Announcements

 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 14 October 2017]
http://cepi.net/
[Undated]
CEPI vaccine R&D pipeline and cost tracking survey
CEPI is inviting you to participate in a survey that is mapping vaccine research and development pipelines and associated costs for emerging infectious diseases.
The survey is open until 10 November 2017.
To achieve its strategic objectives, and to make efficient use of its financial resources, CEPI needs to draw on a variety of vaccine candidates and leverage diversity of product development partners. CEPI is currently building up a comprehensive knowledge base on available vaccine candidates and their current status, in order to serve vaccine preparedness needs against non-commercial epidemic disease threats…

EDCTP    [to 14 October 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
9 October 2017
EDCTP joins forces with WHO AFRO and TDR to fund implementation research
A new partnership has been formed between EDCTP, TDR (the Special Programme for Research and Training in Tropical Diseases), and the World Health Organization’s Regional Office for Africa (WHO AFRO) in recognition of a mutual interest in strengthening the capacity for health research in African countries. Collaboration between these three partners has been realised through a recently launched call “Joint WHO-AFRO/TDR/EDCTP Small Grants Scheme for implementation research on infectious diseases of poverty”, which will close on 30 November 2017…

European Medicines Agency  [to 14 October 2017]
http://www.ema.europa.eu/ema/
13/10/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2017
One generic medicine recommended for approval …
 
 
FDA [to 14 October 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
October 11, 2017 –
Statement by FDA Commissioner Scott Gottlieb, M.D. on new steps by FDA to advance patient engagement in the agency’s regulatory work
The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities.
This is the agency’s first advisory committee that’s comprised solely of patients, care-partners, and those who represent their needs. Founded by the FDA’s Center for Devices and Radiological Health (CDRH), it reflects CDRH’s commitment to keep patients at the center of their work.
The FDA’s work requires us to establish objective, consistent criteria on which we base our decisions. But ultimately, the criteria we use to judge benefit and risk turn on the parameters that matter to patients.
Involving the end-user – the patient – in identifying health priorities and outcomes desired from health interventions is critically important…
 
 
Global Fund [to 14 October 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund and The Union Deepen Partnership to Fight TB
11 October 2017
The Global Fund to Fight AIDS, Tuberculosis and Malaria and the International Union against Tuberculosis and Lung Disease, also known as The Union, announced a partnership agreement to deepen their shared commitment to end tuberculosis as an epidemic.
News
Partners Launch Global Effort to Find Missing Cases of TB
09 October 2017
Global health partners and implementers from 13 countries with a high burden of tuberculosis launched an ambitious program to find and treat an additional 1.5 million missing cases of TB by the end of 2019. The new initiative is critically important to stopping the spread of TB and to reaching the global goal of ending TB as an epidemic by 2030.
 
 
Hilleman Laboratories   [to 14 October 2017]
http://www.hillemanlabs.org/
12/10/2017
Hilleman Labs achieves successful outcome of Phase I/II Clinical Trial of its Oral Cholera Vaccine Hillchol
New Delhi: Delivering on its mission to develop affordable vaccines for global health, Hilleman Laboratories today announced that it has successfully completed the Phase I/II Clinical Trials of its novel Oral Cholera Vaccine HillcholTM to address growing need to stop Cholera in the developing world.
The Phase I/II clinical study was conducted in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). Results of the clinical trials were announced at the Vaccines for Enteric Diseases Conference 2017 recently held in Albufeira, Portugal…

Hilleman Labs successfully completes Phase I/II Clinical Trial of its Heat Stable Rotavirus Vaccine (HSRV)
12th October 2017, New Delhi: Making headway towards providing the developing nations an affordable and easy-to-use Heat Stable Rotavirus Vaccine (HSRV), Hilleman Laboratories, a joint-venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust, today announced the successful completion of Phase I/II clinical trial of its oral vaccine against the deadly Rotavirus disease.
The study was conducted in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)…
 
IAVI  [to 14 October 2017]
https://www.iavi.org/
October 2017
IAVI REPORT – VOL. 21, NO. 3, 2017
:: Decisive Moments in Wake of Paris
:: Stumbling on Greatness
:: PrEParing to Prevent HIV
:: In Brief
 
MSF/Médecins Sans Frontières  [to 14 October 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Governments Must Step Up the Use of Newer Drugs to Fight Multidrug-Resistant TB
Guadalajara, Mexico, October 13, 2017—People with drug-resistant tuberculosis (DR-TB) are still not receiving two newer tuberculosis (TB) drugs, bedaquiline and delamanid, which have shown improved cure rates for the disease, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) at the 48th Union World Conference on Lung Health in Guadalajara, Mexico, where the global TB community is meeting.
 
 
NIH  [to 14 October 2017]
http://www.nih.gov/news-events/news-releases
October 12, 2017
NIH partners with 11 leading biopharmaceutical companies to accelerate the development of new cancer immunotherapy strategies for more patients
October 12, 2017 — Supports Cancer Moonshot goal to bring immunotherapy success to more patients in half the time.

Experimental Ebola vaccines elicit year-long immune response
October 11, 2017 — NIH reports final data from large clinical trial in West Africa.
[See Milestones/Perspectives above for more detail]

NIH completes atlas of human DNA differences that influence gene expression
October 11, 2017 — This atlas will be a critical resource for the scientific community.

Durable end to the HIV/AIDS pandemic likely will require an HIV vaccine
October 10, 2017 — From a practical standpoint, ending the HIV/AIDS pandemic without a vaccine is unlikely.
   AS Fauci. An HIV vaccine is essential for ending the HIV/AIDS pandemic. Journal of the American Medical Association DOI: 10.1001/jama.2017.13505 (2017) (link is external).
[See Milestones/Perspectives above for more detail]

UNAIDS [to 14 October 2017]
http://www.unaids.org/en
Update
International Day of the Girl Child: empowering girls before, during and after crises
11 October 2017
The International Day of the Girl Child, marked every year on 11 October, highlights and addresses the needs and challenges that girls face, while promoting their empowerment and human rights.
In many parts of the world, one of the key challenges that adolescent girls face is HIV. Globally, every week 6900 adolescent girls and young women aged 15–24 years are newly infected with HIV, yet only one in three adolescent girls and young women have comprehensive and correct knowledge of how to prevent HIV. In sub-Saharan Africa, three in four new HIV infections among 15–19-year-olds are among girls.
The theme of the International Day of the Girl Child 2017 is “EmPOWER girls: before, during and after crises”. War and conflict exacerbate the vulnerability of girls to child marriage, intensify inequality and make women and girls susceptible to both household and intimate partner violence, all of which increase the vulnerability of women and girls to HIV…

Press statement
UNAIDS and UNFPA launch road map to stop new HIV infections
Global HIV Prevention Coalition holds first meeting in Geneva, Switzerland, to find ways to strengthen and sustain political commitment for HIV prevention
GENEVA, 10 October 2017—As part of global efforts to end AIDS as a public health threat, UNAIDS, the United Nations Population Fund (UNFPA) and partners have launched a new road map to reduce new HIV infections. The HIV prevention 2020 road map was launched at the first meeting of the Global HIV Prevention Coalition. The coalition is chaired by the Executive Directors of UNAIDS and UNFPA and brings together United Nations Member States, civil society, international organizations and other partners as part of efforts to reduce new HIV infections by 75% by 2020…

Update
New fund for key populations in eastern Europe and central Asia
10 October 2017
The Elton John AIDS Foundation announced on 10 October a new funding initiative for key populations in eastern Europe and central Asia.
The Key Populations Fund for Eastern Europe and Central Asia will focus on prevention and treatment of both HIV and hepatitis C for the people in the region most vulnerable to HIV—people who inject drugs, gay men and other men who have sex with men and sex workers. Over the next three years, the fund will aim to reach 20 000 people in the region with prevention, testing and treatment services…

UNICEF  [to 14 October 2017]
https://www.unicef.org/media/
12 October, 2017
Violence in al-Mayadin district, Deir ez-Zor, reportedly destroys cold room and vaccines
AMMAN/DAMASCUS,– “UNICEF has received reports that ongoing violence in Deir ez-Zor in eastern Syria has destroyed a UNICEF-supported vaccine cold room in al-Mayadin district, with at least 140,000 doses of vaccines lost, including some planned for use in tackling vaccine-preventable childhood diseases in the area. UNICEF is currently verifying this alarming report.

UNICEF emergency supplies for Rohingya children en route to Cox’s Bazar
COX’S BAZAR, 14 September 2017 – UNICEF trucks filled with emergency water, sanitation and hygiene supplies for thousands of Rohingya children are headed to Cox’s Bazar, with a steady stream of supplies in the pipeline for the coming days and weeks.

World’s second largest oral cholera vaccination campaign kicks off at Rohingya camps in Bangladesh
COX’S BAZAR, Bangladesh, 10 October 2017 – A massive cholera immunization campaign started today near Cox’s Bazar, Bangladesh, to protect newly arrived Rohingya and host communities from the life-threatening diarrheal disease. 900,000 doses of the vaccine have been mobilized and are being delivered by more than 200 mobile vaccination teams, making it the second largest oral cholera vaccination campaign ever.
 
Wellcome Trust  [to 14 October 2017]
https://wellcome.ac.uk/news
News / Published: 13 October 2017
Global pledges to speed up action on superbugs
Wellcome is investing £2.4 million in a new project to track the global impact of superbugs as part of our ongoing efforts to help address this urgent global health threat.
The Global Burden of Disease AMR project will be launched today at our international Call to Action conference.

News / Published: 10 October 2017
Findings from new malaria database are ‘wake-up call’
Researchers have compiled and analysed 115 years of malaria data in Africa, providing the most detailed picture yet of where efforts to control malaria infection are being won and lost across the continent.
The largest data repository of any parasitic disease in the world, it includes 7.8 million blood samples from more than 30,000 locations in 43 countries.
The open access dataset (opens in a new tab) was collected and analysed by KEMRI-Wellcome Trust (opens in a new tab) researchers Professor Bob Snow, Abdisalan Noor and colleagues based in Kenya, and is the result of over 20 years of research funded by Wellcome.

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PhRMA    [to 14 October 2017]
http://www.phrma.org/press-room
October 12, 2017
PhRMA, member companies and NIH create public-private partnership for immuno-oncology
A new public-private partnership will help build upon a new era in cancer treatment.

October 11, 2017
Amgen Chairman and CEO Robert A. Bradway Elected PhRMA Board Chairman-Elect
The Pharmaceutical Research and Manufacturers of America elected new officers to its board of directors.

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

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 14 October 2017)

Research article
Spatial model for risk prediction and sub-national prioritization to aid poliovirus eradication in Pakistan
Laina D. Mercer, Rana M. Safdar, Jamal Ahmed, Abdirahman Mahamud, M. Muzaffar Khan, Sue Gerber, Aiden O’Leary, Mike Ryan, Frank Salet, Steve J. Kroiss, Hil Lyons, Alexander Upfill-Brown and Guillaume Chabot-Couture
Published on: 11 October 2017
Abstract
Background
Pakistan is one of only three countries where poliovirus circulation remains endemic. For the Pakistan Polio Eradication Program, identifying high risk districts is essential to target interventions and allocate limited resources.
Methods
Using a hierarchical Bayesian framework we developed a spatial Poisson hurdle model to jointly model the probability of one or more paralytic polio cases, and the number of cases that would be detected in the event of an outbreak. Rates of underimmunization, routine immunization, and population immunity, as well as seasonality and a history of cases were used to project future risk of cases.
Results
The expected number of cases in each district in a 6-month period was predicted using indicators from the previous 6-months and the estimated coefficients from the model. The model achieves an average of 90% predictive accuracy as measured by area under the receiver operating characteristic (ROC) curve, for the past 3 years of cases.
Conclusions
The risk of poliovirus has decreased dramatically in many of the key reservoir areas in Pakistan. The results of this model have been used to prioritize sub-national areas in Pakistan to receive additional immunization activities, additional monitoring, or other special interventions.

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 14 October 2017)

Research article
Epidemiological link of a major cholera outbreak in Greater Accra region of Ghana, 2014
Cholera remains an important public health challenge globally. Several pandemics have occurred in different parts of the world and have been epidemiologically linked by different researchers to illustrate how …
Kennedy Ohene-Adjei, Ernest Kenu, Delia Akosua Bandoh, Prince Nii Ossah Addo, Charles Lwanga Noora, Priscillia Nortey and Edwin Andrew Afari
BMC Public Health 2017 17:801
Published on: 11 October 2017

EMBO Reports
01 October 2017; volume 18, issue 10
http://embor.embopress.org/content/18/10?current-issue=y

Science & Society
Viral taxonomyThe effect of metagenomics on understanding the diversity and evolution of viruses
The advent of next‐generation sequencing and metagenomics is challenging viral taxonomy to define and characterize viruses along with providing novel insights into the vast diversity of viruses and their evolution.
Philip Hunter

The European Journal of Public Health
Volume 27, Issue 5, October 2017
https://academic.oup.com/eurpub/issue/27/5

Editorials
Resilience and 21st century public health
Erio Ziglio; Natasha Azzopardi-Muscat; Lino Briguglio
European Journal of Public Health, Volume 27, Issue 5, 1 October 2017, Pages 789–790, https://doi.org/10.1093/eurpub/ckx116
Extract
The concept of ‘resilience’ is recently being increasingly used in academia, professional bodies, business, human rights and civil society organizations and in a wide-range of policy sectors. Its use in the field of public health has long been part and parcel of preventive policies designed to promote a long-term, holistic and socio-economic developmental approach to individual, community health and wellbeing. With today’s protracted economic crisis, it is more vital than ever to be clear about its particular significance if we are to foster lasting and meaningful action to strengthen resilience to improve health and well-being.
Resilience can be strengthened at individual, community and system levels. There are at least four types of resilience capacity that can be applied to these levels, usually referred to as absorptive, adaptive, anticipatory and transformative…

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 14 October 2017]

Scoping Review
The perspective of gender on the Ebola virus using a risk management and population health framework: a scoping review
In the three decades since the first reported case of Ebola virus, most known index cases have been consistently traced to the hunting of “bush meat”, and women have consistently recorded relatively high fatal…
Miriam N. Nkangu, Oluwasayo A. Olatunde and Sanni Yaya
Infectious Diseases of Poverty 2017 6:135
Published on: 11 October 2017

The Lancet
Oct 14, 2017 Volume 390 Number 10104 p1715-1810   e25-e26
http://www.thelancet.com/journals/lancet/issue/current

WHO launches new leadership, new priorities
The Lancet
Published: 14 October 2017
WHO’s Director-General, Dr Tedros, last week launched his new cabinet to widespread acclaim. His mix of deputy and assistant director-generals is made up of nine women (two-thirds of his leadership team) with a geographical spread across 14 countries. India, Brazil, Saudi Arabia, South Africa, and Barbados are all newly represented. The announcement also translated Tedros’s verbal promises into structural commitments. New priorities include Universal Health Coverage, climate change, and access to medicines. His cabinet is diverse, talented, and experienced. Now it’s all about WHO’s actions. A special session of the Executive Board will be convened in November to agree a future global programme of work for the agency.

