Announcements

Announcements

CARB-X   [to 26 May 2018]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
05.22.2018
UK Government and Bill & Melinda Gates Foundation join CARB-X partnership in fight against superbugs
…The UK Government is committing up to £20 million, and the Bill & Melinda Gates Foundation up to US$25 million, to CARB-X over the next three years. Combined with existing funding commitments from Wellcome Trust and the US Government (BARDA and NIAID), CARB-X now has more than $500 million to invest in antibacterial development. CARB-X is the world’s leading non-profit partnership focused on accelerating the early development of antibiotics, vaccines, diagnostics and other products needed to save lives and to address the rising threat of superbugs. There are currently 33 projects in the CARB-X portfolio from 7 countries…
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 26 May 2018]
http://cepi.net/
Latest News
CEPI Awards $25 Million Contract to Profectus BioSciences and Emergent BioSolutions to Develop Nipah Virus Vaccine
OSLO, Norway, BALTIMORE and GAITHERSBURG, Md., May 24, 2018
CEPI—the Coalition for Epidemic Preparedness Innovations—today announced a collaboration with Profectus BioSciences, Inc. and Emergent BioSolutions Inc. (NYSE: EBS) under which Profectus and Emergent will receive up to $25 million to advance the development and manufacture of a vaccine against the Nipah virus, a bat-borne virus that can spread to both humans and livestock.
Under the terms of the Framework Partnering Agreement for the collaboration among the three parties, Profectus will receive development funding from CEPI for advancing its Nipah virus vaccine and Emergent will provide technical and manufacturing support for the CEPI-funded program. Emergent, through a separate agreement with Profectus, has an exclusive option to license and to assume control of development activities for the Nipah virus vaccine from Profectus. The international nonprofit organization PATH will also be working with the consortium under a separate agreement with CEPI to work on clinical development…

Strong Clinical Research Capacity in At-Risk Countries Key to Global Epidemic Prevention
May 22, 2018   New report outlines urgent need and opportunities in low- and middle-income countries where disease outbreaks most often strike
[See Research/Reports below for more detail]

CEPI Partners with the International AIDS Vaccine Initiative to Advance Lassa Fever Vaccine Development
NEW YORK and OSLO – May 21, 2018
Organizations aim to tackle WHO priority disease and to stockpile emergency vaccines

European Medicines Agency  [to 26 May 2018]
http://www.ema.europa.eu/ema/
24/05/2018
Development of antibiotics for children – towards a global approach
Workshop with regulators from EU, Japan and US open for registration …
 
 
Gavi [to 26 May 2018]
http://www.gavi.org/library/news/press-releases/
23 May 2018
Gavi’s response to the DRC Ebola outbreak
Statement to the 71st World Health Assembly
Gavi, the Vaccine Alliance, would like to congratulate the Government of DRC and particularly,    the leadership shown by the Minister of Health and the support of international partners in the very quick response to the Ebola outbreak.
Ring vaccination started Monday based on a very prompt reaction from the Government. Gavi was instrumental in making 300,000 investigational doses of the rVSV-ZEBOV Ebola vaccine available, some of which will be used in the current Ebola response. Without Gavi’s agreement with the manufacturer making sure that the doses are available immediately for outbreak response, we would be in a much worse position to respond to this outbreak.
Moreover, Gavi is providing US$1 million towards the vaccination drive. Gavi’s funding will support the deployment of health workers, transport, critical supplies and other operations. The vaccination will be implemented by the Government of DRC and partners including WHO, which is leading and coordinating the international health response, and Medecins Sans Frontieres (MSF). Guinea and Niger sent experts in DRC to support implementation that reflects a great solidarity effort in the continent.
Next 10 days are going to be critical. We will have a better sense of how the epidemic is going to evolve…

