WHO & Regional Offices [to 10 September 2016]

WHO & Regional Offices [to 10 September 2016]

WHO and partners battle multiple disease outbreaks in South Sudan
9 September 2016
Infectious diseases continue to pose a major public health threat in South Sudan. Adding to the chronic burden of disease, regular outbreaks further threaten people’s health.
In a conflict setting, WHO and partners are responding to multiple outbreaks including cholera, malaria, measles, suspected hemorrhagic fever, and kala-azar.
“In spite of the insecurity, WHO is taking every opportunity to ensure that we reach the people with health care services to protect them at this time when the health system has crumbled,” says Dr, Abdulmumini Usman, WHO Representative to South Sudan…


WHO-IVB: Call for nomination for experts to serve on a Strategic Advisory Group of Experts (SAGE) on Immunization working group on Pneumococcal Conjugate Vaccine (PCV)
5 September 2016
Deadline for application: 30 September 2016


WHO certifies Sri Lanka malaria-free
September 2016 − In a remarkable public health achievement, Sri Lanka was certified today by WHO on having eliminated malaria, a life-threatening disease which long affected the island country.


:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO :
:: DRC vaccinates more than 10 million people in Africa’s largest yellow fever vaccination campaign
BRAZZAVILLE, 6 September 2016 – The largest emergency vaccination campaign against yellow fever ever attempted in Africa, came to an end on 5 September 2016 with more than 10.6 million people in the Democratic Republic of Congo (DRC) vaccinated against the lethal disease.

WHO Region of the Americas PAHO
:: New PAHO publication brings together strategies for suicide prevention in the Americas (09/09/2016)

WHO South-East Asia Region SEARO
:: South-East Asia countries to set up fund for health emergencies preparedness
9 September 2016
:: Focus on migrant health: WHO 8 September 2016

WHO European Region EURO
:: Preventing alcohol exposure in pregnancy: examples from Member States 08-09-2016
:: WHO governing body for the European Region convenes with eight strategic proposals on the agenda 08-09-2016
:: Evidence-informed policy-making in the spotlight in new edition of Public Health Panorama 07-09-2016
:: WHO Europe launches new action plan for noncommunicable diseases, appeals for urgent joint policy action to achieve global goals and targets 06-09-2016

WHO Eastern Mediterranean Region EMRO
:: Millions of children in Pakistan reached with polio vaccine thanks to United Arab Emirates campaign 7 September 2016
:: WHO supports training of Somali health workers to scale up the cholera outbreak response
4 September 2016

WHO Western Pacific Region
No new announcements identified.

Industry Watch [to 10 September 2016]

Industry Watch [to 10 September 2016]
:: Takeda Initiates Global Phase 3 Clinical Trial (TIDES) of Dengue Vaccine Candidate (TAK-003)
Study to evaluate vaccine protection against all four strains of dengue virus, regardless of previous exposure
September 07, 2016
OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited today announced that it has vaccinated the first subject in the Tetravalent Immunization against Dengue Efficacy Study (TIDES), a Phase 3 double-blind, randomized and placebo-controlled trial of its live-attenuated tetravalent dengue vaccine candidate (TAK-003).

TIDES will enroll approximately 20,000 healthy children between the ages of four and 16 years living in dengue-endemic countries in Latin America and Asia. The study will evaluate the efficacy of the vaccine candidate to protect subjects against symptomatic dengue fever caused by any of the four dengue virus serotypes, regardless of age and whether the individual has previously been exposed to the virus. The study will also evaluate vaccine safety and immunogenicity and will involve two doses of the vaccine candidate or placebo administered 90 days apart.1 …


:: U.S. Biomedical Advanced Research and Development Authority (BARDA) Awards Protein Sciences Multi-Million Dollar Contract for Pandemic Preparedness
MERIDEN, Conn., Sept. 7, 2016 /PRNewswire/ — Protein Sciences Corporation announced today that the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, has awarded the Company a contract that is part of the Authority’s medical countermeasures against pandemic influenza and influenza strains with pandemic potential (contract number HHSO100201600005I). Protein Sciences will perform the contract using its proprietary platform technology for producing vaccines that according to the Food and Drug Administration has revolutionized influenza vaccine manufacturing and stands to receive up to $610 million through 2021 if BARDA exercises all options…


:: Gyeongbuk Kick-Starts Vaccine Industry with ‘Global Vaccine Industry Forum 2016’
– More than 200 experts from industry, academia, research institutes from Korea and abroad, including IVI, in attendance
– MOU between IVI, Gyeongbuk (province), Andong (city) signed; keynote speech, presentations, discussions delivered
– Officials from global vaccine enterprises including GSK, Sanofi Pasteur, Bill & Melinda Gates Foundation invited to attend
Gyeongsangbuk-do (Gyeongbuk or North Gyeongsang Province) held the opening ceremony of the ‘Gyeongbuk Global Vaccine Industry Forum 2016’ at Richell Hotel in Andong on September 9 to seek to set direction and strategy for development of the vaccine industry, form a network with domestic and overseas partners, and expedite mutual exchange in order to lay the foundation to nurture the vaccine industry.

