Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 13, Issue 1, 2017
http://www.tandfonline.com/toc/khvi20/current

Reviews
Current prospects and future challenges for nasal vaccine delivery
Pages 34-45 | Received 07 Jul 2016, Accepted 18 Sep 2016, Published online: 09 Dec 2016
Helmy Yusuf & Vicky Kett
ABSTRACT
Nasal delivery offers many benefits over traditional approaches to vaccine administration. These include ease of administration without needles that reduces issues associated with needlestick injuries and disposal. Additionally, this route offers easy access to a key part of the immune system that can stimulate other mucosal sites throughout the body. Increased acceptance of nasal vaccine products in both adults and children has led to a burgeoning pipeline of nasal delivery technology. Key challenges and opportunities for the future will include translating in vivo data to clinical outcomes. Particular focus should be brought to designing delivery strategies that take into account the broad range of diseases, populations and healthcare delivery settings that stand to benefit from this unique mucosal route.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 13, Issue 1, 2017
http://www.tandfonline.com/toc/khvi20/current

Article
Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women
Pages: 128-135
Published online: 29 Sep 2016
Jesús Zacarías Villarreal Pérez, José Manuel Ramírez Aranda, Manuel de la O Cavazos, Michelle de J. Zamudio Osuna, José Perales Dávila, María Romelia Ballesteros Elizondo, Marco Vinicio Gómez Meza, Francisco Javier García Elizondo & Azucena M. Rodríguez González

ABSTRACT
Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 y of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected. The experimental group received 0.5 mL IM of Tdap and the control group normal saline. Six blood samples were drawn before and after solution application, and from the umbilical cord of the infants and at 2, 4, and 6 months of age. Pertactin and Pertussis toxin antibodies and possible interference of maternal antibodies with the vaccine were determined.

In the experimental group, antibodies against Bordetella pertussis pertactin (anti-PRN) (112 E/mL 95% CI 89.9–139.9) and antibodies against pertussis toxin (anti-PT) (24.0 E/mL, 95% CI 18.3–31.4) were elevated in the mother before vaccination. These were higher in the umbilical cord and descended in the infant at 2 months (71.4 (95% CI 56.8–89.7 and 10.9; 95% CI 8.7–13.7, respectively). Anti-PT showed a delay in production. Tdap safety was confirmed with only mild local pain at 24 and 48 hours.
Anti-PRN and anti-PT antibodies in the infant descend at 2 months of age. There is a delay in anti-PT in children of immunized mothers. Further studies are needed to elucidate its clinical significance.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 13, Issue 1, 2017
http://www.tandfonline.com/toc/khvi20/current

Review
Ebola vaccines in clinical trial: The promising candidates
Pages: 153-168
Published online: 20 Oct 2016
Yuxiao Wang, Jingxin Li, Yuemei Hu, Qi Liang, Mingwei Wei & Fengcai Zhu

Abstract
Ebola virus disease (EVD) has become a great threat to humans across the world in recent years. The 2014 Ebola epidemic in West Africa caused numerous deaths and attracted worldwide attentions. Since no specific drugs and treatments against EVD was available, vaccination was considered as the most promising and effective method of controlling this epidemic. So far, 7 vaccine candidates had been developed and evaluated through clinical trials. Among them, the recombinant vesicular stomatitis virus-based vaccine (rVSV-EBOV) is the most promising candidate, which demonstrated a significant protection against EVD in phase III clinical trial. However, several concerns were still associated with the Ebola vaccine candidates, including the safety profile in some particular populations, the immunization schedule for emergency vaccination, and the persistence of the protection. We retrospectively reviewed the current development of Ebola vaccines and discussed issues and challenges remaining to be investigated in the future.

JAMA
January 24, 2017, Vol 317, No. 4, Pages 333-450
http://jama.jamanetwork.com/issue.aspx
January NaN, 2017
Large HIV Vaccine Trial Launches in South Africa
JAMA. 2017;317(4):350. doi:10.1001/jama.2016.20743
Jennifer Abbasi

Full Text
A vaccine that prevents HIV infection may be a step closer to reality with the launch of the large HVTN 702 clinical trial in South Africa late last year. The trial will test the safety and efficacy of a new version of a candidate vaccine studied in the landmark RV144 clinical trial in Thailand.

In 2009, the RV144 vaccine regimen was found to be 31.2% effective at preventing HIV infection over the 3.5-year follow-up period. Now researchers hope a modified version of the vaccine will improve on the modest results of the Thai trial and provide a longer-lasting immune response against the virus that causes AIDS.

Journal of Medical Ethics
February 2017, Volume 43, Issue 2
http://jme.bmj.com/content/current
JME symposium ‘The benefit/risk ratio challenge in clinical research, and the case of HIV cure.’

Paper
The benefit/risk ratio challenge in clinical research, and the case of HIV cure: an introduction
Nir Eyal, Professor Nir Eyal, Department of Global Health and Population, Harvard
[Full text; References at link above]
There is now hope to find a cure for HIV someday, or at least to accomplish long-term remission of the virus absent antiretroviral treatment (ART). Timothy Brown, the ‘Berlin Patient’, appears to have been completely cured of HIV. Six years after a curative intervention, Brown has no detectable level of the virus, and no need for ART. Patients undergoing a variety of other interventions in France, Boston, and Mississippi developed stable remission of the virus without taking antiretrovirals, typically until a final viral rebound.

While continued ART nearly eliminates morbidity and markedly prolongs life for people living with HIV, ART is treatment, not a cure. Under ART, the virus persists indefinitely in latent reservoirs in the patient’s body; upon ART interruption, it rebounds. And even under ART, some co-morbidities, stigma, costs, and burdens continue to affect patients, and life-long treatment cost prevents adequate coverage for the 35 million people living with HIV.1 ,2

An emphasis area for the International AIDS Society and the US National Institutes of Health, work toward a cure and long-term sustainable remission of HIV is currently the focus of 19 completed studies and at least 35 ongoing or planned ones.3 Complementing old, recent, and planned treatment and prevention strategies to fight HIV, these clinical studies work toward the development of either:
:: A literal ‘cure’ (sometimes called a sterilising cure), namely, eradication of all replication-competent HIV in a patient’s body, or:
:: ‘Long-term remission’, that is, the absence of viral rebound after ART cessation for a period of several years.1

But progress toward a cure and long-term remission comes with a serious ethical challenge.4–6 Many early-phase cure and remission studies would impose substantial risks, uncertainties, and invasive procedures on some participants. Some studies include interventions with high mortality, such as stem cell transplantation. Some include interventions never before tested in (immunocompromised) patients, which are therefore shrouded in complete uncertainty. Some necessitate a clinically-unnecessary interruption of ART in patients who are doing well on ART, potentially leading to morbidity or ART resistance. Some require invasive and clinically-unnecessary exams and biopsies, for example, ones to identify the internal tissue in which latent HIV reservoirs are hiding away from the impact of ART.

In many areas of medicine, early-phase studies to characterise toxicity and pharmacokinetics involve risks and, very rarely, severe adverse events,7 with only little hope for clinical effect. But the challenge in HIV cure studies is special. Many patients who consider joining risky early-phase studies for cancer, for instance, are doing poorly, arguably with sound reason to try just about anything. HIV patients tend nowadays to have good alternatives to study participation, namely, remaining on ART. While being cured without side effects would be even better than remaining on ART, severe side effects may accompany having been cured and even without side effects, being cured does not seem medically far superior to being stable on standard ART—to taking one pill a day with small expected morbidity; the superiority of mere durable remission to remaining stable on ART is even smaller.

Compare the use of stem cell transplantation in early-phase HIV cure studies to its occasional use in early-phase studies for chronic diseases with little short-term mortality, such as sickle cell disease,8 Type I diabetes,9 chronic granulomatous disease,10 and thalassaemia.11 Use of life-risking stem cell transplantation for these chronic diseases was often controversial. While untreated HIV clearly results in serious morbidity and mortality, these chronic diseases may well involve greater morbidity than HIV managed with ART. Since the use of stem cell transplantation for managing these chronic diseases was controversial, its use, and the use of other high-risk strategies, in HIV cure and remission studies pose a serious challenge.
Differently put, a small chance of a slight improvement, accompanied by a greater chance of gaining nothing or being severely burdened or harmed, seems on the face of it like a bad ‘gamble’ for patients. It fails to maximise their medical prospects. A decision to join some early-phase HIV cure and remission trials may appear irrational for patients who are doing well on ART.

Hence, an ethical challenge. We want to identify and hone cure and remission strategies for HIV—we owe as much to patients. But to do so we need study participants, and we must treat these particular patients right too. Is there a way to make trial participation an advantageous ‘gamble’ for all cure study participants? If not, can these studies remain ethical?

This is not the sheer pragmatic challenge, of how to convince enough patients to join cure- and remission studies. In a recent survey of American HIV patients, a majority expressed willingness to participate in all 14 types of HIV cure study.12 Though the per cent who would be willing and able to participate will be much smaller for any actual study, early-phase studies require only few participants. Nor is our challenge simply the ethical concern that, subjectively, patients might not fully comprehend the risks of study participation, or that they must be overestimating the medical benefits to them, so they are choosing a perfectly advantageous option non-autonomously.

The challenge is both ethical and objective. It is the concern that in many early-phase HIV cure and remission studies, a standard requirement in research ethics for a favourable benefit/risk ratio is transgressed.13–15 Are we giving candidate participants a fair ‘bargain’? Or are we inviting them to substitute what are objectively rather good medical prospects by worse ones? And if that is what we do when we conduct some early-phase cure and remission studies, are we acting wrongfully, or is this to some degree our prerogative given the vast global need for these interventions? Could we do things differently in these studies and in their administration, to keep them robustly ethical?