21 May 2018
Ebola vaccine to help tackle DRC outbreak
Vaccination begins in the Democratic Republic of the Congo.
 
 
IAVI  [to 26 May 2018]
https://www.iavi.org/
May 21, 2018
CEPI Partners with the International AIDS Vaccine Initiative to Advance Lassa Fever Vaccine Development
Organizations aim to tackle WHO priority disease and to stockpile emergency vaccines.
The Coalition for Epidemic Preparedness Innovations (CEPI) and the International AIDS Vaccine Initiative (IAVI) announced a partnership today to develop a new vaccine candidate against Lassa fever virus with the goal of creating a stockpile to address future outbreaks.
IAVI CEO Mark Feinberg and CEPI CEO Richard Hatchett sign an agreement to advance vaccines against Lassa fever on May 18 in London. Photo/CEPI
The partnership will support the development of IAVI’s replicating viral vector-based Lassa vaccine candidate, rVSVΔG-LASV-GPC. CEPI will provide US$10.4 million to support the first phase of the project, with options to invest up to a total of US$54.9 million over five years (including stockpile). CEPI is providing support to IAVI to develop the vaccine based on previous findings that the vaccine induced strong immune responses and was highly efficacious in animal models…
 
 
MSF/Médecins Sans Frontières  [to 26 May 2018]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
MSF Welcomes Adoption of World Health Assembly Resolution to Tackle Snakebite Crisis
May 24, 2018
Doctors Without Borders/Médecins Sans Frontières (MSF) made the following statement after the adoption of a resolution on “Addressing the burden of snakebite envenoming” during the 71st World Health Assembly today.

Press release
MSF Response on Launch of Global Hub to Combat Antimicrobial Resistance
May 22, 2018
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) welcomes the launch of the Global Research & Development (R&D) collaboration hub on antimicrobial resistance (AMR) announced at the World Health Assembly today.

 
NIH  [to 26 May 2018]
http://www.nih.gov/news-events/news-releases
May 23, 2018
NIH begins testing Ebola treatment in early-stage trial
— Scientists developed monoclonal antibody from Ebola survivor.
A first-in-human trial evaluating an experimental treatment for Ebola virus disease has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland. The Phase 1 clinical trial is examining the safety and tolerability of a single monoclonal antibody called mAb114, which was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and their collaborators. Investigators aim to enroll between 18 and 30 healthy volunteers aged 18 to 60. The trial will not expose participants to Ebola virus.
Ebola virus disease is a serious and often fatal illness that can cause fever, headache, muscle pain, weakness, fatigue, diarrhea, vomiting, stomach pain and hemorrhage (severe bleeding). It was first discovered in humans in 1976 in the Democratic Republic of the Congo (DRC) and has caused periodic cases and outbreaks in several African countries since then. The largest outbreak, which occurred in West Africa from 2014 to 2016, caused more than 28,600 infections and more than 11,300 deaths, according to the World Health Organization. In May 2018, the DRC reported an Ebola outbreak, located in Équateur Province in the northwest of the country. As of May 20, health officials have reported 51 probable or confirmed cases and 27 deaths. There are currently no licensed treatments available for Ebola virus disease, although multiple experimental therapies are being developed.
“We hope this trial will establish the safety of this experimental treatment for Ebola virus disease — an important first step in a larger evaluation process,” said NIAID Director Anthony S. Fauci, M.D. “Ebola is highly lethal, and reports of another outbreak in the DRC remind us that we urgently need Ebola treatments.”…
 
NIH-funded researchers identify target for chikungunya treatment
May 21, 2018 — Chikungunya is transmitted to humans by the bite of an infected mosquito.

PATH  [to 26 May 2018]
http://www.path.org/news/index.php
Announcement | May 23, 2018
Ebola returns to Democratic Republic of Congo
What PATH is doing
:: Jointly with the MOH, PATH deployed the first wave of 12 MOH investigators on May 10, and on May 23 an additional 10 epidemiologists and 6 communication experts to Mbandaka.
:: PATH’s Dr. Ousmane Ly has been designated as interim Coordinator for the national Emergency Operations Center (EOC) in Kinshasa, and is advising Minister of Health Dr. Oly Ilunga on implementing a strategy for data collection—including using satellite imagery to refine maps to help track the outbreak.
:: This week, PATH will work with the WHO to install and support a provincial EOC in Mbandaka Equateur Province to coordinate response efforts with officials in the national EOC.
:: PATH’s Dr. Leon Kapenga and Dr. Robert Burume are working to support the Ministry on a daily basis for the surveillance and communication commissions.
:: PATH is reestablishing “VSATs” (satellite communications systems) in Equateur, thus reconnecting vital telecommunications capabilities in the remote Bikoro health zone where the outbreak began.
:: PATH delivered Chlorine Makers made by Seattle-based MSR Global Health for critical water treatment and disinfection of biohazard waste from healthcare facilities and trained local personnel on their use and maintenance…
 
