Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

How parents make decisions about their children’s vaccinations
Original Research Article
Pages 5466-5470
Emily K. Brunson

Abstract
Background
Continued parental acceptance of childhood vaccination is essential for the maintenance of herd immunity and disease prevention. As such, understanding parents’ decision-making in relation to their children’s vaccinations is vitally important.

Objective
This qualitative study sought to develop an understanding of the general process parents go through when making decisions about their children’s vaccinations.

Methods
Interviews were conducted with U.S.-born parents living in King County, Washington who had children ≤18 months of age. These interviews were recorded and transcribed verbatim.

Results
Through the application of grounded theory, a general decision-making process was identified. Stages in this process included: awareness, assessing and choosing, followed by either stasis or ongoing assessment. The greatest variation occurred during the assessing stage, which involved parents examining vaccination-related issues to make subsequent decisions. This research suggests that three general assessment groups exist: acceptors, who rely primarily on general social norms to make their vaccination decisions; reliers, who rely primarily on other people for information and advice; and searchers, who seek for information on their own, primarily from published sources.

Conclusions
These results imply that one-size-fits-all approaches to vaccination interventions are inappropriate. Instead, this research suggests that interventions must be targeted to parents based on how they assess vaccination.

Vaccine
Volume 31, Issue 45, Pages 5147-5296 (25 October 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/45

“HPV? Never heard of it!”: A systematic review of girls’ and parents’ information needs, views and preferences about human papillomavirus vaccination
Review Article
Pages 5152-5167
Maggie Hendry, Ruth Lewis, Alison Clements, Sarah Damery, Clare Wilkinso

Abstract
Background and objective
Two human papillomavirus vaccines were licenced in 2006/2007 for cervical cancer prevention. National vaccination programmes for schoolgirls were subsequently introduced in some European countries, North America and Australia. To understand factors influencing vaccine uptake and to inform the development of appropriate UK educational materials, we aimed to synthesise evidence of girls’ and parents’ information needs, views and preferences regarding HPV vaccination.

Design
Systematic review and mixed method synthesis of qualitative and survey data.

Data sources
Twelve electronic databases; bibliographies of included studies 1980 to August 2011.

Review methods
Two reviewers independently screened papers and appraised study quality. Studies were synthesised collaboratively using framework methods for qualitative data, and survey results integrated where they supported, contrasted or added to the themes identified.

Results
Twenty-eight qualitative studies and 44 surveys were included. Where vaccination was offered, uptake was high. Intention to decline was related to a preference for vaccinating later to avoid appearing to condone early sexual activity, concerns about vaccine safety and low perception of risk of HPV infection. Knowledge was poor and there were many misconceptions; participants tried to assess the potential benefits and harms of vaccination but struggled to interpret limited information about HPV in the context of existing knowledge about sexually transmitted infections and cancer.

Conclusion
Many girls and their parents have limited understanding to an extent that impinges on their ability to make informed choices about HPV vaccination and could impact on future uptake of cervical screening. This is a considerable challenge to those who design and provide information, but getting the messages right for this programme could help in developing patient information about other HPV related cancers.

Vaccine
Volume 31, Issue 45, Pages 5147-5296 (25 October 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/45

HPV vaccination among French girls and women aged 14–23 years and the relationship with their mothers’ uptake of Pap smear screening: A study in general practice
Original Research Article
Pages 5243-5249
D. Lutringer-Magnin, C. Cropet, G. Barone, G. Canat, J. Kalecinski, Y. Leocmach, P. Vanhems, F. Chauvin, C. Lasset

Abstract
Introduction
HPV vaccination is recommended in France for girls aged 14 and for those aged 15–23 before sexual debut or who have become sexually active within the previous year. The first aim was to describe vaccination practice among 14–23-year-old girls visiting a general practitioner. A second objective was to investigate factors associated with starting vaccination among girls aged 14–18, in particular the regular practice of Pap-smear screening (PSS) by their mothers.

Methods
A cross-sectional study was conducted from June to August 2009. A total of 87 general practitioners from the large Rhône-Alpes region contributed data on 502 girls/women who came for consultation.

Results
231 (46.0%) of these girls/women had begun the process of HPV vaccination (68.2%, 56.9% and 18.7% of the 14–16, 17–20 and 21–23-year-olds respectively) of whom 139 (60.2%) had received all three doses. 92 girls/women (39.8%) had received only one or two doses at the time of study. However, in 71 (77.2%) cases, the gap between the last dose received and the time of study was within the between-dose interval recommended in the vaccination schedule. GPs reported that 16 (11.5%) had mentioned side effects following injections. Having a mother who practised regular PSS (Odds Ratio 6.2 [1.5–25.8]), having never lived with a partner (4.6 [1.6–13.5]) and vaccination against hepatitis B (3.2 [1.6–6.1]) were found to be independently correlated with the initiation of HPV vaccination among girls/women aged 14–18 years.

Conclusion
Two years after the start of the programme, only half of girls/women aged 14–23 years had begun the process of HPV vaccination. HPV vaccination status was correlated with PSS in the mother, family status and hepatitis B vaccination. Such information may help to better target girls who are less likely to be vaccinated.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Human papillomavirus vaccine intentions among males: A test of the Parallel Processing Model
CW Wheldon, ER Buhi, EM Daley, ND Hernandez… – Journal of Health Psychology …, 2013

Abstract
We investigated the cognitive and emotional reactions resulting from a human papillomavirus–related illness threat (i.e. testing positive for human papillomavirus) and the potential behavioral implications resulting from these psychosocial processes among men (N = 536). Structural equation modeling was used to explore a theoretical model explaining human papillomavirus vaccine intentions. The model fit the data well and explained 16 percent of the variance in vaccine intentions. Negative emotional response mediated the path between illness threat and vaccine intentions. Threat of genital warts was a salient concern and was positively associated with negative emotional response and subsequent vaccine intentions. Implications for vaccine promotion are discussed.

Vaccines and Global Health: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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– Email Summary: Vaccines and Global health : The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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– pdf version: A pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_19 Oct 2013
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– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

    IVI (International Vaccine Institute) announced that a new clinical study shows for the first time that an oral cholera vaccine (Shanchol) provides sustained protection against cholera, with protective efficacy of 65% over a five-year period in humans. The study, published in the Lancet Infectious Diseases, was a collaboration between scientists from the International Vaccine Institute (IVI) an international organization based in Seoul, and the National Institute of Cholera and Enteric Diseases, (NICED), an institute under the Indian Council of Medical Research (ICMR) of India’s Ministry of Health and Family Welfare.    A Phase III clinical trial was jointly conducted by IVI and NICED in Kolkata, India in 2006 to assess the efficacy of the vaccine. More than 30,000 volunteers from one year old and up were enrolled in the study. A placebo group with a similar number of volunteers was also included.
Previous results from this study had shown that the vaccine provided 66% protection over a three-year period, and the new result shows that such protection is sustained for two additional years. Since vaccine protection does not wane over time, the study has important practical implications in terms of vaccination cost and vaccination strategies in developing countries.

Dr. Thomas F. Wierzba, Deputy Director General of Vaccine Development & Delivery at IVI and co-author of the study, said, “The study results suggest that this vaccine will protect persons at risk of severe cholera for five years. With protection sustained for five years, we will be able to provide greater benefits to the poor at reduced costs.” Dr. Christian Loucq, IVI’s Director General, commented, “The vaccine is safe, easy to administer, cost effective, and provides protection for up to five years. The use of the vaccine, combined with other control measures, will make it more feasible for developing countries afflicted by cholera to control a disease that plagues millions of people every year.”
http://www.ivi.org/web/www/07_01?p_p_id=EXT_BBS&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_EXT_BBS_struts_action=%2Fext%2Fbbs%2Fview_message&_EXT_BBS_messageId=560

[See also Journal Watch below: The Lancet Infectious Diseases]

The GAVI Alliance released it Mid-Term Review report, described as “a comprehensive and transparent assessment…aimed at examining the progress GAVI has made midway through its current strategic period from 2011 to 2015, and the challenges it faces in meeting its commitments to developing countries and to donors.” GAVI noted that the report is being published two weeks before GAVI partners – including the World Health Organization, UNICEF, the World Bank, the Bill & Melinda Gates Foundation, implementing and donor countries, civil society organisations and vaccine manufacturers – meet in Stockholm for the Alliance’s Mid-Term Review. GAVI said the report highlights that:

:: Since 2011, GAVI has funded a total of 67 new vaccine introductions and campaigns. By 2014 all 73 GAVI-supported countries will have introduced 5-in-1 pentavalent vaccines, including introductions in Haiti, Myanmar, Somalia and South Sudan.

:: Following a slow start, GAVI’s recently revamped health system strengthening programme now ensures that investments are translated more clearly into improved immunisation outcomes. As a result, GAVI is seeing investments and improvements in health system rapidly picking up speed.

:: GAVI is close to achieving its target of timely receipt of 100% of co-financing payments (contributions made by developing countries towards the cost of the vaccines). As of August, 64 of the 67 co-financing countries had fulfilled their commitments for 2012. And from 2011 to 2013 these payments totalled US$ 125 million, representing 8% of GAVI’s total support to these countries. All this is also helping to drive increases in country investment in their own health systems.

:: GAVI has also helped to produce more predictability and competition in the vaccine market, which has helped to bring down the cost of fully vaccinating a child with three priority vaccines – pentavalent, pneumococcal and rotavirus – from US$ 35 in 2010 to US$ 23 in 2012.

GAVI said the report “also highlights the challenges that the Alliance is attempting to address” including “improving the reliability of supply chains and finding ways to improve in-country data collection; adopting tailored approaches to meet the unique and challenging needs of fragile states; and ensuring the sustainability of immunisation programmes in countries whose wealth has increased to the point that they are no longer eligible for GAVI support.”
http://www.prnewswire.com/news-releases/gavi-alliance-on-track-to-immunise-a-quarter-of-a-billion-children-by-2015-and-prevent-nearly-4-million-deaths-227627121.html

*****

GAVI’s Mid-Term Review report http://midtermreview.gavialliance.org/
October 2013
[Editor’s formatting and extracted detail]

:: Introduction – Foreword by Dagfinn Høybråten, Chair of the GAVI Alliance Board

:: Bigger picture – Overview of the health & immunisation landscape & GAVI’s impact since 2000

:: Results- Delivering on the GAVI mission & strategic goals 2011-2015

:: Challenges – New approaches and measures in response to the changing global context

:: Looking ahead – GAVI’s role until 2015 and beyond

:: Key performance indicators
    Updates on the mission & goal-level indicators that monitor GAVI’s progress

GAVI uses 14 key performance indicators to monitor its five-year strategy. Click on each indicator below for a mid-term assessment of the Alliance’s progress against its 2015 targets. 

