Vaccines: The Week in Review 28 Sep 2013

Vaccines: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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Email Summary: Vaccines: The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_28 Sep 2013
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Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
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Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

Health MDGs: Joint Statement and new USD$1.15 billion fund for MDGs 4 & 5

Joint Statement on accelerating efforts to achieve the health MDGs
WHO, UNFPA, UNAIDS, UNICEF and the UN Secretary General’s Special Envoy for Financing the Health MDGs and for malaria on the occasion of the 68th General Assembly of the United Nations
25 September 2013
Excerpt
We have 829 days to go until the December 2015 MDG deadline. Over the past 12 and a half years, the world has made remarkable progress against the goals, especially the health-related MDGs. Child and maternal deaths have been almost halved from 1990 levels. Malaria deaths have dropped 50%, driven largely by the distribution of over 400 million mosquito nets in the past several years. Over 6 million people, of the 9 million who need TB treatment, are now on treatment. HIV, once a death sentence with virtually no one on treatment, has undergone a dramatic shift with almost 10 million people on treatment today – and if we can finish the job and put everyone on treatment, we will irreversibly halt the AIDS epidemic. These results are unmistakable proof that success is possible.

Now we must come together in one final big push to achieve the health MDGs, and lay the strongest of foundations for a post-2015 world.

We all know that the economic environment has been challenging, but despite that, the pace of our work to end maternal and child deaths, malaria deaths, AIDS-related deaths and eliminating new HIV infections among children has quickened over the past 3 years. This week, an unprecedented US$ 1.15 billion has been freshly mobilized to reach MDGs 4 and 5 – the largest amount ever mobilized for those goals. Funds of this magnitude fill a substantial portion of the remaining financing gap. Last year, at the London FP Summit, some $2.6 billion funds were mobilized for family planning. The Global Fund to Fight AIDS, TB and Malaria is working hard to achieve its replenishment figure of $15 billion…

…It is now time for an unprecedented acceleration of effort to achieve the goals. We know it will take nothing short of a moonshot to accomplish the goals in the time remaining. The lives we must save in this final MDG phase are in the most difficult to reach areas, and are people who are chronically underserved. With a rights-based approach, combined with utilizing the advancements in science (effective antiretroviral therapy, malarial drugs, rapid diagnostics for TB), we can reach more people in need, faster and efficiently. We must do everything we can, to get as far as we can, by December 2015. Anything less will steepen our climb even further post-2015…
http://www.who.int/mediacentre/news/statements/2013/mdgs_20130925/en/index.html

    The World Bank Group, UNICEF, USAID and the Government of Norway announced a collective USD$1.15 billion in funding over the next three years to accelerate progress toward the Millennium Development Goals (MDGs) 4 and 5, and to ensure essential services and medicines reach women and children who need them in developing countries with the highest burdens of maternal and child deaths.

These commitments “represent one of the largest infusions of funds for maternal and child health from global donors since the MDGs were established in 2000, and signal the global community’s determination to support countries in achieving the goals.”  The funding from these four development partners “will work in a complementary and coordinated way to target a set of high-burden countries, in support of each country’s own child and maternal health plan. The resources from the United States, UNICEF, and Norway will largely be used to strengthen existing supply systems, and provide a needed injection of life-saving commodities, to ensure they reach the communities that need them. The resources from the World Bank Group will help countries transform their health service delivery for women and children by explicitly tying payments to health service providers to the successful delivery and independent verification of pre-agreed results…”
http://www.unicef.org/media/media_70444.html

U.S. to host Global Fund Fourth Replenishment Conference; UK commits US$1.6 billion

   The Global Fund confirmed that the U.S. will host its Fourth Replenishment Conference in early December 2013 through an announcement by Secretary of State John F. Kerry. The conference “will secure funding for 2014-2016, enabling the Global Fund to support programs in countries that fight AIDS, TB and malaria effectively, and to save the lives of millions of people.” In April, the U.S. announced a request for US$1.65 billion for the Global Fund in the budget for 2014. The Global Fund noted that “the architecture of this year’s Replenishment Conference signals a commitment to partnership in a 21st Century model, with leaders from implementing countries and leaders from the private sector and leaders from G8 countries, to co-host the event. In addition, thirteen presidents of African countries are acting as champions of the Global Fund Replenishment this year.”
http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-09-25_US_Will_Host_Global_Fund_Replenishment/

Separately, the Global Fund “congratulated the United Kingdom for demonstrating strong leadership in global health with a major contribution of £1 billion (US$1.6 billion) for the 2014-2016 period. The UK commitment “is geared toward encouraging other donors to maximize their own pledges to the Global Fund, effectively unlocking additional funds with each contribution, as the UK contribution is limited to a maximum of 10 per cent of the total raised for the Global Fund.”
http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-09-23_UK_Commits_GBP_1_Billion_to_the_Global_Fund/

