Vaccines: The Week in Review 30 June 2012

Editor’s Notes:

Email Summary: Vaccines: The Week in Review is available as a weekly email summary: please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_30 June 2012

Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.

Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…

Report: WHO – Accountability of Dr Margaret Chan during her first term as WHO Director-General

Report: WHO – Accountability of Dr Margaret Chan during her first term as WHO Director-General
June 2012
“This document sets out the Director General’s assessment of achievements, setbacks, and remaining challenges, structured around the 22 specific promises made prior to her election.” http://www.who.int/entity/dg/Report_card_cover_28_06.pdf

Forward:
Keeping promises
During 2006, to support my candidacy for the post of WHO Director-General, I issued a manifesto with a six-point agenda for leading the Organization forward. Specific commitments were made under each agenda item. I promised results and am holding myself accountable.

This document sets out my frank and personal assessment of achievements, setbacks, and remaining challenges, structured around the 22 specific promises I made prior to my election.

These commitments were personal and are not always formal WHO priorities, which are established by Member States. Some commitments addressed neglected problems.     Others aligned with internationally agreed goals. Still others were “natural” choices as they reflect the traditional technical strengths of WHO.

Given the large number of agencies and initiatives working to improve health, many of the achievements described in this document cannot be attributed solely to the efforts of WHO. At the same time, WHO has unquestionably shaped the health agenda and gathered the technical expertise and guidance that have paved the way for other initiatives to move forward towards their goals.

Across the board, the greatest gains were made when governments gave health objectives high-level political support. In such cases, the job of WHO, at country, regional, and head office levels, has been to follow the country’s lead, stepping in with technical support and guidance whenever needed or requested.

I am proud that WHO, as a custodian of vast technical expertise, can be called upon to provide this kind of support, and trusted to deliver it well.

Midway through my term, the world was rocked by financial, fuel, and food crises, all highly contagious and all with disruptive and lingering effects. I am equally pleased that the determination to improve health remained steadfast despite these jolts, though the task has, in some areas, become harder as funding has fallen.

As my first term in office draws to a close, I humbly submit this personal account of my promises made nearly six years ago, and the extent to which these promises have been kept.

Extracts around immunization/vaccine topics and issues
p.2 “…To expand the power of vaccines to save lives, innovative mechanisms were established to purchase more vaccines and guarantee a market for new vaccines that protect against pneumonia and severe diarrhoea, the two biggest killers of young children. With GAVI support, many countries added yellow fever, hepatitis B, rotavirus, and pneumonococal vaccines to their routine immunization programmes. For the rotavirus vaccine, the impact in early-adopting countries was dramatic, in some cases halving deaths from diarrhoeal disease.

“The Decade of Vaccines was launched in 2010. The following year, leading drug companies announced significant slashes in vaccine prices for the developing world, including a 95% price reduction for the new rotavirus vaccines. Also in 2011, donors pledged more than $4 billion to support the work of GAVI, an amount that exceeded expectations.

“Despite these positive developments, several countries were reluctant to introduce expensive new vaccines into their routine immunization programmes, especially in the absence of an evidence base demonstrating their efficacy. To guide sound policy decisions, WHO supported research, funded in part by GAVI, to establish an evidence base, published in a 2012 supplement to the journal Vaccine, assessing the efficacy of oral rotavirus vaccines in a range of epidemiological settings….”

p.7   “…Several public-private partnerships established to develop new products for the neglected diseases of the poor have matured. Vaccines for malaria have reached the most advanced stage of clinical trials ever experienced for this disease. The Medicines for Malaria Venture has recently licensed new products and has a promising portfolio of novel molecules in the R&D pipeline.

“The Meningitis Vaccine Project, coordinated by WHO and PATH, culminated in December 2010 with the introduction of a new conjugate vaccine, priced at only 50 cents per dose, in the most hyper-endemic countries among the 25 countries that make up Africa’s Meningitis Belt. Coverage was expanded in 2011, when more than 35 million people were protected, promising to end the terror and havoc of recurring seasonal epidemics. The payback will be enormous. A single case of meningitis can cost a household the equivalent of three to four months of income. Mounting a reactive emergency response to epidemics can absorb more than 5% of the country’s entire health budget.

“African countries frequent have to wait years, if not decades, for new medical products to trickle into their health systems. For once, the best technology that the world, working together, can offer was introduced in Africa.

“The WHO prequalification programme allows manufacturers from low- and middle-income countries to enter the market on an equal footing with established manufacturers, provided they produce products that meet international standards for quality, efficacy, and safety. Expansion of the programme continues to change the dynamics of the market for public health vaccines. By assuring the quality of products manufactured in developing and emerging economics, the programme has increased competition as well as supplies, getting prices down and augmenting the purchasing power of investment dollars….”

p.8 …Commitment: Complete polio eradication.
“This commitment has not been met. Though progress towards polio eradication has been made, the goal remains elusive. At the request of the World Health Assembly, an Independent Monitoring Board was convened to monitor and guide the progress of the Global Polio Eradication Initiative’s 2010–2012 Strategic Plan. The plan aims to interrupt polio transmission globally by the end of 2012.

“The Board’s reports have been frequent and hard-hitting. They are consistently frank in their assessment of obstacles and strident in their demands for better programme performance. This public and critical prodding, which has included some bold proposals for doing things differently, brought several significant changes in both operational aspects of the initiative and signals of government commitment in the remaining countries where transmission continues.

“In May 2012, the Health Assembly approved a resolution declaring the completion of poliovirus eradication a “programmatic emergency for public health, requiring the full implementation of current and new eradication strategies, the institution of strong national oversight and accountability mechanisms for all areas affected by poliovirus, and the application of appropriate vaccination recommendations for all travellers to and from areas affected with poliovirus. ”

“In June 2012, the Independent Monitoring Board issued its most optimistic report to date. As noted, polio is at its lowest level since records began and the virus is gone from India, “a magnificent achievement and proof of the capability of a country to succeed.” The report also stressed the magnitude of remaining challenges, pointing out that 2.7 million children in the persistently affected countries have never received even a single dose of polio vaccine. While recent successes have created a unique window of opportunity, the current funding shortfall threatens to undermine the increasing containment of the virus. As the report concluded, “the prize of a polio-free world is drawing closer, but is far from secure”…

p.11   “…In 2010, the international humanitarian community was overwhelmed by two mega-disasters following the earthquake in Haiti and the massive floods in Pakistan. Events in Haiti, and earlier in Zimbabwe, dramatically illustrated the impact of cholera on vulnerable populations. No one anticipated the cholera outbreak in Haiti, a country that had not seen a case of this disease for more than half a century.

“The international humanitarian community needs to anticipate that, as the climate continues to change and extreme weather events become more common, more mega-disasters will occur, often accompanied by outbreaks of infectious diseases.    As part of the reform process at WHO, capacity to lead the health cluster during humanitarian emergencies is being strengthening, also by relying on mechanisms and operational protocols that have been so successful in outbreak response.

“Mechanisms that worked well against epidemics of meningitis and yellow fever are now being used to strengthen WHO’s response to cholera outbreaks. The deaths in Haiti were way too high and tragic, but each and every year in Africa, similar numbers of people, sometimes more, die from cholera.

“Much controversy has surrounded the role of vaccines in bringing a cholera outbreak under control. In April 2012, WHO brought the world’s top cholera experts to Geneva for an urgent consultation. They advised WHO to establish a 2-million dose stockpile of oral cholera vaccines, under the same umbrella mechanism as used for vaccines for epidemic meningitis and outbreaks of yellow fever. WHO will do so, also as a way of stimulating increased vaccine manufacturing capacity.

“At the same time, vaccines will not solve the cholera problem. Evidence of the impact of vaccines during cholera outbreaks is incomplete. This is another objective of the initiative: to gather the evidence to support well-informed policy decisions when responding to future outbreaks of cholera….”

Milestone: WHO European Region marks tenth anniversary of polio-free certification

Milestone: European Region marks tenth anniversary of polio-free certification
Copenhagen, 21 June 2012

“The WHO European Region marked 10 years since it was certified free of poliomyelitis (polio). Stopping transmission of indigenous wild poliovirus in the 53 countries in the Region was a landmark in the effort to eradicate polio globally, and helped accelerate international momentum towards that goal. Certification “followed years of intensive effort by Member States, supported by a public–private coalition of WHO, the United Nations Children’s Fund (UNICEF), Rotary International and the United States Centers for Disease Control and Prevention (CDC). Thus, countries demonstrated the value of large, internationally coordinated vaccination campaigns and of special efforts to reach traditionally underserved groups, such as migrants or nomads.”

“…the past 10 years have not been without challenges, as surveillance for polio and immunity against it have waned. While poliovirus could travel to the Region easily from infected areas, this had not led to outbreaks before 2010, thanks to quick detection and a well-vaccinated population. By 2010, however, immunity had dropped to the point where an importation of wild poliovirus type 1 led to a large polio outbreak in Tajikistan and three neighbouring countries. This outbreak paralysed 478 people – including many adults – and killed 29. The risk of further deadly outbreaks is rising, underscoring the urgent need to eradicate polio globally.

“We have had many successes in the past 10 years, and we should recognize and applaud them,” said the WHO Regional Director for Europe, Zsuzsanna Jakab. “When we faced challenges, such as the 2010 outbreak, we saw countries and international partners mount a rapid and effective response. While this was a powerful reminder of the success we can achieve when we work together to fight common threats, it is important to emphasize that we cannot afford to become complacent. What we do here in Europe will have a significant impact on both the regional and global fight to eradicate polio.”

…“Less than 24 months ago, the countries of Europe rallied to respond to a terrible outbreak on the Region’s eastern borders,” said Bruce Aylward, WHO Assistant Director-General for Polio, Emergencies and Country Collaboration at WHO headquarters. “Today, there are fewer cases of polio in fewer places of the world than ever before, but Europe faces the spectre of similar outbreaks unless it invests in the emergency plan to eradicate polio in the last reservoirs of the virus. The generosity of the people and governments of Europe will be essential to protecting future generations of children in perpetuity.”

http://www.euro.who.int/en/what-we-publish/information-for-the-media/sections/latest-press-releases/european-region-marks-tenth-anniversary-of-polio-free-certification

GAVI launches public consultation on Country by Country Approach

GAVI said it launched a public consultation on its Country by Country Approach. The consultation will be open until Monday 30 July 2012. At its November 2011, the GAVI Alliance Board requested the Secretariat “to develop a policy that clearly defines the GAVI Alliance’s approach to fragile and under-performing countries”. The main objectives of this work are to:

– Recognise current limitations faced by a subset of countries in their ability to access and leverage GAVI support.

– Ensure that country-specific challenges to accessing immunisation support are identified.

– Propose flexibilities in current GAVI policies and how they could be applied equitably on a country by country basis.

Based on preliminary analysis from the work, GAVI’s Programme and Policy Committee (PPC) on 23-24 April 2012 “agreed that a country by country approach would be a more useful option than developing a policy centred on a specific fragile states definition. At the PPC, it was further agreed that links with fragility would, if possible, include immunisation coverage and government structure. The policy should stay simple and indicate clearly what the approaches are and who is eligible, and the final framework should be transparent to avoid an unfair application of the policy between countries.” The Country by Country policy process has consisted of country and expert consultations with various groups of stakeholders.

The consolidated comments and feedback received during this consultation process as well as a revised draft version of the Country by Country Approach and framework will be presented to the PPC in October before it is taken to the Board for endorsement in December 2012.

