WHO & Regional Offices [to 11 March 2017]

The cost of a polluted environment: 1.7 million child deaths a year, says WHO
News release
6 March 2017 | GENEVA – More than 1 in 4 deaths of children under 5 years of age are attributable to unhealthy environments. Every year, environmental risks – such as indoor and outdoor air pollution, second-hand smoke, unsafe water, lack of sanitation, and inadequate hygiene – take the lives of 1.7 million children under 5 years, say two new WHO reports.
The first report, Inheriting a Sustainable World: Atlas on Children’s Health and the Environment reveals that a large portion of the most common causes of death among children aged 1 month to 5 years – diarrhoea, malaria and pneumonia – are preventable by interventions known to reduce environmental risks, such as access to safe water and clean cooking fuels.

“A polluted environment is a deadly one – particularly for young children,” says Dr Margaret Chan, WHO Director-General. “Their developing organs and immune systems, and smaller bodies and airways, make them especially vulnerable to dirty air and water.”…

Harmful exposures can start in the mother’s womb and increase the risk of premature birth. Additionally, when infants and pre-schoolers are exposed to indoor and outdoor air pollution and second-hand smoke they have an increased risk of pneumonia in childhood, and a lifelong increased risk of chronic respiratory diseases, such as asthma. Exposure to air pollution may also increase their lifelong risk of heart disease, stroke and cancer.

Top 5 causes of death in children under 5 years linked to the environment
A companion report, Don’t pollute my future! The impact of the environment on children’s health, provides a comprehensive overview of the environment’s impact on children’s health, illustrating the scale of the challenge.
Every year:
:: 570,000 children under 5 years die from respiratory infections, such as pneumonia, attributable to indoor and outdoor air pollution, and second-hand smoke.
:: 361,000 children under 5 years die due to diarrhoea, as a result of poor access to clean water, sanitation, and hygiene.
: 270,000 children die during their first month of life from conditions, including prematurity, which could be prevented through access to clean water, sanitation, and hygiene in health facilities as well as reducing air pollution.
:: 200,000 deaths of children under 5 years from malaria could be prevented through environmental actions, such as reducing breeding sites of mosquitoes or covering drinking-water storage.
:: 200,000 children under 5 years die from unintentional injuries attributable to the environment, such as poisoning, falls, and drowning…

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Women who decide on their health have brighter futures
Dr Flavia Bustreo,
Assistant Director-General of the World Health Organization and Vice-Chair of GAVI, the Vaccine Alliance
Commentary
8 March 2017
Access to contraception can allow adolescent girls and women to stay in school longer, opening up better economic opportunities and more independent, fulfilling futures. Every additional year of schooling for a girl increases her future earnings by 10% to 20%. On International Women’s Day, WHO calls for unequivocal commitment to gender equality and women’s and girls’ fundamental rights…

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Disease outbreak news
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 10 March 2017
:: Lassa Fever – Benin, Togo and Burkina Faso 10 March 2017
:: Yellow fever – Brazil 6 March 2017

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:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified for this edition.

WHO Region of the Americas PAHO
:: WHO publishes list of bacteria for which new antibiotics are urgently needed (02/27/2017)

WHO South-East Asia Region SEARO
:: Empower women in the workplace, advance health and development across South-East Asia
8 March 2017 – Workforce participation and economic empowerment is a powerful tool for women to achieve greater control of their health and wellbeing.
Women that work and are economically empowered tend to be better placed to make critical life choices, including on reproduction. They are also more likely to be able to seek out and access health care for themselves and their families.
On International Women’s Day, let’s commit to a brighter, healthier future for girls and women. Let’s commit to empowering women in the workplace and advancing health and development across the South-East Asia Region.

WHO European Region EURO
:: International Women’s Day: unlocking the full potential of women at work in the European Region 08-03-2017
:: Danish parliamentarians go to work with a hearing impairment on World Hearing Day 2017 07-03-2017
:: Regional Director outlines links between WHO/Europe’s work to address NCDs and JA-CHRODIS 07-03-2017

WHO Eastern Mediterranean Region EMRO
:: Kidney patients struggle as Yemeni health crisis worsens 9 March 2017.
:: The UN system in the Arab/MENA Region kicks off International Women’s Day with an eye on Planet 50-50 by 2030 8 March 2017
:: WHO support saves lives of malnourished children in Syria 8 March 2017

WHO Western Pacific Region
:: Gender equality makes everyone healthier: WHO
MANILA, 6 March 2017 – On International Women’s Day (8 March), the World Health Organization (WHO) will focus on the powerful link between gender equality and health and well-being. Public health efforts for women used to focus mainly on pregnancy and childbirth. Now gender, equity and human rights concerns are woven into every aspect of WHO’s work in the Western Pacific Region. “International Women’s Day is a great opportunity to challenge the unequal systems and practices that perpetuate health inequalities,” said Dr Shin Young-soo, WHO Regional Director for the Western Pacific.

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CDC/ACIP [to 11 March 2017]
http://www.cdc.gov/media/index.html
Media Statement
FRIDAY, MARCH 10, 2017
CDC updates Zika travel guidance for pregnant women to not travel to any area with Zika risk
CDC has updated its Zika travel guidance and now recommends that pregnant women not travel to any area where there is a risk of Zika virus infection, including areas where the virus has been newly introduced or reintroduced and local mosquito-borne transmission is ongoing; areas where the virus was present before 2015 (endemic) and there is no evidence transmission has stopped; and areas where the virus is likely to be circulating but has not been documented.
To help pregnant women and others identify areas of Zika risk, CDC published a new interactive World Map of Areas with Zika Risk …

Media Statement
FRIDAY, MARCH 10, 2017
CDC adds 4 countries to interim travel guidance related to Zika virus
CDC is working with other public health officials to monitor for ongoing spread of Zika virus?. Today, CDC posted a Zika virus travel notice for Angola, Guinea-Bissau, Maldives and Solomon Islands…

Media Statement
WEDNESDAY, MARCH 8, 2017
CDC: Outbreak of North American avian influenza A(H7N9) in poultry poses low risk to people
CDC is working closely with USDA APHIS and the Tennessee Department of Health to minimize any human health risk posed by the avian influenza outbreak in Lincoln County, Tennessee.

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MMWR Weekly March 10, 2017 / No. 7
[Excerpts]
:: Confidentiality Issues and Use of Sexually Transmitted Disease Services Among Sexually Experienced Persons Aged 15–25 Years — United States, 2013–2015
:: Increase in Human Infections with Avian Influenza A(H7N9) Virus During the Fifth Epidemic — China, October 2016–February 2017

Announcements

New York Times
Health
F.D.A. Official Under Bush Is Trump’s Choice to Lead Agency
By KATIE THOMAS
MARCH 10, 2017
President Trump said Friday that he intended to nominate Scott Gottlieb, a partner at a venture capital fund with longstanding ties to the pharmaceutical and biotech industries, to lead the Food and Drug Administration…

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CEPI – Coalition for Epidemic Preparedness Innovations [to 11 March 2017]
http://cepi.net/
10 March 2017
CEPI Newsletter
Excerpt
More than 30 applications for CEPI’s first call
CEPI received more than 30 applications for our first call for development of vaccines against Lassa, MERS-COV and Nipah, which had deadline 8 March. The applications will now be evaluated, and shortlisted applicants will be invited to submit full proposals in April 2017.
The partner organizations represented among the applicants are from North America, Europe, Africa, the Middle East, South-East Asia and Australia, representing academic institutions, biotechs, large pharmaceutical companies and Product Development Partnerships. There was also a broad diversity displayed in the vaccine platform technologies being used, including novel concepts.

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UNAIDS [to 11 March 2017]
http://www.unaids.org/
Press release
On International Women’s Day UNAIDS is urging countries to stop 1 million women and girls from becoming infected with HIV every year
Nearly 1 million women are becoming infected with HIV every year and only half of all women living with HIV have access to lifesaving treatment—making AIDS now the leading cause of death worldwide among women between the ages of 30 and 49.

GENEVA, 8 March 2017—On International Women’s Day UNAIDS has released a new report which shows that there is an urgent need to scale up HIV prevention and treatment services for women and girls. The report, When women lead, change happens, shows that globally in 2015, there were 18.6 million women and girls living with HIV, 1 million women and girls became newly infected with HIV and 470 000 women and girls died of AIDS-related illnesses.

“Women are leading change in increasing demand for and access to HIV and health services. This movement needs to grow to allow families to thrive, societies to flourish and economies to progress,” said Michel Sidibé, Executive Director of UNAIDS. “Women’s rights are human rights—no exceptions.”