Mission: To save children’s lives and protect people’s health by increasing access to immunisation in poor countriesGAVI is currently on track to meet 2015 targets for its mission indicators. Key issues affecting progress include the strength of country systems and GAVI’s ability to mobilise timely, effective support in response to country demand. Other key issues to watch include uncertainties in global estimates of disease burden and immunisation coverage, and changes in estimates over time.

:: Timeline of vaccine introductions and campaigns, 2011–2013

:: View all the data graphics in this report

:: The role GAVI’s founding partners play in the Alliance

:: Donors to the GAVI Alliance

[See Lancet editorial in Journal Watch below]

    NIAID named John R. Mascola, M.D. as the new director of the Vaccine Research Center (VRC) where “he will lead a comprehensive research program aimed at the design, development and testing of candidate vaccines against HIV/AIDS, influenza and other globally important infectious diseases.” He will also serve as chief of the VRC virology laboratory. NIAID Director Anthony S. Fauci, M.D. commented, “John Mascola is a visionary leader who brings a wealth of talents as a basic scientist, clinician, clinical trialist and administrator to the helm of the Vaccine Research Center. In particular, his exemplary work on elucidating the protective role of antibodies against HIV has greatly influenced current vaccine design efforts.  I am confident that Dr. Mascola will continue and even accelerate our momentum toward the development of novel, effective vaccines against infectious diseases.”

http://www.nih.gov/news/health/oct2013/niaid-01.htm

Update: Polio this week – As of 16 October 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]
:: Eleven new wild poliovirus (WPV) cases were reported in the past week (one from Afghanistan, two from Ethiopia, four from Pakistan and four from Somalia).
:: The total number of WPV cases for 2013 is now 296 (all WPV1), with 99 from endemic countries and 197 from outbreak countries.
:: Although the total WPV count is now higher than the same period 2012, the quantity of cases from the three endemic countries is 60% of the same time period 2012. Afghanistan has one third and Nigeria half the amount of cases when compared to 2012. Pakistan, with the majority of cases from Federally Administered Tribal Areas (FATA), has almost identical numbers to this time 2012. The situation in North Waziristan, FATA, is becoming increasingly severe, as it is the area with the largest number of children being paralyzed by poliovirus in all of Asia; 13 WPV cases and 22 circulating vaccine-derived poliovirus type 2 (cVDPV2). See ‘Pakistan’ section for more.

Afghanistan
:: One new WPV1 case was reported in the past week. The total number of WPV cases for 2013 is now seven (all WPV1), all of which were reported from Eastern Region, close to the Pakistan border. The most recent WPV1 case had onset of paralysis on 15 September, from Kunar province…

Pakistan
:: Four new WPV1 cases were reported in the past week. All were reported from FATA (two from Khyber Agency and two from North Waziristan). The total number of WPV1 cases for Pakistan in 2013 is now 43. The most recent WPV1 case had onset of paralysis on 26 September (from Khyber Agency). The majority of WPV1 cases in Pakistan this year, 31 (72%), are from FATA, of which 14 are from Khyber Agency and 13 from North Waziristan.
:: The situation in North Waziristan is becoming increasingly severe, as it is the area with the largest number of children being paralyzed by wild poliovirus (13 cases) and cVDPV2s (22) in all of Asia. It is in an area where immunization activities have been suspended by local leaders since June 2012. It is critical that children in these areas are vaccinated and protected from poliovirus. Immunizations in neighboring high-risk areas are being intensified, to further boost population immunity levels in those areas and prevent further spread of this outbreak…

Chad, Cameroon and Central African Republic
:: Central African Republic (CAR) continues to be at serious risk of re-infection due to proximity with Chad, ongoing insecurity and humanitarian crises, and destruction of health infrastructure. To minimize the risk and consequences of potential re-infection, SNIDs were conducted on 30 September to 2 October and NIDs are planned for end October…

Horn of Africa
:: Six new WPV1 cases were reported in the past week (four from Somalia and two from Ethiopia). The total number of WPV cases (all WPV1) for 2013 in the Horn of Africa is now 197 (174 from Somalia, 14 from Kenya, six from Ethiopia and three from South Sudan). The most recent WPV1 case in the region had onset of paralysis on 19 September (from Somali region, Ethiopia)…

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – update 18 October 2013
:: Human infection with avian influenza A(H7N9) virus – update 16 October 2013
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – update 14 October 2013

The Weekly Epidemiological Record (WER) for 18 October 2013, vol. 88, 41 (pp. 449–464) includes:
:: Antigenic and genetic characteristics of zoonotic influenza viruses and development of candidate vaccine viruses for pandemic preparedness
:: Monthly report on dracunculiasis cases, January–August 2013
http://www.who.int/entity/wer/2013/wer8842.pdf

Globalization and Health
[Accessed 19 October 2013]
http://www.globalizationandhealth.com/

Debate
Developing global health technology standards: what can other industries teach us?
Hassan Masum, Rebecca Lackman and Karen Bartleson
Globalization and Health 2013, 9:49 doi:10.1186/1744-8603-9-49
Published: 17 October 2013  http://www.globalizationandhealth.com/content/9/1/49/abstract

Abstract (provisional)
Background
There is a lack of effective and affordable technologies to address health needs in the developing world. One way to address problems of innovation and affordability is to design global health technologies to follow agreed-upon standards. This Debate article argues that we can better develop standards for global health technologies if we learn lessons from other industries.

Discussion
The article’s Background section begins by explaining why standards are needed in global health. For example, if global health technologies can be modularized into independent interfacing parts, these parts can then interact via well-defined standards in a “plug and play” fashion. This can avoid development of mutually incompatible solutions by different organizations, speed the pace of innovation, unlock health systems from single providers and approaches, and lower barriers to entry. The Background then gives a brief primer on standards and discusses incentives for health standards. The article’s Discussion section begins with brief relevant cases of standards development from other industries, including electricity, container shipping, CD standards, Universal Serial Bus (USB), and the Internet. It then explores lessons from these and other industries that suggest how to develop standards for global health technologies. The remainder of the Discussion considers intellectual property and regulatory issues and standards-based global health business models, and ends with a checklist of considerations for health standards development leaders. (The associated Additional file discusses observations from standards development for cell phones and semiconductors, as well as challenges in the standards development process itself.) Throughout the article, point-of-care diagnostics are used as an illustrative example. An initiative is already underway to explore standardized diagnostics platforms.

Summary
This Debate article aims to convince the reader that standards can benefit global health technologies if we learn lessons from other industries. The article draws from historical examples and the authors’ experiences to suggest principles, challenges, and opportunities in developing these standards. If implemented well, standardized platforms can lower barriers to entry, improve affordability, and create a vibrant ecosystem of innovative new global health technologies.

International Journal of Infectious Diseases
Vol 17 | No. 11 | November 2013
http://www.ijidonline.com/current

Short Communications
Immune response to hepatitis B vaccine in a group of health care workers in Sri Lanka
L.S. Chathuranga, F. Noordeen, A.M.S.B. Abeykoon
http://www.ijidonline.com/article/S1201-9712%2813%2900177-X/abstract

Summary 
Health care workers (HCWs) are considered at high risk of acquiring the hepatitis B virus (HBV). Seroconversion rates after vaccination against HBV among HCWs have not previously been available in Sri Lanka. In the current study, the response to HBV surface antigen (HBsAg) vaccine was assessed in a selected group of HCWs by testing for antibodies against HBsAg (anti-HBs). This was a retrospective descriptive study to measure the anti-HBs levels, using an ELISA, in an immunized group of HCW referred to Department of Microbiology, Faculty of Medicine, University of Peradeniya, Sri Lanka. Among the 342 participants, 9.9% (n=34) were non-responders. Female participants had a significantly higher immune response (94.7%) than males (p<0.05). The results of the study found no significant decline in the immune response with time (p > 0.05). Post HBsAg vaccination immunity in HCW in Sri Lanka is similar to that of global rates with similar gender variation. Anti-HBs levels should be tested in all HCW following HBsAg vaccination so that necessary precautions can be taken.

Journal of Public Health Policy
Volume 34, Issue 4 (November 2013)
http://www.palgrave-journals.com/jphp/journal/v34/n4/index.html

The Federation’s Pages
Journal of Public Health Policy (2013) 34, 574–579. doi:10.1057/jphp.2013.38
The right to health is coming of age: Evidence of impact and the importance of leadership
Flavia Bustreo a and Paul Hunt b
A Assistant Director-General, Family, Women’s and Children’s Health, World Health Organisation
B UN Special Rapporteur on the right to the highest attainable standard of health (2002–2008)
The content of the Federation’s Page is selected and edited by the WFPHA and not reviewed by JPHP.
 Excerpt http://www.palgrave-journals.com/jphp/journal/v34/n4/full/jphp201338a.html

“At this year’s high-level session of the World Health Assembly, the right to the highest attainable standard of health was mentioned by Ministers of Health more often than at any recent meeting of the Assembly.1 Nepal’s Minister of Health and Population confirmed that his country has adopted a rights-based approach to health. The South African Minister of Health spoke about health care as ‘a birth right’. Colombia’s Assistant Health Minister called for a ‘global effort for the development and effective universalization of the human right to health’.

“Germany’s Minister of Health emphasized that health is ‘a key human right and of vital importance for all human development’. The US Secretary of Health and Human Services quoted the words of President Obama: access to healthcare is ‘not some earned privilege – it is a right’. Speakers observed that the right to the highest attainable standard of health is enshrined in the Constitution of the World Health Organization. Multiple references to the right to the highest attainable standard of health (or ‘right to health’) came from every region of the world.

“Some health policymakers will be quick to dismiss these references as rhetorical. After all, these are high-level speeches, not detailed policy prescriptions. Nonetheless, speeches can tell us something. Sometimes they signal important shifts in opinion and direction.

In our view, the numerous human rights references in Ministers’ speeches reflect profound changes in the relationship between health and human rights – changes beginning to be felt in many countries.

“Today, it is universally accepted that human rights not only include classic civil and political rights, but also economic, social, and cultural rights, including the right to the highest attainable standard of health. This right is to be realized progressively and subject to the availability of resources. It demands accountability that comes in many forms, for example, by way of community groups, parliamentary committees, suitably designed maternal and peri-natal death audits, independent inspectors, national human rights institutions, and UN treaty-bodies…

…So, in conclusion, is it wise to dismiss as rhetorical flourishes the numerous references to human rights in high-level speeches at this year’s World Health Assembly? We do not think so. The speeches reflect growing recognition that the health community has an indispensable role to play in the implementation of the right to the highest attainable standard of health; they acknowledge that this fundamental human right can help health workers achieve their professional objectives; and they reflect profound changes that are taking place in the relationship between health and human rights. Moreover, all of these insights are confirmed by the WHO report: some Ministries of Health are already explicitly and actively using the right to health in their work, with evidence of beneficial impact. In short, the right to health is coming of age.

