath Alahmad
Version of Record online: 3 MAR 2016 | DOI: 10.1111/dewb.12114
Abstract
The Kingdom of Saudi Arabia passed a Law and Implementing Regulations of Ethics of Research on Living Creatures in 14/09/1431 Hijri (24/08/2010). We have performed an ethical analysis of this law and, accordingly, this paper discusses the major components, key strengths, and weaknesses of this law. The Saudi system considers Islamic Shariah in addition to international research ethics guidelines. The Law and its Implementing Regulations contain all ethical requirements for research. We conclude that this law can serve as an example, not only for other Arab countries in the region that have similar values and social structure to the Kingdom of Saudi Arabia, but also for other Islamic countries.

Developing World Bioethics
August 2017  Volume 17, Issue 2  Pages 61–140
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2017.17.issue-2/issuetoc

Benefit Sharing in a Global Context: Working Towards Solutions for Implementation (pages 70–76)
Daniel J. Hurst
Version of Record online: 1 APR 2016 | DOI: 10.1111/dewb.12118
Abstract
Due to the state of globalized clinical research, questions have been raised as to what, if any, benefits those who contribute to research should receive. One model for compensating research participants is “benefit sharing,” and the basic premise is that, as a matter of justice, those who contribute to scientific research should share in its benefits. While incorporated into several international documents for over two decades, benefit sharing has only been sparsely implemented. This analysis begins by addressing the concept of benefit sharing, its historical development, and how it has been applied in the context of virus sharing for influenza research. The second portion of this analysis presents recommendations for ensuring benefit sharing. These recommendations are threefold: 1) an emphasis on social pressure, 2) the revision of international documents as means to ensure benefit sharing, and 3) greater collaboration between sponsor IRB and host country IRB. Because clinical research is a globalized industry, a global model will be proposed in the second that focuses on collaboration between the sponsor and host country. This collaboration is vital in order to ensure that proper forms of benefit sharing are accomplished as a matter of justice.

Developing World Bioethics
August 2017  Volume 17, Issue 2  Pages 61–140
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2017.17.issue-2/issuetoc

Informed Consent in Health Research: Challenges and Barriers in Low-and Middle-Income Countries with Specific Reference to Nepal (pages 84–89)
Pramod R. Regmi, Nirmal Aryal, Om Kurmi, Puspa Raj Pant, Edwin van Teijlingen and Sharada P. Wasti
Version of Record online: 12 AUG 2016 | DOI: 10.1111/dewb.12123
Abstract
Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.

Global Public Health
Volume 12, 2017   Issue 9
http://www.tandfonline.com/toc/rgph20/current

Article
Gender gap matters in maternal mortality in low and lower-middle-income countries: A study of the global Gender Gap Index
Seung-Ah Choe , Sung-il Cho & Hongsoo Kim
Pages: 1065-1076
Published online: 28 Mar 2016

Journal of Immigrant and Minority Health
Volume 19, Issue 4, August 2017
https://link.springer.com/journal/10903/19/4/page/1

Original Paper
Vaccination Coverage Disparities Between Foreign-Born and U.S.-Born Children Aged 19–35 Months, United States, 2010–2012
Aiden K. Varan, Alfonso Rodriguez-Lainz…

Original Paper
Individual, Cultural and Structural Predictors of Vaccine Safety Confidence and Influenza Vaccination Among Hispanic Female Subgroups
Meghan Bridgid Moran, Joyee S. Chatterjee…

Original Paper
U.S. Citizen Children of Undocumented Parents: The Link Between State Immigration Policy and the Health of Latino Children
Edward D. Vargas, Vickie D. Ybarra

Journal of Public Health Management & Practice
July/August 2017 – Volume 23 – Issue 4
http://journals.lww.com/jphmp/pages/default.aspx

Commentary
Severe Deprivations of Education Should Be Considered States of Emergency
Pomeranz, Jennifer L.; Chang, Virginia W.
Journal of Public Health Management & Practice . 23(4):336-338, July/August 2017.

Research Full Report
A Practice-Grounded Approach for Evaluating Health in All Policies Initiatives in the United States
Gase, Lauren N.; Schooley, Taylor; Lee, Meredith; More
Journal of Public Health Management & Practice . 23(4):339-347, July/August 2017.