There are important questions to resolve. How will the new team in Geneva work with regional directors and regional offices? Will the expanded number of priorities and larger executive team create more silos within an organisation that is already partly paralysed by inefficiency? Will the optimism engendered by Dr Tedros’s election be backed by donor investment to a chronically impoverished WHO? Internally, the director-general has signalled to staff that he wants urgent and profound organisational change. Reports suggest that he is likely to appoint a transformation czar and hire McKinsey consultants to manage the change.

Dr Tedros is said to be obsessed by impact, which is welcome. WHO is at its best when it amplifies its voice and reach by establishing radical and innovative initiatives led by internationally recognised technical or political leaders. This was the lesson of Gro Harlem Brundtland’s term as director-general. The goal of transformational change is good. But it might be more practical for WHO to deliver on a limited number of tangible and feasible objectives rather than speaking in terms of broad generalities and aspirations. Dr Tedros and his team will be judged on specific and measurable successes—such as pandemic protection and stronger health systems.

The announcement last week has brought additional and valuable momentum to the renewal of WHO. The agency must now raise its political game.

The Lancet
Oct 14, 2017 Volume 390 Number 10104 p1715-1810   e25-e26
http://www.thelancet.com/journals/lancet/issue/current

Health Policy
Building the foundations for sustainable development: a case for global investment in the capabilities of adolescents
Peter Sheehan, Kim Sweeny, Bruce Rasmussen, Annababette Wils, Howard S Friedman, Jacqueline Mahon, George C Patton, Susan M Sawyer, Eric Howard, John Symons, Karin Stenberg, Satvika Chalasani, Neelam Maharaj, Nicola Reavley, Hui Shi, Masha Fridman, Alison Welsh, Emeka Nsofor, Laura Laski
Summary
Investment in the capabilities of the world’s 1.2 billion adolescents is vital to the UN’s Sustainable Development Agenda. We examined investments in countries of low income, lower-middle income, and upper-middle income covering the majority of these adolescents globally to derive estimates of investment returns given existing knowledge. The costs and effects of the interventions were estimated by adapting existing models and by extending methods to create new modelling tools. Benefits were valued in terms of increased gross domestic product and averted social costs. The initial analysis showed high returns for the modelled interventions, with substantial variation between countries and with returns generally higher in low-income countries than in countries of lower-middle and upper-middle income. For interventions targeting physical, mental, and sexual health (including a human papilloma virus programme), an investment of US$4·6 per capita each year from 2015 to 2030 had an unweighted mean benefit to cost ratio (BCR) of more than 10·0, whereas, for interventions targeting road traffic injuries, a BCR of 5·9 (95% CI 5·8–6·0) was achieved on investment of $0·6 per capita each year. Interventions to reduce child marriage ($3·8 per capita each year) had a mean BCR of 5·7 (95% CI 5·3–6·1), with the effect high in low-income countries. Investment to increase the extent and quality of secondary schooling is vital but will be more expensive than other interventions—investment of $22·6 per capita each year from 2015 to 2030 generated a mean BCR of 11·8 (95% CI 11·6–12·0). Investments in health and education will not only transform the lives of adolescents in resource-poor settings, but will also generate high economic and social returns. These returns were robust to substantial variation in assumptions. Although the knowledge base on the impacts of interventions is limited in many areas, and a major research effort is needed to build a more complete investment framework, these analyses suggest that comprehensive investments in adolescent health and wellbeing should be given high priority in national and international policy.

New England Journal of Medicine
October 12, 2017  Vol. 377 No. 15
http://www.nejm.org/toc/nejm/medical-journal

Misdirections in Informed Consent — Impediments to Health Care Innovation
David A. Asch, M.D., M.B.A., Tracy A. Ziolek, M.S., and Shivan J. Mehta, M.D., M.B.A., M.S.H.P.
N Engl J Med 2017; 377:1412-1414 October 12, 2017 DOI: 10.1056/NEJMp1707991

New England Journal of Medicine
October 12, 2017  Vol. 377 No. 15
http://www.nejm.org/toc/nejm/medical-journal

Voluntary Site Accreditation — Improving the Execution of Multicenter Clinical Trials
S.C. Johnston, C.P. Austin, and F. Lewis-Hall

New England Journal of Medicine
October 12, 2017  Vol. 377 No. 15
http://www.nejm.org/toc/nejm/medical-journal

Original Articles
Ebola RNA Persistence in Semen of Ebola Virus Disease Survivors — Final Report
G.F. Deen and Others

New England Journal of Medicine
October 12, 2017  Vol. 377 No. 15
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia
Stephen B. Kennedy, M.D., Fatorma Bolay, Ph.D., Mark Kieh, M.D., Greg Grandits, M.S., Moses Badio, M.Sc., Ripley Ballou, M.D., Risa Eckes, B.S.N., Mark Feinberg, M.D., Ph.D., Dean Follmann, Ph.D., Birgit Grund, Ph.D., Swati Gupta, Dr.P.H., Lisa Hensley, Ph.D., Elizabeth Higgs, M.D., Krisztina Janosko, B.S., Melvin Johnson, B.Sc., Francis Kateh, M.D., James Logue, M.S., Jonathan Marchand, M.S., Thomas Monath, M.D., Martha Nason, Ph.D., Tolbert Nyenswah, M.P.H., François Roman, Ph.D., Eric Stavale, M.S., Julian Wolfson, Ph.D., James D. Neaton, Ph.D., and H. Clifford Lane, M.D., for the PREVAIL I Study Group*
N Engl J Med 2017; 377:1438-1447 October 12, 2017 DOI: 10.1056/NEJMoa1614067
Abstract
Background
The safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia.
Full Text of Background…
Methods
We initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (ChAd3-EBO-Z) and the recombinant vesicular stomatitis virus vaccine (rVSV∆G-ZEBOV-GP) in Liberia. A phase 2 subtrial was embedded to evaluate safety and immunogenicity. Because the incidence of EVD declined in Liberia, the phase 2 component was expanded and the phase 3 component was eliminated.
Full Text of Methods…
Results
A total of 1500 adults underwent randomization and were followed for 12 months. The median age of the participants was 30 years; 36.6% of the participants were women. During the week after the administration of vaccine or placebo, adverse events occurred significantly more often with the active vaccines than with placebo; these events included injection-site reactions (in 28.5% of the patients in the ChAd3-EBO-Z group and 30.9% of those in the rVSV∆G-ZEBOV-GP group, as compared with 6.8% of those in the placebo group), headache (in 25.1% and 31.9%, vs. 16.9%), muscle pain (in 22.3% and 26.9%, vs. 13.3%), feverishness (in 23.9% and 30.5%, vs. 9.0%), and fatigue (in 14.0% and 15.4%, vs. 8.8%) (P<0.001 for all comparisons); these differences were not seen at 1 month. Serious adverse events within 12 months after injection were seen in 40 participants (8.0%) in the ChAd3-EBO-Z group, in 47 (9.4%) in the rVSV∆G-ZEBOV-GP group, and in 59 (11.8%) in the placebo group. By 1 month, an antibody response developed in 70.8% of the participants in the ChAd3-EBO-Z group and in 83.7% of those in the rVSV∆G-ZEBOV-GP group, as compared with 2.8% of those in the placebo group (P<0.001 for both comparisons). At 12 months, antibody responses in participants in the ChAd3-EBO-Z group (63.5%) and in those in the rVSV∆G-ZEBOV-GP group (79.5%) remained significantly greater than in those in the placebo group (6.8%, P<0.001 for both comparisons).
Full Text of Results…
Conclusions
A randomized, placebo-controlled phase 2 trial of two vaccines that was rapidly initiated and completed in Liberia showed the capability of conducting rigorous research during an outbreak. By 1 month after vaccination, the vaccines had elicited immune responses that were largely maintained through 12 months. (Funded by the National Institutes of Allergy and Infectious Diseases and the Liberian Ministry of Health; PREVAIL I ClinicalTrials.gov number, NCT02344407.)

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
[Accessed 14 October 2017]

First Wave of the 2016-17 Cholera Outbreak in Hodeidah City, Yemen – Acf Experience and Lessons Learned
October 13, 2017 · Research Article
Introduction: Although cases were reported only in 2010 and 2011, cholera is probably endemic in Yemen. In the context of a civil war, a cholera outbreak was declared in different parts of the country October 6th, 2016. This paper describes the ACF outbreak response in Hodeidah city from October 28th, 2016 to February 28th, 2017 in order to add knowledge to this large outbreak.
Methods: The ACF outbreak response in Hodeidah city included a case management component and prevention measures in the community. In partnership with the Ministry of Public Health and Population of Yemen (MoPHP), the case management component included a Cholera Treatment Center (CTC) implemented in the Al Thoraw hospital, 11 Oral Rehydration Therapy Corners (ORTCs) and an active case finding system. In partnership with other stakeholders, prevention measures in the community, including access to safe water and hygiene promotion, were implemented in the most affected communities of the city.
Results: From October 28th, 2016 until February 28th, 2017, ACF provided care to 8,270 Acute Watery Diarrhea (AWD) cases, of which 5,210 (63%) were suspected cholera cases, in the CTC and the 11 ORTCs implemented in Hodeidah city. The attack rate was higher among people living in Al Hali district, with a peak in November 2016. At the CTC, 8% of children under 5 years-old also presented with Severe Acute Malnutrition (SAM). The Case-Fatality Rate (CFR) was low (0.07%) but 15% of admitted cases defaulted for cultural and security reasons. Environmental management lacked the information to appropriately target affected areas. Financial resources did not allow complete coverage of the city.
Conclusion: Response to the first wave of a large cholera outbreak in Hodeidah city was successful in maintaining a CFR <1% in the CTC. However, considering the actual context of Yemen and its water infrastructure, much more efforts are needed to control the current outbreak resurgence.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 14 October 2017)

Research Article
Modeling the environmental suitability of anthrax in Ghana and estimating populations at risk: Implications for vaccination and control
Ian T. Kracalik, Ernest Kenu, Evans Nsoh Ayamdooh, Emmanuel Allegye-Cudjoe, Paul Nokuma Polkuu, Joseph Asamoah Frimpong, Kofi Mensah Nyarko, William A. Bower, Rita Traxler, Jason K. Blackburn
| published 13 Oct 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005885

Is mass drug administration against lymphatic filariasis required in urban settings? The experience in Kano, Nigeria
Dung D. Pam, Dziedzom K. de Souza, Susan Walker, Millicent Opoku, Safiya Sanda, Ibrahim Nazaradeen, Ifeoma N. Anagbogu, Chukwu Okoronkwo, Emmanuel Davies, Elisabeth Elhassan, David Molyneux, Moses J. Bockarie, Benjamin G. Koudou
Research Article | published 11 Oct 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006004

Insights and efforts to control rabies in Zambia: Evaluation of determinants and barriers to dog vaccination in Nyimba district
Carolyn Patricia Mulipukwa, Boyd Mudenda, Allan Rabson Mbewe
Research Article | published 09 Oct 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005946

PLoS One
http://www.plosone.org/

Understanding the perceived logic of care by vaccine-hesitant and vaccine-refusing parents: A qualitative study in Australia
Paul R. Ward, Katie Attwell, Samantha B. Meyer, Philippa Rokkas, Julie Leask
Research Article | published 12 Oct 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0185955

PLoS One
http://www.plosone.org/

Assessing the individual risk of fecal poliovirus shedding among vaccinated and non-vaccinated subjects following national health weeks in Mexico
Leticia Ferreyra-Reyes, Luis Pablo Cruz-Hervert, Stephanie B. Troy, ChunHong Huang, Clea Sarnquist, Guadalupe Delgado-Sánchez, Sergio Canizales-Quintero, Marisa Holubar, Elizabeth Ferreira-Guerrero, Rogelio Montero-Campos, Mauricio Rodríguez-Álvarez, Norma Mongua-Rodriguez, Yvonne Maldonado, Lourdes García-García
Research Article | published 12 Oct 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0185594

PLoS One
http://www.plosone.org/

Violence, insecurity, and the risk of polio: A systematic analysis
Kia Guarino, Arend Voorman, Maxime Gasteen, Donte Stewart, Jay Wenger
Research Article | published 11 Oct 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0185577
Conclusion
National virologic and immunologic indicators understate the risk of poliovirus spread in areas with violence and insecurity, and the inclusion of such factors improves precision. In addition, the link between violence and incidence of disease highlights the broader challenge of implementing health interventions in conflict areas. We discuss practical implications of this work in understanding and measuring the risks to polio eradication and other global health initiatives, and the policy implications of the need to reach vulnerable populations in conflict zones.