“If the right to the highest attainable standard of health is to realize its potential to save lives and reduce suffering, much remains to be done by a wide range of stakeholders. We hope that Ministers, Secretaries of Health, and other leaders of the public health community will chart the way forward in future meetings of the World Health Assembly – and beyond.”

The Lancet  
Oct 19, 2013  Volume 382  Number 9901  p1309 – 1380
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Integrity in research collaborations: The Montreal Statement
The Lancet
Preview
Last week, new guidance was issued as an outcome of the 3rd World Conference on Research Integrity, held in May in Montreal, Canada. The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations was developed before, during, and after the conference. Three workshop sessions at the conference were dedicated to in-depth discussions and further comments after the conference were taken into account to arrive at this version. Cross-boundary research includes collaboration between different institutions, disciplines, sectors, and countries.

The Lancet  
Oct 19, 2013  Volume 382  Number 9901  p1309 – 1380
http://www.thelancet.com/journals/lancet/issue/current

Editorial
The GAVI Alliance—successes and ongoing challenges
The Lancet
[Full text] http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962127-3/fulltext

GAVI’s Mid-Term Review, published on Oct 14, examines the organisation’s progress midway through the period 2011—15. It notes that by 2014, 73 countries with GAVI’s support will introduce five-in-one pentavalent vaccines, including fragile states—Haiti, Burma, Somalia, and South Sudan. The costs of new, priority vaccines, such as those targeting pneumococcal and rotaviral infections, are falling owing to GAVI’s efforts. Countries are graduating from GAVI support to self-financing of vaccines, and provision of new vaccines to those most in need is speeding up.

The report is published ahead of a mutual accountability meeting on Oct 30, in Stockholm, Sweden, to take stock of GAVI’s progress in immunisation and resource mobilisation since 2011.    A Lancet Series on the New Decade of Vaccines, in 2011, highlighted some predicaments facing GAVI—eg, a need to scale-up country commitments, high prices for new vaccines that are slowing delivery, and a need for GAVI to evaluate performance more effectively.

GAVI notes, however, that 2 years after its successful pledging conference in London, 243 million children will be reached with GAVI-supported vaccines in developing countries during 2011—15. Still, at least 22 million children worldwide do not have access to the basic package of childhood vaccines each year. Despite this gap, GAVI argues that it is reaching its strategic goals, which include acceleration of the uptake and use of under-used and new vaccines, strengthening of health systems to improve immunisation coverage, and improvement of vaccine market conditions for developing countries.

Despite the achievements documented in the report, challenges remain: looking for better ways to collect country-level data and ensuring supply chains are more reliable; addressing low-income countries’ unique and challenging needs with individualised approaches; and ensuring sustainability of immunisation programmes in countries wealthy enough to no longer be eligible for GAVI support. GAVI should continue to work hard and successfully to address these issues, to ensure that all children are protected against vaccine-preventable diseases, wherever they live.

The Lancet Infectious Diseases
Oct 2013  Volume 13  Number 10  p823 – 906
http://www.thelancet.com/journals/laninf/issue/current

Online First
Comment
A rare success for cholera vaccines
Saranya Sridhar a, Narendra Kumar Arora b
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970296-2/fulltext?_eventId=login

Cholera is a truly neglected infectious disease that is endemic in most parts of Africa and Asia. Despite an estimated annual burden of 2—4 million cases,1 it garners public attention only when outbreaks rampage through disaster-struck populations.2 Control of cholera depends on the long-term strategy of improving water quality and sanitation systems, but an effective vaccine conferring durable protection could offer an additional weapon in the depleted armoury of prevention strategies for this disease.

In 2001, WHO prequalified the licensed oral cholera vaccine Dukoral (SBL Vaccin AB, Sweden) for purchase by UN organisations.3 However, this vaccine is expensive, its efficacy lasts for only 2 years,4 and it is primarily used to protect travellers.3 In a technology transfer that should serve as a model for vaccine development, a modified version of the vaccine (Shanchol, Shantha Biotechnics, India) was manufactured and licensed in India in 2009. Shanchol was prequalified by the WHO in 2011. A field trial5 showed 67% cumulative efficacy in the first 2 years after vaccination. At that time, we sounded a note of cautious optimism and awaited the results of longer follow-up since other promising cholera vaccines with similar efficacy had failed to deliver longlasting protection.6

In The Lancet Infectious Diseases, Sujit Bhattacharya and colleagues7 report on whether Shanchol was protective over 5 years in a follow-up of 66 900 participants in a cluster-randomised placebo-controlled trial in Kolkata, India. The whole-cell vaccine containing killed strains from the O1 and O139 serogroups was given in two doses 2 weeks apart to non-pregnant individuals older than 1 year. The vaccine showed 65% (95% CI lower boundary of 52%) cumulative efficacy in the 5 year period for prevention of cholera episodes severe enough for individuals to seek treatment. This cholera vaccine is the first in the long history of cholera vaccine development to show more than 50% efficacy lasting up to 5 years. However, in children aged 1—5 years, who are at greatest risk of disease, the vaccine conferred only 42% cumulative efficacy (95% CI lower boundary of 5%) and too few cases occurred during the fifth year of follow-up to judge whether protection in these children lasted into the fifth year after vaccination. This lower level of protection is compounded by the difficulty of delivering oral vaccination to young children in poor sanitary and hygiene conditions. Nonetheless, we believe this result of an unprecedented level of long-term efficacy will be a giant leap forward for global control of cholera.

Despite this advance, questions remain. How do we improve vaccine efficacy in young children? The cholera community might learn from influenza vaccination, in which live attenuated vaccines are most efficacious in children and killed vaccines most efficacious in adults. Perhaps more effort needs to be placed on development, improvement, and testing of new and old attenuated cholera vaccines.8 A booster dose 2—3 years after the first vaccination might be necessary. Would the vaccine work equally well in areas that are not cholera endemic?

In endemic cholera areas, such as the Kolkata trial site,7 the vaccine might boost existing naturally acquired immunity. This boosting effect is given more credence by trial results showing an increased efficacy in the fourth and fifth year of the study, especially in adults, after a large cholera outbreak in the third year. Whether the vaccine will be equally efficacious in immunologically naive individuals, especially in the context of cholera outbreaks, is unknown. Individuals with HIV infection and those who are pregnant and elderly are the other high-risk populations in whom this vaccine needs to be assessed.

Vaccine efficacy was shown only against the O1 strain circulating in the study population. Efficacy against the O139 strains and newly emergent O1 strains expressing the classical toxins should be investigated.3 Resolution of whether the vaccine can reduce infection or transmission and not just protect against severe disease would help to further strengthen the case for vaccination.

We are only allowed the luxury of posing such questions because today’s study offers the cholera community an effective vaccine conferring durable protection. Despite all these unresolved issues, the need for an affordable cholera vaccine for international use has now been partly fulfilled. The focus now shifts to global policy makers and individual governments as they determine how to translate these study results into effective public good. While we celebrate a rare success story, perhaps the first in the WHO supported Decade of Vaccines collaboration, we need to seize this opportunity to transform global cholera control before we are once again overwhelmed by the next, inevitable, outbreak.

Articles
5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial
Sujit K Bhattacharya, Dipika Sur, Mohammad Ali, Suman Kanungo, Young Ae You, Byomkesh Manna, Binod Sah, Swapan K Niyogi, Jin Kyung Park, Banwarilal Sarkar, Mahesh K Puri, Deok Ryun Kim, Jacqueline L Deen, Jan Holmgren, Rodney Carbis, Mandeep Singh Dhingra, Allan Donner, G Balakrish Nair, Anna Lena Lopez, Thomas F Wierzba, John D Clemens
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970273-1/abstract

Summary
Background
Efficacy and safety of a two-dose regimen of bivalent killed whole-cell oral cholera vaccine (Shantha Biotechnics, Hyderabad, India) to 3 years is established, but long-term efficacy is not. We aimed to assess protective efficacy up to 5 years in a slum area of Kolkata, India.

Methods
In our double-blind, cluster-randomised, placebo-controlled trial, we assessed incidence of cholera in non-pregnant individuals older than 1 year residing in 3933 dwellings (clusters) in Kolkata, India. We randomly allocated participants, by dwelling, to receive two oral doses of modified killed bivalent whole-cell cholera vaccine or heat-killed Escherichia coli K12 placebo, 14 days apart. Randomisation was done by use of a computer-generated sequence in blocks of four. The primary endpoint was prevention of episodes of culture-confirmed Vibrio cholerae O1 diarrhoea severe enough for patients to seek treatment in a health-care facility. We identified culture-confirmed cholera cases among participants seeking treatment for diarrhoea at a study clinic or government hospital between 14 days and 1825 days after receipt of the second dose. We assessed vaccine protection in a per-protocol population of participants who had completely ingested two doses of assigned study treatment.

Findings
69 of 31 932 recipients of vaccine and 219 of 34 968 recipients of placebo developed cholera during 5 year follow-up (incidence 2·2 per 1000 in the vaccine group and 6·3 per 1000 in the placebo group). Cumulative protective efficacy of the vaccine at 5 years was 65% (95% CI 52—74; p<0·0001), and point estimates by year of follow-up suggested no evidence of decline in protective efficacy.

Interpretation
Sustained protection for 5 years at the level we reported has not been noted previously with other oral cholera vaccines. Established long-term efficacy of this vaccine could assist policy makers formulate rational vaccination strategies to reduce overall cholera burden in endemic settings.

Funding
Bill & Melinda Gates Foundation.

Medical Decision Making (MDM)
November 2013; 33 (8)
http://mdm.sagepub.com/content/current

Vaccination, Herd Behavior, and Herd Immunity
Matan J. Cohen, Mayer Brezis, Colin Block, Adele Diederich, David Chinitz

Abstract http://mdm.sagepub.com/content/33/8/1026.abstract
Background: During the 2009 outbreak of novel influenza AH1N1, insufficient data were available to adequately inform decision makers about benefits and risks of vaccination and disease. We hypothesized that individuals would opt to mimic their peers, having no better decision anchor. We used Game Theory, decision analysis, and transmission models to simulate the impact of subjective risks and preference estimates on vaccination behavior.

