An updated methodology to review developing-country vaccine manufacturer viability

Vaccine
Volume 35, Issue 31, Pages 3797-3904 (5 July 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/31

An updated methodology to review developing-country vaccine manufacturer viability
Original Research Article
Pages 3897-3903
Nicholas Luter, Ritu Kumar, Dai Hozumi, Tina Lorenson, Shannon Larsen, Bhavya Gowda, Amie Batson
Abstract
In 1997, Milstien, Batson, and Meaney published “A Systematic Method for Evaluating the Potential Viability of Local Vaccine Producers.” The paper identified characteristics of successful vaccine manufacturers and developed a viability framework to evaluate their performance. This paper revisits the original study after two decades to determine the ability of the framework to predict manufacturer success. By reconstructing much of the original dataset and conducting in-depth interviews, the authors developed informed views on the continued viability of manufacturers in low- and middle-income country markets. Considering the marked changes in the market and technology landscape since 1997, the authors find the viability framework to be predictive and a useful lens through which to evaluate manufacturer success or failure. Of particular interest is how incumbent and potentially new developing-country vaccine manufacturers enter and sustain production in competitive international markets and how they integrate (or fail to integrate) new technology into the production process. Ultimately, most manufacturers will need to meet global quality standards to be viable. As governments and donors consider investments in vaccine producers, the updated viability factors will be a useful tool in evaluating the prospects of manufacturers over the mid to long term. The paper emphasizes that while up-front investments are important, other critical factors—including investments in a national regulatory authority, manufacturer independence, and ability to adapt and adopt new technology—are necessary to ensure viability.

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
 
 
BBC
http://www.bbc.co.uk/
Accessed 24 June 2017
Syria war: Polio paralyses 17 children in Mayadin and Raqqa
20 Jun 2017

Vaccines and Global Health : The Week in Review 17 June 2017

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

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

 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_17 June 2017

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

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

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

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

Milestones :: Perspectives

Milestones :: Perspectives

Editor’s Note
We lead this week’s edition with developments around polio, including major commitments of new financial resources for eradication, and updates on type 2 (cVDPV2) outbreaks in Syria and DRC.

Global Leaders Unite to Bring Polio One Step Closer to Eradication
Countries and partners pledge US$ 1.2 billion to protect 450 million children from polio every year
ATLANTA (12 June 2017) – Today, global health leaders gathered at the Rotary Convention in Atlanta to reaffirm their commitment to eradicating polio and pledge US$ 1.2 billion to finance efforts to end the disease.

Thirty years ago, polio paralyzed more than 350,000 children each year in more than 125 countries around the world. Thanks to the extraordinary efforts of governments, health workers, donors and the partners of the Global Polio Eradication Initiative (GPEI), a public-private partnership dedicated to ending the disease, the highly contagious virus has now been eliminated in all but three countries: Afghanistan, Nigeria and Pakistan. There have been only five cases to date in 2017.

However, children remain at risk everywhere until polio is completely stopped. To end the disease for good, government representatives and partners came together to renew their commitment to supporting crucial activities such as vaccination and disease monitoring, which will protect more than 450 million children from polio each year.

“Thanks to the incredible efforts of Rotarians, governments, health workers, partners and donors – including those who have gathered at the Rotary Convention in Atlanta – we are closer than ever to making history,” said Chris Elias, Global Development President, Bill & Melinda Gates Foundation and Chair of the GPEI Polio Oversight Board. “These new commitments will help ensure that we will finish the job.”

In a time of many global challenges and priorities, governments and partners have stepped forward to demonstrate their collective resolve to seeing the second human disease ever eradicated. Major pledges include: US$ 75 million from Canada, US$ 61.4 million from the European Commission, US$ 55 million from Japan, US$ 30 million from Sheikh Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi, United Arab Emirates, US$ 30 million from the Dalio Foundation, US$ 25 million from Bloomberg Philanthropies, US$ 15 million from an anonymous donor, US$ 13.4 million from Australia, US$ 11.2 million from Germany, US$ 5 million from easyJet, US$ 5 million from Italy and US$ 4 million from the Republic of Korea.

Bill Gates, co-chair of the Bill & Melinda Gates Foundation, and John Germ, president of Rotary International, also announced an extension of their partnership in front of more than 20,000 Rotarians. Up to US$ 150 million in funds raised by Rotary members over the next three years will be matched 2:1 by the Gates Foundation, resulting in up to US$ 450 million in the next three years for the GPEI. The Gates Foundation pledged a total of US$ 450 million, including this matching agreement.

“The global eradication of polio has been Rotary’s top priority since 1985. Rotary members have been the driving force behind the fight to end polio since its inception,” said John Germ, President of Rotary International. “Their continued commitment to raising funds for eradication – coupled with today’s match by the Bill & Melinda Gates Foundation – makes that impact even greater.”

Today’s funding helps address a US$1.5 billion funding need that will help ensure that the virus is eliminated from these remaining countries and prevented from regaining a foothold anywhere else in the world.

“Constant innovation has been key to improving vaccination coverage and reaching more children with the polio vaccine,” said Dr. Anne Schuchat, Acting Director of the U.S. Centers for Disease Control and Prevention. “The unrelenting commitment and support of these global leaders will help us do just that—and ultimately end this disease for everyone and forever. CDC remains deeply committed to polio eradication and has contributed US$ 2.28 billion since the beginning of the initiative.”

Today’s funding commitments will enable the program to continue to improve performance and overcome challenges to reach every child, including vaccinating children in conflict areas…

::::::

Gavi to help protect millions more children against polio
Gavi Board agrees to extend support for inactivated polio vaccine (IPV) to 2020; new policy on fragile settings, emergencies and refugees also approved

Geneva, 15 June 2017 – Support for the introduction of inactivated polio vaccine (IPV) will be extended to 2020 in up to 70 low- and middle-income countries, Gavi, the Vaccine Alliance announced today. The Gavi Board decision will enable routine immunisation programmes to reach millions more children with this critical vaccine and support the final drive towards eradication.

“We now have a unique opportunity to consign polio to the history books, but we cannot afford to be complacent,” said Dr Ngozi Okonjo-Iweala, Chair of the Gavi Board. “We cannot and will not rest as long as any child anywhere in the world is at risk of contracting this terrible disease. Gavi fully supports the Global Polio Eradication Initiative and partners, and this decision means we will continue to work together as we edge ever closer to a polio-free world.”

As transmission of wild poliovirus has not yet been stopped, the target date for global certification of eradication has had to be pushed back by at least two years – from 2018 to 2020 at the earliest. Polio remains endemic in three countries – Afghanistan, Nigeria and Pakistan. Five wild poliovirus cases have been recorded since the beginning of the year: three in Afghanistan and two in Pakistan.

Moreover vaccine supply constraints have delayed introductions or interrupted IPV use in some Gavi-supported countries. To date 53 countries have introduced IPV to their immunisation programme with Gavi support. Until all poliovirus cases are fully eradicated and contained all countries are at risk, especially those with weak vaccine coverage levels.

The cost of extending support to 2020 is projected to be up to US$ 250 million which will be financed by additional funding raised by the Global Polio Eradication Initiative (GPEI) and by existing funds from Norway, the Bill & Melinda Gates Foundation and the UK Department for International Development (DFID). The Gavi Board decision should provide reassurance to countries and manufacturers of Gavi’s continued support for IPV and polio eradication.

“We will need to evaluate Gavi support to IPV beyond 2020 to make sure that the disease doesn’t re-emerge after global certification,” said Dr Seth Berkley, CEO of Gavi the Vaccine Alliance. “The vaccine will have to be assessed differently from other vaccines based on its value to the global public good. Polio eradication will rank as one of the greatest achievements in the history of global health, reflecting the combined efforts of funders and of hundreds of thousands of scientists, health workers and ordinary vaccinators over three decades.”

Ensuring continued high immunisation coverage of children in the poorest countries is critical to protect children everywhere from the spread of infectious diseases.

New policy on Fragility, Emergencies and Refugees
Gavi operates in many of the most fragile settings where health needs are often the greatest. These circumstances require a different approach to ensure children get the vaccines they need. The Gavi Board approved a new policy on Fragility, Emergencies and Refugees to enable a rapid and tailored response in these settings.

“As climate change, conflict and economic crises continue to drive people from their homes and devastate health systems, we must make sure that the weakest and most vulnerable are not excluded from receiving life-saving vaccines,” added Dr Berkley. “Good health is a fundamental human right. It is unacceptable that hundreds of thousands of child refugees or children trapped in war-torn countries are excluded from receiving basic health services, including vaccines.”

Gavi-supported host countries will for instance be able to request additional support to immunise refugees. In the case of emergencies, countries can request flexibility in the vaccine application process or while implementing Health System Strengthening (HSS) support. Where needed, the new policy enables Gavi to work more directly with partners and non-state actors including civil society organisations (CSO) operating in affected areas.

Lastly, the Board decided that, due to the on-going conflict, Yemen will continue to receive Gavi support in spite of co-financing challenges that the country is facing.
 
::::::
 
POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 14 June 2017 [GPEI]
:: Global health leaders are meeting this week at the Rotary International Convention in Atlanta, USA, and reaffirmed their commitment to eradicating polio by pledging US$1.2 billion to end the disease.  [See above]

:: Addressing Rotarians from around the world, Bill Gates, co-chair of the Bill & Melinda Gates Foundation, said:  “People often ask me how I know the world is getting better. I usually point to numbers like this one: Because of efforts to eradicate polio by groups like Rotary International, more than 16 million people are walking today who would otherwise have been paralyzed.  That’s more than 16 million people who can walk to school. More than 16 million people who are better able to start a business or carry their child to bed. More than 16 million people who are living better lives, because a group of health care workers, volunteers, government leaders, and funders devoted themselves to fighting polio. Polio eradication is a testament to the compassion, generosity, and kindness of more than a million Rotarians around the world. You are the people who are making it possible to get to zero. And that will be something worth celebrating. Thank you.”  More.

:: Newly-elected WHO Director-General Elect Dr Tedros Adhanom Ghebreyesus addressed the assembled Rotarians:  “Today I speak to you as the Director-General Elect of the World Health Organization and as a Paul Harris Fellow with Rotary International. In both roles, the eradication of polio is close to my heart.  Together we have achieved something phenomenal.  Thanks to all of you, generations of children have grown up without ever experiencing polio.   The end of polio is now in sight, but this is the most critical moment of covering the last mile. We must keep our eyes firmly on the final goal.  Thank you for your commitment.  Together, we will continue to make a difference”.

:: Summary of newly-reported viruses this week: Afghanistan – one new wild poliovirus type 1 (WPV1) was isolated from a healthy household contact of an acute flaccid paralysis (AFP) case.

::::::
 
WHO: Disease Outbreak News [DONs]
Circulating vaccine-derived poliovirus type 2 – Syrian Arab Republic
Disease outbreak news
13 June 2017
A circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak has been confirmed in the Deir Al Zour Governorate of the Syrian Arab Republic. There is evidence of genetic linkage among three isolates of type-2 vaccine-derived polioviruses (VDPV2) isolated in the stool specimens of two acute flaccid paralysis (AFP) cases with dates of onset of paralysis on 5 March and 6 May 2017, and the contact specimen of an AFP case collected on 17 April 2017. Al Mayadeen was also the epi-centre of the wild poliovirus type 1 (WPV1) outbreak in Syrian Arab Republic in 2013. Aggressive multi-country polio outbreak response effectively controlled the WPV1 outbreak and no WPV1 case has been reported in Syrian Arab Republic since 21 January 2014…

Circulating vaccine-derived poliovirus type 2 – Democratic Republic of the Congo
Disease outbreak news
13 June 2017
In the Democratic Republic of the Congo (DRC), two separate circulating vaccine-derived poliovirus type 2s (cVDPV2s) have been confirmed. The first cVDPV2 strain has been isolated from two acute flaccid paralysis (AFP) cases from two districts in Haut-Lomami province, with onset of paralysis on 20 February and 8 March 2017. The second cVDPV2 strain has been isolated from Maniema province, from two AFP cases (with onset of paralysis on 18 April and 8 May 2017) and a healthy contact in the community.
Public health response
The Ministry of Health, supported by WHO and partners of the Global Polio Eradication Initiative (GPEI), has completed a risk assessment, including evaluating population immunity and the risk of further spread.
Outbreak response plans are currently being finalized, consisting of strengthening surveillance, including active case searching for additional cases of AFP, and supplementary immunization activities (SIAs) with monovalent oral polio vaccine type 2 (mOPV2), in line with internationally-agreed outbreak response protocols.
Surveillance and immunization activities are being strengthened in neighbouring countries…
 

Emergencies

Emergencies

WHO Grade 3 Emergencies  [to 17 June 2017]
Iraq 
:: Iraq: WHO and health authorities immediately investigate suspected cases of foodborne illness in Hassan Sham U2 camp
Baghdad, 13 June 2017 – The World Health Organization, in coordination with Erbil and Ninewa Directorates of Health, rapidly responded to a suspected foodborne illness outbreak in Hassan Sham U2 camp by conducting an investigation with the aim of identifying the source and cause of the outbreak, treating those who are ill as well as containing and preventing any spread.
 
The Syrian Arab Republic 
:: WHO and health partners provide vital care to displaced people in northern Syria
13 June 2017– Responding to evacuations and a growing number of displaced people in northern Syria, WHO and its health partners are providing life-saving medical care to thousands of families. In spring 2017, following discussions between the Government of the Syrian Arab Republic and other groups, families from formerly besieged areas of the country were evacuated to areas further north.

