Global Fund releases analysis of audits and investigations

The Global Fund released an analysis of audits and investigations by its Office of the Inspector General which showed “that 3.0 percent of funding audited or investigated between 2005 and 2012 had been misspent, fraudulently misappropriated or inadequately accounted for.” Cees Klumper, Chief Risk Officer at the Global Fund who conducted the analysis, said, “We do not tolerate any misuse of funds, no matter how minor. Although some of these funds were misspent, and are just ineligible expenses, a small percentage of funds are misappropriated through fraud. We actively pursue and expose all such cases.” The Office of the Inspector General is “fully independent and reports directly to the Board” and, since it was established in 2005, has compiled 28 reports on audits and investigations that it has carried out in 27 countries, where a total of $3.8 billion has been disbursed, approximately 23 percent of all disbursements that the Global Fund has made to date.

The analysis showed that, cumulatively, the 3 percent of the funding that not spent in compliance with the grant agreements included:

– Ineligible expenses – or activities not covered by the grant agreements – 1.1 percent

– Inadequately substantiated due to poor or missing documentation – 1.1 percent

– Fraud – 0.5 percent

– Failed to report funds as required – 0.3 percent

The Global Fund noted that the analysis “…did not represent a comprehensive accounting of all misspent funds. Instead, the analysis is a factual rendering of the percentages of funding that had been determined by Global Fund audits and investigations to be ineligible, fraudulently misappropriated or inadequately accounted for.” Further, the release “cautioned that audits and investigations conducted…tend to focus on high-risk areas and on grants where specific risks have been identified, and that it was “…not possible to extrapolate to say that this reflects an accurate picture of misused funds…Our audits and investigations are not a representative sampling of all Global Fund grants.”

http://www.theglobalfund.org/en/mediacenter/newsreleases/2012-07-10_Global_Fund_Releases_an_Analysis_of_Audits_and_Investigations_2012/

London Summit on Family Planning

The London Summit on Family Planning, co-hosted by the UK Government’s Department for International Development and the Bill & Melinda Gates Foundation, was held in London last week, resulting in a “new set of commitments…by more than 150 leaders from donor and developing countries, international agencies, civil society, foundations and the private sector…(to extend” voluntary family planning services to reach an additional 120 million women and girls in the world’s poorest countries by 2020.”

http://www.gatesfoundation.org/press-releases/Pages/summit-women-global-health-120711.aspx

Vaccines and the global mercury treaty

WHO: Questions and answers on new facts and figures on vaccines and the global mercury treaty

[Initial question from document]
Q. Are there new data on the human health impact of thiomersal in vaccines?
A. Yes, an independent scientific advisory body convened by WHO, the Global Advisory Committee on Vaccine Safety (GACVS), reviewed the latest data on 7 June 2012. The report of the meeting will be published in the WHO Weekly Epidemiological Record on 20 July 2012 (http://www.who.int/wer/2012/en/ ). The Committee concluded that numerous well–‐designed Epidemiological studies conducted in many countries have failed to find a causal relationship Between prenatal, neonatal, or postnatal exposures to thiomersal in vaccines and a host of Neuropsychological outcomes, including autism.

The small number of studies which had suggested an association had significant flaws in their design and underlying assumptions, thus invalidating their conclusions. Other studies conducted Since 2008, including analysis of mercury in blood and hair, provided confirmation that the half –‐ life of thiomersal (ethyl mercury) was much shorter than that of methyl mercury.
Document pdf: http://www.who.int/entity/immunization/newsroom/QAs_new_facts_figures_thiomersal_June_2012.pdf

Guidelines on regulatory expectations related to the elimination, reduction or replace of thiomersal in vaccines (2004)
http://www.who.int/entity/biologicals/publications/trs/areas/vaccines/thiomersal/Annex%204%20(95-102)TRS926thiomersal.pdf

 
INC4: The fourth session of the Intergovernmental Negotiating Committee to prepare a global legally binding instrument on Mercury (INC4) was held in Punta del Este, Uruguay, from 27 June to 2 July 2012.
http://www.unep.org/hazardoussubstances/Mercury/Negotiations/INC4/tabid/3470/Default.aspx

WHO Fact Sheet: congenital rubella syndrom

WHO Fact Sheet: Vaccine success story: congenital rubella syndrome
13 July 2012 — A newly released WHO fact sheet explains how vaccination has drastically reduced congenital rubella syndrome and describes the global strategy to achieve elimination. An estimated 110 000 babies are born with congenital rubella syndrome every year. While the illness is generally mild in children, it has serious consequences in pregnant women causing fetal death or congenital defects.

Read the rubella fact sheet

Read the Global Measles and Rubella Strategic Plan

GIN – Global Immunization News 30 June 2012

WHO: GIN – Global Immunization News   30 June 2012
http://www.who.int/entity/immunization/GIN_June_2012.pdf

This issue includes:
SUMMARY TABLES OF WHO ROUTINE IMMUNIZATION RECOMMENDATIONS
The Summary Tables of WHO Routine Immunization Recommendations have been updated as of May 31, 2012 to reflect:
– The new WHO Vaccine Position Paper on Pneumococcal vaccines (published in the WHO Weekly epidemiological record (WER) 6 April 2012); and
– The lifting of the age restrictions for Rotavirus vaccines recommended by SAGE at their April 2012 Meeting (See SAGE Meeting Report in WER 25 May 2012)
– The revised version of the Summary Tables can be downloaded from the WHO website and are also available in French (Note: French version of Table 3 will be available soon).
The Summary Tables are intended for use by national immunization managers and key decision-makers, chairs and members of national advisory committees on immunization, and partner organizations, including industry.
http://www.who.int/immunization/policy/immunization_tables/en/index.html

GLOBAL VACCINE SAFETY BLUEPRINT (WHO/IVB/12.07)
This IVB document is now online. The Global Vaccine Safety Blueprint is a WHO strategic document that proposes new approaches to a consortium for strengthening vaccine pharmacovigilance systems in low-and middle-income countries.
http://extranet.who.int/iris/restricted/bitstream/10665/70919/1/WHO_IVB_12.07_eng.pdf

Weekly Epidemiological Record (WER) for 13 July 2012 – Hepatitis A vaccination

The Weekly Epidemiological Record (WER) for 13 July 2012, vol. 87, 28/29 (pp 261–276) includes: WHO position paper on hepatitis A vaccines – June 2012
http://www.who.int/entity/wer/2012/wer8728_29.pdf

WHO: Hepatitis A vaccination should be part of a comprehensive plan for prevention and control of viral hepatitis
Media Release Extract
13 July 2012 – In an updated position paper, published in the Weekly Epidemiological Record today, WHO recommends that hepatitis A vaccination be integrated into national immunization schedule for children over the age of one, if indicated on the basis of acute hepatitis A incidence and consideration of cost-effectiveness.

Vaccination should particularly be considered in countries with improving socioeconomic status when there is a change from high to intermediate endemicity and when the age of infection shifts to older age group thus increasing the risk of more severe disease and mortality. In these situations vaccination is likely to be cost-effective.    In highly endemic countries where hepatitis A virus is widespread, almost all persons are infected with hepatitis A virus in early childhood, when the infection is asymptomatic or results in very mild disease. In these countries, large-scale vaccination programmes are not recommended.

Vaccination against hepatitis A should be part of a comprehensive plan for the prevention and control of viral hepatitis, including measures to improve hygiene and sanitation and measures for outbreak control. Targeted vaccination of high-risk groups should be considered in low and very low endemicity settings to provide individual health benefits. Groups at increased risk of hepatitis A include travellers to areas of intermediate or high endemicity, those requiring life-long treatment with blood products, men who have sex with men, workers in contact with non-human primates, and injection drug users. In addition, patients with chronic liver disease are at increased risk for fulminant hepatitis A and should be vaccinated…

More at: http://www.who.int/immunization/newsroom/newsstory_hepa_vaccine_control_viral_hepatitis/en/index.html

Twitter Watch [accessed 14 July 2012 – 13:42]

Twitter Watch [accessed 14 July 2012 – 13:42]
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.

GAVI Alliance ‏@GAVIAlliance
There is still plenty of time to give feedback on @GAVIAlliance country by country approach. Share your thoughts! http://ht.ly/ceIJq
6:49 AM – 14 Jul 12

World Bank ‏@WorldBank
News: World Bank to support Nigeria’s final push to eradicate #polio http://bit.ly/NhTnEI
4:51 PM – 13 Jul 12

IVAC at JHSPH ‏@IVACtweets
Did you know scientists discovered Streptococcus pneumoniae bacterium 131 years ago? Find out what’s happened since: http://bit.ly/NeFEwl
Retweeted by History of Vaccines
2:37 PM – 12 Jul 12

IVAC at JHSPH @IVACtweets
New! @HuffingtonPost blog from @OrinLevine. 4 ways that investment bankers can help developing countries http://huff.to/PPU21h #FPSummit
4:50 PM – 12 Jul 12

CDC Global Health ‏@CDCGlobal
With CDC help, Burkina Faso has vaccinated 17M kids for #polio, 2.4M kids for #measles & >12M ppl for #meningitis. http://go.usa.gov/w8X
Retweeted by M&R Initiative
1:54 PM – 11 Jul 12

IAVI @AIDSvaccine
IAVI congratulates @ScrippsResearch @Duke_Medicine on award of @NIAIDnews grants to support #HIV #vaccine R&D http://bit.ly/Mj870D #AIDS2012
2:58 PM – 11 Jul 12

Amanda Glassman @glassmanamanda
HHA declaration on value for money, accountability and sustainability in health in Africa – music to my ears… http://www.hha-online.org/hso/system/files/tunis_declaration_english_july6.pdf
10:52 AM – 10 Jul 12

NIH Research: Vaccine and antibiotics stabilized so refrigeration is not needed

NIH Research: Vaccine and antibiotics stabilized so refrigeration is not needed

Extract from media release
Researchers funded by the National Institutes of Health have developed a new silk-based stabilizer that, in the laboratory, kept some vaccines and antibiotics stable up to temperatures of 140 degrees Fahrenheit. This provides a new avenue toward eliminating the need to keep some vaccines and antibiotics refrigerated, which could save billions of dollars every year and increase accessibility to third world populations.

Vaccines and antibiotics often need to be refrigerated to prevent alteration of their chemical structures; such alteration can result in less potent or ineffective medications. By immobilizing their bioactive molecules using silk protein matrices, researchers were able to protect and stabilize both live vaccines and antibiotics when stored at higher than recommended temperatures for periods far longer than recommended.

The research was led by grantees of NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB), David Kaplan, Ph.D., and Jeney Zhang, Ph.D. candidate, at Tufts University School of Engineering in Medford, Mass. The National Eye Institute and the National Institute of Dental and Craniofacial Research at NIH also contributed to this research. The researchers reported on their findings in the online issue of Proceedings of the National Academy of Sciences on July 9, 2012.

“This truly exciting development is the culmination of years of creative exploration and research focused on a major problem in the delivery of health care. Dr. Kaplan and his team have done a masterful job at both understanding the key properties of silk, and applying these insights to a global medical challenge,” said NIBIB Director Roderic I. Pettigrew, Ph.D., M.D. “This is also a wonderful validation of the type of team science we see in our Biotechnology Resource and Development Centers and their ability to combine cutting edge science in a number of fields to a variety of health needs.”

