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

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary
 
 
BMJ Open
Volume 8, Issue 3 2018
Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: a mixed-methods study protocol
S Audrey, HB Ferrer, J Ferrie, K Evans, M Bell, J Yates…
Abstract
Introduction
The human papillomavirus (HPV) vaccine, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, lack of written parental consent is a key reason why some young women do not receive the vaccine. The national legal framework allows girls to be vaccinated without parental consent provided they are deemed Gillick competent, but there is some reticence about vaccinating without written parental consent. Self-consent procedures are being implemented in Bristol and South Gloucestershire. This study will examine the implementation, acceptability and impact of these new procedures.
Methods and analysis
Statistical analyses of routine data from Public Health England and the Child Health Information System will test if there has been an increase in HPV vaccination uptake in two ways: (a) Is there an increase when comparing before and after the change in our intervention sites? and (b) Does the percentage change in our intervention sites differ from comparison sites (similar to our intervention sites in terms of initial HPV uptake, ethnicity and deprivation levels) in England where no such intervention took place and how? For the process evaluation, we will develop a logic model and use questionnaires, observations and audio-recorded interviews with young women, school nurses, school staff and parents to examine the context, implementation of self-consent and response to the new procedures.
Ethics and dissemination
The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service Health Research Authority provided approvals for the study. We will produce a report with recommendations about self-consent procedures in conjunction with key stakeholders. At least two papers will be written for publication in peer-reviewed journals and for conference presentations. A summary of results will be shared with participating immunisation nurses, school staff, young people and parents as requested.
Trial registration number ISRCTN49086105; Pre-results
 
 
Systematic Reviews
20187:40  Published: 2 March 2018
Barriers, supports, and effective interventions for uptake of human papillomavirus- and other vaccines within global and Canadian Indigenous peoples: a systematic review protocol
KJ Mrklas, S MacDonald, MA Shea-Budgell…
Abstract
Background
Despite the existence of human papilloma virus (HPV) vaccines with demonstrated safety and effectiveness and funded HPV vaccination programs, coverage rates are persistently lower and cervical cancer burden higher among Canadian Indigenous peoples. Barriers and supports to HPV vaccination in Indigenous peoples have not been systematically documented, nor have interventions to increase uptake in this population. This protocol aims to appraise the literature in Canadian and global Indigenous peoples, relating to documented barriers and supports to vaccination and interventions to increase acceptability/uptake or reduce hesitancy of vaccination. Although HPV vaccination is the primary focus, we anticipate only a small number of relevant studies to emerge from the search and will, therefore, employ a broad search strategy to capture literature related to both HPV vaccination and vaccination in general in global Indigenous peoples.
Methods
Eligible studies will include global Indigenous peoples and discuss barriers or supports and/or interventions to improve uptake or to reduce hesitancy, for the HPV vaccine and/or other vaccines. Primary outcomes are documented barriers or supports or interventions. All study designs meeting inclusion criteria will be considered, without restricting by language, location, or data type. We will use an a priori search strategy, comprised of key words and controlled vocabulary terms, developed in consultation with an academic librarian, and reviewed by a second academic librarian using the PRESS checklist. We will search several electronic databases from date of inception, without restrictions. A pre-defined group of global Indigenous websites will be reviewed for relevant gray literature. Bibliographic searches will be conducted for all included studies to identify relevant reviews. Data analysis will include an inductive, qualitative, thematic synthesis and a quantitative analysis of measured barriers and supports, as well as a descriptive synthesis and quantitative summary of measures for interventions.
Discussion
To our knowledge, this study will contribute the first systematic review of documented barriers, supports, and interventions for vaccination in general and for HPV vaccination. The results of this study are expected to inform future research, policies, programs, and community-driven initiatives to enhance acceptability and uptake of HPV vaccination among Indigenous peoples.
Systematic review registration
PROSPERO Registration Number: CRD42017048844

Academic Pediatrics
March 2018 Volume 18, Issue 2, Supplement, Pages S14–S16
Advancing human papillomavirus vaccine delivery: 12 priority research gaps
PL Reiter, MA Gerend, MB Gilkey, RB Perkins…
Abstract
Human papillomavirus (HPV) vaccine has been available in the United States for a decade, yet vaccination coverage remains modest. A recent review identified numerous interventions for increasing HPV vaccination,1 but effects were small and evidence was often insufficient to identify best practices. The National HPV Vaccination Roundtable sponsored a 1-day national meeting in 2016 on best and promising practices in HPV vaccine delivery, in part to identify important research gaps.
Meeting attendees were HPV vaccine delivery experts including scientists, clinicians, and other stakeholders. Approximately 100 people attended in-person and approximately 400 additional people streamed the meeting online (livestream.com/ACS/events/5892004). Throughout the meeting, the meeting facilitators encouraged attendees to identify gaps that future research should address and write them on display boards (or send via e-mail or Twitter). Facilitators did not provide attendees with a predefined list of gaps. Attendees identified a total of 33 gaps (Table). In-person attendees voted for up to 5 gaps they believed were top priorities. We categorized the gaps into themes. The 12 gaps that received the most votes generally fit into these themes: 1) social media and vaccine confidence, 2) health care provider interventions, or 3) system-level approaches. Two gaps in the top 12 that did not fit these themes were determining what interventions work in rural areas (gap 7) and the impact of survivor testimonials (gap 9)…

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
 
 
Forbes
http://www.forbes.com/
Accessed 10 March 2018
Disease X Is What May Become The Biggest Infectious Threat To Our World
Bruce Y. Lee, Contributor
Disease X appeared in a World Health Organization (WHO) list of pathogens that could cause a public health emergency and for which there aren’t adequate drugs and/or vaccines.
 
New York Times
http://www.nytimes.com/
Accessed 10 March 2018
Sanofi may seek U.S. approval for Dengvaxia despite Philippines outrage
7 March 2018
By REUTERS
PARIS — Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines, a senior executive said on Wednesday.

David Loew, head of Sanofi Pasteur, the French drugmaker’s vaccines division, said his teams had complied with all regulations regarding Dengvaxia and had no regrets about the way the product had been developed.

The Philippines, where more than 800,000 school-age children were vaccinated in 2016, suspended a vast public immunisation programme last year because of safety concerns.
Sanofi warned in November that the use of Dengvaxia was to be limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection.

In February, a Philippine government agency filed a lawsuit against Sanofi, demanding compensation for the parents of a 10-year-old girl who the agency said had died as a result of receiving Dengvaxia.
Sanofi has repeatedly said it knew of no deaths resulting from the vaccine. While some experts have said the company and regulators might have ignored warnings about how the vaccine was developed, executives at Sanofi deny any wrongdoing.

“On the whole path of development, we always worked with the World Health Organisation (WHO) and experts in the dengue community. We were always transparent,” Loew told Reuters in an interview, referring to the WHO and other regulators.

“You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say no, we would not have done anything differently.”…
Loew said the company would decide within two months whether to make a regulatory filing for Dengvaxia with the U.S. Food and Drug Administration.

He also said Sanofi was holding discussions with external partners and universities to come up with a test which would be applicable before vaccination. Such a test would take at least two years to bring to the market.

“We operate in environments where the temperature is 30-40 degrees Celsius so you want to be sure that the tests resist (…) If you have a vaccination campaign taking place in a school for example, you want to make sure it is ‘implementable,'” he said.

Dengvaxia has been approved and registered in 19 countries so far, mostly in the developing world. It is currently under review by the European Medicines Agency.

Yellow Fever Circles Brazil’s Huge Cities
5 March 2018
By SHASTA DARLINGTON and DONALD G. McNEIL Jr. MARCH 5, 2018
“Good morning!” a loudspeaker blared recently in the working class São Paulo suburb called Jardim Monte Alegre. “We’ve got your yellow fever vaccine, and today we’re going house to house! You better wake up because mosquitoes never sleep!” Twenty health workers piled out of cars. Though they laughed and chatted with locals, their mission was deadly serious…
 
Scientific American
https://www.scientificamerican.com/
Accessed 10 March 2018
How to Understand, and Help, the Vaccine Doubters
Understand the values behind people’s fears
By Avnika B. Amin, Saad B. Omer, Jesse Graham
6 March 2018
We are in the golden age for vaccines. We have dozens of highly effective vaccines licensed for infectious disease, promising new technologies contributing to massive advancement of vaccine development, and several promising vaccines on the horizon. Unfortunately, vaccines have been a victim of their own success. With the drastic reduction of once-devastating diseases like whooping cough and measles, it seems like some parents think that the vaccines themselves are the new danger. But the threat isn’t gone; it’s been kept at bay by vaccinations. With clusters of vaccine-hesitant individuals especially worrisome, we need to find effective ways to convince people that the true danger is still disease…
 
Washington Post
http://www.washingtonpost.com/
Accessed 10 March 2018
FDA did not issue new statement on vaccines and autism
By Associated Press March 7
Some health websites have misrepresented the fine print on an old vaccine label to falsely claim that the “FDA announced that vaccines are causing autism.” Vaccines do not cause autism and the U.S. Food and Drug Administration did not make any new statement this week about the long-debunked claim.
Autism was listed as one of many “adverse events” on the 2005 label of Sanofi Pasteur’s Tripedia childhood vaccine for diphtheria, tetanus and pertussis. When the vaccine was first approved, such reports were generated voluntarily by consumers and were automatically added to the FDA label, even if there was no plausible connection to the product.
The 2005 label notes that such reports do not “establish a causal relationship” to the vaccine. Since then, the FDA has changed its labeling rules and now only includes adverse events “for which there is some basis to believe there is a causal relationship,” the agency said in a statement.

Vaccines and Global Health: The Week in Review 3 March 2018

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

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

 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_3 March 2018

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

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

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

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

NIAID unveils strategic plan for developing a universal influenza vaccine

Milestones :: Perspectives
 
 
NIH  [to 3 March 2018]
http://www.nih.gov/news-events/news-releases
February 28, 2018
NIAID unveils strategic plan for developing a universal influenza vaccine
Developing a universal influenza vaccine — a vaccine that can provide durable protection for all age groups against multiple influenza strains, including those that might cause a pandemic — is a priority for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Writing in the Journal of Infectious Diseases, NIAID officials detail the Institute’s new strategic plan for addressing the research areas essential to creating a safe and effective universal influenza vaccine. They describe the scientific goals that will be supported to advance influenza vaccine development. The strategic plan builds upon a workshop NIAID convened in June 2017 that gathered scientists from academia, industry and government who developed criteria for defining a universal influenza vaccine, identified knowledge gaps, and delineated research strategies for addressing those gaps.