Methods: We asked 95 students to provide estimates of risk and health state valuations with regard to AH1N1 infection, complications, and expectations of vaccine benefits and risks. These estimates were included in a sequential chain of models: a dynamic epidemic model, a decision tree, and a population-level model. Additionally, participants’ intentions to vaccinate or not at varying vaccination rates were documented.

Results: The model showed that at low vaccination rates, vaccination dominated. When vaccination rates increased above 78%, nonvaccination was the dominant strategy. We found that vaccination intentions did not correspond to the shift in strategy dominance and segregated to 3 types of intentions: regardless of what others do 29/95 (31%) intended to vaccinate while 27/95 (28%) did not; among 39 of 95 (41%) intention was positively associated with putative vaccination rates.

Conclusions: Some people conform to the majority’s choice, either shifting epidemic dynamics toward herd immunity or, conversely, limiting societal goals. Policy leaders should use models carefully, noting their limitations and theoretical assumptions. Behavior drivers were not explicitly explored in this study, and the discrepant results beg further investigation. Models including real subjective perceptions with empiric or subjective probabilities can provide insight into deviations from expected rational behavior and suggest interventions in order to provide better population outcomes.

Nature   
Volume 502 Number 7471 pp271-402  17 October 2013
http://www.nature.com/nature/current_issue.html

Nature | Editorial
High hopes
Care must be taken not to raise unrealistic expectations for RTS,S malaria vaccine.
16 October 2013
Excerpt  http://www.nature.com/news/high-hopes-1.13953

Vaccines have been an unparalleled public-health success: they have eradicated smallpox and driven polio to near extinction, and routine childhood immunization saves millions of children a year from death from diseases such as measles, diphtheria, tetanus and whooping cough. So it is not surprising that the public tend to view vaccines as synonymous with elimination, or near elimination, of our microbial foes.

This may help to explain last week’s extensive and often upbeat media coverage of the 18-month results of a huge phase III trial of the malaria vaccine candidate RTS,S/AS01 in more than 15,000 children across 7 African countries. In the United Kingdom, for example, the front page of The Guardian stated that the vaccine “could save lives of millions of children”.    Unfortunately, however, it won’t. The 18-month results only confirm the disappointing results seen after 12 months.

The RTS,S vaccine is not what most people would think of as a vaccine. It provides only partial protection and most of those vaccinated, particularly those in areas with moderate to high malaria transmission rates, will eventually contract the disease. There is also confusion over its efficacy. Many media reports concluded that although the vaccine did not give the 90%-plus efficacy levels of most childhood vaccines, it might nonetheless be satisfactory, with a reported 46% reduction in cases in children vaccinated when they were aged 5 to 17 months, and 27% in 6–12-week-old babies.

Not so. The efficacy figures given for RTS,S are not directly comparable with those usually given for vaccines. The conventional measurement of a vaccine’s success is how may people remain protected after a given period, such as 12 months. Because RTS,S is only partially protective, a different measurement of efficacy is used — a complex statistical model that computes hazard ratios on the basis of the first clinical episodes of malaria. As the designers of the method themselves concede, “a shortcoming of the vaccine efficacy calculated from hazard ratios could be that it is not intuitively understood”. Too true. In the hands of experts, and regulatory agencies, this hazards-ratio model offers a valid measurement of the efficacy of a partially protective vaccine, but it can be easily misinterpreted by the media, politicians and policy-makers…

… The work will continue. Data on the effects of a booster dose given after 18 months will not be available until next year, and RTS,S is also due to be tested in combination with a vaccine developed by researchers at the University of Oxford, UK, in an early-stage clinical trial. Meanwhile, the RTS,S trials are to be applauded for having left a lasting legacy in the unprecedented collaboration with African scientists who led the study, and a first-class clinical-trials infrastructure on the continent.

RTS,S has been in the works for almost 30 years. Since 2001, the MVI has put some US$200 million into it, and GSK more than $350 million, with a further $260 million earmarked to complete its development. The huge past impact of vaccines risks fuelling illusions over the impact of having a malaria ‘vaccine’. But the modest efficacy of RTS,S means that it falls squarely in competition with other malaria control measures, many of which might be more cost-effective. Care must be taken not to build excessive expectations that can only lead to disappointment over its potentially limited public-health impact.”

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
September 2013  Vol. 34, No. 3
http://www.paho.org/journal/index.php?option=com_content&view=article&id=132&Itemid=228&lang=en

Trends in mortality from respiratory diseases among the elderly and the influenza vaccine intervention, 1980–2009
[Tendencias de la mortalidad por enfermedades respiratorias en ancianos e influencia de la vacuna antigripal, 1980–2009]
Priscila Maria Stolses Bergamo Francisco, Maria Rita Donalisio, and Leticia Marín-León

PLoS One
[Accessed 19 October 2013]
http://www.plosone.org/
Hepatitis B Screening and Vaccination Strategies for Newly Arrived Adult Canadian Immigrants and Refugees: A Cost-Effectiveness Analysis
Carmine Rossi, Kevin Schwartzman, Olivia Oxlade, Marina B. Klein, Chris Greenaway Research Article | published 18 Oct 2013 | PLOS ONE 10.1371/journal.pone.0078548

Abstract
Background
Immigrants have increased mortality from hepatocellular carcinoma as compared to the host populations, primarily due to undetected chronic hepatitis B virus (HBV) infection. Despite this, there are no systematic programs in most immigrant-receiving countries to screen for chronic HBV infection and immigrants are not routinely offered HBV vaccination outside of the universal childhood vaccination program.

Methods and findings
A cost-effective analysis was performed to compare four HBV screening and vaccination strategies with no intervention in a hypothetical cohort of newly-arriving adult Canadian immigrants. The strategies considered were a) universal vaccination, b) screening for prior immunity and vaccination, c) chronic HBV screening and treatment, and d) combined screening for chronic HBV and prior immunity, treatment and vaccination. The analysis was performed from a societal perspective, using a Markov model. Seroprevalence estimates, annual transition probabilities, health-care costs (in Canadian dollars), and utilities were obtained from the published literature. Acute HBV infection, mortality from chronic HBV, quality-adjusted life years (QALYs), and costs were modeled over the lifetime of the cohort of immigrants. Costs and QALYs were discounted at a rate of 3% per year. Screening for chronic HBV infection, and offering treatment if indicated, was found to be the most cost-effective intervention and was estimated to cost $40,880 per additional QALY gained, relative to no intervention. This strategy was most cost-effective for immigrants < 55 years of age and would cost < $50,000 per additional QALY gained for immigrants from areas where HBV seroprevalence is ≥ 3%. Strategies that included HBV vaccination were either prohibitively expensive or dominated by the chronic HBV screening strategy.

Conclusions
Screening for chronic HBV infection from regions where most Canadian immigrants originate, except for Latin America and the Middle East, was found to be reasonably cost-effective and has the potential to reduce HBV-associated morbidity and mortality.

PLoS One
[Accessed 19 October 2013]
http://www.plosone.org/

Impact of Birth Seasonality on Dynamics of Acute Immunizing Infections in Sub-Saharan Africa
Audrey M. Dorélien, Sebastien Ballesteros, Bryan T. Grenfell
Research Article | published 18 Oct 2013 | PLOS ONE 10.1371/journal.pone.0075806

Abstract
We analyze the impact of birth seasonality (seasonal oscillations in the birth rate) on the dynamics of acute, immunizing childhood infectious diseases. Previous research has explored the effect of human birth seasonality on infectious disease dynamics using parameters appropriate for the developed world. We build on this work by including in our analysis an extended range of baseline birth rates and amplitudes, which correspond to developing world settings. Additionally, our analysis accounts for seasonal forcing both in births and contact rates. We focus in particular on the dynamics of measles. In the absence of seasonal transmission rates or stochastic forcing, for typical measles epidemiological parameters, birth seasonality induces either annual or biennial epidemics. Changes in the magnitude of the birth fluctuations (birth amplitude) can induce significant changes in the size of the epidemic peaks, but have little impact on timing of disease epidemics within the year. In contrast, changes to the birth seasonality phase (location of the peak in birth amplitude within the year) significantly influence the timing of the epidemics. In the presence of seasonality in contact rates, at relatively low birth rates (20 per 1000), birth amplitude has little impact on the dynamics but does have an impact on the magnitude and timing of the epidemics. However, as the mean birth rate increases, both birth amplitude and phase play an important role in driving the dynamics of the epidemic. There are stronger effects at higher birth rates.

PLoS One
[Accessed 19 October 2013]
http://www.plosone.org/

The State of Infectious Diseases Clinical Trials: A Systematic Review of ClinicalTrials.gov
Neela D. Goswami, Christopher D. Pfeiffer, John R. Horton, Karen Chiswell, Asba Tasneem, Ephraim L. Tsalik
Research Article | published 16 Oct 2013 | PLOS ONE 10.1371/journal.pone.0077086
Abstract
Background
There is a paucity of clinical trials informing specific questions faced by infectious diseases (ID) specialists. The ClinicalTrials.gov registry offers an opportunity to evaluate the ID clinical trials portfolio.

Methods
We examined 40,970 interventional trials registered with ClinicalTrials.gov from 2007–2010, focusing on study conditions and interventions to identify ID-related trials. Relevance to ID was manually confirmed for each programmatically identified trial, yielding 3570 ID trials and 37,400 non-ID trials for analysis.

Results
The number of ID trials was similar to the number of trials identified as belonging to cardiovascular medicine (n = 3437) or mental health (n = 3695) specialties. Slightly over half of ID trials were treatment-oriented trials (53%, vs. 77% for non-ID trials) followed by prevention (38%, vs. 8% in non-ID trials). ID trials tended to be larger than those of other specialties, with a median enrollment of 125 subjects (interquartile range [IQR], 45–400) vs. 60 (IQR, 30–160) for non-ID trials. Most ID studies are randomized (73%) but nonblinded (56%). Industry was the funding source in 51% of ID trials vs. 10% that were primarily NIH-funded. HIV-AIDS trials constitute the largest subset of ID trials (n = 815 [23%]), followed by influenza vaccine (n = 375 [11%]), and hepatitis C (n = 339 [9%]) trials. Relative to U.S. and global mortality rates, HIV-AIDS and hepatitis C virus trials are over-represented, whereas lower respiratory tract infection trials are under-represented in this large sample of ID clinical trials.