Pettigrew also points out that the next step is to test it in the field.

http://www.nih.gov/news/health/jul2012/nibib-09.htm

[See PNAS citation in Journal Watch below]

Report: HIV and the Law: Risks, Rights & Health

Report: HIV and the Law: Risks, Rights & Health
Global Commission on HIV and the Law (UNDP)
09 July 2012
“The final report presents a coherent and compelling evidence base on human rights and legal issues relating to HIV.”
http://www.undp.org/content/undp/en/home/librarypage/hiv-aids/hiv-and-the-law–risks–rights—health.html

Report pdf:
http://www.undp.org/content/dam/undp/library/HIV-AIDS/Governance%20of%20HIV%20Responses/FinalReport-Risks,Rights&Health-EN.pdf

Report: Horizon 2025: creative destruction in the aid industry

Report: Horizon 2025: creative destruction in the aid industry
Homi Kharas and Andrew Rogerson
ODI (Overseas Development Institute)
July 2012

This paper aims to stimulate debate on the future of the international development architecture and explores how far some of today’s major development agencies are likely to be exposed to the resulting pressures to change course, emulate the disruptors or face irrelevance.

Summary [full text]
The global economic landscape has evolved dramatically since 2000: developing and emerging economies have been driving global growth, new sources of development finance have mushroomed and the diversification of actors, instruments and delivery mechanisms has continued. Transformations in the poverty map and new forces on the supply side of development finance are challenging the international development architecture. This paper aims to stimulate debate on the future of this architecture.
The authors project that, by 2025, the locus of global poverty will overwhelmingly be in fragile, mainly low-income and African, states, contrary to current policy preoccupations with the transitory phenomenon of poverty concentration in middle-income countries. Moreover, a smaller share of industrialised country income than ever before will potentially close the remaining global poverty gap, although direct income transfers are not yet feasible in many fragile country contexts.
Against this backdrop, new institutions, business models and practices are challenging long-established ‘aid industry’ actors. Agencies providing development finance for improved social welfare, for mutual self-interest in growth and trade and for the provision of global public goods will find that, in each area, disruptors to their programmes may force a change in positioning.
The paper focuses on one such disruptor for each of these three complementary rationales for development cooperation. The key disruptor we discuss in the first area is high-impact philanthropy and non-governmental giving channels; in the second, South–South cooperation combining trade and finance, and blended public–private funding in general; and in the third, the power of climate change finance, particularly its quite different country and project allocation logic.
From this analysis, this paper explores how far some of today’s major development agencies are likely to be exposed to the resulting pressures to change course, emulate the disruptors or face irrelevance.
The authors construct an index of vulnerability, presented in a traffic-light ranking, based on recent shares of each agency’s operations going to, first, middle-income and low poverty gap countries and, second, purposes linked respectively to social welfare, growth and global public goods, with appropriate weights.
These assessments are offered not as predictions but as possible stress test tools for further, context-specific analysis. The paper ends with questions for further research.

Problems of stopping trials early

British Medical Journal
14 July 2012 (Vol 345, Issue 7865)
http://www.bmj.com/content/345/7865

Analysis
Problems of stopping trials early
BMJ 2012; 344 doi: 10.1136/bmj.e3863 (Published 15 June 2012
Gordon H Guyatt, Matthias Briel, Paul Glasziou, Dirk Bassler, Victor M Montori,

Extract
When interim analyses of randomised trials suggest large beneficial treatment effects, investigators sometimes terminate trials earlier than planned. Gordon H Guyatt and colleagues show how this practice can have far reaching and harmful consequences

In a seminal simulation study published in 1989, Pocock and Hughes showed that randomised control trials stopped early for benefit will, on average, overestimate treatment effects.1 Since then, the warning implicit in this simulation study has been largely ignored.

Fifteen years later, we reported a systematic survey which showed that trials stopped early for benefit—which we will refer to as truncated trials—yield treatment effects that are often not credible (relative risk reductions over 47% in half, over 70% in a quarter), and that the apparent overestimates were larger in smaller trials.2 We subsequently compared effect estimates from all the truncated trials we could identify that had been included in systematic reviews and meta-analyses with the results of non-truncated trials in those same meta-analyses. We found, on average, substantially larger effects in the truncated trials (ratio of relative risks in truncated versus non-truncated of 0.71). Again, we showed an association with the size of the truncated trial: large overestimates were common when the total number of events was less than 200; smaller but important overestimates occurred with 200 to 500 events; and trials with over 500 events showed small overestimates.3

The results of simulation studies and systematic surveys of truncated trials therefore show that when true underlying treatment effects are modest—as is usually the case—small trials that are stopped early with few events will result in large overestimates. Larger trials will still, on average, overestimate effects, and these overestimates may also lead to important spurious inferences. Uncritical belief in truncated trials will often, therefore, be misleading—and sometimes very misleading.

The tendency for truncated trials …

Models for financing the regulation of pharmaceutical promotion

Globalization and Health
[Accessed 14 July 2012]
http://www.globalizationandhealth.com/

Debate
Models for financing the regulation of pharmaceutical promotion
Joel Lexchin

Abstract (provisional)
Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models considered here have positive and negative features and none may necessarily be ideal in any particular country. Different countries may choose to utilize a combination of two or more of these models in order to raise sufficient revenue. Financing of regulation of drug promotion should more than pay for itself through the prevention of extra unnecessary drug costs and the avoidance of adverse health effects due to inappropriate prescribing. However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs.

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

Assessing PEPFAR – President’s Emergency Plan For AIDS Relief

Health Affairs
July 2012; Volume 31, Issue 7
http://content.healthaffairs.org/content/current

Theme: Assessing The President’s Emergency Plan For AIDS Relief
–  From Emergency to Sustainability

–  How Bush Dramatically Expanded US Response

–  Toward An AIDS-Free Generation

–  Building on the Scientific Progress

–  Applying PEPFAR’s Lessons to the US

–  The Global Health Strategy of HHS

–  PEPFAR’s Public and Private Partnerships

Antiretroviral Drugs: Treatment As Prevention

Eliminating Mother-to-Child HIV Transmission

–  The “Third Wave” of HIV Prevention

–  A Clinician’s Experience In Nigeria

–  Collaborating With the Global Fund

View Table of Contents

Unethical To Divert Antiretroviral Drugs From Treatment To Prevention

Health Affairs
July 2012; Volume 31, Issue 7
http://content.healthaffairs.org/content/current
Theme: Assessing The President’s Emergency Plan For AIDS Relief

Given Financial Constraints, It Would Be Unethical To Divert Antiretroviral Drugs From Treatment To Prevention
Ruth Macklin and Ethan Cowan

Abstract
Striking advances in HIV prevention have set the stage for renewed debate on setting priorities in the fight against HIV/AIDS. Two new prevention strategies—preexposure prophylaxis and treatment as prevention—use antiretroviral drugs for prevention of HIV/AIDS in addition to treating patients. The potential for success of these new prevention strategies sets up an ethical dilemma: where resources are limited and supplies of lifesaving antiretroviral medications are insufficient to treat those currently living with HIV, how should these resources be divided between treatment and prevention? This article explores several ethical principles used in formulating public health policy. Assuming that limited resources are available for spending on drugs, we conclude that it would be unethical to watch patients with treatable AIDS worsen and die, even with supportive care, so that medications for treatment can be diverted for prevention.

Incentives, health promotion and equality

Health Economics, Policy and Law 
Volume 7 – Issue 03 – July 2012
http://journals.cambridge.org/action/displayIssue?jid=HEP&tab=currentissue

Articles
Incentives, health promotion and equality
Kristin Voigt
Department of Politics, Philosophy & Religion, Lancaster University, Lancaster, UK

Abstract
The use of incentives to encourage individuals to adopt ‘healthier’ behaviours is an increasingly popular instrument in health policy. Much of the literature has been critical of ‘negative’ incentives, often due to concerns about equality; ‘positive’ incentives, however, have largely been welcomed as an instrument for the improvement of population health and possibly the reduction of health inequalities. The aim of this paper is to provide a more systematic assessment of the use of incentives from the perspective of equality. The paper begins with an overview of existing and proposed incentive schemes. I then suggest that the distinction between ‘positive’ and ‘negative’ incentives – or ‘carrots’ and ‘sticks’ – is of limited use in distinguishing those incentive schemes that raise concerns of equality from those that do not. The paper assesses incentive schemes with respect to two important considerations of equality: equality of access and equality of outcomes. While our assessment of incentive schemes will, ultimately, depend on various empirical facts, the paper aims to advance the debate by identifying some of the empirical questions we need to ask. The paper concludes by considering a number of trade-offs and caveats relevant to the assessment of incentive schemes.

Viewpoint – The Moral Duty to Buy Health Insurance

JAMA   
July 11, 2012, Vol 308, No. 2
http://jama.ama-assn.org/current.dtl

Viewpoint
The Moral Duty to Buy Health Insurance
Tina Rulli, PhD; Ezekiel J. Emanuel, MD, PhD; David Wendler, PhD

Extract [Free full text]
The 2010 Patient Protection and Affordable Care Act (ACA) was designed to increase health insurance coverage in the United States. Its most controversial feature is the requirement that US residents purchase health insurance or pay a financial penalty.    Although debate focuses on the constitutionality of this individual mandate, the central concern is a moral matter—is it morally appropriate to require individuals to purchase health insurance?

Proponents argue that a mandate could lower insurance premiums for everyone by pooling individuals with varying health risks. Opponents respond that requiring people to contribute to the collective good is inconsistent with respect for individual liberty. Appeal to the collective good could justify requiring individuals to buy gym memberships or eat broccoli.1

Rather than appeal to the collective good, this Viewpoint argues for a duty to buy health insurance based on the moral duty individuals have to reduce certain burdens they pose on others. Because physicians and hospitals have a duty to rescue the uninsured by providing acute and emergency care, individuals have a corresponding duty to purchase insurance to cover the costs of this care. Requiring individuals to meet this obligation is consistent with respect for individual liberty and does not imply that they must buy gym memberships or eat broccoli….

