The United Nations and WHO launched the “Global Strategy for Women’s and Children’s Health” – described as a concerted world-wide effort to save the lives of more than 16 million women and children – at the global summit on the Millennium Development Goals (MDGs) in New York. Stakeholders pledged over US$40 billion in resources for women’s and children’ health as part of the strategy.  WHO said “leaders from government, international organizations, business, academia, philanthropy, health professional associations and civil society have come together to develop this strategy, recognizing that the health of women and children is key to progress on all development goals. The Global Strategy calls for all partners to unite and take real action.”

The announcement noted that execution of the new strategy in the 49 lowest-income countries could help assure that in 2015:

– 43 million new users have access to comprehensive family planning,

– 19 million more women give birth supported by a skilled health worker, with the necessary infrastructure, drugs, equipment and regulations,

– 2.2 million additional neonatal infections are treated,

– 21.9 million more infants are exclusively breastfed for the first six months of life,

– 15.2 million more children are fully immunized in their first year of life

– 117 million more children under five receive vitamin A supplements, and

– 85,000 more quality health facilities and up to 3.5 million more health workers are available.

More documentation and announcement content at:

http://www.who.int/pmnch/activities/jointactionplan/en/index.html

The GAVI Alliance said it received a US$1 million contribution from the Republic of Korea, “the first Asian donor to support the Geneva-based global health partnership whose work on immunisation has saved 5.4 million lives in the past 10 years.” GAVI CEO Julian Lob-Levyt said, “We are delighted that the Republic of Korea has chosen to become a donor to GAVI and look forward to deepening our relationship in the months and years ahead.” GAVI said the contribution was formally announced in New York on Wednesday at the UN summit on accelerating progress to reach the Millennium Development Goals (MDGs). Dr Lob-Levyt “signed a two-page ‘contribution arrangement’ on the sidelines of the UN summit with Sul Kyung-hoon, Director-General for Development Cooperation at the Republic of Korea’s Ministry of Foreign Affairs and Trade,” GAVI noted.

http://www.gavialliance.org/media_centre/press_releases/korea_donor.php

WHO announced a new database for vaccines prequalified by WHO by type of vaccine, manufacturer and country of manufacture, to support immunization programme managers, procurement agencies, regulatory authorities, and other partners. WHO said “the ultimate goal of WHO’s prequalification programme for vaccines is to ensure that all countries have access to vaccines that meet international standards of quality, safety and efficacy and are appropriate for the target population. The rigourous evaluation process includes review of comprehensive documentation on production methods, vaccine composition, quality control and clinical experience; independent testing for consistency by WHO-accredited laboratories; and site audits of the manufacturer to ensure that vaccine and production methods conform to international standards. Complaints about vaccine quality and reports of adverse events following immunization are investigated by WHO. United Nations procurement agencies only purchase vaccines that have been prequalified by WHO.” http://www.who.int/immunization/newsroom/news_prequalified_database_online/en/index.html

Database at: http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html

BARDA announced the first eight contract awards “under an initiative to help modernize and improve the nation’s infrastructure for producing medical countermeasures that protect against natural and man-made biological threats.” BARDA is the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. The awards total US$55 million for the initial phase and up to $100 million over three years, and support the following innovations (full text from announcement):

– VaxDesign will further develop its MIMIC platform, an in vitro (test-tube-based) human immune system mimetic designed to accelerate evaluation of candidate and stockpiled vaccine safety and effectiveness by supplementing animal testing.

– PATH will test multiple innovative formulation chemistries and strategies to increase the shelf-life of influenza vaccines, which has implications for the national vaccine stockpile as well as cold-chain requirements domestically and in developing countries.

– IDRI will develop and evaluate innovative adjuvant formulations to enhance influenza vaccine immunogenicity and cross-protection to make them more effective against novel viral strains that may cause the next pandemic.

– Pfenex will apply its innovative Pfenex Expression Technology Platform to the development of optimized bioprocesses for high yield production of a stable candidate anthrax vaccine.

– Novartis Vaccines and Diagnostics will address a critical issue in the time required to begin manufacturing of influenza vaccine against a newly identified strain by investigating techniques for the rapid development of optimized influenza seed virus.

– Rapid Micro Biosystems will address a critical issue in the time required for release of influenza vaccine after manufacturing by developing methods for accelerated sterility testing. Together, these improvements could shave weeks off the influenza vaccine manufacturing and product release schedule.

– 3M and Northrop Grumman will develop integrated diagnostic capabilities for rapid, high-throughput surveillance and molecular diagnostics.

http://www.businesswire.com/news/home/20100921006822/en/BARDA-Funds-Medical-Countermeasure-Innovation

Emerging Infectious Diseases
Volume 16, Number 10–October 2010
http://www.cdc.gov/ncidod/EID/index.htm

Research
Mobile Phone–based Infectious Disease Surveillance System, Sri Lanka
C. Robertson et al.

Abstract
Because many infectious diseases are emerging in animals in low-income and middle-income countries, surveillance of animal health in these areas may be needed for forecasting disease risks to humans. We present an overview of a mobile phone–based frontline surveillance system developed and implemented in Sri Lanka. Field veterinarians reported animal health information by using mobile phones. Submissions increased steadily over 9 months, with »4,000 interactions between field veterinarians and reports on the animal population received by the system. Development of human resources and increased communication between local stakeholders (groups and persons whose actions are affected by emerging infectious diseases and animal health) were instrumental for successful implementation. The primary lesson learned was that mobile phone–based surveillance of animal populations is acceptable and feasible in lower-resource settings. However, any system implementation plan must consider the time needed to garner support for novel surveillance methods among users and stakeholders.

The Pediatric Infectious Disease Journal
October 2010 – Volume 29 – Issue 10
http://journals.lww.com/pidj/pages/currenttoc.aspx

Optimizing Protection Against Influenza in Children Eligible for the Vaccine for Children Program
Hull, Harry F.; O’Connor, Heidi

Abstract:
Background: Children eligible for the Vaccines for Children (VFC) program are immunized against influenza at lower rates and less likely to receive their second recommended dose. Live, attenuated influenza vaccine (LAIV) has higher vaccine efficacies (VEs) than trivalent, inactivated influenza vaccine (TIV). Increased use of LAIV could provide better protection against influenza for this vulnerable population.

Methods: Published VE estimates and vaccine utilization data from a nationwide study of randomly selected pediatric practices were used to model percentages of VFC children that would be immune following immunization.

Results: A total of 22,329 influenza vaccine doses were administered to 20,626 VFC-eligible children aged 24 months to 17 years in the study population. Among children recommended to receive 2 doses, only 1234 of 3018 (41%) aged 24 to 59 months and 469 of 1908 (25%) aged 5 to 8 years received their second dose. Of the vaccinated VFC population, 73% to 83% would be immune using LAIV compared with 53% to 68% with TIV. Differences in aggregate immunity were greatest among 24- to 59-month olds with 71% to 78% of LAIV immunized children immune compared with 48% to 60% with TIV. In this model, 29% to 47% more children aged 24 to 59 months would be immune prior to peak influenza season when vaccinated with LAIV.

Conclusions: Because VE is higher and most VFC children fail to receive their second recommended dose, population protection is substantially higher with LAIV. Although LAIV cannot be given to all children, LAIV should be used preferentially for the VFC population, particularly for children aged 24 to 59 months and those needing 2 doses.

