Announcements

Announcements
 
FDA [to 30 September 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
September 28, 2017 –
FDA improves access to reports of adverse drug reactions
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

What’s New for Biologics
:: Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World (PDF – 162KB)
Posted: 9/28/2017
:: Important Information for Blood Establishments Regarding Zika Virus Transmission Risk in the World (PDF – 143KB)
Posted: 9/28/2017
:: Influenza Virus Vaccine for the 2017-2018 Season
Updated: 9/28/2017
 
Gavi [to 30 September 2017]
http://www.gavi.org/library/news/press-releases/
29 September 2017
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 resident population.
 [See Cholera above for more detail]
 
Korea commits US$4 million to immunise children in world’s poorest countries
South Korea renews pledge to Gavi, the Vaccine Alliance for 2018
Geneva, 25 September 2017 – The Republic of Korea has committed US$4 million to Gavi, the Vaccine Alliance to fund its work over 2018, helping to reach hundreds of thousands of children across the developing world with lifesaving vaccines.
South Korea became the first East Asian donor to Gavi in 2010, and has since provided $15 million to the Vaccine Alliance. Today’s $4 million commitment, made at a signing ceremony at the Ministry of Foreign Affairs (MOFA) in Seoul, will be delivered in 2018 and will be funded through Korea’s Global Disease Eradication Fund…
 
Hilleman Laboratories   [to 30 September 2017]
http://www.hillemanlabs.org/
28/09/2017
Hilleman Laboratories receives Indo-Swedish grant for developing – Oral Cholera Vaccine (OCV)
New Delhi: Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, received a 6 million krona Indo – Swedish grant for the project ‘Improved, affordable single strain whole cell-B subunit oral cholera vaccine’.
The proposed project carried out by Hilleman Laboratories, is being jointly funded by the Department of Biotechnology (DBT), Government of India and Vinnova, the Swedish Governmental Agency for Innovation Systems.
The project will fuel further Research & Development of the Oral Cholera Vaccine (OCV) with knowledge exchange and transfer of scientists across India and Sweden.
Speaking on the partnership, Dr. Davinder Gill, CEO Hilleman Laboratories said, “Cholera remains a threat to global public health and is a barometer of health inequity and lack of social development. Considering the urgent need for effective and affordable Cholera vaccines, both for use in Cholera outbreaks and in mass vaccination campaigns, we would like to accelerate development of our simplified Oral Cholera Vaccine, HILLCHOLTM.” …
 
Human Vaccines Project   [to 30 September 2017]
http://www.humanvaccinesproject.org/media/press-releases/
Sep 26, 2017, 09:04 ET
Dr. Marie-Paule Kieny Appointed To The Human Vaccines Project Board Of Directors
PRNewswire-USNewswire/ — The Human Vaccines Project, a nonprofit public-private partnership focused on decoding the immune system to improve human health, welcomes Dr. Marie-Paule Kieny to its Board of Directors. Dr. Kieny is currently Director of Research at Institut National de la Santé et de la Recherché Médicale (INSERM) where she connects INSERM with the international health research community, and has held several positions at the World Health Organization (WHO)….
 
IAVI  [to 30 September 2017]
https://www.iavi.org/
September 29, 2017
New IAVI Collaboration Seeks to Expand Evolutionary Data on Cancer and HIV
What do HIV and cancer have in common?
The scientific question gets a fresh start this month as IAVI’s Jonathan Hare and Charles Swanton of the Francis Crick Institute and Cancer Research UK (CRUK) initiate their CRUK Pioneer Award. The £200,000 grant over two years funds their search for immunological parallels between HIV/AIDS and Non-Small Cell Lung Cancer (NSCLC).
Jonathan Hare is senior manager of IAVI’s Human Immunology Lab in London and winner of a CRUK Pioneer Award to expand evolutionary data on HIV and cancer.“ Scientists have ruminated on the crossover between cancer and HIV for years,” said Hare, who is senior manager of IAVI’s Human Immunology Lab at Imperial College London. “Though some data exists to suggest a connection, we can now get started on a more systematic approach to identifying common ground.”…
 
MSF/Médecins Sans Frontières  [to 30 September 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Intensified Bombings Decimate Health Facilities Across Northwestern Syria
Brussels/New York, September 28, 2017—An escalation in the bombing of medical facilities since September 19 has forced the closure and evacuation of hospitals throughout northwestern Syria, leaving people trapped in a war zone without access to health care, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) in a statement today.