The Lancet
Jan 28, 2017 Volume 389 Number 10067 p331-476
http://www.thelancet.com/journals/lancet/issue/current

Comment
Essential medicines for universal health coverage
Pamela Das, Richard Horton
Summary
Access to medicines has long been a potent flashpoint in global health, from antiretrovirals to drugs that cure hepatitis C. Indeed, as a new Lancet Commission report, Essential Medicines for Universal Health Coverage,1 asserts, essential medicines should be at the centre of our vision for global health, affecting, as they do, the lives and dignity of people worldwide. Led by Veronika Wirtz, Hans Hogerzeil, and Andy Gray, the Commission identifies lessons learned from 30 years of implementing essential medicines policies.

The Lancet Commissions
Essential medicines for universal health coverage
Veronika J Wirtz, Hans V Hogerzeil, Andrew L Gray, Maryam Bigdeli, Cornelis P de Joncheere, Margaret A Ewen, Martha Gyansa-Lutterodt, Sun Jing, Vera L Luiza, Regina M Mbindyo, Helene Möller, Corrina Moucheraud, Bernard Pécoul, Lembit Rägo, Arash Rashidian, Dennis Ross-Degnan, Peter N Stephens, Yot Teerawattananon, Ellen F M ‘t Hoen, Anita K Wagner, Prashant Yadav, Michael R Reich
Summary
Essential medicines satisfy the priority health-care needs of the population. Essential medicines policies are crucial to promoting health and achieving sustainable development. Sustainable Development Goal 3.8 specifically mentions the importance of “access to safe, effective, quality and affordable essential medicines and vaccines for all” as a central component of Universal Health Coverage (UHC), and Sustainable Development Goal 3.b emphasises the need to develop medicines to address persistent treatment gaps.

Nature
Volume 541 Number 7638 pp435-568 6 January 2017
http://www.nature.com/nature/current_issue.html
Editorials
Scientists must fight for the facts
President Trump’s unconventional stances cannot go unchallenged.

Vaccine initiative marks bold resolution
Preparation against future epidemic threats is a welcome and essential move.

New England Journal of Medicine
January 26, 2017  Vol. 376 No. 4
http://www.nejm.org/toc/nejm/medical-journal

Original Article
A Recombinant Vesicular Stomatitis Virus Ebola Vaccine
Jason A. Regules, M.D., John H. Beigel, M.D., Kristopher M. Paolino, M.D., Jocelyn Voell, R.N., M.S., Amy R. Castellano, L.P.N., Zonghui Hu, Ph.D., Paula Muñoz, B.S., James E. Moon, M.D., Richard C. Ruck, M.D., Jason W. Bennett, M.D., Patrick S. Twomey, M.D., Ramiro L. Gutiérrez, M.D., Shon A. Remich, M.D., Holly R. Hack, M.S., Meagan L. Wisniewski, Ph.D., Matthew D. Josleyn, M.S., Steven A. Kwilas, Ph.D., Nicole Van Deusen, B.S., Olivier Tshiani Mbaya, M.D., Yan Zhou, Ph.D., Daphne A. Stanley, M.S., Wang Jing, M.S., Kirsten S. Smith, Ph.D., Meng Shi, M.A., Julie E. Ledgerwood, D.O., Barney S. Graham, M.D., Nancy J. Sullivan, Ph.D., Linda L. Jagodzinski, Ph.D., Sheila A. Peel, M.S.P.H., Ph.D., Judie B. Alimonti, Ph.D., Jay W. Hooper, Ph.D., Peter M. Silvera, Ph.D., Brian K. Martin, Ph.D., Thomas P. Monath, M.D., W. Jay Ramsey, M.D., Ph.D., Charles J. Link, M.D., H. Clifford Lane, M.D., Nelson L. Michael, M.D., Ph.D., Richard T. Davey, Jr., M.D., and Stephen J. Thomas, M.D., for the rVSVΔG-ZEBOV-GP Study Group*
N Engl J Med 2017; 376:330-341January 26, 2017DOI: 10.1056/NEJMoa1414216

Abstrat
Background
The worst Ebola virus disease (EVD) outbreak in history has resulted in more than 28,000 cases and 11,000 deaths. We present the final results of two phase 1 trials of an attenuated, replication-competent, recombinant vesicular stomatitis virus (rVSV)–based vaccine candidate designed to prevent EVD.
Full Text of Background…

Methods
We conducted two phase 1, placebo-controlled, double-blind, dose-escalation trials of an rVSV-based vaccine candidate expressing the glycoprotein of a Zaire strain of Ebola virus (ZEBOV). A total of 39 adults at each site (78 participants in all) were consecutively enrolled into groups of 13. At each site, volunteers received one of three doses of the rVSV-ZEBOV vaccine (3 million plaque-forming units [PFU], 20 million PFU, or 100 million PFU) or placebo. Volunteers at one of the sites received a second dose at day 28. Safety and immunogenicity were assessed.
Full Text of Methods…

Results
The most common adverse events were injection-site pain, fatigue, myalgia, and headache. Transient rVSV viremia was noted in all the vaccine recipients after dose 1. The rates of adverse events and viremia were lower after the second dose than after the first dose. By day 28, all the vaccine recipients had seroconversion as assessed by an enzyme-linked immunosorbent assay (ELISA) against the glycoprotein of the ZEBOV-Kikwit strain. At day 28, geometric mean titers of antibodies against ZEBOV glycoprotein were higher in the groups that received 20 million PFU or 100 million PFU than in the group that received 3 million PFU, as assessed by ELISA and by pseudovirion neutralization assay. A second dose at 28 days after dose 1 significantly increased antibody titers at day 56, but the effect was diminished at 6 months.
Full Text of Results…

Conclusions
This Ebola vaccine candidate elicited anti-Ebola antibody responses. After vaccination, rVSV viremia occurred frequently but was transient. These results support further evaluation of the vaccine dose of 20 million PFU for preexposure prophylaxis and suggest that a second dose may boost antibody responses.

(Funded by the National Institutes of Health and others; rVSV∆G-ZEBOV-GP ClinicalTrials.gov numbers, NCT02269423 and NCT02280408.)

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 28 January 2017]

Research Article
Rapid Molecular Detection of Zika Virus in Acute-Phase Urine Samples Using the Recombinase Polymerase Amplification Assay
January 25, 2017 ·
Background: Currently the detection of Zika virus (ZIKV) in patient samples is done by real-time RT-PCR. Samples collected from rural area are sent to highly equipped laboratories for screening. A rapid point-of-care test is needed to detect the virus, especially at low resource settings.

Methodology/Principal Findings: In this report, we describe the development of a reverse transcription isothermal recombinase polymerase amplification (RT-RPA) assay for the identification of ZIKV. RT-RPA assay was portable, sensitive (21 RNA molecules), and rapid (3-15 minutes). No cross-reactivity was detected to other flaviviruses, alphaviruses and arboviruses. Compared to real-time RT-PCR, the diagnostic sensitivity was 92%, while the specificity was 100%.

Conclusions/Significance: The developed assay is a promising platform for rapid point of need detection of ZIKV in low resource settings and elsewhere (e.g. during mass gathering).

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 28 January 2017)

Health in Action
Bolstering Community Cooperation in Ebola Resurgence Protocols: Combining Field Blood Draw and Point-of-Care Diagnosis
Mosoka P. Fallah, Laura A. Skrip, Philomena Raftery, Miata Kullie, Watta Borbor, A. Scott Laney, David J. Blackley, Athalia Christie, Emily Kainne Dokubo, Terrence Q. Lo, Stewart Coulter, April Baller, Benjamin T. Vonhm, Philip Bemah, Sowillie Lomax, Adolphus Yeiah, Yatta Wapoe-Sackie, Jennifer Mann, Peter Clement, Gloria Davies-Wayne, Esther Hamblion, Caitlin Wolfe, Desmond Williams, Alex Gasasira, Francis Kateh, Tolbert G. Nyenswah, Alison P. Galvani
| published 24 Jan 2017 PLOS Medicine
http://dx.doi.org/10.1371/journal.pmed.1002227

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 28 January 2017)

Research Article
A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries
David J. Diemert, Lucas Lobato, Ashley Styczynski, Maria Zumer, Amanda Soares, Maria Flávia Gazzinelli
| published 23 Jan 2017 PLOS Neglected Tropical Diseases
http://dx.doi.org/10.1371/journal.pntd.0005327
[Uncorrected proof]
Abstract
Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States.

A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants’ understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC.

Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there was no difference in the rate of correct answers between participants in Belo Horizonte and Washington, DC, there was a significant gap between participants at these two locations compared to Americaninhas (p = 0.0002 and p = 0.0001, respectively), which had a lower percentage of correct answers. Attitudes towards participating in the clinical trial also differed by site: while approximately 40% had doubts about participating in Washington, DC and Belo Horizonte, only 1.5% had concerns in Americaninhas. Finally, in Belo Horizonte and Washington, high percentages cited a desire to help others as motivation for participating, whereas in Americaninhas, the most common reason for participating was personal interest (p = 0.001).

Understanding of information about a Phase 1 clinical trial of an experimental hookworm vaccine following informed consent was suboptimal, regardless of study site. Although overall there were no differences in knowledge between Brazil and the US, a lower level of understanding about the trial was seen in participants at the rural, resource-limited Brazilian site. These findings demonstrate the need for educational interventions directed at potential clinical trial participants, both in developing and developed countries, in order to improve understanding of the informed consent document.

Author Summary
Informed consent is an essential element of the ethical conduct of clinical trials of new vaccines, regardless of the study setting. However, the quality of informed consent is often suboptimal. Some research has suggested that the quality of the informed consent process may be reduced in resource-limited areas compared to developed country settings. To test this, we conducted a study of the quality of the informed consent process in two similar Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adult volunteers in Brazil and in the United States. In Brazil, the trial was conducted at two sites, one a large urban area (Belo Horizonte), and the other a rural, resource-limited region of the state of Minas Gerais; in the United States, the trial was conducted in Washington, DC. A structured questionnaire was administered after the informed consent document was signed at each of the three clinical trial sites, which tested understanding about the information contained in the document and attitudes toward the volunteers’ participation in the clinical trial. The results indicate that there were no substantial differences between the overall quality of the informed consent obtained from participants in the United States and in Brazil. However, a significant association was found between the particular site where the trial was conducted and the quality of the informed consent process, with residents of the site in rural Brazil having the lowest percentage of correct answers on the informed consent questionnaire. The informed consent process should therefore take into account the specific characteristics of the population in which the trial is being conducted.

