Vaccines and Global Health: The Week in Review 9 Dec 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

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 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_9 Dec 2017

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

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Milestones :: Perspectives

Milestones :: Perspectives
 
Editor’s Note:
WHO published a new Fact Sheet titled “Human rights and health” which we present below [full text]. In reading it, our perspective that full, life-course immunization is and should be the core of “health as a human right” was strengthened.
 
 
WHO Fact Sheet – Human rights and health
December 2017
Key facts
:: The WHO Constitution (1946) envisages “…the highest attainable standard of health as a fundamental right of every human being.”
:: Understanding health as a human right creates a legal obligation on states to ensure access to timely, acceptable, and affordable health care of appropriate quality as well as to providing for the underlying determinants of health, such as safe and potable water, sanitation, food, housing, health-related information and education, and gender equality.
:: A States’ obligation to support the right to health – including through the allocation of “maximum available resources” to progressively realise this goal – is reviewed through various international human rights mechanisms, such as the Universal Periodic Review, or the Committee on Economic, Social and Cultural Rights. In many cases, the right to health has been adopted into domestic law or Constitutional law.
:: A rights-based approach to health requires that health policy and programmes must prioritize the needs of those furthest behind first towards greater equity, a principle that has been echoed in the recently adopted 2030 Agenda for Sustainable Development and Universal Health Coverage. (1)
:: The right to health must be enjoyed without discrimination on the grounds of race, age, ethnicity or any other status. Non-discrimination and equality requires states to take steps to redress any discriminatory law, practice or policy.
:: Another feature of rights-based approaches is meaningful participation. Participation means ensuring that national stakeholders – including non-state actors such as non-governmental organizations – are meaningfully involved in all phases of programming: assessment, analysis, planning, implementation, monitoring and evaluation.

Introduction
“The right to the highest attainable standard of health” implies a clear set of legal obligations on states to ensure appropriate conditions for the enjoyment of health for all people without discrimination.

The right to health is one of a set of internationally agreed human rights standards, and is inseparable or ‘indivisible’ from these other rights. This means achieving the right to health is both central to, and dependent upon, the realisation of other human rights, to food, housing, work, education, information, and participation.

The right to health, as with other rights, includes both freedoms and entitlements:
:: Freedoms include the right to control one’s health and body (for example, sexual and reproductive rights) and to be free from interference (for example, free from torture and non-consensual medical treatment and experimentation).
:: Entitlements include the right to a system of health protection that gives everyone an equal opportunity to enjoy the highest attainable level of health.

Focus on disadvantaged populations
Disadvantage and marginalization serve to exclude certain populations in societies from enjoying good health. Three of the world’s most fatal communicable diseases – malaria, HIV/AIDS and tuberculosis – disproportionately affect the world’s poorest populations, and in many cases are compounded and exacerbated by other inequalities and inequities including gender, age, sexual orientation or gender identity and migration status. Conversely the burden of non-communicable diseases – often perceived as affecting high-income countries – is increasing disproportionately among lower-income countries and populations, and is largely associated with lifestyle and behaviour factors as well as environmental determinants, such as safe housing, water and sanitation that are inextricably linked to human rights.

A focus on disadvantage also reveals evidence of those who are exposed to greater rates of ill-health and face significant obstacles to accessing quality and affordable healthcare, including indigenous populations. While data collection systems are often ill-equipped to capture data on these groups, reports show that these populations have higher mortality and morbidity rates, due to noncommunicable diseases such as cancer, cardiovascular diseases, and chronic respiratory disease. These populations may also be the subject of laws and policies that further compound their marginalization and make it harder for them to access healthcare prevention, treatment, rehabilitation and care services.

Violations of human rights in health
Violations or lack of attention to human rights can have serious health consequences. Overt or implicit discrimination in the delivery of health services – both within the health workforce and between health workers and service users – acts as a powerful barrier to health services, and contributes to poor quality care.

Mental ill-health often leads to a denial of dignity and autonomy, including forced treatment or institutionalization, and disregard of individual legal capacity to make decisions. Paradoxically, mental health is still given inadequate attention in public health, in spite of the high levels of violence, poverty and social exclusion that contribute to worse mental and physical health outcomes for people with mental health disorders.

Violations of human rights not only contribute to and exacerbate poor health, but for many, including people with disabilities, indigenous populations, women living with HIV, sex workers, people who use drugs, transgender and intersex people, the health care setting presents a risk of heightened exposure to human rights abuses – including coercive or forced treatment and procedures.

Human rights-based approaches
A human rights-based approach to health provides a set of clear principles for setting and evaluating health policy and service delivery, targeting discriminatory practices and unjust power relations that are at the heart of inequitable health outcomes.

In pursuing a rights-based approach, health policy, strategies and programmes should be designed explicitly to improve the enjoyment of all people to the right to health, with a focus on the furthest behind first. The core principles and standards of a rights-based approach are detailed below.

Core principles of human rights
Accountability
States and other duty-bearers are answerable for the observance of human rights. However, there is also a growing movement recognising the importance of other non-state actors such as businesses in the respect and protection of human rights. (2)

Equality and non-discrimination
The principle of non-discrimination seeks ‘…to guarantee that human rights are exercised without discrimination of any kind based on race, colour, sex, language, religion, political, or other opinion, national or social origin, property, birth or other status such as disability, age, marital and family status, sexual orientation and gender identity, health status, place of residence, economic and social situation’.