The cornerstone of both seasonal and pandemic influenza prevention and control is the development of vaccines against specific influenza strains that pose a potentially significant risk to the public. Seasonal influenza vaccines are made anew each year to best match the strains projected to circulate in the upcoming season. However, this approach has limitations and difficulties. To reduce the public health consequences of both seasonal and pandemic influenza, vaccines must be more broadly and durably protective. Advances in influenza virology, immunology and vaccinology make the development of a universal influenza vaccine more feasible than a decade ago, according to the authors. To develop a universal influenza vaccine, NIAID will focus resources on three key areas of influenza research: improving the understanding of the transmission, natural history and pathogenesis of influenza infection; precisely characterizing how protective influenza immunity occurs and how to tailor vaccination responses to achieve it; and supporting the rational design of universal influenza vaccines, including designing new immunogens and adjuvants to boost immunity and extend the duration of protection.

The authors state that a coordinated effort of guided discovery, facilitated product development and managed progress through iterative clinical testing will be critical to achieving the goal of a universal influenza vaccine. NIAID will establish and support a consortium of scientists to meet designated goals for a universal influenza vaccine and will expand the Institute’s research resources by establishing long-term human cohorts, supporting improved animal models of influenza infection and expanding capacity for conducting human challenge studies.

The authors emphasize that broad collaboration and coordination in many disciplines and involving government, academia, philanthropies and the private sector will be vital to achieving the goal of developing a universal influenza vaccine. NIAID intends for the plan to serve as the foundation for its research investment strategy to achieve this important public health goal.
Article
AS Fauci et al. A universal influenza vaccine: The strategic plan for the National Institute of Allergy and Infectious Diseases (link is external). Journal of Infectious Diseases  DOI: 10.1093/infdis/jiy103 (2018).

Cost effectiveness methodology for vaccination programmes

 Milestones :: Perspectives

Cost effectiveness methodology for vaccination programmes – Open consultation

U.K. Department of Health and Social Care
Published 26 February 2018
Summary
Consultation on the 2016 report into the cost effectiveness methodology for immunisation programmes and procurement (CEMIPP).
 
Consultation description
The report sets out recommendations from the independent CEMIPP group that was set up by the government to consider whether the method for appraising cost effectiveness of vaccination programmes should change.
We are looking for views from organisations and committees that appraise cost effectiveness within the health and care sector, as well as specialists with an interest in health economics, including:
:: health economists based in academia
:: public health practitioners
:: epidemiologists
:: charities and patient groups
:: clinicians and vaccine industry professionals
 
Documents
:: Cost effectiveness methodology for vaccination programmes: consultation on the CEMIPP report  PDF, 450KB, 19 pages
:: Review of cost effectiveness methodology for immunisation programmes and procurements: 2016 report PDF, 232KB, 26 pages

World leaders join new drive to beat noncommunicable diseases :: BBC: In the Wake of Wakefield :: WHO approves cholera vaccine for use at temperatures high as 40 degrees Celsius for up to 14 days

Milestones :: Perspectives

World leaders join new drive to beat noncommunicable diseases
1 March 2018 | Geneva – WHO is announcing today a new high-level commission, comprised of heads of state and ministers, leaders in health and development and entrepreneurs. The group will propose bold and innovative solutions to accelerate prevention and control of the leading killers on the planet – noncommunicable diseases (NCDs) like heart and lung disease, cancers, and diabetes.

The WHO Independent Global High-level Commission on NCDs is co-chaired by President Tabaré Vázquez of Uruguay; President Maithripala Sirisena of Sri Lanka; President Sauli Niinistö of Finland; Veronika Skvortsova, Minister of Healthcare of the Russian Federation; and Sania Nishtar, former Federal Minister of Pakistan.

Seven in 10 deaths globally every year are from NCDs, the main contributors to which are tobacco use, harmful use of alcohol, unhealthy diets, and physical inactivity. More than 15 million people between the ages of 30 and 70 years die from NCDs annually. Low- and lower-middle income countries are increasingly affected, with half of premature deaths from NCDs occurring in those countries. Many lives can be saved from NCDs through early diagnosis and improved access to quality and affordable treatment, as well as a whole-of-government approach to reduce the main risk factors.

“NCDs are the world’s leading avoidable killers but the world is not doing enough to prevent and control them,” says Dr Vázquez. “We have to ask ourselves if we want to condemn future generations from dying too young, and living lives of ill health and lost opportunity. The answer clearly is ‘no.’ But there is so much we can do to safeguard and care for people, from protecting everyone from tobacco, harmful use of alcohol, and unhealthy foods and sugary drinks, to giving people the health services they need to stop NCDs in their tracks.”

Mr Michael R. Bloomberg, WHO Global Ambassador for Noncommunicable Diseases and Commission member, said: “For the first time in history, more people are dying of noncommunicable diseases, such as heart disease and diabetes, than infectious diseases. This loss of human life spares no one — rich or poor, young or old – and it imposes heavy economic costs on nations. The more public support we can build for government policies that are proven to save lives – as this Commission will work to do – the more progress we’ll be able to make around the world.”

The new Commission was established by WHO Director-General Dr Tedros Adhanom Ghebreyesus and runs until October 2019. It will provide actionable recommendations to contribute to the Third United Nations General Assembly High-level Meeting on NCDs scheduled for the second half of 2018. This will include the submission of its first report to Dr Tedros in early June.

“Everybody deserves the right to a healthy life,” says Dr Tedros. “We can beat the drivers of the NCD epidemic, which are among the world’s main obstacles to health. I am looking to the Commission to show us new ways to unblock the barriers to good health, and identify innovative, bold and practical actions steps to scale up prevention and treatment of NCDs and provide health for all.”

Co-chair Dr Nishtar says the Commission’s establishment has come at an opportune time, as the world prepares for the UN High-level Meeting on NCDs. “This year, governments will be held to account on progress they have made in protecting their citizens from NCDs,” says Dr Nishtar. “While there have been improvements in some countries and regions, the overall rate of progress has been unacceptably slow. This is resulting in too many people suffering and dying needlessly from NCDs, and leaving families, communities and governments to bear the human and economic costs.”

The World Health Assembly has endorsed the set of WHO “best buys” and other cost-effective interventions proven to prevent or delay most premature NCD deaths. Such measures, which can be readily scaled up in countries, target prevention and treatment of, and raising awareness about, NCDs.

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BBC: In the Wake of Wakefield
Archive on 4 :: 58 minutes
Twenty years ago, in February 1998, one of the most serious public health scandals of the 20th century was born, when researcher, Andrew Wakefield and his co-authors published a paper in the medical journal The Lancet suggesting a link between the MMR vaccine and autism. As we know, in the years that followed, Wakefield’s paper was completely discredited as “an elaborate fraud” and retracted. Attempts by many other researchers to replicate his “findings” have all failed and investigations unearthed commercial links and conflicts of interests underpinning his original work. Wakefield himself was struck off the medical register.
And yet, the ripples of that episode are still being felt today all over the world as a resurgent anti-vaccine movement continues to drive down inoculation rates, particularly in developed Western societies, where measles rates have rocketed particularly in Europe and the United States.
But the Wakefield scandal hasn’t just fostered the current ant-vax movement but has played a key role in helping to undermine trust in a host of scientific disciplines from public health research to climate science and GM technology.
Through the archive, science journalist Adam Rutherford explores the continuing legacy of the anti-vaccine movement on the anniversary of one of its most notorious episodes, and explore its impact on health, on research and on culture both at home and abroad.
http://www.bbc.co.uk/programmes/b09rwgcg
 
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Editor’s Note:
We include the following news report but note that we could not identify original announcements by Sanofi, Shanta or WHO as referenced. See OCV articles in PLoS Medicine  and PLoS Neglected Tropical Diseases in Journal Watch below.
 
WHO approves cholera vaccine for use at temperatures high as 40 degrees Celsius for up to 14 days
The Indian Express/EP News Bureau | 26 February 2018
Sanofi Pasteur announced that its affiliate Shantha Biotechnics has received approval from the World Health Organisation (WHO) for Shanchol, its oral cholera vaccine. The vaccine may be kept for single period of time of up to 14 days at temperature of up to 40°C immediately prior to administration, provided the vaccine has not reached its expiry date and vaccine vial monitor has not reached discard point. The approval is of great significance to regions where the vaccine is used, including India, as it eliminates the challenges of maintaining the vaccine cold chain (between +2°C and +8°C to maintain vaccine potency) during transport.

Commenting on this development, Dr Mahesh Bhalgat, Executive Director and Chief Operating Officer, Shantha Biotechnics, said, “This is a significant milestone in our efforts towards effective cholera prevention and control. The WHO’s approval will help us make Shanchol available to populations living in remote, hard-to-reach areas of India and other parts of the world, especially ones with erratic electricity supply.”

The WHO approval for use of Shanchol in controlled temperature chain (CTC) was granted after a review of its stability data. Used for prevention and control of cholera in outbreak, endemic settings during humanitarian crises, Shantha Biotechnics’ Shanchol cholera vaccine is the second “mass campaign” vaccine and first cholera vaccine worldwide to receive such a stamp of approval for storage and distribution outside the traditional cold chain.

“Cholera is an easily preventable disease that has no place in the 21st Century,” said Anuradha Gupta, Deputy CEO of Gavi, the Vaccine Alliance. “This important development will make it easier to deliver vaccines to the remote areas where it is desperately needed, saving lives and contributing to the global effort to finally consign this disease to the history books.”

Responding to the WHO’s approval, N Rajaram, Managing Director, Sanofi India, said, “The storage label change takes us a few steps closer to our vision of a world where no lives are lost to preventable infectious diseases, as it has the potential to significantly change cholera control efforts for the better, not only in India but also in other parts of the world where the vaccine is needed the most. It is indeed a great news as it will help increase vaccine access and decrease the cost of conducting vaccination campaigns worldwide.”

Emergencies

Emergencies

 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 28 February 2018 [GPEI]
:: 23 February marked 64 years since the first large-scale trial of inactivated polio vaccine (IPV). Developed by Joseph Salk, IPV was found to be safe and effective, and is now part of routine vaccination programmes worldwide. Each year, it confers lifelong protection against polio to millions of young children.
:: Learn more about IPV by watching our brand new animation on the two polio vaccines, available in English, French, and Arabic.
::  Summary of newly-reported viruses this week:
Afghanistan: Three new wild poliovirus type 1 (WPV1) positive environmental samples have been reported in Nangarhar province.
Pakistan: Four new WPV1 positive environmental samples have been reported, two collected in Sindh province, one in Khyber Pakhtunkhwa province, and one in Balochistan province.