The Lancet
Jul 15, 2017 Volume 390 Number 10091 p203-332
http://www.thelancet.com/journals/lancet/issue/current

Articles
Healthcare Access and Quality Index based on mortality from causes amenable to personal health care in 195 countries and territories, 1990–2015: a novel analysis from the Global Burden of Disease Study 2015
GBD 2015 Healthcare Access and Quality Collaborators

Nature 
Volume 547 Number 7662 pp137-252  13 July 2017
http://www.nature.com/nature/current_issue.html

Editorials
Proposed US public-health chief is a champion for women and children
In sharp contrast to President Trump, Brenda Fitzgerald has put maternal and child health at the heart of her policies.

Letters
An immunogenic personal neoantigen vaccine for patients with melanoma
Patrick A. Ott, Zhuting Hu, Derin B. Keskin, Sachet A. Shukla, Jing Sun+ et al.
The results of a phase I trial assessing a personal neoantigen multi-peptide vaccine in patients with melanoma, showing feasibility, safety, and immunogenicity.

Letters
Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer
Ugur Sahin, Evelyna Derhovanessian, Matthias Miller, Björn-Philipp Kloke, Petra Simon+ et al.
The authors report the first-in-human application of personalized neo-antigen RNA vaccines in patients with melanoma.
See also
Letter by Ott et al.
See also
News & Views by Melief

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 15 July 2017)

Perspective ‘
Time for trauma immunology
Timothy R. Billiar, Yoram Vodovotz
| published 11 Jul 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002342
While it is intuitive that the damage to bones and soft tissues causes both short- and long-term “organic” dysfunction, the “illness” caused by injury is less appreciated. This results from the systemic manifestations that follow the physiologic, immunologic, and metabolic changes induced by shock from blood loss and direct tissue destruction. The immunologic changes following injury are profound, and have been measured in the circulating leukocytes of injured humans as a massive activation of the innate immune system and a near-simultaneous impairment in adaptive immune responses [1]. This “immune dysfunction,” seen after even moderate injury, can be appreciated clinically as inflammation-associated organ dysfunction (typically peaking on day 2 to day 3 postinjury) and a sustained increase in the susceptibility to secondary infections, especially pneumonia [1,2]. The 2 processes are thought to be linked by the proximal events that activate the immune system immediately following a traumatic event.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 15 July 2017)

Essay
Cancer trials in sub-Saharan Africa: Aligning research and care
Satish Gopal
| published 10 Jul 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002351
Summary points
:: There is an extreme scarcity of evidence to guide cancer treatment in sub-Saharan Africa (SSA), as well as major differences between SSA and resource-rich settings regarding cancer treatment infrastructure.
:: A possible framework for conceptualizing cancer clinical trials in SSA is proposed, and key issues related to equipoise, innovation, and efficiency are addressed within the SSA context.
:: Strongly aligned cancer care and research agendas can generate forward progress for cancer treatment in the region and globally impactful clinical science that can change treatment paradigms even in resource-rich settings.

PLoS One
http://www.plosone.org/
[Accessed 15 July 2017]

Research Article
A self-affirmation exercise does not improve intentions to vaccinate among parents with negative vaccine attitudes (and may decrease intentions to vaccinate)
Rachael D. Reavis, Jacob B. Ebbs, Adaobi K. Onunkwo, L. Mariah Sage
Research Article | published 13 Jul 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0181368

PLoS Pathogens
http://journals.plos.org/plospathogens/
[Accessed 15 July 2017]

Research Matters
What viruses can teach us about the human immune system
Michaela U. Gack
| published 13 Jul 2017 PLOS Pathogens
https://doi.org/10.1371/journal.ppat.1006364

PNAS – Proceedings of the National Academy of Sciences of the United States
of America
http://www.pnas.org/content/early/
[Accessed 15 July 2017]