Held under the theme “Present and Future of Globalization of the Korean Vaccine Industry,’ the forum is taking place on September 8 – 10. The opening ceremony on September 9 was a huge success, as it brought together more than 200 vaccine experts and officials including Gyeongbuk Governor Kim Kwan-yong, Rep. Kim Kim Gwang-lim, Andong Mayor Kwon Young-se, and Jerome Kim, Director General of the International Vaccine Institute…


:: DCVMN [Developing Country Vaccine Manufacturers Network] Annual General Meeting
24 October 2016 to 27 October 2016
Buenos Aires / / Argentina

New Vaccination Strategies Successfully Coach Immune System to Make Powerful HIV-Neutralizing Antibodies

IAVI – International AIDS Vaccine Initiative [to 10 September 2016]

September 8, 2016
New Vaccination Strategies Successfully Coach Immune System to Make Powerful HIV-Neutralizing Antibodies
New approaches that could spur the human body to produce HIV-blocking antibodies have been successful in mice mimicking the human immune system, according to five studies published today in the research journals Cell, Immunity and Science.

The results were produced by scientists affiliated with the International AIDS Vaccine Initiative (IAVI); The Scripps Research Institute (TSRI); U.S National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID); Howard Hughes Medical Institute (HHMI); The Rockefeller University; Ragon Institute of Massachusetts General Hospital, MIT and Harvard; Boston Children’s Hospital; Massachusetts Institute of Technology (MIT); Harvard Medical School (HMS); Vanderbilt University; Columbia University; Fred Hutchinson Cancer Research Center (FHCRC); Duke University School of Medicine and Kymab Ltd…



European Medicines Agency [to 10 September 2016]
Fighting antimicrobial resistance globally
EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new antibacterial agents


NIH [to 10 September 2016]
September 8, 2016
Federal prize competition seeks innovative ideas to combat antimicrobial resistance
Contestants will vie for $20 million in prizes to develop new innovative laboratory diagnostic tools that detect and distinguish antibiotic resistant bacteria.

NCI embraces scientific road map to achieve Cancer Moonshot goals
September 7, 2016 — Blue Ribbon Panel outlines 10 transformative approaches for accelerating progress against cancer.


FDA [to 10 September 2016]
What’s New for Biologics
:: Influenza Virus Vaccine for the 2016-2017 Season Posted: 9/7/2016
:: Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products
Updated to include a link to the webcast; Updated: 9/8/2016
:: Statistical Review – Afluria Quadrivalent (PDF – 251KB) Posted: 9/6/2016
:: Clinical Review – Afluria Quadrivalent (PDF – 587KB) Posted: 9/6/2016
:: Final Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products Updated: 9/6/2016


European Vaccine Initiative [to 10 September 2016]
EVI Annual Report 2015 now available
09 September 2016
The EVI 2015 Annual Report provides a detailed insight into all of EVI’s activities, projects, important meetings etc. We hope you will find it not only enlightening, but interesting reading.

New publication emanating from EVI project AMA1
08 September 2016
New article published on 30 August 2016 in Malaria Journal emanating from EVI project AMA1


Fondation Merieux [to 10 September 2016]
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
7 September 2016, Lyon (France)
“Better Foods for Better Health” White Book: 30 global experts share the latest findings on microbiota in disease prevention and obesity
The 5th edition of the Better Foods for Better Health White Book has been published, providing new insight from 30 thought leaders from science and industry on the growing role and potential of gut microbiota to improve health.


EDCTP [to 10 September 2016]
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.
6 September 2016
Notice of voluntary liquidation of EDCTP-EEIG (legal structure for the first EDCTP programme, 2003-2015)
The EDCTP-EEIG, the legal structure for the first EDCTP programme (2003-2015), is in liquidation (Dutch: in liquidatie). The EDCTP-EEIG was incorporated for the implementation of the activities set out in the contract signed between the EDCTP-EEIG and the European Commission. Following the successful completion of the first programme, the EDCTP-EEIG General Assembly approved on 3 June 2016 the complete liquidation of the EDCTP-EEIG legal entity and the winding up of its affairs…

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


August 2016 :: 28 pages
This report follows the 14th meeting of the Independent Monitoring Board (IMB) of the Global Polio Eradication Initiative (GPEI). The Report comes at a critical time. It is making an assessment of the progress of the Polio Programme with six months to go before the declared GPEI deadline. By the end of December 2016, transmission of the poliovirus should be interrupted everywhere in the world.