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Syria cVDPV2 outbreak situation report 36, 27 February 2018
Situation update 27 February 2018
[Editor’ text bolding]
:: No new cases of cVDPV2 were reported this week. The total number of cVDPV2 cases remains 74. The most recent case (by date of onset of paralysis) is 21 September 2017 from Boukamal district, Deir Ez-Zor governorate.
:: An inactivated polio vaccine (IPV) immunization round continues in accessible areas of Aleppo utilizing mobile and fixed teams. To date the round has reached a total of 233,518 children aged 2-23 months, representing 71% of the estimated target, in Damascus, Hasakah, parts of Aleppo governorates, and Jurmana district of rural Damascus.
:: All empty vials of monovalent Oral Polio Vaccine type 2 (mOPV2) have been collected and destroyed in Damascus.
:: Preparations are ongoing for a nationwide immunization round utilizing bivalent OPV (bOPV), which is planned for March. The campaign will target all children aged less than 5 years.
:: An independent external surveillance review has concluded in Iraq. The Ministry of Health Iraq has accepted a key recommendation to revitalize the AFP surveillance system in conflict affected northern governorates bordering Syria.
:: The Global Certification Commission for Polio Eradication in its 17th meeting in Geneva acknowledged the dedication of frontline health workers and their efforts to help control the cVDPV2 outbreak in Syria, noting innovative operational strategies used to overcome challenges in the field to reach all children and to ensure adequate specimen transportation.

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WHO Grade 3 Emergencies  [to 3 March 2018]
The Syrian Arab Republic
:: Syria cVDPV2 outbreak situation report 36, 27 February 2018
[See Polio above for detail]

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WHO Grade 2 Emergencies  [to 3 March 2018]
Bangladesh/Myanmar: Rakhine Conflict 2017
:: 28 February 2018 Rohingya crisis: KS Relief gives US$2 million to strengthen Sadar District Hospital in Cox’s Bazar
SEAR/PR/1681
Cox’s Bazar, Bangladesh,: The King Salman Humanitarian Aid and Relief Centre announced a US$2 million grant to the World Health Organization for upgrading the Sadar District Hospital in Cox’s Bazar, Bangladesh, to enhance health care services for Rohingyas and their host communities.
WHO leads and coordinates the efforts of over 100 partners managing more than 270 health facilities, while also providing medicines and medical equipment, diagnostics, guidelines and trainings and building laboratory capacity. The existing facilities in and around Cox’s Bazar have reported a 150-200% increase in patients, overwhelming current capacity and resources.

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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. 
Syrian Arab Republic
:: 2 Mar 2018  Geneva Palais Briefing: Children in Syria

Yemen 
:: 30 Jan 2018  Statement by the Humanitarian Coordinator for Yemen Ad Interim, Stephen Anderson, on the Situation in Aden [EN/AR]
:: 27 Feb 2018  Yemen Humanitarian Update Covering 19 – 25 February 2018 [EN/AR]

 
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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 
:: 27 Feb 2018  Ethiopia Humanitarian Bulletin Issue 47 | 12 – 25 February 2018

Nigeria 
:: UN Humanitarian Coordinator in Nigeria Condemns Killing of Three Aid workers in North-east
Abuja, 2 March 2018 – The Humanitarian Coordinator in Nigeria, Edward Kallon, has condemned the killing of three aid workers in Rann town in Borno State, north-east Nigeria last night following an attack by a Non-State Armed Group on the military facilities next to the town. Three aid workers were also injured in the attack, and a female nurse is missing, feared abducted.
“Aid workers put their lives on the line every single day to provide emergency assistance to vulnerable women, children and men,” said Mr Kallon. “Our deepest condolences go to the families of the victims and our brave colleagues and we call on authorities to ensure the perpetrators are brought to justice and account.”..

WHO & Regional Offices [to 3 March 2018]

WHO & Regional Offices [to 3 March 2018]

Highlights

Eradicating dracunculiasis: WHO certifies Kenya as South Sudan and Mali continue to report zero human cases
March 2018 – WHO has certified Kenya free of dracunculiasis transmission following the recommendation of the International Commission for the Certification of Dracunculiasis Eradication (ICCDE). During its 12th meeting held at WHO headquarters in Geneva, Switzerland the ICCDE reviewed the report of an International Certification Team that visited Kenya in October 2017 to assess the country’s claim of having eliminated the disease.

Nigeria battles its largest Lassa fever outbreak on record
February 2018 – Nigeria’s Lassa fever outbreak has reached record highs with 317 laboratory confirmed cases, according to figures released by the Nigeria Centre for Disease Control (NCDC) this week.

Statement for Rare Disease Day
February 2018 – The vision of the Sustainable Development Goals is a world in which no one is left behind, including people who suffer from rare diseases. Just because a disease affects a small number of people does not make it irrelevant or less important than diseases that affect millions.

Innovative approach sheds light on prevalence of STIs and bacterial vaginosis among women in sub-Saharan Africa
February 2018 – Sexually transmitted infections (STIs) and bacterial vaginosis (BV), a common infection of the vagina, are widespread globally. These conditions have important health consequences, including genital symptoms, pregnancy complications, infertility, enhanced HIV transmission, and psychosocial effects.

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Weekly Epidemiological Record, 2 March 2018, vol. 93, 09 (pp. 97–104)
:: Progress towards poliomyelitis eradication: Nigeria, January– December 2017
 
 
Calls for consultants / proposals
Request for proposals: Evaluation of the Strategic Advisory Group of Experts (SAGE) on Immunization pdf, 454kb  Deadline for application: 15 March 2018
 
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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: WHO supports Government of Uganda to respond to the Cholera Outbreak among Refugees
28 February 2018
:: WHO supports response to the suspected meningitis outbreak in Torit County, South Sudan
28 February 2018
:: Nigeria battles its largest Lassa fever outbreak on record  28 February 2018
:: WHO recognizes national efforts towards Malaria elimination  26 February 2018

WHO Region of the Americas PAHO
:: Latin America and the Caribbean have the second highest adolescent pregnancy rates in the world (02/28/2018)
 
WHO European Region EURO
:: Recommendations for the composition of next season’s influenza vaccine released 02-03-2018
:: Denmark campaign rebuilds confidence in HPV vaccination 02-03-2018

WHO Eastern Mediterranean Region EMRO
:: Nursing Now campaign: empowering nurses to improve global health  27 February 2018

WHO Western Pacific Region
:: WHO issues recommendations to tackle health impacts of air pollution in Mongolia 28 February 2018
:: Working together to protect health after Cyclone Gita  26 February 2018

 

CDC/ACIP [to 3 March 2018]

CDC/ACIP [to 3 March 2018]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

 
MMWR News Synopsis for MARCH 1, 2018
https://www.cdc.gov/mmwr/index2018.html
:: Rabies Vaccine Hesitancy and Deaths Among Pregnant and Breastfeeding Women — Vietnam, 2015–2016
As more countries expand access to rabies postexposure prophylaxis (PEP) in an effort to reach zero canine-associated human rabies deaths by 2030, special attention should focus on improving community and village health workers’ education about safety and effectiveness of rabies PEP, particularly among pregnant and breastfeeding women. Despite the availability of the life-saving PEP in Vietnam, six women — four pregnant and two breastfeeding — died of rabies during 2015-2016. Human rabies deaths are preventable through prompt administration of PEP after exposure to rabid animals. Rabies PEP consists of rabies immune globulin and a series of rabies vaccines and is safe for use among pregnant and breastfeeding women. None of the women sought PEP after being bitten by dogs. As reported by their families, the primary barrier to their receiving PEP was fear of risk to the fetus or child, highlighting the importance of education about PEP being safe and critical to preventing death following a rabies exposure.

Progress Toward Poliomyelitis Eradication — Nigeria, January–December 2017
While no wild poliovirus (WPV) cases have been reported in Nigeria since 2016, eradication activities in the northern part of the country continue to be constrained by insecurity and geography. Despite these difficulties, efforts continue to provide vaccination and surveillance to children in hard-to-reach regions. In August and September 2016, after more than two years without any reported cases of wild poliovirus (WPV), Nigeria detected four WPV cases associated with insurgency-held areas in Borno state. Since September 2016 there have been no new reported cases of WPV in Nigeria. However, polio eradication efforts, including surveillance and vaccination, have not reached many northern communities affected by the insurgency. The Nigerian government and its partners continue efforts to reach children living in inaccessible regions, but an estimated 30 percent of settlements in Borno State, with an estimated 160,000 to 210,000 children under the age of five, remain beyond reach. Commitment to strengthening vaccination coverage and surveillance in insurgent-controlled regions is needed to ensure polio eradication in Nigeria and protect every last child.

::::::
 
ECDC – European Centre for Disease Prevention and Control  [to 3 March 2018]
https://ecdc.europa.eu/en/home
3 March 2018
Communicable Disease Threats Report, 3 March 2018
– EN – [PDF-3.04 MB]

Announcements

Announcements

EDCTP    [to 3 March 2018]
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
28 February 2018
Investments in health research for better health: current benefits and future potential of engagement with EDCTP in the East Africa Community
The East Africa Community (EAC) convened its 19th Summit of EAC Heads of State and Joint Retreat on Infrastructure and Health Financing and Development on 21-23 February 2018 in Kampala Uganda. The Retreat on 22 February was preceded by the first Round Table on ‘investing in health infrastructure, systems, services and research for the accelerated attainment of universal health coverage and sustainable development goals’ on 21 February. The Round table programme contributed to the discussions at the Joint EAC Heads of State Retreat the next day. EAC presented its Priority Framework 2018-2028 for investment in the health sector.

European Medicines Agency  [to 3 March 2018]
http://www.ema.europa.eu/ema/
02/03/2018
EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of inflammatory brain disorders
Medicine to be voluntarily withdrawn from the market by the company …

26/02/2018
Towards more ethical use of animals in medicine testing
First report on EMA’s actions to replace, reduce, refine use of animals in medical research …
 
 
 
FDA [to 3 March 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
February 26, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
 
 
Fondation Merieux  [to 3 March 2018]
http://www.fondation-merieux.org/
March 2, 2018
The National Laboratories Directorate and the Continuing Training Center for laboratory technicians are being inaugurated on Friday 2, March, in Guinea. They are part of RESAOLAB (West African Network of Biomedical Analysis Laboratories) and are housed in the Institute for the Professional Development of Healthcare Providers in Conakry.
 