Biological Sciences – Immunology and Inflammation – Physical Sciences – Biophysics and Computational Biology:
Continuous immunotypes describe human immune variation and predict diverse responses
Kevin J. Kaczorowski, Karthik Shekhar, Dieudonné Nkulikiyimfura, Cornelia L. Dekker, Holden Maecker, Mark M. Davis, Arup K. Chakraborty, and Petter Brodin
PNAS 2017 ; published ahead of print July 10, 2017, doi:10.1073/pnas.1705065114
Significance
The human immune system consists of many different white blood cells that coordinate their actions to fight infections. The balance between these cell populations is determined by direct interactions and soluble factors such as cytokines, which serve as messengers between cells. Understanding how the interactions between cell populations influence the function of the immune system as a whole will allow us to better distinguish patients most at risk for specific infections or immune-mediated diseases and inform vaccination strategies. Here, we determine key collective interactions between white blood cells present in blood samples taken from healthy individuals. This perspective allows us to predict functional responses and describe previously unappreciated differences between age groups and in individuals carrying cytomegalovirus.
Abstract
The immune system consists of many specialized cell populations that communicate with each other to achieve systemic immune responses. Our analyses of various measured immune cell population frequencies in healthy humans and their responses to diverse stimuli show that human immune variation is continuous in nature, rather than characterized by discrete groups of similar individuals. We show that the same three key combinations of immune cell population frequencies can define an individual’s immunotype and predict a diverse set of functional responses to cytokine stimulation. We find that, even though interindividual variations in specific cell population frequencies can be large, unrelated individuals of younger age have more homogeneous immunotypes than older individuals. Across age groups, cytomegalovirus seropositive individuals displayed immunotypes characteristic of older individuals. The conceptual framework for defining immunotypes suggested by our results could guide the development of better therapies that appropriately modulate collective immunotypes, rather than individual immune components.

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 15 July 2017]

Editorial
Three recommendations to the new Director-General of the WHO on how to deliver for girls and women
Katja Iversen
Reproductive Health 2017 14:84
Published on: 14 July 2017

Science         
14 July 2017   Vol 357, Issue 6347
http://www.sciencemag.org/current.dtl
Special Issue – Emerging Infectious Diseases
Introduction to special issue

Outbreak
By Caroline Ash
Science14 Jul 2017 : 144-145 Full Access
Outbreaks of infectious diseases regularly shock human societies. Outbreaks may be unpredictable, but future events are inevitable. During an outbreak, the exigencies of current circumstances tend to be overwhelming, and all we can do is respond. Collectively, the international community fails to coordinate and plan interventions preemptively between crises.     Why can’t we predict outbreaks or mount faster and more effective responses?
What should we be doing in anticipation of a future infectious disease outbreak? This special section points to tools that could be incorporated into anticipatory programs, whatever the pathogen involved.
International surveillance is essential for early discovery of potentially dangerous infectious diseases, but this also requires local community involvement and redressing inequalities in health systems. If a pathogen eludes surveillance, mathematicians can be among the first to help by modeling the patterns of transmission among the chaos. Mathematical models can indicate the trajectory of an outbreak and show how to optimally target data collection. As outbreaks develop, vaccines and drugs may become available. However, it is not ethical to deploy such interventions in an affected population without any test of effectiveness. Therefore, we must design rigorous and controlled trials so that interventions are ready for use. Anticipation must also stretch into the post-outbreak phase. As incidence drops and fear declines, emergency responses are redeployed elsewhere. If a pathogen is not eliminated, it can become endemic—as has happened for HIV. The disease becomes normalized, governments lose interest, and elimination become impossible. Then, individuals—often those least able to afford it—are expected to pay the price of treatment and control.

Reviews
Driving improvements in emerging disease surveillance through locally relevant capacity strengthening
By Jo E. B. Halliday, Katie Hampson, Nick Hanley, Tiziana Lembo, Joanne P. Sharp, Daniel T. Haydon, Sarah Cleaveland
Science14 Jul 2017 : 146-148 Restricted Access

Opportunities and challenges in modeling emerging infectious diseases
By C. Jessica E. Metcalf, Justin Lessler
Science14 Jul 2017 : 149-152 Restricted Access

Improving vaccine trials in infectious disease emergencies
By Marc Lipsitch, Nir Eyal
Science14 Jul 2017 : 153-156 Restricted Access
Abstract
Unprecedented global effort is under way to facilitate the testing of countermeasures in infectious disease emergencies. Better understanding of the various options for trial design is needed in advance of outbreaks, as is preliminary global agreement on the most suitable designs for the various scenarios. What would enhance the speed, validity, and ethics of clinical studies of such countermeasures? Focusing on studies of vaccine efficacy and effectiveness in emergencies, we highlight three needs: for formal randomized trials—even in most emergencies; for individually randomized trials—even in many emergencies; and for six areas of innovation in trial methodology. These needs should inform current updates of protocols and roadmaps.