The report shows that women are more vulnerable to HIV than men. Domestic violence and sexual abuse have been shown to increase the risk of HIV among women. Data show that in high HIV prevalence settings women who experience intimate partner violence are up to 50% more likely to acquire HIV.

A lack of access to education and health services and a lack of decision-making power are also contributing factors to women’s vulnerability to HIV. In only 30% of countries worldwide do equal numbers of girls and boys attend upper secondary school and in western and central Africa only a third of young women between the ages of 15 and 24 report having the final say in their own health care. In Botswana, every additional year of school has been shown to reduce the risk of HIV infection by 11.6% among girls.

“Structural, behavioural and biological factors are compounding the risk of HIV infection among women,” said Mr Sidibé. “Every girl should have the opportunity to stay in school, every young woman should have the decision-making power over her own sexual and reproductive health and all women and girls should be able to protect themselves against HIV.”…

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EDCTP [to 11 March 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.
9 March 2017
PanACEA kicks off new clinical trials programme for TB-drug evaluation
The EDCTP-funded PanACEA consortium (Pan-African Consortium for the Evaluation of Antituberculosis Antibiotics) who were recently awarded their second EDCTP grant worth almost € 11.4 million (PanACEA2), held a kick-off meeting in Cape Town, South Africa from 7-8 March 2017. The German and Swiss governments will contribute direct co-funding to PanACEA2 to the amounts of almost 3 million euro and 336.000 euro, respectively. The meeting gathered 80 delegates from all beneficiaries of the grant to go over what will be tackled during the next 5 years. Senior Project Officer Dr Monique Surette attended the meeting on behalf of EDCTP.
The PanACEA2 programme aims to develop at least two promising TB-treatment regimens with sound prediction data for a successful phase III evaluation, and advance one new agent into phase IIB. It will take full advantage of state of the art technologies, including innovative trial designs, new microbiological markers of treatment response, pharmacokinetic-pharmacodynamic analyses and modelling techniques. As a result, drug development processes could be accelerated by several years. PanACEA2 trial activities will be conducted at 11 research sites in six countries (Gabon, Malawi, Mozambique, South Africa, Tanzania, and Uganda) in sub-Saharan Africa with integrated research capacity development…

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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

Missing the signals:  India’s anti-vaccination social media campaign
Confidence Commentary
Heidi Larson
7 Mar, 2017
The Vaccine Confidence Project http://www.vaccineconfidence.org

It is not just in the US and Europe where wealthier populations are among the most vaccine questioning.  India recently launched a one-month campaign to vaccinate over 35 million 9-month to 15-year old children with a measles-rubella vaccine across five states.  The campaign marked the start of a two-year initiative aiming to vaccinate over 400 million children across India – part of a larger global effort to eliminate measles and rubella.

By the end of the first month of the campaign, it became clear that it was struggling to meet its goal. A different kind of campaign was circulating on WhatsApp and Facebook – fuelling a mix of conspiracy theories, safety concerns, and questioning around why the vaccine and the campaign were needed.  What’s more, the rumours were taking hold in the wealthier southern states with generally the best education and health indicators in the country.

Last year, though, there were already signals of waning confidence reported in the newly launched National Family Health Survey (NFHS 2015-2016). While showing progress in immunization uptake in the poorer states, where an extra effort had been made, wealthier states were reported to have declining coverage. The most dramatic drop in immunization coverage was in Tamil Nadu – a decline of 10% over the past decade.

Perhaps it should have been no surprise that Tamil Nadu has struggled the most in the current measles-rubella vaccination campaign. The signals were there.

One official from the Ministry of Health and Family Welfare commented on the situation, noting that while Goa managed 90% vaccine coverage and Karnataka reached above 85%, Tamil Nadu only reached 50% of the children they were aiming to vaccinate, with considerably higher rates of non-acceptance in urban Chennai than in less social media-saturated rural areas. Private schools in Chennai posed a particular challenge, with parents there reporting anxieties about the safety of and need for the vaccine.

Every year in India, measles kills nearly 49,000 children, and approximately 40,000 children become deaf or blind because of rubella-related birth defects. The public health rationale for introducing the measles-rubella vaccine seemed clear. And, for those who don’t trust interventions coming from afar, this vaccine was made in India.

Nonetheless, the rumours and misinformation went viral, provoking fears of sterilization and side effects as well as distrust of the motives of the campaign. Reflecting her uncertainty, one mother in Bengaluru was quoted in The Hindu expressing her concern that “It is worrying as to why the government is pushing vaccination on such a large scale.” Although not specific to the vaccination campaign, coinciding widespread media coverage about Union Minister Kirin Rijiju’s tweets saying that the Hindu population was getting smaller, added fuel to Muslim communities’ suspicions about the motives of the MR vaccination campaign. Other concerns ranged from autism anxieties, to perceptions that the vaccine had been banned in the US and sent instead to India.

With such clear evidence of waning vaccine confidence reported in the recent National Family Health Survey, an extra effort to dialogue with already known-to-be-hesitant communities before the campaign was launched, may have helped to build trust and allow for higher rates of vaccine acceptance.

Perhaps.

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

American Journal of Tropical Medicine and Hygiene
Volume 96, Issue 3, 2017
http://www.ajtmh.org/content/current

Article
An Investment Case to Prevent the Reintroduction of Malaria in Sri Lanka
Rima Shretta, Ranju Baral, Anton L. V. Avanceña, Katie Fox, Asoka Premasiri Dannoruwa, Ravindra Jayanetti, Arumainayagam Jeyakumaran, Rasike Hasantha, Lalanthika Peris and Risintha Premaratne
https://doi.org/10.4269/ajtmh.16-0209
Abstract
Sri Lanka has made remarkable gains in reducing the burden of malaria, recording no locally transmitted malaria cases since November 2012 and zero deaths since 2007. The country was recently certified as malaria free by World Health Organization in September 2016. Sri Lanka, however, continues to face a risk of resurgence due to persistent receptivity and vulnerability to malaria transmission. Maintaining the gains will require continued financing to the malaria program to maintain the activities aimed at preventing reintroduction. This article presents an investment case for malaria in Sri Lanka by estimating the costs and benefits of sustaining investments to prevent the reintroduction of the disease. An ingredient-based approach was used to estimate the cost of the existing program. The cost of potential resurgence was estimated using a hypothetical scenario in which resurgence assumed to occur, if all prevention of reintroduction activities were halted. These estimates were used to compute a benefit–cost ratio and a return on investment. The total economic cost of the malaria program in 2014 was estimated at U.S. dollars (USD) 0.57 per capita per year with a financial cost of USD0.37 per capita. The cost of potential malaria resurgence was, however, much higher estimated at 13 times the cost of maintaining existing activities or 21 times based on financial costs alone. This evidence suggests a substantial return on investment providing a compelling argument for advocacy for continued prioritization of funding for the prevention of reintroduction of malaria in Sri Lanka.

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 11 March 2017)

Research article
Engaging patients in health research: identifying research priorities through community town halls
The vision of Canada’s Strategy for Patient-Oriented Research is that patients be actively engaged as partners in health research. Support units have been created across Canada to build capacity in patient-ori…
Holly Etchegary, Lisa Bishop, Catherine Street, Kris Aubrey-Bassler, Dale Humphries, Lidewij Eva Vat and Brendan Barrett
BMC Health Services Research 2017 17:192
Published on: 11 March 2017

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 11 March 2017)

Research article
Assessment of provider-initiated HIV screening in Nigeria with sub-Saharan African comparison
Despite Nigeria’s high HIV prevalence, voluntary testing and counselling rates remain low. UNAIDS/WHO/CDC recommends provider-initiated testing and counselling (PITC) for HIV in settings with high HIV prevalen…
Felix A. Ogbo, Andrew Mogaji, Pascal Ogeleka, Kingsley E. Agho, John Idoko, Terver Zua Tule and Andrew Page
BMC Health Services Research 2017 17:188
Published on: 9 March 2017

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 March 2017)

Research article
Lack of immunity against rubella among Italian young adults
To support the evaluation of the 2010-15 National Plan for Measles and Congenital Rubella Elimination, the authors designed and performed a serosurveillance survey to verify the immunity/susceptibility rate ag…
Gallone Maria Serena, Gallone Maria Filomena, Larocca Angela Maria Vittoria, Germinario Cinzia and Tafuri Silvio
BMC Infectious Diseases 2017 17:199
Published on: 7 March 2017

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 March 2017)

