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vaccines and global health :: ethics and policy

Vaccines and Global Health: The Week in Reviewis aweekly 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 toEmail 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 [email protected]

pdf versionA pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_26 August 2017

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

– Twitter:Readers can also follow developments on twitter:@vaxethicspolicy.
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– Left: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.Clickhere to donate and thank you in advance for your contribution.

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

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Milestones :: Perspectives

Editor’s note
We generally reserve this section of our digest for major strategic announcements and significant milestones in the vaccines / immunization space. We share below the text from a WHO recognition that represents, in our view, such a milestone.

“WHO would like to express its thanks and appreciation for the contribution and leadership for the advancement of global health by Dr. Philippe Duclos, Secretary to the Strategic Advisory Group of Experts (SAGE) on Immunization 2005 - 2017 ”

We understand that WHO held a celebratory event this past Friday to recognize the retirement and final service day of Dr. Philippe Duclos, Executive Secretary to SAGE for many years as indicated. For those who may have served in roles leading and facilitating the development and implementation of global normative standards (in health or any human endeavor) it is clear that it requires an extraordinary mix of technical competence, political skill, and other sensibilities rarely found together.

Phil Duclos evidenced these attributes splendidly and navigated the changing ecology of SAGE with aplomb. His leadership was critical to the many achievements of SAGE during his tenure.

For our part, CVEP found Phil to be ever patient, ever engaged, and ever open to us and the CSO community, which has been a growing part of that SAGE ecology.

We wish him a splendid next adventure, wherever that may take him.

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 23 August 2017 [GPEI]
:: Read the latest polio updates from WHO Pakistan and from WHO Afghanistan to see information on cases, surveillance and vaccination campaigns.
:: The remarkable impact of frontline workers: read about Khalida, a frontline health worker in Karachi, Pakistan, and her incredible efforts to forge a path to trust in vaccines.
:: Summary of newly-reported viruses this week: No new viruses reported this week.

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Situation reports on the polio outbreak in Syria
Situation update 22 August 2017
:: No new cases of cVDPV2 were reported this week. The total number of cVDPV2 cases remains 33. All confirmed cases to date have had onset of paralysis before 11 July 2017.
:: Final lab results are pending for an additional 11 poliovirus type-2 (PV2) isolates (7 from Mayadeen and 3 from Boukamal districts, Deir Ez-Zor governorate, and 1 from Thawra district, Raqqa governorate).
:: Raqqa governorate concluded its first immunization round on August 17th. According to administrative data, 103,720 children were vaccinated, representing 86% campaign coverage. Additional coverage data from independent third party monitoring is being evaluated.
:: The second immunization round in Deir Ez-Zor governorate is expected to start this week. The second immunization round for Raqqa is being planned for after oath.
:: Under International Health Regulations (2005) (IHR), WHO’s Emergency Committee has issued temporary recommendations for Syria as a ‘state infected with cVDPV2 with potential risk of international spread’.
:: The total number of AFP cases detected in Deir Ez-Zor governorate since the beginning of 2017 is 118 (87 from Mayadeen, 11 from Deir Ez-Zor, and 20 from Boukamal districts).
Raqqa governorate has reported 16 AFP cases (5 from Raqqa, 10 from Tell Abyad, and 1 from Thawra districts).
:: Homs governorate has reported 27 AFP cases (12 from Homs city, 12 from Rastan, 1 from Tadmour and 2 from Talkalakh districts).

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WHO Grade 3 Emergencies [to 26 August 2017]
Iraq
:: Health services for people fleeing the crisis in Iraq
21 August 2017 - As hundreds of people flee the crisis in Telafar, a city west of Mosul, Iraq, WHO and health partners in collaboration with the health authority have established static and mobile medical clinics to offer 24/7 lifesaving emergency and primary health care services to meet the urgent needs of people fleeing the crisis.

The Syrian Arab Republic
:: Situation reports on the polio outbreak in Syria22 August 2017
[See Polio above for more detail]

