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

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

Milestones :: Perspectives

World Health Assembly
WHA70
22–31 May 2017, Geneva

Webcast
Watch WHA70 live
Documentation
All documents
Selected Documents:
A70/9 – Health emergencies: WHO response in severe, large-scale emergencies
A70/10 – Health emergencies: Research and development for potentially epidemic diseases
A70/14 – Poliomyelitis
A70/14 Add.1 – Polio transition planning
A70/17 – Review of the Pandemic Influenza Preparedness Framework
A70/20 – Addressing the global shortage of, and access to, medicines and vaccines
A70/25 – Global vaccine action plan
WHA70.4 – Expression of appreciation to Dr Margaret Chan

Speeches
Opening address by Dr Chan, WHO Director-General
22 May 2017

Address by Dr Tedros Adhanom Ghebreyesus as new WHO Director-General
23 May 2017
 
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World Health Assembly elects Dr Tedros Adhanom Ghebreyesus as new WHO Director-General
News release
23 May 2017 | GENEVA – Today the Member States of WHO elected Dr Tedros Adhanom Ghebreyesus as the new Director-General of WHO.

Dr Tedros Adhanom Ghebreyesus was nominated by the Government of Ethiopia, and will begin his five-year term on 1 July 2017.

Prior to his election as WHO’s next Director-General, Dr Tedros Adhanom Ghebreyesus served as Minister of Foreign Affairs, Ethiopia from 2012–2016 and as Minister of Health, Ethiopia from 2005–2012. He has also served as chair of the Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria; as chair of the Roll Back Malaria (RBM) Partnership Board; and as co-chair of the Board of the Partnership for Maternal, Newborn and Child Health.

As Minister of Health, Ethiopia, Dr Tedros Adhanom Ghebreyesus led a comprehensive reform effort of the country’s health system, including the expansion of the country’s health infrastructure, creating 3500 health centres and 16 000 health posts; expanded the health workforce by 38 000 health extension workers; and initiated financing mechanisms to expand health insurance coverage. As Minister of Foreign Affairs, he led the effort to negotiate the Addis Ababa Action Agenda, in which 193 countries committed to the financing necessary to achieve the Sustainable Development Goals.

As Chair of the Global Fund and of RBM, Dr Tedros Adhanom Ghebreyesus secured record funding for the two organizations and created the Global Malaria Action Plan, which expanded RBM’s reach beyond Africa to Asia and Latin America.

Dr Tedros Adhanom Ghebreyesus will succeed Dr Margaret Chan, who has been WHO’s Director-General since 1 January 2007.

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2017 Public health prizes awarded
26 May 2017 – Every year, national health administrations and former prize recipients submit nominations for prizes awarded for accomplishments in the field of public health. This year’s winners were presented with their awards during the plenary meeting of the Seventieth World Health Assembly.
:: Sasakawa Health Prize
The 2017 Sasakawa Health Prize of US$30 000 for outstanding innovative work in health development, has been awarded to Dr Rinchin Arslan for his remarkable lifelong contribution to the advancement of primary health care in Mongolia and specifically his work in fighting viral hepatitis.
:: United Arab Emirates Health Foundation Prize
The United Arab Emirates Health Foundation Prize of US$ 20 000 went to Professor Lô Boubou Baïdy, 61, of Mauritania, for his significant contribution to the establishment of the national blood transfusion centres and laboratory services , as well as his fight against viral hepatitis, HIV/AIDS and other sexually transmitted infections.
:: Dr LEE Jong-wook Memorial Prize for Public Health
The Dr LEE Jong-wook Memorial Prize for Public Health of US$ 100 000 was awarded to the Henry Reeve International Medical Brigade (Cuba). Established in 2005 by more than 1500 Cuban health professionals, the Henry Reeve Brigade is integrated into the medical cooperation unit of the Ministry of Public Health of Cuba.
 
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Seventieth World Health Assembly update, 26 May 2017
News release
26 May 2017 | GENEVA – Today’s decisions at the World Health Assembly focused on implementation of the International Health Regulations, and improving the prevention, diagnosis and treatment of sepsis.

International Health Regulations
Delegates emphasized the urgent need to achieve full implementation of the International Health Regulations (2005) – the international legal instrument designed to help the global community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide.

The Regulations, which entered into force on 15 June 2007, require countries to report certain disease outbreaks and public health events to WHO. They define the rights and obligations of countries to report public health events, and establish a number of procedures that WHO must follow in its work to uphold global public health security.

Delegates requested the Director-General to work with Member States to develop a five-year global strategic plan for public health preparedness and response and submit it to the World Health Assembly in 2018. The strategic plan is to be based on guiding principles including consultation, country ownership, WHO leadership, broad partnerships, community involvement, regional integration, and results and accountability. The strategic plan is to focus on using an intersectoral approach; integration with the health system; focus on fragile contexts; domestic financing for sustainability; balance between legally binding and voluntary elements; with a guiding focus on monitoring.

Delegates also requested the Director-General to pursue and strengthen efforts to support Member States in full implementation of the Regulations, including through building their core public health capacities.

Sepsis
Delegates also agreed on a resolution to improve the prevention, diagnosis and treatment of sepsis.

Sepsis occurs when a person has an infection and the body’s reaction injures tissues and organs. Sepsis can be triggered by infections caused by bacteria, viruses, fungi, and parasites. Bacterial infections are the most common triggers. Early recognition of sepsis is crucial to treating patients before their condition worsens and becomes fatal. Antimicrobial resistance makes it much more difficult to treat infections and stop them evolving into sepsis.

Antimicrobial resistance occurs when bacteria and other microbes change to resist the effects of antibiotics and other antimicrobial medicine. Most infections can be avoided by improving hygiene, access to vaccinations and other infection prevention measures.

The resolution urges governments to strengthen policies and processes related to sepsis, especially to prevent infections and the further spread of antimicrobial resistance. It emphasizes the importance of reinforcing health worker training to recognize and deal effectively with the condition, improve tracking and reporting of cases, and promote research to develop more tools for sepsis diagnosis and treatment.

Further, the resolution requests that WHO develop a report on sepsis and guidance for its prevention and management. In addition, the resolution directs the Organization to help countries develop the necessary infrastructure, laboratory capacity, strategies and tools to reduce the burden of sepsis. It also asks WHO to work with partners to help developing countries gain access to quality, safe, efficacious and affordable sepsis treatments and tools for infection prevention and control, including immunization.
 
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Seventieth World Health Assembly update, 25 May
News release
25 May 2017 | GENEVA – The World Health Assembly today made decisions relating to polio, the Pandemic Influenza Preparedness Framework, and the health workforce.

Polio
Delegates paid tribute to ongoing efforts to end polio transmission in the last three endemic countries – Afghanistan, Nigeria and Pakistan. They expressed concern about the continued shortage of inactivated poliovirus vaccine, and noted the urgent need to contain polioviruses in safe facilities, destroy unneeded materials, and appropriately contain resources that can be used for research or other purposes. This has become particularly important since the eradication of type 2 of the wild poliovirus in 2015.

The Global Polio Eradication Initiative (GPEI) was launched in 1988, following the adoption for a resolution for the worldwide eradication of polio at the Forty-first World Health Assembly. Since then, the number of polio cases has fallen by over 99.9%. The initiative has also strengthened countries’ capacities to tackle other health issues, for example through better disease surveillance; immunization and health systems strengthening; early warning, emergency and outbreak response.

Delegates also addressed the challenge of scaling down the global polio response as eradication becomes closer, acknowledging the importance of developing a strategy to define the critical functions needed to sustain a polio-free world, as well as the global structures and financial requirements to support them. The development of this Post-eradication Certification Strategy is ongoing, and will be presented to the Executive Board and World Health Assembly next year.
Delegates welcomed efforts to plan for a post-polio world, including WHO’s organization-wide work to identify the key programmatic, financial, human resources and organizational risks associated with the eventual closure of the global polio eradication effort. They requested the Director-General to consider polio transition planning an urgent organizational priority and highlighted the need to ensure that polio transition needs are fully incorporated into the development of the next WHO budget and planning cycle.

Pandemic Influenza Preparedness Framework
Delegates reaffirmed the critical role played by the Pandemic Influenza Preparedness Framework’s (PIP) as a specialized international instrument that facilitates expeditious access to influenza viruses of human pandemic potential, risk analysis and the expeditious, fair and equitable sharing of vaccines and other benefits.

They emphasized the importance of prioritizing and supporting global pandemic influenza preparedness and response, including through the strengthening of domestic seasonal influenza virus surveillance, manufacturing and regulatory capacities and international coordination and collaboration through the Global Influenza Surveillance and Response System (GISRS) to identify and share influenza viruses with pandemic potential rapidly.

The Health Assembly agreed that the WHO secretariat should comprehensively analyse, in consultation with Member States and relevant stakeholders, including the GISRS, the implications of amending the definition of PIP biological materials to include genetic sequence data and expanding the PIP Framework to include seasonal influenza. The delegates further agreed that the PIP Framework model has potential to be used for other pathogens.

The PIP Framework was set up in 2011 to introduce greater equity and solidarity among nations when the next pandemic strikes. The PIP Framework provides WHO with real-time access to approximately 10% of global vaccine production, enabling the Organization to send life-saving doses to developing countries in need.

Health Workforce
The Health Assembly agreed to a five-year action plan under which WHO will collaborate with the International Labour Organization, and the Organization for Economic Cooperation and Development in working with governments and key stakeholders to address the global health and social workforce shortfall and contribute to international efforts to achieve the Sustainable Development Goals.

The plan calls on countries to view the health and social workforce as an investment, rather than a cost, and take advantage of the economic benefits of growth in the health and social sector. It outlines how ILO, OECD and WHO will take intersectoral action on five fronts: galvanizing political support; strengthening data and evidence; transforming and scaling up the education, skills and decent jobs of health and social workers; increasing resources to build the health and social workforces; and maximizing the multiple benefits that can be obtained from international health worker mobility.

It also focuses on maximizing women’s economic empowerment and participation. It addresses occupational health and safety, protection and security of the health and social workforce in all settings. It also covers the reform of service models towards the efficient provision of care, particularly in underserved areas.

The action plan supports the WHO Global Strategy on Human Resources for Health: Workforce 2030. It will facilitate implementation of the recommendations of the United Nations Secretary General’s High-Level Commission on Health Employment and Economic Growth, which found that, as populations grow and change, the global demand for health workers will double by 2030.
 

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 24 May 2017
:: The World Health Assembly (WHA) is meeting this week in Geneva, Switzerland.  Ministers of Health and public health professionals from around the world are discussing global public health issues, including the global drive to eradicate polio.  The Global Polio Eradication Initiative (GPEI) secretariat has prepared a status report, which will inform the discussions by Member States.
:: The Global Polio Eradication Initiative (GPEI) welcomes Dr Tedros Adhanom Ghebreyesus, the new Director-General-elect of the World Health Organization, and looks forward to working with him to achieve a polio-free world. More.
:: Two separate outbreaks of circulating vaccine derived poliovirus type 2 (cVDPV2) have been reported in the Democratic Republic of the Congo, one in Haut Lomami province and one in Maniema.
:: Health Ministers of the Group of Twenty have emphasized the importance of polio eradication and transition planning efforts at their inaugural meeting in Berlin, Germany. More.
:: Polio staff in Nigeria have contributed emergency response expertise to a meningitis outbreak in Sokoto State. More.
:: Summary of newly-reported viruses this week: Afghanistan, one new wild poliovirus type 1 (WPV1) environmental sample. Pakistan, seven new WPV1 environmental samples. Democratic Republic of the Congo, four new cases of circulating vaccine derived poliovirus type 2 (cVDPV2) and one isolate from a healthy individual in the community. For more, see relevant country sections.

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WHO Grade 3 Emergencies  [to 27 May 2017]
Iraq
:: Hundreds of volunteers vaccinate displaced children from Mosul and other underserved areas in Ninewa governorate
Baghdad, 23 May 2017 – More than 1900 health workers and volunteers on Sunday 21 May 2017 began a mass polio vaccination campaign targeting approximately 332 000 children from conflict affected Mosul and other underserved areas in Ninewa governorate.

South Sudan  – No new announcements identified
Yemen – No new announcements identified
Nigeria – No new announcements identified
The Syrian Arab Republic  – No new announcements identified
 

WHO Grade 2 Emergencies  [to 27 May 2017]
Democratic Republic of the Congo
:: Contingency fund aids rapid response to outbreak of suspected Ebola virus
25 May 2017 — Responding quickly to an outbreak means moving people and supplies quickly, and that means moving funds quickly too. When WHO received an alert on 9 May of a cluster of unexplained deaths in a remote part of the Democratic Republic of the Congo, it was able to deploy a team to the affected area just a day later, thanks in part to the WHO Contingency Fund for Emergencies (CFE). The CFE was able to rapidly release the money needed for transport and other vital logistics to get the investigation team to where they were needed.

Cameroon  – No new announcements identified.
Central African Republic  – No new announcements identified.
Ethiopia – No new announcements identified.
Libya – No new announcements identified.
Myanmar – No new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
 
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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Iraq: Mosul Humanitarian Response Situation Report No. 34 (15 May to 21 May 2017) [EN/KU]
:: Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, Stephen O‘Brien, Statement on protection of civilians in Mosul’s Old City, Iraq [EN/AR/KU]
Published on 26 May 2017
I am deeply concerned for the safety of civilians behind ISIL lines in western Mosul.
Although the UN is not present in the areas where fighting is occurring, we have received very disturbing reports of families being shut inside booby-trapped homes and of children being deliberately targeted by snipers. Families in the city still lack access to clean water and medicine and many have only limited access to food.

When humanitarian agencies developed their contingency plan for Mosul last summer, we estimated that as many as one million civilians might flee the city and that 750,000 people would need assistance in a worst case scenario. Seven months into the fighting and almost 760,000 people have already fled their homes.

Yesterday, the Government asked civilians in districts surrounding and inside the Old City to leave and seek safety across government lines. We don’t know for sure how many civilians are still in ISIL-held districts, but as many as 200,000 additional people may try to leave in coming days.

I remind all parties to the conflict of their obligation under international law to protect civilians against all forms of violence and to ensure people in need have access to the assistance they require. Those who choose to flee their homes to access assistance must be free to do so without hindrance. In the context of Mosul, where ISIL fighters are known to be using human shields in densely-populated neighbourhoods, parties to the conflict must take all feasible precautions to protect civilian lives.

