AERAS  [to 6 Oct 2018 ]
OCTOBER 1, 2018
IAVI Acquires Aeras TB Vaccine Clinical Programs and Assets
The International AIDS Vaccine Initiative (IAVI) and Aeras, a nonprofit organization dedicated to developing tuberculosis (TB) vaccines, today announced the transfer to IAVI of Aeras’ TB vaccine clinical research programs and assets, consisting of certain clinical staff, clinical programs, biorepository, funding commitments, and other assets.
 [See Milestones above for detail]
BMGF – Gates Foundation  [to 6 Oct 2018 ]
OCTOBER 04, 2018
Tanganyika Province Affirms Commitment to Strengthening Routine Immunization in Partnership with the Bill & Melinda Gates Foundation
SEATTLE, October 4, 2018 – Today, the honorable Mr. Richard Ngoy Kitangala, governor of Tanganyika Province in the Democratic Republic of the Congo (DRC), and Chris Elias, President, Global Development at the Bill & Melinda Gates Foundation, signed a Memorandum of Understanding (MoU) to improve vaccination coverage among children in Tanganyika Province and thus save people’s lives.
Bill & Melinda Gates Medical Research Institute    [to 6 Oct 2018 ]
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
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CARB-X   [to 6 Oct 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.
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CEPI – Coalition for Epidemic Preparedness Innovations  [to 6 Oct 2018 ]
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EDCTP    [to 6 Oct 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
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Emory Vaccine Center    [to 6 Oct 2018 ]
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European Medicines Agency  [to 6 Oct 2018 ]
News and press releases
Boosting the development of medicines for children
News 02/10/2018
The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published today a joint action plan to support the development of medicines for children in Europe

The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Legislation. It also takes into account the ideas on how to better apply the Paediatric Regulation to boost the development of medicines for children collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.
The actions in the plan are clustered around five key areas:
:: identifying paediatric medical needs;
:: strengthening cooperation between decision makers;
:: ensuring timely completion of paediatric investigation plans (PIPs);
:: improving the handling of PIP applications;
:: increasing transparency around paediatric medicines.
It is expected that the implementation of these actions will increase the efficiency of paediatric regulatory processes in the current legal framework and boost the availability of medicines for children…

Expert meeting on genome editing technologies used in medicine development
European Medicines Agency, London, UK, from 18/10/2017 to 18/10/2017
Genome editing technologies are progressing with an unprecedented speed. Medicinal products developed using these novel technologies may potentially ameliorate or cure genetic diseases. However, they also come with complexities and challenges during their development, manufacture, evaluation and ultimately making them available to patients. This meeting brings together leading academic institutions as well as industry stakeholders with the most advanced development programmes using genome editing to discuss the current state of art, challenges and opportunities linked with genome editing and to present case studies of the most advanced developments.
   Agenda – EMA expert meeting on genome editing technologies used in medicinal product development 
European Vaccine Initiative  [to 6 Oct 2018 ]
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FDA [to 6 Oct 2018 ]
October 05, 2018
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”…

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition…

Fondation Merieux  [to 6 Oct 2018 ]
Vaccinology 2018: 11th International Symposium for Latin America experts
October 17 – 19, 2018 – Panama
Gavi [to 6 Oct 2018 ]
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GHIT Fund   [to 6 Oct 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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Hilleman Laboratories   [to 6 Oct 2018 ]
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Human Vaccines Project   [to 6 Oct 2018 ]
Towards a Universal Influenza Vaccine: Lessons from the Great Influenza Pandemic of 1918 to Now
November 15-16, 2018 I Nashville, TN
The Human Vaccines Project is hosting a scientific summit featuring prominent researchers and thought leaders to discuss cutting-edge influenza research. The 2-day meeting will bring together leading scientists, clinicians and public health specialists including: John Barry, James E. Crowe, Jr., Senator Bill Frist, and Laurie Garrett.  Find a full agenda at:
IAVI  [to 6 Oct 2018 ]
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IVAC  [to 6 Oct 2018 ]
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IVI   [to 6 Oct 2018 ]
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 JEE Alliance  [to 6 Oct 2018 ]
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MSF/Médecins Sans Frontières  [to 6 Oct 2018 ]
Selected Press Releases/Statements
South Sudan
MSF resumes medical activities in Maban after suspension
Project Update 5 Oct 2018
South Sudan
Helping Yambio’s demobilised child soldiers come to terms…
Project Update 5 Oct 2018
MSF suspends activities after attack in Ad Dhale
Statement 2 Oct 2018
Rohingya refugee crisis
Crisis update – September 2018
Crisis Update 1 Oct 2018
NIH  [to 6 Oct 2018 ]
October 1, 2018
NIH-led task force submits recommendations on research needs for pregnant women and nursing mothers
— Group reviewed current research and focused on specific drugs, formulations and other pharmacological factors that may affect health outcomes for pregnant women and nursing mothers.
NIH grantee wins 2018 Nobel Prize in Physiology or Medicine
October 1, 2018 — The 2018 Nobel Prize in Physiology or Medicine has been awarded to NIH grantee James P. Allison, Ph.D., of the University of Texas, M.D. Anderson Cancer Center, Houston, Texas.

