Product development programs for neglected tropical diseases: A crucial role for expert meetings

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 25 February 2017)

Symposium
Product development programs for neglected tropical diseases: A crucial role for expert meetings
Leonie Hussaarts, Kim van der Weijde, Pierre Dome, Elly Kourany-Lefoll, Jutta Reinhard-Rupp, Remco de Vrueh, on behalf of the Pediatric Praziquantel Consortium
| published 23 Feb 2017 P
http://dx.doi.org/10.1371/journal.pntd.0005183

PLoS One

PLoS One
http://www.plosone.org/
[Accessed 25 February 2017]

Research Article
Prevalence of HPV 16 and 18 and attitudes toward HPV vaccination trials in patients with cervical cancer in Mali
Ibrahima Téguété, Amadou Dolo, Kotou Sangare, Abdoulaye Sissoko, Mali Rochas, Sarah Beseme, Karamoko Tounkara, Shahla Yekta, Anne S. De Groot, Ousmane A. Koita
| published 23 Feb 2017 P
http://dx.doi.org/10.1371/journal.pone.0172661

Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study
Andrew Schumacher, William M. Sikov, Matthew I. Quesenberry, Howard Safran, Humera Khurshid, Kristen M. Mitchell, Adam J. Olszewski
Research Article | published 24 Feb 2017 P
http://dx.doi.org/10.1371/journal.pone.0172957

The moderating role of absorptive capacity and the differential effects of acquisitions and alliances on Big Pharma firms’ innovation performance
K. D. S. Fernald, H. P. G. Pennings, J. F. van den Bosch, H. R. Commandeur, E. Claassen
Research Article | published 23 Feb 2017 P
http://dx.doi.org/10.1371/journal.pone.0172488

Effect of maternal death on child survival in rural West Africa: 25 years of prospective surveillance data in The Gambia
Susana Scott, Lindsay Kendall, Pierre Gomez, Stephen R. C. Howie, Syed M. A. Zaman, Samba Ceesay, Umberto D’Alessandro, Momodou Jasseh
Research Article | published 22 Feb 2017 P
http://dx.doi.org/10.1371/journal.pone.0172286

Approving new drugs

Science
24 February 2017 Vol 355, Issue 6327
http://www.sciencemag.org/current.dtl

Editorial
Approving new drugs
By John L. LaMattina
Science24 Feb 2017 : 777
As the Trump administration takes shape, there is much speculation as to what major changes will be made. A dominant theme of the Trump campaign was to cut through bureaucracy in Washington, D.C., thereby enhancing innovation and bringing new technology to Americans more quickly. Nowhere could such a philosophical change have more impact than on Food and Drug Administration (FDA) approval of new drugs.

Decades ago, it was not unusual for the FDA to approve a drug simply on the basis of its effect on disease biomarkers. For example, approval of the first statins, including Merck’s Mevacor and Zocor, was based on their ability to lower low-density lipoprotein (LDL) cholesterol, known to be associated with the buildup of deadly atherosclerotic plaque. It wasn’t until many years later that long-term clinical trials involving thousands of patients actually proved that these drugs reduced heart attacks and strokes.

However, there are far more examples of drugs that failed to provide the desired health outcome despite having favorable effects on disease biomarkers. One example comes from another class of lipid modulators, the cholesteryl ester transfer protein inhibitors (CETPis). When discovered, these drugs looked promising in that they raised high-density lipoprotein (HDL) cholesterol, long associated with cardioprotection, as well as lowered LDL cholesterol, thereby completely remodeling the lipoprotein profile of patients with heart disease. Despite their promise, the FDA would not approve a CETPi without evidence that it did in fact reduce adverse cardiovascular outcomes. To date, clinical trials for these drugs have shown that they do not reduce heart attacks and, in one case, actually increased deaths.

Such occurrences are not exclusive to the cardiovascular field. For Alzheimer’s disease (AD), several companies have discovered experimental drugs that reduce the level of amyloid proteins, which are believed to be an initiating factor in AD. However, despite successfully lowering amyloid levels in AD patients, long-term studies showed that these drugs do not improve cognition in this population. These examples are not unique. There are cases where drugs that lower plasma glucose do not prevent the adverse health consequences of diabetes, and where drugs that shrink tumors do not reduce cancer deaths. Favorably affecting disease biomarkers is an important step in drug research and development (R&D) because it indicates that the experimental drug could potentially prevent the long-term consequences of disease. However, only long-term clinical trials, although time-consuming and expensive, can prove the value of a new medicine.

President Trump and Tom Price, the newly sworn-in Secretary of Health and Human Services (which oversees the FDA) want to streamline the FDA’s approval process for drugs. But changing the current drug approval paradigm would hurt everyone. What if the FDA simply rules that early-stage drugs are safe solely on the basis of biomarker effects? Suppose doctors and patients decide on whether to take such a drug with unproven long-term effects? This would certainly get experimental drugs to patients faster and enable companies to recoup their R&D investment more quickly. However, based on historical precedent, many of the drugs approved in this way would be ineffective. At best, they would be glorified placebos. At worst, they could prove harmful. As a result, patients would not have benefited by taking such a drug, physicians would be called into question for prescribing such a drug, payers would have wasted millions (even billions) of dollars reimbursing the costs of such a drug, and companies would face the inevitable lawsuits that arise in these situations. Everyone loses.

Over the years, the FDA has learned that, for many diseases, it is important that the drug maker prove the benefits of the drug before unleashing it on the public. Does this slow the process and greatly add to the R&D costs? Absolutely. But it is good medical practice.

Vaccine – Volume 35, Issue 9, Pages 1195-1368 (1 March 2017)

Vaccine
Volume 35, Issue 9, Pages 1195-1368 (1 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/9

.

Commentary
Early sexual debut warrants HPV vaccination at an earlier age
Pages 1195-1196
Abbey B. Berenson, Sharon Croisant

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WHO Reports
Polio vaccines: WHO position paper, March 2016–recommendations
Pages 1197-1199
World Health Organization

Dengue vaccine: WHO position paper, July 2016 – recommendations
Pages 1200-1201
World Health Organization

Polio eradication in the African Region on course despite public health emergencies
Pages 1202-1206
Joseph C. Okeibunor, Martin C. Ota, Bartholomew D. Akanmori, Nicksy Gumede, Keith Shaba, Koffi I. Kouadio, Alain Poy, Richard Mihigo, Mbaye Salla, Matshidiso R. Moeti

US medical students’ willingness to offer the HPV vaccine by vaccination status

Vaccine
Volume 35, Issue 9, Pages 1195-1368 (1 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/9

Short communication
US medical students’ willingness to offer the HPV vaccine by vaccination status
Pages 1212-1215
Abbey B. Berenson, Jacqueline M. Hirth, Erika L. Fuchs, the Multidisciplinary Translation Team on Reproductive Women’s Health
Abstract
We surveyed third-year medical students to assess whether personal vaccination status was associated with willingness to recommend the human papillomavirus vaccine to patients. A total of 231 students completed an anonymous survey evaluating their knowledge, attitudes, and personal vaccine history. Of 122 female students, 81 (66.4%) reported initiating the vaccine, as did 16 of 109 males (14.7%). Females and students ⩽25 years old were more likely to be vaccinated. Knowledge did not vary by vaccination status, but anticipated behaviors did. Vaccinated students reported greater willingness to vaccinate adolescents before 15–16 years of age (92.1% vs. 78.6%, p = 0.008) and discuss vaccination at any type of medical visit (100% vs. 89.7%, p < 0.001). Our findings suggest that prior experiences with the HPV vaccine may influence a provider’s future actions. Thus, interventions that increase awareness of this relationship as well as vaccination rates among health care students may be beneficial.

Introduction of inactivated poliovirus vaccine leading into the polio eradication endgame strategic plan; Hangzhou, China, 2010–2014

Vaccine
Volume 35, Issue 9, Pages 1195-1368 (1 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/9

Original Research Article
Introduction of inactivated poliovirus vaccine leading into the polio eradication endgame strategic plan; Hangzhou, China, 2010–2014
Pages 1281-1286
Yan Liu, Jun Wang, Shijun Liu, Jian Du, Liang Wang, Wenwen Gu, Yuyang Xu, Shuyan Zuo, Erping Xu, Zhijie An
Abstract
Background
China’s Expanded Program on Immunization (EPI) has provided 4 doses of oral poliovirus vaccine (OPV) since the 1970s. Inactivated poliovirus vaccine (IPV) became available in 2010 in Hangzhou as a private-sector, parent-chosen alternative to OPV. In 2015, WHO recommended that countries with all-OPV vaccination schedules introduce at least one dose of IPV, to mitigate risk associated with the withdrawal of type 2 OPV. We analyzed polio vaccine coverage and utilization in Hangzhou to determine patterns of IPV use and the occurrence of vaccine-associated paralytic polio (VAPP) in the various patterns identified.
Methods
Children born between 2010 and 2014 and registered in Hangzhou’s Immunization Information System (HZIIS) were included. VAPP cases were detected through the acute flaccid paralysis surveillance system. We used descriptive epidemiological methods to determine IPV and OPV usage patterns and VAPP occurrence.
Results
HZIIS data from 566,894 children were analyzed. Coverage levels of polio vaccine were greater than 92% for each birth cohort. Percentages of children using OPV-only, IPV-only, and IPV/OPV sequential schedules were 70.57%, 27.01% and 2.41%, respectively. IPV-only schedule utilization increased by birth cohort regardless of geographical area or whether the child was locally-born. The highest use of an all-IPV schedule (79.85%) was among urban, locally-born children in the 2014 birth cohort. Five VAPP cases were identified during the study years; all cases occurred following the first polio vaccine dose, which was always OPV for the cases. Type 2 vaccine virus was isolated from 2 VAPP cases, and type 2 and type 3 vaccine virus was isolated from one VAPP case. The incidence of VAPP in the 2010–2014 birth cohorts was 3.76 per 1 million doses of OPV.
Conclusion
Children in Hangzhou had high polio vaccination coverage. IPV-only schedule use increased by year, and was highest in urban areas among locally-born children. All cases of VAPP were associated with the first dose of OPV.

Impact of vaccination on influenza mortality in children <5 years old in Mexico

Vaccine
Volume 35, Issue 9, Pages 1195-1368 (1 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/9

Impact of vaccination on influenza mortality in children
Original Research Article
Pages 1287-1292
Evelyn L. Sánchez-Ramos, Joel Monárrez-Espino, Daniel E. Noyola
Abstract
Background
Influenza is a leading cause of respiratory tract infections among children. In Mexico, influenza vaccination was included in the National Immunization Program since 2004. However, the population health effects of the vaccine on children have not been fully described. Thus, we estimated the impact of influenza immunization in terms of mortality associated with this virus among children younger than 5 years of age in Mexico.
Methods
Mortality rates and years of life lost associated with influenza were estimated using national mortality register data for the period 1998–2012. Age-stratified and cause-specific mortality rates were estimated for all-cause, respiratory and cardiovascular events. Influenza-associated mortality was compared between the period prior to introduction of the influenza vaccine as part of the National Immunization Program (1998–2004) and the period thereafter (2004–2012).
Results
During the 1998–2012 winter seasons, the average number of all-cause, respiratory and cardiovascular deaths attributable to influenza were 1186, 794 and 21, respectively. Influenza-associated mortality was higher prior to the vaccination period than after influenza was included in the immunization program for all-cause (mean 1660 vs. 780) and respiratory (mean 1063 vs. 563) mortality, but no reduction was seen for cardiovascular mortality. The proportion of all-cause and respiratory deaths attributable to influenza was significantly lower in the post-vaccine period compared with the pre-vaccine period (P < 0.001), but no reduction was seen in the proportion of cardiovascular deaths. There was an average annual reduction of 66,558 years of life lost in the post-vaccine compared with the pre-vaccine period.
Conclusion
The introduction of influenza vaccination within the Mexican Immunization Program was associated with a reduction in mortality rates attributable to this virus among children younger than 5 years of age.

