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.

::::::

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]

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]

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]

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.

 

Announcements: AIDS

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.”…

Announcements

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).
 
::::::
 
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
 
::::::
 
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

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

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

A Comparison of Parent- and Provider-Reported Human Papillomavirus Vaccination of Adolescents

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.

American Journal of Public Health 107(6), June 2017

American Journal of Public Health
107(6), June 2017
http://ajph.aphapublications.org/toc/ajph/current

ZIKA
Zika’s Long Haul: Tackling the Causes of Human Vulnerability to Mosquito-Borne Viruses
Laura C. Rodrigues
107(6), pp. 831–833

INFECTIOUS DISEASES
Public Health Surveillance for Communicable Diseases: From Rigid and Static to Flexible and Innovative
David L. Heymann
107(6), pp. 845–846

GLOBAL SURVEILLANCE
Evolution of Public Health Surveillance: Status and Recommendations
Howard S. Burkom
107(6), pp. 848–850

ZIKA
The Zika Virus Outbreak in Brazil: Knowledge Gaps and Challenges for Risk Reduction
Claudia Garcia Serpa Osorio-de-Castro, Elaine Silva Miranda, Carlos Machado de Freitas, Kenneth Rochel de Camargo Jr and Hilarie Hartel Cranmer
107(6), pp. 960–965

Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutions

Annals of Internal Medicine
16 May 2017 Vol: 166, Issue 10
http://annals.org/aim/issue

Research and Reporting Methods
Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutions  
Alex P. Salam, MBChB, MSc; Amanda Rojek, MBBS, MSc; Jake Dunning, MBBS, PhD; Peter W. Horby, MBBS PhD
Abstract
Zika virus (ZIKV) infection in pregnancy is associated with adverse fetal outcomes, such as microcephaly and other congenital malformations. No therapeutic options are available to pregnant women with ZIKV infection to prevent these effects. Drug trials in pregnancy raise several scientific, ethical, and logistic challenges, which are compounded further in ZIKV because of limited knowledge of the disease pathophysiology and a product development pipeline in its infancy. We evaluate the major challenges in choosing therapeutics to prevent congenital ZIKV disease and conducting clinical trials of these treatments, with a focus on preventing congenital central nervous system malformations. These challenges must be characterized and planned for now so that clinical trials can progress expediently and effectively in the future.

Cervical cancer treatment costs and cost-effectiveness analysis of human papillomavirus vaccination in Vietnam: a PRIME modeling study

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 20 May 2017)

Research article
Cervical cancer treatment costs and cost-effectiveness analysis of human papillomavirus vaccination in Vietnam: a PRIME modeling study
Hoang Van Minh, Nguyen Thi Tuyet My and Mark Jit
BMC Health Services Research 2017 17:353
Published on: 15 May 2017
Abstract
Background
Cervical cancer is currently the leading cause of cancer mortality among women in South Vietnam and the second leading cause of cancer mortality in North Vietnam. Human papillomavirus (HPV) vaccination has the potential to substantially decrease this burden. The World Health Organization (WHO) recommends that a cost-effectiveness analysis of HPV vaccination is conducted before nationwide introduction.
Methods
The Papillomavirus Rapid Interface for Modeling and Economics (PRIME) model was used to evaluate the cost-effectiveness of HPV vaccine introduction. A costing study based on expert panel discussions, interviews and hospital case note reviews was conducted to explore the cost of cervical cancer care.
Results
The cost of cervical cancer treatment ranged from US$368 – 11400 depending on the type of hospital and treatment involved. Under Gavi-negotiated prices of US$4.55, HPV vaccination is likely to be very cost-effective with an incremental cost per disability-adjusted life year (DALY) averted in the range US$780 – 1120. However, under list prices for Cervarix and Gardasil in Vietnam, the incremental cost per DALY averted for HPV vaccination can exceed US$8000.
Conclusion
HPV vaccine introduction appears to be economically attractive only if Vietnam is able to procure the vaccine at Gavi prices. This highlights the importance of initiating a nationwide vaccination programme while such prices are still available

BMC Infectious Diseases (Accessed 20 May 2017)

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 20 May 2017)

Research article
Estimation of the burden of varicella in Europe before the introduction of universal childhood immunization
Varicella is generally considered a mild disease. Disease burden is not well known and country-level estimation is challenging. As varicella disease is not notifiable, notification criteria and rates vary between…
Margarita Riera-Montes, Kaatje Bollaerts, Ulrich Heininger, Niel Hens, Giovanni Gabutti, Angel Gil, Bayad Nozad, Grazina Mirinaviciute, Elmira Flem, Audrey Souverain, Thomas Verstraeten and Susanne Hartwig
BMC Infectious Diseases 2017 17:353
Published on: 18 May 2017

TECHNICAL ADVANCE
A framework for evaluating epidemic forecasts
Over the past few decades, numerous forecasting methods have been proposed in the field of epidemic forecasting. Such methods can be classified into different categories such as deterministic vs. probabilistic…
Farzaneh Sadat Tabataba, Prithwish Chakraborty, Naren Ramakrishnan, Srinivasan Venkatramanan, Jiangzhuo Chen, Bryan Lewis and Madhav Marathe
BMC Infectious Diseases 2017 17:345
Published on: 15 May 2017

A qualitative study on acceptable levels of risk for pregnant women in clinical research

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 20 May 2017)
Research article

A qualitative study on acceptable levels of risk for pregnant women in clinical research
Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.
Indira S. E. van der Zande, Rieke van der Graaf, Martijn A. Oudijk and Johannes J. M. van Delden
Published on: 15 May 2017

Avian influenza A/H7N9 risk perception, information trust and adoption of protective behaviours among poultry farmers in Jiangsu Province, China

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 20 May 2017)

Research article
Avian influenza A/H7N9 risk perception, information trust and adoption of protective behaviours among poultry farmers in Jiangsu Province, China
Poultry farmers are at high-risk from avian influenza A/H7N9 infection due to sustained occupational exposures to live poultry. This study examined factors associated with poultry farmers’ adoption of personal…
Bin Cui, Qiuyan Liao, Wendy Wing Tak Lam, Zong Ping Liu and Richard Fielding
BMC Public Health 2017 17:463
Published on: 18 May 2017

Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England

BMJ Open
May 2017 – Volume 7 – 5
http://bmjopen.bmj.com/content/current

Protocol
Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England
Simon de Lusignan, Gaël Dos Santos, Ana Correa, François Haguinet, Ivelina Yonova, Florence Lair, Rachel Byford, Filipa Ferreira, Karen Stuttard, Tom Chan

Using mHealth to Predict Noncommunicable Diseases: A Public Health Opportunity for Low- and Middle-Income Countries

Journal of Medical Internet Research
Vol 19, No 5 (2017): May
http://www.jmir.org/2017/5

Editorial
Using mHealth to Predict Noncommunicable Diseases: A Public Health Opportunity for Low- and Middle-Income Countries
Ellen Rosskam, Adnan A Hyder
J Med Internet Res 2017 (May 05); 19(5):e129
Nearly 70% of the 56 million deaths that took place globally in 2012 were due to noncommunicable diseases (NCDs), in particular, cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes, and nearly two-thirds of all NCD deaths took place in low- and middle-income countries (LMICs) [1]. If effective steps are not taken to curb the epidemic, deaths due to NCDs are projected to rise exponentially in the coming decade [2]. Key risk factors responsible for a majority of NCDs include tobacco use, unhealthy diet, sedentary lifestyle, and excessive use of alcohol. With targeted action, these behavioral risk factors have demonstrated potential to be modified [3] to reduce NCDs and improve population health. Reducing NCDs, particularly in the world’s poorest countries, can lead to increases in equity and socioeconomic development while reducing poverty due to ill health and promoting sustainable development and social justice.

Key to global efforts to prevent and control NCDs is national surveillance. A promising approach increasingly being explored for public health surveillance involves mobile phones. A nascent yet emergent field, mHealth, describes medical and public health activities that leverage the global proliferation of cellular networks and mobile phone ownership or access to improve population health outcomes. There are nearly 7.5 billion wireless phone subscriptions globally, with the majority (78%) in LMICs [4]. Global connectivity to cellular networks can make large proportions of a population accessible through their mobile phones. In response to the increasing NCD disease burden, the intersecting need for NCD data in LMICs and the near-universal population access to mobile phones in a growing number of countries presents an opportunity for public health.

This special Theme Issue of JMIR offers a step forward in documenting what is known about surveillance of risk factors for NCDs in LMICs using mobile phone surveys (MPS). The evidence illustrates that the state-of-the-art is sufficient to roll out population-level surveys in LMICs using mobile phone platforms while paying careful attention to issues such as ethics, methodology, and turning results into practice. The results offer guidance for policy and practice.

The article, “Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda,” proposes a research and development agenda for NCD risk factors and MPS [5]. The goal of the proposed agenda is to help standardize operating procedures for MPS, which will allow for comparisons of NCD risk factors within and across sites and over time. The potential is explored for MPS to collect such data, review key research issues, and introduce a multicountry effort that seeks to partly respond to this public health challenge. It is hoped that the proposed research agenda will catalyze a global dialogue and action to enhance the use of MPS for NCDs and potentially other public health risk factor surveillance.

Limited evidence exists on the comparative effectiveness of MPS modalities in LMICs although a variety of options are available. “Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review” reviews the current landscape of MPS being used for population-level data collection in LMICs, specifically through the use of short message service, interactive voice response (IVR), and computer-assisted telephone interview survey modalities [6]. From the articles identified of MPS use to collect population estimates across a range of topics, results reveal that the state of MPS to collect population-level estimates of health and other indicators is a nascent field, indicating the need for more research.

The methodological approach used to test the use of MPS for NCDs is described in “Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys: A Research Protocol” [7]. Using microtrials, a set of future studies that will help enhance the efficiency and technical effectiveness of MPS is proposed for LMICs. The authors assess the effect of factors such as incentive timing and structure, survey introduction characteristics, different sampling frames, and survey modality on key survey metrics such as survey response, completion, and attrition rates.

Further investigating the literature, “Building the Evidence Base for Remote Data Collection in Low- and Middle-Income Countries: Comparing Reliability and Accuracy Across Survey Modalities” reviews findings that compare a mode of remote data collection to at least one other mode [8]. The synthesis examines MPS mode effects on the reliability and accuracy of results. Findings show, for example, that remote data collection consistently elicited higher reports of socially nondesirable behaviors compared to in-person data collection. The review reveals the need for additional studies that compare reliability and construct validity across survey modalities.

IVR has the potential to expand current surveillance coverage and data collection. Two rounds of IVR pilot testing in Baltimore, Maryland, revealed that most participants felt this type of survey would lead to more honest, accurate responses than face-to-face questionnaires, especially for sensitive topics. In the pilot tests, participants indicated a clear comprehension of the IVR-administered questionnaire and that the IVR platform was user-friendly. Described in “The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing,” the authors conclude that formative research and cognitive testing of the questionnaire are needed for deployment in LMICs [9].

