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

Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice From the American College of Physicians and the Centers for Disease Control and Prevention

Annals of Internal Medicine
5 December 2017 Vol: 167, Issue 11
http://annals.org/aim/issue

Clinical Guidelines
Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice From the American College of Physicians and the Centers for Disease Control and Prevention

Free   PDF

What Recent History Has Taught Us About Responding to Emerging Infectious Disease Threats

Annals of Internal Medicine
5 December 2017 Vol: 167, Issue 11
http://annals.org/aim/issue

Special Article
What Recent History Has Taught Us About Responding to Emerging Infectious Disease Threats
Catharine I. Paules, MD; Robert W. Eisinger, PhD; Hilary D. Marston, MD, MPH; Anthony S. Fauci, MD
Abstract
Presidential administrations face any number of unexpected crises during their tenure, and global pandemics are among the most challenging. As of January 2017, one of the authors had served under 5 presidents as the director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. During each administration, the government faced unexpected pandemics, ranging from the HIV/AIDS pandemic, which began during the Reagan administration, to the recent Zika outbreak in the Americas, which started during the Obama administration. These experiences underscored the need to optimize preparation for and response to these threats whenever and wherever they emerge. This article recounts selected outbreaks occurring during this period and highlights lessons that were learned that can be applied to the infectious disease threats that will inevitably be faced in the current presidential administration and beyond.

Cost-effectiveness of Human Papilloma Virus (HPV) vaccination in Nigeria: a decision analysis using pragmatic parameter estimates for cost and programme coverage

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 9 December 2017)

Research article
Cost-effectiveness of Human Papilloma Virus (HPV) vaccination in Nigeria: a decision analysis using pragmatic parameter estimates for cost and programme coverage
Authors: Obinna I. Ekwunife and Stefan K. Lhachimi
Citation: BMC Health Services Research 2017 17:815
Published on: 8 December 2017
Abstract
Background
World Health Organisation recommends routine Human Papilloma Virus (HPV) vaccination for girls when its cost-effectiveness in the country or region has been duly considered. We therefore aimed to evaluate cost-effectiveness of HPV vaccination in Nigeria using pragmatic parameter estimates for cost and programme coverage, i.e. realistically achievable in the studied context.
Methods
A microsimulation frame-work was used. The natural history for cervical cancer disease was remodelled from a previous Nigerian model-based study. Costing was based on health providers’ perspective. Disability adjusted life years attributable to cervical cancer mortality served as benefit estimate. Suitable policy option was obtained by calculating the incremental costs-effectiveness ratio. Probabilistic sensitivity analysis was used to assess parameter uncertainty. One-way sensitivity analysis was used to explore the robustness of the policy recommendation to key parameters alteration. Expected value of perfect information (EVPI) was calculated to determine the expected opportunity cost associated with choosing the optimal scenario or strategy at the maximum cost-effectiveness threshold.
Results
Combination of the current scenario of opportunistic screening and national HPV vaccination programme (CS + NV) was the only cost-effective and robust policy option. However, CS + NV scenario was only cost-effective so far the unit cost of HPV vaccine did not exceed $5. EVPI analysis showed that it may be worthwhile to conduct additional research to inform the decision to adopt CS + NV.
Conclusions
National HPV vaccination combined with opportunist cervical cancer screening is cost-effective in Nigeria. However, adoption of this strategy should depend on its relative efficiency when compared to other competing new vaccines and health interventions.

A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 9 December 2017)

Research article
A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination
As annual influenza vaccination is recommended for all U.S. persons aged 6 months or older, it is unethical to conduct randomized clinical trials to estimate influenza vaccine effectiveness (VE). Observational…
Authors: Meng Shi, Qian An, Kylie E. C. Ainslie, Michael Haber and Walter A. Orenstein
Citation: BMC Infectious Diseases 2017 17:757
Published on: 8 December 2017

Intention to vaccinate universally against varicella, rotavirus gastroenteritis, meningococcal B disease and seasonal influenza among parents in the Netherlands: an internet survey

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 9 December 2017)

Research note
Intention to vaccinate universally against varicella, rotavirus gastroenteritis, meningococcal B disease and seasonal influenza among parents in the Netherlands: an internet survey
For the decision-making process regarding introduction of new vaccines into the National Immunisation Programme (NIP), advance insight into the potential acceptance among the population is relevant. We studied…
Authors: Alies van Lier, José A. Ferreira, Liesbeth Mollema, Elisabeth A. M. Sanders and Hester E. de Melker
Citation: BMC Research Notes 2017 10:672
Published on: 4 December 2017

Advancing the science of health research capacity strengthening in low-income and middle-income countries: a scoping review of the published literature, 2000–2016

BMJ Open
December 2017 – Volume 7 – 12
http://bmjopen.bmj.com/content/current
Global health – Research

Advancing the science of health research capacity strengthening in low-income and middle-income countries: a scoping review of the published literature, 2000–2016
Substantial development assistance and research funding are invested in health research capacity strengthening (HRCS) interventions in low-income and middle-income countries, yet the effectiveness, impact and value for money of these investments are not well understood. A major constraint to evidence-informed HRCS intervention has been the disparate nature of the research effort to date. This review aims to map and critically analyse the existing HRCS effort to better understand the level, type, cohesion and conceptual sophistication of the current evidence base. The overall goal of this article is to advance the development of a unified, implementation-focused HRCS science.
Laura Dean, Stefanie Gregorius, Imelda Bates, Justin Pulford

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

BMJ Open
December 2017 – Volume 7 – 12
http://bmjopen.bmj.com/content/current

Ethics – Research
Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies
Jennifer E Miller, Marc Wilenzick, Nolan Ritcey, Joseph S Ross, Michelle M Mello
Abstract
Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.
Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.
Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers.
Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level.
Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries.
Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies’ transparency records and recognise exemplary companies may encourage further progress.

Polio, terror and the immunological worldview

Global Public Health
Volume 13, 2017   Issue 2
http://www.tandfonline.com/toc/rgph20/current

Article
Polio, terror and the immunological worldview
Robert Peckham
Pages: 189-210
Published online: 22 Jul 2016
ABSTRACT
This paper adopts a socio-historical perspective to explore when, how and why the eradication of poliomyelitis has become politicised to the extent that health workers and security personnel are targeted in drive-by shootings. Discussions of the polio crisis in Afghanistan and Pakistan have tended to focus on Taliban suspicions of a US-led public health intervention and the denunciation of ‘modernity’ by Islamic ‘extremists’. In contrast, this paper considers a broader history of indigenous hostility and resistance to colonial immunisation on the subcontinent, suggesting how interconnected public health and political crises today have reactivated the past and created a continuity between events. The paper explores how the biomedical threat posed by polio has become intertwined with military and governmental discourses premised on the ‘preemptive strike’. Here, the paper tracks the connections between biological immunity and a postcolonial politics that posits an immunological rationale for politico-military interventions. The paper concludes by reflecting on the consequences for global public health of this entanglement of infectious disease with terror.

Editorial—The Critical Role of Research in Advancing Romani’s Right to Health

Health and Human Rights
Volume 19, Issue 2, December 2017
http://www.hhrjournal.org/
Special Section on Romani People and the Right to Health
in collaboration with the FXB Center for Health and Human Rights, Harvard School of Public Health, Boston, USA – [Nine articles]
December 5, 2017

Editorial—The Critical Role of Research in Advancing Romani’s Right to Health
Jacqueline Bhabha, Margareta Matache, and Teresa Sorde Marti
As we finalize this special section on Romani People and the Right to Health, a landmark ruling on Roma health rights has just been handed down by the European Committee of Social Rights. On October 16, 2017, the committee accepted as admissible the European Roma Rights Centre’s complaint against Bulgaria alleging systemic discrimination against Romani women in maternity wards.[1] The complaint details segregation, substandard and abusive maternity care, and disproportionate barriers in access to health insurance for this part of the Roma population.[2] The committee’s finding advances official recognition of the intersectional discrimination affecting Romani women and girls across Europe and perhaps beyond. We use the word “perhaps” advisedly, for conclusive evidence documenting discriminatory and racist practices against Roma living on other continents is lacking, a point underlined in 2016 by Rita Izsak-Ndiaye, the United Nations (UN) Special Rapporteur on minority issues…[3]

Foreword—Harnessing the Power and Promise of Human Rights to End AIDS by 2030

Special Section on HIV and Human Rights 
in collaboration with UNAIDS, the Joint United Nations Programme on HIV/AIDS, Geneva, Switzerland  [Twelve articles]
Posted on December 5, 2017

Foreword—Harnessing the Power and Promise of Human Rights to End AIDS by 2030

Michel Sidibé

The HIV epidemic and response are at a critical juncture. Our advances against the epidemic have been impressive, with unprecedented numbers of people accessing antiretroviral treatment, especially in low- and middle-income countries, and a global reduction in new HIV infections.

However, the epidemic is not over, and the challenges ahead are significant. More than 15.8 million people are still awaiting treatment, while an estimated 11 million people do not know their HIV status. Globally, adolescent girls and young women account for approximately 7,000 new HIV infections every week. These figures represent an indefensible injustice: millions of people worldwide are being denied their right to health.

Common to these challenges are stigma, discrimination, gender inequality, denial of services, violence, and human rights violations against people living with HIV and those most vulnerable to the epidemic, including women, young people, sex workers, prisoners, people who use drugs, transgender persons, and gay men and men who have sex with men.

In all regions, and regardless of the nature and level of the epidemic, vulnerability to HIV is linked to inequality and disenfranchisement; and women and those at the margins of society remain underserved by health services, including HIV prevention, treatment, care, and support services. This special section of Health and Human Rights comes at an opportune moment to describe and reflect on our progress to realize human rights as an imperative for health…

The underlying message in this special section is that we have a moral and legal responsibility to act. We must build on the rights-based lessons of the past and find innovative ways to expand protections, to promote gender equality, to support civil society and community engagement, to strengthen accountability, and to close the inclusion gap between those who have and those who do not. As the UN High Commissioner for Human Rights reminded us at the 2017 Human Rights Council Social Forum: “When human dignity and equality are placed, strongly, at the core of policy, they unlock better outcomes.”

 

 

Humanitarian Exchange Magazine

Humanitarian Exchange Magazine
http://odihpn.org/magazine/the-humanitarian-consequences-of-violence-in-central-america/
Number 70   October 2017
Special Feature: The Lake Chad Basin: an overlooked crisis?
by Humanitarian Practice Network October 2017
The 70th edition of Humanitarian Exchange, co-edited with Joe Read, focuses on the humanitarian crisis in Nigeria and the Lake Chad Basin. The violence perpetrated by Boko Haram and the counter-insurgency campaign in Nigeria, Cameroon, Chad and Niger has created a humanitarian crisis affecting some 17 million people. Some 2.4 million have been displaced, the vast majority of them in north-eastern Nigeria. Many are living in desperate conditions, without access to sufficient food or clean water. The Nigerian government’s focus on defeating Boko Haram militarily, its reluctance to acknowledge the scale and gravity of the humanitarian crisis and the corresponding reticence of humanitarian leaders to challenge that position have combined to undermine the timeliness and effectiveness of the response…
[Reviewed earlier]

Policies and strategies to facilitate secondary use of research data in the health sciences

International Journal of Epidemiology
Volume 46, Issue 6, 1 December 2017
https://academic.oup.com/ije/issue/46/6

Editorial
Policies and strategies to facilitate secondary use of research data in the health sciences
Paul R Burton; Natalie Banner; Mark J Elliot; Bartha Maria Knoppers; James Banks
International Journal of Epidemiology, Volume 46, Issue 6, 1 December 2017, Pages 1729–1733, https://doi.org/10.1093/ije/dyx195
Abstract
Data are increasingly seen as a fundamental resource that underpins research across biomedicine and the broader health sciences. They often have important value and utility beyond the purpose for which they were originally collected. Recognizing this, many initiatives across the globe actively seek to enable and promote greater sharing of research data, and most major funders now require researchers to set out formal plans for managing and sharing their data with users beyond their own study team. To provide a contextual backdrop to the article and to point the reader to additional sources of relevant information, we include a table listing examples of international, regional and national projects that seek to enhance and facilitate data sharing in a variety of different ways. Table 1 is not intended as an exhaustive catalogue, rather it aims to provide an illustrative listing of a variety of projects we believe to be in good standing around the world, to demonstrate the broad diversity of responses to the important challenges presented by data sharing.