Integration of data from a safety net health care system into the Vaccine Safety Datalink

Vaccine
Volume 35, Issue 9, Pages 1195-1368 (1 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/9

Integration of data from a safety net health care system into the Vaccine Safety Datalink
Original Research Article
Pages 1329-1334
Simon J. Hambidge, Colleen Ross, Jo Ann Shoup, Kris Wain, Komal Narwaney, Kristin Breslin, Eric S. Weintraub, Michael M. McNeil
Abstract
Background
In 2013 the Institute of Medicine suggested that the Vaccine Safety DataLink (VSD) should broaden its population by including data of more patients from low income and racially and ethnically diverse backgrounds. In response, Kaiser Permanente Colorado (KPCO) partnered with Denver Health (DH), an integrated safety net health care system, to explore the integration of DH data.
Methods
We compared three different methods (reference date of September 1, 2013): “Empanelment” (any patient who has had a primary care visit in the past 18 months), “Proxy-enrollment” (two health care visits in 3 years separated by 90 days), and “Enrollment” in a managed care plan. For each of these methods, we compared cohort size, vaccination rates, socio-demographic characteristics, and health care utilization.
Results
The empaneled population at DH provided the best comparison to KPCO. DH’s empaneled population was 111,330 (57,173 adults; 54,157 children), while KPCO had 436,290 empaneled patients (336,462 adults; 99,828 children). Vaccination rates in both health care systems for empaneled patients were comparable. Two year-old up-to-date coverage rates were 83.2% (KPCO) and 86.9% (DH); rates for adolescent Tdap and MCV4 were 85.5% (KPCO) and 90.6% (DH). There were significant differences in the two populations in age, gender, race, preferred language, and % Federal Poverty Level (FPL) (DH 70.7% < 100% FPL; KPCO 17.4%), as well as in healthcare utilization – for example pediatric emergency department utilization was twice as high at DH.
Conclusions
Using a cohort of “empaneled” patients, it is possible to integrate data from a safety net health care system that does not have a uniform managed care population into the VSD, and to compare vaccination rates, socio-demographic characteristics, and health care utilization across the two systems. The KPCO-DH collaboration may serve as a model for incorporating data from a safety net healthcare system into the VSD.

Recommendations and offers for adult influenza vaccination, 2011–2012 season, United States

Vaccine
Volume 35, Issue 9, Pages 1195-1368 (1 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/9

Recommendations and offers for adult influenza vaccination, 2011–2012 season, United States
Original Research Article
Pages 1353-1361
Katharine M. Benedict, Tammy A. Santibanez, Carla L. Black, Helen Ding, Samuel B. Graitcer, Carolyn B. Bridges, Erin D. Kennedy
Abstract
Background
Provider recommendations and offers for influenza vaccination improve adult influenza vaccination coverage. Analysis was performed to describe receipt of influenza vaccination recommendations and offers among adults who visited a healthcare provider (HCP) during the 2011–2012 influenza season and describe differences between those receiving and not receiving recommendations and offers for influenza vaccination. Associations between influenza vaccination and receipt of recommendations and offers were examined.
Methods
Respondents to a random digit dial telephone survey who had visited a HCP since July 1, 2011 were asked if they had received a recommendation for influenza vaccination. Those receiving a recommendation were asked if they received an offer for vaccination. Participants were characterized by demographic and access to health care variables. Logistic regression was used to examine the relationships between participant characteristics and recommendation alone, between participant characteristics and recommendation and offer, and between influenza vaccination and recommendation and offer.
Results
Of those who reported visiting a HCP, 43.8% reported receiving a recommendation for influenza vaccination. Of those who reported receiving a recommendation, 76.6% reported receiving an offer for influenza vaccination. Persons with high-risk conditions and persons over 65 years were more likely to receive recommendations for influenza vaccination when compared to those without high-risk conditions and 18–49 year olds, respectively. Those reporting receipt of a recommendation and offer for influenza vaccination were 1.76 times more likely and those reporting receipt of a recommendation but no offer were 1.72 times more likely to report being vaccinated for influenza controlling for all patient characteristics.
Conclusions
Less than half of respondents reported receipt of recommendations and offers of influenza vaccination during the 2011–2012 influenza season and disparities exist between groups. All healthcare providers seeing adults should recommend or offer influenza vaccination for all patients at every visit during the influenza season.

Addressing Gaps in Cost-Effectiveness Analysis Using Cost-Effectiveness Analysis to Address Health Equity Concerns

Value in Health
February 2017 Volume 20, Issue 2, p181-308
http://www.valueinhealthjournal.com/current

Addressing Gaps in Cost-Effectiveness Analysis Using Cost-Effectiveness Analysis to Address Health Equity Concerns
Richard Cookson, Andrew J. Mirelman, Susan Griffin, Miqdad Asaria, Bryony Dawkins, Ole Frithjof Norheim, Stéphane Verguet, Anthony J. Culyer
p206–212
Published in issue: February 2017
Abstract
This articles serves as a guide to using cost-effectiveness analysis (CEA) to address health equity concerns. We first introduce the “equity impact plane,” a tool for considering trade-offs between improving total health—the objective underpinning conventional CEA—and equity objectives, such as reducing social inequality in health or prioritizing the severely ill. Improving total health may clash with reducing social inequality in health, for example, when effective delivery of services to disadvantaged communities requires additional costs. Who gains and who loses from a cost-increasing health program depends on differences among people in terms of health risks, uptake, quality, adherence, capacity to benefit, and—crucially—who bears the opportunity costs of diverting scarce resources from other uses. We describe two main ways of using CEA to address health equity concerns: 1) equity impact analysis, which quantifies the distribution of costs and effects by equity-relevant variables, such as socioeconomic status, location, ethnicity, sex, and severity of illness; and 2) equity trade-off analysis, which quantifies trade-offs between improving total health and other equity objectives. One way to analyze equity trade-offs is to count the cost of fairer but less cost-effective options in terms of health forgone. Another method is to explore how much concern for equity is required to choose fairer but less cost-effective options using equity weights or parameters. We hope this article will help the health technology assessment community navigate the practical options now available for conducting equity-informative CEA that gives policymakers a better understanding of equity impacts and trade-offs.

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

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

Annals of the NY Academy of Sciences
23 February 2017
CONCISE ORIGINAL REPORT
Human capital gaps in vaccine development: an issue for global vaccine development and global health
Cawein, A., Emini, E., Watson, M., Dailey, J., Donnelly, J., Tresnan, D., Evans, T., Plotkin, S. and Gruber, W.
doi:10.1111/nyas.13316
Abstract
Despite the success of vaccines in reducing the morbidity and mortality associated with infectious diseases, many infectious diseases, both newly emerging and well known, lack vaccines. The global capability for beginning-to-end vaccine development has become limited, primarily owing to a scarcity of human capital necessary to guide the development of novel vaccines from the laboratory to the marketplace. Here, we identify and discuss the gaps in human capital necessary for robust vaccine development and make recommendations to begin to address these deficiencies.

Media/Policy Watch

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.

Der Spiegel
http://www.spiegel.de/
Accessed 25 February 2017
Bill Gates Interview
I Told Trump ‘How Wonderful’ Vaccines Are
22 February 2017
Amid wars, fake news and Donald Trump, the risk of a global pandemic is getting little attention these days. In an interview, Microsoft founder and philanthropist Bill Gates warns of the dramatic consequences.

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Forbes
http://www.forbes.com/
Accessed 25 February 2017
A West Virginian Is Trying To Stop A Senate Bill From Destroying State Vaccination Rates
Kavin Senapathy, Contributor
Feb 23, 2017
Similar anti-vaccine bills have fizzled out but Meredith Snead is taking no chances. The health of West Virginians and the nation are at stake.

Dear Robert Kennedy Jr.: Here Are Two People You Can Give $100,000
18 February 2017
Bruce Y. Lee,  Contributor
Dear Robert Kennedy, Jr., I heard that you have offered $100,000 to anyone who could find a study showing that it’s safe to administer vaccines to children and pregnant women (as indicated in the Washington Post). Actor and Director Robert De Niro was present during the announcement to offer his endorsement. It’s great that you are committing publicly to support medical research. Hope you have a lot of money (this site says $50 million but I don’t know if this has been verified) because there have been a lot of vaccine safety studies out there. Well, to start, if you have a pen handy, here are two people whom you can make the check out to: Dr. Neal Halsey and Dr. Dan Salmon. That’s Neal with an “ea” and Salmon, spelled like the fish…

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Fortune
http://fortune.com/
Accessed 25 February 2017
What Bill and Melinda Gates See That Donald Trump Doesn’t
| 17 February 2017
… It’s no surprise that the cofounder of Microsoft is a techno-enthusiast, but the most high-impact technology for improving global health, Bill and Melinda Gates argue, are simple vaccines. It’s hard to overstate their enthusiasm for the potential of a “basic package” of childhood vaccines to save lives, reduce the cost of healthcare, and unleash economic productivity. The worldwide vaccination rate is the highest it’s ever been (86%,), they explain, thanks in large part to a global Vaccine Alliance that has immunized 580 million children. Vaccines “are one of the great things the rich world does for the rest of the world,” Bill Gates notes, and “for every dollar spent on childhood immunizations, you get $44 of economic benefit.”…

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New York Times

Accessed 25 February 2017
The Anti-Vaccine Movement Gains a Friend in the White House
23 February 2017
By THE EDITORIAL BOARD
Vaccine opponents, often the subject of ridicule, have found fresh energy in the election of a president who has repeated discredited claims linking childhood immunizations to autism and who has apparently decided to pursue them. With President Trump’s support, this fringe movement could win official recognition, threatening lives and making it urgent that health officials, educators and others respond with a science-based defense of vaccines.

Vaccines have saved lives by protecting children and adults from diseases like measles, polio, smallpox, cervical cancer and whooping cough. And there is no evidence whatsoever that vaccines or a preservative used in flu shots cause autism. Scientists have also shown that parents who refuse to immunize their children are threatening to undo decades of public health gains.