More information is available on the GAVI Alliance website http://www.gavialliance.org/about/gavis-business-model/country-by-country-approach/

GAVI posts Board Meeting documentation (12-13 June 2012) – measles prevention decision

GAVI posted documentation associated with its Board meeting held 12-13 June 2012 in Washington DC: http://www.gavialliance.org/about/governance/gavi-board/minutes/2012/12-june/

Editor’s Note: The GAVI Board meting covered a range of topics as detailed in the posted agenda document. WE extract language about a specific decision on measles below:

Decision 7: Options for enhancing GAVI’s investment in measles prevention
The GAVI Alliance Board:
– Approved, on an exceptional basis, the Secretariat to put in place the necessary arrangements in accordance with Annex 2, Option 2 of Doc 12, for six large countries at high risk of measles outbreaks (Afghanistan, Chad, DR Congo, Ethiopia, Nigeria, and Pakistan) to be able to receive GAVI support for measles vaccines and operational costs until these countries are forecasted to have implemented a measles-rubella (MR) campaign, or by no later than 2017. This support would be provided in collaboration with the Measles & Rubella Initiative (MR Initiative, formerly the Measles Initiative).

– Approved US$ 55 million to be made available to the MR Initiative through the UN Foundation for use through 2017 for outbreaks and other emerging needs requiring rapid responses, using the mechanism described in Annex 2, Option 1 of Doc 12.

– Requested the Secretariat – given the importance of measles as an indication of country support for routine immunisation – to develop an indicator for measles first dose routine vaccine coverage as part of the achievement of GAVI’s 2011-2015 Strategy for review by the Evaluation Advisory Committee.

World Bank President Robert B. Zoellick to join Harvard’s Belfer Center and the Peterson Institute

World Bank President Robert B. Zoellick said he would join the Belfer Center for Science and International Affairs at Harvard University and the Peterson Institute for International Economics in Washington DC after he steps down as World Bank Group President on June 30. Mr. Zoellick will become the Peterson Institute’s first Distinguished Visiting Fellow as a Senior Fellow at the Belfer Center.  http://web.worldbank.org/WBSITE/EXTERNAL/NEWS/0,,contentMDK:23229940~pagePK:34370~piPK:34424~theSitePK:4607,00.html

Twitter Watch [accessed 30 June 2012 – 15:52]

Twitter Watch [accessed 30 June 2012 – 15:52]
Items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and is by no means intended to be exhaustive.

OPS/OMS ‏@opsoms
New partner organizations back water and sanitation investments to eliminate cholera from #Hispaniola. Check it out. http://fb.me/1zH3D344E
Retweeted by PAHO/WHO
2:58 PM – 30 Jun 12

UN Development ‏@UNDP
Check out this insightful 2012 edition of the World Economic & Social Survey: http://bit.ly/McLUXI v @unpublications
3:30 PM – 30 Jun 12

USAID ‏@USAID
Learn how we are reforming the agency: http://ow.ly/bVk1x #USAIDForward
3:05 PM – 30 Jun 12

UNICEF ‏@UNICEF
In #Zimbabwe, a weeklong #immunization campaign focuses on ending preventable diseases http://uni.cf/MGlxVW #vaccineswork
12:16 PM – 30 Jun 12

World Bank ‏@WorldBank
World Bank Group support to promote growth and overcome poverty in developing countries hits nearly $53 billion in 2012 http://bit.ly/KJ29WM
10:24 PM – 29 Jun 12

HarvardPublicHealth ‏@HarvardHSPH
TB is mistakenly viewed as a problem of poverty, experts say: “Anyone can get it” http://ht.ly/bVl9t #globalhealth
4:56 PM – 29 Jun 12

WHO ‏@WHO
Dr Chan’s statement looking back at what she accomplished during her first term as WHO Director-General http://goo.gl/Yp1eY
12:30 PM – 29 Jun 12

Arthur Caplan ‏@ArthurCaplan
hpv and catholic bishop http://www.theglobeandmail.com/commentary/we-all-need-the-hpv-vaccine/article4375582/
8:17 PM – 28 Jun 12

UN Spokesperson ‏@UN_Spokesperson
#UNSG’s remarks to General Assembly on outcome of #Rioplus20 http://bit.ly/NSHDaM
5:18 PM – 28 Jun 12

Seth Berkley ‏@GAVISeth
See @GAVIAlliance’s impact by the numbers in our 2011 progress report. Great strides in #globalhealth: http://bit.ly/MY3g55
11:45 AM – 28 Jun 12

Analysis: Aligning U.S. Health Care with U.S. Foreign Policy

Analysis: Aligning U.S. Health Care with U.S. Foreign Policy
Council on Foreign Relations | 28 June 2012
Laurie Garrett

Extract
Millions of lives are prolonged or saved throughout the world, thanks to United States-supported health programs. But Americans aren’t so lucky. For many, the best way to get affordable treatment at U.S. taxpayers’ expense might be to move to a poor country that is committed to building universal coverage, backed by U.S. development aid.

The Supreme Court decision on the Affordable Care Act (PDF) opens the possibility that the United States may now begin to domestically implement policies that foreign aid agencies and the Department of Defense have long supported, both politically and economically, as elements of U.S. foreign policy. It may now be possible to harmonize longstanding U.S. foreign and domestic policies regarding health-care access for poor and middle class peoples…

Supplementary polio immunization activities and prior use of routine immunization services in non-polio-endemic sub-Saharan Africa

Bulletin of the World Health Organization
Volume 90, Number 7, July 2012, 477-556
http://www.who.int/bulletin/volumes/90/7/en/index.html

Supplementary polio immunization activities and prior use of routine immunization services in non-polio-endemic sub-Saharan Africa
Stephane Helleringer, Jemima A Frimpong, Jalaa Abdelwahab, Patrick Asuming, Hamadassalia Touré, John Koku Awoonor-Williams, Thomas Abachie & Flavia Guidetti
http://www.who.int/entity/bulletin/volumes/90/7/11-092494/en/index.html

Objective
To determine participation in polio supplementary immunization activities (SIAs) in sub-Saharan Africa among users and non-users of routine immunization services and among users who were compliant or non-compliant with the routine oral poliovirus vaccine (OPV) immunization schedule.

Methods
Data were obtained from household-based surveys in non-polio-endemic sub-Saharan African countries. Routine immunization service users were children (aged < 5 years) who had ever had a health card containing their vaccination history; non-users were children who had never had a health card. Users were considered compliant with the OPV routine immunization schedule if, by the SIA date, their health card reflected receipt of required OPV doses. Logistic regression measured associations between SIA participation and use of both routine immunization services and compliance with routine OPV among users.

Findings
Data from 21 SIAs conducted between 1999 and 2010 in 15 different countries met inclusion criteria. Overall SIA participation ranged from 70.2% to 96.1%. It was consistently lower among infants than among children aged 1–4 years. In adjusted analyses, participation among routine immunization services users was > 85% in 12 SIAs but non-user participation was > 85% in only 5 SIAs. In 18 SIAs, participation was greater among users (P < 0.01 in 16, 0.05 in 1 and < 0.10 in 1) than non-users. In 14 SIAs, adjusted analyses revealed lower participation among non-compliant users than among compliant users (P < 0.01 in 10, < 0.05 in 2 and < 0.10 in 2).

Conclusion
Large percentages of children participated in SIAs. Prior use of routine immunization services and compliance with the routine OPV schedule showed a strong positive association with SIA participation.

Cash transfer schemes and the health sector

Bulletin of the World Health Organization
Volume 90, Number 7, July 2012, 477-556
http://www.who.int/bulletin/volumes/90/7/en/index.html

PERSPECTIVES
Cash transfer schemes and the health sector: making the case for greater involvement
– Ian Forde et al.
doi: 10.2471/BLT.11.097733

Extract
Cash transfer schemes can be important contributors to human development and social protection. Although they have significant health benefits, they have rarely been considered an integral part of the health policy portfolio. We believe that a case can be made for greater health sector involvement in the design, implementation and evaluation of such schemes.

Cash transfers (CTs) are attracting increasing interest as effective and acceptable means of improving the welfare of disadvantaged households in low- and middle-income countries. They give households regular, predictable amounts of money in the form of pensions, child benefits or regular household grants. Although such social protection mechanisms are often the norm in high-income countries, CTs have historically been rare in low- and middle-income countries. Instead, governments and donors have typically preferred supply-side interventions (expanding health care coverage, for example) or in-kind transfers of goods or food. Financial shocks during the late 1990s, however, triggered a global shift towards social protection schemes more closely resembling European models (emphasizing social security rather than assistance as a last resort). This shift also reflected a desire to correct shortcomings associated with reforms advocated under the Washington consensus, characterized by the dismantling of State services and their replacement with segmented private services…

Reduced price on rotavirus vaccines: enough to facilitate access where most needed?

Bulletin of the World Health Organization
Volume 90, Number 7, July 2012, 477-556
http://www.who.int/bulletin/volumes/90/7/en/index.html

Reduced price on rotavirus vaccines: enough to facilitate access where most needed?
– Lizell B Madsen et al.
doi: 10.2471/BLT.11.094656

Introduction
Rotavirus infections, the most common cause of severe childhood diarrhoea, result in approximately 527 000 child deaths every year. The majority of these deaths occur in low-income countries, particularly in Africa and Asia.1 Rotavirus-associated diarrhoea can be prevented by new live attenuated human rotavirus vaccines. These vaccines have proved safe and efficacious in large-scale clinical trials and post-licensure studies have confirmed their effectiveness in middle- and high-income countries.2,3 However, they have only been partially implemented in national immunization programmes in low-income countries, even though these countries have higher rates of death from rotavirus infection.4

The pharmaceutical companies behind the two internationally licensed rotavirus vaccines, Rotarix® (GlaxoSmithKline Biologicals, Rixensart, Belgium) and RotaTeq® (Merck & Co. Inc., Whitehouse Station, United States of America), have recently pledged to the United Nations Children’s Fund and the international donor community to provide their vaccines to low-income countries at greatly reduced prices.4,5 In spite of these reductions, rotavirus vaccines continue to be more expensive than most traditional childhood vaccines included in the Expanded Programme on Immunization (EPI). This rekindles the traditional debate surrounding access to new childhood vaccines in low-income countries.

In this paper, we examine whether the newly-proposed vaccine prices are low enough to make rotavirus vaccines universally accessible to the millions of children in need of protection against rotavirus infection, a major threat to child health. Furthermore, we discuss the steps that need to be taken in the future to facilitate the introduction of rotavirus vaccines and ensure their sustained financing in low-income countries.

Healthcare workers’ role in keeping MMR vaccination uptake high in Europe

Eurosurveillance
Volume 17, Issue 26, 28 June 2012
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Review articles
Healthcare workers’ role in keeping MMR vaccination uptake high in Europe: a review of evidence
B Simone, P Carrillo-Santisteve, P L Lopalco
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20206

Abstract [Free full text]
Measles is a highly contagious and potentially fatal disease. Europe is far from the 95% coverage rates necessary for elimination of the disease, although a safe and cost-effective vaccine is available. We reviewed the literature on studies carried out in European countries from January 1991 to September 2011 on knowledge, attitudes and practices of health professionals towards measles vaccination and on how health professionals have an impact on parental vaccination choices. Both quantitative and qualitative studies were considered: a total of 28 eligible articles were retrieved. Healthcare workers are considered by parents as a primary and trustworthy source of information on childhood vaccination. Gaps in knowledge and poor communication from healthcare workers are detrimental to high immunisation rates. Correct and transparent information for parents plays a key role in parental decisions on whether to have their children vaccinated. Healthcare workers’ knowledge of and positive attitudes towards measles-mumps-rubella (MMR) vaccination are crucial to meeting the measles elimination goal. An effort should be made to overcome potential communication barriers and to strengthen vaccine education among healthcare professionals.