PLoS One
http://www.plosone.org/

Experiences of operational costs of HPV vaccine delivery strategies in Gavi-supported demonstration projects
Siobhan Botwright, Taylor Holroyd, Shreya Nanda, Paul Bloem, Ulla K. Griffiths, Anissa Sidibe, Raymond C. W. Hutubessy
Research Article | published 10 Oct 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0182663
Abstract
From 2012 to 2016, Gavi, the Vaccine Alliance, provided support for countries to conduct small-scale demonstration projects for the introduction of the human papillomavirus vaccine, with the aim of determining which human papillomavirus vaccine delivery strategies might be effective and sustainable upon national scale-up. This study reports on the operational costs and cost determinants of different vaccination delivery strategies within these projects across twelve countries using a standardized micro-costing tool. The World Health Organization Cervical Cancer Prevention and Control Costing Tool was used to collect costing data, which were then aggregated and analyzed to assess the costs and cost determinants of vaccination. Across the one-year demonstration projects, the average economic and financial costs per dose amounted to US$19.98 (standard deviation ±12.5) and US$8.74 (standard deviation ±5.8), respectively. The greatest activities representing the greatest share of financial costs were social mobilization at approximately 30% (range, 6–67%) and service delivery at about 25% (range, 3–46%). Districts implemented varying combinations of school-based, facility-based, or outreach delivery strategies and experienced wide variation in vaccine coverage, drop-out rates, and service delivery costs, including transportation costs and per diems. Size of target population, number of students per school, and average length of time to reach an outreach post influenced cost per dose. Although the operational costs from demonstration projects are much higher than those of other routine vaccine immunization programs, findings from our analysis suggest that HPV vaccination operational costs will decrease substantially for national introduction. Vaccination costs may be decreased further by annual vaccination, high initial investment in social mobilization, or introducing/strengthening school health programs. Our analysis shows that drivers of cost are dependent on country and district characteristics. We therefore recommend that countries carry out detailed planning at the national and district levels to define a sustainable strategy for national HPV vaccine roll-out, in order to achieve the optimal balance between coverage and cost.

Preventive Medicine
Volume 102, Pages 1-126 (September 2017)
http://www.sciencedirect.com/science/journal/00917435/102?sdc=1

Original Research Article
Determinants of human papillomavirus vaccination uptake among adolescent girls: A theory-based longitudinal study among Hong Kong Chinese parents
Pages 24-30
Linda Dong-Ling Wang, Wendy Wing Tak Lam, Richard Fielding

Science         
13 October 2017   Vol 358, Issue 6360
http://www.sciencemag.org/current.dtl
Special Issue: Remote sensing

In Depth
Drug-resistant malaria advances in Mekong
By Leslie Roberts
Science13 Oct 2017 : 155-156 Restricted Access
Dangerous strain has spread to Vietnam, but experts sharply dispute its risk to the world.

Vaccine
Volume 35, Issue 43, Pages 5731-5946 (13 October 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/43?sdc=1

The value of multi-country joint regulatory reviews: The experience of a WHO joint technical consultation on the CYD-TDV (Dengvaxia®) dossier
Pages 5731-5733
Kirsten Vannice, Liliana Chocarro, Michael Pfleiderer, Ahmed Bellah, Michael Ward, In-Kyu Yoon, Joachim Hombach

Vaccine
Volume 35, Issue 43, Pages 5731-5946 (13 October 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/43?sdc=1

Data and product needs for influenza immunization programs in low- and middle-income countries: Rationale and main conclusions of the WHO preferred product characteristics for next-generation influenza vaccines
Pages 5734-5737
Kathleen M. Neuzil, Joseph S. Bresee, Fernando de la Hoz, Kari Johansen, Ruth A. Karron, Anand Krishnan, Shabir A. Madhi, Punam Mangtani, David J. Spiro, Justin R. Ortiz, On behalf of the WHO Preferred Product Characteristics for Next-Generation Influenza Vaccines Advisory Group

Vaccine
Volume 35, Issue 43, Pages 5731-5946 (13 October 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/43?sdc=1

WHO position on the use of fractional doses – June 2017, addendum to vaccines and vaccination against yellow fever WHO: Position paper – June 2013
Pages 5751-5752
World Health Organization

Vaccine
Volume 35, Issue 43, Pages 5731-5946 (13 October 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/43?sdc=1

Human papillomavirus vaccines: WHO position paper, May 2017–Recommendations
Pages 5753-5755
World Health Organization

Vaccine
Volume 35, Issue 43, Pages 5731-5946 (13 October 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/43?sdc=1

Reviews
The impact of 10-valent and 13-valent pneumococcal conjugate vaccines on hospitalization for pneumonia in children: A systematic review and meta-analysis
Review Article
Pages 5776-5785
Cristiano Alicino, Chiara Paganino, Andrea Orsi, Matteo Astengo, Cecilia Trucchi, Giancarlo Icardi, Filippo Ansaldi
Abstract
Background
This systematic review and meta-analysis aimed at summarizing available data on the impact of PCV10 and PCV13 in reducing the incidence of CAP hospitalizations in children aged <5 years.
Methods
A systematic search of the literature was conducted. We included time-series analyses and before-after studies, reporting the incidence of hospitalization for pneumonia in the periods before and after the introduction of PCV10 or PCV13 into the immunization program. Pooled estimates of Incidence Rate Ratio (IRR) were calculated by using a random-effects meta-analytic model. Results were stratified according to age-groups (<24 months and 24–59 months) and case definitions of pneumonia (clinically and radiologically confirmed pneumonia).
Results
A total of 1533 potentially relevant articles were identified. Of these, 12 articles were included in the analysis. In children aged <24 months, the meta-analysis showed a reduction of 17% (95%CI: 11–22%, p-value < 0.001) an of 31% (95%CI: 26–35%, p-value < 0.001) in the hospitalization rates respectively for clinically and radiologically confirmed pneumonia, respectively, after the introduction of the novel PCVs.
In children aged 24–59 months, the meta-analysis showed a reduction of 9% (95%CI: 5–14%, p-value < 0.001) and of 24% (95%CI: 12–33%, p-value < 0.001) in the hospitalization rates for clinically and radiologically confirmed pneumonia, respectively, after the introduction of the novel PCVs.
High heterogeneity was detected among studies evaluating the hospitalization rate for clinically and radiologically confirmed pneumonia.
Conclusions
The results of this study revealed a significant impact of PCV10 and PCV13 in reducing the hospitalizations for pneumonia, particularly in children aged <24 months and for radiologically confirmed disease. Further appropriately designed studies, comparing the impact of PCV10 and PCV13, are needed in order to obtain solid data on which to establish future immunization strategies.

Vaccine
Volume 35, Issue 43, Pages 5731-5946 (13 October 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/43?sdc=1

Regular Papers
Comparison of two control groups for estimation of oral cholera vaccine effectiveness using a case-control study design
Original Research Article
Pages 5819-5827
Molly F. Franke, J. Gregory Jerome, Wilfredo R. Matias, Ralph Ternier, Isabelle J. Hilaire, Jason B. Harris, Louise C. Ivers
Abstract
Background
Case-control studies to quantify oral cholera vaccine effectiveness (VE) often rely on neighbors without diarrhea as community controls. Test-negative controls can be easily recruited and may minimize bias due to differential health-seeking behavior and recall. We compared VE estimates derived from community and test-negative controls and conducted bias-indicator analyses to assess potential bias with community controls.
Methods
From October 2012 through November 2016, patients with acute watery diarrhea were recruited from cholera treatment centers in rural Haiti. Cholera cases had a positive stool culture. Non-cholera diarrhea cases (test-negative controls and non-cholera diarrhea cases for bias-indicator analyses) had a negative culture and rapid test. Up to four community controls were matched to diarrhea cases by age group, time, and neighborhood.
Results
Primary analyses included 181 cholera cases, 157 non-cholera diarrhea cases, 716 VE community controls and 625 bias-indicator community controls. VE for self-reported vaccination with two doses was consistent across the two control groups, with statistically significant VE estimates ranging from 72 to 74%. Sensitivity analyses revealed similar, though somewhat attenuated estimates for self-reported two dose VE. Bias-indicator estimates were consistently less than one, with VE estimates ranging from 19 to 43%, some of which were statistically significant.
Conclusions
OCV estimates from case-control analyses using community and test-negative controls were similar. While bias-indicator analyses suggested possible over-estimation of VE estimates using community controls, test-negative analyses suggested this bias, if present, was minimal. Test-negative controls can be a valid low-cost and time-efficient alternative to community controls for OCV effectiveness estimation and may be especially relevant in emergency situations.

Vaccine
Volume 35, Issue 43, Pages 5731-5946 (13 October 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/43?sdc=1

An ensemble approach to predicting the impact of vaccination on rotavirus disease in Niger
Original Research Article
Pages 5835-5841
Jaewoo Park, Joshua Goldstein, Murali Haran, Matthew Ferrari
Abstract
Recently developed vaccines provide a new way of controlling rotavirus in sub-Saharan Africa. Models for the transmission dynamics of rotavirus are critical both for estimating current burden from imperfect surveillance and for assessing potential effects of vaccine intervention strategies. We examine rotavirus infection in the Maradi area in southern Niger using hospital surveillance data provided by Epicentre collected over two years. Additionally, a cluster survey of households in the region allows us to estimate the proportion of children with diarrhea who consulted at a health structure. Model fit and future projections are necessarily particular to a given model; thus, where there are competing models for the underlying epidemiology an ensemble approach can account for that uncertainty. We compare our results across several variants of Susceptible-Infectious-Recovered (SIR) compartmental models to quantify the impact of modeling assumptions on our estimates. Model-specific parameters are estimated by Bayesian inference using Markov chain Monte Carlo. We then use Bayesian model averaging to generate ensemble estimates of the current dynamics, including estimates of , the burden of infection in the region, as well as the impact of vaccination on both the short-term dynamics and the long-term reduction of rotavirus incidence under varying levels of coverage. The ensemble of models predicts that the current burden of severe rotavirus disease is 2.6–3.7% of the population each year and that a 2-dose vaccine schedule achieving 70% coverage could reduce burden by 39–42%.

Vaccine: Development and Therapy
https://www.dovepress.com/vaccine-development-and-therapy-archive111
(Accessed 14 October 2017)

Review
The new first-line defense: the potential of nasopharyngeal colonization in vaccine strategies
Chan WY, Cohen JM, Brown JS
Vaccine: Development and Therapy 2016, 6:47-57
Published Date: 17 October 2016

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 14 October 2017)

Open Access
Article
Improving Influenza Vaccination Rate among Primary Healthcare Workers in Qatar
by Khalid H. Elawad, Elmoubasher A. Farag, Dina A. Abuelgasim, Maria K. Smatti, Hamad E. Al-Romaihi, Mohammed Al Thani, Hanan Al Mujalli, Zienab Shehata, Merin Alex, Asmaa A. Al Thani and Hadi M. Yassine
Vaccines 2017, 5(4), 36; doi:10.3390/vaccines5040036 – 10 October 2017
Abstract
The purpose of this study was to improve influenza vaccination, and determine factors influencing vaccine declination among health care workers (HCW) in Qatar. We launched an influenza vaccination campaign to vaccinate around 4700 HCW in 22 Primary Health Care Corporation (PHCC) centers in Qatar between 1st and 15th of November, 2015. Our target was to vaccinate 60% of all HCW. Vaccine was offered free of charge at all centers, and information about the campaign and the importance of influenza vaccination was provided to employees through direct communication, emails, and social media networks. Staff were reported as vaccinated or non-vaccinated using a declination form that included their occupation, place of work and reasons for declining the vaccine. Survey responses were summarized as proportional outcomes. We exceeded our goal, and vaccinated 77% of the target population. Only 9% declined to take the vaccine, and the remaining 14% were either on leave or had already been vaccinated. Vaccine uptake was highest among aides (98.1%), followed by technicians (95.2%), and was lowest amongst pharmacists (73.2%), preceded by physicians (84%). Of those that declined the vaccine, 34% provided no reason, 18% declined it due to behavioral issues, and 21% declined it due to medical reasons. Uptake of influenza vaccine significantly increased during the 2015 immunization campaign. This is attributed to good planning, preparation, a high level of communication, and providing awareness and training to HCW with proper supervision and monitoring

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

Papillomavirus Research
Volume 4, December 2017, Pages 72-78
Human papillomavirus (HPV) vaccine coverage achievements in low and middle-income countries 2007–2016
Introduction
Since 2007, HPV vaccine has been available to low and middle income countries (LAMIC) for small-scale ‘demonstration projects’, or national programmes. We analysed coverage achieved in HPV vaccine demonstration projects and national programmes that had completed at least 6 months of implementation between January 2007–2016.
Open Forum Infectious Diseases
Volume 4, Issue suppl_1, 1 October 2017, Pages S325
Human Papillomavirus (HPV) Knowledge, Vaccine Acceptability and Acceptability of Text Message Reminders for Vaccine Doses in Adolescents Presenting to an Urban Emergency Department (ED)
Waridibo E Allison, MBBS PhD Ada Rubin, BA Deborah Levine, MD
Conclusion
Adolescents find it acceptable to receive HPV vaccination in these EDs and text message reminders for subsequent vaccine doses. Exploration of initial HPV vaccination of unvaccinated adolescents in the ED, with follow up doses in more traditional clinic settings aided by text message reminders warrants further investigation. Though a challenging care environment, the ED should not be ignored as a potential site for public health interventions such as HPV vaccination in adolescents.

