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

Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials
Original Research Article
Pages 1184-1193
Yunda Huang, Lily Zhang, Holly Janes, Nicole Frahm, Abby Isaacs, Jerome H. Kim, David Montefiori, M. Julie McElrath, Georgia D. Tomaras, Peter B. Gilbert
Abstract
Background
The evaluation of durable immune responses is important in HIV vaccine research and development. The efficiency of such evaluation could be increased by incorporating predictors of the responses in the statistical analysis. In this paper, we investigated whether and how baseline demographic variables and immune responses measured two weeks after vaccination predicted durable immune responses measured six months later.
Methods
We included data from seven preventive HIV vaccine regimens evaluated in three clinical trials: a Phase 1 study of four DNA, NYVAC and/or AIDSVAX vaccine regimens (HVTN096), a Phase 2 study of two DNA and/or MVA vaccine regimens (HVTN205), and a Phase 3 study of a single ALVAC/AIDSVAX regimen (RV144). Regularized random forests and linear regression models were used to identify and evaluate predictors of the positivity and magnitude of durable immune responses.
Results
We analyzed 201 vaccine recipients with data from 10 to 127 immune response biomarkers, and 3–5 demographic variables. The best prediction of participants’ durable response positivity based on two-week responses rendered up to close-to-perfect accuracy; the best prediction of participants’ durable response magnitude rendered correlation coefficients between the observed and predicted responses ranging up to 0.91. Though prediction performances differed among biomarkers, durable immune responses were best predicted by the two-week response level of the same biomarker. Adding demographic information and two-week response levels of different biomarkers provided little or no improvement in the predictions.
Conclusions
For some biomarkers and for the vaccines we studied, two-week post-vaccination responses can well predict durable responses six months later. Therefore, if immune response durability is only assessed in a sub-sample of vaccine recipients, statistical analyses of durable responses will have increased efficiency by incorporating two-week response data. Further research is needed to generalize the findings to other vaccine regimens and biomarkers.
Clinicaltrials.gov identifiers: NCT01799954, NCT00820846, NCT00223080.

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

Cochrane Library
First published: 7 February 2017
Qualitative Review
Parents’ and informal caregivers’ views and experiences of communication about routine childhood vaccination: a synthesis of qualitative evidence
Heather MR Ames1,2,*, Claire Glenton1, Simon Lewin3,4
Editorial Group: Cochrane Consumers and Communication Group
DOI: 10.1002/14651858.CD011787.pub2
Abstract
Background
Childhood vaccination is an effective way to prevent serious childhood illnesses, but many children do not receive all the recommended vaccines. There are various reasons for this; some parents lack access because of poor quality health services, long distances or lack of money. Other parents may not trust vaccines or the healthcare workers who provide them, or they may not see the need for vaccination due to a lack of information or misinformation about how vaccinations work and the diseases they can prevent.
Communication with parents about childhood vaccinations is one way of addressing these issues. Communication can take place at healthcare facilities, at home or in the community. Communication can be two-way, for example face-to-face discussions between parents and healthcare providers, or one-way, for instance via text messages, posters or radio programmes. Some types of communication enable parents to actively discuss vaccines and their benefits and harms, as well as diseases they can prevent. Other communication types simply give information about vaccination issues or when and where vaccines are available. People involved in vaccine programmes need to understand how parents experience different types of communication about vaccination and how this influences their decision to vaccinate.
Objectives
The specific objectives of the review were to identify, appraise and synthesise qualitative studies exploring: parents’ and informal caregivers’ views and experiences regarding communication about childhood vaccinations and the manner in which it is communicated; and the influence that vaccination communication has on parents’ and informal caregivers’ decisions regarding childhood vaccination.
Search methods
We searched MEDLINE (OvidSP), MEDLINE In-process and Other Non-Index Citations (Ovid SP), Embase (Ovid), CINAHL (EbscoHOST), and Anthropology Plus (EbscoHost) databases for eligible studies from inception to 30 August 2016. We developed search strategies for each database, using guidelines developed by the Cochrane Qualitative Research Methods Group for searching for qualitative evidence as well as modified versions of the search developed for three related reviews of effectiveness. There were no date or geographic restrictions for the search.
Selection criteria
We included studies that utilised qualitative methods for data collection and analysis; focused on the views and experiences of parents and informal caregivers regarding information about vaccination for children aged up to six years; and were from any setting globally where information about childhood vaccinations was communicated or distributed.
Data collection and analysis
We used maximum variation purposive sampling for data synthesis, using a three-step sampling frame. We conducted a thematic analysis using a constant comparison strategy for data extraction and synthesis. We assessed our confidence in the findings using the GRADE-CERQual approach. High confidence suggests that it is highly likely that the review finding is a reasonable representation of the phenomenon of interest, while very low confidence indicates that it is not clear whether the review finding is a reasonable representation of it. Using a matrix model, we then integrated our findings with those from other Cochrane reviews that assessed the effects of different communication strategies on parents’ knowledge, attitudes and behaviour about childhood vaccination.
Main results
We included 38 studies, mostly from high-income countries, many of which explored mothers’ perceptions of vaccine communication. Some focused on the MMR (measles, mumps, rubella) vaccine.
In general, parents wanted more information than they were getting (high confidence in the evidence). Lack of information led to worry and regret about vaccination decisions among some parents (moderate confidence).
Parents wanted balanced information about vaccination benefits and harms (high confidence), presented clearly and simply (moderate confidence) and tailored to their situation (low confidence in the evidence). Parents wanted vaccination information to be available at a wider variety of locations, including outside health services (low confidence) and in good time before each vaccination appointment (moderate confidence).
Parents viewed health workers as an important source of information and had specific expectations of their interactions with them (high confidence). Poor communication and negative relationships with health workers sometimes impacted on vaccination decisions (moderate confidence).
Parents generally found it difficult to know which vaccination information source to trust and challenging to find information they felt was unbiased and balanced (high confidence).
The amount of information parents wanted and the sources they felt could be trusted appeared to be linked to acceptance of vaccination, with parents who were more hesitant wanting more information (low to moderate confidence).
Our synthesis and comparison of the qualitative evidence shows that most of the trial interventions addressed at least one or two key aspects of communication, including the provision of information prior to the vaccination appointment and tailoring information to parents’ needs. None of the interventions appeared to respond to negative media stories or address parental perceptions of health worker motives.
Authors’ conclusions
We have high or moderate confidence in the evidence contributing to several review findings. Further research, especially in rural and low- to middle-income country settings, could strengthen evidence for the findings where we had low or very low confidence. Planners should consider the timing for making vaccination information available to parents, the settings where information is available, the provision of impartial and clear information tailored to parental needs, and parents’ perceptions of health workers and the information provided.

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.

The Economist
http://www.economist.com/
Accessed 18 February 2017
International
Feb 16th 2017
Has philanthropy reached its limits? Podcast: The Economist asks Bill Gates
The Bill & Melinda Gates Foundation has given away grants of over $36 billion in the past decade. But under a new presidency, philanthropist and Microsoft co-founder Bill Gates faces stiff challenges on vaccine programmes, promised clampdowns on federal aid and a mood of distrust toward technocrats. He tells host Anne McElvoy why he still believes in engaging with Donald Trump

The Guardian
http://www.guardiannews.com/
Accessed 18 February 2017
Bill Gates warns tens of millions could be killed by bio-terrorism
Ewen MacAskill Defence correspondent in Munich
Saturday 18 February 2017 09.00 EST
Microsoft founder and philanthropist tells Munich security conference genetic engineering could be terrorist weapon

Scientific American
http://www.scientificamerican.com/
Accessed 18 February 2017
Guest Blog
Biting Back: Developing a Dengue Vaccine
We’ve been working on it for more than 70 years; here’s how we’re finally getting there, and what still needs to be done
By John Boslego on February 15, 2017
..The development of a safe and effective dengue vaccine candidate has faced many hurdles. An important challenge lies in the virus’s biological makeup. The dengue virus exists in four different forms, called serotypes. Each serotype can be transmitted from mosquito to human, and each can lead to dengue fever. The quest to develop a vaccine that protects against all four serotypes has proved challenging, compounded by the fact that infection by one serotype can lead to a more severe form of dengue fever upon re-infection by a different serotype (an effect called antibody-dependent enhancement). Moreover, multiple serotypes are present in many of the 128 countries where dengue is endemic. This means we must ensure that vaccination is protective against all four serotypes.
New dengue vaccine candidates, including the one I oversee at Takeda’s global vaccine unit, are now in late-stage, Phase 3 clinical trials. The TIDES Phase 3 trial is evaluating safety of the vaccine candidate, as well as efficacy in protecting study subjects against dengue caused by any of the four virus serotypes. If successful, it will be another victory in the collective effort against mosquito-borne diseases…
John Boslego is Senior Vice President and Head of Development for Takeda Pharmaceuticals Global Vaccine Business Unit

Wall Street Journal
http://www.online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 18 February 2017
Italy’s Vaccination Rates Raise Government’s Concern
Measles inoculations have dipped below level of India amid stubborn antivaccine sentiment
13 February 2017
By Pietro Lombardi
Italy is the latest front in Europe’s growing antivaccine trend, fueled in part by groups that oppose mandatory injections and raise doubts over their safety. The share of Italian 1-year-olds immunized against measles has dropped by at least 5 percentage points since 2012, according to the World Health Organization, slipping below the comparable rate for India. The country’s 2015 immunization rates were the lowest in Western Europe, WHO figures show, roughly on par with those in Serbia and Romania…

Washington Post
http://www.washingtonpost.com/
Accessed 18 February 2017
Fact Checker
Analysis
Trump’s claim that there’s ‘tremendous amount of increase’ in autism cases
By Michelle Ye Hee Lee February 16, 2017

Milestones :: Perspectives

In India, 410 million children to be vaccinated against measles-rubella
7 February 2017 – India has launched one of the world’s largest vaccination campaigns against measles and rubella. The campaign to vaccinate more than 410 million children aged 9 months to 15 years over the next 2 years is a big step towards improving child survival and preventing birth defects.

