Global Fund elected Martin Dinha as Chair

    The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria said it elected Martin Dinham, a former Director General in the United Kingdom’s Department for International Development, as the new Board Chair. Dr. Mphu Ramatlapeng, Health Minister of the Kingdom of Lesotho, was elected Vice-Chair.  The Board also approved “a comprehensive reform agenda to maximise the effectiveness of the Global Fund,” as well as the framework for “an ambitious five-year agenda, which will set the direction and targets for the organization.”  The new five-year strategy (2012-2016) proposes that the Global Fund “should strive towards saving up to 20 million additional lives and averting 200 million infections by 2016. This will require improvements in efficiency”

http://www.theglobalfund.org/en/pressreleases/?pr=pr_110513

Symposium – Global Vaccines 202X: Access, Equity, Ethics

The Center for Vaccine Ethics and Policy convened Global Vaccines 202X: Access, Equity, Ethics a three-day symposium held 2-4 May 2011 at The Franklin Institute Science Museum, Philadelphia. The meeting gathered approximately 100 leaders from global public health, government, academia, foundations and the NGO community to assess key issues and lay the foundation for an effective policy framework focused on access, equity and ethics for the decade-plus ahead. Video documentation of the meeting will be posted at the symposium website beginning this week. Upcoming Vaccines: The Week in Review will feature content from symposium sessions. Videos of keynote addresses are available now as below:

– Opening Keynote: Realizing the Promise of Global Vaccines
Seth Berkley, IAVI
Introduction: Phil Johnson, Children’s Hospital of Philadelphia
[video: Part I, Part II, Part III ]

– Keynote: 202X trends and perspectives – Immunization Strategy 
JM Okwo-Bele, WHO IVB
[video: here ]

Keynote: The Value of Evidence in Immunization
Anne Schuchat, Director, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA, CDC
Introduction: Art Caplan, Penn Center for Bioethics
[video: here ]

Dinner Keynote: Vaccination: Personal Responsibility; Community Imperative
Art Caplan, Penn Center for Bioethics
[video: Part I, Part II]

– Keynote: WHO’s Immunization Policy Framework: Is it achieving its goal?
Helen Rees, Chairperson, SAGE/WHO
Introduction: Paul Offit, Children’s Hospital of Philadelphia
[video: Part I, Part II ]

– Dinner Keynote: Global Vaccine Access — Why Now?
Chris Elias, CEO, PATH
Introduction: Art Caplan, Penn Center for Bioethics
Benjamin Franklin National Memorial
[video: Part I, Part II ]

Keynote: Priorities, policies, perceptions & the public
David Salisbury, Department of Health, United Kingdom
Introduction: Art Caplan, Penn Center for Bioethics
[video: Part I, Part II, Part III, Part IV ]

Twitter Watch: Week to 16 May 2011

Twitter Watch

A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and by no means intended to be exhaustive.

AIDSvaccine IAVI
World #AIDS #Vaccine Day is Wednesday. Many significant advances are being made in #HIV prevention #research. Help spread the word!

gatesfoundation Gates Foundation
RT ONECampaign: African health ministers from six countries go “on the record” about #vaccines… http://bit.ly/lyx0xq

whonews WHO News
Tweeting on our World Health Assembly 16-25 May 2011? Join the conversation & use #worldhealthassembly http://j.mp/kbSWfw #globalhealth

AIDSvaccine IAVI
IAVI statement on #HPTN052 trial that finds early ARV treatment can reduce #HIV transmission among discordant couples http://bit.ly/ixogmg

USAIDGH USAID
Tempering Fear When the Winds Blow, great meningitis piece from Marc LaForce, Director Meningitis Vaccine Project: http://1.usa.gov/laTsG1

whonews WHO News

Read Dr Chan’s blog post on saving lives through #immunization http://tinyurl.com/6gqna8d #globalhealth

gatesfoundation Gates Foundation
#Polio campaign in the Congo aims to vaccinate 23 million children under five: http://gates.ly/kJrUsv via @UNICEF

AIDSvaccine IAVI
World #AIDS Vaccine Day/ #HIV #Vaccine Awareness Day is May 18. Build your basic knowledge w/IAVI’s VaxLit Toolkit: http://bit.ly/aSTZXA

Economic evaluation alongside randomised controlled trials

British Medical Journal
11 May 2011 Volume 342, Issue 7806
http://www.bmj.com/content/current

Research Methods & Reporting
Economic evaluation alongside randomised controlled trials: design, conduct, analysis, and reporting
Stavros Petrou, Alastair Gray
BMJ 2011;342:doi:10.1136/bmj.d1548 (Published 7 April 2011)

Extract
Collecting economic data at the same time as evidence of effectiveness maximises the information available for analysis but requires proper consideration at the design stage

Economic evaluation involves the comparative analysis of the costs and consequences of alternative programmes or interventions. 1 It has increasingly been used to inform decision making about healthcare in the United Kingdom and other industrialised nations. 2 3 4 5 Randomised controlled trials are commonly used as a vehicle for economic evaluations. Indeed, many funders, such as the UK National Institute for Health Research Health Technology Assessment Programme, routinely request that assessments of cost effectiveness are incorporated in the design of randomised trials. This article outlines some of the key issues concerning the design, conduct, analysis, and reporting of economic evaluations based on trials with individual patient data. Economic evaluations that synthesise data from disparate sources using decision analytical models (typically using summary rather than individual patient data) are discussed in an accompanying article…

Vaccine Liability in the Supreme Court: Forging a Social Compact

JAMA   
May 11, 2011, Vol 305, No. 18, pp 1833-1926
http://jama.ama-assn.org/current.dtl

Commentaries
Vaccine Liability in the Supreme Court: Forging a Social Compact
John D. Kraemer, Lawrence O. Gostin
JAMA. 2011;305(18):1900-1901.doi:10.1001/jama.2011.615

[First 150 words per JAMA convention]

On February 22, 2011, the US Supreme Court decided Bruesewitz v Wyeth LLC, 1 holding that the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts all design defect claims against vaccine manufacturers in which the plaintiff seeks compensation for injury or death caused by a vaccine’s adverse effects. The public health implications are profound because Congress designed the NCVIA to safeguard a social compact—ensuring access to vaccines by preventing the uncertainty of litigation, while also ensuring vaccine safety and effectiveness.

The Challenge of Vaccine Availability

Vaccines are unquestionably among modern public health’s greatest triumphs. In the United States alone, the incidence of vaccine-preventable diseases declined from more than 1 million cases per year at the start of the 20th century to only a few thousand cases per year by its close. 2 Although vaccines remain a cornerstone of public health, they are far less profitable than most biologics, causing only a few manufacturers …

Editorial: Fighting fake drugs: the role of WHO and pharma

The Lancet  
May 14, 2011  Volume 377  Number 9778  Pages 1625 – 1718
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Fighting fake drugs: the role of WHO and pharma
The Lancet

Preview
Counterfeit medicines pose a serious threat to public health. Up to 15% of all drugs sold worldwide are estimated to be fake. Last year, WHO, at the request of member states at the 2010 World Health Assembly (WHA), convened an intergovernmental working group on counterfeit medicines tasked with deciding the agency’s role in tackling this global scourge. The intergovernmental group was required to make specific recommendations to this year’s 64th WHA (May 16–24). They will, however, fail in this mission.