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.
 
Forbes
http://www.forbes.com/
Accessed 14 October 2017
What’s In The Smallpox Vaccine?
K.N. Smith, Contributor
We still don’t know where the virus in smallpox vaccine actually came from, but a new genetic study offers a tantalizing clue.

Foreign Policy
http://foreignpolicy.com/
Accessed 14 October 2017
Yemen’s Man-Made Cholera Outbreak Is About to Break a Record
In Haiti, it took seven years for the number of cholera cases to surpass 800,000. In Yemen, it’s taken several months.
Dan De Luce | October 9, 2017

New York Times
http://www.nytimes.com/
Accessed 14 October 2017
WHO Says Attack on Syria Vaccine Store Leaves Children at Risk
The World Health Organization said on Friday it had received reports of an attack on medical facilities in eastern Syria that had destroyed a store containing more than 130,000 vaccine doses against measles and polio.
October 13, 2017 – By REUTERS – World –

California Declares Emergency to Fight Hepatitis A Outbreak
California Gov. Jerry Brown on Friday declared a state of emergency to combat a hepatitis A outbreak that has claimed 18 lives in San Diego.
October 13, 2017 – By THE ASSOCIATED PRESS – U

GlaxoSmithKline’s Shingles Vaccine Gets Approval in Canada
Canadian health regulators have approved GlaxoSmithKline’s key shingles vaccine, the company said on Friday.
October 13, 2017 – By REUTERS –

Washington Post
http://www.washingtonpost.com/
Accessed 14 October 2017
The mother jailed for refusing to vaccinate her son says she would ‘do it all over again’
Lindsey Bever and Kristine Phillips · National/health-science · Oct 13, 2017
 

Think Tanks et al

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 14 October 2017
Health in a Time of Austerity – Can Fiscal Measures Help?
Event
10/26/17
In many countries, it is difficult to raise taxes and therefore difficult to increase spending on health care. Nevertheless, many of the factors that determine population health—and how it is distributed among citizens—do not involve spending more on healthcare services, per se. Rather, the burden of many non-communicable diseases and external injuries can be influenced by creative reform of taxes and subsidies. Taxing tobacco, alcohol, and sugar-sweetened beverages can reduce consumption of products which contribute to cardiovascular disease, traffic accidents, and diabetes. Subsidies for condoms, vaccines, and TB diagnostics can reduce the prevalence of many important infectious diseases. Ramanan Laxminarayan, Director of the Center for Disease Dynamics, Economics & Policy, will present findings from his research with Ian Parry at the International Monetary Fund on the potential for health gains from taxes and subsidies. This lunchtime talk will be moderated by William Savedoff, Senior Fellow at the Center for Global Development.

Defining Benefits for Universal Health Care—How Governments Can Get the Most Bang for Their Health Care Buck
Blog Post
10/10/17
Amanda Glassman and Rebecca Forman
Vaccinate children against measles and mumps or pay for the costs of dialysis treatment for kidney disease patients? Pay for cardiac patients to undergo lifesaving surgery, or channel money toward efforts to prevent cardiovascular disease in the first place? For universal health care (UHC) to become a reality, policymakers looking to make their money go as far as possible must make tough life-or-death choices like these.

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_7 October 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

Milestones :: Perspectives
 
New WHO leadership team announced
3 October 2017 – This morning, WHO Director-General Dr Tedros Adhanom Ghebreyesus announced his senior leadership team.

The new team includes former ministers of health, some of the world’s leading physicians, scientists and researchers, and programmatic experts in universal health coverage, health emergencies, communicable and noncommunicable diseases, climate and environmental health, and women’s, adolescents’ and children’s health. Individually and collectively, they have a wealth of experience across government, private sector, multilateral, civil society and academic organizations.

“The team represents 14 countries, including all WHO regions, and is more than 60% women, reflecting my deep-held belief that we need top talent, gender equity and a geographically diverse set of perspectives to fulfil our mission to keep the world safe,” said Dr Tedros.

Deputy Directors-General
:: Dr Soumya Swaminathan will be Deputy Director-General for Programmes and Jane Ellison will be Deputy Director-General for Corporate Operations.
Dr Soumya Swaminathan has more than 30 years of experience in clinical care, research and translating those findings into programs. She most recently served as Secretary of the Department of Health Research in India and as Director General of the Indian Council of Medical Research.
Jane Ellison brings with her more than 30 years of experience in government, commerce and change management. Most recently, she was the Special Parliamentary Adviser to the UK’s Chancellor of the Exchequer. She also served as the UK’s Public Health Minister from 2014 to 2016.
In addition, Dr Peter Salama will remain in his role as the Executive Director of the Health Emergencies Programme.

The Assistant Director-General appointees are:
:: Dr Bernhard Schwartländer, Chef de Cabinet
:: Dr Naoko Yamamoto, Assistant Director-General for Universal Health Coverage and Health Systems Cluster
:: Professor Lubna A. Al-Ansary, Assistant Director-General for Metrics and Measurement
:: Dr Svetlana Akselrod, Assistant Director-General for Noncommunicable Diseases and Mental Health
: Ambassador Michèle Boccoz, Assistant Director-General for External Relations
:: Dr Ranieri Guerra, Assistant Director-General for Special Initiatives
:: Dr Ren Minghui, Assistant Director-General for Communicable Diseases
:: Dr Mariângela Batista Galvão Simão, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals
: Dr Princess Nothemba (Nono) Simelela, Assistant Director-General for Family, Women, Children and Adolescents
:: Mr Stewart Simonson, Assistant Director-General for General Management
: Dr Joy St John, Assistant Director-General for Climate and Other Determinants of Health

All of these appointees will be transitioning into their new roles over the next several weeks.

“I am thrilled to welcome this group of diverse, talented global health leaders to WHO and am grateful for the opportunity to work alongside them to ensure health for all.

“I also would like to acknowledge the work of my transition team, chaired by Dr Senait Fisseha, which has been instrumental not only in helping me seamlessly move into the Director-General role, but also in putting together this leadership team,” said Dr Tedros.
 
 
Editor’s Note:
We include the bios of two appointees whose portfolios seems most closely aligned to our Center’s focus. Bio sketches of all appointees above are available here
 
Dr Ren Minghui, Assistant Director-General for Communicable Diseases
Dr Ren Minghui has served as WHO Assistant Director-General for HIV/AIDS, Tuberculosis, Malaria and Neglected Tropical Diseases since January 2016 and is continuing this work under his new title Assistant Director General for Communicable Diseases. Prior to this role, he was Director-General for International Cooperation in the National Health and Family Planning Commission of the People’s Republic of China. He brings nearly 30 years of public health experience, working on health policy and health reform in China’s Ministry of Health, where he focused primarily on health systems research and health insurance reform. Later, his work focused on international health cooperation, during which time he led a number of health committees and programmes, working closely with international partners. As part of this work, he oversaw the development of the China-Africa health cooperation process, initiated health cooperation with BRICS countries, and engaged in regional health cooperation with ASEAN, APEC and countries of the Greater Mekong subregion. In addition, he has served as Vice-chair of WHO’s Executive Board, a member of the UNAIDS Programme Coordinating Board, and a representative of the Board of the Global Fund to Fight AIDS, TB and Malaria. Dr Ren is a medical doctor and holds a PhD in Social Medicine and Health and a Masters in Public Health.

Dr Mariângela Batista Galvão Simão, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals
Dr Mariângela Batista Galvão Simão from Brazil has been appointed Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals. Most recently, she was Director of Community Support, Social Justice and Inclusion at UNAIDS. In addition to her work at UNAIDS, she brings more than 30 years of experience working in the Brazilian public health system and has played an active role in enhancing access and decentralizing health services in the country. Between 2006 and 2010, she served as Director of the National STD/AIDS and Viral Hepatitis Department in the Brazilian Ministry of Health, where she led successful price negotiations with pharmaceutical companies to lower the price of HIV medication. During this time, she also represented the Brazilian Ministry of Health in the negotiations that led to the constitution of UNITAID in 2006, including its governing body, where she served as a board member until 2008. She was trained as a pediatrician in Brazil and holds an MSc degree in public health from University of London, United Kingdom

Cholera
 
Yemen
Field visits to Ibb and Hudaydah: Summary of immediate action points and recommendations, 20 September 2017
2 October 2017
:: As of 1 of October 2017, the cumulative total of suspected cholera cases reached 777,229 and 2134 associated deaths in 22 out of 23 governorates across the country.
:: The overall case fatality rate shows a noticeable decrease recording 0.27%. Raymah governorate continues to report the highest case fatality rate (0.93%).
:: Children under the age of 5 years represent 25.45% of the cases and 16.93% of deaths. Children under the age of 18 represent 60% of suspected cases.
:: People over the age of 60 continue to report the highest numbers of deaths (668 cases, 31.3%).
:: The trend at country level over the past 3 weeks is considered stable.
:: At governorate level, the trend decreased in 11 governorates ( Amarn -11%), (Al Dhalea -11%), ( Abyan -12%), ( Sana’a -22%), (Hajja, -10), ( Aden, -15%), ( Taiz,-10%), (Al Mahrah, -72%), ( shabwa, -58%), (Moklla, -21%) and ( Say’on, -100). The trend has increased in two governorates (Marib, +12 % and Sa’adah +25%).
 
::::::
 
UN: More Should Have Been Done to Fight Cholera in Yemen
By THE ASSOCIATED PRESSOCT. 3, 2017, 1:18 P.M. E.D.T.
GENEVA — The World Health Organization’s emergencies chief says the agency could have acted faster and sent more vaccines to fight a massive, deadly surge of cholera cases in war-battered Yemen this year.
Dr. Peter Salama still expressed optimism that “we are turning (the) corner” on the preventable, water-borne disease that has topped 700,000 suspected cases and caused more than 2,000 deaths this year.
Salama spoke to reporters Tuesday as the U.N. agency and its partners laid out ambitious projects to reduce the number of annual cholera deaths by 90 percent by 2030…
In Yemen, the country’s 2-1/2 war has devastated the health system and public services and put the country on the brink of famine. Yemen had been set to receive a million doses of cholera vaccine over the summer but the government opted not to take them.
Salama said the Yemen government said it didn’t believe that would be enough.
“Could WHO and the cholera-specific partners have scaled up more quickly the case-management work, and could we have tried to mobilize more doses for cholera vaccine given the very limited supply globally of cholera vaccine? I think so — yes,” Salama said…
 
::::::
::::::
 
Ending Cholera – A Global Roadmap to 2030
Global Task Force on Cholera Control
3 October 2017 :: 32 poges
:: Summary: Ending Cholera – A Global Roadmap to  2030 pdf, 3.07Mb
:: Ending Cholera – A Global Roadmap to 2030 pdf, 6.20Mb
Ending Cholera—A Global Roadmap to 2030 operationalises the new global strategy for cholera control at the country level and provides a concrete path toward a world in which cholera is no longer a threat to public health. By implementing the strategy between now and 2030, the Global Task Force on Cholera Control (GTFCC) partners will support countries to reduce cholera deaths by 90 percent. With the commitment of cholera-affected countries, technical partners, and donors, as many as 20 countries could eliminate disease transmission by 2030.
With input and support from the following partners: the Bill & Melinda Gates Foundation; the Centers for Disease Control and Prevention (CDC); Global Health Visions; Gavi, the Vaccine Alliance; International Federation of the Red Cross (IFRC); Johns Hopkins University; Medecins Sans Frontières (MSF); The Mérieux Foundation; the Task Force for Global Health; UNICEF; the Veolia Foundation; WaterAid; and from the WHO Health Emergencies Programme (WHE); Immunization, Vaccines and Biologicals (IVB); and Public Health, Environmental and Social Determinants (PHE) departments as well as the regional offices at the World Health Organization.
 
Video Press Conference
Launch of Global Roadmap to End Cholera – Press Conference (Geneva, 4 October 2017)
[Video: 1:19:39]
Speakers:
:: Dr Peter Salama, Director, WHO Health Emergencies
:: Julie Hall, Chief of Staff and Special Advisor on Health, IFRC
:: Seth Berkley, Chief Executive Officer, GAVI
:: Tim Wainwright, Chief Executive Officer, WaterAid
:: Benoit Miribel, Director General, Foundation Merieux
 
Media Release
Partners commit to reduce cholera deaths by 90 per cent by 2030
Joint press release – UNICEF, WHO and others join in renewed push on deadly disease

Geneva, 03 October 2017 – An ambitious new strategy to reduce deaths from cholera by 90 per cent by 2030 will be launched tomorrow by the Global Task Force on Cholera Control (GTFCC), a diverse network of more than 50 UN and international agencies, academic institutions, and NGOs that supports countries affected by the disease.
Cholera kills an estimated 95 000 people and affects 2.9 million more every year. Urgent action is needed to protect communities, prevent transmission and control outbreaks.
The GTFCC’s new plan, Ending Cholera: A Global Roadmap to 2030, recognizes that cholera spreads in endemic “hotspots” where predictable outbreaks of the disease occur year after year.
The Global Roadmap aims to align resources, share best practice and strengthen partnerships between affected countries, donors and international agencies. It underscores the need for a coordinated approach to cholera control with country-level planning for early detection and response to outbreaks. By implementing the Roadmap, up to 20 affected countries could eliminate cholera by 2030.