India’s measles-rubella vaccination campaign a big step towards reducing childhood mortality, addressing birth defects
By Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia
World Health Organization congratulates India for launching one of the world’s largest vaccination campaign against measles, a major childhood killer disease, and congenital rubella syndrome (CRS), responsible for irreversible birth defects.
The campaign launched today to vaccinate more than 35 million children in the age group of nine months to 15 years with MR (measles and rubella) vaccine, once again demonstrates India’s commitment to improve health and well-being of its people by protecting children against vaccine preventable diseases.
The first phase of the campaign is significant as it is expected to accelerate the country’s efforts to eliminate measles which affects an estimated 2.5 million children every year, killing nearly 49 000 of them. The campaign also marks the introduction of rubella vaccine in India’s childhood immunization programme to address CRS which causes birth defects such as irreversible deafness and blindness in nearly 40 000 children every year.
India has made important efforts and gains against measles in recent years. Measles deaths have declined by 51% from an estimated 100 000 in the year 2000 to 49 000 in 2015. This has been possible by significantly increasing the reach of the first dose of measles vaccine, given at the age of nine months under routine immunization programme, from 56% in 2000 to 87% in 2015. In 2010 India introduced the second dose of measles-containing vaccine in routine immunization programme to close the immunity gap and accelerate measles elimination. Nearly 118 million children aged nine months to 10 years were vaccinated during mass measles vaccination campaigns between 2010 and 2013 in select states of India.
Today’s campaign, the first in the series to cover a total of 410 million children across the country over the next 2 years, is a truly remarkable, world-beating effort. Apart from improving the life-chances of millions of children in India, the campaign is expected to have a substantial effect on global measles mortality and rubella control target as India accounts for 37% of global measles deaths…

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New York Times
February 8, 2017Op-Ed Contributor
How the Anti-Vaxxers Are Winning
Peter J. Hotez, a pediatrician at Baylor College of Medicine, is director of the Texas Children’s Hospital Center for Vaccine Development.
HOUSTON — It’s looking as if 2017 could become the year when the anti-vaccination movement gains ascendancy in the United States and we begin to see a reversal of several decades in steady public health gains. The first blow will be measles outbreaks in America.
Measles is one of the most contagious and most lethal of all human diseases. A single person infected with the virus can infect more than a dozen unvaccinated people, typically infants too young to have received their first measles shot. Such high levels of transmissibility mean that when the percentage of children in a community who have received the measles vaccine falls below 90 percent to 95 percent, we can start to see major outbreaks, as in the 1950s when four million Americans a year were infected and 450 died. Worldwide, measles still kills around 100,000 children each year.

The myth that vaccines like the one that prevents measles are connected to autism has persisted despite rock-solid proof to the contrary. Donald Trump has given credence to such views in tweets and during a Republican debate, but as president he has said nothing to support vaccination opponents, so there is reason to hope that his views are changing.

However, a leading proponent of the link between vaccines and autism said he recently met with the president to discuss the creation of a presidential commission to investigate vaccine safety. Such a commission would be a throwback to the 2000s, when Representative Dan Burton of Indiana held fruitless hearings and conducted investigations on this topic. And a documentary alleging a conspiracy at the Centers for Disease Control and Prevention, “Vaxxed: From Cover-Up to Catastrophe,” has recently been shown around the country.

As a scientist leading global efforts to develop vaccines for neglected poverty-related diseases like schistosomiasis and Chagas’ disease, and as the dad of an adult daughter with autism and other disabilities, I’m worried that our nation’s health will soon be threatened because we have not stood up to the pseudoscience and fake conspiracy claims of this movement.

Texas, where I live and work, may be the first state to once again experience serious measles outbreaks. As of last fall, more than 45,000 children here had received nonmedical exemptions for their school vaccinations. A political action committee is raising money to protect this “conscientious exemption” loophole and to instruct parents on how to file for it. As a result, some public school systems in the state are coming dangerously close to the threshold when measles outbreaks can be expected, and a third of students at some private schools are unvaccinated.

The American Academy of Pediatrics has produced a 21-page document listing all of the studies clearly showing there is no link between vaccines and autism, in addition to more recent epidemiological studies involving hundreds of thousands of children or pregnant women that also refute any association. A study of infant rhesus monkeys also shows that vaccination does not produce neurobiological changes in the brain.

Vaccines are clearly not the reason children develop autism. So what is? There is strong evidence that genetics play a role, and that defects in the brain of children on the autism spectrum occur during pregnancy. Exposure during early pregnancy to particular chemicals in the environment or infections could be involved. Researchers have suggested that damage could be done by the drugs thalidomide, misoprostol and valproic acid; by exposure to the insecticide chlorpyrifos; and by infection of the mother with the rubella virus.

This is what we need to be focusing on, not the myth that vaccines cause autism. Yet I fear that such myths will be used to justify new rounds of hearings or unwarranted investigations of federal agencies, including the C.D.C. This would only distract attention from these agencies’ crucial work, and the real needs of families with children on the autism spectrum, such as mental health services, work-entry programs for adults and support for the research being done by the National Institutes of Health.

Today, parents in Texas have to live in fear that something as simple as a trip to the mall or the library could expose their babies to measles and that a broader outbreak could occur. Perpetuating phony theories about vaccines and autism isn’t going to help them — and it’s not going to help children on the autism spectrum, either.

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Washington Post
February 8, 2017
More than 350 organizations write Trump to endorse current vaccines’ safety
By Lena H. Sun
More than 350 organizations, including leading U.S. medical, advocacy and professional organizations, have sent a letter to President Trump expressing their “unequivocal support for the safety of vaccines.”

The effort, organized by the American Academy of Pediatrics, reflects the growing alarm among a wide array of groups over Trump’s embrace of discredited claims about vaccine safety. After a meeting in January with Robert F. Kennedy Jr., a proponent of the debunked theory that vaccines cause autism, a Trump spokeswoman said he was considering creation of a commission on autism.

“Vaccines protect the health of children and adults and save lives,” the letter opens. “Vaccines have been part of the fabric of our society for decades and are one of the most significant medical innovations of our time.”

It continues: “Claims that vaccines are unsafe when administered according to expert recommendations have been disproven by a robust body of medical literature.”

The letter was sent to Trump on Tuesday. Organizations that signed on represent families, providers, researchers, patients and consumers. They include the American Medical Association, the advocacy group Autism Speaks and major children’s and disability groups such as the Children’s Defense Fund, Easter Seals and the March of Dimes.

Following their meeting last month, Kennedy said that he and Trump had discussed creation of a vaccine commission, which he would chair. The Centers for Disease Control and Prevention already has a well-established expert panel, the Advisory Committee on Immunization Practices, which follows a scientifically rigorous and open process to evaluate all aspects of vaccine safety.

The letter calls vaccines the safest and most cost-effective way of preventing disease, disability and death. It notes that the United States is still experiencing outbreaks of vaccine-preventable illness, disability and death, such as the 2014-2015 measles outbreak that began at Disneyland and the sharp spike of pertussis, or whooping cough, in 2012.

The organizations wrote that they would welcome a meeting with Trump “to share the robust, extensive, scientific evidence” supporting vaccine safety and effectiveness. After just over a page of text, the letter continues for 26 additional pages to list all the national and state-based groups that signed as well as a summary of more than 40 studies on vaccine safety.
Here is the letter in full

Emergencies

WHO Grade 3 Emergencies [to 11 February 2017]
Iraq – No new announcements identified.
The Syrian Arab Republic – No new announcements identified.
Nigeria – See measles immunization campaign announcement above.

South Sudan –
:: WHO partners with South Sudan’s Government to strengthen disease surveillance and outbreak response to save lives
03 February 2017, Juba, South Sudan – The deteriorating security situation in South Sudan, along with disruption of health services, increased population displacement, overcrowding and poor environmental conditions, led to more frequent disease outbreaks.
:: Read the latest cholera situation report pdf, 994kb 3 February 2017

Yemen –
WHO: Urgent health needs in Yemen
8 February 2017 – WHO has deployed medical teams to provide urgently needed health services for internally displaced persons in Yemen. Roughly 22,000 people are affected by intense fighting in Al-Mokha city. More than 8000 people have fled to neighbouring regions to escape, while thousands more remain trapped and caught in the crossfire.
:: Yemen Emergency Response Plan 2017
:: Launch of UN appeal ‘Life-saving assistance needed in Yemen’
: Q&A: Malnutrition and emergencies

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WHO Grade 2 Emergencies [to 11 February 2017]
Cameroon – No new announcements identified.
Central African Republic – No new announcements identified.
Democratic Republic of the Congo – No new announcements identified.
Ethiopia – No new announcements identified.
Libya – No new announcements identified.
Myanmar – No new announcements identified.
Niger – No new announcements identified.

Ukraine –
Ukraine: Health needs soar as fighting flares in eastern Ukraine
3 February 2017 — A large shipment of WHO interagency emergency health kits is on its way to help meet immediate health needs in response to the recent intensification of fighting and shelling in the eastern part of Ukraine. Thousands of civilians are living in subzero temperatures and many others are injured and urgently in need of life-saving medical care. The emergency health kits will address the health needs of over 300 000 patients for 3 months in Ukraine. Further suffering and loss of life can be expected if preventive and emergency response measures are not taken immediately.

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises.
Iraq
:: Iraq: Mosul Humanitarian Response Situation Report No. 19 (30 January – 5 February 2017) [EN/KU]

Syria
:: Statement by UNICEF Regional Director Geert Cappelaere on reports of children killed and injured in Syria 10 Feb 2017
:: Syrian Arab Republic: Aleppo Situation Report No. 15 (4 February 2017) [EN/AR]

Yemen
:: Yemen Humanitarian Bulletin Issue 20 | As of 31 January 2016
:: 2017 Yemen Humanitarian Response Plan (YHRP)
:: Yemen: UN and Partners Appeal for $2.1 BLN to Provide Life-saving Assistance to 12 million People in 2017 [EN/AR]
:: Yemen: Escalating Conflict – Yemen’s Western Coast Flash Update | 07 February 2017
:: Statement by the Humanitarian Coordinator in Yemen, Jamie McGoldrick, on the Situation in DHUBAB and MOKHA Areas 

POLIO [to 11 February 2017]
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 8 February 2017
:: As the low season for poliovirus transmission continues, the first wild poliovirus case from acute flaccid paralysis (AFP) in the calendar year 2017 is reported from Afghanistan. Wild poliovirus type 1 positive samples from 2017 had previously been reported from environmental samples in Pakistan. Both countries continue to intensify their eradication efforts to urgently interrupt any residual virus transmission.