Any discrimination, for example in access to health care, as well as in means and entitlements for achieving this access, is prohibited on the basis of race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth, physical or mental disability, health status (including HIV/AIDS), sexual orientation ,and civil, political, social or other status, which has the intention or effect of impairing the equal enjoyment or exercise of the right to health.

The principle of non-discrimination and equality requires WHO to address discrimination in guidance, policies, and practices, such as relating to the distribution and provision of resources and health services. Non-discrimination and equality are key measures required to address the social determinants affecting the enjoyment of the right to health. Functioning national health information systems and availability of disaggregated data are essential to be able to identify the most vulnerable groups and diverse needs.

Participation
Participation requires ensuring that all concerned stakeholders including non-state actors have ownership and control over development processes in all phases of the programming cycle: assessment, analysis, planning, implementation, monitoring, and evaluation. Participation goes well beyond consultation or a technical addition to project design; it should include explicit strategies to empower citizens, especially the most marginalized, so that their expectations are recognised by the State.

Participation is important to accountability as it provides “…checks and balances which do not allow unitary leadership to exercise power in an arbitrary manner”.

Universal, indivisible and interdependent
Human rights are universal and inalienable. They apply equally, to all people, everywhere, without distinction. Human Rights standards – to food, health, education, to be free from torture, inhuman or degrading treatment – are also interrelated. The improvement of one right facilitates advancement of the others. Likewise, the deprivation of one right adversely affects the others.

Core elements of a right to health
Progressive realization using maximum available resources
No matter what level of resources they have at their disposal, progressive realisation requires that governments take immediate steps within their means towards the fulfilment of these rights. Regardless of resource capacity, the elimination of discrimination and improvements in the legal and juridical systems must be acted upon with immediate effect.

Non-retrogression
States should not allow the existing protection of economic, social, and cultural rights to deteriorate unless there are strong justifications for a retrogressive measure. For example, introducing school fees in secondary education which had formerly been free of charge would constitute a deliberate retrogressive measure. To justify it, a State would have to demonstrate that it adopted the measure only after carefully considering all the options, assessing the impact and fully using its maximum available resources.

Core components of the right to health
The right to health (Article 12) was defined in General Comment 14 of the Committee on Economic, Social and Cultural Rights – a committee of Independent Experts, responsible for overseeing adherence to the Covenant. (4) The right includes the following core components:

Availability
Refers to the need for a sufficient quantity of functioning public health and health care facilities, goods and services, as well as programmes for all. Availability can be measured through the analysis of disaggregated data to different and multiple stratifiers including by age, sex, location and socio-economic status and qualitative surveys to understand coverage gaps and health workforce coverage

Accessibility
Requires that health facilities, goods, and services must be accessible to everyone. Accessibility has four overlapping dimensions:
:: non-discrimination
:: physical accessibility
:: economical accessibility (affordability)
:: information accessibility.

Assessing accessibility may require analysis of barriers – physical financial or otherwise – that exist, and how they may affect the most vulnerable, and call for the establishment or application of clear norms and standards in both law and policy to address these barriers, as well as robust monitoring systems of health-related information and whether this information is reaching all populations.

Acceptability
Relates to respect for medical ethics, culturally appropriate, and sensitivity to gender. Acceptability requires that health facilities, goods, services and programmes are people-centred and cater for the specific needs of diverse population groups and in accordance with international standards of medical ethics for confidentiality and informed consent.

Quality
Facilities, goods, and services must be scientifically and medically approved. Quality is a key component of Universal Health Coverage, and includes the experience as well as the perception of health care. Quality health services should be:
:: Safe – avoiding injuries to people for whom the care is intended;
:: Effective – providing evidence-based healthcare services to those who need them;
:: People-centred – providing care that responds to individual preferences, needs and values;
:: Timely – reducing waiting times and sometimes harmful delays.
:: Equitable – providing care that does not vary in quality on account of gender, ethnicity, geographic location, and socio-economic status;
:: Integrated – providing care that makes available the full range of health services throughout the life course;
:: Efficient – maximizing the benefit of available resources and avoiding waste

WHO response
WHO has made a commitment to mainstream human rights into healthcare programmes and policies on national and regional levels by looking at underlying determinants of health as part of a comprehensive approach to health and human rights.

In addition, WHO has been actively strengthening its role in providing technical, intellectual, and political leadership on the right to health including:
:: strengthening the capacity of WHO and its Member States to integrate a human rights-based approach to health;
:: advancing the right to health in international law and international development processes; and
:: advocating for health-related human rights, including the right to health.

Addressing the needs and rights of individuals at different stages across the life course requires taking a comprehensive approach within the broader context of promoting human rights, gender equality, and equity.

As such, WHO promotes a concise and unifying framework that builds on existing approaches in gender, equity, and human rights to generate more accurate and robust solutions to health inequities. The integrated nature of the framework is an opportunity to build on foundational strengths and complementarities between these approaches to create a cohesive and efficient approach to promote health and well-being for all.

References

  1. Transforming our World: The 2030 Agenda for Sustainable Development.
    UN General Assembly. 2015. 21 October. UN Doc. A/RES/70/1.
  2. General comment No. 20: Non-discrimination in economic, social and cultural rights
    Committee on Economic, Social and Cultural Rights. 2009.
  3. Guiding principles for business and human rights, Implementing the United Nations “Protect, Respect and Remedy” Framework
    Office of the high Commissioner for Human Rights, Geneva, 2011.