Global health and national borders: the ethics of foreign aid in a time of financial crisis

Globalization and Health
[Accessed 30 June 2012]
http://www.globalizationandhealth.com/

Research
Global health and national borders: the ethics of foreign aid in a time of financial crisis
Johri M, Chung R, Dawson A and Schrecker T Globalization and Health 2012, 8:19 (28 June 2012)

Abstract (provisional) [Open Access]
Background
The governments and citizens of the developed nations are increasingly called upon to contribute financially to health initiatives outside their borders. Although international development assistance for health has grown rapidly over the last two decades, austerity measures related to the 2008 and 2011 global financial crises may impact negatively on aid expenditures. The competition between national priorities and foreign aid commitments raises important ethical questions for donor nations. This paper aims to foster individual reflection and public debate on donor responsibilities for global health.

Methods
We undertook a critical review of contemporary accounts of justice. We selected theories that: (i) articulate important and widely held moral intuitions; (ii) have had extensive impact on debates about global justice; (iii) represent diverse approaches to moral reasoning; and (iv) present distinct stances on the normative importance of national borders. Due to space limitations we limit the discussion to four frameworks.

Results
Consequentialist, relational, human rights, and social contract approaches were considered. Responsibilities to provide international assistance were seen as significant by all four theories and place limits on the scope of acceptable national autonomy. Among the range of potential aid foci, interventions for health enjoyed consistent prominence. The four theories concur that there are important ethical responsibilities to support initiatives to improve the health of the worst off worldwide, but offer different rationales for intervention and suggest different implicit limits on responsibilities.

Conclusions
Despite significant theoretical disagreements, four influential accounts of justice offer important reasons to support many current initiatives to promote global health. Ethical argumentation can complement pragmatic reasons to support global health interventions and provide an important foundation to strengthen collective action. The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

Lancet support for clinical trials in children and young people

The Lancet  
Jun 30, 2012  Volume 379  Number 9835  p2401 – 2500
http://www.thelancet.com/journals/lancet/issue/current

Perspective
The Lancet’s support for clinical trials in children and young people
Dougal S Hargreaves

Preview
In March, 2012, the European Medicines Agency (EMA) issued a call for more clinical trials to be done in children. Despite 5 years of European Union incentives to increase paediatric research, the EMA estimates that only 12% of clinical trials involve children.1 As a result, many medicines are still prescribed to children off licence.

Lancet Seminar: Cholera

The Lancet  
Jun 30, 2012  Volume 379  Number 9835  p2401 – 2500
http://www.thelancet.com/journals/lancet/issue/current

Seminar
Cholera
Jason B Harris, Regina C LaRocque, Firdausi Qadri, Edward T Ryan, Stephen B Calderwood

Summary
Cholera is an acute, secretory diarrhoea caused by infection with Vibrio cholerae of the O1 or O139 serogroup. It is endemic in more than 50 countries and also causes large epidemics. Since 1817, seven cholera pandemics have spread from Asia to much of the world. The seventh pandemic began in 1961 and affects 3—5 million people each year, killing 120 000. Although mild cholera can be indistinguishable from other diarrhoeal illnesses, the presentation of severe cholera is distinct, with pronounced diarrhoeal purging. Management of patients with cholera involves aggressive fluid replacement; effective therapy can decrease mortality from more than 50% to less than 0·2%. Antibiotic treatment decreases volume and duration of diarrhoea by 50% and is recommended for patients with moderate to severe dehydration. Prevention of cholera depends on access to safe water and sanitation. Two oral cholera vaccines are available and the most effective use of these in integrated prevention programmes is being actively assessed.

Efficacy variables of an HIV vaccine trial – Thai phase 3 efficacy trial RV 144

The Lancet Infectious Disease
Jul 2012  Volume 12  Number 7   p497 – 576
http://www.thelancet.com/journals/laninf/issue/current

Comment
Understanding the efficacy variables of an HIV vaccine trial
José Esparza

Preview
In The Lancet Infectious Diseases, Merlin Robb and colleagues1 report results from a post-hoc analysis of the Thai HIV vaccine trial RV 144. The Article provides important insights into behavioural and temporal variables that might have affected the protective efficacy of the vaccine.

Articles
Risk behaviour and time as covariates for efficacy of the HIV vaccine regimen ALVAC-HIV (vCP1521) and AIDSVAX B/E: a post-hoc analysis of the Thai phase 3 efficacy trial RV 144
Merlin L Robb, Supachai Rerks-Ngarm, Sorachai Nitayaphan, Punnee Pitisuttithum, Jaranit Kaewkungwal, Prayura Kunasol, Chirasak Khamboonruang, Prasert Thongcharoen, Patricia Morgan, Michael Benenson, Robert M Paris, Joseph Chiu, Elizabeth Adams, Donald Francis, Sanjay Gurunathan, Jim Tartaglia, Peter Gilbert, Don Stablein, Nelson L Michael, Jerome H Kim

Summary
Background
The Thai phase 3 HIV vaccine trial RV 144 showed modest efficacy of a vaccine against HIV acquisition. Baseline variables of age, sex, marital status, and risk did not modify vaccine efficacy. We did a post-hoc analysis of the trial’s data to investigate behavioural risk and efficacy every 6 months after vaccination.

Methods
RV 144 was a randomised, multicentre, double-blind, placebo-controlled efficacy trial testing the combination of the HIV vaccines ALVAC-HIV (vCP1521) and AIDSVAX B/E to prevent HIV infection or reduce setpoint viral load. Male and female volunteers aged 18—30 years were recruited from the community. In this post-hoc analysis of the modified intention-to-treat population (16 395 participants), HIV risk behaviour was assessed with a self-administered questionnaire at the time of initial vaccination in the trial and every 6 months thereafter for 3 years. We classified participants’ behaviour as low, medium, or high risk. Both the acquisition endpoint and the early viral-load endpoint were examined for interactions with risk status over time and temporal effects after vaccination. Multiple proportional hazards regression models with treatment and time-varying risk covariates were analysed.

Findings
Risk of acquisition of HIV was low in each risk group, but 9187 (58·2%) participants reported higher-risk behaviour at least once during the study. Participants classified as high or increasing risk at least once during follow-up were compared with those who maintained low-risk or medium-risk behaviour as a time-varying covariate, and the interaction of risk status and acquisition efficacy was significant (p=0·01), with greater benefit in low-risk individuals. Vaccine efficacy seemed to peak early—cumulative vaccine efficacy was estimated to be 60·5% (95% CI 22—80) through the 12 months after initial vaccination—and declined quickly. Vaccination did not seem to affect viral load in either early or late infections.

Interpretation
Future HIV vaccine trials should recognise potential interactions between challenge intensity and risk heterogeneity in both population and treatment effects. The regimen tested in the RV 144 phase 3 trial might benefit from extended immunisation schedules.

Funding
US Army Medical Research and Materiel Command and Division of AIDS, National Institute of Allergy and Infectious Disease, National Institutes of Health.

Consensus statement: Optimising manufacture, formulation, and dose of antiretroviral drugs in resource-limited settings

The Lancet Infectious Disease
Jul 2012  Volume 12  Number 7   p497 – 576
http://www.thelancet.com/journals/laninf/issue/current

Review
Optimising the manufacture, formulation, and dose of antiretroviral drugs for more cost-efficient delivery in resource-limited settings: a consensus statement
Keith W Crawford, David H Brown Ripin, Andrew D Levin, Jennifer R Campbell, Charles Flexner, for the participants of The Conference on Antiretroviral Drug Optimization

Summary
It is expected that funding limitations for worldwide HIV treatment and prevention in resource-limited settings will continue, and, because the need for treatment scale-up is urgent, the emphasis on value for money has become an increasing priority. The Conference on Antiretroviral Drug Optimization—a collaborative project between the Clinton Health Access Initiative, the Johns Hopkins University School of Medicine, and the Bill & Melinda Gates Foundation—brought together process chemists, clinical pharmacologists, pharmaceutical scientists, physicians, pharmacists, and regulatory specialists to explore strategies for the reduction of antiretroviral drug costs. The antiretroviral drugs discussed were prioritised for consideration on the basis of their market impact, and the objectives of the conference were framed as discussion questions generated to guide scientific assessment of potential strategies. These strategies included modifications to the synthesis of the active pharmaceutical ingredient (API) and use of cheaper sources of raw materials in synthesis of these ingredients. Innovations in product formulation could improve bioavailability thus needing less API. For several antiretroviral drugs, studies show efficacy is maintained at doses below the approved dose (eg, efavirenz, lopinavir plus ritonavir, atazanavir, and darunavir). Optimising pharmacoenhancement and extending shelf life are additional strategies. The conference highlighted a range of interventions; optimum cost savings could be achieved through combining approaches.

Fulfilling the promise of rotavirus vaccines: how far have we come since licensure?

The Lancet Infectious Disease
Jul 2012  Volume 12  Number 7   p497 – 576
http://www.thelancet.com/journals/laninf/issue/current

Review
Fulfilling the promise of rotavirus vaccines: how far have we come since licensure?
Manish M Patel, Roger Glass, Rishi Desai, Jacqueline E Tate, Umesh D Parashar

Summary
Rotavirus is the most common cause of fatal and severe childhood diarrhoea worldwide. Two new rotavirus vaccines have shown efficacy against severe rotavirus disease in large clinical trials. Between 2006 and 2010, 27 countries introduced rotavirus vaccination into national immunisation programmes and, subsequently, the burden of severe rotavirus disease in these countries has decreased substantially in both vaccinated and unvaccinated children. Rotavirus vaccination has led to large, sustained declines in childhood deaths from diarrhoea in Brazil and Mexico, which supports estimates that rotavirus was the leading cause of diarrhoeal deaths in these countries. Studies after licensing have provided new insights into these vaccines, such as the duration of protection, relative effectiveness in poor populations, and strain evolution after vaccine introduction. The challenge for policy makers worldwide is to analyse the effect of vaccination in early adopter countries and to assess whether the benefits outweigh the costs and encourage wider dissemination of these vaccines.

Bacteremic Pneumococcal Community-acquired Pneumonia in Children Less Than 5 Years of Age in Italy

The Pediatric Infectious Disease Journal
July 2012 – Volume 31 – Issue 7  pp: A7-A8,667-794,e92-e98
http://journals.lww.com/pidj/pages/currenttoc.aspx

Original Studies
Bacteremic Pneumococcal Community-acquired Pneumonia in Children Less Than 5 Years of Age in Italy
Esposito, Susanna; Marchese, Anna; Tozzi, Alberto E.; Rossi, Giovanni A.; Dalt, Liviana Da; Bona, Gianni; Pelucchi, Claudio; Schito, Gian Carlo; Principi, Nicola; the Italian Pneumococcal CAP Group
Pediatric Infectious Disease Journal. 31(7):705-710, July 2012.
doi: 10.1097/INF.0b013e31825384ae

Abstract:
Background: This study was designed to determine the proportion of bacteremic pneumococcal cases in a group of pediatric subjects with community-acquired pneumonia (CAP), the importance of the different serotypes and the impact of the currently available pneumococcal conjugate vaccines (PCVs).