Country Updates [Selected Excerpts]
Afghanistan
:: One new wild poliovirus type 1 (WPV1) case was reported in the past week, with onset of paralysis on 13 January, from Kandahar. It is the first reported case for calendar year 2017. The total number of WPV1 cases for 2016 remains 13. More than half of the 2016 cases are from Bermal district, Paktika.
:: This latest case is linked to the cross-border transmission corridor, affecting both southern Afghanistan and Quetta block, Balochistan, Pakistan. Both countries share common epidemiological reservoirs, and close coordination is ongoing between the country teams to further strengthen immunization and surveillance operations in a joint manner.
Pakistan
:: Three new environmental WPV1 positive samples were reported in the past week, from Quetta, Balochistan; Rawalpindi and Multan, Punjab; all collected in January 2017.

Zika virus [to 11 February 2017]
http://www.who.int/emergencies/zika-virus/en/

Latest Report [now bi-weekly]:
Zika situation report – 2 February 2017
Full report: http://apps.who.int/iris/bitstream/10665/254507/1/zikasitrep2Feb17-eng.pdf?ua=1
Analysis
Overall, the global risk assessment has not changed. Zika virus continues to spread geographically to areas where competent vectors are present. Although a decline in cases of Zika infection has been reported in some countries, or in some parts of countries, vigilance needs to remain high.

Please see Lancet editorial in Journal Watch below.

MERS-CoV [to 11 February 2017]
http://www.who.int/emergencies/mers-cov/en/

Disease outbreak news
Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia
10 February 2017
Between 10 January and 3 February 2017 the National International Health Regulations Focal Point of Saudi Arabia reported seventeen (17) additional cases of Middle East Respiratory Syndrome (MERS) including four (4) fatal cases. Three (3) deaths among previously reported MERS cases (case no. 1 and 2 in DON published on 26 January 2017 and case no. 6 in DON published on 17 January 2017) were also reported…
WHO does not advise special screening at points of entry with regard to this event nor does it currently recommend the application of any travel or trade restrictions.

WHO & Regional Offices [to 11 February 2017]

WHO issues updated tetanus vaccines position paper
10 February 2017
In a revised position paper on tetanus toxoid (TT) vaccines published in today’s edition of the Weekly Epidemiological Record, WHO provided updated guidance on vaccination schedules for primary and booster vaccine doses, according to age and population group.
All children worldwide should be immunized against tetanus. Every country should seek to achieve early and timely infant vaccination. Other tetanus prevention efforts are also needed including individual and community education on clean wound care and the importance of following standard surgical protocols in accordance with WHO guidelines.
Weekly Epidemiological Record,10 February 2017, vol. 92, 6 (pp. 53–76)
Tetanus vaccines: WHO position paper – February 2017

Highlights
Strengthening resilience of hospitals during and after emergencies
February 2017 – 18 hospitals in 7 countries in the WHO European Region were assessed using the WHO Hospital Safety Index tool in 2015–2016. The Hospital Safety Index is a rapid, reliable way of assessing risk in the health sector.

Rehabilitation 2030: A Call for Action
February 2017 – There is a substantial and ever-increasing unmet need for rehabilitation worldwide, which is particularly profound in low- and middle-income countries. The availability of accessible and affordable rehabilitation is necessary for many people with health conditions to remain as independent as possible, to participate in education, to be economically productive, and fulfil meaningful life roles.

:: WHO Regional Offices
Selected Press Releases, Announcements
WHO South-East Asia Region SEARO
:: India’s measles-rubella vaccination campaign a big step towards reducing childhood mortality, addressing birth defects 5 February 2017

WHO European Region EURO
:: Member States invited to propose candidates for the WHO Independent Expert Oversight Advisory Committee 10-02-2017
:: WHO/Europe strengthens resilience of hospitals during and after emergencies 06-02-2017

WHO Eastern Mediterranean Region EMRO
:: Prevention is crucial in tackling Afghanistan’s cancer burden
Kabul 5 February 2017 – New guidance from WHO aims to improve the chances of survival for people living with cancer by ensuring that health services can focus on diagnosing and treating the disease earlier. WHO figures indicate that each year 8.8 million people die from cancer, mostly in low- and middle-income countries. In Afghanistan, according to WHO estimates, there are around 15 000 new cancer cases every year.

CDC/ACIP [to 11 February 2017]
http://www.cdc.gov/media/index.html
http://www.cdc.gov/vaccines/acip/

MMWR Weekly February 10, 2017 / No. 4
[Excerpts]
:: Prevalence and Clinical Attributes of Congenital Microcephaly — New York, 2013–2015
:: Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger — United States, 2017
:: Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2017
: Announcement: Release of National Association of State Public Health Veterinarians’ 2016 Compendium of Animal Rabies Prevention and Control

Register for upcoming February ACIP meeting
February 22-23, 2017
Deadline for registration:
:: Non-US Citizens: February 1, 2017; US Citizens: February 13, 2017
Registration is NOT required to watch the live meeting webcast or to listen via telephone.

Announcements
IAVI – International AIDS Vaccine Initiative [to 11 February 2017]
https://www.iavi.org/

February 8, 2017
IAVI and Oxford University Initiate Africa-Europe Partnership to Develop an AIDS Vaccine
The International AIDS Vaccine Initiative (IAVI) announces an expanded partnership with Oxford University to develop a broadly effective AIDS vaccine candidate.
Led by Tomas Hanke at the Jenner Institute at Oxford University, the Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership (GREAT) is a collaboration with Oxford University, IAVI, Imperial College London, the Kenya AIDS Vaccine Initiative Institute for Clinical Research (KAVI-ICR) at the University of Nairobi, the Uganda Virus Research Institute-IAVI HIV Vaccine Program (UVRI-IAVI), the Medical Research Council/UVRI Uganda Research Unit on AIDS, the Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP) and the Zambia Emory HIV Research Program (ZEHRP).
GREAT includes a series of clinical trials to evaluate a promising vaccine candidate called tHIVconsvX. This candidate is designed to address one of AIDS vaccine science’s primary challenges: HIV’s frequent mutations. Targeting highly “conserved” or less-variable regions of the virus, tHIVconsvX triggers production of specialized immune cells called killer T cells that can destroy HIV-infected cells in the body. A previous Phase I clinical study by Oxford University with support from IAVI at KAVI-ICR in Kenya found an earlier-generation candidate to be safe and immunogenic, and researchers have subsequently adapted it with the aim to expand its breadth of protection.
The GREAT program will evaluate the candidate vaccine in both Europe and Africa. In Africa, the trials will evaluate safety and immunogenicity in young men and women, who account for more than a third of new HIV infections globally, as well as residents of fishing communities along the shores of Lake Victoria in Uganda, where HIV prevalence can be more than four times higher than in the general population. About two-thirds of all new HIV infections occur in sub-Saharan Africa.
GREAT is supported by the European and Developing Countries Clinical Trials Partnership (EDCTP), with co-funding from IAVI and Oxford University, and builds on extensive research expertise and infrastructure, as well as successful community engagement programs, at KAVI, KWTRP, UVRI and ZEHRP. In parallel to the trials, GREAT will support a range of projects at IAVI-partner clinical research centers to prepare them for participation in future large-scale vaccine efficacy trials.

IVI [to 11 February 2017]
http://www.ivi.int/

[Undated]
International Scientific Conference to Focus on Emerging Infectious Diseases and Antimicrobial Resistance in Asia
:: S.-Japan Cooperative Medical Sciences Program’s (USJCMSP) 19th International Conference on Emerging Infectious Diseases (EID) in the Pacific Rim runs from Feb. 7 to 10
:: First time conference held in South Korea; the International Vaccine Institute is the local host
…Since 1996, the United States-Japan Cooperative Medical Sciences Program has been convening the EID conference annually in alternating countries. It serves as a venue for panel meetings and discussion of cross-cutting topics related to infectious disease research to promote international cooperation in research efforts in response to new, emerging infectious disease challenges of Asia and the greater Pacific region…

Global Fund [to 11 February 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
07 February 2017

Catholic Relief Services Accelerates Fight Against Malaria in Niger
NIAMEY, Niger – CRuSh Malaria, a campaign to expand access to antimalarial medication for children in Niger, was launched today by Catholic Relief Services, a key partner in global health.
CRuSh Malaria aims to reduce the number of malaria cases among children under five by 60 percent by 2020. It aims to raise US$5 million from individuals, Catholic youth communities and parishes to support efforts by the Global Fund to end malaria…

UNAIDS [to 11 February 2017]
http://www.unaids.org/
09 February 2017

Update
Faith leaders mobilize to end AIDS in the Caribbean
Caribbean faith leaders met in Port of Spain, Trinidad and Tobago, on 1 and 2 February to determine how they can support the Sustainable Development Goal agenda to end AIDS. The 55 faith leaders from 14 Caribbean countries representing the Bahá’í, Christian, Hindu, Muslim and Voodoo faiths were joined by regional and international development partners, including UNAIDS Deputy Executive Director Luiz Loures.
The faith leaders agreed on a set of recommendations, including offering leadership in support of achieving the 90–90–90 targets—whereby 90% of people living with HIV know their HIV status, 90% of people who know their HIV-positive status are accessing treatment and 90% of people on treatment have suppressed viral loads—and addressing violence against women and girls. Other recommendations include engagement between representatives of religious organizations and key populations, including men who have sex with men, sex workers and people who use drugs.
While religious organizations have long contributed to the Caribbean AIDS response, the consultation aimed to increase knowledge and coordination, while rallying the region around the goal of ending the AIDS epidemic. However, the meeting heard that challenges surrounding stigma, discrimination, prevention and access to services remain.
The consultation, which was organized by a regional Faith Leader Planning Committee with support from the Pan Caribbean Partnership against HIV and AIDS, culminated with an endorsement of the United Nations Political Declaration on Ending AIDS and a road map to deepen their partnerships and capacity.