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UNOG - REGULAR PRESS BRIEFING BY THE INFORMATION SERVICE
25 August 2017
[Excerpt]
Syria immunization programs
Christian Lindmeier, for the World Health Organization, said that routine immunization programs restarted in North-West Syria, starting in the spring of 2017 with technical support and guidance from WHO.
As of August 2017, more than 35 centers in the areas of Idlib and Hama offered vaccinations against tuberculosis, measles, rubella, mumps, polio, hepatitis B, diphtheria, tetanus, whooping cough and a special influenza type.
During the years of the crisis, basic vaccines were not always available and clinics and hospitals in some areas could not offer immunization or were even destroyed. During the crisis, WHO’s field office in Gaziantep, Turkey, had worked with UNICEF to do short term vaccination campaigns that lasted several weeks, with vaccination teams fanning out to reach children in remote areas of Northern Syria.
However on-going outbreaks in Syria indicated low vaccine coverage and WHO had worked with local NGOs and local clinics to re-establish centers. In July 2017 alone, thanks to the immunization work at these centers, more than 20,000 children the North-East area were vaccinated with the pentavalent vaccine which protects against hepatitis B, diphtheria, tetanus, whooping cough and the Haemophilus influenza type B.
WHO partners planned to re-establish routine vaccination programs in dozens more centers in North West by the end of 2017.
Answering questions, Mr. Lindmeier explained that records of immunization had been lost in many cases, with people being displaced; it was very difficult to obtain figures on the number of children who might have died or been sick as a result of low immunization. He also said that, before the war, the level of immunization had been above 95%, but that it was difficult to ascertain the level today. Ongoing outbreaks of polio and measles were indicators that the vaccination level was too low in Syria.
Answering another question, Mr. Lindmeier said that WHO provided supplies to partners on the ground such as NGOs as well as hospitals or health centers, which in turn negotiated with authorities which, in the areas concerned, would be opposition groups.
On immunization, Christophe Boulierac, for the United Nations Children’s Fund (UNICEF), added that the second round of polio vaccination in Deir ez-Zor had started on 22 August. On that first day, 14% of the total target had already been reached.

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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
:: OCHA Iraq | Telafar Flash Update # 1: Telafar Humanitarian Response, August 20, 2017 [EN / AR / KU]
:: Thousands of civilians fleeing Telafar are at extreme risk [EN / AR / KU] Report
Published on 20 Aug 2017

Syrian Arab Republic
:: 25 Aug 2017 Displaced, disoriented and shocked, children from Raqqa and Deir-ez-Zor need urgent assistance and protection [EN / AR]
:: Joint Statement on Civilian Casualties Due to Coalition Airstrikes in Ar-Raqqa City [EN / AR]
Report Published on 22 Aug 2017 -
Ali Al-Za'tari, the Humanitarian Coordinator for Syria, and Ramesh Rajasingham, the Regional Humanitarian Coordinator for Syria ai, express their deep concern over the significant number of civilians reportedly killed in the last few days due to the use of explosive ordnances, including through Coalition airstrikes, against targets of the Islamic State of Iraq and the Levant (ISIL) in densely populated neighborhoods of Ar-Raqqa city ...

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UN OCHA - Corporate Emergencies
When the USG / ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Ethiopia
:: 22 Aug 2017 Ethiopia Weekly Humanitarian Bulletin, 21 August 2017

DRC
:: Bulletin humanitaire R.D. Congo - Numéro 3 | 21 août 2017

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WHO & Regional Offices [to 26 August 2017]

New vision and strengthened partnership for WHO and China
21 August 2017 | GENEVA - WHO Director-General Tedros Adhanom Ghebreyesus concluded a 3-day official visit to the People’s Republic of China paving the way for stronger and more strategic WHO-China collaborations. Outcomes of his visit included a new financial contribution to WHO from China, and strengthened commitments to improve the health of billions of people in the 60 countries in the Belt and Road Initiative.

World Humanitarian Day
21 August 2017 - Dr Tedros honored the heroic people who have died for the humanitarian cause, and thanked those who continue to devote their lives to helping the world’s most vulnerable people - in so many different countries, in such difficult circumstances.

Preventing spread of disease after Sierra Leone mudslide
21 August 2017 - WHO is working closely with the Government of Sierra Leone to prevent the spread of infectious diseases such as malaria and cholera in the wake of last week’s mudslides and flooding in Freetown. The Organization is also working with partners to ensure ongoing health care for the injured and displaced, and to provide psychological aid to those coping with trauma.

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Disease outbreak news
:: Chikungunya - France 25 August 2017

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Weekly Epidemiological Record, August 25, 2017, vol. 92, 34 (pp. 477-500)
:: Cholera vaccines: WHO position paper - August 2017
:: Monthly report on dracunculiasis cases, January-June 2017

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Africa on the verge of winning the fight against Neglected Tropical Disease
Brazzaville, Congo. August 24, 2017 - For more than 40 years, the World Health Organization (WHO) has worked to control river blindness (onchocerciasis), the second major infectious cause of blindness in Africa. Today, 30 years after a major donation of medication by Merck & Co, a pharmaceutical company, and after 20 years of the success of the African Program for Onchocerciasis Control (APOC) the reduction of the disease intensity has allowed WHO to shift the goal from control to elimination - a really ambitious achievement.
The unprecedented donation of medication “as much as needed for as long as needed”, combined with innovative distribution mechanism from WHO was protecting more than 110 million people annually in 19 countries by 2015, when the APOC program closed. It prevented over 40,000 cases of blindness every year between 1995 and 2015 ...

:: Acting on the call (AOTC) 2017 Summit kicks off in Addis Ababa: "Let's make the world a better place for mothers and children"
Addis Ababa, August 24th, 2017: The 4th Acting On The Call (AOTC) conference started on the August 24th 2017 at the African Union, Addis Ababa Ethiopia with a theme “Overcoming Critical Barriers to Maternal and Child Survival”. The AOTC conference which is hosted by the governments of Ethiopia and India gathered more than 500 participants from 24 countries and held in the presence of the President of the Federal Republic of Ethiopia, Ministers and high level policymakers from the public and private sectors, NGOs and UN agencies including UN Women, UNICEF, UNFPA and WHO. ..