Putting research evidence at the heart of policy making

The Lancet
Dec 09, 2017 Volume 390 Number 10112 p2527-2604  e50
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Putting research evidence at the heart of policy making
The Lancet
To improve patient outcomes, research must inform and shape policy. As history sadly teaches, this ideal is not always realised. But in today’s Lancet, two Articles display how research addressing knowledge gaps can inform policy for hypertension control in China.

Stroke is the leading cause of death in China, driven largely by uncontrolled hypertension. Jiapeng Lu and colleagues estimate that 37·2% of Chinese adults aged 35–75 years have hypertension (defined as a blood pressure in excess of 140/90 mm Hg or a patient receiving antihypertensive medications). Among the population with hypertension, 22·9% take prescribed antihypertensive medicines, but only 5·7% achieve hypertension control. In an accompanying paper, Meng Su and colleagues report huge gaps in the availability and prescription of antihypertensive medications in primary health-care centres (PHC) in China. 8·1% of PHCs stocked no antihypertensive drugs. Low-cost and effective medications recommended in Chinese guidelines were only prescribed in 11·2% of PHCs.

The two studies, funded by China National Development and Reform Commission and National Health and Family Planning Commission (NHFPC), have profound implications for China’s health policy. Using the evidence generated from this work, the NHFPC established the National Primary Healthcare Hypertension Management Office in March, 2017. The office will guide hypertension management, provide training for PHC professionals, collect data, and assess the quality of care in PHCs in terms of hypertension control. In September, 2017, new PHC hypertension control guideline and quality measurement indicators were integrated into the Basic Public Health Service Program. Notably, hypertensive medication availability is now included as one of the indicators to evaluate PHC performance.

China’s story of putting research evidence at the very heart of policy making sets an important example for applying the best solutions to the most burdensome health problems, and fitting those solutions into a health service to bring about system change. The next vital step for China to continue to improve its health outcomes would be through the evaluation of policy change via robust research.

The need for a complex systems model of evidence for public health

The Lancet
Dec 09, 2017 Volume 390 Number 10112 p2527-2604  e50
http://www.thelancet.com/journals/lancet/issue/current

Viewpoint
The need for a complex systems model of evidence for public health
Harry Rutter, Natalie Savona, Ketevan Glonti, Jo Bibby, Steven Cummins, Diane T Finegood, Felix Greaves, Laura Harper, Penelope Hawe, Laurence Moore, Mark Petticrew, Eva Rehfuess, Alan Shiell, James Thomas, Martin White
Summary
Despite major investment in both research and policy, many pressing contemporary public health challenges remain. To date, the evidence underpinning responses to these challenges has largely been generated by tools and methods that were developed to answer questions about the effectiveness of clinical interventions, and as such are grounded in linear models of cause and effect. Identification, implementation, and evaluation of effective responses to major public health challenges require a wider set of approaches1,2 and a focus on complex systems.

Research on HIV cure: Mapping the ethics landscape

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 9 December 2017)

Essay
Research on HIV cure: Mapping the ethics landscape
Karine Dubé, Laurie Sylla, Lynda Dee, Jeff Taylor, David Evans, Carl Dean Bruton, Adam Gilberston, Lisa Gralinski, Brandon Brown, Asheley Skinner, Bryan J. Weiner, Sandra B. Greene, Amy Corneli, Adaora A. Adimora, Joseph D. Tucker, Stuart Rennie
| published 08 Dec 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002470
Summary points
:: According to current estimates, 36.7 million people are infected with HIV worldwide. Despite large-scale and growing programs to prevent and treat HIV infection, possible approaches to achieve a cure for HIV infection are of strong interest.
:: In the development of candidate approaches to achieve an HIV cure, issues of future translation to human study participants, evidence-based practice, clinical care, diverse populations, and populations in low- and middle-income countries should all be considered.
: An HIV cure should be effective, safe, simple, affordable, and scalable.
:: Acceptability research is a critical adjunct to ongoing biomedical HIV cure research efforts.
:: Anticipating some of the ethical and implementation challenges related to HIV cure strategies is necessary before the availability of effective interventions.
:: Ongoing engagement of stakeholders is needed to resolve ethical, logistical, social, cultural, policy, regulatory, and implementation challenges at all stages of the HIV cure research development process.
Conclusion
Tremendous human, financial, and social capital is being invested in the discovery of an HIV cure. For an HIV cure regimen to prove valuable, it should be effective, safe, simple, affordable, and scalable [29]. It should also be translatable to human study participants, evidence-based practice, clinical care, and diverse populations. Appreciating the inherent translational ethics issues across the entire research continuum is essential, as HIV cure discoveries must eventually translate to real-world implementation. In this paper, we reviewed some of the considerations at each step of the HIV cure translation and implementation continuum; the issues described are not comprehensive. We asserted that an ethics of translation should begin early in the HIV cure discovery effort, before the availability of efficacious interventions. Logistical, social, cultural, and economic issues will affect the implementation of HIV cure research and interventions at the individual, institutional, national, and global levels. Ongoing community and stakeholder engagement efforts will be crucial to foresee, negotiate, and resolve potential ethical and implementation challenges. Innovative translational and implementation research paradigms utilized at all phases of the HIV cure research continuum will permit us to address critical issues that will ultimately help leverage cutting-edge HIV cure research discoveries to benefit PLWHIV around the globe.

The importance of thinking beyond the water-supply in cholera epidemics: A historical urban case-study

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 9 December 2017)

Research Article
The importance of thinking beyond the water-supply in cholera epidemics: A historical urban case-study
Matthew D. Phelps, Andrew S. Azman, Joseph A. Lewnard, Marina Antillón, Lone Simonsen, Viggo Andreasen, Peter K. M. Jensen, Virginia E. Pitzer
| published 27 Nov 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006103
Conclusions/Significance
Spatially targeted cholera interventions, such as reactive vaccination or sanitation/hygiene campaigns in hotspot neighborhoods, would likely have been more effective in this epidemic than control measures aimed at interrupting long-cycle transmission, such as improving municipal water quality. We recommend public health planners consider programs aimed at interrupting short-cycle transmission as essential tools in the cholera control arsenal.

A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection

Science Translational Medicine
06 December 2017   Vol 9, Issue 419
http://stm.sciencemag.org/

Report
A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection
By Michael C. Sneller, J. Shawn Justement, Kathleen R. Gittens, Mary E. Petrone, Katherine E. Clarridge, Michael A. Proschan, Richard Kwan, Victoria Shi, Jana Blazkova, Eric W. Refsland, Daryl E. Morris, Kristen W. Cohen, M. Juliana McElrath, Rong Xu, Michael A. Egan, John H. Eldridge, Erika Benko, Colin Kovacs, Susan Moir, Tae-Wook Chun, Anthony S. Fauci
Science Translational Medicine06 Dec 2017 Full Access
Despite lack of vaccine efficacy, the kinetics and magnitude of HIV rebound in early-treated patients affect future clinical trial design.
Editor’s Summary
Single-arm trials can leave you hanging
Depending on the study restraints and goals, not all clinical trials include a randomized placebo group. This is often done to minimize risk to patients but can also impair interpretation of the results. When Sneller et al. embarked on their therapeutic HIV vaccine trial, they chose to include a placebo group to get a better understanding of how their vaccine affected viral rebound upon therapy interruption. The vaccine itself generated minimal T cell activation and did not induce protective responses. Somewhat surprisingly, a proportion of individuals in the placebo arm demonstrated sustained viral suppression, although they were no longer being treated. These results suggest that any future HIV intervention trials would benefit from the inclusion of a placebo arm.
Abstract
Despite substantial clinical benefits, complete eradication of HIV has not been possible using antiretroviral therapy (ART) alone. Strategies that can either eliminate persistent viral reservoirs or boost host immunity to prevent rebound of virus from these reservoirs after discontinuation of ART are needed; one possibility is therapeutic vaccination. We report the results of a randomized, placebo-controlled trial of a therapeutic vaccine regimen in patients in whom ART was initiated during the early stage of HIV infection and whose immune system was anticipated to be relatively intact. The objectives of our study were to determine whether the vaccine was safe and could induce an immune response that would maintain suppression of plasma viremia after discontinuation of ART. Vaccinations were well tolerated with no serious adverse events but produced only modest augmentation of existing HIV-specific CD4+ T cell responses, with little augmentation of CD8+ T cell responses. Compared with placebo, the vaccination regimen had no significant effect on the kinetics or magnitude of viral rebound after interruption of ART and no impact on the size of the HIV reservoir in the CD4+ T cell compartment. Notably, 26% of subjects in the placebo arm exhibited sustained suppression of viremia (<400 copies/ml) after treatment interruption, a rate of spontaneous suppression higher than previously reported. Our findings regarding the degree and kinetics of plasma viral rebound after ART interruption have potentially important implications for the design of future trials testing interventions aimed at achieving ART-free control of HIV infection.

Four years of case-based surveillance of meningitis following the introduction of MenAfriVac in Moissala, Chad: lessons learned (pages 1561–1568)

Tropical Medicine & International Health
December 2017  Volume 22, Issue 12  Pages 1463–1608
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2017.22.issue-11/issuetoc

Original Research Papers
Four years of case-based surveillance of meningitis following the introduction of MenAfriVac in Moissala, Chad: lessons learned (pages 1561–1568)
Anne-Laure Page, Matthew E. Coldiron, Kadidja Gamougam, Mahmaat Ali Acyl, Mbaihol Tamadji, Céline Lastrucci, Northan Hurtado, François-Charles Tehoua, Florence Fermon, Dominique A. Caugant and Klaudia Porten
Version of Record online: 26 OCT 2017 | DOI: 10.1111/tmi.12987
Abstract
Objective
Case-based surveillance of bacterial meningitis in sentinel districts has been recommended after the introduction of the conjugated vaccine against Neisseria meningitidis serogroup A (NmA), MenAfriVac, in the African meningitis belt. Here we report data and lessons learnt from four years of surveillance in the district of Moissala, Chad.
Methods
All suspected cases of meningitis were referred free of charge to the district hospital for lumbar puncture and treatment. Cerebrospinal fluid samples were tested with Pastorex latex agglutination in Moissala, and inoculated trans-isolate media were used for culture and PCR at the national reference laboratory and/or at the Norwegian Institute of Public Health.
Results
From July 2012 to December 2016, 237 suspected cases of meningitis were notified, and a specimen was collected from 224. Eighty-three samples were positive for a bacterial pathogen by culture, PCR or Pastorex, including 58 cases due to Streptococcus pneumoniae with only 28 of 49 pneumococcal meningitis confirmed by culture or PCR correctly identified by Pastorex. Four cases of NmA were detected by Pastorex, but none were confirmed by PCR.
Conclusion
Implementation of case-based surveillance for meningitis is feasible in Chad, but has required political and technical engagement. Given the high proportion of S. pneumoniae and its poor detection by Pastorex, continued use of PCR is warranted for surveillance outside of outbreaks, and efforts to accelerate the introduction of pneumococcal conjugate vaccines are needed. Introduction of MenAfriVac in routine immunisation and future availability of a pentavalent meningococcal conjugate vaccine will be key elements for the sustained reduction in meningitis outbreaks in the area.

The frontline of controlled human malaria infections: A report from the controlled human infection models Workshop in Leiden University Medical Centre 5 May 2016

Vaccine
Volume 35, Issue 51  Pages 7065–7212 (18 December 2017)
http://www.sciencedirect.com/journal/vaccine/vol/35/issue/50

Conference report
The frontline of controlled human malaria infections: A report from the controlled human infection models Workshop in Leiden University Medical Centre 5 May 2016
Pages 7065–7069
Meta Roestenberg, Benjamin Mordmüller, Chris Ockenhouse, Annie Mo, … Peter G. Kremsner
Abstract
Controlled Human Malaria Infection (CHMI) is the most practiced controlled human infection model nowadays and there is an exponential increase in implementation of the model worldwide. During the Controlled Human Infection Models Workshop in Leiden, one day was dedicated to the discussion of the advances made and gaps in Controlled Human Malaria Infection (CHMI) trials. Factors contributing to this impressive expansion in the number of CHMI trials have been related to the ability to perform CHMI using injectable cryopreserved sporozoites (a product from Sanaria Inc. – PfSPZ Challenge), the development of a transmission blocking CHMI model and the need to test more vaccine candidates particularly in the field of whole-sporozoite vaccine development. However, with an increasing number of CHMI trials being undertaken, in an ever-growing number of trial sites, heterogeneity in trial design may compromise universal interpretation of results and require an ongoing dialogue on the need and feasibility of standardization. At the workshop, CHMI investigators convened to share their experiences in CHMI trials and discuss the possibilities for future trials.

