IAVI International AIDS Vaccine Initiative [to 24 October2015] :: Human Vaccines Project Welcomes Janssen as Newest Partner

IAVI International AIDS Vaccine Initiative [to 24 October2015]

Human Vaccines Project Welcomes Janssen as Newest Partner
October 23, 2015
The Human Vaccines Project welcomes Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), as the newest industry partner in its effort to accelerate the research and development of vaccines and immunotherapies for infectious diseases and cancer.

Incubated at the International AIDS Vaccine Initiative (IAVI), the Human Vaccines Project is an ambitious new public-private partnership seeking to transform the future of global disease prevention and treatment by solving the primary scientific obstacles impeding the research and development of new vaccines and immunotherapies. Endorsed by 35 leading vaccine scientists, the Project brings together top academic research centers, and government, non-profit and industry research and development efforts into a global consortium.

“The Human Vaccines Project offers an unprecedented opportunity to merge cutting-edge academic science with industrial product development capabilities to elucidate how the human immune system confers effective immunity, and thus accelerate the development of new interventions for a broad range of critical diseases,” said Johan van Hoof, Global Head, Infectious Diseases and Vaccines, Janssen. “Collaborative partnerships such as this, which bring together key expertise to solve complex scientific problems, are essential to deliver the transformational medical innovations needed to advance human health.”…

Research and Development of New Biomedical HIV Prevention Tools for Women and Girls: Combating the Global AIDS Epidemic Through a More Empowered Response in Sub-Saharan Africa
IAVI Policy Brief
September 2015 :: 8 pages
High HIV prevalence and incidence puts a disproportionate burden on girls and women in Sub-Saharan Africa and threatens to reverse current success in combating the global AIDS epidemic. Programs to fight HIV/AIDS among women and girls can be bolstered by new biomedical prevention tools including pre-exposure prophylaxis, microbicides and vaccines that enhance women and girls’ ability to protect themselves. Better aligning research and development efforts with the needs of women and girls can accelerate the introduction of a wider, more effective array of HIV prevention tools to enhance the health of girls and women, as well as the global response to HIV/AIDS.

First oncolytic immunotherapy medicine recommended for approval

European Medicines Agency [to 24 October2015]

First oncolytic immunotherapy medicine recommended for approval
Advanced therapy medicine Imlygic indicated to treat certain stages of melanoma
The European Medicines Agency (EMA) has recommended authorising Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma that cannot be removed by surgery and that has spread either to the surrounding area or to other areas of the body (regionally or distantly metastatic) without affecting the bones, brain, lung or other internal organs.
Imlygic is a first-in-class advanced therapy medicinal product (ATMP) derived from a virus, that has been genetically engineered to infect and kill cancer cells. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP) based on an assessment carried out by the Committee for Advanced Therapies (CAT), the Agency’s expert committee for ATMPs…

Lions and Bil Gates commit to vaccinations – Gavi

Gavi [to 24 October2015]

Lions and Bill Gates commit to vaccinations
21 October 2015
The Lions Clubs International Foundation (LCIF) has committed to raising US$30 million by 2017 to improve access to vaccines through Gavi, The Vaccine Alliance. The funds raised will be matched by the United Kingdom’s Department for International Development and the Bill & Melinda Gates Foundation, bringing the total to US$60 million.

Malawi and Global Fund Deepen Partnership

Global Fund [to 24 October2015]
Malawi and Global Fund Deepen Partnership
22 October 2015
LILONGWE, Malawi – Malawi and the Global Fund are strengthening their partnership by signing grants worth more than US$332 million, to expand treatment and prevention for HIV, TB and malaria and build resilient and sustainable systems for health. This brings the total Global Fund commitment to Malawi to US$616 million from 2014-2017.
The financial resources provided through the Global Fund come from many sources and partners, represented at the signing ceremony today by the United States, the European Union, the United Kingdom, Germany, Japan, Ireland and Norway, as well as technical partners such as UNAIDS and WHO…

New prize competition seeks innovative ideas to advance open science

NIH [to 24 October2015]

New prize competition seeks innovative ideas to advance open science
Applicants asked to develop new products or services to harness the power of “big data” to improve health

October 20, 2015 — The National Institutes of Health has partnered with London-based Wellcome Trust to launch a global science competition for new products or services to advance “open science,” a movement to make scientific research data broadly accessible to the public. Up to six teams of technology experts and researchers stand to win $80,000 each to develop their ideas into a prototype or to advance an existing early stage prototype. The prototype judged to have the greatest potential to further open science will receive $230,000.