Conclusions
This work is the first to characterize ID clinical trials registered in ClinicalTrials.gov, providing a framework to discuss prioritization, methodology, and policy.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Potential cost‐effectiveness of the nonavalent Human Papillomavirus (HPV) vaccine
M Drolet, JF Laprise, MC Boily, EL Franco, M Brisson – International Journal of Cancer, 2013
ABSTRACT Randomized clinical trials are currently examining the efficacy of a nonavalent human papillomavirus (HPV) vaccine, including HPV-types 6/11/16/18/31/33/45/52/58.
Evidence on the cost-effectiveness of the nonavalent is required for timely policy- …

Development of real-time PCR to detect oral vaccine-like poliovirus and its application to environmental surveillance
M Iwai-Itamochi, H Yoshida, M Obara-Nagoya… – Journal of Virological …, 2013
Abstract In order to perform environmental surveillance to track oral poliovirus vaccine-like poliovirus sensitively and conveniently, real-time PCR was developed and applied to a raw
sewage concentrate. The real-time PCR method detected 0.01 to 0.1 TCID 50 of 3 …

Infectious disease: Conjugate vaccine is effective against serogroup A meningococcal meningitis
E Bible – Nature Reviews Neurology, 2013
A collaboration between the African Meningococcal Carriage Consortium (MenAfriCar), the Meningitis Vaccine Project and researchers from several countries has shown that a
meningococcal conjugate vaccine prevented meningitis during an epidemic of serogroup …

Live-attenuated bacteria as a cancer vaccine vector
B Toussaint, X Chauchet, Y Wang, B Polack… – Expert Review of Vaccines, 2013
In the emerging field of active and specific cancer immunotherapy, strategies using live-attenuated bacterial vectors have matured in terms of academic and industrial development.
Different bacterial species can be genetically engineered to deliver antigen to APCs with …

Modeling the effect of water, sanitation, and hygiene and oral cholera vaccine implementation in Haiti
ICH Fung, DL Fitter, RH Borse, MI Meltzer, JW Tappero – The American journal of …, 2013
Abstract. In 2010, toxigenic Vibrio cholerae was newly introduced to Haiti. Because resources are limited, decision-makers need to understand the effect of different preventive
interventions. We built a static model to estimate the potential number of cholera cases …

Declines in human papillomavirus infection observed in the vaccine era
MK Barton – CA: A Cancer Journal for Clinicians, 2013
Currently, 2 HPV vaccines are available: a quadrivalent vaccine against HPV types 6 (HPV-6),-11,-16, and-18; and a bivalent one against HPV-16 and-18. HPV-16 and-18 cause
approximately 70% of cervical cancers and although HPV-6 and-11 are not oncogenic, ..

Protection against hepatitis E virus infection by naturally acquired and vaccine induced immunity
J Zhang, XF Zhang, C Zhou, ZZ Wang, SJ Huang… – Clinical Microbiology and …, 2013
Abstract Immunity acquired from infection or vaccination protects humans from suffering of symptomatic hepatitis E. However, whether the risk of hepatitis E virus (HEV) infection is
reduced by the immunity remains unknown. To understand this issue, a cohort with 12,409 …

Specialized program newsletters, online publications
Dengue Vaccine Initiative: DVI newsletter
October 2013
http://us2.campaign-archive2.com/?u=3805c2f42ef8400c2e9729b91&id=3f238b7401&e=6898e601e9

Vaccines: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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– Email Summary: Vaccines: The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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– pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_12 Oct 2013
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– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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– 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…
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

Letter: Phase III efficacy trial of the RTS,S malaria vaccine candidate
Dear Colleague:
On behalf of the PATH Malaria Vaccine Initiative, GlaxoSmithKline, and 11 African research centers in seven countries, we are writing to inform you that further results from the Phase III efficacy trial of the RTS,S malaria vaccine candidate are to be presented on Tuesday, 8 October, at the 6th Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference in Durban, South Africa. An article with additional findings and data is in preparation for submission to a peer-reviewed journal.

The results presented are the third set from the ongoing Phase III trial. Over 18 months of follow-up, RTS,S was shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination). These results were demonstrated in the context of existing malaria control measures, such as insecticide treated bednets, which were used by 78% of children and 86% of infants in the trial. The presentation abstract concluded by saying that the vaccine “shows potential for a role in malaria control in Africa.”

Over 18 months of follow-up, children aged 5-17 months at first vaccination with RTS,S experienced 46% (95% CI: 42 to 50) fewer cases of clinical malaria, compared to children immunised with a control vaccine; an average of 941 cases of clinical malaria were prevented for every 1,000 children vaccinated. Severe malaria cases were reduced by 36% (95% CI: 15 to 51), malaria hospitalisations by 42% (95% CI: 29 to 52), and all-cause hospitalizations by 19% (95% CI: 9 to 28).

Infants aged 6-12 weeks at first vaccination with RTS,S had 27% (95% CI: 20 to 32) fewer cases of clinical malaria. Over 18 months of follow-up, 444 cases of clinical malaria were prevented for every 1,000 infants vaccinated. The reduction of severe malaria cases and malaria hospitalisations was not statistically significant.

Vaccine efficacy was also assessed separately at each of the trial sites, which represented a wide range of malaria transmission settings; efficacy was found to be statistically significant at all sites in young children and at four sites in infants. At clinical trial sites where there were more cases of malaria, we found greater impact in both age groups.

RTS,S continued to display an acceptable safety and tolerability profile during the 18 month follow-up. Apart from the meningitis signal previously reported, no other safety signal was identified.     The occurrence of meningitis will be followed closely during the remainder of the trial.

Based on these results, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The World Health Organization (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015.

Follow-up in this Phase III trial is ongoing. Further data from 32 months follow-up and the impact of a fourth ‘booster’ dose given 18 months after the initial three doses are expected to become available in 2014.

The RTS,S malaria vaccine candidate is still under development and subject to the evaluation of the benefits and risks by regulatory authorities before being made available.
The abstract for the presentation at MIM is available at:
http://www.malariavaccine.org/rd-rtss.php
A press release on the findings is available at:
http://www.malariavaccine.org/pr2013Oct8-RTSS.php
On behalf of the partners, we are,
Sincerely yours,
David C. Kaslow, MD                                               Sophie Biernaux
Vice President for Product Development            Vice President and Malaria Vaccine Leader
PATH

   PATH and China National Biotec Group Co., Ltd. (CNBG) announced that SA 14-14-2, a live, attenuated Japanese encephalitis (JE) vaccine, won WHO prequalification.  The action also represents the first time a vaccine produced by a Chinese manufacturer has achieved prequalification. The vaccine is manufactured by Chengdu Institute of Biological Products Co., Ltd. (CDIBP), a subsidiary of CNBG. With funding from the Bill & Melinda Gates Foundation, PATH “led a series of pivotal clinical trials to establish the immunogenicity and safety of the vaccine in at-risk children and provided technical and financial support to help CDIBP meet the international manufacturing standards required for WHO prequalification.” Steve Davis, PATH president and CEO, commented, “This milestone brings the world within reach of an audacious goal: the elimination of a devastating disease through expanded access to an affordable and lifesaving vaccine. Our groundbreaking collaboration with leading Chinese partners also helped lay the foundation for reshaping global vaccine supply, pricing, and accessibility through increased competition. This milestone signals China’s rising importance as a global supplier of high-quality vaccines for the most vulnerable children in the world.”

Read more about PATH’s JE Project.

GAVI said it welcomed Canada’s US$20 million pledge to accelerate access to measles vaccines, to be invested in GAVI’s measles programme. The pledge is part of Canada’s commitment to the Muskoka Initiative on Maternal, Newborn and Child Health launched by G8 partners at the Muskoka Summit in 2010. The six countries covered under Canada’s support are Afghanistan, Pakistan, Chad, Democratic Republic of Congo, Nigeria and Ethiopia.

“We are very grateful to Canada for its commitment,” said GAVI CEO Dr Seth Berkley. “As a leader of the Muskoka Initiative for Maternal, Newborn, and Child Health, Canada’s support paves the way for the introduction of the combined measles-rubella vaccine that will significantly improve the health of mothers and children.”

http://www.gavialliance.org/library/news/statements/2013/gavi-welcomes-canada-s-support-for-measles-vaccines/

The Global Fund said it appointed Kate Thomson as “Head of the Critical Enablers and Civil Society hub,” a new position that “underlines the Global Fund’s strengthened efforts to promote human rights and deeper partnership with civil society.” Ms. Thomson joins the Global Fund from UNAIDS, and “brings extensive experience in policy and advocacy, having worked within civil society organizations and multilateral institutions with a particular emphasis on people living with HIV and communities at higher risk,” the announcement noted.

More here: http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-10-11_Global_Fund_Names_Kate_Thomson_as_Head_of_the_Critical_Enablers_and_Civil_Society_Hub/

Security Council Press Statement on POLIO VACCINATION IN SUDAN
11 October 2013
SC/11145 AFR/2719 UN Security Council
   The following Security Council press statement was issued today by Council President Agshin Mehdiyev ( Azerbaijan):

On 10 October, the United Nations Security Council was briefed by the Under Secretary-General for Peacekeeping, Hervé Ladsous, and United Nations Interim Security Force in Abyei Force Commander, Major General Yohannes Tesfamariam, on the situation in Sudan and South Sudan.

The members of the Security Council expressed alarm and grave concern at the imminent threat of the spread of polio through South Kordofan, and the continuing outbreak of polio in the Horn of Africa.  According to the United Nations Office for the Coordination of Humanitarian Affairs, this threat affects more than 165,000 children in South Kordofan and Blue Nile due to a lack of immunization in the border area in more than two years.  Failure to vaccinate exacerbates the risk of the further spread of the disease which the international community has made great strides to eliminate.

The members of the Security Council called upon the Government of Sudan and the Sudan People’s Liberation Movement-North to urgently resolve differences over the technical plans necessary, including for safe passage, to implement the polio vaccination campaign, as proposed by the United Nations Office for the Coordination of Humanitarian Affairs, United Nations Children’s Fund and the World Health Organization, as soon as possible in order for the two-week vaccination campaign to go forward in South Kordofan and Blue Nile on 5 November as planned.  The members of the Security Council reiterated their support for the United Nations’ work in this regard and encouraged the Secretary-General to engage with both sides to ensure full vaccination in the coming weeks.

http://www.un.org/News/Press/docs//2013/sc11145.doc.htm

Update: Polio this week – As of 9 October 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]

:: All 43 circulating vaccine derived poliovirus (cVDPV) polio cases this year are type 2 (cVDPV2) with the majority reported from Asia (Pakistan 29, Afghanistan 3). Most of these cases (22) are from North Waziristan in the Federally Administered Tribal Areas (FATA), Pakistan. The bulk of the remaining cVDPV2 cases (10) are from Chad and an area in and around the connecting borders of Cameroon, Chad, Niger and Nigeria. One case was reported from Somalia in January.
:: The Independent Monitoring Board met 1-2 October in London, UK. The IMB reviewed the latest epidemiology and programme developments. The next IMB report is expected to be issued within two weeks of the meeting..