CESCR General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12)
CESCR (Committee on Economic, Social, and Cultural Rights). 2000. ). 11 August. Doc. E/C.12/2000/4.

Dengue Vaccine – Dengvaxia Update

Dengue Vaccine – Dengvaxia Update
 
Philippines Food and Drug Administration
FDA Advisory No. 2017-318 || Suspension of Sale/Marketing/Distribution of Sanofi Pasteur, Inc.’s Tetravalent Vaccine (Live, Attenuated)(Dengvaxia)
04 December 2017
On 29 November 2017, Sanofi Pasteur, Inc. (Sanofi) released an advisory providing updated information on the Dengue Tetravalent Vaccine (Live, Attenuated), the drug locally registered as Dengvaxia. The advisory contained information on the completion of a post-clinical trial study of the said product indicating potential risk to patients who have not had dengue prior to immunization.
In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to SUSPEND the sale/distribution/marketing of Dengvaxia and cause the WITHDRAWAL of Dengvaxia in the market pending compliance with the directives of the FDA. Sanofi was further directed to conduct an information dissemination campaign through Advisories, Dear Doctor Letters and Patient fora.
The FDA is closely coordinating with the Department of Health (DOH) for any adverse events/ reactions that may be reported by the recipients following their immunization of the Dengvaxia, and will immediately take appropriate measures to protect the public.
All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person.
 
Sanofi ordered to pull Dengvaxia in Philippines as safety episode escalates
by Eric Sagonowsky | Fierce Pharma
Dec 5, 2017 9:15am
…In a Monday advisory, the Philippines’ FDA wrote that it directed Sanofi to “suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.”
The Philippines is the only country now conducting a Dengvaxia vaccination campaign. The effort is focused on areas within the country with high levels of dengue infection.
A Sanofi spokesperson told FiercePharma the company has been “informed of the position of the Philippine Food and Drug Administration … and will work with them to review the implementation of their direction. We will continue to seek constructive and transparent dialogue with them.”
The order comes right after Sanofi issued an advisory about the risks of the shot in recipients with no prior dengue infection. In those patients, the shot can cause more serious dengue infections. To get the word out, the regulators in the Philippines also ordered Sanofi to “conduct an information dissemination campaign,” with public advisories and communications with doctors and patients.
Based on data at hand, Sanofi estimated 1 in 800 dengue infections would be severe among unvaccinated people. In the new analysis of a five-year follow-up study, the increased risk translated to two more cases of “severe dengue” per 1,000 people who had not been exposed to the virus, the company’s spokesperson told FiercePharma. All recovered with treatment….
 
Philippines Orders Probe Into Vaccine, Sanofi Says No Deaths Reported
New York Times/Reuters | 3 December 2017
MANILA — The Philippines ordered a probe on Monday into the immunisation of more than 730,000 children with a dengue vaccine that has since been suspended, while French drug company Sanofi said no deaths had been reported as a result of the programme.
“As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination,” Ruby Dizon, medical director at Sanofi Pasteur Philippines, told a news conference in Manila.
“Of course, rest assured, monitoring is continuing, we are working with the Department of Health (DOH), in collaboration, to make sure this is maintained.”…
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Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 6 December 2017 [GPEI]
:: The Islamic Advisory Group has recently launched a training manual on polio eradication, mother and child health, and immunization.
:: The latest semi-annual status report for the Global Polio Eradication Initiative has been released, covering progress made between January and June 2017.

:: The WHO Executive Board has released a report providing an update on the status of the four objectives of the Polio Eradication and Endgame Strategic Plan.

:: Summary of newly-reported viruses this week:
No new confirmed cases.
Afghanistan: One new wild poliovirus type 1 (WPV1) positive environmental sample, collected from Kandahar province
Pakistan: Two new wild poliovirus type 1 (WPV1) positive environmental samples, one collected from Khyber Pakhtunkhwa province, and one from Sindh province.one new wild poliovirus type 1 (WPV1) case, from Nangarhar province.

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Semi-annual Status Report – January to June 2017PROGRESS AGAINST THE POLIO ERADICATION & ENDGAME STRATEGIC PLAN
Global Polio Eradication Initiative
WHO  2017 :: 36 pages
EXECUTIVE SUMMARY
At the beginning of 2017, progress continued towards each of the Endgame Plan’s four objectives. The world has never been closer to eradicating polio, with fewer cases in fewer areas of fewer countries than at any time in the past.

Pakistan and Afghanistan continued to intensify eradication efforts and implement their respective national emergency action plans, overseen by each country’s head of state. They continued to treat the virus transmission as a single epidemiological block and focused on coordinating activities in both countries.

In Nigeria, and across the Lake Chad subregion, outbreak response persisted in reaction to the detection of wild poliovirus type 1 (WPV1) in Borno in August 2016, Nigeria, the first WPV detected in the country since 2014. It was a sobering reminder of the fragility of progress and of the dangers of subnational surveillance gaps and low-level residual transmission. Although no new cases have been reported from Nigeria since last August, undetected ongoing transmission was assumed in parts of Borno as it remains inaccessible.