PLoS Medicine
(Accessed 26 September 2010)
a title=”http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results” href=”http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results”>http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results

AIDS Vaccine for Asia Network (AVAN): Expanding the Regional Role in Developing HIV Vaccines

Stephen J. Kent, David A. Cooper, Mean Chhi Vun, Yiming Shao, Linqi Zhang, Nirmal Ganguly, Budiman Bela, Hiko Tamashiro, Rossana Ditangco, Supachai Rerks-Ngarm, Punnee Pitisuttithum, Nguyen Van Kinh, Alan Bernstein, Saladin Osmanov Health in Action, published 21 Sep 2010

Summary Points
– The HIV/AIDS pandemic continues to spread and an AIDS vaccine is urgently needed.
– Regional alliances and international collaborations can foster the development and evaluation of the next generation of AIDS vaccine candidates.
– The importance of coordinating and harmonizing efforts across regional alliances has become abundantly clear.
– We recently formed the AIDS Vaccine for Asia Network (AVAN) to help facilitate the development of a regional AIDS vaccine strategy that accelerates research and development of an AIDS vaccine through government advocacy, improved coordination, and harmonization of research; develops clinical trial and manufacturing capacity; supports ethical and regulatory frameworks; and ensures community participation.

Science Translational Medicine
22 September 2010 vol 2, issue 50
http://stm.sciencemag.org/content/current

Review
Vaccine and Drug Development
Long Synthetic Peptides for the Production of Vaccines and Drugs: A Technological Platform Coming of Age
Giampietro Corradin, Andrey V. Kajava, and Antonio Verdini
22 September 2010: 50rv3

Abstract
Long synthetic peptides (LSPs) have a variety of important clinical uses as synthetic vaccines and drugs. Techniques for peptide synthesis were revolutionized in the 1960s and 1980s, after which efficient techniques for purification and characterization of the product were developed. These improved techniques allowed the stepwise synthesis of increasingly longer products at a faster rate, greater purity, and lower cost for clinical use. A synthetic peptide approach, coupled with bioinformatics analysis of genomes, can tremendously expand the search for clinically relevant products. In this Review, we discuss efforts to develop a malaria vaccine from LSPs, among other clinically directed work.

Vaccine
Volume 28, Issue 42 pp. 6809-6942 (4 October 2010)
http://www.sciencedirect.com/science/journal/0264410X

Impact of vaccinating boys and men against HPV in the United States

Original Research Article
Pages 6858-6867
Elamin H. Elbasha, Erik J. Dasbach

Abstract
We assessed the public health impact and value of vaccinating boys and men with the quadrivalent HPV vaccine in the United States. We used mathematical population models, accounting for both the direct and indirect protective effects of vaccination. Inputs for the models were obtained from public data sources, published literature, and analyses of clinical trial data. Compared with a program of vaccinating girls and women only, including boys and men 9–26 years of age would further decrease the cumulative mean number of genital wart cases, cervical intraepithelial neoplasia 2/3 cases, cancer cases, and cancer deaths by 5,146,000, 708,000, 116,000, and 40,000, respectively, within 100 years. The mean cost-effectiveness ratio (2008 US $) of this strategy was $25,700 (range: 13,600–48,800) per QALY gained if vaccination protects against all HPV 6/11/16/18-associated diseases, and $69,000 (range: 37,700–152,300)/QALY if it only protects against diseases currently in the vaccine indication. Vaccinating boys and men age 9–26 against all HPV 6/11/16/18-associated diseases provides substantial public health benefits and is cost-effective at commonly cited thresholds.

The CDC released the 2009 National Immunization Survey (NIS) of more than 17,000 households which looked at vaccination of children born between January 2006 and July 2008 and found that vaccine coverage against poliovirus; measles, mumps and rubella; hepatitis B and varicella (chickenpox), “remained relatively stable and near or above the national Healthy People 2010 goal of 90 percent or higher.

Other findings included:

– 44 percent of children aged 19-35 months had received rotavirus vaccine during infancy; these vaccines were first licensed in 2006.

– 83.6 percent of children aged 19-35 months had received three doses of Haemophilus influenzae B, down by 6.4 points from the previous year, reflecting a national shortage of the vaccine in 2008 and 2009. Vaccine is now readily available.

The report noted that there “was substantial variation between states in vaccination rates, suggesting room for improvements.”

http://www.cdc.gov/media/pressrel/2010/r100916.htm

GAVI said its that the Independent Assessment Committee of the Advance Market Commitment (AMC) for pneumococcal disease has approved Pfizer’s pneumococcal vaccine Prevenar 13, as eligible for purchase pursuant to the AMC terms and conditions. GAVI said the Pfizer vaccine is the second pneumococcal vaccine to be approved by the committee and that it could be delivered to the GAVI eligible countries as early as this year. UNICEF is the procurement agency for the AMC and will work with countries to determine the introduction dates. In March 2010, Pfizer committed to supply as many as 300 million doses of its vaccine to GAVI countries by 2023.  GAVI noted that “seventy percent of the AMC funds remain available to incentivise additional manufacturers to develop and manufacture pneumococcal vaccines. Therefore, other companies can still make offers under the AMC as new calls for supply offers are issued. Panacea Biotec Ltd, and the Serum Institute of India Ltd. have already registered to the programme and other companies have expressed interest.” In 2007, WHO recommended the introduction of pneumococcal vaccines into all national immunisation programmes, particularly in countries with high child mortality.

http://www.gavialliance.org/media_centre/press_releases/pfizer_amc_approval.php

PATH said it won US$5.2 million contract from the Biomedical Advanced Research and Development Authority (BARDA) “to develop stable formulations of both live and subunit influenza vaccines.” PATH will work in collaboration with Arecor Limited and Aridis Pharmaceuticals “to extend the product shelf life of pandemic influenza vaccines, and to facilitate vaccine stockpiling and rapid deployment of fully potent vaccines independent of the vaccine cold chain, activities that could significantly help to contain future influenza pandemics.” Following a base period of project work, options exist for PATH to receive further funding from BARDA—up to $4.2 million more—to advance the stabilization efforts.

Dexiang Chen, PhD, senior technical officer at PATH and principal investigator for influenza vaccine stabilization work conducted under the BARDA contract, said, “The benefits of a stable influenza vaccine are manifold. Most notably, a longer shelf life will decrease the turnover of vaccine stockpiles, reducing costs and boosting confidence in the distribution of fully potent vaccines at an outbreak’s point of origin—a key strategy for containing the virus and preventing a potential pandemic.” http://www.path.org/news/an100915-barda.php

HHS’ Biomedical Advanced Research and Development Authority (BARDA) awarded a US$51 million contract to Emergent BioSolutions, Inc. “for the development of a new anthrax vaccine using the protective antigen (rPA) to stimulate a protective immune response that neutralizes the anthrax toxins.” The potential total value of the five-year award could be US$186.6 million. In the first two years of the contract, Emergent will develop the final vaccine formulation and test its stability. http://www.businesswire.com/news/home/20100917005739/en/BARDA-Awards-51-Million-Contract-Generation-Anthrax

Johnson & Johnson, through an affiliate, currently holds approximately 17.9 percent of the outstanding shares of Crucell. The companies said they expect that “Crucell’s strength in the manufacture, discovery and commercialization of vaccines would create a strong platform for Johnson & Johnson in the vaccine market.” Both companies “expect that Crucell, as Johnson & Johnson’s vaccine center, would retain its entrepreneurial culture that has fostered innovation and growth. http://www.jnj.com/connect/news/all/Johnson-and-Johnson-and-Crucell-in-advanced-negotiations-for-an-all-cash-public-offer Johnson & Johnson and Crucell announced that they are “in advanced negotiations for a potential public offer by Johnson & Johnson or an affiliate for all outstanding ordinary shares of Crucell not already held by Johnson & Johnson and its affiliates.