IFPMA [to 11 February 2017]
http://www.ifpma.org/resources/news-releases/
09 February 2017

Leadership rotation at Fight the Fakes, the worldwide campaign to protect people from fake medicines
Today the International Federation of Pharmaceutical Wholesalers (IFPW) begins its role as secretariat of Fight the Fakes, the global campaign to raise awareness of the threat fake medicines pose to people and public health.
Launched in November 2013, Fight the Fakes has grown into a coalition of over 30 organizations, including healthcare professionals, academia, NGOs, the generic and research-based pharmaceutical industry, healthcare distributers, and consumer protection organizations.
As the Fight the Fakes secretariat, IFPW will continue to coordinate and amplify campaign partners’ activities in combatting fake medicines, and leverage their supply chain expertise and membership base to strengthen the campaign’s network…

Thomas Cueni takes helm of IFPMA as Director General
07 February 2017
Thomas B. Cueni has taken up office as Director General of IFPMA on February 1, representing the interests of the research-based biopharmaceutical industry at a global level.
Thomas Cueni is highly respected across the biopharmaceutical sector, having served for many years as Secretary General of Interpharma, the association of pharmaceutical research companies in Switzerland. He has been closely associated with IFPMA throughout his tenure at Interpharma as a member of the Council of the IFPMA. He has also been instrumental in shaping policy and advocating with European Institutions on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA)…

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

American Journal of Tropical Medicine and Hygiene
February 2017; 96 (2)
http://www.ajtmh.org/content/current

Editorial
Noma: Time to Address a Collective Moral Failure
Raffaella Ravinetto1,*
Author Affiliations
1Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Author Notes
Author’s address: Raffaella Ravinetto, Department of Public Health, Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium, E-mail: rravinetto@itg.be.
↵* Address correspondence to Raffaella Ravinetto, Department of Public Health, Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium. E-mail: rravinetto@itg.be
In this issue of the journal, Srour and others1 give a comprehensive overview of the history, epidemiology, etiology, pathogenesis, microbiology, prevention, diagnosis, and treatment of noma, a devastating orofacial gangrene that affects malnourished children in tropical regions. Even if exclusively present in tropical regions, noma is better described as a “poverty disease” rather than as a “tropical disease,” because it has accompanied extreme poverty and poor nutrition for centuries.2,3 With the exception of cases occurred in concentration camps during World War II,2,4 noma disappeared from Europe and North America by the end of the nineteenth century, thanks to the economic development and improved access to nutrition and health care.1,3 Today, it is particularly present in the sub-Saharan Africa “noma belt,” stretching from Senegal to Ethiopia.
The victims of noma are so neglected that their deaths are not included in mortality statistics5 or in the Global Burden of Diseases.6 Noma incidence is estimated to 30,000–140,000 cases, and its mortality at 85%. In addition, the disease, which is named after a Greek word (νoμη) meaning “devour” and indicating a process that develops very rapidly,2,3 leaves survivors with devastating sequelae: severe facial disfigurement and functional impairment hinder interpersonal relationships and trigger stigma and rejection from societal life.1,3,4,7 The pharmacological treatment is empirical and has not been tested in clinical trials.5 The surgical treatment of sequelae requires tertiary health care that is often unavailable, and it is estimated that at least 770,000 noma survivors remain in need of reconstructive surgery.2…

American Journal of Tropical Medicine and Hygiene
February 2017; 96 (2)
http://www.ajtmh.org/content/current

Articles
Noma: Overview of a Neglected Disease and Human Rights Violation
Am J Trop Med Hyg 2017 96:268-274; Published online January 16, 2017, doi:10.4269/ajtmh.16-0718
M. Leila Srour, Klaas Marck, and Denise Baratti-Mayer
Abstract
Noma is an orofacial gangrene affecting malnourished children and mainly observed in tropical countries, particularly sub-Saharan Africa. Epidemiological data on noma are scarce, but a current estimate of the global incidence is 30,000–40,000 cases per year, with a mortality rate of approximately 85% and a burden of disease calculated to be a loss of 1–10 million disability-adjusted life years. The etiology of noma is multifactorial with malnutrition as an ever present factor, often in combination with concomitant diseases, such as measles, malaria, and human immunodeficiency virus (HIV), and poor oral hygiene. The pathogenesis is a fast-spreading, noncontagious gangrenous infection occurring in the face, often preceded by acute necrotizing gingivitis, and stomatitis. Rare microbiological studies suggest an opportunistic infection caused by an imbalance in normal intraoral microorganisms. Prevention lies in food security, measles vaccination, prevention of malaria and HIV, including the early detection and treatment of necrotizing gingivitis and stomatitis. Early treatment with antibiotics may prevent gangrene or reduce its extent. Late treatment consists of surgical rehabilitation, which is often complex. However, access to medical care is very limited for noma patients due to the extremely poor conditions in which they live that are frequently located in remote rural areas. The authors support the United Nations Human Rights Council Resolution 19/7 adopted on March 22, 2012 “The right to food,” and advocate for the inclusion of noma on the list of neglected tropical diseases to encourage more medical and institutional attention for this often lethal or very mutilating infectious gangrene.

American Journal of Tropical Medicine and Hygiene
February 2017; 96 (2)
http://www.ajtmh.org/content/current

Perspective Piece
Interagency and Commercial Collaboration During an Investigation of Chikungunya and Dengue Among Returning Travelers to the United States
Am J Trop Med Hyg 2017 96:265-267; Published online September 6, 2016, doi:10.4269/ajtmh.16-0298
Emily S. Jentes, Alexander J. Millman, Michelle Decenteceo, Andrew Klevos, Holly M. Biggs, Douglas H. Esposito, Heidi McPherson, Carmen Sullivan, Dayton Voorhees, Jim Watkins, Fanancy L. Anzalone, Linda Gaul, Sal Flores, Gary W. Brunette, and Mark J. Sotir
Abstract
Public health investigations can require intensive collaboration between numerous governmental and nongovernmental organizations. We describe an investigation involving several governmental and nongovernmental partners that was successfully planned and performed in an organized, comprehensive, and timely manner with several governmental and nongovernmental partners.

BMC Cost Effectiveness and Resource Allocation
http://www.resource-allocation.biomedcentral.com/
(Accessed 11 February 2017)

Review
International lessons in new methods for grading and integrating cost effectiveness evidence into clinical practice guidelines
Kathryn M. Antioch, Michael F. Drummond, Louis W. Niessen and Hindrik Vondeling
Published on: 10 February 2017
Abstract
Economic evidence is influential in health technology assessment world-wide. Clinical Practice Guidelines (CPG) can enable economists to include economic information on health care provision. Application of economic evidence in CPGs, and its integration into clinical practice and national decision making is hampered by objections from professions, paucity of economic evidence or lack of policy commitment. The use of state-of-art economic methodologies will improve this. Economic evidence can be graded by ‘checklists’ to establish the best evidence for decision making given methodological rigor. New economic evaluation checklists, Multi-Criteria Decision Analyses (MCDA) and other decision criteria enable health economists to impact on decision making world-wide. We analyse the methodologies for integrating economic evidence into CPG agencies globally, including the Agency of Health Research and Quality (AHRQ) in the USA, National Health and Medical Research Council (NHMRC) and Australian political reforms. The Guidelines and Economists Network International (GENI) Board members from Australia, UK, Canada and Denmark presented the findings at the conference of the International Health Economists Association (IHEA) and we report conclusions and developments since. The Consolidated Guidelines for the Reporting of Economic Evaluations (CHEERS) 24 item check list can be used by AHRQ, NHMRC, other CPG and health organisations, in conjunction with the Drummond ten-point check list and a questionnaire that scores that checklist for grading studies, when assessing economic evidence. Cost-effectiveness Analysis (CEA) thresholds, opportunity cost and willingness-to-pay (WTP) are crucial issues for decision rules in CEA generally, including end-of-life therapies. Limitations of inter-rater reliability in checklists can be addressed by including more than one assessor to reach a consensus, especially when impacting on treatment decisions. We identify priority areas to generate economic evidence for CPGs by NHMRC, AHRQ, and other agencies. The evidence may cover demand for care issues such as involved time, logistics, innovation price, price sensitivity, substitutes and complements, WTP, absenteeism and presentism. Supply issues may include economies of scale, efficiency changes, and return on investment. Involved equity and efficiency measures may include cost-of-illness, disease burden, quality-of-life, budget impact, cost-effective ratios, net benefits and disparities in access and outcomes. Priority setting remains essential and trade-off decisions between policy criteria can be based on MCDA, both in evidence based clinical medicine and in health planning.

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 11 February 2017)

Research article
Active surveillance study of adverse events following immunisation of children in the Czech Republic
Despite the undisputed public health benefits of routine vaccination, adverse events following immunisation (AEFI) remain a concern… The rate of AEFI identified in this study was considerably higher than the officially reported rate. Although the vast majority of AEFI were non-serious, health care providers and the public should be educated and encouraged to report AEFI to address the issue of underreporting, to increase the safety profile of vaccines, and to improve public confidence in immunisation programmes.
Jana Danova, Aneta Kocourkova and Alexander M. Celko
BMC Public Health 2017 17:167
Published on: 6 February 2017

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 11 February 2017)

Research article
Assessing the feasibility of eHealth and mHealth: a systematic review and analysis of initiatives implemented in Kenya
The growth of Information and Communication Technology in Kenya has facilitated implementation of a large number of eHealth projects in a bid to cost-effectively address health and health system challenges. …This review discovered that there is a myriad of eHealth projects being implemented in Kenya, mainly in the mHealth strategic area and focusing mostly on primary care and HIV/AIDs. Based on our analysis, most of the projects were rarely evaluated. In addition, few projects are implemented in marginalised areas and least urbanized counties with more health care needs, notwithstanding the fact that adoption of information and communication technology should aim to improve health equity (i.e. improve access to health care particularly in remote parts of the country in order to reduce geographical inequities) and contribute to overall health systems strengthening.
Martin Njoroge, Dejan Zurovac, Esther A. A. Ogara, Jane Chuma and Doris Kirigia
BMC Research Notes 2017 10:90
Published on: 10 February 2017

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

Research
Global research trends of World Health Organization’s top eight emerging pathogens
Waleed M. Sweileh
Published on: 8 February 2017
Abstract
Background
On December 8th, 2015, World Health Organization published a priority list of eight pathogens expected to cause severe outbreaks in the near future. To better understand global research trends and characteristics of publications on these emerging pathogens, we carried out this bibliometric study hoping to contribute to global awareness and preparedness toward this topic.
Method
Scopus database was searched for the following pathogens/infectious diseases: Ebola, Marburg, Lassa, Rift valley, Crimean-Congo, Nipah, Middle Eastern Respiratory Syndrome (MERS), and Severe Respiratory Acute Syndrome (SARS). Retrieved articles were analyzed to obtain standard bibliometric indicators.
Results
A total of 8619 journal articles were retrieved. Authors from 154 different countries contributed to publishing these articles. Two peaks of publications, an early one for SARS and a late one for Ebola, were observed. Retrieved articles received a total of 221,606 citations with a mean ± standard deviation of 25.7 ± 65.4 citations per article and an h-index of 173. International collaboration was as high as 86.9%. The Centers for Disease Control and Prevention had the highest share (344; 5.0%) followed by the University of Hong Kong with 305 (4.5%). The top leading journal was Journal of Virology with 572 (6.6%) articles while Feldmann, Heinz R. was the most productive researcher with 197 (2.3%) articles. China ranked first on SARS, Turkey ranked first on Crimean-Congo fever, while the United States of America ranked first on the remaining six diseases. Of retrieved articles, 472 (5.5%) were on vaccine – related research with Ebola vaccine being most studied.
Conclusion
Number of publications on studied pathogens showed sudden dramatic rise in the past two decades representing severe global outbreaks. Contribution of a large number of different countries and the relatively high h-index are indicative of how international collaboration can create common health agenda among distant different countries.