Yemen
:: Read the latest situation report on the cholera outbreak in Yemen, 27 April–12 June [pdf 1.27Mb]
:: Epidemiology bulletin 9, 27 April–14 June 2017

NigeriaNo new announcements identified.
South SudanNo new announcements identified.
 

WHO Grade 2 Emergencies  [to 17 June 2017]
Cameroon  No new announcements identified

Central African Republic  – No new announcements identified.  [see UNICEF reports below]
Democratic Republic of the CongoNo new announcements identified.
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
 
::::::
 
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. 37 (5 to 11 June 2017)
…Humanitarian and protection needs remain severe, both among displaced families and vulnerable residents of newly accessible areas. While humanitarian partners continue to respond to the outflow of people providing emergency assistance – including shading, ready-to-eat meals, water, sanitation facilities, and medical and protection services – capacities are being stretched, and funding concerns are being reported in some areas, such as water, sanitation and hygiene (WASH) and health…

Syrian Arab Republic
:: 16 Jun 2017 Mobile clinics reach far-flung regions of Syria

Yemen
:: Key messages on cholera (12 June 2017)
Current situation
Yemen is in the grip of a fast spreading cholera outbreak of an unprecedented scale. As of 12 June, WHO reports a cumulative total of 124,002 suspected cases and 923 associated deaths. More than half of the suspected cholera cases have been reported from four governorates: Amanat Al Asimah, Hajjah, Amran and Al Hudeideh. [These figures likely underrepresent the magnitude of the epidemic since only 45% of health facilities in Yemen are effectively functioning and surveillance systems, data collection and verification continues to be a challenge throughout the country. Although rapid test are available, only 2 labs (Sanaa and Aden) are ‘authorised’ to confirm suspected cases. On 14 May, the MoPHP declared a state of emergency in Sana’a governorate stating that the health system is unable to contain this unprecedented health and environmental disaster.]…
…The risk of the epidemic spreading further and affecting thousands more is real as the health/wash systems are unable to cope. Congested urban centers where garbage remains uncollected and overcrowded IDP collective centers/ settlements with precarious sanitation are at high risk of contagion.
Malnourished children, malnourished pregnant women and people living with other chronic health conditions are now at greater risk of death as they face the “triple threat” of conflict, famine and cholera. Their vulnerability cannot be overstated…

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Somalia
:: Humanitarian Common Feedback Project for Accountability to Affected People & Communication with Communities in Somalia for Prevention of Famine, June 2017
Published on 16 Jun 2017
The humanitarian situation in Somalia continues to deteriorate and an elevated risk of famine persists in some parts of the country, only six years after the devastating 2011 famine led to the death of over a quarter million people, half of them children. Over 6.7 million people are now estimated to need humanitarian assistance. This is more than half of the population of Somalia.
Led by OCHA, the Common Feedback Project (CFP) was rolled out in March through the Drought Operations Coordination Centres as part of a collective approach to strengthening two-way consultations between relief workers and affected communities. Working with humanitarian partners, the CFP is collecting, collating and analysing feedback from multiple platforms to identify key themes and issues being raised by communities, particularly related to ongoing drought…
:: Somalia: Drought Response – Situation Report No. 12 (as of 13 June 2017)

Ethiopia
:: Ethiopia Weekly Humanitarian Bulletin, 12 June 2017

DRC (Kasai crisis)No new announcements identified.
NigeriaNo new announcements identified.

::::::
::::::
 
UNICEF  [to 17 June 2017]
https://www.unicef.org/media/media_94367.html
Children account for half of all suspected cholera cases in Yemen
SANA’A, 13 June 2017- “The cholera outbreak in Yemen continues to spread at an alarming speed. Over 124,000 cases have been recorded – almost half of them are children.
“Children continue to bear the brunt of the war in Yemen. Many who have become ill or have died from cholera were suffering from malnutrition. At least 923 people have died from the disease since late April. Children account for one quarter of the deaths.
“The cholera outbreak is overwhelming what remains of Yemen’s conflict-battered health system. Hospitals and treatment centres are struggling to cope with the large number of patients coming in from across the country. Medicines and intravenous fluids are quickly running out.
“But despite these massive challenges, health workers have spared no effort in responding to the emergency – even when their salaries have not been paid for nearly nine months.
“Without an urgent solution to pay health workers, more children will die – no matter how much humanitarian aid is delivered to the country.
“With no end in sight to the conflict, the cholera outbreak – and potentially other disease will continue to stalk the lives of children.”

::::::

Unicef Steps In to Pay Yemen’s Doctors as War and Cholera Rage
New York Times – JUNE 15, 2017
By RICK GLADSTONE
Desperate to halt the cholera crisis afflicting Yemen, Unicef has taken the unusual step of paying the country’s doctors and nurses, who have not received salaries in months.
The regional director for Unicef, Geert Cappelaere, said on Thursday that Yemen’s health workers are crucial to the effort to combat cholera and that they should not be expected to work for free.
Their normal pay has been disrupted by the civil war that has raged since March 2015 between the Saudi-backed government and the country’s Houthi rebels and their allies.
Mr. Cappelaere said Unicef, the United Nations children’s agency, started paying the health workers about four weeks ago. The agency is borrowing the money from an emergency fund to provide medical workers with about 70 percent of what they ordinarily would be paid. The money, which he described as daily stipends, has already amounted to millions of dollars.
“It’s not a common practice at all,” Mr. Cappelaere said in an interview. “That’s also a practice I would not want to see sustained.”
Still, Mr. Cappelaere said it was necessary because, “We’re not going to let kids die.”
He described the cholera crisis ravaging Yemen as “really a massive, massive outbreak” the magnitude of which the country, the poorest in the Middle East, has never experienced…
Half of the country’s health facilities have been destroyed or closed because of the war, which has left roughly 10,000 people dead and millions displaced.
The cholera crisis, Mr. Cappelaere said, “just comes on top of what already was an incredibly daunting situation.”
 
::::::
::::::

EBOLA/EVD  [to 17 June 2017]
http://www.who.int/ebola/en/
WHO AFRO
External Situation Report 24: 16 June 2017
WHO, UN Agencies, international organizations, non-governmental organizations (NGOs) and partners continue to support the Ministry of Health (MoH) in the Democratic Republic of the Congo to rapidly investigate and respond to the outbreak of Ebola virus disease (EVD) in Likati Health Zone, Bas Uele Province in the north-east of the country.
On 15 June 2017, no new confirmed or probable cases were reported. Since the last situation update on 13 June, 9 alerts have been reported and investigated of which two fulfilled the case definition as a suspected case. Both of these suspected cases were from Ngayi. Samples were collected and both tested negative by PCR for EVD. Therefore there are currently a total of five confirmed and three probable cases….
Data modelling suggests that the risk of further cases is currently low but not negligible, and decreases with each day without new confirmed/probable cases. As of the reporting date, 95% of simulated scenarios predict no further cases in the next 30 days.

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

MERS-CoV [to 17 June 2017]
http://www.who.int/emergencies/mers-cov/en/
DONs- Disease Outbreak News
Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia
13 June 2017
Between 1 and 10 June 2017, the national IHR focal point of Saudi Arabia reported 35 additional cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection including three fatal cases and one death among previously reported cases (case number 5 in the Disease Outbreak News published on 6 June 2017)….
 
Zika virus  [to 17 June 2017]
http://www.who.int/emergencies/zika-virus/en/
[No new digest content identified]

Yellow Fever  [to 17 June 2017]
http://www.who.int/emergencies/yellow-fever/en/
[No new digest content identified]

WHO & Regional Offices [to 17 June 2017]

WHO & Regional Offices [to 17 June 2017]

Bhutan, Maldives eliminate measles
13 June 2017 – Bhutan and Maldives have eliminated measles, a highly infectious disease that is a major childhood killer globally. The 2 countries are the first in the WHO South-East Asia Region to be verified for having interrupted endemic measles virus transmission, ahead of the 2020 regional target.

Abuse of older people on the rise – 1 in 6 affected
14 June 2017 – Around 1 in 6 older people experience some form of abuse, a figure higher than previously estimated and predicted to rise as populations age worldwide. Awareness about elder abuse, still largely a taboo topic, has started to increase across the world. It is defined as actions or lack of appropriate action which can cause harm or distress to an older person, occurring within any relationship where there is an expectation of trust.

Highlights
WHO and health authorities investigate suspected cases of foodborne illness in Hassan Sham U2 camp
June 2017 – WHO, in coordination with Iraq’s Erbil and Ninewa Directorates of Health, rapidly responded to a suspected foodborne illness outbreak in Hassan Sham U2 camp by conducting an investigation with the aim of identifying the source and cause of the outbreak, treating those who are ill as well as containing and preventing any spread.

Weekly Epidemiological Record, 16 June 2017, vol. 92, 24 (pp. 333–344)
Contents
333 Validation of maternal and neonatal tetanus elimination in Equatorial Guinea, 2016

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

WHO Region of the Americas PAHO
:: Caribbean Regulatory System recommends its first generic drugs for sale in the region (06/12/2017)
:: Voluntary blood donors are increasing, but the numbers are not enough to ensure sufficient blood supplies (06/12/2017)

WHO South-East Asia Region SEARO
:: ·  Bhutan, Maldives eliminate measles  13 June 2017
 
WHO European Region EURO
:: Day 3 of Environment and Health Conference: Commitments to advance the agenda in Europe 16-06-2017
:: Day 2 of Environment and Health Conference: Addressing inequalities, good governance, rights and resilience 15-06-2017
: Day 1 of Environment and Health Conference: Taking stock of the past to transform the future 14-06-2017
:: United Nations agencies urge Europe’s action on 1.4 million annual deaths from polluted environments 13-06-2017
:: WHO and health partners provide vital care to displaced people in northern Syria 13-06-2017

WHO Eastern Mediterranean Region EMRO
:: King Salman Centre for Humanitarian Aid and Relief supports cholera response in Yemen
15 June 2017
:: WHO and health authorities immediately investigate suspected cases of foodborne illness in Hassan Sham U2 camp in Iraq
13 June 2017
:: WHO conducts EWARN evaluation protocol training workshop in Cairo  13 June 2017

WHO Western Pacific Region
:: Commonwealth of the Northern Mariana Islands achieves hepatitis B milestone
SAIPAN, 15 June 2017 — The Commonwealth of the Northern Mariana Islands – a stretch of 14 islands in the northwest Pacific – may be small, but it is scoring big goals in health. This island chain in political union with the United States of America has just been confirmed by the World Health Organization (WHO) as having reduced hepatitis B infection among children to less than 1%.
 

Announcements  

Announcements
 
PATH  [to 17 June 2017]
http://www.path.org/news/index.php
Announcement | June 15, 2017
Administration’s budget devastating for the world’s most vulnerable
New analysis from leading humanitarian, development and global health organizations calculates the devastating human costs of cuts to foreign assistance
[See Reports section below for full text]
 
Press release | June 12, 2017
United States and Vietnam launch oral HIV pre-exposure option to reduce new infections
Oral HIV pre-exposure prophylaxis (PrEP) is a powerful tool for HIV prevention, especially for those most at risk

::::::
 
UNAIDS  [to 17 June 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update – 8 June 2017
Partners come together for gender-responsive change management
Partners from across the United Nations system came together on 30 May in UNAIDS headquarters in Geneva, Switzerland, to discuss how behavioural, institutional and cultural change can accelerate progress for gender equality.
In her keynote speech, Jan Beagle, Deputy Executive Director of UNAIDS, emphasized that if change management is undertaken in a gender-responsive manner, barriers to gender equality in the workplace can be addressed and overcome. She shared the progress that UNAIDS has made in gender equality, including near gender parity among staff, 40% of UNAIDS country directors being female and 100% compliance with the performance indicators of the United Nations System-Wide Action Plan on Gender Equality and the Empowerment of Women. She also underlined the need to shift organizational cultures to empower staff everywhere. UNAIDS is taking gender out of isolation and mainstreaming equality and inclusion throughout the Secretariat…
 
::::::
 
European Medicines Agency  [to 17 June 2017]
http://www.ema.europa.eu/ema/
16/06/2017
EMA Management Board: highlights of June 2017 meeting
Focus on Brexit preparations and the development of the EU clinical trial portal and database …
Entry into application of EU Clinical Trial Regulation postponed to 2019
The Board discussed the progress made regarding the development of the EU clinical trial portal and database. Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed. EMA is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress. The Board was informed about the mitigation measures taken and the revised plan from the developer. The Agency will provide an update at the next meeting of the Management Board in October 2017 where a new delivery time frame will be discussed once progress with development has been confirmed. Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled.
EMA’s priority is to ensure that a high quality and functional system is delivered to the EU regulatory network and its stakeholders.
The EU clinical trial portal and database supports the ambitious modernisation of the processes for authorisation and oversight of clinical trials in the EU laid down in the EU Clinical Trial Regulation. The system will provide a single portal for submission and maintenance of clinical trial applications and authorisations, and support coordinated assessment and supervision. The portal and database will also serve as the source of public information on the full lifecycle of all clinical trials conducted in the EU, from their initial review up to the publication of their results.
This is the most ambitious IT system required by the EU legislation in the last decade, involving a complete EU-wide system to be used for clinical trial applications, urgent safety measures and other notifications to regulators before, during and after the conduct of clinical trials.
 