[Introductory Content]
When the IMB issued its previous report, it did so against a background that the Polio Programme in the two remaining endemic countries (Pakistan and Afghanistan) had the
advantage of facing the last Low Season (before the GPEI deadline) with the smallest burden of poliovirus in human history. The IMB entitled its last report: Now is the Time for Peak Performance. This title reflected the IMB’s analysis that, despite a rising tide of improving performance, the Polio Programme still had many islands of mediocrity (within countries and systemically across the programme) where sub-optimal delivery meant that the goal of stopping polio transmission in the near future remained improbable.


Since the last IMB report, there have been further, very substantial, improvements:
:: the global footprint of the poliovirus is the smallest in human history
:: the continent of Africa still has no polio endemic countries within it
:: the Polio Programme in Pakistan is achieving a high level of performance overall and in this respect is transformed from its position three years ago
: the establishment of an Emergency Operations Centre and changes of GPEI personnel in Afghanistan have led to a jump up in the level of performance
:: more female health workers are making a difference, meeting mothers on doorsteps that have not been reached before
:: within the GPEI, the quality of working relationships, the effectiveness of governance structures, and the management of big strategic changes is much better than previously

However, the IMB is quite clear that the Polio Programme has not yet reached peak performance, and this is disappointing. With six months to go, it must do so if the goal of ending polio transmission by the end of 2016 is to be realized. This challenge has become more complex since the last IMB report. It is no longer the polio Low Season in Pakistan and Afghanistan: the High Season is upon those countries’ programmes. There has been a planned global strategic switch in the type of oral polio vaccine used in immunization campaigns, with a resulting heightened risk of outbreaks of vaccine-derived viruses (these are also capable of causing paralysis). There is a world shortage of the inactivated polio vaccine (administered by injection). This vaccine should be acting as vital adjunct to boosting children’s immunity, particularly in communities where access is only being achieved intermittently but there is not
enough of it to go round…


The Polio Programme is entering uncharted waters. The GPEI promise to interrupt polio transmission everywhere in the world by the end of 2016 is only six months from its intended delivery. No one can be sure what it will take to remove every last vestige of the disease from the planet. This is in circumstances where there are many pockets of low immunity in some of the most marginalized populations of the world, and where ongoing use of the oral vaccine can
release virus that causes paralytic polio. The only modern parallel is the smallpox eradication programme: a different disease, in a different time.

Taken together, a weakness in effective surveillance, a heightened risk of vaccine-derived poliovirus, and variable performance of routine immunization demonstrate a potentially hazardous combination for the programme. There are many parts of the world that are in just this situation. In an earlier report, the IMB urged the GPEI to establish a publicly prominent list of vulnerable countries and call it The Red List. This was accepted and ran for a short time but then sank from view, thereby losing the power and transparency of the concept.

The IMB believes that the concept of a Red List should be re-established. The Polio Programme should not be waiting for the predictable to happen, it should be advocating many more preventive immunization activities – both through routine immunization and IPV and OPV campaigns…


1 The level of joint working between the governments of Pakistan and Afghanistan is still falling below that required to interrupt polio transmission in the border areas and from the large reservoirs of infection that span the two countries.

2 The low degree of political engagement in Northern Sindh is a major barrier to eliminating polio from that part of Pakistan.

3 The Polio Programme in many parts of Karachi has been chronically underperforming.

4 The number of missed children in the inaccessible eastern area of Afghanistan has gone up from 26,000 in March 2016 to 130,000 in May 2016.

5 In the southern region of Afghanistan, the proportion of missed children has hardly changed in two years and the proportion of refusals continues to be the highest of all polio-affected countries (and has been stagnant for four years).

6 The Afghanistan Polio Programme is continuing to use male vaccinators from outside despite it being well known that matching of a vaccinator’s characteristics with the religious and cultural composition of the local population is vital to acceptance; the failure of the GPEI to scale up within Afghanistan the use of local female health workers is a serious failing.

7 The performance of the Non-Governmental Organizations (NGOs) that deliver basic health
services through a contract with the Afghanistan Government is patchy and accountability and
performance management arrangements are far too weak. The relationship between this model of service delivery and the requirements to deliver a high-performing Polio Programme are not at all clear.

8 There seems to be either a lack of openness or a lack of situational awareness in the Afghanistan Polio Programme that, taken together with the other concerns, suggests an inappropriate reliance on ending transmission in Pakistan and a “good enough” performance philosophy.