Controlled human infections: A report from the controlled human infection models workshop, Leiden University Medical Centre 4–6 May 2016

Vaccine
Volume 35, Issue 51  Pages 7065–7212 (18 December 2017)
http://www.sciencedirect.com/journal/vaccine/vol/35/issue/50

Conference report
Controlled human infections: A report from the controlled human infection models workshop, Leiden University Medical Centre 4–6 May 2016
Pages 7070–7076
Meta Roestenberg, Annie Mo, Peter G. Kremsner, Maria Yazdanbakhsh
Abstract
The principle of deliberately infecting humans with infectious agents in a controlled setting, so-called controlled human infections (CHI), is not novel. Many CHI models have a long history and were established decades ago such as the intentional exposure to yellow fever and dengue performed in the 1900’s (Reed, 1902) [2]. In these times bioethics and scientific reasoning were in their infancy. Nowadays, clinical trials are highly regulated and CHI are executed worldwide. Controlled human malaria infections and influenza infections are the two most frequently practiced. Others are experiencing a revival or are being carefully developed.    Because CHI models test the efficacy of promising vaccine or drug candidates early in clinical development, they offer the potential to decrease the number of failing phase 2 and 3 trials, reducing risks for patients and saving costs and efforts.
In addition, CHI models provide unprecedented opportunities to dissect the physiological, immunological and metabolic changes that occur upon infection. However, it is clear that controlled infections require careful deliberation of safety, ethics, quarantine, scientific output and the production of infectious material.
An independent international workshop was hosted by the Leiden University Medical Centre in The Netherlands, bringing together clinical investigators, basic scientists, regulators, funders and policy makers from 22 different countries to discuss the opportunities and challenges in CHI. The aim of the workshop was to discuss CHI as a tool to advance science, drug and vaccine development, share the challenges of establishing a CHI model with specific focus on neglected tropical diseases and the possibilities to transfer models to endemic sites. Noticeably, among the 128 participants were clinical investigators from ten different countries in Sub-Saharan Africa. An important dimension of the meeting was to give the floor to young established clinicians and scientists to voice their perspective on the future of CHI models.

Vaccine Volume 35, Issue 51  Pages 7065–7212 (18 December 2017)

Vaccine
Volume 35, Issue 51  Pages 7065–7212 (18 December 2017)
http://www.sciencedirect.com/journal/vaccine/vol/35/issue/50

Original research article
Active SMS-based influenza vaccine safety surveillance in Australian children
Pages 7101–7106
Alexis Pillsbury, Helen Quinn, Patrick Cashman, Alan Leeb, … Kristine Macartney

Original research article
Impact of infant pneumococcal conjugate vaccination on community acquired pneumonia hospitalization in all ages in the Netherlands
Pages 7107–7113
A.M.M. van Deursen, T.M. Schurink-van’t Klooster, W.H. Man, J. van de Kassteele, … M.J. Knol

Original research article
Non-specific effects of childhood vaccinations – A case control study nested into a Health and Demographic Surveillance System in rural Burkina Faso
Pages 7114–7120
Pfeiffer, A.B. Fisker, E. Nebié, J. Hengelbrock, … O. Müller

Original research article
Determinants of influenza vaccination among high-risk Black and White adults
Pages 7154–7159
Sandra Crouse Quinn, Amelia M. Jamison, Vicki S. Freimuth, Ji An, Gregory R. Hancock

Original research article
Measuring the timeliness of childhood vaccinations: Using cohort data and routine health records to evaluate quality of immunisation services
Pages 7166–7173
Suzanne Walton, Mario Cortina-Borja, Carol Dezateux, Lucy J. Griffiths, … Helen Bedford

Original research article
Potential for a booster dose of rotavirus vaccine to further reduce diarrhea mortality
Pages 7198–7203
Eleanor Burnett, Ben A. Lopman, Umesh D. Parashar

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

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

Nature Human Behaviour 
1, 873–880 (2017)
Letter
Association of moral values with vaccine hesitancy
Avnika B. Amin, Robert A. Bednarczyk, […] Saad B. Omer
Abstract
Clusters of unvaccinated children are particularly susceptible to outbreaks of vaccine-preventable disease1,2. Existing messaging interventions demonstrate short-term success, but some may backfire and worsen vaccine hesitancy3. Values-based messages appeal to core morality, which influences the attitudes individuals then have on topics like vaccination4,5,6,7. We must understand how underlying morals, not just attitudes, differ by hesitancy type to develop interventions that work with individual values. Here, we show in two correlational studies that harm and fairness foundations are not significantly associated with vaccine hesitancy, but purity and liberty foundations are. We found that medium-hesitancy parents were twice as likely as low-hesitancy parents to highly emphasize purity (adjusted odds ratio: 2.08; 95% confidence interval: 1.27–3.40). High-hesitancy respondents were twice as likely to strongly emphasize purity (adjusted odds ratio: 2.15; 95% confidence interval: 1.39–3.31) and liberty (adjusted odds ratio: 2.19; 95% confidence interval: 1.50–3.21). Our results demonstrate that endorsement of harm and fairness—ideas often emphasized in traditional vaccine-focused messages—are not predictive of vaccine hesitancy. This, combined with significant associations of purity and liberty with hesitancy, indicates a need for inclusion of broader themes in vaccine discussions. These findings have the potential for application to other health decisions and communications as well.

International Journal of Current Research
Vol. 9, Issue, 07, pp.xxxxxxx, July, 2017
RESEARCH ARTICLE
A STUDY TO ASSESS THE EFFECTIVENESS OF PLANNED TEACHING PROGRAM ON KNOWLEDGE OF IMMUNIZATION AMONG MIGRANT MOTHERS OF UNDER FIVE CHILDREN IN SELECTED CONSTRUCTION SITES AT BANGALORE URBAN
1, *Juliet Tharani, 1Deepa S. Nair and 2Karthika, S.
1Department of Community Health Nursing, SEA College of Nursing, Bangalore, Karnataka, India  2Department of Community Health Nursing, MMCON, MMU, Mullana, Ambala, Haryana, India
ABSTRACT
Prevention of disease is one of the most important goals in child care. For this reason a national effort is being made towards improving the immunization of all the children. Migrant laborers themselves avail the curative care but they fall outside the coverage of preventive care largely due to their movement of work caused by uncertainty of employment. The immunization status of migrant children is poorly understood, as they have less access to health care services. The researcher felt that assessing the knowledge on immunization and teaching them on the importance of immunization would bring about a positive attitudinal change among the migrant mothers to immunize their children regularly.
 
 
Infection and Immunity
Accepted Manuscript Posted Online 4 December 2017
Toward Tuberculosis Vaccine Development: Recommendations for NHP Study Design
Dominick J. Laddy1, Aurelio Bonavia2, Willem A. Hanekom3, Deepak Kaushal4, Ann
4 Williams5, Mario Roederer6, Robert A. Seder6, Sally Sharpe5, Frank A.W. Verreck7,
5 Patricia A. Darrah6 –
ABSTRACT
Clinical trials of novel tuberculosis vaccines are expensive, while global resources for TB vaccine development are limited. There is therefore a need for robust and predictive pre-clinical data to support advancement of candidate vaccines into clinical trials. Here, we provide a rationale for using the nonhuman primate as an essential component of these efforts, as well as guidance to the TB community for standardizing experimental design and aligning endpoints to facilitate development of new TB vaccines.

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.
 

The Economist
http://www.economist.com/
Accessed 9 December 2017
Saving the children: High hopes for a malaria vaccine
December 2017
Geoffrey Carr
…Although the deployment of RTS,S in 2018—in Ghana, Kenya and Malawi—will only be a pilot scheme intended to test the vaccine’s effectiveness in the rough and tumble of African clinical life, it will be a big one. The Malaria Vaccine Implementation Programme, as it is known, will recruit 360,000 children, aged between five months and 17 months, to receive a series of four doses of RTS,S. A similar number of other children, matched for age and circumstances, will be observed without vaccination, in order that comparisons can be made. The programme will be run by the World Health Organisation and the bills paid by three transnational health initiatives, Gavi, the Global Fund and Unitaid…

 
The Guardian
http://www.guardiannews.com/
Accessed 9 December 2017
HPV vaccine
The Observer
Fears for women’s health as parents reject HPV vaccine
Three nations blame social media for fall in number of girls given cervical cancer jabs
3 December 2017
Health officials have become increasingly alarmed at campaigns aimed at blocking the take-up of the human papilloma virus (HPV) vaccine, which protects women against cervical cancer.
Three leading nations have now seen major reductions in the take-up of the vaccine and a growing number of doctors fear its use could be blocked elsewhere, despite its capacity to provide protection against a condition that kills hundreds of thousands of women a year.
Last week, doctors and health officials gathered in Dublin – centre of one of the most vociferous anti-vaccine campaigns – to discuss future tactics. Many believe the use of social media has added new impetus to anti-vaccine campaigners’ protests, and that this factor has been closely involved in the success of the attacks that have been made on immunisation programmes.
“Whenever a new vaccine is introduced, there is always a group of people who say it is unsafe,” said Professor Margaret Stanley of Cambridge University. “But the HPV vaccine seems to raise extraordinary levels of hostility.”
Japan, Ireland and Denmark have already witnessed sustained campaigns that have seen take-up rates plummet. (UK take-up rates are high.) In each case, the vaccine – which scientists insist is safe – has been linked to alleged cases of seizures, walking problems, and neurological issues. Photographs have been exchanged and video clips uploaded to YouTube…

The Health Care Blog
http://thehealthcareblog.com/
Accessed 9 December 2017
A Clinical Trial By Any Other Name …
Dec 7, 2017
By ARTHUR CAPLAN and KELLY McBRIDE FOLKERS
Sanofi Pasteur, Dengvaxia®, Philippines
 
 
New York Times
http://www.nytimes.com/
Accessed 9 December 2017
Philippines to Seek Refund of $59 Million From Sanofi Amid Vaccine Risk
The Philippines will seek the return of 3 billion pesos ($59 million) it paid French drugmaker Sanofi for a dengue vaccine used to immunise hundreds of thousands of children that Sanofi has said could worsen the disease in some cases.
December 08, 2017 – By REUTERS – Business Day

Washington Post
http://www.washingtonpost.com/
Accessed 9 December 2017
The moral differences between pro- and anti-vaccine parents
4 December 2017
By Lena H. Sun
When it comes to persuading parents in the United States who are hesitant about vaccinating their children, the public health messages often rely on facts and science to explain how immunization not only protects those children but also shields other vulnerable people from dangerous infectious diseases.
But information campaigns that emphasize fairness or preventing harm sometimes backfire and can worsen vaccine hesitancy, research has shown. A study published Monday in Nature Human Behaviour suggests a more effective way to reach vaccine-hesitant parents may be to focus on two potentially powerful moral values that underlie people’s attitudes and judgments: individual liberty and purity.
Compared with parents who approve of vaccines, parents who are most reluctant to vaccinate are strongly concerned with liberty and purity, the researchers found. In this framework, liberty is associated with belief in personal responsibility, freedom, property rights and resistance to state involvement in citizens’ lives. Concerns about purity center on boundaries and protection from contamination.

Think Tanks et al

Think Tanks et al
 
Brookings
http://www.brookings.edu/
Accessed 9 December 2017
TechTank
Factors limiting private sector investment in global health R&D
Darrell M. West
Monday, December 4, 2017

 
Council on Foreign Relations
http://www.cfr.org/
Accessed 9 December 2017
December 5, 2017
Health
Pandemic Preparedness: Lessons Learned 100 Years After the Spanish Flu Outbreak
Event by John M. Barry , Laurie Garrett , and Anne Schuchat
Panelists discuss the 1918 Spanish flu pandemic as we near its centennial and how this historic outbreak informs our responses to global health emergencies today.