The Clinton Global Initiative holds its annual meeting 20-23September 2010. The agenda includes a number of sessions addressing global pubic health. Agenda and webcast access at:

http://www.clintonglobalinitiative.org/ourmeetings/2010/meeting_annual_agenda.asp?Section=OurMeetings&PageTitle=Agenda

UN Summit on the Millennium Development Goals

Place: New York, United States
Date: 20-22 September 2010

“With only five years left until the 2015 deadline to achieve the Millennium Development Goals (MDGs), UN Secretary-General Ban Ki-moon has called a summit to accelerate progress towards the MDGs.

“The United Nations Millennium Declaration, signed in September 2000, commits world leaders to combat poverty, hunger, disease, illiteracy, environmental degradation, and discrimination against women. They established eight Millennium Development Goals (MDGs), with targets set for 2015, and identified a number of indicators to monitor progress, several of which relate directly to health.

“Health is key to the achievement of all the MDGs. WHO’s work helps countries improve maternal, child and newborn health; to combat AIDS, TB and malaria; and to improve people’s access to safe food, clean water, sanitation and essential medicines.”

http://www.who.int/mediacentre/events/meetings/2010/mdg_summit/en/index.html

International Vaccine Technology Workshop (September 17-18, 2010 – Hyderabad, India)

Overview

“The World Health Organization (WHO), the U.S. Department of Health, and Human Services (HHS) and other like-minded organizations and governments are committed to assisting in the creation of regionally-based, independent and sustainable vaccine production capacity in developing and emerging economy countries through capacity building and technology transfer.  As a means of initiating a coordinated discussion among the international community regarding this shared goal, WHO and HHS convened the Sustainable Influenza Vaccine Production Capacity Stakeholders’ Workshop in Washington D.C. in January 2010.  Workshop participants identified partnership models, production technologies, and opportunities for technology transfer as some of the elements critical to successful building of sustainable vaccine production capacity worldwide.

“Building upon the Stakeholders’ Workshop, WHO and HHS are hosting the International Vaccine Technology Workshop.  This follow-up workshop will have a technology focus and will differ from the Stakeholders’ Workshop in that it will expand the scope beyond influenza and enable participants to survey and evaluate a broader range of technologies used to develop and manufacture vaccines.  The workshop will bring together policymakers and technical experts to identify needs and gaps in vaccine development and manufacturing capacity; generate ideas for leveraging existing resources; discuss the roles and responsibilities of stakeholders; and delineate potential policy options for the short, medium, and long-term.  This workshop will serve to inform the refinement of the implementation plan for WHO’s Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP).  The new implementation plan will align a timeline to stakeholder roles and responsibilities, and will offer recommendations addressing the challenges inherent in creating sustainable influenza vaccine production capacity worldwide.

“Workshop participants will include a broad range of stakeholders including representatives from multi-national corporations, biotech companies, developing country vaccine manufacturers, government agencies and ministries, international organizations, academic institutions, and non-governmental organizations.”

http://www.globalhealth.gov/topics/vaccineWorkshops/07122010.html

Journal of Infectious Diseases
15 October 2010  Volume 202, Number 8
http://www.journals.uchicago.edu/toc/jid/current

Editorial Commentaries
Has Oseltamivir Been Shown to Be Effective for Treatment of H5N1 Influenza?
Robert B. Couch and Barry R. Davis [Free full text]

Major Articles and Brief Reports
Viruses
Effectiveness of Antiviral Treatment in Human Influenza A(H5N1) Infections: Analysis of a Global Patient Registry [Free full text]
Wiku Adisasmito, Paul K. S Chan, Nelson Lee, Ahmet Faik Oner, Viktor Gasimov, Faik Aghayev, Mukhtiar Zaman, Ebun Bamgboye, Nazim Dogan, Richard Coker, Kathryn Starzyk, Nancy A. Dreyer, and Stephen Toovey

Background.Influenza A(H5N1) continues to cause infections and possesses pandemic potential.

Methods.Data sources were primarily clinical records, published case series, and governmental agency reports. Cox proportional hazards regression was used to estimate the effect of treatment on survival, with adjustment using propensity scores (a composite measure of baseline variables predicting use of treatment).

Results.In total, 308 cases were identified from 12 countries: 41 from Azerbaijan, Hong Kong SAR, Nigeria, Pakistan, and Turkey (from clinical records); 175 from Egypt and Indonesia (from various sources); and 92 from Bangladesh, Cambodia, China, Thailand, and Vietnam (from various publications). Overall crude survival was 43.5%; 60% of patients who received 1 dose of oseltamivir alone (OS+) survived versus 24% of patients who had no evidence of anti‐influenza antiviral treatment (OS−) ( ). Survival rates of OS+ groups were significantly higher than those of OS− groups; benefit persisted with oseltamivir treatment initiation 6–8 days after symptom onset. Multivariate modeling showed 49% mortality reduction from oseltamivir treatment.

Conclusions.H5N1 causes high mortality, especially when untreated. Oseltamivir significantly reduces mortality when started up to 6–8 days after symptom onset and appears to benefit all age groups. Prompt diagnosis and early therapeutic intervention should be considered for H5N1 disease.

The Lancet
Sep 18, 2010  Volume 376  Number 9745  Pages 929 – 1024
http://www.thelancet.com/journals/lancet/issue/current

The Lancet Commissions
The Millennium Development Goals: a cross-sectoral analysis and principles for goal setting after 2015

Jeff Waage, Rukmini Banerji, Oona Campbell, Ephraim Chirwa, Guy Collender, Veerle Dieltiens, Andrew Dorward, Peter Godfrey-Faussett, Piya Hanvoravongchai, Geeta Kingdon, Angela Little, Anne Mills, Kim Mulholland, Alwyn Mwinga, Amy North, Walaiporn Patcharanarumol, Colin Poulton, Viroj Tangcharoensathien, Elaine Unterhalter

[Free pdf:
http://download.thelancet.com/flatcontentassets/pdfs/S0140673610611968.pdf]

The Lancet
Sep 18, 2010  Volume 376  Number 9745  Pages 929 – 1024
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Equity as a shared vision for health and development
The Lancet

Original Text
In 2000, 189 countries signed up to the UN Millennium Declaration—a global commitment to halve extreme poverty and achieve equitable and sustainable development for all. The agreement led to the creation of a historic framework centred around eight Millennium Development Goals (MDGs), designed to tackle poverty, education, gender, health, environment, and global partnerships—all to be met by 2015.    On September 20—22, world leaders will gather in New York to attend the UN MDG review summit, to renew commitments and determine how to accelerate progress in the coming years. Overall, progress is uneven, with some regions, especially in the poorer countries, lagging woefully behind. Clearly, it cannot be business as usual in the next 5 years if the promises made a decade ago are to be met.

This week’s Lancet publishes the results of a Commission jointly supported by The Lancet and the London International Development Centre (LIDC). The Millennium Development Goals: a cross-sectoral analysis and principles for goal setting after 2015 uses a cross-cutting analysis to examine the origins of the goals and targets, their strengths and weaknesses, and the challenges of implementing them. On the positive side, the MDGs have achieved much. They have mobilised unprecedented political support, advocacy efforts, financial resources, and have encouraged improved monitoring and evaluation of programmes.

However, the Commission argues that the targets were narrow and fragmented. Potential linkages and synergies between goals have not been fully realised. An article by Emmanuela Gakidou and colleagues in this week’s issue supports this view, showing clear gains in health through education attainment. The study found that over the past 40 years improvements in women’s education (MDG 2) has reduced child mortality (MDG 4) substantially, averting 4·2 million deaths globally. Furthermore, the results point to the importance of a reduction of the gender gap in educational achievement, thereby promoting gender equity and empowering women (MDG 3).