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 11 February 2017]

Research
The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines
Dearbhail Bracken-Roche, Emily Bell, Mary Ellen Macdonald and Eric Racine
Published on: 7 February 2017
Abstract
Background
The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines.
Methods
We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability.
Results
Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis.
Conclusions
Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort.

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

Research Article
Hepatitis B virus infection in undocumented immigrants and refugees in Southern Italy: demographic, virological, and clinical features
The data on hepatitis b virus (HBV) infection in immigrants population are scanty. The porpoise of this study was to define the demographic, virological, and clinical characteristics of subjects infected with …
Nicola Coppola, Loredana Alessio, Luciano Gualdieri, Mariantonietta Pisaturo, Caterina Sagnelli, Carmine Minichini, Giovanni Di Caprio, Mario Starace, Lorenzo Onorato, Giuseppe Signoriello, Margherita Macera, Italo Francesco Angelillo, Giuseppe Pasquale and Evangelista Sagnelli
Infectious Diseases of Poverty 2017 6:33
Published on: 9 February 2017

JAMA
February 7, 2017, Vol 317, No. 5, Pages 453-546
http://www.jama.jamanetwork.com/issue.aspx

Viewpoint
Population Health Equity: Rate and Burden, Race and Class
David Kindig, MD, PhD
JAMA. 2017;317(5):467-468. doi:10.1001/jama.2016.19435
Although US racial and ethnic minorities have higher rates of poor health because of health care inequities, more low-income white individuals are affected because of greater population numbers. This Viewpoint explains that efforts to improve poor outcomes would be more effective if strategies were not based on proportions of race.

A Global Vaccine Injury Compensation System
Sam F. Halabi, JD, MPhil; Saad B. Omer, MBBS, MPH, PhD
JAMA. 2017;317(5):471-472. doi:10.1001/jama.2016.19492
This Viewpoint discusses the benefits of establishing a global vaccine injury compensation system that is government and manufacturer supported to compensate individuals who experience vaccine injury.

Privatized Pharmaceutical Innovation vs Access to Essential MedicinesA Global Framework for Equitable Sharing of Benefits
Gian Luca Burci; Lawrence O. Gostin, JD
JAMA. 2017;317(5):473-474. doi:10.1001/jama.2016.17994
This Viewpoint proposes a framework for promoting pharmaceutical innovation while ensuring access and affordability of new drugs on a global scale.

Equipoise in ResearchIntegrating Ethics and Science in Human Research
Alex John London, PhD
JAMA. 2017;317(5):525-526. doi:10.1001/jama.2017.0016
This JAMA Guide to Statistics and Methods article reviews the concept of equipoise, which allows for randomization of interventions while also respecting the rights of human subjects in clinical research.

Journal of Immigrant & Refugee Studies
Volume 15, Issue 1, 2017
http://www.tandfonline.com/toc/wimm20/current

Articles
Investigating the Refugee Health Disadvantage Among the U.S. Immigrant Population
Pages 53-70 | Published online: 20 Jun 2016
Holly E. Reed & Guillermo Yrizar Barbosa
ABSTRACT
Much health-disparities research focuses on race and ethnicity, but nativity has proved to be a crucial factor in explaining the immigrant health advantage. Foreign-born subgroups with certain immigration statuses, such as refugees, may have an initial disadvantage. Using nationally representative survey data, we explore differences in health outcomes by analyzing two visa category subgroups in the United States: refugees and nonrefugee immigrants. Our findings show that refugees have a significant disadvantage across multiple health outcomes. This suggests that current refugee health-screening practices should be changed to take into account broader issues, such as chronic disease and functional limitation.

Journal of Medical Internet Research
Vol 19, No 2 (2017): February
http://www.jmir.org/2017/2

Viewpoint
Navigating Ethics in the Digital Age: Introducing Connected and Open Research Ethics (CORE), a Tool for Researchers and Institutional Review Boards
John Torous, Camille Nebeker
ABSTRACT
Research studies that leverage emerging technologies, such as passive sensing devices and mobile apps, have demonstrated encouraging potential with respect to favorably influencing the human condition. As a result, the nascent fields of mHealth and digital medicine have gained traction over the past decade as demonstrated in the United States by increased federal funding for research that cuts across a broad spectrum of health conditions. The existence of mHealth and digital medicine also introduced new ethical and regulatory challenges that both institutional review boards (IRBs) and researchers are struggling to navigate. In response, the Connected and Open Research Ethics (CORE) initiative was launched. The CORE initiative has employed a participatory research approach, whereby researchers and IRB affiliates are involved in identifying the priorities and functionality of a shared resource. The overarching goal of CORE is to develop dynamic and relevant ethical practices to guide mHealth and digital medicine research. In this Viewpoint paper, we describe the CORE initiative and call for readers to join the CORE Network and contribute to the bigger conversation on ethics in the digital age.

The Lancet
Feb 11, 2017 Volume 389 Number 10069 p573-670
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Another kind of Zika public health emergency
The Lancet
Published: 11 February 2017
A year ago, on Feb 1, 2016, WHO declared the Zika virus epidemic a public health emergency. In a brave show of leadership no doubt spurred by the embarrassment of failing to act sooner on the Ebola outbreak threats, Director-General Margaret Chan sounded the alarm about the potential links between Zika virus and rising neurological disorders despite a lack of conclusive data. By doing so she stimulated an international collective effort, scientific research, and funding that helped stabilise the crisis. A year on she has reflected on the rightness of that decision, writing in a commentary on WHO’s website that it strengthened integrated surveillance for mosquito-borne viruses, and accelerated understanding of the modes of transmission and the abnormalities associated with congenital Zika virus syndrome. The coordination that occurred between international and national authorities and health professionals, especially in Latin American countries, to detect, diagnose, and characterise cases of microcephaly is commendable.

But the warm glow of that reflection must be tempered by the challenges ahead. It would be tempting to laud the Zika response as a success and redirect attention to other emergent issues. To do so would ignore the continued spread of Zika virus and its under-appreciated long-term effects. As WHO shifts direction under a new Director-General, we need even bolder Zika leadership that keeps victims and their families firmly on our public health agenda.
As of Feb 1, 2017, the number of countries reporting a Zika virus outbreak since 2015 has grown to 59, 48 of them in North and South America. Seven countries have reported active local transmission of the virus in 2016 or 2017. 13 countries report person-to-person transmission. New affected areas have emerged including Angola, already struggling under yellow fever and cholera epidemics, which reported its first two cases in January.

Continued geographical spread of Zika virus would be a challenge enough were it not for the anticipated long-term effects. Chan’s commentary says WHO “must be ready for the long-haul” but misses the opportunity to urge and specify international attention, research, and resources for the individuals left devastated by Zika virus. It leaves invisible the needs of thousands of children, their families, and future families; and overlooks the responsibility of the world’s community to support them.

Indeed, Zika can only be considered a long-term epidemic. 6 months ago Bruce Aylward, then head of WHO’s outbreaks and health emergencies cluster, told The Lancet that “we don’t know what the full spectrum of the Zika-caused congenital defects will be. Will apparently unaffected children whose mothers had Zika virus infection in pregnancy develop normally? Will they be able to walk and talk normally? Will they be mentally impaired or have other problems that only become evident years later?” We still don’t know. Fully supported research to understand, track, and address the long-term sequelae of congenital, perinatal, and paediatric Zika virus infection on children’s development must be prioritised.

Currently, almost 3000 cases of Zika-related microcephaly or other CNS defects have been recorded in 29 countries. Brazil has been hardest hit: 2366 babies have been born to Zika-infected women and their families, many already vulnerable and lacking the resources to shoulder the burdens of care. Whereas some of these affected children will lead normal lives, many others with congenital Zika virus syndrome will experience severe disability and need long-term medical attention. Medical interventions could involve intensive physical therapy, treatments for neurological impairments, feeding tubes, and others. The US Centers for Disease Control has estimated the costs of treating such children to be tens of millions of dollars. And microcephaly is likely to represent only a portion of those affected. Others will be born blind or deaf, or suffering from seizures, irritability, or swallowing disorders. Even in the absence of microcephaly, congenital brain abnormalities might be present. That Zika virus infection can trigger the autoimmune disorder Guillain-Barré syndrome in adults worsens the long-term effects. A portion of those affected will die without access to respiratory and intensive care; many more will live with disability. Adding to Zika’s economic drain on societies because of lost productivity due to neurological deficits, these medical consequences amount to another kind of Zika public health emergency.

As the world waits for a vaccine, public health efforts will necessarily focus on prevention in the form of mosquito control and travel advisories. But health agencies like WHO, public health researchers, and policy makers must also not forget the individuals affected. They require our unrelenting attention.

The Lancet
Feb 11, 2017 Volume 389 Number 10069 p573-670
http://www.thelancet.com/journals/lancet/issue/current

Articles
Safety and immunogenicity of a recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in Sierra Leone: a single-centre, randomised, double-blind, placebo-controlled, phase 2 trial
Feng-Cai Zhu, Alie H Wurie, Li-Hua Hou, Qi Liang, Yu-Hua Li, James B W Russell, Shi-Po Wu, Jing-Xin Li, Yue-Mei Hu, Qiang Guo, Wen-Bo Xu, Abdul R Wurie, Wen-Juan Wang, Zhe Zhang, Wen-Jiao Yin, Manal Ghazzawi, Xu Zhang, Lei Duan, Jun-Zhi Wang, Wei Chen
621
Published: 22 December 2016

Nature Medicine
February 2017, Volume 23 No 2 pp137-264
http://www.nature.com/nm/journal/v23/n2/index.html

Articles
A chikungunya fever vaccine utilizing an insect-specific virus platform – pp192 – 199
Jesse H Erasmus, Albert J Auguste, Jason T Kaelber, Huanle Luo, Shannan L Rossi, Karla Fenton, Grace Leal, Dal Y Kim, Wah Chiu, Tian Wang, Ilya Frolov, Farooq Nasar & Scott C Weaver
doi:10.1038/nm.4253
New vaccine approaches that safely elicit immunity are needed to protect against infectious disease. Erasmus et al. report their development of an insect-virus-based platform that they use to engineer a protective vaccine against chikungunya fever.