Human rights and health :: WHO Fact Sheet – December 2017

Health – Human Rights

.
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.

Vaccines and Global Health: The Week in Review 2 December 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_2 Dec 2017

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

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

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

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

WHO – Meeting of the Strategic Advisory Group of Experts on immunization, October 2017 – conclusions and recommendations

Milestones :: Perspectives
 
Editor’s Note:
   The SAGE meeting in October 2017 included a number of important reports and addressed a wide range of issues as detailed in the Final Agenda and supported by meeting documentation.         
   The full meeting report in the Weekly Epidemiological Record is referenced below and we encourage readers to engage it. We elected to provide the report’s full text on a key agenda element – the progress report on the Global Vaccine Action Plan [GVAP] and the proposed immunization indictors for the Sustainable Development Goals [SDGs/Agenda 2030].
 
WHO – Meeting of the Strategic Advisory Group of Experts on immunization, October 2017 – conclusions and recommendations
Weekly Epidemiological Record, 1 December 2017, vol. 92, 48 (pp. 729–748)
Global Vaccine Action Plan (GVAP): progress report
SAGE reviewed the draft assessment report and recommendations by the Decade of Vaccines (DoV) Working Group and noted that in 2016, while some progress was made towards the goals set out in the GVAP,9 multiple issues at many levels threaten progress, and have the potential to reverse hard-won gains; these include global economic uncertainty, conflicts and natural disasters, displacement and migration, and infectious disease outbreaks.

Moreover, SAGE noted concerning signs of complacency and inadequate political commitment to immunization, as well as limited global appreciation of its power to achieve wider health and development objectives. Additional risks identified include growing levels of vaccine hesitancy, the worrying rise in vaccine stock-outs disrupting access to vaccines, and the continued under-performance of certain countries (the “outlier countries”) relative to others within their region.10

In order to address the situation and to accelerate progress towards attaining the GVAP goals, SAGE issued 12 recommendations:

Broadening the dialogue: The entire immunization community should ensure that immunization is fully aligned and integrated with global health and development agendas – including global health security and the International Health Regulations, health systems strengthening and universal health coverage, and the battle against antimicrobial resistance – and that dialogue is strengthened with additional constituencies such as the business and financial sectors.

Subsidiary recommendation: 1b. Joint External Evaluations: An assessment should be made of immunization-related inputs into national Joint External Evaluations for the International Health Regulations, in order to review the references made to immunization in the evaluations and resulting national action plans.

Funding transitions: Until polio eradication is achieved, financial and technical support provided through the Global Polio Eradication Initiative, GAVI and WHO support should be maintained in at least the 16 polio priority countries in order to ensure the success of eradication efforts and to mitigate the risks to infectious disease surveillance, routine immunization and global health security more generally.

Polio and communicable disease surveillance: Poliomyelitis laboratory and epidemiological surveillance capacities should be maintained in countries across all WHO Regions throughout and beyond the polio endgame and certification process, and built upon to strengthen communicable disease surveillance systems, especially for measles and rubella, and other vaccine-preventable diseases.

Outlier countries: Comprehensive multidimensional assessments should be undertaken in countries experiencing the greatest difficulties in achieving GVAP goals and used to develop bespoke and costed remediation plans addressing systemic weaknesses, integrating existing improvement plans and including a strong focus on monitoring and evaluation frameworks to support effective implementation.

Maternal and neonatal tetanus: Concerted efforts should be made to achieve global elimination by 2020 and sustain it thereafter, particularly by exploiting the opportunity to expand coverage to underserved populations through use of compact pre-filled auto-disable devices.

Displaced, mobile and neglected populations: Existing knowledge on reaching displaced and mobile populations – including individuals escaping conflict zones or natural disasters, economic migrants, seasonal migrants, those moving to urban centres, and traditional nomadic communities – and other neglected populations should be synthesized to identify good practice, innovative new approaches and gaps in knowledge.

Acceptance and demand: Each country should develop a strategy to increase acceptance and demand for vaccination, which should include ongoing community engagement and trust-building, active hesitancy prevention, regular national assessment of vaccine concerns, and crisis response planning.

Civil Society Organizations: Countries should aim to broaden and deepen their engagement with CSOs, expanding the range of CSOs with which they interact and extending their input into areas such as programme planning.

Subsidiary recommendation: 8b. Legal frameworks: A comprehensive global audit should be undertaken to document the ways in which legislation and regulation have been used to promote or undermine immunization at a national level, to identify how legal and regulatory instruments can be best applied in different contexts and for different purposes to strengthen immunization systems.

Technical capacity-building: Through a multidimensional approach, the technical capacity of countries’ immunization programmes should be systematically assessed and strengthened, by leveraging regional and national expertise and opportunities as well as global tools and resources.

Vaccine access: Multidimensional analyses should be undertaken to identify procurement and other programmatic issues affecting timely provision of vaccination, including to the most neglected and remote populations, and used to develop more effective procurement, stock management and distribution plans.

Vaccine supply: Current and anticipated vaccine supply and demand for routinely used vaccines should continue to be mapped and constraints identified, integrating and expanding other relevant ongoing work and focusing on vaccines most at risk of supply shortages.

Middle-income countries: WHO Regional Offices should support middle-income countries in their Regions by leveraging all opportunities to promote the exchange of information, the sharing of lessons learnt and peer-to-peer support.

 

SAGE was also presented with a selection of indicators for immunization that will be monitored under the Sustainable Development Goals (SDGs) framework, along with an options analysis and the recommendations from the DoV Working Group. SAGE was mindful of the need for ambitious and aspirational indicators which nevertheless allow comparability across time and countries and safeguard country ownership. Hence, SAGE proposed to submit for consideration to the Interagency Expert Group for SDGs the following option for indicator 3.b.1 (proportion of the target population covered by all vaccines included in their national programme): coverage estimates for 4 vaccines, i.e. DTP-containing vaccine third dose, MCV second dose, PCV last dose in the country schedule, and HPV vaccine last dose in the country schedule. For SDG indicator 3.8.1, SAGE proposed MCV second dose as an option for consideration in 2018, which would replace the current indicator which is DTP-containing vaccine third dose. SAGE recognized the opportunity to submit a revised definition (i.e. wording) for indicator 3.b.1 as well as revised metadata to quantify the indicator by 2020.

Finally, SAGE was presented with an overview on the proposed process to develop a global immunization strategy for the next decade (2021–2030). SAGE agreed on the importance of having the strategy adopted by the World Health Assembly in May 2020 and urged WHO to work with all relevant partners from the immunization and the wider public health community towards this objective.
 
9 See http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/, accessed October 2017.
10 2017 SAGE Assessment Report of the Global Vaccine Action Plan. Available at http://http://www.who.int/entity/immunization/web_2017_sage_gvap_assessment_report_en.pdf?ua=1, accessed November 2017.

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Gavi Board Action – Engagement with Transitioning Countries and Post-Transition

 
Gavi [to 2 December 2017]
http://www.gavi.org/library/news/press-releases/
30 November 2017
ENGAGEMENT WITH TRANSITIONING COUNTRIES AND POST-TRANSITION
Between 2016 and 2020, at least 20 Gavi-supported countries are expected to transition out of Gavi’s financial support. Most of these countries are on-track to fully finance their immunisation programmes and sustain the progress they have made since 2000, when Gavi was created. However, the Gavi Board recognised that a small number of countries are facing more significant challenges.

“Sustainability is at the heart of the Gavi model,” said Dr Berkley. “Our transition approach is an unprecedented attempt to systematically support countries with growing economies to take full ownership of their immunisation programmes. The Alliance will work closely with governments to ensure that they remain on track, so that children are not left unprotected against deadly diseases.”

The Gavi Board agreed to allow countries to apply for new vaccine support at any point during their transition. It decided that the Alliance should continue to engage with countries after they transition to track progress and continue to advocate for immunisation.

The Board also made available US$30 million through 2020 for the Alliance to provide targeted technical support to address specific challenges in countries after transition.

“I want to strongly commend the spirit of this Board meeting,” said Dr Ngozi Okonjo-Iweala. “All partners have come together to take this important step towards Gavi’s vision and support countries to develop sustainable health systems and economies, thanks to immunisation.”

The Gavi Board also approved a tailored transition plan for Papua New-Guinea, which is due to transition in 2021, and approved a set of principles to guide the Alliance in developing a tailored transition plan for Nigeria.

At the Board’s request, Gavi will also assess whether tailored post-transition support is needed in Angola, the Congo Republic, and Timor-Leste. The Board emphasised that governments will need to demonstrate clear commitment to ensure the sustainability and full domestic financing of immunisation programmes.

Finally, as part of Gavi’s flexible approach with countries facing fragility or emergencies, the Gavi Board decided that South Sudan will continue to receive Gavi support despite not fulfilling its co-financing obligations in 2016.
 
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Dengue Vaccine – Dengvaxia Update

Dengue Vaccine – Dengvaxia Update
 
Sanofi updates information on dengue vaccine
New analysis of long-term Dengvaxia® data found differences in vaccine performance based on    
    prior dengue infection
Company will ask regulators to update product label to reflect new information
PARIS, FRANCE – November 29, 2017 – Sanofi will ask health authorities to update information provided to physicians and patients on its dengue vaccine Dengvaxia® in countries where it is approved. The request is based on a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection.

Based on up to six years of clinical data, the new analysis evaluated long-term safety and efficacy of Dengvaxia in people who had been infected with dengue prior to vaccination and those who had not. The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.

“These findings highlight the complex nature of dengue infection. We are working with health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries,” said Dr. Su-Peing Ng, Global Medical Head, Sanofi Pasteur.

About half of the world’s population lives in countries where four serotypes of dengue virus are in circulation. Every year an estimated 390 million dengue infections are reported. People can be infected with dengue up to four times in their lifetime and they can get severely ill after any of these infections. Surveillance data from some endemic countries indicate that between 70 and 90 percent of people will have been exposed to dengue at least once by the time they reach adolescence. There are many factors that can lead to severe dengue infection. However, the highest risk of getting more severe disease has been observed in people infected for the second time by a different dengue virus.

Dengvaxia is currently indicated in most of the countries for individuals 9 years of age and older living in a dengue-endemic area. In this indicated population, Dengvaxia has been shown to prevent 93 percent of severe disease and 80 percent of hospitalizations due to dengue over the 25 month phase of the large-scale clinical studies conducted in 10 countries in Latin America and Asia where dengue is widespread.

Proposed Label Update
Based on the new analysis, Sanofi will propose that national regulatory agencies update the prescribing information, known as the label in many countries, requesting that healthcare professionals assess the likelihood of prior dengue infection in an individual before vaccinating. Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease). For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.

The Sanofi label proposal will be reviewed by national regulatory agencies in each of the countries where the vaccine is registered or under registration. Following their review, each agency might amend the company proposed label.
 
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WHO: Updated Questions and Answers related to information presented in the Sanofi Pasteur press release on 30 November 2017 with regards to the dengue vaccine Dengvaxia®
30 November 2017
[Excerpt]
What is WHO’s interim interpretation of the data?
WHO’s interim interpretation of data is that:
:: The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied;
:: The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;
WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.
Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.

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Philippines Suspends Dengue Shots After Drug Firm’s Warning
More than 740,000 students have already received Dengvaxia vaccinations, which could pose health risks for people not previously infected.
New York Times, December 01, 2017 – By FELIPE VILLAMOR
 
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Emergencies

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 29 November 2017 [GPEI]
:: Both the Technical Advisory Group (TAG) on Polio Eradication in Afghanistan, and in Pakistan, have met this week. The TAGs are reviewing the latest epidemiology, and performing a thorough program review. The outcomes will help advise each country program on improving the planning and implementation of their National Emergency Action Plans.

:: Summary of newly-reported viruses this week:
Afghanistan: one new wild poliovirus type 1 (WPV1) case, from Nangarhar province.