The addition of new targets over time has also been unsuccessful, as seen with universal access to reproductive health. Newer priorities facing the world, such as non-communicable diseases (NCDs) and climate change, have been slow to be accepted in the current framework, although the focus on NCDs at the next UN General Assembly in September, 2011, is an important step forward. Given these problems and challenges, the Commission proposes that the next MDG framework be built on a shared vision of development across the life course rather than on separate goals and targets.

Central to the Commission is the issue of equity. Conventional wisdom is that more lives are saved by focusing on populations easier to reach with proven interventions than those who are marginalised. But the poorest communities have the worst health outcomes. Addressing the needs of the better-off simply widens disparities between the richest and poorest within communities and between countries. New UN child mortality estimates in this issue show a one-third decline in deaths in children under 5 years since 1990, far short of its 67% target. But now reports from UNICEF and Save the Children conclude that targeting the most disadvantaged children is not only morally right, but could also save the lives of millions more children. The UNICEF study found that using an equity-focused strategy, a US$1 million investment in reducing deaths in children under 5 years in a low-income, high-mortality country would avert an estimated 60% more deaths than the current approach.

Undoubtedly a key agenda item at the forthcoming summit will be future financing for global health. In times of economic austerity, foreign aid will need to be more effective and sustainable. Having public support for aid to developing countries is crucial if donors are to increase their aid budgets in line with international commitments. In a comment from Japan this week, the public supports foreign aid assistance for health. However, by contrast, a UK public survey from the Institute of Development Studies found that although most people feel development aid is morally right, over half of respondents believe aid is wasted. They do not support ring-fencing aid spending. The fact that the public are not convinced that aid works is troubling. The development community should reflect on why this is so.

The Lancet—LIDC Commission proposes a different way of approaching health and development, replacing goals and targets with principles. A revitalised effort to reach the poorest between now and 2015 would do much to ensure that the spirit of the Millennium Declaration continues to motivate all those concerned with human health in a global setting.

Science
17 September 2010  Vol 329, Issue 5998, Pages 1427-1558
http://www.sciencemag.org/current.dtl

News Focus
Public Health:
No Vaccines in the Time of Cholera

Martin Enserink
With millions of people homeless, clean drinking water in short supply, and the infrastructure in tatters, water-borne diseases are one of the biggest threats in the Pakistani regions ravaged by floods. Experts are particularly worried about cholera, a disease that can cause explosive and lethal outbreaks. The International Vaccine Institute is lobbying for production of an inexpensive new oral cholera vaccine to be ramped up. But so far, the Pakistani government has no plans for a mass vaccination campaign, and the World Health Organization does not advocate one. One key problem: The vaccine requires two doses, given 2 weeks apart, which is nearly impossible to do in a massive population on the move, experts say. The debate is just the latest in an ongoing tussle about exactly how useful the new vaccine, called Shanchol—and an older, more expensive vaccine called Dukoral—is.

The WHO reported that Angola and the Democratic Republic of Congo (DR Congo) are experiencing outbreaks of wild poliovirus type 1 (WPV1). In Angola, the outbreak, which began in April 2007, has this year spread to re-infect previously polio-free areas in Angola (the provinces of Bie, Bengo, Huambo, Lunda Norte, Lunda Sul and Uige), as well as to neighbouring DR Congo, re-infecting Kasai Occidental province which borders Angola. This outbreak is classified as ‘re-established’ transmission, as it has persisted for a period greater than 12 months.

The report notes that, “given the recent progress achieved in Nigeria (99% reduction in cases this year compared to the same period in 2009), west Africa (no cases since 1 May 2010) and the Horn of Africa (no cases in more than 12 months), central Africa is now considered to be the greatest risk to Africa’s polio eradication efforts. Angola’s outbreak is currently the only geographically expanding outbreak in Africa. This situation increases the risk to achieving the next global milestone of the new Global Polio Eradication Initiative (GPEI) Strategic Plan 2010-2012, the cessation of all re-established WPV transmission by end-2010.”

WHO said that there is currently a high risk of international spread of WPV from Angola and DR Congo, given the limited impact to date of control measures and the historical cross-border spread from both countries. In 2010, outbreak response in both countries has been inadequate to stop transmission of the imported viruses. Independent monitoring of supplementary immunization activities (SIAs) indicate as many as 25% of children are regularly missed during SIAs in key areas of Angola (including Luanda, Lunda Norte and Lunda Sul). In DR Congo, no response activities have been conducted in the east of the country since November 2009.

WHO stressed that the outbreaks require urgent action to reach a higher proportion of children with oral polio vaccine (OPV) across Angola and DR Congo and improve surveillance across Angola and DR Congo. Due to sub-national surveillance gaps, further undetected circulation of WPV1 cannot be ruled out. Given the increasingly widespread transmission of WPV1 in Angola and documented spread to DR Congo, the World Health Organization (WHO) considers the risk of further international spread as high. Given persistent undetected transmission of WPV1 in eastern DR Congo, and historical evidence of international spread, WHO considers the risk of further international spread as high.

http://www.who.int/csr/don/2010_09_08/en/index.html

The Pharmaceutical Research and Manufacturers of America (PhRMA) released a new report – Medicines in Development for Infectious Diseases 2010 – which highlights that “critical challenges remain in the centuries-old battles against infectious diseases, particularly as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America’s biopharmaceutical research companies this year have 395 new medicines and vaccines in the pipeline to fight infectious diseases. All 395 are in later stages of development, meaning in clinical trials or under Food and Drug Administration (FDA) review.”

The report also notes that “a total of 145 vaccines are in development to prevent a variety of infections, including a number of forms of influenza. Additionally, 88 antibiotics and 96 antivirals are in development. Treatments for HIV infection are not included in the most recent report, but a 2009 survey identified 97 medicines and vaccines in testing for HIV/AIDS.”

The full report  is available at: http://www.phrma.org/sites/phrma.org/files/attachments/Infectious_Diseases_2010.pdf

The MMWR for September 10, 2010 / Vol. 59 / No. 35 includes:

– Parental Attitudes and Experiences During School Dismissals Related to 2009 Influenza A (H1N1) — United States, 2009

http://www.cdc.gov/mmwr/mmwr_wk.html

The Weekly Epidemiological Record (WER) for 10 September 2010, vol. 85, 37 (pp 357–364) includes: Evaluation of elimination of neonatal tetanus in Madagascar, 2009;  Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2010

Download full text [pdf 241kb]

International Symposium on Hepatitis E

Organized by the International Vaccine Institute (IVI) with sponsorship of the Centers for Disease Control (CDC) and in collaboration with the World Health Organization (WHO) Seoul, Korea

September 15-16, 2010

http://www.ivi.org/popup/hepE_symposium/default.asp

UN Inter-Agency Support Group on Indigenous Peoples’ Issues (IASG)

Place: Geneva, Switzerland
Date: 16–17 September 2010

WHO is hosting the annual meeting of the UN Inter-Agency Support Group on Indigenous Peoples’ Issues (IASG). This year’s meeting will focus on the health of indigenous people. The meeting will discuss work carried out in this area to date, with a view to sharing best practices and fostering collaboration between UN organizations and other IASG members.

The IASG was established in 2002 to support and promote the UN Permanent Forum on Indigenous Issues (UNPFII), which focuses on indigenous issues related to economic and social development, culture, the environment, education, health and human rights. It constitutes an important arena for international cooperation and dialogue on indigenous peoples’ issues.