“The World Health Organization is proud to be part of this new joint initiative to stop deaths from cholera. The disease takes its greatest toll on the poor and the vulnerable – this is quite unacceptable. This roadmap is the best way we have to bring this to an end,” said Dr Tedros Adhanom Ghebreyesus, Director General of the World Health Organization.
“Every death from cholera is preventable with the tools available today, including use of the Oral Cholera Vaccine and improved access to basic safe water, sanitation and hygiene as set out in the Roadmap,” said Dr Tedros Adhanom Gebreyesus, Director General of the World Health Organization. “This is a disease of inequity that affects the poorest and most vulnerable. It is unacceptable that nearly two decades into the 21st century, cholera continues to destroy livelihoods and cripple economies. We must act together. And we must act now.”
Advances in the provision of water sanitation and hygiene (WASH) services have made Europe and North America cholera-free for several decades.  Today, although access to WASH is recognized as a basic human right by the United Nations, over 2 billion people worldwide still lack access to safe water and are potentially at risk of cholera. Weak health systems and low early detection capacity further contribute to the rapid spread of outbreaks.

“It is intolerable that so many of the world’s poorest and most vulnerable children should die as a result of cholera,” said Ted Chaiban, Director of UNICEF’s global programmes.  “We know how to prevent it. This requires the commitment and action from all sides, including investment in safe water and sanitation, key health interventions and engaging communities on basic health and hygiene behaviours. We can make a difference.”

Cholera disproportionally impacts communities already burdened by conflict, lack of infrastructure, poor health systems, and malnutrition. Protecting these communities before cholera strikes is significantly more cost-effective than continually responding to outbreaks.
The introduction of the oral cholera vaccine has been a game-changer in the battle to control cholera, bridging the gap between emergency response and longer-term control. Two WHO-approved oral cholera vaccines are now available and individuals can be fully vaccinated for just US$6 per person, protecting them from the disease for up to three years.
The Global Roadmap provides an effective mechanism to synchronize the efforts of countries, donors, and technical partners. It underscores the need for a multi-sectoral approach to cholera control with country-level planning for early detection and response to outbreaks.
By strengthening WASH in endemic “hotspots”, cholera outbreaks can be prevented. By detecting cholera outbreaks early, and responding immediately, large-scale uncontrolled outbreaks like the one observed in Yemen can be avoided – even in crisis situations.

Featured Journal Content
 
The Lancet
Oct 07, 2017 Volume 390 Number 10103 p1623-1714   e24
http://www.thelancet.com/journals/lancet/issue/current
Editorial
Cholera: ending a 50-year pandemic
The Lancet
Published: 07 October 2017

The global annual cholera burden is estimated at around 2·9 million cases per year, resulting in 95 000 deaths. In 2017, these estimates could be far exceeded due to a number of devastating outbreaks, including those in Yemen and northern Nigeria. So far this year, 750 000 suspected cases, causing over 2000 deaths, have occurred in Yemen alone. Currently, there is concern about the risk of a cholera epidemic among Rohingya refugees in the Cox’s Bazar region of Bangladesh. In response to this public health threat, the Global Task Force on Cholera Control (GTFCC), has brought together representatives from cholera-affected countries, donors, and technical experts to develop a Global Roadmap to 2030. Published on Oct 3, the document describes a multisectoral strategy that could reduce cholera deaths by 90% and eliminate the disease from a further 20 countries by 2030.

As John Clemens and colleagues describe in a Seminar published recently in The Lancet, cholera is an ancient disease. Endemic in the Ganges river basin, it has caused a series of pandemics since 1817, the most devastating being the seventh pandemic, which began in 1961 and is ongoing. Cholera is a disease steeped in medical history—it was during the third pandemic that John Snow plotted his famous map of Broad Street, and during the fifth epidemic, that Robert Koch sought to identify the causative agent. Spread by the faeco-oral route, the disease affects poor people and the most vulnerable. Cholera is endemic in 47 countries, particularly in areas where the water, sanitation and hygiene (WASH) infrastructure is poor. In these areas, children are particularly at risk. Epidemics occur both within and outside of endemic areas, often amid humanitarian crises, when WASH infrastructure breaks down or is overwhelmed. In situations where the population lacks immunity, a wider age range is affected, often with more severe clinical manifestations. Currently the worldwide cholera burden is high. 60–70% of cholera cases and deaths occur in endemic areas of Africa, which could increase as urbanisation, particularly the growth of slums, places increasing numbers at risk.

Fluid resuscitation as the core of cholera treatment is well established, but recent developments in disease prevention strategies underlie the GTFCC’s roadmap. Improvements in WASH systems can eliminate cholera, but although the rate of return on investment is good, these are initially expensive, and the slow expansion of WASH provision has failed to tackle the burden of cholera and other water-borne diarrhoeal diseases. The pivotal change in cholera control has been the development of oral cholera vaccines (OCV), underpinned by an improved understanding of the mechanism of cholera immunity. In a series of landmark research developments over the past 10 years, the efficacy, safety, acceptability, and feasibility of these vaccines have been demonstrated. The creation of a growing global OCV stockpile by WHO, with long-term funding support from Gavi, signalled the step-change in cholera prevention strategies and, since 2013, 13 million vaccine doses have been deployed, mostly in the emergency control of epidemics.

The novelty of the GTFCC eradication strategy is based on three key axes. First, the emphasis on rapid response to outbreaks: controlling epidemics through community engagement, improved early warning surveillance, and the rapid delivery of cholera control kits, OCV, and WASH supplies. Second, the strategy implements a multisectoral approach in hotspots of endemic cholera. OCV programmes will be used as a bridge, immediately reducing disease burden and mortality while long-term solutions are developed: sustainable WASH infrastructure, strengthened health systems able to anticipate epidemics, and strong community engagement required to stop transmission. The third axis is the coordination of operational support, local and global resourcing, and technical expertise delivered by GTFCC. Over the next 18 months, the task force will support six to eight countries to develop cholera control plans, develop an investment case on cholera, and create operational guidance on integrated prevention strategies ahead of a review meeting planned in 2019.

The bold vision of the Global Roadmap is welcome but the challenges that lie ahead should not be underestimated, Paul Spiegel, director of the Center for Humanitarian Health at Johns Hopkins University told The Lancet. Ending cholera depends both on successful delivery of the prevention strategies on the ground and mitigating risks to the Global Roadmap at a high-level (securing financing, ensuring vaccine availability, and galvanising political will). The technical ability to control cholera is within our capabilities. After 50 years, could the tide be finally turning on the seventh pandemic?

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UNICEF’s preventive plan to mitigate the risk of Acute Water Diarrhoea (AWD) and Cholera among Rohingya Refugees
UNICEF’s preventive plan to mitigate the risk of Acute Water Diarrhoea (AWD) and Cholera among Rohingya Refugees
Remarks attributable to Maya Vandenant, Chief of Health, UNICEF Bangladesh
GENEVA/DHAKA, Bangladesh 6 October 2017 – This is a situation update from Maya Vandenant, Chief of Health, UNICEF Bangladesh, – to whom quoted text may be attributed – for today’s press briefing at the Palais des Nations in Geneva.
Key Facts
:: 515,000 new Rohingya arrivals into Cox’s Bazar, Bangladesh since 25th August;
:: 225,000 of new arrivals are living in new spontaneous settlements with very limited Water, Sanitation and Hygiene (WASH) infrastructure due to an absence of planning;
:: 60% of new arrivals are children and 30% are children under 5 years old;
:: In the last week, 5011 cases of diarrhoea have been reported;
:: Since 25th August 2017, over 300 tube wells and 3,000 latrines have been constructed to improve WASH within both the extended existing makeshift settlements and the new spontaneous settlements;
:: UNICEF has launched a response plan to prevent an outbreak of Acute Watery Diarrhoea and Cholera;
:: There are high levels of severe malnutrition amongst child refugees which exacerbates the risks associated with an outbreak of acute watery diarrhoea and cholera.
“What we are seeing is that people are exhausted and children are at a heightened risk of diseases. There are real risks of acute watery diarrhoea and cholera outbreaks. We are very concerned, and therefore, we are mounting an urgent response across the health sector.
“Planning of the extension camps is largely absent and there is no infrastructure in terms of ensuring good sanitation and drainage. We see that after the rains, water flushes through the camps everywhere, including the toilets. Additionally, the camps are now subject to high population densities. These factors increase the risk of disease outbreak and transmission.

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Editor’s Note:
Repeating from last week’s edition:

900,000 vaccines ‘en route’ to Cox’s Bazar to prevent cholera
Oral cholera vaccine will protect Rohingya refugees seeking shelter in Bangladesh as well as the resident population
Cox’s Bazar, Bangladesh, 29 September 2017 – The International Coordinating Group (ICG) on Vaccine Provision will release 900,000 doses of the Oral Cholera Vaccine (OCV) from the global stockpile to prevent the spread of cholera among recently arrived vulnerable populations and host communities in areas around Cox’s Bazar.
The Government of Bangladesh made the request to the ICG on 27 September, and the approval was granted in 24 hours by the coordinating mechanism that brings together WHO, UNICEF, Médecins Sans Frontières (MSF), and the International Federation of the Red Cross (IFRC).
ICG partners – with support from Gavi, the Vaccine Alliance – will deliver 900,000 doses of Oral Cholera Vaccine to Bangladesh within two weeks for an immunisation campaign due to start in October.
 

Featured Journal Content

The Critical Role of Biomedical Research in Pandemic Preparedness
Hilary D. Marston, MD, MPH1; Catharine I. Paules, MD1; Anthony S. Fauci, MD1
JAMA. Published online October 4, 2017. doi:10.1001/jama.2017.15033
Viewpoint
Unusual reports of Kaposi sarcoma and Pneumocystis carinii (now P jiroveci) pneumonia in previously healthy gay men in 1981 alerted the world to a new infectious disease threat, heralding the HIV/AIDS pandemic. The medical and public health communities faced a steep learning curve in coordinating public health and biomedical research efforts as the pandemic evolved.

Since then, international partners in academia, government, and industry have devoted substantial efforts to pandemic preparedness, building on lessons learned from HIV and other outbreaks ranging from the abrupt onset of the severe acute respiratory syndrome coronavirus (SARS-CoV) to the spread of Zika in the Americas to the devastating outbreak of Ebola in West Africa.

Comprehensive preparedness is a multifaceted endeavor including global surveillance networks, health care infrastructure ranging from primary care centers to referral hospitals, health care workforce capacity, and engagement with affected communities. Governments, the United Nations, and other nongovernmental organizations have made important strides in these areas. For example, the World Health Organization’s International Health Regulations, updated in 2005 after the SARS-CoV epidemic, helped improve global disease surveillance.1 Individual nations worked together to build on this foundation, creating the multilateral Global Health Security Agenda (GHSA) to “prevent, detect and respond” to new threats. Nearly 60 nations including the United States have joined the GHSA, collaborating in multisectoral preparedness including enhanced capacity for surveillance and laboratory diagnostics.2

A critical component of effective pandemic preparedness is biomedical research, including domestic and international research capacity. The research enterprise complements other elements of preparedness by improving understanding of the pathogenesis of infectious diseases and by developing interventions in the form of diagnostics, treatments, and vaccines. The foundation of this work is a portfolio of basic research applicable to multiple pathogens of public health significance. Through these investigations, the research community develops an understanding of the microbiology and pathogenesis of known infectious diseases.

Even for pathogens not yet identified as major human health threats, research on related organisms can bolster efforts in the event of an outbreak. When Zika virus emerged in the western hemisphere, investigators working on the closely related dengue flavivirus were quickly marshaled against Zika. The presence of active researchers with relevant expertise facilitated the rapid launch of the Zika research response. For example, applying knowledge gained from work with dengue and other flaviviruses, researchers rapidly developed mouse models that recapitulate critical aspects of Zika infection, including replication and disease in the fetus; these were subsequently used as surrogates to study congenital Zika syndrome. These tools have been used to evaluate treatments, including monoclonal antibodies capable of neutralizing Zika and protecting mouse pups.3 Evaluation in human trials is under consideration.

The basic research portfolio leads naturally into and is complemented by investments in countermeasure development. Although treatments and vaccines are essential
countermeasures, so too are rapid, deployable, and point-of-care diagnostics. The latter are key to an effective response in an evolving pandemic.4 In the case of arthropod-borne viruses, research into novel methods of vector control is also critical.

In shaping the research agenda for pandemic preparedness, prediction of microbes likely to cause outbreaks is often more art than science; as HIV, SARS, and Zika have demonstrated, no single algorithm will “get it right” all the time. For this reason, several research approaches are pursued in pandemic preparedness, including (1) pathogen-specific work; (2) platform-based technology; and (3) prototype-pathogen efforts. Each approach has strengths and weaknesses. Vaccine-related efforts serve as examples for each approach.

In pathogen-specific work, resources are invested between outbreaks to advance countermeasure development for microbes deemed most likely to emerge and cause significant morbidity and mortality. Given finite resources, only a handful of pathogens can be prioritized. The World Health Organization’s Research and Development Blueprint offers a robust method for pathogen selection, assessing lethality and severity of disease, transmissibility, animal hosts and vectors, and dearth of existing countermeasures.5 The list allows the global research community to target its countermeasure development programs.

The US government used its own priority pathogen list based on the potential use of microbes as agents of bioterror (as designated by the Centers for Disease Control and Prevention) in the wake of the 2001 anthrax attacks. Ebola, one of the hemorrhagic fever viruses, was on the list of Category A Agents of Bioterrorism, and as a result, several Ebola vaccine candidates were developed. In response to the Ebola outbreak of 2014-2016 in West Africa, these vaccine candidates were advanced into phase 1 trials and field efficacy trials in early 2015.6

Some organizations, such as the Coalition for Epidemic Preparedness Innovations, are working to compress this timeline further, closing the gap between outbreak initiation and countermeasure availability by preparing selected vaccine candidates a priori for rapid evaluation in an outbreak. These efforts are promising; however, their utility depends on predictive capability of the prioritization algorithm. In the cases of HIV, SARS, and Zika, no list or algorithm predicted their public health impact.