International law is unambiguous. The protection of civilian lives is a legal and moral duty that stands above all other objectives.
New York, 26 May 2017

Syrian Arab Republic
:: 25 May 2017  Syria: WoS Nutrition Reach by sub-district / Jan – Apr 2017
:: Syria Crisis: Ar-Raqqa Situation Report No. 5 (as of 15 May 2017) [EN/AR]

Yemen
:: 24 May 2017  Statement by the Humanitarian Coordinator in Yemen, Mr. Jamie McGoldrick, on the Urgent need for Funding to Halt the Spread of Cholera [EN/AR]
Sana’a, 24 May 2017
Cholera continues to spread at an unprecedented rate throughout Yemen affecting men, women, and children who have for more than two years withstood the consequences of a conflict that is collapsing institutions and social safety nets. With urgency I appeal to United Nations Members States for financial and political support to help avert what is sure to be an additional and devastating blow to Yemen.

In the last three weeks, health authorities have reported over 35,500 suspected cholera cases, a third of whom are children, and 361 associated deaths in 19 of 22 governorates.

Malnutrition and cholera are interconnected; weakened and hungry people are more likely to contract cholera and cholera is more likely to flourish in places where malnutrition exists. Seventeen million people in Yemen are food insecure, including 462,000 children in the grip of acute malnutrition. Seven million people in Yemen face the possibility of famine and now over one hundred thousand people are estimated to be at risk of contracting cholera.

The speed at which cholera is spreading among the population exceeds the capacity of the health system to respond given its weakened state after more than two years of conflict, import restrictions and the lack of regular salary payments to health workers. Hundreds of thousands of people are at a greater risk of dying as they face the ‘triple threat’ of conflict, starvation and cholera.

Building on their presence in all 22 governorates across the country, national and international humanitarians are valiantly doing everything they can to prevent and treat cholera. However, they are doing so while facing a worst-case scenario – the majority of health care centers are closed, those that are open have limited staff and supplies, water and sanitation services are unable to provide clean water to the population, and humanitarian funds available to cover the existing institutional gaps and thwart the spread of the disease are meager.

Humanitarians are seeking US$55.4 million to prevent and treat cholera at the national, governorate and community level in the next six months. However, every day that funding is delayed the outbreak affects more people and more resources are needed to control it.

Cholera is preventable and treatable and no life should be lost to this disease. Humanitarians are acting and responding and we now need UN Member States to please help us by providing new funds and by ensuring that all funds pledged during the High Level Pledging Event in Geneva are made effective without delay.

:: Integrated Response Plan: Yemen Cholera Outbreak (23 May 2017)
[22 pages. OCV mention: Case Management Conduct cholera risk assessment to identify hotspot areas for possible oral cholera vaccine. May 2017, WHO]
 

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
:: Somalia: Drought Response – Situation Report No. 9 (as of 23 May 2017)

Ethiopia
:: Ethiopia Weekly Humanitarian Bulletin, 22 May 2017

Nigeria
:: New UN fund to tackle looming famine in Nigeria reaches $24 million  23 May 2017

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UNICEF  [to 27 May 2017]
https://www.unicef.org/media/media_94367.html
24 May 2017
From cholera in Yemen to attacks on hospitals in Syria, conflict threatens lives of over 24 million children in the Middle East and North Africa
[Editor’s text bolding]
AMMAN, 24 May 2017 – Violence and conflict in the Middle East and North Africa have put in jeopardy the health of 24 million children in Yemen, Syria, the Gaza Strip, Iraq, Libya and Sudan. Damage to health infrastructure is depriving children of essential health care. Water and sanitation services have been compromised, causing waterborne diseases to spread while preventative health care and nutritious food are insufficient to meet children’s needs.

“Violence is crippling health systems in conflict-affected countries and threatens children’s very survival,” said Geert Cappelaere, UNICEF Regional Director for the Middle East and North Africa. “Beyond the bombs, bullets and explosions, countless children are dying in silence from diseases that could easily be prevented and treated.”

In Yemen (9.6 million children in need):
::The two-year conflict has pushed Yemen to the brink of famine and plunged the country into one of the world’s worst humanitarian crises, with widespread severe acute malnutrition among children,
::Salaries for health care and sanitation workers haven’t been paid for more than seven months,
::Contaminated water sources, untreated sewage and uncollected garbage, sparked a cholera outbreak with 323 associated deaths in the last month alone.
::Two thirds of the population use unsafe water,
::Health care facilities are struggling to cope with the volume of patients – many of them children – amid shortages of medical supplies and clean water.

In Syria (5.8 million children in need):
::More than 2 million children live under siege and in hard-to-reach areas with little to no humanitarian aid. Surgical and other lifesaving supplies are regularly removed from the few convoys that are allowed into these areas,
::Many children do not have access to life-saving vaccinations and those who fall ill or are injured struggle to get treatment,
::Attacks on hospitals and other health facilities have become commonplace – almost 20 per month between January and March this year. The few hospitals that are still operational function with limited staff and services.
::The threat of polio – such as the outbreak that hit Syria in 2013 – still looms.

In the Gaza Strip (1 million children in need):
::Since the main power plant shut down on 16 April, power cuts have reduced water supply to 40 litres per person per day, less than half of the minimum international standard,
::Wastewater treatment plants now deposit 100,000 cubic metres of raw sewage into the sea daily, increasing the risk of waterborne diseases,
::14 public hospitals are operating for critical services only.

In Iraq (5.1 million children in need):
::Water supplies in camps for the displaced around Mosul are stretched to the limit with new families arriving daily, many with malnourished children,
::The widespread use of unsafe well water, with the accumulation of solid waste in and around Mosul, are exposing children to the risk of waterborne diseases,
::UNICEF estimates that 85,000 children are trapped in western Mosul, cut off from humanitarian aid for the past seven months and with limited access to medical care.

In Libya (450,000 children in need):
::Last year, Libya recorded 20 attacks against health facilities, second only to Syria,
::Immunization programmes have been facing challenges since the conflict erupted in 2011, with suspected measles cases reported among young children,
::Without new funding, over 1.3 million children won’t be vaccinated against measles or rubella, putting these children – and others in the country – at risk of highly contagious and potentially fatal diseases.

In Sudan (2.3 million children in need):
::Over 8,000 cases of acute watery diarrhoea have been recorded across 10 of the 18 states in just eight months, including those hosting large numbers of refugees from South Sudan.
::Cases of acute watery diarrhoea are set to rise rapidly once the rainy season begins in June.
::Over 200,000 children under the age of five in parts of the conflict affected Jabel Marra, Nuba Mountains and Blue Nile areas have not had access to basic health services such as vaccination, for more than four years.

Across these countries, UNICEF and its partners are working around the clock to provide vulnerable children with safe water, water treatment, medical and nutrition supplies to prevent the total collapse of essential health and water systems. But as conflicts continue, and amid a shrinking humanitarian space, challenges to reach all vulnerable children with lifesaving assistance are growing.

“When children can’t access healthcare or improved nutrition, when they drink contaminated water, when they live surrounded by waste with no sanitation, they become ill and some die as a result,” said Cappelaere. “There is very little standing between them and life-threatening illness, especially when humanitarian access is denied.”

UNICEF is appealing for children’s needs to be prioritized in all conflict-affected countries through:
   :: Unconditional and sustained access to all children in need for UNICEF and other partners to deliver humanitarian assistance and supplies, including lifesaving medical items and vaccination, water purification material and waste treatment.
:: Parties to conflicts should put an immediate end to attacks on health facilities. Health facilities and civilian infrastructure should be protected at all times.
:: Urgent funding for the health, nutrition and WASH sectors. UNICEF received only one third of its 2017 funding requirements for health, nutrition and water and sanitation in these countries.
 
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EBOLA/EVD  [to 27 May 2017]
http://www.who.int/ebola/en/

Ebola Situation report: 25 May 2017
25 May 2017

Situation update

WHO, UN Agencies, International organizations, non-governmental organizations (NGOs) and partners con­tinue to support the Ministry of Health in the Democratic Republic of Congo to rapidly investigate and respond to the outbreak of Ebola virus disease (EVD) in Likati Health Zone, Bas Uele Province located in the north-east of the country.

On 24 May 2017, no new confirmed or probable EVD cases were reported. Two suspected EVD cases were reported, one each from Muma and Nambwa Health Areas in Likati Health Zone. The last confirmed case was reported on 11 May 2017.

Currently there are a total of two confirmed cases, three probable and 37 suspected cases. The confirmed and probable cases were reported from Nambwa (one confirmed and two probable) and Muma (one con­firmed and one probable). The suspected cases have been reported from six health areas (Nambwa, Muma, Ngayi, Azande, Mobenge and Mabongo). No healthcare workers have been affected to date. The outbreak currently remains confined to Likati Health Zone.

As of 24 May 294 contacts remain under follow up for signs and symptoms of Ebola. A total number of 520 contacts have been listed and 226 have completed 21 days of contact monitoring….

Current risk assessment
:: The risk is high at the national level due to the known impact of Ebola outbreaks, remoteness of the af­fected area, and limited access to health care including suboptimal surveillance.
:: The risk at the regional level is moderate due to the proximity of international borders and the recent influx of refugees from Central African Republic.
:: The risk is low at global level due to the remoteness and inaccessibility of the area to major international ports….

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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 27 May 2017]
http://www.who.int/emergencies/zika-virus/en/
Disease outbreak news
Zika virus infection – India  26 May 2017

On 15 May 2017, the Ministry of Health and Family Welfare-Government of India (MoHFW) reported three laboratory-confirmed cases of Zika virus disease in Bapunagar area, Ahmedabad District, Gujarat, State, India….

MERS-CoV [to 27 May 2017]
http://www.who.int/emergencies/mers-cov/en/
[No new digest content identified]
 
Yellow Fever  [to 27 May 2017]
http://www.who.int/emergencies/yellow-fever/en/
[No new digest content identified]

WHO & Regional Offices [to 27 May 2017]

Report: Ten years of transformation
26 May 2017 — WHO has made extraordinary progress
 in its bold reform agenda over the past decade. Innovative leadership, managerial structures and systems have resulted in increased effectiveness, efficiency, responsiveness, transparency and accountability. This report tells the story of WHO’s transformation from 2007 through to the current day.

Highlights
Stand up for human rights to – and through – health, experts urge Governments
May 2017 – The world is at a watershed moment that could lead to greater dignity for everyone throughout their lives, but only if Governments invest in the relationship between human rights and health specifically for women, children and adolescents, a UN-backed group of politicians and health and human rights experts said.

Double-duty actions for ending malnutrition within a decade
May 2017 – Malnutrition has many forms. Undernutrition can see children dangerously thin for their height (wasting), or their growth permanently impeded (stunting). Inadequate intake of key nutrients may weaken immune systems, impair brain development, and worsen the risk of conditions such as anaemia and blindness.

WHO list of priority medical devices for cancer management
May 2017 – From kick buckets to MRI units, medical devices are an indispensable part of preventing, diagnosing and treating cancer, as well as for palliative care for cancer patients. WHO’s new List of priority medical devices for cancer management describes hundreds of devices that are needed for six types of cancer: breast, cervical, colorectal, leukemia, lung and prostate.

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Weekly Epidemiological Record, 26 May 2017, vol. 92, 21 (pp. 293–300)
:: Virologic monitoring of poliovirus type 2 after OPV2 withdrawal in April 2016: an important advance in eradicating poliomyelitis and eliminating live oral poliovirus vaccines worldwide, 2016–2017

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

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Unprecedented New Organizational Reforms for WHO in the African Region announced
Three years after Ebola crisis, Dr Matsidisho Moeti’s Transformation Agenda yields numerous achievements by WHO in the Africa region; sets stage for new focus on adolescent health and establishment of emergency response hubs
Geneva, 22 May 2017 – The World Health Organization’s (WHO) Regional Director for Africa announced today four new flagship programs for the region over the next two years, including a major push on adolescent health and the creation of regional emergency hubs. She also announced that WHO country offices in the African region will be held accountable to a mandatory set of performance deliverables over the next two years as part of the next phase of an ambitious reform program begun in 2015 in the wake of the Ebola crisis in West Africa…

WHO Region of the Americas PAHO
:: Sudamérica adapta estrategia mundial para mejorar la salud de las mujeres, niños, niñas y adolescentes (05/25/2017)
 
WHO European Region EURO
:: Strengthening women’s leadership in public health in Ukraine 23-05-2017

WHO Eastern Mediterranean Region EMRO
:: Jumbo jet lands in war-torn Yemen carrying 67 tons of cholera response supplies
25 May 2017 – A World Health Organization-chartered aircraft carrying intravenous fluids and cholera kits has successfully landed at Sana’a airport in Yemen. At 67 tons, it constitutes the largest planeload of medical goods WHO has brought into the country since the escalation of the conflict in March 2015. The supplies, sufficient for the treatment of 10 000 patients, are a welcome boost to the country’s response to a cholera outbreak which has caused more than almost 70 000 suspected cases since it began in October 2016. The epidemic had shown signs of slowing but recently reignited, causing 42 207 suspected cases and 420 deaths between 27 April 2017 and 24 May 2017.
:: WHO mobilizes health response for Ar-Raqqa, Syria  23 May 2017

Announcements
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 27 May 2017]
http://cepi.net/
CEPI Newsletter 26 May 2017
Address from the CEO
As I mentioned at the end of my last note, the CEPI Scientific Advisory Committee held a special meeting on May 10 to review the white papers submitted in response to CEPI’s first call for proposals. The very next day, while the Scientific Advisory Committee was meeting in regular session, an Ebola outbreak was confirmed in the Bas-Uele province in northern Democratic Republic of Congo, not far from Yambuku, the town where the virus first emerged in 1976. On May 12, a young man, Onwuegbuzie Stanley-Samuel, died of Lassa Fever at the University of Calabar Teaching Hospital in southeastern Nigeria, the latest victim of a Lassa fever outbreak that has been percolating in Nigeria for several months. If we need to be reminded that the threat of epidemic disease is real, these developments do just that (they have prompted me to ask the CEPI team to accelerate the development of our emergency response plans, which are in a very early state).

It is thus not surprising that CEPI continues to attract a great deal of attention and support from global public health partners. Last Friday, Australia announced a donation of $2 million, becoming CEPI’s seventh investor, joining Germany, Japan, Norway, Wellcome, the Bill & Melinda Gates Foundation and Belgium.