 
UNAIDS [to 26 May 2018]
http://www.unaids.org/en
Feature story
Global HIV Prevention Coalition accelerates action to reduce new HIV infections
23 May 2018
The Global HIV Prevention Coalition has launched its first progress report.
Taking stock of the progress made in strengthening political commitment for HIV prevention and reducing new HIV infections, the report shows that significant progress has been made since the launch of the Global HIV Prevention Coalition six months ago. National prevention coalitions have been established to accelerate and better coordinate responses, new and ambitious prevention programme targets have been set in many countries and HIV strategies that focus on prevention have been launched…
 
Vaccine Confidence Project  [to 26 May 2018]
http://www.vaccineconfidence.org/
Confidence Commentary
Ebola outbreak: Importance of gaining community trust during vaccine roll-out – expert comment
Heidi Larson | 24 May, 2018
The experimental Ebola vaccine rVSV-ZEBOV is being deployed in the Democratic Republic of Congo to help stop the spread of the disease.
At this crucial time Dr Heidi Larson, Director of The Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine, comments on the importance of gaining the trust of the local population.
“In the context of uncertainty, fear, a known deadly virus and an unknown foreign vaccine, it is not surprising that some particularly remote or marginalized communities might turn to their faith-based groups and religious leaders.
“We have come a long way since the 2014 West Africa Ebola outbreak in terms of having vaccine candidates that have shown to be effective, albeit it yet-to-be registered for population-wide use outside of emergencies, but they are still very new and we need to build trust.
“As long as there are Ebola reservoirs in animals we will continue to have outbreaks. Our immediate task is to build community trust to help contain the current outbreak, and we must continue with building vaccine awareness and confidence in order to be ready for the next one.”
“The new vaccine is an important additional measure which we hope will help control the outbreak, but equally important are the tried and tested methods of Ebola outbreak response, such as increased hygiene methods and safe burials of those affected by Ebola to prevent spread to family and community.”
Dr Larson leads the Vaccine Confidence Project which in 2016 found that the European region is the most sceptical about vaccine safety, with France the country least confident with 41% of those surveyed disagreeing that vaccines are safe.

Wellcome Trust  [to 26 May 2018]
https://wellcome.ac.uk/news
News / Published: 23 May 2018
Wellcome pledges £2m after new Ebola outbreak confirmed
Wellcome is making an initial fund of up to £2 million available to support a rapid response to the new Ebola outbreak in the Democratic Republic of Congo (DRC).
The pledge comes after the DRC government announced the latest outbreak following tests that confirmed two cases of Ebola in the Bikoro area, near the north-west border. It’s the ninth Ebola outbreak in DRC.
The funding will be available to the government of the DRC and the World Health Organization (WHO) for the critical research needed to support the operational response now underway in the country.

News / Published: 23 May 2018
Second global call to action against drug-resistant infections
Wellcome is to co-host a second global conference, in Ghana, to help drive pioneering action to stop the rise and spread of superbugs.
The two-day Call to Action, taking place in Accra this November, is co-hosted with the governments of Ghana and Thailand, and the United Nations Foundation, and is organised in partnership with the Inter-Agency Coordination Group (IACG) on Antimicrobial Resistance.
Health representatives from national governments and agencies, civil society, the private sector and global philanthropies will be invited to come together at the Call to Action to focus on how to address the most critical gaps in tackling the development and spread of drug-resistant infections.

World Organisation for Animal Health (OIE)   [to 26 May 2018]
http://www.oie.int/en/for-the-media/press releases/2018/
24/05/18
State of play of the global animal health situation
The 86th OIE General Session was the occasion to give OIE Member Countries, an overview of the global animal health situation, as well as to analyse trends in the evolution of priority terrestrial and aquatic animal diseases. In addition, new disease status were officially recognised for 10 countries.

22/05/18
OIE International Standards implementation, a path to more efficient national animal health systems
The 86th General Session of the OIE is the occasion to present a report on the state of play on the implementation and capacity building needs in respect to OIE International Standards. Topics cover the challenges faced to implement these standards, the role that the new OIE Observatory will play in this regard and the perspective from International Organisations on creating greater transparency for improved animal health, welfare and safe trade.