::::::
 
Wellcome Trust  [to 17 June 2017]
https://wellcome.ac.uk/news
News / Published: 17 June 2017
MBE for Beth Thompson in Queen’s Birthday Honours
Beth Thompson, Wellcome’s Head of Policy (UK and EU), has been awarded an MBE for her work on the EU Data Protection Regulation.
Jeremy Farrar, Wellcome’s Director, says: “I am thrilled that Beth Thompson’s outstanding leadership in policy has been recognised today in the Queen’s Birthday Honours. Beth’s determination to bring policy makers, researchers and patients together during negotiations about EU Data Protection Regulation resulted in a solution that allows vital cross-border research to take place while protecting individuals’ privacy.
 
::::::
 
Industry Watch
:: Nearly One in Four New and Expectant Parents Have Never Heard of Invasive Pneumococcal Disease According to a New Survey
Pfizer and Parents Magazine Team Up to Educate Parents About a Serious Disease That Can Put a Child’s Life at Risk
June 13, 2017
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE), in partnership with Parents magazine (NYSE:MDP), announced today the results of a national survey of more than 2,000 new and expectant parents assessing their knowledge of childhood infectious diseases, such as measles, whooping cough and invasive pneumococcal disease (IPD), and the measures parents can take to help prevent them…
Conducted online by Harris Poll, the survey found that parents were least knowledgeable about IPD, when compared among 11 childhood illnesses. In fact, only three of every 10 (30%) parents of children under two years of age and expectant parents report they are knowledgeable about IPD.1 Although IPD may be discussed in well-child visits, nearly one in four (23%) have never even heard of it, illustrating the need for more education.1,2 …
 
::::::
::::::
 

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

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

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

[U.S] Administration’s budget devastating for the world’s most vulnerable
New analysis from leading humanitarian, development and global health organizations calculates the devastating human costs of cuts to foreign assistance
15 June 2017,  Washington, DC—Leading American humanitarian, development and health organizations working around the globe have analyzed the Administration’s proposed International Affairs budget for Fiscal Year 2018 (FY 2018) and have estimated that the impact of the proposed cuts would be devastating for the poorest and most vulnerable women, children, and families around the world, as well as for American interests. The organizations, including Bread for the World, Catholic Relief Services, CARE USA, the International Rescue Committee, InterAction, Mercy Corps, ONE Campaign, Oxfam, PATH, Save the Children, and World Vision strongly urge Congress to reject the President’s foreign affairs budget request and maintain current funding of $60 billion.

Congress is considering the FY 2018 budget and the nomination of Ambassador Mark Green to lead the U.S. Agency for International Development in the context of a daunting set of simultaneous and significant global challenges—including famine conditions that threaten the lives of 30 million people, global displacement at an all-time high of 65 million, and more frequent infectious disease outbreaks.

Slashing foreign aid by nearly one-third would shirk America’s longstanding bipartisan commitment to help the world’s most vulnerable people, and would also put the health, security and prosperity of Americans at risk. The deep and disproportionate cuts proposed in the Administration’s FY 2018 International Affairs budget request will have life and death consequences today, and will also undercut America’s – and the world’s – ability to address tomorrow’s global threats.

Sterile statistics on paper are excruciating choices in practice for aid agencies and those we seek to serve in nearly every country around the world. If enacted, the Administration’s FY 2018 budget proposal could result in:
: A 50% cut to agricultural development and nutrition, which would in turn deprive 9 million children of life-saving nutrition interventions and treatments and abandon 5.25 million farmers working to feed their families;
:: The complete elimination of (Title II) food aid and of food security programming- during a hunger crisis and famine constituting the most serious humanitarian crisis since World War II- removing access to life-saving food assistance and long-term food security programming from 30 million people;
: A 45% cut to water and sanitation programs, resulting in over 2 million people losing access to drinkable water;
:: A 53% cut to basic education programming – critical to the futures of millions caught in crisis around the world – including the total elimination of basic education funding in Djibouti, Liberia, Malawi, Mozambique, Rwanda, South Africa, Zambia, Burma, Cambodia, Laos, Ukraine, Tajikistan, Dominican Republic, Nicaragua, Peru, Barbados and Eastern Caribbean;
:: A 44% cut to international disaster assistance, lessening the ability of USAID and partner agencies to reach tens of millions of vulnerable men, women and children with basic humanitarian aid, including over 3 million Yemenis and nearly 2 million Syrians;
: An 18% cut to migration and refugee assistance, cutting off 3.5 million refugees and internally-displaced persons from basic assistance, leading to increased displacement and instability;
:: A 17% cut to the Global Fund to Fight AIDS, TB and Malaria, resulting in the inability to prevent over 4 million new HIV, TB and malaria infections; an 11% cut to the President’s Emergency Plan for AIDS relief (PEPFAR), resulting in over 77,000 AIDS-related deaths; and a 10% cut to the President’s Malaria Initiative, putting an additional 40 million people at risk of contracting malaria;
: A nearly 8% cut to maternal, newborn, and child health funding, which would result in more than 30,000 deaths of mothers and children each year;
Zero funding for the USAID Emergency Reserve Fund and a 14% cut to core global health security programs at the Centers for Disease Control that would increase the likelihood of a global pandemic which is capable of claiming twice as many American lives as the total number of US battlefield fatalities since 1776;
: A 55% cut to gender programs, which would prevent nearly 2 million girls from receiving an education.

In addition to the moral defeat inherent in abandoning millions who rely on lifesaving US assistance around the world, this analysis shows that the impact of these cuts to global humanitarian and development assistance as laid out in the Administration’s budget request, if enacted, would be swift, devastating, and felt for years to come, imperiling millions of lives and the course of global development, stability, and partnership. The U.S. FY 2018 International Affairs budget should match the scale and nature of the global challenges facing America, and reflect the U.S. government’s longstanding bipartisan commitment to shared responsibility and the safeguarding of its own vital interests.

Editor’s Note: The NGOs were listed as involved in the analysis above:
BREAD FOR THE WORLD
CRS
CARE
IRC
INTERACTION
MERCY CORPS
ONE CAMPAIGN
OXFAM
PATH
SAVE THE CHILDREN
WORLD VISION

Journal Watch

Journal Watch

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

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

Cost-effectiveness analysis of the diarrhea alleviation through zinc and oral rehydration therapy (DAZT) program in rural Gujarat India: an application of the net-benefit regression framework

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 17 June 2017)

Research
Cost-effectiveness analysis of the diarrhea alleviation through zinc and oral rehydration therapy (DAZT) program in rural Gujarat India: an application of the net-benefit regression framework
This study evaluates the cost-effectiveness of the DAZT program for scaling up treatment of acute child diarrhea in Gujarat India using a net-benefit regression framework.
Samuel D. Shillcutt, Amnesty E. LeFevre, Christa L. Fischer-Walker, Sunita Taneja, Robert E. Black and Sarmila Mazumder
Published on: 8 June 2017

Assessing the knowledge of expectant mothers on mother–to-child transmission of viral hepatitis B in Upper West region of Ghana

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 17 June 2017)

Research article
Assessing the knowledge of expectant mothers on mother–to-child transmission of viral hepatitis B in Upper West region of Ghana
Viral Hepatitis B is of a major public health concern globally, especially in developing countries. Expectant mothers’ knowledge of Mother-To-Child Transmission (MTCT) of the disease is significant in preventi…
Frederick Dun-Dery, Martin Nyaaba Adokiya, Williams Walana, Ernestina Yirkyio and Juventus B. Ziem
BMC Infectious Diseases 2017 17:416
Published on: 12 June 2017

How to select a proper early warning threshold to detect infectious disease outbreaks based on the China infectious disease automated alert and response system (CIDARS)

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 17 June 2017)

Research article
How to select a proper early warning threshold to detect infectious disease outbreaks based on the China infectious disease automated alert and response system (CIDARS)
China Centre for Diseases Control and Prevention (CDC) developed the China Infectious Disease Automated Alert and Response System (CIDARS) in 2005. The CIDARS was used to strengthen infectious disease surveill…
Ruiping Wang, Yonggen Jiang, Engelgau Michael and Genming Zhao
BMC Public Health 2017 17:570
Published on: 12 June 2017

Public access to clinical trials: Lessons from an organizational implementation of policy

Contemporary Clinical Trials
Volume 57, Pages 1-100 (June 2017)
http://www.sciencedirect.com/science/journal/15517144/57

Clinical Trial Results
Public access to clinical trials: Lessons from an organizational implementation of policy
Pages 87-89
Grant D. Huang, Jane K. Altemose, Timothy J. O’Leary
Abstract
Efforts to make clinical trials and their results more publicly available have been increasing in recent years. However, there is a need to better understand ways to achieve these goals aimed at benefiting a diverse set of stakeholders. Since 2005, the U.S. Department of Veterans Affairs Office of Research and Development (ORD), part of the nation’s largest integrated health care system, has required the clinical trials its funds to be registered in ClinicalTrials.gov as a condition of the award. Furthermore, summary results of studies active since 2007 have been included in the registry. This paper highlights ORD activities, challenges and lessons at investigator, study, and organizational levels. Key factors in ORD’s approach include: a mission-oriented approach; leadership support; a working group for organizational policies and practices; prioritizing communication; and recognizing the needs of investigators. Making clinical trials available to the public should represent a focal point for groups desiring to maximize the contributions from such research. The ability to do so must involve a commitment by sponsors and a critical evaluation of the reasons, requirements and resources at multiple levels.

Estimation of age-specific rates of reactivation and immune boosting of the varicella zoster virus

Epidemics
Volume 19, Pages 1-84 (June 2017)
http://www.sciencedirect.com/science/journal/17554365

Regular Articles
Estimation of age-specific rates of reactivation and immune boosting of the varicella zoster virus
Original Research Article
Pages 1-12
Isabella Marinelli, Alies van Lier, Hester de Melker, Andrea Pugliese, Michiel van Boven
Abstract
Studies into the impact of vaccination against the varicella zoster virus (VZV) have increasingly focused on herpes zoster (HZ), which is believed to be increasing in vaccinated populations with decreasing infection pressure. This idea can be traced back to Hope-Simpson’s hypothesis, in which a person’s immune status determines the likelihood that he/she will develop HZ. Immunity decreases over time, and can be boosted by contact with a person experiencing varicella (exogenous boosting) or by a reactivation attempt of the virus (endogenous boosting). Here we use transmission models to estimate age-specific rates of reactivation and immune boosting, exogenous as well as endogenous, using zoster incidence data from the Netherlands (2002–2011, n = 7026). The boosting and reactivation rates are estimated with splines, enabling these quantities to be optimally informed by the data. The analyses show that models with high levels of exogenous boosting and estimated or zero endogenous boosting, constant rate of loss of immunity, and reactivation rate increasing with age (to more than 5% per year in the elderly) give the best fit to the data. Estimates of the rates of immune boosting and reactivation are strongly correlated. This has important implications as these parameters determine the fraction of the population with waned immunity. We conclude that independent evidence on rates of immune boosting and reactivation in persons with waned immunity are needed to robustly predict the impact of varicella vaccination on the incidence of HZ.

Defining epidemics in computer simulation models: How do definitions influence conclusions?

Epidemics
Volume 19, Pages 1-84 (June 2017)
http://www.sciencedirect.com/science/journal/17554365

Defining epidemics in computer simulation models: How do definitions influence conclusions?
Original Research Article
Pages 24-32
Carolyn Orbann, Lisa Sattenspiel, Erin Miller, Jessica Dimka
Abstract
Computer models have proven to be useful tools in studying epidemic disease in human populations. Such models are being used by a broader base of researchers, and it has become more important to ensure that descriptions of model construction and data analyses are clear and communicate important features of model structure. Papers describing computer models of infectious disease often lack a clear description of how the data are aggregated and whether or not non-epidemic runs are excluded from analyses. Given that there is no concrete quantitative definition of what constitutes an epidemic within the public health literature, each modeler must decide on a strategy for identifying epidemics during simulation runs. Here, an SEIR model was used to test the effects of how varying the cutoff for considering a run an epidemic changes potential interpretations of simulation outcomes. Varying the cutoff from 0% to 15% of the model population ever infected with the illness generated significant differences in numbers of dead and timing variables. These results are important for those who use models to form public health policy, in which questions of timing or implementation of interventions might be answered using findings from computer simulation models.

Sub-national assessment of aid effectiveness: A case study of post-conflict districts in Uganda

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 17 June 2017]

Research
Sub-national assessment of aid effectiveness: A case study of post-conflict districts in Uganda
In post-conflict settings, many state and non-state actors interact at the sub-national levels in rebuilding health systems by providing funds, delivering vital interventions and building capacity of local gov…
Freddie Ssengooba, Justine Namakula, Vincent Kawooya and Suzanne Fustukian
Globalization and Health 2017 13:32
Published on: 13 June 2017

A global research agenda on migration, mobility, and health

The Lancet
Jun 17, 2017 Volume 389 Number 10087 p2349-2442  e15
http://www.thelancet.com/journals/lancet/issue/current

Comment
A global research agenda on migration, mobility, and health
Johanna Hanefeld, Johanna Hanefeld, Jo Vearey, Neil Lunton behalf of the
Researchers on Migration, Mobility and Health Group
Summary
With 1 billion people on the move globally—more than 244 million of whom have crossed international borders1—and a recognised need to strengthen efforts towards universal health coverage,2 developing a better understanding of how to respond to the complex interactions between migration, mobility, and health is vital. At the 2nd Global Consultation on Migrant Health in Sri Lanka earlier this year, a group of global experts in health and migration discussed the progress and shortfalls in attaining the actions set out in the 2008 World Health Assembly (WHA) Resolution on the Health of Migrants.

