Announcements

 
Paul G. Allen Frontiers Group    [to 23 Feb 2019]
https://www.alleninstitute.org/news-press/
News
2 million-cell experiment traces how a mammal grows, cell by single cell
February 20, 2019
Largest single-cell database of its kind sheds light on early mouse development, lays groundwork for understanding developmental diseases
 
 
BMGF – Gates Foundation  [to 23 Feb 2019]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 23 Feb 2019]
https://www.gatesmri.org/
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 23 Feb 2019]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 23 Feb 2019]
http://cepi.net/
11 Feb 2019
CEPI partners with IVI to accelerate development of vaccines against emerging global health threats
Oslo, Norway; Seoul, Republic of Korea 11 February 2019—The Coalition for Epidemic Preparedness Innovations (CEPI) and the Republic of Korea-based International Vaccine Institute (IVI), an international organisation devoted to vaccines for global health, today announced a collaboration to accelerate the development of vaccines against emerging infectious diseases.
Under the terms of the CEPI–IVI Master Implementing Partner Services Agreement, IVI will provide technical services for CEPI-funded projects, executing specific activities as needs arise on behalf of CEPI in the course of advancing new vaccines against emerging pathogens. To this end, IVI will receive funding and support from CEPI to implement the necessary technical services per service orders for vaccine development by engaging local scientists in Korea, and by mobilising IVI’s expertise and capabilities, which include: laboratory and vaccine process research and development, epidemiological studies, and clinical trial and regulatory support…
 
 
EDCTP    [to 23 Feb 2019]
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
Latest news
No new digest content identified.
 
 
Emory Vaccine Center    [to 23 Feb 2019]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 European Medicines Agency  [to 23 Feb 2019]
http://www.ema.europa.eu/ema/
News and press releases
No new digest content identified.
 
 
 
European Vaccine Initiative  [to 23 Feb 2019]
http://www.euvaccine.eu/news-events
Latest news
5th Call for TRANSVAC Vaccine Development Services
18 February 2019
TRANSVAC2  project offers high-quality technical services to support the development of prophylactic and therapeutic vaccines…
 
 
FDA [to 23 Feb 2019]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
February 22, 2019 –
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
 
 
Fondation Merieux  [to 23 Feb 2019]
http://www.fondation-merieux.org/
No new digest content identified.
 
 
Gavi [to 23 Feb 2019]
https://www.gavi.org/
22 February 2019
Typhoid vaccination campaign to tackle outbreak in Zimbabwe
Geneva, 22 February 2019 – A major typhoid vaccination campaign begins today in Harare to tackle a drug-resistant outbreak of the disease.
The campaign aims to vaccinate 325,000 people in nine suburbs of Zimbabwe’s capital. It will be the first campaign in Africa to use a new typhoid conjugate vaccine (TCV) which, unlike other typhoid vaccines, can be administered to young children and has long-lasting immunity.
This is the second wave of a major typhoid outbreak in Harare which first began in October 2017. This second wave began in September 2018 and has so far resulted in 1,810 cases and two deaths.
Around one in five cases in Harare are estimated to be resistant to the antibiotic ciprofloxacin – the first line of defence against the disease – with an alarming 73% resistance reported in certain areas. With drug resistant genes circulating, there is a risk that resistance could grow.
“While typhoid vaccines have existed for over a century, previously they could only offer short term protection and couldn’t be used to protect those most vulnerable to this severe disease: young children,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “These new conjugate vaccines will be a game-changer, not only in the battle against typhoid but also in the global effort to tackle drug resistance. The fact that they are now ready to be used to contain this devastating outbreak in Zimbabwe is fantastic news.”…
 
 
GHIT Fund   [to 23 Feb 2019]
https://www.ghitfund.org/newsroom/press
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 23 Feb 2019]
https://www.theglobalfund.org/en/news/
News
No new digest content identified.
 
 
Hilleman Laboratories   [to 23 Feb 2019]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 23 Feb 2019]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 23 Feb 2019]
https://www.iavi.org/newsroom
No new digest content identified.
 
 
IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.
 
 
IVAC  [to 23 Feb 2019]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 23 Feb 2019]
http://www.ivi.int/
IVI News & Announcements
Typhoid conjugate vaccine from Indonesia found to be safe, immunogenic in phase 1 clinical trial
SEOUL, Korea, JAKARTA, Indonesia, February 22, 2019 — Scientists from Bio Farma, the University of Indonesia, and the International Vaccine Institute (IVI), recently published the results of a phase I clinical trial study of a novel typhoid conjugate vaccine involving Indonesian adults and children, showing that the vaccine was safe and generated potentially protective immune responses…
Researchers at IVI and Indonesian partners aimed to define the safety and immunogenicity of a new S. typhi Vi-DT conjugate vaccine. The latest study, published recently in the journal PLoS ONE, suggests that the new vaccine is safe and immunogenic in adults and children over 2 years of age, with a single dose inducing strong immune responses regardless of age.
“This study is an important step towards the development of Vi-DT typhoid vaccine that can safeguard the world’s most vulnerable -especially young children, against typhoid fever,” said Dr. Sushant Sahastrabuddhe, Director of the Typhoid Program at IVI…
 