In platform-based technology, developers are agnostic about specific pathogens. Research instead focuses on the platform used to present a relevant immunogen to the host. Vaccine platforms such as viral vectors can be used with genetic material coding for the relevant immunogen against which an immune response would be directed. In theory, such a platform could be used to present the genes from a range of pathogens. In this area, preparedness efforts typically involve the development of the platforms themselves, including manufacturing capacity.

Platform technology was used in the 2002-2003 SARS outbreak, during which the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (and others) developed vaccine candidates to meet the emerging threat. The platform in this case was a DNA plasmid into which was inserted the gene for the SARS glycoprotein serving as the immunogen. In 2003 and 2004, one program spanned just 17 months from sequencing the SARS-CoV genome and identifying the relevant gene to be inserted into the plasmid to initiation of the first clinical trial of a DNA vaccine for SARS, although the epidemic ended before trial results were obtained.7 In addition to DNA, vaccine platforms include nanoparticles, virus-like particles, and mRNA, among others.

Another approach using prototype pathogens can hasten the platform-based approach by prospectively filling research gaps necessary to advance successful candidates as efficiently as possible. In this approach, investigators would conduct countermeasure research for prototype pathogens, understanding that the prototype may not emerge as a threat but assuming that techniques would be applicable to closely related microorganisms (oral communication, Barney S. Graham, MD, PhD, and Nancy J. Sullivan, PhD, June 2017).

One example is the flavivirus prototype. Zika virus was not on priority pathogen lists before 2015, and essentially no Zika-specific research had been undertaken at NIAID. However, because of an extensive research portfolio on related flaviviruses such as dengue and West Nile viruses, researchers were able to leverage approaches such as animal models, immunogenicity assays, and vaccine design elements to develop Zika vaccine candidates. In this regard, DNA vaccine development for Zika took 13 weeks to move from sequence selection to first-in-human trial, largely because of the “road map” that West Nile research provided. The vaccine candidate is currently in a phase 2/2b trial; however, further development and distribution will require a commercial partner. Adapting this model for the future, countermeasure development approaches could be mapped out for multiple prototype pathogens, and if that pathogen (or a related one) emerges, the community would be poised for rapid countermeasure development, evaluation, and implementation.

While priority-pathogen lists might not reflect the next emerging threat, platform and prototype-pathogen approaches run the risk of taking too long. The most prudent path is to invest in research on all 3, bolstering the current ability to predict emerging infections, developing platforms that can be more rapidly adapted to new threats, and pursuing prototype-pathogen efforts to accelerate candidate development. However, broad availability of vaccines requires partnerships with industry, affected countries, and local communities. Moreover, even though considerable attention has been given to improved vaccine preparedness, solutions for treatments and diagnostics require further consideration, as both may play critical roles in any effective response.

Infectious disease outbreaks have been with humankind forever and will continue to occur. Whether dealing with HIV/AIDS, SARS, Ebola, Zika, or the inevitable unanticipated pathogen that will surely emerge, research has played and will play a critical role before, during, and after the outbreak. Looking ahead, the biomedical research community must maintain its critical role in comprehensive pandemic preparedness.

[References at title link above]

Emergencies
 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 4 October 2017</strong [GPEI]
:: Summary of newly-reported viruses this week:
…Syria: seven new circulating vaccine derived poliovirus 2 (cVDPV2) cases reported, five cases from Mayadeen and one case from Boukamal districts, Deir Ez-Zor governorate, and one case from Thawra district, Raqqa governorate. Three new cVDPV2 positives from healthy children, two from Mayadeen and one from Bokamal districts, Deir Ez-Zor governorate.
…Pakistan: four new wild poliovirus 1 (WPV1) positive environmental samples, three reported in Sindh province, and one in Balochistan province.

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Situation reports on the polio outbreak in Syria
Situation update 3 October 2017
:: Seven (7) new cases of cVDPV2 have been confirmed this week —5 cases from Mayadeen and 1 from Boukamal districts, Deir Ez-Zor governorate, and 1 case from Thawra district (newly infected), Raqqa governorate. Isolates from some cases had been laboratory pending for some time. The most recent case, a child from Boukamal with no history of polio vaccination, had onset of paralysis on 5 August.
:: The total number of cVDPV2 cases is 47.
:: Poliovirus has been isolated from stool samples collected from a healthy child in Damascus, as part of screening in place for IPDs from Deir Ez-Zor and Raqqa. The child, from Boukamal, Deir Ez-Zor, had samples collected on 19 August, the day of arrival. WHO and MoH will continue to take samples from healthy children in areas of Damascus with high numbers of IDPs, to ensure there is no wider circulation.
:: Preparation for the second immunization round for Raqqa is ongoing. Newly accessible villages in Thawra district have been included in campaign plans.
:: A series of meetings between partners to review outbreak response activities to date and to identify priorities for the next two months took place in Beirut 29-30 September.

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WHO Grade 3 Emergencies  [to 7 October 2017]
The Syrian Arab Republic
:: Syria cVDPV2 outbreak situation report 16, 3 October 2017
[See Polio above for detail]

Yemen
:: Field visits to Ibb and Hudaydah: Summary of immediate action points and recommendations, 20 September 2017  2 October 2017
[See Cholera above for more detail]

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WHO Grade 2 Emergencies  [to 7 October 2017]
Myanmar
:: Situation Report 4 – 3 October 2017
 Key Highlights

1. Current estimation of vulnerable people in Bangladesh: As of 28 September 2017, cumulative number of new arrivals in all sites of Ukiah, Teknaf, Cox’s Bazar and Ramu are 501 8001. This includes 448 100 in four upazilas of Cox’s Bazar district, 35 000 in registered camps for affected population and 18 700 in Naikhongchhari of Bandarbhan district. The total Rohingya population in Bangladesh is now estimated to be approximately 800 000.
2. Status on the new site development: Site Development Task Force is collaborating with Office of the Refugee Relief and Repatriation Commission (RRRC) and army officials on road construction in Kutapalong extension site and development of the 2000 acre site plan. Construction will start once Master Plan is finalized and refining of zoning diagram drafted by RRRC is completed.
3. Special vaccination campaign reaches its target: Vaccination campaign ended on 03 October with 135,519 receiving MR vaccines; 72,334 children receiving bOPV and 72,064 children receiving Vitamin A, since the campaign began on 16 September. WHO and partners are now ensuring that routine immunization activities are scaled-up in the makeshift and spontaneous settlements.
4. 900,000 doses of oral cholera vaccines sanctioned: International Coordinating Group (ICG) on Vaccine Provision has released 900 000 doses of OCV from the global stockpile to prevent spread of cholera amongst recently arrived vulnerable populations and host communities in areas around Cox’s Bazar. The vaccines are anticipated to arrive in Bangladesh on 07 October.

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Iraq: Humanitarian Bulletin, 16-30 September 2017 | Issued on 1 October [EN/AR/KU]

Syrian Arab Republic
:: 5 Oct 2017  Statement by Panos Moumtzis, the Regional Humanitarian Coordinator for the Syria Crisis on the recent escalation of violence in Syria [EN/AR]

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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.
DRC  – No new announcements identified
Ethiopia – No new announcements identified
Nigeria  – No new announcements identified
Somalia  – No new announcements identified

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Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.

EBOLA/EVD  [to 7 October 2017]
http://www.who.int/ebola/en/

HHS accelerates development of first Ebola vaccines and drugs
September 29, 2017
Actions under Project BioShield could protect health from bioterrorism, naturally occurring outbreaks
Hundreds of thousands of Americans could be protected from or treated for Ebola infections through the first purchase of vaccines and therapeutic drugs by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. The vaccines and drugs are the first for Ebola to receive Project BioShield funding which supports late-stage development toward licensure and stockpile purchases.

“Today we are prepared to add four Ebola countermeasures to the stockpile whereas three years ago, very few products were even in early stages of development,” BARDA Director Rick Bright, Ph.D., said. “This marks a pivotal moment in U.S. and global preparedness for future public health emergencies from viral hemorrhagic fevers like Ebola. We reached this point at unprecedented speed, and that’s a direct result of innovative approaches to product development and to partnering across the U.S. government, other nations, and private industry.”…

Under the agreements announced today, BARDA will provide Project BioShield funding for each company to validate its manufacturing processes and undertake the final preparations necessary to apply for approval through the U.S. Food and Drug Administration (FDA). While that work is completed, BARDA can purchase the vaccines and drugs for potential use in a public health emergency.

BARDA could purchase up to 1.13 million regimens of vaccine, including a single-dose vaccine from Merck Sharp & Dohme Corp of Whitehouse Station, New Jersey, and a two-dose vaccine from Janssen Vaccines and Prevention B.V. of Leiden, The Netherlands. In addition, BARDA will purchase a therapeutic drug from Mapp Biopharmaceutical, Inc. of San Diego, California, and a therapeutic drug from Regeneron Pharmaceuticals, Inc. of Tarrytown, New York.

Merck Sharp & Dohme Corp’s single-shot vaccine would be used to protect people who are at high risk of exposure to Ebola. BARDA will provide $39.2 million for late stage development and purchase. The vaccine showed potential efficacy during testing in Guinea, West Africa, using a ring-vaccination protocol. This approach aims to stop the spread of a virus by vaccinating everyone a patient came in contact with and everyone who came in contact with the patient’s contacts…

Janssen Vaccines and Prevention B.V.’s vaccine is a two-dose vaccine regimen that would be used to prevent illness in people who have not been exposed to Ebola but could be, such as health care workers and the general public. The regimen requires an initial vaccine which is protective against Ebola, followed by a second vaccine that uses different technology and boosts the body’s immune response. This two-dose approach has progressed into multiple Phase 3 studies and demonstrated efficacy in animal models…

WHO & Regional Offices [to 7 October 2017]
 
High level meeting for the Evaluation of the International Coordinating Group on Vaccine Provision (ICG)
Date: 17 October 2017
Place: Geneva, Switzerland
Background
The management of emergency stockpiles has become increasingly complex due to the growing number of epidemics, the number of countries able to access emergency stockpiles, new vaccine stockpiles managed by the ICG, the increased number of stakeholders involved in outbreak response and a fragile vaccine supply market. ICG partners and stakeholders asked for an independent external evaluation to highlight the strengths and weaknesses of ICG’s governance, decision-making and communications mechanisms, and to develop actionable options for improving the functioning of the ICG.
Objective
The aim of the meeting is to reach agreement about actions to improve the ICG’s governance, accessibility and management of disease-specific, emergency stockpiles and their composition, the transparency of decision-making processes as well as ICG internal and external communication processes.
Outcome
Action plan for improving the functioning of the ICG.

Highlights
WHO provides 1.2 million antibiotics to fight plague in Madagascar
News release
6 October 2017 | ANTANANARIVO, MADAGASCAR – WHO has delivered nearly 1.2 million doses of antibiotics and released US$1.5 million dollars in emergency funds to fight plague in Madagascar.

“Plague is curable if detected in time. Our teams are working to ensure that everyone at risk has access to protection and treatment. The faster we move, the more lives we save,” said Dr. Charlotte Ndiaye, WHO Representative in Madagascar.
WHO has delivered 1 190 000 doses of antibiotics to the Ministry of Health and partners this week, and a further supply of 244 000 doses is expected in the days ahead.

The different types of drugs will be used for both curative and prophylactic care. They are enough to treat up to 5000 patients and protect up to 100 000 people who may be exposed to the disease.

The medicines are being distributed to health facilities and mobile health clinics across the country with the support of the Ministry of Health and partners.

WHO is also filling critical shortages in disinfection materials and personal protective equipment for health professionals and safe burials.

WHO and the Ministry of Health are training local health workers on how to identify and care for patients, and how to trace people who have had close contact with symptomatic patients so that they may be given protective treatment.

Most of the 231 infections and 33 deaths that the Ministry of Health has reported since August are associated with pneumonic plague – a more dangerous form of the disease that affects the lungs and is transmitted through coughing at close range.

Both bubonic and pneumonic plague can be cured using common antibiotics if delivered early. Antibiotics can also help prevent infection among people who have been exposed to plague.

WHO has rapidly released $1.5 Million from it emergency funds to allow for immediate support to the country until more substantial funds are received.

WHO is appealing for US$5.5 million to effectively respond to the outbreak and save lives.

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Weekly Epidemiological Record, 6 October 2017, vol. 92, 40 (pp. 589–608)
:: Summary of global update on preventive chemotherapy implementation in 2016: crossing the billion
:: Global programme to eliminate lymphatic filariasis: progress report, 2016
 
::::::
 
Call for nomination for experts to serve on the SAGE working group on influenza vaccines
3 October 2017  [Deadline for application: 27 October 2017]
 
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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO provides 1.2 million antibiotics to fight plague in Madagascar 06 October 2017
: WHO and the Ministry of Health strengthens immunization program in South Sudan
06 October 2017
:: Dr Moeti focuses on “Transforming Africa’s Health: Leaving No-one Behind”  05 October 2017
:: Planning and roll out for first malaria vaccine implementation in Kenya underway 03 October 2017
:: WHO Regional Director For Africa Visits Botswana  03 October 2017
The Ministry of Health and Wellness will host the World Health…
:: Eritrea – Health Facility Standards Validation Workshop  03 October 2017
:: WHO scales up response to plague in Madagascar  03 October 2017

WHO South-East Asia Region SEARO
:: WHO appeals for USD 10.2 million to support critical health interventions in Cox’s Bazar, Bangladesh  6 October 2017

WHO European Region EURO
:: Healthy places, healthy people – applying Scotland’s Place Standard tool 05-10-2017
:: Understanding behaviours as a first step to addressing declining vaccination uptake in Europe 04-10-2017
:: Cycling: a vital link between transport, health, environment and economy 02-10-2017
:: Comprehensive approach to tobacco control in Russian Federation shows results 02-10-2017

WHO Eastern Mediterranean Region EMRO
:: Developing a universal health coverage priority benefit package for Member States of the Region  2 October 2017

WHO Western Pacific Region
:: Health leaders to meet in Brisbane, Australia, for WHO Regional Committee
Ministers of health and senior officials from the WHO Western Pacific Region’s 37 countries and areas will meet in Brisbane, Australia from 9 to 13 October..
 