WHO European Region EURO
:: Chikungunya cases reported in France 25-08-2017
:: Report shows progress towards Health 2020 targets 24-08-2017
:: Towards tobacco-free generations: stopping second-hand smoke and smoking initiation among children 22-08-2017

WHO Eastern Mediterranean Region EMRO
:: WHO and health authorities deliver 24/7 health services for hundreds of people fleeing the crisis in Telafar, Iraq Baghdad, 22 August 2017

WHO Western Pacific Region
:: New vision and strengthened partnership for WHO and China 21 August 2017

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CDC / ACIP [to 26 August 2017]
http://www.cdc.gov/media/index.html
Thursday, August 24, 2017
Most U.S. teens are getting cancer-preventing vaccine
CDC encourages parents to protect children from cancers caused by HPV
Six out of 10 U.S. parents are choosing to get the human papillomavirus (HPV) vaccine for their children, according to a report published in this week’s Morbidity and Mortality Weekly Report. The Centers for Disease Control and Prevention (CDC) recommends parents get two doses of HPV vaccine for their children at ages 11 or 12 to protect against cancers caused by HPV infections. Although most children are getting their first dose of HPV vaccine, many children are not completing the vaccination series.

"I'm pleased with the progress, but too many teens are still not receiving the HPV vaccine - which leaves them vulnerable to cancers caused by HPV infection," said CDC Director Brenda Fitzgerald, M.D. "We need to do more to increase the vaccination rate and protect American youth today from future cancers tomorrow."

Adolescents who get the first dose of HPV vaccine before their 15th birthday need two doses of HPV vaccine to be protected against cancers caused by HPV. Teens and young adults who start the series at ages 15 through 26 years need three doses of HPV vaccine to be protected against cancers caused by HPV.

Teen HPV vaccination: key findings
The annual National Immunization Survey-Teen (NIS-Teen) report, which examines vaccination coverage among U.S. adolescents, found that 60 percent of teens ages 13 to 17 received one or more doses of HPV vaccine in 2016, an increase of 4 percentage points from 2015.

The report also showed that HPV vaccination is becoming more common among boys. The difference in vaccination rates between boys and girls has been narrowing in recent years. About 65 percent of girls received the first dose of HPV vaccine compared to 56 percent of boys receiving the first dose. These latest estimates represent a 6 percentage point increase from 2015 for boys, while rates for girls were similar to 2015.

Despite these increases, areas for improvement remain. While most adolescents have received the first dose of HPV vaccine, only 43 percent of teens are up to date on all the recommended doses of HPV vaccine. HPV vaccination rates were also lower in rural and less urban areas compared to more urban areas ...

MMWR News Synopsis for August 24, 2017
:: National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years - United States, 2016
Human Papilloma Vvirus (HPV) vaccination prevents cancer. Six out of 10 U.S. parents are choosing to get the HPV vaccine for their children. Although most children are getting their first dose of HPV vaccine, many children are not completing the vaccination series. CDC recommends 11- to 12-year-olds get two doses of HPV vaccine at least six months apart. Most U.S. parents are getting the first dose of HPV vaccine for their child, according to the latest estimates from the National Immunization Survey-Teen. In 2016, 60 percent of teens aged 13-17 years received one or more doses of HPV vaccine, an increase of 4 percentage points from 2015. The gap in HPV vaccination rates between boys and girls continues to narrow. Roughly 65 percent of girls received the first dose of HPV vaccine compared to 56 percent of boys who received the first dose of HPV vaccine. Although most children are getting their first dose of HPV vaccine, there continue to be many children who do not complete the vaccination series. HPV vaccination coverage is lower in rural and less urban areas. Those communities could benefit from additional efforts to increase coverage. Recent changes to HPV vaccine recommendations make it easier for parents to protect their children at the recommended ages. CDC recommends 11 to 12 year olds get two doses of HPV vaccine at least six months apart.

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Announcements

EDCTP [to 26 August 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV / AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
22 August 2017
Workshop to launch EDCTP Alumni Network in October
Since its inception, EDCTP has invested in support for individual researchers at different stages of their careers through an evolving ...

European Medicines Agency [to 26 August 2017]
http://www.ema.europa.eu/ema/
23/08/2017
Strengthening EU-US cooperation in medicine inspections
New commitment allows FDA to share full inspection reports with European Commission and EMA ...