 
JEE Alliance  [to 23 Feb 2019]
https://www.jeealliance.org/
Selected News and Events
Mali – A Multi-sectoral and Multi-stakeholder Cooperation Success Story
8.2.2019
Article
Disease outbreaks continue to occur in Mali and the ongoing security crisis highlights the importance of a comprehensive national framework for health security. Recognizing the need for cooperation…
 
 
MSF/Médecins Sans Frontières  [to 23 Feb 2019]
http://www.msf.org/
Selected News; Project Updates, Reports [as presented on website]
Nauru
Nauru | Concerns over reopening Christmas Island detention centre
MSF Australia. 21 Feb 2019
 
 
Central African Republic
Unprotected: Report on violence and lack of protection for civili…
Report 19 Feb 2019
 
 
NIH  [to 23 Feb 2019]
http://www.nih.gov/news-events/news-releases
February 19, 2019
New protocol could ease diagnosis of bacterial infections in infants
— Findings promise to reduce need for spinal tap, antibiotics, and hospitalizations.
 
 
PATH  [to 23 Feb 2019]
https://www.path.org/media-center/
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 23 Feb 2019]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 23 Feb 2019]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
22 February 2019
Faith-based organizations: essential partners in the AIDS response for migrants

20 February 2019
Tanzanian and South African experts exchange expertise

19 February 2019
HIV testing campaign brings the community together in Bangui

18 February 2019
We need action on human rights
 
 
UNICEF  [to 23 Feb 2019]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Press release
Increasing number of people face severe food shortages in South Sudan
Joint UNFAO, UNICEF, WFP Press Release
22/02/2019

Statement
Redeployment agreement from Hudaydah welcome – calls to bring positive change for children
Statement by Geert Cappelaere, UNICEF Regional Director for the Middle East and North Africa
20/02/2019

Statement
Central African Republic peace agreement brings hope to millions of children
Statement attributable to UNICEF Executive Director Henrietta Fore
18/02/2019

Statement
UNICEF Executive Director Henrietta Fore’s remarks at Munich Security Conference: Town Hall Event: “Update on Ebola in the DRC & Beyond”
Munich, Germany, 16 February 2019 –
“Once again, we’re facing an outbreak of Ebola — the 10th in the DRC.
“And once again, we face familiar challenges — and more. An unforgiving disease that requires 100 per cent of cases to be controlled and isolated. A high-density, mobile population.    A lingering mistrust of aid. More children and women among those infected and dying of the disease. And a new, unexpected threat: security concerns and direct attacks that impede access.
“In some ways, we’re in a better place than 2014. Building on what we’ve learned from previous outbreaks, we’re now working as a tightly co-ordinated team, using a common Strategic Response Plan.
“Since the beginning of the epidemic, UNICEF and our partners have deployed more than 650 staff members to the effort. All under the excellent leadership of the Ministry of Health, which is well-trained and experienced from previous outbreaks.
“Together, we’re providing drinking water to more than 1.3 million people. We’re providing sanitation and hygiene kits — and emergency nutritional care for Ebola patients. We’re directly assisting 950 affected families. We’re supporting orphans and unaccompanied children. And we’ve reached more than 10 million people with information on preventing this disease and reducing transmission — including in schools.
“We’re also deploying innovative approaches — isolation cubes for treatment, new vaccines, experimental therapeutics, and big-data analysis to track the spread of the outbreak.
“Our protection teams are doing intense-contact follow-up work, to ensure well-being within communities and to prevent spread to non-affected areas.
“We’re putting a renewed emphasis on risk communication and community engagement, to improve trust in — and uptake of — vital health and prevention services.
“And the UN peacekeeping force is providing a welcome security umbrella for all that we’re doing.
“Thanks to this work, we’ve controlled the outbreak in Equateur, and in many spots in North Kivu, including Beni. We’ve also succeeded in preventing the outbreak from spreading to other regions and countries.
“But the outbreak remains active. There is a serious risk of it reaching major urban centres, like Goma.
“Our staff members — across all of our organizations — are stretched thin. They’re facing continued community resistance — and new security threats.
“In this uncertain environment, we will be strained to control new outbreaks in DRC — or even respond to other health emergencies like cholera or polio that might emerge in neighbouring countries.
“We must find ways to stay one step ahead of Ebola.
“And we can do it. The excellent work of Uganda and Rwanda to prepare has made all the difference in preventing an outbreak.
“Which is why — in addition to our immediate response — UNICEF is working with our partners with a new urgency to strengthen health systems and local response capabilities over the long-term.
“This includes bolstering immunization stocks and capacity.
“It includes scaling-up surveillance and isolation capabilities, especially in urban areas — so important in controlling the Lagos outbreak in 2014.
“And it includes investing in stronger communication efforts with communities, and new prevention and control efforts in health facilities and schools. This includes a new team of anthropologists and communication for development specialists to improve our research and assessment efforts.
“In the meantime, we must make the most of a key window of opportunity, before the Strategic Response Plan ends in July 2019. We must continue raising the alarm on this emergency to summon more funds, recruit more staff, and be strategic about where — and when — we deploy current staff.
“Throughout, we must work closely with the new government to reduce security threats, strengthen health systems for the future, and gain access to every child and community affected.
“Ebola is unforgiving — but it’s not unbeatable.
“Let’s draw inspiration — and learn lessons — from our successes so far, and act now, before the outbreak spreads to Goma or crosses the border.
Thank you.”
 