February 28, 2018
The WASH working group of the Global Task Force on Cholera Control (GTFCC) meets on February 27 and 28 to discuss the challenges of improving water, sanitation and hygiene in countries where cholera is endemic. The meeting will be an opportunity to present an update on the GTFCC and the Ending Cholera Roadmap, which aims to reduce deaths from cholera by 90% by 2030.
 
 
Gavi [to 3 March 2018]
http://www.gavi.org/library/news/press-releases/
02 March 2018
Call for new ID technology to help immunise every child
Apply before 10 April to grow your innovation with INFUSE.
Geneva, 2 March 2018 – Gavi, the Vaccine Alliance is calling for talented problem solvers, entrepreneurs and established corporations to help immunise the world’s most vulnerable children. As part of its 2018 call, INFUSE (or, Innovation for Uptake, Scale and Equity in immunisation) – Gavi’s innovation acceleration platform – is looking for new proven digital technology for registration and verification of identity to accelerate and improve immunisation coverage and delivery.

While more children than ever before are protected with life-saving vaccines, an estimated 1.5 million children still die annually from vaccine preventable diseases. To ensure that all children have access to immunisation we will require better insight into which children are missing out. A common challenge in many developing countries is that an increasing number of people live in communities not well served or under the radar, invisible to often outdated, paper-based methods used to certify births, deaths and marriages.

“One in three children under age five does not officially exist because their birth wasn’t registered. This can have a lasting impact on children’s lives, leaving them vulnerable to neglect and abuse. But most importantly, we cannot vaccinate the children who we do not know exist”, said Gavi CEO Dr Seth Berkley.

“We need affordable, secure digital identification systems that can store a child’s medical history, and that can be accessed even in places without reliable electricity”, he added.

Do you have a proven solution which addresses this issue and is ready to scale-up at a national, regional or global level? Then we need you to be part of INFUSE 2018 and help us protect the world’s most vulnerable children.
 
 
IVI   [to 3 March 2018]
http://www.ivi.int/
[Undated]
Sida provides increased unrestricted funding of US$620,000 in 2018
IVI is pleased to announce that Sida**, the Swedish International Development Agency, is providing a further unrestricted contribution of SEK5 million (US$620,000) that the Institute will use to support three special high-priority projects in 2018.
These three new projects will include IVI laboratory assays to support a post-licensure study of the safety and effectiveness of Dengvaxia®* in dengue primed and non-primed children in Cebu, Philippines, ‘Modeling of the impact and cost-effectiveness of WHO’s “Ending Cholera – A Global Roadmap to 2030” strategy’ and ‘Conduct of a global economic burden assessment on antimicrobial resistance to typhoid fever treatments.’
*Dengvaxia®, manufactured by Sanofi Pasteur, is the only licensed dengue vaccine and to-date has been introduced in subnational public health programs in two countries; the Philippines and Brazil. Despite its overall positive public health impact in highly endemic settings, concerns have arisen about disease enhancement in dengue naïve vaccine recipients. The IVI project in Cebu will test blood samples collected prior to Dengvaxia® implementation to assess the effect of dengue primed status on vaccine safety. The results could make a significant contribution to our understanding of dengue, dengue hemorrhagic fever and potential interactions with dengue vaccines.
The second study on modeling and economic evaluation of cholera is expected to provide evidence on the value of investments and inform strategic decisions on cholera elimination and development of new vaccines. With antimicrobial resistance (AMR) being one of the biggest threats to global health, the third project will seek to estimate the economic implications of AMR on typhoid fever. These two projects will be led by IVI’s Policy and Economic Research (PER) Department.
**Sida is a long-term funder of IVI and is providing the Institute with support of SEK 35.5 million over the 5 years to 2019 in addition to this supplemental funding.
 
 
JEE Alliance  [to 3 March 2018]
https://www.jeealliance.org/
24.1.2018
Alliance successes in 2017 and an update on 2018
The year 2017 was the first full year of the work of the JEE Alliance. During the year, 15 new members joined the Alliance, contributing the wealth of expertise and experience. There are now 68…
 
 
MSF/Médecins Sans Frontières  [to 3 March 2018]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Nigeria: MSF Suspends Medical Activities in Rann Following Attack
GENEVA/NEW YORK, MARCH 2, 2018—Following a violent attack yesterday near Rann, in Nigeria’s Borno state, Doctors Without Borders/Médecins Sans Frontières (MSF) suspended its medical activities in the town and evacuated 22 Nigerian and international staff.
It is still unclear how many people were killed and injured in the attack, but before leaving, MSF medical staff treated nine wounded patients.

 
NIH  [to 3 March 2018]
http://www.nih.gov/news-events/news-releases
February 28, 2018
NIAID unveils strategic plan for developing a universal influenza vaccine
February 28, 2018 — Developing a vaccine that can provide durable protection for all age groups against multiple influenza strains is a priority.
[Please see Milestones above for full text]

NIH researchers find a potential treatment for disorders involving excess red blood cells
February 26, 2018 — Study in mice suggests that experimental drug may be effective against mountain sickness and other polycythemias.
 

UNAIDS [to 3 March 2018]
http://www.unaids.org/en
27 February 2018
Five-point plan to prevent and address all forms of harassment for greater accountability and transparency within UNAIDS

27 February 2018
A call for an HIV catch-up plan for the First Nations in Canada

26 February 2018
Partnership connects African law schools to the AIDS response

UNICEF  [to 3 March 2018]
https://www.unicef.org/media/
1 March 2018
Nearly 19 million newborns at risk of brain damage every year due to iodine deficiency
NEW YORK, 1 March 2018 – Nearly 19 million babies born globally every year – 14 per cent – are at risk of permanent yet preventable brain damage and reduced cognitive function due to a lack of iodine in the earliest years of life, according to a new joint report by UNICEF and GAIN released today. More than 1 in 4 of these children – 4.3 million – lives in South Asia.

Vaccine Confidence Project  [to 3 March 2018]
http://www.vaccineconfidence.org/
Confidence Commentary
To wipe out measles, governments must regain social trust
Heidi Larson | 28 Feb, 2018
[See Report, Research, Commentary below for full text]

Wellcome Trust  [to 3 March 2018]
https://wellcome.ac.uk/news
News / Published: 28 February 2018
Public Engagement Fund to relaunch with tighter focus on outcomes
Wellcome’s Public Engagement Fund is reopening on 5 March after being closed briefly. We’ve changed elements of how we’re going to run the scheme and what we’re looking for. In particular, we want applicants to be clearer about the change they are going to make in the world.
This reflects a strategic shift by Wellcome’s Public Engagement team towards involving the public in ways that will best support our mission of improving health.

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

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders
Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org
 
 
Vaccine Confidence Project  [to 3 March 2018]
http://www.vaccineconfidence.org/
Confidence Commentary
To wipe out measles, governments must regain social trust
Heidi Larson | 28 Feb, 2018
To wipe out measles, governments must regain social trust
Published in the Financial Times</em  
Europe’s measles outbreaks have made headlines in recent weeks, with more than 21,000 cases, hundreds of hospitalisations and 35 deaths reported in 2017. The World Health Organization called the numbers “a tragedy we simply cannot accept”.While some of these patients were too young to be vaccinated, or had other health concerns that made vaccination inadvisable, the majority of cases are of people who shunned immunisation. Among those, some cited safety fears and others ideological reasons, or simply their distrust in “the system”.

This week marks 20 years since Andrew Wakefield published his faulty research linking the measles, mumps, and rubella, or MMR, vaccine to autism, sparking a public panic. Most people who still cling to the debunked myth have never read Mr Wakefield’s article, but the dangerous rumours it sparked have nevertheless gone global.  The UK’s immunisation coverage rates have only recently recovered to their pre-autism-scare levels. The rest of the world remains sceptical.
Internationally, more people are refusing the vaccine. In south India last year, Facebook and WhatsApp campaigns against the measles vaccine cited the autism connection, prompting a drop in vaccine acceptance. In Malaysia, the ministry of health has worked to overcome public anxiety as vaccine refusal rises.

But the measles outbreaks in Europe cannot be blamed on the autism rumour alone. Reluctance and refusal to vaccinate reflects deeper issues around public trust in government, anger about vaccine mandates and resistance to medical treatments that are perceived as “not natural”. Spurious claims spread quickly via social media.

Last week, Italians marched in Rome to protest against fascism, neo-racism, labour reforms and mandatory vaccines. In the Philippines, the measles vaccine suffered collateral damage from public distrust around the dengue fever vaccine Dengvaxia. After its manufacturer, Sanofi Pasteur, reported findings that Dengvaxia provides valuable protection for some, but higher risks for others, fears spiralled into a general distrust of the country’s immunisation programme. Some parents refused measles vaccinations for their children and outbreaks of the disease increased.

In Brazil in 2016, when links between the Zika virus and microcephaly were being investigated, rumours began to swirl that the MMR vaccine was the cause of the birth defect, reflecting entrenched distrust in the state. Governments are at the heart of every element of vaccination policy, from regulation of safety controls to approving immunisation schedules. So gaining public trust will not only be key to the sustainability of routine immunisation programmes, but especially critical in the face of epidemic threats.

This year marks the 100th anniversary of the 1918 Spanish flu pandemic that infected 500m people, causing debilitating illness and killing between 40m and 50m. The threat is still present: the World Bank estimates that, in addition to millions of deaths, devastating illness and social disruption, the annual global cost of moderately severe to severe pandemics is roughly $570bn, or 0.7 per cent of global income. In 2009, during the swine flu pandemic of the H1N1 influenza virus, poor public co-operation and low acceptance of the vaccine was a wake-up call. The public might fall for faulty science, but the more worrying trend in 2009 was the lack of civic responsibility and co-operation.

Governments should see in this an urgent need for a new social contract. The long cherished dream of eliminating measles is not an impossible task. Every country that achieved the goal would also demonstrate the strength of its citizens’ trust — a measure of its ability to manage future threats.

::::::

Stakeholders meeting on maternal interventions vigilance: safety monitoring and surveillance in vaccine and other research settings
Domaine de Penthes
Geneva, Switzerland
20-21 November 2017
World Health Organization – 2018 :: 45 pages  WHO/EMP/2018.1
Background
There is increasing evidence that maternal immunization has the potential to improve health outcomes for both mothers and their babies. As a number of promising vaccines are in the process of development, there is need to ensure that mechanisms are in place for appropriate safety monitoring. The Stakeholders Meeting on Maternal Interventions Vigilance was organized by the World Health Organization (WHO) to assess current vigilance methods for maternal immunization and other interventions in pregnancy and to propose a roadmap for harmonization of vigilance across programmes.