 

Nature  Volume 546 Number 7658 pp327-446  15 June 2017

Nature 
Volume 546 Number 7658 pp327-446  15 June 2017
http://www.nature.com/nature/current_issue.html

Letters
Genomic epidemiology reveals multiple introductions of Zika virus into the United States
Nathan D. Grubaugh, Jason T. Ladner, Moritz U. G. Kraemer, Gytis Dudas, Amanda L. Tan
+ et al.
Genome sequencing of Zika virus samples from infected patients and Aedes aegypti mosquitoes in Florida shows that the virus was probably introduced into the United States on multiple occasions, and that the Caribbean is the most likely source.

Establishment and cryptic transmission of Zika virus in Brazil and the Americas
R. Faria, J. Quick, I.M. Claro, J. Thézé, J. G. de Jesus
+ et al.
Virus genomes reveal the establishment of Zika virus in Brazil and the Americas, and provide an appropriate timeframe for baseline (pre-Zika) microcephaly in different regions.
 
Zika virus evolution and spread in the Americas
Hayden C. Metsky, Christian B. Matranga, Shirlee Wohl, Stephen F. Schaffner, Catherine A. Freije+ et al.
One hundred and ten Zika virus genomes from ten countries and territories involved in the Zika virus epidemic reveal rapid expansion of the epidemic within Brazil and multiple introductions to other regions.

PLoS One [Accessed 17 June 2017]

PLoS One
http://www.plosone.org/
[Accessed 17 June 2017]

Research Article
Protecting an island nation from extreme pandemic threats: Proof-of-concept around border closure as an intervention
Matt Boyd, Michael G. Baker, Osman D. Mansoor, Giorgi Kvizhinadze, Nick Wilson
| published 16 Jun 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0178732

Research Article
Increasing prevalence of infectious diseases in asylum seekers at a tertiary care hospital in Switzerland
he increasing number of refugees seeking asylum in Europe in recent years poses new challenges for the healthcare systems in the destination countries. The goal of the study was to describe the evolution of medical problems of asylum seekers at a tertiary care centre in Switzerland.
Constantine Bloch-Infanger, Veronika Bättig, Jürg Kremo, Andreas F. Widmer, Adrian Egli, Roland Bingisser, Manuel Battegay, Stefan Erb
| published 15 Jun 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0179537

Experiences of Ebola Survivors: Causes of Distress and Sources of Resilience

Prehospital & Disaster Medicine
Volume 32 – Issue 3 – June 2017
https://www.cambridge.org/core/journals/prehospital-and-disaster-medicine/latest-issue

Original Research
Experiences of Ebola Survivors: Causes of Distress and Sources of Resilience
Patricia M. Schwerdtle, Veronique De Clerck, Virginia Plummer
DOI: https://doi.org/10.1017/S1049023X17000073
Published online: 20 February 2017, pp. 234-239
Abstract
An appreciation of the experience of Ebola survivors is critical for community engagement and an effective outbreak response. Few qualitative, descriptive studies have been conducted to date that concentrate on the voices of Ebola survivors.
This study aimed to explore the experiences of Ebola survivors following the West African epidemic of 2014.
An interpretive, qualitative design was selected using semi-structured interviews as the method of data collection. Data were collected in August 2015 by Médecins Sans Frontières (MSF) Belgium, for the purposes of internal evaluation. Data collection occurred at three sites in Liberia and Sierra Leone and involved 25 participants who had recovered from Ebola. Verbal consent was obtained, audio recordings were de-identified, and ethics approval was provided by Monash University (Melbourne, Australia).
Two major themes emerged from the study: “causes of distress” and “sources of resilience.”    Two further sub-themes were identified from each major theme: the “multiplicity of death,” “abandonment,” “self and community protection and care,” and “coping resources and activities.” The two major themes were dominant across all three sample groups, though each survivor experienced infection, treatment, and recovery differently.
By identifying and mobilizing the inherent capacity of communities and acknowledging the importance of incorporating the social model of health into culturally competent outbreak responses, there is an opportunity to transcend the victimization effect of Ebola and empower communities, ultimately strengthening the response.

The effect of timing of influenza vaccination and sample collection on antibody titers and responses in the aged

Vaccine
Volume 35, Issue 30, Pages 3691-3796 (27 June 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/30

Regular papers
The effect of timing of influenza vaccination and sample collection on antibody titers and responses in the aged
Original Research Article
Pages 3700-3708
Raj K. Kurupati, Andrew Kossenkoff, Senthil Kannan, Larissa H. Haut, Susan Doyle, Xiangfan Yin, Kenneth E. Schmader, Qin Liu, Louise Showe, Hildegund C.J. Ertl
Abstract
Antibody responses, B cell subset distribution in blood and the blood transcriptome were analyzed in younger and aged human subjects before and after vaccination with the inactivated influenza vaccine. In the aged, but not the younger, individuals we saw a clear difference in antibody titers including those at baseline depending on the time of vaccination and sample collection. Differences in baseline titers in aged individuals treated in the morning or afternoon in turn affected responsiveness to the vaccine. In both younger and aged individuals, the time of sample collection also affected relative numbers of some of the B cell subsets in blood. A global gene expression analysis with whole blood samples from the aged showed small but statistically significant differences depending on the time of sample collection. Our data do not indicate that timing of vaccination affects immune responsiveness of the aged, but rather shows that in clinical influenza vaccine trials timing of collection of samples can have a major and potentially misleading influence on study outcome. In future vaccine trials, timing of vaccination and sample collection should be recorded carefully to allow for its use as a study covariant.

Factors associated with parental acceptance of seasonal influenza vaccination for their children – A telephone survey in the adult population in Germany

Vaccine
Volume 35, Issue 30, Pages 3691-3796 (27 June 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/30

Factors associated with parental acceptance of seasonal influenza vaccination for their children – A telephone survey in the adult population in Germany
Original Research Article
Pages 3789-3796
Lena Boes, Birte Boedeker, Patrick Schmich, Matthias Wetzstein, Ole Wichmann, Cornelius Remschmidt
Abstract
Introduction
Influenza vaccination of children with underlying chronic diseases is currently recommended in Germany, but targeting all children constitutes an alternative approach to control seasonal influenza. To inform the modelling of vaccination impact and possible communication activities, we aimed to assess among parents the acceptance of universal childhood vaccination against seasonal influenza and possible modifiers.
Methods
We conducted a telephone survey in households in Germany using random digit dialing. We interviewed parents with children aged <18 years by constructing three hypothetical scenarios in subsequent order: (1) hearing about the influenza vaccination recommendation through the media, (2) the vaccine being recommended by a physician, and (3) being informed about the availability of the vaccine as a nasal spray. We calculated the proportion of parents who would immunize their child and used univariable and multivariable logistic regression to identify factors associated with influenza vaccination intention.
Results
Response was between 22 and 46%. Of 518 participants, 74% were female, mean age was 41.3 years. Participants had on average 1.6 children with a mean age of 8.9 years. In scenario 1, 52% of parents would immunize their child, compared to 64% in scenario 2 (p<0.01) and to 45% in scenario 3 (p=0.20). Factors independently associated with vaccination acceptance in scenario 1 were previous influenza vaccination of the child or parent (adjusted odds ratio [aOR] 4.5 and 8.6, respectively), perceived severity of influenza (aOR=5.1) and living in eastern Germany (aOR=2.4).
Conclusion
If seasonal influenza vaccination was recommended for all children, more than half of the parents would potentially agree to immunize their child. Involving physicians in future information campaigns is essential to achieve high uptake. As intranasal vaccine administration is non-invasive and easily done, it remains unclear why scenario 3 was associated with low acceptance among parents, and the underlying reasons should be further explored.

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

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

BMJ Open
Volume 7, Issue 6  2017
Health economics
Research
A systematic review of economic evaluations of seasonal influenza vaccination for the elderly population in the European Union
GE Shields, J Elvidge, LM Davies
Abstract
Objectives The Council of the European Union (EU) has recommended that action should be taken to increase influenza vaccination in the elderly population. The aims were to systematically review and critically appraise economic evaluations for influenza vaccination in the elderly population in the EU.
Methods Electronic searches of the NHS Economic Evaluation, Health Technology Assessment, MEDLINE and Embase databases were run to identify full economic evaluations. Two levels of screening were used, with explicit inclusion criteria applied by two independent reviewers at each stage. Prespecified data extraction and critical appraisal were performed on identified studies. Results were summarised qualitatively.
Results Of the 326 search results, screening identified eight relevant studies. Results varied widely, with the incremental cost-effectiveness ratio ranging from being both more effective and cheaper than no intervention to costing €4 59 350 per life-year gained. Cost-effectiveness was most sensitive to variations in influenza strain, vaccination type and strategy, population and modelling characteristics.
Conclusions Most studies suggest that vaccination is cost-effective (seven of eight studies identified at least one cost-effective scenario). All but one study used economic models to synthesise data from different sources. The results are uncertain due to the methods used and the relevance and robustness of the data used. Sensitivity analysis to explore these aspects was limited. Integrated, controlled prospective clinical and economic evaluations and surveillance data are needed to improve the evidence base. This would allow more advanced modelling techniques to characterise the epidemiology of influenza more accurately and improve the robustness of cost-effectiveness estimates.
 
 
Expert Review of Pharmacoeconomics & Outcomes Research
Latest Articles
Review
A systematic review of the health economic consequences of quadrivalent influenza vaccination
P.T. de Boer, B.M. van Maanen, Oliver Damm, Bernhard Ultsch, Franklin C.K. Dolk, Pascal Crépey, Richard Pitman, J.C. Wilschut & M.J. Postma http://orcid.org/0000-0002-6306-3653
This is the author accepted version which has not been proofed or edited
Abstract
Background: Quadrivalent influenza vaccines (QIVs) contain antigens derived from an additional influenza type B virus as compared with currently used trivalent influenza vaccines (TIVs). This should overcome a potential reduced vaccine protection due to mismatches between TIV and circulating B viruses. In this study, we systematically reviewed the available literature on health economic evaluations of switching from TIV to QIV.
Areas Covered: The databases of Medline and Embase were searched systematically to identify health economic evaluations of QIV versus TIV published before September 2016.A total of sixteen studies were included, thirteen cost-effectiveness analyses and three cost-comparisons.
Expert commentary: Published evidence on the cost-effectiveness of QIV suggests that switching from TIV to QIV would be a valuable intervention from both the public health and economic viewpoint. However, more research seems mandatory. Our main recommendations for future research include: 1) more extensive use of dynamic models in order to estimate the full impact of QIV on influenza transmission including indirect effects, 2) improved availability of data on disease outcomes and costs related to influenza type B viruses, and 3) more research on immunogenicity of natural influenza infection and vaccination, with emphasis on cross-reactivity between different influenza B viruses and duration of protection.

ASCO Annual Meeting 2017 – Paper
Prevention of HPV-Related Cancers: A Case for Global Equity and Local Action
June 2, 2017
By Cosette M. Wheeler, PhD; Isabel C. Scarinci, PhD, MPH; Silvia de Sanjosé, MD, PhD; and Silvina Arrossi, PhD
Article Highlights
HPV causes virtually all cervical cancer, with 87% of deaths occurring in low- and middle-income countries. HPV vaccines can dramatically reduce HPV-related cancer incidence, and international efforts are underway to promote HPV vaccination.
The structure and strength of local health care systems and infrastructure for vaccine delivery are key to HPV vaccine implementation, and approaches may require adaptations to existing delivery settings to provide effective vaccination programs.
Given that health care provider recommendation is the strongest predictor of HPV vaccination,36-39 providers in the United States have a prime opportunity to promote HPV vaccination by pairing HPV vaccination with required vaccinations, such as tetanus-diphtheria-acellular pertussis (Tdap) and meningococcal vaccinations.36-39
Although HPV vaccination is the primary tool in our fight to eliminate cervical and other HPV-related cancers, it does not replace cervical cancer screening, including screening of women who have received HPV vaccination or who are already infected with high-risk HPV.