The near-ubiquitous ownership of phones in LMICs, high population mobility, and low cost demand a reexamination of statistical recommendations for MPS, especially when surveys are automated. In “Health surveys using mobile phones in developing countries: automated active strata monitoring and other statistical considerations for improving precision and reducing biases,” methods are proposed to reduce estimate bias and to adjust for selectivity due to mobile ownership [10]. The authors describe using automated active strata monitoring (AASM) to improve representativeness of the sample distribution to that of the source population. They conclude that although some statistical challenges remain, MPS represents a promising emerging means for population-level data collection in LMICs.

The increasing use of MPS in LMICs brings forth a cluster of ethical challenges. The existing literature regarding the ethics of mobile or digital health, however, mainly focuses on the use of technologies in high-income countries and does not consider the specific ethical issues associated with the conduct of MPS for NCD risk factor surveillance in LMICs. In “Ethics Considerations in Global Mobile Phone-Based Surveys of Noncommunicable Diseases: A Conceptual Exploration,” the authors explored central ethics issues in this domain, including identifying the nature of the activity, stakeholder engagement, appropriate design, anticipating and managing potential harms and benefits, consent, reaching intended respondents, data ownership, access and use, and ensuring LMIC sustainability [11]. The authors call for future work to develop a broad conceptual framework for the ethical, legal, and societal issues associated with MPS for NCD risk factors. They further point to the need for guidance documents to identify key issues, outline pros and cons of options available to stakeholders for each issue, review additional points to consider, and provide references to resources relevant to each issue. In order to begin to address the various needs, the researchers hope to establish a global working group inclusive of experts in ethics, mHealth survey implementation, regulatory oversight and policy, public health, social science, and MPS platform development.

The article, “Moving the Agenda on Noncommunicable Diseases: Policy Implications of Mobile Phone Surveys in Low- and Middle-Income Countries,” presents the special challenges for policy makers [12]. The article discusses potential benefits of MPS for developing, implementing, and evaluating NCD prevention and control policies. It includes an overview of major global commitments to NCD prevention and control as well as an exploration of how countries can translate these commitments into policy action at the national level. Potential benefits of MPS are discussed, including cost benefits of MPS for informing NCD policy actions compared to using traditional household surveys, timeliness of assessments to feed into policy and planning cycles, tracking progress of interventions, timely course correction for suboptimal or noneffective interventions, and assessing fairness in financial contribution and financial risk protection for those affected by NCDs in the spirit of universal health coverage, inter alia. The authors demonstrate how MPS can become a powerful tool for collecting population-based data to inform policies that address key public health challenges such as NCDs. Further research in real-life settings will help to provide additional realistic world experiences.

This special issue of JMIR offers a step forward in benchmarking what is known and what is possible to know using MPS for data collection and surveillance systems. These results offer guidance for research expectations and opportunities to understand and curb the rise of NCDs in LMICs. Additional next steps are foreseen to continue documenting empirical experiences of MPS use in LMICs to collect risk factor data on NCDs, engaging with global bodies toward the development of a research agenda, establishing a global working group of experts to address the ethical issues surrounding MPS use in LMICs, and working with international and national level policy-makers to create a comparative framework for turning results into policy and practice.

Journal of Medical Internet Research Vol 19, No 5 (2017): May

Journal of Medical Internet Research
Vol 19, No 5 (2017): May
http://www.jmir.org/2017/5

Guest Editorial

Leveraging Mobile Phones for Monitoring Risks for Noncommunicable Diseases in the Future
Jennifer A Ellis
J Med Internet Res 2017 (May 05); 19(5):e137

Ethics Considerations in Global Mobile Phone-Based Surveys of Noncommunicable Diseases: A Conceptual Exploration
Joseph Ali, Alain B Labrique, Kara Gionfriddo, George Pariyo, Dustin G Gibson, Bridget Pratt, Molly Deutsch-Feldman, Adnan A Hyder
J Med Internet Res 2017 (May 05); 19(5):e110
Health Surveys Using Mobile Phones in Developing Countries: Automated Active Strata Monitoring and Other Statistical Considerations for Improving Precision and Reducing Biases
Alain Labrique, Emily Blynn, Saifuddin Ahmed, Dustin Gibson, George Pariyo, Adnan A Hyder
J Med Internet Res 2017 (May 05); 19(5):e121

Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review
Dustin G Gibson, Amanda Pereira, Brooke A Farrenkopf, Alain B Labrique, George W Pariyo, Adnan A Hyder
J Med Internet Res 2017 (May 05); 19(5):e139

Knowledge, Attitude, Behavior, and Practices Regarding HIV, Viral Hepatitis, and Sexually Transmitted Infections Among Migrants From Sub-Saharan Africa Living in Germany: A Multicenter Survey Protocol
Claudia Santos-Hövener, Carmen Koschollek, Anna Kuehne, Adama Thorlie, Viviane Bremer
JMIR Res Protoc 2017 (May 02); 6(5):e80

Journal of the Pediatric Infectious Diseases Society (JPIDS) Volume 6, Issue 2 1 June 2017

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 6, Issue 2   1 June 2017
http://jpids.oxfordjournals.org/content/current

Editor’s Choice
Evaluation of the Impact of Pneumococcal Conjugate Vaccine on Pediatric Community-Acquired Pneumonia Using an Emergency Database System
Guilhem Noel; Gilles Viudes; Remi Laporte; Philippe Minodier

 

ORIGINAL ARTICLES AND COMMENTARIES
Tolerability of Japanese Encephalitis Vaccine in Pediatric Patients
Shauna Butler; Deena Sutter; Ashley Maranich

WHO: Director-General campaign closes amid anxiety and hope

The Lancet
May 20, 2017 Volume 389 Number 10083 p1953-2080
http://www.thelancet.com/journals/lancet/issue/current

Editorial
WHO: Director-General campaign closes amid anxiety and hope
The Lancet
The current race to replace Margaret Chan, outgoing Director-General of WHO, has been a different kind of contest. The unprecedented level of transparency and accountability in the election campaign is to be welcomed—voting by member states and not only by the agency’s executive board, publication and scrutiny of candidate manifestos, and public debates. But will the final decision making, to take place next week at the World Health Assembly in Geneva, also be different? The vote remains a secret ballot, member states can pledge their support to one candidate but vote for another, and, in the end, the choice of WHO’s next leader, still the world’s top international health post, will be as political as ever.

The election comes at a time of unparalleled uncertainty for WHO. Meeting the expectations of the Sustainable Development Goals demands political legitimacy and courageous leadership. Yet the landscape of global health initiatives has never been more complex, narrowing opportunities for WHO to play a decisive part in shaping the future of health. And WHO’s finances are terrifyingly limited. The agency is in an unenviable position: vastly more is expected of WHO while its role is contested and constrained.

A tall order for the remaining candidates, Tedros Adhanom Ghebreyesus, David Nabarro, and Sania Nishtar, who have each proved to be strong, credible, and hard working. All have participated in countless discussions and interviews, and travelled around the world competing for country votes, showcasing their particular strengths and priorities. At this juncture in the history of WHO it feels right that there are two candidates from low and middle income countries, and one a woman.

Tedros has been credited with transforming the Ethiopian health system and his country’s population health. He also has deep and valuable experience of several key global health initiatives that sometimes compete with WHO. As potentially the first Director-General from sub-Saharan Africa, his ascent to WHO’s leadership would be a major win for the continent. That said, Tedros has had to contend with considerable political mudslinging. He was Health Minister and Foreign Minister until November, 2016, leading to concerns being raised over his links with an Ethiopian regime guilty of extensive violations of human rights. Some of this criticism has been openly discussed, and also refuted, in social media. Furthermore, Tedros strenuously denies the damaging accusations (made by an adviser to his closest competitor, David Nabarro) that he covered up cholera epidemics in Ethiopia while Health Minister, branding it a smear campaign.

David Nabarro has wide experience on the front lines of global health and in the UN system, where he has spent much of his career. He has strong and proven managerial skills. And he has led and coordinated important global programmes, ranging from nutrition to Ebola. But Nabarro is supported by a present and likely future UK Government sceptical of multilateralism, distracted by Brexit, and lacking the enthusiasm of past administrations for health as an important foreign policy issue. Added to which, some member states may question whether now is the right time to be appointing a UN insider. Does WHO need fresh and more radical thinking, they might ask.

Sania Nishtar has her origins firmly rooted in civil society. A highly successful campaigner to address the abject international neglect of non-communicable diseases, she has also gained experience, albeit briefly, as Pakistan’s Health Minister, among other portfolios. She has successfully chaired important global health working groups, and she has shown an impressive independence of thinking—suggesting, for example, that she might only serve one term as Director-General to free her to take the tough decisions she believes WHO needs to take. But some observers may ask whether her high-level organisational experience is sufficient to lead WHO at such a critical moment in its history.

Each candidate has strengths. And each has weaknesses. The Lancet has, at various times, worked closely with all three. We can attest to their commitment to WHO and its values. But that is not enough. To achieve genuine internal reforms and to restore public confidence might seem to favour Tedros and Nishtar. The complex management and diplomacy requirements could favour Nabarro. The new campaign process has succeeded in enhancing transparency about the qualities and attributes of the candidates. But, as in any election, unpredictability reigns. We encourage member states to vote for the candidate who they believe mixes proven managerial competence with a clear and deliverable vision for WHO’s next 5 years. No empty promises. Just realisable results. And, perhaps most importantly, someone with the skills to handle the unexpected.

Evolution and patterns of global health financing 1995–2014: development assistance for health, and government, prepaid private, and out-of-pocket health spending in 184 countries

The Lancet
May 20, 2017 Volume 389 Number 10083 p1953-2080
http://www.thelancet.com/journals/lancet/issue/current

Articles
Evolution and patterns of global health financing 1995–2014: development assistance for health, and government, prepaid private, and out-of-pocket health spending in 184 countries
Global Burden of Disease Health Financing Collaborator Network
Open Access
Interpretation
Health spending remains disparate, with low-income and lower-middle-income countries increasing spending in absolute terms the least, and relying heavily on OOP spending and development assistance. Moreover, tremendous variation shows that neither time nor economic development guarantee adequate prepaid health resources, which are vital for the pursuit of universal health coverage.

Future and potential spending on health 2015–40: development assistance for health, and government, prepaid private, and out-of-pocket health spending in 184 countries

The Lancet
May 20, 2017 Volume 389 Number 10083 p1953-2080
http://www.thelancet.com/journals/lancet/issue/current

Future and potential spending on health 2015–40: development assistance for health, and government, prepaid private, and out-of-pocket health spending in 184 countries
Global Burden of Disease Health Financing Collaborator Network
Open Access
Interpretation
Health spending is associated with economic development but past trends and relationships suggest that spending will remain variable, and low in some low-resource settings. Policy change could lead to increased health spending, although for the poorest countries external support might remain essential.

Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: a cluster randomised controlled trial

Lancet Global Health
Jun 2017 Volume 5 Number 6 e556-e632
http://www.thelancet.com/journals/langlo/issue/current

Articles
Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: a cluster randomised controlled trial
Muhammad Atif Habib, Sajid Soofi, Simon Cousens, Saeed Anwar, Najib ul Haque, Imran Ahmed, Noshad Ali, Rehman Tahir, Zulfiqar A Bhutta
Summary
Background
Pakistan faces huge challenges in eradicating polio due to widespread poliovirus transmission and security challenges. Innovative interventions are urgently needed to strengthen community buy-in, to increase the coverage of oral polio vaccine (OPV) and other routine immunisations, and to enhance immunity through the introduction of inactivated polio vaccine (IPV) in combination with OPV. We aimed to evaluate the acceptability and effect on immunisation coverage of an integrated strategy for community engagement and maternal and child health immunisation campaigns in insecure and conflict-affected polio-endemic districts of Pakistan.
Methods
We did a community-based three-arm cluster randomised trial in healthy children aged 1 month to 5 years that resided within the study sites in three districts of Pakistan at high risk of polio. Clusters were randomly assigned by a computer algorithm using restricted randomisation in blocks of 20 by an external statistician (1:1:1) to receive routine polio programme activities (control, arm A), additional interventions with community outreach and mobilisation using an enhanced communication package and provision of short-term preventive maternal and child health services and routine immunisation (health camps), including OPV (arm B), or all interventions of arm B with additional provision of IPV delivered at the maternal and child health camps (arm C). An independent team conducted surveys at baseline, endline, and after each round of supplementary immunisation activity for acceptability and effect. The primary outcome measures for the study were coverage of OPV, IPV, and routine extended programme on immunisation vaccines and changes in the proportion of unvaccinated and fully vaccinated children. This trial is registered with ClinicalTrials.gov, number NCT01908114.
Findings
Between June 4, 2013, and May 31, 2014, 387 clusters were randomised (131 to arm A, 127 to arm B, and 129 to arm C). At baseline, 28 760 children younger than 5 years were recorded in arm A, 30 098 in arm B, and 29 126 in arm C. 359 clusters remained in the trial until the end (116 in arm A, 120 in arm B, and 123 in arm C; with 23 334 children younger than 5 years in arm A, 26 110 in arm B, and 25 745 in arm C). The estimated OPV coverage was 75% in arm A compared with 82% in arm B (difference vs arm A 6·6%; 95% CI 4·8–8·3) and 84% in arm C (8·5%, 6·8–10·1; overall p<0·0001). The mean proportion of routine vaccine doses received by children younger than 24 months of age was 43% in arm A, 52% in arm B (9%, 7–11) and 54% in arm C (11%, 9–13; overall p<0·0001). No serious adverse events requiring hospitalisation were reported after immunisation.
Interpretation
Despite the challenges associated with the polio end-game in high-risk, conflict-affected areas of Pakistan, a strategy of community mobilisation and targeted community-based health and immunisation camps during polio immunisation campaigns was successful in increasing vaccine coverage, including polio vaccine coverage.
Funding
Bill & Melinda Gates Foundation.

Ebola exposure, illness experience, and Ebola antibody prevalence in international responders to the West African Ebola epidemic 2014–2016: A cross-sectional study

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 20 May 2017)

Research Article
Ebola exposure, illness experience, and Ebola antibody prevalence in international responders to the West African Ebola epidemic 2014–2016: A cross-sectional study
Catherine F. Houlihan, Catherine R. McGowan, Steve Dicks, Marc Baguelin, David A. J. Moore, David Mabey, Chrissy h. Roberts, Alex Kumar, Dhan Samuel, Richard Tedder, Judith R. Glynn
| published 16 May 2017 PLOS Medicine

NTD policy priorities: Science, values, and agenda setting

 PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 20 May 2017)

Viewpoints
NTD policy priorities: Science, values, and agenda setting
Ana S. Ilt s, Kirstin R. W. Matthews
| published 18 May 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005431
Conclusion
Eliminating NTD epidemics by 2030 requires setting an agenda to meet specific and actionable NTD targets over time. If we focus on all diseases and methods simultaneously, only marginal impact can be attained. Selecting priorities will facilitate more significant achievements. NTD policy aimed at specific targets requires decisions about the balance between funding research, development, treatments, and preventative measures; which diseases to focus on, in what order, how much attention to pay to each; what constraints the agenda must respect; and who will have a voice in agenda setting. Scientists ought to acknowledge the need to set priorities to achieve goals; the importance of collaborating with public health experts, policy makers and communities to make substantial progress toward eliminating NTDs; and the inherently value-laden nature of priority setting. Only through explicitly setting priorities will effective and sustainable policies be achieved over time.

PLoS One [Accessed 20 May 2017]

PLoS One
http://www.plosone.org/
[Accessed 20 May 2017]

Research Article
Modelling the transmission and control strategies of varicella among school children in Shenzhen, China
Xiujuan Tang, Shi Zhao, Alice P. Y. Chiu, Hanwu Ma, Xu Xie, Shujiang Mei, Dongfeng Kong, Yanmin Qin, Zhigao Chen, Xin Wang, Daihai He
Research Article | published 18 May 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0177514

 

Research Article
Effect of early measles vaccine on pneumococcal colonization: A randomized trial from Guinea-Bissau
Nadja Skadkær Hansen, Stine Byberg, Lars Hervig Jacobsen, Morten Bjerregaard-Andersen, Aksel Karl Georg Jensen, Cesario Martins, Peter Aaby, Jørgen Skov Jensen, Christine Stabell Benn, Hilton Whittle
Research Article | published 17 May 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0177547

 

Essential information: Uncertainty and optimal control of Ebola outbreaks

PNAS – Proceedings of the National Academy of Sciences of the United States
of America

http://www.pnas.org/content/early/
[Accessed 20 May 2017]

Biological Sciences – Ecology:
Essential information: Uncertainty and optimal control of Ebola outbreaks
Shou-Li Li, Ottar N. Bjørnstad, Matthew J. Ferrari, Riley Mummah, Michael C. Runge, hristopher J. Fonnesbeck, Michael J. Tildesley, illiam J. M. Probert, and Katriona Shea
PNAS 2017 ; published ahead of print May 15, 2017, doi:10.1073/pnas.1617482114
Significance
The 2014 Ebola outbreak illustrates the complexities of decision making in the face of explosive epidemics; management interventions must be enacted, despite imperfect or missing information. The wide range in projected caseload generated attention as a source of uncertainty, but debate did not address whether uncertainty affected choice of action. By reevaluating 37 published models, we show that most models concur that reducing funeral transmission and reducing community transmission are robust and effective management actions to minimize projected caseload. Although models disagreed about absolute caseload, this measure has little relevance for evaluating candidate interventions. Our study highlights the importance of projecting the impact of interventions and is applicable to management of other epidemic outbreaks where rapid decision making is critical.
Abstract
Early resolution of uncertainty during an epidemic outbreak can lead to rapid and efficient decision making, provided that the uncertainty affects prioritization of actions. The wide range in caseload projections for the 2014 Ebola outbreak caused great concern and debate about the utility of models. By coding and running 37 published Ebola models with five candidate interventions, we found that, despite this large variation in caseload projection, the ranking of management options was relatively consistent. Reducing funeral transmission and reducing community transmission were generally ranked as the two best options. Value of information (VoI) analyses show that caseloads could be reduced by 11% by resolving all model-specific uncertainties, with information about model structure accounting for 82% of this reduction and uncertainty about caseload only accounting for 12%. Our study shows that the uncertainty that is of most interest epidemiologically may not be the same as the uncertainty that is most relevant for management. If the goal is to improve management outcomes, then the focus of study should be to identify and resolve those uncertainties that most hinder the choice of an optimal intervention. Our study further shows that simplifying multiple alternative models into a smaller number of relevant groups (here, with shared structure) could streamline the decision-making process and may allow for a better integration of epidemiological modeling and decision making for policy.

Impact of International Monetary Fund programs on child health

PNAS – Proceedings of the National Academy of Sciences of the United States
of America

http://www.pnas.org/content/early/
[Accessed 20 May 2017]

Social Sciences – Economic Sciences – Biological Sciences – Population Biology:
Impact of International Monetary Fund programs on child health
Adel Daoud, Elias Nosrati, Bernhard Reinsberg, Alexander E. Kentikelenis, Thomas H. Stubbs,
and Lawrence P. King
PNAS 2017 ; published ahead of print May 15, 2017, doi:10.1073/pnas.1617353114
Significance
This study adds to the state of the art by analyzing the impact of International Monetary Fund (IMF) programs on children’s health, mediated by their parents’ education. It is the first to combine macrodata and microdata to address this issue systematically across five dimensions of child health: water, malnutrition, shelter, sanitation, and health care access. The sample represents about 2.8 billion (about 50%) of the world’s population in year 2000. Using multilevel models, we find that, although IMF programs do not correlate directly with child health indicators, they reduce the protective effect of parental education on child health, especially in rural areas, and have a mixed impact across the five dimensions of urban child health.
Abstract
Parental education is located at the center of global efforts to improve child health. In a developing-country context, the International Monetary Fund (IMF) plays a crucial role in determining how governments allocate scarce resources to education and public health interventions. Under reforms mandated by IMF structural adjustment programs, it may become harder for parents to reap the benefits of their education due to wage contraction, welfare retrenchment, and generalized social insecurity. This study assesses how the protective effect of education changes under IMF programs, and thus how parents’ ability to guard their children’s health is affected by structural adjustment. We combine cross-sectional stratified data (countries, 67; children, 1,941,734) from the Demographic and Health Surveys and the Multiple Indicator Cluster Surveys. The sample represents ∼2.8 billion (about 50%) of the world’s population in year 2000. Based on multilevel models, our findings reveal that programs reduce the protective effect of parental education on child health, especially in rural areas. For instance, in the absence of IMF programs, living in an household with educated parents reduces the odds of child malnourishment by 38% [odds ratio (OR), 0.62; 95% CI, 0.66–0.58]; in the presence of programs, this drops to 21% (OR, 0.79; 95% CI, 0.86–0.74). In other words, the presence of IMF conditionality decreases the protective effect of parents’ education on child malnourishment by no less than 17%. We observe similar adverse effects in sanitation, shelter, and health care access (including immunization), but a beneficial effect in countering water deprivation.

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)

 
Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
http://www.paho.org/journal/index.php?option=com_content&view=featured&Itemid=101
This issue is focused on health reform In Ecuador and its implications.