The same day, Chancellor Angela Merkel of Germany told the assembled Health Ministers of the G20 nations, who had gathered in Berlin for their first ever meeting, that help for the African nations affected by Ebola in 2014/2015 had been “too late, too slow, and too uncoordinated”. She urged her G20 peers to support CEPI, the WHO Contingency Fund for Emergencies, and the World Bank Pandemic Emergency Financing Facility, noting emphatically that where preparedness is concerned there is “no free lunch”.

On Monday, in her Address to the Seventieth World Health Assembly, Dr. Margaret Chan, the Director General of WHO, reflected on her ten years of service in that role and the role of WHO in responding to the 2009 pandemic, outbreaks of MERS and H7N9 influenza, and the Ebola and Zika epidemics. She pointed to the establishment of CEPI as a key initiative to enhance global preparedness for such threats.

Monday night, with Dr. Chan’s address still fresh in everyone’s mind, Ministers of Health Bent Høie of Norway and Hermann Gröhe of Germany hosted a side event on CEPI at the World Health Assembly. An audience of some 200 delegates filled the room. The interest in CEPI’s progress, and desire for CEPI to succeed, was palpable.

Richard Hatchett, CEPI CEO
 
::::::
 
Sabin Vaccine Institute  [to 27 May 2017]
http://www.sabin.org/updates/pressreleases
Blog
From Evidence to Action: Typhoid Experts Exchange Data, Strategies During Biannual Conference
05.24.17
More than 300 researchers from 45 countries gathered in Kampala, Uganda in early April for the 10th International Conference on Typhoid and Other Invasive Salmonelloses.
Blog

World Health Assembly Discusses Global Vaccine Action Plan During Historic Meeting
05.22.17
When the 70th World Health Assembly (WHA) begins today in Geneva, Switzerland, it will be one of historic measure. Not only because the WHA be electing a new Director-General of the World Health Organization (WHO), but also because of its sheer scope.
 

Editor’s Note:
We cluster below announcements from selected organizations saluting and otherwise messaging the new WHO Director General.
 
Gavi [to 27 May 2017]
http://www.gavi.org/library/news/press-releases/
23 May 2017
Gavi welcomes election of new WHO Chief
Former Gavi Board member Dr Tedros Adhanom Ghebreyesus is elected Director General of the World Health Organisation (WHO).
 
 
Global Fund [to 27 May 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund welcomes Dr. Tedros Adhanom Ghebreyesus as Director-General of WHO
23 May 2017

The Global Fund congratulates Dr. Tedros Adhanom Ghebreyesus on his election as the new Director-General of World Health Organization.
 
 
PATH  [to 27 May 2017]
http://www.path.org/news/index.php
Announcement | May 23, 2017
PATH statement on election of Dr. Tedros Adhanom Ghebreyesus as Director-General of the World Health Organization
PATH congratulates Dr. Tedros and urges his action to address pressing global health challenges and needs for WHO reform

Announcement | May 23, 2017
PATH statement on the US Administration’s proposed full Fiscal Year 2018 budget
Significant cuts to global health and research programs put the health and security of millions—including Americans—at risk
 
 
UNAIDS  [to 27 May 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update
Global health partners reflect on priorities for the new WHO Director-General
The panellists shared recommendations for a stronger WHO, from pandemic preparedness to United Nations reform.
 
Update
#STOPHIVAIDS in the Russian Federation
The campaign is part of the Russian Government’s State Strategy and Implementation Plan on HIV until 2020 and beyond.

Wellcome Trust  [to 27 May 2017]
https://wellcome.ac.uk/news
Opinion / Published: 26 May 2017
Our letter to the new WHO Director-General
In an open letter, our Director Jeremy Farrar congratulates the new head of the World Health Organization Tedros Adhanom Ghebreyesus, and sets out what Wellcome thinks the WHO’s priorities should be.

News / Published: 26 May 2017
Genomes chart Zika’s spread in the Americas
New research from the 2015-16 Zika outbreak shows how far we have come in being able to study disease outbreaks in close to real time.
Three papers, two by Wellcome-funded researchers and all published in the journal Nature, show what can be achieved when researchers collect and analyse genome sequences rapidly on the ground.
The genomes, obtained from infected patients and Aedes aegypti mosquitoes, show that:
the virus circulated undetected for many months before transmission was detected
Northeast Brazil had a crucial role in establishing the spread of the virus throughout the Americas.
The research also demonstrates the enormous potential of combining traditional epidemiology – looking at how a virus affects people at a population level – with rapid genome sequencing to look at the spread and evolution of a virus…

::::::

Fondation Merieux  [to 27 May 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.
22 May 2017, Bamako (Mali)
Mali: Phase 2 Launch of the LABOMEDCAMP Country Medical Laboratory Project
The official ceremony to launch phase 2 of the LABOMEDCAMP project took place at the Charles Mérieux Center for Infectious Disease on April 5, 2017.
 
::::::
 
IAVI – International AIDS Vaccine Initiative   [to 27 May 2017]
https://www.iavi.org/
May 25, 2017
IAVI Statement on the US Administration’s Proposed Full Fiscal Year 2018 Budget
The International AIDS Vaccine Initiative (IAVI) expresses deep concern over drastic cuts to HIV/AIDS biomedical research and development proposed in the U.S. President’s FY 18 budget.
This budget is built on the unfortunate fallacy that the AIDS epidemic can be sustainably controlled using current tools. The proposed 18 percent cut to PEPFAR limits capacity to maintain treatment programs at present levels only, and fails to accommodate treatment for millions of people who will require it. Steadily increased investment in PEPFAR is what has saved millions of lives and given 11.5 million people access to treatment.

To truly end AIDS, we must look to the horizon of new prevention technologies, including an AIDS vaccine. This budget eliminates USAID funding for IAVI, preventing our researchers from moving 10 promising vaccine candidates into the clinic and from understanding the biological basis of HIV infection that has already helped devise approaches to fighting other infectious diseases.

We call on Congress to fully fund the PEPFAR program, including critical support provided by USAID for HIV prevention R&D. This support promotes economic growth at home and abroad, illuminates the value of American innovation, and helps maintain political stability and global security.

The end of AIDS is within our grasp. This budget will keep us from ever realizing a world without AIDS.
 
::::::
 
NIH  [to 27 May 2017]
http://www.nih.gov/news-events/news-releases
May 24, 2017
Zika virus spread undetected for many months, NIH-supported study finds
May 24, 2017 — Virus quickly spread in the Americas, then diverged into distinct genetic groups.

Modified experimental vaccine protects monkeys from deadly malaria
Scientists modified an existing vaccine to more closely mimics the protein complex used by the parasite.
May 22, 2017 — Researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, modified an experimental malaria vaccine and showed that it completely protected four of eight monkeys who received it against challenge with the virulent Plasmodium falciparum malaria parasite. In three of the remaining four monkeys, the vaccine delayed when parasites first appeared in the blood by more than 25 days…

::::::
 
FDA [to 27 May 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
FDA News Release
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
May 23, 2017
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.

“This is an important first for the cancer community,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “Until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”…
 
::::::
 
European Medicines Agency  [to 27 May 2017]
http://www.ema.europa.eu/ema/
23/05/2017
East African Community looks to EMA as model for future regional agency
EMA and East African regulators met on 18-19 May 2017
As part of the European Medicines Agency’s (EMA) ongoing collaboration with African regulators, a delegation from the East African Community (EAC) visited the Agency on 18-19 May 2017. The goal of the two-day meeting was to gather information and experience to support the potential creation of a networking medicines agency for the EAC.
The delegation included the heads of national agencies from the EAC Partner States, together with representatives from the World Health Organization (WHO) and the World Bank Group. The EAC has six Partner States: Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda…

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

Plotkin’s Vaccines. Edition No. 7
Authors: Stanley Plotkin, Walter Orenstein, Paul Offit
June 2017 :: 1504 Pages
Elsevier Health Science
eBook ISBN: 9780323393027
eBook ISBN: 9780323393010
Hardcover ISBN: 9780323357616
Description
From the development of each vaccine to its use in reducing disease, Plotkin’s Vaccines, 7th Edition, provides the expert information you need to provide optimal care to your patients. This award-winning text offers a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as “an indispensable guide to the enhancement of the well-being of our world,” Plotkin’s Vaccines is a must-have reference for current, authoritative information in this fast-moving field.
Key Features
:: Includes complete information for each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, epidemiology, and public health and regulatory issues – plus complete information for each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies.
:: Analyzes the cost-benefit and cost-effectiveness of different vaccine options.

Journal Watch

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

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

American Journal of Infection Control
June 01, 2017 Volume 45, Issue 6, p583-702, e53-e68
http://www.ajicjournal.org/current

Major Articles
Evaluation of low immunization coverage among the Amish population in rural Ohio
Christine Kettunen, John Nemecek, Olivia Wenger
p630–634
Published online: March 13, 2017

Stepwise intervention including 1-on-1 counseling is highly effective in increasing influenza vaccination among health care workers
Younghee Jung, Mihye Kwon, Jeongmi Song
p635–641
Published online: January 4, 2017

Global Perspective Article
Infection prevention and control and the refugee population: Experiences from the University of Louisville Global Health Center
Ruth M. Carrico, Linda Goss, Timothy L. Wiemken, Rahel S. Bosson, Paula Peyrani, William A. Mattingly, Allison Pauly, Rebecca A. Ford, Stanley Kotey, Julio A. Ramirez
p673–676
Published online: April 18, 2017
Abstract
Background
During 2016, approximately 140,000 individuals entered the United States as part of the federal government refugee resettlement program and established themselves in communities in virtually every state. No national database regarding refugee health currently exists; therefore, little is known about existing infectious diseases, conditions, and cultural practices that impact successful acculturation. The objective of this report is to identify what is currently known about refugees and circumstances important to infection prevention and control with respect to their roles as new community members, employees, and consumers of health care.
Methods
Using data from the University of Louisville Global Health Center’s Newly Arriving Refugee Surveillance System, health issues affecting refugees from the perspective of a community member, an employee, and a patient were explored.
Results
Lack of immunity to vaccine-preventable diseases is the most widespread issue impacting almost every adult, adolescent, and child refugee resettled in Kentucky. Health issues of concern from an infection prevention and control perspective include latent tuberculosis infection, HIV, hepatitis B, hepatitis C, syphilis, and parasites. Other health conditions that may also be important include anemia, obesity, oral health, diabetes, and cardiovascular disease.
Conclusions
Refugee resettlement provides motivation for collaborative work among those responsible for infection prevention and control in all settings, their public health partners, and those responsible for and interested in community workforce concerns.

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 27 May 2017)

Research article
Comprehensive taxonomy and worldwide trends in pharmaceutical policies in relation to country income status
Maniadakis, G. Kourlaba, J. Shen and A. Holtorf
BMC Health Services Research 2017 17:371
Published on: 25 May 2017
Abstract
Background
Rapidly evolving socioeconomic and technological trends make it challenging to improve access, effectiveness and efficiency in the use of pharmaceuticals. This paper identifies and systematically classifies the prevailing pharmaceutical policies worldwide in relation to a country’s income status.
Methods
A literature search was undertaken to identify and taxonomize prevailing policies worldwide. Countries that apply those policies and those that do not were then grouped by income status.
Results
Pharmaceutical policies are linked to a country’s socioeconomics. Developed countries have universal coverage and control pharmaceuticals with external and internal price referencing systems, and indirect price–cost controls; they carry out health technology assessments and demand utilization controls. Price-volume and risk-sharing agreements are also evolving. Developing countries are underperforming in terms of coverage and they rely mostly on restrictive state controls to regulate prices and expenditure.
Conclusions
There are significant disparities worldwide in the access to pharmaceuticals, their use, and the reimbursement of costs. The challenge in high-income countries is to maintain access to care whilst dealing with trends in technology and aging. Essential drugs should be available to all; however, many low- and middle-income countries still provide most of their population with only poor access to medicines. As economies grow, there should be greater investment in pharmaceutical care, looking to the policies of high-income countries to increase efficiency. Pharmaceutical companies could also develop special access schemes with low prices to facilitate coverage in low-income countries.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 27 May 2017)

Research article
An assessment of the geographical risks of wild and vaccine-derived poliomyelitis outbreaks in Africa and Asia
Kathleen M. O’Reilly, Christine Lamoureux, Natalie A. Molodecky, Hil Lyons, Nicholas C. Grassly and Graham Tallis
BMC Infectious Diseases 2017 17:367
Published on: 26 May 2017
Abstract
Background
The international spread of wild poliomyelitis outbreaks continues to threaten eradication of poliomyelitis and in 2014 a public health emergency of international concern was declared. Here we describe a risk scoring system that has been used to assess country-level risks of wild poliomyelitis outbreaks, to inform prioritisation of mass vaccination planning, and describe the change in risk from 2014 to 2016. The methods were also used to assess the risk of emergence of vaccine-derived poliomyelitis outbreaks.
Methods
Potential explanatory variables were tested against the reported outbreaks of wild poliomyelitis since 2003 using multivariable regression analysis. The regression analysis was translated to a risk score and used to classify countries as Low, Medium, Medium High and High risk, based on the predictive ability of the score.
Results
Indicators of population immunity, population displacement and diarrhoeal disease were associated with an increased risk of both wild and vaccine-derived outbreaks. High migration from countries with wild cases was associated with wild outbreaks. High birth numbers were associated with an increased risk of vaccine-derived outbreaks.
Conclusions
Use of the scoring system is a transparent and rapid approach to assess country risk of wild and vaccine-derived poliomyelitis outbreaks. Since 2008 there has been a steep reduction in the number of wild poliomyelitis outbreaks and the reduction in countries classified as High and Medium High risk has reflected this. The risk of vaccine-derived poliomyelitis outbreaks has varied geographically. These findings highlight that many countries remain susceptible to poliomyelitis outbreaks and maintenance or improvement in routine immunisation is vital.