PLoS One
http://www.plosone.org/
[Accessed 28 January 2017]

Research Article
Justice Is the Missing Link in One Health: Results of a Mixed Methods Study in an Urban City State
Tamra Lysaght, Benjamin Capps, Michele Bailey, David Bickford, Richard Coker, Zohar Lederman, Sangeetha Watson, Paul Anantharajah Tambyah
Research Article | published 27 Jan 2017 PLOS ONE

Abstract
Background
One Health (OH) is an interdisciplinary collaborative approach to human and animal health that aims to break down conventional research and policy ‘silos’. OH has been used to develop strategies for zoonotic Emerging Infectious Diseases (EID). However, the ethical case for OH as an alternative to more traditional public health approaches is largely absent from the discourse. To study the ethics of OH, we examined perceptions of the human health and ecological priorities for the management of zoonotic EID in the Southeast Asia country of Singapore.

Methods
We conducted a mixed methods study using a modified Delphi technique with a panel of 32 opinion leaders and 11 semi-structured interviews with a sub-set of those experts in Singapore. Panellists rated concepts of OH and priorities for zoonotic EID preparedness planning using a series of scenarios developed through the study. Interview data were examined qualitatively using thematic analysis.

Findings
We found that panellists agreed that OH is a cross-disciplinary collaboration among the veterinary, medical, and ecological sciences, as well as relevant government agencies encompassing animal, human, and environmental health. Although human health was often framed as the most important priority in zoonotic EID planning, our qualitative analysis suggested that consideration of non-human animal health and welfare was also important for an effective and ethical response. The panellists also suggested that effective pandemic planning demands regional leadership and investment from wealthier countries to better enable international cooperation.

Conclusion
We argue that EID planning under an OH approach would benefit greatly from an ethical ecological framework that accounts for justice in human, animal, and environmental health.

PLoS One
http://www.plosone.org/
[Accessed 28 January 2017]

Influenza Vaccination of Healthcare Workers Is an Important Approach for Reducing Transmission of Influenza from Staff to Vulnerable Patients
Andrew C. Hayward
Formal Comment | published 27 Jan 2017 PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0169023

Influenza Vaccination of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement
Gaston De Serres, Danuta M. Skowronski, Brian J. Ward, Michael Gardam, Camille Lemieux, Annalee Yassi, David M. Patrick, Mel Krajden, Mark Loeb, Peter Collignon, Fabrice Carrat
Research Article | published 27 Jan 2017 PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0163586

PLoS One
http://www.plosone.org/
[Accessed 28 January 2017]

Barriers of Influenza Vaccination Intention and Behavior – A Systematic Review of Influenza Vaccine Hesitancy, 2005 – 2016
Philipp Schmid, Dorothee Rauber, Cornelia Betsch, Gianni Lidolt, Marie-Luisa Denker
Research Article | published 26 Jan 2017 PLOS ONE
http://dx.doi.org/10.1371/journal.pone.0170550

Abstract
Background
Influenza vaccine hesitancy is a significant threat to global efforts to reduce the burden of seasonal and pandemic influenza. Potential barriers of influenza vaccination need to be identified to inform interventions to raise awareness, influenza vaccine acceptance and uptake.

Objective
This review aims to (1) identify relevant studies and extract individual barriers of seasonal and pandemic influenza vaccination for risk groups and the general public; and (2) map knowledge gaps in understanding influenza vaccine hesitancy to derive directions for further research and inform interventions in this area.

Methods
Thirteen databases covering the areas of Medicine, Bioscience, Psychology, Sociology and Public Health were searched for peer-reviewed articles published between the years 2005 and 2016. Following the PRISMA approach, 470 articles were selected and analyzed for significant barriers to influenza vaccine uptake or intention. The barriers for different risk groups and flu types were clustered according to a conceptual framework based on the Theory of Planned Behavior and discussed using the 4C model of reasons for non-vaccination.

Results
Most studies were conducted in the American and European region. Health care personnel (HCP) and the general public were the most studied populations, while parental decisions for children at high risk were under-represented. This study also identifies understudied concepts. A lack of confidence, inconvenience, calculation and complacency were identified to different extents as barriers to influenza vaccine uptake in risk groups.

Conclusion
Many different psychological, contextual, sociodemographic and physical barriers that are specific to certain risk groups were identified. While most sociodemographic and physical variables may be significantly related to influenza vaccine hesitancy, they cannot be used to explain its emergence or intensity. Psychological determinants were meaningfully related to uptake and should therefore be measured in a valid and comparable way. A compendium of measurements for future use is suggested as supporting information.

Vaccine
Volume 35, Issue 5, Pages 713-850 (1 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/5

Regular paper
Writing a scientific paper—A brief guide for new investigators
Original Research Article
Pages 722-728
Caroline L. Vitse, Gregory A. Poland

Abstract
When applying for funding, researchers must demonstrate their productivity. For most funding organizations, a key measure of productivity is the number of papers published. The road to publication is rarely straightforward; few journals provide practical guidance to researchers who are struggling to publish their data. Here, we outline the sections of a research paper and describe practical steps in each part of the publication process as an aid to newer authors.

Vaccine
Volume 35, Issue 5, Pages 713-850 (1 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/5

Regular paper
Evaluating the first introduction of rotavirus vaccine in Thailand: Moving from evidence to policy
Original Research Article
Pages 796-801
Piyanit Tharmaphornpilas, Suchada Jiamsiri, Somchit Boonchaiya, Onwipa Rochanathimoke, Wiravan Thinyounyong, Sumana Tuntiwitayapun, Ratigorn Guntapong, Arthorn Riewpaiboon, Aim-on Rasdjarmrearnsook, Roger I. Glass

Abstract
Background
We assessed the effectiveness and possible impact of introducing rotavirus vaccine into the routine immunization program.

Methods
Two provinces were selected for an observational study, one where vaccine was introduced and another where vaccine was not available. In these areas, two sub-studies were linked. The prospective cohort study enrolled children 2 month old and followed them to the age of 18 months to detect all diarrhea episodes. The hospital surveillance study enrolled all children up to age 5 hospitalized with diarrhea whose fecal samples were tested for rotavirus. Rates of rotavirus hospitalizations in older children who had not been vaccinated in both settings provided data to determine whether immunization had an indirect herd effect. The key endpoints for the study were both vaccine effectiveness (VE) based upon hospitalized rotavirus diarrhea and herd protection.

Findings
From the cohort study, the overall VE for hospitalized rotavirus diarrhea was 88% (95%CI 76–94). Data from hospital surveillance indicated that for 2 consecutive years, the seasonal peak of rotavirus admissions was no longer present in the vaccinated area. Herd protection was observed among older children born before the rotavirus vaccine program was introduced, who experienced a 40–69% reduction in admission for rotavirus.

Conclusions
Rotavirus vaccine was highly effective in preventing diarrheal hospitalizations and in conferring herd protection among older children who had not been vaccinated.

Vaccine
Volume 35, Issue 5, Pages 713-850 (1 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/5

Regular paper
Associations of trust and healthcare provider advice with HPV vaccine acceptance among African American parents
Original Research Article
Pages 802-807
Linda Y. Fu, Gregory D. Zimet, Carl A. Latkin, Jill G. Joseph

Abstract
Objective
Healthcare providers (HCPs) are advised to give all parents a strong recommendation for HPV vaccination. However, it is possible that strong recommendations could be less effective at promoting vaccination among African Americans who on average have greater mistrust in the healthcare system. This study examines the associations of parental trust in HCPs and strength of HCP vaccination recommendation on HPV vaccine acceptance among African American parents.

Methods
Participants were recruited from an urban, academic medical center between July 2012 and July 2014. We surveyed 400 African American parents of children ages 10–12 years who were offered HPV vaccine by their HCPs to assess sociodemographic factors, vaccine beliefs, trust in HCPs, and the HPV vaccine recommendation received. Medical records were reviewed to determine vaccination receipt.

Results
In multivariable analysis, children whose parents were “very strongly” recommended the HPV vaccine had over four times higher odds of vaccine receipt compared with those whose parents were “not very strongly” recommended the vaccine. Having a parent with “a lot of” versus “none” or only “some” trust in HCPs was associated with over twice the odds of receiving HPV vaccine. Very strong HCP recommendations were associated with higher odds of vaccination among all subgroups, including those with more negative baseline attitudes toward HPV vaccine and those with lower levels of trust. Adding the variables strength of HCP recommendation and parental trust in HCPs to a multivariable model already adjusted for sociodemographic factors and parental vaccine beliefs improved the pseudo R2 from 0.52 to 0.55.

Conclusions
Among participants, receiving a strong vaccine recommendation and having a higher level of trust in HCPs were associated with higher odds of HPV vaccination, but did not add much to the predictive value of a model that already adjusted for baseline personal beliefs and sociodemographic factors.

Vaccine
Volume 35, Issue 5, Pages 713-850 (1 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/5

Regular paper
Text messages for influenza vaccination among pregnant women: A randomized controlled trial
Original Research Article
Pages 842-848
Mark H. Yudin, Niraj Mistry, Leanne R. De Souza, Kate Besel, Vishal Patel, Sonia Blanco Mejia, Robyn Bernick, Victoria Ryan, Marcelo Urquia, Richard H. Beigi, Michelle H. Moniz, Michael Sgro

Abstract
Objective
To evaluate if text message reminders increase the likelihood of receiving the influenza vaccine among pregnant women.

Methods
Pregnant women were randomized to either receive or not receive weekly text messages. Women were told the messages would be about health-related behavior in pregnancy. Those randomized to the intervention group received two messages weekly for four consecutive weeks reinforcing that the influenza vaccine is recommended for all pregnant women and safe during pregnancy and breastfeeding. Women were contacted six weeks postpartum to determine if they had received the vaccine. Sample size calculation determined that 108 women were required in both groups to see a 75% increase in vaccination rates over baseline in the text message group compared to the control group.

