Announcements

Announcements

CEPI – Coalition for Epidemic Preparedness Innovations  [to 28 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 28 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
No new digest content identified.

European Medicines Agency  [to 28 October 2017]
http://www.ema.europa.eu/ema/
27/10/2017
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2017

26/10/2017
EU scientific opinion: how to assess progress on reduction of antimicrobial resistance and antimicrobial consumption
ECDC, EFSA & EMA recommend set of indicators to measure progress in EU Member States
A set of indicators will assist European Union (EU) Member States to assess their progress in reducing the use of antimicrobials and combatting antimicrobial resistance (AMR). These indicators have been established by the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), following a request from the European Commission
 
 
FDA [to 28 October 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New in Biologics
October 20, 2017 Approval Letter – SHINGRIX (PDF – 74KB)
Posted: 10/23/2017
 
 
Gavi [to 28 October 2017]
http://www.gavi.org/library/news/press-releases/
26 October 2017
Substantial decline in global measles deaths, but disease still kills 90,000 per year
Joint news release CDC/Gavi/UNICEF/WHO.
[See Milestones above for more detail]

24 October 2017
Gavi and the Aspen Institute to strengthen health management capacity in developing countries
Malawi will be the first country to benefit from the new partnership
Geneva, 24 October 2017 – Gavi, the Vaccine Alliance and the Aspen Institute have joined forces to strengthen national leadership, management and coordination of Malawi’s immunisation programme through the Aspen Management Partnership for Health (AMP Health). The partnership will improve managerial capacity to support Gavi’s mission to ensure that every child in Malawi is protected with life-saving vaccines…

Throughout 2016, Gavi began to roll out a series of interventions aimed at strengthening Expanded Programme for Immunization (EPI) teams and national coordination forums. This included embedding peer coaches within the EPI teams in Malawi and Papua New Guinea, for example. This initiative is run in partnership with the Aspen Management Partnership for Health and Dalberg Global Development Advisors. We also developed a set of tools and training courses to help strengthen the capacity of coordination forums.

A new training programme for EPI managers will combine a mentoring component with online learning and in-person group sessions. We will further boost the management capacity of EPI teams by funding critical positions for a time-limited period.

The partnership between Gavi and the Aspen Institute seeks to address these challenges by embedding a management partner into Malawi’s immunisation team, who will coach staff and build capacity to improve the performance of the immunisation programme.

“At Gavi we know that effective management of immunisation programmes is key to building strong health systems and extending those systems to reach all children who desperately need them”, said Dr Seth Berkley, CEO of Gavi. “Our partnership with the Aspen Institute is one of many innovative investments in effective management that Gavi is rolling out. Aspen’s leadership and management expertise will be an important boost to our mission to ensure no child goes without lifesaving vaccines”, he added….
 
 
GHIT Fund   [to 28 October 2017]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical ·
No new digest content identified.

 
Global Fund [to 28 October 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund Names Finalist Candidates for Executive Director
23 October 2017
The Global Fund Board named four finalist candidates for Executive Director, and is scheduled to select one at a Board meeting on 14 November 2017.
:: Simon Bland is the Director of the New York Office of the Joint United Nations Programme on HIV/AIDS. He served as the Chair of the Global Fund Board from 2011 to 2013. Formerly, he worked for three decades at the Department for International Development of the United Kingdom, and led its operations in Kenya.
:: Frannie Leautier is the former Senior Vice President of the African Development Bank where she was a key member of President Adesina’s transition team. Previously, she was Chief Executive Officer of the African Capacity Building Foundation, after a successful career at the World Bank, during which she spent time as Chief of Staff to President Wolfensohn, and ran the World Bank Institute, the institution’s capacity building branch.
:: Peter Sands is the former Group Chief Executive of Standard Chartered Bank. He began his career at McKinsey & Company. After having spent a sustained period leading a major bank with global operations in relevant countries, he has held a fellowship at Harvard, and immersed himself in a range of global public health projects.
:: Anil Soni is a senior executive at Mylan, the global pharmaceutical company, co-leading development, sales, and partnerships for medicines to prevent and treat HIV/AIDS, tuberculosis, malaria and hepatitis C. He was closely involved in the early years of the Global Fund as an adviser to Richard Feachem, after which he led the advocacy work of Friends of the Global Fight in Washington, DC. He spent six years at the Clinton Health Access Initiative, latterly as its Chief Executive.
 