New England Journal of Medicine
February 9, 2017  Vol. 376 No. 6
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Powerful Ideas for Global Access to Medicines
Suerie Moon, M.P.A., Ph.D.
N Engl J Med 2017; 376:505-507 February 9, 2017 DOI: 10.1056/NEJMp1613861

One of the few issues uniting U.S. voters in the 2016 election was outrage over the high prices of medicines. From the quadrupling of EpiPen prices to $1,000-per-pill hepatitis C treatments, from six-digit pricing of cancer drugs to the 55-fold price increase on a 62-year-old toxoplasmosis drug, the scandals keep coming. In Europe, where government involvement in price negotiations means that new drugs, diagnostics, and vaccines (“medicines”) can cost less than half their U.S. prices, there is nevertheless serious concern that yearly price increases will break health system budgets. Worldwide drug spending grew by about 9% in 2014 and 2015, outpacing both overall health expenditures and economic growth.1

But what has recently been headline news in high-income countries has long been a concern everywhere else. Whether low- and middle-income countries (LMICs) are struggling to treat millions of people living with HIV or to immunize refugee children against pneumonia, unaffordable prices mean that many people simply go without. Meanwhile, despite billions of public and private dollars invested in pharmaceutical research and development, urgent needs for new antibiotics and tools for other public health priorities go unmet. Unaffordable medicines and inadequate innovation have become global issues. Like climate change, they require new public policies and international cooperation.

Responding to concerns raised by patients and health advocates worldwide, in 2015 United Nations (UN) Secretary General Ban Ki-Moon convened a High-Level Panel on Access to Medicines led by two former heads of state, Ruth Dreifuss of Switzerland and Festus Mogae of Botswana, together with 13 international experts with wide-ranging perspectives. Even before the report was published in September 2016 (www.unsgaccessmeds.org/final-report), it had attracted an unusual degree of attention — both positive and negative — from governments, the pharmaceutical industry, and civil society. Some of the reaction, epitomized by the U.S. Chamber of Commerce statement “condemn[ing the] U.N. report attacking patents,”2 reflected a decades-old debate over the appropriate relationship between intellectual property monopolies and medicine prices. Yet the report does not generally go beyond preexisting international agreements on patents. Rather, the true source of consternation may be that it reframes the access-to-medicines challenge not only as involving prices in LMICs, but also as requiring systemic changes to the prevailing research-and-development business model for the sake of all countries. The panel then advances some powerful ideas regarding such changes.

One of those ideas is transparency. Reliable, thorough public information is not generally available on the safety, efficacy, prices, patent status, sources of investment, and costs of developing lifesaving medicines. Given its profound implications for the public interest, the drug-development system is shrouded in a disproportionate degree of secrecy. The panel recommended that governments mandate disclosure of information on various aspects of pharmaceutical development, including research-and-development costs. Depending on the information source and the methods used, estimates of the cost of developing a new drug vary by a factor of 40 or more — ranging from $92 million to $4.2 billion.3 Transparency could introduce some measure of reason and evidence into heated pricing debates, which too often deteriorate into hyperbolic claims that any interference with free-market pricing would destroy innovation. A more granular understanding of research and development could also shed light on the efficiency of the processes involved and spark debate about how society ought to appropriately compensate investment, outcomes, and risk and calibrate financial rewards to the degree of therapeutic advance offered.

Transparency is also key to another powerful idea endorsed by the panel: ensuring public return on public investment in medicine development. Drug development is a public–private enterprise, with the public investing in basic research and early-stage discovery through taxpayer funding of academic and public laboratories and then purchasing the medicines that private firms develop through insurance policies or out-of-pocket expenditures. In areas in which the market fails to offer adequate incentives for innovation — such as neglected diseases, emerging infectious diseases, or antimicrobial resistance — public funding and priority setting play an even greater role, subsidizing all stages of product development. For example, the U.S. government’s Biomedical Advanced Research and Development Authority has funded private firms to develop medicines for use in potential outbreaks and has obtained approval from the Food and Drug Administration for 24 products since its founding in 2006.

Transparency regarding public contributions to the research underlying a medicine could provide a foundation for tempering excessive pricing, either in advance through conditions imposed on public financing or after development through government regulation.
The report also calls for testing and implementing new business models of research and development that would build affordability into the product-development process by delinking research financing from end-product prices. Some such models have already been proven to work in not-for-profit drug-development efforts. For example, with $290 million from public funds and philanthropic contributions, the Drugs for Neglected Diseases Initiative (DNDi) put 26 candidate products into the development pipeline and brought 6 to market in 10 years; because the research costs have already been covered, DNDi’s products can be sold for approximately the cost of production.4 Though there are important differences between drug development for neglected diseases and other therapeutic areas, this example offers proof of principle regarding better ways to manage public and private investments to channel research and development in the public interest.

Finally, the panel called for governments and companies to adhere to established agreements to protect access to medicines under international trade rules. For example, governments have the authority to decide when a private patent right can be set aside in the interest of public health — a right that has been reaffirmed in every relevant UN political declaration since 2001. Though the pharmaceutical industry has criticized the report as an attack on patents, the panel in fact recommended only that preexisting agreements be enforced; it did not recommend additional patent flexibilities beyond what has been agreed on for 15 years. Indeed, some panel members and civil-society organizations expressed disappointment that it did not call for a more dramatic overhaul of intellectual-property treaties.

Among the report’s authors is the chief executive officer of GlaxoSmithKline (GSK), Andrew Witty, who has occasionally become a thorn in his industry’s side by taking positions ahead of the curve. For example, he has called the $1 billion research-and-development price tag a myth reflecting inefficiencies rather than required costs; he expanded GSK’s policy of licensing generic versions of patented medicines in some LMICs beyond HIV to include cancer; and he has endorsed new research-and-development models to combat antimicrobial resistance and pathogens of pandemic potential. His peers may wish to reexamine some of the business models advanced in the report, which could continue rewarding innovation while satisfying growing public demands for affordability and needs-driven innovation.

Given the charged politics of debates over access to medicines, I believe Secretary General Ban was courageous to convene this panel — though the report’s fate in the UN system is uncertain, given that there is a new secretary general, a new U.S. president, and a new director general of the World Health Organization in 2017. Nevertheless, the panel’s greatest impact may be realized not through intergovernmental talks, but by stimulating public debate over ways of reforming the research-and-development system to better serve the global public interest. The Netherlands’ trade and health ministers recently echoed three panel recommendations, calling for transparency of pharmaceutical research-and-development costs, adequate public return on public investment, and testing of new business models.5

This report comes at a time when the public appetite for change is growing, the pharmaceutical industry’s reputation is in the doldrums, and demand for a more equitable global trade system is building. It puts forth ideas that deserve a fair hearing in countries struggling to provide access to medicines for their people and in the boardrooms of companies with the vision to try new ways of delivering innovation. Business as usual is no longer an option.

New England Journal of Medicine
February 9, 2017  Vol. 376 No. 6
http://www.nejm.org/toc/nejm/medical-journal

Special Report
Middle East Respiratory Syndrome
Yaseen M. Arabi, M.D., Hanan H. Balkhy, M.D., Frederick G. Hayden, M.D., Abderrezak Bouchama, M.D., Thomas Luke, M.D., J. Kenneth Baillie, M.D., Ph.D., Awad Al-Omari, M.D., Ali H. Hajeer, Ph.D., Mikiko Senga, Ph.D., Mark R. Denison, M.D., Jonathan S. Nguyen-Van-Tam, D.M., Nahoko Shindo, M.D., Ph.D., Alison Bermingham, Ph.D., James D. Chappell, M.D., Ph.D., Maria D. Van Kerkhove, Ph.D., and Robert A. Fowler, M.D., C.M., M.S. (Epi)
N Engl J Med 2017; 376:584-594 February 9, 2017 DOI: 10.1056/NEJMsr1408795
The Middle East respiratory syndrome is caused by a coronavirus that was first identified in Saudi Arabia in 2012. Periodic outbreaks continue to occur in the Middle East and elsewhere. This report provides the latest information on MERS.

PLOS Currents: Disasters
http://currents.plos.org/disasters/
[Accessed 11 February 2017]

Brief Report
Health Consequences of Typhoon Haiyan in the Eastern Visayas Region Using a Syndromic Surveillance Database
February 6, 2017 ·
Introduction: Typhoon Haiyan was the strongest storm recorded in Philippine history. Surveillance in Post Extreme Emergencies and Disasters (SPEED) was activated during the typhoon response. This study analyzes the health impact of different diseases during different timeframes post-disaster during Typhoon Haiyan in 2013 using a syndromic surveillance database.
Methods: SPEED reports medical consultations based on 21 syndromes covering a range of conditions from three syndrome groups: communicable diseases, injuries, and non-communicable diseases (NCDs). We analyzed consultation rates for 150 days post-disaster by syndrome, syndrome group, time period, and health facility type for adults as well as for children under the age of five.
Results: Communicable diseases had the highest consultation rates followed by similar rates for both injuries and NCDs. While communicable diseases were the predominant syndrome group for children, wounds and hypertension were common syndromes observed in adults. Village health centers had the most consultations amongst health facilities, but also showed the highest variability.
Discussion: Children were more vulnerable to communicable diseases compared to adults. Community health centers showing consistently high consultation rates point out a need for their prioritization. The predominance of primary care conditions requires disaster managers to focus on basic health care and public health measures in community health centers that target the young, elderly and impoverished appropriate to the time period.

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

Review
Environmental and Social Change Drive the Explosive Emergence of Zika Virus in the Americas
Sofia Ali, Olivia Gugliemini, Serena Harber, Alexandra Harrison, Lauren Houle, Javarcia Ivory, Sierra Kersten, Rebia Khan, Jenny Kim, Chris LeBoa, Emery Nez-Whitfield, Jamieson O’Marr, Emma Rothenberg, R. Max Segnitz, Stephanie Sila, Anna Verwillow, Miranda Vogt, Adrienne Yang, Erin A. Mordecai
published 09 Feb 2017 P
http://dx.doi.org/10.1371/journal.pntd.0005135
Abstract
Since Zika virus (ZIKV) was detected in Brazil in 2015, it has spread explosively across the Americas and has been linked to increased incidence of microcephaly and Guillain-Barré syndrome (GBS). In one year, it has infected over 500,000 people (suspected and confirmed cases) in 40 countries and territories in the Americas. Along with recent epidemics of dengue (DENV) and chikungunya virus (CHIKV), which are also transmitted by Aedes aegypti and Ae. albopictus mosquitoes, the emergence of ZIKV suggests an ongoing intensification of environmental and social factors that have given rise to a new regime of arbovirus transmission. Here, we review hypotheses and preliminary evidence for the environmental and social changes that have fueled the ZIKV epidemic. Potential drivers include climate variation, land use change, poverty, and human movement. Beyond the direct impact of microcephaly and GBS, the ZIKV epidemic will likely have social ramifications for women’s health and economic consequences for tourism and beyond.