Results
Recruitment began November 4, 2013, and 317 women were randomized. The mean gestational age at recruitment was 22 weeks. There were 40/129 (31%) women in the text message group and 41/152 (27%) women in the control group who received the vaccine (p = 0.51). Significant predictors of vaccine acceptance were being married compared to single (95% vs. 67%, p < 0.001), having higher household income (55% vs. 39%, p = 0.03) and having received the vaccine before (77% vs. 36%, p < 0.001). Among women receiving text messages, the majority were satisfied, with only 15/129 (12%) reporting that they did not like receiving the messages, and 24/129 (19%) stating that the information in the messages was not helpful.

Conclusion
Weekly text messages reinforcing the recommendation for and safety of the influenza vaccine in pregnancy did not increase the likelihood of actually receiving the vaccine among pregnant women. Overall vaccination rates were low, highlighting the need for patient education and innovative techniques to improve vaccine acceptance.

Registered with ClinicalTrials.gov at http://www.clinicaltrials.gov, registration number NCT 02428738.

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.

BBC
http://www.bbc.co.uk/
Accessed 28 January 2017
Brazil orders 11.5 million yellow fever vaccine doses
26 January 2017
Brazil’s health ministry has ordered 11.5 million doses of yellow fever vaccine amid the largest outbreak of the disease in the country since 2000.
Seventy cases – including 40 deaths – are confirmed, mostly in rural areas of the state of Minas Gerais. More than 300 cases are under investigation.
Vaccinations are being recommended for people travelling to Minas and other areas with confirmed cases…

Forbes
http://www.forbes.com/
Accessed 28 January 2017
Letting Seriously Ill Patients Try Drugs Whose Safety, Efficacy Hasn’t Been Proven Could Be Deadly
Rita Rubin, Contributor
Critics of the Food and Drug Administration, including at least one person under consideration to serve as its commissioner, accuse the agency of unnecessarily dragging out the drug approval process at a cost to both manufacturers and desperately ill patients.
But a new FDA report makes the point that the early promise of experimental treatments doesn’t always pan out. The report includes examples of 16 drugs, five vaccines and one device, a heart stent, that appeared to be safe and effective in phase 2 trials, which usually involve a few hundred patients, but failed on one or both counts in much larger, more rigorous phase 3 trials…

Foreign Policy

Home

Accessed 28 January 2017
Deadly Yellow Fever Outbreak in Brazil Sparks Fears of Zika-Like Epidemic
23 January 2017
By Robbie Gramer
… Brazil has recorded 25 deaths, 47 cases, and 160 suspected cases of yellow fever as of Monday. “The introduction of the virus in these areas could potentially trigger large epidemics of yellow fever,” the World Health Organization (WHO) warned in a statement released on Jan. 13 as the outbreak first emerged.
The WHO is concerned yellow fever could quickly spread from the outbreak’s ground zero to other states in the north and west because of the region’s low rates of vaccinations and mosquito-friendly environments. The governor of Minas Gerais declared a state of emergency, while the Brazilian Ministry of Health deployed technical teams to respond to and surveil the outbreak. The WHO said the Zika virus “further complicated” Brazil’s response to the yellow fever outbreak…

New York Times

Accessed 28 January 2017
China Jails Two Over Vaccine Scandal
January 24, 2017 – By REUTERS
BEIJING — A court in China on Tuesday jailed two people for selling vaccines without a license, state media said, after a scandal last year that sparked public anger.
The case, involving possibly as much as $90 million of illegal trades of vaccines through a black market drugs ring, underscored regulatory weaknesses in the world’s second largest pharmaceuticals market.
The court in Jinan city sentenced Pang Hongwei to 15 years in prison for illegally purchasing vaccines, including rabies vaccines, which she stored in warehouses in Jinan and another city, before selling them around China, Xinhua news agency said.
Pang improperly stored the vaccines she bought, and earned nearly 75 million yuan ($10.93 million) from selling them, Xinhua added.
She was also given another six years for a previous accusation of illegally trading vaccines, and so will serve a total of 19 years, the news agency said.

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 28 January 2017
Business
Latest Bout of Bird Flu Threatens U.S. Poultry Flocks
By Kelsey Gee
Jan. 26, 2017 10:24 pm ET
Avian influenza is spreading rapidly across Europe and Asia, roiling the global poultry industry as farmers destroy millions of infected birds…

Think Tanks et al

Center for Global Development
http://www.cgdev.org/page/press-center
Accessed 28 January 2017

A Global Treaty to Reduce Antimicrobial Use in Livestock
1/25/17
Kimberly Ann Elliott , Charles Kenny and Janeen Madan
While the misuse of antimicrobials in human health is a key factor accelerating the emergence of drug resistance, we should not overlook the role of agriculture. This paper makes the case for a global treaty to reduce antimicrobial use in livestock.

Milestones :: Perspectives

Global partnership launched to prevent epidemics with new vaccines
Media release, Davos 18 Jan 2017 – Coalition for Epidemic Preparedness Innovations
A global coalition to create new vaccines for emerging infectious diseases, designed to help give the world an insurance policy against epidemics, launches today at the World Economic Forum in Davos, Switzerland.

With an initial investment of US$460m from the governments of Germany, Japan and Norway, plus the Bill & Melinda Gates Foundation and the Wellcome Trust, CEPI – the Coalition for Epidemic Preparedness Innovations will seek to outsmart epidemics by developing safe and effective vaccines against known infectious disease threats that could be deployed rapidly to contain outbreaks, before they become global health emergencies.

CEPI also hopes to shorten the time it takes to develop new vaccines to protect against viruses that emerge suddenly as public health threats, as Zika did recently, by capitalising on exciting developments in adaptable vaccine technology and investing in facilities that could respond quickly to previously unknown pathogens.

Today’s financial commitments mean that CEPI has raised almost half of the $1bn it needs for its first five years, and it is now calling for proposals from researchers and companies around the world to support the development of vaccines against its first target diseases.

CEPI will initially target the MERS-CoV, Lassa and Nipah viruses, which have known potential to cause serious epidemics. It aims to develop two promising vaccine candidates against each of these diseases before any epidemic, so these are available without delay if and when an outbreak begins. CEPI will also scope out potential support for vaccines against multiple strains of the Ebola and Marburg viruses, and Zika.

To achieve all these goals, CEPI will need significant additional investment, and the initial CEPI funders are calling today for other governments and philanthropic organisations to join them in helping to protect the world against future epidemics. CEPI is looking to complete its fundraising by the end of 2017.

Erna Solberg, Prime Minister of Norway, said: “Just over a year ago 193 states adopted the Sustainable Development Goals – the roadmap for the future we want. Epidemics threaten that future. They can ruin societies on a scale only matched by wars and natural disasters. They respect no borders and don’t care if we are rich or poor. Protecting the vulnerable is protecting ourselves. This is why we all must work together to be better prepared – and why my Government is fully committed to ensure that CEPI achieves its mission.”

Bill Gates, Co-chair of the Bill and Melinda Gates Foundation, said: “Ebola and Zika showed that the world is tragically unprepared to detect local outbreaks and respond quickly enough to prevent them from becoming global pandemics. Without investments in research and development, we will remain unequipped when we face the next threat.

“The ability to rapidly develop and deliver vaccines when new ‘unknown’ diseases emerge offers our best hope to outpace outbreaks, save lives and avert disastrous economic consequences. CEPI is a great example of how supporting innovation and R&D can help the world to address some of its most pressing health challenges.”

Dr Jeremy Farrar, Director of the Wellcome Trust, said: “We know from Ebola, Zika and SARS that epidemics are among the significant threats we face to life, health and prosperity. Vaccines can protect us, but we’ve done too little to develop them as an insurance policy. CEPI is our chance to learn the lessons of recent tragedies, and outsmart epidemics with new vaccine defences. If others join us in supporting CEPI, we can realise our goal of creating a safer world.”

CEPI is a direct response to calls from four independent expert reports into the Ebola epidemic for a new system for stimulating the development of vaccines against epidemic threats. It was founded by the governments of India and Norway, the Bill & Melinda Gates Foundation, Wellcome and the World Economic Forum, which has played a key convening role, bringing together stakeholders at the 2016 Davos meeting and other events.

CEPI is also backed by major pharmaceutical corporations, the World Health Organization and Médecins Sans Frontières / Doctors Without Borders, as well as philanthropies and leading academic vaccine research groups.

The Government of India is currently finalising the level of a significant funding commitment to CEPI. In addition to financing for vaccine development that will be available through CEPI’s pooled fund, the European Commission will contribute to CEPI’s objectives and plans to co-fund actions with CEPI, such as through the Innovative Medicines Initiative (IMI).

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Wellcome Trust [to 21 January 2017]
https://wellcome.ac.uk/news
News / Published: 18 January 2017
Global fund to outsmart epidemics
Wellcome is committing $100m to a new partnership to create vaccines for epidemic diseases.
CEPI – the Coalition for Epidemic Preparedness Innovation – launches on Thursday 19 January at the World Economic Forum in Davos, Switzerland.

A collaboration between government, industry, philanthropy and civil society, CEPI will finance and coordinate development of vaccines against known infectious diseases.
Wellcome is a founding partner of CEPI and is providing $100m over five years – part of $460m funding from initial investors.

CEPI needs to raise $1bn in its first five years. Wellcome is joining initial funders in calling on other governments and philanthropic organisations to add their support…

.
News / Published: 17 January 2017
Ebola vaccine development: still more to be done
A panel of international experts has called for continued commitment to Ebola vaccine development to fully prepare for the next outbreak.
The Ebola vaccine developed during the West African epidemic is the first to be shown to be shown to be safe and effective against the disease. But the third report from Wellcome and the University of Minnesota’s CIDRAP Ebola Team B stresses that there are still critical gaps in preparedness for the next inevitable outbreak.

Safe, effective and durable multivalent Ebola vaccines are critical for preventing outbreaks and quickly halting future outbreaks when they occur.
They are also necessary to prove that vaccines against other neglected or emerging infectious diseases can be successfully developed.