Research article
Which recommendations are considered essential for outbreak preparedness by first responders?
Preparedness is considered essential for healthcare organizations to respond effectively to outbreaks. In the current study we aim to capture the views of first responders on what they consider key recommendat…
Evelien Belfroid, Aura Timen, Jim E. van Steenbergen, Anita Huis and Marlies E. J. L. Hulscher
BMC Infectious Diseases 2017 17:195
Published on: 7 March 2017

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 March 2017)

Incomplete childhood immunization in Nigeria: a multilevel analysis of individual and contextual factors
Sulaimon T. Adedokun, Olalekan A. Uthman, Victor T. Adekanmbi and Charles S. Wiysonge
BMC Public Health 2017 17:236
Published on: 8 March 2017
Abstract
Background
Under-five mortality remains high in sub-Saharan Africa despite global decline. One quarter of these deaths are preventable through interventions such as immunization. The aim of this study was to examine the independent effects of individual-, community- and state-level factors on incomplete childhood immunization in Nigeria, which is one of the 10 countries where most of the incompletely immunised children in the world live.
Methods
The study was based on secondary analyses of cross-sectional data from the 2013 Nigeria Demographic and Health Survey (DHS). Multilevel multivariable logistic regression models were applied to the data on 5,754 children aged 12–23 months who were fully immunized or not (level 1), nested within 896 communities (level 2) from 37 states (level 3).
Results
More than three-quarter of the children (76.3%) were not completely immunized. About 83% of children of young mothers (15–24 years) and 94% of those whose mothers are illiterate did not receive full immunization. In the fully adjusted model, the chances of not being fully immunized reduced for children whose mothers attended antenatal clinic (adjusted odds ratio [aOR] = 0.49; 95% credible interval [CrI] = 0.39–0.60), delivered in health facility (aOR = 0.62; 95% CrI = 0.51–0.74) and lived in urban area (aOR = 0.66; 95% CrI = 0.50–0.82). Children whose mothers had difficulty getting to health facility (aOR = 1.28; 95% CrI = 1.02–1.57) and lived in socioeconomically disadvantaged communities (aOR = 2.93; 95% CrI = 1.60–4.71) and states (aOR = 2.69; 955 CrI =1.37–4.73) were more likely to be incompletely immunized.
Conclusions
This study has revealed that the risk of children being incompletely immunized in Nigeria was influenced by not only individual factors but also community- and state-level factors. Interventions to improve child immunization uptake should take into consideration these contextual characteristics.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 March 2017)

EDITORIAL
Vulnerability and Dignity: Labeling Problems Away (pages 2–3)
Udo Schuklenk and William Rooney
Version of Record online: 1 MAR 2017 | DOI: 10.1111/dewb.12142

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 March 2017)

Articles
Reconsidering counselling and consent (pages 4–10)
David R. Hall and Anton A. van Niekerk
Version of Record online: 1 DEC 2015 | DOI: 10.1111/dewb.12100
Abstract
In the current era patient autonomy is enormously important. However, recently there has also been some movement back to ensure that trust in the doctor’s skill, knowledge and virtue is not excluded in the process. These new nuances of informed consent have been referred to by terms such as beneficent paternalism, experience-based paternalism and we would add virtuous paternalism. The purpose of this paper is to consider the history and current problematic nature of counselling and consent. Starting with the tradition founded by Hippocrates we trace and seek to understand how relevant aspects of the patient-doctor relationship have evolved under the influences of subsequent moral theories. Finally we tentatively endorse certain modes of counselling in the current era in order to promote morally sound, good clinical practice.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 March 2017)

Articles
Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity (pages 11–21)
Lisa Diependaele, Julian Cockbain and Sigrid Sterckx
Version of Record online: 27 JAN 2016 | DOI: 10.1111/dewb.12105
Abstract
Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity.
Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator’s data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs.
This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry’s arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry’s appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 March 2017)

Articles
Factors Affecting Women’s Autonomous Decision Making In Research Participation Amongst Yoruba Women Of Western Nigeria (pages 40–49)
Chitu Womehoma Princewill, Ayodele S. Jegede, Karin Nordström, Bolatito Lanre-Abass and Bernice Simone Elger
Version of Record online: 12 FEB 2016 | DOI: 10.1111/dewb.12112
Abstract
Research is a global enterprise requiring participation of both genders for generalizable knowledge; advancement of science and evidence based medical treatment. Participation of women in research is necessary to reduce the current bias that most empirical evidence is obtained from studies with men to inform health care and related policy interventions. Various factors are assumed to limit autonomy amongst the Yoruba women of western Nigeria. This paper seeks to explore the experience and understanding of autonomy by the Yoruba women in relation to research participation. Focus is on factors that affect women’s autonomous decision making in research participation.
An exploratory qualitative approach comprising four focus group discussions, 42 in-depth interviews and 14 key informant interviews was used. The study permits a significant amount of triangulation, as opinions of husbands and religious leaders are also explored. Interviews and discussions were audiotaped and transcribed verbatim. Content analysis was employed for data analysis.
Findings show that concepts of autonomy varied amongst the Yoruba women. Patriarchy, religion and culture are conceived to have negative impact on the autonomy of women in respect to research participation. Among the important findings are: 1) male dominance is strongly emphasized by religious leaders who should teach equality, 2) while men feel that by making decisions for women, they are protecting them, the women on the other hand see this protection as a way of limiting their autonomy. We recommend further studies to develop culturally appropriate and workable recruitment methods to increase women’s participation in research.

EMBO Reports
Volume 18, Issue 3, 2017
http://embor.embopress.org/front.current-issue
Science & Society

Improving research misconduct policiesEvidence from social psychology could inform better policies to prevent misconduct in research
Current policies for dealing with research misconduct emphasize the role and responsibility of individuals. Evidence from social psychology, however, shows that the environment determines personal conduct. Research misconduct policies should address these institutional factors.
Barbara K Redman, Arthur L Caplan
Published online 10.03.2017

Epidemics
Volume 18, Pages 1-112 (March 2017)
http://www.sciencedirect.com/science/journal/17554365
Multi-model comparisons for neglected tropical diseases – validation and projection
Edited by Déirdre Hollingsworth and Graham Medley

Learning from multi-model comparisons: Collaboration leads to insights, but limitations remain
Original Research Article
Pages 1-3
T.D. Hollingsworth, G.F. Medley
[Initial text]
Neglected tropical diseases (known as NTDs) are a group of diseases predominantly affecting the poorest populations of the globe (sometimes called the ‘bottom billion’). The risk of disease is related to poor housing, poor sanitation and poor health systems as well as the environmental suitability of tropical areas. The NTDs are not a well-defined group, and comprise a variety of pathogens with different transmission routes, life cycles and behavioural risk factors, although they are similar in that they are currently relatively hard to diagnose. The host population factors and relatively poor surveillance data present particular challenges for providing transmission dynamics models. This collection reflects the current state-of-the-art for modelling NTDs, as well as judging on the suitability of models to provide quantitative policy advice

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 11 March 2017]

Research
Controlling corporate influence in health policy making? An assessment of the implementation of article 5.3 of the World Health Organization framework convention on tobacco control
Gary Jonas Fooks, Julia Smith, Kelley Lee and Chris Holden
Published on: 8 March 2017

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 11 March 2017]

Research
The health impact of trade and investment agreements: a quantitative systematic review and network co-citation analysis
Pepita Barlow, Martin McKee, Sanjay Basu and David Stuckler
Published on: 8 March 2017

Health Affairs
February 2017; Volume 36, Issue 2
http://content.healthaffairs.org/content/current
Issue Focus: Delivery System Innovation

Global Health Innovation
Primary Health Care That Works: The Costa Rican Experience
Madeline Pesec, Hannah L. Ratcliffe, Ami Karlage, Lisa R. Hirschhorn, Atul Gawande, and Asaf Bitton
Health Aff March 2017 36:531-538; doi:10.1377/hlthaff.2016.1319
Abstract
Long considered a paragon among low- and middle-income countries in its provision of primary health care, Costa Rica reformed its primary health care system in 1994 using a model that, despite its success, has been generally understudied: basic integrated health care teams. This case study provides a detailed description of Costa Rica’s innovative implementation of four critical service delivery reforms and explains how those reforms supported the provision of the four essential functions of primary health care: first-contact access, coordination, continuity, and comprehensiveness. As countries around the world pursue high-quality universal health coverage to attain the Sustainable Development Goals, Costa Rica’s experiences provide valuable lessons about both the types of primary health care reforms needed and potential mechanisms through which these reforms can be successfully implemented.

