AERAS  [to 14 Jul 2018]
JULY 11, 2018)
New England Journal of Medicine Publishes Final Results from Innovative Phase 2 Study Showing Vaccines Can Reduce Rate of Sustained TB Infections in Adolescents at High Risk
Trial offers hope for new revaccination strategies with Bacille Calmette-Guerin (BCG) against Tuberculosis, the world’s leading infectious disease killer
ROCKVILLE, MARYLAND (–Aeras, a nonprofit organization dedicated to developing vaccines against tuberculosis (TB), today announced the publication of the full results from a Phase 2, randomized, controlled clinical trial of two TB vaccines— the currently available BCG vaccine and an investigational vaccine, H4:IC31—in the New England Journal of Medicine (NEJM).
This proof-of-concept study showed that vaccination can reduce the rate of sustained TB infections in a high-transmission setting, such as in uninfected, healthy adolescents in the Western Cape of South Africa where the study was conducted. In the trial, revaccination with BCG significantly reduced sustained TB infections in adolescents with a 45.4% vaccine efficacy. H4:IC31 also reduced sustained infections, although not at statistically significant levels, showing 30.5% vaccine efficacy. However, the trend observed for H4:IC31 is the first time a subunit vaccine has shown any signal that it may be able to protect against TB infection or disease in humans. In the trial, TB infections were measured by a blood test (QuantiFERON-TB Gold In-Tube (QFT)) converting from negative to positive, and sustained infections were defined by a QFT test that remained positive for at least six months.
Jacqueline Shea, PhD, Chief Executive Officer at Aeras, said: “With this study, we showed that vaccines against TB infection can work. The results highlight the importance of investing in new approaches to fighting the leading infectious disease killer and to evaluating new concepts in clinical trials. Further, the collaborative effort established between industry leaders, nonprofits and clinical sites during this trial showed how powerful combining such forces can be for developing new interventions against a global health threat. The BCG results are important findings with significant public health implications that could lead to saving millions of lives. Likewise, the novel prevention-of-infection trial design can be used to inform clinical development of new vaccine candidates before entry into large-scale prevention-of-disease efficacy trials. We are very grateful to the trial participants and our partners and funders who enabled the conduct of this trial.”
Initial results from the study were presented at the 5th Global Forum in New Delhi, India in February 2018…
BMGF – Gates Foundation  [to 14 Jul 2018]
JULY 05, 2018
Gates Foundation Names Carolyn Ainslie as Chief Financial Officer
SEATTLE, July 5, 2018 — The Bill & Melinda Gates Foundation today announced that Carolyn Ainslie has been named chief financial officer, effective October 1, 2018. Currently, Ainslie is Vice President for Finance and Treasurer at Princeton University where she serves as the chief financial officer, responsible for the central financial functions of the University.


Bill & Melinda Gates Medical Research Institute    [to 14 Jul 2018]
   The Bill & Melinda Gates Medical Research Institute is a non-profit research organization dedicated to combating diseases that impact the world’s poorest. We strive to combat inequities in health by accelerating progress in translational science to ensure life-saving products are available and accessible to everyone. We consider ourselves pioneers dedicated to uncovering radical solutions that will close the gap between cutting-edge scientific innovation and its application to challenges in global health.
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CARB-X   [to 14 Jul 2018]
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
CARB-X funds Summit Therapeutics to support development of a new class of antibiotics to treat Gonorrhoea Superbug
CARB-X awards Summit Therapeutics $2 million in non-dilutive funding, with the possibility of up to $2.5 million more, to support the development of a new class of antibiotics to treat gonorrhoea. This project bring to 10 the number of new classes in the portfolio; 34 projects to fight superbugs

CEPI – Coalition for Epidemic Preparedness Innovations  [to 14 Jul 2018]
No new digest content identified.


EDCTP    [to 14 Jul 2018]
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
10 July 2018
MTBVAC in Newborns: kick-off meeting in South Africa
The kick-off meeting of the EDCTP-funded project MTBVAC in Newborns took place in Cape Town, South Africa on 6-7 June 2018. The candidate TB vaccine MTBVAC was developed by researchers from the University of Zaragoza, Spain, and the Institut Pasteur…


Emory Vaccine Center    [to 14 Jul 2018]
No new digest content identified.


