AERAS  [to 18 Aug 2018]
No new digest content identified.
BMGF – Gates Foundation  [to 18 Aug 2018]
No new digest content identified.


Bill & Melinda Gates Medical Research Institute    [to 18 Aug 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
No new digest content identified.


CARB-X   [to 18 Aug 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.
CARB-X funds SciBac to develop a microbe drug that kills C. difficile superbugs
(BOSTON, MA) – July 31, 2018 – CARB-X is awarding SciBac of San Francisco, CA, USA, $0.68 million in non-dilutive funding, with the possibility of up to $3.08 million more in two additional stages if certain project milestones are met, to develop a novel biotherapeutic to fight deadly Clostridium difficile infections (CDI). SciBac’s SCB-102 project, if it succeeds, has the potential to effectively treat and prevent C. difficile infections.
“The world urgently needs antibiotic alternatives, like those that SciBac is developing, as well as other life-saving products to treat and prevent deadly infections,” said Kevin Outterson, Executive Director of CARB-X. “The microbiome is providing exciting new approaches to the prevention and treatment of life-threatening infections. The projects in the Powered by CARB-X portfolio are in the early stages of development, but if successful, they offer tremendous potential in the global fight against superbugs.”…

CEPI – Coalition for Epidemic Preparedness Innovations  [to 18 Aug 2018]
16TH AUG 2018
CEPI Awards Contract Worth up to $36 million to Profectus BioSciences and Emergent BioSolutions to Develop Lassa Virus Vaccine
Posted on by Mario Christodoulou
CEPI (the Coalition for Epidemic Preparedness Innovations) today announced a new collaboration with Profectus BioSciences, Inc. and Emergent BioSolutions Inc. (NYSE: EBS) under which they will receive up to USD$36 million to advance the development and manufacture of a vaccine against the Lassa virus—an estimated 100,000 to 300,000 cases of Lassa virus infection occur each year.
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 Lassa virus vaccine. CEPI will provide $4.3 million to support the first phase of the project, with options to invest up to a total of $36 million over five years, including procurement of the vaccine for stockpiling purposes. Emergent will provide technical and manufacturing support for the CEPI-funded program. Through a separate agreement with Profectus, Emergent has an exclusive option to license and to assume control of development activities for the Lassa-virus vaccine from Profectus. The global non-profit organization PATH will also be working with the consortium under a separate agreement with CEPI to work on clinical development. This is CEPI’s second award to the collaboration following an award in May, 2018, for the development of a Nipah virus vaccine…

EDCTP    [to 18 Aug 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
3 August 2018
NIFTY study on yellow fever vaccine dosing will improve epidemic preparedness
The EDCTP-funded NIFTY study, led by Professor Philip Bejon (University of Oxford, UK, and KEMRI-Wellcome Trust research Programme, Kilifi, Kenya), held its kick-off meeting in Kilifi from 02-03 August 2018. The NIFTY consortium prepares for a ‘Non-Inferiority of Fractional Doses Trial for Yellow…

2 August 2018
EDCTP seeks several new members for its Scientific Advisory Committee as of January 2019
EDCTP is calling on high-level experts from across multiple fields and sectors to apply to become members of its Scientific Advisory Committee from January 2019. EDCTP is looking for up to seven new members. The Scientific Advisory Committee is the principal advisory…

Emory Vaccine Center    [to 18 Aug 2018]
No new digest content identified.

European Medicines Agency  [to 18 Aug 2018]
Press release  01/08/2018
Brexit preparedness: EMA to further temporarily scale back and suspend activities
Next phase of business continuity plan aimed at securing essential public and animal health activities
The European Medicines Agency (EMA) will launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.

The temporary cuts in activities are required because it has also become clear that the Agency will lose more staff than initially anticipated. Staff who will not relocate to Amsterdam have already started to leave the Agency and this trend is expected to accelerate. In addition, due to the employment rules in the Netherlands, 135 short-term contract staff will no longer be able to work for EMA. Overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.