There are an estimated 370 million indigenous peoples living in more than 70 countries worldwide. They represent a rich diversity of cultures, religions, traditions, languages and histories; yet continue to be among the world’s most marginalized population groups. The health status of indigenous peoples varies significantly from that of non-indigenous population groups in countries all over the world.

http://www.who.int/mediacentre/events/meetings/2010/iasg/en/index.html

United Nations Permanent Forum on Indigenous Issues http://www.un.org/esa/socdev/unpfii/

JAMA
Vol. 304 No. 10, pp. 1041-1140, September 8, 2010
http://jama.ama-assn.org/current.dtl

Commentaries
Public Reporting of Hospital Hand Hygiene Compliance—Helpful or Harmful?
Matthew P. Muller; Allan S. Detsky

[First 150 words per JAMA convention; we include this commentary as it relates to public reporting strategies associated with HCW influenza immunization uptake]

Public reporting of hospital performance has been proposed as a means of improving quality of care while ensuring both transparency and accountability.1 Organizations feel pressure to perform well, deriving from their desire to protect market share and defend reputations. This pressure, if effectively harnessed, can lead to an increase in quality improvement activities and better patient outcomes, although the evidence supporting the latter claim is mixed.1

In 2002, it was estimated that approximately 1.7 million hospital-acquired infections (HAIs) and 99 000 HAI-related deaths occurred in the United States each year.2 Hand hygiene is considered the most important strategy to prevent HAIs.3 Since 2002, an increasing number of US states have mandated public reporting of quality indicators related to HAI prevention; to date, none have included reports of hand hygiene compliance in their mandates. This Commentary suggests the need for caution…

JAMA
Vol. 304 No. 10, pp. 1041-1140, September 8, 2010
http://jama.ama-assn.org/current.dtl

Commentaries
Do IRBs Protect Human Research Participants?
Christine Grady

[First 150 words per JAMA convention]

Institutional review boards (IRBs) are the core of the well-established US system for the protection of human research participants. Institutional review boards were initially created to provide independent review of research conducted by researchers at their own institutions, impartial assessment of the ethical acceptability of proposed research, and a check on investigators’ interests.1 Subsequently, advances in knowledge, technology, and resources have changed the face of research. Pharmaceutical industry research spending exceeds the National Institutes of Health (NIH) budget, which increased from approximately $1 billion in 1970 to $30 billion in 2010.2 Multisite research, expansion into international and community settings, novel scientific opportunities, freezers of stored samples, expanded categories of researchers, and entities including contract research organizations, data and safety monitoring committees, clinical trial coordinating centers, and commercial IRBs have transformed the clinical research enterprise. Concurrently, the number of, investment in, and responsibilities of IRBs have increased. . . .

JAMA
Vol. 304 No. 10, pp. 1041-1140, September 8, 2010
http://jama.ama-assn.org/current.dtl

Editorial
A Theme Issue on Infectious Disease and Immunology—Call for Papers
Gianna Zuccotti; Phil B. Fontanarosa

[First 150 words per JAMA convention]

Infectious diseases and immunologic disorders are common reasons patients seek medical care, can be associated with considerable morbidity, and account for substantial health care expenditures. Each year, there are millions of outpatient visits for a variety of infectious disorders, such as upper respiratory tract infections, acute otitis media, skin infections, community-acquired pneumonia, hepatitis, and sexually transmitted infections. In addition, infectious processes may represent life-threatening conditions for hospitalized patients, ranging from severe sepsis and ventilator-acquired pneumonia to nosocomial infection with resistant organisms and surgical site infections.

Despite control of some infectious processes, novel pathogens continue to emerge and cause severe and widespread illness, such as pandemic 2009 influenza A(H1N1) and outbreaks with multidrug-resistant organisms. At the same time, the pipeline for new antibiotics is limited since many pharmaceutical companies have curtailed antimicrobial research and development because of concerns about high costs, low . . .

The Lancet
Sep 11, 2010  Volume 376 Number 9744  Pages 845 – 928
http://www.thelancet.com/journals/lancet/issue/current

Article
Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial
Feng-Cai Zhu, Jun Zhang, Xue-Feng Zhang, Cheng Zhou, Zhong-Ze Wang, Shou-Jie Huang, Hua Wang, Chang-Lin Yang, Han-Min Jiang, Jia-Ping Cai, Yi-Jun Wang, Xing Ai, Yue-Mei Hu, Quan Tang, Xin Yao, Qiang Yan, Yang-Ling Xian, Ting Wu, Yi-Min Li, Ji Miao, Mun-Hon Ng, James Wai-Kuo Shih, Ning-Shao Xia

Summary
Background

Seroprevalence data suggest that a third of the world’s population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial.

Methods
ealthy adults aged 16—65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov, number NCT01014845.

Findings
11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0% (95% CI 72·1—100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted.

Interpretation
HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16—65 years.

Funding
Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars.

Nature Medicine
September 2010, Volume 16 No 9
http://www.nature.com/nm/index.html

Commentary
The 2010 scientific strategic plan of the Global HIV Vaccine Enterprise
The Council of the Global HIV Vaccine Enterprise: Seth Berkley, Kenneth Bertram, Jean-François Delfraissy, Ruxandra Draghia-Akli, Anthony Fauci, Cynthia Hallenbeck,
Madame Jeannette Kagame, Peter Kim, Daisy Mafubelu, Malegapuru W Makgoba, Peter Piot, Mark Walport, Mitchell Warren & Tadataka Yamada; for Members of the Enterprise: José Esparza, Catherine Hankins, Margaret I Johnston, Yves Lévy & Manuel Romaris; for Alternate members: Rafi Ahmed & Alan Bernstein

[Selected excerpts from the full Commentary]

The 2010 Plan’s two scientific priorities
Recognizing the importance of pursuing a diverse range of vaccine concepts and approaches, the 2010 Plan prioritizes two main drivers key to the next phase of HIV vaccine research and development that specifically require global collaboration.

First, the Plan recognizes that clinical trials and human clinical investigation present an unequalled opportunity to obtain important information about the human immune system and its response to vaccine candidates and that they are pivotal to advancing both vaccine discovery and vaccine development. Human efficacy trials are essential to defining the ability of vaccines to prevent infection or disease and for the discovery of vaccine-induced correlates and signatures of protection, which would ultimately accelerate the development or improvement of HIV vaccines for future licensure and public health use. This scientific imperative—made possible by major advances in laboratory and computational techniques that have opened up complex biological systems, including the human immune system, to rigorous and rapid scientific analysis—underpins the importance of clinical efficacy trials to advancing vaccine discovery and development.

Second, the Plan recognizes that trials must be linked to and build upon the tools and concepts of basic biomedical science, including genomics and computational biology, immunology, virology and model systems, to optimize both vaccine design and information on vaccine biology in humans. A strengthened clinical trials effort must therefore be accompanied by sustained, strong support for fundamental vaccine discovery research. In pursuing an increasingly science-driven clinical trials effort, the field will advance promising candidates toward vaccine licensure and, at the same time, contribute fundamental scientific insights that will improve future vaccine design, product development and clinical trials.

The 2010 Plan is therefore predicated on a multidisciplinary approach that bridges the lab and the clinic, entrenching human research as intrinsic to the discovery process, and mobilizing the collaborative efforts of basic, preclinical and clinical scientists in highly iterative vaccine design and testing…

Conclusion and next steps
The creation of the Global HIV Vaccine Enterprise and its emphasis on a shared Scientific Strategic Plan represents an unprecedented response by the international scientific community to the scientific, public health and humanitarian challenges posed by HIV/AIDS. Enterprise stakeholders have a shared commitment to fulfill three essential functions: conducting regular assessments of scientific priorities and updating them to reflect lessons learned, new opportunities and the influence of new scientific findings and new technologies, establishing global processes to address priority areas and establishing a culture of mutual accountability for effective implementation of the Plan by funders and investigators. These commitments remain imperative to the fulfillment of the 2010 Plan in driving progress in the field.