9 The surveillance functions of the Polio Programme have been given much less emphasis than the immunization activities; as a result, surveillance is not fit for the purpose of addressing the challenges that the Programme now faces.

10 A poliovirus was discovered in Borno that had been circulating undetected for nearly two years, whilst half a million children have been missed. This, and multiple IMB sources speaking of a waning commitment in Nigeria, means that the Polio Programme in this country is not yet fully resilient against a re-emergence of poliovirus.

11 It is alarming that the Polio Programme has failed to meet the standards for dealing with outbreaks of vaccine-derived polioviruses (particularly so in Guinea and Madagascar). Slow reactions and delayed decision-making when viruses are discovered could be the Polio Programme’s downfall unless it learns quickly from these dysfunctions.

12 The apparent intractability of a situation, in a $1billion a year programme, in which an area of 1.5 Km in Eastern Afghanistan with a population of 1000 people has been responsible for 20% of the entire world’s polio cases in 2016 is extraordinary; the area has been inaccessible to
polio immunization teams for four years.

13 The list of countries with low levels of immunity to polio and inadequate surveillance is lengthy; the Polio Programme is not gaining from the beneficial pressures that flow from maintaining a publicly prominent Red List (as previously).

14 The Polio Programme has a wide range of innovative quantitative social data but their use is
not mainstreamed at all levels, it needs qualitative data; as a result striking findings on parental and community attitudes are not being used to generate definitive and transformational improvement in performance.

15 The outbreak of wild poliovirus in Bannu, Pakistan in April and May was a surprise; it seemed to be well protected. The Polio Programmes in Pakistan, Afghanistan, and Nigeria need to have more structured systems of soft intelligence to identify places where official monitoring data shows a “too good to be true” situation; the Programme cannot afford “more Bannus.”

16 The global oral polio vaccine switch will have left many countries with large supplies of redundant trivalent vaccine. There is a risk that an ill-informed local decision maker, mindful of waste and costs, might deploy the trivalent vaccine in immunization campaigns; it is not clear whether the GPEI has eliminated this source of risk.

17 After polio eradication has been officially certified, the oral polio vaccine will still be in use. At this point the GPEI will have been disbanded. It is not clear that there is a plan for this eventuality.


1 A very high-level GPEI leader should be appointed to strengthen the cohesiveness of the joint working of the Pakistan and Afghanistan governments. The person appointed should have the seniority and personal qualities to operate effectively in this role and should be perceived as politically neutral. The person should work out of Geneva, not the WHO Eastern Mediterranean Office (EMRO). In post by mid-September 2016.

2 The WHO Eastern Mediterranean Office (EMRO) should appoint a senior female official to its Polio Programme team. She should be charged with rapidly strengthening the role and capacity of female workers in the successful delivery of polio immunization (and in due course routine immunization). She should give immediate attention to removing the barriers to progress in Afghanistan. In post by end September 2016.

3 CDC Atlanta should facilitate the Polio Programmes in Pakistan and Afghanistan in undertaking a full process mapping of Acute Flaccid Paralysis (AFP) reporting and assessment. This should involve evaluating the shortfalls in quality in each step of the process and identify measures to strengthen them. It should be well informed with detailed local knowledge of the current situation and sufficiently granular to take account of context-specific aspects of the process that will vary from place to place. An action plan, informed by this work, should be
immediately implemented in Karachi, as a pilot, and its impact monitored. Completed by end-
September 2016.

4 The GPEI should introduce a system of financial incentives for reporting Acute Flaccid Paralysis (AFP) cases in Pakistan. To this end, any healthcare worker who reports a case should be paid, with a higher payment being given for confirmed cases. Safeguards should be built in for independent validation to prevent unfair manipulation of the system. The scheme should
be piloted in Karachi where awareness of frontline healthcare staff is very low. The urgent advice of public health officials in the Egyptian government should be sought in designing the scheme. Operational by end September 2016.

5 UNICEF should specially commission rapid qualitative data gathering to provide an in-depth understanding of the reasons for poor performance on social indicators in communities within the Pakistan-Afghanistan Core Reservoirs. Report of the findings to be with the IMB by end-September 2016.

6 Each Emergency Operations Centre (EOC) – both national and regional –should designate one team member to regularly gather soft intelligence from the field to identify situations where monitoring data are providing a falsely positive picture. This person should be someone who is completely trusted by field workers, who can speak to him or her on condition of anonymity, and who can feed back synthesized information to the EOC team; the information should be used for learning and improvement and on no account for retribution against any fieldworker.
Arrangements in place by end-September 2016.