Methods: The study involved children who were ≤5 years with radiographically confirmed CAP admitted to hospital in Italy between September 2008 and March 2011. A diagnosis of laboratory-confirmed bacteremic pneumococcal CAP was made in the presence of a culture and/or real-time polymerase chain reaction (PCR) positive for Streptococcus pneumoniae.

Results: A total of 510 children were included in the study. Pneumococcal CAP was diagnosed in 73 cases (14.3%): S. pneumoniae was identified by means of positive real-time PCR in 67 cases (91.8%), a positive blood culture in 1 (1.4%) and both in 5 (6.8%). Complicated pneumonia was observed significantly more often in the pneumococcal-positive cases (P= 0.02) and empyema was the main complication (P= 0.007). Serotype 19A was most frequently encountered (17 cases; 25.8%), followed by serotypes 14 (10 cases, 15.1%), 4 (5 cases, 7.6%) and 3 (4 cases, 6.1%). The theoretical coverage offered by the available PCVs was calculated to be 31% for PCV7, 37% for PCV10 and 71% for PCV13.

Conclusions: In Italy, bacteremic pneumococcal CAP accounts for a significant number of CAP cases in children who were ≤5 years, with serotypes 19A and 14 being the most frequent. This suggests that PCV13 is the best means of preventing pneumococcal CAP.

Rotavirus Vaccine Postmarketing Surveillance – Intussusception in Mexico

The Pediatric Infectious Disease Journal
July 2012 – Volume 31 – Issue 7  pp: A7-A8,667-794,e92-e98
http://journals.lww.com/pidj/pages/currenttoc.aspx

Vaccine Reports
Postmarketing Surveillance of Intussusception Following Mass Introduction of the Attenuated Human Rotavirus Vaccine in Mexico
Velázquez, F. Raúl; Colindres, Romulo E.; Grajales, Concepción; Hernández, M. Teresa; Mercadillo, María Guadalupe; Torres, F. Javier; Cervantes-Apolinar, MariaYolanda; DeAntonio-Suarez, Rodrigo; Ortega-Barria, Eduardo; Blum, Maxim; Breuer, Thomas; Verstraeten, Thomas
Pediatric Infectious Disease Journal. 31(7):736-744, July 2012.
doi: 10.1097/INF.0b013e318253add3

Abstract:
Background: Mexico initiated mass vaccination with the attenuated human rotavirus vaccine (Rotarix) in 2006. This postlicensure study aimed to assess any potential temporal association between vaccination and intussusception in Mexican infants.

Methods: Prospective, active surveillance for intussusception among infants aged less than 1 year was conducted in 221 hospitals across Mexico from the Mexican Institute of Social Security between January 2008 and October 2010. The temporal association between vaccination and intussusception was assessed by self-controlled case-series analysis.

Results: Of the 753 episodes of intussusception reported in 750 infants, 701 were in vaccinated infants (34.5% post–dose 1, 65.5% post–dose 2). The relative incidence of intussusception within 31 days of vaccination was 1.75 (95.5% confidence interval [CI]: 1.24–2.48; P = 0.001) post–dose 1 and 1.06 (95.5% CI: 0.75–1.48; P = 0.75) post–dose 2. The relative incidence of intussusception within 7 days of vaccination was 6.49 post–dose 1 (95.5% CI: 4.17–10.09; P < 0.001) and 1.29 post–dose 2 (95.5% CI: 0.80–2.11; P = 0.29). Clustering of intussusception within 7 days of vaccination was observed post–dose 1. An attributable risk of 3 to 4 additional cases of intussusception per 100,000 vaccinated infants was estimated.

Conclusion: This is the largest surveillance study for intussusception after rotavirus vaccination to date. A temporal increase in the risk for intussusception was seen within 7 days of administration of the first vaccine dose. It is still uncertain whether rotavirus vaccination has any impact on the overall incidence of intussusception. This finding has to be put in perspective with the well-documented substantial benefits of rotavirus vaccination.

Current Measles Outbreaks: Can We Do Better for Infants at Risk?

The Pediatric Infectious Disease Journal
July 2012 – Volume 31 – Issue 7  pp: A7-A8,667-794,e92-e98
http://journals.lww.com/pidj/pages/currenttoc.aspx

ESPID Reports and Reviews
Current Measles Outbreaks: Can We Do Better for Infants at Risk?
Machaira, Maria; Papaevangelou, Vassiliki
Pediatric Infectious Disease Journal. 31(7):756-758, July 2012.
doi: 10.1097/INF.0b013e31825ad11b

Extract
The implementation of measles vaccination policies worldwide has decreased the mortality rate attributed to measles by 78% between 2000 and 2008.1 Routine measles vaccination coverage in Europe and Central Asia has increased to 93%, thus resulting steadily in <1000 deaths per year from 1999 to 2004. During the same period, the most significant reduction in mortality has been observed in the sub-Saharan African region (from 530,000 to 216,000 deaths per year) due to the increase in measles vaccination coverage (from 49% to 65%).2 However, outbreaks continue to occur highlighting the major obstacles to measles eradication, phenomena that are directly associated with pockets of susceptible children and adults due to accumulation of subjects with suboptimal vaccination coverage. Moreover, globalization, including enhanced travel and migration of population groups, impedes the elimination of measles.3,4 Recent data support that infants too young to get immunized are at increased risk due to earlier loss of maternal antibodies in offspring of vaccinated mothers.5 Moreover, current outbreaks have shown that although the majority of cases involve susceptible young adults, there has been an increase in the percentage of infants affected.6,7 In Germany, the age-specific incidence of measles has increased between 2001 and 2006, while in France an increase in the percentage of infants affected was observed between 2008 and 2010.8,9 Table 1 summarizes the most recent measles outbreaks over the past couple of years in the developed world and the percentage of infants involved. This article reviews the window of susceptibility for infection during infancy, occurring from the loss of passively acquired maternal antibodies through the first dose of recommended vaccination, and also identifies potential solutions in light of current global epidemics…

Impact of H1N1 on Socially Disadvantaged Populations: Systematic Review

PLoS One
[Accessed 30 June 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Impact of H1N1 on Socially Disadvantaged Populations: Systematic Review
Andrea C. Tricco, Erin Lillie, Charlene Soobiah, Laure Perrier, Sharon E. Straus
PLoS ONE: Research Article, published 25 Jun 2012 10.1371/journal.pone.0039437

Abstract 
Background
The burden of H1N1 among socially disadvantaged populations is unclear. We aimed to synthesize hospitalization, severe illness, and mortality data associated with pandemic A/H1N1/2009 among socially disadvantaged populations.

Methods/Principal Findings
Studies were identified through searching MEDLINE, EMBASE, scanning reference lists, and contacting experts. Studies reporting hospitalization, severe illness, and mortality attributable to laboratory-confirmed 2009 H1N1 pandemic among socially disadvantaged populations (e.g., ethnic minorities, low-income or lower-middle-income economy countries [LIC/LMIC]) were included. Two independent reviewers conducted screening, data abstraction, and quality appraisal (Newcastle Ottawa Scale). Random effects meta-analysis was conducted using SAS and Review Manager.

Conclusions/Significance
Sixty-two studies including 44,777 patients were included after screening 787 citations and 164 full-text articles. The prevalence of hospitalization for H1N1 ranged from 17–87% in high-income economy countries (HIC) and 11–45% in LIC/LMIC. Of those hospitalized, the prevalence of intensive care unit (ICU) admission and mortality was 6–76% and 1–25% in HIC; and 30% and 8–15%, in LIC/LMIC, respectively. There were significantly more hospitalizations among ethnic minorities versus non-ethnic minorities in two studies conducted in North America (1,313 patients, OR 2.26 [95% CI: 1.53–3.32]). There were no differences in ICU admissions (n = 8 studies, 15,352 patients, OR 0.84 [0.69–1.02]) or deaths (n = 6 studies, 14,757 patients, OR 0.85 [95% CI: 0.73–1.01]) among hospitalized patients in HIC. Sub-group analysis indicated that the meta-analysis results were not likely affected by confounding. Overall, the prevalence of hospitalization, severe illness, and mortality due to H1N1 was high for ethnic minorities in HIC and individuals from LIC/LMIC. However, our results suggest that there were little differences in the proportion of hospitalization, severe illness, and mortality between ethnic minorities and non-ethnic minorities living in HIC.

Global Health Governance and the Commercial Sector

PLoS Medicine
(Accessed 30 June 2012)
http://www.plosmedicine.org/article/browse.action?field=date

Global Health Governance and the Commercial Sector: A Documentary Analysis of Tobacco Company Strategies to Influence the WHO Framework Convention on Tobacco Control
Heide Weishaar, Jeff Collin, Katherine Smith, Thilo Grüning, Sema Mandal, Anna Gilmore Research Article, published 26 Jun 2012
doi:10.1371/journal.pmed.1001249

Abstract 
Background
In successfully negotiating the Framework Convention on Tobacco Control (FCTC), the World Health Organization (WHO) has led a significant innovation in global health governance, helping to transform international tobacco control. This article provides the first comprehensive review of the diverse campaign initiated by transnational tobacco corporations (TTCs) to try to undermine the proposed convention.

Methods and Findings
The article is primarily based on an analysis of internal tobacco industry documents made public through litigation, triangulated with data from official documentation relating to the FCTC process and websites of relevant organisations. It is also informed by a comprehensive review of previous studies concerning tobacco industry efforts to influence the FCTC. The findings demonstrate that the industry’s strategic response to the proposed WHO convention was two-fold. First, arguments and frames were developed to challenge the FCTC, including: claiming there would be damaging economic consequences; depicting tobacco control as an agenda promoted by high-income countries; alleging the treaty conflicted with trade agreements, “good governance,” and national sovereignty; questioning WHO’s mandate; claiming the FCTC would set a precedent for issues beyond tobacco; and presenting corporate social responsibility (CSR) as an alternative. Second, multiple tactics were employed to promote and increase the impact of these arguments, including: directly targeting FCTC delegations and relevant political actors, enlisting diverse allies (e.g., mass media outlets and scientists), and using stakeholder consultation to delay decisions and secure industry participation.

Conclusions
TTCs’ efforts to undermine the FCTC were comprehensive, demonstrating the global application of tactics that TTCs have previously been found to have employed nationally and further included arguments against the FCTC as a key initiative in global health governance. Awareness of these strategies can help guard against industry efforts to disrupt the implementation of the FCTC and support the development of future, comparable initiatives in global health.

NTDs as Hidden Causes of Cardiovascular Disease

PLoS Neglected Tropical Diseases
June 2012
http://www.plosntds.org/article/browseIssue.action

Editorial
Neglected Tropical Diseases as Hidden Causes of Cardiovascular Disease
Yasmin Moolani, Gene Bukhman, Peter J. Hotez

Extract
An important component of the burden of cardiovascular disease in low- and middle-income countries may be attributed to the neglected tropical diseases.