In background information for the meeting, WHO noted that safety monitoring of vaccines administered during pregnancy will require “enhanced vigilance mechanisms and standardized case definitions of key events in pregnant women and newborns”. However, there are numerous medical interventions during pregnancy and early childhood, requiring that immunization and safety monitoring of vaccines should be harmonized with a range of methods by a range of stakeholders.

The Stakeholders Meeting on Maternal Interventions Vigilance was convened as a result of collaboration between four technical departments of WHO (Immunization, Vaccines and Biologicals; Essential Medicines and Health Products; Reproductive Health and Research; and Maternal, Newborn, Child and Adolescent Health). Those core organizers were also guided by advice from a further six WHO departments, covering all health issues relating to pregnancy and newborn health.1

Specifically, the meeting set out to:
:: review current methods or methodologies to monitor outcomes of maternal immunization and other interventions, with a particular focus on pharmacovigilance;
:: assess these vigilance methodologies and identify where harmonization is needed;
:: assess their global applicability for maternal immunization and other interventions;
:: propose coordination mechanisms and a roadmap to support their harmonization across programmes and partners working on improving pregnancy and early childhood health outcomes.

Journal Watch

Journal Watch

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

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Determining training and education needs pertaining to highly infectious disease preparedness and response: A gap analysis survey of US emergency medical services practitioners

American Journal of Infection Control
March 2018 Volume 46, Issue 3, p245-362, e13-e24
http://www.ajicjournal.org/current

Major Articles
Determining training and education needs pertaining to highly infectious disease preparedness and response: A gap analysis survey of US emergency medical services practitioners
Aurora B. Le, Sean A. Buehler, Paul M. Maniscalco, Pamela Lane, Lloyd E. Rupp, Eric Ernest, Debra Von Seggern, Katherine West, Jocelyn J. Herstein, Katelyn C. Jelden, Elizabeth L. Beam, Shawn G. Gibbs, John J. Lowe
p246–252
Published in issue: March 2018

Higher pharmaceutical public expenditure after direct price control: improved access or induced demand? The Colombian case

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 3 March 2018)

Research
2 March 2018
Higher pharmaceutical public expenditure after direct price control: improved access or induced demand? The Colombian case
Authors: Sergio I. Prada, Victoria E. Soto, Tatiana S. Andia, Claudia P. Vaca, Álvaro A. Morales, Sergio R. Márquez and Alejandro Gaviria

Screening for infectious diseases of asylum seekers upon arrival: the necessity of the moral principle of reciprocity

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 3 March 2018)

Debate
Screening for infectious diseases of asylum seekers upon arrival: the necessity of the moral principle of reciprocity
With a large number of forcibly displaced people seeking safety, the EU is facing a challenge in maintaining solidarity. Europe has seen millions of asylum seekers crossing European borders, the largest number…
Authors: Dorien T. Beeres, Darren Cornish, Machiel Vonk, Sofanne J. Ravensbergen, Els L. M. Maeckelberghe, Pieter Boele Van Hensbroek and Ymkje Stienstra
Citation: BMC Medical Ethics 2018 19:16
Published on: 2 March 2018

Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation

BMC Medical Ethics

(Accessed 3 March 2018)

Research article
Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation
Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regu…
Authors: Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn and Monica Taljaard
Citation: BMC Medical Ethics 2018 19:14
Published on: 27 February 2018
 

Determinants of immunization status among 12- to 23-month-old children in Indonesia (2008–2013): a multilevel analysis

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 3 March 2018)

Research article
Determinants of immunization status among 12- to 23-month-old children in Indonesia (2008–2013): a multilevel analysis
Immunization is one of the most cost-effective public health interventions to prevent children from contracting vaccine-preventable diseases. Indonesia launched the Expanded Program for Immunization (EPI) in 1…
Authors: Holipah, Asri Maharani and Yoshiki Kuroda
Citation: BMC Public Health 2018 18:288
Published on: 27 February 2018

Research priorities during infectious disease emergencies in West Africa

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 3 March 2018)

Research note
Research priorities during infectious disease emergencies in West Africa
This paper presents the results of the consultations conducted with various stakeholders in Africa and other experts to document community perspectives on the types of research to be prioritised in outbreak co…
Authors: Morenike Oluwatoyin Folayan, Bridget Haire, Dan Allman, Aminu Yakubu and Muhammed O. Afolabi
Citation: BMC Research Notes 2018 11:159
Published on: 1 March 2018

Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: a mixed-methods study protocol

BMJ Open
March 2018 – Volume 8 – 3
http://bmjopen.bmj.com/content/current

Infectious diseases
Protocol
Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: a mixed-methods study protocol
(3 March, 2018)
Suzanne Audrey, Harriet Batista Ferrer, Joanne Ferrie, Karen Evans, Michael Bell, Julie Yates, Marion Roderick, John MacLeod, Matthew Hickman
Abstract
Introduction
The human papillomavirus (HPV) vaccine, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, lack of written parental consent is a key reason why some young women do not receive the vaccine. The national legal framework allows girls to be vaccinated without parental consent provided they are deemed Gillick competent, but there is some reticence about vaccinating without written parental consent. Self-consent procedures are being implemented in Bristol and South Gloucestershire. This study will examine the implementation, acceptability and impact of these new procedures.
Methods and analysis
Statistical analyses of routine data from Public Health England and the Child Health Information System will test if there has been an increase in HPV vaccination uptake in two ways: (a) Is there an increase when comparing before and after the change in our intervention sites? and (b) Does the percentage change in our intervention sites differ from comparison sites (similar to our intervention sites in terms of initial HPV uptake, ethnicity and deprivation levels) in England where no such intervention took place and how? For the process evaluation, we will develop a logic model and use questionnaires, observations and audio-recorded interviews with young women, school nurses, school staff and parents to examine the context, implementation of self-consent and response to the new procedures.
Ethics and dissemination
The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service Health Research Authority provided approvals for the study. We will produce a report with recommendations about self-consent procedures in conjunction with key stakeholders. At least two papers will be written for publication in peer-reviewed journals and for conference presentations. A summary of results will be shared with participating immunisation nurses, school staff, young people and parents as requested.
Trial registration number ISRCTN49086105;

Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016

Bulletin of the World Health Organization
Volume 96, Number 3, March 2018, 145-224
http://www.who.int/bulletin/volumes/96/3/en/

Policy & Practice
Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016
Ellen FM ‘t Hoen, Jacquelyn Veraldi, Brigit Toebes & Hans V Hogerzeil
Abstract
Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.

Thresholds for decision-making: informing the cost-effectiveness and affordability of rotavirus vaccines in Malaysia

Health Policy and Planning
Volume 33, Issue 2, 1 March 2018
http://heapol.oxfordjournals.org/content/current

Articles
Thresholds for decision-making: informing the cost-effectiveness and affordability of rotavirus vaccines in Malaysia
Tharani Loganathan; Chiu-Wan Ng; Way-Seah Lee; Raymond C W Hutubessy; Stéphane Verguet
Health Policy and Planning, Volume 33, Issue 2, 1 March 2018, Pages 204–214, https://doi.org/10.1093/heapol/czx166

How do external donors influence national health policy processes? Experiences of domestic policy actors in Cambodia and Pakistan

Health Policy and Planning
Volume 33, Issue 2, 1 March 2018
http://heapol.oxfordjournals.org/content/current

How do external donors influence national health policy processes? Experiences of domestic policy actors in Cambodia and Pakistan
Mishal S Khan; Ankita Meghani; Marco Liverani; Imara Roychowdhury; Justin Parkhurst
Health Policy and Planning, Volume 33, Issue 2, 1 March 2018, Pages 215–223, https://doi.org/10.1093/heapol/czx145

Social costs of illicit financial flows in low- and middle-income countries: the case of infant vaccination coverage

Health Policy and Planning
Volume 33, Issue 2, 1 March 2018
http://heapol.oxfordjournals.org/content/current

Social costs of illicit financial flows in low- and middle-income countries: the case of infant vaccination coverage
Bienvenido Ortega; Jesús Sanjuán; Antonio Casquero
Health Policy and Planning, Volume 33, Issue 2, 1 March 2018, Pages 224–236, https://doi.org/10.1093/heapol/czx170
Abstract
The liberalization of capital flows is generally associated with prospects of higher growth. However, in developing countries, opening the capital account may also facilitate the flow of capital out of the country through illicit financial flows (IFFs). Given that IFFs drain the scarce public resources available to finance the provision of public goods and services, the extent of illicit capital flows from developing countries is serious cause for concern. In this context, as a first step in analysing the social costs of IFFs in developing countries, this article studied the relationship between IFFs and infant immunization coverage rates. Data for 56 low- and middle-income countries for the period 2002–13 were used in the empirical analysis. The main result was that the relative level of IFFs to total trade negatively impacted vaccination coverage but only in the case of countries with very high levels of perceived corruption. In this case, the total effect of an annual 1 p.p. increase in the ratio of IFFs to total trade was to reduce the level of vaccination coverage rates over the coming years by 0.19 p.p. Given that there was an annual average of 18 million infants in this cluster of 25 countries, this result suggests that at least 34 000 children may not receive this basic health care intervention in the future as a consequence of this increase in IFFs in any particular year.

Developing a workbook to support the contextualisation of global health systems guidance: a case study identifying steps and critical factors for success in this process at WHO

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 3 March 2018]

Research
2 March 2018
Developing a workbook to support the contextualisation of global health systems guidance: a case study identifying steps and critical factors for success in this process at WHO
Global guidance can help countries strengthen their health systems to deliver effective interventions to their populations. However, to have an impact, guidance needs to be contextualised or adapted to local settings; this process includes consideration of health system arrangements and political system factors. To date, methods to support contextualisation do not exist. In response, a workbook was designed to provide specific methods and strategies to enable the contextualisation of WHO’s ‘Optimizing health worker roles to improve maternal and newborn health’ (OptimizeMNH) guidance at the national or subnational level. The objective of this study was to describe the process of developing the workbook and identify key steps of the development process, barriers that arose and facilitators that helped overcome some of these barriers.
Authors: Elizabeth Alvarez, John N. Lavis, Melissa Brouwers and Lisa Schwartz

International Medical Graduates—A Critical Component of the Global Health Workforce

JAMA
February 27, 2018, Vol 319, No. 8, Pages 745-840
http://jama.jamanetwork.com/issue.aspx

Viewpoint
International Medical Graduates—A Critical Component of the Global Health Workforce
Joseph Nwadiuko, MD, MPH; Varshini Varadaraj, MBBS, MS, MPH; Anju Ranjit, MD, MPH
JAMA. 2018;319(8):765-766. doi:10.1001/jama.2017.17961
This Viewpoint discusses international medical graduates practicing in the United States and Canada—benefits and drawbacks to remaining in North America or returning to their country of origin to practice.

