Announcements

Announcements

Gavi [to 25 March 2017]
http://www.gavi.org/library/news/press-releases/
21 March 2017
Gavi ‘effective and fit for purpose’
Network of 19 donor countries assesses Gavi, the Vaccine Alliance’s performance

Gavi is an effective, ‘fit for purpose’ organisation, scoring top ratings in a number key performance areas, according to the Multilateral Organisation Performance Assessment Network (MOPAN).

In its second institutional review of the organisation, MOPAN commends Gavi as being both “strategic and nimble in meeting new vaccine challenges and countries’ evolving needs, while keeping a clear focus on its mission goals.” Gavi is also recognised as being a “strong model for sustainability”.

MOPAN is a network of 19 donor countries, representing 95% of Overseas Development Assistance (ODA), which assesses the effectiveness of the multilateral organisations that receive development and humanitarian funding.

“Gavi has a clear long-term vision based on a distinct business and partnership model” states the report. “It plays a catalytic role in expanding immunisation coverage and shaping the global vaccine market.”

The review, covering the period from 2014 to mid-2016, notes that Gavi demonstrates transparency and accountability in its operations, with strong compliance with fiduciary and social requirements and safeguards. It has recently strengthened its internal audit and risk management functions to meet its increased organisational ambition, complexity and size.
As a performance and results orientated organisation, “Gavi has a clear framework of indicators, targets and metrics at the country level. Results-based management is integral to its planning and grant allocation.”…

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NIH [to 25 March 2017]
http://www.nih.gov/news-events/news-releases
March 24, 2017
NIH Statement on World Tuberculosis Day
Statement of Christine F. Sizemore, PhD., Richard Hafner, M.D., and Anthony S. Fauci, M.D. National Institute of Allergy and Infectious Diseases.
Tuberculosis (TB) is one of the world’s most devastating infectious diseases. March 24th marks the day in 1882 when German microbiologist Robert Koch announced he had discovered Mycobacterium tuberculosis, the bacterium that causes this ancient scourge. Today, in recognition of World TB Day, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), reasserts its commitment to improving our understanding of TB and how to prevent, diagnose and treat it. Around the globe, researchers and the public health community are united in working toward these goals.

TB is the world’s leading cause of death from an infectious disease, especially among women and children. The World Health Organization estimates that more than 1.8 million people worldwide died of TB in 2015. The symptoms of the disease, which is transmitted through the air and primarily affects the lungs, often begin with coughing, shortness of breath or swollen lymph nodes — but can end in death if left untreated. People with HIV are especially vulnerable: of deaths among people co-infected with HIV and TB, about one quarter are due to TB. In addition, the World Health Organization estimates that about one-third of the world’s population is infected with “latent” TB, in which people carry the bacterium while exhibiting no symptoms.  Five to 10 percent of these latent TB carriers risk developing active TB at some point in their lifetimes. For latent TB carriers who are infected with HIV, this risk is approximately 10 percent per year. Finally, it is important to note that smoking substantially increases TB disease occurrence and risk of death due to TB worldwide.

A safe and highly effective vaccine against TB will be a critical tool in ultimately controlling the infection. Currently, the only available vaccine against TB is bacille Calmette-Guerin (BCG), developed in 1921. While this vaccine offers protection against disseminated disease and death in children, it is much less effective against the transmissible pulmonary form of the disease in adults. NIAID supports research across the spectrum of basic, preclinical and clinical development to arrive at innovative new approaches toward the development of vaccines to prevent this disease…

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NIH achieves milestone to accelerate multisite clinical studies
March 23, 2017 — CTSA Program paves way for nationwide single IRB mode
Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

The National Institutes of Health is leading policy and programmatic initiatives to streamline this overly cumbersome process. NIH’s National Center for Advancing Translational Sciences (NCATS) announced today that all Clinical and Translational Science Awards (CTSA) Program sites have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement. This agreement — which now includes a total of more than 150 top medical research institutions — will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference.

The SMART IRB authorization agreement serves as a model to help investigators adhere to the NIH’s policy on single IRB use for multisite studies. This policy was designed to improve IRB efficiencies while ensuring the protection of research participants so that research can proceed expeditiously.

The authorization agreement effort was led by Harvard CatalystUniversity of Wisconsin-Madison Institute for Clinical and Translational Research, and Dartmouth Synergy. Through these institutions, a team of NCATS-supported SMART IRB ambassadors facilitated and provided critical guidance and support to assist institutions in joining and implementing the SMART IRB authorization agreement.

“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”…

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Global Fund [to 25 March 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund and Inter-Parliamentary Union Sign MOU
23 March 2017
The Global Fund and the Inter-Parliamentary Union (IPU) have signed a memorandum of understanding to promote mutual advocacy, engage in joint technical work and raise awareness in the fight against AIDS, TB and malaria and building resilient and sustainable systems for health.

News
Senegal and the Global Fund Extend Their Partnership
21 March 2017
The Honorable Macky Sall, President of the Republic of Senegal, today welcomed a delegation from the Global Fund to Fight AIDS, Tuberculosis and Malaria led by Dr. Mark Dybul, Executive Director. The meeting marked the official signing of the Agreement on the Privileges and Immunities of the Global Fund, a symbolic step in strengthening the partnership between the Global Fund and Senegal that has been in place for 15 years. Senegal is now the 15th country to sign the agreement; Côte d’Ivoire, Togo, Burkina Faso, Rwanda as well as some ten European and African states have already done so.