Health Affairs
February 2017; Volume 36, Issue 2
http://content.healthaffairs.org/content/current
Issue Focus: Delivery System Innovation

From the Publisher
Designating The Health Workforce As A Global Good
Tom Kenyon
Health Aff March 2017 36:584; doi:10.1377/hlthaff.2016.1676
Extract
The United Nations has registered a milestone: declaring that within thirteen years, everyone, wherever they live in the world, should have access to health care regardless of their financial situation. This aspiration, contained in the Sustainable Development Goals (SDGs) calling for universal health coverage by 2030 (UHC 2030), was agreed upon at the United Nations (UN) General Assembly in 2015 and is a significant one—yet it brings with it another challenge: the sustained shortage of health workers…

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 11 March 2017]

Research Article
Initiating community engagement in an ecohealth research project in Southern Africa
Community Engagement (CE) in health research ensures that research is consistent with the socio-cultural, political and economic contexts where the research is conducted. The greatest challenges for researcher…
Rosemary Musesengwa, Moses J. Chimbari and Samson Mukaratirwa
Infectious Diseases of Poverty 2017 6:22
Published on: 7 March 2017

JAMA
March 7, 2017, Vol 317, No. 9, Pages 883-984
http://jama.jamanetwork.com/issue.aspx

Viewpoint
The European Medicines Agency and Publication of Clinical Study ReportsA Challenge for the US FDA
Anna L. Davis, JD, MPH; James Dabney Miller, JD, MPH
JAMA. 2017;317(9):905-906. doi:10.1001/jama.2017.0918
This Viewpoint argues that publication by the European Medicines Agency of clinical study reports as part of its approval process for commercial drugs sets a standard of transparency that could challenge the reputation of the US Food and Drug Administration as the international standard-bearer in drug and device approval.

JAMA Pediatrics
March 1, 2017, Vol 171, No. 3, Pages 207-312
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
Improving Access to Evidence-Based Antipoverty Government Programs in the United States – A Novel Primary Care Initiative
Michael K. Hole, MD, MBA; Lucy E. Marcil, MD, MPH; Robert J. Vinci, MD
JAMA Pediatr. 2017;171(3):211-212. doi:10.1001/jamapediatrics.2016.3868
This Viewpoint discusses ways in which the medical community can help low-income families by providing other services, namely free tax preparation, in primary care clinics.

JAMA Pediatrics
March 1, 2017, Vol 171, No. 3, Pages 207-312
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
In the Aftermath of the National Children’s Study Is Large Birth Cohort Data Still a Priority?
Terence Dwyer, MPH, MD, MB, BS, AO; Per Magnus, MD, PhD; Jørn Olsen, MD, PhD
JAMA Pediatr. 2017;171(3):214-215. doi:10.1001/jamapediatrics.2016.3968
This Viewpoint discusses the ending of the National Children’s Study and the implications for the future of large birth cohort studies.

JAMA Pediatrics
March 1, 2017, Vol 171, No. 3, Pages 207-312
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Association Between Pandemic Influenza A(H1N1) Vaccination in Pregnancy and Early Childhood Morbidity in Offspring
Anders Hviid, DrMedSci; Henrik Svanström, PhD; Ditte Mølgaard-Nielsen, MSc; et al.
JAMA Pediatr. 2017;171(3):239-248. doi:10.1001/jamapediatrics.2016.4023
This cohort study evaluates whether influenza A(H1N1) vaccination in pregnancy is associated with early childhood morbidity in offspring.
Key Points
Question  Is pandemic influenza A(H1N1) vaccination in pregnancy associated with an increased risk for early childhood morbidity in offspring?
Findings  In this cohort study, children exposed to maternal vaccination during pregnancy were not significantly more likely to be hospitalized in early childhood than unexposed children.
Meaning  These results support the safety profile of influenza A(H1N1) vaccine used in pregnancy.

Journal of Infectious Diseases
Volume 215, Issue 3 1 Feburayr 2017
http://jid.oxfordjournals.org/content/current

Editor’s Choice
Completing Polio Eradication: The Case for Antiviral Drugs
Roland W. Sutter John F. Modlin Michel Zaffran

Journal of Infectious Diseases
Volume 215, Issue 3 1 Feburayr 2017
http://jid.oxfordjournals.org/content/current

VIRUSES
Antiviral Activity of Pocapavir in a Randomized, Blinded, Placebo-Controlled Human Oral Poliovirus Vaccine Challenge Model
Marc S. Collett; Jeffrey R. Hincks; Kimberley Benschop; Erwin Duizer; Harrie van der Avoort …
Abstract
Background.
Immunodeficient individuals who excrete vaccine-derived polioviruses threaten polio eradication. Antivirals address this threat.
Methods.
In a randomized, blinded, placebo-controlled study, adults were challenged with monovalent oral poliovirus type 1 vaccine (mOPV1) and subsequently treated with capsid inhibitor pocapavir or placebo. The time to virus negativity in stool was determined.
Results.
A total of 144 participants were enrolled; 98% became infected upon OPV challenge. Pocapavir-treated subjects (n=93) cleared virus a median duration of 10 days after challenge, compared with 13 days for placebo recipients (n=48; P=.0019). Fifty-two of 93 pocapavir-treated subjects (56%) cleared virus in 2–18 days with no evidence of drug resistance, while 41 of 93 (44%) treated subjects experienced infection with resistant virus while in the isolation facility, 3 (3%) of whom were infected at baseline, before treatment initiation. Resistant virus was also observed in 5 placebo recipients (10%). Excluding those with resistant virus, the median time to virus negativity was 5.5 days in pocapavir recipients, compared with 13 days in placebo recipients (P<.0001). There were no serious adverse events and no withdrawals from the study.
Conclusions.
Treatment with pocapavir was safe and significantly accelerated virus clearance. Emergence of resistant virus and transmission of virus were seen in the context of a clinical isolation facility.
Clinical Trials Registration.
EudraCT 2011-004804-38.

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Original Article
National legislation and spending on vaccines in Latin America and the Caribbean
Michael McQuestion, Ana Gabriela Felix Garcia…
Abstract
This study examined the dynamics of vaccine spending and vaccine legislation in the Americas Region over the period 1980–2013. Annual vaccine expenditures from thirty-one countries were extracted from the Pan American Health Organization Revolving Fund database. Information on vaccine laws and regulations was provided by the PAHO Family, Gender, and Life Course Unit. Both time series and event history models were estimated. The results show that passing an immunization law led a representative country to increase its vaccine spending, controlling for income, infant mortality, population size, and DPT3 vaccine coverage. Countries with higher vaccine coverage were also more likely to have passed laws. Conversely, higher income countries were less likely to have vaccine laws. Vaccine legislation will likely play a similarly important role in other regions as more countries move towards immunization program ownership

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Original Article
Knowledge and perceptions of polio and polio immunization in polio high-risk areas of Pakistan
Muhammad Atif Habib, Sajid Bashir Soofi, Noshad Ali…
Abstract
Pakistan and Afghanistan remain the only countries where polio is endemic, and Pakistan reports the most cases in the world. Although the rate is lower than in previous years, the situation remains alarming. We conducted a mixed methods study in high-risk areas of Pakistan to identify knowledge, attitudes, and practices of target populations about polio vaccine and its eradication, and to estimate coverage of routine immunization and oral polio vaccine. We surveyed 10,685 households in Karachi, 2522 in Pishin, and 2005 in Bajaur. Some knowledge of polio is universal, but important misconceptions persist. The findings of this study carry strategic importance for program direction and implementation.

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Commentary
Understanding ‘perceptions’ is critical for all vaccination efforts, not only polio eradication
Roy Widdus
Abstract
Because Pakistan is the country with the most daunting challenges for ending transmission of endemic poliovirus, the work of Habib et al in this issue is critical for achieving polio eradication globally. Understanding why immunization programs are not reaching all children is important for success in reducing spread of all vaccine preventable diseases. The methods and insights are important for public health generalists, not only those employed in the pursuit of polio eradication.

Journal of Public Health Policy
Volume 38, Issue 1, February 2017
http://link.springer.com/journal/41271/38/1/page/1

Viewpoint
Peer-reviewed public health journals from Arabic-speaking countries: An updated snapshot
Basil H. Aboul-Enein, Joshua Bernstein…
Abstract
There is a positive association between availability of regional peer-reviewed public health information systems and progressive change in community and population health. The objective of this brief report was to identify public health journals in Arabic-speaking countries actively publishing as of 2016. We conducted an electronic search in several electronic database records for public health journals using a combination of search terms. We excluded journals that focused on human medicine, veterinary medicine, nursing, and other discipline-specific or clinical health professions. We identified twenty-five public health journals for review. Five journals were interrupted or discontinued. Only three journals had a consistent, uninterrupted active publication history of greater than 20 years. Most journals were not in the regional native language. Introduction of regional public health-dedicated journals with in-print and electronic availability and also to be published in region-native languages may require interdisciplinary partnerships. Region-wide public health journals such as the Eastern Mediterranean Health Journal could serve as an ideal model for the establishment of additional local and regional public health journals in Arabic-speaking countries.

