International Journal of Epidemiology
Volume 46, Issue 3, 1 June 2017
http://ije.oxfordjournals.org/content/current

Cohort Profiles
Cohort Profile: The Kilifi Vaccine Monitoring Study
Ifedayo MO Adetifa; Tahreni Bwanaali; Jackline Wafula; Alex Mutuku; Boniface Karia …
International Journal of Epidemiology, Volume 46, Issue 3, 1 June 2017, Pages 792–792h, https://doi.org/10.1093/ije/dyw202
…The Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP) in Kilifi set up the Haemophilus influenzae type b (Hib) conjugate vaccine effectiveness study in 2000. It was further expanded in 2008 with addition of the real-time vaccine monitoring component, in anticipation of the introduction of pneumococcal conjugate vaccine (PCV) in Kenya. The objective of the Kilifi Vaccine Monitoring Study (KiVMS), a long-term continuous cohort study, is to investigate effectiveness, impact, coverage, safety and indirect vaccine effects by recruiting birth cohorts as well as cohorts of older children and adults where applicable, within a well-characterized population and area. In addition, KiVMS is used to explore the determinants of vaccine coverage and acceptability in the population. Built on the platform of a Health and Demographic Surveillance System (HDSS), KiVMS integrates morbidity surveillance systems at the County Department of Health (CDOH), Kilifi, and a population-based, computerized information system for collecting vaccination data. Therefore it has the following essential attributes: continuously updated demographic data from the population of interest (e.g. births, deaths and migration); and complete and accurate vaccination records for the catchment population. Vaccine information systems are rare in tropical Africa..

International Journal of Epidemiology
Volume 46, Issue 3, 1 June 2017
http://ije.oxfordjournals.org/content/current

Cancer
Childhood vaccinations and risk of acute lymphoblastic leukaemia in children
It has been proposed that childhood vaccinations protect against acute lymphoblastic leukaemia (ALL) in children by modulation of future responses to common infections in childhood. However, the available studies provide inconsistent findings, and population-based cohort studies with longitudinal information on vaccinations are lacking.
Signe Holst Søegaard; Klaus Rostgaard; Kelda Schmiegelow; Mads Kamper-Jørgensen; Marie Hargreave …
International Journal of Epidemiology, Volume 46, Issue 3, 1 June 2017, Pages 905–913, https://doi.org/10.1093/ije/dyx052

 International Journal of Infectious Diseases
August 2017 Volume 61, p1-126
http://www.ijidonline.com/issue/S1201-9712(17)X0008-8

Original Reports
Impact of rotavirus vaccination on child mortality, morbidity, and rotavirus-related hospitalizations in Bolivia
Lucia Inchauste, Maritza Patzi, Kjetil Halvorsen, Susana Solano, Raul Montesano, Volga Iñiguez
p79–88
Published online: June 13, 2017

 JAMA
http://jama.jamanetwork.com/issue.aspx
August 15, 2017, Vol 318, No. 7, Pages 587-676

Editorial
Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk
Robert M. Califf, MD
Abstract
When people use medical products, they generally expect that the benefits of doing so will outweigh the risks in terms of living longer, feeling better, or improving their functional status. However, most drugs and biologics and many medical devices that enter early evaluation in humans are found either to have no benefit or to have risks that outweigh the observed benefits when proper clinical trials are conducted. The complexity and high failure rates of medical product development have appropriately led to a regulatory system that requires compelling evidence of safety and efficacy from clinical trials for drugs, biologics, and high-risk devices before they are allowed on the market.

JAMA
http://jama.jamanetwork.com/issue.aspx
August 15, 2017, Vol 318, No. 7, Pages 587-676

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration
Huseyin Naci, PhD, MHS; Katelyn R. Smalley, BSc; Aaron S. Kesselheim, MD, JD, MPH
JAMA. 2017;318(7):626-636. doi:10.1001/jama.2017.9415
Abstract
This study uses public US Food and Drug Administration (FDA) data to characterize drug trials used to obtain FDA accelerated approval and to describe the existence, timing, and characteristics of postapproval trials mandated by the FDA as part of the accelerated approval decision.

JAMA
http://jama.jamanetwork.com/issue.aspx
August 8, 2017, Vol 318, No. 6, Pages 493-584

Viewpoint
Challenges in International Comparison of Health Care Systems
Irene Papanicolas, PhD; Ashish K. Jha, MD, MPH
JAMA. 2017;318(6):515-516. doi:10.1001/jama.2017.9392
This Viewpoint discusses the challenges in cross-national comparisons of health care system performance, including defining the responsibilities of the health system, managing limitations of data, and accounting for different values in different nations.

JAMA Pediatrics
August 2017, Vol 171, No. 8, Pages 717-820
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
Rubella and Zika Vaccine Research—A Cautionary Tale About Caution
Anne Drapkin Lyerly, MD, MA; Samantha G. Robin, BS; Elana Jaffe, BA
Abstract
The public health response to the Zika crisis has evoked debate and critique, although there has been at least 1 clear success: rapid progress toward a vaccine, with phase 2 testing starting in early 2017, just a year after the Public Health Emergency of International Concern was declared.
Among the challenges of developing a vaccine to prevent Zika infection during pregnancy are ethically complex questions about the appropriate role of pregnant women in the vaccine development agenda. Though ideally women will be vaccinated before conceiving, inadvertent vaccination during pregnancy is unavoidable when women of childbearing age are targeted. Vaccination during pregnancy may also be beneficial because the risks of Zika infection persist through gestation.1 Both underscore the importance of developing an approach that meets the needs of those most at risk: pregnant women and their offspring.

JBI Database of Systematic Review and Implementation Reports
August 2017 – Volume 15 – Issue 8
http://journals.lww.com/jbisrir/Pages/currenttoc.aspx

Editorial
Quality of systematic reviews is poor, our fault, our responsibility
Campbell, Jared M.
JBI Database of Systematic Reviews and Implementation Reports . 15(8):1977-1978, August 2017.
Meta-research is research that is carried out with existing research as the subject of investigation. As systematic reviews – themselves a form of meta-research – have become more widespread, they in turn have come to the attention of meta-research as available subject matter (meta-meta-research, perhaps?). Researchers’ fascination with their own “meta” may be viewed by some as amusing (meta-meta-meta-research!), however the meta endeavours have uncovered some worrying findings.

While exceptions exist, chiefly in high impact1,2 and systematic review specific journals,3 the conduct, reporting and publication of systematic reviews of poor quality is prevalent to the point of being the norm rather than the exception.4-7 Worryingly, despite the growing prominence of explicit guidelines (like the PRISMA statement8 and the AMSTAR checklist9) as well as the expanding profile of evidence-based practice organisations that focus on systematic reviews (Cochrane, the Campbell Collaboration and the Joanna Briggs Institute), the average quality of systematic reviews in many areas has not meaningfully improved over time,10,11 or has even worsened.12

Considering this state of affairs, it seems reasonable to suggest that although evidence-based practice organizations have succeeded in evangelizing the importance of systematic reviews, they have not been successful at stressing the importance of reviews being conducted and reported in a thorough and rigorous manner. In this way they have counterintuitively contributed to the growing number of poor quality and unreliable systematic reviews despite their direct and persistent attempts to the contrary.