In May 2017, confirmation was received of new circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks in both the Syrian Arab Republic and the Democratic Republic of the Congo. The emergence of new cVDPV2 in the 12- to 18-month period following the globally coordinated switch from trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV) in April 2016 was anticipated, with the most at-risk areas foreseen to be those with weak health systems, insecurity or inaccessibility. In preparation for the anticipated risks, internationally-agreed outbreak response protocols had been established to rapidly address cVDPV2 in the post-switch era, including by maintaining a global stockpile of monovalent OPV type 2 (mOPV2). An outbreak response is now under way in both countries to rapidly stop these strains. In the Syrian Arab Republic, the same response strategies were employed that successfully stopped a WPV1 outbreak in the same area of the country in 2013/2014.

These outbreaks underscored the continued risk posed by immunity gaps anywhere in the world, more than any risks associated with the vaccine. In areas of adequate immunity levels, surveillance for type 2 polioviruses from any source revealed a steady and rapid decline of these strains’ persistence. These outbreaks are tragic, in particular for the children who have so far been paralysed by these strains, and emphasize the urgent need to fully withdraw all tOPV stock everywhere. By extension, it also highlights the need to fully withdraw all OPV use, once the remaining strains of WPVs (types 1 and 3) have been declared as eradicated.

A global supply constraint of inactivated polio vaccine (IPV) continued to be managed carefully, allocating available supply to areas deemed at highest risk of cVDPV2 emergence. Increasing clinical evidence indicates that fractional dose IPV provides equal (and in a two-dose schedule, even superior) protection to full dose IPV, but this approach is already stretching limited supply.

On containment, the GPEI continued to work with countries to accelerate efforts to identify all facilities retaining poliovirus stock, reduce their number to an absolute minimum and put in place all necessary biosafety conditions to ensure the safe handling of all residual stock.

Polio transition planning will continue to be intensified through 2017. The 16 countries with the greatest polio-funded infrastructure drafted and are finalizing their transition plans. Transition planning and implementation are being conducted in such a manner as to minimize any associated programme-related risks and to ensure that a successful and lasting polio-free world will be achieved as rapidly and efficiently as possible. A post-certification strategy, request by Member States at the May 2017 World Health Assembly, is being developed and will be presented to the World Health Assembly in 2018, specifying the global technical standards that will be needed after the certification of wild poliovirus eradication to maintain a polio-free world.

Thanks to the generous continuing support of the international development community, including Member States (especially the countries where poliomyelitis is endemic and the generous donors to the GPEI) as well as multilateral and bilateral organizations, development banks, foundations and Rotary International, the budget for 2017 for planned activities was fully financed. At an extraordinary pledging moment at the Rotary International convention in June 2017 in Atlanta, USA, numerous public- and private-sector partners from around the world joined Rotary in announcing new commitments, bringing total pledges against the additional US$ 1.5 billion budget to US$ 1.2 billion. Securing a lasting polio-free world will not only be associated with significant humanitarian and global health benefits but also with economic advantages, as eradicating polio worldwide will result in global savings of US$ 50 billion.
 
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Syria cVDPV2 outbreak situation report 25: 6 December 2017
Situation update 6 December 2017
:: No new cases of cVDPV2 were reported this week. The most recent case (by date of onset) is 9 September 2017 from Mayadeen district.
:: The total number of confirmed cVDPV2 cases remains 70.
:: Planning continues for the second phase of the outbreak response. The Syrian Ministry of Health has requested additional doses of mOPV2 and IPV for two further immunization rounds.
::Training of health staff for the assessment of cold chain capacity across the country is ongoing in Damascus. Health staff have been trained on mobile data collection. All accessible health facilities will be assessed starting 10 December.

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WHO Grade 3 Emergencies  [to 9 December 2017]
The Syrian Arab Republic
:: Syria cVDPV2 outbreak situation report 25: 6 December 2017
[See Polio above for detail]

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WHO Grade 2 Emergencies  [to 9 December 2017]
Myanmar
:: Diphtheria is spreading fast in Cox’s Bazar, Bangladesh
News release
6 December 2017 | Geneva – Diphtheria is rapidly spreading among Rohingya refugees in Cox’s Bazar, Bangladesh, WHO warned today.
More than 110 suspected cases, including 6 deaths, have been clinically diagnosed by health partners, including Médecins Sans Frontières (MSF) and the International Federation of the Red Cross (IFRC).
“These cases could be just the tip of the iceberg. This is an extremely vulnerable population with low vaccination coverage, living in conditions that could be a breeding ground for infectious diseases like cholera, measles, rubella, and diphtheria,” said Dr Navaratnasamy Paranietharan, WHO Representative to Bangladesh.
“This is why we have protected more than 700,000 people with the oral cholera vaccine, as well as more than 350,000 children with measles-rubella vaccine in a campaign that ended yesterday. Now we have to deal with diphtheria.”…

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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. 
Syrian Arab Republic
:: 7 Dec 2017   Syria IDP Operations Summary 2017 (Valid as of 7/12/2017) [EN/AR]

Yemen 
:: 4 Dec 2017  Statement by the Humanitarian Coordinator for Yemen, Jamie McGoldrick, Requesting a Humanitarian Pause [EN/AR]
:: Yemen: 2018 Humanitarian Needs Overview (HNO)
:: Yemen: Escalation of Armed Clashes and Airstrikes in Sana’a City – Update 1 | 04 December 2017
:: Statement by IASC Principals requesting the immediate lifting of the blockade | 2 December 2017
 
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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.
ROHINGYA CRISIS
:: ISCG Situation Update: Rohingya Refugee Crisis, Cox’s Bazar – 07 December 2017
 