EMA has put in place supporting measures to facilitate the relocation of staff to Amsterdam and additional support is provided by the Dutch government. Other mitigating actions, such as a comprehensive staff recruitment programme, are already underway. However, in the short- to mid-term EMA will have to reprioritise its resources to fully maintain its core activities related to the evaluation and supervision of medicines to the level of quality and within the timelines expected…
European Vaccine Initiative  [to 18 Aug 2018]
No new digest content identified.
FDA [to 18 Aug 2018]
August 16, 2018 –
FDA approves first generic version of EpiPen

August 16, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
August 10, 2018 –
FDA approves new treatment for a rare genetic disorder, Fabry disease
August 10, 2018 –
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
August 08, 2018 –
FDA approves treatment for two rare types of non-Hodgkin lymphoma
August 08, 2018 –
FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
Fondation Merieux  [to 18 Aug 2018]
No new digest content identified.
Gavi [to 18 Aug 2018]
15 August 2018
New initiative to bring vaccination to over 8 million people across Africa
Gavi, the Vaccine Alliance teams up with The Audacious Project to scale up immunisation across Africa through digitally-empowered community health programs.
[See Milestones/Perspectives above for more detail]
31 July 2018
Fingerprint records and digital health cards to help solve global identity crisis
Four companies will receive Gavi support to help scale emerging digital identification technologies in developing countries.
[See Milestones/Perspectives above for more detail]
GHIT Fund   [to 18 Aug 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
No new digest content identified.
Global Fund [to 18 Aug 2018];&country=
No new digest content identified.
Hilleman Laboratories   [to 18 Aug 2018]
No new digest content identified.
Human Vaccines Project   [to 18 Aug 2018]
No new digest content identified.
IAVI  [to 18 Aug 2018]
AUGUST 02, 2018
IAVI and the Public Health Agency of Canada Enter into License Agreement for Technology to Enable Lassa Fever Vaccine Development
NEW YORK –– The International AIDS Vaccine Initiative (IAVI) today announced that it has entered into a non-exclusive license agreement with the Public Health Agency of Canada (PHAC) toward advancing development, regulatory approval, and supply of a new vaccine candidate against Lassa fever virus, an ongoing public health threat in West Africa.
Through this agreement, IAVI obtained technology for a recombinant vesicular stomatitis virus (VSV) Lassa fever vaccine candidate, rVSV∆G-LASV-GPC. Developed by scientists at the PHAC’s National Microbiology Laboratory and based on the same platform used to produce Merck’s successful Ebola Zaire virus vaccine, this candidate provided high-level protection from Lassa fever virus in previously conducted animal studies.
With support from the Coalition for Epidemic Preparedness Innovations, the IAVI-led Lassa fever vaccine development program will further develop this candidate and create a stockpile to address future outbreaks. An estimated 100,000 to 300,000 Lassa fever cases are diagnosed annually, resulting in approximately 5,000 deaths. The World Health Organization (WHO) has identified Lassa fever as one of the top emerging pathogens likely to cause severe outbreaks in the near future.
In addition to its core HIV vaccine effort, IAVI seeks to maximize its impact on global public health by working with partners to address other urgent unmet public health needs – including vaccines for other infectious diseases – where its technologies and experience in vaccine and monoclonal antibody discovery and development can add unique value…
No new digest content identified.

IVAC  [to 18 Aug 2018]
August 2018
Press Release: Rotavirus vaccine cuts infant diarrhea deaths by a third in Malawi
A major new study has shown that rotavirus vaccination reduced infant diarrhea deaths by one-third in rural Malawi, a region with high levels of child deaths. The study led by scientists at the University of Liverpool, UCL, the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health and partners in Malawi provides […]

IVI   [to 18 Aug 2018]
No new digest content identified.