The Lancet
Mar 11, 2017 Volume 389 Number 10073 p983-1074
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Evaluating industry’s role in vaccine access
The Lancet
Published: 11 March 2017
DOI: http://dx.doi.org/10.1016/S0140-6736(17)30694-3
On March 6, 2017, the Access to Medicine Foundation released its first Access to Vaccines Index, a baseline analysis of industry activities to improve access to vaccines worldwide. Two targets for the Sustainable Development Goals (SDG 3.8 and SDG 3.B) explicitly mention vaccines. Yet, despite the global consensus on the centrality of vaccines to modern health systems, access is highly variable, and in 2016 there were 19 million unvaccinated and under-vaccinated children in the world.
Challenges to universal and sustainable access to vaccines include development of new vaccines, financing, affordability, supply, and implementation. Recognising the vital role of the pharmaceutical industry—as innovators, manufacturers, and suppliers—the index examines the behaviour of eight companies across 69 diseases, 107 countries, and three areas: research and development (R&D), pricing and registration, and manufacture and supply. Although most companies were found to make some consideration of affordability when setting vaccine prices, a more systematic approach is required, particularly for middle-income countries. For the most part, current R&D activities are linked to commercial incentives, with vaccines for seasonal influenza, pneumococcal disease, and human papillomavirus receiving the most attention. Although a third of R&D projects targeted a disease for which no vaccine exists, the report also identified 32 important diseases with no current R&D projects, including yaws, cytomegalovirus, and schistosomiasis. While detailing recent successes in the development of new vaccines for diseases of global health importance (specifically, dengue and malaria), the report highlights the ongoing need to improve vaccines once they reach the market to ensure they address usage needs in resource-limited settings.
Overall, the index paints a mixed picture of industry efforts. But in setting clear benchmarks it shows a path forward for industry to take a conscious and leading role in ensuring that every person, regardless of geography or income, has access to effective and affordable vaccines.

Lancet Public Health
Mar 2017 Volume 2 Number 3 e121-e156
http://thelancet.com/journals/lanpub/issue/current

Comment
The price of delaying measles eradication
Open Access
David N Durrheim, Natasha S Crowcroft
DOI: http://dx.doi.org/10.1016/S2468-2667(17)30026-9

On September 27, 2016, the Pan American Health Organization (PAHO) verified that the Americas had eliminated endemic measles transmission.1 This phenomenal achievement provides irrefutable empirical evidence supporting the determination reached by a global technical consultation, convened by WHO in 2010, that global measles eradication is biologically, technically, and operationally feasible.2 The prospect of a world where no child dies because of measles has resonated with global leaders and all WHO regions have established goals to eliminate measles by 2020 or before. Against this backdrop of proven feasibility and stated political will, it is truly disappointing that the recently completed mid-term review of the Global Measles and Rubella Strategic Plan, 2012–2020, states that “recent years have seen a slowing of progress” and “it is premature to set a timeframe for eradication at this point”.3

The increasing global coverage with measles vaccination accounted for a cumulative estimated 17·1 million lives saved between 2000 and 2015.4 However, with the stagnation of progress, tragically an estimated 114 900 people, mostly children, died due to measles in 2014.5 These deaths could have been prevented with a simple, safe, cost-effective health measure—timely measles vaccination.

The gains in reducing measles mortality and morbidity are fragile—each new birth cohort requires effective vaccine delivery to ensure that at least 95% of individuals are immune or measles virus comes back with a vengeance to discover the immunity gaps.6 Unfortunately many mature immunisation programmes have cohorts of older children or young adults remaining susceptible to measles owing to incomplete reach of immunisation programmes in previous years. Once children leave school, they are difficult to reach with immunisation. Global surveillance data show 40% of confirmed cases in the European region and 29% in the Western Pacific region were 15 years of age or older, and 19% in the European region and 13% in the Western Pacific region were 25 years of age or older. 7

Waning immunity could be more important than previously recognised with the window for eradicating measles potentially closing. Older generations, who were immune through natural infection, are dying and being replaced with infants with lower levels of immunity who are born to mothers immune through vaccination. Reinfection of fully vaccinated individuals with transmission of infection to others might present a real risk in elimination settings where natural boosting is no longer occurring.8 Sustaining herd immunity while the rest of the world catches up is now the greatest challenge facing the Americas and countries in other regions that have been verified as having interrupted endemic measles transmission.

Responding to outbreaks in countries that have achieved, or are close to achieving, elimination of endemic transmission can be enormously expensive and disruptive to the health service and society. Thus, it is not surprising that the Columbian Minister of Health, Alejandro Gaviria Uribe, will present a resolution calling for a measles eradication target date at the 2017 World Health Assembly, a proposal supported by all Latin American Ministers of Health.9

Measles vaccination, providing each child with two immunisation doses either through the routine programme or campaigns, is one of the most cost-effective public health interventions but eradication is even more financially attractive because treatment costs for measles infections are avoided (>US$2 billion per year) and prevents disability-adjusted life year (DALY) losses prevented (>15 million DALYs per year valued at >$63 billion).10 Measles vaccination can also prevent congenital rubella syndrome through combining measles and rubella vaccines, and there is the potential to add a range of other health interventions.

Important ethical drivers exist to complete measles eradication. The 1989 Convention on the Rights of the Child states that children have the right to the best health care possible and that rich countries should help poorer countries achieve this. Every government and the international donor community have a duty of care to ensure that children enjoy the protection offered by measles vaccine, which is both affordable and effective in preventing severe disease and death. The rule of rescue demands that those that are able, in this case governments and international donors, rescue identifiable individuals facing avoidable death if personal sacrifice is not excessive. Because children who are at high-risk for missing out on vaccine, including migrants, nomadic communities, and the rural poor, are often at greatest risk of severe disease because of poor nutrition, co-infections, and limited access to health care, reaching them with immunisation can have a real effect on health inequities. Measles could be called the equity virus: without vaccination, everyone gets measles, and without equitable health-care systems to deliver vaccination, measles will continue to present a threat to the most vulnerable. We should not risk waiting for the perfect day to set a target. An aspirational vision could fan the flames of optimism we need to drive us to the target of eradication faster. The world needs a global measles eradication target supported by a global verification commission; we should not settle for less.
We declare no competing interests. [Reference at link in title]

The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy
March 2017 Volume 95, Issue 1 Pages 1–209
http://onlinelibrary.wiley.com/doi/10.1111/milq.2017.95.issue-1/issuetoc

Op-Eds
Volunteering for Clinical Research Studies and Public Health (pages 40–42)
CATHERINE D. DeANGELIS
Version of Record online: 7 MAR 2017 | DOI: 10.1111/1468-0009.12244

The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy
March 2017 Volume 95, Issue 1 Pages 1–209

Original Investigations
Measuring, Reporting, and Rewarding Quality of Care in 5 Nations: 5 Policy Levers to Enhance Hospital Quality Accountability (pages 136–183)
CHRISTOPH PROSS, ALEXANDER GEISSLER and REINHARD BUSSE
Version of Record online: 7 MAR 2017 | DOI: 10.1111/1468-0009.12248
Abstract
Policy Points:
:: Similarities and disparities between countries and initiatives are identified. Measuring, reporting, and rewarding quality is heavily focused on process measures. Hospital-level benchmarking is not always available publicly. Quality-related payment schemes vary widely, with several countries only piloting small-scale initiatives.
:: To increase quality accountability, the government has to set standards and incentives. The right balance between system centralization and decentralization has to be struck. Accountability needs to be based on outcomes, not process measures, and focus should be on hospital and medical condition levels. Providers have a central role as quality accountability advocates.
Context
Studies have documented wide quality variation among hospitals within and across countries. Increasing quality-of-care accountability for hospitals, especially for patients and the general public, is an important policy objective, but no study has yet systematically and comprehensively compared leading countries’ initiatives in this regard.
Methods
Based on expert interviews and an extensive literature review, we investigate hospital quality accountability in England, Germany, the Netherlands, Sweden, and the United States. The underlying framework includes 3 elements: measuring quality, reporting quality, and rewarding quality. Each element is subdivided into 2 dimensions, with measuring composed of indicator type and data source, reporting composed of degree of reporting centralization and data accessibility, and rewarding composed of extent of application and type of quality-related payments.
Findings
The results show a wide spectrum of approaches and progress levels. Measuring strategies are more similar across countries, while quality reporting and financial rewards are more dissimilar. Reporting of process indicators is more prevalent than reporting of outcomes. Most countries have introduced some quality-related payment schemes, with the United States having the most comprehensive approach. Based on the cross-country assessment, 5 policy levers to enhance quality transparency are identified and illustrated through country-specific examples: (1) the government should take a central role in establishing standards and incentives for quality transparency and health IT system integration; (2) system centralization and decentralization need to be balanced to ensure both national comparability and local innovation; (3) health systems need to focus more on outcome transparency and less on process measures; (4) health systems need to engage providers as proponents of quality transparency; and (5) reporting should focus on hospital and condition levels to ensure comparability and enable meaningful patient choice.
Conclusions
The findings facilitate cross-country learning and best-practice adoption by assessing hospital quality accountability strategies in 5 countries in a structured and comparative manner. The identified policy levers are relevant for enhancing breadth, depth, and value of quality accountability.