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WHO & Regional Offices [to 9 December 2017]
Uganda ends Marburg virus disease outbreak
News release
8 December 2017 | Geneva – Uganda has successfully controlled an outbreak of Marburg virus disease and prevented its spread only weeks after it was first detected, the World Health Organization said on Friday (December 8).
“Uganda has led an exemplary response. Health authorities and partners, with the support of WHO, were able to detect and control the spread of Marburg virus disease within a matter of weeks,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.
The Ugandan Ministry of Health notified WHO of the outbreak on October 17, after laboratory tests confirmed that the death of a 50-year-old woman was due to infection with the Marburg virus. A Public Health Emergency Operations Centre was immediately activated and a national taskforce led the response.
Three people died over the course of the outbreak which affected two districts in eastern Uganda near the Kenyan border, Kween and Kapchorwa. Health workers followed up with a total 316 close contacts of the patients in Uganda and Kenya to ensure that they had not acquired the illness…

Diphtheria is spreading fast in Cox’s Bazar, Bangladesh
6 December 2017 – Diphtheria is rapidly spreading among Rohingya refugees in Cox’s Bazar, Bangladesh, WHO warned today. More than 110 suspected cases, including 6 deaths, have been clinically diagnosed by health partners, including Médecins Sans Frontières (MSF) and the International Federation of the Red Cross (IFRC).

Highlights
The Latvian eHealth Journey
December 2017 – In a journey that started over a decade ago, and in line with the 2013 World Health Assembly resolution on eHealth standardization and interoperability, the Ministry of Health of Latvia demonstrated its commitment to achieving Universal Health Coverage by creating a national programme of eHealth – which was seen as a key effort in ensuring that Latvian people receive the right care in the right place and time. The WHO Country Office in Latvia has provided coordination and technical support for Latvia’s eHealth efforts.

Recruitment for external members for WHO’s Guideline Review Committee
December 2017 – The WHO Guideline Review Committee (GRC) seeks new external members for the 2018-2020 term. The GRC oversees WHO’s quality assurance process for all of its guidelines (information products that contain technical recommendations across a wide variety of topics). GRC members serve a 3-year term and involves 40-50 hours of work per year, including virtual attendance at ten 2-hour monthly meetings and the performance of peer review of 3-4 documents.

New guidance on insecticide resistance monitoring and management
December 2017 – This framework provides guidance on developing a national insecticide resistance monitoring and management plan. It is designed to help countries ensure adherence to the Global plan for insecticide resistance management in malaria vectors.

WHO commends South African parliament decision to pass tax bill on sugary drinks
December 2017 – The South African Parliament has taken a brave and powerful step towards promoting the health of the country’s citizens and reducing diet-related noncommunicable diseases (NCDs), such as diabetes, by passing a bill to implement a tax on sugar-sweetened beverages, according to Dr Rufaro Chatora, WHO’s Representative to South Africa.

Fact Sheets
:: Meningococcal meningitis  Updated December 2017
:: Human rights and health  December 2017
:: Cholera   Updated December 2017
:: Dementia  Updated December 2017
:: Mental health of older adults  Updated December 2017

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Weekly Epidemiological Record, 8 December 2017, vol. 92, 49 (pp. 749–760)
Schistosomiasis and soil-transmitted helminthiases: number of people treated in 2016
 
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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: The Marburg Virus Disease outbreak in Uganda is over   08 December 2017
:: Experts Call for Increased Investments to Drive Immunization Progress in Africa   08 December 2017
:: Momentum grows towards improved reproductive health services :  Experts pledge renewed commitment to scale up access to reproductive health services  08 December 2017
:: WHO supports ministry of health to train district rapid response teams in malaria surveillance, epidemic preparedness and response
:: WHO commends South African parliament decision to pass tax bill on sugary drinks  06 December 2017
:: World AIDS Day in South Sudan heightens campaigns to end AIDS by 2030  06 December 2017
:: With threat of famine looming for 2018, WHO helps worst cases of malnutrition in children in South Sudan   05 December 2017
:: Men urged to seek HIV & AIDS services at the World AIDS Day 2017 commemoration in Uganda  05 December 2017
:: WHO with support from Government of Japan strengthens blood transfusion services for safe, sustainable and quality blood in South Sudan  04 December 2017
:: Supporting breastfeeding to boost child survival  04 December 2017
:: South Sudan implements a road map to introduce and institutionalize National Health Accounts  04 December 2017
:: Botswana conducts a Joint External Evaluation to assess the country’s International Health Regulations (2005) core capacities  04 December 2017
:: The biggest AIDS Conference in Africa, opens in Abidjan, Cote d’Ivoire  03 December 2017
:: Dr Moeti calls for greater commitment to access, diagnosis and treatment for children and adolescents living with HIV/AIDS  03 December 2017
:: HIV experts take stock of progress and challenges in tackling HIV among children and young adults, ahead of ICASA   03 December 2017