Yet, activists like Robert Kennedy Jr. continue to push pseudoscience about immunizations. The terrifying thing is that they appear to have Mr. Trump’s ear. After a meeting with the president last month, Mr. Kennedy said that the president would name him to head a new committee on vaccine safety; the government already has an advisory group that is meeting this week. And last week, during a news conference with Robert De Niro, Mr. Kennedy offered a $100,000 reward to anyone who could prove that vaccines are safe for children and pregnant women.
Of course, countless studies show that vaccines are safe and effective — more than 350 health groups compiled a list for Mr. Trump — but they haven’t penetrated the reality distortion field created by Mr. Kennedy and his fellow travelers. The biggest danger is that their movement will sow enough doubt that more parents will refuse to let their children be immunized. In some states like Texas the number of children who do not receive vaccines has risen sharply over the last decade and is now in the tens of thousands. Not only does this increase the risk of infections to the youths who don’t get shots, but it also threatens infants who are too young and children who cannot be vaccinated for medical reasons. This phenomenon has already led to outbreaks of measles and mumps.

Some parents are understandably anxious about autism. But scientists say there are several possible explanations for why more children have been found to have autism spectrum disorders in recent years, and none of them are linked to vaccines. Doctors have gotten better at identifying those conditions. Genetic factors could be at play, as well as fetal brain defects that develop during pregnancy because of exposure to chemicals and infections.

Mr. Trump does not have the authority to change vaccination requirements for schools and day care centers. States set those rules and determine whether families can opt out based on religious or personal beliefs. But he has a bully pulpit and appoints the heads of health agencies. People who care about public health ought to pressure Mr. Trump not to empower this antiscience movement.

The good news is that members of Congress are pushing back. Six influential lawmakers from both parties, including Senators Lamar Alexander, Republican of Tennessee, and Patty Murray, Democrat of Washington, sent a letter to their colleagues on Tuesday declaring, “Simply put, vaccines save lives.”

Vaccines and Global Health : The Week in Review :: 18 February 2017

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

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

 pdf version A pdf of the current issue is available here: vaccines-and-global-health_the-week-in-review_18-february-2017

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

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

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

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

Milestones :: Perspectives

Milestones :: Perspectives

Twelfth meeting of the Emergency Committee under the International Health Regulations (2015) regarding the international spread of poliovirus
[Excerpts; text bolding by Editor]
13 February 2017 – The twelfth meeting of the Emergency Committee (EC) under the International Health Regulations (2005) (IHR) regarding the international spread of poliovirus was convened via teleconference by the Director General on 7 February 2017…

Conclusion
The Committee unanimously agreed that the international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC), and recommended the extension of the Temporary Recommendations for a further three months. The Committee considered the following factors in reaching this conclusion:
:: The outbreak of WPV1 and cVDPV in Nigeria highlighting that there are high-risk areas where surveillance is compromised by inaccessibility, resulting in ongoing circulation of WPV for several years without detection. The risk of transmission in the Lake Chad sub-region appears high.
:: The continued international spread of WPV1 between Pakistan and Afghanistan.
:: The persistent, wide geographical distribution of positive WPV1 in environmental samples and AFP cases in Pakistan, while acknowledging the intensification of environmental surveillance inevitably increasing detection rates.
:: The current special and extraordinary context of being closer to polio eradication than ever before in history, with the lowest number of WPV1 cases ever recorded occurring in 2016.
:: The risk and consequent costs of failure to eradicate globally one of the world’s most serious vaccine preventable diseases. Even though global transmission has fallen dramatically and with it the likelihood of international spread, the consequences and impact of international spread should it occur would be grave.
:: The possibility of global complacency developing as the numbers of polio cases continues to fall and eradication becomes a possibility.
:: The serious consequences of further international spread for the increasing number of countries in which immunization systems have been weakened or disrupted by conflict and complex emergencies. Populations in these fragile states are vulnerable to outbreaks of polio. Outbreaks in fragile states are exceedingly difficult to control and threaten the completion of global polio eradication during its end stage.
:: The continued necessity for a coordinated international response to improve immunization and surveillance for WPV1, to stop international spread and reduce the risk of new spread.
:: The importance of a regional approach and strong crossborder cooperation, as much international spread of polio occurs over land borders, while also recognizing that the risk of distant international spread remains from zones with active poliovirus transmission.

:: Additionally with respect to cVDPV:
:: cVDPVs also pose a risk for international spread, which without an urgent response with appropriate measures threatens vulnerable populations as noted above;
:: The ongoing circulation of cVDPV2 in Nigeria and Pakistan, demonstrates significant gaps in population immunity at a critical time in the polio endgame;
:: The ongoing urgency to prevent type 2 cVDPVs following the globally synchronized withdrawal of the type 2 component of the oral poliovirus vaccine in April 2016;
:: The ongoing challenges of improving routine immunization in areas affected by insecurity and other emergencies, including the post Ebola context;
:: The global shortage of IPV which poses an additional threat from cVDPVs

…The Committee strongly urged global partners in polio eradication to provide optimal support to all infected and vulnerable countries at this critical time in the polio eradication programme for implementation of the Temporary Recommendations under the IHR, as well as providing ongoing support to all countries that were previously subject to Temporary Recommendations (Somalia, Ethiopia, Syria, Iraq and Israel).

The committee requested the secretariat to provide data on routine immunization in countries subject to Temporary Recommendations. Recognizing that cVDPV illustrates serious gaps in routine immunization programmes in otherwise polio free countries, the Committee recommended that the international partners in routine immunization, for example Gavi, should assist affected countries to improve the national immunization programme.

The Committee noted the Secretariat’s report on the identification of Sabin 2 virus detected in environmental samples in several countries, and in some of these cases probably due to the ongoing use of tOPV in the private sector. The Committee requested a full report on this at the next meeting.

The Committee noted a more detailed analysis of the public health benefits and costs of implementing temporary recommendations was completed and warranted further discussion and review.

The Committee urged all countries to avoid complacency which could easily lead to a polio resurgence. Surveillance particularly needs careful attention to quickly detect any resurgent transmission.

Based on the advice concerning WPV1 and cVDPV, and the reports made by Afghanistan, Pakistan, Nigeria, and the Central African Republic, the Director General accepted the Committee’s assessment and on 13 February 2017 determined that the events relating to poliovirus continue to constitute a PHEIC, with respect to WPV1 and cVDPV. The Director General endorsed the Committee’s recommendations for countries falling into the definition of ‘States currently exporting WPV1 or cVDPV’, for ‘States infected with WPV1 or cVDPV but not currently exporting’ and for ‘States no longer infected by WPV1, but which remain vulnerable to international spread, and states that are vulnerable to the emergence and circulation of VDPV’ and extended the Temporary Recommendations as revised by the Committee under the IHR to reduce the international spread of poliovirus, effective 13 February 2017.

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Grand challenges for the next decade in global health policy and programmes
Dr Margaret Chan
Director-General of the World Health Organization
Keynote address at a celebration of the 10th anniversary of the University of Washington’s Department of Global Health
Seattle, Washington, USA
8 February 2017
[Editor’s text bolding]
Honourable ministers, distinguished fellow speakers, faculty and staff at the University of Washington, colleagues in public health, ladies and gentlemen,

For global health, this is a jubilee year for the University of Washington’s Department of Global Health and at least seven other Washington-based health organizations.

I congratulate the Department of Global Health on its tenth anniversary celebration. With well over 600 current research projects in nearly 130 countries, your contribution to global health is broad and your productivity is astonishing.

Many of these projects are operating at the cutting edge of innovation and several are being conducted in close collaboration with WHO. Several are dear to my heart, especially in the era of sustainable development…

I have been asked to speak about grand challenges for health policy and programmes in the coming decade.

Your interdisciplinary panels will be exploring four of these challenges: preparedness for outbreaks of emerging and re-emerging diseases, the control of noncommunicable diseases, the health impact of environmental degradation and climate change, and the need for innovative approaches to education and training. I would add antimicrobial resistance, and its nightmare bacteria, to that list.

In our world of radically increased interdependence, the forces that have shaped these challenges are universal, and they are not easily reversed. The world has changed dramatically since the start of this century, when the Millennium Development Goals were put forward as the overarching framework for development cooperation.

World leaders at the Millennium Summit sought to create what they called “a more peaceful, prosperous, and just world”. That did not happen as planned.

To understand the newer challenges now embodied in the 2030 Agenda for Sustainable Development, we need to look at the larger sea in which these trends were set afloat.

Since 2001, terrorist attacks that deliberately target civilians have become more deadly, daring, and common. Armed conflicts are now the largest and longest experienced since the end of World War II. The refugee crisis in Europe taught the world that wars in faraway places will not stay remote.

International humanitarian law is now largely ignored, with the deliberate bombing of health care facilities and the use of siege and starvation as weapons of war.

Warnings about the consequences of climate change are increasingly shrill. Records for extreme weather events are being broken a record number of times. The past three years have been the hottest ever.

The phrase “mega-disaster” entered the humanitarian vocabulary following devastating earthquakes, tsunamis, tropical cyclones, droughts, and floods.

The world population is now bigger, more urban, and a lot older, adding dementia to the list of top health priorities. Everywhere in the world, people are living longer sicker lives, increasing the burden on health services, budgets, and the workforce.

Hunger has persisted, but most of the world got fat. The world has 800 million chronically hungry people, but it also has countries where more than 70% of the adult population is obese or overweight.

The globalized marketing of unhealthy products opened wide the entry point for the rise of lifestyle-related chronic conditions. Noncommunicable diseases have overtaken infectious diseases as the biggest killers worldwide.

This is a unique time in history, where economic progress, improved living conditions, and greater purchasing power are actually increasing diseases instead of reducing them.

Social media have become a new voice with considerable force, yet few safeguards governing the accuracy of its content. The proliferation of front groups and lobbies, protecting commodities that harm health, has created arguments that further muddle public thinking and challenge the authority of evidence.

The Oxford Dictionary of the English Language chose “post-truth” as its word of the year for 2016. In a post-truth, post-fact world, views that appeal to emotions and personal beliefs are more influential than objective evidence-based facts.

What does this mean for public trust in the evidence produced by science, medicine, and public health?

The 21st century has been rocked by the emergence of four new human pathogens: SARS, the H5N1 and H7N9 influenza viruses, and the MERS coronavirus. Other older diseases have remerged in ominous ways, including Ebola, yellow fever, and Zika virus disease.

As the century progressed, more and more first- and second-line antimicrobials failed. The pipeline of replacement products has nearly run dry, raising the spectre of a post-antibiotic era in which common infections will once again kill.

The world is also much richer than at the start of this century. Countries like China and India lifted millions of their citizens out of poverty, but in many countries, the benefits of growing wealth have gone to the privileged few.

The number of rich countries full of poor people has grown, changing the poverty map. Today, 70% of the world’s poor live in middle-income countries.

The consequences of the world’s extreme social inequalities are profound. Last month’s World Economic Forum identified growing inequalities in income and wealth as the single most significant trend that will shape global development over the next ten years.

In essence, the SDGs are a corrective strategy that looks at the root causes of inequality and aims to transform them. The international systems that govern finance, business relations, trade, and foreign affairs need a corrective strategy.

As some critics argue, the long-standing social contract that obliges the privileged few to care for those less fortunate has been broken in a world that has lost its moral compass.

Ladies and gentlemen,
As we collectively address these challenges, I ask you to keep in mind four overarching priorities that should guide health policies and programmes.

First, tackle inequality. Second, improve information. Third, stimulate innovation. Fourth, and above all, show impeccable integrity.

For inequality, the 2030 Agenda for Sustainable Development has the focus right. Leave no one behind. This is not easy, especially in these uncertain times.

