Announcements

Announcements
 

Human Vaccines Project   [to 13 May 2017]
http://www.humanvaccinesproject.org/media/press-releases/
08 May, 2017
New Study Aims to Explain the Rules of How The Immune System Works
Findings from this research will inform how to generate long-lasting immunity against diseases
NEW YORK, May 8, 2017 /PRNewswire-USNewswire/ — The Human Vaccines Project, a nonprofit public-private partnership focused on decoding the immune system to improve human health, announced today the initial enrollment of its first clinical trial in a new program aimed at dramatically increasing knowledge of how the immune system works. The study is the first step in a series of trials, with the goal of engineering the human immune system to confer lifelong protection from infectious and non-communicable diseases across global populations.

“While vaccines are among the greatest successes in the history of public health, we do not fully understand how most vaccines work and why some are less effective in certain populations,” said Wayne C. Koff, Ph.D., president and CEO of the Human Vaccines Project. “Determining the core principles of how the human immune system recognizes pathogens and fights diseases will enable a more precise approach for developing vaccines and immunotherapies for a wide range of diseases such as AIDS, tuberculosis, diabetes, multiple sclerosis and cancer.”

The initial study will assess immune responses of 10 healthy adults (ages 40-80) to a licensed hepatitis B vaccine. It will feature one of the most comprehensive analyses of how people respond to vaccinations to learn why some individuals are protected from a single dose, while others are not. The study will expand to include several hundred people – from neonates to the elderly in middle and low-income countries.

“Developing a better understanding of why some groups of people are protected from disease is a goal that simply must be achieved,” said Co-Principal Investigator Tobias Kollmann, M.D., Ph.D., professor of pediatrics at the University of British Columbia (UBC) and an investigator at the Vaccine Evaluation Center in Vancouver, Canada. “The licensed hepatitis B vaccine, which only works in about 30 percent of people on the first shot, is an ideal model vaccine to study general principles of human immunological protection because it is one of the few vaccines for which we know how it protects.”

The study will take place at the at the Vaccine Evaluation Center, in Vancouver, Canada, and will be augmented by extensive immunological and bioinformatic analyses at the Project’s San Diego Mesa Consortium, which includes the J. Craig Venter Institute, the La Jolla Institute, The Scripps Research Institute, and UC San Diego, with clinical coordination by the Vanderbilt Institute for Clinical and Translational Research.

“With technological advances in biomedical, computational and engineering sciences, we have an unprecedented opportunity to decipher the immune system’s components and core principles required to generate long-lasting immunity against disease, and usher in a new era of global health,” added Stanley Plotkin, M.D., Chairman of the Human Vaccines Project’s Board of Directors.

 
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Gavi [to 13 May 2017]
http://www.gavi.org/library/news/press-releases/
08 May 2017
U.S. approves US$ 275 million for Gavi in fiscal year 2017 budget
Funding to provide life-saving vaccines to children.
Washington, DC, 8 May 2017– Gavi, the Vaccine Alliance welcomed final approval of the U.S. fiscal year 2017 appropriations bill that includes US$ 275 million for Gavi, funding that will greatly enhance Gavi’s capacity to purchase and deliver life-saving vaccines for children in the world’s poorest countries. This will help immunise millions of children in developing countries against vaccine-preventable diseases, which claim 1.5 million lives every year.
The contribution to Gavi is part of the US$ 814.5 million approved for USAID’s Maternal and Child Health programs for 2017. This funding not only supports the introduction of new vaccines, innovative approaches and tools to expand equitable access to vaccines, but a range of other life-saving interventions.
“We are extremely grateful for the continued strong bipartisan support for Gavi’s role in expanding global immunisation programs, especially in a particularly challenging budget environment. Vaccines are one of the best buys in global health and healthy families contribute to healthy economies,” said Gavi CEO Dr. Seth Berkley…

 
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CEPI – Coalition for Epidemic Preparedness Innovations  [to 13 May 2017]
http://cepi.net/
Newsletter 12 May 2017
[Excerpt]
Address from CEO
Last week I had the pleasure of attending the World Economic Forum – Africa meeting in Durban, South Africa, which began with a session on “Leadership in an Era of Disruption” that probed the question of how Africa’s leaders can better respond to the many challenges they face. At the end of the session, the moderator asked the audience to remain seated for a memorial video honoring Ahmed Kathrada, one of the last surviving and youngest of the Rivonia Trialists who had been imprisoned with Nelson Mandela on Robben Island, who passed away in March. It was an inspiring session, honoring the sacrifices of the past and looking with hope toward the future.
In Durban, I met many inspiring individuals: Victor Ochen, the Director of AYINET, an organization that addresses the needs of children displaced by conflict, who in 2015 became the youngest African ever to be nominated for a Nobel prize; Keller Rinaudo, an entrepreneur who founded Zipline, which has established the world’s first commercial drone delivery system — in Rwanda, delivering blood products to remote hospitals in as little as 30 minutes; and John Nkengasong, the first director of the recently established Africa CDC – to name just a few. Each has an incredible story to tell, and each is making the continent – and the world – a better place.
CEPI is part of this unfolding story. African scientists still command too small a share of Africa’s GDP but increasingly are asserting their right to set the science agenda for the continent. CEPI, for its part, is committed to working closely with African scientists and institutions to develop products and design clinical trials that serve the needs of their communities. While the World Economic Forum was convening in South Africa, a meeting on Ebola, hosted by President Condé of Guinea, took place in Conakry.  In her opening remarks at that meeting, Margaret Chan, the Director-General of the World Health Organization, said “A safe and efficacious Ebola vaccine was the world’s best gift during 2016” and highlighted the contributions of scientists from Guinea, the Guinea national medicine and regulatory agency, and the national ethics committee who worked with the international team to complete the ring vaccination study there. She also highlighted the role of CEPI in contributing to global preparedness for such threats in the future.
This week, in London, CEPI’s Scientific Advisory Committee reviewed the white papers submitted in response to CEPI’s first call for proposals. The best of these will now be developed into full proposals.  CEPI is taking its first definitive steps toward fulfilling its promise.