Nature
Volume 543 Number 7644 pp152-280 9 March 2017
http://www.nature.com/nature/current_issue.html

Comment
Show drugs work before selling them
08 March 2017
Regulation makes economic sense, argue Douglas Sipp, Christopher McCabe and John E. J. Rasko.
Under US President Donald Trump, defunct economic arguments about prescription drugs are coming to the fore. His advisers contend that today’s system is a bad deal. They want to undo regulations that require companies to show that a medical product actually works before it is sold. The advisers argue that removing the burden of large, lengthy clinical trials will cut costs and reduce delays, and that the marketplace can be trusted to sort good drugs from bad ones
Although many have raised concerns about a Trump Food and Drug Administration (FDA; see, for example, Nature http://doi.org/bz92; 2017), few have debunked the economic arguments. Here we outline what the case for deregulation gets wrong. All nations should take note — weaker standards for entry of drugs onto the US market will harm health everywhere…

Nature
Volume 543 Number 7644 pp152-280 9 March 2017
http://www.nature.com/nature/current_issue.html

Letters
Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination
Norbert Pardi, Michael J. Hogan, Rebecca S. Pelc, Hiromi Muramatsu, Hanne Andersen+ et al.
A single, low-dose intradermal immunization with lipid-nanoparticle-encapsulated nucleoside-modified mRNA encoding the pre-membrane and envelope glycoproteins of Zika virus protects both mice and rhesus macaques against infection and elicits rapid and long-lasting neutralizing antibody responses.
Zika virus (ZIKV) has recently emerged as a pandemic associated with severe neuropathology in newborns and adults1. There are no ZIKV-specific treatments or preventatives. Therefore, the development of a safe and effective vaccine is a high priority. Messenger RNA (mRNA) has emerged as a versatile and highly effective platform to deliver vaccine antigens and therapeutic proteins2, 3. Here we demonstrate that a single low-dose intradermal immunization with lipid-nanoparticle-encapsulated nucleoside-modified mRNA (mRNA–LNP) encoding the pre-membrane and envelope glycoproteins of a strain from the ZIKV outbreak in 2013 elicited potent and durable neutralizing antibody responses in mice and non-human primates. Immunization with 30 μg of nucleoside-modified ZIKV mRNA–LNP protected mice against ZIKV challenges at 2 weeks or 5 months after vaccination, and a single dose of 50 μg was sufficient to protect non-human primates against a challenge at 5 weeks after vaccination. These data demonstrate that nucleoside-modified mRNA–LNP elicits rapid and durable protective immunity and therefore represents a new and promising vaccine candidate for the global fight against ZIKV.

New England Journal of Medicine
March 9, 2017  Vol. 376 No. 10
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Chimpanzee Adenovirus Vector Ebola Vaccine
Julie E. Ledgerwood, D.O., Adam D. DeZure, M.D., Daphne A. Stanley, M.S., Emily E. Coates, Ph.D., Laura Novik, M.A., Mary E. Enama, M.A., Nina M. Berkowitz, M.P.H., Zonghui Hu, Ph.D., Gyan Joshi, M.S., Aurélie Ploquin, Ph.D., Sandra Sitar, M.S., Ingelise J. Gordon, R.N., Sarah A. Plummer, C.R.N.P., LaSonji A. Holman, F.N.P., Cynthia S. Hendel, C.R.N.P., Galina Yamshchikov, M.S., Francois Roman, M.D., Alfredo Nicosia, Ph.D., Stefano Colloca, Ph.D., Riccardo Cortese, M.D., Robert T. Bailer, Ph.D., Richard M. Schwartz, Ph.D., Mario Roederer, Ph.D., John R. Mascola, M.D., Richard A. Koup, M.D., Nancy J. Sullivan, Ph.D., and Barney S. Graham, M.D., for the VRC 207 Study Team*
N Engl J Med 2017; 376:928-938 March 9, 2017 DOI: 10.1056/NEJMoa1410863
Abstract
Background
The unprecedented 2014 epidemic of Ebola virus disease (EVD) prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3–vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species, that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation.
Full Text of Background...
Methods
We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×1010 particle units or 2×1011 particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 8 weeks after vaccination; in addition, longer-term vaccine durability was assessed at 48 weeks after vaccination.
Full Text of Methods…
Results
In this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccination in two participants who had received the 2×1011 particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 participants; the titers were of greater magnitude in the group that received the 2×1011 particle-unit dose than in the group that received the 2×1010 particle-unit dose (geometric mean titer against the Zaire antigen at week 4, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2×1011 particle-unit dose than among those who received the 2×1010 particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07) at week 4. Assessment of the durability of the antibody response showed that titers remained high at week 48, with the highest titers in those who received the 2×1011 particle-unit dose.
Full Text of Results…
Conclusions
Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2×1011 particle-unit dose, glycoprotein Zaire–specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates, and responses were sustained to week 48. Phase 2 studies and efficacy trials assessing cAd3-EBO are in progress. (Funded by the Intramural Research Program of the National Institutes of Health; VRC 207 ClinicalTrials.gov number, NCT02231866.)

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 11 March 2017)

Research Article
GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic
John Whitehead, Peter Horby
| published 09 Mar 2017 P
http://dx.doi.org/10.1371/journal.pntd.0005439
This is an uncorrected proof.
Abstract
Background
Conducting clinical trials to assess experimental treatments for potentially pandemic infectious diseases is challenging. Since many outbreaks of infectious diseases last only six to eight weeks, there is a need for trial designs that can be implemented rapidly in the face of uncertainty. Outbreaks are sudden and unpredictable and so it is essential that as much planning as possible takes place in advance. Statistical aspects of such trial designs should be evaluated and discussed in readiness for implementation.
Methodology/Principal findings
This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. The primary endpoint is a categorisation of patient outcome according to an ordinal scale. A sequential approach is adopted, stopping as soon as it is clear that the experimental treatment has an advantage or that sufficient advantage is unlikely to be detected. The properties of the design are evaluated using large-sample theory and verified for moderate sized samples using simulation. The trial is powered to detect a generic clinically relevant difference: namely an odds ratio of 2 for better rather than worse outcomes. Total sample sizes (across both treatments) of between 150 and 300 patients prove to be adequate in many cases, but the precise value depends on both the magnitude of the treatment advantage and the nature of the ordinal scale. An advantage of the approach is that any erroneous assumptions made at the design stage about the proportion of patients falling into each outcome category have little effect on the error probabilities of the study, although they can lead to inaccurate forecasts of sample size.
Conclusions/Significance
It is important and feasible to pre-determine many of the statistical aspects of an efficient trial design in advance of a disease outbreak. The design can then be tailored to the specific disease under study once its nature is better understood.
Author summary
Since many outbreaks of infectious diseases last only six to eight weeks, there is a need for trial designs that can be implemented rapidly in the face of uncertainty. The Generic Ordinal Sequential Trial (GOST) is a flexible statistical design for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The details of the design are derived to satisfy a generic power requirement using large sample theory. The accuracy of the approach for moderate sample sizes is then checked using million-fold simulations, and found to be very reliable under a wide range of circumstances. Total sample sizes (across both treatments) of between 150 and 300 patients prove to be adequate in many cases, although more patients may be needed if the majority of patients die or if the majority experience complete recovery, as there is then less evidence available to distinguish between treatments. An advantage of the approach is that any erroneous assumptions made at the design stage about the proportion of patients falling into each outcome category have little effect on the error probabilities of the study, although they can lead to inaccurate forecasts of sample size.