Clinical practice guidelines in India: Quality appraisal and the use of evidence in their development (pages 26–39)

Journal of Evidence-Based Medicine
February 2018   Volume 11, Issue 1  Pages 1–67
http://onlinelibrary.wiley.com/doi/10.1111/jebm.2018.11.issue-1/issuetoc

Articles
Clinical practice guidelines in India: Quality appraisal and the use of evidence in their development (pages 26–39)
Soumyadeep Bhaumik, Soushieta Jagadesh, May Ellatar, Neeraj Kohli, Muhammad Riedha and Monday Moi
Version of Record online: 11 JAN 2018 | DOI: 10.1111/jebm.12285

Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry (pages 46–50)

Journal of Evidence-Based Medicine
February 2018   Volume 11, Issue 1  Pages 1–67
http://onlinelibrary.wiley.com/doi/10.1111/jebm.2018.11.issue-1/issuetoc

Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry (pages 46–50)
Udaya K. Ranawaka, Ashwini de Abrew, Manu Wimalachandra, Nithushi Samaranayake and Colvin Goonaratna
Version of Record online: 11 JAN 2018 | DOI: 10.1111/jebm.12284

Stem cells, regenerative medicine, and Prometheus

The Lancet
Mar 03, 2018 Volume 391 Number 10123 p813-910
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Stem cells, regenerative medicine, and Prometheus
The Lancet
Published: 03 March 2018
The possibility of regeneration fascinates us as much today as it did the ancient Greeks. In the story of Prometheus, an eagle was sent to peck his liver each day as punishment, while at night it regrew. Stem cells have a similar mythical character—part fact, part fantasy—that captures the imagination but also blurs reality. In today’s issue, we publish the Lancet Commission: Stem Cells and Regenerative Medicine (published online Oct 4, 2017) to assess advances in the field, including gene therapy, since our last Series on the topic in 2013, and how to plan future developments in a way that both promotes science and protects the public.

The commissioners emphasise the importance of well funded basic science that led to the insights and techniques that have made stem cell therapies possible. However, in-vitro findings have not always been replicated in humans. To improve translation, they suggest wider collaboration with clinician-scientists. The report notes that many regenerative therapies appeal to potentially vulnerable people, which raises concerns about ethics, safety (particularly for unregulated autologous cell use), and financial structures for development and marketing. At the same time, the enormous advantage of curative gene therapy for a disease like Duchenne muscular dystrophy, which can restore independence and reduce health-care costs, is clear. To guide practice, the Commissioners propose a social contract that emphasises best science, equitable funding, strong governance, and transparent engagement with patients and the public.

Prometheus was punished by Zeus for stealing fire and giving it to humans, which enabled civilisation. In other interpretations, Prometheus is associated with scientific enquiry. Since our previous Series, the spark of regenerative medicine has become a flame that offers vast potential benefits, such as limbal stem cells licensed for corneal repair. But dangers persist that are incompletely understood, and the best way to harness stem cells and genes to alleviate true clinical need is unclear. The Commission provides a welcome mechanism to move past the smoke of hype and cultivate the flame of hope.

Lancet Commission: Stem cells and regenerative medicine

The Lancet
Mar 03, 2018 Volume 391 Number 10123 p813-910
http://www.thelancet.com/journals/lancet/issue/current

The Lancet Commissions
Lancet Commission: Stem cells and regenerative medicine
Giulio Cossu, Martin Birchall, Tracey Brown, Paolo De Coppi, Emily Culme-Seymour, Sahra Gibbon, Julian Hitchcock, Chris Mason, Jonathan Montgomery, Steve Morris, Francesco Muntoni, David Napier, Nazanin Owji, Aarathi Prasad, Jeff Round, Prince Saprai, Jack Stilgoe, Adrian Thrasher, James Wilson
Summary
In this Commission, we argue that a combination of poor quality science, unclear funding models, unrealistic hopes, and unscrupulous private clinics threatens regenerative medicine’s social licence to operate. If regenerative medicine is to shift from mostly small-scale bespoke experimental interventions into routine clinical practice, substantial rethinking of the social contract that supports such research and clinical practice in the public arena will be required.

Promising HIV vaccines could stall without coordinated research

Nature 
Volume 555 Number 7694 pp5-126  1 March 2018
http://www.nature.com/nature/current_issue.html

News in Focus
Promising HIV vaccines could stall without coordinated research
Therapies to prevent infection are advancing in a crowded field.
Amy Maxmen
Several vaccines and drugs for preventing the spread of HIV are showing signs of success in clinical trials, three decades after scientists began the search. But some researchers fear that progress will stall without a coordinated strategy to ensure that the most promising therapies to prevent infection win support from policymakers and reach the people who need them.

A meeting convened by the World Health Organization (WHO) in Geneva, Switzerland, on 28 February to 1 March aims to address a lack of long-term thinking about the factors — such as cost and ease of use — that can determine whether a vaccine or other preventive therapy succeeds in reducing disease. Some HIV researchers argue that they should study these issues now, while clinical trials of potential vaccines and drugs to block HIV infection are ongoing, to avoid delays in delivering effective therapies to people at risk of infection. Many hope that the WHO meeting will trigger broader discussions about how to support such research given limited resources, and how to prioritize therapies in development.

Waiting to conduct such studies after trials are finished prolongs the time until a preventive therapy reaches people, and in the meantime, the epidemic grows. Worldwide, about 1.8 million people contracted the disease in 2016. “You need to have a good idea about where you want to end up and all of the steps you need to make to get there,” says Mark Feinberg, president of the International AIDS Vaccine Initiative in New York City.
But it is not clear who would make decisions about which projects to prioritize, or when such choices would be made.

Some 25,000 people around the world are participating in clinical trials of treatments to prevent HIV infection. Twelve late-stage trials worldwide are testing experimental vaccines; these include a 2,600-person study in southern Africa of a vaccine designed to block multiple strains of the virus. Others are assessing the potential of proteins called broadly neutralizing antibodies, which might stop HIV from infecting a person’s immune cells. And a pair of phase III trials has enrolled 7,700 people to test whether injections of a drug called cabotegravir can prevent HIV infection for two months at a time.

Delivery concerns
At the meeting, researchers, policymakers and HIV activists will discuss stumbling blocks that have limited the use of potent vaccines and treatments against other diseases, such as high costs and cumbersome delivery requirements. Because no therapy has approached 100% protection against HIV, regulators face tough decisions when considering the cost and effort of delivering treatment to people at risk. In 2009, for example, a phase III study1 of the most promising vaccine identified so far found that it reduced a person’s risk of contracting HIV by only one-third. Health authorities did not recommend it for widespread use.

A modified version of that vaccine is now being tested in 5,400 people in South Africa, and researchers hope that it will reduce a person’s chance of contracting HIV by at least 50%. But even if the trial succeeds, the expense and difficulty of administering the vaccine, which must be given as six shots over 18 months, could make it a hard sell to policymakers and funders. Health-care workers around the world struggle to persuade healthy people to get one-time shots that are highly effective against other deadly diseases.

Similar concerns surround the antibodies in development, because they are given as intravenous infusions, and it is unclear how long treatment must continue to prevent HIV. The antibodies are also relatively expensive to make. Eventually, scientists must be prepared to choose which projects to stall, and which to supplement with studies aimed at developing cheaper, easier ways of administering a given therapy, says Mitchell Warren, executive director of AVAC, an HIV-prevention advocacy organization in New York City.

Money is limited, as is the pool of people available for clinical trials, which becomes larger and more complex as a vaccine or antibody treatment progresses towards the market. “We will need prioritization,” Warren says. “That view needs to be driven by science and financial realities, and the decision process needs to be clear and transparent.”

Another issue facing researchers is how to improve the likelihood that people at risk of HIV infection will take preventive treatments. Success is not guaranteed: Truvada, a daily pill for preventing HIV infection, has not reduced the number of new HIV cases globally since regulators approved it six years ago. In eastern and southern Africa, for instance, young women rarely take the drug, even though they account for 26% of the region’s new infections. Tian Johnson, founder of the African Alliance for HIV Prevention in Johannesburg, South Africa, says that researchers did not adequately consider how poverty, pregnancy, discrimination and abuse might affect whether young women at risk are likely to seek out Truvada. “If you disregard the complexity of a woman’s daily life and reality, you put at risk the millions of dollars you invest in developing a product,” he says.

Despite the challenges ahead, the fact that such discussions are happening is an important step forward, says Feinberg. “You can’t keep your head in the sand,” he says. “You need to work ahead and think of ways that we as a research development community can solve these problems — and they are solvable.”
[References at title link above]

Vaccination without Litigation — Addressing Religious Objections to Hospital Influenza-Vaccination Mandates

New England Journal of Medicine
March 1, 2018  Vol. 378 No. 9
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Vaccination without Litigation — Addressing Religious Objections to Hospital Influenza-Vaccination Mandates
Douglas J. Opel, M.D., M.P.H., James A. Sonne, J.D., and Michelle M. Mello, J.D., Ph.D.
[Closing text]
Influenza-vaccination mandates for health care workers represent good policy, but heavy-handed, context-free implementation does not. Hospitals that pursue an inflexible approach to minimize religious exemptions are likely to find that the juice isn’t worth the squeeze. In contrast, well-drafted and reasonably applied policies should avoid or withstand legal challenge, while also protecting patients.

Epilepsy in Children After Pandemic Influenza Vaccination

Pediatrics
March 2018, VOLUME 141 / ISSUE 3
http://pediatrics.aappublications.org/content/141/3?current-issue=y

Articles
Epilepsy in Children After Pandemic Influenza Vaccination
Siri E. Håberg, Kari M. Aaberg, Pål Surén, Lill Trogstad, Sara Ghaderi, Camilla Stoltenberg, Per Magnus, Inger Johanne Bakken
Pediatrics Mar 2018, 141 (3) e20170752; DOI: 10.1542/peds.2017-0752
Through linkage of Norwegian registries, this study investigated the risk of epilepsy in children in a period of up to 5 years after pandemic influenza vaccination.