 
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IAVI – International AIDS Vaccine Initiative   [to 13 May 2017]
https://www.iavi.org/
[Undated]
HIV VACCINE AWARENESS DAY – HVAD 2017 Campaign Toolkit
On May 18, join IAVI in recognizing the thousands of trial volunteers, clinicians, scientists, advocates, and communities leading the global search for a vaccine.

 
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UNAIDS  [to 13 May 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update
UNAIDS and Xinhua partnership brings the common goal of ending AIDS closer
News agency is a key partner through its efforts of reaching billions of people with life-saving…

Feature Story
Germany—ending AIDS by 2020
Deutsche AIDS-Hilfe has launched a new campaign to end AIDS in Germany by 2020. The campaign features Maik, who nine years ago was fighting for his life.

Feature Story
Interviews with the candidates for WHO Director-General
David Nabarro, Sania Nishtar and Tedros Adhanom Ghebreyesus talk to unaids.org about the AIDS epidemic and global health.

 
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NIH  [to 13 May 2017]
http://www.nih.gov/news-events/news-releases
May 10, 2017
Cell particles may help spread HIV infection, NIH study suggests
HIV appears to enlist the aid of nano-sized structures released by infected cells to infect new cells, according to a study by researchers at the National Institutes of Health. Known as extracellular vesicles (EVs), these bubble-like structures are made by many kinds of cells and, under most circumstances, are thought to ferry molecules from one cell to another, providing a means of communication. NIH scientists discovered that cells infected with HIV appear to produce EVs that manipulate prospective host cells to pass infection to other cells. The study appears in Scientific Reports

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FDA [to 13 May 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
:: May 2, 2017 Approval Letter – ACAM2000 (PDF – 33KB)  Posted: 5/9/2017
:: Complete List of Currently Approved Premarket Approvals (PMAs) (PDF – 16KB)
Posted: 5/9/2017; Updated as of 5/4/2017
:: Complete List of Currently Approved NDA and ANDA Application Submissions (PDF – 17KB)
Posted: 5/9/2017; Updated as of 5/4/2017

 
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Wellcome Trust  [to 13 May 2017]
https://wellcome.ac.uk/news
11 May 2017
Largest UK resource of human stem cells created
Scientists have created the UK’s largest resource of human stem cells from healthy people. This is a powerful research tool for studying human development and disease.
Researchers generated human induced pluripotent stem cells (iPSCs) on a large scale to study cell differences between individuals…
9 May 2017
International Research Scholars announced
Wellcome has teamed up with the Howard Hughes Medical Institute (HHMI), the Bill & Melinda Gates Foundation, and the Calouste Gulbenkian Foundation for a new research award that will develop scientific talent around the world.
Today the first 41 early-career scientists to receive the International Research Scholars awards (opens in a new tab) were announced.
This group of scholars will receive a total of nearly $26.7 million, with each researcher receiving $650,000 over five years…
8 May 2017
23 researchers given prestigious fellowships
Members of the Wellcome community have been elected fellows of two prestigious organisations.
Fourteen have been elected Fellows of the Academy of Medical Sciences, and nine have been elected Fellows of the Royal Society.

 
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European Medicines Agency  [to 13 May 2017]
http://www.ema.europa.eu/ema/
08/05/2017
Involving patients in discussions on benefits and risks of medicines
EMA publishes report on CHMP pilot project
The European Medicines Agency (EMA) has published a final report on the experience gained during its pilot project to involve patients directly in the assessment of the benefits and risks of medicines in its Committee for Medicinal Products for Human Use (CHMP).
The report concludes that patients should continue to be invited to oral explanations when their input could be valuable to the assessment of a medicine. This could be the case, for example, when the Committee is considering whether to recommend the authorisation of a new medicine or the maintenance, suspension or revocation of an existing authorisation, or a restriction of indication of an authorised medicine…

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GHIT Fund   [to 13 May 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 companies, the Japanese Government and the Bill & Melinda Gates Foundation.
2017.05.10      News
New interview articles posted on our 5th Anniversary website:
– Dr. Hannah Kettler Senior Program Officer, Life Science Partnerships, Global Health Program, Office of the President, Bill & Melinda Gates Foundation
– Mr. George Nakayama, Representative Director, Chairman and CEO, Daiichi Sankyo Company, Limited
– Mr. Yoshihiko Hatanaka, Representative Director, President and CEO, Astellas Pharma Inc.
– Mr. Gen Miyazawa, Executive Corporate Officer EVP, President of Media Group, Yahoo Japan Corporation