Editorial
Health systems reform in the quest for universal health [La reforma de los sistemas de salud en la búsqueda de la cobertura universal]
Carissa F. Etienne
Published 15 May

 

Editorial
La reforma en salud del Ecuador [Health reform in Ecuador]
Verónica Espinosa, Cecilia Acuña , Daniel de la Torre, Gina Tambini
Published 15 May |

Tolerance of uncertainty: Conceptual analysis, integrative model, and implications for healthcare

Social Science & Medicine
Volume 180, Pages 1-196 (May 2017)
http://www.sciencedirect.com/science/journal/02779536/180

Review article
Tolerance of uncertainty: Conceptual analysis, integrative model, and implications for healthcare
Review Article
Pages 62-75
Marij A. Hillen, Caitlin M. Gutheil, Tania D. Strout, Ellen M.A. Smets, Paul K.J. Han
Abstract
Rationale
Uncertainty tolerance (UT) is an important, well-studied phenomenon in health care and many other important domains of life, yet its conceptualization and measurement by researchers in various disciplines have varied substantially and its essential nature remains unclear.
Objective
The objectives of this study were to: 1) analyze the meaning and logical coherence of UT as conceptualized by developers of UT measures, and 2) develop an integrative conceptual model to guide future empirical research regarding the nature, causes, and effects of UT.
Methods
A narrative review and conceptual analysis of 18 existing measures of Uncertainty and Ambiguity Tolerance was conducted, focusing on how measure developers in various fields have defined both the “uncertainty” and “tolerance” components of UT—both explicitly through their writings and implicitly through the items constituting their measures.
Results
Both explicit and implicit conceptual definitions of uncertainty and tolerance vary substantially and are often poorly and inconsistently specified. A logically coherent, unified understanding or theoretical model of UT is lacking. To address these gaps, we propose a new integrative definition and multidimensional conceptual model that construes UT as the set of negative and positive psychological responses—cognitive, emotional, and behavioral—provoked by the conscious awareness of ignorance about particular aspects of the world. This model synthesizes insights from various disciplines and provides an organizing framework for future research. We discuss how this model can facilitate further empirical and theoretical research to better measure and understand the nature, determinants, and outcomes of UT in health care and other domains of life.
Conclusion
Uncertainty tolerance is an important and complex phenomenon requiring more precise and consistent definition. An integrative definition and conceptual model, intended as a tentative and flexible point of departure for future research, adds needed breadth, specificity, and precision to efforts to conceptualize and measure UT.

The effects of women’s education on maternal health: Evidence from Peru

Social Science & Medicine
Volume 180, Pages 1-196 (May 2017)
http://www.sciencedirect.com/science/journal/02779536/180

Regular articles
The effects of women’s education on maternal health: Evidence from Peru
Original Research Article
Pages 1-9
Abigail Weitzman
Abstract
This article examines the causal effect of women’s education on maternal health in Peru, a country where maternal mortality has declined by more than 70% in the last two and a half decades. To isolate the effects of education, the author employs an instrumented regression discontinuity that takes advantage of an exogenous source of variation—an amendment to compulsory schooling laws in 1993. The results indicate that extending women’s years of schooling reduced the probability of several maternal health complications at last pregnancy/birth, sometimes by as much as 29%. Underlying these effects, increasing women’s education is found to decrease the probability of short birth intervals and unwanted pregnancies (which may result in unsafe abortions) and to increase antenatal healthcare use, potentially owing to changes in women’s cognitive skills, economic resources, and autonomy. These findings underscore the influential role of education in reducing maternal morbidity and highlight the contributions of women’s education to population health and health transitions

Reduced burden of childhood diarrheal diseases through increased access to water and sanitation in India: A modeling analysis

Social Science & Medicine
Volume 180, Pages 1-196 (May 2017)
http://www.sciencedirect.com/science/journal/02779536/180

Regular articles
Reduced burden of childhood diarrheal diseases through increased access to water and sanitation in India: A modeling analysis
Original Research Article
Pages 181-192
Arindam Nandi, Itamar Megiddo, Ashvin Ashok, Amit Verma, Ramanan Laxminarayan
Abstract
Each year, more than 300,000 children in India under the age of five years die from diarrheal diseases. Clean piped water and improved sanitation are known to be effective in reducing the mortality and morbidity burden of diarrhea but are not yet available to close to half of the Indian population. In this paper, we estimate the health benefits (reduced cases of diarrheal incidence and deaths averted) and economic benefits (measured by out-of-pocket treatment expenditure averted and value of insurance gained) of scaling up the coverage of piped water and improved sanitation among Indian households to a near-universal 95% level. We use IndiaSim, a previously validated, agent-based microsimulation platform to model disease progression and individual demographic and healthcare-seeking behavior in India, and use an iterative, stochastic procedure to simulate health and economic outcomes over time. We find that scaling up access to piped water and improved sanitation could avert 43,352 (95% uncertainty range [UR] 42,201–44,504) diarrheal episodes and 68 (95% UR 62–74) diarrheal deaths per 100,000 under-5 children per year, compared with the baseline. We estimate a saving of (in 2013 US$) $357,788 (95% $345,509–$370,067) in out-of-pocket diarrhea treatment expenditure, and $1646 (95% UR $1603–$1689) in incremental value of insurance per 100,000 under-5 children per year over baseline. The health and financial benefits are highly progressive, i.e. they reach poorer households more. Thus, scaling up access to piped water and improved sanitation can lead to large and equitable reductions in the burden of childhood diarrheal diseases in India.

Cost-effectiveness analysis of vaccinations and decision makings on vaccination programmes in Hong Kong: A systematic review

Vaccine
Volume 35, Issue 24, Pages 3153-3280 (31 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/24

Reviews
Cost-effectiveness analysis of vaccinations and decision makings on vaccination programmes in Hong Kong: A systematic review
Review Article
Pages 3153-3161
Carlos K.H. Wong, Qiuyan Liao, Vivian Y.W. Guo, Yiqiao Xin, Cindy L.K. Lam
Abstract
Objectives
To describe and systematically review the modelling and reporting of cost-effectiveness analysis of vaccination in Hong Kong, and to identify areas for quality enhancement in future cost-effectiveness analyses.
Methods
We conducted a comprehensive and systematic review of cost-effectiveness studies related to vaccination and government immunisation programmes in Hong Kong published from 1990 to 2015, through database search of Pubmed, Web of Science, Embase, and OVID Medline. Methodological quality of selected studies was assessed using Consolidated Health Economic Evaluation Reporting Standards checklist (CHEERS). Decision making of vaccination was obtained from Scientific Committee on Vaccine Preventable Diseases (SCVPD) and Department of Health in Hong Kong.
Results
Nine eligible studies reporting twelve comparative cost-effectiveness comparisons of vaccination programme for influenza (n = 2), pneumococcal disease (n = 3), influenza plus pneumococcal disease (n = 1), chickenpox (n = 2), Haemophilus influenzae b (n = 1), hepatitis A (n = 1), cervical cancer (n = 1) and rotavirus (n = 1) were identified. Ten comparisons (83.3%) calculated the incremental cost-effectiveness ratio (ICER) of a vaccination strategy versus status quo as outcomes in terms of cost in USD per life-years, cost per quality-adjusted life-years, or cost per disability-adjusted life-years. Among those 10 comparisons in base-case scenario, 4 evaluated interventions were cost-saving relative to status quo while the ICER estimates in 3 of the 6 remaining comparisons were far below commonly accepted threshold and WHO willingness-to-pay threshold, suggestive of very cost-effective. Seven studies were of good quality based on the CHEERS checklist; one was of moderate quality; and one was of excellent quality. The common methodological problems were characterisation of heterogeneity and reporting of study parameters.
Conclusions
There was a paucity of cost-effectiveness models evaluating vaccination targeted to the Hong Kong population. All evaluated vaccinations and immunisation interventions in Hong Kong, except for Haemophilus influenzae b, hepatitis A and HPV vaccinations, were considered either cost-saving or very cost-effective when compared to status quo.

No association between influenza vaccination during pregnancy and adverse birth outcomes

Vaccine
Volume 35, Issue 24, Pages 3153-3280 (31 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/24

No association between influenza vaccination during pregnancy and adverse birth outcomes
Original Research Article
Pages 3186-3190
Ousseny Zerbo, Sharareh Modaressi, Berwick Chan, Kristin Goddard, Ned Lewis, Karin Bok, Bruce Fireman, Nicola P. Klein, Roger Baxter
Abstract
Background
Pregnant women are recommended to receive inactivated influenza vaccination anytime during pregnancy. Studies have investigated the impact of influenza vaccination during pregnancy on birth outcomes and results on preterm birth have been inconsistent.
Methods
We conducted a retrospective cohort study among children born at a gestational age ≥ 24 weeks from January 1, 2010 to December 31, 2015 at Kaiser Permanente Northern California facilities (KPNC). We evaluated the association between maternal influenza vaccination during pregnancy and risk of preterm birth, small and large for gestational age, admission to the neonatal intensive care unit (NICU), respiratory distress syndrome, low birth weight, and low Apgar score. We ascertained the dates of maternal influenza vaccination, conception, and delivery, as well as birth outcomes from KPNC inpatient and outpatient databases. Conditional multivariate Cox regression and logistic regression analyses were used to determine the association between maternal vaccination during pregnancy and risk of each birth outcome.
Results
The study included 145,869 children. Maternal influenza vaccination during pregnancy was not associated with risk of small or large for gestational age births, preterm birth, need for mechanical ventilation at birth, respiratory distress syndrome, admission to the NICU, low birth weight, or low Apgar score. However, when we did not control for immortal time bias, the risk of preterm birth (odds ratio [OR] = 0.69, 95% confidence interval [CI] 0.66–0.72) was lower among infants of vaccinated mothers.
Conclusion
We found no association between maternal influenza vaccination during pregnancy and adverse birth outcomes. When investigating preterm birth outcome in association with vaccination during pregnancy, immortal time bias should be taken into account in the analysis.

Needle adapters for intradermal administration of fractional dose of inactivated poliovirus vaccine: Evaluation of immunogenicity and programmatic feasibility in Pakistan

Vaccine
Volume 35, Issue 24, Pages 3153-3280 (31 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/24

Needle adapters for intradermal administration of fractional dose of inactivated poliovirus vaccine: Evaluation of immunogenicity and programmatic feasibility in Pakistan
Original Research Article
Pages 3209-3214
Ali Faisal Saleem, Ondrej Mach, Mohammad T. Yousafzai, Asia Khan, William C. Weldon, M. Steven Oberste, Roland W. Sutter, Anita K.M. Zaidi
Abstract
Administration of 1/5th dose of Inactivated poliovirus vaccine intradermally (fIPV) provides similar immune response as full-dose intramuscular IPV, however, fIPV administration with BCG needle and syringe (BCG NS) is technically difficult. We compared immune response after one fIPV dose administered with BCG NS to administration with intradermal devices, referred to as Device A and B; and assessed feasibility of conducting a door-to-door vaccination campaign with fIPV. In Phase I, 452 children 6–12 months old from Karachi were randomized to receive one fIPV dose either with BCG NS, Device A or Device B in a health facility. Immune response was defined as seroconversion or fourfold rise in polio neutralizing antibody titer 28 days after fIPV among children whose baseline titer ≤362. In Phase II, fIPV was administered during one-day door-to-door campaign to assess programmatic feasibility by evaluating vaccinators’ experience. For all three poliovirus (PV) serotypes, the immune response after BCG NS and Device A was similar, however it was lower with Device B (34/44 (77%), 31/45 (69%), 16/30 (53%) respectively for PV1; 53/78 (68%), 61/83 (74%), 42/80 (53%) for PV2; and; 58/76 (76%), 56/80 (70%), 43/77 (56%) for PV3; p < 0.05 for all three serotypes). Vaccinators reported problems filling Device B in both Phases; no other operational challenges were reported during Phase II. Use of fIPV offers a dose-saving alternative to full-dose IPV.