PATH  [to 6 Oct 2018 ]
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Sabin Vaccine Institute  [to 6 Oct 2018 ]
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 UNAIDS [to 6 Oct 2018 ]
News   1 October 2018
UNAIDS joins United Nations and world leaders to stand together against sexual exploitation and abuse
UNICEF  [to 6 Oct 2018 ]
Selected Press Releases/Reports/Statements
Press release
UNICEF supports Indonesian authorities in identifying unaccompanied and separated children in areas affected by earthquake and tsunami in Indonesia
Press release
Health workers in Yemen reach more than 306,000 people with cholera vaccines during four-day pause in fighting – WHO, UNICEF
Vaccination campaign covers war-torn areas of Hudaydah and Ibb
Press release
UNICEF is concerned for safety of thousands of children in Indonesia following Sulawesi earthquake and tsunami
Vaccine Confidence Project  [to 6 Oct 2018 ]
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Vaccine Education Center – Children’s Hospital of Philadelphia  [to 6 Oct 2018 ]
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Wellcome Trust  [to 6 Oct 2018 ]
News / Published: 6 October 2018
Sir Roger Gibbs, 1934-2018
It was with great sadness that we learned yesterday that Sir Roger Gibbs has died. Sir Roger was the Chairman of Wellcome from 1989 to 1999, overseeing perhaps the biggest transformation in our history and laying the foundations for what Wellcome has become today.

News / Published: 4 October 2018
The quest to know everything: 25 years of the Sanger Institute
Since 1993, the Wellcome Sanger Institute has been uncovering the secrets of life through its ground-breaking genomics projects. In this special feature to mark its first 25 years, Rob Reddick explores how its unique work is changing the world.

Opinion / Published: 3 October 2018
Used effectively, your research can improve policy and practice
In this blog I’m focusing on using knowledge effectively, the third pillar of Wellcome’s Science strategy. The first pillar concerns knowledge creation, but the appropriate use of that knowledge to improve health is fundamental to what we’re trying to achieve.
The Wistar Institute   [to 6 Oct 2018 ]
Press Release
Oct. 4, 2018
Engineered Synthetic DNA-Encoded Checkpoint Inhibitor Antibodies Advance the Field of Cancer Immunotherapy
This novel approach opens new avenues of research and may expand clinical approaches for cancer immunotherapy.
World Organisation for Animal Health (OIE)   [to 6 Oct 2018 ]
Launch of the OIE Rinderpest Challenge
What would happen if the rinderpest virus, the only animal disease eradicated in the world, returns from the past threatening animal health security globally? The World Organisation for Animal Health (OIE) launches today the Rinderpest Game with a global Challenge on its dedicated website: From 4 October to 1 November 2018 players are invited to find the source of the rinderpest outbreak and save the world!

BIO    [to 6 Oct 2018 ]
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DCVMN – Developing Country Vaccine Manufacturers Network  [to 6 Oct 2018 ]
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IFPMA   [to 6 Oct 2018 ]
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PhRMA    [to 6 Oct 2018 ]
October 3, 2018
PhRMA Statement on the United States-Mexico-Canada Agreement
“The United States-Mexico-Canada Agreement marks a historic point for U.S. trade policy, cementing critical intellectual property (IP) protections and other standards that will pave the way for the next generation of treatments and cures.