Comment: The cost of dengue control

The Lancet  
May 14, 2011  Volume 377  Number 9778  Pages 1625 – 1718
http://www.thelancet.com/journals/lancet/issue/current

Comment
The cost of dengue control
Eduardo Massad, Francisco Antonio Bezerra Coutinho

Preview
Dengue is thought to be the most important vector-borne disease,1 with about 2·5 billion people (two-fifths of the world’s population) living in regions affected by dengue.2 There are 50–100 million new infections annually.3 According to WHO, the incidence is increasing because of human population growth and wider spread of vector mosquitoes due to climate change (figure).4,5 The total yearly cost of treatment in dengue-endemic areas can reach US$2 billion.3 Without an effective vaccine or specific antiviral treatment, control of the main mosquito vector, Aedes aegypti, is the only option for the prevention and control of dengue,6 at a cost of between $0·207 and $1·008 a head.

Sharing information on adverse events

The Lancet  
May 14, 2011  Volume 377  Number 9778  Pages 1625 – 1718
http://www.thelancet.com/journals/lancet/issue/current

Sharing information on adverse events
Koichiro Yuji, Hiroto Narimatsu, Tetsuya Tanimoto, Tsunehiko Komatsu, Masahiro Kami

Preview
The communication gap between researchers and the mass media has become a serious problem worldwide. Emotive media reports have amplified people’s distrust in medicine, and have widened the communication gap between medical professionals and patients. Japan recently experienced a case of a misleading media report about a cancer vaccine clinical trial which had a great impact on cancer patients.

Dengue vector control strategies in an urban setting

The Lancet  
May 14, 2011  Volume 377  Number 9778  Pages 1625 – 1718
http://www.thelancet.com/journals/lancet/issue/current

Dengue vector control strategies in an urban setting: an economic modelling assessment
Paula Mendes Luz, Tazio Vanni, Jan Medlock, A David Paltiel, Alison P Galvani

Summary
Background
An estimated 2·5 billion people are at risk of dengue. Incidence of dengue is especially high in resource-constrained countries, where control relies mainly on insecticides targeted at larval or adult mosquitoes. We did epidemiological and economic assessments of different vector control strategies.

Methods
We developed a dynamic model of dengue transmission that assesses the evolution of insecticide resistance and immunity in the human population, thus allowing for long-term evolutionary and immunological effects of decreased dengue transmission. We measured the dengue health burden in terms of disability-adjusted life-years (DALYs) lost. We did a cost-effectiveness analysis of 43 insecticide-based vector control strategies, including strategies targeted at adult and larval stages, at varying efficacies (high-efficacy [90% mortality], medium-efficacy [60% mortality], and low-efficacy [30% mortality]) and yearly application frequencies (one to six applications). To assess the effect of parameter uncertainty on the results, we did a probabilistic sensitivity analysis and a threshold analysis.

Findings
All interventions caused the emergence of insecticide resistance, which, with the loss of herd immunity, will increase the magnitude of future dengue epidemics. In our model, one or more applications of high-efficacy larval control reduced dengue burden for up to 2 years, whereas three or more applications of adult vector control reduced dengue burden for up to 4 years. The incremental cost-effectiveness ratios of the strategies for two high-efficacy adult vector control applications per year was US$615 per DALY saved and for six high-efficacy adult vector control applications per year was $1267 per DALY saved. Sensitivity analysis showed that if the cost of adult control was more than 8·2 times the cost of larval control then all strategies based on adult control became dominated.

Interpretation
Six high-efficacy adult vector control applications per year has a cost-effectiveness ratio that will probably meet WHO’s standard for a cost-effective or very cost-effective intervention. Year-round larval control can be counterproductive, exacerbating epidemics in later years because of evolution of insecticide resistance and loss of herd immunity. We suggest the reassessment of vector control policies that are based on larval control only.

Funding
The Fulbright Programme, CAPES (Brazilian federal agency for post-graduate education), the Miriam Burnett trust, and the Notsew Orm Sands Foundation.

Pediatrics Supplement: Vaccine Safety Throughout the Product Life Cycle

Pediatrics
May 2011, VOLUME 127 / ISSUE Supplement 1
http://pediatrics.aappublications.org/content/127/Supplement_1

Editors’ Introduction: Vaccine Safety Throughout the Product Life Cycle
Daniel A. Salmon, Andrew Pavia, and Bruce Gellin
Pediatrics 2011; 127:S1-S4

The development and widespread use, in the United States and globally, of safe and effective vaccines has been one of the greatest achievements in science, medicine, and public health—saving lives, preventing disabilities, contributing to improvements in life expectancy, and reducing health care costs. Serious and once common childhood infections are increasingly joining the ranks of “vaccine-preventable diseases.” The number of childhood and adolescent diseases prevented by vaccines has increased from 10 to 16 in just the last 10 years. Moreover, we now have vaccines that can prevent the infections that can lead to cervical and liver cancer.

Ironically, as the threat of disease has been diminished by vaccines, there has been increasing attention on the risks, both real and perceived, from vaccines. When vaccines are used effectively, the incidence of vaccine-preventable diseases declines, and over time, the diseases that vaccines have prevented are less common. The result is that there is a subtle shift in the benefit/risk ratio. With the recent addition of new vaccines to the recommended childhood immunization schedule, an increasing number of parents have raised concerns that their children are receiving more vaccines than they need.    Changes in information technology, such as the Internet, provide more access to information, both accurate and inaccurate.

The safety standards for vaccines are arguably higher than those of any other medical product because vaccines are given to healthy persons to prevent disease, are recommended for near-universal use, and are often required by state laws for school entrance. Nevertheless, no medical product, including vaccines, is risk free.

Similar to other infrastructures, the components of the US vaccine-safety system may not be familiar to many people. Because the quality and transparency of this system are critical to maintaining public confidence in our immunization program, this supplement to Pediatrics has been assembled to help …

This supplement includes articles on two broad thematic areas:
– Vaccine-Safety System and Vaccine-Safety Studies
– Identifying and Addressing Vaccine-Safety Concerns Among Parents

Towards a Global Agreement on National and Global Responsibilities for Health

PLoS Medicine
(Accessed 15 May 2011)
http://www.plosmedicine.org/article/browse.action?field=date

The Joint Action and Learning Initiative: Towards a Global Agreement on National and Global Responsibilities for Health
Lawrence O. Gostin, Eric A. Friedman, Gorik Ooms, Thomas Gebauer, Narendra Gupta, Devi Sridhar, Wang Chenguang, John-Arne Røttingen, David Sanders Policy Forum, published 10 May 2011
doi:10.1371/journal.pmed.1001031

Summary Points
– A coalition of civil society organizations and academics are initiating a Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI) to research key conceptual questions involving health rights and responsibilities, with the goal of securing a global health agreement and supporting civil society mobilization around the human right to health.
– This agreement—such as a Framework Convention on Global Health—would inform post-Millennium Development Goal (MDG) global health commitments.
– Using broad partnerships and an inclusive consultation process, JALI seeks to clarify the health services to which everyone is entitled under the right to health, the national and global responsibilities for securing this right, and global governance structures that can realize these responsibilities and close major health inequities.
– Mutual benefits to countries in the Global South and North would come from a global health agreement that defines national and global health responsibilities.
– JALI aims to respond to growing demands for accountability, and to create the political space that could make a global health agreement possible.