“The success of future efforts will depend on our continued action with the Ebola vaccine,” says Wellcome’s Director Jeremy Farrar, who co-chaired the report. “We must maintain the sense of urgency that has pushed this work forward in previous years.”

Today’s report identifies three main areas where work is still needed if Ebola is to no longer be a public health threat:
:: tracking progress to ensure multivalent Ebola vaccines are readily available and can be rapidly deployed
: identifying where additional effort is needed to overcome challenges and barriers
:: creating high-level recommendations for a robust Ebola virus disease prevention programme that includes prophylactive vaccination of frontline workers and provides vaccine stockpiles.

The group also recommends creating an international consortium to champion Ebola vaccines.
The final results from the trials of the rVSV-ZEBOV vaccine were published in December 2016 and confirm that it provides a high level of protection against the disease.
The vaccine, made by Merck, Sharpe & Dohme, was developed rapidly during the epidemic but came too late to have a significant impact on the outbreak.
Report available on the CIDRAP website.

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BIO Applauds Launch of Coalition for Epidemic Preparedness Innovations
Coalition aims to fill critical gaps in global infectious disease readiness
January 19, 2017 03:00 AM Eastern Standard Time
WASHINGTON–(BUSINESS WIRE)–The Biotechnology Innovation Organization (BIO) applauds today’s launch of the Coalition for Epidemic Preparedness Innovations (CEPI), a new alliance to finance and coordinate the development of vaccines to prevent and contain infectious disease epidemics, at the World Economic Forum in Davos, Switzerland.
“CEPI’s public-private partnership model has the potential to close those gaps, particularly those which the private sector alone is unable to address due to the lack of a sufficient potential market for such technologies.”

Vaccines have long been one of the most important and effective public health interventions, preventing millions of illnesses and deaths around the world. However, as we have seen in recent years with devastating Ebola and Zika virus pandemics, critical gaps remain in the global public health arsenal to combat emerging infectious diseases,” said BIO President and CEO Jim Greenwood. “CEPI’s public-private partnership model has the potential to close those gaps, particularly those which the private sector alone is unable to address due to the lack of a sufficient potential market for such technologies.”

“Only by working together can we address barriers to vaccine development and prevent and contain infectious global health epidemics. Working alone, industry players face barriers to vaccine development. CEPI’s collaborative approach is vital in helping biotechs and other industry leaders pursue innovative efforts to help prepare against future pandemics and fight against global public health threats,” said Nima Farzan, PaxVax President and CEO and the Biotechnology Innovation Organization (BIO) delegate on the board of the Coalition for Epidemic Preparedness Innovations.

“Innovative vaccines companies are eager to partner with CEPI to tackle the many daunting challenges in epidemic preparedness facing the global health community. By combining the resources, expertise and global reach of many public, private and philanthropic global health stakeholders, CEPI will make possible progress on a scale not previously possible,” said Julie Gerberding, M.D., M.P.H., and Executive Vice President for Strategic Communications, Global Public Policy and Population Health for Merck & Co Inc. Dr. Gerberding also serves on the Board of Directors for CEPI…

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22 Biopharma Companies Partner and Launch First-of-its-kind Global Initiative to Address Rise of Non-Communicable Diseases
18 January 2017
:: Global, multi-stakeholder collaboration, called Access Accelerated, to be delivered in partnership with World Bank Group and Union for International Cancer Control (UICC)
:: Initial three-year commitment will catalyze, develop, measure and replicate sustainable programs in low and lower-middle income countries
: Collective funding of $50 million and increased individual company program commitments to address NCDs
Davos, Switzerland, January 18, 2017 — Today at the World Economic Forum, twenty-two leading biopharmaceutical companies launched Access Accelerated, a global initiative to advance access to non-communicable disease (NCD) prevention and care in low and lower-middle income countries (LICs and LMICs).

NCDs have reached a point of crisis, particularly in lower and middle income countries, where nearly 80 percent of NCD-related deaths occur. The goal of Access Accelerated, in partnership with the World Bank Group and the Union for International Cancer Control (UICC), is to work towards the United Nations Sustainable Development Goal (SDG) target to reduce premature deaths from NCDs by one-third by 2030.

“Through the commitment and expertise of the Access Accelerated partners, we will work towards a shared vision where no person dies prematurely from a preventable, treatable disease,” said Ian Read, Chief Executive Officer of Pfizer and President of The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), on behalf of the initiative. “If the current trend in NCDs in low- and lower-middle countries is not reversed, there is a real possibility we will undermine the progress we have made in health around the world. To reach our goal, we need to catalyze new partnerships, learn quickly and advance the resources and knowledge that will enable countries to tackle NCDs.”

Building on long-standing individual company investments in global health, Access Accelerated will address a variety of access barriers to NCD prevention, treatment and care. Efforts will be evaluated with the support of independent experts at Boston University to establish a framework for progress, measure effectiveness and deliver ongoing reporting.

With the World Bank Group the initiative will identify solutions to address financing, regulatory and service delivery barriers at country level. Additionally, the World Bank Group will conduct pilots in primary care to improve NCD outcomes in several countries.

“The rapid increase in NCDs in developing countries is a serious threat to our goal of improving the health of the world’s poorest citizens and achieving universal health coverage,” said Tim Evans, Senior Director of Health, Nutrition and Population at the World Bank Group. “Tackling this successfully will take coordinated effort by governments, civil society, the private sector and international partners. This new effort is an opportunity for all players to test and scale up innovative ways to deliver effective care for NCDs, with a strong focus on primary health care.”…

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140th session of the Executive Board
23 January–1 February 2017, Geneva
FOLLOW LIVE: Executive Board
The Executive Board will open at 09:30 on Monday 23 January 2017 and can be watched live via webcast. The discussions will be translated into the six UN official languages: Arabic, Chinese, English, French, Russian and Spanish.
During the meeting, WHO’s Executive Board will draw up a short list of 5 candidates on Tuesday 24 January. The following day the Executive Board members will then interview the five candidates and up to three of them to go forward to the World Health Assembly in May 2017.
Live web stream (begins 09:30 CET on Monday 23 January 2017)

Provisional agenda
Main Documents [Selected]
EB140/7
Health emergencies
WHO response in severe, large-scale emergencies

EB140/9
Research and development for potentially epidemic diseases
A blueprint for research and development preparedness and rapid research response

EB140/13
Poliomyelitis

EB140/14
Implementation of the International Health Regulations (2005)
Draft global implementation plan

EB140/15
Implementation of the International Health Regulations (2005)
Public health implications of the implementation of the Nagoya Protocol

EB140/16
Review of the Pandemic Influenza Preparedness Framework

EB140/25
Global vaccine action plan

Emergencies

WHO Grade 3 Emergencies [to 21 January 2017]
The Syrian Arab Republic –
:: Joint Statement on Syria 16 January 2017

Iraq –
:: Read the health situation report from Mosul pdf, 646kb 14 January 2016

South Sudan – No new announcements identified.
Nigeria – See measles immunization campaign announcement above.
Yemen – No new announcements identified.

WHO Grade 2 Emergencies [to 21 January 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.

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. 16 (9 January – 15 January 2017) [EN/AR/KU]

Syria
:: Syrian Arab Republic: Aleppo Situation Report No. 14 (20 January 2017)
:: 16 Jan 2017 Joint statement on Syria – WFP, UNICEF, OCHA, WHO, UNHCR
[See full text below]

Yemen
:: 18 Jan 2017 Yemen: Cholera Outbreak Situation Report | As of 15 Jan 2017

Corporate Emergencies
Haiti
:: Haiti: Hurricane Matthew Situation Report No. 32 (17 January 2017)

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Joint Statement on Syria- WFP, UNICEF, OCHA, WHO, UNHCR
WFP Executive Director Ertharin Cousin
UNICEF Executive Director Anthony Lake
Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator Stephen O’Brien
WHO Director-General Dr Margaret Chan
United Nations High Commissioner for Refugees Filippo Grandi

DAVOS, Switzerland, January 16, 2017– While efforts to fully implement a ceasefire in Syria continue, we again appeal for immediate, unconditional, and safe access to reach the children and families who are still cut off from humanitarian aid across the country.

In Syria today, there are 15 besieged areas where up to 700,000 people, including an estimated 300,000 children, still remain trapped. Nearly five million people, including more than two million children, live in areas that are extremely difficult to reach with humanitarian assistance due to fighting, insecurity and restricted access.

All over Syria, people continue to suffer because they lack the most basic elements to sustain their lives – and because of the continued risk of violence.  We – indeed, the world – must not stand silent while parties to the conflict continue to use denial of food, water, medical supplies, and other forms of aid as weapons of war.

Children are at heightened risk of malnutrition, dehydration, diarrhoea, infectious diseases, and injury. Many need support after being exposed to traumatic events, violence and other violations.  Tragically, far too many children have known little but conflict and loss in their young lives.

The horrors of the siege of the eastern districts of Aleppo have disappeared from the public consciousness – but we must not let the needs, the lives and the futures of Syria’s people fade from the world’s conscience.

We must not let 2017 repeat the tragedies of 2016 for Syria.

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Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO pages for updates and key developments.

MERS-CoV [to 21 January 2017]
http://www.who.int/emergencies/mers-cov/en/
Disease Outbreak News [DONs]
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 17 January 2017

Zika virus [to 21 January 2017]
http://www.who.int/emergencies/zika-virus/en/

Zika situation report – 20 January 2017
Full report: http://apps.who.int/iris/bitstream/10665/253604/1/zikasitrep20Jan17-eng.pdf?ua=1
…Analysis
Overall, the global risk assessment has not changed. Zika virus continues to spread geographically to areas where competent vectors are present. Although a decline in cases of Zika infection has been reported in some countries, or in some parts of countries, vigilance needs to remain high.