Decades of experience tell us that this world will not become a fair place for health all by itself. Health systems will not automatically gravitate towards greater equality or naturally evolve towards universal coverage.

Economic decisions within a country will not automatically protect the poor or promote their health. Globalization will not self-regulate in ways that ensure the fair distribution of benefits. International trade agreements will not, by themselves, guarantee food security, or job security, or health security, or access to affordable medicines.

All of these outcomes require deliberate policy decisions.

I call on you to promote the SDG target for universal health coverage as the ultimate expression of fairness. It is one of the most powerful social equalizers among all policy options.

For information, some 85 countries, representing 65% of the world’s population, do not have reliable cause-of-death statistics. This means that causes of death are neither known nor recorded, and health programmes are left to base their strategies on crude and imprecise estimates. Until more countries have good systems for civil registration and vital statistics, health programmes will be working in the dark, throwing money into a black hole.

This is totally unacceptable in the current climate that places a premium on transparency, accountability, and independent monitoring of results. I am aware of the many current projects, undertaken by the Global Health Department and its partners, which are using the latest information technologies to address precisely this problem.

For innovation, we know that the supremely ambitious health targets set out in the SDGs cannot be met without powerful new medical tools. We know that new vaccines can prevent infections that currently contribute to the overuse of antibiotics.

We know that at least 11 epidemic-prone human pathogens, including the Zika, Lassa fever, and Nipah viruses, have no vaccine to protect populations during outbreaks.

We know that R&D incentives preferentially encourage the development of new products for markets that can pay.

One strategy that has worked well at WHO is to let the people, working in the field and seeing practical constraints on a daily basis, design the profile of an ideal new product, right down to its price. This was the strategy used so successfully in the Meningitis Vaccine Project, funded by the Bill and Melinda Gates Foundation, and coordinated by WHO and PATH. I encourage others to use a similar approach.

Finally, we must all work according to the highest standards of scientific integrity. Like others, I see a number of disturbing trends. Let me respond to just one.

Regulatory agencies everywhere must resist the push to replace randomized clinical trials, long the gold standard for approving new drugs, with research summaries provided by pharmaceutical companies.

As some argue, making this change would speed up regulatory approval, lower the costs to industry, and get more products on the market sooner. This kind of thinking is extremely dangerous.

We must not let anything, including economic arguments or industry pressure, lower our scientific standards or compromise our integrity. This is an absolute duty.

Don’t let politicians, the public, or industry forget the lessons from the thalidomide disaster.
Thank you.

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Editor’s Note:
While we have been monitoring the growing anti-vaccine/vaccine hesitancy “movement” globally, we have not formally designated space in this digest for such content. However, early signals from the new U.S. administration around vaccines and vaccine safety suggest we begin. Below is an announcement we felt warranted inclusion, however incredulous we are about its grounding.

Feb 15, 2017, 11:00 ET
Robert F. Kennedy, Jr. announces the World Mercury Project’s $100,000 challenge with goal of stopping use of highly toxic mercury in vaccines.
…Kennedy announced the “World Mercury Project Challenge” to American journalists and others “who have been assuring the public about the safety of mercury in vaccines.”
Kennedy explained that the WMP will pay $100,000 to the first journalist, or other individual, who can find a peer-reviewed scientific study demonstrating that thimerosal is safe in the amounts contained in vaccines currently being administered to American children and pregnant women….
…Actor Robert De Niro…who also spoke at the press conference, is a supporter of the WMP, whose vision is a world where mercury is no longer a threat to the health of our planet and people. The group focuses on making sound science the driver of public policy…

Emergencies

Emergencies

WHO Grade 3 Emergencies [to 18 February 2017]
Iraq
Iraq: Urgently needed medicines and medical supplies delivered to east Mosul
Erbil 15 February 2017 – The World Health Organization (WHO) has responded to an acute shortage of medical supplies in the newly retaken areas of Mosul by delivering medicines and other medical supplies to 16 primary health centers, one hospital and the Directorate of Health (DOH) in Ninewa. The donation will support treatment of patients with infectious diseases, chronic conditions, diarrheal diseases and trauma cases who have been deprived of medical care.

Nigeria
WHO teams assist people in hard-to-reach areas of Nigeria
17 February 2017 – Medical teams supported by WHO set up mobile clinics in hard to access areas of north-eastern Nigeria. The teams are called “hard-to-reach” teams (HTR) because their mission is to reach remote and insecure areas to provide urgently needed care to populations deprived of essential health services. The 8-year conflict has caused widespread forced displacement and acute food and nutrition insecurity. Large areas of Borno state, the most-affected state, remain inaccessible to humanitarian assistance.

Yemen
:: WHO responds to health needs of populations fleeing conflict in Yemen
February 2017 – As violent conflict continues in Al-Mokha City in Taizz governorate, Yemen, more than more than 8000 internally displaced persons have fled to several other districts. WHO teams in are providing trauma care and primary health care services to newly displaced persons, and delivering medicines and supplies to health facilities.

The Syrian Arab RepublicNo new announcements identified
South Sudan No new announcements identified

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WHO Grade 2 Emergencies [to 18 February 2017]
Cameroon – No new announcements identified.
Central African Republic – No new announcements identified.
Democratic Republic of the Congo – No new announcements identified.
Ethiopia – No new announcements identified.
Libya – No new announcements identified.
Myanmar – No new announcements identified.
Niger – No new announcements identified.
Ukraine – No new announcements identified.

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises.
Iraq
:: Iraq: Mosul Humanitarian Response Situation Report No. 20 (6 February – 12 February 2017)

Syria
:: Turkey | Syria: Developments in Idleb Governorate and Western Countryside of Aleppo (as of 15 February 2017)
:: 17 Feb 2017 – Syria Operation Overview (January 2017)

Yemen
:: Statement by the Humanitarian Coordinator in Yemen, Jamie McGoldrick, women and children killed by airstrikes in Sana’a [EN/AR] 16 February 2017

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POLIO [to 18 February 2017]
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 15 February 2017
:: The 12th meeting of the Emergency Committee under the International Health Regulations (IHR) met on 7 February and concluded that current global polio epidemiology continues to constitute a Public Health Emergency of International Concern (PHEIC).  The Temporary Recommendations promulgated under the IHR remain in effect.  National polio emergency action plans continue to be implemented in all countries affected by circulation of either wild poliovirus or vaccine-derived poliovirus, and all countries currently thus affected have declared these events to be a national public health emergency…

Country Updates [Selected Excerpts]
Pakistan
:: One new environmental WPV1 positive sample was reported in the past week, from Killa Abdullah, Balochistan, collected on 19 January.

Twelfth meeting of the Emergency Committee under the International Health Regulations (2015) regarding the international spread of poliovirus
13 February 2017 – The twelfth meeting of the Emergency Committee (EC) under the International Health Regulations (2005) (IHR) regarding the international spread of poliovirus was convened via teleconference by the Director General on 7 February 2017.
[See more detail in Milestones/Perspectives above]

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

Zika virus [to 18 February 2017]
http://www.who.int/emergencies/zika-virus/en/
Latest Report [now bi-weekly]:
Zika situation report – 2 February 2017
Full report: http://apps.who.int/iris/bitstream/10665/254507/1/zikasitrep2Feb17-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.

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Yellow Fever [to 18 February 2017]
http://www.who.int/emergencies/yellow-fever/en/
WHO: The yellow fever outbreak in Angola and Democratic Republic of the Congo ends
Brazzaville, 14 February 2017 – The Democratic Republic of Congo (DRC) declared the end of the yellow fever outbreak in that country today following a similar announcement in Angola on 23 December 2016, bringing an end to the outbreak in both countries after no new confirmed cases were reported from both countries for the past six months.

“We are able to declare the end of one of the largest and most challenging yellow fever outbreak in recent years through the strong and coordinated response by national authorities, local health workers and partners,” said Dr Matshidiso Moeti, the World Health Organization (WHO) Regional Director for Africa, commending the unprecedented and immense response to the outbreak.

The outbreak, which was first detected in Angola in December 2015, had caused 965 confirmed cases of yellow fever across the two countries, with thousands more cases suspected.  The last case detected in Angola was on 23 June 2016 and DRC’s last case was on 12 July the same year.

More than 30 million people were vaccinated in the two countries in emergency vaccination campaigns. This key part of the response included mop up and preventative campaigns in hard to reach areas up until the end of the year to ensure vaccine protection for as many people in all areas of risk as possible.  This unprecedented response exhausted the global stockpile of yellow fever vaccines several times.

More than 41,000 volunteers and 8,000 vaccination teams with more than 56 NGO partners were involved in the mass immunization campaigns. The vaccines used came from a global stockpile co-managed by Médecins Sans Frontières (MSF), International Federation of the Red Cross and Red Crescent Societies (IFRC), UNICEF and WHO. In the first 6 months of 2016 alone, the partners delivered more than 19 million doses of the vaccine – three times the 6 million doses usually put aside for an outbreak. Gavi, the Vaccine Alliance financed a significant proportion of the vaccines…

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EBOLA/EVD [to 18 February 2017]
http://www.who.int/ebola/en/
No new digest content identified for this edition.

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MERS-CoV [to 18 February 2017]
http://www.who.int/emergencies/mers-cov/en/
No new digest content identified for this edition.

 

WHO & Regional Offices [to 18 February 2017]

WHO & Regional Offices [to 18 February 2017]

Reducing maternal and newborn deaths by half
14 February 2017 – Today, 9 countries – Bangladesh, Cote d’Ivoire, Ethiopia, Ghana, India, Malawi, Nigeria, Tanzania and Uganda – committed to halving preventable deaths of pregnant women and newborns in their health facilities within the next 5 years. Through a new network supported by WHO, UNICEF, and other partners, these countries will improve the quality of care mothers and babies receive.

Highlights
Operationalising national plans on noncommunicable diseases prevention and control in Bhutan
Reducing harmful alcohol use, and improving diet and nutrition in Bhutan were among key areas focused on by the first joint mission to the country by the United Nations Interagency Task Force on the Prevention and Control of Noncommunicable diseases (NCDs).

Weekly Epidemiological Record, 17 February 2017, vol. 92, 7 (pp. 77–88)
:: Human rabies: 2016 updates and call for data

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:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO and the African Union Commission map the way forward for stronger partnership
Brazzaville, 17 February 2017 – The World Health Organization (WHO) and the African Union Commission (AUC) held a bilateral meeting at the WHO Regional Office for Africa (WHO AFRO) Secretariat in Brazzaville on 16-17 February 2017 to take stock of progress in implementing their partnership agreement, discuss lessons learnt and map out the way forward. The meeting was attended by Senior Management from the African Union Commission, WHO AFRO and the WHO Regional Office for the Eastern and Mediterranean Region (WHO EMRO). Both organizations are undergoing reforms, and the meeting was an opportunity to synergize efforts around common goals such… read more
: WHO teams assist people in hard-to-reach areas of Nigeria – 17 February 2017
:: The yellow fever outbreak in Angola and Democratic Republic of the Congo ends – 14 February 201
[See Yellow Fever summary above for more detail]

WHO Region of the Americas PAHO
:: Cartoon Network, PAHO and UNICEF launch second phase of campaign to educate kids about preventing Zika (02/16/2017)

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

WHO European Region EURO
:: Cultural contexts of health project expands with grant to build better evidence base for Health 2020 17-02-2017
:: WHO’s commitment to air quality: from the 1950s to today 17-02-2017
:: New WHO/Europe report offers policy options to reduce out-of-pocket payments for medicines in Kyrgyzstan 15-02-2017
:: Expert meeting lays foundation for scaled-up action on strengthening public health services in Europe 15-02-2017

WHO Eastern Mediterranean Region EMRO
:: WHO responds to health needs of populations fleeing conflict in Al-Mokha City in Taizz governorate, Yemen
Sana’a, 12 February 2017 — As violent conflict continues in Al-Mokha City in Taizz governorate, Yemen, more than more than 8000 internally displaced persons have fled to several districts of Al-Hudaydah governorate. WHO teams in the governorate are providing trauma care and primary health care services to newly displaced persons, and delivering medicines and supplies to health facilities.