Gavi [to 26 August 2017]
http://www.gavi.org/library/news/press-releases/
23 August 2017
Gavi, the Vaccine Alliance welcomes Haiti’s commitment to immunization
Government commits to fund vaccines and to strengthen its national immunization program to protect more Haitian children.
... According to WHO and UNICEF estimates, in 2016 Haiti had 58% coverage for Diphtheria-Tetanus-Pertussis vaccine (DTP3), the lowest rate in the Americas. While the country remains polio, measles and rubella free, recent outbreaks like diphtheria show the potential consequences of weak vaccine coverage. Significant inequity across provinces, districts as well as urban and rural areas also need to be addressed to reduce under five child mortality from 69 to 25 / 1,000 by 2030 and thereby reach the Sustainable Development Goal for Health (SDG).
"The Prime Minister’s commitment also encourages Gavi and partners to further scale up support to the country," said Anuradha Gupta. “In the near future, we hope that Haiti will further prioritize investments in health to advance Universal Health Coverage so that all Haitians can have access to quality health services including immunization.”…

Gavi welcomes contribution from the United Arab Emirates
US $ 5 million pledge will support INFUSE initiative, started in 2016 to help modernize vaccine delivery systems
Geneva, August 21, 2017 - The United Arab Emirates (UAE) has committed US $ 5 million to Gavi, the Vaccine Alliance, to support its Innovation for Uptake, Scale and Equity in Immunization (INFUSE) initiative. Launched at the 2016 World Economic Forum meeting in Davos, INFUSE helps developing countries accelerate the introduction of tried and tested technology which will modernize their immunization systems ...

IVI [to 26 August 2017]
http://www.ivi.int/
August 22, 2017
ICMR, Department of Health and Family Welfare of MOHFW sign MoU with International Vaccine Institute to support vaccine development in India
The Indian Council of Medical Research (ICMR) under the Department of Health Research and the Department of Health and Family Welfare of the Ministry of Health and Family Welfare (MOHFW) signed a tripartite memorandum of understanding today with the International Vaccine Institute (IVI) to collaborate on vaccine research and development. The agreement will also strengthen the relationship between IVI and India ...

MSF /Médecins Sans Frontières[to 26 August 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Indian Patent Office Delivers Major Blow to Affordable Pneumonia Vaccine Hopes
August 22, 2017

NIH [to 26 August 2017]
http://www.nih.gov/news-events/news-releases
August 22, 2017
Scientists develop infection model for tick-borne flaviviruses
Researchers say the work will greatly increase knowledge about how flaviviruses infect ticks.

UNAIDS [to 26 August 2017]
http://www.unaids.org/en
Update
Ending stigma and discrimination in health centers in Mexico
25 August 2017
Mexico has taken steps to strengthen access to health-care services by lesbian, gay, bisexual, transgender and intersex (LGBTI) people. A new Ministry of Health code of conduct aims to put an end to stigma and discrimination based on gender identity and sexual orientation in all health centers in the country.
Establishing guidelines and specific actions for the provision of health-care services, the code of conduct will be implemented throughout the national health system to guarantee effective access to health by respecting the dignity and autonomy of LGBTI people ...

Update
UNAIDS fully compliant with UN-SWAP
22 August 2017
UNAIDS has been recognized for meeting or exceeding all of the 15 performance indicators of the United Nations System-wide Action Plan on Gender Equality and the Empowerment of Women (UN-SWAP), a year ahead of the deadline established by the United Nations System Chief Executives Board for Coordination….

Wellcome Trust [to 26 August 2017]
https://wellcome.ac.uk/news
News / Published: 25 August 2017
A global call for action on drug-resistant infections
A global conference in October will accelerate action on tackling drug-resistant infections, one of the greatest health and economic challenges of our time.
The conference, in Berlin on 12 and 13 October 2017, is organized by Wellcome in partnership with the UK and Thai governments and the UN Foundation. It will support the work of the Antimicrobial Resistance Inter-Agency Coordination Group (IACG).
The event is an opportunity for national governments and multilateral institutions to come together with the civil society, private and philanthropic sectors to focus on the most critical gaps in tackling the development and spread of drug-resistant infections, and to commit to concerted and tangible actions ...

News / Published: 24 August 2017
Leprosy turns the immune system against itself
Researchers have shown for the first time how leprosy bacteria damage nerves by infiltrating the immune cells that are meant to protect us.
The research found that leprosy hijacks the immune system, turning an important repair mechanism into one that causes potentially irreparable damage to nerve cells….

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Journal Watch

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

If you would like to suggest other journal titles to include in this service, please contact David Curry at: [email protected]

 

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BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed August 26, 2017)

Research
Cost-effectiveness analysis of a universal mass vaccination program with a PHiD-CV 2 + 1 schedule in Malaysia
Xiao Jun Wang, Ashwini Saha, and Xu-Hao Zhang
Published on: 22 August 2017
Conclusions
A PHiD-CV 2 + 1 universal mass vaccination program could substantially reduce pneumococcal disease burden versus no vaccination, and was expected to be cost-effective in Malaysia. A PHiD-CV 2 + 1 program was also expected to be a dominant choice over a PCV13 2 + 1 program in Malaysia.