POLIO [to 21 January 2017]
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 17 January 2017
:: Independent Monitoring Board (IMB) – changes to its membership: The IMB, established in 2010 to independently monitor progress towards a polio-free world, is undertaking changes to its membership. Under the guidance of the IMB and its chair, Sir Liam Donaldson, polio has been restricted to areas of just three countries: Pakistan, Afghanistan and Nigeria. To help achieve a polio-free world, the structure and composition of the IMB is now being revisited, in particular to strengthen its remit to focus solely on Objective 1 of the Polio Endgame Plan – detection and interruption of poliovirus transmission. At the request of the Polio Oversight Board (POB), Sir Liam will continue to chair the IMB and will form a selection committee to identify a new set of members. A call for nomination will be issued over the coming weeks. The GPEI owe a great debt of gratitude for the invaluable contribution that the current members of the IMB have made to this historic endeavour, and we look forward to working with the new, re-structured IMB to lead us over the finish line.

Country Updates [Selected Excerpts]

Afghanistan
:: One new wild poliovirus type 1 (WPV1) case was reported in the past week from Bermal district, Paktika province, with onset of paralysis on 16 December 2016.  This brings the total number of WPV1 cases for 2016 to 13.  More than half of the country’s cases in 2016 are from Bermal district.
:: One new environmental WPV1 positive sample was reported in the past week from Jalalabad, Nangarhar, collected on 26 December 2016.

Pakistan
:: One new wild poliovirus type 1 (WPV1) case was reported in the past week, from Killa Abdullah, Balochistan, with onset of paralysis on 22 December 2016. This brings the total number of WPV1 cases for 2016 to 20.
:: One new circulating vaccine-derived poliovirus type 2 (cVDPV2) positive environmental sample was reported in the past week, from Quetta, Balochistan, collected on 28 December 2016. This isolate is linked to an ongoing, confirmed cVDPV2 outbreak currently affecting Quetta.

Nigeria
:: A circulating vaccine-derived poliovirus type 2 (cVDPV2) has been detected from Bodinga Local Government Area (LGA), Sokoto state. Two genetically-related viruses were isolated from an acute flaccid paralysis (AFP) case with onset of paralysis on 28 October 2016, and from a healthy community contact, collected on 24 November.

Lake Chad Basin
:: The detection of wild poliovirus type 1 (WPV1) and vaccine-derived poliovirus type 2 (VDPV2) in Nigeria poses a risk to the neighbouring countries of the Lake Chad basin and hence an outbreak response plan is being implemented as part of the response to the Nigeria outbreak.

WHO & Regional Offices [to 21 January 2017]

140th session of the Executive Board
23 January–1 February 2017, Geneva
[see selected main documents summary and live webcast information above]

Finding priorities for health research and development
20 January 2017 – Today’s investments in health R&D are poorly aligned with global public health needs. As little as 1% of all funding for health R&D is allocated to diseases such as malaria and tuberculosis, although they account for more than 12% of the global disease burden. The WHO Global Observatory on Health R&D builds on existing data to enable decisions on R&D priorities.

Disease Outbreak News [DONs]
:: Human infection with avian influenza A(H7N9) virus – China 18 January 2017
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 17 January 2017
:: Human infection with avian influenza A(H7N9) virus – China 17 January 2017

Weekly Epidemiological Record, 20 January 2017, vol. 92, 3 (pp. 21–36)
:: Maternal and neonatal tetanus elimination: validation in Punjab Province, Pakistan, November 2016
:: Monthly report on dracunculiasis cases, January– November 2016

WHO Region of the Americas PAHO
:: Overweight affects almost half the population of all countries in Latin America and the Caribbean except for Haiti (01/18/2017)

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

WHO European Region EURO
:: Global Health Case Challenge: fighting antibiotic resistance 19-01-2017
:: Cold weather increases health risks for refugees and migrants in Serbia and other countries in the Region 18-01-2017

WHO Eastern Mediterranean Region EMRO
:: Joint Statement on Syria 16 January 2017
[See full text above]

CDC/ACIP [to 21 January 2017]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/
THURSDAY, JANUARY 19, 2017
South African Study Provides Compelling New Evidence on Role of Person-to Person Transmission in Drug-Resistant TB Epidemics
A study published today in The New England Journal of Medicine provides compelling evidence that extensively drug-resistant tuberculosis (XDR TB) is spread from person-to-person in the KwaZulu-Natal province, South Africa…

MMWR Weekly January 20, 2017/No. 1
[Excerpts]
:: West Nile Virus and Other Nationally Notifiable Arboviral Diseases — United States, 2015
:: Coverage with Tetanus, Diphtheria, and Acellular Pertussis Vaccine and Influenza Vaccine Among Pregnant Women — Minnesota, March 2013–December 2014

Register for upcoming February ACIP meeting
February 22-23, 2017
Deadline for registration:
:: Non-US Citizens: February 1, 2017; US Citizens: February 13, 2017
Registration is NOT required to watch the live meeting webcast or to listen via telephone.

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Gavi [to 21 January 2017]
http://www.gavi.org/library/news/press-releases/

18 January 2017
Google & Gavi partner to scale up high-tech innovations for vaccine delivery
New funding through Gavi will help start-up Nexleaf Analytics provide real-time data solutions for cold chain equipment performance and maintenance in developing countries.
Davos, 18 January 2017 – Google.org and Gavi announced a new partnership today to help tech start-up Nexleaf Analytics strengthen vaccine cold chain equipment for developing countries. Google.org’s contribution of US$ 2 million, which will be matched by the Bill & Melinda Gates Foundation’s funding to the Gavi Matching Fund, will be used to help countries to make evidence-based decisions on the purchase and maintenance of vaccine refrigerators.
Over the next years the volume of vaccines in Gavi-supported countries is expected to rise significantly. Vaccines are highly sensitive to high and low temperatures, and high-performing and well-maintained cold chain technologies are essential for ensuring vaccine potency…

18 January 2017
Deutsche Post DHL Group and Gavi forge global partnership to improve delivery of life-saving vaccines
Organisations to collaborate on addressing supply chain challenges to improve developing country access to life-saving vaccines.
Test programme announced with Kenyan Health Ministry: DHL and Gavi to provide efficient transport management solution for vaccine distribution.
Davos, Switzerland, 18 January 2017 – Deutsche Post DHL Group, the leading global mail and logistics company, and Gavi, the Vaccine Alliance, today announced a global partnership to help improve vaccine supply chains in developing countries.
As immunisation programmes expand to deliver new, life-saving vaccines to more people, often in remote areas, they are increasingly constrained by outdated supply chains. With vaccine volumes continuing to increase and the persistence of often weak or broken health systems, there is a critical need for improvements in immunisation supply chain infrastructure.
Over the next three years, the new partnership will be vital in helping to provide countries with efficient supply chain solutions to improve healthcare delivery. Deutsche Post DHL Group’s industry-leading logistics expertise in life sciences and healthcare, combined with the global DHL transportation network, will help countries overcome challenges, and make the vaccine supply chain more efficient…

18 January 2017
Gavi and Unilever’s Lifebuoy join forces to tackle preventable diseases and save children’s lives
Ground-breaking partnership will raise awareness of the power of immunisation and of handwashing with soap to accelerate child survival efforts
Davos, Switzerland, 18 January 2017 – Gavi, the Vaccine Alliance and Lifebuoy, Unilever’s leading health soap brand, have launched an innovative partnership to protect children under five from illnesses and premature death. By promoting handwashing with soap and immunisation together – two of the most cost-effective child survival interventions – the partnership aims to improve and save many young lives in India.

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Fondation Merieux [to 21 January 2017]
http://www.fondation-merieux.org/news
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.

18 January 2017, Dakar (Senegal)
Senegal Welcomes Major West African Experts in Clinical Biology: 4th International Steering Committee of West African Laboratory Network of Biomedical Analysis Laboratories
Some 70 participants, including the leading figures in clinical biology of Benin, Burkina Faso, Guinea, Mali, Niger, Senegal and Togo, are gathering in Dakar in Senegal, January 18-20 for the 4th International Steering Committee of the West African laboratory network of biomedical analysis laboratories (RESAOLAB). They are sharing their results in fighting against epidemics and improving laboratory services.

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EDCTP [to 21 January 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials.

17 January 2017
Switzerland fully associated to Horizon 2020 per 1 January 2017
Switzerland became an Associated Country for the full Horizon 2020 programme
as of 1 January 2017. Consequently, Switzerland has regained the possibility to fully participate in the European & Developing Countries Clinical Trials Partnership. Swiss legal entities may participate and receive funding in EDCTP2 actions*. Switzerland may also become a full member of the EDCTP Association, the legal implementation structure for the second EDCTP programme….

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FDA [to 21 January 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

January 19, 2017
Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Center of Excellence launch

January 18, 2017
Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications

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Industry Watch [to 21 January 2017]
:: MSD for Mothers Commits $10 Million and Business Expertise to the Global Financing Facility to Help End Preventable Deaths of Mothers
Represents a Critical Step toward Meeting the Sustainable Development Goals for Women, Children and Adolescent Health

January 19, 2017 01:30 AM Eastern Standard Time
DAVOS, Switzerland–(BUSINESS WIRE)–MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., inside the United States and Canada, announced today its $10 million commitment to the Global Financing Facility (GFF) in support of Every Woman Every Child to improve maternal and child health in low- and lower-middle-income countries worldwide through its MSD for Mothers initiative. Through the GFF – a multi-stakeholder partnership hosted by the World Bank Group – countries are aiming to make a much greater impact on the lives of their most vulnerable citizens, with the goal of preventing an estimated 3.8 million maternal deaths, 101 million child deaths and 21 million stillbirths by 2030…

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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 Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 21 January 2017)

Study protocol
Effects of community health volunteers on infectious diseases of children under five in Volta Region, Ghana: study protocol for a cluster randomized controlled trial
In many low- and middle-income countries, community health volunteers (CHVs) are employed as a key element of the public health system in rural areas with poor accessibility. However, few studies have assessed…
Yeonji Ma, Heunghee Kim, Yinseo Cho, Jaeeun Lee, Joseph Kwami Degley, Abdul-Ghaffa Adam, Gyuhong Lee, Hoonsang Lee and Seungman Cha
BMC Public Health 2017 17:95
Published on: 19 January 2017’