Viewpoint – Ending Preventable Child Death in a Generation

JAMA   
July 11, 2012, Vol 308, No. 2
http://jama.ama-assn.org/current.dtl

Viewpoint | July 11, 2012 ONLINE FIRST
Ending Preventable Child Death in a Generation
Roger I. Glass, MD, PhD; Alan E. Guttmacher, MD; Robert E. Black, MD

Extract [Free full text]
During the past 20 years, there has been a substantial decline in mortality among children younger than 5 years from 12.0 million deaths in 1990 to 7.6 million in 2010.1 In these decades alone, global health and development efforts have saved the lives of more than 50 million children, half of them by preventing deaths due to pneumonia, diarrhea, and measles.2 This improvement in child survival was catalyzed in part by setting aspirational global targets such as the Millennium Development Goals (MDGs).3

As 2015 approaches, and with it a final assessment of progress toward MDG 4 on reducing child mortality, it is appropriate to consider a post-2015 vision for child health.    A new common vision for a global commitment to end all preventable child deaths is needed. Such a vision will not be compelling unless it can be tied to concrete and measurable benchmarks at the global and country levels that are both ambitious and plausible. In this Viewpoint, a new benchmark is detailed: that all countries achieve a national under-5 mortality rate (U5MR) of no more than 20 deaths per 1000 live births by 2035 and that the global average U5MR should decline to 15 deaths per 1000 in 2035. Of 195 countries, 98 already have U5MRs of 20 per 1000 or fewer; 43 countries would be expected to reach this goal by 2035 at current annual rates of reduction (ARRs), and 54 countries would have to accelerate progress above the 2000-2010 ARRs.4

Risk of Guillain-Barré Syndrome Following H1N1 Influenza Vaccination in Quebec

JAMA   
July 11, 2012, Vol 308, No. 2
http://jama.ama-assn.org/current.dtl

Original Contribution | July 11, 2012
Risk of Guillain-Barré Syndrome Following H1N1 Influenza Vaccination in Quebec
Philippe De Wals, PhD; Geneviève Deceuninck, MD; Eveline Toth, MSc; Nicole Boulianne, MSc; Denis Brunet, MD; Renée-Myriam Boucher, MD; Monique Landry, MD; Gaston De Serres, PhD

Abstract
Context  In fall 2009 in Quebec, Canada, an immunization campaign was launched against the 2009 influenza A(H1N1) pandemic strain, mostly using an AS03 adjuvant vaccine. By the end of the year, 57% of the 7.8 million residents had been vaccinated.

Objective  To assess the risk of Guillain-Barré syndrome (GBS) following pandemic influenza vaccine administration.

Design  Population-based cohort study with follow-up over the 6-month period October 2009 through March 2010. The investigation was ordered by the chief medical officer of health in accordance with the Quebec Public Health Act.

Setting  All acute care hospitals and neurology clinics in Quebec.

Population  Suspected and confirmed GBS cases reported by physicians, mostly neurologists, during active surveillance or identified in the provincial hospital summary discharge database. Medical records were reviewed and cases classified according to Brighton Collaboration definitions (categorized as level 1, 2, or 3, corresponding to criteria of decreasing certainty in diagnosis). Immunization status was verified and denominators were estimated from the provincial immunization registry (4.4 million vaccinated) and census data (total target population aged ≥6 months, 7.8 million), with a total of 3 623 046 person-years of observation.

Main Outcome Measures  Relative and attributable risks were calculated using a Poisson model and the self-controlled case-series method.

Results  Over a 6-month period, 83 confirmed GBS cases were identified, including 71 Brighton level 1 through 3 cases. Twenty-five confirmed cases had been vaccinated against 2009 influenza A(H1N1) 8 or fewer weeks before disease onset, with most (19/25) vaccinated 4 or fewer weeks before onset. In the Poisson model, the age- and sex-adjusted relative risk was 1.80 (95% CI, 1.12-2.87) for all confirmed cases during the 8-week postvaccination period and was 2.75 (95% CI, 1.63-4.62) during the 4-week postvaccination period. Using the self-controlled case-series method, relative risk estimates during the 4-week postvaccination period were 3.02 (95% CI, 1.64-5.56) for all confirmed cases (n = 42) and 2.33 (95% CI, 1.19-4.57) for Brighton level 1 through 3 cases (n = 36). The number of GBS cases attributable to vaccination was approximately 2 per 1 million doses. There was no indication of an excess risk in persons younger than 50 years.

Conclusions  In Quebec, the 2009 influenza A(H1N1) vaccine was associated with a small but significant risk of GBS. It is likely that the benefits of immunization outweigh the risks.

Guillain-Barré syndrome (GBS) is a peripheral neuropathy with acute onset and is characterized, in its typical presentation, by rapidly developing motor weakness and areflexia.1 – 2 The disease is thought to be autoimmune and triggered by a stimulus of external origin.1 – 2 In 1976-1977, an unusually high rate of GBS was identified in the United States following the administration of inactivated “swine” influenza A(H1N1) vaccines.3 In 2003, the Institute of Medicine (IOM) concluded that the evidence favored acceptance of a causal relationship between the 1976 swine influenza vaccines and GBS in adults.4 Studies of seasonal influenza vaccines administered in subsequent years have found small or no increased risk.5 In mice, different influenza vaccines can induce antiganglioside antibodies that are associated with the development of GBS in humans.6 Extrapolation of results of animal studies to humans, however, is difficult. In a more recent assessment of epidemiologic studies on seasonal influenza vaccines, experimental studies in animals, and case reports in humans, the IOM Committee to Review Adverse Effects of Vaccines concluded that the evidence was inadequate to accept or reject a causal relationship.7

In the province of Quebec, Canada, a mass immunization campaign was launched in the fall of 2009 to control a pandemic caused by a new influenza A(H1N1) virus.8 – 9 Herein we report results of a population-based epidemiologic investigation ordered by the chief medical officer of health, based on GBS cases notified to public health authorities and others found in the MEDECHO provincial hospitalization database.

Editorial: Influenza Pandemics – Pregnancy, Pathogenesis, and Perinatal Outcomes

JAMA   
July 11, 2012, Vol 308, No. 2
http://jama.ama-assn.org/current.dtl

Editorial | July 11, 2012
Influenza Pandemics—Pregnancy, Pathogenesis, and Perinatal Outcomes
Mark C. Steinhoff, MD; Noni E. MacDonald, MD, MSc, FRCPC

Extract [Free full text]
Since the 1918 influenza pandemic, it has been clear that pandemic influenza is associated with increased morbidity and mortality in pregnancy, and more recent studies have shown that nonpandemic seasonal influenza strains also lead to morbidity for pregnant women and their infants.1 In the 2009 worldwide pandemic of influenza A(H1N1)pdm09, pregnant women were at high risk for severe complications, including death and intensive care unit admission.2

The adverse effects of antenatal influenza infection on pregnant women and their infants suggest a biological effect of influenza infection in the mother that compromises the fetus. These effects are rarely associated with direct infection of the fetus with influenza virus, although fetal infection has been reported infrequently during epidemics, pandemics,3 – 4 and with the H5N1 influenza strain.5 Instead, it appears that the normal pregnancy-associated immunologic changes may inhibit the inflammatory response to influenza virus infection in pregnancy,6 leading to increased risks to mother and infant. Because of these observations, pregnant women have been listed among high-risk groups for seasonal influenza vaccine in the United States since 1997, and safety data suggest these vaccines are safe in pregnancy.7 – 8 Pregnant women were prioritized for immunization during the 2009 influenza A(H1N1)pdm09 pandemic, despite limited data on the safety of pandemic influenza vaccines in pregnancy.

In this issue of JAMA, Pasternak and colleagues9 report the results of an observational cohort study on the safety in pregnancy of the monovalent inactivated ASO3-adjuvanted split virion influenza A(H1N1)pdm09 vaccine…

Risk of Adverse Fetal Outcomes Following A(H1N1) Vaccine During Pregnancy

JAMA   
July 11, 2012, Vol 308, No. 2
http://jama.ama-assn.org/current.dtl

Original Contribution | July 11, 2012
Risk of Adverse Fetal Outcomes Following Administration of a Pandemic Influenza A(H1N1) Vaccine During Pregnancy
Björn Pasternak, MD, PhD; Henrik Svanström, MSc; Ditte Mølgaard-Nielsen, MSc; Tyra G. Krause, MD, PhD; Hanne-Dorthe Emborg, DVM; Mads Melbye, MD, DrMedSci; Anders Hviid, MSc, DrMedSci

Abstract
Context  Assessment of the fetal safety of vaccination against influenza A(H1N1)pdm09 in pregnancy has been limited.

Objective  To investigate whether exposure to an adjuvanted influenza A(H1N1)pdm09 vaccine during pregnancy was associated with increased risk of adverse fetal outcomes.

Design, Setting, and Participants  Registry-based cohort study based on all liveborn singleton infants in Denmark, delivered between November 2, 2009, and September 30, 2010. In propensity score–matched analyses, we estimated prevalence odds ratios (PORs) of adverse fetal outcomes, comparing infants exposed and unexposed to an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine during pregnancy.

Main Outcome Measures  Major birth defects, preterm birth, and small size for gestational age.

Results  From a cohort of 53,432 infants (6989 [13.1%] exposed to the influenza A[H1N1]pdm09 vaccine during pregnancy [345 in the first trimester and 6644 in the second or third trimester]), 660 (330 exposed) were included in propensity score–matched analyses of adverse fetal outcomes associated with first-trimester exposure. For analysis of small size for gestational age after second- or third-trimester exposure, 13 284 (6642 exposed) were included; for analyses of preterm birth, 12,909 (6543 exposed) were included. A major birth defect was diagnosed in 18 of 330 infants (5.5%) exposed to the vaccine in the first trimester, compared with 15 of 330 unexposed infants (4.5%) (POR, 1.21; 95% CI, 0.60-2.45). Preterm birth occurred in 31 of 330 infants (9.4%) exposed in the first trimester, compared with 24 of 330 unexposed infants (7.3%) (POR, 1.32; 95% CI, 0.76-2.31), and in 302 of 6543 infants (4.6%) with second- or third-trimester exposure, compared with 295 of 6366 unexposed infants (4.6%) (POR, 1.00; 95% CI, 0.84-1.17). Small size for gestational age was observed in 25 of 330 infants (7.6%) with first-trimester exposure compared with 31 of 330 unexposed infants (9.4%) (POR, 0.79; 95% CI, 0.46-1.37), and in 641 of 6642 infants (9.7%) with second- or third-trimester exposure, compared with 657 of 6642 unexposed infants (9.9%) (POR, 0.97; 95% CI, 0.87-1.09).

Conclusions  In this Danish cohort, exposure to an adjuvanted influenza A(H1N1)pdm09 vaccine during pregnancy was not associated with a significantly increased risk of major birth defects, preterm birth, or fetal growth restriction.

Equity in financing and use of health care in Ghana, South Africa, and Tanzania: implications for paths to universal coverage

The Lancet  
Jul 14, 2012  Volume 380  Number 9837  p75 – 186  e1
http://www.thelancet.com/journals/lancet/issue/current

Articles
Equity in financing and use of health care in Ghana, South Africa, and Tanzania: implications for paths to universal coverage
Anne Mills, John E Ataguba, James Akazili, Jo Borghi, Bertha Garshong, Suzan Makawia, Gemini Mtei, Bronwyn Harris, Jane Macha, Filip Meheus, Di McIntyre

Summary
Background
Universal coverage of health care is now receiving substantial worldwide and national attention, but debate continues on the best mix of financing mechanisms, especially to protect people outside the formal employment sector. Crucial issues are the equity implications of different financing mechanisms, and patterns of service use. We report a whole-system analysis—integrating both public and private sectors—of the equity of health-system financing and service use in Ghana, South Africa, and Tanzania.

Methods
We used primary and secondary data to calculate the progressivity of each health-care financing mechanism, catastrophic spending on health care, and the distribution of health-care benefits. We collected qualitative data to inform interpretation.