Organisations and individuals that are responsible for spreading the popularity of systematic reviews also hold responsibility for safe guarding their quality. As mentioned, systematic review specific journals do an excellent job of enforcing the rigor of reviews published on their own pages, and high impact journals have likewise succeeded in setting the bar high. These types of publications do not have to be exceptions, however. Those of us who most frequently carry out and publish systematic reviews have an increased likelihood of being invited to act as peer reviewers for them. Peer review therefore gives us the opportunity and responsibility to act directly to improve the quality of published systematic reviews. Detailed guidance on the proper conduct and reporting of systematic reviews of diverse types is easily available and accessible,3,9,13-15 along with useful review management tools which can be accessed free of charge (RevMan, Covidence). It therefore cannot be seen as understandable for an article labelled as a systematic review that lacks basic components of the process (i.e. a registered protocol, critical appraisal, or a detailed and comprehensive search) to be considered as a serious candidate for publication.

In our capacity as peer reviewers, editors or authors, the quality of systematic reviews is not an area where compromise should be viewed as acceptable. Standards have been agreed upon and set. If systematic reviews are to deserve their status at the preferred resource for informing evidence-based care, they must be upheld.

The Lancet
http://www.thelancet.com/journals/lancet/issue/current
Aug 12, 2017 Volume 390 Number 10095 p625-714

Yemen and cholera: a modern humanity test
The Lancet
Urgent warnings began in May as aid agencies called for an immediate response to the growing cholera outbreak in Yemen. By mid-July, over 330 000 cholera cases were reported, with 1700 deaths. Since 2015, a civil war has left 14·5 million people (half the country’s population) without access to clean water and sanitation. The UN has called it the “world’s worst cholera outbreak in the context of the world’s worst humanitarian crisis”. The war, unpaid worker salaries, a decimated health system, controversies around the undeployed cholera vaccine stockpile, and slow global funding efforts are all somehow to blame. Pre-existing health indicators are grim and the estimated 400 000 severely malnourished Yemeni children are particularly vulnerable. Famine and other preventable communicable diseases are forecast. Indisputedly, a ceasefire is needed to allow access to humanitarian aid and abate further suffering and death.

As a collective humanity, the shame is ours to bear. The position of The Lancet family of journals is that with all current knowledge and commitments to acting early on cholera outbreaks, such escalated death rates quite simply should not happen. Cholera has been ravaging communities for two centuries. Yet in 2017, outbreaks are entirely containable early with coordinated efforts to implement water, sanitation, and medical rehydration treatment.

There is a vaccine and antibiotics exist. For workers who witnessed the 1994 cholera outbreak among the Rwandan refugees, which killed 12 000 people in Goma, eastern Zaire, this current humanitarian crisis echoes both the indignation and the slow response to an early warning. Unlike Goma, however, the Yemen crisis has unfolded under the global scrutiny of the internet.

On the eve of World Humanitarian Day, Aug 19, Yemen must be foremost among priorities of every institution and government acting for global health. Containing the cholera crisis and reinstating health and personal security for 27 million Yemeni people is the high stakes sustainable development test for how humanity can and will organise around vocalised commitments to protect the most vulnerable among us today.

The Lancet
http://www.thelancet.com/journals/lancet/issue/current
Aug 12, 2017 Volume 390 Number 10095 p625-714

Articles
The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial
Nadine G Rouphael, Michele Paine, Regina Mosley, Sebastien Henry, Devin V McAllister, Haripriya Kalluri, Winston Pewin, Paula M Frew, Tianwei Yu, Natalie J Thornburg, Sarah Kabbani, Lilin Lai, Elena V Vassilieva, Ioanna Skountzou, Richard W Compans, Mark J Mulligan, Mark R Prausnitz for the TIV-MNP 2015 Study Group
Summary
Background
Microneedle patches provide an alternative to conventional needle-and-syringe immunisation, and potentially offer improved immunogenicity, simplicity, cost-effectiveness, acceptability, and safety. We describe safety, immunogenicity, and acceptability of the first-in-man study on single, dissolvable microneedle patch vaccination against influenza.
Methods
The TIV-MNP 2015 study was a randomised, partly blinded, placebo-controlled, phase 1, clinical trial at Emory University that enrolled non-pregnant, immunocompetent adults from Atlanta, GA, USA, who were aged 18–49 years, naive to the 2014–15 influenza vaccine, and did not have any significant dermatological disorders. Participants were randomly assigned (1:1:1:1) to four groups and received a single dose of inactivated influenza vaccine (fluvirin: 18 μg of haemagglutinin per H1N1 vaccine strain, 17 μg of haemagglutinin per H3N2 vaccine strain, and 15 μg of haemagglutinin per B vaccine strain) (1) by microneedle patch or (2) by intramuscular injection, or received (3) placebo by microneedle patch, all administered by an unmasked health-care worker; or received a single dose of (4) inactivated influenza vaccine by microneedle patch self-administered by study participants. A research pharmacist prepared the randomisation code using a computer-generated randomisation schedule with a block size of 4. Because of the nature of the study, participants were not masked to the type of vaccination method (ie, microneedle patch vs intramuscular injection). Primary safety outcome measures are the incidence of study product-related serious adverse events within 180 days, grade 3 solicited or unsolicited adverse events within 28 days, and solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after administration, and secondary safety outcomes are new-onset chronic illnesses within 180 days and unsolicited adverse events within 28 days, all analysed by intention to treat. Secondary immunogenicity outcomes are antibody titres at day 28 and percentages of seroconversion and seroprotection, all determined by haemagglutination inhibition antibody assay. The trial is completed and registered with ClinicalTrials.gov, number NCT02438423.
Findings
Between June 23, 2015, and Sept 25, 2015, 100 participants were enrolled and randomly assigned to a group. There were no treatment-related serious adverse events, no treatment-related unsolicited grade 3 or higher adverse events, and no new-onset chronic illnesses. Among vaccinated groups (vaccine via health-care worker administered microneedle patch or intramuscular injection, or self-administered microneedle patch), overall incidence of solicited adverse events (n=89 vs n=73 vs n=73) and unsolicited adverse events (n=18 vs n=12 vs n=14) were similar. Reactogenicity was mild, transient, and most commonly reported as tenderness (15 [60%] of 25 participants [95% CI 39–79]) and pain (11 [44%] of 25 [24–65]) after intramuscular injection; and as tenderness (33 [66%] of 50 [51–79]), erythema (20 [40%] of 50 [26–55]), and pruritus (41 [82%] of 50 [69–91]) after vaccination by microneedle patch application. The geometric mean titres were similar at day 28 between the microneedle patch administered by a health-care worker versus the intramuscular route for the H1N1 strain (1197 [95% CI 855–1675] vs 997 [703–1415]; p=0·5), the H3N2 strain (287 [192–430] vs 223 [160–312]; p=0·4), and the B strain (126 [86–184] vs 94 [73–122]; p=0·06). Similar geometric mean titres were reported in participants who self-administered the microneedle patch (all p>0·05). The seroconversion percentages were significantly higher at day 28 after microneedle patch vaccination compared with placebo (all p<0·0001) and were similar to intramuscular injection (all p>0·01).
Interpretation
Use of dissolvable microneedle patches for influenza vaccination was well tolerated and generated robust antibody responses.