JAIDS Journal of Acquired Immune Deficiency Syndromes
1 July 2017 – Volume 75 – Issue – p S370–S374
Increasing Human Papillomavirus Vaccine Coverage Among Men Who Have Sex With Men—National HIV Behavioral Surveillance, United States, 2014
SE Oliver, BE Hoots, G Paz-Bailey, LE Markowitz… –
Abstract
Background: Human papillomavirus (HPV) can cause oropharyngeal and anogenital cancers among men who have sex with men (MSM). In 2011, the Advisory Committee on Immunization Practices (ACIP) extended HPV vaccine recommendations to males through age 21 and MSM through age 26. Because of this distinction, vaccination for some MSM might rely on sexual behavior disclosure to health care providers. Receipt of ≥1 HPV vaccination among MSM aged 18–26 in National HIV Behavioral Surveillance (NHBS) was 4.9% in 2011. We evaluated HPV vaccine coverage and associated factors among MSM in 2014.
Setting: Twenty US metropolitan statistical areas in 2014.
Methods: Coverage was calculated as percentage of MSM self-reporting ≥1 HPV vaccination. Adjusted prevalence ratios were calculated from Poisson regression models to estimate associations of demographic and behavioral characteristics with HPV vaccination.
Results: Among 2892 MSM aged 18–26 years, HPV vaccine coverage was 17.2%. Overall, 2326 (80.4%) reported a health care visit within 12 months, and 2095 (72.4%) disclosed MSM attraction or behavior to a health care provider. Factors associated with vaccination included self-reported HIV infection; having a health care visit within 12 months, health insurance, or a usual place of care; and disclosing MSM attraction or behavior to a health care provider.
Conclusions: Since the 2011 recommendation for vaccination of males, HPV vaccine coverage among MSM increased, but remains low. Most MSM reported a recent health care visit and disclosed sexual behavior, indicating opportunities for vaccination. Potential strategies for increasing MSM coverage include improving access to recommended care, and offering education for providers and patients

Media/Policy Watch

Media/Policy Watch

This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

 

BBC
http://www.bbc.co.uk/
Accessed 17 June 2017
14 Jun 2017
DR Congo polio outbreak ‘from poor vaccine coverage’

14 Jun 2017
Drone vaccine delivery trial for island nation Vanuatu
Lifesaving vaccines in the island nation of Vanuatu will soon be delivered to remote areas by drone.
A partnership between the government and the United Nations children’s fund (Unicef) will see a trial on drone medical delivery next year…
Vanuatu’s director general at the ministry of health said the test was a milestone for the small island nation.
“If the trial shows that vaccine delivery using drones can work, and that it can be integrated into our existing national and provincial systems, then it will change the way we operate forever,” George Taleo said.
Unicef said: “Ensuring vaccines are consistently available in isolated and remote communities is one of the keys to sustaining high rates of immunisation.”…

Forbes
http://www.forbes.com/
Accessed 17 June 2017
Gates Foundation And Rotary Pledge Additional $450 Million To End Polio
Michela Tindera, Forbes Staff
As the world inches closer toward eradicating polio, the Bill & Melinda Gates Foundation and service organization Rotary will spend nearly half a billion dollars in an effort to eliminate the disease over the next three years.

New York Times
http://www.nytimes.com/
Accessed 17 June 2017
UN: Trucks Readied to Send Polio Vaccine for IS-Held Syria
June 15, 2017 – By THE ASSOCIATED PRESS
GENEVA — A U.N. humanitarian aid adviser for Syria says trucks are being prepared to ship polio vaccine into Islamic State group-held areas of Deir el-Zour governorate following confirmation of a “very dangerous” outbreak …

Washington Post
http://www.washingtonpost.com/
Accessed 17 June 2017
The World Health Organization just picked a new leader. These are the challenges he faces.
15 June 2017
… Tedros may be in the impossible position of trying to satisfy too many demands with not nearly enough money. He and WHO will once again be tested. In his first news conference after his victory, Tedros suggested that he wanted to diversify the financial base of support of WHO by tapping other organizations such as the vaccine alliance GAVI, and by emulating UNICEF, which raises funds via high-profile Halloween collection boxes and sponsorship from the international soccer club Barcelona…

Vaccines and Global Health: The Week in Review 10 June 2017

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

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

 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_10 June 2017

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

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

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

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

Milestones :: Perspectives

Milestones :: Perspectives

Editor’s Note:
Two polio-related items lead our coverage this week.
   The first is the impending financial and programmatic sustainability crisis stemming from the wind-down of the GPEI and its funding of much non-GPEI WHO staff and programming. This crisis is noted “with great concern” by the WHA action below.
   The second is an outbreak of a circulating vaccine-derived poliovirus type 2 (cVDPV2) in Syria as reported in the weekly GPEI update below
 
 

Poliomyelitis: polio transition planning
SEVENTIETH WORLD HEALTH ASSEMBLY   WHA70(9)
Agenda item 12.3
29 May 2017
[Full text; Editor’s text bolding]
The Seventieth World Health Assembly, having considered the updated report on polio
transition planning,1 decided:

[1] to acknowledge that the active role taken by the Office of the Director -General in
directing and leading this process is of key importance;

(2) to emphasize the critical and urgent need to maintain and pursue eradication efforts in polio-endemic countries and to sustain surveillance in countries through polio eradication certification, and the importance of ensuring that the Global Polio Eradication Initiative is fit for purpose, with adequate levels of qualified staff;

(3) to acknowledge that the ramp -down of the Global Polio Eradication Initiative has started and highlight the need for WHO to strategically manage the resulting impact on WHO human resources and other assets;

(4) to note the ongoing process of developing a post-certification strategy that will define the essential polio functions needed to sustain eradication and maintain a polio-free world;

(5) to highlight the need for WHO to work with all relevant stakeholders on options for ensuring effective accountability and oversight after eradication in the post-certification strategy;

(6) to note with great concern the reliance on the Global Polio Eradication Initiative’s funding of WHO at global, regional and country levels, involving many WHO programme activities, and the financial, organizational and programmatic risks that this reliance entails for WHO, including risks for the sustainability of WHO’s capacity to ensure effective delivery in key programmatic areas and to maintain essential continuing functions;
 
(7) to note also the proposed list of actions to be implemented by the end of 2017, as referred to in document A70/14 Add.1, in particular in relation to the development of a comprehensive WHO strategic action plan on polio transition;

(8) to urge the Director-General:

(a) to make polio transition a key priority for the Organization at its three levels;
(b) to ensure that the development of the WHO strategic action plan on polio transition is guided by an overarching principle of responding to country needs and priorities, including by participating in and supporting Global Polio Eradication Initiative country transition planning;
(c) to mainstream best practices from polio eradication into all relevant health interventions and build capacity and responsibility for polio eradication ongoing functions and assets in national programmes, while maintaining WHO’s capacity to provide norms and standards for post-eradication planning and oversight;
(d) to explore innovative ways for mobilizing additional funding for the period 2017−2019 in order to mitigate the possible impact on the ramp-down of the Global Polio Eradication Initiative and on the longer-term sustainability of key assets that are currently financed by the Global Polio Eradication Initiative, and to update Member States on this work, through a dedicated session at the forthcoming financing dialogue;

(9) to request the Director-General:

(a) to develop a strategic action plan on polio transition by the end of 2017, to be submitted for consideration by the Seventy-first World Health Assembly, through the Executive
Board at its 142nd session, that:

(i) clearly identifies the capacities and assets, especially at country and, where appropriate, community levels, that are required to:
– sustain progress in other programmatic areas, such as: disease
surveillance; immunization and health systems strengthening; early
warning, emergency and outbreak response, including the strengthening
and maintenance of core capacities under the International Health
Regulations (2005);
– maintain a polio-free world after eradication;

(ii) provides a detailed costing of these capacities and assets;

(b) to present to the Seventy-first World Health Assembly a report on the efforts to
mobilize funding for transitioning capacities and assets that are currently
financed by the Global Polio Eradication Initiative into the programme budget,
to enable the Seventy-first World Health Assembly to provide guidance for the
development of the programme budget for the biennium 2020–2021 and the Thirteenth
General Programme of Work on a realistic basis;

(c) to report regularly on the planning and implementation of the transition process to the
Health Assembly, through the Regional Committees and the Executive Board.

 

(Ninth plenary meeting, 29 May 2017
[1] Document A70/14 Add.1

Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 7 June 2017
:: In Syria, a circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak has been confirmed.  The virus strain was isolated from two cases of acute flaccid paralysis (AFP) and one healthy contact, from Deir-Ez-Zor governorate.  See the ‘Syrian Arab Republic’ section below for more information.

:: The final decision made by the World Health Assembly on 29 May on polio transition planning is now available online.  The decision follows extensive discussions by Member States on the need to address the challenge of scaling down the polio programme as eradication comes closer, including the potential impact on achieving and sustaining a polio-free world, on health system programmes and on systems currently supported by polio assets.  Delegates welcomed existing efforts to plan for the post-polio world, and stressed the importance of careful, considered and strategic approaches to the transition of polio assets, requesting the Director-General to prepare a detailed transition action plan.

:: Summary of newly-reported viruses this week: Syria – two new circulating vaccine-derived poliovirus type 2 (cVDPV2) isolated from acute flaccid paralysis (AFP) cases and one cVDPV2 isolated from a healthy contact; and, Pakistan – four new environmental sample positive for wild poliovirus type 1 (WPV1).

Weekly country updates as of 7 June 2017
Syrian Arab Republic
:: In Syria, a circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak has been confirmed.  The virus strain was isolated from two cases of acute flaccid paralysis (AFP) and one healthy contact (collection date: 25 April 2017), from Deir-Ez-Zor governorate.  The cases had onset of paralysis on 5 March and 6 May.
:: No case of WPV1 has been reported in Syria since 21 January 2014.
:: Outbreak response plans are being finalized, in line with internationally-agreed outbreak response protocols.  Although access to Deir-Ez-Zor is compromised due to insecurity, the Governorate has been partially reached by several vaccination campaigns against polio and other vaccine-preventable diseases since the beginning of 2016. Most recently, two campaigns have been conducted in March and April 2017 using the bivalent oral polio vaccine (OPV). However, only limited coverage was possible through these campaigns.

::::::

WHO Grade 3 Emergencies  [to 10 June 2017]
Nigeria
Overview of WHO operations in north eastern Nigeria
June 2017 —WHO has decided to adopt a sub-regional approach across the four Lake Chad basin affected countries, to increase its interventions, which will address the health needs of the displaced populations and host communities alike.

Iraq  – No new announcements identified.
South SudanNo new announcements identified.
The Syrian Arab Republic  – No new announcements identified
YemenNo new announcements identified.
[see UNICEF reports below]

WHO Grade 2 Emergencies  [to 10 June 2017]
Cameroon 
WHO opened a field office in Maroua to support the emergencies in the north.
2 June 2016 — The WHO Country Office in Cameroon is strengthening the emergency response in the North Region. It has opened a field office in Maroua, capital of the Region, located 1153 km from Yaounde.

Central African Republic  – No new announcements identified.  [see UNICEF reports below]
Democratic Republic of the CongoNo new announcements identified.
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
 
::::::
 
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. 36 (29 May to 4 June 2017) [EN/KU]

Syrian Arab Republic
:: 9 Jun 2017  Palais briefing notes on cholera in Yemen and circulating vaccine-derived poliovirus in Syria
:: Syria Crisis: Ar-Raqqa Situation Report No. 7 (as of 3 June 2017)

Yemen
:: 9 Jun 2017  Palais briefing notes on cholera in Yemen and circulating vaccine-derived poliovirus in Syria
:: Yemen Humanitarian Bulletin Issue 24 | 07 June 2017
[see UNICEF reports below]

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
DRC (Kasai crisis)
:: Complex Emergency in the Kasai region DR Congo Situation Report No.7 (31 May 2017)

Somalia
:: Somalia: Drought Response – Situation Report No. 11 (as of 6 June 2017)
:: Humanitarian Bulletin Somalia May 2017 | Issued on 2 June 2017

Ethiopia
:: Ethiopia Weekly Humanitarian Bulletin, 05 June 2017

NigeriaNo new announcements identified.

::::::
::::::
 

UNICEF  [to 10 June 2017]
https://www.unicef.org/media/media_94367.html
82 June, 2017

Number of suspected cholera cases reaches 100,000 in Yemen
SANA’A, Yemen, 8 June 2017 – The number of suspected cholera cases in Yemen continues to rise, reaching 101,820 with 791 deaths as of 7 June 2017. Worst affected are the country’s most vulnerable: children under the age of 15 account for 46 per cent of cases, and those aged over 60 represent 33 per cent of fatalities.

The World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) are honing in on areas reporting the highest number of cases to stop the disease from spreading further.

“These cholera ‘hot spots’ are the source of much of the country’s cholera transmission,” said Dr Nevio Zagaria, the head of WHO’s office in Yemen. “Stamp out cholera in these places and we can slow the spread of the disease and save lives. At the same time, we’re continuing to support early and proper treatment for the sick and conducting prevention activities across the country.”

The race to contain the cholera outbreak will not be won easily. The country’s health system has been nearly destroyed by more than two years of intense conflict. Less than half of the country’s health centres are fully functional. Medical supplies are flowing into the country at a third of the rate that they were entering Yemen before March 2015. Important infrastructure has been damaged by the violence, cutting 14.5 million people off from regular access to clean water and sanitation. Health and sanitation workers have not received their salaries in more than eight months.

“The cholera outbreak is making a bad situation for children drastically worse. Many of the children who have died from the disease were also acutely malnourished”, said Dr Meritxell Relano, UNICEF’s Representative in Yemen. “Today, life for children in Yemen is a desperate struggle for survival, with cholera, malnutrition and the relentless violence constantly sounding a death knell at their doorsteps,” she said.

UNICEF, WHO, along with their partners, are working on a war footing to respond to this latest outbreak. Nearly 3.5 million people across the country have been reached by disinfecting water tanker filling stations, chlorinating drinking water, restoration of water treatment plants, rehabilitation of water supply systems, providing household water treatments and distributing hygiene kits (soaps and washing powders).  UNICEF and WHO are both providing support and medical supplies to Oral Rehydration Centres and Diarrheal treatment centres across the country where patients are being screened and provided immediate medical support.  All this is done along with disseminating hygiene awareness to the affected populations.

The total funding needed for the joint response activities of health, water and sanitation partners comes to US$ 66.7 million for six months. While donors have been generous to date, more funding is still required, particularly for water and sanitation interventions. The biggest need, however, is for an increased number of partners in the field across the country, including in areas with poor access due to conflict.
 
::::::
::::::

EBOLA/EVD  [to 10 June 2017]
http://www.who.int/ebola/en/

Ebola Situation report: 09 June 2017
09 June 2017
Situation update
WHO, UN Agencies, international organizations, non-governmental organizations (NGOs) and partners con­tinue to support the Ministry of Health (MoH) in the Democratic Republic of the Congo to rapidly investigate and respond to the outbreak of Ebola virus disease (EVD) in Likati Health Zone, Bas Uele Province in the north-east of the country.