There is a growing awareness of the importance of chronic non-communicable diseases (CNCDs) in the world’s low- and middle-income countries (LMICs). Beginning in the 1990s, Murray and Lopez predicted a doubling of death rates due to cardiovascular disease in developing countries by 2020 [1], while a substantial rise was also predicted by Leeder et al. [2]. Based on World Health Organization (WHO) predictions, 75% of the burden of cardiovascular disease is found in LMICs [3]. Alarming increases have also been noted for other CNCDs in LMICs including cancer, chronic respiratory diseases, and diabetes [4]. In September 2011, a report by the World Economic Forum and the Harvard School of Public Health estimated the global economic burden of CNCDs over the next two decades to be US$47 trillion [5]. During this same month, the United Nations General Assembly held a high-level meeting to discuss prevention and control of CNCDs, including cardiovascular diseases, in LMICs [6]. These initiatives have focused on preventable risk factors attributable to lifestyle changes such as tobacco and alcohol use, prolonged unhealthy nutrition, and physical inactivity, which currently account for a high proportion of cardiovascular deaths in North America and Europe [4][6]

Gates Foundation in venture capital shift

Financial Times
http://www.ft.com
Accessed 30 June 2012

Gates Foundation in venture capital shift
By Andrew Jack in London
Financial Times | 26 June 2012
http://www.ft.com/cms/s/0/17bec15e-bfa8-11e1-bb88-00144feabdc0.html#ixzz1zJ5dm9g

Extract
The Gates Foundation plans to take equity stakes in up to a dozen biotech companies this year, signalling a shift towards a “venture capital” approach at the world’s biggest philanthropic organisation. Trevor Mundel, the foundation’s recently appointed head of global health, told the Financial Times he hoped to oversee a series of investments in companies each likely to be worth several million dollars. The move – still on a small financial scale given the foundation’s endowment of $37bn – marks a further move away from its traditional approach of grant-giving and towards a more business-oriented way to support the development of treatments and vaccines for infectious diseases affecting the world’s poor….

Vaccines: The Week in Review 23 June 2012

Editor’s Notes:

Email Summary: Vaccines: The Week in Review is available as a weekly email summary: please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_23 June 2012

Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.

Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…

GPEI Independent Monitoring Board Report – “Every Missing Child” – 2.7 million children in six countries never vaccinated

Statement: UNICEF – Report finds millions of children never vaccinated, UNICEF calls for action to reach them
NEW YORK, 20 June 2012 – “The Independent Monitoring Board on progress with global polio eradication reports the significant finding that 2.7 million children in six countries have never been reached with a single polio vaccine. This is a clarion call to accelerate all efforts to reach these unreached children,” said Anthony Lake, Executive Director of UNICEF.

“Not only have these millions of children never had a polio vaccine but many of these ‘never’ children have not been reached by the life-saving benefits of routine immunization. The report calls on all of us to help find and vaccinate these children, make every encounter with these children count, and make history by wiping out this crippling disease.
“As many of these ‘never’ children live in volatile areas of conflict such as eastern DR Congo, northern Nigeria, the Northwest region of Pakistan, humanitarian space must always be protected and preserved so that the heroes of the polio campaigns – the volunteers, the vaccinators and the social mobilizers – can have full access to children. This is especially the case in a global campaign like the fight against polio.
“The polio campaign is dangerously under-funded. But we are on the verge of victory. Not only can we make history by succeeding in eradicating polio but we will be condemned by history if we fail.
“UNICEF is committed, with partners, to implementing the recommendations outlined in the report such as using polio vaccination campaigns for integrated public health campaigns around good sanitation and nutrition, scaling up use of social mobilization activities so communities take ownership of the health campaigns and finding innovative ways of reaching missed children.”
http://www.unicef.org/media/media_62667.html

Report: Every Missed Child
Independent Monitoring Board of the Global Polio Eradication Initiative
June 2012
The 44-page report issued in conjunction with the 6th meeting of the IMB.
Pdf: http://www.polioeradication.org/Portals/0/Document/Aboutus/Governance/IMB/6IMBMeeting/IMB6_Report.pdf

The Weekly Epidemiological Record (WER) for 22 June 2012, vol. 87, 25 (pp 241–244) includes: Global Polio Eradication Initiative: 6th meeting of the Independent Monitoring Board; Monthly report on dracunculiasis cases, January–April 2012
http://www.who.int/entity/wer/2012/wer8725.pdf

Global Polio Eradication Initiative: 6th meeting of the Independent Monitoring Board

The Independent Monitoring Board (IMB) was established in November 2010, at the request of the World Health Assembly, to monitor and guide progress of the 2010–2012 Strategic Plan of the Global Polio Eradication Initiative (GPEI). The goal of this plan is to interrupt polio transmission globally by the end of 2012.

The IMB held its 6th meeting on 15–17 May 2012, in London, United Kingdom. Following this meeting the IMB issued its 5th report1 to the heads of WHO, the US Centers for Disease Control and Prevention (CDC), UNICEF, Rotary International, and the Bill & Melinda Gates Foundation’s Global Health Program. This report summarizes the conclusions of the IMB.

   1. Polio is no longer present in India.
No case of poliomyelitis has been reported from Angola or the Democratic Republic of Congo since the beginning of 2012, and Chad has reported only 3 cases. In Pakistan, less than half the number of poliomyelitis cases occurred in the first 4 months of 2012 than during the same period in 2011. However both Afghanistan and Nigeria have seen many more poliomyelitis cases in 2012 compared to the same period in 2011.

   2. Among the 6 persistently affected countries, 2.7 million children have never received a single dose of polio vaccine, an unacceptable situation.
The precise reasons for “Every Missed Child” – not only those who have never received 1 dose – should be exposed and rapid corrective action taken.

   3. During its meeting, the IMB spoke of a crisis because:
(i) recent successes have created a unique window of opportunity, which must not be lost;

(ii) a funding shortfall threatens to undermine the increasing containment of the polio virus;

(iii) an explosive resurgence in the immediate future would see country after country under attack from a disease against which their children were considered to be protected.

   4. In its latest report, the IMB highlights a number of key and urgent actions on which the GPEI must focus in order to avert this crisis.
– The primary risk to the programme is its precarious financial situation. Under-financing is not compatible with the ambitious goal of stopping polio transmission globally. Currently, vaccination campaigns are being cancelled, thereby escalating the risk of an explosive return of polio at a time when it is at its lowest recorded level.

– Greater emphasis on the “global public good” of polio eradication will drive the programme forward. Currently, participation in eradication efforts and the donation of resources are uneven. The 65th World Health Assembly adopted a resolution declaring polio to be a global health emergency. The IMB hopes that this will bring countries together once more in a common cause.

= Consistently high quality vaccination and surveillance must be achieved everywhere, not only in ‘islands of excellence’. Considerable improvements to the programme’s management approach have been set in motion, but the required degree of change has not yet been achieved.

– Stakeholders need to know what is planned for the months and years after 2012. This is a far-reaching and complex matter. Planning for the “polio end-game” is under way but the IMB is not convinced that the fundamental nature of what is required is fully understood by the programme.

– Further outbreaks risk substantially harming the programme, bolstering transmission and diverting finances and focus. More innovative methods need to be used to eliminate the possibility of outbreaks more comprehensively.

– The programme operates too much in isolation. Children missed by polio teams may be reached by other services. Stronger, more effective alliances can bring eradication closer.

   5. The IMB meeting focused on the “sanctuaries” for the polio virus – those discrete geographical locations with large numbers of missed children where the virus can take safe refuge and multiply. In these sanctuaries, reaching missed children is the first operational objective. The extraordinary challenges faced require extraordinary actions, determination and resolve.

   6. Of greatest current concern are the polio virus sanctuaries in Afghanistan and Nigeria:
– In Afghanistan insecurity has been an explanation for poor performance in the past, but it is a cause for considerable concern that although security has recently begun to show signs of improvement, poliomyelitis case numbers are rising.

– Nigeria is now the only country to have 3 types of polio virus and consequently it poses a substantial risk to the global goal, in part because many of its neighbouring countries are vulnerable to the spread of infection.

7. The IMB concluded that although the programme has missed all but one of its 2010–2012 Strategic Plan milestones, its operation has strengthened considerably in the last 6 months.

In order to capitalize on this once-in-a-generation opportunity the IMB made 7 recommendations:
i) An emergency meeting of the Global Polio Partners Group should be held to mobilize urgent funding to re-instate cancelled vaccination campaigns.

ii) The Polio Oversight Board should continuously review the effectiveness of the programme in order to achieve improvement.

iii) A polio “end-game and legacy” strategy should be published urgently for public and professional consultation.

iv) A plan to integrate polio vaccination into the humanitarian response to the food crisis and conflict in West Africa should be rapidly formulated and implemented. Alliances with all relevant programmes need to be urgently explored, in order to benefit from every contact.

v) The presence of polio virus in environmental samples should trigger action equivalent to that of an outbreak response (this recommendation subject to rapid feasibility review).

vi) Contingency plans should be drawn up immediately to invoke the International Health Regulations to require travellers from polio-affected countries to carry a valid vaccination certificate.

vii) The number of missed children should henceforth be the predominant metric for the programme.

The IMB will continue to provide a frank and independent assessment of the progress being made towards global interruption of polio transmission. The next IMB meeting will be held in London, United Kingdom, on 29–31 October 2012.

Rio+20 puts health at the heart of development goals

Joint Statement: Rio+20 puts health at the heart of development goals
22-06-2012

The United Nations Conference on Sustainable Development, Rio+20, recognizes in its final document the fundamental need to act on the social and environmental determinants of health to create inclusive, equitable, economically productive and healthy societies. Equity should be at the core of this task, with special attention given to the poor and the most vulnerable.

WHO/Europe, the Pan American Health Organization and WHO headquarters, taking part in the Conference, advocated for health as both a contribution to and a beneficiary of sustainable development.

Health in all policies is a key approach to sustainable development
Reductions in air, water and chemical pollution can prevent up to one fifth of the overall European burden of disease. Great opportunities for progress lie in reducing consumption levels and fostering healthy and green developments in energy, transport, housing, urban management and agriculture, as well as in the health sector. Sustainable development calls for a new health governance approach, introducing the health dimension into decision-making processes across all public policy areas.

Good health is a prerequisite for achieving sustainability goals
Universal health care is an important step in enhancing the health status of populations; it requires a multisectoral approach coupled with an overall strengthening of health systems. Promoting affordable access to prevention, treatment and care strengthens the fight against communicable diseases — such as HIV/AIDS, malaria and tuberculosis — and noncommunicable diseases — such as cancers and cardiovascular diseases — which remain a serious global concern, as well as emerging diseases and challenges arising from demographic change, including migration.

Health is a way of measuring the impact of sustainable development policies
Monitoring progress towards sustainable development goals means being able to evaluate the economic, environmental and social dimensions of policy. Investment in health alone cannot solve the problems of sovereign debt, volatile food prices or the environmental impact of climate change. But people’s health remains vitally important as a measure of the impact of policies in all these areas and this should be fully acknowledged by those aiming to promote a fairer, greener and more sustainable approach to globalization. Not only are health outcomes readily measurable, health concerns are immediate, personal and local.

http://www.euro.who.int/en/what-we-do/health-topics/environment-and-health/Climate-change/news/news/2012/06/rio20-puts-health-at-the-heart-of-development-goals

 
Statement: Remarks by Anthony Lake, UNICEF Executive Director on Sustainable Development in an Unequal World at Rio+20
Rio de Janeiro, Brazil, June 20, 2012

Extract (concluding remarks)
…In short: a pro-equity strategy is not only right in principle; it is right in practice.

To that end, over the last two years, UNICEF has reviewed our programs through an equity lens, and is now working, with our partners, to reach still more of the children our efforts are missing.  The almost 20% of children still not covered by routine vaccination …  The 67 million children still out of primary school … The infants who die, unnecessarily, from the complications of preterm birth or from pneumonia and diarrhea, the other biggest – and highly treatable – killers of children.

Last week, the global community came together at a conference in Washington DC hosted by Ethiopia, India, and the United States, in collaboration with UNICEF and WHO, to reach those unreached children – by rallying again around the goal of child survival.