The Lancet
http://www.thelancet.com/journals/lancet/issue/current
Aug 12, 2017 Volume 390 Number 10095 p625-714

Viewpoint
Universal health coverage, priority setting, and the human right to health
Benedict Rumbold, Rachel Baker, Octavio Ferraz, Sarah Hawkes, Carleigh Krubiner, Peter Littlejohns, Ole F Norheim, Thomas Pegram, Annette Rid, Sridhar Venkatapuram, Alex Voorhoeve, Daniel Wang, Albert Weale, James Wilson, Alicia Ely Yamin, Paul Hunt

Lancet Public Health
Aug 2017 Volume 2 Number 8 e341-e386
http://thelancet.com/journals/lanpub/

Articles
Burden of paediatric respiratory syncytial virus disease and potential effect of different immunisation strategies: a modelling and cost-effectiveness analysis for England
Deborah Cromer, Albert Jan van Hoek, Anthony T Newall, Andrew J Pollard, Mark Jit

Lancet Respiratory Medicine
Aug 2017 Volume 5 Number 8 p599-666  e27-e28
http://www.thelancet.com/journals/lanres/issue/current

Articles
Effect of high-valency pneumococcal conjugate vaccines on invasive pneumococcal disease in children in SpIDnet countries: an observational multicentre study
Camelia Savulescu, Pavla Krizova, Agnes Lepoutre, Jolita Mereckiene, Didrik F Vestrheim, Pilar Ciruela, Maria Ordobas, Marcela Guevara, Eisin McDonald, Eva Morfeldt, Jana Kozakova, Emmanuelle Varon, Suzanne Cotter, Brita A Winje, Carmen Munoz-Almagro, Luis Garcia, Jesus Castilla, Andrew Smith, Birgitta Henriques-Normark, Lucia Pastore Celentano, Germaine Hanquet and the SpIDnet group
Summary
Background
The Streptococcus pneumoniae Invasive Disease network (SpIDnet) actively monitors populations in nine sites in seven European countries for invasive pneumococcal disease. Five sites use 13-valent pneumococcal conjugate vaccine (PCV13) alone and four use the ten-valent PCV (PCV10) and PCV13. Vaccination uptake is greater than 90% in six sites and 67–78% in three sites. We measured the effects of introducing high-valency PCVs on the incidence of invasive pneumococcal disease in children younger than 5 years.
Methods
We compared the incidence of invasive pneumococcal disease in each of the 4 years after the introduction of PCV13 alone or PCV10 and PCV13 with the average incidence during the preceding period of heptavalent PCV (PCV7) use, overall and by serotype category. We calculated incidence rate ratios (IRRs) and 95% CIs for each year and pooled the values for all sites in a random effects meta-analysis.
Findings
4 years after the introduction of PCV13 alone or PCV10 and PCV13, the pooled IRR was 0·53 (95% CI 0·43–0·65) for invasive pneumococcal disease in children younger than 5 years caused by any serotype, 0·16 (0·07–0·40) for disease caused by PCV7 serotypes, 0·17 (0·07–0·42) for disease caused by 1, 5, and 7F serotypes, and 0·41 (0·25–0·69) for that caused by 3, 6A and 19A serotypes. We saw a similar pattern when we restricted the analysis to sites where only PCV13 was used. The pooled IRR for invasive pneumococcal disease caused by non-PCV13 serotypes was 1·62 (1·09–2·42).
Interpretation
The incidence of invasive pneumococcal disease caused by all serotypes decreased due to a decline in the incidence of vaccine serotypes. By contrast, that of invasive pneumococcal disease caused by non-PCV13 serotypes increased, which suggests serotype replacement. Long-term surveillance will be crucial to monitor the further effects of PCV10 and PCV13 vaccination programmes in young children.
Funding
European Centre for Disease Prevention and Control, Czech National Institute of Public Health, French National Agency for Public Health, Irish Health Services Executive, Norwegian Institute of Public Health, Public Health Agency of Catalonia, Public Health Department of Community of Madrid, Navarra Hospital Complex, Public Health Institute of Navarra, CIBER Epidemiology and Public Health, Institute of Health Carlos III, Public Health Agency of Sweden, and NHS Scotland.

Nature 
http://www.nature.com/nature/current_issue.html
Volume 548 Number 7667 pp259-366  17 August 2017
[New issue: No digest content identified]

Volume 548 Number 7665 pp5-130  3 August 2017
Letters
Sequencing and de novo assembly of 150 genomes from Denmark as a population reference
Lasse Maretty, Jacob Malte Jensen, Bent Petersen, Jonas Andreas Sibbesen, Siyang Liu+ et al.
A report of high-depth, short-read sequencing and de novo assemblies for 150 individuals from 50 parent–offspring trios as part of establishing a population reference genome for the GenomeDenmark project.
 

Nature 
http://www.nature.com/nature/current_issue.html
Volume 548 Number 7667 pp259-366  17 August 2017
[New issue: No digest content identified]

Volume 548 Number 7666 pp135-254  10 August 2017
Editorials
Drug approval needs a helping hand
It’s time for researchers to lend their expertise to expediting the arrival of cutting-edge therapies that are waiting in the wings.

Letters
Global patterns of drought recovery
Christopher R. Schwalm, William R. L. Anderegg, Anna M. Michalak, Joshua B. Fisher, Franco Biondi + et.al.
A global analysis of gross primary productivity reveals that drought recovery is driven by climate and carbon cycling, with recovery longest in the tropics and high northern latitudes, and with impacts increasing over the twentieth century.