Targeted outreach hepatitis B vaccination program in high-risk adults: The fundamental challenge of the last mile

Vaccine
Volume 35, Issue 24, Pages 3153-3280 (31 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/24

Targeted outreach hepatitis B vaccination program in high-risk adults: The fundamental challenge of the last mile
Original Research Article
Pages 3215-3221
M.-J.J. Mangen, H. Stibbe, A. Urbanus, E.C. Siedenburg, Q. Waldhober, G.A. de Wit, J.E. van Steenbergen, on behalf of the National Working Group of hepatitis B behavioural risk-groups vaccination program
Abstract
Background
The aim of this study was to evaluate the cost-effectiveness of the on-going decentralised targeted hepatitis B vaccination program for behavioural high-risk groups operated by regional public health services in the Netherlands since 1-November-2002. Target groups for free vaccination are men having sex with men (MSM), commercial sex workers (CSW) and hard drug users (HDU). Heterosexuals with a high partner change rate (HRP) were included until 1-November-2007.
Methods
Based on participant, vaccination and serology data collected up to 31-December-2012, the number of participants and program costs were estimated. Observed anti-HBc prevalence was used to estimate the probability of susceptible individuals per risk-group to become infected with hepatitis B virus (HBV) in their remaining life. We distinguished two time-periods: 2002–2006 and 2007–2012, representing different recruitment strategies and target groups. Correcting for observed vaccination compliance, the number of future HBV-infections avoided was estimated per risk-group. By combining these numbers with estimates of life-years lost, quality-of-life losses and healthcare costs of HBV-infections – as obtained from a Markov model-, the benefit of the program was estimated for each risk-group separately.
Results
The overall incremental cost-effectiveness ratio of the program was €30,400/QALY gained, with effects and costs discounted at 1.5% and 4%, respectively. The program was more cost-effective in the first period (€24,200/QALY) than in the second period (€42,400/QALY). In particular, the cost-effectiveness for MSM decreased from €20,700/QALY to €47,700/QALY.
Discussion and conclusion
This decentralised targeted HBV-vaccination program is a cost-effective intervention in certain unvaccinated high-risk adults. Saturation within the risk-groups, participation of individuals with less risky behaviour, and increased recruitment investments in the second period made the program less cost-effective over time. The project should therefore discus how to reduce costs per risk-group, increase effects or when to integrate the vaccination in regular healthcare.

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

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

Pediatric Drugs
First Online: 16 May 2017
Review Article
Immunization During Pregnancy: Impact on the Infant
KP Perrett, TM Nolan –
Abstract
Maternal immunization has undergone a paradigm shift in recent years, as women and healthcare providers accept and recognize the benefits of this strategy not only for the pregnant woman but also for the developing fetus and young infant. This article reviews the evidence for active immunization during pregnancy, with an emphasis on perinatal and infant outcomes. Current recommendations for immunization during pregnancy are presented, with particular focus on the routinely recommended vaccines during pregnancy: influenza and Tdap (tetanus, diphtheria, and pertussis). We discuss future research directions, maternal vaccines in development, and considerations for optimizing and advancing this underutilized strategy.

 

Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences
Volume 64, August 2017, Pages 11–21
Biotechnology and the transformation of vaccine innovation: The case of the hepatitis B vaccines 1968–2000
F Huzair, S Sturdy
Highlights
:: The recombinant hepatitis B vaccines rehabilitated vaccines as commercially interesting pharmaceutical products.
:: The recombinant hepatitis B vaccines helped substantially to establish the commercial viability of the biotech sector.
:: The commercial success of the recombinant hepatitis B vaccines was largely unanticipated.
:: The recombinant hepatitis vaccines helped establish a two-tier global vaccine innovation system.
Abstract
The approval, from 1986, of a series of recombinant hepatitis B vaccines was a landmark both in the growth of biotechnology and in the development of the vaccine innovation system. In this paper, we show how the early development of the hepatitis B vaccines was shaped by a political and economic context that newly favoured commercialisation of academic research, including the appropriation and management of intellectual property; we elucidate the contingent interests and motivations that led new biotechnology companies and established pharmaceutical businesses to invest in developing recombinant vaccines specifically against hepatitis B; and we show how these and other factors combined to make those vaccines an unexpected commercial success. Broadening the scope of our analysis to include not just North America and Europe but also low- and middle-income countries, we show how the development of the hepatitis B vaccines facilitated the emergence of a two-tier innovation system structured by tensions between the demands for commercial profitability on the one hand, and the expectation of public health benefit for low- and middle-income countries on the other.

 

American Journal of Epidemiology
2017 May 6. doi: 10.1093/aje/kwx048. [Epub ahead of print]
Imputing direct and indirect vaccine effectiveness of childhood pneumococcal conjugate vaccine against invasive disease by surveying temporal changes in nasopharyngeal pneumococcal colonization
SA Nzenze, SA Madhi, T Shiri, KP Klugman…
Abstract
The limited capabilities in most low-middle income countries to study the bebfit of pneumococcal conjugate vaccine (PCV) against invasive pneumococcal disease (IPD), calls for alternate strategies to assess this. We used a mathematical model, to predict the direct and indirect effectiveness of PCV by analyzing serotype specific colonization prevalence and IPD incidence prior to and following childhood PCV immunization in South Africa. We analyzed IPD incidence from 2005-2012 and colonization studies undertaken in HIV-uninfected and HIV-infected child-mother dyads from 2007-2009 (pre-PCV era), in 2010 (7-valent PCV era) and 2012 (13-valent PCV era). We compared the model-predicted to observed changes in IPD incidence, stratified by HIV-status in children >3 months to 5 years and also in women aged >18-45 years. We observed reductions in vaccine-serotype colonization and IPD due to vaccine serotypes among children and women after PCV introduction. Using the changes in vaccine-serotype colonization data, the model-predicted changes in vaccine-serotype IPD incidence rates were similar to the observed changes in PCV-unvaccinated children and adults, but not among children <24 months. Surveillance of colonization prior and following PCV use can be used to impute PCVs’ indirect associations in unvaccinated age groups, including in high HIV-prevalence settings.

Media/Policy Watch

Media/Policy Watch

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

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

 

BBC
http://www.bbc.co.uk/
Accessed 20 May 2017
Italy makes 12 vaccinations compulsory for children
19 May 2017
[See Milestones above for more detail]
Forbes
http://www.forbes.com/
Accessed 20 May 2017
The Anti-Vaccine And Anti-GMO Movements Are Inextricably Linked And Cause Preventable Suffering
18 May 2017

Millions Of U.S. Travelers Might Be At Risk For Importing Measles Because They Skipped The Vaccine
May 16, 2017   Rita Rubin, Contributor
In a study of people who visited travel health clinics before departing the United States, more than half of thoe who should have been vaccinated against measles didn’t get immunized, leaing them vulnerable to becoming infected overseas and bringing the disease back home.

 

The Guardian
http://www.guardiannews.com/
Accessed 20 May 2017
Vaccination in adults – a change in attitude could help prevent serious disease
Kim Thomas  Thursday 18 May 2017 1
Many of us take a lot of care over our diet and make sure we take regular exercise – yet we neglect to get ourselves vaccinated. Experts say this needs to change …

 

New York Times
http://www.nytimes.com/
Accessed 20 May 2017
The Opinion Pages | Op-Ed Contributor
Seth Berkley: The Looming Threat of Yellow Fever
14 May 2017
Three years ago, the West African Ebola epidemic set off a worldwide panic and the biggest global-health security crisis in years. Then Zika struck and the reality of those transmittable disease threats was brought even closer to home in the United States, with more than 5,000 cases reported and America still on high alert. Yet today, an even greater potential threat to the world is sweeping across Brazil.

The disease, yellow fever, is a deadly virus that spreads as rapidly as Zika, with symptoms that can be as horrific as Ebola. It is transmitted by certain species of mosquito, including the same Aedes aegypti that carries Zika. Up to 15 percent of those bitten become severely ill, with symptoms that include black vomit and bleeding from the nose, mouth and eyes. For up to half of those who develop severe symptoms, yellow fever ends in a painful death.

Until about a century ago, the disease regularly caused urban epidemics in the United States, including one in Philadelphia that killed 10 percent of the population in 1793, forcing President George Washington and others in his administration to flee what was then the nation’s capital.
Now, with Brazil facing an unusually large outbreak of yellow fever — there are 715 confirmed cases, more than 820 suspected cases and 240 confirmed deaths — another global health crisis looms. So far, the outbreaks have largely been confined to sparsely populated jungle areas. There is serious concern, however, that if the virus starts spreading in a major city, health authorities will be ill equipped to contain it. Rio de Janeiro, for one, is aggressively vaccinating its citizens in hopes of inoculating 12 million by the end of the year.

Yellow fever already kills upward of 30,000 people a year worldwide, though in 2013 as many as 60,000 might have died from the disease. With the threat of yellow fever returning to regions where it was once expunged, that number could rise significantly. What is particularly worrying is the possibility of yellow fever taking hold in previously unaffected parts of the world like Asia. The combination of Aedes aegypti being prevalent there and about 1.8 billion unvaccinated people living in densely populated parts of that continent makes for a potential disaster.

While there is no cure for yellow fever, a licensed vaccine has long been available that is safe, affordable and highly effective, providing lifetime protection with just one dose.

Last year, Angola’s capital, Luanda, endured the world’s largest outbreak of yellow fever in three decades. A surge in demand resulted in vaccine shortages, particularly when the disease spread to the neighboring Democratic Republic of Congo and farther afield to Kenya. With a large Chinese work force in Angola, many whom were unvaccinated, 11 cases reached China. Miraculously those were contained without further spread.

The shortages made the situation so desperate that the World Health Organization and Unicef had to resort to fractional dosing in Kinshasa, capital of the Democratic Republic of Congo, administrating one-fifth of a normal dose. We got lucky: The Brazilian manufacturer made available up to 2.5 million doses of the vaccine, and the outbreak was curbed.

Now, the situation has reversed. Having already distributed 15 million vaccine doses since the outbreak began in December, Brazil has been forced to request 3.5 million doses from the International Coordinating Group on Vaccine Provision, which oversees emergency stocks financed by Gavi, the Vaccine Alliance, the nonprofit group I manage. With a global emergency stockpile of six million doses and about 12 million people living in and around Rio, it is easy to see why public health experts are worried. If Rio and one other major city experience an outbreak, it is doubtful whether stocks could be replenished fast enough to keep up with demand.