PLoS One
http://www.plosone.org/
[Accessed 11 March 2017]

Research Article
Volunteer feedback and perceptions after participation in a phase I, first-in-human Ebola vaccine trial: An anonymous survey
Julie-Anne Dayer, Claire-Anne Siegrist, Angela Huttner
Research Article | published 08 Mar 2017 P
http://dx.doi.org/10.1371/journal.pone.0173148
Abstract
The continued participation of volunteers in clinical trials is crucial to advances in healthcare. Few data are available regarding the satisfaction and impressions of healthy volunteers after participation in phase I trials, many of which lead to unexpected adverse events. We report feedback from over 100 adult volunteers who took part in a first-in-human trial conducted in a high-income country testing an experimental Ebola vaccine causing significant reactogenicity, as well as unexpected arthritis in one fifth of participants. The anonymous, internet-based satisfaction survey was sent by email to all participants upon their completion of this one-year trial; it asked 24 questions concerning volunteers’ motivations, impressions of the trial experience, and overall satisfaction. Answers were summarized using descriptive statistics. Of the 115 trial participants, 103 (90%) filled out the survey. Fifty-five respondents (53%) were male. Thirty-five respondents (34%) were healthcare workers, many of whom would deploy to Ebola-affected countries. All respondents cited scientific advancement as their chief motivation for participation, while 100/103 (97%) and 61/103 (59%) reported additional “humanitarian reasons” and potential protection from Ebolavirus, respectively. Although investigators had documented adverse events in 97% of trial participants, only 74 of 103 respondents (72%) recalled experiencing an adverse event. All reported an overall positive experience, and 93/103 (90%) a willingness to participate in future trials. Given the high level of satisfaction, no significant associations could be detected between trial experiences and satisfaction, even among respondents reporting adverse events lasting weeks or months. Despite considerable reactogenicity and unexpected vaccine-related arthritis, all survey respondents reported overall satisfaction. While this trial’s context was unique, the positive feedback is likely due at least in part to the intense communication of trial information to participants, which included both general findings and personalized results.

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 11 March 2017]

Review
Research capacity strengthening for sexual and reproductive health: a case study from Latin America
Rita Kabra, Marco Castillo, Mercedes Melián, Moazzam Ali, Lale Say and A. Metin Gulmezoglu
Reproductive Health 2017 14:35
Published on: 7 March 2017
Abstract
An essential, but often overlooked part of health promotion and development support to achieve self-sufficiency in developing countries is the concomitant need to build and strengthen research capacity. This is even more challenging and critical in the area of sexual and reproductive health because of diverse interplay of socio cultural, religious, economic factors in relation to reproductive health.
This paper presents the case study of HRP’s efforts to build research capacity in Latin America by studying and analyzing the 5-year history of institutional development support to an institution in Paraguay. In reviewing the efforts, we identify the strengths in the approaches used by HRP, the challenges and outcomes of the process and we present recommendations for future efforts to strengthen research capacity to improve sexual and reproductive health. The authors call for greater support from and collaborative efforts of developmental partners and governments to strengthen research capacity in low and middle-income countries to improve sexual and reproductive health.

Science Translational Medicine
08 March 2017 Vol 9, Issue 380
http://stm.sciencemag.org/

Research Articles
An oral microjet vaccination system elicits antibody production in rabbits
By Kiana Aran, Marc Chooljian, Jacobo Paredes, Mohammad Rafi, Kunwoo Lee, Allison Y. Kim, Jeanny An, Jennifer F. Yau, Helen Chum, Irina Conboy, Niren Murthy, Dorian Liepmann
Science Translational Medicine08 Mar 2017 Restricted Access
A needle-free device delivers a liquid jet of vaccine that penetrates the buccal mucosa and elicits antibody production in rabbits.

Research Articles
A semisynthetic Streptococcus pneumoniae serotype 8 glycoconjugate vaccine
By Benjamin Schumann, Heung Sik Hahm, Sharavathi G. Parameswarappa, Katrin Reppe, Annette Wahlbrink, Subramanian Govindan, Paulina Kaplonek, Liise-anne Pirofski, Martin Witzenrath, Chakkumkal Anish, Claney L. Pereira, Peter H. Seeberger
Science Translational Medicine08 Mar 2017 Restricted Access
Automated glycan assembly enabled antibody reverse engineering to develop a semisynthetic carbohydrate–based vaccine against the highly virulent Streptococcus pneumoniae serotype 8.

Social Science & Medicine
Volume 175, Pages 1-252 (February 2017)
http://www.sciencedirect.com/science/journal/02779536/175

Review articles
Equity in healthcare resource allocation decision making: A systematic review
Review Article
Pages 11-27
Haylee Lane, Mitchell Sarkies, Jennifer Martin, Terry Haines
Abstract
Objective
To identify elements of endorsed definitions of equity in healthcare and classify domains of these definitions so that policy makers, managers, clinicians, and politicians can form an operational definition of equity that reflects the values and preferences of the society they serve.
Design
Systematic review where verbatim text describing explicit and implicit definitions of equity were extracted and subjected to a thematic analysis.
Data sources
The full holdings of the AMED, CINAHL plus, OVID Medline, Scopus, PsychInfo and ProQuest (ProQuest Health & Medical Complete, ProQuest Nursing and Allied Health Source, ProQuest Social Science Journals) were individually searched in April 2015.
Eligibility criteria for selecting studies
Studies were included if they provided an original, explicit or implicit definition of equity in regards to healthcare resource allocation decision making. Papers that only cited earlier definitions of equity and provided no new information or extensions to this definition were excluded.
Results
The search strategy yielded 74 papers appropriate for this review; 60 of these provided an explicit definition of equity, with a further 14 papers discussing implicit elements of equity that the authors endorsed in regards to healthcare resource allocation decision making.
Five key themes emerged
i) Equalisation across the health service supply/access/outcome chain, ii) Need or potential to benefit, iii) Groupings of equalisation, iv) Caveats to equalisation, and v) Close enough is good enough.
Conclusions
There is great inconsistency in definitions of equity endorsed by different authors. Operational definitions of equity need to be more explicit in addressing these five thematic areas before they can be directly applied to healthcare resource allocation decisions.

Social Science & Medicine
Volume 175, Pages 1-252 (February 2017)
http://www.sciencedirect.com/science/journal/02779536/175

Review Article
Effects of donor proliferation in development aid for health on health program performance: A conceptual framework
Pages 177-186
Sarah Wood Pallas, Jennifer Prah Ruger
Abstract
Development aid for health increased dramatically during the past two decades, raising concerns about inefficiency and lack of coherence among the growing number of global health donors. However, we lack a framework for how donor proliferation affects health program performance to inform theory-based evaluation of aid effectiveness policies. A review of academic and gray literature was conducted. Data were extracted from the literature sample on study design and evidence for hypothesized effects of donor proliferation on health program performance, which were iteratively grouped into categories and mapped into a new conceptual framework. In the framework, increases in the number of donors are hypothesized to increase inter-donor competition, transaction costs, donor poaching of recipient staff, recipient control over aid, and donor fragmentation, and to decrease donors’ sense of accountability for overall development outcomes. There is mixed evidence on whether donor proliferation increases or decreases aid volume. These primary effects in turn affect donor innovation, information hoarding, and aid disbursement volatility, as well as recipient country health budget levels, human resource capacity, and corruption, and the determinants of health program performance. The net effect of donor proliferation on health will vary depending on the magnitude of the framework’s competing effects in specific country settings. The conceptual framework provides a foundation for improving design of aid effectiveness practices to mitigate negative effects from donor proliferation while preserving its potential benefits.

Travel Medicine and Infectious Diseases
January-February, 2017 Volume 15
http://www.travelmedicinejournal.com/
Issue Highlights
Yellow fever vaccination – Once in a lifetime?
Martin P. Grobusch, Mariëlle van Aalst, Abraham Goorhuis
Vol. 15, p1–2
Published online: December 22, 2016

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Regular Papers
Factors affecting the willingness of nursing students to receive annual seasonal influenza vaccination: A large-scale cross-sectional study
Original Research Article
Pages 1482-1487
Kin Cheung, Sin Man Simone Ho, Winsome Lam
Abstract
Nursing students are at high risk of exposure to vaccine-preventable diseases such as seasonal influenza. However, due to the limited number of studies conducted in this area, the prevalence and factors affecting annual seasonal influenza vaccination (ASIV) uptake remain unclear. This was a large-scale cross-sectional survey study conducted among 902 nursing students in different years of study. The questionnaire was developed based on the Health Belief Model (HBM), and logistic regression was used to determine the predictors of ASIV uptake. The results of our study reveal that only 15.2% of nursing students declared having the vaccine in the previous year, and that ASIV uptake was self-reported. ASIV uptake was associated with perceived susceptibility (odds ratio = 2.76), perceived seriousness (odds ratio = 2.06) and perceived barriers (odds ratio = 0.50). The odds of receiving ASIV were 17.96 times higher for those participants having had ASIV at least once than those who had not received ASIV in the previous five years. In addition, the odds of receiving ASIV were 4.01 times higher for master’s than undergraduate students. Our study concludes that the ASIV uptake among nursing students is low. In order to increase vaccination uptake in subsequent years, future studies should promote vaccination based on HBM, focusing on nursing students in undergraduate studies by emphasizing not only vaccination knowledge, but also their social responsibility to protect patients. Influenza vaccination can be viewed as an ethical professional responsibility and a patient safety issue, as well as being an infection control strategy.