Diagnosing the Individual to Control the Epidemic

Science Translational Medicine
11 May 2011 vol 3, issue 82
http://stm.sciencemag.org/content/current

Perspective: Infectious Disease
Diagnosing the Individual to Control the Epidemic
Graham F. Medley
11 May 2011: 82ps18

Abstract
When vaccination is not an option, the only way to actively control an epidemic is to identify infectious individuals and “remove” them (by treatment, quarantine, or culling). In a recent Science paper, Charleston et al. present data and an analysis suggesting that clinical diagnosis of foot-and-mouth disease is very closely linked in time to shedding of virus; as such, removal of clinically affected animals might be sufficient to control an epidemic. Although these results are for a veterinary disease, they are very pertinent for all infectious diseases, including those of humans. In this Perspective, we consider the role of experimental research in determining the biology of infection as well as the importance of diagnosis for epidemic control.

Addressability of global disease burden: R&D – maternal and perinatal health

Tropical Medicine & International Health
June 2011  Volume 16, Issue 6  Pages 661–772
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2011.16.issue-6/issuetoc

Maternal Health
Relative and absolute addressability of global disease burden in maternal and perinatal health by investment in R&D (pages 662–668)
Nicholas M. Fisk, Martin McKee and Rifat Atun
Article first published online: 7 APR 2011 | DOI: 10.1111/j.1365-3156.2011.02778.x

Summary
Maternal and perinatal disease accounts for nearly 10% of the global burden of disease, with only modest progress towards achievement of the Millennium Development Goals. Despite a favourable new global health landscape in research and development (R&D) to produce new drugs for neglected diseases, R&D investment in maternal/perinatal health remains small and non-strategic. Investment in obstetric R&D by industry or the not-for-profit sector has lagged behind other specialties, with the number of registered pipeline drugs only 1–5% that for other major disease areas. Using a Delphi exercise with maternal/perinatal experts in global and translational research, we estimate that equitable pharmaceutical R&D and public sector research funding over the next 10–20 years could avert 1.1% and 1.9% of the global disease burden, respectively. In contrast, optimal uptake of existing research would prevent 3.0%, justifying the current focus on health service provision. Although R&D predominantly occurs in high-income countries, more than 98% of the estimated reduction in disease burden in this field would be in developing countries. We conclude that better pharmaceutical and public sector R&D would prevent around 1/3 and 2/3, respectively, of the disease burden addressable by optimal uptake of existing research. Strengthening R&D may be an important complementary strategy to health service provision to address global maternal and perinatal disease burden.

HPV vaccine acceptability in Ghana, West Africa

Vaccine
Volume 29, Issue 23 pp. 3931-4078 (23 May 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
HPV vaccine acceptability in Ghana, West Africa  
Original Research Article  Pages 3945-3950
Maame Aba Coleman, Judy Levison, Haleh Sangi-Haghpeykar

Abstract
Objective
Cervical cancer is a leading cause of cancer-related mortality among women in Ghana. As of this writing no data are available concerning knowledge, attitudes and acceptability of human papillomavirus (HPV) vaccination by women in Ghana.

Methods
Between November and December 2009, a self-administered survey was used to elicit information from 264 Ghanaian women, ages 18–65.

Results
Overall, 40% had heard about HPV vaccine and 94% were willing to vaccinate themselves or their daughters. Ideal age for vaccination was 12.7 years. Most women (75%) thought the vaccine should be received regardless of one’s number of sex partners. The most prevalent concerns were whether the vaccine would be administered safely using clean needles (82%), and possible future side effects (77%). Concerns about cost and vaccine encouraging earlier sex were reported by nearly half. Significant barriers to vaccine acceptance were women’s lack of knowledge about the gravity of cervical cancer in Ghana and utility of Pap test in detecting it, low perceived risk for cervical cancer, low social support to vaccine use, and low self-efficacy to find a doctor or clinic to get vaccinated (p < 05). About 55% of the women did not know the vaccine only works among those who are not yet infected with HPV. Schools and television were the most preferred methods of educating the public and cervical cancer prevention ranked as the ideal message (80%). Most respondents believed the decision to vaccinate their daughter should be made by both parents (34%) or in conjunction with the daughter (37%), as opposed to the government (17%).

Conclusions
Educational programs addressing specific barriers identified in the current study have the potential to significantly improve HPV vaccine uptake in Ghana.

Ethnic and racial differences in HPV knowledge and vaccine intentions

Vaccine
Volume 29, Issue 23 pp. 3931-4078 (23 May 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
Ethnic and racial differences in HPV knowledge and vaccine intentions among men receiving HPV test results  Original Research Article
Pages 4013-4018
Ellen M. Daley, Stephanie Marhefka, Eric Buhi, Natalie D. Hernandez, Rasheeta Chandler, Cheryl Vamos, Stephanie Kolar, Christopher Wheldon, Mary R. Papenfuss, Anna R. Giuliano

Abstract
We examined factors associated with HPV vaccine intentions by racial/ethnic group among men participating in a HPV natural history study. HPV knowledge, vaccine intentions and perceived barriers were assessed among non-Hispanic White, non-Hispanic Black and Hispanic men. Men were tested for HPV every 6 months. After receiving test results from their previous visit, participants (N = 477) reported their intentions for HPV vaccination in a computer-assisted survey instrument (CASI). Vaccine intentions were high among all respondents, although differences were found between racial and ethnic groups in awareness and knowledge of HPV and, vaccine intentions and perceived access and barriers to receiving the HPV vaccine. In order to effectively disseminate the vaccine among men, factors that may promote or inhibit vaccine acceptability need to be identified. Identifying these factors related to vaccine intentions among minority and majority men offers an opportunity for addressing barriers to health equity and, in turn, reductions in HPV-related disparities.

64th WHA Documentation Published/Decade of Vaccines

Documentation supporting the Sixty-fourth World Health Assembly, 16–24 May 2011, Geneva, Switzerland was published at http://apps.who.int/gb/e/e_wha64.html
including:

A64/1 – Provisional agenda

A64/8 – Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits

A64/10 – Implementation of the International Health Regulations (2005). Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009

A64/14 – Global immunization vision and strategy

A64/17 – Smallpox eradication: destruction of variola virus stocks

The Global immunization vision and strategy document above (A64/14) includes an overview of the Decade of Vaccines Collaboration and its status, reproduced in full text below. The paragraph numeration continues from a more general update on GIVS earlier in the document:

“THE DECADE OF VACCINES, 2011–2020: A COMPREHENSIVE VENTURE TO ADVANCE IMMUNIZATION

19. The Decade of Vaccines envisages a world in which children, families and communities enjoy lives free from the fear of vaccine-preventable diseases. Its goal is to extend the full benefits of immunization to all people, regardless of where they live. This goal reflects the perspective that access to safe and effective vaccines is a human right that is not currently enjoyed by all people, particularly in low- and middle-income countries.

20. Achieving this goal will require full engagement of the diverse stakeholders needed to facilitate the discovery, development and delivery of vaccines, including donor governments, policy-makers, industry, researchers, the private sector and civil society, philanthropic bodies, and health workers in the countries where most vaccine-preventable diseases currently occur.