Press release
Yemen: Government Health Staff are Saving Lives Without Salaries in War-Torn Country
September 28, 2017
Yemen’s public health staff have not received their regular salaries in a year, bringing medical services to the edge of collapse, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) in a report released today.
 
NIH  [to 30 September 2017]
http://www.nih.gov/news-events/news-releases
September 28, 2017
Disease resistance successfully spread from modified to wild mosquitoes
— NIAID-funded group assesses mating of genetically modified species
 
PATH  [to 30 September 2017]
http://www.path.org/news/index.php
Press release | September 28, 2017
New global initiative will connect the world for better health through digital technology
Digital Square, led by PATH, will align multi-sector investments into scalable solutions that strengthen national digital health systems

Announcement | September 26, 2017
PATH welcomes $10.5 million grant to expand contraceptive choice and access
Subcutaneous DMPA Access Collaborative will provide coordination and technical assistance for product introduction and scale-up in family planning programs

Press release | September 26, 2017
Serum Institute’s vaccine demonstrates significant efficacy against severe rotavirus gastroenteritis
Indian Government orders the vaccine for use in Universal Immunization Programme

UNAIDS [to 30 September 2017]
http://www.unaids.org/en
Update
Governments of Belarus and the Netherlands exchange best practices
29 September 2017
During a two-day visit on 25 and 26 September to Belarus, UNAIDS Deputy Executive Director Luiz Loures and the Ambassador for Sexual and Reproductive Health and Rights & HIV/AIDS of the Netherlands, Lambert Grijns, met with civil society organizations and communities of people who inject drugs, women living with HIV, men who have sex with men and sex workers to hear their perspectives on the current needs and challenges of the AIDS response in the country.
 
Wellcome Trust  [to 30 September 2017]
https://wellcome.ac.uk/news
News / Published: 29 September 2017
New typhoid vaccine could halve infection rate
Researchers have shown that a new typhoid vaccine called Vi-TT is safe, well-tolerated and could be effective in tackling typhoid rates in affected areas.
 
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DCVMN – Developing Country Vaccine Manufacturers Network  [to 30 September 2017]
http://www.dcvmn.org/
25 September 2017 to 28 September 2017
DCVMN Annual General Meeting
Seoul / Korea
Download the Agenda
 
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Industry Watch
:: Moderna Announces Publication in Molecular Therapy Characterizing Potent Immune Response Generated by Its mRNA Prophylactic Vaccines
–Research led by Karolinska Institutet describes how Moderna’s vaccines target key antigen-presenting cells, leading to both B cell and T cell responses–
September 26, 2017 08:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced a new publication in Molecular Therapy that provides mechanistic insights about its mRNA prophylactic vaccines. The research, led by Professor Karin Loré, Ph.D., and her group at the Karolinska Institutet in Stockholm, Sweden, characterizes how Moderna’s vaccines target key antigen-presenting cells, leading to both B cell and T cell activation, which yields a potent immune response.
The study utilized a research version of Moderna’s influenza H10N8 vaccine, which encodes for the viral antigenic protein hemagglutinin (HA) encapsulated in lipid nanoparticles (LNPs). In the study, the H10N8 vaccine induced protective titers of HA antibody, as well as CD4+ T cell responses, after intramuscular or intradermal injection into non-human primates (NHPs)…
 
“Given the software-like nature of our medicines, these findings should translate across our vaccine platform. We look forward to publishing additional mechanism of action insights as we continue to advance our ambitious pipeline of prophylactic vaccines.”