::::::
 
BIO    [to 26 May 2018]
https://www.bio.org/insights/press-release
access to the medicines they need …”

DCVMN – Developing Country Vaccine Manufacturers Network  [to 26 May 2018]
http://www.dcvmn.org/
access to the medicines they need …”
 
IFPMA   [to 26 May 2018]
http://www.ifpma.org/resources/news-releases/
25 May 2018
IFPMA Welcomes Set-Up of New African Medicines Agency
Geneva, 25 May 2018 – To mark Africa Day, soon after African health ministers of 55-country African Union, all gathered at the 71st World Health Assembly, unanimously adopted a treaty to establish the African Medicines Agency, IFPMA seizes this momentum to welcome this important milestone. The new African Medicines Agency (AMA) will support the varying regulatory capacities of its member states and will help set-up a comprehensive, regional system of regulatory supervision that serves to harmonize regulations across national boundaries, make efficient use of its limited resources, and deepen its capacity building. It is a vital step that will help improve timely access to effective, quality therapies, and vaccines for all patients, in every corner of Africa…

News Release: International Alliance of Patients’ Organizations joins Fight the Fakes as 36th partner
24 May 2018

News Release: The pharmaceutical industry advocates for even greater collaboration as critical to future global health progress
Geneva, 22 May 2018 – IFPMA launches today “50 Years of Global Health Progress”. The report traces global health progress over the past 50 years and the pioneering collaborative role the research-based biopharmaceutical industry has played not only to deliver prevention and treatment, but to strengthen health systems around the world. The report reviews some of the research-based biopharmaceutical industry’s major scientific advances, as well as acknowledging challenges the industry faces and areas of unfinished business. The industry’s track record of partnerships over recent decades demonstrates what can be achieved by uniting governments, civil society and business. The report concludes with a commitment to continue to innovate and partner with a shared goal to deliver better health for everyone, everywhere…
 
PhRMA    [to 26 May 2018]
http://www.phrma.org/press-room
access to the medicines they need …”

Industry Watch    [to 26 May 2018]
:: A Study Analyzing Observational Data Shows Real-World Effectiveness of Prevnar® 13 in Adults Age 65+
   Study Finds Prevnar 13 was Associated With Reduced Risk of Hospitalization From Vaccine-Type Community-Acquired Pneumonia in Older Adults1
May 22, 2018

:: Pfizer Begins a Phase 1/2 Study to Evaluate Respiratory Syncytial Virus (RSV) Vaccine
May 22, 2018
   RSV affects 33 million children globally and leads to approximately 120,000 childhood deaths every year1
   In the United States approximately 177,000 older adults are hospitalized annually because of RSV2
   The clinical program aims to develop a vaccine for populations at highest risk of infection: infants through maternal immunization, and older adults through direct vaccination

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

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders
Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org
 
 
Full Report: Money and Microbes: Strengthening Research Capacity to Prevent Epidemics
The International Vaccines Task Force (IVTF)
Supported by the International Vaccines Task Force was supported by the World Bank Group and the [CEPI] Coalition for Epidemic Preparedness Innovations.
World Bank – Working Paper  2018/05/01:: 75 pages
PDF: http://documents.worldbank.org/curated/en/120551526675250202/pdf/126338-REVISED-27231-IVTF-Report-reduced.pdf
Abstract
In the last 5 years alone, the world has been tested with serious challenges from two viral diseases. The Ebola outbreak that unfolded between 2014 and 2016 devastated West Africa, and while its health and economic impacts beyond the continent were limited, it sent a loud message to the rest of the world about how vulnerable it was to the next epidemic. This was followed by the Zika Virus outbreak that began in early 2016, which also remained confined largely to Latin America, and served to remind the rest of the world that there was no room for complacency. Further warnings were not needed—but they nevertheless came in quick succession. In May 2017, the Democratic Republic of the Congo notified international public health agencies of a cluster of suspected cases of Ebola virus disease in the Likati health zone of the province of Bas Uélé. In October 2017, Madagascar reported an outbreak of the deadliest form of plague, pneumonic, which had hit its major cities and towns and was spreading fast. Around the same time, a Marburg virus disease outbreak was detected in the Kween district of eastern Uganda. And a few months later, Nigeria begun experiencing what would turn out to be its worst Lassa fever outbreak ever, recording more cases in January 2018 alone than during all of 2017.