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BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed August 26, 2017)

Research article
Distribution of Streptococcus pneumoniae serotypes in the northeast macro-region of São Paulo state / Brazil after the introduction of conjugate vaccine
Infections caused by Streptococcus pneumoniae (Spn) still challenge health systems around the world, even with advances in vaccination programs. The present study evaluated the frequency of various Spn serotypes ...
Marta Inês Cazentini Medeiros, Samanta Cristine Grassi Almeida, Maria Luiza Leopoldo Silva Guerra, Paulo da Silva, Ana Maria Machado Career and Denise de Andrade
BMC Infectious Diseases 2017 17: 590
Published on: 25 August 2017

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BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed August 26, 2017)

Research article
The impact of repeated vaccination on influenza vaccine effectiveness: a systematic review and meta-analysis
From the patient perspective, our results support current season vaccination regardless of prior season vaccination. We found no overall evidence that prior season vaccination negatively impacts current season VE. It is important that future VE studies include vaccination history over multiple seasons in order to evaluate repeated vaccination in more detail.
Lauren C. Ramsay, Sarah A. Buchan, Robert G. Stirling, Benjamin J. Cowling, Shuo Feng, Jeffrey C. Kwong and Bryna F. Warshawsky
BMC Medicine 2017 15: 159
Published on: 21 August 2017

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EMBO reports
01 August 2017; volume 18, issue 8
http://embor.embopress.org/content/18/8

Science & Society
Archives of and for scienceArchives for molecular biology preserve the heritage of science beyond the published record for future scholars
Through preservation, cataloging and guaranteeing the authenticity of historical evidence, scientific archives provide unique insight for future scholars into the history of science.
Anne-Flore Laloë

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Globalization and Health
http://www.globalizationandhealth.com/
[Accessed August 26, 2017]

Research
Association of experienced and evaluative well-being with health in nine countries with different income levels: a cross-sectional study
It is important to know whether the relationships between experienced and evaluative well-being and health are consistent across countries with different income levels. This would allow to confirm whether the ...
Marta Miret, Francisco Félix Caballero, Beatriz Olaya, Seppo Koskinen, Nirmala Naidoo, Beata Tobiasz-Adamczyk, Matilde Leonardi, Josep Maria Haro, Somnath Chatterji and José Luis Ayuso-Mateos
Globalization and Health 2017 13:65
Published on: 23 August 2017

Research
Mapping mHealth (mobile health) and mobile penetrations in sub-Saharan Africa for strategic regional collaboration in mHealth scale-up: an application of exploratory spatial data analysis
Mobile health (mHealth), a term used for healthcare delivery via mobile devices, has gained attention as an innovative technology for better access to healthcare and support for performance of health workers i ...
Seohyun Lee, Yoon-min Cho and Sun-Young Kim
Globalization and Health 2017 13:63
Published on: 22 August 2017

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JAMA
August 22/29, 2017, Vol 318, No. 8, Pages 677-764
http://jama.jamanetwork.com/issue.aspx

Viewpoint
August 22/29, 2017
Multidimensional Evidence Generation and FDA Regulatory Decision Making - Defining and Using “Real-World” Data
Jonathan P. Jarow, MD1; Lisa LaVange, PhD1; Janet Woodcock, MD1
JAMA. 2017; 318 (8): 703-704. doi: 10.1001 / jama.2017.9991
Initial text
Evidence linking interventions with health outcomes is the basis for good health care decision making. The widespread use of electronic health records, administrative claims, and social media and the ubiquity of smart devices have created “big data” that heretofore have not been widely utilized. There is substantial enthusiasm for the use of real-world data sources to generate so-called real-world evidence (RWE), but confusion remains about what RWE means. Evidence generation is multidimensional, including data source, study design, and degree of pragmatism. Real-world evidence is defined by the data source and degree of pragmatism independent of study design. Generation of RWE therefore is not limited to observational studies but also includes randomized trials conducted in clinical settings. The US Food and Drug Administration (FDA) currently uses RWE in safety surveillance and development of drugs for rare diseases, but there are other potential applications ...

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The Lancet
Aug 26, 2017 Volume 390 Number 10097 p821-912
http://www.thelancet.com/journals/lancet/issue/current

Articles
Infection-related microcephaly after the 2015 and 2016 Zika virus outbreaks in Brazil: a surveillance-based analysis
Wanderson Kleber de Oliveira, Giovanny Vinícius Araújo de França, Eduardo Hage Carmo, Bruce Bartholow Duncan, Ricardo de Souza Kuchenbecker, Maria Inês Schmidt

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Nature
Volume 548 Number 7668 pp371-494 August 24, 201
http://www.nature.com/nature/current_issue.html