More than seven hundred representatives of civil society … faith-based organizations … the private sector … and some seventy governments reviewed significant new modeling, based on innovations in health and education, which shows not only that it is possible to achieve dramatic reductions in child mortality by 2035 – but also that it is feasible to greatly decrease that most outrageous of inequities: the huge gap in child mortality between the poorest and richest nations.

Almost sixty governments, and many dozens of non-governmental organizations, signed a pledge on the spot to redouble efforts to achieve that goal, through measurable benchmarks.  We expect many more to follow suit in the coming weeks and months.
In doing so, they will renew the promise the world made in 1990 at the World Summit for Children … in MDGs 4 and 5 … and ten years ago in the General Assembly Resolution on a World Fit for Children.

The goal of 2035 represents a giant step towards what must be our ultimate ambition – a world in which no child dies of preventable causes, of treatable disease.

And with a view to increasing our efficiency and achieving ever better results, UNICEF has developed a new tool to monitor our progress and accelerate those results.

Because results are all that matter … if children’s rights are to be realized.

If we can increase vaccinations so that fewer children die of diseases we know how to prevent … if we can provide more micronutrients so that young brains and young bodies grow strong … if we can give more boys and girls a quality education, we will give children everywhere – this generation and the next – the start in life they deserve.   And make sustainable the future of which they dream.

That is their right … our responsibility … and, I hope, one legacy of Rio+ 20

The World Bank announced that more than 80 nations, private companies and international organizations declare support for Global Partnership for Oceans

[Editor’s Note: We continue to monitor the emergence and performance of broad collaborative initiatives involving governments, civil society organizations (CSOs), international organizations, NGOs, industry and academia for models which might inform global immunization (i.e. GVAP) in terms of governance, modes of collaboration, metrics, roles and accountability frameworks.]

The World Bank announced that more than 80 nations, private companies and international organizations declared support for Global Partnership for Oceans, “signaling their commitment to work together around coordinated goals to restore the world’s oceans to health and productivity.” Support for a “Declaration for Healthy and Productive Oceans to Help Reduce Poverty” at the Rio+20 conference are 17 private firms and associations “including some of the largest seafood purchasing companies in the world, representing over $6 billion per year in seafood sales, as well as one of the world’s largest cruise lines.” The World Bank noted that supporter include 13 nations, 27 civil society groups, 17 private sector firms and associations, seven research institutions, five UN agencies and conventions, seven regional and multi-lateral organizations and seven private foundations.

The Global Partnership for Oceans is described as “a new and diverse coalition of public, private, civil society, research and multilateral interests working together for healthy and productive oceans. It was first announced in February 2012 by World Bank President Robert B. Zoellick at the World Oceans Summit and has been gathering growing support.”

http://www.worldbank.org/en/news/2012/06/16/more-than-80nations-private-companies-international-organizations-declare-support-global-partnership-oceans

Twitter Watch [accessed 23 June 2012 – 09:17]

Twitter Watch [accessed 23 June 2012 – 09:17]
Items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and is by no means intended to be exhaustive.

WHO ‏@WHO
#Rioplus20 reiterates the importance of better sanitation in cities, villages to protect against the spread of infectious diseases
8:08 PM – 22 Jun 12

NIH for Health @NIHforHealth
The Real Promise of Mobile Health Apps: Scientific American http://www.scientificamerican.com/article.cfm?id=real-promise-mobile-health-apps&WT.mc_id=SA_sharetool_Twitter via @sciam
10:13 AM – 22 Jun 12

Mirta Roses Periago ‏@mirtaroses
Lack of universal access to water & sanitation in the island Hispaniola is a growing social, economic & health issue http://bit.ly/MkBGjF
Retweeted by PAHO/WHO
4:08 PM – 21 Jun 12

UNICEF @UNICEF
UNICEF calls for action to reach mns of children never vaccinated for #polio http://uni.cf/LkVuWC @carlzimmer @hari @specterm @mpkolmar
11:27 AM – 21 Jun 12

Sabin Vaccine Inst. @sabinvaccine
de Quadros gets “Development Cooperation” award for work w @WHO to eradicate smallpox & eliminate measles & polio in the Western Hemisphere
9:51 AM – 21 Jun 12

WHO ‏@WHO
We need to start thinking about health as a way of measuring progress across all pillars of sustainable development policy #Rioplus20
4:17 AM – 21 Jun 12

World Bank @WorldBank
Heads of state stepping up commitments to implement natural capital accounting http://bit.ly/MrLREQ #Rioplus20 #naturalcapital
12:34 AM – 21 Jun 12

World Bank ‏@WorldBank
What is Natural Capital Accounting? Video explains: http://bit.ly/Ki6PTl  #Rioplus20 #naturalcapital
11:30 PM – 20 Jun 12

M&R Initiative ‏@MeaslesRubella
‘It’s unjustifiable that there are cases of measles in Europe.” Expert Ciro de Quadros talks candidly to El Mundo. http://www.elmundo.es/elmundosalud/2012/06/19/biociencia/1340130308.html
10:00 PM – 20 Jun 12

ACIP Handbook for Developing Evidence-based Recommendations

ACIP Handbook for Developing Evidence-based Recommendations
Centers for Disease Control and Prevention (CDC. Atlanta, GA)
Version 1.1 – 2012
Ahmed et al.

Practical handbook for use by ACIP Work Groups in development of evidence-based recommendations for presentation to the Advisory Committee on Immunization Practices.
Pdf: http://www.cdc.gov/vaccines/recs/acip/GRADE/downloads/handbook.pdf

Global Fund: Governance Handbook

Global Fund: Governance Handbook

Multi-section pdf document
Undated
http://www.theglobalfund.org/en/board/

This multi-section handbook opens with an eight-page Overview which includes discussion of the Global Fund’s 2012 – 2016 Strategy Framework and Guiding Principles:

Global Fund Guiding Principles
The Global Fund was founded on a set of principles that guides everything the organization does, from governance to grant-making. As stated in the Global Fund Framework Document, these are to:

1 Operate as a financial instrument, not as an implementing entity

2 Make available and leverage additional financial resources

3 Support programs that evolve from national plans and priorities

4 Operate in a balanced manner in terms of regions, diseases and interventions

5 Pursue an integrated, balanced approach to prevention and treatment

6 evaluate proposals through independent review processes

7 Operate with transparency and accountability

8 Strengthen and reflect the involvement of those infected and affected, scaling up and reflecting existing national programs and priorities.

Section 1; Overview
download (PDF – 2 MB)

Section 2: Core Structures
download (PDF – 2 MB)

Section 3: Funding Model
download (PDF – 1 MB)

Section 4: Global Fund Board
download (PDF – 1 MB)

Section 5: Coordinating Group
download (PDF – 987 KB)

Section 6: Standing Committees
download (PDF – 1 MB)

Section 7: Board Constituencies
download (PDF – 1 MB)

Section 8: Board Operations
download (PDF – 1 MB)

Section 9: Financial Resources
download (PDF – 1 MB)

Vocabulary
download (PDF – 242 KB)

Paper: The Global Partnership for Effective Development Cooperation

Paper: The Global Partnership for Effective Development Cooperation
Brookings – Series: Global Views | No. 35 of 35
June 2012
Homi Kharas
http://www.brookings.edu/research/papers/2012/06/06-global-partnership-kharas

INTRODUCTION
These are important times for how the world manages the annual flow of around $200 billion in development cooperation assistance to developing countries. A number of changes in global international development cooperation are in the offering: within a one month span, development issues will be taken up by the G-20 at the Leaders’ Summit at Los Cabos, by the United Nations at its Rio+20 Summit, and by Jim Kim upon taking over as the first ever development professional to become president of the World Bank. The key issues on the table are implementation of the Millennium Development Goals, building consensus on a new set of post-2015 Sustainable Development Goals, implementing a New Deal on fragile states, and closer integration of environmental, security, trade, investment and development agendas.

There is now an opportunity to establish a new paradigm and governance structure for coordinating the many state and non-state actors engaged in development cooperation.     A new Global Partnership for Effective Development Cooperation is taking shape, backstopped by the Development Assistance Committee (DAC) of the Organization for Economic Cooperation and Development (OECD) and the United Nations Development Program (UNDP). Establishing this partnership was one of the key outcomes of the Busan High Level Forum on Aid Effectiveness held in December 2011.

On June 28-29, 2012, the Working Party on Aid Effectiveness, a DAC-supported international partnership for aid effectiveness, will hold a plenary meeting in Paris which should conclude with three consequential outcomes: (i) it will bring into being a new Global Partnership for Effective Development Cooperation with a governance structure that truly reflects the multi-stakeholder nature of development today; (ii) it will dissolve itself, marking one of the first times that a multilateral structure is actually replaced by a more suitable mechanism; and (iii) it will adopt a set of indicators for monitoring global progress towards more effective development cooperation.

Already, the outlines of the new partnership are becoming clear, thanks to a transparent process of meetings and dialogue. There is much to be encouraged about, but as with most efforts for institutional change, the devil is in the details. At first glance, while the Global Partnership promises to deliver substantial and significant improvements in governance, its proposed new monitoring indicators are still rooted in the past and do not reflect the new style of development cooperation that is expected in the next decade. This policy paper explores the approach to building indicators and suggests improvements to ensure better development cooperation.

Full Paper download:

http://www.brookings.edu/~/media/research/files/papers/2012/6/06%20global%20partnership%20kharas/06%20global%20partnership%20kharas.pdf

Report: Taking Stock: How Global Biotechnology Benefits from Intellectual Property Rights

Report: Taking Stock: How Global Biotechnology Benefits from Intellectual Property Rights
Biotechnology Industry Organization (BIO)
June 2012
Meir Perez Pugatch, David Torstensson and Rachel Chu of the Pugatch Consilium
Pdf: http://www.bio.org/sites/default/files/Pugatch%20Consilium%20-%20Taking%20Stock%20Final%20Report%20%282%29.pdf.

BIO released a report on the role of intellectual property rights in encouraging upstream research and development as well as downstream commercialization of biotechnology at the 2012 BIO International Convention.

Joseph Damond, BIO Senior Vice President of International Affairs, said, “This report is further proof of the positive impact of intellectual property rights in both established and emerging economies, and will be a useful tool as we work with the many countries seeking to grow the biotechnology industry.  We felt it was important to provide empirical evidence and case studies for a more informed discussion on the role of intellectual property in global economic development and in commercializing innovative products for patients and other consumers.”

The report outlines “how intellectual property rights and technology transfer mechanisms encourage collaboration and lead to the research and development of new biotechnologies, particularly in emerging and developing economies.”

http://www.bio.org/media/press-release/intellectual-property-encourages-collaboration-rd-developing-economies

Cervical Cancer Screening: USPSTF, ACS/ASCCP/ASCP Recommendations

Annals of Internal Medicine
19 June 2012, Vol. 156. No. 12
http://www.annals.org/content/current

Editorials
Cervical Cancer Screening: Primum Non Nocere  [FREE]]
Nora Kizer, MD, MSCI; and Jeffrey F. Peipert, MD, PhD

Extract
The Hippocratic Oath cautions us to abstain from doing harm. We must remember this basic tenet of our profession as we address new evidence and guidelines for cervical cancer screening. The purpose of screening is to identify at-risk individuals and to enable early intervention to reduce mortality and suffering. As such, screening should fit the ideal of doing no harm, yet providing substantial benefit.

However, screening tests can unintentionally cause significant harm. False-positive test results can lead to overdiagnosis; misdiagnosis; and the potential for unnecessary diagnostic testing, procedures, and treatments and their inherent risks. For these reasons, screening tests, especially for a disease with a low incidence, must have high sensitivity in addition to acceptable specificity. Tradeoffs of increased sensitivity for decreased specificity can shift the balance of benefits and harms.