Findings
Overall health-care financing was progressive in all three countries, as were direct taxes. Indirect taxes were regressive in South Africa but progressive in Ghana and Tanzania. Out-of-pocket payments were regressive in all three countries. Health-insurance contributions by those outside the formal sector were regressive in both Ghana and Tanzania. The overall distribution of service benefits in all three countries favoured richer people, although the burden of illness was greater for lower-income groups. Access to needed, appropriate services was the biggest challenge to universal coverage in all three countries.

Interpretation
Analyses of the equity of financing and service use provide guidance on which financing mechanisms to expand, and especially raise questions over the appropriate financing mechanism for the health care of people outside the formal sector. Physical and financial barriers to service access must be addressed if universal coverage is to become a reality.

Funding
European Union and International Development Research Centre

Cambodian outbreak tests International Health Regulations

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

[Reviewed earlier]
Online First
Cambodian outbreak tests International Health Regulations
The Lancet Infectious Diseases

Extract
The news that emerged from Cambodia in the first week of July of an unknown fatal illness that had killed at least 60 children in the previous 3 months, and the subsequent interagency response, shows how the International Health Regulations (IHRs) can work in practice. The event also serves as a timely reminder of the progress that still needs to be made to implement the IHR provisions in all WHO member states…

Mathematical Modelling: Replacing Prevnar7 with Prevnar13 in England and Wales

PLoS One
[Accessed 14 July 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Mathematical Modelling Long-Term Effects of Replacing Prevnar7 with Prevnar13 on Invasive Pneumococcal Diseases in England and Wales
Yoon Hong Choi, Mark Jit, Stefan Flasche, Nigel Gay, Elizabeth Miller
PLoS ONE: Research Article, published 13 Jul 2012 10.1371/journal.pone.0039927

Abstract 
Introduction
England and Wales recently replaced the 7-valent pneumococcal conjugate vaccine (PCV7) with its 13-valent equivalent (PCV13), partly based on projections from mathematical models of the long-term impact of such a switch compared to ceasing pneumococcal conjugate vaccination altogether.

Methods
A compartmental deterministic model was used to estimate parameters governing transmission of infection and competition between different groups of pneumococcal serotypes prior to the introduction of PCV13. The best-fitting parameters were used in an individual based model to describe pneumococcal transmission dynamics and effects of various options for the vaccination programme change in England and Wales. A number of scenarios were conducted using (i) different assumptions about the number of invasive pneumococcal disease cases adjusted for the increasing trend in disease incidence prior to PCV7 introduction in England and Wales, and (ii) a range of values representing serotype replacement induced by vaccination of the additional six serotypes in PCV13.

Results
Most of the scenarios considered suggest that ceasing pneumococcal conjugate vaccine use would cause an increase in invasive pneumococcal disease incidence, while replacing PCV7 with PCV13 would cause an overall decrease. However, the size of this reduction largely depends on the level of competition induced by the additional serotypes in PCV13. The model estimates that over 20 years of PCV13 vaccination, around 5000–62000 IPD cases could be prevented compared to stopping pneumococcal conjugate vaccination altogether.

Conclusion
Despite inevitable uncertainty around serotype replacement effects following introduction of PCV13, the model suggests a reduction in overall invasive pneumococcal disease incidence in all cases. Our results provide useful evidence on the benefits of PCV13 to countries replacing or considering replacing PCV7 with PCV13, as well as data that can be used to evaluate the cost-effectiveness of such a switch.

Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers

PLoS One
[Accessed 14 July 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers
Anna Llupià, Alberto L. García-Basteiro, Guillermo Mena, José Ríos, Joaquim Puig, José M. Bayas, Antoni Trilla
PLoS ONE: Research Article, published 11 Jul 2012 10.1371/journal.pone.0039496

Abstract 
Background
Published influenza vaccination coverage in health care workers (HCW) are calculated using two sources: self-report and vaccination records. The objective of this study was to determine whether self-report is a good proxy for recorded vaccination in HCW, as the degree of the relationship is not known, and whether vaccine behaviour influences self-reporting.

Methods
A cross-sectional study was conducted using a self-administered survey during September 2010. Considering the vaccination record as the gold standard of vaccination, the properties of self-report as a proxy of the record (sensitivity, specificity, positive predictive value, negative predictive value) were calculated. Concordance between the vaccination campaigns studied (2007–2010) was made using the Kappa index, and discordance was analyzed using McNemar’s test.

Results
248 HCW responded. The 95% confidence intervals of coverage according to the vaccination record and to self-report overlapped, except for 2007, and the Kappa index showed a substantial concordance, except for 2007. McNemar’s test suggested that differences between discordant cases were not due to chance and it was found that the proportion of unvaccinated discordant cases was higher than that of vaccinated discordant cases.

Conclusions
In our study population, self-reported influenza vaccination coverage in HCW in the previous two years is a good proxy of the vaccination record. However, vaccination behaviour influences the self-report and explains a trend to overestimate coverage in self-reporting compared to the vaccination record. The sources of coverage should be taken into account whenever comparisons are made.

Pap Smears, Self-Sampling and HPV Vaccination among Adult Women in Kenya

PLoS One
[Accessed 14 July 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Knowledge and Acceptability of Pap Smears, Self-Sampling and HPV Vaccination among Adult Women in Kenya
Anne F. Rositch, Ann Gatuguta, Robert Y. Choi, Brandon L. Guthrie, Romel D. Mackelprang, Rose Bosire, Lucy Manyara, James N. Kiarie, Jennifer S. Smith, Carey Farquhar screening
PLoS ONE: Research Article, published 10 Jul 2012 10.1371/journal.pone.0040766

Abstract 
Objectives
Our study aimed to assess adult women’s knowledge of human papillomavirus (HPV) and cervical cancer, and characterize their attitudes towards potential screening and prevention strategies.

Methods
Women were participants of an HIV-discordant couples cohort in Nairobi, Kenya. An interviewer-administered questionnaire was used to obtain information on sociodemographic status, and sexual and medical history at baseline and on knowledge and attitudes towards Pap smears, self-sampling, and HPV vaccination at study exit.

Results
Only 14% of the 409 women (67% HIV-positive; median age 29 years) had ever had a Pap smear prior to study enrollment and very few women had ever heard of HPV (18%). Although most women knew that Pap smears detect cervical cancer (69%), very few knew that routine Pap screening is the main way to prevent ICC (18%). Most women reported a high level of cultural acceptability for Pap smear screening and a low level of physical discomfort during Pap smear collection. In addition, over 80% of women reported that they would feel comfortable using a self-sampling device (82%) and would prefer at-home sample collection (84%). Nearly all women (94%) reported willingness to be vaccinated to prevent cervical cancer if offered at no or low cost.

Conclusions
These findings highlight the need to educate women on routine use of Pap smears in the prevention of cervical cancer and demonstrate that vaccination and self-sampling would be acceptable modalities for cervical cancer prevention and screening.

Stabilization of vaccines and antibiotics in silk and eliminating the cold chain

PNAS – Proceedings of the National Academy of Sciences of the United States
of America

(Accessed 14 July 2012)
http://www.pnas.org/content/early/recent

Stabilization of vaccines and antibiotics in silk and eliminating the cold chain
Jeney Zhanga,b,1, Eleanor Pritcharda,1, Xiao Hua, Thomas Valentina, Bruce Panilaitisa,
Fiorenzo G. Omenettoa, and David L. Kaplana,2
+ Author Affiliations
aTufts University, Department of Biomedical Engineering, Medford, MA 02155; and
bTufts University, Department of Chemical & Biological Engineering, Medford, MA 02155
Edited by Arnold L. Demain, Drew University, Madison, NJ, and approved June 12, 2012 (received for review April 12, 2012)

Abstract
Sensitive biological compounds, such as vaccines and antibiotics, traditionally require a time-dependent “cold chain” to maximize therapeutic activity. This flawed process results in billions of dollars worth of viable drug loss during shipping and storage, and severely limits distribution to developing nations with limited infrastructure. To address these major limitations, we demonstrate self-standing silk protein biomaterial matrices capable of stabilizing labile vaccines and antibiotics, even at temperatures up to 60 °C over more than 6 months. Initial insight into the mechanistic basis for these findings is provided. Importantly, these findings suggest a transformative approach to the cold chain to revolutionize the way many labile therapeutic drugs are stored and utilized throughout the world.

Science – Special Issue: HIV/AIDS in America

Science        
13 July 2012 vol 337, issue 6091, pages 125-256
http://www.sciencemag.org/current.dtl

Introduction to Special Issue: HIV/AIDS in America
Leslie Roberts

[Full text]
The epidemic of acquired immunodeficiency syndrome was first recognized in the United States. As clinicians from Los Angeles, California, reported in the 5 June 1981 issue of Morbidity and Mortality Weekly Report, they had seen odd immune problems and opportunistic infections in five young “active homosexuals.” Similar reports soon came in from all over the country and the world, making it clear that AIDS affected heterosexuals and homosexuals alike and also spread from mother to child and via tainted blood products and dirty needles. In the following years, U.S. researchers helped prove that HIV causes the disease, which led to a critical blood test to detect the novel retrovirus. The U.S. National Institutes of Health and the Centers for Disease Control and Prevention—prodded by AIDS activists such as Mark Harrington of the Treatment Action Group (pictured here)—steadily ramped up support for basic research as well as efforts to develop and test treatment and prevention interventions. In the early 2000s, the U.S. government poured billions of dollars into programs that now bring life-saving antiretrovirals to millions of people in cash-strapped countries.

By any measure, the United States has played a vital global role in unraveling HIV’s mysteries, providing help to the infected and protecting the vulnerable.

It may seem odd, then, that since 1990 this country has not hosted the International AIDS Conference, a megameeting that has gathered 20,000 participants every other year. But that will change on 22 to 27 July, when the gathering will take place in Washington, D.C. The meeting organizers shunned the United States because of an immigration ban on HIV-infected people imposed by Congress in 1987, which President Barack Obama ended in 2010.

In keeping with that shift, Science is focusing this special HIV/AIDS issue on America, now home to an estimated 1.2 million HIV-infected people—many of whom have little in common with the original five gay men in Los Angeles. The Deep South has become the epicenter; blacks—gay and straight—face a far higher risk of becoming infected than whites, and poverty is a major driver for all races. The biggest challenge the country faces today is diagnosing all of its HIV-infected people and helping them take full advantage of the existing treatments, which both stave off disease and make people less infectious. It is a problem shared worldwide.