21. The planned activities of the decade build on and apply the lessons learnt from the work done so far in implementing the Global Immunization Vision and Strategy, and extend the base and time period of the strategy’s framework. WHO, UNICEF, the Bill & Melinda Gates Foundation and other partners are beginning a 12-month collaborative process to draft together a global vaccine action plan for consideration by the Sixty-fifth World Health Assembly. Such a plan should enable greater coordination between all stakeholders, outline the steps necessary to achieve the vision and goals outlined above, and identify gaps that must be filled in order to realize the potential of vaccines by

2020 and beyond. The action plan will comprise four essential components:

(i) establishing and sustaining broad public and political support for the use of vaccines and the financing of immunization services,

(ii) strengthening the equitable delivery of immunization services so as to achieve universal coverage of safe and effective vaccines by 2020 in order to prevent, control, eliminate or eradicate vaccine-preventable diseases,

(iii) cultivating a robust scientific environment for innovation in the discovery and development of new and improved vaccines and associated technologies for high-priority diseases,

(iv) creating the right market incentives to ensure an adequate and reliable supply of affordable vaccines.

Delivering immunization services in the next decade

22. Initial discussions on the strategies and key actions needed to improve delivery of immunization services have been held with stakeholders and country representatives, under the joint coordination of WHO and UNICEF. The ensuing programme of work recognizes the centrality of demand-driven, country-led approaches and action, based on equity, responsibility and accountability and a spirit of national self-reliance and gradual self-sufficiency to achieve commonly-shared global immunization goals.

23. The overall goal is to prevent, eliminate or eradicate diseases by means of achieving high and equitable coverage with effective and safe immunization along with other essential health-care interventions throughout the life course.

24. The proposed delivery strategy comprises five overarching objectives:

Objective 1. To uphold immunization as a human right: creating, increasing and sustaining community trust in immunization and awareness of this right; and focusing on underserved and marginalized communities by shifting the current emphasis on “Reaching Every District” to “Reaching Every Community”.

Objective 2. To achieve equity in the use of vaccines: reaching every community with vaccination through complementary delivery methods that engage all appropriate health service providers in the public, private and nongovernmental sectors, thereby ensuring that vaccination covers the poorest and least-served as well as all persons at risk and not just children; building demand for the wider use of new vaccines; and strengthening the efforts to eradicate poliomyelitis and eliminate measles and maternal and neonatal tetanus.

Objective 3. To seek synergies with other programmes and re-establish immunization as a core component of primary health care: putting increased emphasis on reducing the disease burden; coordinating the multiplicity of interventions needed to achieve this reduction with vaccination as an entry point or a complement to other interventions; and participating in collaborative efforts to renovate and strengthen health systems overall.

Objective 4. To develop immunization systems able to meet the challenges posed by the ambitious new goals: improving systems and tools for generating evidence, the monitoring of programme performance and the use of data for action; training, deploying and supporting adequate human resources for programme management and implementation; and building, maintaining and sustaining systems for regular procurement, delivery and effective supply of vaccines.

Objective 5. To bolster national self reliance and partnerships: strengthening structures and processes for countries to develop immunization policies, strategies and best practices; promoting greater ownership, political commitment, accountability and self-reliance of national immunization programmes; enabling formation of collaborative endeavours and engaging actors with diverse expertise across different sectors; achieving sustainable financing of immunization and sound financial management; and establishing national structures and enforcing processes for accountability.

NEXT STEPS

25. The process for preparing the global vaccine action plan will include extensive consultations with Member States and engage various stakeholders, including civil society organizations, professional societies and the private sector, and will provide an opportunity to estimate the costs of implementing the action plan. The Decade of Vaccines secretariat will ensure the overall oversight and coordination of the collaborative project (see paragraph 21) with working groups corresponding to each of the four proposed components undertaking detailed planning.”

Global Fund completes financial review panel

The Global Fund announced completion of the selection of the panel that will review its financial safeguards. The panel’s co-chairs – Festus Mogae and Michael O. Leavitt – “selected the group of eminent persons and experts who will jointly conduct the assessment” and agreed on the scope and timeline of the review, which is scheduled to be concluded by 15 September 2011. The members selected to complete the high-level panel are:

– Zeinab Bashir El Bakri, Director, Office of His Highness the Prime Minister of Kuwait and former Vice-President Sector Operations of the African Development Bank;

– Norbert Hauser, Germany’s Vice-President of the Federal Court of Audit;

– Gabriel Jaramillo, Chairman of the Sovereign Bank Board and Special Advisor at the United Nations Secretary-General Office of the Special Envoy for Malaria;

– The Honourable Barry O’Keefe, Consultant, Clayton UTZ Sydney and former Justice of the Supreme Court of New South Wales (Australia); and

– Claude Rubinowicz, Chief Executive for France’s Agence du patrimoine immatériel de l’État (APIE, Agency for Public Intangibles of France) and former Inspecteur Général des Finances.

The panel “is assessing the risk of fraud and misappropriation in the current Global Fund portfolio, and the systems and controls in place which seek to ensure that the resources reach beneficiaries and are used for their intended purposes. To perform the assessment, the members of the panel will examine a representative sample of grants in countries in different risk categories, drawing conclusions and making recommendations, as appropriate.”

http://www.theglobalfund.org/en/pressreleases/?pr=pr_110504

Twitter Watch: Week to 9 May 2011

 Twitter Watch

A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and by no means intended to be exhaustive.

AIDSvaccine IAVI
Seth Berkley sat down with John Donnelly from #GlobalHealth Magazine’s blog for a Q&A about the #AIDS #vaccine field. http://bit.ly/iUSlpN

EndPolioNow EndPolioNow
In 10 years, 15 million more kids are alive because of vaccines. See the vaccine PSA from ONE. http://www.one.org/us/actnow/vaccines2011/

Cholera Epidemic in Haiti, 2010

Annals of Internal Medicine
May 3, 2011; 154 (9)
http://www.annals.org/content/current

Original Research
Cholera Epidemic in Haiti, 2010: Using a Transmission Model to Explain Spatial Spread of Disease and Identify Optimal Control Interventions
Ashleigh R. Tuite, Joseph Tien, Marisa Eisenberg, David J.D. Earn, Junling Ma, and David N. Fisman
Ann Intern Med May 3, 2011 154:593-601; published ahead of print March 7, 2011,

Abstract
Background: Haiti is in the midst of a cholera epidemic. Surveillance data for formulating models of the epidemic are limited, but such models can aid understanding of epidemic processes and help define control strategies.

Objective: To predict, by using a mathematical model, the sequence and timing of regional cholera epidemics in Haiti and explore the potential effects of disease-control strategies.

Design: Compartmental mathematical model allowing person-to-person and waterborne transmission of cholera. Within- and between-region epidemic spread was modeled, with the latter dependent on population sizes and distance between regional centroids (a “gravity” model).

Setting: Haiti, 2010 to 2011.

Data Sources: Haitian hospitalization data, 2009 census data, literature-derived parameter values, and model calibration.

Measurements: Dates of epidemic onset and hospitalizations.

Results: The plausible range for cholera’s basic reproductive number (R0, defined as the number of secondary cases per primary case in a susceptible population without intervention) was 2.06 to 2.78. The order and timing of regional cholera outbreaks predicted by the gravity model were closely correlated with empirical observations. Analysis of changes in disease dynamics over time suggests that public health interventions have substantially affected this epidemic. A limited vaccine supply provided late in the epidemic was projected to have a modest effect.

Limitations: Assumptions were simplified, which was necessary for modeling. Projections are based on the initial dynamics of the epidemic, which may change.

Conclusion: Despite limited surveillance data from the cholera epidemic in Haiti, a model simulating between-region disease transmission according to population and distance closely reproduces reported disease patterns. This model is a tool that planners, policymakers, and medical personnel seeking to manage the epidemic could use immediately.