The proportion of people living in urban areas, where diseases can spread far more rapidly than in rural areas with scattered populations, is forecast to rise from one-third of the planet’s population in 1950 to two-thirds by 2050. Clearly, we need to revise our risk assessments for infectious diseases to reflect this trend. But just how large should vaccine stockpiles be? And for how many cities should we prepare?

And while these emergency stockpiles are essential, if we have to call upon them we have in some way already failed. They should be our last line of defense. Instead, if we want to avoid a return of the kind of urban epidemic that killed 5,000 people in Philadelphia two centuries ago, we need to prevent outbreaks from occurring in the first place. That means improving mosquito control and simultaneously increasing immunity against yellow fever through routine immunization and pre-emptive vaccination campaigns.

With winter arriving next month in South America, the outbreak will most likely be brought to heel. But as mosquito season approaches in the north, control measures will be essential if we want to avoid yellow fever following Zika’s path, making its way north through Latin America to southern states in the United States like Florida.

And if, or when, it arrives, awareness will also be critical to prevent its spread, especially because very few doctors in the United States have ever seen a case and hardly anyone is vaccinated. As things stand, shortages are already affecting the availability of yellow fever travel vaccines in the United States.

History has shown that preventive approaches can be highly effective at controlling yellow fever, but if they are to work we first need to recognize there is a problem. To quote a long-ago Philadelphian, Benjamin Franklin, “an ounce of prevention is worth a pound of cure.”

 

Washington Post
http://www.washingtonpost.com/
Accessed 20 May 2017
Health & Science
Doctors worry as Texas lawmakers OK vaccine restrictions
By Paul J. Weber | AP May 19
AUSTIN, Texas — Texas moved closer Friday to restricting emergency immunizations given to children removed from troubled homes, worrying doctors and handing a political victory for vaccination opponents in a state where the number of families forgoing shots is soaring.
Vaccination critics are trying to build a foothold in Texas, and the state’s Republican-controlled House has now signed off on prohibiting doctors from administering any immediate immunizations— other than for tetanus — for children newly taken into state custody.
Doctors argue there are real implications…

 

Vaccines and Global Health: The Week in Review 13 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_13 May 2017

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

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

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

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

Milestones :: Perspectives

Milestones :: Perspectives

World Health Assembly
22–31 May 2017, Geneva
WHA70 – Main documents
:: A70/1 – Provisional agenda

::::::

EBOLA/EVD  [to 13 May 2017]
http://www.who.int/ebola/en/
12 May 2017
Statement on Ebola in the Democratic Republic of the Congo
WHO Statement
On 9 May, WHO was informed of a cluster of undiagnosed illness and deaths including haemorrhagic symptoms in Likati Health Zone, Bas Uele Province in the north of the Democratic Republic of the Congo (DRC), bordering Central African Republic.
On 11 May, the Ministry of Health of the Democratic Republic of Congo informed WHO that of 5 laboratory samples tested, 1 tested positive for Ebola virus at the Institut National de Recherche Biomédicale (INRB) laboratory in Kinshasa. Additional laboratory samples are currently being tested.
Since 22 April, nine suspected cases including 3 deaths have been reported. Six cases are currently hospitalized.
“An investigation team led by the Ministry of Health and supported by WHO and partners has deployed and is expected to reach the affected area in the coming days”, says Dr Peter Salama, WHO Executive Director for Emergencies.
WHO and partners are supporting the Ministry of Health in all aspects of the response, including epidemiological investigation, surveillance, logistics and supplies, communications and community engagement.

Dr Oly Ilunga Kalenga, Minister of Public Health, announces an outbreak of Ebola Virus Disease in Likati district, Bas-Uélé Province (northern DRC) following confirmation by the National Biomedical Research Institute.
KINSHASA, 12 May 2017
The Minister of Public Health of the Democratic Republic of the Congo (DRC), Dr Oly Ilunga Kalenga, has informed the World Health Organization (WHO) of “an outbreak of Ebola Virus Disease (EVD)” in Likati health district (Aketi, Bas-Uélé province), more than 1300 kilometres from Kinshasa in the northern DRC, following confirmation of the disease by the National Biomedical Research Institute (INRB), the national reference laboratory. ‘‘Of the five blood specimens taken from suspected cases and analysed at INRB, one has tested positive for Ebola virus (Zaïre serotype) using real-time polymerase chain reaction,’’ the Minister of Public Health indicated in a letter to the WHO representative in the DRC, and requested ‘‘support from WHO to strengthen the response to this outbreak’’. Since 22 April 2017, 9 suspected EVD cases have been reported including 3 deaths in Likati health district, i.e. a case-fatality rate of 33.3%, according to an official assessment on 11 May 2017.

‘‘The WHO Country Office in the DRC is working closely with the national and provincial authorities and with the WHO Regional Office for Africa, WHO headquarters in Geneva and all other partners to facilitate deployment of health workers and protective kits in the field  to strengthen epidemiological surveillance and rapidly control the outbreak’’, says Dr Yokouidé Allarangar, WHO representative in the DRC.  Dr Allarangar also announced that Dr Matshidiso Moeti, WHO Regional Director for Africa, would arrive in Kinshasa this weekend to attend a coordination meeting of the national committee at the Ministry of Health to deal with this emergency and ensure that WHO provides all necessary assistance to the DRC.

WHO has also drawn up a comprehensive logistics plan to meet  urgent requirements. ‘‘The first teams of epidemiologists, biologists, and experts in the areas of social mobilization, risk communication and community engagement, and also personnel specializing in water, hygiene and sanitation, are scheduled to reach the affected area today or tomorrow via Kisangani’’, the administrative centre of Tshopo (350 kilometres from Buta), Dr Allarangar added.  ‘‘The Likati health district is in a remote area, but contact tracing is essential to contain the outbreak in its focus; the DRC can rely on very experienced health workers for this purpose.’’ Dr Allarangar also appealed to other partners to work with the country to put in place an appropriately coordinated multisectoral approach. Médecins Sans Frontières, the NGO ALIMA, the United Nations Children’s Fund (UNICEF), the Gavi Alliance, the World Food Programme/United Nations Humanitarian Air Service (WFP-UNHAS), and the United Nations Organization Stabilization Mission in the Democratic Republic of the Congo (MONUSCO) are now standing ready to lend their support to the authorities in the DRC.

This confirmed outbreak is centred on the Nambwa health area approximately 130 kilometres from Buta, the administrative centre of Bas-Uélé province, which shares a border with the Central African Republic; it is the eighth EVD outbreak in the DRC since 1976. The most recent recorded outbreak was in August 2014 in Boende region, where the disease was brought under control where it started in Lokolia, now in Tshuapa province.

WHO Fact sheets
Ebola virus disease  Updated May 2017

::::::
::::::

Emergencies

Emergencies
 

Public Health Emergencies of International Concern (PHEIC)  [to 13 May 2017]

POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 10 May 2017
:: A major global polio event will be held this June at the Rotary Convention in Atlanta. Find out more.
:: Pakistan’s polio surveillance network provides a silent force behind eradication efforts. Read more.
:: New animations from the WHO highlight the global scope of the polio surveillance system, how they respond to a polio outbreak and efforts to reach every last child with vaccines.
Summary of newly-reported viruses this week:  Pakistan – two new wild poliovirus type 1 (WPV1) environmental samples.

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.
Pakistan
:: Two new WPV1 positive environmental samples were reported in the past week, from Sindh (Khi Gadap and Khi Landhi, in greater Karachi), collected on 10 and 12 April, respectively.

::::::

WHO Grade 3 Emergencies  [to 13 May 2017]
Iraq 
:: Separated by conflict but reunited: health care in action
7 May 2017 – Thousands of people have been seriously wounded as a result of the conflict in Mosul, with many patients facing permanent disability as a result of their injuries. To date, more than 8000 people, many of them civilians including women and children, have received treatment in hospitals for trauma injuries since west Mosul operations began. For some, these injuries are life-changing.
:: Special health situation report from Mosul  7 May 2017
 
South Sudan 
:: Read the latest cholera situation report pdf, 674kb  5 May 2017
[Excerpts]
…Working with Health and Wash cluster partners, WHO has completed a rational plan for deploying 9 million doses of oral cholera vaccines alongside WASH interventions over the next two years targeting at least 4.5 million people aged one year and above in cholera transmission hotspots. The plan has been submitted to the Global Taskforce for cholera control for approval…

Planned Activities/recommendations

  1. The next weekly EPR/cholera taskforce meeting is scheduled for 10 May 2017 starting 2:00pm in the WHO Conference Hall.
  2. Roll out a comprehensive integrated response including oral cholera vaccination in response to the cholera outbreak in Mingkaman IDPs, Bentiu PoC, and Bor PoC.
  3. Continue with the ongoing response to the outbreaks in Mingkaman, Yirol East, Yirol West, Northern Liech, and Pigi/Malakal Town in Central Upper Nile states.
  4. Deploy additional WASH partners to support the cholera response in Yirol East and Yirol West.
  5. Develop tailored strategies for cholera prevention and response in affected and at-risk cattle camps.
  6. Enhance cholera preparedness, investigation and response activities in Kapoeta North and Kapoeta East as well as Torit county.
  7. Identify areas with active transmission that should be prioritized

Yemen
:: WHO responds to resurgent cholera in Yemen
11 May 2017, Sana’a, Yemen — The World Health Organization (WHO) and partners are responding to an upsurge in cholera transmission in several parts of Yemen that has claimed 51 lives and caused around 2752 suspected cases since 27 April 2017. [No OCV mention]
 
NigeriaNo new announcements identified
The Syrian Arab Republic  – No new announcements identified
 

::::::

WHO Grade 2 Emergencies  [to 13 May 2017]
Cameroon  – No new announcements identified.
Central African Republic  – No new announcements identified.
Democratic Republic of the CongoNo new announcements identified.
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified.

