Vaccines and Global Health: The Week in Review 20 May 2017

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

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

 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_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.

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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

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

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

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

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
YemenNo new announcements identified
NigeriaNo 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.
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified

Democratic Republic of the CongoSee 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
:: IraqAlarming numbers of people fleeing western Mosul city [EN/KU/AR]  16 May 2017
:: Ethiopia Weekly Humanitarian Bulletin, 15 May 2017

Syrian Arab RepublicNo new announcements identified
YemenNo 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

NigeriaNo 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]

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.

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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 –