Primary Funding Source: None.

Editorials
Cholera in Haiti: Fully Integrating Prevention and Care
David Walton, Arjun Suri, and Paul Farmer
Ann Intern Med May 3, 2011 154:635-637; published ahead of print March 7, 2011,

Cost is an ethical issue

British Medical Journal
7 May 2011 Volume 342, Issue 7805
http://www.bmj.com/content/current

Editor’s Choice
Cost is an ethical issue
Fiona Godlee, editor, BMJ

Money is tight, so getting value for money has to be a top priority for all of us in healthcare. As Jim Easton, the man in charge of improvement and efficiency for the NHS, says whenever he speaks, cost is an ethical issue. Why, then, do we have so little information on cost effectiveness?

Teppo Järvinen and colleagues find this especially worrying in the case of drug treatments for prevention (doi:10.1136/bmj.d2175). They say that for major preventive drugs, such as statins, antihypertensives, and bisphosphonates, there are “no valid data” on effectiveness or cost effectiveness. This may come as a surprise to some of you. It did to me. They explain that claims for the cost effectiveness of these and other drugs are based on efficacy data from randomised trials in idealised populations. In the real world of clinical care, true cost effectiveness may be much lower. Malcolm Willett’s cartoon shows a man standing on the bottom “efficacy” rung of a ladder: “This is fine,” he says. “I can see all the evidence I need from here.”

What Järvinen and colleagues urge us to recognise is that we can’t. To really see whether these drugs represent value for money, we need to take two steps up. We need to understand effectiveness and cost effectiveness in real clinical settings. As an example of how to do this, they refer to a 2001 study by Clare Robertson and colleagues (BMJ 2001;322:701, doi:10.1136/bmj.322.7288.701). But they point out that this assessed a non-drug intervention—exercise for preventing falls in older adults. “We wonder at the virtual absence of empirical cost effectiveness data on preventive drugs when drug companies stand to make millions of profit a week if their drugs are shown to reduce important clinical outcomes in the community setting.”

The BMJ has a longstanding policy of publishing cost effectiveness studies alongside or after randomised trials and systematic reviews. This week we apply the policy to the challenge of how best to treat heavy menstrual bleeding. A systematic review and individual patient data meta-analysis published last year found that hysterectomy scores higher (least dissatisfaction among patients) than endometrial ablation or the Mirena coil (BMJ 2010;341:c3929, doi:10.1136/bmj.c3929). Now the same group has done a full cost effectiveness analysis (doi:10.1136/bmj.d2202) and concludes that hysterectomy is likely to be the most cost effective strategy. NICE guidelines currently favour Mirena.

At least we do have NICE. With all its inevitable imperfections, it’s still a national treasure. Spare a thought for those charged with creating something similar in the United States, where the C word can’t be mentioned. Instead of “cost,” the focus is firmly on comparative effectiveness in the form of head to head comparisons. And even then, as Doug Kamerow reports (doi:10.1136/bmj.d2635), the Wall Street Journal snipes “Comparative effectiveness isn’t about informing choices, it’s about taking away options.” But there’s no alternative to comparing one treatment with another if we are to make rational decisions; and whatever your health system, cost is an ethical issue.

The true cost of pharmacological disease prevention

British Medical Journal
7 May 2011 Volume 342, Issue 7805
http://www.bmj.com/content/current

Analysis
The true cost of pharmacological disease prevention
Teppo L N Järvinen, Harri Sievänen, Pekka Kannus, Jarkko Jokihaara, Karim M Khan
BMJ 2011;342:doi:10.1136/bmj.d2175 (Published 19 April 2011)

Extract
Despite widespread use of preventive drugs such as statins, antihypertensives, and bisphosphonates, there is no valid evidence that they represent value for money, argue Teppo Järvinen and colleagues

Large randomised clinical trials are considered to represent the strongest form of evidence in assessing whether a particular healthcare intervention works. However, little attention has been paid to the fact that people treated in large multicentre randomised trials may not accurately reflect the population receiving the drug in real world settings.

Recently, van Staa and colleagues assessed the external validity of published cost effectiveness studies of selective cyclo-oxygenase-2 (COX 2) inhibitors by comparing the data used in these studies (typically from randomised trials) with observed clinical data.   2 The trial data suggested that the cost of avoiding one adverse gastrointestinal event by switching patients from conventional non-steroidal anti-inflammatory drugs to COX 2 inhibitors would be about $20 000 (£12 500; €14 000). However, when the same analysis was performed using the UK’s General Practice Research Database, comprising anonymised medical records of general practitioners, the cost of preventing one bleed was fivefold greater ($104 000). 2 The authors concluded that the published cost effectiveness analyses of COX 2 inhibitors neither had external validity nor represented the patients treated in clinical practice. They emphasised that external validity should be an explicit requirement for cost effectiveness analyses that are used to guide treatment policies and practices.

Efficacy versus effectiveness

This striking difference between the results from randomised trials and the real world clinical implications was recognised by Archie Cochrane, the pioneering clinical epidemiologist. Almost 40 years ago, Professor Cochrane introduced a specific hierarchy of evidence required from any healthcare intervention before it can be applied to real life situations (table ⇓ ). Three simple questions summarise Cochrane’s scheme: can it work (efficacy)? does it work (effectiveness)? and is it worth it (cost …

Response to Commentaries – AMCs/GAVI

Human Vaccines
Volume 7, Issue 5    May 2011
http://www.landesbioscience.com/journals/vaccines/toc/volume/7/issue/4/

NEWS, POLICY AND PROFILES
Response to Commentaries
Open Access Article
Donald W. Light

Extract
Human Vaccines has assembled a set of high quality, important commentaries on my policy analysis and concerns about the future of GAVI and its Advanced Market Commitment (AMC). Several affirm the value of GAVI in raising funds and playing a key role in immunizing millions more children than before, and I fully agree. The real worries concern their current and upcoming use of donations….

RotaTeq in 6 Asian countries

Human Vaccines
Volume 7, Issue 5    May 2011
http://www.landesbioscience.com/journals/vaccines/toc/volume/7/issue/4/

RESEARCH PAPERS
Projecting the effectiveness of RotaTeq® against rotavirus-related hospitalizations and deaths in 6 Asian countries
Open Access Article
Antoine El Khoury, T. Christopher Mast, Max Ciarlet, Leona Markson and Michelle Goveia

RotaTeq is an oral pentavalent rotavirus vaccine (RV5) that has shown high and consistent efficacy in preventing rotavirus gastroenteritis (RGE) in randomized clinical trials conducted mostly in industrialized countries. We projected the effectiveness of RV5 against RGE-related hospitalizations and deaths in 6 Asian countries by using a simple mathematical model. Model inputs included rotavirus surveillance data collected 2006-2007 in China, 2001-2002 in Hong Kong, 2005-2007 in India, 2005-2007 in South Korea, 2005-2007 in Taiwan, and 2001-2003 in Thailand; the numbers of rotavirus-related deaths in each country; and published rotavirus serotype-specific efficacy of RV5. The model projected an overall effectiveness in the region of 82% to 89% against RGE-related hospitalizations and a substantial reduction in RGE-related deaths, suggesting that RV5 could substantially reduce the burden of rotavirus disease in Asia.