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Syria cVDPV2 outbreak situation report 24: 28 November 2017
Situation update 28 November 2017
:: No new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported this week in Syria. The most recent case (by date of onset) is 9 September 2017 from Mayadeen district.
:: The total number of confirmed cVDPV2 cases remains 70.
:: Outbreak response teams continue to use inactivated polio vaccine (IPV) strategically to boost immunity and additional vaccines are being prepositioned as part of ongoing contingency planning to ensure that the programme is able to respond quickly in areas where there has been recent evidence of virus transmission. Activities will be carried out when the security situation allows.
:: 7751 children aged 2–23 months were reported vaccinated with IPV in Damascus (representing 86% of the administrative target), as part of a subnational campaign aiming to reach children with bOPV and IPV. The campaign also reached more than 14 000 children aged 2–23 months from 5 camps for internally displaced people in Hasakah governorate, hosting populations from Deir Ez-Zor.
:: WHO continues to support the strengthening of active AFP surveillance in outbreak areas. In Ein Eisa IDP camp, Raqqa governorate and Al-Arysha IDP camp in Hasakah governorate, orientation sessions on reporting of AFP cases are being conducted for physicians operating out of camps.

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WHO Grade 3 Emergencies  [to 2 December 2017]
The Syrian Arab Republic
:: Beyond the bullets and bombs: Saving the lives of chronic disease patients living in conflict settings
WHO has developed a new health kit to support treatment for chronic disease patients in emergency settings. Three years after the kit’s conceptualization, the first shipment of 6 kits, enough for 60 000 medical treatments, has been delivered cross-border from Turkey to northern Syria.
23 November 2017, Cairo, Egypt – In countries facing ongoing violence, the most direct victims are the people caught in the crossfire who sustain life-threatening trauma injuries. But in the longer term, conflict affects another group of people: those who are unable to access medicines and regular treatment for noncommunicable diseases such as diabetes, cancer, kidney diseases and other chronic conditions…

:: Polio- Situation update 28 November 2017
[See Polio above for detail]

Yemen
:: WHO delivers medicines as diphtheria spreads in Yemen
News release
27 November 2017 | Sana’a – WHO has delivered medicines to tackle an outbreak of diphtheria in Yemen, warning that sustained humanitarian access is critical to stopping its spread.
The shipment of 1,000 vials of life-saving anti-toxins and 17 tonnes of medical supplies arrived in Sanaa on Monday (November 27) after being stalled by the three-week closure of sea and air ports.
“It is shocking that in 2017, there are children dying of an ancient disease that is vaccine-preventable and can be easily treated,” said Dr Nevio Zagaria, WHO Country Representative in Yemen.
The anti-toxins can help stop the spread of the bacterium to vital organs in patients already infected with diphtheria. But no supplies were available in Yemen before the arrival of the WHO shipment on Monday.
Antibiotics and vaccines are also critical to treating and preventing the highly infectious respiratory disease – both of which are in short supply in Yemen…
Despite the conflict and recent closures, WHO, UNICEF, and partners have continued to work with available supplies, vaccinating 8,500 children under five years in al-Sadah and Yarim districts in Ibb governorate during November.
A vaccination campaign targeting 300,000 children younger than 12 months began on Saturday (November 25). Further vaccination rounds for more than 3 million children and young adults in priority districts are due in December.

Iraq  
:: Iraq: Lifesaving mobile health teams reach people in newly liberated areas of Hawiija, Iraq
27 November 2017 – For more than three years, the people of Hawiija district in Kirkuk governorate, Iraq, were cut off from lifesaving health care and immunization services, leaving many children susceptible to vaccine-preventable diseases.

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WHO Grade 2 Emergencies  [to 2 December 2017]
Democratic Republic of the Congo
:: Democratic Republic of the Congo – cholera in Lomami district
22 November 2017 Kinshasa — WHO Country Office in the Democratic Republic of the Congo and health partner ALIMA (Alliance for International Medical Action) signed an financing agreement, US$ 70 000 USD, to support and response to the cholera epidemic in Lomami Province. ALIMA will support the activities of case management for a period of two months. The focus will be on treated water supply, hygiene and increasing community awarenes of the importance of sanitation.

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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
:: 30 Nov 2017  Syria Arab Republic: Whole of Syria Shelter/NFI Sector Winter Assistance Update 2 (30 November 2017)
:: Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, Mark Lowcock: Statement to the Security Council on the humanitarian situation in Syria, 29 November 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 – 30 November 2017

Ethiopia  
:: 28 Nov 2017  Ethiopia Humanitarian Bulletin Issue 41 | 13 – 26 Nov. 2017
The OCHA-managed Ethiopia Humanitarian Fund (EHF) allocated US$11.35 million under its Reserve Allocation as a bridging response to the critical requirements identified until early 2018.
 
Somalia 
:: Humanitarian Bulletin Somalia, 01 – 29 November 2017
HIGHLIGHTS
…Food security needs nearly double five-year average.
…Late Deyr rainfall falls short, risk of fifth poor rains.
…Number of newly displaced people decline in October.
…Plans underway to kick start measles vaccination campaign.
…Additional funding required to support humanitarian assistance.
 
 
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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.
 
Yellow Fever  [to 2 December 2017]
http://www.who.int/csr/disease/yellowfev/en/
:: 1 December 2017 1.4 million vaccines from global stockpile support yellow fever control in Nigeria
Geneva – The International Coordinating Group (ICG) on vaccine provision for yellow fever has provided 1.4 million vaccine doses for an immunization campaign that starts on Saturday (2 December) to help control an ongoing yellow fever outbreak in Nigeria.
The Government of Nigeria, supported by World Health Organization and partners, is expected to vaccinate 1.3 million people to contain the outbreak in affected areas. The vaccines, funded by Gavi, the Vaccine Alliance, will be administered in parts of Zamfara state where cases of the deadly disease have been confirmed.
“WHO is working with the Government of Nigeria to address the low immunity among affected populations that is giving rise to cases of yellow fever,” said Dr Wondimagegnehu Alemu, WHO Representative in Nigeria.
The release of 1.4 million doses from the global stockpile builds on earlier efforts in October that reached 874 000 people in Kwara and Kogi states…
 
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WHO & Regional Offices [to 2 December 2017]

WHO & Regional Offices [to 2 December 2017]

World AIDS Day: Everybody counts
1 December 2017 – “Everybody counts” is the slogan for this year’s World AIDS Day. WHO is advocating for access to safe, effective, quality and affordable HIV services, medicines, diagnostics other health commodities for all people who need them. Universal health coverage means that all people receive the health services they need without experiencing financial hardship, including access to the full range of HIV services.
WHO Director-General’s statement
World AIDS Day campaign
 
 
Encounters with plague: tracing and preventing illness
30 November 2017 – In Madagascar, where a severe plague epidemic has unfolded since August 2017, the number of new infections is finally in decline. WHO is supporting health authorities to respond to the outbreak, from setting up specialized plague treatment units in health centres, to distributing medicines across the country.
Disease outbreak news:
Plague – Madagascar  27 November 2017
27 November 2017
Madagascar’s plague epidemic is slowing, but we must sustain the response 
 
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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO deploys mobile laboratory to support Marburg outbreak response  02 December 2017
:: Village Health Teams Contribute Tremendously to the Marburg Response in Eastern Uganda
02 December 2017
:: Message of the Regional Director for Africa, Dr Matshidiso Moeti, on World AIDS Day 2017
02 December 2017
:: Kenya’s chance for Guinea Worm FREE status  01 December 2017
:: Canada and WHO strides to improve maternal and child health in South Sudan  01 December 2017
:: Government of Sweden and four UN agencies announce new Joint Programme to boost efforts to achieve universal access to sexual and reproductive health and to end AIDS
30 November 2017
:: The World Health Organization supports the Ministry of Health to strengthen efforts to eliminate Viral Hepatitis in South Sudan   30 November 2017
:: With support from WHO and partners, the Ministry of Health launches the ‘Treat All’ and HIV Testing Guidelines to end AIDS  30 November 2017
:: Nigeria requires commitment by the 3-tiers of government to avert deaths among untreated 2 million persons living with HIV/AIDs.  29 November 2017
:: The Kingdom of Swaziland dedicates November to diabetes  29 November 2017
:: WORLD DIABETESE DAY 2017 COMMEMORATED IN THE GAMBIA  29 November 2017
:: Liberia joins the global community to commemorate the World Antibiotic Awareness Week
29 November 2017
:: The Ministry of Health in partnership with WHO and partners strengthens health information system for effective health service delivery in South Sudan  27 November 2017
:: Madagascar’s plague epidemic is slowing, but we must sustain the response  27 November 2017

WHO Region of the Americas PAHO
:: Six Caribbean territories and states eliminate mother-to-child transmission of HIV and syphilis (11/30/2017)
:: PAHO, UNAIDS call for stepping up HIV prevention efforts and offering all available options to prevent new infections (11/29/2017)

WHO European Region EURO
:: 105 000 doses of vaccine flown into Kyrgyzstan to kick-start influenza immunization campaign 29-11-2017
:: 1 in 2 people living with HIV in Europe is diagnosed late: ECDC and WHO urge improvement in testing practices 28-11-2017

WHO Eastern Mediterranean Region EMRO
:: World AIDS Day 2017: HIV is treatable, test for HIV  30 November 2017
:: WHO delivers medicines as diphtheria spreads in Yemen  27 November 2017

  CDC/ACIP [to 2 December 2017]

 
CDC/ACIP [to 2 December 2017]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Wednesday, November 29, 2017
Vital Signs Teleconference: HIV Testing Frequency – Transcript

Frequency of HIV Testing and Time from Infection to Diagnosis Improves – Digital Press Kit Tuesday, November 28, 2017

Frequency of HIV Testing and Time from Infection to Diagnosis Improve – Press Release Tuesday, November 28, 2017

MMWR News Synopsis for November 30, 2017
Scale-Up of Voluntary Medical Male Circumcision Services for HIV Prevention – 12 Countries in Southern and Eastern Africa, 2013 – 2016
A substantial increase in voluntary medical male circumcision (VMMC) through CDC-supported programs is helping to prevent the spread of HIV in the world’s most heavily affected countries. The latest data show that meeting the global target of 27 million circumcisions by 2021 will require redoubling current efforts and developing new strategies to increase the number of men seeking circumcisions. New data show that a substantial increase in voluntary medical male circumcision (VMMC) through CDC-supported programs is helping to prevent the spread of HIV in the world’s most heavily affected countries – and that more needs to be done. The number of circumcisions supported by CDC has increased from over 1 million in nine countries during 2010–2012 to nearly 5 million during 2013–2016 in 12 Southern and Eastern African countries. VMMC reduces a man’s risk of heterosexually acquired HIV by 60 percent. As a key agency for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), CDC supports VMMC in 12 Eastern and Southern African countries with high HIV prevalence and low male circumcision rates. While millions of men have successfully accessed this prevention intervention, the number of VMMCs decreased during 2016.

Fractional-Dose Inactivated Poliovirus Vaccine Campaign – Sindh Province, Pakistan, 2016
Countries should weigh the potential benefits of using fractional-dose intradermal inactivated polio vaccine (fIPV) against the operational challenges associated with its use. In response to isolation of type 2 vaccine derived poliovirus (VDPV2) from sewage samples taken from Hyderabad, Pakistan,  fIPV was used in a polio vaccination campaign targeting children ages 4-23 months. The vaccine coverage rate during the campaign was relatively high; however, operational challenges related to the use of an intradermally injected vaccine were encountered during the campaign. Countries that decide to use fIPV should undertake meticulous planning and preparation to address operational challenges and to ensure judicious use of fIPV due to the limited global stock of IPV.
 

Announcements   

Announcements

EDCTP    [to 2 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
1 December 2017
Ethiopia and Angola join the EDCTP Association
EDCTP is pleased to welcome Ethiopia and Angola as member countries of the EDCTP Association.

1 December 2017
World AIDS Day 2017: EDCTP invests in clinical research to support health for all
Significant gains have been made in tackling the HIV epidemic: deaths from AIDS-related causes declined by 48% between 2005 and…

European Medicines Agency  [to 2 December 2017]
http://www.ema.europa.eu/ema/
01/12/2017
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017
PRAC starts two safety referrals and reaches conclusion on re-examination
Revised strategy to measure the impact of pharmacovigilance is adopted
The PRAC adopted a revision to its strategy to measure the impact of pharmacovigilance activities. The strategy was launched in January 2016, with the aim to improve safety monitoring practices and determine which activities are most successful. The strategy has been revised to reflect, among others, how major regulatory interventions benefit patients’ health.
 