European Medicines Agency  [to 14 Jul 2018]
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018
European Vaccine Initiative  [to 14 Jul 2018]
No new digest content identified.
FDA [to 14 Jul 2018]
July 13, 2018 –
FDA approves the first drug with an indication for treatment of smallpox
[See Milestones above for more detail]
July 11, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry (PDF – 486KB) July 2018

Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry (PDF – 294KB) July 2018

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry (PDF – 124KB) July 2018

Human Gene Therapy for Hemophilia; Draft Guidance for Industry (PDF – 371KB) July 2018

Human Gene Therapy for Rare Diseases; Draft Guidance for Industry (PDF – 136KB) July 2018

Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry (PDF – 172KB) July 2018
Fondation Merieux  [to 14 Jul 2018]
Launch of a study on lower acute respiratory infections in Rohingya refugee camps to improve and adapt patient care in a humanitarian crisis
July 12, 2018 – Cox’s Bazar (Bangladesh)
The Mérieux Foundation is conducting a new study to identify the pathogens at the onset of Lower Acute Respiratory Infections (LARI) in the context of a humanitarian crisis and to determine the healthcare interventions needed to improve patient care in such a setting.

Gavi [to 14 Jul 2018]
11 July 2018
Shifo & Gavi join hands to help make vaccines work for every child
The Shifo Foundation, in collaboration with Gavi and other key partners will work to strengthen registration and data quality across The Gambia and ensure no child misses out on life-saving vaccines.
GHIT Fund   [to 14 Jul 2018]
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical
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Global Fund [to 14 Jul 2018];&country=
Global Fund Appoints Philippe François as Head of Sourcing & Supply Chain
09 July 2018
Peter Sands, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, today named Philippe François as Head of Sourcing & Supply Chain, bringing a recognized track record of innovation in supplying healthcare products and services worldwide.

Hilleman Laboratories   [to 14 Jul 2018]
No new digest content identified.
Human Vaccines Project   [to 14 Jul 2018]
No new digest content identified.
IAVI  [to 14 Jul 2018]
No new digest content identified.
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IVAC  [to 14 Jul 2018]
No new digest content identified.
IVI   [to 14 Jul 2018]
No new digest content identified.

JEE Alliance  [to 14 Jul 2018]
No new digest content identified.
MSF/Médecins Sans Frontières  [to 14 Jul 2018]
Selected Press Releases/Statements
DRC 2018 Ebola outbreak
“Congolese health workers have shown an amazing commitment to fighting Ebloa
Voices from the Field 11 Jul 2018

NIH  [to 14 Jul 2018]
July 12, 2018
Imaging technique illuminates immune status of monkeys with HIV-like virus
— Approach could improve understanding of immune system recovery in people treated for HIV infection

NIAID scientists create 3D structure of 1918 influenza virus-like particles
July 11, 2018 — Details could advance vaccine development for several human diseases.

NIH researchers identify sequence leading to release of malaria parasites from red blood cells
July 11, 2018 — Findings could inform the development of new antimalarial drugs.

NIH and VA collaborate to boost veterans’ access to cancer clinical trials
July 10, 2018 — NAVIGATE will launch at 12 VA facilities across the nation.


PATH  [to 14 Jul 2018]
No new digest content identified.


Sabin Vaccine Institute  [to 14 Jul 2018]
No new digest content identified.
UNAIDS [to 14 Jul 2018]
Feature story
Monaco becomes a Fast-Track city
09 July 2018
Monaco has joined a network of more than 250 cities worldwide by signing the Paris Declaration, making a commitment to Fast-Track its response to the HIV epidemic and adopt the 90–90–90 targets.
The 90-90-90 targets are that, by 2020, 90% of all people living with HIV will know their HIV status, 90% of all people living with HIV will have access to antiretroviral therapy and 90% of all people on antiretroviral therapy will have viral suppression…


UNICEF  [to 14 Jul 2018]
Selected Press Releases/Reports/Statements
Press release
UNICEF Executive Director to serve as board chair of Global Partnership to End Violence Against Children