‘Public Health Epidemiological Logic’

Human Vaccines
Volume 7, Issue 5    May 2011
http://www.landesbioscience.com/journals/vaccines/toc/volume/7/issue/4/

Commentaries
Application of ‘Public Health Epidemiological Logic’ in devising a vaccination policy: A broad public health criteria-for routine Immunization
Rajan R. Patil

There is a need to develop clear cut public health criteria for consideration of new vaccines for use in public health. Most of the vaccines which have become recently available or will soon be available are mostly recommended for use in clinical/office practice. A new vaccine that is highly recommended for use in clinical setting may not be effective at all for larger public health use or may even lack rationale to put it in use for public health. It is stressed that a new vaccine which is proven to be good clinical tool for preventing particular disease at individual level need not necessarily be good public health tool in combating the same disease at community level.
The present paper takes a closer look at the logical basis for use of any vaccine in public health. Rabies vaccine is used as a case study to set the background to scrutinize the criteria for eligibility for considering any new vaccine to be included in routine immunization program A rough & ready algorithm is proposed as a check list for a new vaccine as a likely candidate for inclusion in Universal immunization programme. The suggested new algorithm is basically a public health criteria called as Public Health Epidemiological Logic [PHEL] Criteria.. The public health debate and the arguments against inclusion of Rabies vaccine in routine national immunization programme in India is a argued in the frame work of PHEL criteria in this paper Rabies vaccine to drive home the point, that a vaccine which is a good clinical tool need not always be a good public health tool, where as a vaccine which is proven to be a good public health tool will always invariably be a good clinical tool as well.

Comparative Efficacy Data and Drug Approval in U.S.

JAMA   
May 4, 2011, Vol 305, No. 17, pp 1733-1824
http://jama.ama-assn.org/current.dtl

Brief Report
Availability of Comparative Efficacy Data at the Time of Drug Approval in the United States
Nikolas H. Goldberg, Sebastian Schneeweiss, Mary K. Kowal, Joshua J. Gagne
JAMA. 2011;305(17):1786-1789.doi:10.1001/jama.2011.539

Abstract
Context Comparative effectiveness is taking on an increasingly important role in US health care, yet little is known about the availability of comparative efficacy data for drugs at the time of their approval in the United States.

Objective To quantify the availability of comparative efficacy data for new molecular entities (NMEs) approved in the United States.

Data Sources Approval packages publicly available through the online database of drug products approved by the US Food and Drug Administration (FDA).

Study Selection Identification of efficacy studies that supported approval of each NME approved by FDA between 2000 and 2010.

Data Extraction We determined whether eligible studies were head-to-head active controlled trials and whether the results of such studies were available in the approval packages. We recorded the approved indication, whether the NME was an orphan product, whether the NME had undergone priority review, and whether the control group was a specific active comparator or standard care.

Results Of 197 NMEs identified that met eligibility criteria, 100 (51% [95% confidence interval {CI}, 44%-58%]) met criteria for having comparative efficacy data available at the time of market authorization. After excluding NMEs designated as orphan products (n = 37) and those approved for indications for which no alternative treatments existed (n = 17), this proportion increased to 70% (95% CI, 62%-77%). The proportions of NMEs with available comparative efficacy data varied widely by therapeutic area, from 33% (95% CI, 9%-67%) for hormones and contraceptives to 89% (95% CI, 56%-99%) for diabetes medications.

Conclusion Publicly available FDA approval packages contain comparative efficacy data for about half of NMEs recently approved in the United States and for more than two-thirds of NMEs for which alternative treatment options exist. We did not investigate the extent to which available comparative efficacy information is useful for clinical guidance.

What Next for QALYs?

JAMA   
May 4, 2011, Vol 305, No. 17, pp 1733-1824
http://jama.ama-assn.org/current.dtl

Commentaries
What Next for QALYs?
Peter J. Neumann
JAMA. 2011;305(17):1806-1807.doi:10.1001/jama.2011.566

Extract
The quality-adjusted life-year (QALY) has come under fire lately. In the United States, health reform legislation prohibited use of cost-per-QALY thresholds. 1 The United Kingdom has proposed that the National Institute for Health and Clinical Excellence (NICE), which has influenced reimbursement through cost-per-QALY ratios, will not in the future use such information to make yes or no recommendations; instead NICE’s cost-effectiveness assessments would provide an input into price negotiations for technologies. 2 In Germany, the Institute for Quality and Efficiency in Health Care implemented a new system for evaluating the value of medical technologies but rejected the cost-per-QALY model on ethical and methodological grounds. 3 Many countries (including France, Spain, and Italy) have opted for other approaches. Other articles have criticized use of QALYs. 4, 5

The drawbacks of QALYs are well known. QALYs represent health over time as a series of preference-weighted health states, for which the preference …

Financing HPV vaccination in developing countries

The Lancet  
May 07, 2011  Volume 377 Number 9777  Pages 1543 – 1624
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Financing HPV vaccination in developing countries
The Lancet

Preview
5 years have passed since the first vaccines against the human papillomaviruses (HPV) that cause cervical cancer came onto the market. At the end of 2010, 33 countries had national HPV immunisation programmes. However, few of these initiatives were in developing countries and none were in Africa.

Russia pledges $4 billion for Pharma-2020 plan

Nature Medicine
May 2011, Volume 17 No 5
http://www.nature.com/nm/index.html

News
Russia pledges $4 billion for Pharma-2020 plan – p517
Gary Peach
doi:10.1038/nm0511-517

Russia’s biomedical industry is woefully underdeveloped, accounting for only 0.2% of the world market. But plans are afoot to change that. Speaking at the opening of a new birth center in Ryazan on 11 March, for example, Prime Minister Vladimir Putin stated that the government wants to boost Russia’s presence on the world biopharma stage to 3–5% in the next decade. And he emphasized that the country already possesses the necessary academic and research institutions to achieve that. “We need to come up with measures to stimulate demand for Russia-made biotechnological products and remove barriers that often prevent businesses from working,” he said.

To that end, Russian leaders announced in March that they have approved 120 billion rubles ($4 billion) for a strategic investment program aimed at developing the country’s massively import-dependent pharmaceutical and medical supplies industries.

Dubbed Pharma-2020, the program—which was adopted two years ago although financing was only approved by the government last month—will attempt to boost output of local medicines, in gross sales terms, from nearly 25% last year to 50% by 2020. In addition, the program calls for ensuring that 90% of vital medicines are domestically produced, retooling some 160 companies to good manufacturing practice standards, establishing ten research and development centers that will focus on creating innovative products and boosting exports to $100 million.

Like nearly all of Russia’s state-driven initiatives, Pharma-2020 sets seemingly unattainable targets. Still, some insiders believe it is realistic. “Everyone acknowledges that it’s an ambitious program, but, considering the amount of construction work going on right now, and the state funds being allocated, then this task is manageable,” says Nikolai Bespalov, an analyst at Pharmexpert, a Moscow-based market research center.

Others have reservations. “I perceive the program as a document and not much more.      The strategy is written, the concept approved, but there are more acute problems that could be solved today without strategies and concepts, such as the low level of domestic products in state purchases,” says Viktor Dmitriev, director of the Association of Russian Pharmaceutical Manufacturers, based in Moscow.

Pragmatic Trials — Guides to Better Patient Care?