Articles
A randomized synbiotic trial to prevent sepsis among infants in rural India
Pinaki Panigrahi, Sailajanandan Parida, Nimai C. Nanda, Radhanath Satpathy, Lingaraj Pradhan
+ et al.
Abstract
Sepsis in early infancy results in one million annual deaths worldwide, most of them in developing countries. No efficient means of prevention is currently available. Here we report on a randomized, double-blind, placebo-controlled trial of an oral synbiotic preparation (Lactobacillus plantarum plus fructooligosaccharide) in rural Indian newborns. We enrolled 4,556 infants that were at least 2,000 g at birth, at least 35 weeks of gestation, and with no signs of sepsis or other morbidity, and monitored them for 60 days. We show a significant reduction in the primary outcome (combination of sepsis and death) in the treatment arm (risk ratio 0.60, 95% confidence interval 0.48-0.74), with few deaths (4 placebo, 6 synbiotic). Significant reductions were also observed for culture-positive and culture-negative sepsis and lower respiratory tract infections. These findings suggest that a large proportion of neonatal sepsis in developing countries could be effectively prevented using a synbiotic containing L. plantarum ATCC-202195.

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PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed August 26, 2017)

Research Article
"We are survivors and not a virus:" Content analysis of media reporting on Ebola survivors in Liberia
Elisabeth Anne-Sophie Mayrhuber, Thomas Niederkrotenthaler, Ruth Kutalek
Research Article | published 24 Aug 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005845
Abstract
Background
The Ebola virus disease epidemic between 2013 and 2016 in West Africa was unprecedented. It resulted in approximately 28,000 cases and 10,000 Ebola survivors. Many survivors face social, economic and health-related predicaments and media reporting is crucially important in infectious disease outbreaks. However, there is little research on reporting of the social situation of Ebola survivors in Liberia.
Methods
The study used a mixed methods approach and analyzed media reports from the Liberian Daily Observer (DOL), a daily newspaper available online in English. We were interested to know how the situation of Ebola survivors was portrayed; in what way issues such as stigma and discrimination were addressed; and which stigma reduction interventions were covered and how. We included all articles on the situation of Ebola survivors in the quantitative and in-depth qualitative analysis published between April 2014 and March 2016.
Results
The DOL published 148 articles that portrayed the social situation of Ebola survivors between the 24 months observation period. In these articles, Ebola survivors were often defined beyond biological terms, reflecting on a broader social definition of survivorship. Survivorship was associated with challenges such as suffering from after-effects, social and economic consequences and psychological distress. Almost 50% of the articles explicitly mentioned stigmatization in their reporting on Ebola survivors. This was contextualized in untrustworthiness towards international responses and the local health care system and inconclusive knowledge on cures and transmission routes. In the majority of DOL articles stigma reduction and engaging survivors in the response was reported as crucially important.
Discussion
Reporting in the DOL was educational-didactical and well-balanced in terms of disseminating available medical knowledge and reflecting the social situation of Ebola survivors. While the articles contextualized factors contributing to stigmatization throughout the reporting, journalistic scrutiny regarding effectiveness of interventions by government and NGOs was missing.
Author summary
The largest Ebola epidemic occurred in West Africa between 2013 and 2016. Liberia was one of the most affected countries with more than 1500 survivors registered. In the height of the Ebola outbreak survivors were increasingly included in the treatment and care of patients and in health sensitizing and social mobilization efforts. However, the reintegration of survivors back into their communities proved to be challenging across West Africa. Media reporting plays a crucial role in health emergency situations. It gives visibility to what is considered as relevant, frames risk perception and can induce positive health behavior practices and attitudes. In this study we analyzed how one of Liberia’s largest newspapers portrayed and informed the public on the social situation of survivors, in what way it addressed the issues of stigma and discrimination and which stigma reduction interventions were covered and how. We found that reporting was overall comprehensive and well-balanced in terms of disseminating available medical knowledge, scrutinizing stigma. Reports also reflected on contributing factors such as untrustworthiness towards response as well as inconclusive understanding of cures and transmission routes. In a larger context this specific reporting was acting as corrective to what the larger public believed.

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PLoS One
http://www.plosone.org/
[Accessed August 26, 2017]

Research Article
Religion and HPV vaccine-related awareness, knowledge, and receipt among insured women aged 18-26 in Utah
Julia Bodson, Andrew Wilson, Echo L. Warner, Deanna Kepka
Research Article | published 25 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0183725

Research Article
Cost-effectiveness of inactivated seasonal influenza vaccination in a cohort of Thai children ≤60 months of age
Wanitchaya Kittikraisak, Piyarat Suntarattiwong, Darunee Ditsungnoen, Sarah E. Pallas, Taiwo O. Abimbola, Chonticha Klungthong, Stefan Fernandez, Suchada Srisarang, Tawee Chotpitayasunondh, Fatimah S. Dawood, Sonja J. Olsen, Kim A. Lindblade
Research Article | published 24 Aug 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0183391

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Science
25 August 2017 Vol 357, Issue 6353
http://www.sciencemag.org/current.dtl