New England Journal of Medicine
http://www.nejm.org/toc/nejm/medical-journal
August 10, 2017  Vol. 377 No. 6

Perspective
Supporting Women’s Autonomy in Prenatal Testing
Johnston, R.M. Farrell, and E. Parens
[Excerpt]
…It is daunting to envision informed consent processes robust enough to prepare patients to receive information as voluminous and complex as sequencing results. Yet these studies clearly indicate that women have a strong preference for receiving help in parsing the distinction between empowering and disempowering information. As part of that process, clinicians have an ethical responsibility to discuss the small but real possibility that information from testing will lead women to face pivotal decisions about ending or continuing their pregnancy.
The need for fully informed consent in prenatal screening and testing has never been more urgent. Meeting this need will require adoption of reimbursement policies and professional practice guidelines that support clinicians in breaking with current routine practices, which too often involve dispensing with or failing to adequately carry out an informed consent process. It will also require funding for development of approaches to pretest and posttest education and counseling that empower patients to decide whether to be tested and what to do after receiving their results. Policies in a range of areas, from education to social welfare to health care, that support people with disabilities and their families are also needed so that women’s choices are less likely to be constrained by financial concerns or fear for the future welfare of a disabled child. And respect for women’s autonomy also crucially requires access to abortion services. Only with these practices and policies in place can women’s decisions about prenatal screening, diagnostic testing, and termination or continuation of pregnancy be truly free and informed.

New England Journal of Medicine
http://www.nejm.org/toc/nejm/medical-journal
August 10, 2017  Vol. 377 No. 6

Original Articles
Influenza Vaccine Effectiveness in the United States during the 2015–2016 Season
M.L. Jackson and Others
Abstract
Background
The A(H1N1)pdm09 virus strain used in the live attenuated influenza vaccine was changed for the 2015–2016 influenza season because of its lack of effectiveness in young children in 2013–2014. The Influenza Vaccine Effectiveness Network evaluated the effect of this change as part of its estimates of influenza vaccine effectiveness in 2015–2016.
Methods
We enrolled patients 6 months of age or older who presented with acute respiratory illness at ambulatory care clinics in geographically diverse U.S. sites. Using a test-negative design, we estimated vaccine effectiveness as (1−OR)×100, in which OR is the odds ratio for testing positive for influenza virus among vaccinated versus unvaccinated participants. Separate estimates were calculated for the inactivated vaccines and the live attenuated vaccine.
Results
Among 6879 eligible participants, 1309 (19%) tested positive for influenza virus, predominantly for A(H1N1)pdm09 (11%) and influenza B (7%). The effectiveness of the influenza vaccine against any influenza illness was 48% (95% confidence interval [CI], 41 to 55; P<0.001). Among children 2 to 17 years of age, the inactivated influenza vaccine was 60% effective (95% CI, 47 to 70; P<0.001), and the live attenuated vaccine was not observed to be effective (vaccine effectiveness, 5%; 95% CI, −47 to 39; P=0.80). Vaccine effectiveness against A(H1N1)pdm09 among children was 63% (95% CI, 45 to 75; P<0.001) for the inactivated vaccine, as compared with −19% (95% CI, −113 to 33; P=0.55) for the live attenuated vaccine.
Conclusions
Influenza vaccines reduced the risk of influenza illness in 2015–2016. However, the live attenuated vaccine was found to be ineffective among children in a year with substantial inactivated vaccine effectiveness. Because the 2016–2017 A(H1N1)pdm09 strain used in the live attenuated vaccine was unchanged from 2015–2016, the Advisory Committee on Immunization Practices made an interim recommendation not to use the live attenuated influenza vaccine for the 2016–2017 influenza season. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health.)

New England Journal of Medicine
http://www.nejm.org/toc/nejm/medical-journal
August 3, 2017  Vol. 377 No. 5

Perspective
Recognizing Sepsis as a Global Health Priority — A WHO Resolution
Reinhart and Others
…The WHA resolution, with its implicit recognition of sepsis as a major threat to patient safety and global health, has the potential to save millions of lives. To realize this potential, the actions proposed in the resolution need to be taken. These actions require coordinated efforts by politicians, policymakers, health care administrators, researchers, and clinicians working with people of all ages in all health care settings and in the community. Actions will vary by region and country and must acknowledge the unique challenges faced by LMICs.

New England Journal of Medicine
http://www.nejm.org/toc/nejm/medical-journal
 August 3, 2017  Vol. 377 No. 5

Review Article
The Changing Face of Clinical Trials: Evidence for Health Decision Making — Beyond Randomized, Controlled Trials
T.R. Frieden
[Concluding text]
…Moving Forward — Overcoming the “Dark Matter” of Clinical Medicine
For much, and perhaps most, of modern medical practice, RCT-based data are lacking and no RCT is being planned or is likely to be completed to provide evidence for action. This “dark matter” of clinical medicine leaves practitioners with large information gaps for most conditions and increases reliance on past practices and clinical lore.4,69,70 Elevating RCTs at the expense of other potentially highly valuable sources of data is counterproductive. A better approach is to clarify the health outcome being sought and determine whether existing data are available that can be rigorously and objectively evaluated, independently of or in comparison with data from RCTs, or whether new studies (RCT or otherwise) are needed.

New ways of obtaining valuable health data continue to emerge. “Big data,” including information from electronic health records and expanded patient registries, along with increased willingness of patients to participate and share health information, are generating useful data for large interventional studies and providing new opportunities for complementary use of multiple data sources to gain stronger evidence for action.71 For example, although an RCT may show the benefit of a drug, large observational studies can be conducted to refine dosages and identify rare adverse events. In addition, new strategies have been undertaken to increase the efficacy and efficiency of RCTs, including collaborative and adaptive trials to increase enrollment, reduce costs and time to completion, and better identify populations that benefit from treatments.72-74 Advances in genomic science may allow for better understanding of unique characteristics in patients that can affect outcomes of RCTs and other studies and be used to improve the validity of study findings.

There is no single, best approach to the study of health interventions; clinical and public health decisions are almost always made with imperfect data (Table 1Table 1Selected Strengths and Weaknesses of Various Study Designs, along with Examples of Studies with Effects on Policy or Practice.). Promoting transparency in study methods, ensuring standardized data collection for key outcomes, and using new approaches to improve data synthesis are critical steps in the interpretation of findings and in the identification of data for action, and it must be recognized that conclusions may change over time. There will always be an argument for more research and for better data, but waiting for more data is often an implicit decision not to act or to act on the basis of past practice rather than best available evidence. The goal must be actionable data — data that are sufficient for clinical and public health action that have been derived openly and objectively and that enable us to say, “Here’s what we recommend and why.”

Pediatrics
August 2017, VOLUME 140 / ISSUE 2
http://pediatrics.aappublications.org/content/140/2?current-issue=y

Pediatrics Perspectives
The Ethics of Open-Label Placebos in Pediatrics
Brit Trogen, Arthur Caplan, Perri Klass
Pediatrics Aug 2017, 140 (2) e20164328; DOI: 10.1542/peds.2016-4328

Pediatrics
August 2017, VOLUME 140 / ISSUE 2
http://pediatrics.aappublications.org/content/140/2?current-issue=y

Review Articles
Promoting Early Child Development With Interventions in Health and Nutrition: A Systematic Review
Tyler Vaivada, Michelle F. Gaffey, Zulfiqar A. Bhutta
Pediatrics Aug 2017, 140 (2) e20164308; DOI: 10.1542/peds.2016-4308
This overview summarizes what is known about the impact of evidence-based health and nutrition interventions on early child development with a focus on low-resource settings.