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PATH [to 25 March 2017]
http://www.path.org/news/index.php
Announcement | March 23, 2017
PATH welcomes new promising study results for rotavirus vaccine candidate
A new article published today in the New England Journal of Medicine provides the results of a recent Phase 3 clinical trial conducted in Niger with a rotavirus vaccine candidate from India. The study, conducted by Médecins Sans Frontières (MSF) and Epicentre, evaluated the efficacy and safety of the pentavalent bovine-human reassortant rotavirus vaccine (BRV-PV) manufactured by Serum Institute of India Pvt. Ltd. in infants in Niger. Data from the trial revealed the BRV-PV to be highly efficacious for the prevention of severe rotavirus gastroenteritis and to have an excellent safety profile. In addition, the vaccine was transported and stored at ambient temperature, thus bypassing the typically challenging cold-chain requirements that apply to most other vaccines…

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UNAIDS [to 25 March 2017]
http://www.unaids.org/
Press release
UNAIDS warns that countries will miss the 2020 target of reducing HIV-associated TB deaths by 75% unless urgent action is taken
GENEVA, 24 March 2017—On World Tuberculosis Day, 24 March, UNAIDS is urging countries to do much more to reduce the number of tuberculosis (TB) deaths among people living with HIV. TB is the most common cause of hospital admission and death among people living with HIV. In 2015, 1.1 million people died from an AIDS-related illness—around 400 000 of whom died from TB, including 40 000 children.
“It is unacceptable that so many people living with HIV die from tuberculosis, and that most are undiagnosed or untreated,” said Michel Sidibé, Executive Director of UNAIDS. “Only by stepping up collaboration between HIV and tuberculosis programmes to accelerate joint action can the world reach its critical HIV and tuberculosis targets.”
Eight countries—the Democratic Republic of the Congo, India, Indonesia, Mozambique, Nigeria, South Africa, the United Republic of Tanzania and Zambia—account for around 70% of all TB deaths among people living with HIV. Scaling up action in these eight countries would put the world on track to reach the ambitious target in the 2016 United Nations Political Declaration on Ending AIDS of reducing TB-related deaths among people living with HIV by 75% by 2020…

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Wellcome Trust [to 25 March 2017]
https://wellcome.ac.uk/news
Published: 24 March 2017
Breakthrough in battle against resistant TB
A cutting-edge technique developed by Wellcome-funded researchers in Oxford means that tuberculosis (TB) can now be diagnosed much faster and more accurately.
The researchers’ method uses whole genome sequencing to quickly assess which strains of TB a patient is infected with. Patients will receive their diagnosis in just over a week, rather than waiting up to a month.
This will improve treatments and help reduce the spread of drug-resistant infections.
It will also be possible to improve identification and treatment of other resistant pathogens.
The news comes as World TB Day marks global efforts to eliminate a disease that infects 10 million people and kills 1.5 million each year. The spread of resistant strains of TB are of particular concern. In 2015, an estimated 480,000 people worldwide developed multidrug-resistant TB…

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EDCTP [to 25 March 2017]
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
24 March 2017
World TB day 2017: closing the gaps to end tuberculosis
Ending the tuberculosis (TB) epidemic by 2030 is one of the health targets of the Sustainable Development Goals. Although TB incidence has fallen by an average of 1.5% per year since 2000, TB is still one of the top 10 causes of death worldwide. Over 95% of TB deaths occur in low- and middle-income countries. In 2015, an estimated 480,000 people globally developed multidrug-resistant TB (MDR-TB). This ambitious aim to end the TB epidemic by 2030 can only be achieved by uniting efforts to close the research gaps…

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Industry Watch [to 25 March 2017]
:: Pfizer Receives Positive CHMP Opinion for TRUMENBA® for Prevention of Meningococcal Group B Disease
TRUMENBA Has Been Studied in a Global Clinical Development Program Evaluating the Vaccine in Adolescents and Adults1
The Majority of Meningococcal Disease Cases in Europe are Caused by Meningococcal Group B (MenB), with Adolescents and Young Adults at Increased Risk2
March 24, 2017
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that TRUMENBA® (Meningococcal Group B Vaccine) be granted marketing authorization in the European Union (EU) for active immunization of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB).3 The CHMP’s opinion will now be sent to the European Commission (EC) for final decision.
“This positive opinion by the CHMP to recommend marketing authorization of TRUMENBA in the EU is an additional step toward the fight to help protect individuals over 10 years of age from meningococcal disease caused by serogroup B, an uncommon yet devastating and life-threatening disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “This decision further affirms the effectiveness and robust safety profile of TRUMENBA.”…

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AERAS [to 25 March 2017]
http://www.aeras.org/pressreleases
No new digest content identified.

BIO [to 25 March 2017]
http://www.bio.org/insights
No new digest content identified.

BMGF – Gates Foundation [to 25 March 2017]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 25 March 2017]
http://cepi.net/
No new digest content identified.

DCVMN [to 25 March 2017]
http://www.dcvmn.org/
No new digest content identified.

European Vaccine Initiative [to 25 March 2017]
http://www.euvaccine.eu/news-events
No new digest content identified.

FDA [to 25 March 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.

Fondation Merieux [to 25 March 2017]
http://www.fondation-merieux.org/news
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
No new digest content identified.

GHIT Fund [to 25 March 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.
No new digest content identified.

Hilleman Laboratories [to 25 March 2017]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 25 March 2017]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.

IAVI – International AIDS Vaccine Initiative [to 25 March 2017]
http://www.iavi.org/
No new digest content identified.

IFPMA [to 25 March 2017]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.

IVI [to 25 March 2017]
http://www.ivi.int/
No new digest content identified.

PhRMA [to 25 March 2017]
http://www.phrma.org/press-room
No new digest content identified.

Sabin Vaccine Institute [to 25 March 2017]
http://www.sabin.org/updates/pressreleases
No new digest content identified.