Press Release
Strong Clinical Research Capacity in At-Risk Countries Key to Global Epidemic Prevention
New report outlines urgent need and opportunities in low- and middle-income countries where disease outbreaks most often strike
GENEVA, May 22, 2018 – Robust clinical research capacity in low- and middle-income countries is key to stemming the spread of epidemics, according to a new report from the International Vaccines Task Force (IVTF). The report, entitled Money and Microbes: Strengthening Research Capacity to Prevent Epidemics, lays out how to develop the political support, financing and coordination required to build this capacity as a crucial component of global epidemic preparedness. The IVTF was convened by the World Bank Group (WBG) and the Coalition for Epidemic Preparedness Innovations (CEPI) in October 2017.
There have been many global and country-level efforts to strengthen pandemic preparedness and response since the deadly West African Ebola outbreak in 2014-2015 that killed 11,000 people—and the last few weeks have provided evidence of this. During the current Ebola outbreak in the Democratic Republic of Congo (DRC) with 49 total cases and 26 deaths so far, the government of DRC has approved the use for trials starting this week of a new, as-yet unlicensed Ebola vaccine, the rVSV-ZEBOV. The vaccine has proven highly effective in a clinical trial conducted in Guinea in 2015. Nigeria had its worst Lassa Fever outbreak on record earlier this year, and also pushed forward with conducting clinical trials as the outbreak unfolded.
“Times of crisis present the opportunity to focus capabilities and energy on solving important problems,” said Marie-Paule Kieny, Director of Research at INSERM and co-chair of IVTF. “Robust clinical research capacity is the only way to ensure that we don’t face future outbreaks with the same knowledge gaps over and over again.”
Of the 96 countries that have conducted vaccine trials in the past 20 years, 56 have conducted only between 1 and 10 trials, according to a registry maintained by the World Health Organization (WHO). This is insufficient to advance promising new vaccines, therapeutics and diagnostics for epidemic infectious diseases at the scale that is needed. The report recommends building capacity at a national or regional level that can flexibly scale up to run clinical trials during outbreaks, and focus on ongoing high-priority disease research based on local needs in between outbreaks…

Journal Watch

Journal Watch

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

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Prediction of mortality in severe dengue cases

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 26 May 2018)

Research article
Prediction of mortality in severe dengue cases
Increasing incidence of dengue cases in Malaysia over the last few years has been paralleled by increased deaths. Mortality prediction models will therefore be useful in clinical management.
Authors: Saiful Safuan Md-Sani, Julina Md-Noor, Winn-Hui Han, Syang-Pyang Gan, Nor-Salina Rani, Hui-Loo Tan, Kanimoli Rathakrishnan, Mohd Azizuddin A-Shariffuddin and Marzilawati Abd-Rahman
Citation: BMC Infectious Diseases 2018 18:232
Published on: 21 May 2018

Informing real-world practice with real-world evidence: the value of PRECIS-2

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 26 May 2018)

Commentary
Informing real-world practice with real-world evidence: the value of PRECIS-2
Authors: Gila Neta and Karin E. Johnson
Citation: BMC Medicine 2018 16:76
Published on: 21 May 2018
Abstract
Real-world evidence is needed to inform real-world practice. Pragmatic controlled trials are intended to provide such evidence by assessing the effectiveness of medicines and other interventions in real-world settings, as opposed to explanatory trials that assess efficacy in highly controlled settings. Dal-Ré and colleagues (BMC Med 16:49, 2018) recently performed a literature review of studies published between 2014 and 2017 to assess the degree to which studies that self-identified as pragmatic were truly so. The authors found that over one-third of randomized controlled trials of drugs and biologics that were self-labeled as pragmatic used placebo controls (as opposed to usual care), tested medicines before licensing, or were conducted in a single site. Further, they proposed that, in order to improve the reliability of the ‘pragmatic’ label, investigators should assess their trials using the PRECIS-2 tool upon submission to funders, ethics boards, or journals. We appreciate the value of PRECIS-2 as an indicator to assess the pragmatic versus explanatory features in a trial, and we herein highlight the potential challenges and opportunities that may arise with its systematic and widespread use.