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Demographics, epidemiology and the impact of vaccination campaigns in a measles-free world – Can elimination be maintained?
Original Research Article
Pages 1488-1493
J.M. Prada, C.J.E. Metcalf, S. Takahashi, J. Lessler, A.J. Tatem, M. Ferrari
Abstract
Introduction
All six WHO regions currently have goals for measles elimination by 2020. Measles vaccination is delivered via routine immunization programmes, which in most sub-Saharan African countries reach children around 9 months of age, and supplementary immunization activities (SIAs), which target a wider age range at multi-annual intervals. In the absence of endemic measles circulation, the proportion of individuals susceptible to measles will gradually increase through accumulation of new unvaccinated individuals in each birth cohort, increasing the risk of an epidemic. The impact of SIAs and the financial investment they require, depend on coverage and target age range.
Materials and methods
We evaluated the impact of target population age range for periodic SIAs, evaluating outcomes for two different levels of coverage, using a demographic and epidemiological model adapted to reflect populations in 4 sub-Saharan African countries.
Results
We found that a single SIA can maintain elimination over short time-scales, even with low routine coverage. However, maintaining elimination for more than a few years is difficult, even with large (high coverage/wide age range) recurrent SIAs, due to the build-up of susceptible individuals. Across the demographic and vaccination contexts investigated, expanding SIAs to target individuals over 10 years did not significantly reduce outbreak risk.
Conclusions
Elimination was not maintained in the contexts we evaluated without a second opportunity for vaccination. In the absence of an expanded routine program, SIAs provide a powerful option for providing this second dose. We show that a single high coverage SIA can deliver most key benefits in terms of maintaining elimination, with follow-up campaigns potentially requiring smaller investments. This makes post-campaign evaluation of coverage increasingly relevant to correctly assess future outbreak risk.

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Is Colombia reaching the goals on infant immunization coverage? A quantitative survey from 80 municipalities
Original Research Article
Pages 1501-1508
Javier Narváez, May Bibiana Osorio, Carlos Castañeda-Orjuela, Nelson Alvis Zakzuk, Natalia Cediel, Luz Ángela Chocontá-Piraquive, Fernando de La Hoz-Restrepo
Abstract
Objectives
This study aimed to evaluate the coverage of the Colombian Expanded Program on Immunization among children less than 6 years old, to evaluate the timeliness of immunization, to assess the coverage of newly introduced vaccines, and to identify factors associated with lack of immunization.
Methods
We conducted a cross-sectional survey in 80 municipalities of Colombia, using a two-stage cluster random sampling. We attempted to contact all children less than 6 years old living in the sampled blocks, and asked their caregivers to provide immunization record cards. We also collected basic sociodemographic information.
Results
We reached 81% of the attempted household contacts, identifying 18,232 children; of them, 14,805 (83%) had an immunization record card. Coverage for traditional vaccines was above 90%: BCG (tuberculosis) 95.7% (95%CI: 95.1–96.4), pentavalent vaccine 93.3% (92.4–94.3), MMR (measles, mumps, rubella) initial dose 94.5% (93.5–95.6); but it was lower for recently introduced vaccines: rotavirus 80% (77.8–82.1), influenza 48.4% (45.9–50.8). Results for timely vaccination were not equally successful: pentavalent vaccine 44.2% (41.4–47.1), MMR initial dose 71.2% (68.9–73.4). Mother’s education was significantly associated with higher immunization odds. Older age, a greater number of siblings, low socioeconomic status, and not having health insurance were significantly associated with lower immunization odds. There was significant heterogeneity in immunization rates by municipality across the country.
Conclusions
Although absolute immunization coverage for traditional vaccines met the goal of 90% for the 80 municipalities combined, disparities in coverage across municipalities, delayed immunization, and decline of coverage with age, are common problems in Colombia that may result in reduced protection. Newly introduced vaccines require additional efforts to reach the goal. These results highlight the association of health inequities with low immunization coverage and delayed immunization. Identification of vulnerable populations and their missed opportunities for vaccination may help to improve the reach of immunization programs.

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Investigating adverse events following immunisation with pneumococcal polysaccharide vaccine using electronic General Practice data
Original Research Article
Pages 1524-1529
L. Trinh, K. Macartney, P. McIntyre, C. Chiu, A. Dey, R. Menzies
Abstract
Background
In early 2011, following an increased number of reports of severe vaccine-related injection site reactions, Australian authorities recommended against administering repeat doses of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) in otherwise healthy adults. The aim of this study was to assess a source of electronic medical record data from primary care providers (General Practitioners, GPs), for validity and ability to retrospectively detect this adverse event signal.
Methods
The General Practice Research Network (GPRN) holds data routinely collected from a representative sample of Australian GPs. Data were extracted on persons 18 years or older who had received at least one dose of 23vPPV or influenza vaccine (as comparator) between January 2002 and June 2012. Increases above background levels were assessed using 95% confidence intervals of reaction rates, calculated from the Poisson distribution of counts.
Results
There was an average of 253 practices and 532 GPs contributing data per year. Over the study period there were 95,760 recorded 23vPPV administrations and 823 reactions, of which 233 were local. For influenza vaccine the numbers were 683,829 doses, 3001 and 387 respectively. Patterns of vaccinations and reactions were consistent with known safety profiles. There were 3 local reactions following 23vPPV in early 2011 (235/100,000 doses, 95% CI 49–717), which was not significantly different to the historical average (260, 225–298). We estimate that this system could have detected a 3-fold increase over background levels.
Conclusions
Using GP consultation data, we were unable to confirm an increase in local reactions detected by passive surveillance, suggesting that this apparent signal was artefactual. GP consultation data captures large numbers of vaccine recipients and medically attended adverse reactions at low cost. If available in a timely manner and expanded, this system has significant potential for use in validation of apparent signals from passive surveillance.

Vaccine
Volume 35, Issue 11, Pages 1475-1578 (13 March 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/11

Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh
Original Research Article
Pages 1538-1543
Ashraful Islam Khan, Mohammad Ali, Fahima Chowdhury, Amit Saha, Iqbal Ansary Khan, Arifuzzaman Khan, Afroza Akter, Muhammad Asaduzzaman, Md. Taufiqul Islam, Alamgir Kabir, Young Ae You, Nirod Chandra Saha, Alejandro Cravioto, John D. Clemens, Firdausi Qadri
Abstract
Background
Pregnant women are vulnerable to complications of cholera. Killed oral cholera vaccines (OCV) are not recommended for pregnant women though there is no evidence of harmful effects during pregnancy. We evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh.
Methodology
Individuals ⩾1 year were invited to participate in the trial, conducted in 2011 in Dhaka, Bangladesh. Pregnancy by history was an exclusion criterion and all women of reproductive age (15–49 years) were verbally questioned about pregnancy at enrollment and prior to vaccination. Out of 48,414 women of reproductive age 286 women received the OCV unknowingly while pregnant. Out of these, we could recruit 69 women defined as exposed to OCV. Accordingly, we selected 69 pregnant women randomly from those who did not take the OCV (non-exposed to OCV). We evaluated adverse pregnancy outcome (spontaneous miscarriages, still births, or congenital malformations) between those who were exposed to OCV and those who were not exposed to OCV.
Results
About 16% of pregnant women exposed to OCV had pregnancy loss, as compared to 12% of unvaccinated pregnant women (P = 0.38). One congenital anomaly was observed and occurred in women non-exposed to OCV group. Models that adjusted for baseline characteristics that were unbalanced between the exposed and non-exposed groups, revealed a no elevation of risk of adverse pregnancy outcomes in vaccinees versus non-vaccinees (Adj. OR (95% CI): 0.45 (0.11–1.88).
Conclusions
No excess of adverse fetal outcomes associated with receipt of OCV was observed in this study.
Trial registration: Clinical Trials.gov number NCT01339845.