On 08 June 2017, no new confirmed, probable or suspected EVD cases were reported. The last confirmed case was isolated on 17 May 2017 and tested negative for EVD by PCR for the second time on 21 May 2017.

There are currently a total of five confirmed and three probable cases. Of these, four survived and four died, resulting in a case fatality rate of 50%. The confirmed and probable cases were reported from Nambwa (four confirmed and two probable), Ngayi (one probable) and Mabongo (one confirmed) in Likati Health Zone. All contacts completed the follow up monitoring period. Active case search is ongoing and thirteen community alerts were reported and investigated, none of which fulfilled the criteria to be a suspect case.

Modelling suggests the risk of further cases is currently low but not negligible, and decreases with each day without new confirmed/probable cases. As of the reporting date, 83% of simulated scenarios predict no fur­ther cases in the next 30 days.

All seven response committees are maintaining functionality at the national level, namely monitoring, case management, water sanitation and hygiene (WASH) and biosafety, laboratory and research, pyscho-social management, logistics, and communication. A response team will remain in the affected areas until the dec­laration of the end of the outbreak.

Current risk assessment

The previous risk assessment was re-evaluated by WHO in light of the evolution of the outbreak and the available information.

  • :: The overall risk at the national level has been revised to moderate due to the fact that a rapid response team was deployed, field investigation identified cases and contacts and all contacts completed their 21 day monitoring period. A response team remains in the field and treatment units are established.
  • :: The risk at the regional and global level is low as no cases have been reported outside of Likati health zone and the area is remote with limited access and transport to/from the affected area.

Vaccination

  • :: The protocol for a possible ring vaccination has been formally approved by the national regulatory author­ity and Ethics Review Board of the Democratic Republic of the Congo Vaccine…
  • :: International vaccine deployment and cold chain shipment to DRC is not advised at this point.

 
WHO responds to Ebola in Democratic Republic of the Congo
6 June 2017 – Multidisciplinary teams face numerous challenges as they respond to an outbreak of Ebola virus disease in the remote, forested regions of the Democratic Republic of the Congo. WHO and partners are supporting the country’s Ministry of Health in all aspects of the response, including epidemiological investigation, surveillance, logistics and supplies, communications, and community engagement.

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

Zika virus  [to 10 June 2017]
http://www.who.int/emergencies/zika-virus/en/
[No new digest content identified]

MERS-CoV [to 10 June 2017]
http://www.who.int/emergencies/mers-cov/en/
DONs- Disease Outbreak News
Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia, United Arab Emirates, and Qatar
6 June 2017
Between 21 April and 29 May 2017, the National IHR Focal Point of Saudi Arabia reported 25 additional cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection including six fatal cases. On 16 May 2017, the IHR NFP of the United Arab Emirates reported two (2) additional case of MERS-CoV. On 23 May 2017, the National IHR Focal Point of Qatar reported one additional case of MERS-CoV…
 
Yellow Fever  [to 10 June 2017]
http://www.who.int/emergencies/yellow-fever/en/
[No new digest content identified]

WHO & Regional Offices [to 10 June 2017]

WHO & Regional Offices [to 10 June 2017]
 
WHO updates Essential Medicines List with new advice on use of antibiotics, and adds medicines for hepatitis C, HIV, tuberculosis and cancer
News release
6 June 2017 | Geneva – New advice on which antibiotics to use for common infections and which to preserve for the most serious circumstances is among the additions to the WHO Model list of essential medicines for 2017. Other additions include medicines for HIV, hepatitis C, tuberculosis and leukaemia.

The updated list adds 30 medicines for adults and 25 for children, and specifies new uses for 9 already-listed products, bringing the total to 433 drugs deemed essential for addressing the most important public health needs. The WHO Essential Medicines List (EML) is used by many countries to increase access to medicines and guide decisions about which products they ensure are available for their populations.

“Safe and effective medicines are an essential part of any health system,” said Dr Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. “Making sure all people can access the medicines they need, when and where they need them, is vital to countries’ progress towards universal health coverage.”…
:: Model List of Essential Medicines, 20th List (March 2017) pdf, 1.50Mb
19.3 Vaccines [p.43]
:: Model List of Essential Medicines for Children, 6th List (March 2017) pdf, 1.19Mb
19.3 Vaccines [p.32]

Highlights
Health facilities in 7 Caribbean countries to be transformed to be disaster resistant
June 2017 – WHO PAHO analyzed the safety situation of nearly 350 hospitals and health centers, and their likelihood of continuing to function in disasters. WHO then selected 16 hospitals and health centers in seven Caribbean countries to make them safer, greener and more resilient to natural disasters.

Mothers’ groups play key role in lowering Sierra Leone’s high rates of maternal and child deaths
June 2017 – Mothers’ Support Groups have been trained in many communities in Sierra Leone, with the support of WHO. As well as promoting trust and use of health services, they raise awareness on nutrition, vaccines and disease prevention, to help save the lives of both women and their children.

Statement on Dr Babatunde Osotimehin
June 2017 – WHO is profoundly saddened by the news that Dr Babatunde Osotimehin passed away on 4 June 2017. As Executive Director of the United Nations Population Fund (UNFPA), Dr Osotimehin was a champion of health for all, but especially for women and adolescent girls.

Huge bed net campaign kicks off in Sierra Leone
June 2017 – Sierra Leone kicked off bed net distribution campaign to help protect its population against malaria, which remains as one of the most deadly diseases in the country. In total, 4.3 million insecticide treated bed nets will be distributed through the landmark nationwide campaign. Sierra Leone is one of the most severely malaria-burdened nations in Africa, with its entire population of 7 million people at risk of the disease.

Weekly Epidemiological Record, 9 June 2017, vol. 92, 23 (pp. 321–332)
The International Health Regulations (IHR) – 10 years of global public health security
Japanese encephalitis: surveillance and immunization in Asia and the Western Pacific, 2016
Monthly report on dracunculiasis cases, January– April 2017

GIN May 2017 pdf, 1.67Mb 2 June 2017

Request for proposals: evaluation of malaria vaccine RTS,S/AS01 pilot implementation
22 May 2017

::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Dr Moeti’s Interview with United Nations Radio: “Flexible funding” key under new UN health agency chief – 05 June 2017
:: In equatorial Congo, WHO and its partners respond to an Ebola outbreak – 02 June 2017

WHO Region of the Americas PAHO
:: Health facilities in seven Caribbean countries to be transformed to be disaster resistant (06/07/2017)

WHO South-East Asia Region SEARO
:: Make cities green for better health  5 June 2017
 
WHO European Region EURO
:: Minister of Health of Montenegro visits WHO/Europe 08-06-2017
:: Hepatitis A outbreaks in European Region mostly affecting men who have sex with men 08-06-2017
:: Can Europe exceed the global target and reduce premature mortality by 45%? 08-06-2017
:: Nordic and Baltic countries gather to discuss intersectoral action to prevent child maltreatment 07-06-2017

WHO Eastern Mediterranean Region EMRO
:: Treating trauma and the wounds of war in Helmand 8 June 2017

WHO Western Pacific Region
No new digest content identified.
 

CDC/ACIP [to 10 June 2017]

CDC/ACIP [to 10 June 2017]
http://www.cdc.gov/media/index.html
Transcript

Friday, June 09, 2017
Transcript : CDC Telebriefing – Update on Zika pregnancy outcomes in U.S. Territories
Transcript for CDC Telebriefing: Update on Zika pregnancy outcomes in U.S. Territories
…ANNE SCHUCHAT: Thanks, everybody, for joining us this afternoon. Today’s report marks the first analysis of data reported to the Zika pregnancy and infant registries from the U.S. territories including the commonwealth of Puerto Rico, the U.S. Virgin Islands, the Federated States of Micronesia, the republic of the Marshall Islands and American Samoa. CDC scientists analyzed 3,900 pregnancies reported between January 1, 2016, and April 25th of this year. Of these, 2,549 pregnant women in the U.S. territories with evidence of Zika virus infection completed their pregnancies within this time frame. And 122, or 5%, had Zika associated birth defects. This percentage is consistent with what was reported earlier for Zika associated birth defects for pregnancies in women from the 50 states and District of Columbia during 2016…

Press Release
Tuesday, June 06, 2017
Community Mitigation Guidelines to Prevent Pandemic Influenza – United States, 2017 – Digital Press Kit 
…The updated guidelines:
:: Encourage state and local public health officials to plan and prepare for implementing NPIs early in a pandemic in community settings.
:: Summarize key lessons learned from the 2009 H1N1 pandemic response, describe new or updated pandemic planning and assessment tools, and provide the latest scientific findings on the use of NPIs.
:: Include supplemental guides for six different community audiences that provide straightforward guidance about the use of NPIs and pandemic flu resources.

MMWR News Synopsis for June 8, 2017
Measures Taken to Prevent Zika Virus Infection During Pregnancy — Puerto Rico, 2016
CDC Media Relations
404-639-3286
While health care providers are following recommendations to counsel pregnant women about Zika virus infection in Puerto Rico, there is still a need for efforts that reinforce the importance of using prevention strategies during pregnancy. Since less than 50 percent of women reported daily use of insect repellent and protective clothing during pregnancy and less than 40 percent reported consistent use of measures to prevent sexual transmission, an understanding of how to bridge the gap between awareness and use of Zika prevention measures during pregnancy is needed. Scientists at CDC and the Puerto Rico Department of Health describe behaviors and experiences related to Zika virus prevention among women in Puerto Rico who were pregnant during the Zika virus outbreak in 2016. Ninety-eight percent of women reported using at least one measure to avoid mosquitoes in their homes during pregnancy. However, personal protective measures were used less frequently: 46 percent reported using insect repellent daily, and 12 percent reported wearing long-sleeved shirts and long pants daily. Slightly more than 33 percent of respondents reported either abstaining from sex or consistently using condoms to prevent sexual transmission of Zika during pregnancy. More than 90 percent of the women reported that their health care provider counseled them about Zika virus infection during pregnancy, and 77 percent of women reported being tested for Zika virus infection by their health care provider during the first or second trimester of pregnancy.

Japanese Encephalitis Surveillance and Immunization — Asia and Western Pacific Regions, 2016
CDC Media Relations
404-639-3286
There has been substantial progress in prevention and control of Japanese encephalitis (JE), the most important vaccine-preventable cause of encephalitis in Asia. Continued progress will require strengthening JE surveillance, sustaining national commitment to JE prevention and control, and ensuring adequate resources for JE vaccination. JE virus is the most important vaccine-preventable cause of encephalitis in Asia. The World Health Organization recommends integration of JE vaccination into national immunization schedules in all areas where the disease is a public health priority. A review of surveillance and immunization program data in the 24 countries with JE virus transmission risk showed that in 2016, 22 countries conducted at least some surveillance for JE, and 12 had implemented a JE immunization program. This represents substantial progress in JE prevention and control efforts, but challenges remain.

Announcements

Announcements
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 10 June 2017]
http://cepi.net/
Newsletter 9 June 2017
Address from CEO
It appears that the recent outbreak of Ebola in the Democratic Republic of Congo has been brought under control. Merck’s investigational rVSV ZEBOV vaccine was approved for use under an Expanded Access Protocol by the national regulatory and ethical authorities in the DRC, but the outbreak had already subsided by the time these reviews were completed and no individuals have been vaccinated. It is possible, of course, that new cases could yet emerge, but so far so good.
I have received a number of calls since the outbreak began from people asking what, if any, role CEPI played in the response. Our role in the response to this outbreak was limited: we offered support, if needed, to WHO, and WHO kept us apprised of developments. But what role should CEPI play, especially as its capabilities evolve and the organization grows?
For the vaccines in its portfolio, CEPI will play a critical role in ensuring the early engagement of regulatory authorities, public health officials, and clinical scientists in countries at risk for the diseases targeted. Early engagement will facilitate the review of clinical trial protocols before outbreaks occur by institutional review board and ethics panels and thereby facilitate more rapid responses.
CEPI will also need to build strong partnerships and coordinate its efforts with agencies that have strong logistical capabilities and the ability to project medical personnel and support wherever and whenever needed. Médecins Sans Frontières is such an organization and its representatives have contributed substantially to CEPI’s understanding of the problem it is tackling and to the development of CEPI’s goals and policies. CEPI needs to build more such relationships.
We are also in the process of developing an investment strategy and financing mechanisms that will allow CEPI to respond rapidly to new threats. Mobilizing resources – particularly financial resources – quickly in a crisis is a great challenge. The Obama Administration, for example, requested a supplemental appropriation to address the Zika epidemic in February 2016 but the U.S. Congress did not provide such funding until the end of September. It is critical that CEPI be in a position to move much more rapidly if the situation demands.
Finally, CEPI has an important advocacy role and will be vocal in supporting the importance of preparedness for infectious disease outbreaks. It is all too easy for governments to neglect preparedness to address more immediate concerns. CEPI has a right and duty to speak on behalf of its coalition members in support of preparedness as a critical priority.
As I mentioned in my last note, I have asked CEPI staff to accelerate the development of our emergency response plans, which will take account of all the steps required to deliver vaccine rapidly in an emergency. This is a critical initiative for CEPI and I will keep you updated as our plans evolve.
Richard Hatchett, CEPI CEO
 
::::::

IAVI – International AIDS Vaccine Initiative   [to 10 June 2017]
https://www.iavi.org/
June 5, 2017
New Studies Improve Candidate Vaccine Design for HIV Subtypes Most Common in India and Africa
IAVI Scientists Demonstrate How to Produce a Variety of HIV Surface Protein Variants
Two papers published recently in the journal Immunity provide important information to inform HIV vaccine design. Using cutting-edge tools, scientists with the International AIDS Vaccine Initiative’s Neutralizing Antibody Center (IAVI NAC) at The Scripps Research Institute describe the first successful attempt at obtaining a high-resolution snapshot of a subtype C outer envelope or protein “spike” that decorates the surface of the virus. Until now, researchers have only been able to do so for subtypes A, B, and G. In the second study, researchers isolate and analyze neutralizing antibodies that are generated following vaccination of non-human primates (monkeys) with these vaccine candidates, which can penetrate these well-shielded spikes.