Pediatrics
August 2017, VOLUME 140 / ISSUE 2
http://pediatrics.aappublications.org/content/140/2?current-issue=y

Articles
Vaccines and Outpatient Antibiotic Stewardship
Adam L. Hersh, Katherine E. Fleming-Dutra
[Excerpt]
… The Danish and American experiences demonstrate that vaccines combat antibiotic resistance through the direct effect of preventing diseases from antibiotic-resistant pathogens and likely also through the indirect effect of changing the way pediatric clinicians practice medicine. Vaccines have long been hailed as one of the greatest public health achievements of the 20th century. Combined with other measures to reduce unnecessary antibiotic use, vaccines remain at the forefront of our tools for antibiotic stewardship and combating antibiotic resistance in the 21st century.

PharmacoEconomics
Volume 35, Issue 8, August 2017
https://link.springer.com/journal/40273/35/8/page/1

Systematic Review
Defining and Measuring the Affordability of New Medicines: A Systematic Review
Fernando Antoñanzas, Robert Tercile, Paul M. Overton, Natalie Shalet…
Abstract
Background
In many healthcare systems, affordability concerns can lead to restrictions on the use of expensive efficacious therapies. However, there does not appear to be any consensus as to the terminology used to describe affordability, or the thresholds used to determine whether new drugs are affordable.
Objectives
The aim of this systematic review was to investigate how affordability is defined and measured in healthcare.
Methods
MEDLINE, EMBASE and EconLit databases (2005–July 2016) were searched using terms covering affordability and budget impact, combined with definitions, thresholds and restrictions, to identify articles describing a definition of affordability with respect to new medicines. Additional definitions were identified through citation searching, and through manual searches of European health technology assessment body websites.
Results
In total, 27 definitions were included in the review. Of these, five definitions described affordability in terms of the value of a product; seven considered affordability within the context of healthcare system budgets; and 15 addressed whether products are affordable in a given country based on economic factors. However, there was little in the literature to indicate that the price of medicines is considered alongside both their value to individual patients and their budget impact at a population level.
Conclusions
Current methods of assessing affordability in healthcare may be limited by their focus on budget impact. A more effective approach may involve a broader perspective than is currently described in the literature, to consider the long-term benefits of a therapy and cost savings elsewhere in the healthcare system, as well as cooperation between healthcare payers and the pharmaceutical industry to develop financing models that support sustainability as well as innovation.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 19 August 2017)

Policy Forum
Antimicrobial resistance: The complex challenge of measurement to inform policy and the public
Didier Wernli, Peter S. Jørgensen, Stephan Harbarth, Scott P. Carroll, Ramanan Laxminarayan, Nicolas Levrat, John-Arne Røttingen, Didier Pittet
| published 17 Aug 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002378
 
Research Article
Assessing the impact of healthcare research: A systematic review of methodological frameworks
Increasingly, researchers need to demonstrate the impact of their research to their sponsors, funders, and fellow academics. However, the most appropriate way of measuring the impact of healthcare research is subject to debate. We aimed to identify the existing methodological frameworks used to measure healthcare research impact and to summarise the common themes and metrics in an impact matrix.
Samantha Cruz Rivera, Derek G. Kyte, Olalekan Lee Aiyegbusi, Thomas J. Keeley, Melanie J. Calvert
| published 09 Aug 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002370

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 19 August 2017)

Research Article
Development of a set of community-informed Ebola messages for Sierra Leone
John Kinsman, Kars de Bruijne, Alpha M. Jalloh, Muriel Harris, Hussainatu Abdullah, Titus Boye-Thompson, Osman Sankoh, Abdul K. Jalloh, Heidi Jalloh-Vos
Research Article | published 07 Aug 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005742
Abstract
The West African Ebola epidemic of 2013–2016 was by far the largest outbreak of the disease on record. Sierra Leone suffered nearly half of the 28,646 reported cases. This paper presents a set of culturally contextualized Ebola messages that are based on the findings of qualitative interviews and focus group discussions conducted in ‘hotspot’ areas of rural Bombali District and urban Freetown in Sierra Leone, between January and March 2015. An iterative approach was taken in the message development process, whereby (i) data from formative research was subjected to thematic analysis to identify areas of community concern about Ebola and the national response; (ii) draft messages to address these concerns were produced; (iii) the messages were field tested; (iv) the messages were refined; and (v) a final set of messages on 14 topics was disseminated to relevant national and international stakeholders. Each message included details of its rationale, audience, dissemination channels, messengers, and associated operational issues that need to be taken into account. While developing the 14 messages, a set of recommendations emerged that could be adopted in future public health emergencies. These included the importance of embedding systematic, iterative qualitative research fully into the message development process; communication of the subsequent messages through a two-way dialogue with communities, using trusted messengers, and not only through a one-way, top-down communication process; provision of good, parallel operational services; and engagement with senior policy makers and managers as well as people in key operational positions to ensure national ownership of the messages, and to maximize the chance of their being utilised. The methodological approach that we used to develop our messages along with our suggested recommendations constitute a set of tools that could be incorporated into international and national public health emergency preparedness and response plans.
Author summary
The work on which the paper is based was conducted in two Ebola ‘hotspots’ in Sierra Leone (urban Freetown and rural Bombali district) between January and April 2015. Numerous misperceptions about Ebola had developed in the community over the course of 2014, and it was becoming increasingly clear that the largely top-down messaging strategy in use was not as effective as it could have been. Our project aimed to actively include the community in the development of a set of actionable Ebola messages that responded directly to their needs and concerns. While developing our messages on such topics as ambulances, burial teams, and the use of chlorine, we derived a set of recommendations that could also be applicable to control efforts relating to other infectious disease outbreaks. These include the importance of listening to community concerns during an outbreak, communicating on a two-way basis using trusted messengers, and engaging with relevant officials throughout the project in order to maximise the likelihood of the findings being utilised. While our work is based empirically on one disease in one setting, the messaging principles that emerged out of it are to a large degree generic.