Correspondent Jon Cohen, working with photographers Malcolm Linton and Darrow Montgomery, visited 10 U.S. cities this spring, and the package of stories that begins on p. 168 describes the varied epidemics and responses. A News Focus by Cohen spends a day with Anthony Fauci, who leads the NIH branch that funds more HIV/AIDS researchers than any institution in the world (p. 152). This special issue also includes an Editorial by Salim Abdool Karim (p. 133), who highlights problems rolling out what’s known as pre-exposure prophylaxis, as well as an update on HIV antibody research by Dennis Burton and colleagues (p. 183) that promises to inform AIDS vaccine development. Online, a slideshow offers more images and stories about the country’s epidemic, and Science Careers features profiles of two young HIV/AIDS public health workers making a big dent in big-city epidemics

Acellular pertussis vaccine use in risk groups (adolescents, pregnant women, newborns and health care workers)

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 33  pp. 4897-5058 (13 July 2012)

Reviews
Acellular pertussis vaccine use in risk groups (adolescents, pregnant women, newborns and health care workers): A review of evidences and recommendations
Review Article
Pages 5179-5190
Angela Bechini, Emilia Tiscione, Sara Boccalini, Miriam Levi, Paolo Bonanni

Abstract
Background
Pertussis is an acute infectious illness, caused by the bacteria Bordetella pertussis and commonly known as “whooping cough”. Waning immunity after vaccination or after natural infection contributes significantly to the increasing incidence rates in adolescents and adults. Prevention of pertussis in industrialized countries is mainly based on immunization with acellular vaccines in combination with other antigens. A booster dose with an adult-formulation tetanus-diphtheria toxoid and acellular pertussis vaccine (Tdap) is now recommended for all adolescents by several countries, and replacement of the decennial Td dose with a single or more doses of Tdap is recommended for adults.

Objective
Our review aims at describing the current knowledge on the impact of acellular pertussis vaccination in adolescents and adults, with particular focus on specific risk groups: adolescents, pregnant women and their newborns, and health care workers (HCWs), and secondly at suggesting possible immunization strategies.

Methods
Data were retrieved by searches of Pubmed, references, from relevant articles and open-access websites.

Results
In countries where an adolescent booster dose was adopted, a certain decrease of incidence rates was observed. No serologic correlate of protection after immunization exists, but subjects with high antibody levels against pertussis antigens are less likely to develop the disease. Tdap vaccine was demonstrated to induce antibodies to pertussis antigens exceeding those associated with efficacy in infants, in both adolescents and adults. Tdap use in pregnant women seems to be safe and might represent a useful tool in order to prevent pertussis cases in the first months of life. Neonatal immunization with monovalent acellular pertussis vaccine can efficiently prime T and B cells and act as a basis for future immune responses. Cocooning strategies involving all those surrounding newborns have started to be implemented. Their impact on infant pertussis cases will be evaluated in the coming years. Coverage in HCWs should be increased, given their important role in pertussis transmission in health care settings.

Conclusions
Despite the more recent position paper of WHO gives priority to infant and childhood vaccination against pertussis and leaves adolescent, adult and risk group immunization as an option for the future, data are quickly accumulating to support the need to consider pertussis vaccination as a crucial preventative intervention even in adolescents and special risk groups.

Review: Malaria vaccines – Focus on adenovirus based vectors

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 33  pp. 4897-5058 (13 July 2012)

Reviews
Malaria vaccines: Focus on adenovirus based vectors
Review Article
Pages 5191-5198
Nathaniel J. Schuldt, Andrea Amalfitano

Abstract
Protection against malaria through vaccination is known to be achievable, as first demonstrated over 30 years ago. Vaccination via repeated bites with Plasmodium falciparum infected and irradiated mosquitoes provided short lived protection from malaria infection to these vaccinees. Though this method still remains the most protective malaria vaccine to date, it is likely impractical for widespread use. However, recent developments in sub-unit malaria vaccine platforms are bridging the gap between high levels of protection and feasibility. The current leading sub-unit vaccine, RTS,S (which consists of a fusion of a portion of the P. falciparum derived circumsporozoite protein to the Hepatitis B surface antigen), has demonstrated the ability to induce protection from malaria infection in up 56% of RTS,S vaccinees. Though encouraging, these results may fall short of protection levels generally considered to be required to achieve eradication of malaria. Therefore, the use of viral vectored vaccine platforms has recently been pursued to further improve the efficacy of malaria targeted vaccines. Adenovirus based vaccine platforms have demonstrated potent anti-malaria immune responses when used alone, as well when utilized in heterologous prime boost regimens. This review will provide an update as to the current advancements in malaria vaccine development, with a focus on the use of adenovirus vectored malaria vaccines.

Assessing potential introduction of universal or targeted hepatitis A vaccination: the Netherlands

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 33  pp. 4897-5058 (13 July 2012)

Regular Papers
Assessing potential introduction of universal or targeted hepatitis A vaccination in the Netherlands
Original Research Article
Pages 5199-5205
A.W.M. Suijkerbuijk, A.K. Lugnér, W. van Pelt, J. Wallinga, L.P.B. Verhoef, H.E. de Melker, G.A. de Wit

Abstract
In many industrialized countries, hepatitis A incidence rates have declined steadily in the past decades. Since future cohorts of non-vaccinated elderly will lack protection against disease and the burden of hepatitis A is higher with increasing age, this could be an argument in favour of taking preventive measures such as including hepatitis A vaccine into the National Immunisation Program, or offering hepatitis A vaccine to the elderly only. Using a vaccination evaluation scheme, we assessed the potential benefits and drawbacks of introducing hepatitis A vaccine in the National Immunisation Program in the Netherlands. The average number of annual hepatitis A notifications is declining, from 957 in the period 1991 to 1995 to 211 over the period 2006 to 2010. The direct health care costs and costs due to productivity losses per patient are rising, because the age at infection increases and older patients require a relatively higher number of hospitalizations. Initiating a vaccination program would most likely not be cost-effective yet. The annual costs of mass-vaccination are large: about €10 million for infants and €13 million for older people (and only in the first year €210 million), based on current retail prices. The annual effects of mass-vaccination are small: the cost-of-illness in recent years attributed to hepatitis A infection is estimated to be €650,000 per year, and the disease burden is on average 17 DALYs. Given the current low hepatitis A incidence, and the continuing decline in incidence, targeted preventive measures such as vaccinating travellers and other high-risk groups and timely vaccination of close contacts of hepatitis A patients are adequate. However, because susceptibility to hepatitis A is increasing in the group with the highest risk of developing severe complications upon infections, careful monitoring of the epidemiology of hepatitis A remains important.

Prevalence of type-specific HPV infection among women in France

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 33  pp. 4897-5058 (13 July 2012)

Regular Papers
Prevalence of type-specific human papillomavirus infection among women in France: Implications for screening, vaccination, and a future generation of multivalent HPV vaccines
Original Research Article
Pages 5215-5221
Joseph Monsonego, Laurent Zerat, Kari Syrjänen, Jean-Claude Zerat, Jennifer S. Smith, Philippe Halfon

Abstract
To assess human papillomavirus (HPV) prevalence and genotype distribution by age and cervical cytology/histology status among women undergoing routine gynecological examinations, and to discuss the possible impact on preventive strategies. Liquid-based cytology (LBC) samples were tested for HPV DNA, mRNA, and HPV genotypes. Women with atypical squamous cells of undetermined significance or greater (ASC-US+) and/or at least one positive HPV test were referred to colposcopy. Those with normal colposcopy results had biopsies taken at the 6 and 12 O’clock positions of the normal transformation zone. Of the 5002 women, 515 (10.3%) were <25 and 4487 (89.7%) were ≥25 years old. Overall HPV prevalence varied between 10.1% and 16.1% depending on the assay. Risk factors for HPV infection included greater number of recent sexual partners, history of abnormal cervical pathology, age <25 years, and smoking. HPV prevalence increased with the cytological and histological severity of cervical lesions. Prevalence of HPV 16/18 was 5.2% and 2.7% in women <25 and ≥25 years old, respectively. HPV 16 was the type most strongly associated with a diagnosis of cervical intraepithelial neoplasia grade 3 or higher (CIN3+) (odds ratio = 11.64 vs. HPV 16 absent, P < 0.001). A high proportion of high-grade cervical lesions (60.6% of genotyping assay-positive CIN2+) were associated with HPV types 31, 33, 45, 52, or 58. These data indicate that almost all young women could benefit from HPV prophylactic vaccination, but confirm the need for continued cervical screening and highlight the potential benefit of future vaccines targeting a wider range of HPV types.

Variation in adult vaccination policies across Europe

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 33  pp. 4897-5058 (13 July 2012)

Regular Papers
Variation in adult vaccination policies across Europe: An overview from VENICE network on vaccine recommendations, funding and coverage
Original Research Article
Pages 5222-5228
Elisabeth E. Kanitz, Lauren A. Wu, Cristina Giambi, Raymond A. Strikas, Daniel Levy-Bruhl, Pawel Stefanoff, Jolita Mereckiene, Eva Appelgren, Fortunato D’Ancona, VENICE (Vaccine European New Integrated Collaboration Effort) National Gatekeepers, Contact Points

Abstract
Background
In 2010–2011, in the framework of the VENICE project, we surveyed European Union (EU) and Economic Area (EEA) countries to fill the gap of information regarding vaccination policies in adults. This project was carried out in collaboration with the United States National Vaccine Program Office, who conducted a similar survey in all developed countries.

Methods
VENICE representatives of all 29 EU/EEA-countries received an online questionnaire including vaccination schedule, recommendations, funding and coverage in adults for 17 vaccine-preventable diseases.

Results
The response rate was 100%. The definition of age threshold for adulthood for the purpose of vaccination ranged from 15 to 19 years (median = 18 years). EU/EEA-countries recommend between 4 and 16 vaccines for adults (median = 11 vaccines). Tetanus and diphtheria vaccines are recommended to all adults in 22 and 21 countries respectively. The other vaccines are mostly recommended to specific risk groups; recommendations for seasonal influenza and hepatitis B exist in all surveyed countries. Six countries have a comprehensive summary document or schedule describing all vaccines which are recommended for adults. None of the surveyed countries was able to provide coverage estimates for all the recommended adult vaccines.

Conclusions
Vaccination policies for adults are not consistent across Europe, including the meaning of “recommended vaccine” which is not comparable among countries. Coverage data for adults should be collected routinely like for children vaccination.

Monitoring AEs for a new meningococcus conjugate vaccine, Niger, September 2010

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 33  pp. 4897-5058 (13 July 2012)

Regular Papers
Monitoring adverse events following immunization with a new conjugate vaccine against group A meningococcus in Niger, September 2010
Original Research Article
Pages 5229-5234
Maman S. Chaibou, Harouna Bako, Laouali Salisou, Téné M. Yaméogo, Mariama Sambo, Sung Hye Kim, Mamoudou H. Djingarey, Patrick L.F. Zuber, William A. Perea, Lorenzo Pezzoli

Abstract
Introduction
MenAfriVac is a new conjugate vaccine against Neisseria meningitidis serogroup A, the major cause of meningitis outbreaks in sub-Saharan Africa. In Niger, the MenAfriVac introduction campaign was conducted in the District of Filingue, during September 2010, targeting 392,211 individuals aged 1–29 years. We set up an enhanced spontaneous surveillance system to monitor adverse events following immunization (AEFI) during the campaign period and 42 days thereafter.

Methods
All the 33 health centres of the district have been designated as surveillance units, which reported AEFIs on a daily basis to the health district headquarters. Health care workers were instructed to screen patients presenting with predefined conditions of interest and patients spontaneously presenting at units or at vaccination posts with complaints after vaccination. Cases were classified as serious (resulting in death, hospitalization or long-term disability) or minor. A National Expert Committee was established to determine if serious cases were causally associated with the vaccine.