“Research is a global, data-driven enterprise and our ability to improve health increasingly hinges on our ability to manage and make sense of the enormous amounts of data being produced by scientific research,” said NIH Director Francis S. Collins, M.D., Ph.D. “I expect the Open Science Prize to generate innovative ideas to improve data access and establish new international collaborations that will illustrate the transformative power of sharing research data.”…

FAO Food & Agriculture Organization [to 24 October2015]

FAO Food & Agriculture Organization [to 24 October2015]
U.S. backs FAO efforts to combat global animal disease threats with $87 million
Ebola, MERS-CoV and H5N1 avian influenza among diseases with human health implications and pandemic potential being targeted in Africa, Middle East and Asia
20 October 2015, Rome – The United States Agency for International Development (USAID) is backing FAO’s efforts to combat pandemic animal disease threats in Asia, Africa and the Middle East with an additional $87 million in funding covering the 2015-19 period.

USAID and FAO have worked in partnership on controlling animal diseases and managing related human health threats for over a decade. USAID financial backing for this work now amounts to $320 million since 2004.

The new funds will support monitoring and surveillance, epidemiological studies, prevention and control activities as well as improving veterinary capacities in Asia, Africa and the Middle East and promoting links between animal health specialists and the public health sector.

FAO Director-General José Graziano da Silva thanked the U.S. for its support and longstanding partnership. “This shows how important transboundary diseases are for FAO and the UN system, and how much more important they will be in in the future if we want to achieve the Sustainable Development Goals,” he said. “Millions of people rely on livestock for survival, income and nutrition, and their livelihoods must be protected,” he said…

The Selection and Use of Essential Medicines – Report of the WHO Expert Committee, 2015

The Selection and Use of Essential Medicines
WHO Technical Report Series
Report of the WHO Expert Committee, 2015
(including the 19th WHO Model List of Essential Medicines and the 5th WHO Model List of Essential Medicines for Children)
Executive summary
The 20th meeting of the WHO Expert Committee on the Selection and Use of Essential medicines took place in Geneva, Switzerland, from 20 to 24 April 2015. The goal of the meeting was to review and update the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc).
In accordance with approved procedures,1 the Expert Committee evaluated the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines. Both lists went through major revisions this year, as the Committee considered 77 applications, including 29 treatment regimens for cancer, and innovative hepatitis C and tuberculosis (TB) medicines.
The Expert Committee –
:: recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list); and
:: recommended the addition of 16 new medicines to the EMLc (four to the core list and 12 to the complementary list).

Section 19: Immunologicals [p. 313]
19.3: Vaccines (review) – EML and EMLc
The EML Secretariat, with input from the WHO Immunization, Vaccines and Biologicals Department, proposed a slightly revised approach to the listing of vaccines on the EML and EMLc for consideration by the Expert Committee.

The revised approach involves the full alignment of vaccines on the Model Lists with current WHO immunization policy recommendations as published in vaccine position papers on the basis of recommendations made by the Strategic Advisory Group of Experts on Immunization (SAGE).

SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development to delivery of immunization and its linkages with other health interventions in accordance with its mandate to provide guidance to Member States on health policy matters (http://www.who.int/immunization/policy/sage/en). SAGE consists of 15 internationally renowned independent experts in the field of immunization and is concerned not just with childhood vaccines and immunization but with all vaccine-preventable diseases. SAGE meets twice a year, generally in April and October. Working groups are established for detailed review of specific topics in advance of discussion by SAGE. Members of working groups review the evidence and prepare options for recommendations for discussion by the full SAGE group in an open forum. In developing recommendations, SAGE follows an evidence-based review process and applies GRADE. Processes follow the critical elements required by WHO’s Guideline Review Committee in the development of WHO guidelines.

SAGE may decide to recommend specific vaccines to be used universally or to be used conditionally or to not use specific vaccines at a given point in time. These recommendations translate into WHO policy recommendations. WHO publishes its global vaccine policy recommendations as vaccine position papers within the Weekly Epidemiological Record, available on the WHO website at http://www.who.int/immunization/documents/positionpapers/en/index.html. The position papers summarize essential background information on diseases and vaccines, and conclude with the current WHO position concerning vaccine use in the global context. The papers are designed for use by national public health officials and immunization programme managers. They may also be of interest to international funding agencies, the vaccine manufacturing industry, the medical community, and the scientific media.

WHO position papers undergo a formal review process both internally and externally before publication. Processes for managing potential conflicts of interest and ensuring careful and critical appraisal of the best scientific evidence have become more rigorous in recent years. The need for updating vaccine position papers is reviewed periodically and depends primarily on the availability of new scientific evidence and public health priorities. A brief update concerning a specific recommendation in a paper is released when warranted.

The Expert Committee agreed that the EML and EMLc should include those vaccines for which a WHO position paper exists (as at a specific publication date), with reference to the WHO immunization website for up-to-date recommendations at any point in time. The Committee also agreed that the EML and EMLc should specify whether vaccines are recommended for universal or conditional use (e.g. only in certain regions, populations, or in other specified circumstances), with reference to relevant WHO vaccine position papers for detail.