JEE Alliance  [to 18 Aug 2018]
No new digest content identified.
MSF/Médecins Sans Frontières  [to 18 Aug 2018]
Selected Press Releases/Statements
MSF applauds World Health Organization’s recommendation of improved tuberculosis treatment options
Press Release 17 Aug 2018
MSF calls on Johnson & Johnson to make key drug bedaquiline affordable for all people who need it.
Geneva – Médecins Sans Frontières (MSF) today welcomed the new World Health Organization (WHO) recommendations for improved treatment for people with drug-resistant tuberculosis (DR-TB), prioritising the use of several oral drugs, including the newer drug bedaquiline, and minimising the use of drugs that must be injected.
The newly recommended 18- to 20-month treatment regimen can help improve cure rates, decrease mortality and have far fewer side effects. For these recommendations to be put in place and for many more people with DR-TB to receive treatment, MSF today called on the US pharmaceutical corporation Johnson and Johnson (J&J), which produces bedaquiline, to take immediate steps to make the drug affordable for all who need it, in particular in low- and middle-income countries and high DR-TB burden countries…
Rohingya refugee crisis
Crisis update – August 2018
Crisis Update 16 Aug 2018
DRC 2018 Ebola outbreak
MSF Ebola treatment centre opens in Mangina, North Kivu
Project Update 16 Aug 2018
One year after the battle, medical needs remain high in Arsal
Project Update 16 Aug 2018
Treating severely malnourished children in N’Djamena
Project Update 10 Aug 2018
DRC 2018 Ebola outbreak
MSF responds to new Ebola outbreak, the tenth in DRC
Project Update 8 Aug 2018
DRC 2018 Ebola outbreak
New Ebola outbreak declared in North Kivu
Project Update 7 Aug 2018
NIH  [to 18 Aug 2018]
August 16, 2018
NIH begins clinical trial of live, attenuated Zika vaccine
— Combination Zika-Dengue vaccine planned.
Vaccinations have begun in a first-in-human trial of an experimental live, attenuated Zika virus vaccine developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial will enroll a total of 28 healthy, non-pregnant adults ages 18 to 50 at the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, Maryland, and at the Vaccine Testing Center at the Larner College of Medicine at the University of Vermont in Burlington. NIAID is sponsoring the trial…
NIH study shows how MERS coronavirus evolves to infect different species
August 14, 2018 — Evidence suggests that MERS and SARS originated in bats.
During HIV infection, antibody can block B cells from fighting pathogens
August 13, 2018 — NIH scientists suspect process aims to curb immune-system hyperactivity.

Experts highlight Ebola vaccine progress and suggest next steps

August 13, 2018 — Despite promising advances, important scientific questions remain unanswered in the effort to develop a safe and effective Ebola vaccine, according to members of an international Ebola research consortium. In a Viewpoint published in The Lancet, the experts review the current field of Ebola vaccine candidates and clinical trials and highlight key gaps in knowledge that need to be addressed by future research.
NIH researchers discover highly infectious vehicle for transmission of viruses among humans
August 8, 2018 — Membrane-bound virus clusters provide promising target for the treatment of gastroenteritis, other diseases.

PATH  [to 18 Aug 2018]
No new digest content identified.

Sabin Vaccine Institute  [to 18 Aug 2018]
No new digest content identified.
UNAIDS [to 18 Aug 2018]

14 August 2018
Cities in Philippines pledge to lower HIV infections and improve their track record

9 August 2018
Youth voices count and safe spaces do too

3 August 2018
Progress, but still miles to go, to increase HIV prevention and treatment in Central African Republic

1 August 2018
Thailand brings PrEP to scale

UNICEF  [to 18 Aug 2018]
Selected Press Releases/Reports/Statements

Press release
Children at risk in DRC Ebola outbreak – UNICEF

Press release
Ebola outbreak in the DRC: UNICEF mobilizes communication specialists in support of the vaccination campaign

Press release
New Ebola outbreak in the DRC: UNICEF mobilizes staff and supplies to help with the response

Drinking water systems under repeated attack in Yemen
UNICEF calls for immediate halt to attacks on water facilities and civilian infrastructure

Press release
3 in 5 babies not breastfed in the first hour of life
Breastfeeding within an hour after birth is critical for saving newborn lives

Press release
Rohingya refugee children face onset of deadly monsoon rains
Vaccine Confidence Project  [to 18 Aug 2018]
Confidence Commentary
Breaking down Barriers, Building Bridges
Heidi Larson | 28 Jul, 2018
The theme of this year’s AIDS2018—International AIDS Conference, was on the theme of “Breaking down Barriers, Building Bridges.”  The opening plenary session included a presentation by AIDS physician, Dr. David Malebranche. As I listened to his presentation, there were moments that resonated with the tensions and debates around vaccines.
Here are some excerpts. The relevance to what is driving wavering vaccine confidence should be clear…
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 18 Aug 2018]
Webinar registration open
Registration is now open for the next “Current Issues in Vaccines” webinar. Dr. Offit will speak about the following topics during the event scheduled for Wednesday, Sept. 5, 2018, at noon ET
Wellcome Trust  [to 18 Aug 2018]
Explainer  / Published: 26 July 2018
Human Cell Atlas: we’re funding scientists at six UK research institutes
Wellcome is committing £7 million to the Human Cell Atlas, a global endeavour to map every single cell type in the human body. Dr Katrina Gold, from the Genetics and Molecular Sciences team, explains why Wellcome is backing this ambitious project.