New England Journal of Medicine
May 5, 2011  Vol. 364 No. 18
http://content.nejm.org/current.shtml

Perspective
Statistics in Medicine: Pragmatic Trials — Guides to Better Patient Care?
J.H. Ware, M.B. Hamel

[no abstract, first 100 words…]
Although randomized clinical trials provide essential, high-quality evidence about the benefits and harms of medical interventions, many such trials have limited relevance to clinical practice. The investigations are often framed in ways that fail to address patients’ and clinicians’ actual questions about a given treatment. For example, placebo-controlled trials of a new migraine medication help to establish its efficacy, but they may not help clinicians and patients choose between the new medication and other available treatments. Moreover, since most randomized clinical trials are efficacy trials, researchers enroll a homogeneous patient population, define treatment regimens carefully and require that they be . . .

Meta-analyses of Adverse Effects Data

PLoS Medicine
(Accessed 8 May 2011)
http://www.plosmedicine.org/article/browse.action?field=date

Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview
Su Golder, Yoon K. Loke, Martin Bland Research Article, published 03 May 2011
doi:10.1371/journal.pmed.1001026

Abstract 
Background
There is considerable debate as to the relative merits of using randomised controlled trial (RCT) data as opposed to observational data in systematic reviews of adverse effects. This meta-analysis of meta-analyses aimed to assess the level of agreement or disagreement in the estimates of harm derived from meta-analysis of RCTs as compared to meta-analysis of observational studies.

Methods and Findings
Searches were carried out in ten databases in addition to reference checking, contacting experts, citation searches, and hand-searching key journals, conference proceedings, and Web sites. Studies were included where a pooled relative measure of an adverse effect (odds ratio or risk ratio) from RCTs could be directly compared, using the ratio of odds ratios, with the pooled estimate for the same adverse effect arising from observational studies. Nineteen studies, yielding 58 meta-analyses, were identified for inclusion. The pooled ratio of odds ratios of RCTs compared to observational studies was estimated to be 1.03 (95% confidence interval 0.93–1.15). There was less discrepancy with larger studies. The symmetric funnel plot suggests that there is no consistent difference between risk estimates from meta-analysis of RCT data and those from meta-analysis of observational studies. In almost all instances, the estimates of harm from meta-analyses of the different study designs had 95% confidence intervals that overlapped (54/58, 93%). In terms of statistical significance, in nearly two-thirds (37/58, 64%), the results agreed (both studies showing a significant increase or significant decrease or both showing no significant difference). In only one meta-analysis about one adverse effect was there opposing statistical significance.

Conclusions
Empirical evidence from this overview indicates that there is no difference on average in the risk estimate of adverse effects of an intervention derived from meta-analyses of RCTs and meta-analyses of observational studies. This suggests that systematic reviews of adverse effects should not be restricted to specific study types.

EDITORIAL: Indigenous Genomics

Science                                                
6 May 2011 vol 332, issue 6030, pages 625-752
http://www.sciencemag.org/current.dtl

EDITORIAL
Indigenous Genomics
Vanessa Hayes
Science 6 May 2011: 639

Summary
Studies of indigenous peoples are a crucial part of genomic research, not only to define the extent of human diversity but to provide medical benefit to all people. There are more than 370 million indigenous people living in almost half the countries of the world. Exploding interest in indigenous genomics and global population structure has raised debate about issues of informed consent and community benefit. As was evident in March 2011 during the African and Southern African Society of Human Genetics Meeting in Cape Town, South Africa, the inclusion of indigenous people in future genomic research is paramount, but ethical guidelines must address local concerns. Scientific practices and values must be integrated with indigenous governance so that such genomic research can continue, with the benefits fully realized by all.

Tdap uptake barriers: U.S. adults 2005–2007

Vaccine
Volume 29, Issue 22 pp. 3827-3930 (17 May 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
Barriers to early uptake of tetanus, diphtheria and acellular pertussis vaccine (Tdap) among adults—United States, 2005–2007  Original Research Article
Pages 3850-3856
Brady L. Miller, Katrina Kretsinger, Gary L. Euler, Peng-Jun Lu, Faruque Ahmed

Abstract
Background
The tetanus, diphtheria and acellular pertussis vaccine (Tdap) was recommended by the Advisory Committee on Immunization Practices (ACIP) for U.S. adults in 2005. Our objective was to identify barriers to early uptake of Tdap among adult populations.

Methods
The 2007 National Immunization Survey (NIS)-Adult was a telephone survey sponsored by the Centers for Disease Control and Prevention (CDC). Immunization information was collected for persons aged ≥18 years on all ACIP-recommended vaccines. A weighted analysis accounted for the complex survey design and non-response.

Results
Overall, 3.6% of adults aged 18–64 years reported receipt of a Tdap vaccination. Of unvaccinated respondents, 18.8% had heard of Tdap, of which 9.4% reported that a healthcare provider had recommended it. A low perceived risk of contracting pertussis was the single most common reason for either not vaccinating with Tdap or being unwilling to do so (44.7%). Most unvaccinated respondents (81.8%) indicated a willingness to receive Tdap if it was recommended by a provider.

Conclusions
During the first two years of availability, Tdap uptake was likely inhibited by a low collective awareness of Tdap and a low perceived risk of contracting pertussis among U.S. adults, as well as a paucity of provider-to-patient vaccination recommendations. Significant potential exists for improved coverage, as many adults were receptive to vaccination.

Mumps outbreaks in four universities: England

Vaccine
Volume 29, Issue 22 pp. 3827-3930 (17 May 2011)
http://www.sciencedirect.com/science/journal/0264410X

Mumps outbreaks in four universities in the North West of England: Prevention, detection and response  Original Research Article
Pages 3883-3887
D. Kay, M. Roche, J. Atkinson, K. Lamden, R. Vivancos

Abstract
Evidence suggests that primary and secondary vaccine failure have contributed to recent university-based mumps outbreaks. We describe the epidemiology and public health management of two such outbreaks that occurred simultaneously in two areas of the North West of England, affecting four universities, using data from routine surveillance, serology testing, and telephone interviews and electronic questionnaires. Vaccination status was obtained from GP records. Cases were predominantly first year students living in university halls of residence. Public health response involved active surveillance, isolation advice and targeted vaccination clinics. Many students lack natural immunity and mumps vaccination. Factors hindering the public health response include delayed notifications, inability to readily define the ‘at risk’ population, low vaccine uptake, and lack of an evidence-based, cost effective strategy.

Rwanda, QIAGEN N.V. and Merck announce cervical cancer program

    The Government of Rwanda, QIAGEN N.V. and Merck announced “the launch of a comprehensive national cervical cancer prevention program that includes vaccination with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls 12 to 15 years of age and modern molecular diagnostic screening for women between the ages of 35 and 45.” Rwanda “is the first nation in Africa to offer a comprehensive prevention program that incorporates both HPV vaccination and HPV testing.” Rwanda has a population of 2.72 million women ages 15 years and older. Cervical cancer ranks as the most frequent cancer in women of all ages in Rwanda. Dr. Richard Sezibera, Rwanda’s Minister of Health, commented, “It is our goal to create a comprehensive, coordinated program that includes HPV vaccination, cancer screening with HPV DNA testing, and treatment in order to address the nation’s unmet needs for cervical cancer-related health services. This vaccination and screening program brings us one step closer to reaching our goal of protecting the girls and women in our country. We are pleased to have the support of Merck and QIAGEN on this important government initiative.”