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 18 February 2017]

CDC/ACIP [to 18 February 2017]
http://www.cdc.gov/media/index.html
http://www.cdc.gov/vaccines/acip/

MMWR Weekly February 17, 2017 / No. 6
[Excerpts]
:: Update: Influenza Activity — United States, October 2, 2016–February 4, 2017
:: Interim Estimates of 2016–17 Seasonal Influenza Vaccine Effectiveness — United States, February 2017
…This report uses data, as of February 4, 2017, from 3,144 children and adults enrolled in the U.S. Influenza Vaccine Effectiveness Network (U.S. Flu VE Network) during November 28, 2016–February 4, 2017, to estimate an interim adjusted effectiveness of seasonal influenza vaccine for preventing laboratory-confirmed influenza virus infection associated with medically attended ARI. During this period, overall vaccine effectiveness (VE) (adjusted for study site, age group, sex, race/ethnicity, self-rated general health, and days from illness onset to enrollment) against influenza A and influenza B virus infection associated with medically attended ARI was 48% (95% confidence interval [CI] = 37%–57%). Most influenza infections were caused by A (H3N2) viruses. VE was estimated to be 43% (CI = 29%–54%) against illness caused by influenza A (H3N2) virus and 73% (CI = 54%–84%) against influenza B virus….
:: Transmission of Zika Virus — Haiti, October 12, 2015–September 10, 2016
:: Notes from the Field: Ongoing Cholera Epidemic — Tanzania, 2015–2016

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.

Sabin Vaccine Institute [to 18 February 2017]

Sabin Vaccine Institute [to 18 February 2017]
http://www.sabin.org/updates/pressreleases
February 13, 2017
Sabin Vaccine Institute Names Deputy Assistant Secretary for Health as New President of Global Immunization
WASHINGTON, D.C.,– Sabin Vaccine Institute (Sabin), a non-profit dedicated to making life-improving vaccines more accessible, enabling innovation and expanding immunization across the globe, today announced the appointment of Dr. Bruce Gellin as President, Global Immunization. Dr. Gellin, a 15-year U.S. Department of Health and Human Services (HHS) veteran, has served as Deputy Assistant Secretary for Health and Director of the National Vaccine Program Office since 2002. Among his roles, Dr. Gellin led discussions on behalf of the United States at high-level global and domestic policy advisory groups and was responsible for developing the National Vaccine Plan, our country’s blueprint for all aspects of vaccines and immunization.

Fondation Merieux [to 18 February 2017]

Fondation Merieux [to 18 February 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.
http://www.wellcome.ac.uk/news/drug-resistant-bugs-threaten-global-malaria-control

17 February 2017, Bamako (Mali)
From a Mobile Laboratory in Mali to a G5 Sahel Biosecurity Network
Plans are being made to create a biosecurity network covering the entire G5 Sahel area (Burkina Faso, Chad, Mali, Mauritania, and Niger), designed to deliver an improved response to biological threats, and more efficiently combat epidemics and the emergence of new categories of crises.
Financially backed by the GIZ (German Federal Enterprise for International Cooperation), the G5 Sahel project is mainly delivered on the ground by Fondation Mérieux and the Bundeswehr Institute of Microbiology in Munich, as part of the German Partnership Programme for Excellence in Biological and Health Security from the German Ministry of Foreign Affairs. The project is setting out to create a network of mobile laboratories in the G5 Sahel countries…

NIH [to 18 February 2017]

NIH [to 18 February 2017]
http://www.nih.gov/news-events/news-releases

Thursday, February 16, 2017
Investigational PfSPZ malaria vaccine demonstrates considerable protection in Malian adults for duration of malaria season
An investigational malaria vaccine given intravenously was well-tolerated and protected a significant proportion of healthy adults against infection with Plasmodium falciparum malaria — the deadliest form of the disease — for the duration of the malaria season, according to new findings published in the February 15th issue of the journal Lancet Infectious Diseases. The study participants live in Mali, Africa, where they are naturally exposed to the parasite.
The investigational vaccine, known as the PfSPZ Vaccine, contains live but weakened sporozoites, the form of the parasite that infects humans, and was developed by scientists at Sanaria Inc., of Rockville, Maryland. The study was conducted by researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the University of Science, Techniques, and Technologies of Bamako (USTTB), Mali, one of NIAID’s International Centers of Excellence in Malaria Research…

NIH research helps explain how antibody treatment led to sustained remission of HIV-like virus
February 15, 2017 — Research presents a new target for HIV prevention and treatment, and sheds light on how HIV develops.

UNAIDS [to 18 February 2017]

UNAIDS [to 18 February 2017]
http://www.unaids.org/
Update
HIV and gender inextricably linked
17 February 2017
The need to increase linkages between gender inequalities and HIV has been stressed as critical to advancing progress in health and across the Sustainable Development Goals (SDGs) at the launch of a new Centre for Gender and Global Health at University College London in the United Kingdom on 16 February.

Update
New HIV infections down by 18% in the United States of America
16 February 2017

EDCTP [to 18 February 2017]

EDCTP [to 18 February 2017]

Home


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.
16 February 2017
PredART trial: prednisone reduces risk of TB-IRIS in HIV-infected patients by 30%
Results of the EDCTP-funded PredART clinical trial, led by Dr Graeme Meintjes, University of Cape Town, South Africa were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) (Abstract #81LB) on 15 February 2017. The trial showed that prednisone, a cheap drug readily accessible in low- and middle-income countries, reduces the risk of developing TB-IRIS by 30% in patients on tuberculosis (TB) treatment starting antiretroviral therapy (ART). The trial also showed that prednisone is safe when used in patients with advanced HIV.
The findings of the PredART trial provide the first evidence of an effective strategy to reduce the risk of this very common complication of starting ART in HIV-infected patients undergoing TB treatment…
Read: Abstract ‘Randomized controlled trial of prednisone for prevention of paradoxical TB-IRIS’ presented a CROI 2017 on 15 February 2017.

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

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

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BMGF – Gates Foundation [to 18 February 2017]
http://www.gatesfoundation.org/Media-Center/Press-Releases
February 14, 2017
Our 2017 Annual Letter
By Bill and Melinda Gates
[Excerpt]
The Best Deal Is Vaccines
Melinda: And if you want to know the best deal within the deal—it’s vaccines. Coverage for the basic package of childhood vaccines is now the highest it’s ever been, at 86 percent. And the gap between the richest and the poorest countries is the lowest it’s ever been. Vaccines are the biggest reason for the drop in childhood deaths.

Melinda: They’re an incredible investment. The pentavalent vaccine, which protects against five deadly infections in a single shot, now costs under a dollar.

Bill: And for every dollar spent on childhood immunizations, you get $44 in economic benefits. That includes saving the money that families lose when a child is sick and a parent can’t work.

Melinda: At the start, we just couldn’t understand why vaccines weren’t available to every child who needed them. We were naïve. There were no market incentives to serve people, and we had never seen that before.

Bill: The market wasn’t working for vaccines for poor kids because the families who needed them couldn’t afford them. But this gave us an opening. If we could create a purchasing fund so pharmaceutical companies would have enough customers, they’d have the market incentives to develop and produce vaccines.

Melinda: That’s the magic of philanthropy. It doesn’t need a financial return, so it can do things business can’t. But the limit of philanthropy is that the money runs out before the need is met. That’s why business and government have to play a role if the change is going to last.

Bill: That led us to partner with business and government to set up Gavi, the Vaccine Alliance, with the goal of getting vaccines to every child in the world. Gavi connects companies who develop vaccines with wealthy governments that help with funding and developing countries that get the vaccines to their people. Since 2000, Gavi has helped immunize 580 million children around the world. The United States is a major donor to Gavi—with bipartisan support—along with the UK, Norway, Germany, France, and Canada. It’s one of the great things the rich world does for the rest of the world.

Melinda: But there’s more to do—19 million children, many of them living in conflict zones or remote areas, are still not fully immunized. Their governments have to work harder to reach these kids. It’s crucial to the goal of cutting childhood deaths in half again—down below 3 million by 2030…

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Wellcome Trust [to 18 February 2017]
https://wellcome.ac.uk/news
Explainer Published: 13 February 2017
Preprints: we’re supporting calls for a Central Service
We now allow researchers to cite preprints in their grant applications. And, along with major international research funders, we’re supporting plans to establish a Central Service for Preprints. Robert Kiley, Open Research Development Lead, explains why.

For more than 25 years, researchers in disciplines such as high-energy physics and mathematics have been able to access the very latest research findings in the online repository known as arXiv (pronounced ‘archive’).

Here, researchers deposit their preprints – complete and public drafts of scientific documents, not yet certified by peer review – to:
:: ensure their findings are quickly and widely disseminated
:: establish priority of their discoveries
:: invite feedback and discussion to help improve the work.

Despite these benefits, researchers in the life sciences have been slow to share preprints. While the arXiv holds over 1.2 million articles, the number of preprints shared in the life and biomedical sciences is estimated to be less than 25,000. However, this disguises significant growth over the past two years, which has been aided by the work of ASAPbio (opens in a new tab), a scientist-driven initiative to promote the productive use of preprints in the life sciences…

While it’s positive that preprints are becoming a recognised part of the scholarly communications ecosystem, the downside is that it’s becoming more difficult for researchers to discover relevant content and to know, for example, which preprints have been subject to some initial screening to weed out ethically questionable or unscientific content.