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

Research Article
Effectiveness of 23-valent pneumococcal polysaccharide vaccination in preventing community-acquired pneumonia hospitalization and severe outcomes in the elderly in Spain
Àngela Domínguez, Núria Soldevila, Diana Toledo, Núria Torner, Luis Force, María José Pérez, Vicente Martín, Lourdes Rodríguez-Rojas, Jenaro Astray, Mikel Egurrola, Francisco Sanz, Jesús Castilla, Working Group of the Project PI12/02079
Research Article | published 10 Feb 2017 P
http://dx.doi.org/10.1371/journal.pone.0171943

Research Article
Cost-effectiveness of maternal influenza immunization in Bamako, Mali: A decision analysis
Evan W. Orenstein, Lauren A. V. Orenstein, Kounandji Diarra, Mahamane Djiteye, Diakaridia Sidibé, Fadima C. Haidara, Moussa F. Doumbia, Fatoumata Diallo, Flanon Coulibaly, Adama M. Keita, Uma Onwuchekwa, Ibrahima Teguete, Milagritos D. Tapia, Samba O. Sow, Myron M. Levine, Richard Rheingans
| published 07 Feb 2017 P
http://dx.doi.org/10.1371/journal.pone.0171499

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

Study protocol
A study protocol for facility assessment and follow-up evaluations of the barriers to access, availability, utilization and readiness of contraception, abortion and postabortion services in Zika affected areas
The Zika virus epidemic in Latin America has elicited official recommendations for women to delay or avoid pregnancy in affected countries, which has increased demand for family planning services. It is likely…
Moazzam Ali, Rachel Folz, Kelsey Miller, Brooke Ronald Johnson and James Kiarie
Reproductive Health 2017 14:18
Published on: 2 February 2017

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
Recently Published Articles –
http://www.paho.org/journal/index.php?option=com_content&view=featured&Itemid=101

Special Report
Promoting and regulating generic medicines: Brazil in comparative perspective
[La promoción y la regulación de los medicamentos genéricos: el caso del Brasil desde una perspectiva comparativa]
Elize Massard da Fonseca and Kenneth C. Shadlen
Published 8 February

Letter to the editor
Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación [An ethics call to include pregnant women in research: Reflections from the Global Forum on Bioethics in Research]
Carla Saenz, Jackeline Alger, Juan Pablo Beca, José M. Belizán, Maria Luisa Cafferata, Julio Arturo Canario Guzmán, Jesica E. Candanedo P., Lissette Duque, Lester Figueroa, Ana Garcés, Lionel Gresh, Ida Cristina Gubert, Dirce Guilhem, Gabriela Guz, Gustavo Kaltwasser, A. Roxana Lescano, Florencia Luna, Alexandrina A. M. Cardelli, Ignacio Mastroleo, Irene N. Melamed, Agueda Muñoz del Carpio Toia, Ricardo Palacios, Gloria I. Palma, Sofía P. Salas, Xochitl Sandoval, Sergio Surugi de Siqueira, Hans Vásquez, y Bertha Ma. Villela de Vega
Published 8 February |

Science
10 February 2017 Vol 355, Issue 6325
http://www.sciencemag.org/current.dtl

Editorial
Act for science
Rush Holt
Summary
This year’s American Association for the Advancement of Science (AAAS, the publisher of Science) Annual Meeting in Boston (16 to 20 February) promises again to be one of the world’s most recognized forums for communicating the excitement, beauty, power, and relevance of science. Attendees from dozens of countries, from nearly every field of study, and from all sectors will share ideas and build collaborations. Attendees share a cherished understanding that science practiced with diligence and reverence for evidence illuminates the human condition, leads to measurable progress, and provides the best insurance against error and deception. These amazing benefits depend on open communication as a fundamental ingredient of science. This is why President Trump’s recent immigration ban has been a jolt across the global scientific enterprise.

Social Science & Medicine
Volume 172, Pages 1-162, e1-e2 (January 2017)
http://www.sciencedirect.com/science/journal/02779536/172

Original Research Article
Public health and public trust: Survey evidence from the Ebola Virus Disease epidemic in Liberia
Pages 89-97
Robert A. Blair, Benjamin S. Morse, Lily L. Tsai
Abstract
Trust in government has long been viewed as an important determinant of citizens’ compliance with public health policies, especially in times of crisis. Yet evidence on this relationship remains scarce, particularly in the developing world. We use results from a representative survey conducted during the 2014–15 Ebola Virus Disease (EVD) epidemic in Monrovia, Liberia to assess the relationship between trust in government and compliance with EVD control interventions. We find that respondents who expressed low trust in government were much less likely to take precautions against EVD in their homes, or to abide by government-mandated social distancing mechanisms designed to contain the spread of the virus. They were also much less likely to support potentially contentious control policies, such as “safe burial” of EVD-infected bodies. Contrary to stereotypes, we find no evidence that respondents who distrusted government were any more or less likely to understand EVD’s symptoms and transmission pathways. While only correlational, these results suggest that respondents who refused to comply may have done so not because they failed to understand how EVD is transmitted, but rather because they did not trust the capacity or integrity of government institutions to recommend precautions and implement policies to slow EVD’s spread. We also find that respondents who experienced hardships during the epidemic expressed less trust in government than those who did not, suggesting the possibility of a vicious cycle between distrust, non-compliance, hardships and further distrust. Finally, we find that respondents who trusted international non-governmental organizations (INGOs) were no more or less likely to support or comply with EVD control policies, suggesting that while INGOs can contribute in indispensable ways to crisis response, they cannot substitute for government institutions in the eyes of citizens. We conclude by discussing the implications of our findings for future public health crises.

Tropical Medicine & International Health
February 2017 Volume 22, Issue 2 Pages 123–251
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2017.22.issue-2/issuetoc

Original Articles
Evaluation of response strategies against epidemics due to Neisseria meningitidis C in Niger (pages 196–204)
Halima Boubacar Maïnassara, Garba Idé Oumarou, Bassira Issaka, Ali Sidiki, Issa Idi, Jean-Paul Moulia Pelat, Arnaud Fontanet and Judith E. Mueller
Version of Record online: 7 DEC 2016 | DOI: 10.1111/tmi.12815
Abstract
Objective
To inform public health recommendations, we evaluated the effectiveness and efficiency of current and hypothetical surveillance and vaccine response strategies against Neisseria meningitidis C meningitis epidemics in 2015 in Niger.
Methods
We analysed reports of suspected and confirmed cases of meningitis from the region of Dosso during 2014 and 2015. Based on a definition of epidemic signals, the effectiveness and efficiency of surveillance and vaccine response strategies were evaluated by calculating the number of potentially vaccine-preventable cases and number of vaccine doses needed per epidemic signal.
Results
A total of 4763 weekly health area reports, collected in 90 health areas with 1282 suspected meningitis cases, were included. At a threshold of 10 per 100 000, the total number of estimated vaccine-preventable cases was 29 with district-level surveillance and vaccine response, 141 with health area-level surveillance and vaccination and 339 with health area-level surveillance and district-level vaccination. While being most effective, the latter strategy required the largest number of vaccine doses (1.8 million), similar to the strategy of surveillance and vaccination at district level (1.3 million), whereas the strategy of surveillance and vaccination at health area level would have required only 0.8 million doses. Thus, efficiency was lowest for district-level surveillance and highest for health area-level surveillance with district-level vaccination.
Conclusion
In this analysis, we found that effectiveness and efficiency were higher at health area-level surveillance and district-level vaccination than for other strategies. Use of N. meningitidis C vaccines in a preventive strategy thus should be considered, in particular as most reactive vaccine response strategies in our analysis had little impact on disease burden.

Vaccine
Volume 35, Issue 7, Pages 993-1100 (15 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/7

Short communication
Impact of universal infant hepatitis B vaccination in the US-affiliated Pacific Islands, 1985–2015
Pages 997-1000
W.E. Abara, M.G. Collier, E.H. Teshale
Abstract
The US-affiliated Pacific Island countries (USAPI) is an endemic region for hepatitis B virus (HBV) infection. Universal infant hepatitis B vaccination was introduced in the USAPI in the mid-1980s to mitigate the HBV burden. We assessed the impact of universal infant vaccination on the HBV infection prevalence over time among children born in the 1980s, 1990s, and 2000s in the USAPI. Demographic and serologic data from serial sero-surveys conducted between 1985 and 2015 were obtained. Descriptive statistics and analysis of variance were performed. From data obtained from 4827 children (2–11 years), HBV prevalence decreased markedly: 8.4% in the 1980s; 2.5% in the 1990s; and 0.2% in the 2000s (P<0.0001) as vaccination coverage increased: 76.4% in the 1980s; 87.3% in the 1990s; and 97.5% in the 2000s (P<0.0001). These findings underscore the protective effect of universal infant hepatitis B vaccination over time on the HBV burden in an HBV endemic region.

Vaccine
Volume 35, Issue 7, Pages 993-1100 (15 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/7

Vaccine shot-limiting: Estimating the prevalence, indicators, and impact on vaccination status — Michigan, 2012
Original Research Article
Pages 1018-1023
Meghan Weinberg, Stephanie Dietz, Rachel Potter, Robert Swanson, Corinne Miller, Jevon McFadden
Abstract
Background
Concerns regarding vaccine safety and pain have prompted certain parents to limit the number of shots their child receives per visit. We estimated the prevalence of shot-limited children in Michigan, described their characteristics, assessed whether shot-limited children were up-to-date on recommended vaccinations, and investigated possible intervention points for vaccination education.
Methods
We analyzed vaccination registry and birth record data of children born in Michigan during 2012 who had ⩾2 vaccination visits, with ⩾1 visits after age 5 months. Shot-limited was defined as receiving ⩽2 shots at all visits through age 24 months. Nonlimited children received >2 shots at ⩾1 visits. Up-to-date vaccination was based on receipt of a seven-vaccine series and was determined at ages 24 months and 35 months. Risk ratios (RR) were calculated using risk regression.
Results
Of 101,443 children, a total of 2,967 (3%) children were shot-limited. Mothers of shot-limited children were more likely to be white (RR: 1.2; 95% confidence interval [CI]: 1.2–1.2), college graduate (RR: 1.9; 95% CI: 1.9–2.0), and married (RR: 1.5; 95% CI: 1.5–1.5). Compared with nonlimited children, shot-limited children were more likely to be born in a nonhospital setting (RR: 11.7; 95% CI: 9.4–14.6) and have a midwife attendant (RR: 1.9; 95% CI: 1.7–2.1). Shot-limited children were less likely to be up-to-date on recommended vaccinations (RR: 0.2; 95% CI: 0.2–0.3); this association was stronger for those with a midwife birth attendant (RR: 0.1; 95% CI: 0.1–0.2) rather than a medical doctor (RR: 0.3; 95% CI: 0.2–0.3).
Conclusions
Shot-limited children are less likely to be up-to-date on vaccinations, possibly leading to increased risk for vaccine-preventable diseases. This association was stronger for those with a midwife birth attendant. This analysis should prompt targeted education, such as to midwives, concerning risks associated with shot-limiting behavior.