It is important to consider these issues as one reads the U.S. Preventive Services Task Force (USPSTF) most current recommendations for cervical cancer screening in this issue (1). The American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology (ACS/ASCCP/ASCP) have also published new joint cervical cancer prevention guidelines based on a broadly attended consensus conference (2). These 2 sets of recommendations are largely congruent and are important steps forward to maximally efficient and effective cervical cancer screening. Health care providers should welcome these new recommendations with enthusiasm and incorporate them into routine clinical practice…

…Unlike the USPSTF recommendations, the ACS/ASCCP/ASCP guidelines address women who have received the HPV vaccine, recommending that they continue routine screening. Although evidence shows the vaccine to be highly effective at preventing HPV 16/18–associated CIN3+ lesions in individuals not infected with HPV, 30% of cases of cervical cancer are attributable to other HPV strains. In addition, the vaccine’s true duration of coverage is unknown, which is of particular concern for women who received vaccination during early adolescence. Future evidence may show that less frequent screening is appropriate for vaccinated women, but given the limitations of current research and the low vaccination coverage among U.S. adolescents prior to first intercourse, the screening protocol should be the same for both vaccinated and unvaccinated women…

… Promotion of the HPV vaccine before first intercourse, when prophylactic vaccination is most beneficial, is another important prevention message. The United States lags far behind other health care systems, such as those in Australia and the United Kingdom, with only 32% of eligible women who have received the complete HPV 16/18 vaccine (4). Vaccinating young women before the onset of sexual activity should be encouraged (5)….

Clinical Guidelines

Screening for Cervical Cancer: U.S. Preventive Services Task Force Recommendation Statement [FREE]

Virginia A. Moyer, MD, MPH

Communicating risk

British Medical Journal
23 June 2012 (Vol 344, Issue 7862)
http://www.bmj.com/content/344/7862

Clinical Review
Communicating risk
Haroon Ahmed
BMJ 2012;344:e3996 (Published 18 June 2012)

Summary points
– Risk communication is the open two way exchange of information and opinion about harms and benefits; it aims to improve understanding of risk and promote better decisions about clinical management

– Strong evidence suggests that the format in which risk information is presented affects patients’ understanding and perception of risk

– There is emerging evidence that effective risk communication can lead to more informed decision making in screening

– Decision aids can be an effective adjunct to risk communication and can improve knowledge, awareness, and decision making

– The presentation of data uncertainty is one of the most difficult aspects of risk communication

Proposed: A WHO-UNICEF Global Code of Practice on the Marketing of Unhealthy Food and Beverages to Children

Global Health Governance
Latest Issue: 22 June 2012
http://blogs.shu.edu/ghg/

[Editor’s Note: We continue to broadly monitor the literature for strategies and analysis which might inform global immunization (i.e. GVAP) in terms of governance, modes of collaboration, metrics, roles, legal options, and accountability frameworks.]

A WHO-UNICEF Global Code of Practice on the Marketing of Unhealthy Food and Beverages to Children
Allyn L. Taylor, Ibadat S. Dhillon, Lenias Hwenda

The High-level Meeting of the United Nations General Assembly on the Prevention and Control of Non-Communicable Diseases (“NCDs”) has drawn much-needed attention for the development and implementation of a cogent global strategy to reduce risk factors related to alcohol abuse and unhealthy diets starting in childhood. Absent in the Political Declaration of the High Level Meeting (“the NCD Political Declaration”), however, is any proposal for adoption of an international legal framework to advance cooperation in addressing these global challenges. The lack of a global legal framework to guide national action and international cooperation to reduce risk factors related to alcohol abuse and unhealthy diet significantly hinders the capacity of nations worldwide to unilaterally and collectively curb the expanding NCD epidemics. Recognizing the growing burden of NCDs, a number of commentators have suggested the adoption of comprehensive treaties or framework conventions on obesity, or alcohol or both.1 Given the legal, political, budgetary, and time-related limitations to the development and adoption of all-encompassing treaty regimes to address obesity and alcohol abuse, the authors recommend an alternative legal strategy to counter these rising NCD epidemics. In particular, the authors call for the prompt adoption of a WHO/UNICEF Global Code of Practice on the Marketing of Unhealthy Foods and Beverages to Children. Such a non-binding international legal instrument has significant advantages over a treaty approach at the present time. It would provide a much-needed step towards advancing meaningful engagement with and holding to account all relevant actors, including national governments, private industry, and UN agencies, in protecting children everywhere from harm. The WHO Framework Convention on Tobacco Control (“FCTC”) addresses one of the major risk factors contributing to NCDs by establishing a global legal framework to counter the tobacco pandemic; the global community should now act collectively to establish a legal architecture to regulate a central component of these two other major risk factors.

Enacting Accountability- Networked Governance, NGOs and the FCTC

Global Health Governance
Latest Issue: 22 June 2012
http://blogs.shu.edu/ghg/

[Editor’s Note: We continue to broadly monitor the literature for strategies and analysis which might inform global immunization (i.e. GVAP) in terms of governance, modes of collaboration, metrics, roles, legal options, and accountability frameworks.]

Enacting Accountability- Networked Governance, NGOs and the FCTC
Raphael Lenchuha, Anita Kothari, and Ronald Labonté

Accountability is a pressing challenge within the present system of international lawmaking. Scholars continue to examine the role of non-governmental organizations (NGOs) to encourage the accountability of governments during this process. The negotiation of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) provides an important context to examine accountability as it is and was inherently influenced by corporate interests and government economics, and involved extensive NGO participation. We conducted in depth interviews and document analysis to examine the role of Canadian NGO representatives in the negotiation of the FCTC. We highlight two sets of findings about Canadian NGO enactment of accountability during FCTC negotiations. First, we describe the efforts of the NGOs to ensure that the FCTC gave precedence to population health over tobacco-related trade agreements (external accountability) between WHO member states. We then describe the efforts of this group to include NGOs from low and middle income countries (internal accountability). The implications of these findings within the broader discourse on accountability in international lawmaking are discussed.

Developed-developing country partnerships: Benefits to developed countries?

Globalization and Health
[Accessed 23 June 2012]
http://www.globalizationandhealth.com/

Review
Developed-developing country partnerships: Benefits to developed countries?
Syed SB, Dadwal V, Rutter P, Storr J, Hightower JD, Gooden R, Carlet J, Bagheri Nejad S et al.
Globalization and Health 2012, 8:17 (18 June 2012)

Abstract (provisional)
Developing countries can generate effective solutions for today’s global health challenges. This paper reviews relevant literature to construct the case for international cooperation, and in particular, developed-developing country partnerships. Standard database and web-based searches were conducted for publications in English between 1990 and 2010. Studies containing full or partial data relating to international cooperation between developed and developing countries were retained for further analysis. Of 227 articles retained through initial screening, 65 were included in the final analysis. The results were two-fold: some articles pointed to intangible benefits accrued by developed country partners, but the majority of information pointed to developing country innovations that can potentially inform health systems in developed countries.    This information spanned all six WHO health system components. Ten key health areas where developed countries have the most to learn from the developing world were identified and include, rural health service delivery; skills substitution; decentralisation of management; creative problem-solving; education in communicable disease control; innovation in mobile phone use; low technology simulation training; local product manufacture; health financing; and social entrepreneurship. While there are no guarantees that innovations from developing country experiences can effectively transfer to developed countries, combined developed-developing country learning processes can potentially generate effective solutions for global health systems.    However, the global pool of knowledge in this area is virgin and further work needs to be undertaken to advance understanding of health innovation diffusion. Even more urgently, a standardized method for reporting partnership benefits is needed–this is perhaps the single most immediate need in planning for, and realizing, the full potential of international cooperation between developed and developing countries.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions – New IOM Report

JAMA   
June 20, 2012, Vol 307, No. 23
http://jama.ama-assn.org/current.dtl

Viewpoint | June 20, 2012 ONLINE FIRST
A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions – Opportunities Provided by a New IOM Report
Bruce M. Psaty, MD, PhD; Eric M. Meslin, PhD; Alasdair Breckenridge, MD, FRCP
[Free full text: http://jama.jamanetwork.com/article.aspx?articleid=1153777 ]

Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs.  Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: National Academies Press; 2012. http://www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Approved-Drugs.aspx.

Herpes Zoster Vaccine and Recurrent Herpes Zoster in an Immunocompetent Elderly Population

Journal of Infectious Diseases
Volume 206 Issue 2 July 15, 2012
http://www.journals.uchicago.edu/toc/jid/current

MAJOR ARTICLES AND BRIEF REPORTS
VIRUSES
Hung Fu Tseng, Margaret Chi, Ning Smith, Stephen M. Marcy, Lina S. Sy, and Steven J. Jacobsen
Editor’s choice: Herpes Zoster Vaccine and the Incidence of Recurrent Herpes Zoster in an Immunocompetent Elderly Population
J Infect Dis. (2012) 206(2): 190-196 doi:10.1093/infdis/jis334

Abstract
Background. The benefit of vaccinating immunocompetent patients who have had shingles has not been examined. The study assessed the association between vaccination and the incidence of herpes zoster recurrence among persons with a recent episode of clinically diagnosed herpes zoster.

Methods. This is a matched cohort study in Kaiser Permanente Southern California. Study populations were immunocompetent elderly individuals ≥60 years old with a recent episode of herpes zoster. Incidence of recurrent herpes zoster was compared between the vaccinated and the unvaccinated matched cohorts.

Results. A total of 1036 vaccinated and 5180 unvaccinated members were included. On the basis of clinically confirmed cases, the incidence of recurrent herpes zoster among persons aged <70 years was 0.99 (95% confidence interval [CI], .02–5.54) and 2.20 (95% CI, 1.10–3.93) cases per 1000 person-years in the vaccinated and unvaccinated cohorts, respectively. The adjusted hazard ratio was 0.39 (95% CI, .05–4.45) among persons aged <70 years and 1.05 (95% CI, .30–3.69) among persons aged ≥70 years.

Conclusions. The risk of herpes zoster recurrence following a recent initial episode is fairly low among immunocompetent adults, regardless of vaccination status. Such a low risk suggests that one should evaluate the necessity of immediately vaccinating immunocompetent patients who had a recent herpes zoster episode

Journal of Medical Microbiology: Vaccines and adjuvants – Special Issue

Journal of Medical Microbiology
July 2012; 61 (Pt 7)
http://jmm.sgmjournals.org/content/current

Vaccines and adjuvants – Special Issue
Karen Robinson and Petra Oyston

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

A symposium on vaccines was held at the SGM Spring Conference in Harrogate on 11–14 April 2011. The symposium, which attracted over 140 attendees, consisted of 32 invited presentations and eight offered papers. Speakers, selected from the worlds of academia and industry, travelled from around the globe, including the USA, Australia, Africa and Europe, as well as the UK and Ireland, to showcase the leading research on vaccines for major public health diseases.

The main aim of the symposium was to discuss the current difficulties encountered in vaccine development and to comprehensively cover the latest advances in vaccines against major bacterial, viral, fungal and parasitic infections. The huge impact of such pathogens on affected populations was presented by some speakers who had been searching for effective vaccines for many years and this provided some real-life insights into the problems that researchers are addressing. In addition to discussions on optimal choice of vaccine antigens, there was also an emphasis on vaccine-mediated stimulation of immune responses, both systemically and for the protection of mucosal surfaces, which constitute major portals for entry of pathogens into the body. Several novel adjuvants and vaccine-delivery technologies were highlighted and current findings on the currently poorly understood mechanisms of action of traditional adjuvants were described. In addition, there were also very interesting presentations on immunization strategies to block the transmission, as opposed to infection, of pathogens and how immune evasion strategies of some pathogens can be a problem, or may even be harnessed, in vaccine development.