Global Health Investment Fund formed

    Investors led by JPMorgan Chase & Co. (JPM) and the Bill & Melinda Gates Foundation formed the Global Health Investment Fund, which “will back late-stage development of technologies to fight killer diseases in low-income countries.” A group of investors including the Canadian and German governments and the Children’s Investment Fund Foundation committed $94 million to the fund. The International Finance Corp., GlaxoSmithKline Plc (GSK), Merck & Co. (MRK), Pfizer Inc. (PFE)’s foundation, Storebrand ASA (STB) are participating.
http://www.bloomberg.com/news/2013-09-23/jpmorgan-joins-gates-foundation-drugmakers-in-investment-fund.html

Global Health Investment Fund – Prospectus Excerpt
http://ifcext.ifc.org/IFCExt/spiwebsite1.nsf/DocsByUNIDForPrint/7062F2FE8E6BA8BA85257AAE0066A86A?opendocument

General
The Fund will invest in multiple companies and/or Product Development Partnerships (PDPs) who are advancing the development of promising health products and technologies for diseases that disproportionately affect developing countries.

The project being proposed is a US$10mm equity investment in a mezzanine fund, the Global Health Investment Fund, LLC (“GHIF” or the “Fund”), sponsored by the Bill and Melinda Gates Foundation. GHIF is seeking to raise approximately US$100mm for the purpose of improving global health. The Fund would support the development of drugs, vaccines, preventatives, diagnostics and other related technologies aimed at infectious diseases that cause significant morbidity and mortality in developing countries (e.g. neglected infectious diseases), as well as those that provide solutions for maternal, neonatal and child-health challenges.

Expected Development Impact
Given the Fund’s focus on the late stage in the development of many of the drugs, vaccines and diagnostics in the pipeline, it is reasonable to expect a large development impact on several fronts:
(i) possible replication of the business model and scale-up of the flow of additional funding into late stage development of drugs for neglected diseases;
(ii) millions of patients, and especially those in vulnerable population (children and pregnant women) will benefit from the drugs that will be commercialized through this vehicle;
(iii) by demonstrating the commercial viability of the proposed funding structure, this could prove to be an important catalyst for the development of drugs that otherwise would not be developed; and
(iv) demonstration effect to other charitable foundations that their money could be multiplied and effects of their charitable giving amplified through this funding mechanism, which is expected to bring positive financial return to investors…

 
 

HOOKVAC consortium awarded grant of six million Euros to develop and test vaccine for human hookworm

The HOOKVAC consortium said it was awarded a grant of six million Euros from the European Commission FP7 programme to expand the Sabin Vaccine Institute Product Development Partnership’s (Sabin PDP) work to develop and test a vaccine for human hookworm. Under this grant, the HOOKVAC consortium, which includes partners from the European Union, United States and Africa, will begin the first clinical testing of the human hookworm vaccine in the West African nation of Gabon. The Consortium noted that human hookworm infects 600-700 million of the world’s poorest people, primarily those living below the global poverty line, particularly pregnant women and children in sub-Saharan Africa, Southeast Asia, and Latin America. Left untreated, hookworm causes internal blood loss leading to iron-deficiency anemia and malnutrition. Hookworm also contributes to physical and cognitive impairment, poor school performance and attendance, and low birth weights. Ruxandra Draghia-Akli, MD, PhD, director of the Health Directorate at the Research DG of the European Commission, commented, “The European Commission is proud to support the critical work of the consortium for the development of a human hookworm vaccine. Ultimately, we hope that the knowledge, innovations and research expertise resulting from this global collaboration will accelerate the development of the world’s first, effective hookworm vaccine and encourage additional European SME partnerships to explore vaccines for NTDs.”
26 September 2013 – http://www.sabin.org/updates/pressreleases/new-global-consortium-advance-first-ever-clinical-testing-human-hookworm

GPEI Update: Polio this week – As of 25 September 2013

Update: Polio this week – As of 25 September 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]

:: In the Horn of Africa, intensive outbreak response is continuing. The impact of the response is beginning to be seen, as the number of newly-reported cases from Banadir, Somalia (the epicentre of the outbreak) has declined. At the same time, operations are improving as more children are being reached, including in some inaccessible areas of south-central Somalia. The risk this outbreak poses for the entire region was again underscored this week, however, as two further cases from Ethiopia have been confirmed. See ‘Horn of Africa’ section below, for more information.

:: In Pakistan, 12 new cVDPV2 cases are reported this week, the bulk in North Waziristan, FATA. See ‘Pakistan’ section for more details….