Vaccine
Volume 35, Issue 7, Pages 993-1100 (15 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/7

Timeliness and risk factors associated with delay for pneumococcal conjugate 10-valent routine immunization in Brazilian children
Original Research Article
Pages 1030-1036
Ana Lucia Sartori, Ruth Minamisava, Eliane Terezinha Afonso, Gabriela Moreira Policena, Grécia Carolina Pessoni, Ana Luiza Bierrenbach, Ana Lucia Andrade
Abstract
Background
Vaccination coverage is the usual metrics to evaluate the immunization programs performance. For the 10-valent pneumococcal conjugate (PCV10) vaccine, measuring the delay of vaccination is also important, particularly as younger children are at increased risk of disease. Routinely collected administrative data was used to assess the timeliness of PCV10 vaccination, and the factors associated with delay to receive the first and second doses, and the completion of the PCV10 3 + 1 schedule.
Methods
A population-based retrospective cohort study was conducted with children born in 2012 in Central Brazil. Children who received the PCV10 first dose in public health services were followed-up until 23 months of age. Timeliness of receiving each PCV10 dose at any given age was defined as receiving the dose within 28 days grace period from the recommended age by the National Immunization Program. Log-binomial regression models were used to examine risk factors for delays of the first dose and the completion PCV10 3 + 1 schedule.
Results
In total, 14,282 children were included in the cohort of study. Delayed vaccination occurred in 9.4%, 23.8%, 36.8% and 39.9% children for the first, second, third and the booster doses, respectively. A total of 1912 children (12.8% of the cohort) were not adequately vaccinated at the 6 months of life; 1,071 (7%) received the second dose after 6 months of age, 784 (5.4%) did not receive the second dose, and 57 (0.4%) received the first dose after six months of life.
Conclusion
A considerable delay was found in PCV10 third and booster doses. Almost 2 thousand children had not received the recommended PCV10 doses at 6 months of age. Timeliness of vaccination is an issue in Brazil although high vaccination coverages.

Vaccine
Volume 35, Issue 7, Pages 993-1100 (15 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/7

Cost-effectiveness of 13-valent pneumococcal conjugate vaccination in Mongolia
Original Research Article
Pages 1055-1063
Neisha Sundaram, Cynthia Chen, Joanne Yoong, Munkh-Erdene Luvsan, Kimberley Fox, Amarzaya Sarankhuu, Sophie La Vincente, Mark Jit
Abstract
Objective
The Ministry of Health (MOH), Mongolia, is considering introducing 13-valent pneumococcal conjugate vaccine (PCV13) in its national immunization programme to prevent the burden of disease caused by Streptococcus pneumoniae. This study evaluates the cost-effectiveness and budget impact of introducing PCV13 compared to no PCV vaccination in Mongolia.
Methods
The incremental cost-effectiveness ratio (ICER) of introducing PCV13 compared to no PCV vaccination was assessed using an age-stratified static multiple cohort model. The risk of various clinical presentations of pneumococcal disease (meningitis, pneumonia, non-meningitis non-pneumonia invasive pneumococcal disease and acute otitis media) at all ages for thirty birth cohorts was assessed. The analysis considered both health system and societal perspectives. A 3 + 0 vaccine schedule and price of US$3.30 per dose was assumed for the baseline scenario based on Gavi, the Vaccine Alliance’s advance market commitment tail price.
Results
The ICER of PCV13 introduction is estimated at US$52 per disability-adjusted life year (DALY) averted (health system perspective), and cost-saving (societal perspective). Although indirect effects of PCV have been well-documented, a conservative scenario that does not consider indirect effects estimated PCV13 introduction to cost US$79 per DALY averted (health system perspective), and US$19 per DALY averted (societal perspective). Vaccination with PCV13 is expected to cost around US$920,000 in 2016, and thereafter US$820,000 every year. The programme is likely to reduce direct disease-related costs to MOH by US$440,000 in the first year, increasing to US$510,000 by 2025.
Conclusion
Introducing PCV13 as part of Mongolia’s national programme appears to be highly cost-effective when compared to no vaccination and cost-saving from a societal perspective at vaccine purchase prices offered through Gavi. Notwithstanding uncertainties around some parameters, cost-effectiveness of PCV introduction for Mongolia remains robust over a range of conservative scenarios. Availability of high-quality national data would improve future economic analyses for vaccine introduction.

Vaccine
Volume 35, Issue 7, Pages 993-1100 (15 February 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/7

Demand- and supply-side determinants of diphtheria-pertussis-tetanus nonvaccination and dropout in rural India
Original Research Article
Pages 1087-1093
Arpita Ghosh, Ramanan Laxminarayan
Abstract
Background
Although 93% of 12- to 23-month-old children in India receive at least one vaccine, typically Bacillus Calmette–Guérin, only 75% complete the recommended three doses of diphtheria-pertussis-tetanus (DPT, also referred to as DTP) vaccine. Determinants can be different for nonvaccination and dropout but have not been examined in earlier studies. We use the three-dose DPT series as a proxy for the full sequence of recommended childhood vaccines and examine the determinants of DPT nonvaccination and dropout between doses 1 and 3.
Methods
We analyzed data on 75,728 6- to 23-month-old children in villages across India to study demand- and supply-side factors determining nonvaccination with DPT and dropout between DPT doses 1 and 3, using a multilevel approach. Data come from the District Level Household and Facility Survey 3 (2007–08).
Results
Individual- and household-level factors were associated with both DPT nonvaccination and dropout between doses 1 and 3. Children whose mothers had no schooling were 2.3 times more likely not to receive any DPT vaccination and 1.5 times more likely to drop out between DPT doses 1 and 3, compared with children whose mothers had 10 or more years of schooling. Although supply-side factors related to availability of public health facilities and immunization-related health workers in villages were not correlated with dropout between DPT doses 1 and 3, children in districts where 46% or more villages had a healthcare subcentre were 1.5 times more likely to receive at least one dose of DPT vaccine compared with children in districts where 30% or fewer villages had subcentres.
Conclusions
Nonvaccination with DPT in India is influenced by village- and district-level contextual factors over and above individuals’ background characteristics. Dropout between DPT doses 1 and 3 is associated more strongly with demand-side factors than with village- and district-level supply-side factors.

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

Clinical and Experimental Vaccine Research
2017 Jan;6(1):31-37. English.
Published online Jan 25, 2017.
Psychogenic illness following vaccination: exploratory study of mass vaccination against pandemic influenza A (H1N1) in 2009 in South Korea
TU Yang, HJ Kim, YK Lee, YJ Park
Abstract
Purpose
Adverse events during mass vaccination campaigns have had a profoundly negative impact on vaccine coverage rates. The objective of the study was to identify the characteristics of reported psychogenic illness cases following mass vaccination that needed further interventions of the national immunization program.
Materials and Methods
We collected documents that were submitted to the Korea Centers for Disease Control and Prevention for vaccine injury compensation, and analyzed cases of psychogenic illness following pandemic influenza A (H1N1) vaccination in 2009 which were confirmed by the Korean Advisory Committee on Vaccine Injury Compensation.
Results
During the 2009-2010 influenza season, 13 million Koreans were vaccinated against pandemic influenza. Of 28 reported psychogenic illness cases following immunization, 25 were vaccinated through school-located mass immunization. Significant numbers of them were female adolescents (68%) or had underlying vulnerable conditions or emotional life stressors (36%). They required lengthy hospitalization (median, 7 days) and high medical costs (median, US $1,582 per case).
Conclusion
Health authorities and organizers of future mass vaccinations should be well aware of the possible occurrence of psychogenic illness, acknowledge their detailed characteristics, and take its economic burden into account to mitigate the risk of transmission of infectious diseases efficiently.

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.

New Yorker
http://www.newyorker.com/
Accessed 11 February 2017
February 3, 2017
The Deep Denialism of Donald Trump
By Michael Specter
This White House, unlike any other, has already crossed the threshold into a space where facts appear to mean nothing.

New York Times
http://www.nytimes.com/
Accessed 11 February 2017
Venezuelan Girl’s Diphtheria Death Highlights Country’s Health Crisis
February 10, 2017
…Her death and a wider Venezuelan outbreak of diphtheria, once a major global cause of child death but increasingly rare due to immunizations, shows how vulnerable the country is to health risks amid a major economic crisis that has sparked shortages of basic medicines and vaccines….
– By REUTERS –

Turning the Tide Against Cholera
6 February 2017
…Just as important, after 35 years of work, researchers in Bangladesh and elsewhere have developed an effective cholera vaccine. It has been accepted by the W.H.O. and stockpiled for epidemics like the one that struck Haiti in 2010. Soon, there may be enough to begin routine vaccination in countries where the disease has a permanent foothold.
Merely creating that stockpile — even of a few million doses — profoundly improved the way the world fought cholera, Dr. Margaret Chan, secretary general of the W.H.O., said last year. Ready access to the vaccine has made countries less tempted to cover up outbreaks to protect tourism, she said.
That has sped up emergency responses and attracted more vaccine makers, lowering costs. “More cholera vaccines have been deployed over the last two years than in the previous 15 years combined,” Dr. Chan said…

Washington Post
http://www.washingtonpost.com/
Accessed 11 February 2017
More than 350 organizations write Trump to endorse current vaccines’ safety
The letter reflects growing concern over Trump’s embrace of discredited claims about vaccine safety.
Lena H. Sun | National/health-science | Feb 8, 2017
[See Milestones above for more detail]