Policy Forum
Fostering reproducibility in industry-academia research
By BR Jasny, N. Wigginton, M. McNutt, T. Bubela, S. Buck, R. Cook-Deegan, T. Gardner, B. Hanson, C. Hustad, V. Kiermer, D. Lazer, A. Lupia, A. Manrai, L. McConnell, K. Noonan, E. Phimister, B. Simon, K. Strandburg, Z. Summers, D. Watts
Science 25 Aug 2017: 759-761 Full Access
Summary
Many companies have proprietary resources and / or data that are indispensable for research, and academics provide the creative fuel for much early-stage research that leads to industrial innovation. It is essential to the health of the research enterprise that collaborations between industrial and university researchers flourish. This system of collaboration is under strain. Financial motivations driving product development have led to concerns that industry-sponsored research comes at the expense of transparency (1). Yet many industry researchers distrust quality control in academia (2) and question whether academics value reproducibility as much as rapid publication. Cultural differences between industry and academia can create or increase difficulties in reproducing research findings. We discuss key aspects of this problem that industry-academia collaborations must address and for which other stakeholders, from funding agencies to journals, can provide leadership and support.

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Vaccine
Volume 35, Issue 36, Pages 4659-4824 (24 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/36?sdc=1

Conference report
Immune correlates of protection for dengue: State of the art and research agenda
Pages 4659-4669
Leah C. Katzelnick, Eva Harris, Participants in the Summit on Dengue Immune Correlates of Protection
Abstract
Dengue viruses (DENV1-4) are mosquito-borne flaviviruses estimated to cause up to 400 million infections and ∼100 million dengue cases each year. Factors that contribute to protection from and risk of dengue and severe dengue disease have been studied extensively but are still not fully understood. Results from Phase 3 vaccine efficacy trials have recently become available for one vaccine candidate, now licensed for use in several countries, and more Phase 2 and 3 studies of additional vaccine candidates are ongoing, making these issues all the more urgent and timely. At the “Summit on Dengue Immune Correlates of Protection”, held in Annecy, France, on March 8–9, 2016, dengue experts from various fields came together to discuss the current understanding of the immune response to and protection from DENV infection and disease , identify key unanswered questions, discuss data on immune correlates and plans for comparison of results across assays / consortia, and propose a research agenda for investigation of dengue immune correlates, all in the context of both natural infection studies and vaccine trials.

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Vaccine
Volume 35, Issue 36, Pages 4659-4824 (24 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/36?sdc=1

Socioeconomic factors influencing childhood vaccination in two northern Italian regions
Original Research Article
Pages 4673-4680
Paola Anello, Laura Cestari, Tatjana Baldovin, Lorenzo Simonato, Gabriella Frasca, Nicola Caranci, Maria Grazia Pascucci, Francesca Valent, Cristina Canova
Abstract
Background
Infant vaccination rates have been declining in Italy over the past 5-7 years. The aims of this study were to assess the trend in the proportions of children unvaccinated at 24 months old, to identify sociodemographic factors associated with non-vaccination; and to examine changes in parental attitudes to vaccination over time.
Methods
We conducted a population-based birth cohort study by combining existing electronic data sets. The study population consisted of children born from 1995 to 2010 in the Friuli-Venezia Giulia (FVG) region, and from 2007 to 2011 in part of the Emilia Romagna (ER) region, in north-eastern Italy. The immunization registers were linked with the medical birth registers, which contain sociodemographic data on both parents and the newborn. Unconditional logistic regressions were used to identify associations between vaccine uptake at 24 months and maternal sociodemographic variables.
Results
Of 145,571 babies born in FVG and 75,308 in ER, there were 4222 (1.9%) who had not been vaccinated at all, and 23,948 (11.0%) without the optional measles, mumps and rubella (MMR) vaccination. The number of unvaccinated infants increased over time. Mothers who were over 35 or under 25 years old, unmarried, with a higher formal education, and citizens of highly-developed countries were less compliant with vaccination recommendations in both the regions. A cohort effect was observed in FVG, for both educational level and citizenship: babies born between 1995 and 2000 to mothers without an Italian citizenship and with a lower formal education were more likely to refuse vaccination for their offspring, while this association was reversed between 2006 and 2010.
Conclusions
Mothers who are Italian citizens and have a good formal education have begun to refuse vaccination for their children in recent years. Future public health action in this setting should target highly educated parents.

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Vaccine
Volume 35, Issue 36, Pages 4659-4824 (24 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/36?sdc=1