Results
In total, 356,532 vaccine doses were administered. During 61 days of monitoring, 82 suspected AEFIs were reported: 16 severe and 66 minor. The cumulative incidence was of 23.0 per 100,000 doses. Among severe cases, 14 were classified as coincidences, one urticaria complicated by respiratory distress was classified as a probable vaccine reaction, and one death was unclassifiable because post-mortem information was unavailable. The number of units that reported at least one case was 19/33 (57.6%).

Conclusions
Although these results are limited by underreporting of cases, we did not identify safety concerns with MenAfriVac. The lessons learned from this experience should be used to reinforce the national pharmacovigilance system in Niger to make it complaint with international standards. In order to do so, we recommend using a lighter system for routine; and conducting regular training and supervisory activities to increase its acceptance among local health workers.

Effects of influenza vaccine given to children in rural India

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 33  pp. 4897-5058 (13 July 2012)

Regular Papers
Design and initiation of a study to assess the direct and indirect effects of influenza vaccine given to children in rural India
Original Research Article
Pages 5235-5239
Wayne Sullender, Karen Fowler, Anand Krishnan, Vivek Gupta, Lawrence H. Moulton, Kathryn Lafond, Marc-Alain Widdowson, Renu B. Lal, Shobha Broor

Abstract
The burden of disease due to influenza is not well characterized for children in developing countries and the effectiveness of available influenza vaccines in lower resource settings has not been established. We initiated a prospective, longitudinal, phase IV, household-randomized, controlled, observer-blinded three year study (2009–2011) in a rural community of India to measure the total and indirect household protective effects of immunizing children ages 6 months through 10 years with seasonal inactivated trivalent influenza vaccine (TIV) or a control vaccine (n = 3697). Active weekly surveillance was conducted year round with home visits for identification of febrile acute respiratory illness (FARI) conducted for all vaccine recipients and household members (n = 18,220). Nasal and throat swabs were collected from each FARI episode for influenza detection by real-time reverse transcription polymerase chain reaction. The primary outcome was reduction in laboratory confirmed influenza infections in the influenza vaccine versus control vaccine group, with secondary outcome assessing indirect effects among the entire study population. This report describes the study site, cluster study design, choice of study and control vaccines, and the initial enrollment in the study.

Comment: BMGF and development action

Economist
http://www.economist.com/
Accessed 14 July 2012

Contraception and development: Opening the Gates
Jul 12th 2012, 13:53 by J.P. | LONDON

WHEN several heads of state, a dozen health ministers and hundreds of delegates piled into a conference centre in the middle of London on July 11th, there was a sound of broken barriers everywhere. The family-planning summit was the first big international meeting on birth control since a United Nations conference in Cairo in 1994, a sign that international attitudes seem to be changing towards a long-neglected subject. It was an indication that the British government, the joint sponsor of the meeting, is ploughing something of a lonely furrow in development at the moment. As Duncan Green, the head of research at Oxfam, has pointed out, this is a period of British exceptionalism. “The UK is pretty much alone among traditional donors,” he writes, “in sticking to its promises to increase aid despite deep public spending cuts, and is simultaneously pushing ahead in the multilateral arena.” In addition to the family-planning meeting, Britain will convene a “hunger summit” during the Olympic Games, and the prime minister, David Cameron, is one of three co-chairs of a UN panel to look at what comes after the millennium development goals. But in some ways the loudest sound of broken barriers comes from the summit’s other sponsor, the Bill and Melinda Gates Foundation.

When the foundation began in 1994, Mr Gates’s idea was that it would focus on areas neglected by others-vaccines not being financed by governments; complex crop research that was too long-term for governments or companies to contemplate. Where governments or the private sector were taking a lead, the idea was, the foundation would stay away.

But over time, that self-denying ordinance has proved hard to maintain. At first, the foundation concentrated mainly on diseases and health. But nutrition is one of the main determinants of health; agriculture is vital to nutrition-and the Gates foundation has ended up as one of the most important financiers of agricultural research today (especially into the crops of the poor, such as cassava and millet). Something similar seems to be happening with birth control. Family planning was part of the foundation’s health programmes from the start. But its programmes were small and now are being scaled up quickly. Perhaps more important, the summit shows that the modest “after-you-Claude” approach is hard to reconcile with an operation that paid out $2.4 billion in grants in 2010, making the Gates foundation the size of a medium-sized country donor, comparable to Australia or Belgium.

The family-planning summit was an example of the Gates foundation not merely filling in gaps left by others but acting to change the behaviour of countries. Donors have avoided or downplayed family planning for years, partly because of its former association with coercion, partly because of religious objections, especially to abortion, and partly because some developing-country governments have viewed it as white people coming to poor nations and telling them to have fewer children. But as evidence collected in the new edition of the Lancet, a medical journal, convincingly shows, family planning also has substantial, long-term health and economic benefits. The attitude of some developing countries has already started to change; Rwanda, Malawi, Tanzania and Nigeria have all launched or expanded family-planning programmes in the past few years. But it has taken the Gates foundation to team up with Britain to push western donors into a big expansion of official support: at the London summit, they promised $2.6 billion worth of aid, aiming to cut by more than half the number of women in developing countries without access to modern contraceptive methods.

http://www.economist.com/blogs/feastandfamine/2012/07/contraception-and-development

More on CIA, Vaccines, bin Laden

New Yorker
http://www.newyorker.com/
Accessed 14 July 2012
July 12, 2011
Blog: News Desk
The C.I.A., Vaccines, and bin Laden
Ahh—the old phony-vaccination ruse. How does the C.I.A. come up with this stuff? On Monday we learned, from a report in the Guardian, that our vaunted intelligence community decided to use a staged vaccination…
by Michael Specter
Read more http://www.newyorker.com/search?qt=dismax&sort=score+desc&query=vaccine&submit=#ixzz20dpHqDC0

New York Times
http://www.nytimes.com/
Accessed 14 July 2012
C.I.A. Vaccine Ruse May Have Harmed Pakistan’s War on Polio …
4 days ago … The team sent into Pakistan to obtain DNA from Osama bin Laden’s family had an unintended consequence.
July 10, 2012 – By THE NEW YORK TIMES – World – India Ink

Vaccines: The Week in Review 7 July 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_7 July 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…

WHO: Global Alert and Response (GAR) – Undiagnosed illness in Cambodia – update

[Editor’s Note: We provide the full text of this GAR update below given the continuing identification of this presumably infectious syndrome]

WHO: Global Alert and Response (GAR) – Undiagnosed illness in Cambodia – update

6 July 2012 – The Ministry of Health of the Kingdom of Cambodia is conducting active investigation into the cause of a recent undiagnosed syndrome that has caused illness and deaths among children in the country.

Preliminary findings of the investigation identified a total of 74 cases who were hospitalised from April to 5 July 2012. Of these, 57 cases (including 56 deaths), presented a common syndrome of fever, respiratory and neurological signs, which is now the focus of the investigation.

The majority of the identified cases to date were under three years old. Most of them were from the southern and central parts of the country and received treatment at Kantha Bopha Children’s hospital, which is a reference paediatric hospital. Despite all efforts, many of the children died within 24 hours of admission.

Available samples have been tested at the Institut Pasteur in Cambodia. Although a causative agent remains to be formally identified, all these samples were found negative for H5N1 and other influenza viruses, SARS, and Nipah.

The Ministry of Health was first alerted to this by Kantha Bopha Children’s hospital in Phnom Penh, where the majority of the cases were hospitalised.

The Ministry of Health notified WHO about this event through the IHR notification mechanism as it met the criteria for notification of any event where the underlying agent or disease or mode of transmission is not formally identified.

WHO and partners are assisting the Ministry of Health with this event which focuses on hospitalised cases, early warning surveillance data, laboratory data and field investigations.

While this event is being actively investigated, the Government is also looking at other diseases occurring in the country, including dengue, hand-foot-mouth and Chikungunya.

Parents have been advised to take their children to hospital if they identify any signs of unusual illness. The Government is also reinforcing awareness of good hygiene practices to the public, which includes frequent washing of hands.

http://www.who.int/csr/don/2012_07_06a/en/index.html

GHI (Global Health Initiative) Office to close, Office of Global Health Diplomacy formed

Announcement: U.S. State Department Global Health Initiative Office (S/GHI) to close, Office of Global Health Diplomacy (S/GHD) formed

Global Health Initiative Next Steps – A Joint Message from Administrator Rajiv Shah, Ambassador Eric Goosby, Director Thomas Frieden, and GHI Executive Director Lois Quam

Extract

“…The Quadrennial Diplomacy and Development Review (QDDR) provided a forum for review of the structure of GHI. After careful consideration of evolving U.S. global health leadership needs, we have reached several key conclusions that will help guide the next phase of GHI:

First, we continue to recognize the capabilities of our global health agencies. Each has critical leadership responsibilities that must be maintained in the next phase of GHI as we seek greater impact and efficiency from our collective whole-of-government efforts to implement our health programs.

Second, we believe that a continued emphasis on country-level leadership of our global health activities will best achieve improved USG coordination of programs in the field, stronger country partnerships and ownership, and innovation for results.

Third, we recognize the critical role of health diplomacy to increase political will and resource commitments around global health among partner countries and increase external coordination among donors and stakeholders.

As a result of our analysis and conclusions, we have made a collective recommendation to close the QDDR benchmark process and shift our focus from leadership within the U.S. Government to global leadership by the U.S. Government. This recommendation has been accepted.

Our recommendation and the decision to move forward are a reflection of the strength and leadership of each agency.

–          The success of the recent Child Survival Call to Action, spearheaded by USAID, to launch a program to end preventable child death is a sterling example of our GHI principles at work, challenging countries with the greatest child mortality to take greater ownership and coordinating efforts from partners.

–          USAID is also assuming management responsibility for Saving Mothers, Giving Life, a public-private partnership to help reduce maternal mortality during labor, delivery, and the first 24 hours postpartum.

–          The Office of the Global AIDS Coordinator will continue to lead PEPFAR, ensuring that all Country Operational Plans reflect the principles of GHI in activities, thus improving programmatic integration and coordination, supporting country ownership and health systems strengthening, and focusing on gender equality. Through these activities, among others, PEPFAR is helping to create an AIDS free generation.

–          CDC is continuing its remarkable work implementing programs and leading the strengthening of public health systems across a diverse range of activities around the world.

What does this approach mean for the future of GHI work in country and at headquarters? The Global Health Initiative will continue as the priority global health initiative of the U.S. Government. GHI will continue to function with a collaborative leadership structure headed by the three core entities – USAID, CDC, OGAC – and with the enduring mandate of ensuring the GHI principles are implemented in the field to achieve our ambitious GHI goals. GHI country teams and GHI planning leads will continue to work to implement GHI strategies under the leadership of the U.S. Ambassador.

At the State Department, the GHI Office (S/GHI) will close and the Office of Global Health Diplomacy (S/GHD) will be stood up. Unlike S/GHI’s focus on interagency coordination, the S/GHD office’s mandate will be to champion the priorities and policies of GHI in the diplomatic arena. Success in the next phase will be measured by our ability to leverage our collective interagency leadership to influence global stakeholders, align donor investments with country resources and oversight and maintain and build country-focused technical support that expands capacity for global health priorities.