CDC/ACIP [to 7 October 2017]
http://www.cdc.gov/media/index.html

MMWR News Synopsis for October 5, 2017
:: Retention in Medical Care Among Insured Children with Diagnosed HIV – United States, 2010-2014
A significant proportion of HIV-diagnosed children might not be receiving the recommended frequency of medical care. An estimated 2,477 children ages 12 and younger were living with diagnosed HIV in the United States in 2014. U.S. Department of Health and Human Services pediatric HIV treatment guidelines recommend medical assessments every three to four months for the first two years of antiretroviral therapy, and suggest that there is value in maintaining this frequency for all HIV-diagnosed children. CDC researchers analyzed insurance claims data to evaluate retention in medical care for children with diagnosed HIV and found that 60 percent of the Medicaid cohort and 69 percent of the commercial claims cohort were retained care during a two-year period between 2010 and 2014. The proportions of children retained in care for both groups were similar to those described in analyses conducted with insurance claims for adults with diagnosed HIV. Further investigation into the causes of non-retention in pediatric HIV care is indicated to identify possible ways to improve medical care consistency for children living with HIV.

Human Adenovirus Surveillance — United States, 2003-2016
CDC initiated the National Adenovirus Type Reporting System (NATRS) in 2014 to monitor trends in circulating human adenovirus types in the United States, which can be useful to inform diagnostic and surveillance activities by clinicians and public health practitioners. Human adenoviruses (HAdVs) are associated with a wide spectrum of clinical illness including respiratory illness, gastroenteritis, and conjunctivitis. More than 60 HAdV genotypes have been identified to date. Severity of HAdV illness can range from asymptomatic infections to severe illness and death. Although cases are frequently reported sporadically, outbreaks of HAdV have been reported globally in a variety of settings. CDC initiated the NATRS in 2014 to monitor trends in circulating HAdV types in the United States. Year-to-year fluctuations in HAdV types circulating in the U.S. varied considerably during the surveillance period. Surveillance for circulating HAdV types in the U.S. can be useful to inform diagnostic and surveillance activities by clinicians and public health practitioners.

Update: Influenza Activity — United States and Worldwide, May 21-September 23, 2017
CDC recommends yearly influenza vaccination for all people 6 months of age and older who do not have contraindications. Vaccination by the end of October is recommended, if possible, but should continue throughout the influenza season as long as influenza viruses are circulating and unexpired vaccine is available. While a yearly influenza vaccination is the best way to prevent influenza, treatment with influenza antiviral medications as soon as possible after the onset of illness is recommended for patients with confirmed or suspected influenza who have severe, complicated, or progressive illness; who require hospitalization; or who are at high risk for influenza complications. Antiviral drugs work best when started within two days of getting sick. Although summer influenza activity in the United States was low, seasonal and novel influenza cases and outbreaks occurred during summer months. Clinicians should remain vigilant in considering novel influenza virus infections in people with influenza-like illness and swine or poultry exposure, or with severe acute respiratory infection after travel to areas where avian influenza viruses have been detected. There was low-level seasonal influenza activity from May 21 to September 23, 2017, in the United States. Influenza B viruses predominated from late May through late June, and influenza A viruses predominated beginning in early July. Influenza A H1N1pdm09, influenza A H3N2, and influenza B viruses were detected in the United States and worldwide. Typical seasonal patterns of influenza activity were seen in Southern Hemisphere countries. The majority of the influenza viruses from the United States and other countries analyzed at CDC were similar to the reference viruses representing the recommended components for the 2017-18 vaccine.

Announcements

EDCTP    [to 7 October 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
2 October 2017
Call for participants: Workshop in Portuguese on EDCTP grant proposal writing
EDCTP is calling for applications from researchers interested in participating in a workshop on EDCTP Calls for Proposals and grant…

European Medicines Agency  [to 7 October 2017]
http://www.ema.europa.eu/ema/
06/10/2017
EMA Management Board: highlights of October 2017 meeting
Board hears update on preparations for Brexit and adopts Agency’s mid-year report …

05/10/2017
EMA takes yet another step in public engagement with its first public hearing
Summary report now published …

European Vaccine Initiative  [to 7 October 2017]
http://www.euvaccine.eu/news-events
04 October 2017
Report on Role and Impact of EU’s ‘Poverty-Related and Neglected Diseases’ projects
The European Commission Research and Innovation Directorate published a report it had commissioned to evaluate the role and impact of the European Union’s (EU) Research Framework Programme activities in the field of Poverty-Related and Neglected Diseases (PRNDs).
The study focuses on the impact of past EU funding (€1.445bn) in PRND research supported from EU Framework Programmes (FP5–7, 1998–2013), as well as the first European and Developing Countries Clinical Trials Partnership (EDCPT) (2003–2013) and relevant research under the Innovative Medicines Initiative (IMI) (2008–2013). EVI is positively mentioned on several occasions throughout the report and is listed as one of the top ten organisations receiving EDCTP funding during the evaluation period.
PDF: https://publications.europa.eu/en/publication-detail/-/publication/1f324128-a4c1-11e7-837e-01aa75ed71a1/language-en/format-PDF
 
 
FDA [to 7 October 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
October 06, 2017 – FDA awards six grants for natural history studies in rare diseases

October 06, 2017 – FDA awards 15 grants for clinical trials to stimulate product development for rare diseases

October 05, 2017 – FDA approves first test for screening Zika virus in blood donations

October 02, 2017 – Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool

What’s New for Biologics
:: October 5, 2017 Approval Letter – cobasZika (PDF – 39KB)  Posted: 10/6/2017
:: Influenza Virus Vaccine for the 2017-2018 Season  Updated: 10/5/2017
 
 
Fondation Merieux  [to 7 October 2017]
http://www.fondation-merieux.org/
October 6, 2017
The “Cent Gardes” Conference brings together the world’s foremost experts on HIV/AIDS at Les Pensières
On October 6-8, the Mérieux Foundation organizes the “Cent Gardes” Conference focusing on HIV/AIDS, in partnership with the Agence France Recherche Nord&Sud Sida-HIV Hépatites (ANRS) and the Institut national de la santé et de la recherche médicale (Inserm).
More than 50 experts from 10 countries will participate in this edition of the Cent Gardes Conference. The symposium focuses on the HIV vaccine, which remains a high priority to end the global HIV epidemic.
The experts will notably discuss the role of antibodies in HIV prevention and therapy. The mechanisms of HIV transmission and mucosal immunity will also be explored. Some presentations will highlight the functional cure for HIV, which aims to remove the negative effects of HIV infection without eliminating all virus from the body…
 
 
IAVI  [to 7 October 2017]
https://www.iavi.org/
October 4, 2017
New HIV-Prevention Discoveries Harness the Power of Potent Antibodies
Scientists have known for some time that a fraction of people living with chronic HIV infection produce broadly neutralizing antibodies (bnAbs), which can overcome HIV’s high levels of diversity to block replication. At IAVI’s Neutralizing Antibody Center (NAC) in La Jolla, California, a team of researchers from IAVI and The Scripps Research Institute (TSRI) recently found themselves out to pasture, thanks to similarities between bnAbs and cow antibodies.
Now two more discoveries involving NAC researchers could have implications for development of both a vaccine and long-acting HIV prevention, according to studies published in PLOS Pathogens and Science…

 
 
MSF/Médecins Sans Frontières  [to 7 October 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Doctors Without Borders Brings Interactive Exhibition on Global Refugee Crisis to Seattle
October 04, 2017
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) opens Forced From Home this week in Seattle. The interactive exhibit seeks to tell the individual stories of the more than 65 million displaced people worldwide, and to help visitors understand the humanitarian consequences of displacement. Forced From Home exhibitions has already toured Boulder and Salt Lake City in September, welcoming more than 6,000 visitors.
 
 
NIH  [to 7 October 2017]
http://www.nih.gov/news-events/news-releases
October 6, 2017
DNA damage caused by cancer treatment reversed by ZATT protein
— Scientists discover a new way that cells fix an important and dangerous type of DNA damage.

NIH to fund Centers of Excellence on Minority Health and Health Disparities
October 5, 2017 — Twelve specialized research centers will conduct multidisciplinary research, research training, and community engagement activities.

NIH to fund seven Research Centers in Minority Institutions
October 5, 2017 — Awards to support institutional research capacity and foster the career development of new and early career investigators.

Monoclonal antibodies against Zika show promise in monkey study
October 5, 2017 — Further development toward clinical evaluation is warranted.

NIH Director’s high-risk research awards announced for 2017
October 5, 2017 — NIH Common Fund funds 86 awards for highly innovative biomedical research.

Multiple research approaches are key to pandemic preparedness, NIAID officials say
October 5, 2017 — Preparedness in the face of major disease outbreaks can save thousands of lives.
[See Featured Journal Content above for more detail]

NIDCR announces 2017 Sustaining Outstanding Achievement in Research awards
October 4, 2017 — Grants support ambitious, long-term research of meritorious mid-career investigators.

NIH Grantee Wins 2017 Nobel Prize in Chemistry
October 4, 2017 — The 2017 Nobel Prize in Chemistry has been awarded to National Institutes of Health grantee Joachim Frank, Ph.D., of Columbia University, New York City.
 
 
PATH  [to 7 October 2017]
http://www.path.org/news/index.php
Announcement | October 02, 2017
PATH hires chief of staff for the Office of the President
Erica Sessle brings international, multi-sectoral leadership experience in health sciences and public health

UNAIDS [to 7 October 2017]
http://www.unaids.org/en
Press statement
UNAIDS welcomes appointment of Natalia Kanem as Executive Director of UNFPA
GENEVA, 5 October 2017—UNAIDS welcomes the appointment by the United Nations Secretary-General of Natalia Kanem as the Executive Director of the United Nations Population Fund (UNFPA).
“As part of the Joint United Nations Programme on HIV/AIDS, the United Nations Population Fund’s work is critical in meeting the reproductive health needs of women and adolescents,” said Michel Sidibé, Executive Director of UNAIDS. “I look forward to working closely with Ms Kanem. Her experience in public health, her strong leadership and her commitment to social justice will be invaluable in our efforts to end AIDS as a public health threat.”…

Press statement
UNAIDS congratulates Mariangela Simão on her appointment as Assistant Director-General at the World Health Organization
GENEVA, 3 October 2017—UNAIDS warmly congratulates Mariângela Batista Galvão Simão on her appointment as the Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals at the World Health Organization (WHO)…

UNICEF  [to 7 October 2017]
https://www.unicef.org/media/
6 October 2017
UNICEF’s preventive plan to mitigate the risk of Acute Water Diarrhoea (AWD) and Cholera among Rohingya Refugees
GENEVA/DHAKA, Bangladesh – This is a situation update from Maya Vandenant, Chief of Health, UNICEF Bangladesh, – to whom quoted text may be attributed – for today’s press briefing at the Palais des Nations in Geneva.
[See Milestones above for more detail]
 
Partners commit to reduce cholera deaths by 90 per cent by 2030
Geneva, 03 October 2017 – An ambitious new strategy to reduce deaths from cholera by 90 per cent by 2030 will be launched tomorrow by the Global Task Force on Cholera Control (GTFCC), a diverse network of more than 50 UN and international agencies, academic institutions, and NGOs that supports countries affected by the disease.
[See Milestones above for more detail]

 
 
Wellcome Trust  [to 7 October 2017]
https://wellcome.ac.uk/news
Published: 4 October 2017
Introducing our new science strategy
After almost a year as Director of Science, Jim Smith gives an update on our new approach to science funding: Improving health through the best research.
I have been Director of Science at Wellcome for 10 months now. During this time I’ve been learning how Wellcome works and spending as much time as possible meeting the people we support, both in the UK and abroad. With my first anniversary coming up, it’s a good time to set out our stall and discuss Wellcome’s approach to funding science.
I set out this approach today in our new science strategy: Improving health through the best research [PDF 1MB]. The strategy outlines what we plan to do over the next five years and how we plan to do it. It has four broad aims:
:: creating knowledge
:: strengthening research capacity
:: using knowledge effectively
:: promoting an environment in which research can flourish.
 
::::::
 
BIO    [to 7 October 2017]
https://www.bio.org/insights/press-release
Oct 3 2017
Sixth Annual BIO Patient and Health Advocacy Summit Concludes Today
The 2017 Patient and Health Advocacy Summit wrapped up today, having offered the nearly 240 patient groups, companies and organizations new ways to connect, strategize, learn and partner.  For the past six years, the BIO Patient and Health Advocacy Summit has brought together a diverse group of organizations including patient advocacy, health care providers, academia, government, think tanks, professional societies and the biotechnology industry to focus on bringing the patients’ voice to the drug development process.
 