WHO South-East Asia Region SEARO
:: Amid concern over drug resistance, Mekong countries call for accelerated action to eliminate malaria before 2030   SEAR/PR/1673
NAY PYI TAW, Myanmar 8 December 2017 – Representatives from Cambodia, China, the Lao People’s Democratic Republic, Myanmar, Thailand and Viet Nam today called for accelerated action to eliminate malaria in the Greater Mekong Subregion (GMS) by the year 2030.
The call comes amid concern over resistance of malaria parasites to antimalarial drugs, including artemisinin—the core compound of the best available antimalarial medicines. To date, resistance has been detected in five of the six GMS countries. The best way to address the threat posed by drug resistance is to eliminate malaria altogether from the countries of the Mekong.
At a high-level meeting convened by the Ministry of Health and Sports of Myanmar in collaboration with the World Health Organization (WHO) and the Asia Pacific Leaders Malaria Alliance (APLMA), representatives from the six GMS countries stressed that eliminating malaria in the Subregion requires urgent and coordinated action, with support from implementing agencies, funders and other partners.
Ministers from the six countries pledged to:
…ensure activities to eliminate malaria in the subregion are fully funded, including with more domestic funds;
…improve cross-border collaboration and establish an independent oversight body, for which WHO will act as the secretariat;
..strengthen systems for the identification and timely reporting of malaria infections, including drug-resistant forms;
…provide the best possible prevention, diagnosis and care for all people at risk of malaria, including free services for ethnic minorities and mobile and migrant populations, as part of universal health coverage;
..ensure available antimalarial medicines are safe and effective for use;
…bring all concerned sectors together to translate policies into time-bound and results-oriented actions; and
..engage communities in malaria elimination using innovative communication tools…
 
WHO European Region EURO
:: Challenging the supply chain to reduce sugar in foods 05-12-2017

WHO Western Pacific Region
:: Amid concern over drug resistance, Mekong countries call for accelerated action to eliminate malaria before 2030   SEAR/PR/1673

CDC/ACIP [to 9 December 2017]

CDC/ACIP [to 9 December 2017]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for December 7, 2017
Update: Influenza Activity in the United States
Since influenza activity is just beginning to increase, receiving influenza vaccine at this time should still offer substantial public health benefit. Health care providers should recommend influenza vaccine now and throughout the influenza season to all unvaccinated people 6 months and older who do not have contraindications. Prescription antiviral medications can treat influenza illness and are recommended for use in patients who are very sick with influenza or who are sick and at high risk of serious influenza complications. Influenza antiviral drugs can lessen duration and severity of illness and help prevent more severe illness. Influenza activity in the United States remained low during October 2017 but has been increasing since early November with influenza A (H3N2) viruses being most frequently identified. Almost all influenza viruses collected so far are similar to the cell-derived reference viruses representing 2017–18 season influenza vaccines. Annual vaccination varies in its effectiveness but it is the best available method for preventing influenza and its complications. Since the 2017-18 influenza season is just beginning, receiving an influenza vaccine now should still offer substantial public health benefit. Anyone who has not yet been vaccinated should get vaccinated as soon as possible. Influenza antiviral treatment, an adjunct to vaccination, can lessen duration and severity of illness. Antiviral drugs work best when started within two days of illness.

Progress Toward Global Eradication of Dracunculiasis, January 2016–June 2017
With only 25 Dracunculiasis cases in humans reported in 2016, the goal of eradicating Guinea worm disease appears to be on the horizon. However, infections in dogs and insecurity in Mali and South Sudan remain challenges to eradication efforts. Dracunculiasis, also known as Guinea worm disease, is a parasitic infection targeted for global eradication. Annual cases declined from about 3.5 million in 20 countries in 1986 to just 25 in 2016 from only 19 villages in Chad, Ethiopia, and South Sudan. In Chad, dog infections have far outnumbered human cases since 2012. In the first 6 months of 2017, however, there were fewer dog infections in Chad compared with the same period in 2016. While the world is closer than ever to Guinea worm eradication, infections in dogs and insecurity in Mali and South Sudan continue to be a challenge.

Announcements

Announcements

EDCTP    [to 9 December 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
8 December 2017
EDCTP 2018 Prizes: Call for nominations
EDCTP opens the call for nominations for its 2018 Prizes today…The EDCTP prizes recognise outstanding individuals and research teams from Africa and Europe who have made significant contributions to health research. In addition to their scientific excellence, the awardees will have made major contributions to the EDCTP objectives of strengthening clinical research capacity in Africa and supporting South-South and North-South networking.

8 December 2017
EDCTP and Global Health Innovative Technology Fund partnership
The Global Health Innovative Technology Fund (GHIT) and the European & Developing Countries Clinical Trials Partnership (EDCTP) announced a new partnership today, 8 December 2017, to support product development research. The partners’ first action will be co-funding the PZQ4PSAC phase III clinical study, which is sponsored by Merck KGaA and conducted by the Pediatric Praziquantel Consortium…

European Medicines Agency  [to 9 December 2017]
http://www.ema.europa.eu/ema/
04/12/2017
Call for patient organisation representatives to join the Committee for Orphan Medicines
Deadline for applications is 20 December 2017 …

European Vaccine Initiative  [to 9 December 2017]
http://www.euvaccine.eu/news-events
05 December 2017
New Project Manager vacancy at EVI
EVI has an exciting new Project Manager position. Deadline for applications: 15th January 2018, 17:00 CET.
 
 
FDA [to 9 December 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
December 07, 2017 –
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation

December 07, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation

 
Fondation Merieux  [to 9 December 2017]
http://www.fondation-merieux.org/
December 4, 2017
The Center on Infectiology Lao Christophe Merieux Hosts Workshops on HIV and Viral Hepatitis, Organized by Merieux Foundation
The Mérieux Foundation organized two workshops in Vientiane, Laos: one on viral hepatitis, November 22-24, and the other on HIV, November 29-30. They brought together nearly 150 people to address these major public health issues in Laos and neighboring countries.
 