To address these issues, we’re working with an international group of research funders to explore the value and feasibility of establishing a Central Service for Preprints.
The service would seek to aggregate content from multiple sources – such as the preprint servers listed above – and provide new ways for researchers and machines to search, access and reuse this content…

Journal Watch

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

Modelling the cost-effectiveness of introducing the RTS,S malaria vaccine relative to scaling up other malaria interventions in sub-Saharan Africa

BMJ Global Health
January 2017; volume 2, issue 1
http://gh.bmj.com/content/2/1?current-issue=y

Article
Modelling the cost-effectiveness of introducing the RTS,S malaria vaccine relative to scaling up other malaria interventions in sub-Saharan Africa
Peter Winskill, Patrick GT Walker, Jamie T Griffin, Azra C Ghani
January 24, 2017, 2 (1) e000090; DOI: 10.1136/bmjgh-2016-000090
Abstract
Objectives
To evaluate the relative cost-effectiveness of introducing the RTS,S malaria vaccine in sub-Saharan Africa compared with further scale-up of existing interventions.
Design
A mathematical modelling and cost-effectiveness study.
Setting
Sub-Saharan Africa.
Participants
People of all ages.
Interventions
The analysis considers the introduction and scale-up of the RTS,S malaria vaccine and the scale-up of long-lasting insecticide-treated bed nets (LLINs), indoor residual spraying (IRS) and seasonal malaria chemoprevention (SMC).
Main outcome measure The number of Plasmodium falciparum cases averted in all age groups over a 10-year period.
Results
Assuming access to treatment remains constant, increasing coverage of LLINs was consistently the most cost-effective intervention across a range of transmission settings and was found to occur early in the cost-effectiveness scale-up pathway. IRS, RTS,S and SMC entered the cost-effective pathway once LLIN coverage had been maximised. If non-linear production functions are included to capture the cost of reaching very high coverage, the resulting pathways become more complex and result in selection of multiple interventions.
Conclusions
RTS,S was consistently implemented later in the cost-effectiveness pathway than the LLINs, IRS and SMC but was still of value as a fourth intervention in many settings to reduce burden to the levels set out in the international goals.

INTRODUCTION OF A NEW VACCINE INTO NATIONAL IMMUNISATION PROGRAMMES IN AFRICA: THE ROLE OF CAPACITY BUILDING

BMJ Global Health
January 2017; volume 2, issue 1
http://gh.bmj.com/content/2/1?current-issue=y

INTRODUCTION OF A NEW VACCINE INTO NATIONAL IMMUNISATION PROGRAMMES IN AFRICA: THE ROLE OF CAPACITY BUILDING
Carine Dochez, Rosemary Burnett, M. Jeffrey Mphahlele
DOI: 10.1136/bmjgh-2016-000260.141 Published 12 February 2017
Abstract
Background
Members of National Immunisation Technical Advisory Groups, policy-makers, EPI managers and vaccinators are tasked with making evidence-based recommendations and decisions on whether a new vaccine merits introduction into national immunisation programmes; implementation of new vaccine introduction; and efficient management of immunisation programmes. Therefore it is paramount that they are equipped with the latest state-of-the-art information on vaccines and immunisation.
Methods
Capacity building activities – such as high-level in-service vaccinology courses, other interactive courses and workshops (mid-level management training and experience exchange workshops) – address all steps required for decision-making on new vaccine introduction into national immunisation programmes. These include establishing: 1) burden of disease to be prevented; 2) existence of a good intervention (i.e. is the vaccine efficacious, safe and acceptable for the target population); 3) the cost of the new vaccine, its implementation and the comparative effectiveness with other vaccines/interventions in terms of health gains; 4) whether finances to pay for the new vaccine are available; and 5) programmatic implications. Interested parties are trained on this rational decision-making process to be followed before embarking on new vaccine introduction, on key implementation steps, and efficient management of immunisation programmes.
Results
Several inter-country vaccinology courses and interactive workshops, which were organised during the last years in the African region (e.g. Kenya and South Africa), will be presented in detail. These capacity building activities have contributed to successful introduction of new vaccines in the African region, key ones being rotavirus, pneumococcal and currently human papillomavirus vaccines. This concerted effort has contributed for example to the successful introduction of rotavirus vaccine in 29 African countries to date.
Conclusions
Capacity building efforts, like high-level in-service courses and interactive workshops have enabled interested parties to make evidence-based recommendations and decisions on the introduction of any new vaccine, and to successfully implement new vaccine introduction.

Factors associated with the length of delay with tuberculosis diagnosis and treatment among adult tuberculosis patients attending at public health facilities in Gondar town, Northwest, Ethiopia

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 18 February 2017)

Research article
Factors associated with the length of delay with tuberculosis diagnosis and treatment among adult tuberculosis patients attending at public health facilities in Gondar town, Northwest, Ethiopia
Early diagnosis and prompt treatment is essential for an effective tuberculosis (TB) control program. However, significant proportion of cases remains undiagnosed and untreated. Delay in diagnosis and treatmen…
Selamsew Bogale, Ermias Diro, Atsede Mazengia Shiferaw and Melaku Kindie Yenit
BMC Infectious Diseases 2017 17:145
Published on: 14 February 2017

“I passed the test!” Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 18 February 2017)

Research article
“I passed the test!” Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa
Francis Masiye, Bongani Mayosi and Jantina de Vries
Published on: 15 February 2017
Abstract
Background
Advances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for an H3Africa genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand ethical challenges in obtaining informed consent in the RHDGen study.
Methods
We used a qualitative study methodology involving in-depth interviews and participant observations. Our study participants were RHDGen cases (patients), healthy controls and research staff involved in the recruitment of RHDGen cases and controls. In total, we conducted 32 in-depth interviews with RHDGen cases and controls, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen cases and controls. The interviews were conducted in English, audio-recorded and transcribed verbatim. Data were analyzed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa.
Results
Most healthy controls joined the RHDGen study in order to be screened for rheumatic heart disease (diagnostic misconception). A majority of RHDGen cases decided to join the RHDGen study because of therapeutic misconception.
Conclusion
The ethical challenges that impacted on obtaining informed consent in the RHDGen study were complex. In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases.

Factors affecting the implementation of childhood vaccination communication strategies in Nigeria: a qualitative study

BMC Public Health
http://www.bmcpublichealth.biomedcentral.com/articles
(Accessed 18 February 2017)

Research article
Factors affecting the implementation of childhood vaccination communication strategies in Nigeria: a qualitative study
Afiong Oku, Angela Oyo-Ita, Claire Glenton, Atle Fretheim, Glory Eteng, Heather Ames, Artur Muloliwa, Jessica Kaufman, Sophie Hill, Julie Cliff, Yuri Cartier, Xavier Bosch-Capblanch, Gabriel Rada and Simon Lewin
BMC Public Health 2017 17:200
Published on: 15 February 2017
Abstract
Background
The role of health communication in vaccination programmes cannot be overemphasized: it has contributed significantly to creating and sustaining demand for vaccination services and improving vaccination coverage. In Nigeria, numerous communication approaches have been deployed but these interventions are not without challenges. We therefore aimed to explore factors affecting the delivery of vaccination communication in Nigeria.
Methods
We used a qualitative approach and conducted the study in two states: Bauchi and Cross River States in northern and southern Nigeria respectively. We identified factors affecting the implementation of communication interventions through interviews with relevant stakeholders involved in vaccination communication in the health services. We also reviewed relevant documents. Data generated were transcribed verbatim and analysed using thematic analysis.
Results
We used the SURE framework to organise the identified factors (barriers and facilitators) affecting vaccination communication delivery. We then grouped these into health systems and community level factors. Some of the commonly reported health system barriers amongst stakeholders interviewed included: funding constraints, human resource factors (health worker shortages, training deficiencies, poor attitude of health workers and vaccination teams), inadequate infrastructure and equipment and weak political will. Community level factors included the attitudes of community stakeholders and of parents and caregivers. We also identified factors that appeared to facilitate communication activities. These included political support, engagement of traditional and religious institutions and the use of organised communication committees.
Conclusions
Communication activities are a crucial element of immunization programmes. It is therefore important for policy makers and programme managers to understand the barriers and facilitators affecting the delivery of vaccination communication so as to be able to implement communication interventions more effectively.

Scientific research and the public good

The European Journal of Public Health
Volume 27, Issue 1, 1 February 2017
http://www.academic.oup.com/eurpub/issue/27/1

Editorials
Scientific research and the public good
Diana M.J. Delnoij
Extract
Randomized clinical trials are the state-of-the-art method to study comparative effectiveness of healthcare interventions. However, sometimes a discrepancy is observed between the effects of an intervention in routine clinical practice as compared with the effects that were demonstrated in randomized controlled clinical trials.1 Real-world data, e.g. from registries or claims databases, could help to unravel the effectiveness of interventions in clinical practice. The hope is that the use of these data will allow healthcare decision makers to be more certain when it is (cost-)effective to provide access to new treatments. Real-world data could therefore contribute to the public good…Recently, the Dutch National Health Care Institute hosted an international workshop on the IMI-GetReal project. GetReal is a 3-year project of the Innovative Medicines Initiative (IMI), an EU public-private consortium…

Examples of sex/gender sensitivity in epidemiological research: results of an evaluation of original articles published in JECH 2006–2014

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 18 February 2017]

Research
Examples of sex/gender sensitivity in epidemiological research: results of an evaluation of original articles published in JECH 2006–2014
During the last decades, sex and gender biases have been identified in various areas of biomedical and public health research, leading to compromised validity of research findings. As a response, methodologica…
Ingeborg Jahn, Claudia Börnhorst, Frauke Günther and Tilman Brand
Health Research Policy and Systems 2017 15:11
Published on: 15 February 2017

New “21st Century Cures” Legislation: Speed and Ease vs Science

JAMA
February 14, 2017, Vol 317, No. 6, Pages 555-656
http://www.jama.jamanetwork.com/issue.aspx

Viewpoint
New “21st Century Cures” Legislation: Speed and Ease vs Science
Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD
JAMA. 2017;317(6):581-582. doi:10.1001/jama.2016.20640
This Viewpoint discusses potential threats to public health that arise from provisions of the 2016 21st Century Cures Act that allow drug manufacturers to use surrogate measures of safety and that encourage the US Food and Drug Administration to emphasize speed over science in the drug approval process.

Yemen’s silent killers

The Lancet
Feb 18, 2017 Volume 389 Number 10070 p671-762
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Yemen’s silent killers
The Lancet
Published: 18 February 2017
DOI: http://dx.doi.org/10.1016/S0140-6736(17)30390-2
Nearly 2 years of war have devastated Yemen. 14·8 million people currently lack access to basic health care, 7 million people are facing food insecurity, and 2·1 million children are acutely malnourished. On Feb 8, WHO and its health partners released their emergency response plan for Yemen’s health sector in 2017, including its funding requirement: US$321·6 million.

Around 75 people are either killed or injured in the conflict every day. But beyond these casualties, Rick Brennan, Director of WHO’s Emergency Operations, notes that “many Yemeni people die in silence” from diseases that are preventable and treatable, but that go unnoticed in reporting of the crisis. The main causes of avoidable deaths are communicable diseases and maternal, perinatal, and nutritional conditions (together responsible for 50% of deaths), and non-communicable diseases (39% of deaths). Lives are being lost because Yemen’s health system is under severe strain; chronic shortages of drugs and other medical supplies exist and less than 45% of health facilities are functioning.

In their response plan for 2017, WHO and its health partners are targeting 10.4 million people, mostly women and children, and others in acute need. Their key strategic objectives include providing integrated primary, secondary, and referral health services, surveillance and response, and medical supplies in priority districts; strengthening reproductive, maternal, newborn, child, and adolescent health interventions; and improving health sector coordination and health information systems.

Amid the dire health and humanitarian data for Yemen, it might be easy for some donors to dismiss the crisis as too difficult and large. But they should not. Last year, WHO and its health partners received financial support that, among its achievements, sustained the functionality of 414 health facilities in 145 districts, delivered 541 child health and nutrition interventions in 323 districts, and provided essential medicine and medical supplies to assist an estimated 3 million people. The 2017 emergency response plan is realistic and targeted, focusing on priority accessible districts and interventions for delivery. It deserves to be fully supported.