Published: 8 August 2018
How we judge research outputs when making funding decisions
Robert Kiley, Head of Open Research, and Jim Smith, Director of Science, discuss the steps Wellcome is taking to fulfil the principles of the San Francisco Declaration on Research Assessment (DORA).
When we published our open access policy over a decade ago, we made it clear that what counts when we make funding decisions is the intrinsic merit of the work and not the journal or publisher.
Despite significant progress in making our research open access, we know many researchers remain unconvinced that it’s the work that counts and not where it’s published. We’re worried about this and so we’re continuing our efforts to promote best practice in research assessment.
What we’re doing
Funding for DORA
We were one of the first funders to sign the San Francisco Declaration on Research Assessment (opens in a new tab) (DORA), publicly committing that we will consider all research outputs and look at a broader range of qualitative measures of impact, such as influence on policy and practice. In partnership with other funders and publishers, we are providing funding to DORA to help promote the broad adoption of these principles and to collect evidence of good practice…

Published: 1 August 2018
Professor Bongani Mayosi (1967–2018): a tribute
This week we heard the deeply sad news that Professor Bongani Mayosi has died. Wellcome’s Director of Science Jim Smith pays tribute to a world-renowned scientist.
Bongani was a highly regarded clinical research scientist from South Africa who made a huge contribution to the inception of the H3Africa (opens in a new tab) initiative, which is jointly funded by Wellcome and the US National Institutes of Health.
In his most recent role as Dean at the University of Cape Town, Bongani led the faculty of health sciences. He was also an adviser on policy and strategy for health research to the South African Ministry of Health…

Published: 31 July 2018
Putting research at heart of response to epidemics like Ebola saves lives
With the recent outbreak of Ebola in the Democratic Republic of the Congo declared officially over, Michael Regnier looks at how Wellcome’s support has helped the people of DRC – and the rest of the world – to be better prepared for the next one.
The Wistar Institute   [to 18 Aug 2018]
Press Release  Aug. 7, 2018
Wistar Receives Support of More Than $5.5M from Private Foundations and Funding Agencies
PHILADELPHIA — (Aug. 7, 2018) — In the first half of 2018, The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, received funds of more than $5.5 million in grants and awards from local foundations, and national and international funding agencies to support research, education and training at the Institute.

World Organisation for Animal Health (OIE)   [to 18 Aug 2018]
No new digest content identified.

BIO    [to 18 Aug 2018]
Aug 10 2018
BIO Releases Statement on NGA’s Report on Prescription Drug Costs
Washington, DC (August 10, 2018) – Tom Dilenge, president of advocacy, law & public policy at the Biotechnology Innovation Organization (BIO), issued the following statement today after the National Governors Association (NGA) released a report outlining “potential state strategies” to address prescription drug costs…
DCVMN – Developing Country Vaccine Manufacturers Network  [to 18 Aug 2018]
14 August 2018
DCVMN welcomes Butantan’s new Directorate
Sao Paulo, 15th June 2018 – Institute Butantan’s Director, Prof. Dimas Tadeu Covas, invited DCVMN Executive Secretary, Dr. Sonia Pagliusi, to meet the new Directorate and visit the new facility to be dedicated to the manufacture of second generation dengue vaccines.
Founded in 1901, the Butantan Institute is one of Brazil’s most prestigious scientific institutions. Butantan generates scientific knowledge and research to develop and produce immunotherapies and biopharmaceuticals of public health interest and seeks to stimulate advances in innovative health technology.
A second generation dengue vaccine candidate is set to progress into Phase 3 clinical studies in 17,000 subjects. Sponsored by the Brazilian government, these studies represent an investment of approximately US $100 million…
IFPMA   [to 18 Aug 2018]
No new digest content identified.
PhRMA    [to 18 Aug 2018]
No new digest content identified.

Industry Watch   [to 18 Aug 2018]
:: BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza

Mainz, Germany, and NEW YORK, August 16, 2018 – BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of influenza (flu).

Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA-based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines, following BioNTech’s completion of a first in human clinical study.

BioNTech will receive $120 million in upfront, equity and near-term research payments and up to an additional $305 million in potential development, regulatory and commercial milestone payments. In addition, BioNTech will receive up to double-digit tiered royalty payments associated with worldwide sales if the program reaches commercialization.

BioNTech is an industry leader in mRNA vaccine approaches with validated science, innovative manufacturing expertise and a broad understanding of the clinical applications of this technology.