When an emerging disease becomes endemic
By Graham F. Medley, Anna Vassall
Science14 Jul 2017 : 156-158 Restricted Access
 
In Depth
Labmade smallpox is possible, study shows
By Kai Kupferschmidt
Science14 Jul 2017 : 115-116 Restricted Access
Reconstitution of horsepox virus from mail-order DNA reignites synthetic biology debate

Travel Medicine and Infectious Diseases
May-June, 2017  Volume 17
http://www.travelmedicinejournal.com/

Meta Analysis and Systematic Review
Prophylactic efficacy of primaquine for preventing Plasmodium falciparum and Plasmodium vivax parasitaemia in travelers: A meta-analysis and systematic review
Goodarz Kolifarhood, Ahmad Raeisi, Mansour Ranjbar, Ali Akbar Haghdoust, Allan Schapira, Saeed Hashemi, Hossein Masoumi-Asl, Hossein Mozafar Saadati, Sara Azimi, Nasim Khosravi, Anatoly Kondrashin
Vol. 17, p5–18
Published online: April 24, 2017

Vaccine
Volume 35, Issue 33, Pages 4057-4294 (24 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/33?sdc=1

Commentary
Italy’s response to vaccine hesitancy: An innovative and cost effective National Immunization Plan based on scientific evidence
Pages 4057-4059
Signorelli, R. Guerra, R. Siliquini, W. Ricciardi

[No abstract]

Vaccine
Volume 35, Issue 33, Pages 4057-4294 (24 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/33?sdc=1

Short communication
Increasing seasonal influenza vaccination among high risk groups in China: Do community healthcare workers have a role to play?
Pages 4060-4063
Ying Song, Tao Zhang, Liling Chen, Bo Yi, Xiaoning Hao, Suizan Zhou, Ran Zhang, Carolyn Greene
Abstract
Background
Seasonal influenza vaccine uptake in China is low. This study aims to assess the role of community healthcare workers (HCWs) in increasing vaccination among high risk groups in China.
Methods
We analyzed data from four knowledge, attitude and practice (KAP) studies on seasonal influenza vaccination in China targeting guardians of young children, pregnant women, adults aged ≥60 years, and HCWs from 2012 to 2014.
Results
Thirty-one percent of pregnant women and 78% adults aged ≥60 years reported willingness to follow HCWs’ recommendations for influenza vaccination. Guardians were more likely to vaccinate their children if they received HCWs’ recommendations (35% vs. 17%, p < 0.001). Community HCWs were more likely to recommend seasonal influenza vaccination than hospital HCWs (58% vs. 28%, p < 0.001).
Conclusion
Study results suggest the value of incorporating community HCWs’ recommendation for seasonal influenza vaccination into existing primary public health programs to increase vaccination coverage among high risk groups in China.

Vaccine
Volume 35, Issue 33, Pages 4057-4294 (24 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/33?sdc=1

Review
The complexity and cost of vaccine manufacturing – An overview
Review Article
Pages 4064-4071
Stanley Plotkin, James M. Robinson, Gerard Cunningham, Robyn Iqbal, Shannon Larsen
Abstract
As companies, countries, and governments consider investments in vaccine production for routine immunization and outbreak response, understanding the complexity and cost drivers associated with vaccine production will help to inform business decisions. Leading multinational corporations have good understanding of the complex manufacturing processes, high technological and R&D barriers to entry, and the costs associated with vaccine production. However, decision makers in developing countries, donors and investors may not be aware of the factors that continue to limit the number of new manufacturers and have caused attrition and consolidation among existing manufacturers. This paper describes the processes and cost drivers in acquiring and maintaining licensure of childhood vaccines. In addition, when export is the goal, we describe the requirements to supply those vaccines at affordable prices to low-resource markets, including the process of World Health Organization (WHO) prequalification and supporting policy recommendation. By providing a generalized and consolidated view of these requirements we seek to build awareness in the global community of the benefits and costs associated with vaccine manufacturing and the challenges associated with maintaining consistent supply. We show that while vaccine manufacture may prima facie seem an economic growth opportunity, the complexity and high fixed costs of vaccine manufacturing limit potential profit. Further, for most lower and middle income countries a large majority of the equipment, personnel and consumables will need to be imported for years, further limiting benefits to the local economy.