Safety, tolerability, and antiviral effect of RG-101 in patients with chronic hepatitis C: a phase 1B, double-blind, randomised controlled trial

The Lancet
Feb 18, 2017 Volume 389 Number 10070 p671-762
http://www.thelancet.com/journals/lancet/issue/current

Articles
Safety, tolerability, and antiviral effect of RG-101 in patients with chronic hepatitis C: a phase 1B, double-blind, randomised controlled trial
Meike H van der Ree, J Marleen de Vree, Femke Stelma, Sophie Willemse, Marc van der Valk, Svend Rietdijk, Richard Molenkamp, Janke Schinkel, Ad C van Nuenen, Ulrich Beuers, Salah Hadi, Marten Harbers, Eva van der Veer, Kai Liu, John Grundy, Amy K Patick, Adam Pavlicek, Jacqueline Blem, Michael Huang, Paul Grint, Steven Neben, Neil W Gibson, Neeltje A Kootstra, Hendrik W Reesink

Reimagining WHO: leadership and action for a new Director-General

The Lancet
Feb 18, 2017 Volume 389 Number 10070 p671-762
http://www.thelancet.com/journals/lancet/issue/current

Health Policy
Reimagining WHO: leadership and action for a new Director-General
Prof Lawrence O Gostin, JD, Eric A Friedman, JD
Published: 27 January 2017
Summary
Three candidates to be the next WHO Director-General remain: Tedros Adhanom Ghebreyesus, David Nabarro, and Sania Nishtar. The World Health Assembly’s ultimate choice will lead an organisation facing daunting internal and external challenges, from its own funding shortfalls to antimicrobial resistance and immense health inequities. The new Director-General must transform WHO into a 21st century institution guided by the right to health. Topping the incoming Director-General’s agenda will be a host of growing threats—risks to global health security, antimicrobial resistance, non-communicable diseases, and climate change—but also the transformative potential of the Sustainable Development Goals, including their universal health coverage target. Throughout, the next Director-General should emphasise equality, including through national health equity strategies and, more boldly still, advancing the Framework Convention on Global Health. Success in these areas will require a reinvigorated WHO, with sustainable financing, greater multisector engagement, enhanced accountability and transparency, and strengthened normative leadership. WHO must also evolve its governance to become far more welcoming of civil society and communities. To create the foundation for these transformative changes, the Director-General will need to focus first on gaining political support. This entails improving accountability and transparency to gain member state trust, and enabling meaningful civil society participation in WHO’s governance and standing up for the right to health to gain civil society support. Ultimately, in the face of a global environment marked by heightened nationalism and xenophobia, member states must empower the next Director-General to enable WHO to be a bulwark for health and human rights, serving as an inspiring contra-example to today’s destructive politics, demonstrating that the community of nations are indeed stronger together.

New England Journal of Medicine – February 16, 2017 Vol. 376 No. 7

New England Journal of Medicine
February 16, 2017  Vol. 376 No. 7
http://www.nejm.org/toc/nejm/medical-journal

Perspective
New Vaccines against Epidemic Infectious Diseases
John-Arne Røttingen, M.D., Ph.D., Dimitrios Gouglas, M.Sc., Mark Feinberg, M.D., Ph.D., Stanley Plotkin, M.D., Krishnaswamy V. Raghavan, Ph.D., Andrew Witty, B.A., Ruxandra Draghia-Akli, M.D., Ph.D., Paul Stoffels, M.D., and Peter Piot, M.D., Ph.D.
N Engl J Med 2017; 376:610-613 February 16, 2017 DOI: 10.1056/NEJMp1613577
The newly formed international Coalition for Epidemic Preparedness Innovations aims to stimulate, finance, and coordinate the development of vaccines against epidemic infectious diseases, especially in cases in which market incentives alone are insufficient.

Perspective
The Common Rule, Updated
Jerry Menikoff, M.D., J.D., Julie Kaneshiro, M.A., and Ivor Pritchard, Ph.D.
N Engl J Med 2017; 376:613-615 February 16, 2017 DOI: 10.1056/NEJMp1700736
The Common Rule — the set of federal regulations for ethical conduct of human-subjects research — has finally been updated. A long process of deliberation and discussion has resulted in a final rule that differs significantly from what was initially proposed.

Review Article
FDA Regulation of Prescription Drugs
Audrey L. Gassman, M.D., Christine P. Nguyen, M.D., and Hylton V. Joffe, M.D., M.M.Sc.
N Engl J Med 2017; 376:674-682 February 16, 2017 DOI: 10.1056/NEJMra1602972
Share:
Over the past 5 years, the FDA has approved 182 new drugs. This overview explains the FDA’s drug-approval process, including its approach to benefit–risk assessment, drug labeling, risk evaluation and mitigation strategies, and postmarketing surveillance.

First Report of the East-Central South African Genotype of Chikungunya Virus in Rio de Janeiro, Brazil

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 18 February 2017]

Research Article
First Report of the East-Central South African Genotype of Chikungunya Virus in Rio de Janeiro, Brazil
February 14, 2017 ·
Background: Chikungunya virus (CHIKV) is an arbovirus that causes an acute febrile syndrome with a severe and debilitating arthralgia. In Brazil, the Asian and East-Central South African (ECSA) genotypes are circulating in the north and northeast of the country, respectively. In 2015, the first autochthonous cases in Rio de Janeiro, Brazil were reported but until now the circulating strains have not been characterized. Therefore, we aimed here to perform the molecular characterization and phylogenetic analysis of CHIKV strains circulating in the 2016 outbreak occurred in the municipality of Rio de Janeiro.
Methods: The cases analyzed in this study were collected at a private Hospital, from April 2016 to May 2016, during the chikungunya outbreak in Rio de Janeiro, Brazil. All cases were submitted to the Real Time RT-PCR for CHIKV genome detection and to anti-CHIKV IgM ELISA. Chikungunya infection was laboratorially confirmed by at least one diagnostic method and, randomly selected positive cases (n=10), were partially sequenced (CHIKV E1 gene) and analyzed.
Results: The results showed that all the samples grouped in ECSA genotype branch and the molecular characterization of the fragment did not reveal the A226V mutation in the Rio de Janeiro strains analyzed, but a K211T amino acid substitution was observed for the first time in all samples and a V156A substitution in two of ten samples.
Conclusions: Phylogenetic analysis and molecular characterization reveals the circulation of the ECSA genotype of CHIKV in the city of Rio de Janeiro, Brazil and two amino acids substitutions (K211T and V156A) exclusive to the CHIKV strains obtained during the 2016 epidemic, were reported.

Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 18 February 2017)

Research Article
Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine
Jill B. Brelsford, Jordan L. Plieskatt, Anna Yakovleva, Amar Jariwala, Brian P. Keegan, Jin Peng, Pengjun Xia, Guangzhao Li, Doreen Campbell, Maria Victoria Periago, Rodrigo Correa-Oliveira, Maria Elena Bottazzi, Peter J. Hotez, David Diemert, Jeffrey M. Bethony
published 13 Feb 2017 P
http://dx.doi.org/10.1371/journal.pntd.0005385

Systems analysis of protective immune responses to RTS,S malaria vaccination in humans

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/
[Accessed 18 February 2017]

Biological Sciences – Systems Biology:
Systems analysis of protective immune responses to RTS,S malaria vaccination in humans
Dmitri Kazmina,1, Helder I. Nakayab,1, Eva K. Leec, Matthew J. Johnsond, Robbert van der Moste, Robert A. van den ergf, W. Ripley Ballouf, Erik Jongerte, Ulrike Wille-Reeceg,
Christian Ockenhouseg, Alan Aderemh, Daniel E. Zakh, Jerald Sadoffi, Jenny Hendriksi, Jens Wrammerta, Rafi Ahmeda,2, and Bali Pulendrana,j,2
Significance
The RTS,S malaria vaccine is the most advanced malaria vaccine candidate to be tested in humans. Despite its promise, there is little understanding of its mechanism of action. In this work, we describe the use of a systems biological approach to identify “molecular signatures” that are induced rapidly after the standard RTS,S vaccination regimen, consisting of three RTS,S immunizations, or with a different regimen consisting of a primary immunization with recombinant adenovirus 35 (Ad35) expressing the circumsporozoite malaria antigen followed by two immunizations with RTS,S. These results reveal important insights about the innate and adaptive responses to vaccination and identify signatures of protective immunity against malaria.
Abstract
RTS,S is an advanced malaria vaccine candidate and confers significant protection against Plasmodium falciparum infection in humans. Little is known about the molecular mechanisms driving vaccine immunity. Here, we applied a systems biology approach to study immune responses in subjects receiving three consecutive immunizations with RTS,S (RRR), or in those receiving two immunizations of RTS,S/AS01 following a primary immunization with adenovirus 35 (Ad35) (ARR) vector expressing circumsporozoite protein. Subsequent controlled human malaria challenge (CHMI) of the vaccinees with Plasmodium-infected mosquitoes, 3 wk after the final immunization, resulted in ∼50% protection in both groups of vaccinees. Circumsporozoite protein (CSP)-specific antibody titers, prechallenge, were associated with protection in the RRR group. In contrast, ARR-induced lower antibody responses, and protection was associated with polyfunctional CD4+ T-cell responses 2 wk after priming with Ad35. Molecular signatures of B and plasma cells detected in PBMCs were highly correlated with antibody titers prechallenge and protection in the RRR cohort. In contrast, early signatures of innate immunity and dendritic cell activation were highly associated with protection in the ARR cohort. For both vaccine regimens, natural killer (NK) cell signatures negatively correlated with and predicted protection. These results suggest that protective immunity against P. falciparum can be achieved via multiple mechanisms and highlight the utility of systems approaches in defining molecular correlates of protection to vaccination.

Moving from legality to reality: how medical abortion methods were introduced with implementation science in Zambia

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 18 February 2017]

Research
Moving from legality to reality: how medical abortion methods were introduced with implementation science in Zambia
Although abortion is technically legal in Zambia, the reality is far more complicated. This study describes the process and results of galvanizing access to medical abortion where abortion has been legal for m…
Tamara Fetters, Ghazaleh Samandari, Patrick Djemo, Bellington Vwallika and Stephen Mupeta
Reproductive Health 2017 14:26
Published on: 16 February 2017

Total Economic Consequences of an Influenza Outbreak in the United States (pages 4–19)

Risk Analysis
January 2017 Volume 37, Issue 1 Pages 1–192
http://www.onlinelibrary.wiley.com/doi/10.1111/risa.2017.37.issue-1/issuetoc

Original Research Articles
Total Economic Consequences of an Influenza Outbreak in the United States (pages 4–19)
Fynnwin Prager, Dan Wei and Adam Rose
Version of Record online: 23 MAY 2016 | DOI: 10.1111/risa.12625
Abstract
Pandemic influenza represents a serious threat not only to the population of the United States, but also to its economy. In this study, we analyze the total economic consequences of potential influenza outbreaks in the United States for four cases based on the distinctions between disease severity and the presence/absence of vaccinations. The analysis is based on data and parameters on influenza obtained from the Centers for Disease Control and the general literature. A state-of-the-art economic impact modeling approach, computable general equilibrium, is applied to analyze a wide range of potential impacts stemming from the outbreaks. This study examines the economic impacts from changes in medical expenditures and workforce participation, and also takes into consideration different types of avoidance behavior and resilience actions not previously fully studied. Our results indicate that, in the absence of avoidance and resilience effects, a pandemic influenza outbreak could result in a loss in U.S. GDP of $25.4 billion, but that vaccination could reduce the losses to $19.9 billion. When behavioral and resilience factors are taken into account, a pandemic influenza outbreak could result in GDP losses of $45.3 billion without vaccination and $34.4 billion with vaccination. These results indicate the importance of including a broader set of causal factors to achieve more accurate estimates of the total economic impacts of not just pandemic influenza but biothreats in general. The results also highlight a number of actionable items that government policymakers and public health officials can use to help reduce potential economic losses from the outbreaks.