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 27 May 2017)

Research article
Staff’s normative attitudes towards coercion: the role of moral doubt and professional context—a cross-sectional survey study
The use of coercion is morally problematic and requires an ongoing critical reflection. We wondered if not knowing or being uncertain whether coercion is morally right or justified (i.e. experiencing moral dou…
Bert Molewijk, Almar Kok, Tonje Husum, Reidar Pedersen and Olaf Aasland
BMC Medical Ethics 2017 18:37
Published on: 25 May 2017
Abstract
Background
The use of coercion is morally problematic and requires an ongoing critical reflection. We wondered if not knowing or being uncertain whether coercion is morally right or justified (i.e. experiencing moral doubt) is related to professionals’ normative attitudes regarding the use of coercion.
Methods
This paper describes an explorative statistical analysis based on a cross-sectional survey across seven wards in three Norwegian mental health care institutions.
Results
Descriptive analyses showed that in general the 379 respondents a) were not so sure whether coercion should be seen as offending, b) agreed with the viewpoint that coercion is needed for care and security, and c) slightly disagreed that coercion could be seen as treatment. Staff did not report high rates of moral doubt related to the use of coercion, although most of them agreed there will never be a single answer to the question ‘What is the right thing to do?’.
Bivariate analyses showed that the more they experienced general moral doubt and relative doubt, the more one thought that coercion is offending. Especially psychologists were critical towards coercion. We found significant differences among ward types. Respondents with decisional responsibility for coercion and leadership responsibility saw coercion less as treatment. Frequent experience with coercion was related to seeing coercion more as care and security.
Conclusions
This study showed that experiencing moral doubt is related to some one’s normative attitude towards coercion. Future research could investigate whether moral case deliberation increases professionals’ experience of moral doubt and whether this will evoke more critical thinking and increase staff’s curiosity for alternatives to coercion.

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 27 May 2017)

Research Article
Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting
Lawton, N. Hallowell, C. Snowdon, J. E. Norman, K. Carruthers and F. C. Denison
BMC Medical Ethics 2017 18:36
Published on: 24 May 2017
Abstract
Background
Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment.
Methods
Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used.
Results
Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment.
Conclusions
While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways.

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 27 May 2017)

Research article
Strengthening capacity to research the social determinants of health in low- and middle-income countries: lessons from the INTREC programme
The INDEPTH Training & Research Centres of Excellence (INTREC) collaboration developed a training programme to strengthen social determinants of health (SDH) research in low- and middle-income countries (LMICs…
Nicholas Henschke, Anna Mirny, Joke A Haafkens, Heribert Ramroth, Siwi Padmawati, Martin Bangha, Lisa Berkman, Laksono Trisnantoro, Yulia Blomstedt, Heiko Becher, Osman Sankoh, Peter Byass and John Kinsman
BMC Public Health 2017 17:514
Published on: 25 May 2017

Clinical Therapeutics
May 2017 Volume 39, Issue 5, p873-1076
http://www.clinicaltherapeutics.com/issue/S0149-2918(17)X0004-0

Commentary
Vitamin D Status and the Host Resistance to Infections: What It Is Currently (Not) Understood
Pierre Olivier Lang, Richard Aspinall
p930–945
Published online: April 27, 2017

Reviews
The New Drug Conditional Approval Process in China: Challenges and Opportunities
Xuefang Yao, Jinxi Ding, Yingfang Liu, Penghui Li
p1040–1051
Published online: April 18, 2017
Abstract
Purpose
Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration.
Methods
We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google.
Findings
Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process.
Implications
In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency’s function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform.

Commentary
Incorporating Site-less Clinical Trials Into Drug Development: A Framework for Action
Irl B. Hirsch, Joe Martinez, E. Ray Dorsey, Gerald Finken, Alexander Fleming, Chris Gropp, Philip Home, Daniel I. Kaufer, Spyros Papapetropoulos
p1064–1076
Published online: April 14, 2017
Open Access

The European Journal of Public Health
Volume 27, Issue 3, June 2017
https://academic.oup.com/eurpub/issue/27/3

Infectious diseases
Increase in vaccination coverage between subsequent generations of orthodox Protestants in The Netherlands
Henri Spaan; Wilhelmina L.M. Ruijs; Jeannine L.A. Hautvast; Alma Tostmann

Migration
Interventions to improve immigrant health. A scoping review
Esperanza Diaz; Gaby Ortiz-Barreda; Yoav Ben-Shlomo; Michelle Holdsworth; Bukola Salami …
Abstract
Background: Disparities in health between immigrants and their host populations have been described across countries and continents. Hence, interventions for improving health targeting general populations are not necessarily effective for immigrants.
Aims: To conduct a systematic search of the literature evaluating health interventions for immigrants; to map the characteristics of identified studies including range of interventions, immigrant populations and their host countries, clinical areas targeted and reported evaluations, challenges and limitations of the interventions identified. Following the results, to develop recommendations for research in the field.
Methods: A scoping review approach was chosen to provide an overview of the type, extent and quantity of research available. Studies were included if they empirically evaluated health interventions targeting immigrants and/or their descendants, included a control group, and were published in English (PubMed and Embase from 1990 to 2015).
Results: Most of the 83 studies included were conducted in the USA, encompassed few immigrant groups and used a randomized controlled trial (RCT) or cluster RCT design. Most interventions addressed chronic and non-communicable diseases and attendance at cancer screening services, used individual targeted approaches, targeted adult women and recruited participants from health centres. Outcome measures were often subjective, with the exception of interventions for cardiovascular risk and diabetes. Generally, authors claimed that interventions were beneficial, despite a number of reported limitations.
Conclusions: Recommendations for enhancing interventions to improve immigrant health are provided to help researchers, funders and health care commissioners when deciding upon the scope, nature and design of future research in this area.

Assessing trauma and mental health in refugee children and youth: a systematic review of validated screening and measurement tools
A.K. Gadeberg; E. Montgomery; H.W. Frederiksen; M. Norredam

Global region of birth is an independent risk factor for type 2 diabetes in Stockholm, Sweden
Liselotte Schäfer Elinder; Shawn Hakimi; Anton Lager; Emma Patterson

Adolescent immigrants, the impact of gender on health status
Cheryl Zlotnick; Daphna Birenbaum-Carmeli; Hadass Goldblatt; Yael Dishon; Omer Taychaw …

Access to healthcare for undocumented migrants: analysis of avoidable hospital admissions in Sicily from 2003 to 2013
Daniele Mipatrini; Sebastiano Pollina Addario; Roberto Bertollini; Mario Palermo; Alice Mannocci

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 13, Issue 5, 2017
http://www.tandfonline.com/toc/khvi20/current

Article
Persistence of antibodies 20 y after vaccination with a combined hepatitis A and B vaccine
Pierre Van Damme, Geert Leroux-Roels, P. Suryakiran, Nicolas Folschweiller & Olivier Van Der Meeren
Pages: 972-980
Published online: 10 Mar 2017

Article
Persistence of immunity 18–19 years after vaccination against hepatitis B in 2 cohorts of vaccinees primed as infants or as adolescents in Italy
Luisa Romanò, Cristina Galli, Catia Tagliacarne, Maria Elena Tosti, Claudio Velati, Laura Fomiatti, Maria Chironna, Rosa Cristina Coppola, Mario Cuccia, Rossana Mangione, Fosca Marrone, Francesco Saverio Negrone, Antonino Parlato, Carla Maria Zotti, Alfonso Mele, Alessandro Remo Zanetti & the Study Group
Pages: 981-985
Published online: 08 Mar 2017

Review
Research progress of therapeutic vaccines for treating chronic hepatitis B
Jianqiang Li, Mengru Bao, Jun Ge, Sulin Ren, Tong Zhou, Fengchun Qi, Xiuying Pu & Jia Dou
Pages: 986-997
Published online: 24 Jan 2017

Review
Progress in HIV vaccine development
Denise C. Hsu & Robert J. O’Connell MD
Pages: 1018-1030
Published online: 10 Mar 2017

Review
Vaccines licensed and in clinical trials for the prevention of dengue
Torresi, G. Ebert & M. Pellegrini
Pages: 1059-1072
Published online: 14 Feb 2017
ABSTRACT
Dengue has become a major global public health threat with almost half of the world’s population living in at-risk areas. Vaccination would likely represent an effective strategy for the management of dengue disease in endemic regions, however to date there is only one licensed preventative vaccine for dengue infection. The development of a vaccine against dengue virus (DENV) has been hampered by an incomplete understanding of protective immune responses against DENV. The most clinically advanced dengue vaccine is the chimeric yellow fever-dengue vaccine (CYD) that employs the yellow fever virus 17D strain as the replication backbone (Chimerivax-DEN; CYD-TDV). This vaccine had an overall pooled protective efficacy of 65.6% but was substantially more effective against severe dengue and dengue hemorrhagic fever. Several other vaccine approaches have been developed including live attenuated chimeric dengue vaccines (DENVax and LAV Delta 30), DEN protein subunit V180 vaccine (DEN1–80E) and DENV DNA vaccines. These vaccines have been shown to be immunogenic in animals and also safe and immunogenic in humans. However, these vaccines are yet to progress to phase III trials to determine their protective efficacy against dengue. This review will summarize the details of vaccines that have progressed to clinical trials in humans.

Brief Report
Cost analysis of measles in refugees arriving at Los Angeles International Airport from Malaysia
Margaret S. Coleman, Heather M. Burke, Bethany L. Welstead, Tarissa Mitchell, Eboni M. Taylor, Dmitry Shapovalov, Brian A. Maskery, Heesoo Joo & Michelle Weinberg
Pages: 1084-1090
Published online: 09 Jan 2017

Article
Economic evaluation of routine infant rotavirus immunisation program in Japan
Shu-ling Hoshi, Masahide Kondo & Ichiro Okubo
Pages: 1115-1125
Published online: 20 Oct 2016

Article Commentary
Teaching children about immunization in a digital age
Kumanan Wilson, Katherine Atkinson & Natasha Crowcroft
Pages: 1155-1157
Published online: 06 Feb 2017

Review
Vaccinating healthcare workers: Level of implementation, barriers and proposal for evidence-based policies in Turkey
Lale Ozisik, Mine Durusu Tanriover, Serdar Altınel & Serhat Unal
Pages: 1198-1206
Published online: 06 Jan 2017

JAMA
May 23/30, 2017, Vol 317, No. 20, Pages 2033-2142
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Single IRBs in Multisite TrialsQuestions Posed by the New NIH Policy
Robert Klitzman, MD; Ekaterina Pivovarova, PhD; Charles W. Lidz, PhD
JAMA. 2017;317(20):2061-2062. doi:10.1001/jama.2017.4624
This Viewpoint describes measures needed for an effective NIH policy in which a single IRB would work with multiple local IRBs to ensure protection of participants in multisite trials.

Journal of Infectious Diseases
Volume 215, Issue 8   15 April 2017
http://jid.oxfordjournals.org/content/current

Editor’s Choice
Measles Vaccination Is Effective at Under Nine Months of Age, and Provides Nonspecific Immunological Benefits
Katie L. Flanagan

HIV/AIDS
Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial
Supachai Rerks-Ngarm; Punnee Pitisuttithum; Jean-Louis Excler; Sorachai Nitayaphan; Jaranit Kaewkungwal …

Lancet Infectious Diseases
Jun 2017 Volume 17 Number 6 p563-672  e166-e196
http://www.thelancet.com/journals/laninf/issue/current

Articles
Effectiveness and cost-effectiveness of a nurse-delivered intervention to improve adherence to treatment for HIV: a pragmatic, multicentre, open-label, randomised clinical trial
Marijn de Bruin, Edwin J M Oberjé, Wolfgang Viechtbauer, Hans-Erik Nobel, Mickaël Hiligsmann, Cees van Nieuwkoop, Jan Veenstra, Frank J Pijnappel, Frank P Kroon, Laura van Zonneveld, Paul H P Groeneveld, Marjolein van Broekhuizen, Silvia M A A Evers, Jan M Prins

Safety and immunogenicity of one versus two doses of Takeda’s tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study
Xavier Sáez-Llorens, Vianney Tricou, Delia Yu, Luis Rivera, Suely Tuboi, Pedro Garbes, Astrid Borkowski, Derek Wallace

Asymptomatic infection and unrecognised Ebola virus disease in Ebola-affected households in Sierra Leone: a cross-sectional study using a new non-invasive assay for antibodies to Ebola virus
Judith R Glynn, Hilary Bower, Sembia Johnson, Catherine F Houlihan, Carla Montesano, Janet T Scott, Malcolm G Semple, Mohammed S Bangura, Alie Joshua Kamara, Osman Kamara, Saidu H Mansaray, Daniel Sesay, Cecilia Turay, Steven Dicks, Raoul E Guetiya Wadoum, Vittorio Colizzi, Francesco Checchi, Dhan Samuel, Richard S Tedder

Characteristics and survival of patients with Ebola virus infection, malaria, or both in Sierra Leone: a retrospective cohort study
Matthew Waxman, Adam R Aluisio, Soham Rege, Adam C Levine

Lancet Respiratory Medicine
Jun 2017 Volume 5 Number 6 p457-534  e20-e22
http://www.thelancet.com/journals/lanres/issue/current

Articles
Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study
John H Beigel, Pablo Tebas, Marie-Carmelle Elie-Turenne, Ednan Bajwa, Todd E Bell, Charles B Cairns, Shmuel Shoham, Jaime G Deville, Eric Feucht, Judith Feinberg, Thomas Luke, Kanakatte Raviprakash, Janine Danko, Dorothy O’Neil, Julia A Metcalf, Karen King, Timothy H Burgess, Evgenia Aga, H Clifford Lane, Michael D Hughes, Richard T Davey on behalf of the IRC002 Study Team
Summary
Background
Influenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza.
Methods
In this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients’ respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20–38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480.
Findings
Between Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96–3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02–1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4–16] vs 11 days [5–25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0–6] vs 3 days [0–14], p=0·14). Fewer plasma plus standard care participants had serious adverse events compared with standard care alone recipients (nine [20%] of 46 vs 20 [38%] of 52, p=0·041), the most frequent of which were acute respiratory distress syndrome (one [2%] vs two [4%] patients) and stroke (one [2%] vs two [4%] patients).
Interpretation
Although there was no significant effect of plasma treatment on the primary endpoint, the treatment seemed safe and well tolerated. A phase 3 randomised trial is now underway to further assess this intervention.
Funding
National Institute of Allergy and Infectious Diseases, US National Institutes of Health.

Nature Reviews Immunology
June 2017 Vol 17 No 6
http://www.nature.com/nri/journal/v17/n6/index.html

Comment:
Emil von Behring: translational medicine at the dawn of immunology
Stefan H. E. Kaufmann
p341 | doi:10.1038/nri.2017.37
Remembering Emil von Behring, one of the founders of immunology, 100 years after his death.