Research article
Community-based health care is an essential component of a resilient health system: evidence from Ebola outbreak in Liberia
Trained community health workers (CHW) enhance access to essential primary health care services in contexts where the health system lacks capacity to adequately deliver them. In Liberia, the Ebola outbreak fur…
Kendra Siekmans, Salim Sohani, Tamba Boima, Florence Koffa, Luay Basil and Saïd Laaziz
BMC Public Health 2017 17:84
Published on: 17 January 2017

Issue Focus: Coverage Expansion, Accountable Care & More

Global Health
Large Reductions In Amenable Mortality Associated With Brazil’s Primary Care Expansion And Strong Health Governance
Thomas Hone, Davide Rasella, Mauricio Barreto, Rifat Atun, Azeem Majeed, and Christopher Millett

Abstract
Strong health governance is key to universal health coverage. However, the relationship between governance and health system performance is underexplored. We investigated whether expansion of the Brazilian Estratégia de Saúde da Família (ESF; family health strategy), a community-based primary care program, reduced amenable mortality (mortality avoidable with timely and effective health care) and whether this association varied by municipal health governance. Fixed-effects longitudinal regression models were used to identify the relationship between ESF coverage and amenable mortality rates in 1,622 municipalities in Brazil over the period 2000–12. Municipal health governance was measured using indicators from a public administration survey, and the resulting scores were used in interactions. Overall, increasing ESF coverage from 0 percent to 100 percent was associated with a reduction of 6.8 percent in rates of amenable mortality, compared with no increase in ESF coverage. The reductions were 11.0 percent for municipalities with the highest governance scores and 4.3 percent for those with the lowest scores. These findings suggest that strengthening local health governance may be vital for improving health services effectiveness and health outcomes in decentralized health systems.

Issue Focus: Coverage Expansion, Accountable Care & More

ANALYSIS & COMMENTARY: Global Health: A Pivotal Moment Of Opportunity And Peril
Lawrence O. Gostin and Eric A. Friedman
Health Aff January 2017 36:159-165; doi:10.1377/hlthaff.2016.1492

Abstract
A growing tide of populism in Europe and the United States, combined with other factors, threatens the solidarity upon which the global health movement is based. The highest-profile example of the turn toward populism is US president-elect Donald Trump, whose proposals would redefine US engagement in global health, development, and environmental efforts. In this challenging landscape, three influential global institutions—the United Nations, the World Health Organization, and the World Bank—are undergoing leadership transitions. This new global health leadership should prioritize global health security, including antimicrobial resistance, health system strengthening, and action on mass migration and climate change. They will need to work as a team, leveraging the World Health Organization’s technical competence and mandate to set health norms and standards, the United Nations’ political clout, and the World Bank’s economic strength. Human rights, including principles of equality, participation, and accountability, should be their foremost guide, such as holding a United Nations special session on health inequities and advancing the Framework Convention on Global Health. The need for predictable and innovative financing and high ethical standards to prevent conflicts of interest can further guide global health leaders.

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 21 January 2017]

Research
Development and validation of SEER (Seeking, Engaging with and Evaluating Research): a measure of policymakers’ capacity to engage with and use research
Capacity building strategies are widely used to increase the use of research in policy development. However, a lack of well-validated measures for policy contexts has hampered efforts to identify priorities for capacity building and to evaluate the impact of strategies. We aimed to address this gap by developing SEER (Seeking, Engaging with and Evaluating Research), a self-report measure of individual policymakers’ capacity to engage with and use research.
Sue E. Brennan, Joanne E. McKenzie, Tari Turner, Sally Redman, Steve Makkar, Anna Williamson, Abby Haynes and Sally E. Green
Published on: 17 January 2017

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 21 January 2017]

Scoping Review
Towards interruption of schistosomiasis transmission in sub-Saharan Africa: developing an appropriate environmental surveillance framework to guide and to support ‘end game’ interventions
J. Russell Stothard, Suzy J. Campbell, Mike Y. Osei-Atweneboana, Timothy Durant, Michelle C. Stanton, Nana-Kwadwo Biritwum, David Rollinson, Dieudonné R. Eloundou Ombede and Louis-Albert Tchuem-Tchuenté
Infectious Diseases of Poverty 2017 6:10
Published on: 14 January 2017

Abstract
Schistosomiasis is a waterborne parasitic disease in sub-Saharan Africa, particularly common in rural populations living in impoverished conditions. With the scale-up of preventive chemotherapy, national campaigns will transition from morbidity- to transmission-focused interventions thus formal investigation of actual or expected declines in environmental transmission is needed as ‘end game’ scenarios arise. Surprisingly, there are no international or national guidelines to do so in sub-Saharan Africa. Our article therefore provides an introduction to key practicalities and pitfalls in the development of an appropriate environmental surveillance framework. In this context, we discuss how strategies need to be adapted and tailored to the local level to better guide and support future interventions through this transition. As detection of egg-patent infection in people becomes rare, careful sampling of schistosome larvae in freshwater and in aquatic snails with robust species-specific DNA assays will be required. Appropriate metrics, derived from observed prevalence(s) as compared with predetermined thresholds, could each provide a clearer insight into contamination- and exposure-related dynamics. Application could be twofold, first to certify areas currently free from schistosomiasis transmission or second to red-flag recalcitrant locations where extra effort or alternative interventions are needed.

International Health
Volume 9, Issue 1 1 January 2017
http://inthealth.oxfordjournals.org/content/current

COMMENTARY
Sustainable development goals and the human resources crisis
Joseph Freer

Abstract
Achieving universal health coverage by 2030 requires that lessons from the Millennium Development Goals must be heeded. The most important lesson is that the workforce underpins every function of the health system, and is the rate-limiting step. The three dimensions that continue to limit the success of the development agenda are availability, distribution and performance of health workers – and the Sustainable Development Goals cannot be achieved without addressing all three. Hence, the traditional response of scaling up supply is inadequate: a paradigm shift is required in the design of systems that can properly identify, train, allocate and retain health workers.

International Health
Volume 9, Issue 1 1 January 2017
http://inthealth.oxfordjournals.org/content/current

Original Articles
Dedicated health systems strengthening of the Global Fund to Fight AIDS, Tuberculosis, and Malaria: an analysis of grants
Victoria Y. Fan; Feng-Jen J. Tsai; Zubin C. Shroff; Branden Nakahara; Nabil Vargha …

Abstract
Background
This study aims to understand the determinants of the Global Fund to Fight AIDS, Tuberculosis, and Malaria’s dedicated channel for health systems strengthening (HSS) funding across countries and to analyze their health system priorities expressed in budgets and performance indicators.

Methods
We obtained publicly available data for disease-specific and HSS grants from the Global Fund over 2004–2013 prior to the new funding model. Regression analysis was employed to assess the determinants of dedicated HSS funding across 111 countries. Documents for 27 dedicated HSS grants including budgets and performance indicators were collected, and activities were analyzed by health system functions.

Results
HSS funding per capita is significantly associated with TB and HIV funding per capita, but not per capita income and health worker density. Of 27 dedicated HSS grants, 11 had line-item budgets publicly available, in which health workforce and medical products form the majority (89% or US$132 million of US$148 million) of funds. Yet these areas accounted for 41.7% (215) of total 516 performance indicators.

Conclusions
Health worker densities were not correlated with HSS funding, despite the emphasis on health workforce in budgets and performance indicators. Priorities in health systems in line-item budgets differ from the numbers of indicators used.

International Journal of Infectious Diseases
December 2016
http://www.ijidonline.com/issue/S1201-9712(16)X0011-2
Volume 53, Supplement, p1-176

International Meeting on Emerging Diseases and Surveillance (IMED) 2016
Highlights from the 6th International Meeting on Emerging Diseases and Surveillance (IMED 2016) Vienna, Austria from Nov 3 to 7, 2016
Britta Lassmann, Lawrence C. Madoff

Journal of Community Health
Volume 42, Issue 1, February 2017
http://link.springer.com/journal/10900/42/1/page/1

Original Paper
Human Papillomavirus Vaccine Uptake in Texas Pediatric Care Settings: A Statewide Survey of Healthcare Professionals
Mehwish Javaid, Dana Ashrawi, Rachel Landgren, Lori Stevens, Rosalind Bello, Lewis Foxhall, , Melissa Mims, Lois Ramondetta

Abstract
The purpose of this study was to identify barriers to and facilitators of human papillomavirus (HPV) vaccination in children aged 9–17 years across Texas. A literature review informed the development of a web-based survey designed for people whose work involves HPV vaccination in settings serving pediatric patients. The survey was used to examine current HPV vaccine recommendation practices among healthcare providers, barriers to HPV vaccination, reasons for parent/caregiver vaccine refusal, staff and family education practices, utilization of reminder and recall systems and status of vaccine administration (payment, ordering and stocking). 1132 responses were received representing healthcare providers, administrative and managerial staff. Respondents identified perceived barriers to HPV vaccination as parental beliefs about lack of necessity of vaccination prior to sexual debut, parental concerns regarding safety and/or side effects, parental perceptions that their child is at low risk for HPV-related disease, and parental lack of knowledge that the vaccine is a series of three shots. Of responding healthcare providers, 94 % (n=582) reported they recommend the vaccine for 9–12 year olds; however, same-day acceptance of the vaccine is low with only 5 % (n=31) of providers reporting the HPV vaccine is “always” accepted the same day the recommendation is made. Healthcare providers and multidisciplinary care teams in pediatric care settings must work to identify gaps between recommendation and uptake to maximize clinical opportunities. Training in methods to communicate an effective HPV recommendation and patient education tailored to address identified barriers may be helpful to reduce missed opportunities and increase on-time HPV vaccinations.