Pakistan
:: Three new WPV1 cases were reported in the past week. All were reported from FATA (one from North Waziristan and two from Khyber). The total number of WPV1 cases for Pakistan in 2013 is now 39. The most recent WPV1 case had onset of paralysis on 10 September (from North Waziristan).
:: The majority of WPV1 cases in Pakistan this year, 27 (69%), are from FATA, of which 11 are from North Waziristan and 12 from Khyber.
:: Five new cVDPV2 cases were reported in the past week. All are from North Waziristan. The total number of cVDPV2 cases for Pakistan is now 29. The majority of Pakistan’s cVDPV2 cases, 23 (79%), come from FATA, of which all but one are from North Waziristan. The latest cVDPV2 case had onset of paralysis 12 September (from North Waziristan).
:: The situation in North Waziristan is particularly concerning, as it is in an area where immunization activities have been suspended by local leaders since June 2012. Immunizations in neighbouring high-risk areas are being intensified, to further boost population immunity levels in those areas and prevent further spread of this outbreak.
:: NIDs were conducted on 30 September to 2 October targeted 34.5 million children with tOPV.

Horn of Africa
:: The three cases reported from South Sudan in the previous week triggered a full outbreak response from a GPEI operational perspective. South Sudan has launched an immediate response covering children up to 15 years of age in the infected areas, targeting 544,000 children. This will be followed by a SNID and three NIDs using bOPV by the end of year. The last WPV in the country occurred in 2009 in Eastern Equatoria, an area connected with Kakuma refugee camp in northern Kenya with a large Somali population.
:: At risk countries have been put on alert. Sudan will synchronize its October SNID with South Sudan, and SIAs are on-going in Uganda.
:: Because of routes of poliovirus spread in previous Horn of Africa outbreaks, both Ethiopia and South Sudan were already considered at ‘high risk’ this year, and have been conducting immunization campaigns since the current Horn of Africa outbreak was first confirmed in May 2013.
:: Ethiopia and Somalia have deployed permanent vaccination points at all major entry points.
:: Outbreak response in Somalia and Kenya is continuing, as well as in other areas of the greater Horn of Africa, notably in Yemen. Yemen conducted a SNID in 5-8 October, targeting 65% of the country’s children. The next SNID in Yemen is planned for December. Somalia will conduct an all-age campaign covering the whole country from 20 October…

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html

Yellow fever in Cameroon
8 October 2013 – The Ministry of Health of Cameroon carried out a yellow fever mass vaccination campaign with a reported 94% coverage of the targeted population of 663 900 in 13 health districts considered to be at high risk of yellow fever.

The vaccination campaign was carried out between 27 August to 1 September 2013 in the Littoral Region, following laboratory-confirmation of two cases with yellow fever in the area in April 2013. The index case was a 43-year-old woman from Ndom Health district who became ill on 15 March 2013.

The patients were laboratory confirmed at the Institute Pasteur of Cameroon by IgM ELISA (antibody) test, which was followed by the seroneutralizing test (PRNT) for yellow fever by the Institute Pasteur in Dakar, Senegal, a WHO regional reference laboratory for yellow fever.

In 2012, suspected cases were reported from the South-West area which includes North-West, South-West and West regions. These cases were identified as part of the surveillance system which identifies patients with fever and jaundice within the 14 days of onset.

WHO country office has been working with the health authorities in the field investigation and  response to the outbreak. There is ongoing surveillance for yellow fever in the country.

GAVI Alliance and the International Coordinating Group on Yellow Fever Vaccine Provision (YF-ICG1) supported the reactive mass vaccination campaign which covered over 663 900 people in 13 health districts considered to be at high risk for yellow fever, namely Dibombari, Edea, Loum, Manjo, Manoka, Mbanga, Melong, Ndom, Ngambe, Nkondjock, Nkongsamba, Pouma and Yabass.

http://www.who.int/csr/don/2013_10_08/en/index.html

1The YF-ICG is a partnership that manages the stockpile of yellow fever vaccines for emergency response on the basis of a rotation fund. It is represented by United Nations Children’s Fund (UNICEF), Médecins Sans Frontières (MSF) and the International Federation of Red Cross and Red Crescent Societies (IFRC) and WHO, which also serves as the Secretariat. The stockpile was created by GAVI Alliance.

The Weekly Epidemiological Record (WER) for 11 October 2013, vol. 88, 41 (pp. 437–448) includes:
:: Recommended composition of influenza virus vaccines for use in the 2014 southern hemisphere influenza season

http://www.who.int/entity/wer/2013/wer8841.pdf

Analysis: The State of the Poor – Where Are The Poor, Where Is Extreme Poverty Harder to End, and What Is the Current Profile of the World’s Poor?
World Bank – Pedro Olinto, Kathleen Beegle, Carlos Sobrado, and Hiroki Uematsu
October 2013 – Number 125

Report Finds 400 Million Children Living in Extreme Poverty new study

Although the world witnessed an unprecedented pace of poverty reduction over the last decades, reducing the number of people living in extreme poverty by more than 700 million, approximately 1.2 billion people remained entrenched in destitution in 2010.1 In order to leverage developing country efforts and galvanize the international development community to exert concerted effort to end extreme poverty, the World Bank has established the twin goals of ending extreme poverty by 2030 and promoting shared prosperity by fostering income growth of the bottom 40 percent of the population in every country. Ending extreme poverty in just one generation is a formidable challenge by all accounts that requires a thorough understanding of the state of the poor.

Media Release: http://www.worldbank.org/en/news/press-release/2013/10/10/report-finds-400-million-children-living-extreme-poverty

American Journal of Public Health
Volume 103, Issue 11 (November 2013)
http://ajph.aphapublications.org/toc/ajph/current

Commentaries
Modern Cholera in the Americas: An Opportunistic Societal Infection
Rodrigo Cerda, Patrick T. Lee
American Journal of Public Health: November 2013, Vol. 103, No. 11: 1934–1937.
http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2013.301567

Abstract
In the Americas, the only two cholera epidemics of the past century have occurred in the past 25 years.

Lessons from the 1991 Peruvian cholera epidemic can help to focus and refine the response to the current Haitian epidemic. After three years of acute epidemic response, we have an opportunity to refocus on the chronic conditions that make societies vulnerable to cholera.

More importantly, even as international attention wanes in the aftermath of the earthquake and acute epidemic, we are faced with a need for continued and coordinated investment in improving Haiti’s structural defenses against cholera, in particular access to improved water and sanitation.

American Journal of Public Health
Volume 103, Issue 11 (November 2013)
http://ajph.aphapublications.org/toc/ajph/current

Linking Research to Global Health Equity: The Contribution of Product Development Partnerships to Access to Medicines and Research Capacity Building
Bridget Pratt, Bebe Loff
American Journal of Public Health: November 2013, Vol. 103, No. 11: 1968–1978.
http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2013.301341

Abstract
Certain product development partnerships (PDPs) recognize that to promote the reduction of global health disparities they must create access to their products and strengthen research capacity in developing countries.

We evaluated the contribution of 3 PDPs—Medicines for Malaria Venture, Drugs for Neglected Diseases Initiative, and Institute for One World Health—according to Frost and Reich’s access framework. We also evaluated PDPs’ capacity building in low- and middle-income countries at the individual, institutional, and system levels.

We found that these PDPs advance public health by ensuring their products’ registration, distribution, and adoption into national treatment policies in disease-endemic countries.       Nonetheless, ensuring broad, equitable access for these populations—high distribution coverage; affordability, particularly for the poor; and adoption at provider and end-user levels—remains a challenge.

American Journal of Tropical Medicine and Hygiene
October 2013; 89 (4)
http://www.ajtmh.org/content/current

Cholera
Perspective Piece – ASTMH Presidential Address
Eyes on the Prize: Lessons from the Cholera Wars for Modern Scientists, Physicians, and Public Health Officials
Edward T. Ryan
Am J Trop Med Hyg 2013 89:610-614; doi:10.4269/ajtmh.13-0173
Full Text

AJTMH and PAHO: Commemorating the 3rd Anniversary of the Cholera Outbreak in Haiti: Invited Papers
Overview

Cholera Elimination in Hispaniola
Carissa F. Etienne, Jordan W. Tappero, Barbara J. Marston, Thomas R. Frieden, Thomas A. Kenyon, and Jon K. Andrus
Am J Trop Med Hyg 2013 89:615-616; doi:10.4269/ajtmh.13-0510
Full Text

Use of Oral Cholera Vaccine in Haiti: A Rural Demonstration Project
Am J Trop Med Hyg 2013 89:617-624; doi:10.4269/ajtmh.13-0183
Louise C. Ivers, Jessica E. Teng, Jonathan Lascher, Max Raymond, Jonathan Weigel, Nadia Victor, J. Gregory Jerome, Isabelle J. Hilaire, Charles P. Almazor, Ralph Ternier, Jean Cadet, Jeannot Francois, Florence D. Guillaume, and Paul E. Farmer
Abstract

Predictors of Disease Severity in Patients Admitted to a Cholera Treatment Center in Urban Haiti
Am J Trop Med Hyg 2013 89:625-632; doi:10.4269/ajtmh.13-0170
Claude-Lyne Valcin, Karine Severe, Claudia T. Riche, Benedict S. Anglade, Colette Guiteau oise, Michael Woodworth, Macarthur Charles, Zhongze Li, Patrice Joseph, Jean W. Pape, and Peter F. Wright
Abstract

Modeling the Effect of Water, Sanitation, and Hygiene and Oral Cholera Vaccine Implementation in Haiti
Isaac Chun-Hai Fung, David L. Fitter, Rebekah H. Borse, Martin I. Meltzer, and Jordan W. Tappero
Am J Trop Med Hyg 2013 89:633-640; doi:10.4269/ajtmh.13-0201
Abstract

Laboratory-Confirmed Cholera and Rotavirus among Patients with Acute Diarrhea in Four Hospitals in Haiti, 2012–2013
Maria W. Steenland, Gerard A. Joseph, Mentor Ali Ber Lucien, Nicole Freeman, Marisa Hast, Benjamin L. Nygren, Eyal Leshem, Stanley Juin, Michele B. Parsons, Deborah F. Talkington, Eric D. Mintz, John Vertefeuille, S. Arunmozhi Balajee, Jacques Boncy, and Mark A. Katz
Am J Trop Med Hyg 2013 89:641-646; doi:10.4269/ajtmh.13-0307
Abstract