 
GHIT Fund   [to 9 December 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 ·
Press Room
EDCTP and Global Health Innovative Technology Fund partnership for the development of a paediatric formulation for schistosomiasis
2017.12.08
The European & Developing Countries Clinical Trials Partnership (EDCTP) and The Global Health Innovative Technology Fund (GHIT) announced a new partnership today, 8 December 2017, to support product development research. The partners’ first action will be co-funding the PZQ4PSAC phase III clinical study, which is sponsored by Merck KGaA and conducted by the Pediatric Praziquantel Consortium. This study will provide clinical data and support for registration of a new praziquantel (PZQ) tablet formulation to treat schistosomiasis in preschool-aged children (PSAC). EDCTP will be contributing €1,99M1 and GHIT €3,22M2 to the study consortium for a total project value of €12,10M including in-kind and cash contributions by all related parties.
“The joint investment in this project reflects the true value of global partnership with a noble goal of creating local solutions in disease endemic countries.  Moreover, this pivotal study aims to generate valuable evidence and support for registration of a paediatric formulation for preschool-aged children against schistosomiasis, thus addressing a neglected population and disease – the EDCTP programme embraces populations often excluded from clinical studies but with major unmet medical needs.” said, Dr Michael Makanga, EDCTP Executive Director…

 
Global Fund [to 9 December 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund, ADB Sign MOU to Help Countries in Asia Strengthen Health Systems to Fight HIV, Tuberculosis and Malaria
08 December 2017
NAY PYI TAW, Myanmar – The Global Fund and the Asian Development Bank (ADB) have signed a memorandum of understanding to support the financing, design and implementation of country-led programs to fight HIV, tuberculosis and malaria, and build resilient health systems in ADB member countries eligible for Global Fund financing.
Through a framework of mutual cooperation, ADB and the Global Fund can complement each other’s contributions to health programs in the Asia and Pacific region.
“The agreement exemplifies the Global Fund’s commitment to strategic partnerships with multilateral development banks,” said Marijke Wijnroks, Interim Executive Director of the Global Fund. “Development finance institutions like ADB can augment the impact and footprint of Global Fund grants by leveraging additional investment, building financial sustainability, and reinforcing transparency.”…
 
 
IVI   [to 9 December 2017]
http://www.ivi.int/
[Undated]
International Vaccine Institute joins the JEE Alliance
The International Vaccine Institute (IVI) joined the JEE Alliance (Alliance for Country Assessments for Global Health Security and IHR Implementation) on November 14, 2017.
The JEE Alliance is a multi-sectoral platform for international cooperation to promote political, financial and technical support for implementation of the International Health Regulations (2005), which was launched in Geneva, Switzerland in May 2016. The alliance brings together like-minded players from relevant sectors in countries, organizations and other stakeholders involved in health security. As of November 2017, the alliance had 65 members including governments, international organizations, financial institutions, NGOs and a group of private sector organizations.
“IVI’s experience in and commitment to health security is a valuable contribution to the JEE Alliance. We look forward to IVI’s active participation in the JEE Alliance initiatives” co-chairs Ambassador Blair Exell and Dr Päivi Sillanaukee of the Alliance said in a letter to IVI.
Dr. Jerome Kim, Director General of IVI, said, “As an organization concerned with the development of vaccines for global health security, we are pleased to join the JEE Alliance and have a chance to promote vaccine R&D and vaccination as a critical component of global health security, and partner with other parties to contribute to health security.”
 
 
JEE Alliance  [to 9 December 2017]
https://www.jeealliance.org/
1.12.2017
International Vaccine Institute (IVI) joins the JEE Alliance
 
 
MSF/Médecins Sans Frontières  [to 9 December 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Yemen: Warring Parties Show New Level of Disregard for Suffering Civilians
December 06, 2017
SANA’A/HAJJAH, YEMEN—The warring parties in Yemen are showing a whole new level of disregard for civilians, as heavy street fighting and airstrikes have paralyzed Sana’a, leaving the wounded without safe access to medical care. Meanwhile, a crippling blockade prevents vital supplies from entering the country, the international medical humanitarian organization Doctors Without Borders Médecins Sans Frontières (MSF) said today.
 
 
NIH  [to 9 December 2017]
http://www.nih.gov/news-events/news-releases
December 4, 2017
Gene-based Zika vaccine is safe and immunogenic in healthy adults
— Vaccine developed by NIH scientists shows promise in Phase 1 testing
Results from two Phase 1 clinical trials show an experimental Zika vaccine developed by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is safe and induces an immune response in healthy adults. The findings will be published on Dec. 4 in The Lancet. NIAID is currently leading an international effort to evaluate the investigational vaccine in a Phase 2/2b safety and efficacy trial…

Trials show inactivated Zika virus vaccine is safe and immunogenic
December 4, 2017 — Results support further clinical development.
 