Contributors to the meeting were invited to submit review articles for this vaccine-themed special issue of the Journal of Medical Microbiology. Articles were subjected to an independent peer-review process and these seven reviews were accepted as a representation of the major themes discussed at the symposium. The special issue starts off with a review by ourselves (Oyston & Robinson, 2012), outlining the current major challenges in vaccine development. This includes the hurdles arising from how vaccine research is usually conducted and also the financial difficulties associated with vaccine production and use. We also review some initiatives that have been attempted in order to deliver new vaccines to the populations most in need.

Vaccines remain elusive for certain organisms or groups of pathogens, despite there being a great need for them and a lot of intensive research. We included three papers exemplifying this, which review the main challenges and discuss the strategies being employed. The first of these, by Edwards (2012), is a review of the advances being made in the development of fungal cell-wall vaccines. This article, which mainly focuses on Candida albicans, but also describes vaccine development for several other important fungal infections, describes the increasing clinical need for such vaccines and highlights the fact that none have yet been approved for use. Innovative vaccine strategies are described, including the successful preclinical use of a live attenuated Candida strain and a heat-killed Saccharomyces vaccine formulation that protects mice against a variety of fungal infections. The leading rALs3p-N Candida vaccine is also reviewed, describing its successful performance in recent Phase I clinical trials and its protective mechanisms in mice.

Bijker & Sauerwein (2012) provide a very interesting perspective on strategies for successful immunization against malaria. This important goal has not yet been achieved despite work by a huge number of research teams worldwide and many millions of dollars of funding over at least 60 years. It has been known for some time that recurrent natural infections in endemic areas elicit immunity. The authors focus on the idea that innovative use of antimalaria drugs could provide the key to safely generating protective immunization. It may be possible to avoid many of the problems with vaccine development, such as poor immunogenicity of parasite antigens and finding the optimal delivery system, by using controlled human malaria infections under chemoprophylaxis to induce effective protective immunity. Recent data from human volunteer studies and the pros and cons of such a strategy are discussed from the point of view of visitors to, or inhabitants of, endemic areas.

The paper by Williamson & Oyston (2012), reviews the natural history of Yersinia pestis infections and the advances being made towards achieving a protective human plague vaccine. This dangerous pathogen has been a scourge of humanity for centuries. A crude killed vaccine has been used historically but has been known to provide suboptimal protection. The increased awareness of biodefence needs in recent years has reinvigorated research in this area, applying modern techniques in vaccinology to an ancient problem. It is interesting how, despite the advantages of conducting research in the ‘post-genomic era’, the immunogenic, protective antigens pursued were discovered by empirical methods in the first half of the last century. Thus, although there has been much hype about exploiting genomic information for ‘reverse vaccinology’, the traditional methods should not be forgotten or ignored. This article also highlights the considerable challenges that now exist for licensing vaccines in development, such as the requirements for robust assays for correlates of protection and relevant animal models of human disease.

The second part of the symposium focused on vaccine technologies and we selected three review articles along this theme. Many bacterial vaccines currently in use in humans are composed of protein coupled to a glycan, such as capsular polysaccharide.   The production of these conjugates is problematic and requires an expensive multi-step process. Terra et al. (2012) review the discovery of the Campylobacter jejuni N-linked glycosylation system and how it may be harnessed in the ready production of novel and inexpensive glycoconjugate vaccine antigens using a recombinant E. coli-based expression system.

Two further papers review the use and mechanisms of action of adjuvants, both old and new. The first of these, by Kool et al. (2012), is concerned with alum which has been the main adjuvant in clinical use over many decades. Despite its widespread use, information on its mode of action is only just coming to the fore. Having a detailed knowledge of how it stimulates the immune system is vital for determining when it may be best utilized and how it may be improved in future formulations. In contrast, Baz Morelli et al. (2012) describe a recently developed adjuvant, ISCOMATRIX™. This formulation has undergone extensive preclinical and clinical testing in a variety of studies. Unlike alum, there has been much work undertaken to understand the mechanism of action in order to facilitate licensing. This adjuvant appears to stimulate CD8+ T-cell responses as well as CD4+ cells and antibodies. It has been used with a wide variety of vaccine antigen systems, including those for control of infectious diseases and cancer. This article reviews the nature of the adjuvant, how it is currently thought to stimulate the immune system and the results of various studies in animal models and humans, with an update on very recent findings.

In summary, there are many efforts under way to develop new vaccines or to develop adjuvants to make current and novel vaccines more effective. The research featured in this themed volume draws out many of the challenges facing vaccine research and development efforts generally, using specific examples.

References

Baz Morelli A., Becher D., Koernig S., Silva A., Drane D., Maraskovsky E.

(2012). ISCOMATRIX: a novel adjuvant for use in prophylactic and therapeutic vaccines against infectious diseases. J Med Microbiol 61, 935–943.

Abstract/FREE Full Text

Bijker E. M., Sauerwein R. W.

(2012). Enhancement of naturally acquired immunity against malaria by drug use. J Med Microbiol 61, 904–910.

Abstract/FREE Full Text

Edwards J. E. Jr.

(2012). Fungal cell wall vaccines: an update. J Med Microbiol 61, 895–903.

Abstract/FREE Full Text

Kool M., Fierens K., Lambrecht B. N.

(2012). Alum adjuvant: some of the tricks of the oldest adjuvant. J Med Microbiol 61, 927–934.

Abstract/FREE Full Text

Oyston P. C., Robinson K.

(2012). The current challenges for vaccine development. J Med Microbiol 61, 889–894.

Abstract/FREE Full Text

Terra V. S., Mills D. C., Yates L. E., Abouelhadid S., Cuccui J., Wren B. W.

(2012). Recent developments in bacterial protein glycan coupling technology and glycoconjugate vaccine design. J Med Microbiol 61, 919–926.

Abstract/FREE Full Text

Williamson D., Oyston P. C. F.

(2012). The natural history and incidence of Yersinia pestis and prospects for vaccination. J Med Microbiol 61, 911–918.

Abstract/FREE Full Text

Thiomersal vaccines debate continues ahead of UN meeting

The Lancet  
Jun 23, 2012  Volume 379  Number 9834  p2313 – 2400
http://www.thelancet.com/journals/lancet/issue/current

World Report
Thiomersal vaccines debate continues ahead of UN meeting
Nayanah Siva

Experts are meeting for the fourth time at the end of June to discuss a global treaty on mercury. But such an agreement could hinder vaccination programmes worldwide. Nayanah Siva reports.

The Rise and Fall of the Lyme Disease Vaccines: A Cautionary Tale

The Milbank Quarterly
June 2012  Volume 90, Issue 2  Pages 215–416
http://onlinelibrary.wiley.com/doi/10.1111/milq.2012.90.issue-2/issuetoc

Original Articles
The Rise and Fall of the Lyme Disease Vaccines: A Cautionary Tale for Risk Interventions in American Medicine and Public Health (pages 250–277)
ROBERT A. ARONOWITZ
Article first published online: 18 JUN 2012 | DOI: 10.1111/j.1468-0009.2012.00663.x

Abstract
Context: Two vaccines to prevent Lyme disease (LD) were developed and tested in the 1990s. Despite evidence of their safety and efficacy in clinical trials and initial postmarketing surveillance, one vaccine was withdrawn before the regulatory review and the other after only three years on the market. An investigation of their history can illuminate (1) the challenges faced by many new risk-reducing products and practices and (2) the important role played by their social and psychological, as distinct from their biomedical or scientific, efficacy in how they are used, and their ultimate market success or failure.

Methods: This article reviewed medical and popular literature on LD vaccines, analyzed the regulatory hearings, and conducted interviews with key participants.

Findings: Even if proved safe and effective, LD vaccines faced regulatory and market challenges because the disease was geographically limited, treatable, and preventable by other means. Pharmaceutical companies nevertheless hoped to appeal to consumers’ desire for protection and control and to their widespread fear of the disease. The LD advocacy community initially supported the vaccines but soon became critical opponents. The vaccines’ success was seen as threatening their central position that LD was chronic, protean, and difficult to treat. The activists’ opposition flipped the vaccines’ social and psychological efficacy. Instead of the vaccines restoring control and reducing fear, demand was undermined by beliefs that the vaccines caused an LD-like syndrome.

Conclusions: The social and psychological efficacy of many risk-reducing practices and products, such as new “personalized vaccines,” is to provide insurance and reduce fear. Yet the actions of self-interested actors can easily undermine this appeal. In addition to evaluating the scientific efficacy and safety of these practices and products, policymakers and others need to understand, anticipate, and perhaps shape the potential social and psychological work they might do.

The First Rotavirus Vaccine and the Politics of Acceptable Risk

The Milbank Quarterly
June 2012  Volume 90, Issue 2  Pages 215–416
http://onlinelibrary.wiley.com/doi/10.1111/milq.2012.90.issue-2/issuetoc

Original Articles
The First Rotavirus Vaccine and the Politics of Acceptable Risk (pages 278–310)
JASON L. SCHWARTZ
Article first published online: 18 JUN 2012 | DOI: 10.1111/j.1468-0009.2012.00664.x

Abstract
Context: Vaccination in the United States is a frequent source of controversy, with critics alleging failures by public health officials to adequately identify, monitor, and respond to risks associated with vaccines. In response to these charges, the case of RotaShield, a vaccine withdrawn in 1999 following confirmation of a serious adverse event associated with its use, is regularly invoked as evidence of the effectiveness of current vaccine safety activities.

Methods: This article examines the history of RotaShield, with particular attention paid to decision making regarding its use in the United States and internationally. I reviewed and analyzed federal advisory committee meeting transcripts, international conference reports, government and scientific publications, media coverage, and other primary and secondary source materials. I also conducted six semistructured interviews with former senior officials and advisory committee members at the U.S. Centers for Disease Control and Prevention who participated in decisions regarding the vaccine.

Findings: Decision making regarding RotaShield, including the ultimate withdrawal of its recommendation for use, was shaped significantly by government health officials’ concern for preserving public confidence in overall U.S. vaccination efforts amid several unrelated vaccine risk controversies ongoing at that time. This attention to public perception and external pressures occurred in tandem with the evaluation of the quantitative evidence regarding the magnitude and severity of the risk associated with the vaccine. The decisions made in the United States resulted in foreseen but unintended consequences for international use of the vaccine, including in nations where the profile of risks and potential benefits was dramatically different.

Conclusions: As enthusiasm for evidence-based decision making grows throughout medicine and public health, greater explicit attention should be directed to the processes by which decision makers and their expert advisers evaluate such evidence and translate it into regulation and policy by means of qualitative judgments.

Informed consent – issues

Nature  
Volume 486 Number 7403 pp293-434  21 June 2012
http://www.nature.com/nature/current_issue.html

Editorials
Time to open up

If scientists want the public to continue to volunteer for research projects, they must learn to be a lot more forthcoming about the ways in which the information they garner will be used.

Nature | News Feature
Informed consent: A broken contract
20 June 2012

As researchers find more uses for data, informed consent has become a source of confusion. Something has to change.
Erika Check Hayden
http://www.nature.com/news/informed-consent-a-broken-contract-1.10862