Access to Safe Water in Rural Artibonite, Haiti 16 Months after the Onset of the Cholera Epidemic
Molly Patrick, David Berendes, Jennifer Murphy, Fabienne Bertrand, Farah Husain, and Thomas Handzel
Am J Trop Med Hyg 2013 89:647-653; doi:10.4269/ajtmh.13-0308
Abstract

Seroepidemiologic Survey of Epidemic Cholera in Haiti to Assess Spectrum of Illness and Risk Factors for Severe Disease
Brendan R. Jackson, Deborah F. Talkington, James M. Pruckler, M. D. Bernadette Fouché, Elsie Lafosse, Benjamin Nygren, Gerardo A. Gómez, Georges A. Dahourou, W. Roodly Archer, Amanda B. Payne, W. Craig Hooper, Jordan W. Tappero, Gordana Derado, Roc Magloire, Peter Gerner-Smidt, Nicole Freeman, Jacques Boncy, Eric D. Mintz, and the Cholera Serosurvey Working Group
Am J Trop Med Hyg 2013 89:654-664; doi:10.4269/ajtmh.13-0208
Abstract

Water, Sanitation and Hygiene in Haiti: Past, Present, and Future
Richard Gelting, Katherine Bliss, Molly Patrick, Gabriella Lockhart, and Thomas Handzel
Am J Trop Med Hyg 2013 89:665-670; doi:10.4269/ajtmh.13-0217
Abstract

Cholera Vaccination in Urban Haiti
Vanessa Rouzier, Karine Severe, Marc Antoine Jean Juste, Mireille Peck, Christian Perodin, Patrice Severe, Marie Marcelle Deschamps, Rose Irene Verdier, Sabine Prince, Jeannot Francois, Jean Ronald Cadet, Florence D. Guillaume, Peter F. Wright, and Jean W. Pape
Am J Trop Med Hyg 2013 89:671-681; doi:10.4269/ajtmh.13-0171
Abstract

Development of a Cholera Vaccination Policy on the Island of Hispaniola, 2010–2013
Andrea S. Vicari, Cuauhtémoc Ruiz-Matus, Ciro de Quadros, and Jon K. Andrus
Am J Trop Med Hyg 2013 89:682-687; doi:10.4269/ajtmh.13-0200
Abstract

Implementation of an Alert and Response System in Haiti during the Early Stage of the Response to the Cholera Epidemic
Patricia Santa-Olalla, Michelle Gayer, Roc Magloire, Robert Barrais, Marta Valenciano, Carmen Aramburu, Jean Luc Poncelet, Juan Carlos Gustavo Alonso, Dana Van Alphen, Florence Heuschen, Roberta Andraghetti, Robert Lee, Patrick Drury, and Sylvain AldighieriAm J Trop Med Hyg 2013 89:688-697; doi:10.4269/ajtmh.13-0267
Abstract

Cost Effectiveness and Resource Allocation
(Accessed 12 October 2013)
http://www.resource-allocation.com/

Methodology
Balancing efficiency, equity and feasibility of HIV treatment in South Africa – development of programmatic guidance
Baltussen R, Mikkelsen E, Tromp N, Hurtig AK, Byskov J, Olsen Ø, Bærøe K, Hontelez JA et al. Cost Effectiveness and Resource Allocation 2013, 11:26 (9 October 2013

Abstract
South Africa, the country with the largest HIV epidemic worldwide, has been scaling up treatment since 2003 and is rapidly expanding its eligibility criteria. The HIV treatment programme has achieved significant results, and had 1.8 million people on treatment per 2011. Despite these achievements, it is now facing major concerns regarding (i) efficiency: alternative treatment policies may save more lives for the same budget; (ii) equity: there are large inequalities in who receives treatment; (iii) feasibility: still only 52% of the eligible population receives treatment.

Hence, decisions on the design of the present HIV treatment programme in South Africa can be considered suboptimal. We argue there are two fundamental reasons to this. First, while there is a rapidly growing evidence-base to guide priority setting decisions on HIV treatment, its included studies typically consider only one criterion at a time and thus fail to capture the broad range of values that stakeholders have. Second, priority setting on HIV treatment is a highly political process but it seems no adequate participatory processes are in place to incorporate stakeholders’ views and evidences of all sorts.

We propose an alternative approach that provides a better evidence base and outlines a fair policy process to improve priority setting in HIV treatment. The approach integrates two increasingly important frameworks on health care priority setting: accountability for reasonableness (A4R) to foster procedural fairness, and multi-criteria decision analysis (MCDA) to construct an evidence-base on the feasibility, efficiency, and equity of programme options including trade-offs. The approach provides programmatic guidance on the choice of treatment strategies at various decisions levels based on a sound conceptual framework, and holds large potential to improve HIV priority setting in South Africa.

Development in Practice
Volume 23, Issue 5-06, 2013
http://www.tandfonline.com/toc/cdip20/current

Special Issue: Civil societies at crossroads: eruptions, initiatives, and evolution in citizen activism

Abstract
This Special Issue has grown from the sense that important changes in the last two decades pose dilemmas and challenges for civil societies in many countries. The Issue reports on a series of studies of the evolving roles of civil society sectors and citizen initiatives in several regions of the world. This introduction identifies a series of events and forces that over the last two decades have fundamentally changed the contexts of civil society activities in many countries. These changes have catalyzed a wide range of citizen eruptions and initiatives on particular issues as well as national civil society evolutions in many countries. The papers in this Special Issue have resulted from a multi-country collective reflection organized by five civil society support organizations from different regions. They sought to identify roles, capacities, contributions, and limitations of civil society in these changing contexts using a variety of approaches to data collection and analysis. This introduction briefly describes the papers in the Special Issue. They include regional overviews, descriptions of national sector evolution, and cases of citizen activism in Southern and Eastern Africa, Asia, Southern Latin America, Western Europe and Russia. The final paper provides an overview of the lessons learned from comparative analysis across these and other cases and draws some of the implication of those lessons for practitioners and policy makers.

Eurosurveillance
Volume 18, Issue 41, 10 October 2013
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Rapid communications
Hajj pilgrims’ knowledge about Middle East respiratory syndrome coronavirus, August to September 2013
by P Gautret, S Benkouiten, I Salaheddine, K Belhouchat, T Drali, P Parola, P Brouqui

Summary
In preparation for Hajj 2013, 360 French pilgrims were interviewed regarding their knowledge about Middle East respiratory syndrome (MERS). Respondents were aged 20–85 years, male-female ratio was 1.05:1; 64.7% were aware of the MERS situation in Saudi Arabia; 35.3% knew about the Saudi Ministry of Health recommendations for at-risk pilgrims to postpone participation in the 2013 Hajj. None of 179 at-risk individuals (49.9%) decided to cancel their Hajj participation even after advice during consultation.

Health Policy and Planning
Volume 28 Issue 7 October 2013
http://heapol.oxfordjournals.org/content/current

Access to medicines from a health system perspective
Health Policy Plan. (2013) 28 (7): 692-704 doi:10.1093/heapol/czs108
Maryam Bigdeli, Bart Jacobs, Goran Tomson, Richard Laing, Abdul Ghaffar, Bruno Dujardin, and Wim Van Damme
Abstract

Most health system strengthening interventions ignore interconnections between systems components. In particular, complex relationships between medicines and health financing, human resources, health information and service delivery are not given sufficient consideration. As a consequence, populations’ access to medicines (ATM) is addressed mainly through fragmented, often vertical approaches usually focusing on supply, unrelated to the wider issue of access to health services and interventions. The objective of this article is to embed ATM in a health system perspective. For this purpose, we perform a structured literature review: we examine existing ATM frameworks, review determinants of ATM and define at which level of the health system they are likely to occur; we analyse to which extent existing ATM frameworks take into account access constraints at different levels of the health system. Our findings suggest that ATM barriers are complex and interconnected as they occur at multiple levels of the health system. Existing ATM frameworks only partially address the full range of ATM barriers. We propose three essential paradigm shifts that take into account complex and dynamic relationships between medicines and other components of the health system. A holistic view of demand-side constraints in tandem with consideration of multiple and dynamic relationships between medicines and other health system resources should be applied; it should be recognized that determinants of ATM are rooted in national, regional and international contexts. These are schematized in a new framework proposing a health system perspective on ATM.

Health Policy and Planning
Volume 28 Issue 7 October 2013
http://heapol.oxfordjournals.org/content/current

For-profit sector immunization service provision: does low provision create a barrier to take-up?
Neeraj Sood and Zachary Wagner
Health Policy Plan. (2013) 28 (7): 730-738 doi:10.1093/heapol/czs113
Abstract

Achievement of the health-related Millennium Development Goals is dependent on increasing take-up of preventive public health services (PHSs) in developing countries. Poor country governments often lack the resources to provide optimal access to preventive services and a great deal of attention is being directed towards the private sector to fill this void. In many developing countries, the private sector already plays a large role in health care. However, the for-profit private sector has little incentive to provide PHSs. The lack of provision of services by the for-profit sector may create a barrier to take-up of these services. In this study, we use data from a census of health facilities combined with data from community and provider surveys from Kenya to analyse whether the private for-profit sector has lower provision rates of child immunization services, and subsequently whether this creates a barrier that results in lower immunization take-up. We show that only 34% of for-profit facilities provide immunizations and that in areas with a larger share of for-profit providers, children are more likely to have no immunization coverage. Our model predicts that the odds of a child receiving no immunization coverage are 4.8 times higher in areas where all health facilities are for-profit compared to areas with no for-profit facilities. This indicates that a policy of engagement with the private for-profit sector aimed at increasing provision of immunization services may be an effective strategy for increasing take-up.

Journal of Infectious Diseases
Volume 208 suppl 1 November 1, 2013
http://jid.oxfordjournals.org/content/208/suppl_1.toc

Supplement: Cholera in Africa: Microbiology, Epidemiology, Prevention and Control
Editorial Committee Introduction
Martin Mengel1, Eric Mintz2, Gopinath Balakrish Nair3 and Bradford D. Gessner1
1 Agence de Medecine Preventive, Paris, France
2 US Centers for Disease Control and Prevention, Atlanta, Georgia
3 National Institute of Cholera and Enteric Diseases, Kolkata, India

The current supplement presents an overview of cholera disease burden and critical issues for the diagnosis, detection, prevention, and control of cholera in Africa. In 2013, the seventh cholera pandemic reached its 43rd year in Africa, with no evidence that it will end soon. More than 20 African countries have reported cholera to the World Health Organization (WHO) every year between 2007 and 2012, including large recent epidemics in the Democratic Republic of Congo (DRC), Sierra Leone, Uganda, Ghana, Niger, and Guinea [1].