New England Journal of Medicine
May 25, 2017  Vol. 376 No. 21
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Accelerated Approval and Expensive Drugs — A Challenging Combination
Walid F. Gellad, M.D., M.P.H., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
N Engl J Med 2017; 376:2001-2004 May 25, 2017 DOI: 10.1056/NEJMp1700446

Perspective
Sharing Clinical and Genomic Data on Cancer — The Need for Global Solutions
The Clinical Cancer Genome Task Team of the Global Alliance for Genomics and Health
N Engl J Med 2017; 376:2006-2009 May 25, 2017 DOI: 10.1056/NEJMp1612254

PLoS Currents: Outbreaks

http://currents.plos.org/outbreaks/

[Accessed 27 May 2017]

Integrating Environmental Monitoring and Mosquito Surveillance to Predict Vector-borne Disease: Prospective Forecasts of a West Nile Virus Outbreak

May 23, 2017 · Research Article

Introduction: Predicting the timing and locations of future mosquito-borne disease outbreaks has the potential to improve the targeting of mosquito control and disease prevention efforts. Here, we present and evaluate prospective forecasts made prior to and during the 2016 West Nile virus (WNV) season in South Dakota, a hotspot for human WNV transmission in the United States.

Methods: We used a county-level logistic regression model to predict the weekly probability of human WNV case occurrence as a function of temperature, precipitation, and an index of mosquito infection status. The model was specified and fitted using historical data from 2004-2015 and was applied in 2016 to make short-term forecasts of human WNV cases in the upcoming week as well as whole-year forecasts of WNV cases throughout the entire transmission season. These predictions were evaluated at the end of the 2016 WNV season by comparing them with spatial and temporal patterns of the human cases that occurred.

Results: There was an outbreak of WNV in 2016, with a total of 167 human cases compared to only 40 in 2015. Model results were generally accurate, with an AUC of 0.856 for short-term predictions. Early-season temperature data were sufficient to predict an earlier-than-normal start to the WNV season and an above-average number of cases, but underestimated the overall case burden. Model predictions improved throughout the season as more mosquito infection data were obtained, and by the end of July the model provided a close estimate of the overall magnitude of the outbreak.

Conclusions: An integrated model that included meteorological variables as well as a mosquito infection index as predictor variables accurately predicted the resurgence of WNV in South Dakota in 2016. Key areas for future research include refining the model to improve predictive skill and developing strategies to link forecasts with specific mosquito control and disease prevention activities.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 27 May 2017)

Research Article
Data sharing in clinical trials: An experience with two large cancer screening trials
Claire S. Zhu, Paul F. Pinsky, James E. Moler, Andrew Kukwa, Jerome Mabie, Joshua M. Rathmell, Tom Riley, Philip C. Prorok, Christine D. Berg
Health in Action | published 23 May 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002304
Summary points
:: Broad sharing of clinical trial data is important for ensuring reproducibility, transparency, and maximal use of the data by the research community. However, in practice, such data sharing typically requires planning, effort, and resources.
:: Here, we describe a web-based data sharing system, the Cancer Data Access System (CDAS), developed for two large cancer screening trials: the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial and the National Lung Screening Trial (NLST).
:: Deidentified individual participant data were organized into standard datasets readily downloadable from CDAS via a simple web-based application process that involves minimal scientific review. CDAS provides a “one-stop shop” for access requests, review, and data downloads.
:: Since the launch of CDAS in November 2012 and through October 2016, 215 requests were received for PLCO data, of which 199 (93%) were approved, and 240 requests were received for NLST, of which 216 (90%) were approved.
:: The estimated cost of CDAS was around US$300,000 for the initial development, plus additional maintenance and user-support costs of about US$26,000 per month. Because of its modular nature, additional studies can be added to CDAS with relatively little additional cost.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 27 May 2017)

Editorial
Russian–United States vaccine science diplomacy: Preserving the legacy
Peter J. Hotez
| published 25 May 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005320
[Initial text]
United States–Russia tensions over the hostilities in Ukraine, collapsed cease-fires and chemical weapons use in Syria, and accusations of alleged cyberattacks may require a diplomatic reset. To help ease growing strains and restore dialogue and cooperation, it is worth looking to a productive and extraordinary historical record of international scientific collaborations.
Throughout the last half of the 20th century, the United States and Soviet Union managed a complex Cold War foreign policy relationship by opening and maintaining channels in sports, the arts, literature, and other humanitarian endeavors. One of the most productive engagements was through a mostly clandestine joint initiative to develop, test, and deliver life-saving vaccines that targeted the ancient scourges of humankind. Ultimately, through Cold War vaccine diplomacy, smallpox was eradicated, and polio was mostly eliminated [1]…

PLoS One
http://www.plosone.org/
[Accessed 27 May 2017]

Research Article
The emergence and evolution of the research fronts in HIV/AIDS research
David Fajardo-Ortiz, Malaquias Lopez-Cervantes, Luis Duran, Michel Dumontier, Miguel Lara, Hector Ochoa, Victor M. Castano
Research Article | published 25 May 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0178293

Projected savings through public health voluntary licences of HIV drugs negotiated by the Medicines Patent Pool (MPP)
Sandeep Juneja, Aastha Gupta, Suerie Moon, Stephen Resch
Research Article | published 25 May 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0177770

Effectiveness of pneumococcal vaccines in preventing pneumonia in adults, a systematic review and meta-analyses of observational studies
Myint Tin Tin Htar, Anke L. Stuurman, Germano Ferreira, Cristiano Alicino, Kaatje Bollaerts, Chiara Paganino, Ralf René Reinert, Heinz-Josef Schmitt, Cecilia Trucchi, Thomas Vestraeten, Filippo Ansaldi
Research Article | published 23 May 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0177985

Vaccine
Volume 35, Issue 27, Pages 3431-3514 (14 June 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/27

Short Communications
Dengue vaccine safety signal: Immune enhancement, waning immunity, or chance occurrence?
Pages 3452-3456
Bradford D. Gessner, Neal Halsey
Abstract
A new dengue vaccine was associated with increased risk of hospitalized virologically-confirmed disease during year 3 of follow-up among children age 2–5 years. Among hypotheses to explain this finding, we could not distinguish definitively between antibody dependent enhancement, waning immunity, or chance occurrence. However, any theory must account for the following: (a) the signal occurred mainly because of decreased dengue among controls rather than increased dengue among vaccinees; (b) among 48 data points, a statistically significant increase in hospitalization among vaccinated children occurred for only one age group, during one year, and in one region; (c) cumulative risk was similar for vaccinated vs. control children age 2–5 years at the end of year 5 and lower for vaccinated vs. control children among older age groups; (d) the protective effect of vaccine against hospitalization decreased from years 1–2 to years 3–5 of follow-up for all age groups and regions.

Vaccine
Volume 35, Issue 27, Pages 3431-3514 (14 June 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/27

Cost-effectiveness analysis of typhoid conjugate vaccines in five endemic low- and middle-income settings
Original Research Article
Pages 3506-3514
Marina Antillón, Joke Bilcke, A. David Paltiel, Virginia E. Pitzer
Abstract
Background
Typhoid fever remains endemic in low- and middle-income countries. Programmatic use of existing vaccines is limited, but upcoming typhoid conjugate vaccines (TCVs) could warrant wider use. We evaluated the cost-effectiveness of five TCV delivery strategies in three urban areas (Delhi and Kolkata, India and Nairobi, Kenya) and two rural settings (Lwak, Kenya and Dong Thap, Vietnam) with varying incidence.
Methods and findings
We evaluated routine infant vaccination with and without catch-up campaigns among older individuals. We used a dynamic model of typhoid transmission to simulate cases, hospitalizations, deaths, disability-adjusted life-years (DALY) lost, treatment and intervention costs. We estimated cost-effectiveness (in terms of cost in international dollars (I$) per DALY averted) from the healthcare payer perspective, and assessed how it was influenced by uncertain model parameters. Compared to no vaccination, routine infant vaccination at I$1/dose was cost-saving in Delhi and Dong Thap, “very cost-effective” in Kolkata and Nairobi, and “cost-effective” in Lwak according to World Health Organization thresholds. However, routine vaccination was not the optimal strategy compared to strategies that included a catch-up campaign, which yielded the highest probability of being cost-saving in Delhi and Dong Thap and were most likely to provide a return on investment above a willingness-to-pay threshold of I$1440 in Kolkata, I$2300 in Nairobi, and I$5360 in Lwak. Vaccine price impacted the optimal strategy, and the number of doses required and rate of hospitalization were the primary sources of uncertainty.
Conclusion
Routine vaccination with TCV would be cost-effective in most settings, and additional one-time catch-up campaigns would also be economically justified.

Vaccine
Volume 35, Issue 25, Pages 3281-3354 (5 June 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/25

Regular papers
Assessing age-dependent susceptibility to measles in Japan
Original Research Article
Pages 3309-3317
Ryo Kinoshita, Hiroshi Nishiura
Abstract
Background
Routine vaccination against measles in Japan started in 1978. Whereas measles elimination was verified in 2015, multiple chains of measles transmission were observed in 2016. We aimed to reconstruct the age-dependent susceptibility to measles in Japan so that future vaccination strategies can be elucidated.
Methods
An epidemiological model was used to quantify the age-dependent immune fraction using datasets of vaccination coverage and seroepidemiological survey. The second dose was interpreted in two different scenarios, i.e., booster and random shots. The effective reproduction number, the average number of secondary cases generated by a single infected individual, and the age at infection were explored using the age-dependent transmission model and the next generation matrix.
Results
While the herd immunity threshold of measles likely ranges from 90% to 95%, assuming that the basic reproductive number ranges from 10 to 20, the estimated immune fraction in Japan was below those thresholds in 2016, despite the fact that the estimates were above 80% for all ages. If the second dose completely acted as the booster shot, a proportion immune above 90% was achieved only among those aged 5 years or below in 2016. Alternatively, if the second dose was randomly distributed regardless of primary vaccination status, a proportion immune over 90% was achieved among those aged below 25 years. The effective reproduction number was estimated to range from 1.50 to 3.01 and from 1.50 to 3.00, respectively, for scenarios 1 and 2 in 2016; if the current vaccination schedule were continued, the reproduction number is projected to range from 1.50 to 3.01 and 1.39 to 2.78, respectively, in 2025.
Conclusion
Japan continues to be prone to imported cases of measles. Supplementary vaccination among adults aged 20–49 years would be effective if the chains of transmission continue to be observed in that age group.

Vaccine
Volume 35, Issue 26, Pages 3355-3430 (8 June 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/26

Review
Global economic evaluations of rotavirus vaccines: A systematic review
Review Article
Pages 3364-3386
Surachai Kotirum, Naaon Vutipongsatorn, Khachen Kongpakwattana, Raymond Hutubessy, Nathorn Chaiyakunapruk
Abstract
Introduction: World Health Organization (WHO) recommends Rotavirus vaccines to prevent and control rotavirus infections. Economic evaluations (EE) have been considered to support decision making of national policy. Summarizing global experience of the economic value of rotavirus vaccines is crucial in order to encourage global WHO recommendations for vaccine uptake. Therefore, a systematic review of economic evaluations of rotavirus vaccine was conducted.
Methods: We searched Medline, Embase, NHS EED, EconLit, CEA Registry, SciELO, LILACS, CABI-Global Health Database, Popline, World Bank – e-Library, and WHOLIS. Full economic evaluations studies, published from inception to November 2015, evaluating Rotavirus vaccines preventing Rotavirus infections were included. The methods, assumptions, results and conclusions of the included studies were extracted and appraised using WHO guide for standardization of EE of immunization programs.
Results: 104 relevant studies were included. The majority of studies were conducted in high-income countries. Cost-utility analysis was mostly reported in many studies using incremental cost-effectiveness ratio per DALY averted or QALY gained. Incremental cost per QALY gained was used in many studies from high-income countries. Mass routine vaccination against rotavirus provided the ICERs ranging from cost-saving to highly cost-effective in comparison to no vaccination among low-income countries. Among middle-income countries, vaccination offered the ICERs ranging from cost-saving to cost-effective. Due to low- or no subsidized price of rotavirus vaccines from external funders, being not cost-effective was reported in some high-income settings.
Conclusion: Mass vaccination against rotavirus was generally found to be cost-effective, particularly in low- and middle-income settings according to the external subsidization of vaccine price. On the other hand, it may not be a cost-effective intervention at market price in some high-income settings. This systematic review provides supporting information to health policy-makers and health professionals when considering rotavirus vaccination as a national program.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 27 May 2017)

Article
The Potential Cost-Effectiveness of Pre-Exposure Prophylaxis Combined with HIV Vaccines in the United States
by Blythe J. S. Adamson, Josh J. Carlson, James G. Kublin and Louis P. Garrison
Vaccines 2017, 5(2), 13; doi:10.3390/vaccines5020013 – 24 May 2017
Abstract
This economic evaluation aims to support policy-making on the combined use of pre-exposure prophylaxis (PrEP) with HIV vaccines in development by evaluating the potential cost-effectiveness of implementation that would support the design of clinical trials for the assessment of combined product safety and efficacy. The target study population is a cohort of men who have sex with men (MSM) in the United States. Policy strategies considered include standard HIV prevention, daily oral PrEP, HIV vaccine, and their combination. We constructed a Markov model based on clinical trial data and the published literature. We used a payer perspective, monthly cycle length, a lifetime horizon, and a 3% discount rate. We assumed a price of $500 per HIV vaccine series in the base case. HIV vaccines dominated standard care and PrEP. At current prices, PrEP was not cost-effective alone or in combination. A combination strategy had the greatest health benefit but was not cost-effective (ICER = $463,448/QALY) as compared to vaccination alone. Sensitivity analyses suggest a combination may be valuable for higher-risk men with good adherence. Vaccine durability and PrEP drug prices were key drivers of cost-effectiveness. The results suggest that boosting potential may be key to HIV vaccine value.

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

INDIAN JOURNAL OF COMMUNITY HEALTH
VOL 29 / ISSUE NO 01 / JAN – MAR 2017
Primary immunization coverage among Migrant children in the age group of 12 to 23 months in Sriperumbudur Taluk, Kanchipuram District
R Dutta, P Dekal, T Jain, DR Jeyapal, K Sivakumar…
Abstract

Background: Migrants carry with them a burden of health risks and public health implications due to their poverty, unequal access to social benefits including health care services like immunization.

Aims & Objectives: To describe the socio-demographic profile and the primary immunization status of migrant children in the age group 12 to 23 months and also identify the various factors related to immunization failure if any in Sriperumbudur Taluk, Kanchipuram District of Tamil Nadu.