PLoS One
http://www.plosone.org/
[Accessed 19 August 2017]

Research Article
Ranking 93 health interventions for low- and middle-income countries by cost-effectiveness
Susan Horton, Hellen Gelband, Dean Jamison, Carol Levin, Rachel Nugent, David Watkins
Research Article | published 10 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0182951
Abstract
Background
Cost-effectiveness rankings of health interventions are useful inputs for national healthcare planning and budgeting. Previous comprehensive rankings for low- and middle- income countries were undertaken in 2005 and 2006, accompanying the development of strategies for the Millennium Development Goals. We update the rankings using studies published since 2000, as strategies are being considered for the Sustainable Development Goals.
Methods
Expert systematic searches of the literature were undertaken for a broad range of health interventions. Cost-effectiveness results using Disability Adjusted Life-Years (DALYs) as the health outcome were standardized to 2012 US dollars.
Results
149 individual studies of 93 interventions qualified for inclusion. Interventions for Reproductive, Maternal, Newborn and Child Health accounted for 37% of interventions, and major infectious diseases (AIDS, TB, malaria and neglected tropical diseases) for 24%, consistent with the priorities of the Millennium Development Goals. More than half of the interventions considered cost less than $200 per DALY and hence can be considered for inclusion in Universal Health Care packages even in low-income countries.
Discussion
Important changes have occurred in rankings since 2006. Priorities have changed as a result of new technologies, new methods for changing behavior, and significant price changes for some vaccines and drugs. Achieving the Sustainable Development Goals will require LMICs to study a broader range of health interventions, particularly in adult health. Some interventions are no longer studied, in some cases because they have become usual care, in other cases because they are no longer relevant. Updating cost-effectiveness rankings on a regular basis is potentially a valuable exercise.

PLoS One
http://www.plosone.org/
[Accessed 19 August 2017]

Research Article
Re–evaluation of the cost–effectiveness and effects of childhood rotavirus vaccination in Norway
Christina Hansen Edwards, Birgitte Freiesleben de Blasio, Beatriz Valcárcel Salamanca, Elmira Flem
Research Article | published 17 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0183306

Research Article
Changes in the incidence of pneumonia, bacterial meningitis, and infant mortality 5 years following introduction of the 13-valent pneumococcal conjugate vaccine in a “3+0” schedule
Sylvia Becker-Dreps, Bryan Blette, Rafaela Briceño, Jorge Alemán, Michael G. Hudgens, Gilberto Moreno, Ana Ordoñez, Julio Rocha, David J. Weber, Erick Amaya
Research Article | published 16 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0183348

Overview
Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks
Toon van der Gronde, Carin A. Uyl-de Groot, Toine Pieters
Overview | published 16 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0182613

Research Article
The cost of entry: An analysis of pharmaceutical registration fees in low-, middle-, and high-income countries
Steven G. Morgan, Brandon Yau, Murray M. Lumpkin
Research Article | published 15 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0182742

Research Article
The impact of access to immunization information on vaccine acceptance in three countries
Lori K. Handy, Stefania Maroudi, Maura Powell, Bakanuki Nfila, Charlotte Moser, Ingrid Japa, Ndibo Monyatsi, Elena Tzortzi, Ismini Kouzeli, Anthony Luberti, Maria Theodoridou, Paul Offit, Andrew Steenhoff, Judy A. Shea, Kristen A. Feemster
Research Article | published 03 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0180759

Science         
http://www.sciencemag.org/current.dtl
11 August 2017  Vol 357, Issue 6351

Policy Forum
U.S. attitudes on human genome editing
By Dietram A. Scheufele, Michael A. Xenos, Emily L. Howell, Kathleen M. Rose, Dominique Brossard, Bruce W. Hardy
Science11 Aug 2017 : 553-554 Restricted Access
Summary
The emergence of CRISPR-Cas9 gene editing has given new urgency to calls from social scientists, bench scientists, and scientific associations for broad public dialogue about human genome editing and its applications. Most recently, these calls were formalized in a consensus report on the science, ethics, and governance of human genome editing released by the U.S. National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) that argued for public engagement to be incorporated into the policy-making process for human genome editing (1). So, where does the public stand on the issue of human genome editing? And how do those attitudes translate into the desire for more public input on human genome editing as new applications emerge in the policy arena?

Science         
http://www.sciencemag.org/current.dtl
18 August 2017  Vol 357, Issue 6352

Feature
On the trail of yellow fever
By Sam Kean
Science18 Aug 2017 : 637-641 Full Access
Monkeys and mosquitoes hold clues to when and where the virus could resurge in Brazil.

Policy Forum
What do revised U.S. rules mean for human research?
By Lisa Nichols, Lois Brako, Suzanne M. Rivera, Ara Tahmassian, Martha F. Jones, Heather H. Pierce, Barbara E. Bierer
Science18 Aug 2017 : 650-651 Restricted Access

Policy Forum
What do revised U.S. rules mean for human research?
By Lisa Nichols, Lois Brako, Suzanne M. Rivera, Ara Tahmassian, Martha F. Jones, Heather H. Pierce, Barbara E. Bierer
Science18 Aug 2017 : 650-651 Restricted Access
The updated Common Rule raises many questions

Science Translational Medicine
http://stm.sciencemag.org/
09 August 2017  Vol 9, Issue 402

Focus
Combating corruption in global health
By Tim K. Mackey, Jillian Kohler, Maureen Lewis, Taryn Vian
Science Translational Medicine 09 Aug 2017 Restricted Access
Corruption is a critical challenge to global health efforts, and combating it requires international action, advocacy, and research.

Tropical Medicine & International Health
August 2017   Volume 22, Issue 8  Pages 917–1052
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2017.22.issue-8/issuetoc

Reviews
Dengue data and surveillance in Tanzania: a systematic literature review (pages 960–970)
Tara Ward, Moody Samuel, Dorit Maoz, Silvia Runge-Ranzinger, Ross Boyce, Joao Toledo, Raman Velayudhan and Olaf Horstick
Version of Record online: 10 JUL 2017 | DOI: 10.1111/tmi.12903

Vaccine
Volume 35, Issue 35, Part B, Pages 4491-4658 (16 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/35/part/PB?sdc=1

Short communications
The web and public confidence in MMR vaccination in Italy
Pages 4494-4498
Francesco Aquino, Gabriele Donzelli, Emanuela De Franco, Gaetano Privitera, Pier Luigi Lopalco, Annalaura Carducci
Abstract
Measles, mumps and rubella (MMR) vaccination coverage in Italy has been decreasing starting from 2012 and, at the present, none of the Italian regions has achieved the goal of 95% coverage target. A decision of the Court of Justice of Rimini in March 2012 that awarded vaccine-injury compensation for a case of autism has been indicated as a probable trigger event leading to a reduction of vaccine confidence in Italy. The aim of the study was to explore the relationship between MMR vaccination coverage to online search trends and social network activity on the topic “autism and MMR vaccine”, during the period 2010–2015.
A significant inverse correlation was found between MMR vaccination coverage and Internet search activity, tweets and Facebook posts. New media might have played a role in spreading misinformation. Media monitoring could be useful to assess the level of vaccine hesitancy and to plan and target effective information campaigns.