 
IFPMA   [to 7 October 2017]
http://www.ifpma.org/resources/news-releases/
Published on: 03 October 2017
WIPO and the Research-Based Pharmaceutical Industry Team up to Facilitate Access to Key Medicine Patent Information
GENEVA, 13h00 CET – 3 October 2017 – The World Intellectual Property Organization (WIPO) and the research-based pharmaceutical industry today launched a new partnership to promote the accessibility of patent information for health agencies tasked with procurement of medicines.
WIPO Director General Francis Gurry and Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), signed an agreement establishing the Patent Information Initiative for Medicines, or “Pat-INFORMED,” on the sidelines of the Assemblies of the Member States of WIPO.
WIPO and IFPMA, the global trade association representing the research-based pharmaceutical industry, are co-sponsors of the initiative, which originated in the industry’s efforts to add clarity to the patent information around medicines. It couples the industry’s work in this area with WIPO’s well-established expertise in organizing patent data from across the globe.
Pat-INFORMED will clearly link public patent information to registered medicines in a new online global gateway, helping health professionals to navigate the medicine-procurement process for the benefit of their citizens.
“Pat-INFORMED will make it easier for procurement experts to assess the patent status of medicines, underlining how a well-designed and implemented patent system incentivizes innovation while making available and accessible key information about patented inventions,” said Mr. Gurry. “I welcome the engagement of IFPMA and its membership in this initiative, which responds to real needs in the public health community.”…
 
 
::::::
 
Industry Watch
:: Bavarian Nordic Secures Contract Award for Supply of Freeze-dried IMVAMUNE Smallpox Vaccine to the U.S. Government
:: Initial base award secures additional IMVAMUNE bulk contract of USD 100 million
:: Contract includes initial options valued at USD 439 million
:: Potential for contract value to increase if options to purchase additional IMVAMUNE bulk or freeze dried doses are exercised.
COPENHAGEN, Denmark, September 27, 2017 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the award of a sole source contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), for the procurement of freeze-dried IMVAMUNE® smallpox vaccine. The potential value of the initial base and optional awards is in excess of USD 539 million.

The initial award in the contract calls for the manufacturing and storage of USD 100 million of IMVAMUNE bulk. This is the third such award to manufacture vaccine bulk; with the two prior orders totaling USD 233 million. The initial options in the contract are divided between two distinct areas, the first of which is the filling and freeze-drying of IMVAMUNE from the three bulk awards, with total potential value of USD 299 million. The second part of the contract contains provisions for clinical development, regulatory commitments, and parts of the establishment and validation of fill/finish activities, with potential value of up to USD 140 million. The award also contains options to acquire additional vaccine bulk and/or freeze-dried doses of IMVAMUNE in the future.

To ensure the production capacity to secure the future IMVAMUNE stockpile at the U.S. Strategic National Stockpile, Bavarian Nordic will invest approximately USD 75 million over the coming years in the construction of a fill/finish manufacturing line at its facility in Denmark. As part of Bavarian Nordic’s long-standing partnership with BARDA, a potential optional award of up to USD 33 million (part of the USD 140 million mentioned above) is dedicated to process transfer, and validation of the new manufacturing line. This strategic investment will allow Bavarian Nordic to recognize the full value chain of the manufacturing process, to maintain control of the product cycle throughout, and the potential to provide these services to third parties in the future.

“We are proud to be part of a long-standing and successful partnership with BARDA and this latest contract starts a new chapter, as we supply an improved formulation of our vaccine as part of the U.S. government commitment to protect the nation from a smallpox outbreak “ said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “Our latest strategic investment that will expand our manufacturing capacities will add value, not only to our partnerships, but also to our proprietary pipeline.”…

:: PnuVax awarded $29.4 million USD grant to advance innovative vaccine into clinical trials
   :: Pneumonia, one of the diseases caused by pneumococcal bacteria, is currently the leading single killer of young children worldwide, despite advances in prevention and treatment
   :: $29.4 million USD grant from the Bill & Melinda Gates Foundation will advance vaccine’s clinical development and biomanufacturing scale-up
   :: Novel low-cost approach that may lead to increased access to vaccine, with potential to save millions of lives
Kingston, Canada – 2 October 2017 – PnuVax Incorporated, an organization dedicated to the production of high quality vaccines and biopharmaceuticals for the promotion of public health worldwide, today announced that it is the recipient of a $29.4 million USD ($36 million CDN) grant. The grant will be used to further develop and clinically evaluate PnuVax’s innovative pneumococcal conjugate vaccine. Milestone payments will be received over the next three years as the vaccine progresses from process development through to biomanufacturing scale-up and proof-of-concept clinical trials…
 

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

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 7 October 2017)

Research Article
Community-based surveillance of norovirus disease: a systematic review
Norovirus is a common cause of infectious gastrointestinal disease. Despite the increased ability to detect norovirus in affected people, the number of reported cases and outbreaks in the community is still su…
Thomas Inns, John Harris, Roberto Vivancos, Miren Iturriza-Gomara and Sarah O’Brien
BMC Infectious Diseases 2017 17:657
Published on: 29 September 2017

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 7 October 2017)

Research article
The cost determinants of routine infant immunization services: a meta-regression analysis of six country studies
Nicolas A. Menzies, Christian Suharlim, Fangli Geng, Zachary J. Ward, Logan Brenzel and Stephen C. Resch
Published on: 6 October 2017
Abstract
Background
Evidence on immunization costs is a critical input for cost-effectiveness analysis and budgeting, and can describe variation in site-level efficiency. The Expanded Program on Immunization Costing and Financing (EPIC) Project represents the largest investigation of immunization delivery costs, collecting empirical data on routine infant immunization in Benin, Ghana, Honduras, Moldova, Uganda, and Zambia.
Methods
We developed a pooled dataset from individual EPIC country studies (316 sites). We regressed log total costs against explanatory variables describing service volume, quality, access, other site characteristics, and income level. We used Bayesian hierarchical regression models to combine data from different countries and account for the multi-stage sample design. We calculated output elasticity as the percentage increase in outputs (service volume) for a 1% increase in inputs (total costs), averaged across the sample in each country, and reported first differences to describe the impact of other predictors. We estimated average and total cost curves for each country as a function of service volume.
Results
Across countries, average costs per dose ranged from $2.75 to $13.63. Average costs per child receiving diphtheria, tetanus, and pertussis ranged from $27 to $139. Within countries costs per dose varied widely—on average, sites in the highest quintile were 440% more expensive than those in the lowest quintile. In each country, higher service volume was strongly associated with lower average costs. A doubling of service volume was associated with a 19% (95% interval, 4.0–32) reduction in costs per dose delivered, (range 13% to 32% across countries), and the largest 20% of sites in each country realized costs per dose that were on average 61% lower than those for the smallest 20% of sites, controlling for other factors. Other factors associated with higher costs included hospital status, provision of outreach services, share of effort to management, level of staff training/seniority, distance to vaccine collection, additional days open per week, greater vaccination schedule completion, and per capita gross domestic product.
Conclusions
We identified multiple features of sites and their operating environment that were associated with differences in average unit costs, with service volume being the most influential. These findings can inform efforts to improve the efficiency of service delivery and better understand resource needs.

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 7 October 2017)

Research article
The risk of type 2 oral polio vaccine use in post-cessation outbreak response
Kevin A. McCarthy, Guillaume Chabot-Couture, Michael Famulare, Hil M. Lyons and Laina D. Mercer
Published on: 4 October 2017
Abstract
Background
Wild type 2 poliovirus was last observed in 1999. The Sabin-strain oral polio vaccine type 2 (OPV2) was critical to eradication, but it is known to revert to a neurovirulent phenotype, causing vaccine-associated paralytic poliomyelitis. OPV2 is also transmissible and can establish circulating lineages, called circulating vaccine-derived polioviruses (cVDPVs), which can also cause paralytic outbreaks. Thus, in April 2016, OPV2 was removed from immunization activities worldwide. Interrupting transmission of cVDPV2 lineages that survive cessation will require OPV2 in outbreak response, which risks seeding new cVDPVs. This potential cascade of outbreak responses seeding VDPVs, necessitating further outbreak responses, presents a critical risk to the OPV2 cessation effort.
Methods
The EMOD individual-based disease transmission model was used to investigate OPV2 use in outbreak response post-cessation in West African populations. A hypothetical outbreak response in northwest Nigeria is modeled, and a cVDPV2 lineage is considered established if the Sabin strain escapes the response region and continues circulating 9 months post-response. The probability of this event was investigated in a variety of possible scenarios.
Results
Under a broad range of scenarios, the probability that widespread OPV2 use in outbreak response (~2 million doses) establishes new cVDPV2 lineages in this model may exceed 50% as soon as 18 months or as late as 4 years post-cessation.
Conclusions
The risk of a cycle in which outbreak responses seed new cVDPV2 lineages suggests that OPV2 use should be managed carefully as time from cessation increases. It is unclear whether this risk can be mitigated in the long term, as mucosal immunity against type 2 poliovirus declines globally. Therefore, current programmatic strategies should aim to minimize the possibility that continued OPV2 use will be necessary in future years: conducting rapid and aggressive outbreak responses where cVDPV2 lineages are discovered, maintaining high-quality surveillance in all high-risk settings, strengthening the use of the inactivated polio vaccine as a booster in the OPV2-exposed and in routine immunization, and gaining access to currently inaccessible areas of the world to conduct surveillance.

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 7 October 2017)

Research article
Association between parent attitudes and receipt of human papillomavirus vaccine in adolescents
Human papillomavirus (HPV) vaccine coverage rates remain low. This is believed to reflect parental hesitancy, but few studies have examined how changes in parents’ attitudes impact HPV vaccine uptake. This stu…
Jeffrey J. VanWormer, Casper G. Bendixsen, Elizabeth R. Vickers, Shannon Stokley, Michael M. McNeil, Julianne Gee, Edward A. Belongia and Huong Q. McLean
BMC Public Health 2017 17:766
Published on: 2 October 2017

BMJ Open
October 2017 – Volume 7 – 10
http://bmjopen.bmj.com/content/current

Communication – Research
Comparing human papillomavirus vaccine concerns on Twitter: a cross-sectional study of users in Australia, Canada and the UK
Gilla K Shapiro, Didi Surian, Adam G Dunn, Ryan Perry, Margaret Kelaher

Evidence based practice
Research
Search for unpublished data by systematic reviewers: an audit
Hedyeh Ziai, Rujun Zhang, An-Wen Chan, Nav Persaud
Abstract
Objectives We audited a selection of systematic reviews published in 2013 and reported on the proportion of reviews that researched for unpublished data, included unpublished data in analysis and assessed for publication bias.
Design Audit of systematic reviews.
Data sources We searched PubMed and Ovid MEDLINE In-Process & Other Non-Indexed Citations between 1 January 2013 and 31 December 2013 for the following journals: Journal of the American Medical Association, The British Medical Journal, Lancet, Annals of Internal Medicine and the Cochrane Database of Systematic Reviews. We also searched the Cochrane Library and included 100 randomly selected Cochrane reviews.
Eligibility criteria Systematic reviews published in 2013 in the selected journals were included. Methodological reviews were excluded.
Data extraction and synthesis Two reviewers independently reviewed each included systematic review. The following data were extracted: whether the review searched for grey literature or unpublished data, the sources searched, whether unpublished data were included in analysis, whether publication bias was assessed and whether there was evidence of publication bias.
Main findings 203 reviews were included for analysis. 36% (73/203) of studies did not describe any attempt to obtain unpublished studies or to search grey literature. 89% (116/130) of studies that sought unpublished data found them. 33% (68/203) of studies included an assessment of publication bias, and 40% (27/68) of these found evidence of publication bias.
Conclusion A significant fraction of systematic reviews included in our study did not search for unpublished data. Publication bias may be present in almost half the published systematic reviews that assessed for it. Exclusion of unpublished data may lead to biased estimates of efficacy or safety in systematic reviews.

Bulletin of the World Health Organization
Volume 95, Number 10, October 2017, 665-728
http://www.who.int/bulletin/volumes/95/10/en/

PERSPECTIVES
Strategic procurement and international collaboration to improve access to medicines
Alessandra Ferrario, Tifenn Humbert, Panos Kanavos & Hanne Bak Pedersen
http://dx.doi.org/10.2471/BLT.16.187344
Efficient procurement of medicines is more than just obtaining the lowest price. It is about creating a healthy market where products of good quality are available at affordable prices on a sustainable basis and at the right time.1 In this context, a strategic approach to procurement is vital. Such an approach should encompas all activities that might improve the efficiency of procurement – e.g. activities to minimize low-value repetitive purchases, increase the benefit of economies of scale and reduce transaction and transport costs.2 Here, we will provide examples of the experiences of countries in the World Health Organization’s European Region in improving the efficiency of procurement of medicines. We will also explain how international collaboration could help improve individual country’s efforts.

Clinical Therapeutics
September 2017 Volume 39, Issue 9, p1751-1906
http://www.clinicaltherapeutics.com/issue/S0149-2918(17)X0012-X

Commentary
Data Sharing in the Pharmaceutical Enterprise: The Genie’s Out of the Bottle
Paul Beninger, James Connelly, Chandrasekhar Natarajan
p1890–1894
Published online: August 17, 2017
DOI: http://dx.doi.org/10.1016/j.clinthera.2017.08.001
Abstract
Objective
This Commentary shows that the present emphasis on the sharing of data from clinical trials can be extended to the entire pharmaceutical enterprise.
Methods
The authors constructed a Data Sharing Dashboard that shows the relationship between all of the life-cycle domains of the pharmaceutical enterprise from discovery to obsolescence and the domain-bridging disciplines, such as target credentialing, structure-activity relationships, and exposure-effect relationships.
Findings
The published literature encompassing the pharmaceutical enterprise is expansive, covering the major domains of discovery, translation, clinical development, and post-marketing outcomes research, all of which have even larger, though generally inaccessible, troves of legacy data bases. Notable exceptions include the fields of genomics and bioinformatics.
Implications
We have the opportunity to broaden the present momentum of interest in data sharing to the entire pharmaceutical enterprise, beginning with discovery and extending into health technology assessment and post-patent expiry generic use with the plan of integrating new levels and disciplines of knowledge and with the ultimate goal of improving the care of our patients.