Material & Methods: A community based cross sectional descriptive study was done among 173 migrant children in the age group of 12 to 23 months from 12 construction sites in the study area between July 2016 – September 2016. The data was collected using a pre-designed, structured questionnaire.

Results: The age group of mothers varied from 18-39yrs. About 46 (26.6%) mothers were illiterate. Majority of the children 159 (91.9%) had a birth certificate. Almost all 171 (98.8%) children were having immunization card. Only one child was found to be partially immunized. Lack of time was found to be the reason for not taking the child for immunization. All others 172 (99.4%) were fully immunized.

Conclusion: Awareness should be created among migrant workers regarding importance of immunization through regular health education activities.

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 27 May 2017
Germany vaccination: Fines plan as measles cases rise
26 May 2017
Parents in Germany who fail to seek medical advice on vaccinating their children could face fines of up to €2,500 (£2,175; $2,800).
Health Minister Hermann Gröhe said it was necessary to tighten the law because of a measles epidemic…

New York Times
http://www.nytimes.com/
Accessed 27 May 2017
German Kindergartens Must Report Parents for Refusing Vaccine Advice Under New Law
Germany will pass a law next week obliging kindergartens to inform the authorities if parents fail to provide evidence that they have received advice from their doctor on vaccinating their children, the health ministry said on Friday….
May 26, 2017 – By REUTERS

AP Exclusive: Outgoing WHO Head Practiced Art of Appeasement
LONDON — As the World Health Organization struggled to coordinate vaccine production during the 2009 swine flu pandemic, its director-general met with Vladimir Putin, then Russia’s prime minister, during an official visit to
May 23, 2017 – By THE ASSOCIATED PRESS

AP Exclusive: UN Health Agency Slammed for High Travel Costs
May 22, 2017 – By THE ASSOCIATED PRESS
 

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 27 May 2017
Are We Now Ready for Ebola?
By Betsy McKay, Nicholas Bariyo
May 26, 2017 11:27 am ET
The deadly Ebola virus is back, and the world is responding more aggressively this time. But it’s still not as prepared as it needs to be to thwart deadly infectious disease threats, despite the hard lessons of the last epidemic.

New York City Issues Zika Travel Warning
By Melanie Grayce West
May 25, 2017 6:13 pm ET
In advance of the summer travel season, New York City health officials on Thursday stepped up warnings to would-be parents about the threat of contracting Zika, a mosquito-borne virus that has been linked to serious birth defects in babies and, in some cases, in utero deaths.

Washington Post
http://www.washingtonpost.com/
Accessed 27 May 2017
Imams in U.S. take on the anti-vaccine movement during Ramadan
Lena H. Sun · Health-Environment-Science · May 26, 2017

Minnesota’s measles outbreak is about to exceed the total number of cases reported in the entire United States last year, with no sign of slowing. Health officials worry that the start of the holy month of Ramadan, which began Friday night and brings Muslims together in prayer and festivities, will accelerate the spread of the highly infectious and potentially deadly disease, which is plaguing the close-knit Somali American community.

Minnesota health officials are working closely with faith leaders in an unprecedented effort to spread the message that parents should get their children vaccinated and keep them home if they show symptoms of the disease. It’s the first time that imams in the United States have taken such an active role in a public health crisis, health officials and Somali Americans said.

The imams are up against the anti-vaccine movement, which in recent years has targeted the Somali American community with misinformation linking the measles-mumps-rubella vaccine to autism, a claim that extensive research has disproved. Somali American children in Minnesota had a vaccination rate of 92 percent in 2004, higher than the state average, but that rate has dropped to 42 percent, leaving children vulnerable to disease…

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_20 May 2017

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

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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– 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.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and PolicyVaccines and Global Health_The Week in Review_6 May 2017

World Health Assembly
WHA70
22–31 May 2017, Geneva

Webcast
Watch WHA70 live
Starts at 09:30 CEST on 22 May 2017, Monday

Documentation
Preliminary Journal
Provisional agenda
All documents
Selected Documents:
A70/9 – Health emergencies: WHO response in severe, large-scale emergencies
A70/10 – Health emergencies: Research and development for potentially epidemic diseases
A70/14 – Poliomyelitis
A70/14 Add.1 – Polio transition planning
A70/17 – Review of the Pandemic Influenza Preparedness Framework
A70/20 – Addressing the global shortage of, and access to, medicines and vaccines
A70/25 – Global vaccine action plan

Themes
Medicines and health products
Noncommunicable diseases
Nutrition
Emergencies preparedness, response
Poliomyelitis (polio)
Antimicrobial resistance
Maternal, newborn, child and adolescent health

Election process for WHO Director-General
The process to elect the next Director-General of WHO is underway. An overview of the election process follows:
:: Names of candidates for the next Director-General nominated by Member States were announced on 23 September 2016.
:: In October 2016, Member States and candidates were given the opportunity to interact in a password-protected web forum hosted by WHO.
:: On 1–2 November 2016, a live forum was held, at which candidates presented their vision to Member States and were also able to answer questions on their candidacy. The candidates’ forum was webcast on the WHO website in all official languages.
:: In January 2017, WHO’s Executive Board drew up a short list of 5 candidates. Executive Board members then interviewed these candidates and selected 3 nominees to go forward to the World Health Assembly in May 2017.
:: At the Seventieth World Health Assembly, Member States will vote in a new Director-General, who will take office on 1 July 2017.
 
Nominees for the post of WHO Director-General
The WHO Executive Board selected by vote the following 3 candidates to be presented to World Health Assembly as nominees for the post of Director-General of WHO.
:: Tedros Adhanom Ghebreyesus
The Government of Ethiopia has submitted the nomination of Dr Tedros Adhanom Ghebreyesus.
: David Nabarro
The Government of the United Kingdom of Great Britain and Northern Ireland has submitted the nomination of Dr David Nabarro.
: Sania Nishtar
The Government of Pakistan has submitted the nomination of Dr Sania Nishtar.

Italy makes 12 vaccinations compulsory for children
BBC  19 May 2017
The government in Italy has ruled that children must be vaccinated against 12 common illnesses before they can enrol for state-run schools.
Prime Minister Paolo Gentiloni blamed a decrease in vaccinations in part on a “spread of anti-scientific theories”.
Italy has recorded nearly three times as many measles cases so far this year than for all of 2016.
If children are not vaccinated by the age of six, the school starting age, their parents will be fined…
In Italy, the number of two-year-olds vaccinated against measles has dropped from more than 90% to below 80%. This is well short of the World Health Organization’s recommended coverage of 95% or more.
“The lack of appropriate measures over the years and the spread of anti-scientific theories, especially in recent months, has brought about a reduction in protection,” Mr Gentiloni told a press conference on Friday.
The twelve conditions children must be immunised against are: polio; diphtheria; tetanus; hepatitis B; haemophilus influenzae B; meningitis B; meningitis C; measles; mumps; rubella whooping cough; chickenpox.
“We are sending a very strong message to the public,” said Health Minister Beatrice Lorenzin…
 

Major research funders and international NGOs to implement WHO standards on reporting clinical trial results
News release
18 May 2017 | GENEVA – Some of the world’s largest funders of medical research and international non-governmental organizations today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.
Signatories to the] joint statement [below]…agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry. They also agreed that all results would be disclosed within specified timeframes on the registry and/or by publication in a scientific journal.
Today, about 50% of clinical trials go unreported, according to several studies, often because the results are negative. These unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices, and can lead to use of suboptimal or even harmful products.
“Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed,” said Dr Marie-Paule Kieny, Assistant Director-General for Health Systems and Innovation at WHO.
The signatories to the statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting:
 
Joint statement on public disclosure of results from clinical trials
Signatories on 18 May 2017
Indian Council of Medical Research
Inserm
Research Council of Norway
UK Medical Research Council
Médecins Sans Frontières
Epicentre
CEPI
PATH
Institut Pasteur
Drugs for Neglected Diseases Initiative (DNDi)
Bill and Melinda Gates Foundation
Wellcome Trust

Download as PDF (including footnotes) pdf, 531kb
[Text bolding from original]
Introduction
The current 2013 Declaration of Helsinki states that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” and that “Researchers have a duty to make publicly available the results of their research …. Negative and inconclusive as well as positive results must be published or otherwise made publicly available”. In addition to the ethical imperative, poor allocation of resources for product development and financing of available interventions, and suboptimal regulatory and public health recommendations may occur where decisions are based on only a subset of all completed clinical trials.

The signatories of this joint statement affirm that the prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. Furthermore timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health.

Within 12 months of becoming a signatory of this statement, we each pledge to develop and implement a policy with mandated timeframes for prospective registration and public disclosure of the results of clinical trials that we fund, co-fund, sponsor or support. We each agree to monitor registration and endorse the development of systems to monitor results reporting on an ongoing basis. We agree to share challenges and progress in the monitoring of these policies. We agree that transparency is important and therefore the outputs from the monitoring process will be publicly available.

Benefits and costs of requiring public disclosure of results
The benefits of implementing and monitoring policies on public disclosure of results relate to access to more complete information about the results of clinical trials. The benefits are summarised below.
:: The current bias in the reporting of results will be reduced allowing for more informed decisions in the following areas:
: Licensure/marketing authorization (including risk-benefit assessments),
: Public health policy recommendation on use (including cost-effectiveness), and
: Financing decisions by public procurement bodies, and multilateral agencies
: Optimal implementation and delivery
: Individual treatment choices by doctors and patients

:: Research funding allocation will be more efficient (avoiding the current situation, whereby funds may be allocated to answer scientific questions that have already been answered in unreported clinical trials, and waste occurs because learning from previous trials cannot be taken into account in design of current trials)

:: The development of interventions will be more efficient

:: Ethical requirements for dissemination of information will be met, potentially increasing trust of trial participants in the utility of clinical research

:: The scientific state-of-the-art will be based on a more complete cross-section of clinical trial data; in particular the many negative clinical trials will be more available for assessments.

A further benefit is that doctors, professional bodies and the general public will be able to access the results from a larger proportion of clinical trials.

Finally patients seeking enrollment in clinical trials will be able to access results from previously completed clinical trials in their area, as they make decisions on which clinical trials they may wish to seek enrollment into.

There will be modest costs associated with public disclosure of clinical trial results. The costs of disseminating the results of research are a minor component of the overall costs of conducting such research, and results reporting is an essential component of the research enterprise. The resource allocation, public health and scientific benefits – together with the need to meet ethical imperatives – far outweigh the costs.

Proposed common elements of agencies’ policies on results reporting
Principles that could be included in harmonized policies on results reporting include the following:

Registration of clinical trials
Before any clinical trial is initiated (at any Phase) its details must be registered in a publicly available, free to access, searchable clinical trial registry complying with WHO’s international agreed standards (www.who.int/ictrp). The clinical trial registry entry must be made before the first subject receives the first medical intervention in the trial (or as soon as possible afterwards). Clinical trial registry records should be updated as necessary to include final enrolment numbers achieved, and the date of primary study completion (defined as the last data collection timepoint for the last subject for the primary outcome measure). If clinical trials are terminated, their status should be updated to note the date of termination, and to report the numbers enrolled up to the date of termination.

Completeness and accuracy of the clinical trial registry records can be a limiting factor for use of information from the registries, and it is encouraged that care is taken to ensure good quality registry entries.

Reporting timeframes for clinical trials
We jointly agree that summary results of clinical trials should be made publicly available in a timely manner following primary study completion. There are two main modalities for this to occur. By posting to the results section of the clinical trial registry and by journal publication. We will work towards a timeframe of 12 months from primary study completion (the last visit of the last subject for collection of data on the primary outcome) as the global norm for summary results disclosure . As timelines for publication in a journal are not fully within the control of the sponsor or investigator, this joint statement focuses on use of registries – such as clinicaltrials.gov and EU-CTR – to meet this results disclosure expectation. Publication in a journal is also an expectation, with an indicative timeframe of 24 months from study completion to allow for peer review etc. Access to a sufficiently detailed clinical trial protocol is necessary in order to be able to interpret summary results. Therefore we also encourage development of requirements that the protocols are made publicly available no later than the time of the summary results disclosure as part of the clinical trial registry summary results information (including amendments approved by ethics committees/institutional review boards, and either as uploaded electronic document formats such as pdfs or links to the pdf).

At the time of the initial grant submission, the plan for public disclosure of results should be included, including specific time bound commitments. Reasonable funds to enable compliance with these considerations is a cost eligible item in clinical trial budgets.

Trial ID in clinical trial publication
The Trial ID or registry identifier code/number should be included in all publications of clinical trials, and should be provided as part of the abstract to PubMed and other bibliographic search databases for easy linking of trial related publications with clinical trial registry site records. This is essential for linking journal publications with registry records.

Registration and reporting of past trials
Reporting of previous trials realises the value of funding; therefore the contribution made from reporting previous trials, whatever their results, will be considered in the assessment of a funding proposal. When a PI applies for new funding, they may be asked to provide a list of all previous trials on which they were PI within a specified timeframe and their reporting status, with an explanation where trials have remained unreported.

A note on sharing of individual participants’ data
As trials are registered, this sets a basis for development of IPD sharing. The benefit of sharing individual participants’ data (IPD) and the facilitation of research through greater access to primary datasets is a principle which we consider important. This statement is not directed towards sharing of IPD. However we are all actively engaged with initiatives related to IPD sharing, and support sharing of health research datasets whenever appropriate. We will continue to engage with partners in support of an enabling environment to allow data sharing to maximise the value of health research data. We will support activities that enable the development of explicit ethical and legal frameworks that govern data collection and use and enable development of international norms and standards for sharing of IPD from clinical trials.

A note on open access policies
We are all supporters of open access policies, and consider that publications describing clinical trial results should be open access from the date of publication, wherever possible. Open access fees should be included in clinical trial budget requests, if necessary.

A note on the scope of this statement
While this statement focuses on clinical trials, transparency and reduction of waste and reporting bias are important for other types of research including public health intervention studies, observational studies, implementation research and pre-clinical studies of experimental therapeutics and preventives.

We encourage formative work on development of possible transparency frameworks for these types of research, including how best to develop registries that publicly disclose research studies in the above categories.