Infant Hospitalizations and Mortality After Maternal Vaccination

Pediatrics
March 2018, VOLUME 141 / ISSUE 3
http://pediatrics.aappublications.org/content/141/3?current-issue=y

Infant Hospitalizations and Mortality After Maternal Vaccination
Lakshmi Sukumaran, Natalie L. McCarthy, Elyse O. Kharbanda, Gabriela Vazquez-Benitez, Heather S. Lipkind, Lisa Jackson, Nicola P. Klein, Allison L. Naleway, David L. McClure, Rulin C. Hechter, Alison T. Kawai, Jason M. Glanz, Eric S. Weintraub
Pediatrics Mar 2018, 141 (3) e20173310; DOI: 10.1542/peds.2017-3310
Using the VSD, we conducted a case-control study to evaluate the safety of maternal influenza and Tdap vaccination in infants 0 to 6 months old.

Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 3 March 2018)

Research Article
Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study
Thomas J. Hwang, Paolo A. Tomasi, Florence T. Bourgeois
| published 01 Mar 2018 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002520
Abstract
Background
Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless granted a waiver. We aimed to evaluate the availability of paediatric trial results from studies required under the Paediatric Regulation for new medicines authorised in the EU.
Methods and findings
The European Medicines Agency (EMA) public database of paediatric investigation plans was searched for new medicines centrally authorised in the EU between 1 January 2010 and 31 December 2014 with at least 1 required paediatric study. For our study cohort of paediatric clinical trials required for these medicines, we used internal EMA databases and publicly available trial registries to determine changes to the planned completion date or study design, rates of trial completion, time to trial completion, and results reporting (peer-reviewed publication or posting on trial registry). Cox proportional hazards regression models were constructed to examine factors associated with study completion. A total of 326 paediatric clinical trials were required for 122 novel medicines authorised by the EMA between 2010 and 2014. In all, 76% (247/326) of paediatric studies were not planned to be completed until after the initial marketing authorisation. The planned completion dates for 50% (162/326) were further postponed by a median of 2.2 years. Overall, 38% (124/326) of paediatric studies were completed as of 30 November 2017. The rate of trial completion for paediatric studies planned to be completed after initial marketing authorisation was 23% (56/247), versus 86% (68/79) for trials planned to be completed before authorisation (adjusted hazard ratio 0.11; 95% CI 0.06–0.19). Among completed studies, the results were reported in a public registry or in the peer-reviewed literature for 85% (105/124) at a median of 1.1 years after study completion, and 60% (74/124) were published in a peer-reviewed journal. Limitations of this study include the potential lack of generalisability to medicines not authorised by the EMA and the possibility for more of these trials to be completed or published in the future.
Conclusions
The completion of many paediatric studies required under the Paediatric Regulation has been delayed. Paediatric studies planned to be completed after marketing authorisation were associated with a lower likelihood of eventual completion, highlighting the need to examine the implementation of current policies in ensuring timely availability of important paediatric information.

Author summary
:: Why was this study done?
Most new medicines are developed and tested in adults, and clinicians often need to treat paediatric patients with products lacking paediatric safety, efficacy, or dosing information.
To increase the number of medicines that are appropriately studied in children, the European Union adopted the Paediatric Regulation in 2007, requiring pharmaceutical companies to study new medicines in children.
Ten years since its implementation, there has been limited assessment of the availability of paediatric trial information resulting from studies required under the regulation.
 
:: What did the researchers do and find?
For all new medicines centrally authorised in the EU between 2010 and 2014, we identified those with paediatric trial requirements under the Paediatric Regulation. A total of 326 paediatric clinical trials were required for 122 medicines and comprised our study cohort.
After a median follow-up of roughly 7 years, 38% of paediatric trials had been completed, and 17% of medicines had all paediatric requirements fulfilled.
Most paediatric studies (76%) were not planned to be completed until after marketing authorisation. In addition, delays occurred due to changes in the planned completion date, with 50% of studies extending the completion date at the request of pharmaceutical companies.
Overall, trials planned to be completed after marketing authorisation were associated with an 89% lower likelihood of completion compared to trials with planned completion before marketing authorisation.
The results for 85% of completed studies were published or publicly reported in a trial registry, at a median of 1.1 years after the completion date.
 
:: What do these findings mean?
Many paediatric studies required under the Paediatric Regulation have not been completed due to delays.
Among paediatric trials that were completed, trial results were disseminated in a timely fashion for a majority of the studies.
Our findings highlight the need to examine the implementation of current policies—including requirements around the timing of trial completion—to ensure timely availability of important paediatric information for new medicines.

Preventing cholera outbreaks through early targeted interventions

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 3 March 2018)

Perspective
Preventing cholera outbreaks through early targeted interventions
Lorenz von Seidlein, Jacqueline L. Deen
| published 27 Feb 2018 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002510
[Excerpt]
Cholera outbreaks: Hit or miss
With funding from Gavi in place and an increasing OCV supply assured, one would think that large and disastrous cholera outbreaks would have been confined to history. However, events during the past few months have demonstrated how much of a hit-or-miss affair cholera outbreak control and prevention remains. In October 2017, 900,000 doses of OCV were mobilised from the international stockpile to prevent cholera outbreaks in Rohingya camps along the border between Bangladesh and Myanmar, even before cholera cases were reported [14]. Considering the cholera endemicity in Bangladesh in combination with desperate conditions in the refugee camps, WHO and the stockpile managers are to be congratulated for their timely action and foresight.

In contrast, OCV doses did not arrive in Yemen despite a humanitarian crisis of enormous proportions (994,751 suspected cases; 2,226 deaths by December 2017) [15]. Not only did WHO fail to mount the essential mass vaccination campaigns, but the explanation for this omission was once more that oral cholera vaccinations during an ongoing outbreak are inappropriate [16], a statement that is factually incorrect. Management of the Yemen cholera outbreak has been complex, and many parties carry responsibility for the lack of successful interventions. Yet, WHO has the mandate to support decision-making in such difficult circumstances. By the time the vaccines were requested and shipment was finally approved (though never used), the outbreak had already reached its peak, highlighting the critical need for a rapid response.

The decision of which requests to the OCV stockpile should be granted (and for how many doses) falls to an International Coordinating Group (ICG) composed of representatives from United Nations Children’s Fund (UNICEF), Médecins Sans Frontières (MSF), the International Federation of Red Cross and Red Crescent Societies (IFRC), and WHO [17]. Over the years, some requests were rejected on technical grounds, while others were assigned too low a priority to ever be delivered. Ultimately, only half the requested doses (51%; 12.8 million doses) have been shipped in 46 deployments between 2013 and 2017 [10]. The criteria for these decisions and any competing interests of the coordinating group members are not transparently disclosed, and the decisions do not always appear fair; yet they have far-reaching consequences…

The potential impact of case-area targeted interventions in response to cholera outbreaks: A modeling study

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 3 March 2018)

Research Article
The potential impact of case-area targeted interventions in response to cholera outbreaks: A modeling study
Flavio Finger, Enrico Bertuzzo, Francisco J. Luquero, Nathan Naibei, Brahima Touré, Maya Allan, Klaudia Porten, Justin Lessler, Andrea Rinaldo, Andrew S. Azman
| published 27 Feb 2018 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002509
Cholera prevention and control interventions targeted to neighbors of cholera cases (case-area targeted interventions [CATIs]), including improved water, sanitation, and hygiene, oral cholera vaccine (OCV), and prophylactic antibiotics, may be able to efficiently avert cholera cases and deaths while saving scarce resources during epidemics. Efforts to quickly target interventions to neighbors of cases have been made in recent outbreaks, but little empirical evidence related to the effectiveness, efficiency, or ideal design of this approach exists. Here, we aim to provide practical guidance on how CATIs might be used by exploring key determinants of intervention impact, including the mix of interventions, “ring” size, and timing, in simulated cholera epidemics fit to data from an urban cholera epidemic in Africa.

Prolonging herd immunity to cholera via vaccination: Accounting for human mobility and waning vaccine effects

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 3 March 2018)

Research Article
Prolonging herd immunity to cholera via vaccination: Accounting for human mobility and waning vaccine effects
Corey M. Peak, Amanda L. Reilly, Andrew S. Azman, Caroline O. Buckee
| published 28 Feb 2018 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006257
Abstract
Background
Oral cholera vaccination is an approach to preventing outbreaks in at-risk settings and controlling cholera in endemic settings. However, vaccine-derived herd immunity may be short-lived due to interactions between human mobility and imperfect or waning vaccine efficacy. As the supply and utilization of oral cholera vaccines grows, critical questions related to herd immunity are emerging, including: who should be targeted; when should revaccination be performed; and why have cholera outbreaks occurred in recently vaccinated populations?
Methods and findings
We use mathematical models to simulate routine and mass oral cholera vaccination in populations with varying degrees of migration, transmission intensity, and vaccine coverage. We show that migration and waning vaccine efficacy strongly influence the duration of herd immunity while birth and death rates have relatively minimal impacts. As compared to either periodic mass vaccination or routine vaccination alone, a community could be protected longer by a blended “Mass and Maintain” strategy. We show that vaccination may be best targeted at populations with intermediate degrees of mobility as compared to communities with very high or very low population turnover. Using a case study of an internally displaced person camp in South Sudan which underwent high-coverage mass vaccination in 2014 and 2015, we show that waning vaccine direct effects and high population turnover rendered the camp over 80% susceptible at the time of the cholera outbreak beginning in October 2016.
Conclusions
Oral cholera vaccines can be powerful tools for quickly protecting a population for a period of time that depends critically on vaccine coverage, vaccine efficacy over time, and the rate of population turnover through human mobility. Due to waning herd immunity, epidemics in vaccinated communities are possible but become less likely through complementary interventions or data-driven revaccination strategies.
Author summary
Cholera vaccination can be a relatively quick means to temporarily prevent cholera from spreading in an at-risk population. In order to understand how long this temporary protection remains and therefore the timeline for when we need to install longer-term water and sanitation solutions, we must know how long we can expect the vaccine to provide herd protection. To answer this and other related questions, we developed a mathematical model to test different vaccination strategies in a simulated population and in a case study of a displaced-persons camp in Bentiu, South Sudan. We found that the duration of vaccine-derived herd protection can be short (<1 year) in settings of moderate transmission potential and high population mobility, but this duration can be extended through a strategy that complements a one-time mass vaccination campaign with ongoing, routine vaccination. We show that short-lived vaccine efficacy and high population turnover in the Bentiu camp can help explain why the camp had a cholera outbreak despite two high-coverage vaccination campaigns in the two previous years. Our results support, and provide timelines for, cholera vaccination as initial protection while longer-term structural interventions can be implemented.