 
FDA [to 2 December 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
November 30, 2017 –
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH”

 
Gavi [to 2 December 2017]
http://www.gavi.org/library/news/press-releases/
30 November 2017
Millions of children set to be protected against typhoid fever
Gavi Board approves US$ 85 million funding window for 2019-2020 to support the introduction of typhoid conjugate vaccine in developing countries.
.
Vientiane, 30 November 2017 – Millions of children in the poorest countries could soon be protected against typhoid fever following the Gavi Board’s approval today of a support window for typhoid conjugate vaccines (TCVs).

“Typhoid fever imposes a dramatic burden on children in the poorest nations affecting countries, communities and families,” said Dr Ngozi Okonjo-Iweala, Gavi Board Chair. “This disease has long been eliminated from most industrialised nations, but it is still a serious threat in developing countries where the vast majority of deaths occur,” she said. “I lost my cousin and nearly lost my son because of typhoid. This vaccine will be a lifesaver for millions of children, especially those living without access to clean water or sanitation.”…

“This vaccine is safe, effective and can provide lasting protection,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “The growing spread of drug resistant strains of typhoid is a major threat, not just to individuals but also to our efforts to control the disease, and requires us to prioritise prevention strategies. Strong coverage through routine immunisation together with efforts to improve access to clean water and hygiene will play a key role in dramatically reducing the disease.”

A new typhoid conjugate vaccine manufactured by Bharat Biotech International Limited and first licensed in India in 2013, is currently under review for prequalification by the World Health Organization (WHO).

This follows the recent recommendation by the WHO Strategic Advisory Group of Experts on Immunization (SAGE) that typhoid conjugate vaccines should be introduced in endemic countries to all children over six months of age. Vaccines from five additional manufacturers are also under development and are expected to be available between 2018 and 2022.

Gavi expects the first countries to apply in 2018 with introductions forecasted to begin the year after. The Gavi Board also noted that the use of this new vaccine will enable further studies on the impact of the disease, challenges with diagnosis and appropriate immunisation strategies.

Typhoid conjugate vaccines were first seen as a priority by the Gavi Board in the 2008 Vaccine Investment Strategy (VIS) although no financial commitment was made at that time in the absence of a suitable vaccine.

The Vaccine Investment Strategy is Gavi’s evidence-based process for assessing the suitability of new vaccines to further support countries. Developed every five years, the next VIS will be completed at the end of 2018.

Today, the Gavi Board approved the evaluation criteria that will be used for assessing potential new investments in vaccines and other immunisation products for endemic disease prevention.

ENGAGEMENT WITH TRANSITIONING COUNTRIES AND POST-TRANSITION
Between 2016 and 2020, at least 20 Gavi-supported countries are expected to transition out of Gavi’s financial support. Most of these countries are on-track to fully finance their immunisation programmes and sustain the progress they have made since 2000, when Gavi was created. However, the Gavi Board recognised that a small number of countries are facing more significant challenges…
[See Milestones above for more detail].
 
 
GHIT Fund   [to 2 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 ·
2017.11.30      Events
Upcoming Event: UHC Forum Side Event: STRATEGIC INVESTMENT IN GLOBAL HEALTH VACCINE R&D

2017.11.30      Events
Upcoming Event: UHC Forum Side Event: Linking R&D to Access & Delivery: Virtuous Systems Powered by UHC

 
Global Fund [to 2 December 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
WHO and Global Fund Sign Cooperation Agreements
01 December 2017
WHO and the Global Fund signed cooperation and financing agreements amounting to an estimated US$50 million today, with the aim of providing vital technical support to countries to fight HIV, TB and malaria, and securing additional progress toward universal health coverage.
News
Spain, Three African Countries and the Global Fund Launch New Debt2Health Initiative
29 November 2017
The government of Spain today announced an agreement to waive debts owed by Cameroon, the Democratic Republic of Congo and Ethiopia in exchange for investments in domestic health programs supported by the Global Fund.
 
Human Vaccines Project   [to 2 December 2017]
http://www.humanvaccinesproject.org/media/pressreleases/
December 01, 2017
Human Vaccines Project Presents Initial Findings from First Clinical Trials
Scientists leading the clinical programs for the Human Vaccines Project reported today high-level outcomes from two concurrent clinical studies aimed at deciphering the components and mechanisms used by the human immune system to prevent and control disease at the World Vaccine and Immunotherapy Congress in San Diego, Calif. The findings from the studies may provide important new insights on human immunity that the Human Vaccines Project – a public-private partnership aimed at decoding the immune system to advance human health – will leverage to launch expanded studies in 2018.
The Project’s first program, the Human Immunome Program, aims to identify the core components that exist across everyone’s immune systems and utilize this information to enable development of new and improved vaccines. The team is sequencing millions of recombined and expressed B and T cell genes in healthy adults and cord blood samples at an unprecedented depth, seeking to identify shared elements of the human immune system not previously recognized. The team is led by James E. Crowe, Jr., MD, Director of Vanderbilt University Medical Center’s Vaccine Center, the scientific hub of the Human Immunome Program…
Early findings from a second and complementary clinical research program of the Human Vaccines Project, aimed at revealing the key principles or rules that the human immune system follows when it comes to the prevention and control of disease, will be shared in two separate presentations by Manish Sadarangani, MD, PhD, Director of the Vaccine Evaluation Center of the University of British Columbia and BC Children’s Hospital Research Institute and Richard Scheuermann, PhD, Director, J. Craig Venter Institute, La Jolla Campus. The long-term goal of this program is to understand the rules of the human immune system that will enable one-shot vaccines to provide long term protective immunity in all populations. The aim of this study is to understand why some people respond effectively to a single immunization of a licensed Hepatitis B vaccine, while others require up to three immunizations for generating protective immunity…
 
 
IAVI  [to 2 December 2017]
https://www.iavi.org/
November 30, 2017
Research Roundup: IAVI & Partner Discoveries 2017
The road toward an effective HIV is marked by fresh findings, promising new pathways for development, and the occasional breakthrough. This year offered a mix of all three, and as always with scientific progress – more questions to answer…

IVAC  [to 2 December 2017]
http://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
IVAC Blog  28 Nov 2017
SAGE Wisdom: What’s it like to sit on WHO’s expert immunization advisory group?
…From October 17-19, three faculty members from the International Vaccine Access Center (IVAC), of the Johns Hopkins Bloomberg School of Public Health (JHSPH), provided technical expertise and leadership at the annual SAGE meeting, an advisory body formed in 1999 to provide guidance on immunizations to the WHO.
IVAC’s delegation included Director of Epidemiology Bill Moss, Director of Science Maria Deloria Knoll, and IVAC Executive Director Kate O’Brien. The meeting, held in the August Room where WHO’s 34-member Executive Board meets, was attended by about 200 people and included presentations from nine Working Groups. SAGE Working Groups delve in to key immunization-related questions of interest to policymakers around the world…
 
MSF/Médecins Sans Frontières  [to 2 December 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Syria: Bombing and Shelling in East Ghouta Overwhelm Medical Services
November 27, 2017
Doctors Without Borders/Médecins Sans Frontières (MSF) calls for urgent medical supplies and respect for International Humanitarian Law protecting medical facilities
 
 
NIH  [to 2 December 2017]
http://www.nih.gov/news-events/news-releases
December 1, 2017
NIH Statement on World AIDS Day 2017
— After 30 years of marking progress against HIV, we are closer than ever to the beginning of the end of the HIV/AIDS pandemic.
[Excerpt]
…The ultimate goal for HIV prevention is development of a safe and effective vaccine. The National Institutes of Health announced yesterday that a new Phase 2b, proof-of-concept trial of an HIV vaccine has been launched in southern Africa. The study, called Imbokodo (HVTN 705), aims to enroll 2,600 HIV-negative women in sub-Saharan Africa. This new trial joins HVTN 702, a Phase 2b/3 vaccine efficacy trial being conducted in South Africa, aiming to build on the modest results of the RV144 vaccine trial in Thailand…

NIH and partners launch HIV vaccine efficacy study
November 30, 2017 — Public-private partnership begins clinical trial in sub-Saharan Africa.
The National Institutes of Health and partners have launched a large clinical trial to assess whether an experimental HIV vaccine regimen is safe and able to prevent HIV infection. The new Phase 2b proof-of-concept study, called Imbokodo, aims to enroll 2,600 HIV-negative women in sub-Saharan Africa. Of 1.8 million new HIV infections worldwide in 2016, 43 percent occurred in eastern and southern Africa, with women and girls disproportionately affected.
“Imbokodo,” the Zulu word for rock, is part of a well-known proverb in South Africa that refers to the strength of women and their importance in the community. The study is sponsored by Janssen Vaccines & Prevention, B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with co-funding from two primary partners, the Bill & Melinda Gates Foundation (BMGF) and NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

The vaccine regimen being tested in Imbokodo is based on “mosaic” immunogens — vaccine components designed to induce immune responses against a wide variety of global HIV strains. This regimen differs from the one being tested in the Phase 2b/3 HVTN 702 study, an ongoing HIV vaccine efficacy trial sponsored by NIAID that launched late last year in South Africa with major co-funding from NIAID and BMGF. HVTN 702 is evaluating a newer version of the vaccine regimen tested in the RV144 Thai trial — the only candidate HIV vaccine regimen ever shown to provide some protection against the virus.

“Together with the implementation of existing HIV prevention and treatment strategies, the development and delivery of a preventive HIV vaccine that is safe and at least moderately effective would help bring about a durable end to the HIV/AIDS pandemic,” said NIAID Director Anthony S. Fauci, M.D. “We are committed to pursuing multiple vaccine development strategies to achieve this goal.”

The first Imbokodo participants have received vaccinations at clinical research sites in South Africa. Regulatory approvals are being sought to conduct the study at additional sites in Malawi, Mozambique, Zambia and Zimbabwe. With the start of Imbokodo, two HIV vaccine efficacy trials now are taking place in sub-Saharan Africa. Results from HVTN 702, which is enrolling HIV-negative men and women in South Africa, are expected in late 2020. Results from Imbokodo are expected in 2021…

The NIAID-funded HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, is implementing Imbokodo. The South African Medical Research Council (SAMRC) is helping implement the study in South Africa. Additional partners providing support include the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research, the U.S. Army Medical Materiel Development Activity, and the Ragon Institute of MGH, MIT and Harvard…

NIH launches HIV prevention trial of long-acting injectable medication in sexually active women
November 30, 2017 — Study to test efficacy, safety of injectable cabotegravir compared with daily oral PrEP.
The first large-scale clinical trial of a long-acting injectable medication for HIV prevention in sexually active women has begun. The study in southern and eastern Africa will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every eight weeks can safely protect women at risk for HIV infection. The only drug regimen currently licensed for HIV pre-exposure prophylaxis, or PrEP, is the anti-HIV medication Truvada taken daily as an oral tablet. The U.S. National Institutes of Health (NIH) is sponsoring the trial, and the NIH-funded HIV Prevention Trials Network (HPTN) is conducting the study, called HPTN 084…

Combination HIV prevention reduces new infections by 42 percent in Ugandan district
November 29, 2017 — NIH-supported study provides evidence for implementing approach broadly.
A study published today in the New England Journal of Medicine provides real-world evidence that implementing a combination of proven HIV prevention measures across communities can substantially reduce new HIV infections in a population.
Investigators found that HIV incidence dropped by 42 percent among nearly 18,000 people in Rakai District, Uganda, during a seven-year period in which the rates of HIV treatment and voluntary medical male circumcision increased significantly…
 
 
PATH  [to 2 December 2017]
http://www.path.org/news/index.php
Press release | November 30, 2017
Novel drug delivery system has game-changing potential to reduce rates of HIV infection
An international collaboration announces preclinical development of a microarray patch delivery system for HIV pre-exposure prophylaxis
Seattle, WA, December 1, 2017—The United States Agency for International Development (USAID), through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), awarded PATH a three-year, $9.4 million grant to advance a needle-free microarray patch for delivery of HIV pre-exposure prophylaxis (PrEP). Microarray patches are a discreet, easy-to-use technology that contains an array of tiny projections that painlessly penetrate the top layer of skin to deliver a drug.
PATH, ViiV Healthcare, Queen’s University Belfast, the Population Council, and LTS Lohmann Therapie-Systeme AG will combine their complementary expertise to develop a novel microarray patch for HIV PrEP in preparation for future clinical trials. The collaborators will engage with women and health care workers in Kenya, South Africa, and Uganda to design a microarray patch product that meets their needs…
 
Announcement | November 28, 2017
PATH statement on the World Health Organization’s World Malaria Report, 2017
Regaining progress against malaria requires new tools
A statement from PATH’s Vice President for Essential Medicines, Dr. David C. Kaslow, follows:
This week, the World Health Organization (WHO) released the 2017 World Malaria Report on the state of malaria control and elimination across the globe and, worryingly, emphasized that although more countries have accelerated toward malaria elimination, the global progress to prevent malaria disease and death has stalled after a period of unprecedented positive impact.
The new data find that malaria killed an estimated 445,000 people in 2016, a number essentially unchanged in the last three years. The report also finds that there were an estimated 216 million cases of malaria globally in 2016, a consistent figure for the past five years.