Vaccine
Volume 35, Issue 35, Part B, Pages 4491-4658 (16 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/35/part/PB?sdc=1

Content of web-based continuing medical education about HPV vaccination
Original Research Article
Pages 4510-4514
Melanie L. Kornides, Jacob M. Garrell, Melissa B. Gilkey
Abstract
Background
Addressing low HPV vaccination coverage will require U.S. health care providers to improve their recommendation practices and vaccine delivery systems. Because readily available continuing medical education (CME) could be an important tool for supporting providers in this process, we sought to assess the content of web-based CME activities related to HPV vaccination.
Methods
We conducted a content analysis of web-based CME activities about HPV vaccination available to U.S. primary care providers in May-September 2016. Using search engines, educational clearinghouses, and our professional networks, we identified 15 activities eligible for study inclusion. Through a process of open coding, we identified 45 commonly occurring messages in the CME activities, which we organized into five topic areas: delivering recommendations for HPV vaccination, addressing common parent concerns, implementing office-based strategies to increase HPV vaccination coverage, HPV epidemiology, and guidelines for HPV vaccine administration and safety. Using a standardized abstraction form, two coders then independently assessed which of the 45 messages each CME activity included.
Results
CME activities varied in the amount of content they delivered, with inclusion of the 45 messages ranging from 17% to 86%. Across activities, the most commonly included messages were related to guidelines for HPV vaccine administration and safety. For example, all activities (100%) specified that routine administration is recommended for ages 11 and 12. Most activities (73%) also noted that provider recommendations are highly influential. Fewer activities modeled examples of effective recommendations (47%), gave specific approaches to addressing common parent concerns (47%), or included guidance on office-based strategies to increase coverage (40%).
Conclusions
Given that many existing CME activities lack substantive content on how to change provider practice, future activities should focus on the practical application of interpersonal and organizational approaches for improving HPV vaccine delivery in the clinical setting.

Vaccine
Volume 35, Issue 35, Part B, Pages 4491-4658 (16 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/35/part/PB?sdc=1

Text message reminders for vaccination of adolescents with chronic medical conditions: A randomized clinical trial
Original Research Article
Pages 4554-4560
Annika M. Hofstetter, Angela Barrett, Stewin Camargo, Susan L. Rosenthal, Melissa S. Stockwell
Abstract
Background
Many adolescents with chronic medical conditions (CMCs) are at risk of vaccine-preventable infection, yet are frequently under-vaccinated. Text message reminders, particularly those with embedded educational information, have been shown to increase general pediatric vaccination. Their use has not been studied specifically among adolescents with CMCs.
Methods
Eligible parents of adolescents with CMCs receiving care at one of 4 academically-affiliated pediatric clinics and requiring human papillomavirus (first dose), influenza, and/or pneumococcal polysaccharide vaccines were randomized in 4 consecutive cohorts to receive text message vaccine reminders with or without embedded educational information (“educational” vs. “plain” arm, respectively). Educational reminders, including one interactive message, addressed infection risk, vaccine safety/efficacy, and physician recommendations. Up to 5 weekly and 2 booster reminders were sent (October 2014–January 2015). Receipt of any needed vaccine and missed vaccination opportunities by 4, 12, and 24 weeks after the initial reminder were compared between arms.
Results
Of randomized parents (n = 295), 175 (59.3%) were Spanish-speaking; most had adolescents with CMCs who were 13–17 years (n = 229; 77.6%) and publically insured (n = 272; 92.5%). Baseline demographics and parental vaccine beliefs were similar between arms. More adolescents in the plain vs. educational reminder arm received any needed vaccine by 4 weeks (31.9% vs. 22.7%, adjusted relative risk [aRR] 1.47, 95% CI 1.01–2.14), but not by 12 or 24 weeks. Plain reminders were noted in post hoc analyses to have a greater effect than educational reminders in certain sub-populations, including 11–12 year-olds and those sent the initial reminder in early fall. Fewer adolescents in the plain vs. educational reminder arm had a missed vaccination opportunity by 4 weeks (10.9% vs. 41.3%; aRR 0.21, 95% CI 0.07–0.60), but not by 12 or 24 weeks.
Conclusion
Plain text message vaccine reminders appear to have a positive effect compared to educational ones in the short-term and for certain families.
Trial registration: NCT02231957 (www.clinicaltrials.gov)

Vaccine
Volume 35, Issue 35, Part A, Pages 4451-4490 (16 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/35/part/PA?sdc=1
10th Vaccine Congress

Edited by Gregory A. Poland
Vaccinology in the 21st century–The 10th Annual Vaccine Congress
Pages 4451-4452
Elena B. Kostova, Gregory A. Poland
[No abstract]

Vaccine
Volume 35, Issue 35, Part A, Pages 4451-4490 (16 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/35/part/PA?sdc=1
10th Vaccine Congress

Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic
Original Research Article
Pages 4465-4469
Beth-Ann G. Coller, Jeffrey Blue, Rituparna Das, Sheri Dubey, Lynn Finelli, Swati Gupta, Frans Helmond, Rebecca J. Grant-Klein, Kenneth Liu, Jakub Simon, Sean Troth, Susan VanRheenen, Julie Waterbury, Ashley Wivel, Jayanthi Wolf, D. Gray Heppner, Tracy Kemp, Rick Nichols, Thomas P. Monath
Abstract
The 2014–2016 Ebola outbreak caused over 28,000 cases and 11,000 deaths. Merck & Co. Inc., Kenilworth, NJ USA and NewLink Genetics are working with private and public partners to develop and license an Ebola vaccine that was evaluated extensively during the outbreak. The vaccine referred to as V920 is a recombinant vesicular stomatitis virus (rVSV) in which the VSV-G envelope glycoprotein (GP) is completely replaced by the Zaire ebolavirus GP (rVSVΔG-ZEBOV-GP). Eight Phase I and four Phase II/III clinical trials enrolling approximately 17,000 subjects were conducted in parallel to the outbreak to assess the safety, immunogenicity, and/or efficacy of V920. Immunogenicity data demonstrate that anti-GP antibodies are generally detectable by ELISA by 14 days postvaccination with up to 100% seroconversion observed by 28 days post dose. In addition, the results of a ring vaccination trial conducted by the WHO and their partners in Guinea suggest robust vaccine efficacy within 10 days of receipt of a single dose of vaccine. The vaccine is generally well-tolerated when administered to healthy, non-pregnant adults. The development of this vaccine candidate in the context of this unprecedented epidemic has involved the close cooperation of large number of international partners and highlights what we as a public health community can accomplish when working together towards a common goal.
Study identification: V920-001 to V920-012.
CLINICALTRIALS.GOV identifiers: NCT02269423; NCT02280408; NCT02374385; NCT02314923; NCT02287480; NCT02283099; NCT02296983; NCT02344407; NCT02378753; NCT02503202.