As we move into the next phase of GHI, we are committed to working together to achieve our ambitious GHI goals and to support and enhance our combined efforts to save lives.”

http://www.ghi.gov/newsroom/blogs/2012/194472.htm

Global Fund: “Outstanding Value for Money” and New Funding Model

Speech: General Manager Says Global Fund Offers Outstanding Value for Money
Gabriel Jaramillo, General Manager of the Global Fund to Fight AIDS, Tuberculosis and Malaria
5 July 2012, Tunis: Conference of Ministers of Finance and Health by Harmonization for Health in Africa (HHA)

Media Release – Extract
General Manager Jaramillo, told a gathering of finance and health ministers that the financing institution offers outstanding value for money by effectively treating and preventing the spread of disease. He said the changing economic climate had forced the Global Fund to change its operations to make grants more strategic, improve efficiency and become more effective overall.

The Global Fund will invest US$8 billion over the coming 20 months, US$5 billion of it in Africa. Mr. Jaramillo said that with productivity gains and more co-investment by countries that receive grants, there is a tremendous opportunity.

“As a former banker, I know a good deal when I see one,” said Mr. Jaramillo. “There is no better deal that investing to prevent these diseases.”

Mr. Jaramillo urged the ministers not to fear the investment necessary just because the up-front costs look high, because maintaining gains is less-expensive than the initial investments.

“Front-end these programs now, put your skin in the game now, because the out-years will be much cheaper as your number of cases goes down,” he said. “Sustaining your programs is much-less costly than you believe, and the return on investment is potentially huge.”
http://www.theglobalfund.org/en/mediacenter/newsreleases/2012-07-05_General_Manager_Says_Global_Fund_Offers_Outstanding_Value_for_Money/

 
Blog Post: Global Fund Consults on New Funding Model
[full text]
Strategic planners at the Global Fund are designing a new funding model, and have been seeking suggestions and comments from committee members and some outside partners. In an effort to modify the way countries apply for grants, the new funding model will replace the old ‘rounds-based’ system with a procedure that allows dialogue and early feedback, which should strengthen proposals and increase overall success rates. Early preparation for grant implementation, built-in to the system, is expected to speed up the entire process. Instructions from the Board are to make the funding model more flexible and more effective. Senior staff in the Global Fund’s Strategy Investment and Impact division have been reaching out to partners and committee members to canvass their views, gathering input for the designing the new funding model.

“It’s important that we hear views from different stakeholders,” said Ruwan de Mel, Head of Strategy and Access to Funding at the Global Fund. “We will be consulting broadly over the coming weeks.” A meeting of the Board’s Strategy and Investment and Impact Committee starting 9 July will consider aspects of the new funding model. The principles being followed in the design include a commitment to remaining global while focusing on interventions, countries and populations most in need, and simplifying the grant process while maintaining high standards of technical review. More flexibility on timing, and more predictability on available funding, are other improvements.

Consultations are expected to continue. The aim will also be to figure out how to best forecast true need or demand for support treating and preventing disease, and how other funding models or donor processes might improve the design of an allocation and application process.
Global Fund News Flash: Issue 05
Posted on Tuesday, 03 July 2012: http://www.theglobalfund.org/en/blog/29479/

Twitter Watch [accessed 7 July 2012 – 13:29]

Twitter Watch [accessed 7 July 2012 – 13:29]
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
UPDATE: Cambodia unknown disease: Samples tested were found negative for #H5N1, other #influenza, SARS and Nipah http://goo.gl/N3rvS
1:24 PM – 6 Jul 12

UNDP Policy Centre ‏@UNDP_IPC
‘Looking beyond Rio+20’ – Special issue of the Inclusive Growth bulletin launched today: http://bit.ly/NbRKa2 @UNDPS @UNEP @UNDP
10:20 AM – 6 Jul 12

GAVI Alliance @GAVIAlliance
. @GAVISeth emphasises importance of long-term sustainable funding 4 vaccines at high-level Ministerial conference. http://ht.ly/c3z5u
9:30 AM – 6 Jul 12

Seth Berkley ‏@GAVISeth
Seismic change in vaccine market; Serum Institute buys Dutch vax co for production of inactivated polio & other vax http://bit.ly/L1Hty7
4:32 AM – 5 Jul 12

UN: 2012 Report on the Millennium Development Goals

Report: 2012 Report on the Millennium Development Goals
United Nations, 2 July 2012
Report: (pdf; 72 pages):2012 Report on the Millennium Development Goals
Chart: (pdf; 1 page) 2012 MDG Progress Chart

Press Release: extract
With three important targets on poverty, slums and water having been met, a new United Nations report stresses the need for a true global partnership to achieve the remaining Millennium Development Goals (MDGs) by the 2015 deadline. The 2012 MDG Report offers “the most comprehensive picture yet” on global progress towards the Goals, Secretary-General Ban Ki-moon said as he launched the report at the high-level segment of the annual session of the UN Economic and Social Council (ECOSOC). “The current economic crises besetting much of the developed world must not be allowed to decelerate or reverse the progress that has been made. Let us build on the successes we have achieved so far, and let us not relent until all the MDGs have been attained,” he said in the foreword.

[Full text from initial Overview section of report]
Overview
   Three years to the deadline, we can report broad progress on the MDGs
The Millennium Development Goals (MDGs) agreed to by world leaders over a decade ago have achieved important results. Working together, Governments, the United Nations family, the private sector and civil society have succeeded in saving many lives and improving conditions for many more.

The world has met some important targets—ahead of the deadline.

•• Extreme poverty is falling in every region
For the first time since poverty trends began to be monitored, the number of people living in extreme poverty and poverty rates fell in every developing region—including in sub-Saharan Africa, where rates are highest. The proportion of people living on less than $1.25 a day fell from 47 per cent in 1990 to 24 per cent in 2008—a reduction from over 2 billion to less than 1.4 billion.

•• The poverty reduction target was met
Preliminary estimates indicate that the global poverty rate at $1.25 a day fell in 2010 to less than half the 1990 rate. If these results are confirmed, the first target of the  MDGs—cutting the extreme poverty rate to half its 1990 level—will have been achieved at the global level well ahead of 2015.

•• The world has met the target of halving the proportion of people without access to improved sources of water
The target of halving the proportion of people without sustainable access to safe drinking water was also met by 2010, with the proportion of people using an improved water source rising from 76 per cent in 1990 to 89 per cent in 2010. Between 1990 and 2010, over two billion people gained access to improved drinking water sources, such as piped supplies and protected wells.

•• Improvements in the lives of 200 million slum dwellers exceeded the slum target
The share of urban residents in the developing world living in slums declined from 39 per cent in 2000 to 33 per cent in 2012. More than 200 million gained access to either improved water sources, improved sanitation facilities, or durable or less crowded housing. This achievement exceeds the target of significantly improving the lives of at least 100 million slum dwellers, well ahead of the 2020 deadline.

•• The world has achieved parity in primary education between girls and boys
Driven by national and international efforts and the MDG campaign, many more of the world’s children are enrolled in school at the primary level, especially since 2000. Girls have benefited the most. The ratio between the enrolment rate of girls and that of boys grew from 91 in 1999 to 97 in 2010 for all developing regions. The gender parity index value of 97 falls within the plus-or-minus 3-point margin of 100 per cent, the accepted measure for parity.

•• Many countries facing the greatest challenges have made significant progress towards universal primary education
Enrollment rates of children of primary school age increased markedly in sub-Saharan Africa, from 58 to 76 per cent between 1999 and 2010. Many countries in that region succeeded in reducing their relatively high out-of-school rates even as their primary school age populations were growing.

•• Child survival progress is gaining momentum
Despite population growth, the number of under-five deaths worldwide fell from more than 12.0 million in 1990 to 7.6 million in 2010. And progress in the developing world as a whole has accelerated. Sub-Saharan Africa—the region with the highest level of under-five mortality—has doubled its average rate of reduction, from 1.2 per cent a year over 1990-2000 to 2.4 per cent during 2000-2010.

•• Access to treatment for people living with HIV increased in all regions
At the end of 2010, 6.5 million people were receiving antiretroviral therapy for HIV or AIDS in developing regions. This total constitutes an increase of over 1.4 million people from December 2009, and the largest one-year increase ever. The 2010 target of universal access, however, was not reached.

•• The world is on track to achieve the target of halting and beginning to reverse the spread of tuberculosis
Globally, tuberculosis incidence rates have been falling since 2002, and current projections suggest that the 1990 death rate from the disease will be halved by 2015.

•• Global malaria deaths have declined
The estimated incidence of malaria has decreased globally, by 17 per cent since 2000. Over the same period, malaria-specific mortality rates have decreased by 25 per
cent. Reported malaria cases fell by more than 50 per cent between 2000 and 2010 in 43 of the 99 countries with ongoing malaria transmission.

  Inequality is detracting from these gains, and slowing advances in other key areas
Achievements were unequally distributed across and within regions and countries. Moreover, progress has slowed for some MDGs after the multiple crises of 2008-2009.

•• Vulnerable employment has decreased only marginally over twenty years
Vulnerable employment—defined as the share of unpaid family workers and own-account workers in total employment—accounted for an estimated 58 per cent of all employment in developing regions in 2011, down only moderately from 67 per cent two decades earlier. Women and youth are more likely to find themselves in such insecure and poorly remunerated positions than the rest of the employed population.

•• Decreases in maternal mortality are far from the 2015 target
There have been important improvements in maternal health and reduction in maternal deaths, but progress is still slow. Reductions in adolescent childbearing and expansion of contraceptive use have continued, but at a slower pace since 2000 than over the decade before.

•• Use of improved sources of water remains lower in rural areas
While 19 per cent of the rural population used unimproved sources of water in 2010, the rate in urban areas was only 4 per cent. And since dimensions of safety, reliability and sustainability are not reflected in the proxy indicator used to track progress towards the MDG target, it is likely that these figures overestimate the actual number of people using safe water supplies. Worse, nearly half of the population in developing regions—2.5 billion—still lacks access to improved sanitation facilities. By 2015, the world will have reached only 67 per cent coverage, well short of the 75 per cent needed to achieve the MDG target.

•• Hunger remains a global challenge
The most recent FAO estimates of undernourishment set the mark at 850 million living in hunger in the world in the 2006/2008 period—15.5 per cent of the world population. This continuing high level reflects the lack of progress on hunger in several regions, even as income poverty has decreased. Progress has also been slow in reducing child undernutrition. Close to one third of children in Southern Asia were underweight in 2010.

•• The number of people living in slums continues to grow
Despite a reduction in the share of urban populations living in slums, the absolute number has continued to grow from a 1990 baseline of 650 million. An estimated 863 million people now live in slum conditions.

   In the years ahead, we have the opportunity to achieve more and to shape the agenda for our future
The 2015 deadline is fast approaching. The contributions of national Governments, the international community, civil society and the private sector will need to intensify as we take on the longstanding and long-term challenge of inequality, and press forward on food security, gender equality, maternal health, rural development, infrastructure and environmental sustainability, and responses to climate change. A new agenda to continue our efforts beyond 2015 is taking shape. The MDG campaign, with its successes as well as setbacks, provides rich experience on which this discussion can draw, as well as confidence that further success is feasible.