“Today’s agreement with Pfizer is one of a number of steps that we are taking to rapidly build a sustainable R&D presence in infectious disease, combining our deep understanding of the immune system to treat disease with the cutting-edge technologies and significant infrastructure that we have built-up over many years to develop immunotherapy treatments,” said Prof. Dr. Ugur Sahin, Co-Founder and CEO of BioNTech. “A significant presence in infectious disease supports our goal of building a global immunotherapy company that provides more effective and precise immune-mediated approaches for the prevention and treatment of serious illnesses, such as the prevention of flu and the treatment of cancer.”

Kathrin Jansen, Senior Vice President and Head of Pfizer’s Vaccine Research and Development Unit said, “Innovative vaccine approaches are urgently needed to provide improved protection against seasonal flu, and to respond rapidly and in quantity to pandemic influenza threats. mRNA vaccines offer a novel approach to code for any protein or multiple proteins, and the potential to manufacture higher potency flu vaccines more rapidly and at a lower cost than contemporary flu vaccines. BioNTech is one of the industry leaders in mRNA technology and we are looking forward to working closely with them to help bring cutting-edge mRNA influenza vaccines to the market to improve people’s lives.”

:: Emergent BioSolutions to Acquire Specialty Vaccines Company PaxVax
…Adds two revenue-generating FDA-licensed vaccines that protect against cholera and typhoid fever, both with dual-market potential
…Broadens development pipeline with an adenovirus 4/7 vaccine funded by the DoD for military requirements as well as other programs addressing emerging infectious diseases for both commercial and government markets
…Expands sales capabilities with the addition of global specialty salesforce and marketing and distribution partners focused on the travelers market
…Establishes international manufacturing footprint and provides opportunities for growth of CDMO business with European-based cGMP biologics facilities
…All-cash transaction of $270 million
…Expected to generate revenues of $70 million to $90 million in 2019 and be accretive by year-end 2019
GAITHERSBURG, Md., Aug. 09, 2018 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement to acquire PaxVax, a company focused on specialty vaccines that protect against existing and emerging infectious diseases, for an all-cash consideration of $270 million. PaxVax is majority owned by an affiliate of Cerberus Capital Management, L.P.
Upon the closing of the transaction, Emergent will acquire:
:: Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of typhoid fever, a potentially severe and life-threatening infection caused by the bacterium S. Typhi. Vivotif is licensed for sale in 27 countries.
:: Vaxchora® (Cholera Vaccine Live Oral), the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease
:: An Adenovirus 4/7 vaccine candidate being developed for military personnel under contract with the U.S. Department of Defense (DoD) and additional clinical-stage vaccine candidates targeting Chikungunya and other emerging infectious diseases
:: European-based cGMP biologics manufacturing facilities
:: Approximately 250 employees including those in research and development (R&D), manufacturing, and commercial operations with a specialty salesforce
“The acquisition of PaxVax solidifies our position as a global leader in the public health threats market, expands our portfolio of only-in-class products, advances our growth strategy, and progresses us towards the achievement of our 2020 financial and operational goals,” said Daniel J. Abdun-Nabi, CEO of Emergent BioSolutions. “Importantly, we believe this acquisition will contribute incremental 2019 revenues of $70 million to $90 million and be accretive by the end of 2019. We look forward to continuing to drive growth in the business by building on the successes of PaxVax in the travelers market, leveraging our core competencies in government contracting and manufacturing, and advancing the development pipeline while remaining disciplined in our approach to R&D.”
:: Ology Bioservices Wins $8.4 Million Defense Department Award to Produce Anti-Ebola Medical Countermeasure
August 17, 2018
Ology Bioservices, Inc., a biologics contract development and manufacturing organization (CDMO), announced today that it was awarded an Other Transaction Agreement (OTA) to support the Joint Project Manager Medical Countermeasure Systems (JPM-MCS), a component of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO CBRND) for advanced biologics manufacturing services—specifically, to manufacture an anti-Ebola monoclonal antibody (mAb). The award was made possible through collaborative funding between JPEO CBRND and the Defense Advanced Research Projects Agency (DARPA).       The antibody, designated mAb114, was developed at the Vaccine Research Center (VRC), part of the National Institute of Allergy and Infectious Diseases (NIAID) with the National Institutes of Health, in part through funding previously provided by DARPA. The VRC is a collaborator with JPM-MCS, DARPA, and Ology Bioservices on this program. Including optional work, the agreement has a value of $8.4 million…