Pakistan
:: …12 new cVDPV2 cases were reported in the past week, 11 from North Waziristan, Federally Administered Tribal Areas (FATA) and one from Gadap, greater Karachi, Sindh. Onsets of paralysis of the new cases are from 3 July to 21 August. This brings the total number of cVDPV2 cases for 2013 to 24.
:: The cases in North Waziristan are particularly concerning, as it is in an area where immunizations have been suspended by local leaders since last June. Immunizations in neighbouring high-risk areas are being intensified, to further boost population immunity levels in those areas and prevent further spread of this outbreak. North Waziristan is also affected by WPV1 transmission.
:: Additionally, four new environmental samples tested positive for WPV1, from Peshawar, FATA; Gadap, Sindh; Rawalpindi, Punjab; and, Multan, Punjab. Detection of the sample in Multan is particularly concerning, as WPV1 had not been detected in this area since early 2012.
:: Confirmation of these latest cases in FATA underscores the risk ongoing polio transmission (be it due to WPV or cVDPV) in this area continues to pose to children everywhere, and in particular to children living in areas where access has not been possible for extended periods of time. :: FATA is the major poliovirus reservoir in Pakistan and in Asia, with confirmed circulation of both WPV1 and cVDPV2. More than 350,000 children in this area are regularly missed in inaccessible areas, during immunization activities. Efforts are ongoing to curb transmission in this area, including through vaccination at transit points and conducting Short Interval Additional Dose (SIADs) campaigns in areas that have recently become accessible.

Horn of Africa
:: Seven new WPV1 cases were reported in the past week, five from Somalia and two from Ethiopia. The total number of WPV1 cases for 2013 in the Horn of Africa is 191 (174 from Somalia, 14 from Kenya and three from Ethiopia. The most recent WPV1 case in the region had onset of paralysis on 30 August (from Ethiopia).
:: The two new cases from Ethiopia are both from Somali region, bordering Somalia. It is from this region that the first case from the country had been reported. Active case searches for any additional potential cases is continuing.
:: Because of routes of poliovirus spread in previous Horn of Africa outbreaks, this area of Ethiopia had been considered at ‘high risk’, and since June had been conducting large-scale immunization campaigns. The response continues to be further strengthened. For example, World Food Programme (WFP) field monitors have been sensitized on AFP surveillance, and a proposal is being evaluated to use community volunteers to further intensify surveillance.
:: Nationally and regionally, public-private partnership coordination is continuing, with National Command Post meetings being held every Monday, chaired by the Health State Minister or Director MCH. Similar coordination meetings are taking place in Somali region.
:: 28 Permanent Vaccination Posts have now been established along the Ethiopia-Somalia border areas and at large transit points.
:: Social mobilization and mass media activities continue to be scaled up in the country, including jingles on TV and radio and banner productions for local levels…

WHO Statement on the Third Meeting of the IHR Emergency Committee concerning MERS-CoV

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html
Disease outbreak news
No new DON items

WHO Statement on the Third Meeting of the IHR Emergency Committee concerning MERS-CoV
25 September 2013
Excerpt, Bolded text by Editor
The third meeting of the Emergency Committee convened by the Director-General under the International Health Regulations (2005) [IHR (2005)] was held by teleconference on Wednesday, 25 September 2013, from 12:00 to 14:30 Geneva time (CET).

During the informational session, Kingdom of Saudi Arabia and Qatar presented on recent developments in their countries. The WHO Secretariat provided an update on epidemiological developments, Hajj and Umrah and recent WHO activities related to MERS-CoV. The Committee reviewed and deliberated on the information provided.

The Committee concluded that it saw no reason to change its advice to the Director-General. Based on the current information, and using a risk-assessment approach, it was the unanimous decision of the Committee that the conditions for a Public Health Emergency of International Concern (PHEIC) have not at present been met.

While not considering the events to constitute a PHEIC, Members of the Committee reiterated their prior advice for consideration by WHO and Member States and emphasized the importance of:
:: strengthening surveillance, especially in countries with pilgrims participating in Umrah and the Hajj;
:: continuing to increase awareness and effective risk communication concerning MERS-CoV, including with pilgrims;
:: supporting countries that are particularly vulnerable, especially in Sub-Saharan Africa taking into account the regional challenges;
:: increasing relevant diagnostic testing capacities;
:: continuing with investigative work, including identifying the source of the virus and relevant exposures through case control studies and other research; and
:: timely sharing of information in accordance with the International Health Regulations (2005) and ongoing active coordination with WHO…
http://www.who.int/mediacentre/news/statements/2013/mers_cov_20130925/en/index.html