Over the past 18 months, major scientific advances have signaled the beginning of an important new phase in HIV vaccine research. At the same time, there is increasing evidence that the epidemic is in danger of spinning out of control. It is our collective responsibility to ensure that this moment is not lost. Continued progress in the field urgently requires that funders, aid agencies, researchers, industry, regulatory agencies, advocates and civil society commit to working together as an open and collaborative global community. Until a deployable, efficacious vaccine is developed, that objective will be the only and ultimate goal of the Global HIV Vaccine Enterprise.

Vaccine
http://www.sciencedirect.com/science/journal/0264410
Volume 28, Issue 41 pp. 6653-6808 (24 September 2010)

Original Research Article
Girls’ preferences for HPV vaccination: A discrete choice experiment
Pages 6692-6697
Esther W. de Bekker-Grob, Robine Hofman, Bas Donkers, Marjolein van Ballegooijen, Theo J.M. Helmerhorst, Hein Raat, Ida J. Korfag

Abstract
A discrete choice experiment was developed to investigate if girls aged 12–16 years make trade-offs between various aspects of human papillomavirus (HPV) vaccination, and to elicit the relative weight that girls’ place on these characteristics. Degree of protection against cervical cancer, protection duration, risk of side-effects, and age of vaccination, all proved to influence girls’ preferences for HPV vaccination. We found that girls were willing to trade-off 38% protection against cervical cancer to obtain a lifetime protection instead of a protection duration of 6 years, or 17% to obtain an HPV vaccination with a 1 per 750,000 instead of 1 per 150,000 risk of serious side-effects. We conclude that girls indeed made a trade-off between degree of protection and other vaccine characteristics, and that uptake of HPV vaccination may change considerably if girls are supplied with new evidence-based information about the degree of protection against cervical cancer, the protection duration, and the risk of serious side-effects.

Vaccine
http://www.sciencedirect.com/science/journal/0264410
Volume 28, Issue 41 pp. 6653-6808 (24 September 2010)

Original Research Article
Factors affecting compliance with measles vaccination in Lao PDR
Pages 6723-6729
Maniphet Phimmasane, Somthana Douangmala, Paulin Koffi, Daniel Reinharz, Yves Buisson

Abstract
In line with WHO objectives, the Lao Government is committed to eliminate measles by 2012. Yet from 1992 to 2007, the annual incidence of measles remained high while the vaccination coverage showed a wide diversity across provinces. A descriptive study was performed to determine factors affecting compliance with vaccination against measles, which included qualitative and quantitative components. The qualitative study used a convenience sample of 13 persons in charge of the vaccination program, consisting of officials from different levels of the health care structure and members of vaccination teams. The quantitative study performed on the target population consisted of a matched, case-control survey conducted on a stratified random sample of parents of children aged 9–23 months. Overall, 584 individuals (292 cases and 292 controls) were interviewed in the three provinces selected because of low vaccination coverage. On the provision of services side (supply), the main problems identified were a lack of vaccine supply and diluent, a difficulty in maintaining the cold chain, a lack of availability and competence among health workers, a lack of coordination and a limited capacity to assess needs and make coherent decisions. In the side of the consumer (demand), major obstacles identified were poor knowledge about measles immunization and difficulties in accessing vaccination centers because of distance and cost. In multivariate analysis, a low education level of the father was a factor of non-immunization while the factors of good compliance were high incomes, spacing of pregnancies, a feeling that children must be vaccinated, knowledge about immunization age, presenting oneself to the hospital rather than expecting the mobile vaccination teams and last, immunization of other family members or friends’ children. The main factors affecting the compliance with vaccination against measles in Laos involve both the supply side and the demand side. Obtaining an effective coverage requires upgrading and training the Expanded Programme on Immunization (EPI) staff and a reinforcement of health education for target populations in all provinces.

Vaccine
http://www.sciencedirect.com/science/journal/0264410
Volume 28, Issue 41 pp. 6653-6808 (24 September 2010)

Original Research Article
Seasonal influenza vaccine supply and target vaccinated population in China, 2004–2009
Pages 6778-6782
Luzhao Feng, Anthony Wayne Mounts, Yunxia Feng, Yuan Luo, Peng Yang, Zijian Feng, Weizhong Yang, Hongjie Yu

Abstract
To better understand the gap between limited influenza vaccine supply and the target population for vaccination in China, we conducted a retrospective survey to quantify the production capacity, supply and sale of seasonal trivalent inactive vaccine (TIV) from the 2004–2005 through the 2008–2009 season, and estimated the target population who should receive annual influenza vaccine. The maximum domestic capacity to produce TIV was 126 million doses in 2009. A total of 32.5 million doses of TIV were supplied in 2008–2009, with an average annual increase rate of 18% from 16.9 million in 2004–2005. This represents an amount sufficient to vaccinate 1.9% of Chinese population. The average number of doses of TIV for sale by province ranged from <5 to 108 per 1000 people. The differences are explained in part by level of economic development but also influenced by local reimbursement policies in some provinces. Based on national recommendations, we estimated a target population of 570.6 million or 43% of the total population. Supply and domestic production capacity for influenza vaccine is currently insufficient to vaccinate the estimated target population in China. The Government of China should consider measures to improve domestic production capacity of influenza vaccine, expand successful promotional campaigns, and add cost subsidies in high risk groups to further encourage influenza vaccine usage.

Vaccine
http://www.sciencedirect.com/science/journal/0264410
Volume 28, Issue 41 pp. 6653-6808 (24 September 2010)

Original Research Article
Control of hepatitis A by universal vaccination of children and adolescents: An achieved goal or a deferred appointment?
Pages 6783-6788
Domenico Martinelli, Isabella Bitetto, Silvio Tafuri, Pietro L. Lopalco, Rosa Maria Mininni, Rosa Prato

Abstract
Temporal trends of Hepatitis A cases and vaccination coverage data against Hepatitis A Virus have been investigated to analyse the impact of the universal routine vaccination strategy more than 10 years from its introduction in Puglia (region of Southern Italy). The basic reproductive number (R0) before vaccination introduction and the effective reproductive number (Re) after introduction have been calculated. A progressive decrease in incidence has been recorded in Puglia during last 10 years. Vaccination coverage is actually 64.8% (95% CI: 52.7–76.9%) for children aged 12–24 months and of 67.6% (95% CI: 58.4–76.8%) for 12-year-old adolescents. R0 estimated in 1996 was 2.01; actually Re is 0.651. Theoretical age at infection is 31.82 years. Universal routine vaccination aimed at the control of direct transmission remains the milestone in the strategy for the containment of the disease in settings at an intermediate level of endemicity.

Vaccine
Volume 28, Issue 39 pp. 6403-6548 (7 September 2010)

Short Communications
Implementing a birth dose of hepatitis B vaccine for home deliveries in Africa—Too soon?
Pages 6408-6410
Anna Kramvis, C. John Clements

Abstract
Despite the recommendation of the World Health Organization (WHO) to provide the first hepatitis B vaccine dose at birth (within 24 h), there are epidemiological, economic and logistical reasons why this may not be the best approach for home births in Africa. The WHO policy presupposes that the epidemiology of hepatitis B infection in Africa is similar to the rest of the world and that the organizational, infrastructural and financial support is adequate. While babies born in health facilities may be relatively easy to immunize at birth, health systems and infrastructures in many resource-poor countries in Africa would be severely challenged, if required to reach home deliveries within 24 h of birth.