•• Gender equality and women’s empowerment are key
Gender inequality persists and women continue to face discrimination in access to education, work and economic assets, and participation in government. Violence against women continues to undermine efforts to reach all goals. Further progress to 2015 and beyond will largely depend on success on these interrelated challenges.

•• MDG progress shows the power of global goals and a shared purpose
The MDGs have been a fundamental framework for global development. A clear agenda, with measurable goals and targets, and a common vision have been crucial for this
success. There is now an expectation around the world that sooner, rather than later, all these goals can and must be achieved. Leaders will be held to this high standard.

Sectors such as government, business, academia and civil society, often known for working at cross-purposes, are learning how to collaborate on shared aspirations. The comprehensive statistics and clear analysis in this year’s MDG Report give us all a good idea of where our efforts should be directed.
Sha Zukang
Under-Secretary-General for Economic and Social Affairs

Vaccine programmes must consider their effect on general resistance

British Medical Journal
07 July 2012 (Vol 345, Issue 7864)
http://www.bmj.com/content/345/7864

Analysis
Vaccine programmes must consider their effect on general resistance
BMJ 2012; 344 doi: 10.1136/bmj.e3769 (Published 14 June 2012)
Cite this as: BMJ 2012;344:e3769
Peter Aaby, Hilton Whittle, Christine Stabell Benn,

Extract
   Recent randomised trials have shown that live vaccines such as measles and BCG enhance general resistance, preventing other infections as well as the target infection.   However, current vaccination strategies assume a proportionate response. Peter Aaby, Hilton Whittle, and Christine Stabell Benn argue that we need to rethink our approach

Global health leaders have committed to making 2010-19 the decade of vaccines, with the aim of ensuring that lifesaving vaccines are available globally. The Bill and Melinda Gates Foundation pledged $10bn (£6.5bn; €8bn) to the new decade,1 which was established in recognition of the astonishing technological progress in developing new vaccines and our ethical obligation to make these vaccines available to all children in the poorest countries of the world.1 2 w1-8 The ultimate goal is to save lives, and vaccination programmes measure potential impact in terms of the lives saved.1 2 w1

Surprisingly, therefore, there are few observational studies and virtually no randomised clinical trials documenting the effect on child mortality of any of the existing vaccines. A notable exception is the high titre measles vaccine, which was withdrawn because an interaction with diphtheria-tetanus-pertussis (DTP) vaccine resulted in a 33% (95% confidence interval 2% to 73%) increase in mortality among children aged 4-60 months in several west African randomised trials.3 w9 Among the newer vaccines, conjugate pneumococcal vaccine has been found to be associated with an 11% (−1% to 21%) reduction in mortality in a meta-analysis.4

The lack of data on mortality is not considered a problem. If a vaccine is shown to produce immunity against a specific disease, the effect on survival is estimated using the burden of disease, and the efficacy and the coverage of the specific vaccine. For example, if rotavirus causes 527 000 annual deaths, 90% occurring in low income …

WHO essential medicines for children in Guatemala: availability, prices and affordability

Globalization and Health
[Accessed 7 July 2012]
http://www.globalizationandhealth.com/

Research
Availability, prices and affordability of the World Health Organization’s essential medicines for children in Guatemala
Angela Anson, Brooke Ramay, Antonio Ruiz de Esparza and Lisa Bero

Abstract (provisional)
Background
Several World Health Organization (WHO) initiatives aim to improve the accessibility of safe and effective medicines for children. A first step in achieving this goal is to obtain a baseline measure of access to essential medicines. The objective of this project was to measure the availability, prices, and affordability of children’s medicines in Guatemala.

Methods
An adaption of the standardized methodology developed by the World Health Organization and Health Action International (HAI) was used to conduct a cross sectional survey to collect data on availability and final patient prices of medicines in public and private sector medicine outlets during April and May of 2010.

Results
A subset of the public sector, Programa de Accesibilidad a los Medicamentos (PROAM), had the lowest average availability (25%) compared to the private sector (35%). In the private sector, highest and lowest priced medicines were 22.7 and 10.7 times more expensive than their international reference price comparison. Treatments were generally unaffordable, costing as much as 15 days wages for a course of ceftriaxone.

Conclusions
Analysis of the procurement, supply and distribution of specific medicines is needed to determine reasons for lack of availability. Improvements to accessibility could be made by developing an essential medicines list for children and including these medicines in national purchasing lists.

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

Health and Human Rights- Call for Submissions – Special Issue on Proposed Framework Convention on Global Health

Health and Human Rights
Vol 14, No 1 (2012)
http://hhrjournal.org/index.php/hhr
[Reviewed earlier]

Call for Submissions: Special Issue on Proposed Framework Convention on Global Health
Health and Human Rights, a peer-reviewed open access journal under the editorship of Partners in Health co-founder Paul Farmer, is published semi-annually, with new issues released in June and December. From 2012, selected papers in press are available prior to issue publication, thereby fast-tracking access to new research and enabling authors to cite their work. Submissions are welcomed at any time.

Health and Human Rights will be publishing a special issue in June 2013 on a proposed Framework Convention on Global Health (FCGH). An FCGH would be based in the right to health and aimed at reducing national and global health inequities. It would ensure universal health coverage, establish a framework for sufficient and sustained funding, improve accountability, raise the priority of health in other legal regimes, and meet major challenges in global governance for health, such as poor coordination. For more information, please see the website for the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI): http://www.jalihealth.org.

Human Vaccines: Special Focus – Meningococcal Vaccine Development

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 8, Issue 7  July 2012
http://www.landesbioscience.com/journals/vaccines/toc/volume/8/issue/7/

Special Focus: Meningococcal Vaccine Development
RESEARCH PAPERS  [Open Access Articles]
The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine: A randomized, controlled non-inferiority study
Ghassan Dbaibo, Noel Macalalad, Mari Rose Aplasca-De Los Reyes, Efren Dimaano, Veronique Bianco, Yaela Baine and Jacqueline Miller
http://dx.doi.org/10.4161/hv.20211
Abstract | Full Text | PDF

The investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults
Mari Rose Aplasca-De Los Reyes, Efren Dimaano, Noel Macalalad, Ghassan Dbaibo, Veronique Bianco, Yaela Baine and Jacqueline Miller
http://dx.doi.org/10.4161/hv.20212
Abstract | Full Text | PDF

A Phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults
Eric Sheldon, Howard Schwartz, Qin Jiang, Peter Giardina and John Perez
Abstract | Full Text

Review: Effectiveness and harms of seasonal and pandemic influenza vaccines in children, adults and elderly

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 8, Issue 7  July 2012
http://www.landesbioscience.com/journals/vaccines/toc/volume/8/issue/7/

REVIEW
Effectiveness and harms of seasonal and pandemic influenza vaccines in children, adults and elderly: A critical review and re-analysis of 15 meta-analyses
Lamberto Manzoli, John P.A. Ioannidis, Maria Elena Flacco, Corrado De Vito and Paolo Villari

Abstract:
Fifteen meta-analyses have been published between 1995 and 2011 to evaluate the efficacy/effectiveness and harms of diverse influenza vaccines—seasonal, H5N1 and 2009(H1N1) —in various age-classes (healthy children, adults or elderly). These meta-analyses have often adopted different analyses and study selection criteria. Because it is difficult to have a clear picture of vaccine benefits and harms examining single systematic reviews, we compiled the main findings and evaluated which could be the most reasonable explanations for some differences in findings (or their interpretation) across previously published meta-analyses. For each age group, we performed analyses that included all trials that had been included in at least one relevant meta-analysis, also exploring whether effect sizes changed over time. Although we identified several discrepancies among the meta-analyses on seasonal vaccines for children and elderly, overall most seasonal influenza vaccines showed statistically significant efficacy/effectiveness, which was acceptable or high for laboratory-confirmed cases and of modest magnitude for clinically-confirmed cases. The available evidence on parenteral inactivated vaccines for children aged < 2 y remains scarce. Pre-pandemic “avian” H5N1 and pandemic 2009 (H1N1) vaccines can achieve satisfactory immunogenicity, but no meta-analysis has addressed H1N1 vaccination impact on clinical outcomes. Data on harms are overall reassuring, but their value is diminished by inconsistent reporting.

Commentary: Inactivated Polio Vaccine – Time to introduce it in India’s national immunization schedu

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 8, Issue 7  July 2012
http://www.landesbioscience.com/journals/vaccines/toc/volume/8/issue/7/

Commentary
Inactivated Polio Vaccine: Time to introduce it in India’s national immunization schedule
Ramesh Verma, Pardeep Khanna and Suraj Chawla
http://dx.doi.org/10.4161/hv.20089

Abstract:
Polio is a communicable disease caused by poliovirus that may attack nerve cells of the brain and spinal cord. The victims develop neurological complications, likes stiffness of the neck, muscular weakness, or paralysis of one or more limbs. In severe cases, it may be fatal due to respiratory paralysis. The world has seen tremendous gains in polio eradication over the past year. India and Nigeria saw a reduction in cases of almost 95% from 2009 to 2010, and cases of wild poliovirus type 3 (WPV3) fell by 92% globally over the same period. In fact, no case has been reported in India since February 2011, such that India may be on the verge of eradicating polio. Nevertheless, polio control experts are particularly worried about Vaccine-Derived Poliovirus (VDPV). Global surveillance efforts picked up 430 cases of VDPV from several countries between July 2009 and March 2011. In India, 7 cases of VDPV were reported during the year 2011. As long as OPV is used, virologists say that the world is at risk of VDPV causing polio in unprotected children. Achieving a polio-free world will require the “cessation of all OPV” and with it the elimination of the risk of vaccine-associated paralytic polio (VAPP) or VDPV infections. To this effect, in 2011 the Global Polio Eradication Initiative (GPEI) will produce and develop a new roadmap for VDPV Elimination. Several countries have shifted from all OPV to sequential OPV-IPV schedules and all-IPV schedules with elimination of live poliovirus. IPV will be indispensable in the post-eradication era when use of OPV has to stop but “vaccination against polio” cannot stop. IPV offers complete individual protection and has been considered as an additional tool at present for those who can afford the vaccine, and since we are nearing the eradication of polio, it is time to shift from OPV to sequential OPV-IPV schedule in India. Such a strategy will avoid inevitable problems with VAPP.

Report from the field: Fifth vaccine renaissance

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 8, Issue 7  July 2012
http://www.landesbioscience.com/journals/vaccines/toc/volume/8/issue/7/

SPECIAL FOCUS COMMENTARIES
Report from the field: Fifth vaccine renaissance in Providence RI
Denice Spero, Nikolai Petrovsky and Annie De Groo

Abstract:
Emerging and re-emerging infectious diseases represent a major challenge to vaccine development since it involves two seemingly contradictory requirements. Rapid and flexible vaccine generation while using technologies and processes that can facilitate accelerated regulatory review. Development in the “-omics” in combination with advances in vaccinology offer novel opportunities to meet these requirements. Here we describe how a consortium of five different organizations from academia and industry is addressing these challenges. This novel approach has the potential to become the new standard in vaccine development allowing timely deployment to avert potential pandemics.