7 The contractual arrangements governing the accountability and performance management of the Non-Governmental Organizations delivering basic health services in Afghanistan should be redrawn to address chronic underperformance and strengthen alignment with polio activities. Redesigned accountability and performance management arrangements in place by end-October 2016.

8 A publicly prominent Red List of countries and areas vulnerable to polio transmission should be re- established and more targeted, preventive immunization activities should be funded and
implemented. Red List to be posted by end-September 2016.

9 The process of implementing the GPEI standards for responding to outbreaks should be urgently reviewed at high level. This should include an open and honest assessment of the poor response to recent outbreaks, notably in Guinea. It should involve a thorough examination of the working relationships and decision-making between the headquarters of the United Nations GPEI Partners and their Regional and Country Offices. A senior independent person would be best placed to do this. Lessons learned report to be ready by end October 2016.

10 The GPEI leadership should make an intervention to urgently engage with the political leadership in Northern Sindh to establish a clear commitment and ownership of the goals of the Polio Programme. This should be done in consultation with the Pakistan Government and the Polio Programme leadership in this part of Pakistan. Political engagement secured by end-September 2016.

11 The GPEI should urgently review options for innovative approaches to environmental sampling in areas without substantial sewage systems. Environmental sampling programme
commenced in FATA by early November 2016.

12 Nigeria’s Presidential Task Force should reconvene–and the Executive Governors of each of the states should publicly reconfirm their commitment to the actions agreed in the Abuja Commitment. By end of September 2016.

The Anticipated Clinical and Economic Effects of 90–90–90 in South Africa

Annals of Internal Medicine
6 September 2016, Vol. 165. No. 5

Original Research
The Anticipated Clinical and Economic Effects of 90–90–90 in South Africa
Rochelle P. Walensky, MD, MPH; Ethan D. Borre, BA; Linda-Gail Bekker, MD, PhD; Stephen C. Resch, PhD; Emily P. Hyle, MD, SM; Robin Wood, MMed, DSc (Med); Milton C. Weinstein, PhD; Andrea L. Ciaranello, MD, MPH; Kenneth A. Freedberg, MD, MSc; and A. David Paltiel, MBA, PhD
Background: The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90–90–90 global treatment target aims to achieve 73% virologic suppression among HIV-infected persons worldwide by 2020.
Objective: To estimate the clinical and economic value of reaching this ambitious goal in South Africa, by using a microsimulation model of HIV detection, disease, and treatment.
Design: Modeling of the “current pace” strategy, which simulates existing scale-up efforts and gradual increases in overall virologic suppression from 24% to 36% in 5 years, and the UNAIDS target strategy, which simulates 73% virologic suppression in 5 years.
Data Sources: Published estimates and South African survey data on HIV transmission rates (0.16 to 9.03 per 100 person-years), HIV-specific age-stratified fertility rates (1.0 to 9.1 per 100 person-years), and costs of care ($11 to $31 per month for antiretroviral therapy and $20 to $157 per month for routine care).
Target Population: South African HIV-infected population, including incident infections over the next 10 years.
Perspective: Modified societal perspective, excluding time and productivity costs.
Time Horizon: 5 and 10 years.
Intervention: Aggressive HIV case detection, efficient linkage to care, rapid treatment scale-up, and adherence and retention interventions toward the UNAIDS target strategy.
Outcome Measures: HIV transmissions, deaths, years of life saved, maternal orphans, costs (2014 U.S. dollars), and cost-effectiveness.
Results of Base-Case Analysis: Compared with the current pace strategy, over 5 years the UNAIDS target strategy would avert 873 000 HIV transmissions, 1 174 000 deaths, and 726 000 maternal orphans while saving 3 002 000 life-years; over 10 years, it would avert 2 051 000 HIV transmissions, 2 478 000 deaths, and 1 689 000 maternal orphans while saving 13 340 000 life-years. The additional budget required for the UNAIDS target strategy would be $7.965 billion over 5 years and $15.979 billion over 10 years, yielding an incremental cost-effectiveness ratio of $2720 and $1260 per year of life saved, respectively.
Results of Sensitivity Analysis: Outcomes generally varied less than 20% from base-case outcomes when key input parameters were varied within plausible ranges.
Limitation: Several pathways may lead to 73% overall virologic suppression; these were examined in sensitivity analyses.
Conclusion: Reaching the 90–90–90 HIV suppression target would be costly but very effective and cost-effective in South Africa. Global health policymakers should mobilize the political and economic support to realize this target.
Primary Funding Source: National Institutes of Health and the Steve and Deborah Gorlin MGH Research Scholars Award.