UNAIDS [to 9 December 2017]
http://www.unaids.org/en
Press statement
Message on the occasion of Human Rights Day
10 December 2017
Michel Sidibé
Executive Director of UNAIDS

Under-Secretary-General of the United Nations
The advances in the response to HIV have been unprecedented. In South Africa in 2000, just 90 people had access to antiretroviral therapy. Today, South Africa has the largest treatment programme in the world, with 4.2 million people living with HIV in the country now on treatment. We have exceeded global targets and today around the world 20.9 million people have access to life-saving HIV medicines.
However, we cannot be complacent—AIDS is not over in any part of the world and the challenges ahead remain significant. Studies from 19 countries show that approximately one in five people living with HIV had been denied health care (including dental care, family planning services or sexual and reproductive health services). Data from eight countries show that 25% of people living with HIV avoided going to hospital because they feared stigma or discrimination related to their HIV status, and one in three women living with HIV had experienced at least one form of discrimination in health-care settings related to their sexual and reproductive health…

Press release
UNAIDS and IOM renew partnership agreement to promote access to HIV services for migrants and crisis-affected populations
GENEVA, 8 December 2017—UNAIDS and the International Organization for Migration (IOM) today signed a new cooperation agreement to promote access to HIV prevention, treatment, care and support services for migrants, mobile populations and people affected by humanitarian emergencies.
“Migrants and people displaced through conflict or emergencies must be supported and enabled through their journeys to exercise their right to health,” said Michel Sidibé, Executive Director of UNAIDS. “This new partnership agreement between UNAIDS and the International Organization for Migration will be essential in strengthening our efforts to make sure that no one is left behind.”

6 December 2017
PEPFAR announces continued progress against HIV

UNICEF  [to 9 December 2017]
https://www.unicef.org/media/
5 December 2017
West and Central Africa left behind in Global HIV response
ABIDJAN/DAKAR/NEW YORK/GENEVA, 5 December 2017 – More than four decades into the HIV epidemic, four in five children living with HIV in West and Central Africa are still not receiving life-saving antiretroviral therapy, and AIDS-related deaths among adolescents aged 15-19 are on the rise, according to a new report released today.

Wellcome Trust  [to 9 December 2017]
https://wellcome.ac.uk/news
News / Published: 5 December 2017
Six new partnerships to translate research into treatments
Today, we’re announcing collaborations with six institutions to find new ways to translate scientific discoveries into real world impact.
We are committing £6 million to these first translational partnerships with the universities of Bristol, Cambridge, Edinburgh, Manchester, Imperial College and Oxford through the Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok.
Researchers can face a number of barriers to taking the first step to translating their research – and often need more than financial support, including mentorship and regulatory advice.
Making the transition between discovery science and translation easier is one of the core aims of Wellcome’s Innovation for Impact [PDF 200KB].
Earlier this year, we set out a series of commitments – Transforming UK translation [PDF 99KB] – together with the Royal Society, Academy of Medical Sciences and Royal Academy of Engineering.
How we will work together
Through our new translational partnerships we will work closely with partners to explore new ways of supporting transition and to share best practice.
By working at institutional level, we can work with each university to develop support which will best suit its own researchers.
Support through the new partnerships will be primarily, but not exclusively, for Wellcome-supported scientists. It will include a portfolio of activities, for example:
:: developing seed funds, identifying mentors and entrepreneurs in residence
:: access to Wellcome’s network of advisers, experts and mentors
:: introductions to potential partners to take promising advances forward…

::::::
Industry Watch    [to 9 December 2017]
:: Bioethics International Releases the “Good Pharma Scorecard” in BMJ Open, Ranking the Top 20 Largest Pharmaceutical Companies on Clinical Trial Transparency
NEW YORK, Dec. 5, 2017 /PRNewswire/ — Bioethics International announced today the second publication of its Good Pharma Scorecard (“GPS”), an annual index ranking large pharmaceutical companies and new drugs on their clinical trial transparency, in BMJ Open. Bioethics International is a not-for-profit organization dedicated to raising the bar on ethics, trustworthiness, and patient-centricity in pharma.
Two of eleven ranked companies—Johnson & Johnson and Sanofi—achieved the highest overall clinical trial transparency scores, both scoring 100%. AbbVie, Celgene, Merck and Astra Zeneca all scored at or above the industry median.
The 2017 GPS ranking evaluates clinical trial registration, results reporting, clinical study report synopsis sharing, and journal article publication rates for new drugs approved by the Food and Drug Administration (FDA) in 2014 that were sponsored by large drug companies. Bioethics International is the first organization to consistently measure large pharma companies and their FDA-approved drugs on their clinical trial transparency performance. This learning system helps advance high-quality, patient-centric, and ethical healthcare innovation, medical evidence, and drug development…

:: Sanofi ends development of Clostridium difficile vaccine
Paris, France – December 1, 2017 – Following a planned interim analysis, the Independent Data Monitoring Committee (IDMC) for the phase III Cdiffense clinical trial program concluded that the probability that the study will meet its primary objective is low. Based on this, Sanofi has therefore decided to discontinue clinical development of its experimental Clostridium difficile vaccine, to focus on six key vaccine projects currently in development….

:: Boehringer Ingelheim Invests $80 Million to Expand Animal Vaccine Manufacturing Capacity in the U.S.
DULUTH, Ga., Dec. 4, 2017 /PRNewswire/ — Boehringer Ingelheim, a leading provider of animal health products for pets and livestock, today announced investments totaling more than $80 million to expand its existing facilities in Athens, GA and St. Joseph, MO to accommodate increased production of animal vaccines.
Boehringer Ingelheim’s facility in Athens, GA will grow from its current footprint of approximately 350,000 square feet to 400,000 square feet and will nearly double its filling capacity for companion animal and avian vaccine…

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