 

::::::

 
UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Mosul Humanitarian Crisis, 9 May 2017
..616,264 People displaced, cumulatively, from Mosul city as of 9 May 409,604 people currently displaced from western Mosul city as of 9 May
…6,612 family plots immediately available to shelter displaced people in 9 priority sites and 10 other sites as of 9 May
…3,100 m³ water trucked every day to eastern Mosul by humanitarian partners
…12,081 people have been referred from frontline areas to hospitals to receive treatment for trauma injuries as of 7 May
OVERVIEW
…Re-intensification of hostilities on 4 May between the Iraqi Security Forces (ISF) and the Islamic State in Iraq and the Levant (ISIL) has significantly impacted the humanitarian situation. Many families have been arriving at the newly established Badoush mustering point, northeast of Mosul city, where humanitarian partners are providing emergency relief assistance…
:: Iraq: Humanitarian Bulletin, April 2017 | Issued on 10 May
:: Iraq: Mosul Humanitarian Response Situation Report No. 32 (1 May to 7 May 2017) [EN/KU]

Syrian Arab Republic
:: Syria Crisis: Menbij and Ar-Raqqa Situation Report No. 4 (as of 1 May 2017)
:: Syrian Arab Republic: Whole of Syria CCCM Cluster response snapshot for 2017 (as of end March) 13 May 2017

Yemen
:: Yemen Humanitarian Response Plan – Funding Status (As of 09 May 2017) [EN/AR]
:: Yemen Humanitarian Bulletin Issue 23 | 9 May 2017
:: Statement on behalf of the humanitarian coordinator, Jamie McGoldrick on the need to ensure funding and humanitarian access into and throughout Yemen [EN/AR] 7 May 2017

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. 7 (as of 9 May 2017)

Ethiopia
:: 9 May 2017  Ethiopia Weekly Humanitarian Bulletin, 08 May 2017

Nigeria
:: Press Statement by Peter Lundberg, Deputy Humanitarian Coordinator/Humanitarian Coordinator A.I on the Release of 82 Chibok Girls
(Abuja, 8 May 2017): The United Nations welcomes the release of the 82 Chibok girls in northeastern Nigeria and appeals to all Nigerians, including the families and communities of the liberated girls, to fully embrace them and provide all necessary support to ensure their reintegration into society.
Over 100 of these school girls are still unaccounted for, and the United Nations urges the international community to continue supporting the Government of Nigeria in its efforts to ensure the release, rehabilitation and reintegration of all the children, women and men who are victims of Boko Haram.
Despite this encouraging news, insecurity continues to affect millions of people living in six states in north-eastern Nigeria amid a deepening humanitarian crisis. Borno, Adamawa and Yobe States, where 8.5 million people are in need of life-saving humanitarian assistance and protection, are the most directly affected by conflict and mass forced displacement. The United Nations and partners are committed to supporting the Government of Nigeria to providing much needed relief to these vulnerable people.

::::::

UNICEF  [to 13 May 2017]
https://www.unicef.org/media/media_94367.html
12 May 2017
Statement attributable to UNICEF’s Regional Office for Latin America and the Caribbean on health data in Venezuela
PANAMA CITY, 12 May 2017 – “Data on infant and maternal deaths released last week by the Ministry of Health in Venezuela provides stark evidence of the impact of the prolonged crisis on women and children in the country.
“Despite the efforts of the Government and other stakeholders, the data indicates that 30 per cent more children died before their first birthday and 64 per cent more women died during pregnancy or within 42 days after giving birth in 2016 compared to 2015. More than 240,000 people were infected with malaria in 2016, up 76 per cent from 2015. Cases of diarrhea, pertussis, pneumonia, HIV, and measles –all potentially deadly for children– also show marked increases.
“The publication of the data by the Ministry of Health is a crucial step in addressing health challenges in Venezuela. UNICEF is deeply concerned about the situation and stands ready to strengthen its ongoing support to partners in government and civil society, which has included the provision of medicine for the treatment of malaria, diphtheria and other diseases, within the framework of agreed cooperation priorities.”

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 13 May 2017
World
Venezuela’s Maduro Replaces Top Health Official After Data Released
By Kejal Vyas
May 12, 2017 12:40 am ET
Move comes days after publication of figures showing sharp declines in public health
Venezuela President Nicolás Maduro replaced his top health official just days after her ministry reported a severe worsening in public health in a rare release of government statistics.
After withholding data since 2015, the Health Ministry in Venezuela this week published an epidemiological bulletin showing a 30% increase in infant mortality…

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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.
 
EBOLA/EVD  [to 13 May 2017]
http://www.who.int/ebola/en/
12 May 2017
WHO: Statement on Ebola in the Democratic Republic of the Congo
[See Milestones section above for detail]

MERS-CoV [to 13 May 2017]
http://www.who.int/emergencies/mers-cov/en/
[No new digest content identified]
 
Yellow Fever  [to 13 May 2017]
http://www.who.int/emergencies/yellow-fever/en/
[No new digest content identified]
 
Zika virus  [to 13 May 2017]
http://www.who.int/emergencies/zika-virus/en/
[No new digest content identified]
 
::::::
::::::

WHO & Regional Offices [to 13 May 2017]

WHO & Regional Offices [to 13 May 2017]

WHO: Access to medicines: making market forces serve the poor
11 May 2017
Nearly 2 billion people have no access to basic medicines, causing a cascade of preventable misery and suffering. Since the landmark agreement on the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, WHO and its partners have launched a number of initiatives that are making market forces serve the poor. The WHO prequalification programme is now firmly established as a mechanism for improving access to safe, effective and quality-assured products.
Access to medicines
WHO has struggled to improve access to medicines throughout its nearly 70-year history, and rightly so. Good health is impossible without access to pharmaceutical products. Universal health coverage depends on the availability of quality-assured affordable health technologies in sufficient quantities.
Lack of access to medicines causes a cascade of misery and suffering, from no relief for the excruciating pain of a child’s earache, to women who bleed to death during childbirth, to deaths from diseases that are easily and inexpensively prevented or cured. Lack of access to medicines is one inequality that can be measured by a starkly visible yardstick: numbers of preventable deaths.
Efforts to improve access to medicines are driven by a compelling ethical imperative. People should not be denied access to life-saving or health-promoting interventions for unfair reasons, including those with economic or social causes.
Millions of yearly childhood deaths from diseases that could have been prevented or cured by existing medical products would be unthinkable in a fair and just world.
The world is neither. An estimated two billion people have no access to essential medicines, effectively shutting them off from the benefits of advances in modern science and medicine.

WHO improves transparency of financial data
12 May 2017 – WHO is improving transparency and accountability with the launch of a redesigned Programme Budget Web Portal that makes budget and spending information easier to access, use and understand. The redesigned portal provides timely and detailed budget, financing and expenditure data on WHO activities and how they are funded in countries, regions and internationally.

WHO calls for immediate action in Somalia
11 May 2017 – WHO is concerned by the shortage of funding for life-saving work in Somalia in response to the ongoing drought that has plunged the country further towards famine, disease, and health insecurity. Drought in Somalia led to the destruction of crops and livestock, leaving more than 3.3 million people hungry. If this continues, famine could soon be a reality, creating a devastating cycle of hunger and disease.

Highlights
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.

WHO responds to resurgent cholera in Yemen
May 2017 – WHO and partners are responding to an upsurge in cholera transmission in several parts of Yemen that has claimed 51 lives and caused around 2752 suspected cases since 27 April 2017. WHO has rapidly distributed medicines and medical supplies, including cholera kits, oral rehydration solutions and intravenous (IV) fluids as well as medical furniture and equipment for diarrhoea treatment centres.

Preparing for the next influenza pandemic
May 2017 – This year the World Health Assembly will receive the first review of the Pandemic Influenza Preparedness (PIP) Framework – an agreement helping to prepare the world for the next influenza pandemic by ensuring that all countries, whether rich or poor, have access to influenza vaccines.
::::::

Weekly Epidemiological Record, 12 May 2017, vol. 92, 19 (pp. 241–268)
Human papillomavirus vaccines: WHO position paper, May 2017

::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Ebola virus disease – Democratic Republic of the Congo 13 May 2017 [See  Milestones above for more detail]
:: Dr Oly Ilunga Kalenga, Minister of Public Health, announces an outbreak of Ebola Virus Disease in Likati district, Bas-Uélé Province (northern DRC) following confirmation by the National Biomedical Research Institute. – 12 May 2017
:: Ebola vaccines for Guinea and the world – 08 May 2017

WHO Region of the Americas PAHO
No new announcements identified.

WHO South-East Asia Region SEARO
:: Amitabh Bachchan appointed WHO Goodwill Ambassador for Hepatitis in South-East Asia Region  SEAR/PR/1649
Mumbai, 12 May 2017 – World Health Organization today appointed legendary Indian movie star Mr Amitabh Bachchan as its Goodwill Ambassador for Hepatitis in South-East Asia Region to boost awareness and intensify action to arrest the hepatitis epidemic.
 
WHO European Region EURO
:: Reviewing the health impact and effectiveness of urban green space interventions 11-05-2017
:: Reducing the SDG reporting burden: WHO/Europe’s initiative presented at the Regional Forum on Sustainable Development 09-05-2017

WHO Eastern Mediterranean Region EMRO
:: WHO support gives new life to Syrian refugees in Egypt requiring emergency medical care
7 May 2017

WHO Western Pacific Region
:: DOH, WHO Launch Cooperation Strategies Toward a Healthy Philippines
DAVAO CITY, 11 May 2017 – Health statistics over the years indicate that more Filipinos live longer now as a result of collaborative efforts of the government, various development partners and stakeholders. Several health sector reforms have been made to expand the breadth and depth of health service delivery and coverage. The World Health Organization has been a staunch partner of the Government in developing strategies to improve the health of the people.

CDC/ACIP [to 13 May 2017]

CDC/ACIP [to 13 May 2017]
http://www.cdc.gov/media/index.html

Press Release
Thursday, May 11, 2017
New Hepatitis C Infections Nearly Tripled over Five Years
Deadly virus concentrated among baby boomers and increasing rapidly among new generations of Americans
Over just five years, the number of new hepatitis C virus infections reported to CDC has nearly tripled, reaching a 15-year high, according to new preliminary surveillance data released today by the Centers for Disease Control and Prevention (CDC).

Because hepatitis C has few symptoms, nearly half of people living with the virus don’t know they are infected and most new infections go undiagnosed. Further, limited surveillance resources have led to underreporting, meaning the annual number of hepatitis C virus cases reported to CDC (850 cases in 2010 and 2,436 cases in 2015) does not reflect the true scale of the epidemic. CDC estimates about 34,000 new hepatitis C infections actually occurred in the U.S. in 2015.

Hepatitis C kills more Americans than any other infectious disease reported to CDC. The data released today indicate that nearly 20,000 Americans died from hepatitis C-related causes in 2015, and the majority of deaths were people ages 55 and older.

“By testing, curing, and preventing hepatitis C, we can protect generations of Americans from needless suffering and death,” said Jonathan Mermin, M.D., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. “We must reach the hardest-hit communities with a range of prevention and treatment services that can diagnose people with hepatitis C and link them to treatment. This wide range of services can also prevent the misuse of prescription drugs and ultimately stop drug use – which can also prevent others from getting hepatitis C in the first place.”…

Announcements

Announcements
 

Human Vaccines Project   [to 13 May 2017]
http://www.humanvaccinesproject.org/media/press-releases/
08 May, 2017
New Study Aims to Explain the Rules of How The Immune System Works
Findings from this research will inform how to generate long-lasting immunity against diseases
NEW YORK, May 8, 2017 /PRNewswire-USNewswire/ — The Human Vaccines Project, a nonprofit public-private partnership focused on decoding the immune system to improve human health, announced today the initial enrollment of its first clinical trial in a new program aimed at dramatically increasing knowledge of how the immune system works. The study is the first step in a series of trials, with the goal of engineering the human immune system to confer lifelong protection from infectious and non-communicable diseases across global populations.