Merck “will provide more than two million doses of GARDASIL to the Government of Rwanda at no cost, while QIAGEN will provide 250,000 HPV screening tests at no cost along with all necessary equipment and training to successfully perform the tests. Thereafter, the Government of Rwanda will continue routine vaccination of appropriate 12 year old girls, and Merck will provide GARDASIL at a discounted access price that is made available for national vaccination programs in GAVI-eligible countries. Similarly, QIAGEN will make its HPV tests accessible under a tiered-market pricing structure designed to enable developing countries to establish and maintain the use of HPV testing within national cervical cancer screening and treatment programs.”

http://www.businesswire.com/news/home/20110425005622/en/Rwanda-Merck-QIAGEN-Launch-Africa’s-Comprehensive-Cervical

Caliber Biotherapeutics opens world’s largest plant-made facility

Caliber Biotherapeutics, “a fully-integrated biopharmaceutical company,” announced the opening of the world’s largest plant-made pharmaceutical manufacturing facility in Bryan, Texas, “with the capability of producing 10-100 million doses of vaccines per month,” and hundreds of thousands of doses of protein biotherapeutics such as monoclonal antibodies. Caliber “will also develop a proprietary product pipeline for cancer and infectious diseases utilizing cell- and microbial-based production systems. The end result will be new, more effective and affordable vaccines and biotherapeutics for patients – delivered in a time frame in which they are needed.” http://www.prnewswire.com/news-releases/new-biopharmaceutical-company-to-accelerate-delivery-of-vaccines-and-protein-therapeutics-120619094.html

GAVI’s Helen Evans: rotavirus vaccines for all children

“We need to make rotavirus vaccines available to all children”

Statement by the GAVI Alliance interim CEO, Helen Evans

Geneva, 28 April 2011 – Rotavirus disease continues to be a significant global health problem. As illustrated in newly released surveillance data by WHO and CDC, globally, 36% of children’s hopitalisation for diarrhoea are due to rotavirus infection.

But while the global rotavirus disease burden remains high, encouraging and growing evidence suggests that the introduction of rotavirus vaccines substantially reduce severe and fatal diarrhoea in young children.

Recognising the enormous potential impact of rotavirus vaccines on reducing child mortality, GAVI added rotavirus vaccines to its portfolio of vaccines for the poorest countries around the world. To date, four GAVI eligible countries have introduced the vaccine: Nicaragua, Honduras, Bolivia and Guyana. Sudan will be the first African country to introduce rotavirus vaccines before the end of the year.

GAVI is committed to working with its partners to accelerate the introduction of rotavirus vaccines in poor countries, and demand for rotavirus vaccines from GAVI-eligible countries is high.

With such life-saving tools within our reach, GAVI counts on the support of policymakers and donors to help accelerate the introduction of new and underused vaccines to the poorest children of the world. A successful outcome of GAVI’s Pledging Conference on 13 June will allow another 4 million lives to be saved.

http://www.gavialliance.org/media_centre/statements/rotavirus.php

Twitter Watch: Week to 2 May 2011

Twitter Watch

A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and by no means intended to be exhaustive.

GAVIAlliance GAVI Alliance
News Update: We need to make rotavirus vaccines available to all children http://ow.ly/1cpEki
29 Apr

gatesfoundation Gates Foundation
Stories, videos, and photos from European #Immunization Week: http://gates.ly/kGSxKg

AIDSvaccine IAVI
We’re pleased to announce the launch of IAVI’s Fellowship Program in #AIDS #Vaccine #Research & Dev http://bit.ly/j2oX0L #globalhealth #HIV

USAIDGH USAID
Polio Immunization Efforts Showing Positive Results in Southern Sudan. Read more here: http://go.usa.gov/bb0

GAVIAlliance GAVI Alliance
Malaria vaccine development: Marking progress and impact http://ht.ly/4GXeM

PATHtweets PATH
Elias: Malaria drug resistance is a growing threat. We need to keep investing in new tools to stay ahead of the parasite. #WorldMalariaDay

MalariaVaccine PATH MVI
Interview: MVI’s Dr. Christian Loucq discusses his life-long passion for #vaccines one.org/blog/2011/04/2… #malaria

Vector-borne infections

Emerging Infectious Diseases
Volume 17, Number 5–May 2011
http://www.cdc.gov/ncidod/EID/index.htm

Perspective
Vector-borne Infections
R. Rosenberg and C.B. Beard

Abstract
Infections with vector-borne pathogens are a major source of emerging diseases. The ability of vectors to bridge spatial and ecologic gaps between animals and humans increases opportunities for emergence. Small adaptations of a pathogen to a vector can have profound effects on the rate of transmission to humans.

The worldwide epidemic of multidrug-resistant tuberculosis

The Lancet Infectious Disease
May 2011  Volume 11  Number 5  Pages 333 – 416
http://www.thelancet.com/journals/laninf/issue/current

Editorial
The worldwide epidemic of multidrug-resistant tuberculosis
The Lancet Infectious Diseases

WHO estimates that a third of the world’s population is infected with Mycobacterium tuberculosis. In 2009, there were almost 9 million new cases of tuberculosis and the disease killed almost 1 million people around the world. Since the discovery of the BCG vaccine, and the development of new antibiotics in the 1950s, the incidence of tuberculosis has fallen substantially. From 1995 to 2009, about 49 million people received treatment for the disease, 41 million of whom were cured, saving up to 6 million.

Jeddah declaration on mass gatherings health

The Lancet Infectious Disease
May 2011  Volume 11  Number 5  Pages 333 – 416
http://www.thelancet.com/journals/laninf/issue/current

Comment
Jeddah declaration on mass gatherings health
Ziad A Memish, Abdullah A Alrabeeah

Planning of events attended by millions of people is a daunting undertaking, and all too often it is done on an ad-hoc basis or via general operations oversight that includes health care along with a multitude of other responsibilities. Recognition that mass gatherings need a coordinated medical infrastructure is not new. What is new and different is an improved understanding of infectious diseases that originate and then disseminate from mass gatherings. Containment of this risk is a global priority.

Vaccines and public health in Europe – conference

The Lancet Infectious Disease
May 2011  Volume 11  Number 5  Pages 333 – 416
http://www.thelancet.com/journals/laninf/issue/current

Newsdesk
Vaccines and public health in Europe
Raffaella Bosurgi

The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference on the Impact of Vaccines on Public Health was held in Prague, Czech Republic (April 1–3, 2011), with support from The Lancet Infectious Diseases. The conference shared expert insights and scientific evidence about a diverse range of topics including human papillomavirus (HPV) and women’s health, vaccines for infants and elderly people, the pipeline for malaria vaccines, vaccination for HIV, and the big challenges of the 21st century.

‘Breakthrough’ Deal on Flu Strains Has Modest Provisions

Science                                                          <
29 April 2011 vol 332, issue 6029, pages 501-624
http://www.sciencemag.org/current.dtl

News & Analysis – Infectious Diseases
‘Breakthrough’ Deal on Flu Strains Has Modest Provisions
Martin Enserink

When exhausted negotiators in Geneva finally reached a deal about the global sharing of influenza viruses early in the morning on Saturday, 15 April, the World Health Organization (WHO) was quick to call it a “landmark agreement.” WHO chief Margaret Chan hailed the 45-page document as “a very significant victory for public health.” But the most significant breakthrough may be that, after 4 years of complex and often contentious negotiations, there is a deal at all. The actual text of the agreement—which promises developing countries certain benefits in return for sharing their flu viruses with the world—contains mostly “soft” language that’s not legally binding.