“Together the two studies show how structure-based immunogen design can advance vaccine development for HIV, and potentially other infectious diseases,” said Richard Wyatt, Director of Viral Immunology at the IAVI NAC. “Through enhanced understanding of subtype C’s structural complexities, we understand how antibodies can penetrate HIV’s dense protective armor – a camouflaging sugar shield – to target and latch onto a surface region called V2 that possesses some conserved sites.” Targeting of V2 also was seen in human volunteers in the RV144 – the Thai trial – the only HIV vaccine clinical trial to date to show any effectiveness.

Seeking a more effective vaccine, IAVI’s scientists generated a stabilized version of the envelope protein from a subtype C virus isolated previously from an HIV-infected Indian individual and generated crystals that permitted the determination of its atomic structure. They arranged these envelope spikes on the outside of nanoparticles, and injected the spiked nanoparticles into monkeys. Subsequent analysis showed that the vaccinated monkeys mounted immune defenses, including B-cell responses and HIV antibodies capable of blocking this subtype C HIV strain virus. The monkeys’ immune response is one indication that an HIV vaccine may be developed from this initial immunogen design approach, perhaps using many spikes derived from multiple strains to accommodate viral diversity.

Wyatt’s findings are important for several reasons. Subtype C HIV strains are responsible for the majority of HIV-1 infections worldwide and the findings presented in these two studies define a roadmap to produce vaccines for subtype C HIV viral variants. Also, the identification of which regions are immunogenic on these envelope glycoprotein immunogens, that is which elements stimulate neutralizing antibodies, inform future vaccine re-design efforts.

These findings further inform future clinical trials toward a vaccine that can prevent infection with multiple strains of HIV – otherwise known as a “broadly effective” vaccine.
 
::::::
 
NIH  [to 10 June 2017]
http://www.nih.gov/news-events/news-releases
June 5, 2017
NIAID-Sponsored Trial of Experimental Chikungunya Vaccine Begins
A clinical trial of an experimental vaccine to prevent infection with chikungunya virus is now enrolling healthy adult volunteers at three sites in the United States. The Phase 1/2 trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is being conducted at several NIAID-funded Vaccine and Treatment Evaluation Units. The candidate vaccine, MV-CHIKV, was developed by Themis Bioscience of Vienna, Austria.
Although chikungunya is rarely fatal, the mosquito-transmitted virus causes an intense inflammatory reaction resulting in severe joint pain, fever, rash and muscle pain. While most symptoms usually resolve in days, the joint inflammation can linger.
“Chikungunya virus can cause debilitating joint pain that can last for months or even longer,” said NIAID Director Anthony S. Fauci, M.D. “A vaccine to prevent infection with this virus would be of considerable benefit to people living in the more than 60 countries where chikungunya transmission has occurred, as well as travelers to those countries.”…
 
::::::
 
FDA [to 10 June 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
High-dose influenza vaccine appears better than standard-dose vaccines in preventing deaths from A(H3N2) influenza among older adults
Posted: 6/9/2017
High-dose influenza vaccine was more effective at preventing post-influenza deaths among elderly individuals during the 2012-2013 influenza season than standard-dose vaccines– when the A(H3N2) influenza viruses were broadly circulating– according to a study done by researchers at the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.
Specifically, people who received the high-dose influenza vaccine during the 2012-2013 influenza season were 36.4% less likely to die in the 30 days following hospitalization or an emergency department visit that included an influenza diagnosis compared to the standard-dose vaccine. During the following season (2013-2014), when H1N1 viruses dominated and the standard-dose vaccine had better effectiveness than the previous season, the high-dose vaccine was not significantly better at preventing deaths among the Medicare patients studied.
The findings suggest that the high-dose influenza vaccine offers greater benefit to older adults than do standard-dose vaccines when A(H3N2) influenza viruses are widely circulating…
::::::
 
IVI   [to 10 June 2017]
http://www.ivi.int/
June 8,2017
University of Siena, Incheon National University and the International Vaccine Institute (IVI) Launch New Joint Executive Master’s in Biotechnology & Pharmaceutical Clinical Development

Incheon, Korea: On June 8th, 2017, Incheon National University hosted a kickoff event to announce a new International partnership with the Institute for Global Health, from University of Siena, Italy. Both institutions, with support from IVI, the International Vaccine Institute based in Seoul, launched a new and unique Executive Master Program in Public Health, Biotechnology and Pharmaceutical Clinical Development. Successful graduates will receive a joint master degree from the Medical Faculty of University of Siena, one of the oldest and most prestigious universities in Europe, and the Incheon National University, Korea.
The program is an extension of the University of Siena’s current Executive Master in Vaccinology and Pharmaceutical Clinical Development, a successful and much appraised course intended for public health and biotechnology industry professionals. Whilst the Master’s Program in Siena focuses exclusively on vaccines, this new joint master broadens the scope including the pharmaceutical development of small molecules and biologicals beyond vaccines…
 
::::::
 
Fondation Merieux  [to 10 June 2017]
http://www.fondation-merieux.org/news
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
8 June 2017, Paris (France)
Serge Eholié and Xavier Anglaret Winners of the 2017 Christophe Mérieux Prize: Rewarding Infectious Disease Research in Côte d’Ivoire
The 2017 Christophe Mérieux prize has been awarded to Serge Eholié and Xavier Anglaret of the Centre de recherche sur les maladies infectieuses et pathologies associées* in Abidjan (Côte d’Ivoire).
Serge Eholié and Xavier Anglaret together manage a team that was founded in 1994 and is made up of highly respected Ivorian and French researchers. The team has two main roles: conducting infectious disease research to improve the health of the population and training young scientists in medical research. These multidisciplinary studies combine clinical medicine, biology and medical sciences with international research organizations.
Over its 23 years of activity, the team has expanded and today carries out studies in 15 countries, 11 of which are in Africa. Its research programs now include all types of infectious disease with epidemic potential, including Ebola virus disease. Thanks to its clinical research experience, this team was one of the rare teams in the world able to mobilize rapidly during the Ebola virus epidemic in 2014 to carry out therapeutic trials in Guinea…
 
::::::
 
PATH  [to 10 June 2017]
http://www.path.org/news/index.php
Press release | June 07, 2017
New WHO Designation for Oxygen Could Save Thousands of Lives Globally
Additional listing for oxygen on the Model List of Essential Medicines part of broader effort by PATH and other organizations to improve global health by making oxygen more accessible
 
Announcement | June 06, 2017
PATH’s contribution to global disease prevention recognized by US National Vaccine Program Office 2017 UpShot Award
 
::::::
 
Global Fund [to 10 June 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Coca-Cola’s “Project Last Mile” Expands to Liberia and Swaziland Strengthening Health Systems across Africa
08 June 2017
Today at the European Development Days, The Coca-Cola Company and its Foundations, in partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria, the U.S. Agency for International Development and the Bill & Melinda Gates Foundation, announced the latest expansion of “Project Last Mile” with innovative programs to strengthen local health systems in Liberia and Swaziland. Launched in 2010 to transform the delivery of medical supplies in Tanzania, Project Last Mile has since worked with Ministries of Health in Ghana, Mozambique, Nigeria and South Africa to improve the availability of essential medicines.
News
Remembering Babatunde Osotimehin
06 June 2017
The Global Fund expressed its profound sadness at the news that Babatunde Osotimehin, Executive Director of UNFPA, the United Nations Population Fund, passed away. He was 68 years old.
 
::::::
 
UNAIDS  [to 10 June 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Press Release – 5 June 2017
UNAIDS gala returns to Basel in June to raise awareness and funds to support efforts to end AIDS by 2030
To be hosted by Princess Eugenie of York, Caroline Rupert and Ndaba Mandela.
 
::::::
 
Wellcome Trust  [to 10 June 2017]
https://wellcome.ac.uk/news
Explainer / Published: 5 June 2017
EC report: testing on non-human primates falling but still needed
A European Commission report on the use of non-human primates in research says there has been sustained scientific progress and a reduction in primate use and suffering, but still more can be done.
 

Journal Watch

Journal Watch

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

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

 

The Human Microbiome in the Fight Against Tuberculosis

American Journal of Tropical Medicine and Hygiene
Volume 96, Issue 6, 2017
http://www.ajtmh.org/content/current

Review Articles
The Human Microbiome in the Fight Against Tuberculosis
Authors: Madeleine R. Wood, Elaine A. Yu and Saurabh Mehta
https://doi.org/10.4269/ajtmh.16-0581
Abstract
The human microbiome is an intriguing potentially modifiable risk factor in our arsenal against Mycobacterium tuberculosis, the leading infectious disease killer globally. Previous studies have shown associations between the human microbiome and pulmonary disease states; however, etiological links between the microbiome and tuberculosis (TB) infection or disease remain unclear. Immunomodulatory roles of the microbiome may prove to be a critical asset in the host response against TB, including in preventing TB infection, reducing progression from latency, mitigating disease severity, and lowering the incidence of drug resistance and coinfections. This review examined the associations between TB and the gut and lung microbiome. Eight studies were identified through a PubMed database search, including one animal study (N = 1), case report (N = 1), and case–control studies (N = 6). TB infection and disease were associated with reduced gastrointestinal microbial diversity in a murine model and human case report. Sputum microbial diversity differed by TB status in case–control studies, although some reported heterogeneous findings. Current evidence suggests that the gut and lung microbiome are associated with TB infection and disease. However, as studies are limited, etiological and longitudinal research is needed to determine clinical relevance.

 

American Journal of Tropical Medicine and Hygiene Volume 96, Issue 6, 2017

American Journal of Tropical Medicine and Hygiene
Volume 96, Issue 6, 2017
http://www.ajtmh.org/content/current

Perspective Pieces
The Cuba–United States Thaw: Building Bridges Through Science and Global Health
Authors: Daniel G. Bausch, Vivian Kouri, Sonia Resik, Belsy Acosta, Gerardo Guillen, Karen Goraleski, Marcos Espinal and Maria G. Guzman
https://doi.org/10.4269/ajtmh.17-0136

Articles
High Hepatitis E Seroprevalence Among Displaced Persons in South Sudan
Authors: Andrew S. Azman, Malika Bouhenia, Anita S. Iyer, John Rumunu, Richard Lino Laku, Joseph F. Wamala, Isabel Rodriguez-Barraquer, Justin Lessler, Etienne Gignoux, Francisco J. Luquero, Daniel T. Leung, Emily S. Gurley and Iza Ciglenecki
https://doi.org/10.4269/ajtmh.16-0620

Evaluation of the Field Performance of ImmunoCard STAT!® Rapid Diagnostic Test for Rotavirus in Dadaab Refugee Camp and at the Kenya–Somalia Border
Authors: Maurice Ope, Raymond Nyoka, Ahmed Unshur, Fredrick O. Oyier, Shafe A. Mowlid, Brian Owino, Steve B. Ochieng, Charles I. Okello, Joel M. Montgomery, Burton Wagacha, Aleksandar Galev, Abdikadir Abdow, Mathew D. Esona, Jacqueline Tate, David Fitter, Susan T. Cookson, Balajee Arunmozhi and Nina Marano
https://doi.org/10.4269/ajtmh.16-0885

Phase 1 Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults in the United States
Authors: Alexander C. Schmidt, Leyi Lin, Luis J. Martinez, Richard C. Ruck, Kenneth H. Eckels, Alix Collard, Rafael De La Barrera, Kristopher M. Paolino, Jean-François Toussaint, Edith Lepine, Bruce L. Innis, Richard G. Jarman and Stephen J. Thomas
https://doi.org/10.4269/ajtmh.16-0634

Development of a consensus operational definition of child assent for research

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 10 June 2017)

Research article
Development of a consensus operational definition of child assent for research
Alan R. Tait and Michael E. Geisser
Published on: 9 June 2017
Abstract
Background
There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research.
Methods
Based on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel.
Results
Consensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children.
Conclusions
It is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children’s developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

Assessing the efficiency of catch-up campaigns for the introduction of pneumococcal conjugate vaccine: a modelling study based on data from PCV10 introduction in Kilifi, Kenya

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 10 June 2017)

Research article
Assessing the efficiency of catch-up campaigns for the introduction of pneumococcal conjugate vaccine: a modelling study based on data from PCV10 introduction in Kilifi, Kenya
The World Health Organisation recommends the use of catch-up campaigns as part of the introduction of pneumococcal conjugate vaccines (PCVs) to accelerate herd protection and hence PCV impact. The value of a catch-up campaign is a trade-off between the costs of vaccinating additional age groups and the benefit of additional direct and indirect protection. There is a paucity of observational data, particularly from low- and middle-income countries, to quantify the optimal breadth of such catch-up campaigns… We find that catch-up campaigns are a highly dose-efficient way to accelerate population protection against pneumococcal disease.
Stefan Flasche, John Ojal, Olivier Le Polain de Waroux, Mark Otiende, Katherine L. O’Brien, Moses Kiti, D. James Nokes, W John Edmunds and J. Anthony G. Scott
Published on: 7 June 2017