Risk Analysis – January 2017 Volume 37, Issue 1 Pages 1–192

Risk Analysis
January 2017 Volume 37, Issue 1 Pages 1–192
http://www.onlinelibrary.wiley.com/doi/10.1111/risa.2017.37.issue-1/issuetoc

Determinants of Seeking and Avoiding Risk-Related Information in Times of Crisis (pages 27–39)
Jan M. Gutteling and Peter W. de Vries
Version of Record online: 2 MAY 2016 | DOI: 10.1111/risa.12632

Communicating Uncertain Science to the Public: How Amount and Source of Uncertainty Impact Fatalism, Backlash, and Overload (pages 40–51)
Jakob D. Jensen, Manusheela Pokharel, Courtney L. Scherr, Andy J. King, Natasha Brown and Christina Jones
Version of Record online: 12 MAR 2016 | DOI: 10.1111/risa.12600

Science – 17 February 2017 Vol 355, Issue 6326

Science
17 February 2017 Vol 355, Issue 6326
http://www.sciencemag.org/current.dtl

Editorial
Data in public health
By Jeremy Berg
Science17 Feb 2017 : 669
Summary
In 1854, physician John Snow helped curtail a cholera outbreak in a London neighborhood by mapping cases and identifying a central public water pump as the potential source. This event is considered by many to represent the founding of modern epidemiology. Data and analysis play an increasingly important role in public health today. This can be illustrated by examining the rise in the prevalence of autism spectrum disorders (ASDs), where data from varied sources highlight potential factors while ruling out others, such as childhood vaccines, facilitating wise policy choices.

Policy Forum
Ensuring scientific integrity in the Age of Trump
By Gretchen T. Goldman, Emily Berman, Michael Halpern, Charise Johnson, Yogin Kothari, Genna Reed, Andrew A. Rosenberg
Science17 Feb 2017 : 696-698 Full Access
Policies to protect government scientists must be defended

Improving the selection and development of influenza vaccine viruses – Report of a WHO informal consultation on improving influenza vaccine virus selection, Hong Kong SAR, China, 18–20 November 2015

Vaccine
Volume 35, Issue 8, Pages 1101-1194 (22 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/8

WHO Report
Improving the selection and development of influenza vaccine viruses – Report of a WHO informal consultation on improving influenza vaccine virus selection, Hong Kong SAR, China, 18–20 November 2015
Pages 1104-1109
Hampson Alan, Barr Ian, Cox Nancy, Donis Ruben O., Hirve Siddhivinayak, Jernigan Daniel, Katz Jacqueline, McCauley John, Motta Fernando, Odagiri Takato, John S. Tam, Waddell Anthony, Webby Richard, Ziegler Thedi, Zhang Wenqing
Abstract
Since 2010 the WHO has held a series of informal consultations to explore ways of improving the currently highly complex and time-pressured influenza vaccine virus selection and development process. In November 2015 experts from around the world met to review the current status of efforts in this field.
Discussion topics included strengthening influenza surveillance activities to increase the availability of candidate vaccine viruses and improve the extent, timeliness and quality of surveillance data. Consideration was also given to the development and potential application of newer laboratory assays to better characterize candidate vaccine viruses, the potential importance of antibodies directed against influenza virus neuraminidase, and the role of vaccine effectiveness studies. Advances in next generation sequencing and whole genome sequencing of influenza viruses were also discussed, along with associated developments in synthetic genomics technologies, evolutionary analysis and predictive mathematical modelling.
Discussions were also held on the late emergence of an antigenic variant influenza A(H3N2) virus in mid-2014 that could not be incorporated in time into the 2014–15 northern hemisphere vaccine. There was broad recognition that given the current highly constrained influenza vaccine development and production timeline it would remain impossible to incorporate any variant virus which emerged significantly long after the relevant WHO biannual influenza vaccine composition meetings. Discussions were also held on the development of pandemic and broadly protective vaccines, and on associated regulatory and manufacturing requirements and constraints.
With increasing awareness of the health and economic burdens caused by seasonal influenza, the ever-present threat posed by zoonotic influenza viruses, and the significant impact of the 2014–15 northern hemisphere seasonal influenza vaccine mismatch, this consultation provided a very timely opportunity to share developments and exchange views. In all areas, a renewed and strengthened emphasis was placed on developing concrete and measurable actions and identifying the key stakeholders responsible for their implementation.

The Advisory Committee on Immunization Practices’ controversial recommendation against the use of live attenuated influenza vaccine is based on a biased study design that ignores secondary protection

Vaccine
Volume 35, Issue 8, Pages 1101-1194 (22 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/8

Commentary
The Advisory Committee on Immunization Practices’ controversial recommendation against the use of live attenuated influenza vaccine is based on a biased study design that ignores secondary protection
Pages 1110-1112
Parker A. Small Jr., Brendan J. Cronin

An expensive adult measles outbreak and response in office buildings during the era of accelerated measles elimination, Beijing, China

Vaccine
Volume 35, Issue 8, Pages 1101-1194 (22 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/8

Regular papers
An expensive adult measles outbreak and response in office buildings during the era of accelerated measles elimination, Beijing, China
Original Research Article
Pages 1117-1123
Rui Ma, Li Lu, Luodan Suo, Xiaomei Li, Fan Yang, Tao Zhou, Lijun Zhai, Hongwei Bai, Xinghuo Pang
Abstract
Background
Few measles outbreaks among adults are reported in China, and outbreak response costs are seldom documented. We report an adult measles outbreak and response in 4 linked office buildings in Beijing and its associated costs.
Method
The World Health Organization measles case definitions were used to determine suspected and confirmed measles cases. Surveillance data were used to describe the outbreak, and records and interviews of response staff were used to describe the response. Costs were determined by use of retrospective surveys of cases, review of records, and interviews of staff.
Results
The outbreak lasted 19 days, and involved 22 cases aged 23–49 years. Nineteen cases had a local household registration. All cases were employed by 8 companies in 4 linked office buildings. Among the 22 cases, 8 had temperature less than 38.5 degree, 18 had no Koplik spots and none had complications or hospitalizations. A total of 7930 contacts were identified, and of these, 6869 were employees in the office buildings. All the child contacts aged 8 months–14 years had been up-to-date for measles-containing vaccine (MCV); no adult could document their vaccination or measles history. Of contacts, about 96% were offered post-exposure vaccination. The total household costs were $13,298, or $605 per case. Control costs were $384,594, or $17,481 per case. Involved companies paid for 90.7% of control costs.
Conclusion
Office buildings provide a mechanism for measles transmission. Timely control activities were challenged by the highly infectious nature of measles and mild presentations of cases. The outbreak response was very costly. Financial support by involved companies can provide needed resources for outbreak management.

Survey of vaccination knowledge and acceptance among adults admitted to an urban emergency department

Vaccine
Volume 35, Issue 8, Pages 1101-1194 (22 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/8

Survey of vaccination knowledge and acceptance among adults admitted to an urban emergency department
Original Research Article
Pages 1148-1151
Kathryn Sutcliffe, Paul E. Kilgore, Kaitlyn DeHoff, Richard Evans, Keith S. Kaye, Ryan E. Malosh, Robert Sherwin, Emily T. Martin
Abstract
Background
Adult vaccination rates in the United States have fallen below national target levels and may be exacerbated by lack of access to a primary care physician. We assessed patient knowledge of and attitudes towards vaccines in an urban emergency department population and analyzed the feasibility of using this setting as a vaccine delivery site from a patient perspective.
Methods
In-person interviewers administered surveys to 250 adult patients presenting to the Detroit Receiving Hospital emergency department in Detroit, Michigan. Respondents were asked about vaccination status, preferences, and willingness to accept vaccination reminders via text messaging. Odds ratios and 95% Wald confidence intervals assessing differences between vaccinated and non-vaccinated individuals were generated with univariate logistic regression.
Results
Vaccinated adults were more likely to have a primary care provider than non-vaccinated adults (OR 1.94, 95% CI: 1.09–3.45). Non-vaccinated adults were significantly more likely to have unvaccinated adult relatives (OR8.64, 95% CI: 4.10–18.22). Nearly all respondents used a cell phone, and 75.8% of unvaccinated adults were willing to receive text messages reminders about vaccines.
Conclusions
Although less likely to have a primary care access point than vaccinated participants, non-vaccinated respondents reported interest in receiving vaccinations. Emergency departments could serve as vaccination hubs for patients and unvaccinated accompanying family members. Text message reminders offer a potential source of additional vaccine prompts and education.

Exploring racial influences on flu vaccine attitudes and behavior: Results of a national survey of White and African American adults

Vaccine
Volume 35, Issue 8, Pages 1101-1194 (22 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/8

Exploring racial influences on flu vaccine attitudes and behavior: Results of a national survey of White and African American adults
Original Research Article
Pages 1167-1174
Sandra Crouse Quinn, Amelia Jamison, Vicki S. Freimuth, Ji An, Gregory R. Hancock, Donald Musa
Abstract
Introduction
Racial disparities in adult flu vaccination rates persist with African Americans falling below Whites in vaccine acceptance. Although the literature has examined traditional variables including barriers, access, attitudes, among others, there has been virtually no examination of the extent to which racial factors including racial consciousness, fairness, and discrimination may affect vaccine attitudes and behaviors.
Methods
We contracted with GfK to conduct an online, nationally representative survey with 819 African American and 838 White respondents. Measures included risk perception, trust, vaccine attitudes, hesitancy and confidence, novel measures on racial factors, and vaccine behavior.
Results
There were significant racial differences in vaccine attitudes, risk perception, trust, hesitancy and confidence. For both groups, racial fairness had stronger direct effects on the vaccine-related variables with more positive coefficients associated with more positive vaccine attitudes. Racial consciousness in a health care setting emerged as a more powerful influence on attitudes and beliefs, particularly for African Americans, with higher scores on racial consciousness associated with lower trust in the vaccine and the vaccine process, higher perceived vaccine risk, less knowledge of flu vaccine, greater vaccine hesitancy, and less confidence in the flu vaccine. The effect of racial fairness on vaccine behavior was mediated by trust in the flu vaccine for African Americans only (i.e., higher racial fairness increased trust in the vaccine process and thus the probability of getting a flu vaccine). The effect of racial consciousness and discrimination for African Americans on vaccine uptake was mediated by perceived vaccine risk and flu vaccine knowledge.
Conclusions
Racial factors can be a useful new tool for understanding and addressing attitudes toward the flu vaccine and actual vaccine behavior. These new concepts can facilitate more effective tailored and targeted vaccine communications.