The brunt, by far, of the burden of disease and deaths is shouldered by sub-Saharan Africa (with the exception of India, which had the third highest number of malaria deaths in 2016).
The good news is that malaria control works when there is sufficient funding and political will behind the effort. But current malaria funding levels are insufficient, and while we wait for funding to keep pace with global need, the malaria parasite continues to kill, debilitate and evolve.

Regaining progress made in driving malaria to zero will require more than just maintaining the status quo. Though existing tools may be imperfect, when used at scale they are having an impact. However, in the end, current tools will only take us so far, and new tools are needed, particularly in geographies with the highest malaria burden.

This new report makes clear that to keep up with the parasite, malaria control efforts must make the best use of currently available bednets, diagnostic tests, drugs, and indoor residual spraying. It also makes abundantly clear that investment must be made in research and development of new tools—including drugs, diagnostics and surveillance tools, vaccines, and vector control—that build on the progress already made, and bring new approaches to preventing disease and death and stopping the spread of malaria parasites.

The increasing number of countries that have eliminated malaria, and all of those approaching elimination, provide clear evidence that the parasite can be controlled. At the same time, setbacks in countries with a high disease burden serve as a wake-up call that the global community needs to fund and scale existing control efforts, and invest in the research and development of new tools.
Posted November 28, 2017.
 

UNAIDS [to 2 December 2017]
http://www.unaids.org/en
1 December 2017
UNAIDS Congratulates French President Macron for his leadership on AIDS

30 November 2017
Geneva international community unites to end violence against women and girls
To galvanize joint action to end the epidemic of violence against women and girls, the African Women Ambassadors to the United Nations in Geneva and UNAIDS convened a special event on the eve of the International Day for the Elimination of Violence against Women and to kick off 16 Days of Activism.
The event, held on 24 November in UNAIDS’ headquarters in Geneva, Switzerland, was attended by more than 35 ambassadors to the United Nations in Geneva…

UNICEF  [to 2 December 2017]
https://www.unicef.org/media/
NEW YORK/JOHANNESBURG, 01 December 2017
Global complacency threatens the lives of children and adolescents as world set to miss global AIDS target – UNICEF
NEW YORK/JOHANNESBURG, 01 December 2017 – In 2016, 120,000 children under the age of 14 died of AIDS related causes, and 18 children were infected with HIV every single hour. If current trends persist, there will be 3.5 million new adolescent HIV infections by 2030, according to projections from the 2017 UNICEF Statistical Update on Children and AIDS released today.

Global agreements on migration and refugees should include commitments to protect children, UNICEF urges world leaders
MEXICO CITY/NEW YORK/GENEVA, 30 November 2017 – The rights, protection and wellbeing of uprooted children should be central commitments of global migration policies, UNICEF said today ahead of a meeting in Puerto Vallarta, Mexico, on safe, regular and orderly migration.

Wellcome Trust  [to 2 December 2017]
https://wellcome.ac.uk/news
News / Published: 27 November 2017
New Research Enrichment awards available for grantholders
Today, we’re pleased to launch new Research Enrichment awards. These extend our dedicated funding for public engagement to encompass open research, and diversity and inclusion.
We’re doing this because we believe this new funding will increase the impact of the work we fund and so benefit society.
Research Enrichment funding is available to support activities in:
:: public engagement – this replaces the Provision for Public Engagement scheme
:: open research
:: diversity and inclusion.
The new enrichment awards will allow our grantholders to widen participation in their research by:
:: inspiring, consulting or collaborating with the public
:: developing innovative ways to make research open, accessible and reusable
:: identifying and tackling barriers to diversity and inclusion…

::::::
 
 
IFPMA   [to 2 December 2017]
http://www.ifpma.org/resources/news-releases/
Published on: 28 November 2017
Press Release: 3rd Biennial Scientific Conference on Medical Products Regulation in Africa
PRESS RELEASE, 27 November 2017, Accra – Ghana
Significant strides have been made over the years to enhance and modernize the regulation of pharmaceutical manufacturing and product quality across the world. However, the drug registration system in Africa remains complex and varied, and separate national review processes currently in place impact patients’ access to medicines in Africa. Harmonisation of the processes for medicine registration is long overdue.
Under the African Medicines Regulatory Harmonization (AMRH) initiative, there are some ongoing pilot projects that are aimed at improving national registration processes, and these will go a long way towards meeting the goal of regulatory harmonization and convergence.
The proposed African Medicines Agency is at the centre of the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa taking place at Alisa Hotel in Accra from 27-28th November.
Organised by international stakeholders with support from the West African Health Organisation, (WAHO), NEPAD, the Government of Ghana, the Federation of African Pharmaceutical Manufacturers Associations (FAPMA), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the meeting brings together the key stakeholders including regulators, policymakers, academia, the scientific community, private sector and civil society from across Africa.
The theme for the conference is “Sustaining the Momentum for Regulatory Harmonisation in Africa”. This theme will enable participants to contribute towards the future of regulation and harmonisation in Africa, which affects both industrial and regulatory aspects, as well as the aspirations of civil society and its wish to benefit from best practice, and best medicine…

 
PhRMA    [to 2 December 2017]
http://www.phrma.org/press-room
December 1, 2017
World AIDS Day 2017: Scientific breakthroughs paving the way for an AIDS-free generation
On World AIDS Day, the hope for an AIDS-free generation is within reach.

November 29, 2017
EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing
In a new survey with EFPIA and PhRMA, considerable data sharing is taking place.
Stakeholders are gathering in London this week for a workshop entitled Data Anonymization – a Key Enabler for Clinical Data Sharing. The workshop, jointly organized by the European Medicines Agency (EMA) and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, is but one example of efforts by a broad range of stakeholders to enhance clinical trial data sharing. The workshop will seek to propose guiding principles to enable international data sharing – an area in which PhRMA and its member companies are leading the way.

Making research data available to qualified researchers has the great potential to advance medical research to benefit patients by accelerating the development of new medicines and improving patient care. The biopharmaceutical industry has been at the forefront of initiatives to improve access to clinical trial data and has led the way in sharing patient-level data. Industry details its commitments to sharing clinical trial data in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing (or Principles) which were adopted by the boards of both associations in July 2013. The Principles support enhanced data sharing while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research.

Today, EFPIA and PhRMA released the Report on the 2016 Member Company Survey which details the results of a joint survey conducted between July and September 2016, to assess the degree to which member companies had made progress in implementing the commitments under the Principles. The survey results show that 98 percent of EFPIA and PhRMA member companies share clinical trial data beyond any legal or regulatory requirements. In addition, EFPIA and PhRMA member companies collectively documented more than 1,000 requests for access to clinical trial data between January 1, 2014 (the date that the companies began to implement the Principles), and the close of the survey. Of the 935 requests on which a decision had been made, the vast majority, 80 percent, were approved, showing that considerable data sharing is now taking place…

Industry Watch    [to 2 December 2017]
:: Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate
November 28, 2017
:: Takeda’s investigational Zika virus vaccine candidate (TAK-426) progresses into Phase 1 clinical trial
:: The clinical trial (ZIK-101) will evaluate safety and immunogenicity of TAK-426 in 240 subjects between the ages of 18 and 49 across the continental U.S. and U.S. territories
:: Takeda’s Zika program is funded with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201600015C

:: Sanofi updates information on dengue vaccine
New analysis of long-term Dengvaxia® data found differences in vaccine performance based on    
    prior dengue infection
Company will ask regulators to update product label to reflect new information
[See Milestones/Perspectives above for detail]

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

World Malaria Report 2017
WHO
29 November 2017 :: 196 pages
Overview
The World Malaria Report 2017 draws on data from 91 countries and areas with ongoing malaria transmission. The information is supplemented by data from national household surveys and databases held by other organizations.
This year’s report shows that after an unprecedented period of success in global malaria control, progress has stalled. In 2016, there were an estimated 216 million cases of malaria, an increase of about 5 million cases over 2015. Deaths reached 445 000, a similar number to the previous year.
PDF: http://www.who.int/entity/malaria/publications/world-malaria-report-2017/report/en/index.html

Press Release
Global response to malaria at crossroads   29 November 2017
WHO report shows gains are levelling
News release
29 November 2017 | Geneva – After unprecedented global success in malaria control, progress has stalled, according to the World malaria report 2017. There were an estimated 5 million more malaria cases in 2016 than in 2015. Malaria deaths stood at around 445 000, a similar number to the previous year.

“In recent years, we have made major gains in the fight against malaria,” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO. “We are now at a turning point. Without urgent action, we risk going backwards, and missing the global malaria targets for 2020 and beyond.”

The WHO Global Technical Strategy for Malaria calls for reductions of at least 40% in malaria case incidence and mortality rates by the year 2020. According to WHO’s latest malaria report, the world is not on track to reach these critical milestones.

A major problem is insufficient funding at both domestic and international levels, resulting in major gaps in coverage of insecticide-treated nets, medicines, and other life-saving tools.
Funding shortage

An estimated US$ 2.7 billion was invested in malaria control and elimination efforts globally in 2016. That is well below the US $6.5 billion annual investment required by 2020 to meet the 2030 targets of the WHO global malaria strategy…

The global figures
The report shows that, in 2016, there were an estimated 216 million cases of malaria in 91 countries, up from 211 million cases in 2015. The estimated global tally of malaria deaths reached 445,000 in 2016 compared to 446,000 the previous year.

While the rate of new cases of malaria had fallen overall, since 2014 the trend has levelled off and even reversed in some regions. Malaria mortality rates followed a similar pattern.

The African Region continues to bear an estimated 90% of all malaria cases and deaths worldwide. Fifteen countries – all but one in sub-Saharan Africa – carry 80% of the global malaria burden…

Tackling malaria in complex settings
The report also outlines additional challenges in the global malaria response, including the risks posed by conflict and crises in malaria endemic zones. WHO is currently supporting malaria responses in Nigeria, South Sudan, Venezuela (Bolivarian Republic of) and Yemen, where ongoing humanitarian crises pose serious health risks. In Nigeria’s Borno State, for example, WHO supported the launch of a mass antimalarial drug administration campaign this year that reached an estimated 1.2 million children aged under 5 years in targeted areas. Early results point to a reduction in malaria cases and deaths in this state.

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WHO Global Surveillance and Monitoring System for substandard and falsified medical products
WHO
November 2017 :: 73 pages:
PDF: http://www.who.int/entity/medicines/regulation/ssffc/publications/GSMS_Report.pdf?ua=1
This report has grown out of the work of the GSMS, which provides national regulatory authorities with an interconnected network. This allows them, for the first time, to cross-reference reports of suspect products with those reported from other regions by searching the WHO database and accessing photograph libraries of confirmed substandard and falsified products.
Excerpts]
p.11  …Equally the manufacture of falsified products is also a global and complex activity. Manufacturing sites linked to the clandestine production of falsified medicines and vaccines have been discovered on all continents. Sometimes production is carried out on an industrial scale at one location or it may be on a smaller and less sophisticated scale…
p.13
TABLE 1: EXAMPLES OF SUBSTANDARD AND FALSIFIED PRODUCTS REPORTED TO THE GSMS (2013–2017)
[Excerpt from Table]
Type of Product: Vaccines
Number of Member State Reporting: 11
Total No. of Product Reports: 29
   Also: vaccine case examples involving from Niger [MenC], and Indonesia [YF]

A study on the public health and socioeconomic impact of substandard and falsified medical products
WHO
November 2017 :: 77 pages:
PDF: http://www.who.int/entity/medicines/regulation/ssffc/publications/Layout-SEstudy-WEB.pdf?ua=1
The presence of substandard and falsified medical products in countries and their use by patients threatens to undermine progress towards meeting the Sustainable Development Goals. Such products may be of poor quality, unsafe or ineffective, threatening the health of those that take them. The problem of substandard and falsified medical products continues to increase, as globalized manufacturing and distribution systems grow ever more complex. That complexity heightens the risk that production errors will occur, or that medicines will degrade between factory and consumer. Increasing demand for medicines, vaccines and other medical products in almost every country, in addition to poor supply-chain management and the growth of e-commerce also creates opportunities for falsified medicines to be introduced into the supply chain.