Transparency in authors’ contributions and responsibilities to promote integrity in scientific publication

PNAS – Proceedings of the National Academy of Sciences of the United States
of America
http://www.pnas.org/content/early/
[Accessed 3 March 2018]

Transparency in authors’ contributions and responsibilities to promote integrity in scientific publication
Marcia K. McNutt, Monica Bradford, Jeffrey M. Drazen, Brooks Hanson, Bob Howard, Kathleen Hall Jamieson, Véronique Kiermer, Emilie Marcus, Barbara Kline Pope, Randy Schekman, Sowmya Swaminathan, Peter J. Stang and Inder M. Verma
PNAS 2018; published ahead of print February 27, 2018, https://doi.org/10.1073/pnas.1715374115

Researcher Self-Care in Emotionally Demanding Research: A Proposed Conceptual Framework

Qualitative Health Research
Volume 28, Issue 4, March 2018
http://qhr.sagepub.com/content/current

Research Articles
Researcher Self-Care in Emotionally Demanding Research: A Proposed Conceptual Framework
Smita Kumar, Liz Cavallaro
First Published December 9, 2017; pp. 648–658
Preview
Researchers are emotionally and psychologically affected by emotionally demanding research that demands a tremendous amount of mental, emotional, or physical energy and potentially affects or depletes the researcher’s well-being. Little attention has been given to preparing doctoral students and novice researchers engaged in such studies. Four possible types of emotionally demanding research experiences are presented: sensitive issues, personal trauma previously experienced, experience of traumatic life events during research, and unexpected events that arise during research in what was previously not identified as a sensitive issue. The need for self-care is highly relevant to each type, despite their different impacts on researcher well-being. This conceptual article furthers conversation in the field about how researchers and educators can address the need for self-care to prepare novice researchers and proposes a conceptual framework for researcher self-care in emotionally demanding research, with an aim for future empirical study.

Toward achieving precision health

Science Translational Medicine
28 February 2018  Vol 10, Issue 430
http://stm.sciencemag.org/

Perspective
Toward achieving precision health
By Sanjiv Sam Gambhir, T. Jessie Ge, Ophir Vermesh, Ryan Spitler
Science Translational Medicine28 Feb 2018 Restricted Access
Precision health can help to prevent disease occurrence, detect disease earlier, and advance human health through the use of integrated diagnostics.
Abstract
Health care systems primarily focus on patients after they present with disease, not before. The emerging field of precision health encourages disease prevention and earlier detection by monitoring health and disease based on an individual’s risk. Active participation in health care can be encouraged with continuous health-monitoring devices, providing a higher-resolution picture of human health and disease. However, the development of monitoring technologies must prioritize the collection of actionable data and long-term user engagement.

The National Vaccine Advisory Committee at 30: Impact and opportunity

Vaccine
Volume 36, Issue 11   Pages 1323-1520 (7 March 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/11

Review
The National Vaccine Advisory Committee at 30: Impact and opportunity
Review article
Pages 1330-1344
Kimberly M. Thompson, Bruce G. Gellin, Alan R. Hinman, Walter A. Orenstein
Abstract
Thirty years after passage of legislation that created the National Vaccine Advisory Committee (NVAC) “to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines,” this review reflects NVAC’s role and impact on the U.S. vaccine and immunization enterprise as an external advisor to the Department of Health and Human Services. We reviewed the history of NVAC in the context of the principles of its establishment, with a focus on its reports and recommendations. We performed a systematic literature review to identify NVAC reports published in widely-accessible public health journals, and we reviewed the available archives to identify other reports and resolutions approved by the committee not published in journals. We characterized key issues considered by NVAC according to the five goals of the 2010 National Vaccine Plan. The predominance of NVAC activities to date related to the implementation of immunization across the lifespan and the many aspects of the system needed to foster the goal of full immunization. Reflecting on the impacts of NVAC to date, this review identified 30 NVAC approved reports published in journals, 22 stand-alone resolutions, and 26 unique unpublished reports. The development of new and improved vaccines continues to represent a significant priority for NVAC, and we identified several challenges related to future vaccine innovation. Given the many factors that impact on policy changes in the vaccine and immunization enterprise, we encountered challenges associated with demonstrating attribution of specific policy changes to NVAC recommendations. Although difficult to quantify, this review suggests that NVAC played an important role in the improvements in the U.S. immunization enterprise over the past 30 years and that NVAC can and will continue to play an important role supporting U.S. immunization going forward.

Vaccination timeliness and co-administration among Kenyan children

Vaccine
Volume 36, Issue 11   Pages 1323-1520 (7 March 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/11

Vaccination timeliness and co-administration among Kenyan children
Original research article
Pages 1353-1360
Nina B. Masters, Abram L. Wagner, Bradley F. Carlson, Matthew L. Boulton
Abstract
Background
Timely administration of recommended vaccines requires children to have multiple vaccines co-administered in the first year of life. The objectives of this study were to estimate the proportion of timely vaccinations and the proportion of co-administered vaccines, and to assess the relationship between vaccine co-administration and vaccine timeliness in Kenyan children.
Methods
Using the 2014 Kenyan Demographic and Health Survey (DHS), we calculated the proportion of children who received co-administered and timely vaccine doses. Co-administration was defined as doses administered on the same day with dates recorded on vaccination cards. Vaccines were considered timely if given within four days before to four weeks after the recommended interval for administration.
Results
10,385 children aged 1–4 years in the Kenyan 2014 DHS dataset had vaccination cards which comprised the study sample. Analysis revealed wide a range for receipt of timely doses, from 90.2% for OPV0 to 56.0% for Measles. Co-administration of the 6-week dose was associated with 2.81 times higher odds of a timely Penta dose 1 (95% CI: 2.28, 3.46) and birth-dose co-administration was associated with a substantial increase in timely BCG vaccination: AOR 7.43 (95% CI: 6.31, 8.75).
Conclusions
Though vaccine coverage in Kenya was high, timely vaccination was markedly low, with resultant implications for population immunity and potential spread of communicable diseases in unvaccinated infants. Co-administration of vaccines, place of residence, wealth index, and child age were consistently related to the odds of timely vaccine receipt. These relationships reinforce the importance of dedicating resources to programs that educate low socio-economic groups about the importance of vaccine co-administration.

Improving human papilloma virus vaccination rates throughout military treatment facilities

Vaccine
Volume 36, Issue 11   Pages 1323-1520 (7 March 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/11

Improving human papilloma virus vaccination rates throughout military treatment facilities
Original research article
Pages 1361-1367
Rachel Dawson, Keith Lemmon, Nidhi J. Trivedi, Shana Hansen
Abstract
Objectives
The four objectives of this study were to (1) educate military healthcare providers on HPV disease and vaccine, (2) assess short term recall of information presented at educational sessions, (3) assess provider comfort level with the vaccine, and (4) assess improvement in HPV vaccination rates.
Methods
Standardized interactive educational sessions were conducted at military primary care clinics with pre- and post-educational quizzes administered before and immediately following the sessions. Provider attitudes were assessed using Likert scale questionnaires. Vaccination rates in children and young adolescents ages 11-18 at one of the participating regions that had a champion and started a Quality Improvement (QI) project were assessed at baseline, at 3-months and at 6-months post sessions.
Results
200 providers were reached at 48 primary care clinics during May 2014 through October 2015 with 200 quizzes and Likert scale questionnaires returned. There was increase in knowledge following the educational sessions as revealed in the pre- and post- test scores [t(57)=-5.04, p< 0.001]. There was a significant overall increase in comfort in answering patients’ and parents’ questions about HPV vaccine [p= 0.003]. There was a significant increase in the number of vaccines given at all the clinics 3-months after the educational sessions at the region who had a champion dedicated to monitoring vaccine rates and ensuring implementation efforts [p=0.01] and started a QI project. This increase was not sustained at 6-months [p=0.324].
Conclusions
Improvement in provider short term knowledge recall and comfort level in answering parents’ questions was seen. We found that educational sessions can improve HPV vaccination rates in military clinics that have a vaccine champion for up to 3-months. Further research into the effects of having clinic vaccine champions is critical.

The impact of immunization programs on 10 vaccine preventable diseases in Italy: 1900–2015

Vaccine
Volume 36, Issue 11   Pages 1323-1520 (7 March 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/11

The impact of immunization programs on 10 vaccine preventable diseases in Italy: 1900–2015
Original research article
Pages 1435-1443
Patrizio Pezzotti, Stefania Bellino, Francesca Prestinaci, Simone Iacchini, … Giovanni Rezza
Abstract
Background
Vaccination has determined a dramatic decline in morbidity and mortality from infectious diseases over the last century. However, low perceived risk of the infectious threat and increased concern about vaccines’ safety led to a reduction in vaccine coverage, with increased risk of disease outbreaks.
Methods
Annual surveillance data of nationally communicable infectious diseases in Italy between 1900 and 2015 were used to derive trends in morbidity and mortality rates before and after vaccine introduction, focusing particularly on the effect of vaccination programs. Autoregressive integrated moving average models were applied to ten vaccine-preventable diseases: diphtheria, tetanus, poliomyelitis, hepatitis B, pertussis, measles, mumps, rubella, chickenpox, and invasive meningococcal disease. Results of these models referring to data before the immunization programs were projected on the vaccination period to estimate expected cases. The difference between observed and projected cases provided estimates of cases avoided by vaccination.
Results
The temporal trend for each disease started with high incidence rates, followed by a period of persisting reduction. After vaccine introduction, and particularly after the recommendation for universal use among children, the current rates were much lower than those forecasted without vaccination, both in the whole population and among the 0-to-4 year olds, which is, generally, the most susceptible age class. Assuming that the difference between incidence rates before and after vaccination programs was attributable only to vaccine, more than 4 million cases were prevented, and nearly 35% of them among children in the early years of life. Diphtheria was the disease with the highest number of prevented cases, followed by mumps, chickenpox and measles.
Conclusions
Universal vaccination programs represent the most effective prevention tool against infectious diseases, having a major impact on human health. Health authorities should make any effort to strengthen public confidence in vaccines, highlighting scientific evidence of vaccination benefits.