Vaccine Confidence Project  [to 14 Jul 2018]
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia  [to 14 Jul 2018]
No new digest content identified.
Wellcome Trust  [to 14 Jul 2018]
Published: 10 July 2018
Director’s update: taking risks on bold ideas
Today we’re announcing a new £250m Leap Fund to back bold ideas. Director Jeremy Farrar explains how it will accelerate discovery and innovation.
…Today we’re announcing a new £250m not-for-profit fund: the Wellcome Leap Fund. The Leap Fund will accelerate discovery and innovation, with the aim of delivering breakthroughs over a five- to ten-year horizon.
It will draw inspiration from the technology and venture capital sectors – taking on early stage, high-risk ideas and funding at scale – and apply these principles to charitable programme investments in the health and life sciences. It will run for an initial five years from 2020 and will account for around 5% of our total charitable spend during this time.
We think this addresses a gap in funding in the health and life sciences, where venture capital is often injected in the later stages of translation and restricted to investments that will guarantee financial returns. As an independent charitable foundation, Wellcome is well placed to offer something different. We can take an unconventional approach by taking risks on things we know may not succeed, but would be transformational if they did.
The Leap Fund will not replace or duplicate any of our current research funding schemes. We’ll continue to support these through our Primary Fund to the tune of over £900m a year, rising with inflation.
Leap funding will instead come from the separate Reserve Fund, which was established last year to support ambitious programmes where Wellcome has the capacity to drive significant progress towards addressing a global health challenge, or to advance science in a specific space within five to ten years…
The Wistar Institute   [to 14 Jul 2018]
No new digest content identified.


World Organisation for Animal Health (OIE)   [to 14 Jul 2018]
No new digest content identified.

BIO    [to 14 Jul 2018]
No new digest content identified.


DCVMN – Developing Country Vaccine Manufacturers Network  [to 14 Jul 2018]
No new digest content identified.

IFPMA   [to 14 Jul 2018]
No new digest content identified.

PhRMA    [to 14 Jul 2018]
July 12, 2018
PhRMA Statement on Efforts to Support Real-World Evidence
WASHINGTON, D.C. (July 12, 2018) – Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson Andrew Powaleny issued the following statement on comments made by U.S. Food and Drug Administration Commissioner Scott Gottlieb:
“We agree with Commissioner Gottlieb that the use of real-world evidence and innovative clinical trial designs hold great promise for enhancing the drug development process. When leveraged with the latest science and methodologies, these approaches can lead to more efficient drug development programs, provide more robust information about the benefits and risks of new medicines and can ultimately lead to more timely access to innovative, safe and effective medicines for patients…

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

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

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at:
The Economist Intelligence Unit Limited 2018 :: 35 pages
Executive summary
This study aims to explore whether the varying regulatory requirements for pharmaceutical products across the world are associated with medicine and vaccine shortages. This research project included a rapid literature review involving database and grey literature searches and a series of interviews with representatives of academia, industry, regulatory authorities, international organisations and global non-governmental organisations.

Key messages from the findings of the literature review and insights from the expert interviews are presented below.
:: Medicine and vaccine shortages are a global problem affecting rich and poor countries alike
Medicines and vaccines shortages are a global problem with significant impact on populations and health care systems. Shortages continue to persist, despite increased efforts from a range of stakeholders including international organisations, governments, regulators, healthcare providers, pharmacists and industry over the past decade. Vaccines shortages in particular are a serious public health issue, as they can lead to reduced population coverage and delays in prevention and control programmes for infectious diseases.

:: Causes for shortages are complex, multifaceted and not well understood
Causes for shortages are complex and interrelated, and vary for different products and countries. To channel the activities for prevention and mitigation of shortages, we need more research into the interplay of related causes, with a particular emphasis on economic and market-related causes. There is a need to identify critical products such as vaccines and risk factors that could affect the uninterrupted supply of these products to the people who need them.

:: This study found little evidence for the existence of a direct correlation between the global complexity of regulatory requirements for post approval changes and shortages
This study explored the question of whether the global complexity of regulatory requirements for post approval changes (PACs) to the terms of marketing authorisation could be a contributing factor for medicine and vaccine shortages; however we found little evidence in support of this hypothesis. In situations of shortages however, the regulatory complexity for PACs on a global scale could be an aggravating factor that delays or hinders mitigation actions.