 
Vaccine Confidence Project  [to 23 Feb 2019]
http://www.vaccineconfidence.org/
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 23 Feb 2019]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 23 Feb 2019]
https://wellcome.ac.uk/news
Opinion | 19 February 2019
Open access and Plan S: how Wellcome is tackling four key concerns
by Robert Kiley, David Carr
There has been lots of reaction to the changes we’re making to Wellcome’s open access policy to ensure that no research is behind a paywall. This is how we are working to address them.
 
 
The Wistar Institute   [to 23 Feb 2019]
https://www.wistar.org/news/press-releases
Press Release    Feb. 21, 2019
The Wistar Institute and Anixa Biosciences Extend Collaborative Research Agreement
Philadelphia and San Jose, Calif. – (Feb. 21, 2019) – The Wistar Institute has extended its collaboration with Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer. The project is focused on understanding the role of myeloid-derived suppressor cells (MDSCs) and how they can be used in diagnostic and therapeutic applications…
 
 
World Organisation for Animal Health (OIE)   [to 23 Feb 2019]
http://www.oie.int/en/for-the-media/press-releases/2019/
No new digest content identified.
 
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BIO    [to 23 Feb 2019]
https://www.bio.org/insights/press-release
No new digest content identified.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 23 Feb 2019]
http://www.dcvmn.org/
No new digest content identified.
 
 
IFPMA   [to 23 Feb 2019]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.
 
 
PhRMA    [to 23 Feb 2019]
http://www.phrma.org/press-room
No new digest content identified.
 
 
Industry Watch  [to 23 Feb 2019]

:: Bharat Biotech Acquires Chiron Behring Vaccines
Hyderabad, India, February 15 th 2019:

Bharat Biotech announces the forthcoming acquisition of Chiron Beh-ring Vaccines Pvt Ltd, located in Ankleshwar, Gujarat from GlaxoSmithKline Asia. Bharat Biotech will acquire 100% equity stake in Chiron Behring Vaccines in an all cash transaction, subject to a number of closing condi-tions which Bharat Biotech and GSK intend to complete in the coming weeks.

Chiron Behring Vaccines was formed as a result of the purchase of the vaccines business of Hoechst AG by Chiron Corporation USA. It is one of the largest manufacturers of high quality rabies vaccines in the world. Chiron Behring Vaccines is a WHO Pre-qualified manufacturer of rabies vaccines, eligible for supplies to UN agencies and has product registrations in more than 20 countries. The rabies vaccine manufactured at An-kleshwar is a result of decades of research & product development..

Bharat Biotech has a wide portfolio of vaccines, with market access to more than 70 countries. The addition of this rabies vaccine will establish Bharat Biotech as a global leader in rabies vaccines manufacturing. Bharat Biotech plans to enhance upon the manufacturing capabilities at Chiron Behring Vaccines and expand mar-ket access through product registrations in additional high demand countries.

Announcing the deal, Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said:

“This acquisition is strategic in helping us enhance our opportunities to achieve greater scale in tackling pub-lic health problems. Bharat Biotech will strengthen its product portfolio and substantially increase product availability in response to the growing demand for this vaccine. With the significant disease burden of rabies in India and other countries, I appreciate GSK’s vision in this transition to Bharat Biotech, to continue to meet the needs of the patients…

Philippines revokes Sanofi’s product license for dengue vaccine
February 19, 2019,  MANILA (Reuters) – The Philippines has permanently halted the sale, distribution and marketing of Sanofi’s dengue vaccine in the country after the French drug maker failed to meet the directives of regulators.

Food and Drug Administration (FDA) Director General Nela Charade Puno said on Tuesday registration certificates for Dengvaxia products have been revoked because of Sanofi’s “brazen defiance” of the agency’s directives.

The FDA said Sanofi failed to comply with post marketing authorization requirements as of December last year.

Sanofi said it disagreed with the FDA’s findings.

“Sanofi Pasteur respectfully disagrees with the conclusions stated in the order and considers that the Philippines FDA has taken this decision despite our diligence, including the submission of documents from completed post-approval commitments and regular updates on the status of post-marketing studies,” the company said in a statement.

Sanofi, which filed a motion for reconsideration, said the agency had not questioned the safety and efficacy of Dengvaxia…