Vaccine
Volume 35, Issue 35, Part A, Pages 4451-4490 (16 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/35/part/PA?sdc=1
10th Vaccine Congress

The importance of vaccine supply chains to everyone in the vaccine world
Original Research Article
Pages 4475-4479
Bruce Y. Lee, Leila A. Haidari
Abstract
While the focus of many in the vaccine world has been on developing new vaccines and measuring their effects on humans, failure to understand and properly address vaccine supply chain issues can greatly reduce the impact of any vaccine. Therefore, everyone involved in vaccine decision-making may want to take into account supply chains when making key decisions. In fact, considering supply chain issues long before a vaccine reaches the market can help design vaccines and vaccine programs that better match the system. We detail how vaccine supply chains may affect the work and decision making of ten examples of different members of the vaccine community: preclinical vaccinologists, vaccine clinical trialists, vaccine package designers, health care workers, epidemiologists and disease surveillance experts, policy makers, storage equipment manufacturers, other technology developers, information system specialists, and funders. We offer ten recommendations to help decision makers better understand and address supply chains.

Vaccine
Volume 35, Issue 35, Part A, Pages 4451-4490 (16 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/35/part/PA?sdc=1
10th Vaccine Congress

Platform technologies for modern vaccine manufacturing
Original Research Article
Pages 4480-4485
Hayley K. Charlton Hume, Linda H.L. Lua
Abstract
Improved understanding of antigenic components and their interaction with the immune system, as supported by computational tools, permits a sophisticated approach to modern vaccine design. Vaccine platforms provide an effective tool by which strategically designed peptide and protein antigens are modularized to enhance their immunogenicity. These modular vaccine platforms can overcome issues faced by traditional vaccine manufacturing and have the potential to generate safe vaccines, rapidly and at a low cost. This review introduces two promising platforms based on virus-like particle and liposome, and discusses the methodologies and challenges.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 19 August 2017)

Articles
Challenges in Estimating Vaccine Coverage in Refugee and Displaced Populations: Results From Household Surveys in Jordan and Lebanon
by Timothy Roberton, William Weiss, The Jordan Health Access Study Team, The Lebanon Health Access Study Team and Shannon Doocy
Vaccines 2017, 5(3), 22; doi:10.3390/vaccines5030022 – 12 August 2017
Abstract
Ensuring the sustained immunization of displaced persons is a key objective in humanitarian emergencies. Typically, humanitarian actors measure coverage of single vaccines following an immunization campaign; few measure routine coverage of all vaccines. We undertook household surveys of Syrian refugees in Jordan and Lebanon, outside of camps, using a mix of random and respondent-driven sampling, to measure coverage of all vaccinations included in the host country’s vaccine schedule. We analyzed the results with a critical eye to data limitations and implications for similar studies. Among households with a child aged 12–23 months, 55.1% of respondents in Jordan and 46.6% in Lebanon were able to produce the child’s EPI card. Only 24.5% of Syrian refugee children in Jordan and 12.5% in Lebanon were fully immunized through routine vaccination services (having received from non-campaign sources: measles, polio 1–3, and DPT 1–3 in Jordan and Lebanon, and BCG in Jordan). Respondents in Jordan (33.5%) and Lebanon (40.1%) reported difficulties obtaining child vaccinations. Our estimated immunization rates were lower than expected and raise serious concerns about gaps in vaccine coverage among Syrian refugees. Although our estimates likely under-represent true coverage, given the additional benefit of campaigns (not captured in our surveys), there is a clear need to increase awareness, accessibility, and uptake of immunization services. Current methods to measure vaccine coverage in refugee and displaced populations have limitations. To better understand health needs in such groups, we need research on: validity of recall methods, links between campaigns and routine immunization programs, and improved sampling of hard-to-reach populations.

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 19 August 2017
UK rations hepatitis B vaccine amid global shortage
8 Aug 2017
UK health officials are putting a temporary limit on who can have a hepatitis B vaccination because stocks are running low.
The move is in response to the wider, global shortage of the jab caused by manufacturing issues.
UK travellers are being told they may not be able to get it before they leave Britain for higher-risk countries…

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 19 August 2017
Global Health Gets a Checkup: Interview with Tedros Adhanom Ghebreyesus
September/October 2017

New York Times
http://www.nytimes.com/
Accessed 19 August 2017
Yellow Fever Outbreak That Threatened Brazil’s Megacities Ends
An alarming surge in cases that started in January appears to have stopped short of the country’s largest cities, health officials reported.
August 05, 2017 – By DONALD G. McNEIL Jr –

Washington Post
http://www.washingtonpost.com/
Accessed 19 August 2017
UN completes first round of Syria polio vaccination campaign
The United Nations says the first round of a vaccination campaign following a polio outbreak in eastern Syria has been completed.
Fran Equiza, the UNICEF representative to Syria, says the relief agency teamed up with the World Health Organization and local partners to vaccinate 355,000 children under 5 years of age in the country’s Deir el-Zour and Raqqa provinces..
Associated Press Aug 18, 2017

Court: State can’t vaccinate kids in temporary custody
By Dave Collins | AP August 15
HARTFORD, Conn. — The Connecticut Supreme Court ruled Tuesday that the state’s child welfare agency cannot vaccinate children placed temporarily in its custody when the parents object.
Justices said in the 7-0 decision that state law allows the Department of Children and Families to provide medical treatment to children in temporary state custody, but ruled that immunizing them against diseases does not constitute medical treatment.
The ruling overturned a lower court decision that allowed DCF to vaccinate two young children in its care. The lower court ruling was put on hold pending the appeal to the Supreme Court.
The case involved a couple, whose names were not disclosed, who oppose vaccinations on religious grounds…

Think Tanks et al

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 19 August 2017
Implementing Clinical Trials during Epidemics: The Ebola Experience
Event
8/10/17
The 2014-2015 Ebola epidemic broke out and affected thousands of people at a time when there were no medicines approved to treat or prevent Ebola. Poor infrastructure, capacity gaps, widespread mistrust, and disagreements over the design and ethical nature of any clinical trials complicated efforts to conduct research on investigational drugs and vaccines. In the wake of the outbreak, the National Academies of Sciences, Engineering, and Medicine tasked a committee with analyzing the clinical trials carried out during the outbreak and developing recommendations to improve the implementation of such trials in the future. In this session, committee members Gerald Keusch and David Peters will discuss findings from the committee’s recently released report and the kind of governance structures that need to be in place for effective international coordination and collaboration.
 

CSIS
https://www.csis.org/
Accessed 19 August 2017
What are the barriers to reaching children with immunizations?
August 11, 2017 – Podcast
Recent World Health Organization and UNICEF data reveal that one in 10 infants worldwide did not receive any vaccines in 2016. Vaccines are considered one of the most effective and cost effective public health tools. Yet, despite new focus on building immunization systems that can routinely reach all the world’s children with this potentially lifesaving intervention, many gaps remain. We asked Dr. Jon Kim Andrus, Adjunct Professor and Senior Investigator in the Division of Vaccines and Immunization at the University of Colorado, and Lora Shimp, Senior Immunization Technical Expert and Specialist in Communication and Behavior Change with John Snow, Inc., to reflect on what is being done to improve immunization systems, and why vaccinating children has been so difficult in some areas.
Hosted by Nellie Bristol. Produced by Cathryn Streifel. Edited by Ribka Gemilangsari.