Journal of Community Health
Volume 42, Issue 1, February 2017
http://link.springer.com/journal/10900/42/1/page/1

Original Paper
Improving Human Papillomavirus (HPV) Vaccination in the Postpartum Setting
Reni Soon, Stephen Sung, May Rose Dela Cruz, John J. Chen, Mark Hiraoka

Abstract
Although the HPV vaccine has been shown to be highly effective in preventing cervical dysplasia, vaccination rates remain low. The objective of this study was to assess the effectiveness of an electronic medical record (EMR) prompt on HPV vaccination rates in the postpartum setting. We conducted a pre-post intervention study among postpartum women ages 18–26 seen at an outpatient clinic from 09/01/2012–08/31/2013 (pre-intervention) and from 10/01/2013–03/31/2014 (post-intervention). The intervention was a drop-down menu that was inserted into the EMR postpartum note template inquiring about the patient’s HPV vaccination status and whether or not the vaccine was administered at that visit. HPV vaccination uptake was compared pre and post-intervention. Of the 278 postpartum visits during the study period, 241 were eligible for analysis. There was a significant increase of the HPV vaccine uptake, from 1.2 % (2/173) among pre-intervention visits to 26.5 % (18/68) among post-intervention visits (p < 0.001). After adjusting for age, ethnicity, insurance, and religion, HPV vaccination was significantly higher at postpartum visits during the intervention period, with an adjusted OR=93.49 [95 % CI 15.29–571.52]. Among visits in which the vaccine was not given, HPV vaccination was not discussed in 46 % and patients refused the vaccine in 40% of visits. An EMR prompt in the postpartum note could be an effective way to promote HPV vaccination in the postpartum setting. It will likely take a combination of strategies to optimize vaccination uptake.

Journal of Infectious Diseases
Volume 215 Issue 1 January 1, 2017
http://jid.oxfordjournals.org/content/current

EDITORIAL COMMENTARIES
Vaccines Against Respiratory Syncytial Virus: The Time Has Come
J Infect Dis. (2017) 215 (1): 4-7 doi:10.1093/infdis/jiw455
Janet A. Englund and Helen Y. Chu
Extract
Respiratory syncytial virus (RSV) remains the single most important cause of respiratory tract disease in infants, both in the United States [1] and worldwide [2]. This virus is responsible for bronchiolitis in infants and for clinical disease often indistinguishable from influenza in elderly or immunocompromised hosts. RSV disease was first characterized by astute clinicians such as John Adams in the 1940s, as the cause of primary viral pneumonitis in infants in winter months [3]. RSV was subsequently propagated in Robert Chanock’s laboratory in the late 1950s [4], confirming the laboratory and clinical findings of disease caused by “chimpanzee coryza” virus described earlier by Morris et al in 1956 [5]. Over the next 50 years, innovative clinical studies by Caroline Breese Hall, Paul Glezen, Ann Falsey, and many others demonstrated the ubiquity, importance, and potential severity of RSV infection in preterm infants, young children, immunocompromised patients, and elderly individuals [6–8]. The article by Langley et al [9] in this issue of The Journal of Infectious Diseases adds considerably to our knowledge regarding vaccines against RSV, a saga that has been ongoing for decades with remarkably little success [10].
There is still no approved vaccine against RSV. The tragic outcome of a formalin-inactivated, alum-precipitated RSV vaccine candidate in the 1960s has resulted in a near moratorium on RSV vaccine research since that time [11, 12]. The early formalin-inactivated vaccine candidate not only failed to protect young seronegative infants against RSV disease but resulted in severe enhanced respiratory disease in vaccine recipients after…

Journal of Infectious Diseases
Volume 215 Issue 1 January 1, 2017
http://jid.oxfordjournals.org/content/current

MAJOR ARTICLES AND BRIEF REPORTS
A Randomized, Controlled, Observer-Blinded Phase 1 Study of the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine With or Without Alum Adjuvant
J Infect Dis. (2017) 215 (1): 24-33 doi:10.1093/infdis/jiw453
Joanne M. Langley, Naresh Aggarwal, Azhar Toma, Scott A. Halperin, Shelly A. McNeil, Laurence Fissette, Walthere Dewé, Maarten Leyssen, Jean-François Toussaint, and Ilse Dieussaert

Abstract
Background.
Respiratory syncytial virus (RSV) is a leading cause of childhood bronchiolitis and pneumonia, particularly in early infancy. Immunization of pregnant women could boost preexisting immune responses, providing passive protection to newborns through placental transfer of anti-RSV antibody.

Methods.
In this first-in-humans clinical trial of a purified recombinant RSV protein F vaccine engineered to preferentially maintain prefusion conformation (RSV-PreF), 128 healthy men 18–44 years old were randomized to one dose of a RSV-PreF vaccine containing 10, 30, or 60 µg of RSV-PreF antigen, with or without alum adjuvant, or control, and followed for one year for safety and immunogenicity outcomes.

Results.
Injection site pain was the most common adverse event, reported by up to 81.3% of participants. The highest RSV neutralizing antibody responses were in the 30 µg RSV-PreF/alum, 60 µg RSV-PreF/alum, and 60 µg RSV-PreF/nonadjuvant groups. Responses were evident on day 7, and 30 days after vaccination these participants had RSV-A neutralizing antibody titers of ≥1:512, and >70% had titers of 1:1024, with titers increasing by 3.2–4.9 fold. Responses remained high on day 60 but waned on days 180 and 360.

Conclusions.
The RSV-PreF vaccine elicited rapid RSV neutralizing antibody responses in healthy young men, with an acceptable adverse event profile.

Journal of Infectious Diseases
Volume 215 Issue 1 January 1, 2017
http://jid.oxfordjournals.org/content/current

MAJOR ARTICLES AND BRIEF REPORTS
Significant Correlation Between the Infant Gut Microbiome and Rotavirus Vaccine Response in Rural Ghana
J Infect Dis. (2017) 215 (1): 34-41 doi:10.1093/infdis/jiw518
Vanessa C. Harris, George Armah, Susana Fuentes, Katri E. Korpela, Umesh Parashar, John C. Victor, Jacqueline Tate, Carolina de Weerth, Carlo Giaquinto, Willem Joost Wiersinga, Kristen D. C. Lewis, and Willem M. de Vos
Abstract

Background.
Rotavirus (RV) is the leading cause of diarrhea-related death in children worldwide and 95% of RV-associated deaths occur in Africa and Asia where RV vaccines (RVVs) have lower efficacy. We hypothesize that differences in intestinal microbiome composition correlate with the decreased RVV efficacy observed in poor settings.

Methods.
We conducted a nested, case-control study comparing prevaccination, fecal microbiome compositions between 6-week old, matched RVV responders and nonresponders in rural Ghana. These infants’ microbiomes were then compared with 154 age-matched, healthy Dutch infants’ microbiomes, assumed to be RVV responders. Fecal microbiome analysis was performed in all groups using the Human Intestinal Tract Chip.

Results.
We analyzed findings in 78 Ghanaian infants, including 39 RVV responder and nonresponder pairs. The overall microbiome composition was significantly different between RVV responders and nonresponders (FDR, 0.12), and Ghanaian responders were more similar to Dutch infants than nonresponders (P=.002). RVV response correlated with an increased abundance of Streptococcus bovis and a decreased abundance of the Bacteroidetes phylum in comparisons between both Ghanaian RVV responders and nonresponders (FDR, 0.008 vs 0.003) and Dutch infants and Ghanaian nonresponders (FDR, 0.002 vs 0.009).

Conclusions.
The intestinal microbiome composition correlates significantly with RVV immunogenicity and may contribute to the diminished RVV immunogenicity observed in developing countries.

The Lancet
Jan 21, 2017 Volume 389 Number 10066 p225-330
http://www.thelancet.com/journals/lancet/issue/current

Comment
CEPI—a new global R&D organisation for epidemic preparedness and response
Børge Brende, Jeremy Farrar, Diane Gashumba, Carlos Moedas, Trevor Mundel, Yasuhisa Shiozaki, Harsh Vardhan, Johanna Wanka, John-Arne Røttingen
Summary
The outbreak of Ebola virus disease in west Africa in 2013–16 showed that the world is not sufficiently prepared to detect and respond to epidemic threats. It exposed a systemic need for stronger operational and strategic capabilities in infectious disease response, and for the development of more effective tools and technologies to manage, treat, and prevent disease. Evaluations of the Ebola response highlight that the global community must rethink how vaccines, diagnostics, and drugs for emerging infections are developed given their lack of commercial profitability, especially since outbreaks are most likely to occur in resource-constrained environments.

The Lancet
Jan 21, 2017 Volume 389 Number 10066 p225-330
http://www.thelancet.com/journals/lancet/issue/current

Comment
Access to Medicine Index—what about sustainability?
Summary
A pharmaceutical company representative described the Access to Medicine Index 2016 as “a force for good, and not yet another stick with which to beat industry”.1 The Access to Medicine Index 2016,1 which will be presented at a public meeting later this month at the time of the WHO Executive Board meeting in Geneva, ranks the top 20 research-based pharmaceutical companies on their efforts to improve access to medicine in low-income and middle-income countries (LMICs). And those companies with high ranking tout their success to their stockholders and the media.

The Lancet
Jan 21, 2017 Volume 389 Number 10066 p225-330
http://www.thelancet.com/journals/lancet/issue/current

Review
Neglected tropical diseases: progress towards addressing the chronic pandemic
David H Molyneux, Lorenzo Savioli, Dirk Engels
Summary
The concept of neglected tropical diseases (NTDs) emerged more than a decade ago and has been recognised as a valid way to categorise diseases that affect the poorest individuals. Substantial progress in control and elimination has been achieved and policy momentum has been generated through continued bilateral, philanthropic, and non-governmental development organisation (NGDO) support, and donations of drugs from pharmaceutical companies. WHO has defined a Roadmap to reach 2020 targets, which was endorsed by member states in a World Health Assembly Resolution in 2013. NTDs have been included within the Sustainable Development Goal targets and are a crucial component of universal health coverage, conceptualised as “leaving no one behind”. WHO reported that more than 1 billion people in 88 countries have benefited from preventive chemotherapy in 2014. The research agenda has defined the need for affordable products (diagnostics, drugs and insecticides). However challenges such as insecurity and weak health systems continue to prevail in the poorest countries, inhibiting progress in scaling up and also in achieving Roadmap goals.