Vaccine
Volume 28, Issue 39 pp. 6403-6548 (7 September 2010)
Original Research Article
Predictors of universal influenza vaccination uptake in grades 1 and 2 Toronto school children: Effective vaccination strategies should not end with at risk children
Richard G. Foty, Astrid Guttmann, Jeffrey C. Kwong, Sarah Maaten, Doug Manuel, David M. Stieb, Sharon D. Dell

The new Global Immunization News 31 August 2010 leads the issue with a report on the Pakistan Flood situation noting that “polio eradication staff and resources have been mobilized to support the response to the devastating floods directly affecting one in 10 people in Pakistan. All polio-funded technical staff – polio epidemiologists and surveillance officers – have been relocated to the worst-affected areas of the country to assist in the recovery. These staff are focused on three main areas: a rapid assessment of the extent of damage to health facilities; the establishment of early warning systems for disease outbreaks; and, the planning, delivery and monitoring of  broad immunization activities in internally-displaced-persons camps…”

More at: http://www.who.int/immunization/GIN_August_2010.pdf

Dr Margaret Chan, Director-General of the World Health Organization, commented on MDG goals and African nations in an address to the Regional Committee for Africa, Sixtieth Session, Malabo, Equatorial Guinea, on 30 August 2010. Below is a portion of her remarks that related to vaccines and immunization:

“…African nations can reach the health-related Millennium Development Goals

health initiatives, like the Global Fund, like the GAVI Alliance, have done great good over the past decade and are widely praised as models of success. In Africa, for example, 76% of external financial support for malaria control has come from the Global Fund.

These initiatives introduced the principle of results-based funding. And yet despite their own excellent, measurable results, they are now strapped for cash.

Other initiatives speeded the development of new vaccines to prevent pneumonia and diarrhoeal disease, the two biggest killers of young children in the developing world. Yet the implementation of these life-saving vaccines into routine immunization programmes is now in jeopardy because of funding shortfalls.

Tremendous progress towards the elimination of measles, especially here in Africa, is also now in jeopardy because of funding shortfalls. A highly contagious disease like measles can resurge very quickly. Some 28 countries in Africa have suffered measles outbreaks this year. As I said, progress is fragile.

Antiretroviral therapy for AIDS is a life-line, for a lifetime. Can we cut this life-line off because funds are running short, or because donors decide that investment in other priorities will yield a bigger payback? Do we have this moral option?

What will it mean if a financial crisis, seeded by greed, cancels out fragile health gains made possible by so much good will and innovation? Does the worst in human nature win over the best? These are big-picture issues, and they need to be raised.

Progress towards polio eradication is also fragile. Last year, this region faced widespread polio epidemics across 20 countries of West Africa, Central Africa, and the Horn of Africa. The situation was so alarming that some people began to talk about abandoning the goal of polio eradication.

The situation looks much better today. With your collaboration, we now have an aggressive new strategic plan to complete polio eradication. Among other things, it address head-on the problem of international spread that has made progress so fragile. It also introduces accountability at the sub-national level.

Today, Nigeria has reduced the incidence of polio by a striking 99%. The Horn of Africa is again polio-free. No virus has been detected in West Africa since the start of May, though it is too early to say the outbreak has been stopped.

We are deeply concerned about the outbreak in Angola, which is the only expanding polio outbreak in the world this year. Polio also persists in neighbouring Democratic Republic of the Congo, where the virus circulated undetected in one area for nearly two years.

This situation must be reversed. Every child must be reached, during campaigns and through strong routine immunization. A resurgence of polio, of deaths, and childhood paralysis is the predictable consequence if we fail to stay the course.

Ladies and gentlemen,

We need to raise some big-picture issues, but we also need to preserve our optimism and keep building the momentum.

I asked earlier: what does it mean that progress towards the MDGs is so uneven in Africa? One thing is clear. It means you cannot generalize about conditions in Africa.

Old perceptions, that Africa is uniformly poor and needy, universally sick and hungry, or badly governed across the board, no longer pertain to modern Africa. Countries at similar levels of socioeconomic development have strikingly different health outcomes, and this already tells us something.

Governance is improving and democracy is gaining ground. A middle class is emerging. Fertility is going down. Your populations are comparatively young, and this is an asset. As the economists argue, Africa is poised to cash in on a “demographic dividend” that can perpetuate a cycle of growth.

Let me state my view very clearly. The health-related MDGs are within the reach of African nations…

…In early December, a new conjugate meningitis vaccine, tailor-made and priced for Africa, will be launched in Burkina Faso in a mass campaign. This vaccine has the power to transform the terrifying, recurring epidemics uniquely seen in the African meningitis belt.

You asked for this vaccine. You wanted it and you stated the price you could afford. As Niger’s minister of health argued at the time, “A vaccine that Africa cannot afford is worse than no vaccine at all.”

A unique WHO-PATH partnership, the Meningitis Vaccine Project, developed the new conjugate vaccine. It is manufactured in India, using technology transferred from the USA. The price per dose is less than 50 cents.

African scientists designed the study protocols and conducted the clinical trials. Canada assisted with regulatory approval. WHO pre-qualified the vaccine in June. The first 1.35 million doses arrived in Burkina Faso on 12 August.

Africa has a first-rate vaccine for an African disease. You also have a powerful model of partnership for the development of new products…”

Full text of remarks at: http://www.who.int/dg/speeches/2010/AFRO_Regcom_20100830/en/index.html

IFPMA released a new study at the Options for the Control of Influenza VII conference in Hong Kong showing that “global vaccine coverage remains uneven and low overall, despite total distribution of seasonal influenza vaccines nearly doubling over the last six years.” The IFPMA report influenza “found that less than one in three countries receives sufficient vaccine to immunize 10% of its inhabitants, although the number of seasonal influenza vaccine doses distributed annually worldwide between 2004 and 2009 grew from 262 million to 449 million, an increase of 72%. “

Dr. Kristin Nichol, Professor of Medicine at the University of Minnesota and influenza policy consultant, commented, “Seasonal influenza continues to represent a major threat to public health, so the increases in vaccine provision revealed by this IFPMA study are highly encouraging. It is essential that governments continue to increase vaccine coverage, because the study results also show that uptake remains low in many countries. This is despite the WHO setting a goal for immunization programs to reach at least 75% of the elderly by 2010.”
More at: The IFPMA Study “Provision of seasonal influenza vaccines in 157 countries (2004-2009)” http://www.ifpma.org/fileadmin/webnews/2010/pdfs/20100903_IVS226_IFPMA_IVS_seasonal_flu_vac_dose_distribution_study.pdf

Sabin Vaccine Institute said its President Dr. Peter Hotez, writing in PLoS Neglected Tropical Diseases, “calls on the G8, Gulf Cooperation Council nations, and neglected tropical disease (NTDs) endemic countries, such as Nigeria and Indonesia, to fund global NTD control efforts.” Dr. Hotez notes that “despite a growing awareness of NTDs as both a global health and security threat, the burden of funding has been primarily shouldered by three nations—the United States, United Kingdom, and Japan…” The Italian government hosted a high profile NTD workshop in 2009 but has “so far failed to translate the conclusions of this meeting into meaningful action,” while the German government, which developed praziquantel, a drug used to treat schistosomiasis, has failed to find a mechanism to donate the drug to African nations where it is desperately needed. The richest non-G8 European countries have also failed to support global NTD control notes the editorial.  “If together the BRIC countries and Nigeria and Indonesia would commit to controlling their own NTDs, it would likely double the impact of the current US commitment,” Dr. Hotez concludes.

Read “Neglected Tropical Disease Control in the “Post-American World.”