Untangling the psychosocial predictors of HPV vaccination decision-making among parents of boys
Original Research Article
Pages 4713-4721
Samara Perez, Ovidiu Tatar, Vladimir Gilca, Gilla K. Shapiro, Gina Ogilvie, Juliet Guichon, Anila Naz, Zeev Rosberger
Abstract
Background
HPV vaccination uptake in boys is suboptimal in many jurisdictions, particularly in the absence of publicly funded HPV vaccination programs. Parents represent key decision-makers of HPV vaccination and their HPV vaccine decision-making stage is influenced by multiple psychosocial determinants. Our objective was to assess the relationship between a broad range of psychosocial factors and parents of boys ’HPV vaccine decision-making stage.
Methods
Data were collected through an online survey from a nationally representative sample of Canadian parents of boys in February (T1) and November 2014 (T2). We assessed a broad number of psychosocial factors including: socio-demographics, health behaviors and validated scales for assessing HPV knowledge, attitudes and beliefs. Parents selected their HPV vaccination adoption stage based on the Precaution Adoption Process Model (PAPM). Multinomial logistic regression was used to test the association between predictors and PAPM stage at T1 and T2.
Results
Discussion with a healthcare provider about the HPV vaccine and increased HPV knowledge was associated with increased odds of being in the more advanced PAPM stages. Increased perception of risks in the absence of HPV vaccination, increased perception that others endorse HPV vaccination and positive attitudes related to vaccines in general were associated with increased odds of being in the decided to vaccinate stage. Believing that HPV vaccination is harmful increased, and perceiving the benefits of HPV vaccination decreased the odds of deciding not to vaccinate.
Conclusions
This study highlights the psychosocial predictors of the decision-making stage reported by parents regarding HPV vaccination of their sons, that were significant at two time-points. Targeted interventions that consider the impact of the health care provider and address knowledge gaps as well as individual beliefs about benefits, risks, and harms of the HPV vaccine and vaccines in general should be implemented to help parents make better informed decisions that is to move closer to actual vaccination adoption.

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Vaccine
Volume 35, Issue 36, Pages 4659-4824 (24 August 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/36?sdc=1

Responding to a cVDPV1 outbreak in Ukraine: Implications, challenges and opportunities
Original Research Article
Pages 4769-4776
Nino Khetsuriani, Ihor Perehinets, Dorit Nitzan, Dragoslav Popovic, Thomas Moran, Vusala Allahverdiyeva, Shahin Huseynov, Eugene Gavrilin, Liudmyla Slobodianyk, Olha Izhyk, Anna Sukhodolska, Sahar Hegazi, Katerina Bulavinova, Sergei Platov,
Abstract
Background
The European Region, certified polio-free in 2002, remains at risk of wild poliovirus reintroduction and emergence of circulating vaccine-derived polioviruses (cVDPV) until global polio eradication is achieved, as demonstrated by the cVDPV1 outbreak in Ukraine in 2015.
Methods
We reviewed epidemiologic, clinical and virology data on cVDPV cases, surveillance and immunization coverage data, and reports of outbreak-related surveys, country missions, and expert group meetings.
Results
In Ukraine, 3-dose polio vaccine coverage declined from 91% in 2008 to 15% by mid-2015. In summer, 2015, two unrelated children from Zakarpattya province were paralyzed by a highly divergent cVDPV1. The isolates were 20 and 26 nucleotide divergent from prototype Sabin strain (with 18 identical mutations) consistent with their common origin and ∼2-year evolution. Outbreak response recommendations developed with international partner support included conducting three nationwide supplementary immunization activities (SIAs) with tOPV, strengthening surveillance and implementing communication interventions. SIAs were conducted during October 2015-February 2016 (officially reported coverage, round 1–64.4%, round 2–71.7%, and round 3–80.7%). Substantial challenges to outbreak response included lack of high-level support, resistance to OPV use, low perceived risk of polio, widespread vaccine hesitancy, anti-vaccine media environment, economic crisis and military conflict. Communication activities improved caregiver awareness of polio and confidence in vaccination. Surveillance was enhanced but did not consistently meet applicable performance standards. Post-outbreak assessments concluded that cVDPV1 transmission in Ukraine has likely stopped following the response, but significant gaps in population immunity and surveillance remained.
Conclusions
Chronic under-vaccination in Ukraine resulted in the accumulation of children susceptible to polioviruses and created favorable conditions for VDPV1 emergence and circulation, leading to the outbreak. Until programmatic gaps in immunization and surveillance are addressed, Ukraine will remain at high-risk for VDPV emergence and circulation, as well as at risk for other vaccine-preventable diseases.

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

Pan African Medical Journal
2017; 27 (Supp 3): 19.
doi: 10.11604 / pamj.supp.2017.27.3.11544
Commentary
Delayed introduction of the birth dose of Hepatitis B vaccine in EPI programs in East Africa: a missed opportunity for combating vertical transmission of Hepatitis B
B Bodo, OO Malande -
Abstract
Vertical transmission of hepatitis B virus is a major route through which children acquire hepatitis B infection. Only 10 out of 47 countries in Africa, and none from East Africa; have implemented the WHO recommendation of introducing a birth-dose of hepatitis B vaccine in their EPI program. This article therefore examines the challenges as well as the opportunities that exists for the introduction of a birth-dose of hepatitis vaccine in the National Expanded Program for Immunization (EPI) program by countries in the East African Region. It explores probable health systems factors that have hindered the countries from introducing the birth dose of hepatitis B and proposes actions that countries can take to introduce the vaccine based on their context by drawing on the experience of some Asian countries.

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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