Emergencies
 
Public Health Emergencies of International Concern (PHEIC)  [to 20 May 2017]

POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 17 May 2017
:: The World Health Assembly (WHA) is meeting next week in Geneva, Switzerland.  Ministers of Health and public health professionals from around the world will convene to discuss global public health issues, including the global drive to eradicate polio.  Delegates are anticipated to review current status against each of the four objectives of the Polio Endgame Plan, including reviewing a report requested by the Executive Board (EB) in January 2017 on issues related to transition planning.  The Global Polio Eradication Initiative (GPEI) secretariat has prepared a status report, which will inform the discussions by Member States.

Country Updates [Selected Excerpts]
New cases or environmental samples reported across the monitored country/region settings:
Afghanistan, Pakistan, Nigeria, Lake Chad Basin. Guinea and West Africa, and Lao People’s Democratic Republic have been removed from the monitored geographies list.
:: No new country report of case activity or environmental samples.

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WHO Grade 3 Emergencies  [to 20 May 2017]
Iraq  – No new announcements identified
South Sudan  – No new announcements identified
Yemen – No new announcements identified
Nigeria – No new announcements identified
The Syrian Arab Republic  – No new announcements identified
 

WHO Grade 2 Emergencies  [to 20 May 2017]
Cameroon  – No new announcements identified.
Central African Republic  – No new announcements identified.
Ethiopia – No new announcements identified.
Libya – No new announcements identified.
Myanmar – No new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified

Democratic Republic of the Congo – See Ebola coverage below
 
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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Iraq – Alarming numbers of people fleeing western Mosul city [EN/KU/AR]  16 May 2017
:: Ethiopia Weekly Humanitarian Bulletin, 15 May 2017

Syrian Arab Republic – No new announcements identified
Yemen – No new announcements identified

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
:: Somalia: Drought Response – Situation Report No. 8 (as of 16 May 2017)
:: Horn of Africa: Humanitarian Impacts of Drought – Issue 4 (15 May 2017)
:: Somalia: Drought Response – Situation Report No. 8 (as of 16 May 2017)

Ethiopia
:: Ethiopia Weekly Humanitarian Bulletin, 15 May 2017

Nigeria – No new announcements identified

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EBOLA/EVD  [to 20 May 2017]
http://www.who.int/ebola/en/

Press briefing on Ebola virus disease in the Democratic Republic of the Congo
18 May 2017, audio recording

EVD – DRC: External Situation Report 5: 19 May 2017

1. Situation update

WHO, UN Agencies, International organizations, non-governmental organizations (NGOs) and partners con­tinue to support the Ministry of Health in the Democratic Republic of Congo to rapidly investigate and respond to the outbreak of Ebola virus disease (EVD) in Likati Health Zone, Bas Uele Province located in the north-east of the country.

On 19 May 2017, three new EVD cases were reported, including one probable case in Ngayi and two sus­pected cases in a new health area called Ngabatala. The suspected cases are being investigated and will be classified accordingly. As of 19 May 2017, a total of 32 EVD cases [two confirmed, three probable and 27 suspected] have been reported. To date, four deaths have been reported, giving a case fatality rate of 13%. The reported cases are from five health areas, namely Nambwa (11 cases and two deaths), Muma (three cases and one death), Ngayi (14 cases and one death), Azande (two cases and no deaths), and Ngabatala (two cases and no deaths). Most of the cases presented with fever, vomiting, bloody diarrhoea and other bleeding symptoms and signs. The outbreak currently remains confined to Likati Health Zone. According to available information at this stage, no healthcare workers have been affected.

Out of the five blood samples analysed at the national reference laboratory, Institut National de Recherche Biomédicale (INRB) in Kinshasa, two were confirmed Zaire ebolavirus. At least 416 close contacts have been registered in Likati Health Zone and are being monitored.

This EVD outbreak in the Democratic Republic of Congo was notified to WHO by the Ministry of Health (MOH) on 11 May 2017. The cluster of cases and deaths of previously unidentified illness have been report­ed since late April 2017. Likati Health Zone shares borders with two provinces in the Democratic Republic of the Congo and with the Central African Republic (Fig. 1). The affected areas are remote and hard to reach, with limited communication and transport networks. The current outbreak is the eighth EVD outbreak in the Democratic Republic of Congo since the disease was first discovered in 1976 in Yambuku (then Zaire)…

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CEPI – Coalition for Epidemic Preparedness Innovations  [to 20 May 2017]
http://cepi.net/
[Undated]
Ebola outbreak in DRC
CEPI is closely following the current outbreak of Ebola Zaire in DRC.

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PATH statement on the Ebola outbreak in the Democratic Republic of the Congo

Announcement | May 17, 2017

…A statement from PATH President and CEO Steve Davis follows:

“In a fast-moving public health emergency like this, a rapid response is critical to contain and control the outbreak. Our thoughts are with the individuals, families, and communities directly affected by this outbreak and with the many dedicated health workers who have responded to it so quickly.

Together with key partners like WHO, CDC, Médecins Sans Frontières, and the University of California, Los Angeles-DRC Research program, PATH was one of the first organizations on the ground to respond to this outbreak with technologies, data, and support for the DRC government, which is leading the response.

Working closely with the Ministry, PATH has quickly mobilized support for disease surveillance and outbreak response efforts, created data-sharing procedures, and provided immediate funding so the Ministry could deploy a team of investigators to the affected area.

Within 24 hours of learning about the outbreak, PATH also mobilized a cross-sector group of international partners to support the government with high-resolution satellite imagery, geospatial mapping capabilities, GPS-enabled smart phones, and other tools to help map and investigate the outbreak.

Improving epidemic preparedness and prevention are urgent priorities in our increasingly interconnected world. Heading off outbreaks before they become epidemics or pandemics depends on our ability to connect innovation end to end—from research and development of new vaccines, diagnostics, and other tools to the logistic capabilities critical to delivering innovative health solutions where they are needed.

America’s leadership in international health security is vital to preventing and containing future threats. Continued US investment in epidemic preparedness protects the health and safety of Americans as well as citizens of other nations.
PATH remains committed to doing all we can to support the DRC, and we urge other governments, international organizations, and the private sector to join with the DRC government on a coordinated response to stop this outbreak as quickly as possible.”

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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 20 May 2017]
http://www.who.int/emergencies/mers-cov/en/
May 2017
WHO Target Product Profiles for MERS-CoV Vaccines
Purpose of the document
Selected disease areas are identified as WHO priorities for research and product development. In the case of MERS-CoV, target product profile development followed prioritization of MERS-CoV as part of the WHO R&D Blueprint for Action to Prevent Epidemics. The target audience includes vaccine scientists, product developers, manufacturers and funding agencies…
Modelling of the potential impact of MERS-CoV vaccines with different efficacy profiles and administered using different immunization strategies is a high priority to further refine desired characteristics. Modelling of both camel and human vaccination would be helpful. For certain vaccine characteristics, additional footnotes are provided on the rationale and assumptions made.
 
Yellow Fever  [to 20 May 2017]
http://www.who.int/emergencies/yellow-fever/en/
[See op-ed by Seth Berkley in Media Watch below – New York Times]
 
Zika virus  [to 20 May 2017]
http://www.who.int/emergencies/zika-virus/en/
[No new digest content identified]
 

WHO & Regional Offices [to 20 May 2017]

Keynote speech at the G20 Health Ministers’ Meeting
19 May 2017 — “I am honoured to address this G20 meeting of health ministers as you consider ways to strengthen global health security, especially as these meetings can have such a strong impact on international policies.” Dr Chan, WHO Director-General.

World Health Statistics: Cause of almost half of all deaths recorded
17 May 2017 – Almost half of all deaths globally are now recorded with a cause, new data from WHO show, highlighting improvements countries have made on collecting vital statistics and monitoring progress towards the Sustainable Development Goals (SDGs). WHO’s World Health Statistics compiles data from the organization’s 194 Member States on 21 health-related SDG targets, providing a snapshot of both gains and threats to the health of the world’s people.

More than 1.2 million adolescents die every year
16 May 2017 – More than 3000 adolescents die every day, totalling 1.2 million deaths a year, from largely preventable causes, according to a new report from WHO and partners. In 2015, more than two thirds of these deaths occurred in low- and middle-income countries in Africa and South-East Asia. Road traffic injuries, lower respiratory infections, and suicide are the biggest causes of death among adolescents.

Highlights
Double-duty actions for ending malnutrition within a decade
May 2017 – Malnutrition has many forms. Undernutrition can see children dangerously thin for their height (wasting), or their growth permanently impeded (stunting). Inadequate intake of key nutrients may weaken immune systems, impair brain development, and worsen the risk of conditions such as anaemia and blindness.

::::::

Weekly Epidemiological Record, 19 May 2017, vol. 92, 20 (pp. 269–292)
:: Dracunculiasis eradication: global surveillance summary, 2016
:: Fact sheet on Ebola virus disease (updated May 2017)

::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO Regional Director for Africa, Dr Matshidiso Moeti arrives in Kinshasa to discuss response to Ebola outbreak – 13 May 2017

WHO Region of the Americas PAHO
:: Countries of the Americas show benefits of initiative to reduce cardiovascular risk through the control of hypertension (05/17/2017)
::  PAHO Encourages Caribbean Countries to Tax Tobacco, Alcohol and Sugar-Sweetened Beverages to Reduce Burden of Noncommunicable Disease (05/16/2017)

WHO South-East Asia Region SEARO
[No new digest content identified]
 
WHO European Region EURO
:: eHealth and public health – a beautiful marriage 19-05-2017
:: Engaging policy-makers and youth in Malta to slow down and save lives 18-05-2017
:: New WHO study on health and well-being of Europe’s youth reveals that obesity continues to rise 17-05-2017
:: Historic 20th meeting of the Joint Task Force on the Health Aspects of Air Pollution 16-05-2017

WHO Eastern Mediterranean Region EMRO
:: Fourth UN Global Road Safety Week: speed management key to saving lives
Cairo, Sunday 14 May 2017 –

CDC/ACIP [to 20 May 2017]
http://www.cdc.gov/media/index.html
Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine — Advisory Committee on Immunization Practices, 2016
If vaccinating with MenB-FHbp – including during serogroup B meningococcal disease outbreaks – ACIP recommends that three doses of MenB-FHbp be administered at 0, 1–2, and 6 months for people at increased risk of meningococcal disease. ACIP recommends that two doses of MenB-FHbp should be administered at 0 and 6 months when given to healthy adolescents who are not at increased risk for meningococcal disease. Recommendations regarding use of MenB-4C vaccine (Bexsero) are unchanged. Either MenB vaccine can be used when indicated; however, they are not interchangeable and the same product must be used for all doses in a series. Two serogroup B meningococcal (MenB) vaccines are currently licensed for use among people aged 10–25 years in the United States: MenB-FHbp (trade name, Trumenba) and MenB-4C (trade name, Bexsero). Changes to the dosage and administration of MenB-FHbp vaccines were recently approved by FDA to include both a three-dose series (administered at 0, 1–2, and 6 months) and a two-dose series (administered at 0 and 6 months). For people at increased risk for meningococcal disease and for use during serogroup B meningococcal disease outbreaks, ACIP recommends that three doses of MenB-FHbp be administered at 0, 1–2, and 6 months. When given to healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends that 2 doses of MenB-FHbp should be administered at 0 and 6 months.

Gavi [to 20 May 2017]
http://www.gavi.org/library/news/press-releases/
13 May 2017
India’s most vulnerable children to get access to new vaccine against pneumonia
Pneumococcal vaccine will reach 2.1 million children in the first year.
Geneva, 13 May 2017 – For the first time, millions of children in India will receive protection for free against the leading cause of pneumonia – which kills more children under the age of five than any other infectious disease in the world – thanks to the launch of the pneumococcal conjugate vaccine (PCV).

PCV is being introduced to India’s Universal Immunization Program (UIP) with support from Gavi, the Vaccine Alliance, a move that will help to reduce the number of under-five pneumonia deaths in India, the highest in the world.

Currently, almost 200,000 children under five die from pneumonia in India each year. Until now PCV, a relatively new vaccine, has only been made available in the private market, putting it beyond the reach of most of the population. With this phased introduction, nearly 2.1 million children in Himachal Pradesh, Bihar and Uttar Pradesh will be vaccinated with PCV. This coverage will be expanded across the entire country in the coming years.

“This is a huge milestone because it means that, for the first time, India’s most vulnerable children will be protected against one of India’s most deadly diseases,” said Gavi CEO Seth Berkley. “India is not only the largest Gavi-supported country, but it also has the single largest number of under-immunised children in the world. This vaccine will save many lives.”…

UNICEF  [to 20 May 2017]
https://www.unicef.org/media/media_94367.html
17 May 2017
Five-fold increase in number of refugee and migrant children traveling alone since 2010 – UNICEF
NEW YORK, 17 May 2017 – The global number of refugee and migrant children moving alone has reached a record high, increasing nearly five-fold since 2010, UNICEF said today in a new report. At least 300,000 unaccompanied and separated children were recorded in some 80 countries in the combined years of 2015 and 2016, up from 66,000 in 2010 and 2011.

UNICEF joins tech giants in artificial intelligence group
New York, 17 May 2017 – UNICEF joins the Partnership on Artificial Intelligence (AI) founded by Amazon, Apple, Google/DeepMind, Facebook, IBM and Microsoft.

At least one in four children live in poverty in the Middle East and North Africa
RABAT, 15 May 2017 – According to a recent UNICEF analysis covering 11 countries in the Middle East and North Africa[1], poverty continues to impact at least 29 million children – one in four children in the region. These children are deprived of the minimum requirements in two or more of the most basic life necessities including basic education, decent housing, nutritious food, quality health care, safe water, sanitation and access to information.

IAVI – International AIDS Vaccine Initiative   [to 20 May 2017]
https://www.iavi.org/
May 18, 2017
Canadian Researcher Wins Grant to Explore Promising HIV Vaccine Candidate
Canadian Institutes of Health Research funds Gary Kobinger to develop HIV vaccine in partnership with IAVI.
The Canadian Institutes of Health Research (CIHR) has awarded a new CA$3.99 million grant to Dr. Gary Kobinger of Université Laval for work on a vaccine to prevent HIV infection.

This three-year grant supports a scientific collaboration between Kobinger and the Design and Development Lab, a state-of-the-art research facility in Brooklyn, New York, operated by the International AIDS Vaccine Initiative (IAVI). Led by Kobinger and IAVI’s Dr. Chris Parks, the respective Canadian and U.S. research teams aim to improve upon a promising HIV vaccine candidate designed by Parks, with the goal of advancing the candidate to clinical testing in human volunteers.