:: There is a universal agreement that regulatory convergence and harmonisation are beneficial to all stakeholders
Regulatory harmonisation has been supported by the World Health Organization (WHO) since the 1980s. Numerous global and regional initiatives have been set up, including the European Regulatory System for medicines and the International Council on Harmonisation (ICH). There is a trend towards greater co-operation and regulatory convergence in the Americas, Asia-Pacific and South-East Asia, which could only be positive in terms of strengthening the regulatory systems in these regions and building trust between national regulatory authorities (RAs). The developments in Africa leading towards the establishment of an African Medicines Agency that follows the European model will also have a positive effect on the processes and timelines for PACs. © The Economist Intelligence Unit Limited 2018 4

:: Trust and strong political will are required for harmonisation and convergence initiatives to succeed
It is important to develop an understanding of the expectations and priorities of all stakeholders, and to pursue the harmonisation goal, even though progress may seem slow at times. A look at the history of the European Medicines Agency (EMA) since its establishment in 1995 shows that it has taken decades of work and strong political will to achieve the current level of harmonisation. The recent increase in mutual recognition agreements between the EMA and other RAs shows that regulators can work together to avoid duplication in effort and rely on each other’s expertise in challenging areas for regulatory science. The adoption of WHO guidelines for procedures and data requirements for changes to approved vaccines by national RAs, and further developments related to ICH quality guideline proposals for product lifecycle management, would help to reduce the complexity of requirements for the same changes across different jurisdictions.

:: Finding a permanent solution for shortages is critical for achieving global health goals
We hope that this report will help to raise awareness about the global impact of medicine and vaccine shortages, and the need for coordinated action from multiple stakeholders at international and national level. Finding a permanent solution for shortages is crucial for achieving the UN Sustainable Development Goal for health, including access to “safe, effective, quality and affordable essential medicines and vaccines for all” by 2030.

Journal Watch

Journal Watch

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

If you would like to suggest other journal titles to include in this service, please contact David Curry at:



Preparedness and response against diseases with epidemic potential in the European Union: a qualitative case study of Middle East Respiratory Syndrome (MERS) and poliomyelitis in five member states

BMC Health Services Research
(Accessed 14 Jul 2018)

Research article
Preparedness and response against diseases with epidemic potential in the European Union: a qualitative case study of Middle East Respiratory Syndrome (MERS) and poliomyelitis in five member states
EU Decision 1082/2013/EU on serious cross-border health threats provides a legal basis for collaboration between EU Member States, and between international and European level institutions on preparedness, pre
Authors: John Kinsman, John Angrén, Fredrik Elgh, Maria Furberg, Paola A. Mosquera, Laura Otero-García, René Snacken, Tarik Derrough, Paloma Carrillo Santisteve, Massimo Ciotti and Svetla Tsolova
Citation: BMC Health Services Research 2018 18:528
Published on: 6 July 2018

Standards of practice in empirical bioethics research: towards a consensus

BMC Medical Ethics
(Accessed 14 Jul 2018)

Research article
Standards of practice in empirical bioethics research: towards a consensus
This paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds.
Authors: Jonathan Ives, Michael Dunn, Bert Molewijk, Jan Schildmann, Kristine Bærøe, Lucy Frith, Richard Huxtable, Elleke Landeweer, Marcel Mertz, Veerle Provoost, Annette Rid, Sabine Salloch, Mark Sheehan, Daniel Strech, Martine de Vries and Guy Widdershoven
Citation: BMC Medical Ethics 2018 19:68
Published on: 10 July 2018
The Correspondence to this article has been published in BMC Medical Ethics 2018 19:67
The Correspondence to this article has been published in BMC Medical Ethics 2018 19:69
The Correspondence to this article has been published in BMC Medical Ethics 2018 19:66

Modelling population-level impact to inform target product profiles for childhood malaria vaccines

BMC Medicine
(Accessed 14 Jul 2018)

Research article
Modelling population-level impact to inform target product profiles for childhood malaria vaccines
The RTS,S/AS01 vaccine for Plasmodium falciparum malaria demonstrated moderate efficacy in 5–17-month-old children in phase 3 trials, and from 2018, the vaccine will be evaluated through a large-scale pilot imple…
Authors: Alexandra B. Hogan, Peter Winskill, Robert Verity, Jamie T. Griffin and Azra C. Ghani
Citation: BMC Medicine 2018 16:109
Published on: 13 July 2018