 
 
Human Vaccines Project   [to 28 October 2017]
http://www.humanvaccinesproject.org/media/press-releases/
Oct 26, 2017
The Human Vaccines Project Launches New Initiative To Accelerate Development Of Universally Effective Influenza Vaccines
NEW YORK, Oct. 26, 2017 /PRNewswire-USNewswire/ — The Human Vaccines Project, a public-private partnership with a mission to decode the immune system to advance human health, announced today the launch of the Universal Influenza Vaccine Initiative (UIVI), a first-of-its-kind program that will address the underlying scientific barrier impeding the development of broadly protective, universal influenza vaccines: the human immune response…
[See Milestones above for more detail]

IVAC  [to 28 October 2017]
http://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
September 2017
VIEW-hub Report: Global Vaccine Introduction and Implementation – A report on current global access to new childhood vaccines
New vaccine introduction updates (since June 2017) include:
– Seychelles has introduced rotavirus vaccine
– Liberia has introduced IPV
 
 
IVI   [to 28 October 2017]
http://www.ivi.int/
Oct 25, 2017
IVI secures $2,850,057 supplemental grant for SETA Program
The International Vaccine Institute (IVI) has just secured a $2,850,057 supplemental grant for the Severe Typhoid in Africa (SETA) Program from the Bill & Melinda Gates Foundation. With the addition of the latest grant, total SETA grant revenue has reached $9,528,322.
The SETA program led by IVI’s Epidemiology Unit will continue to carry out severe typhoid surveillance activities in Burkina Faso, the Democratic Republic of the Congo, Ghana, Ethiopia, Nigeria and Madagascar in close collaboration with local and international partners, IVI laboratories in charge of assessing immune responses in typhoid patients; the Policy and Economic Research Department, which is responsible for typhoid cost analyses; and the Biostatistics and Data Management Department.  Of note, SETA/TSAP (Typhoid Fever Surveillance in Africa Program) data has helped inform WHO-SAGE recommendations for future usage of typhoid conjugate vaccines. Final SETA data will be available by Q1/2020.
 
[undated]
IVI acquires  $797,000 grant to support licensure of OCV in Bangladesh
The International Vaccine Institute has acquired a grant of $797,519 from the Bill & Melinda Gates Foundation to support Incepta for the development and production of Cholvax®, which was developed with technology transfer from IVI. Managed by IVI’s Development and Delivery Unit, the grant will support Incepta applying for licensure of Cholvax, in Bangladesh. The D&D Unit will conduct this project in collaboration with the Bangladeshi company and IVI’s Vaccine Process Development Unit, to ensure the successful completion of this project by September 2018

October 10, 2017
Vaccine investment brings 16-fold return… partnering with Bill Gates
– Jerome Kim, International Vaccine Institute Director General
– On the occasion of the 20th anniversary of IVI’s development and delivery of cholera and other vaccines

By Kim Sung-mo, The Chosun Ilbo
“Investment in vaccines can bring a 16-fold return, and a $1 investment can result in $16 in savings through disease prevention,” said Jerome Kim (58), IVI Director General, citing research by Johns Hopkins University in an interview marking the institute’s 20th anniversary.
The Director General added, “IVI developed an oral cholera vaccine that has been introduced in Haiti and Malawi and elsewhere, saving the lives of children and the impoverished in developing countries.”…
 
 
NIH  [to 28 October 2017]
http://www.nih.gov/news-events/news-releases
October 26, 2017
NIH study identifies new targets for anti-malaria drugs
 — The deadliest malaria parasite needs two proteins to infect red blood cells.
The deadliest malaria parasite needs two proteins to infect red blood cells and exit the cells after it multiplies, a finding that may provide researchers with potential new targets for drug development, according to researchers funded by the National Institutes of Health. Their study appears in the latest issue of Science…
In the current study, researchers sought to uncover the role of plasmepsins IX and X, two of the 10 types of plasmepsin proteins produced by P. falciparum for metabolic and other processes. They created malaria parasites that lacked plasmepsin IX or X under experimental conditions and compared them to those that had the two proteins.
 
 
PATH  [to 28 October 2017]
http://www.path.org/news/index.php
Press release | October 24, 2017
Global Alliance Releases New Tools to Guide Evidence-based Solutions Across Health, Development, and Environment
London, United Kingdom, October 25, 2017 — The Bridge Collaborative, a global alliance of 90 organizations from 23 countries, today released two new tools to assist decision-makers solving big challenges facing health, development, and the environment.
The Bridge Collaborative Practitioner’s Guide on Principles and Guidance for Cross-sector Action Planning and Evidence Evaluation and the policy-focused Call to Action for Health, Environment, and Development Leaders were developed to accelerate progress towards building a shared, cross-sector evidence base that informs strategies, shapes policies, and directs funding decisions to achieve concrete solutions. These resources are available at: www.bridgecollaborativeglobal.org