The MMWR for 3 September 3, 2010 / Vol. 59 / No. 34 includes:
– Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23)

– Announcements: Clinical Vaccinology Course — November 5–7, 2010

http://www.cdc.gov/mmwr/mmwr_wk.html

The WHO released WHO/IVB/10.06: The Initiative for Vaccine Research Report 2008-2009. The “biennial report 2007-2008 documents and evaluates the activities and achievements of IVR during this period against its stated objectives, and highlights its plans for the future in vaccine and immunization R&D.”

http://whqlibdoc.who.int/hq/2010/WHO_IVB_10.06_eng.pdf

Clinical Infectious Diseases
1 October 2010  Volume 51, Number 7
http://www.journals.uchicago.edu/toc/cid/current

Correspondence
Risk of Fatal Adverse Events after H1N1 Influenza Vaccine: Limitations of Passive Surveillance Data
Michael M. McNeil, Karen R. Broder, Claudia Vellozzi, and Frank DeStefano

Informal Network of Communication Tools Played an Important Role in Sharing Safety Information on H1N1 Influenza Vaccine
Haruka Nakada, Naoko Murashige, Tomoko Matsumura, Yuko Kodama, and Masahiro Kami

Human Vaccines
Volume 6, Issue 9  September 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/8/

Review
HPV vaccine acceptance, utilization and expected impacts in the US: Where are we now?
Amanda F. Dempsey and Divya A. Patel

Abstract
Human papillomavirus (HPV) vaccines represent a remarkable opportunity for the primary prevention of cervical cancer and other HPV-related diseases. With almost four years of vaccine availability now accrued in the United States (US.), data are beginning to accumulate about vaccine utilization patterns and how these may be affected by public opinions about the vaccines. This article describes the burden of HPV infection and related disease in the US, and reviews what is currently known about HPV vaccine utilization among adolescent and young adult females in this country. In addition, we report on emerging data on the personal and attitudinal factors that appear to influence HPV vaccine utilization and discuss how these data may be useful for designing future interventions to improve uptake of these vaccines. Finally, we re-examine cost-effectiveness studies of HPV vaccines, taking into account updated information on utilization of, and public attitudes about, these vaccines.

Human Vaccines
Volume 6, Issue 9  September 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/8/

Commentary
Public health measures & individualized decision-making: The confluence of H1N1 vaccine and Islamic bioethics
Aasim I. Padela

Abstract
Vaccinations are amongst the most cost-effective and successful public health interventions. During the H1N1 influenza pandemic public health organizations around the world mobilized to procure and deliver vaccinations to the at-risk populations in order to reduce spread of, and decrease morbidity and mortality from, the swine flu. With the focus on delivering vaccines at a population-level, state and national governmental agencies coordinated to procure vaccine supplies within the United States. However all healthcare decisions trickle down to the individual level. In this essay I narrate the tensions and challenges I faced to make decisions for myself and my family on whether we should get the H1N1 vaccines, while being true to both religious values and the medical science. At the end of the narration I reflect on ethical and policy questions we must address during public health vaccination efforts.

JAMA
Vol. 304 No. 9, pp. 935-1028, September 1, 2010
http://jama.ama-assn.org/current.dtl

Commentaries
Improving Access to Health Care Data: The Open Government Strategy
Patrick H. Conway; Jordan M. VanLare

Extract (Initial article language per JAMA convention]
Access to high-quality data is critical to innovation, quality improvement, and increased efficiency in health care. The federal government has signaled that expanding access to and improving the quality of health care data for the purpose of research is a priority. In its report to Congress, the Federal Coordinating Council for Comparative Effectiveness Research emphasized the need for investment in data infrastructure and access to support comparative effectiveness research. The Office of the National Coordinator for Health Information Technology included the promotion of a nationwide health information technology infrastructure to facilitate health and clinical research as part of its mission.

The April 2010 release of the Department of Health and Human Services’ (DHHS’) Open Government strategy was a major step forward in expanding health data access. The DHHS developed the strategy in response to President Obama’s Open Government Directive…

Journal of Infectious Diseases
1 October 2010  Volume 202, Number 7
http://www.journals.uchicago.edu/toc/jid/current

Major Articles and Brief Reports
Parasites

Evaluation of the Safety and Immunogenicity of the RTS,S/AS01E Malaria Candidate Vaccine When Integrated in the Expanded Program of Immunization
Selidji T. Agnandji, Kwaku Poku Asante, John Lyimo, Johan Vekemans, Solange S. Soulanoudjingar, Ruth Owusu, Mwanajaa Shomari, Amanda Leach, Jose Fernandes, David Dosoo, Maria Chikawe, Saadou Issifou, Kingsley Osei-Kwakye, Marc Lievens, Maria Paricek, Stephen Apanga, Grace Mwangoka, Blaise Okissi, Evans Kwara, Rose Minja, Jorn Lange, Owusu Boahen, Kingsley Kayan, George Adjei, Daniel Chandramohan, Erik Jongert, Marie-Anger Demote, Marie-Claude Dubois, Terrell Carter, Pretty Vandalia, Tonya Villa Ana, Marla Silliman, Barbara Savories, Didier Lapeer, William Ripley Ballot, Brian Greenwood, Marcel Tanner, Joe Cohen, Peter G. Krasner, Bertrand Loll, Seth Owusu-Agyei, and Salim Abdulla

Background.The RTS,S/AS01E malaria candidate vaccine is being developed for immunization of African infants through the Expanded Program of Immunization (EPI).

Methods.This phase 2, randomized, open, controlled trial conducted in Ghana, Tanzania, and Gabon evaluated the safety and immunogenicity of RTS,S/AS01E when coadministered with EPI vaccines. Five hundred eleven infants were randomized to receive RTS,S/AS01E at 0, 1, and 2 months (in 3 doses with diphtheria, tetanus, and whole-cell pertussis conjugate [DTPw]; hepatitis B [HepB]; Haemophilus influenzae type b [Hib]; and oral polio vaccine [OPV]), RTS,S/AS01E at 0, 1, and 7 months (2 doses with DTPwHepB/Hib+OPV and 1 dose with measles and yellow fever), or EPI vaccines only.

Results.The occurrences of serious adverse events were balanced across groups; none were vaccine-related. One child from the control group died. Mild to moderate fever and diaper dermatitis occurred more frequently in the RTS,S/AS01E coadministration groups. RTS,S/AS01E generated high anti–circumsporozoite protein and anti–hepatitis B surface antigen antibody levels. Regarding EPI vaccine responses upon coadministration when considering both immunization schedules, despite a tendency toward lower geometric mean titers to some EPI antigens, predefined noninferiority criteria were met for all EPI antigens except for polio 3 when EPI vaccines were given with RTS,S/AS01E at 0, 1, and 2 months. However, when antibody levels at screening were taken into account, the rates of response to polio 3 antigens were comparable between groups.

Conclusion.RTS,S/AS01E integrated in the EPI showed a favorable safety and immunogenicity evaluation.

Trial registration.ClinicalTrials.gov identifier: NCT00436007. GlaxoSmithKline study ID number: 106369 (Malaria-050).

Nature
Volume 467 Number 7311 pp7-124  2 September 2010
http://www.nature.com/nature/current_issue.html

Letters
Bacterial charity work leads to population-wide resistance

Summary
Bacteria regularly evolve antibiotic resistance, but little is known about this process at the population level. Here, a continuous culture of Escherichia coli facing increasing antibiotic levels is followed. Most isolates taken from this population are less antibiotic resistant than the population as a whole. A few highly resistant mutants provide protection to the less resistant constituents, in part by producing the signalling molecule indole, which serves to turn on drug efflux pumps and oxidative-stress protective mechanisms.

Henry H. Lee, Michael N. Molla, Charles R. Cantor & James J. Collins