Press Release
1 in 10 medical products in developing countries is substandard or falsified  
28 November 2017
An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to new research from WHO.

This means that people are taking medicines that fail to treat or prevent disease. Not only is this a waste of money for individuals and health systems that purchase these products, but substandard or falsified medical products can cause serious illness or even death.

“Substandard and falsified medicines particularly affect the most vulnerable communities,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action.”

Since 2013, WHO has received 1500 reports of cases of substandard or falsified products. Of these, antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the WHO African Region, 21% from the WHO Region of the Americas, and 21% from the WHO European Region.

This is likely just a small fraction of the total problem and many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region, and just 2% from the WHO South-East Asia Region…

WHO is publishing two reports today:
:: WHO launched its Global Surveillance and Monitoring System for substandard and falsified medicines, vaccines and in-vitro diagnostic tests in July 2013. This first report is based on data collected during the first 4 years of operation up to 30 June 2017.
:: A study on the public health and socioeconomic impact of substandard or falsified medical products conducted by WHO and the Member State Mechanism.
This study is based on 100 literature reviews and two peer-reviewed models developed by the University of Edinburgh and The London School of Hygiene and Tropical Medicine. The 100 papers reviewed provide data for more than 48 000 samples of medicines from 88 countries.    Because only 178 samples were taken in high-income countries, prevalence estimates of substandard or falsified medical products were limited to low- and middle-income countries.
Despite these limitations, these two reports represent the most comprehensive compilation to date of data related to substandard and falsified medical products and are a first step towards better understanding their public health and socioeconomic impact.

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

American Journal of Preventive Medicine December 2017 Volume 53, Issue 6, p745-934

American Journal of Preventive Medicine
December 2017 Volume 53, Issue 6, p745-934
http://www.ajpmonline.org/current

Research Articles
Pneumococcal Vaccination Among Adults With Work-related Asthma
Katelynn E. Dodd, Jacek M. Mazurek
p799–809
Published online: September 27, 2017

Cost Effectiveness of a Shingles Vaccine Booster for Currently Vaccinated Adults in the U.S.
Phuc Le, Michael B. Rothberg
p829–836
Published in issue: December 2017

Text4baby Influenza Messaging and Influenza Vaccination Among Pregnant Women
Jessica A. Bushar, Juliette S. Kendrick, Helen Ding, Carla L. Black, Stacie M. Greby
p845–853
Published online: August 28, 2017

Enforcement Associated With Higher School-Reported Immunization Rates
Kylie J. Hall, Molly A. Howell, Rick J. Jansen, Paul J. Carson
p892–897
Published in issue: December 2017

American Journal of Public Health December 2017 107(12)

American Journal of Public Health
December 2017  107(12)
http://ajph.aphapublications.org/toc/ajph/current

PREEXPOSURE PROPHYLAXIS
Integrating HIV Preexposure Prophylaxis (PrEP) Into Routine Preventive Health Care to Avoid Exacerbating Disparities
Sarah K. Calabrese, Douglas S. Krakower and Kenneth H. Mayer
107(12), pp. 1883–1889

VACCINES
Vaccines and the Trump Administration—Reasons for Optimism Amid Uncertainty
Jason L. Schwartz
107(12), pp. 1892–1893

Vaccine-derived poliovirus surveillance in China during 2001–2013: the potential challenge for maintaining polio free status

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 2 December 2017)

Research article
Vaccine-derived poliovirus surveillance in China during 2001–2013: the potential challenge for maintaining polio free status
The goal of polio eradication is to complete elimination and containment of all wild, vaccine-related and Sabin polioviruses. Vaccine-derived poliovirus (VDPV) surveillance in China from 2001–2013 is summarize…
Authors: Hai-Bo Wang, Hui-Ming Luo, Li Li, Chun-Xiang Fan, Li-Xin Hao, Chao Ma, Qi-Ru Su, Hong Yang, Kathleen H. Reilly, Hua-Qing Wang and Ning Wen
Citation: BMC Infectious Diseases 2017 17:742
Published on: 2 December 2017

Options for financing pandemic preparedness

Bulletin of the World Health Organization
Volume 95, Number 12, December 2017, 793-852
http://www.who.int/bulletin/volumes/95/12/en/

Options for financing pandemic preparedness
Patrick L Osewe
…In February 2018, the World Bank in partnership with WHO, the Africa Centres for Disease Control and Prevention and the Bill & Melinda Gates Foundation will host a regional event to define the core elements of a multisectoral pandemic preparedness plan, including planning and coordination mechanisms. In addition, during the Prince Mahidol Award Conference9 to be held in January 2018 in Bangkok, the World Bank will host a series of meetings to share lessons learnt from country implementation, as well as models for financing pandemic preparedness.
To ensure the success of pandemic financing preparedness, countries should engage in dialogue on the importance of investing in such preparedness. The World Bank’s early successes need to continue through partnerships to renew and sustain national, regional and global commitment and investments for pandemic preparedness and response.

A public health research agenda informed by guidelines in development

Bulletin of the World Health Organization
Volume 95, Number 12, December 2017, 793-852
http://www.who.int/bulletin/volumes/95/12/en/

A public health research agenda informed by guidelines in development
Dermot Maher & Nathan Ford
The World Health Organization (WHO) is the leading and coordinating authority on public health within the United Nations system. Setting norms and standards, and shaping the research agenda are two of WHO’s six core activities.1 WHO can use this normative role to support the development of an agenda for public health research.

WHO develops global, clinical, programmatic and public health guidelines that support best practice in health delivery. In 2007, WHO established the Guidelines Review Committee to ensure that WHO produces high-quality guidelines that are based on internationally recognized methods and standards and are developed through a transparent, evidence-based decision-making process.2 Each guideline development process starts with the establishment of a guideline development group that includes leading experts in the field and relevant stakeholders from across all WHO Regions affected by the public health problem. The group may involve patients and those who most likely will implement the guidelines’ recommendations. The guideline development groups use systematic reviews of relevant evidence to make recommendations, and the Grading of Evidence, Assessment and Evaluation (GRADE) system to determine and qualify these recommendations.3 GRADE includes an appraisal of the quality of evidence and an assessment of potential benefits and harms, resource use, user values and preferences regarding the recommended intervention. The group considers these elements together to determine the direction and strength of a recommendation. When significant uncertainty exists with respect to the balance of an intervention’s benefits and harms, the guideline development group should describe the knowledge gap and set priorities for what further research is needed to address these gaps.4

Here we suggest that the WHO guideline development process be used as a foundation for building an agenda on public health research. We argue that this process provides a unique and efficient opportunity to compile an agenda from the research needs identified by each of the guideline development groups. Several aspects of the process support this suggestion. First, guideline development relies on comprehensive assessments of the evidence from high-quality systematic reviews, complemented with other sources of information. Second, identifying research gaps and needs is a core objective of any systematic review5 and a function of WHO guidelines.6 Third, leading experts review evidence from key systematic reviews to formulate recommendations. Fourth, the variety of stakeholders in the guidelines development group provides a much broader perspective for formulating research priorities than relying on academic researchers alone…

Improving the health and well-being of children of migrant workers

Bulletin of the World Health Organization
Volume 95, Number 12, December 2017, 793-852
http://www.who.int/bulletin/volumes/95/12/en/

PERSPECTIVES
Improving the health and well-being of children of migrant workers
Catherine Jan, Xiaolin Zhou & Randall S Stafford
[Excerpts]
The United Nations Convention on the Rights of the Child emphasizes that the states parties to the convention have the responsibility to ensure that children grow up in a family environment with happiness, love and understanding.1 There are almost 1 billion migrants worldwide, with 214 million international migrants and another 740 million internal migrants moving within countries.2 Migrants with children may leave their children behind while pursuing economic opportunities. Although there are no available data on the total number of children left behind globally, several reports on international migrants reflect the magnitude of this phenomenon. The Regional Thematic Working Group on International Migration including Human Trafficking estimates that in east and south-east Asia, one child is left behind for each adult working abroad.3 Similarly, in the Republic of Moldova, the proportion of children younger than 14 years who are left behind is estimated to have increased from 16% to 31% between 2000 and 2004; in Mexico, more than a third of children experience household disruption due to migration.4 The number of children left behind because their parents become internal migrants is even greater, particularly in those areas experiencing rapid urbanization.5
…To mitigate the adverse effects of migration on migrant families and pursue the agenda’s ambitious goals, many governments and child protection systems are increasingly adopting a holistic approach that focuses on poverty reduction, family-oriented education programmes, community support, early identification of risks and provision of specialist services for vulnerable children and their families. Strategies that may improve health outcomes include providing antenatal care, parental leave, child allowance for all families, nursery school for all children aged one to six years (as in some European countries), free medical care for all preschool children (as in Japan) and incentives for health-care professionals to practice in rural regions (as in Australia and New Zealand).9

Public health implications of complex emergencies and natural disasters

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 2 December 2017]

29 November 2017
Public health implications of complex emergencies and natural disasters
Authors: Amanda Culver, Roger Rochat and Susan T. Cookson
Abstract
Background
During the last decade, conflict or natural disasters have displaced unprecedented numbers of persons. This leads to conditions prone to outbreaks that imperil the health of displaced persons and threaten global health security. Past literature has minimally examined the association of communicable disease outbreaks with complex emergencies (CEs) and natural disasters (NDs).
Methods
To examine this association, we identified CEs and NDs using publicly available datasets from the Center for Research on the Epidemiology of Disasters and United Nations Flash and Consolidated Appeals archive for 2005–2014. We identified outbreaks from World Health Organization archives. We compared findings to identify overlap of outbreaks, including their types (whether or not of a vaccine-preventable disease), and emergency event types (CE, ND, or Both) by country and year using descriptive statistics and measure of association.
Results
There were 167 CEs, 912 NDs, 118 events linked to ‘Both’ types of emergencies, and 384 outbreaks. Of CEs, 43% were associated with an outbreak; 24% NDs were associated with an outbreak; and 36% of ‘Both’ types of emergencies were associated with an outbreak. Africa was disproportionately affected, where 67% of total CEs, 67% of ‘Both’ events (CE and ND), and 46% of all outbreaks occurred for the study period. The odds ratio of a vaccine-preventable outbreak occurring in a CE versus an ND was 4.14 (95% confidence limits 1.9, 9.4).
Conclusions
CEs had greater odds of being associated with outbreaks compared with NDs. Moreover, CEs had high odds of a vaccine-preventable disease causing that outbreak. Focusing on better vaccine coverage could reduce CE-associated morbidity and mortality by preventing outbreaks from spreading.

The need for speed: the peer-review process and what are we doing about it?

Health Policy and Planning
Volume 32, Issue 10, 1 December 2017
http://heapol.oxfordjournals.org/content/current

Editorial
The need for speed: the peer-review process and what are we doing about it?
Diana Epstein; Virginia Wiseman; Natasha Salaria; Sandra Mounier-Jack
Health Policy and Planning, Volume 32, Issue 10, 1 December 2017, Pages 1345–1346, https://doi.org/10.1093/heapol/czx129
Extract
The editorial office receives multiple author requests in regards to the status of their papers. In fact Mondays and Fridays seem to be the busiest time for working on those requests with an average of 20 requests on those particular days.
The intention of this Editorial is to summarize the key steps for processing papers once submitted, explain the different factors affecting turn-around times, and update authors and readers on initiatives Health Policy and Planning is undertaking to speed up the processing of papers.
Upon submission approximately 60% of papers are rejected after internal peer-review with an additional 15–20% being rejected after external peer-review…