Press release | October 23, 2017
US leadership and sustained funding urgently needed to prevent pandemics
New PATH report warns that gains from investments to stop Ebola and Zika outbreaks are at risk
Washington, DC, October 24, 2017 — Recent progress made in protecting Americans and people around the world from pandemics is at risk of being lost if US support is not sustained, PATH warns in a new report titled “Healthier World, Safer America: A US Government Roadmap for International Action to Prevent the Next Pandemic.” Programs established or strengthened with supplemental funding to thwart outbreaks of Ebola and Zika face a drastic cut in funding if the US administration and Congress do not act to protect these investments.
“Unfortunately, global health security funding too often comes in reaction to a crisis rather than ahead of time, when we can make more cost-effective and sustainable investments in systems that help stop disease outbreaks at their source, before they spread to our shores,” said Carolyn Reynolds, Vice President of Policy and Advocacy at PATH. “The US and the world are just beginning to reap the benefits of efforts made post-Ebola. Now is not the time to step back.”…

Sabin Vaccine Institute  [to 28 October 2017]
http://www.sabin.org/updates/pressreleases
October 22, 2017
Health Leaders Gather in Dubai for Regional Workshop on Adolescent Health and Immunization
DUBAI, UNITED ARAB EMIRATES –– Today, the Sabin Vaccine Institute (Sabin) convened public health leaders from across the Middle East and North Africa for a two-day interactive workshop to share experiences and strategies in strengthening adolescent health and immunization.

UNICEF  [to 28 October 2017]
https://www.unicef.org/media/
27 October, 2017
Growing number of unaccompanied refugee and migrant children in Greece in urgent need of shelter, care and protection
ATHENS/GENEVA, 27 October 2017 – Only a third of the nearly 3,000 unaccompanied refugee and migrant children currently in Greece are receiving proper shelter and care, UNICEF warned today. The children’s agency is urging key policy and legal reforms to help keep vulnerable children safe.

Substantial decline in global measles deaths, but disease still kills 90 000 per year
GENEVA/NEW YORK /ATLANTA, 26 October 2017– In 2016, an estimated 90,000 people died from measles – an 84 per cent drop from more than 550 000 deaths in 2000 – according to a new report published today by leading health organizations. This marks the first time global measles deaths have fallen below 100 000 per year.
[See Milestones above for more detail]

Two months since outbreak of violence in Myanmar, Rohingya refugee children still at acute risk
NEW YORK/GENEVA/DHAKA, 23 October 2017 – Nearly two months since Rohingya families began fleeing en masse to Bangladesh, thousands of children and women are still without basic lifesaving services, UNICEF said today.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 28 October 2017]
http://www.dcvmn.org/
26 October 2017
Inaugural address of the DCVMN 2017 Annual Meeting in Seoul
by Deok Cheol Kwon, Deputy Minister of Health and Welfare 26th September 2017
 
 
IFPMA   [to 28 October 2017]
http://www.ifpma.org/resources/news-releases/
Published on: 26 October 2017
Global coalition in the fight against falsified medicines meets in Brussels as it welcomes its 35th partner
Wednesday, 25 October 2017, Brussels – Fight the Fakes campaign partners representing healthcare professionals, academia, NGOs, the generic and research-based pharmaceutical industry, healthcare distributers, and consumer protection organizations met this week to work on their future plans to raise awareness of the widespread sale and use of falsified medicines across the world and the dangers associated with these fake products.
With virtually all countries around the world impacted by fake medicines, and potentially 15% of medicines worldwide and up to 30% in some regions being fake, this a real danger to public health. By passing themselves off as something they are not, fake medicines put patients at risk for continued illness, disability, or even death. Some estimates put the number of deaths by falsified medicines at 700,000 per year. In addition, online sale of medicines is an increasing international threat, as there are more than 40,000 “active rogue online pharmacies” at active at any one time.  Fake medicines represent a crime against patients and are a danger to public health, contributing to resistance of genuine treatments and undermining confidence in health systems.
As the campaign approaches its four-year anniversary, Fight the Fakes is gathering pace in its efforts to inform, inspire, empower, and mobilize communities against fake medicines; as well as building up further momentum to call for the creation and strict application of legislative and regulatory frameworks. Partners today reinforced their commitment to the campaign and the issue of falsified medicines, committing themselves to tangible actions to further raise the profile of this global health threat.
IFPMA proudly joined this meeting as one of the founding members of this coalition…Today, Fight the Fakes is proud to also announce that the National Association of Boards of Pharmacy (NABP) has joined the campaign, bringing the total number of partners to 35…
 
 
 
Industry Watch  [to 28 October 2017]
:: CDC’s Advisory Committee on Immunization Practices recommends Shingrix as the preferred vaccine for the prevention of shingles for adults aged 50 and up
Committee recommends immunization for up to 62 million additional adults in the US
LONDON, Oct. 25, 2017 /PRNewswire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of three recommendations for the use of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster):
:: Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older.
:: Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received Zoster Vaccine Live (Zostavax).
:: Herpes Zoster subunit vaccine (Shingrix) is preferred over Zoster Vaccine Live (Zostavax) for the prevention of herpes zoster and related complications.
The new recommendations mean up to 62 million more adults in the US should be immunized, approximately 42 million aged 50-59 years old and 20 million who have previously been vaccinated against shingles…