“We are encouraged by this support of Gary Kobinger’s work and the prospects of his collaboration with IAVI’s Design and Development Lab,” said Mark Feinberg, IAVI CEO. “The innovative work of the Kobinger lab provides a great illustration of how creative and insightful science can advance the global response to emerging infectious diseases, and exemplifies ways in which the benefits of research progress in one disease area can be translated to another, in this case, from an understanding of how to develop an effective Ebola vaccine to the ongoing search for an AIDS vaccine.”

Using a modified animal virus called Vesicular Stomatitis Virus (VSV) that does not cause disease in humans, the IAVI vaccine candidate delivers copies of a protein taken from HIV’s surface. Once inside the body, the protein stimulates protective immune defenses against HIV infection. Studies in animals to date have yielded encouraging results.

Kobinger’s team will further modify the IAVI candidate vaccine for greater efficacy and clinical testing. An expert in the Ebola virus, Kobinger helped develop the Ebola (rVSV-ZEBOV) vaccine, which to date has proven the most effective at preventing Ebola infection, and which also uses a VSV backbone…
 
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NIH  [to 20 May 2017]
http://www.nih.gov/news-events/news-releases
May 18, 2017
NIH statement on HIV Vaccine Awareness Day – 2017
— Anthony S. Fauci, M.D., Director, NIAID and Carl W. Dieffenbach, Ph.D., Director, Division of AIDS, NIAID.
Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981. Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives — an outcome that once seemed unattainable. Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has proven that when antiretroviral therapy durably keeps HIV at undetectable levels, the risk that the treated individual will sexually transmit the virus to an HIV-negative partner is negligible. When implemented in communities, treatment as prevention is remarkably successful at preventing the spread of HIV infection. Pre-exposure prophylaxis, or PrEP, is another prevention strategy in which HIV-negative people take one pill a day to reduce their risk of acquiring the virus. This intervention is highly effective when individuals adhere to the drug regimen.

While these and other prevention tools have the power to dramatically decrease the incidence of HIV infection, a safe and effective vaccine would be transformative. More than two million new HIV infections occurred worldwide in 2015 alone, and this rate of infection has declined only slightly since 2010. A new National Institutes of Health-funded modeling study (link is external) suggests that a 50-percent effective preventative vaccine could reduce the number of people living with HIV by 36 percent globally over a period of 15 years. Together with the other medical and behavioral prevention modalities that have been proven to decrease the risk of acquiring HIV, a vaccine could change the epidemic’s trajectory, dramatically reducing the number of people who become infected with HIV.

Developing a safe and effective HIV vaccine is one of the most formidable challenges facing scientists today. HIV mutates rapidly, evading immune responses and thwarting the attempts of scientists to develop an effective vaccine. Only a minority of individuals living with HIV develop broadly neutralizing antibodies, a powerful type of antibody that can fight an array of HIV strains by binding to key sites on the virus. In those individuals who do develop such antibodies, they generally appear only after several years of infection, when the virus has already gained a strong foothold in the body.

Despite these challenges, scientists are working to develop a vaccine that may reduce the spread of HIV. On World AIDS Day 2016, NIAID and its partners launched HVTN 702, a phase 2b/3 HIV vaccine efficacy trial. This trial is the first HIV vaccine efficacy study to launch in 7 years, and is currently enrolling 5,400 men and women in South Africa between the ages of 18 and 35. This study will test an experimental vaccine regimen to see if it can extend and amplify the modest success of the vaccine candidate tested in RV144, a clinical trial in Thailand that showed a modest degree of efficacy in 2009.

Another component of the HIV vaccine research effort focuses on inducing the immune system to make the kind of broadly neutralizing antibodies that may protect people from HIV. The NIAID Vaccine Research Center and several NIAID grantees are at the vanguard of this effort.
Two multinational clinical trials testing an investigational anti-HIV broadly neutralizing antibody for preventing HIV infection began last year. Known as the AMP Studies, for antibody-mediated prevention, the trials will test whether giving people a broadly neutralizing HIV antibody as an intravenous infusion every 8 weeks is safe, tolerable and effective at preventing HIV infection among the study participants. With a projected enrollment of 4,200 men and women across three continents, the trials are designed to answer fundamental scientific questions for the fields of HIV prevention and vaccine research.

While the pursuit of a safe and effective HIV vaccine is challenging, this prevention strategy holds lifesaving potential and is NIAID’s highest priority for AIDS research. On this HIV Vaccine Awareness Day, we recognize and thank the thousands of HIV vaccine clinical trial volunteers, researchers, health professionals, activists and others who work together with us toward this goal.

May 18, 2017
Antibodies from Ebola survivor protect mice and ferrets against related viruses
— NIAID-funded study could lead to broad, versatile treatments for many different Ebolaviruses.

FDA-approved drug helps treat rare immunologic disease, study finds
May 17, 2017 — NIH co-funded clinical trial tested alternative treatment for eosinophilic syndrome.

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UNAIDS  [to 20 May 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update
Myanmar launches new HIV strategic plan
The Ministry of Health and Sports of Myanmar launched the country’s latest five-year HIV plan on 17 May. The plan provides a road map on how to Fast-Track the national HIV response…
 
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PhRMA    [to 20 May 2017]
http://www.phrma.org/press-room
May 15, 2017
ICYMI: New study shows medicines advance life expectancy for HIV patients
… A new study from the Antiretroviral Therapy Cohort Collaboration (ART-CC) found that HIV patients in Europe and North America treated with a combination of three or more antiretroviral therapy (ART) medicines can achieve the same life expectancy of people without HIV. ART-CC estimates that a 20-year-old patient who began treatment with ART between 2008 and 2010 could now live to age 78 – the same life expectancy for the general U.S. population.
In a recent article in STAT, reflecting on the new research, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, commented on the study: “We’re just getting better at what we do….We have better drugs… People are adhering better because they know these drugs really work.”…

European Vaccine Initiative  [to 20 May 2017]
http://www.euvaccine.eu/news-events
18 May 2017
Workshop on universal influenza vaccines
The EDUFLUVAC partners, as part of their work programme on the development of a broadly reactive influenza vaccine, are planning a workshop in close collaboration with the FLUTCORE and UNISEC consortia entitled: “Four years of European research on the development of universal influenza vaccines: what have we learnt and how can we move forward?”.
The workshop will be held in Brussels, Belgium on 12-14 June 2017…
 
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IFPMA   [to 20 May 2017]
http://www.ifpma.org/resources/news-releases/
18 May 2017
New Alliance to Drive and Measure Industry Progress to Curb Antimicrobial Resistance
:: New Industry Alliance brings together research-based pharmaceutical companies, generics, biotech and diagnostic companies, to drive and measure industry progress to curb antimicrobial resistance.
:: The AMR Industry Alliance will ensure that signatories collectively deliver on the commitments made in the Declaration (January 2016) and the Roadmap (September 2016) and will measure industry’s progress in the fight against AMR.
:: The Alliance will develop a reporting mechanism to track progress, identify gaps and set targets for the future. Its progress reports will also help to assess what are the key hurdles impeding actions outside of industry’s sole control on reducing antimicrobial resistance and facilitate collaboration between the public and private sector.
 
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Wellcome Trust  [to 20 May 2017]
https://wellcome.ac.uk/news
Opinion / Published: 19 May 2017
Drug-resistant infections: the clock is ticking
This week marks a year since the publication of the International Review on Antimicrobial Resistance (opens in a new tab), a review led by Lord Jim O’Neill and supported by Wellcome and the UK Department of Health.
It set out a plan for governments to tackle the growing problem of drug-resistant infections.
Writing in The Guardian today, Ed Whiting, Wellcome’s Head of Policy and Chief of Staff, looks at what has happened since the review’s publication and explains why without action on antibiotics, medicine will return to the dark ages (opens in a new tab).
 
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FDA [to 20 May 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
:: May 16, 2017 Approval Letter – MMR II (PDF – 55KB)  Posted: 5/17/2016
:: Meeting Transcript for the Public Workshop: Emerging Tick-Borne Diseases and Blood Safety (PDF – 429KB)  Posted: 5/16/2017
::  May 16, 2017 Approval Letter – PROQUAD (PDF – 56KB) Posted: 5/16/2017
 
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European Medicines Agency  [to 20 May 2017]
http://www.ema.europa.eu/ema/
19/05/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 May 2017
Eleven medicines recommended for approval, including one advanced therapy medicine
 
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Global Fund [to 20 May 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund Rates Highly in Australian Aid Review
15 May 2017
The Global Fund scored a top rating for its effective investment of donor money to respond to HIV, tuberculosis and malaria in a newly released Multilateral Performance Assessment published in the Performance of Australian Aid Report by the Department of Foreign Affairs and Trade.  The assessment confirmed the Global Fund as a strong, results-driven partner, giving consistent ratings of 5 out of 6 across its six criteria.
 
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PATH  [to 20 May 2017]
http://www.path.org/news/index.php
Announcement | May 18, 2017
PATH joins world leaders in defining global health and development priorities at 70th World Health Assembly
PATH leaders are slated to deliver remarks at Assembly Committee meetings and to lend their expertise to several events on the formal agenda, as well as key side events covering issues including research and development, global health security, noncommunicable diseases, access to essential medicines and health technologies, and planning for polio eradication.
 
Announcement | May 17, 2017
PATH statement on the Ebola outbreak in the Democratic Republic of the Congo
[See Ebola/EVD above for full statement]
 
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Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

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

IVI   [to 20 May 2017]
http://www.ivi.int/
May 15, 2017
World must join forces to prevent infectious diseases
Op-ed by Dr. Jerome Kim, Director General, IVI
The Dong-A Ilbo (Business Section)
Imagine a world where the emergence of Ebola was rapidly terminated by vaccines that had been developed and stockpiled in anticipation of a crisis. Over 11,000 lives lost and 6 billion dollars later, a year after the Ebola outbreak started, we had the first hint of an effective vaccine.  Bill Gates, Co-chair of the Bill and Melinda Gates Foundation, notes, “Ebola and Zika showed that the world is tragically unprepared to detect local outbreaks and respond quickly enough to prevent them from becoming global pandemics. Without investments in research and development, the world will remain unequipped when we face the next threat.”

The launch of a global coalition that will support development of new vaccines for emerging infectious diseases, was announced at the World Economic Forum in Davos, Switzerland in January. The Coalition for Epidemic Preparedness Innovations (CEPI) has already raised almost half of the $1billion it needs for its first five years. The governments of Germany, Japan and Norway joined forces with the Bill & Melinda Gates Foundation and the Wellcome Trust to make an initial investment of US $460 million. India is considering a major investment. The coalition would welcome other leading scientific countries including Korea to join this partnership, and benefit from it.

There is an already precedent of successful global public-private partnerships that have developed new vaccines, laboratory tests and drugs for global health. As independent Gates Foundation funded projects, organizations like the Foundation for Innovative New Diagnostics (FIND), International Vaccine Institute (IVI), and the Medicines for Malaria Venture (MMV) have work with Korean companies to make products for global health – new tests for rapid diagnosis of infectious diseases, a new vaccine against the disease called cholera, or a medication that works against malaria. In a similar way, but targeting those epidemic diseases that threaten us all, CEPI will be proactive, collective defense through vaccine development, and stockpiling.

CEPI is already receiving proposals from researchers and companies around the world to support the development of vaccines for the initial set of emerging diseases: MERS, Lassa fever and Nipah. Companies can be incentivized for the development of outbreak vaccines and to offset their investments with CEPI funding. Korean biotechnology companies, large and small, have an opportunity, and the Korean government’s plans for the future growth and development of the vaccines industry could be leveraged against CEPI’s funding.

After MERS, and the recent outbreaks of avian influenza and hoof-and-mouth disease, Korea knows the human and economic cost of epidemic disease (animal and human).  The US National Academy of Sciences estimated that the average yearly cost of pandemic disease in the 21st century was 60 billion US dollars.  Against this cost to the global society, GAVI, the Vaccine Alliance estimates that vaccines provide a return on investment (ROI) of 16:1, in other words, 16 dollars of benefit for every dollar spent!.

Infectious diseases do not respect borders. These are potentially lingering problems for Korea but they are also global problems and can be more efficiently addressed collectively by the world. CEPI’s funders commit to the collaborative identification and prioritization of threats, the development of vaccine solutions, and the stockpiling of vaccines against the inevitable outbreaks. To meet these goals, CEPI will need significant additional investment. Korea as the current chair of the Global Health Security Agenda should show leadership by funding CEPI and challenging other nations to do the same.

Journal Watch

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

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

American Journal of Preventive Medicine
June 2017 Volume 52, Issue 6, p691-894, e157-e182
http://www.ajpmonline.org/current

Research Articles
A Comparison of Parent- and Provider-Reported Human Papillomavirus Vaccination of Adolescents
Eric Adjei Boakye, Betelihem B. Tobo, Nosayaba Osazuwa-Peters, Kahee A. Mohammed, Christian J. Geneus, Mario Schootman
p742–752
Published online: November 24, 2016
Abstract
Introduction
There is considerable effort at the state and national levels to monitor human papillomavirus (HPV) vaccine uptake and understand the factors that influence who gets vaccinated. Accurate measurement of vaccination coverage is critical for monitoring HPV vaccination. This study aimed to determine comparability between parent- and provider-reported HPV vaccination status for a sample of adolescents in the U.S.
Methods
Data from the 2014 National Immunization Survey−Teen were analyzed in 2016 for 20,827 adolescents. Information on HPV vaccine uptake (initiation [one or more dose] and completion [three or more doses]) was obtained using parental (recall) and provider reports (electronic medical records). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and κ-coefficient were computed to determine how comparable parental and provider (ref group) reports were for HPV vaccination.
Results
Prevalence of HPV vaccine initiation was comparable between parental and provider report (51.3% vs 50.0%) and for completion (30.7% vs 27.3%). Compared with provider report, parent-reported HPV vaccine initiation had high sensitivity (86.0%), specificity (87.4%), PPV (87.5%), NPV (85.9%), and acceptable κ-coefficient (0.73). Compared with provider report, parent-reported HPV vaccine completion had a sensitivity of 71.5%, specificity of 91.1%, PPV of 78.5%, NPV of 87.6%, and κ-coefficient of 0.64. Similar characteristics—adolescent age, sex, number of doctor visits, and region—were associated with HPV vaccine uptake using parental and provider reports.
Conclusions
Parental recall is comparable to provider report in monitoring HPV vaccine uptake for adolescents, although parental recall is less comparable for HPV vaccine completion.