Immunization, urbanization and slums – a systematic review of factors and interventions

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 10 June 2017)

Research article
Immunization, urbanization and slums – a systematic review of factors and interventions
Tim Crocker-Buque, Godwin Mindra, Richard Duncan and Sandra Mounier-Jack
BMC Public Health 2017 17:556
Published on: 8 June 2017
Abstract
Background
In 2014, over half (54%) of the world’s population lived in urban areas and this proportion will increase to 66% by 2050. This urbanizing trend has been accompanied by an increasing number of people living in urban poor communities and slums. Lower immunization coverage is found in poorer urban dwellers in many contexts. This study aims to identify factors associated with immunization coverage in poor urban areas and slums, and to identify interventions to improve coverage.
Methods
We conducted a systematic review, searching Medline, Embase, Global Health, CINAHL, Web of Science and The Cochrane Database with broad search terms for studies published between 2000 and 2016.
Results
Of 4872 unique articles, 327 abstracts were screened, leading to 63 included studies: 44 considering factors and 20 evaluating interventions (one in both categories) in 16 low or middle-income countries. A wide range of socio-economic characteristics were associated with coverage in different contexts. Recent rural-urban migration had a universally negative effect. Parents commonly reported lack of awareness of immunization importance and difficulty accessing services as reasons for under-immunization of their children. Physical distance to clinics and aspects of service quality also impacted uptake. We found evidence of effectiveness for interventions involving multiple components, especially if they have been designed with community involvement. Outreach programmes were effective where physical distance was identified as a barrier. Some evidence was found for the effective use of SMS (text) messaging services, community-based education programmes and financial incentives, which warrant further evaluation. No interventions were identified that provided services to migrants from rural areas.
Conclusion
Different factors affect immunization coverage in different urban poor and slum contexts. Immunization services should be designed in collaboration with slum-dwelling communities, considering the local context. Interventions should be designed and tested to increase immunization in migrants from rural areas.

BMJ Open June 2017 – Volume 7 – 6

BMJ Open
June 2017 – Volume 7 – 6
http://bmjopen.bmj.com/content/current
Health economics
Research
A systematic review of economic evaluations of seasonal influenza vaccination for the elderly population in the European Union
Gemma E Shields, Jamie Elvidge, Linda M Davies

Epidemiology
Research
Timing of two versus three doses of quadrivalent HPV vaccine and associated effectiveness against condyloma in Sweden: a nationwide cohort study
Lamb F, Herweijer E, Ploner A, Uhnoo I, Sundström K, Sparén P, Arnheim-Dahlström L

Emerging Infectious Diseases Volume 23, Number 6—June 2017

Emerging Infectious Diseases
Volume 23, Number 6—June 2017
http://wwwnc.cdc.gov/eid/

Research
Stockpiling Ventilators for Influenza Pandemics PDF Version [PDF – 1018 KB – 8 pages
Huang et al.
Abstract
In preparing for influenza pandemics, public health agencies stockpile critical medical resources. Determining appropriate quantities and locations for such resources can be challenging, given the considerable uncertainty in the timing and severity of future pandemics. We introduce a method for optimizing stockpiles of mechanical ventilators, which are critical for treating hospitalized influenza patients in respiratory failure. As a case study, we consider the US state of Texas during mild, moderate, and severe pandemics. Optimal allocations prioritize local over central storage, even though the latter can be deployed adaptively, on the basis of real-time needs. This prioritization stems from high geographic correlations and the slightly lower treatment success assumed for centrally stockpiled ventilators. We developed our model and analysis in collaboration with academic researchers and a state public health agency and incorporated it into a Web-based decision-support tool for pandemic preparedness and response.

Commentaries
Stockpiling Ventilators for Influenza Pandemics PDF Version [PDF – 1.25 MB – 2 pages]
I. Meltzer and A. Patel

Pursuing Health Equity

Health Affairs
June 2017; Volume 36, Issue 6
http://content.healthaffairs.org/content/current

Issue Focus: Pursuing Health Equity
From The Editor-in-Chief
Pursuing Health Equity
Alan R. Weil
Extract
If equity is one dimension of what the Institute of Medicine (IOM) defined as health care quality, what are the obligations of the health care sector to achieve health equity? Early evidence of health disparities led to a focus on the health care system—the roles of bias and discrimination, as captured by the title of the 2003 IOM report Unequal Treatment. Yet as Steven Woolf points out in his lead paper, growing understanding of the role of social factors in determining health outcomes makes it clear that achieving equity requires widening the lens. This month’s Health Affairs examines health equity from both perspectives: equity in care, and the relationship between social factors and health equity.

Health systems research in fragile and conflict affected states: a qualitative study of associated challenges

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 10 June 2017]

Research
Health systems research in fragile and conflict affected states: a qualitative study of associated challenges
Tim Martineau, Aniek Woodward, Kate Sheahan and Egbert Sondorp
Published on: 7 June 2017
Abstract
Background
High quality health systems research (HSR) in fragile and conflict-affected states (FCAS) is essential to guiding the policies and programmes that will improve access to health services and, ultimately, health outcomes. Yet, conducting HSR in FCAS is challenging. An understanding of these challenges is essential to tackling them and to supporting research conducted in these complex environments. Led by the Thematic Working Group on Health Systems in FCAS, the primary aim of this study was to develop a research agenda on HSR in FCAS. The secondary aim was to identify the challenges associated with conducting HSR in these contexts. This paper presents these challenges.
Methods
Guided by a purposely-selected steering group, this qualitative study collected respondents’ perspectives through an online survey (n = 61) and a group discussion at the Third Global Symposium on HSR in September 2014 (n = 11). Respondents with knowledge and/or experience of HSR in FCAS were intentionally recruited.
Results
Of those ever involved in HSR in FCAS (45/61, 75%), almost all (98%) experienced challenges in conducting their research. Challenges fall under three broad thematic areas: (1) lack of appropriate support; (2) complex local research environment, including access constraints, weak local research capacity, collaboration challenges and lack of trust in the research process; and (3) limited research application, including rapidly outdated findings and lack of engagement with the research process and results.
Conclusions
This study shows that those familiar with HSR in FCAS face many challenges in gaining support for and in conducting and applying high-quality research. There is a need for more sustainable support, including commitment to and long-term funding of HSR in FCAS; investment in capacity building within FCAS to meet the challenges related to implementation of research in these complex environments; relationship and trust building among stakeholders involved in HSR, particularly between local and international researchers and between researchers and participants; and innovative and flexible approaches to research design and implementation in these insecure and rapidly changing contexts.

International Journal of Epidemiology Volume 46, Issue 2 April 2017

International Journal of Epidemiology
Volume 46, Issue 2    April 2017
http://ije.oxfordjournals.org/content/current

Miscellaneous
Vaccinations against smallpox and tuberculosis are associated with better long-term survival: a Danish case-cohort study 1971–2010
Andreas Rieckmann; Marie Villumsen; Signe Sørup; Line Klingen Haugaard; Henrik Ravn

Distance to health services modifies the effect of an 11-valent pneumococcal vaccine on pneumonia risk among children less than 2 years of age in Bohol, Philippines
Elisabeth Dowling Root; Marilla Lucero; Hanna Nohynek; Rebecca Stubbs; Veronica Tallo

Progress Toward Achieving UNAIDS 90-90-90 in Rural Communities in East Africa

JAMA
June 6, 2017, Vol 317, No. 21, Pages 2145-2248
http://jama.jamanetwork.com/issue.aspx

Progress Toward Achieving UNAIDS 90-90-90 in Rural Communities in East Africa
Carlos del Rio, MD; Wendy S. Armstrong, MD
JAMA. 2017;317(21):2172-2174. doi:10.1001/jama.2017.5704
Preview
In recent years, the results of several studies, including Human Immunodeficiency Virus (HIV) Prevention Trials Network (HPTN) 052,1 Strategic Timing of Antiretroviral Treatment (START),2 and Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa (TEMPRANO),3 have rapidly changed the global approach to HIV treatment and have raised the possibility of ending AIDS by 2030. These 3 studies demonstrated that HIV-infected persons with viral suppression receiving antiretroviral therapy (ART) do not transmit HIV to their uninfected sex partners,1 and that initiating ART resulted in net health benefits to HIV-infected persons in high-income and low-income countries regardless of CD4 lymphocyte count.2,3 In sum, ART has been shown to be beneficial for individual and public health and that “treatment is prevention.”

Association of Implementation of a Universal Testing and Treatment Intervention With HIV Diagnosis, Receipt of Antiretroviral Therapy, and Viral Suppression in East Africa

JAMA
June 6, 2017, Vol 317, No. 21, Pages 2145-2248
http://jama.jamanetwork.com/issue.aspx

Original Investigation
Association of Implementation of a Universal Testing and Treatment Intervention With HIV Diagnosis, Receipt of Antiretroviral Therapy, and Viral Suppression in East Africa
Maya Petersen, MD, PhD; Laura Balzer, PhD; Dalsone Kwarsiima, MBChB, MPH; et al.
JAMA. 2017;317(21):2196-2206. doi:10.1001/jama.2017.5705
This analysis examines intervention communities in rural Uganda and Kenya in an ongoing cluster randomized trial to assess the change in the proportions of HIV-positive residents diagnosed with HIV, treated with ART, and achieving HIV viral suppression.

JAMA Pediatrics June 2017, Vol 171, No. 6, Pages 501-608

JAMA Pediatrics
June 2017, Vol 171, No. 6, Pages 501-608
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Child and Adolescent Health From 1990 to 2015 – Findings From the Global Burden of Diseases, Injuries, and Risk Factors 2015 Study
The Global Burden of Disease Child and Adolescent Health Collaboration
JAMA Pediatr. 2017;171(6):573-592. doi:10.1001/jamapediatrics.2017.0250
Key Points
Question
What are the levels and trends of mortality and nonfatal health loss among children and adolescents from 1990 to 2015?
Findings
This study found significant global decreases in all-cause child and adolescent mortality from 1990 to 2015, but with increasing global inequality. In countries with a low Socio-demographic Index (SDI), mortality is the primary driver of health loss in children and adolescents, largely owing to infectious, nutritional, maternal, and neonatal causes, while nonfatal health loss prevails in locations with a higher SDI.
Meaning
Nations should evaluate drivers of disease burden among children and adolescents to aid implementation of appropriate strategies to maximize the health of populations.
Abstract
Importance
Comprehensive and timely monitoring of disease burden in all age groups, including children and adolescents, is essential for improving population health.
Objective
To quantify and describe levels and trends of mortality and nonfatal health outcomes among children and adolescents from 1990 to 2015 to provide a framework for policy discussion.
Evidence Review
Cause-specific mortality and nonfatal health outcomes were analyzed for 195 countries and territories by age group, sex, and year from 1990 to 2015 using standardized approaches for data processing and statistical modeling, with subsequent analysis of the findings to describe levels and trends across geography and time among children and adolescents 19 years or younger. A composite indicator of income, education, and fertility was developed (Socio-demographic Index [SDI]) for each geographic unit and year, which evaluates the historical association between SDI and health loss.
Findings
Global child and adolescent mortality decreased from 14.18 million (95% uncertainty interval [UI], 14.09 million to 14.28 million) deaths in 1990 to 7.26 million (95% UI, 7.14 million to 7.39 million) deaths in 2015, but progress has been unevenly distributed. Countries with a lower SDI had a larger proportion of mortality burden (75%) in 2015 than was the case in 1990 (61%). Most deaths in 2015 occurred in South Asia and sub-Saharan Africa. Global trends were driven by reductions in mortality owing to infectious, nutritional, and neonatal disorders, which in the aggregate led to a relative increase in the importance of noncommunicable diseases and injuries in explaining global disease burden. The absolute burden of disability in children and adolescents increased 4.3% (95% UI, 3.1%-5.6%) from 1990 to 2015, with much of the increase owing to population growth and improved survival for children and adolescents to older ages. Other than infectious conditions, many top causes of disability are associated with long-term sequelae of conditions present at birth (eg, neonatal disorders, congenital birth defects, and hemoglobinopathies) and complications of a variety of infections and nutritional deficiencies. Anemia, developmental intellectual disability, hearing loss, epilepsy, and vision loss are important contributors to childhood disability that can arise from multiple causes. Maternal and reproductive health remains a key cause of disease burden in adolescent females, especially in lower-SDI countries. In low-SDI countries, mortality is the primary driver of health loss for children and adolescents, whereas disability predominates in higher-SDI locations; the specific pattern of epidemiological transition varies across diseases and injuries.
Conclusions and Relevance
Consistent international attention and investment have led to sustained improvements in causes of health loss among children and adolescents in many countries, although progress has been uneven. The persistence of infectious diseases in some countries, coupled with ongoing epidemiologic transition to injuries and noncommunicable diseases, require all countries to carefully evaluate and implement appropriate strategies to maximize the health of their children and adolescents and for the international community to carefully consider which elements of child and adolescent health should be monitored.

Editorial
Importance of Innovations in Neonatal and Adolescent Health in Reaching the Sustainable Development Goals by 2030
Christopher R. Sudfeld, ScD; Wafaie W. Fawzi, DrPH