“While vaccines are among the greatest successes in the history of public health, we do not fully understand how most vaccines work and why some are less effective in certain populations,” said Wayne C. Koff, Ph.D., president and CEO of the Human Vaccines Project. “Determining the core principles of how the human immune system recognizes pathogens and fights diseases will enable a more precise approach for developing vaccines and immunotherapies for a wide range of diseases such as AIDS, tuberculosis, diabetes, multiple sclerosis and cancer.”

The initial study will assess immune responses of 10 healthy adults (ages 40-80) to a licensed hepatitis B vaccine. It will feature one of the most comprehensive analyses of how people respond to vaccinations to learn why some individuals are protected from a single dose, while others are not. The study will expand to include several hundred people – from neonates to the elderly in middle and low-income countries.

“Developing a better understanding of why some groups of people are protected from disease is a goal that simply must be achieved,” said Co-Principal Investigator Tobias Kollmann, M.D., Ph.D., professor of pediatrics at the University of British Columbia (UBC) and an investigator at the Vaccine Evaluation Center in Vancouver, Canada. “The licensed hepatitis B vaccine, which only works in about 30 percent of people on the first shot, is an ideal model vaccine to study general principles of human immunological protection because it is one of the few vaccines for which we know how it protects.”

The study will take place at the at the Vaccine Evaluation Center, in Vancouver, Canada, and will be augmented by extensive immunological and bioinformatic analyses at the Project’s San Diego Mesa Consortium, which includes the J. Craig Venter Institute, the La Jolla Institute, The Scripps Research Institute, and UC San Diego, with clinical coordination by the Vanderbilt Institute for Clinical and Translational Research.

“With technological advances in biomedical, computational and engineering sciences, we have an unprecedented opportunity to decipher the immune system’s components and core principles required to generate long-lasting immunity against disease, and usher in a new era of global health,” added Stanley Plotkin, M.D., Chairman of the Human Vaccines Project’s Board of Directors.

 
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Gavi [to 13 May 2017]
http://www.gavi.org/library/news/press-releases/
08 May 2017
U.S. approves US$ 275 million for Gavi in fiscal year 2017 budget
Funding to provide life-saving vaccines to children.
Washington, DC, 8 May 2017– Gavi, the Vaccine Alliance welcomed final approval of the U.S. fiscal year 2017 appropriations bill that includes US$ 275 million for Gavi, funding that will greatly enhance Gavi’s capacity to purchase and deliver life-saving vaccines for children in the world’s poorest countries. This will help immunise millions of children in developing countries against vaccine-preventable diseases, which claim 1.5 million lives every year.
The contribution to Gavi is part of the US$ 814.5 million approved for USAID’s Maternal and Child Health programs for 2017. This funding not only supports the introduction of new vaccines, innovative approaches and tools to expand equitable access to vaccines, but a range of other life-saving interventions.
“We are extremely grateful for the continued strong bipartisan support for Gavi’s role in expanding global immunisation programs, especially in a particularly challenging budget environment. Vaccines are one of the best buys in global health and healthy families contribute to healthy economies,” said Gavi CEO Dr. Seth Berkley…

 
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CEPI – Coalition for Epidemic Preparedness Innovations  [to 13 May 2017]
http://cepi.net/
Newsletter 12 May 2017
[Excerpt]
Address from CEO
Last week I had the pleasure of attending the World Economic Forum – Africa meeting in Durban, South Africa, which began with a session on “Leadership in an Era of Disruption” that probed the question of how Africa’s leaders can better respond to the many challenges they face. At the end of the session, the moderator asked the audience to remain seated for a memorial video honoring Ahmed Kathrada, one of the last surviving and youngest of the Rivonia Trialists who had been imprisoned with Nelson Mandela on Robben Island, who passed away in March. It was an inspiring session, honoring the sacrifices of the past and looking with hope toward the future.
In Durban, I met many inspiring individuals: Victor Ochen, the Director of AYINET, an organization that addresses the needs of children displaced by conflict, who in 2015 became the youngest African ever to be nominated for a Nobel prize; Keller Rinaudo, an entrepreneur who founded Zipline, which has established the world’s first commercial drone delivery system — in Rwanda, delivering blood products to remote hospitals in as little as 30 minutes; and John Nkengasong, the first director of the recently established Africa CDC – to name just a few. Each has an incredible story to tell, and each is making the continent – and the world – a better place.
CEPI is part of this unfolding story. African scientists still command too small a share of Africa’s GDP but increasingly are asserting their right to set the science agenda for the continent. CEPI, for its part, is committed to working closely with African scientists and institutions to develop products and design clinical trials that serve the needs of their communities. While the World Economic Forum was convening in South Africa, a meeting on Ebola, hosted by President Condé of Guinea, took place in Conakry.  In her opening remarks at that meeting, Margaret Chan, the Director-General of the World Health Organization, said “A safe and efficacious Ebola vaccine was the world’s best gift during 2016” and highlighted the contributions of scientists from Guinea, the Guinea national medicine and regulatory agency, and the national ethics committee who worked with the international team to complete the ring vaccination study there. She also highlighted the role of CEPI in contributing to global preparedness for such threats in the future.
This week, in London, CEPI’s Scientific Advisory Committee reviewed the white papers submitted in response to CEPI’s first call for proposals. The best of these will now be developed into full proposals.  CEPI is taking its first definitive steps toward fulfilling its promise.

 
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IAVI – International AIDS Vaccine Initiative   [to 13 May 2017]
https://www.iavi.org/
[Undated]
HIV VACCINE AWARENESS DAY – HVAD 2017 Campaign Toolkit
On May 18, join IAVI in recognizing the thousands of trial volunteers, clinicians, scientists, advocates, and communities leading the global search for a vaccine.

 
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UNAIDS  [to 13 May 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update
UNAIDS and Xinhua partnership brings the common goal of ending AIDS closer
News agency is a key partner through its efforts of reaching billions of people with life-saving…

Feature Story
Germany—ending AIDS by 2020
Deutsche AIDS-Hilfe has launched a new campaign to end AIDS in Germany by 2020. The campaign features Maik, who nine years ago was fighting for his life.

Feature Story
Interviews with the candidates for WHO Director-General
David Nabarro, Sania Nishtar and Tedros Adhanom Ghebreyesus talk to unaids.org about the AIDS epidemic and global health.

 
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NIH  [to 13 May 2017]
http://www.nih.gov/news-events/news-releases
May 10, 2017
Cell particles may help spread HIV infection, NIH study suggests
HIV appears to enlist the aid of nano-sized structures released by infected cells to infect new cells, according to a study by researchers at the National Institutes of Health. Known as extracellular vesicles (EVs), these bubble-like structures are made by many kinds of cells and, under most circumstances, are thought to ferry molecules from one cell to another, providing a means of communication. NIH scientists discovered that cells infected with HIV appear to produce EVs that manipulate prospective host cells to pass infection to other cells. The study appears in Scientific Reports

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FDA [to 13 May 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
:: May 2, 2017 Approval Letter – ACAM2000 (PDF – 33KB)  Posted: 5/9/2017
:: Complete List of Currently Approved Premarket Approvals (PMAs) (PDF – 16KB)
Posted: 5/9/2017; Updated as of 5/4/2017
:: Complete List of Currently Approved NDA and ANDA Application Submissions (PDF – 17KB)
Posted: 5/9/2017; Updated as of 5/4/2017

 
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Wellcome Trust  [to 13 May 2017]
https://wellcome.ac.uk/news
11 May 2017
Largest UK resource of human stem cells created
Scientists have created the UK’s largest resource of human stem cells from healthy people. This is a powerful research tool for studying human development and disease.
Researchers generated human induced pluripotent stem cells (iPSCs) on a large scale to study cell differences between individuals…
9 May 2017
International Research Scholars announced
Wellcome has teamed up with the Howard Hughes Medical Institute (HHMI), the Bill & Melinda Gates Foundation, and the Calouste Gulbenkian Foundation for a new research award that will develop scientific talent around the world.
Today the first 41 early-career scientists to receive the International Research Scholars awards (opens in a new tab) were announced.
This group of scholars will receive a total of nearly $26.7 million, with each researcher receiving $650,000 over five years…
8 May 2017
23 researchers given prestigious fellowships
Members of the Wellcome community have been elected fellows of two prestigious organisations.
Fourteen have been elected Fellows of the Academy of Medical Sciences, and nine have been elected Fellows of the Royal Society.

 
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European Medicines Agency  [to 13 May 2017]
http://www.ema.europa.eu/ema/
08/05/2017
Involving patients in discussions on benefits and risks of medicines
EMA publishes report on CHMP pilot project
The European Medicines Agency (EMA) has published a final report on the experience gained during its pilot project to involve patients directly in the assessment of the benefits and risks of medicines in its Committee for Medicinal Products for Human Use (CHMP).
The report concludes that patients should continue to be invited to oral explanations when their input could be valuable to the assessment of a medicine. This could be the case, for example, when the Committee is considering whether to recommend the authorisation of a new medicine or the maintenance, suspension or revocation of an existing authorisation, or a restriction of indication of an authorised medicine…

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GHIT Fund   [to 13 May 2017]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical companies, the Japanese Government and the Bill & Melinda Gates Foundation.
2017.05.10      News
New interview articles posted on our 5th Anniversary website:
– Dr. Hannah Kettler Senior Program Officer, Life Science Partnerships, Global Health Program, Office of the President, Bill & Melinda Gates Foundation
– Mr. George Nakayama, Representative Director, Chairman and CEO, Daiichi Sankyo Company, Limited
– Mr. Yoshihiko Hatanaka, Representative Director, President and CEO, Astellas Pharma Inc.
– Mr. Gen Miyazawa, Executive Corporate Officer EVP, President of Media Group, Yahoo Japan Corporation

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

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

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

 

Report Launch: “Global Health and the Future Role of the United States”
May 15, 2017 (11:00 AM Eastern)  Register here (Webcast Available)
National Academy of Sciences Building (Rm. 125) • 2101 Constitution Avenue, NW, Washington, DC 20418
The report “Global Health and the Future Role of the United States” examines the changing landscape of global health and opportunities for the U.S. government, as well as nongovernmental organizations and the private sector, to improve responsiveness, coordination, and efficiency.

 

Journal Watch

Journal Watch

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

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

Reaching beyond the review of research evidence: a qualitative study of decision making during the development of clinical practice guidelines for disease prevention in healthcare

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 13 May 2017)

Research article
Reaching beyond the review of research evidence: a qualitative study of decision making during the development of clinical practice guidelines for disease prevention in healthcare
The judgment and decision making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We have studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on five decision-criteria: research evidence; curative/preventive effect size, severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives (i.e. a prioritization group) was assigned the task of ranking condition-intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision making process during the two-year development of national guidelines for methods of preventing disease.
Linda Richter Sundberg, Rickard Garvare and Monica Elisabeth Nyström
BMC Health Services Research 2017 17:344
Published on: 11 May 2017