In the current supplement, articles from individual countries highlight the human toll of cholera, including more than 200 000 cases and 7000 deaths in DRC from 2000 through 2008 [2]; 68 000 cases and 2600 deaths in Kenya from 1998 through 2010 [3]; 28 000 cases and 1300 deaths in Cameroon from 2010 through 2011 [4]; 25 000 cases and 220 deaths in Mozambique from 2009 through 2011 [5]; and more than 12 000 cases and 500 deaths in Togo from 1996 through 2010 [6]. Two patterns emerge from these reports. The first is endemic, as in DRC, where cholera has occurred continuously in specific regions with an increase in the number of outbreaks during the rainy season. The second pattern is epidemic or outbreak driven, as in Mozambique, where many districts have been affected over relatively short periods, separated by prolonged quiescent periods. Although factors such as climate might increase outbreak risk, in these settings it remains difficult to predict the specific districts or communities that will be affected during any given year.

Difficulties in interpreting country-level data exist. Most African countries currently rely on reporting of aggregate data from the district level, whose completeness remains unknown. This could lead to serious underestimation of …

The Lancet  
Oct 12, 2013  Volume 382  Number 9900   p1225 – 1308  e11 – 20
http://www.thelancet.com/journals/lancet/issue/current

Mapping of available health research and development data: what’s there, what’s missing, and what role is there for a global observatory?
Prof John-Arne Røttingen MD a b c, Sadie Regmi BSc d, Mari Eide e, Alison J Young MA f, Roderik F Viergever MD g h, Christine Årdal MBA a i, Javier Guzman MD j, Danny Edwards MBioeth k, Stephen A Matlin DSc l, Robert F Terry MPhil m
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2961046-6/abstract

Summary
The need to align investments in health research and development (R&D) with public health demands is one of the most pressing global public health challenges. We aim to provide a comprehensive description of available data sources, propose a set of indicators for monitoring the global landscape of health R&D, and present a sample of country indicators on research inputs (investments), processes (clinical trials), and outputs (publications), based on data from international databases. Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion. Of the US$214 billion invested in high-income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non-profit organisations). Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries. This report confirms that substantial gaps in the global landscape of health R&D remain, especially for and in low-income and middle-income countries. Too few investments are targeted towards the health needs of these countries. Better data are needed to improve priority setting and coordination for health R&D, ultimately to ensure that resources are allocated to diseases and regions where they are needed the most. The establishment of a global observatory on health R&D, which is being discussed at WHO, could address the absence of a comprehensive and sustainable mechanism for regular global monitoring of health R&D.

Nature   
Volume 502 Number 7470 pp141-264  10 October 2013
http://www.nature.com/nature/current_issue.html

Special Focus
Outlook – Tuberculosis
Tony Scully

Epidemiology: A mortal foe
Tom Paulson

Drug development: A combined effort
Amy Maxmen

Perspective: Graduation time
David G. Russell & Carl F. Nathan

Vaccines: An age-old problem
Sarah DeWeerdt

Diagnosis: Waiting for results
Catherine de Lange

Perspective: Weigh all TB risks
Christopher Dye & Mario Raviglione

Latency: A sleeping giant
Courtney Humphries

Transmission: Control issues
Ewen Callaway

Nature Medicine
October 2013, Volume 19 No 10 pp1191-1350
http://www.nature.com/nm/journal/v19/n10/index.html

Focus on 2013 Albert Lasker Medical Research Awards – An interview with Bill and Melinda Gates – pp1249 – 1251
doi:10.1038/nm.3331
Bill and Melinda Gates have led a profound transformation in the way we view the world’s most pressing health concerns, looking for effective ways to improve the lives of millions of people. Claire Pomeroy, president of the Albert and Mary Lasker Foundation, spoke with them about their current concerns and plans to advance their agenda.

Pharmacoeconomics
Volume 31, Issue 10, October 2013
http://link.springer.com/journal/40273/31/10/page/1

Systematic Review
The Road Not Taken: Transferability Issues in Multinational Trials
Pepijn Vemer, Maureen P. M. H. Rutten-van Mölken

Abstract
Background
National regulatory agencies often have to use cost-effectiveness (CE) data from multinational randomized controlled trials (RCTs) for national decision making on reimbursement of new drugs. We need to make the best use of these patient-level data to obtain estimates of country-specific CE. Several methods, ranging from simple to statistically complex, have existed for years. We investigated which of these methods are used to estimate CE ratios in economic evaluations performed alongside recent, multinational RCTs that enrolled at least 500 patients.

Methods
In this systematic literature review, studies were classified based on whether resource use, unit costs, health outcomes and utility value sets were obtained from all countries, a subset of countries or one country. We recorded if the study presented trial-wide and country-specific CE results and reported the statistical analyses that were used to estimate them.

Results
We included 21 studies, of which the majority used measurements of health care utilization and health outcomes from all countries to estimate CE. Thirteen studies used a one-country valuation of health care utilization; six used a multi-country valuation. Despite the availability of country-specific utility value sets, none of the studies that presented quality-adjusted life-years (QALYs) used multi-country valuation. Valuation of health care utilization and health outcomes was not always consistent within a study: three studies combined a multi-country valuation of health care utilization, with a one-country valuation of health outcomes. Most studies calculated trial-wide CE estimates, while 11 studies calculated country- or region-specific estimates. Thirteen studies used relatively simple methods, which do not take the possible interaction between the country and treatment effect on health care utilization and health outcomes into account. Eight studies used more advanced statistical methods. Three of them used a fixed-effects modeling approach. Five studies explicitly took the hierarchical structure of the data into account, which leads to more appropriate estimates of population average results and associated standard errors. In this way, they help improve transferability of the published results.

Conclusion
Based on this systematic review, we concluded that the uptake of more advanced statistical methods has been relatively slow, while simpler naïve methods are still routinely employed.

PLoS One
[Accessed 12 October 2013]
http://www.plosone.org/

Vaccination against Foot-And-Mouth Disease: Do Initial Conditions Affect Its Benefit?
Thibaud Porphyre, Harriet K. Auty, Michael J. Tildesley, George J. Gunn, Mark E. J. Woolhouse Research Article | published 04 Oct 2013 | PLOS ONE 10.1371/journal.pone.0077616

Abstract
When facing incursion of a major livestock infectious disease, the decision to implement a vaccination programme is made at the national level. To make this decision, governments must consider whether the benefits of vaccination are sufficient to outweigh potential additional costs, including further trade restrictions that may be imposed due to the implementation of vaccination. However, little consensus exists on the factors triggering its implementation on the field. This work explores the effect of several triggers in the implementation of a reactive vaccination-to-live policy when facing epidemics of foot-and-mouth disease. In particular, we tested whether changes in the location of the incursion and the delay of implementation would affect the epidemiological benefit of such a policy in the context of Scotland. To reach this goal, we used a spatial, premises-based model that has been extensively used to investigate the effectiveness of mitigation procedures in Great Britain. The results show that the decision to vaccinate, or not, is not straightforward and strongly depends on the underlying local structure of the population-at-risk. With regards to disease incursion preparedness, simply identifying areas of highest population density may not capture all complexities that may influence the spread of disease as well as the benefit of implementing vaccination. However, if a decision to vaccinate is made, we show that delaying its implementation in the field may markedly reduce its benefit. This work provides guidelines to support policy makers in their decision to implement, or not, a vaccination-to-live policy when facing epidemics of infectious livestock disease.

PLoS Medicine
(Accessed 12 October 2013)
http://www.plosmedicine.org/

Research Article
Assessing Optimal Target Populations for Influenza Vaccination Programmes: An Evidence Synthesis and Modelling Study
Marc Baguelin, Stefan Flasche, Anton Camacho, Nikolaos Demiris, Elizabeth Miller, W. John Edmunds
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001527

Abstract
Background
Influenza vaccine policies that maximise health benefit through efficient use of limited resources are needed. Generally, influenza vaccination programmes have targeted individuals 65 y and over and those at risk, according to World Health Organization recommendations. We developed methods to synthesise the multiplicity of surveillance datasets in order to evaluate how changing target populations in the seasonal vaccination programme would affect infection rate and mortality.

Methods and Findings
Using a contemporary evidence-synthesis approach, we use virological, clinical, epidemiological, and behavioural data to develop an age- and risk-stratified transmission model that reproduces the strain-specific behaviour of influenza over 14 seasons in England and Wales, having accounted for the vaccination uptake over this period. We estimate the reduction in infections and deaths achieved by the historical programme compared with no vaccination, and the reduction had different policies been in place over the period. We find that the current programme has averted 0.39 (95% credible interval 0.34–0.45) infections per dose of vaccine and 1.74 (1.16–3.02) deaths per 1,000 doses. Targeting transmitters by extending the current programme to 5–16-y-old children would increase the efficiency of the total programme, resulting in an overall reduction of 0.70 (0.52–0.81) infections per dose and 1.95 (1.28–3.39) deaths per 1,000 doses. In comparison, choosing the next group most at risk (50–64-y-olds) would prevent only 0.43 (0.35–0.52) infections per dose and 1.77 (1.15–3.14) deaths per 1,000 doses.

Conclusions
This study proposes a framework to integrate influenza surveillance data into transmission models. Application to data from England and Wales confirms the role of children as key infection spreaders. The most efficient use of vaccine to reduce overall influenza morbidity and mortality is thus to target children in addition to older adults.

PLoS Medicine
(Accessed 12 October 2013)
http://www.plosmedicine.org/

The Final Push for Polio Eradication: Addressing the Challenge of Violence in Afghanistan, Pakistan, and Nigeria
Seye Abimbola, Asmat Ullah Malik, Ghulam Farooq Mansoor
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001529

Summary Points
:: Polio eradication in Nigeria, Pakistan, and Afghanistan (the three remaining endemic countries) depends on understanding the common determinants and country-specific factors that underlie the failure to eradicate polio in these countries.
:: Our review of the current situation suggests that the global health community and the governments of Afghanistan, Pakistan, and Nigeria need to build trust and to prioritise polio eradication as part of routine health services rather than highlighting it as “the only” health problem.
:: Coercive strategies for making people take the polio vaccine and censorship of discussions around the controversies about polio vaccines need to be avoided.
:: Because polio workers are a newly recognised soft target for anti-West terrorist groups in these countries, the publicity surrounding vaccination activities should be minimised.
:: The global health community and national governments need to work directly with community members and their immediate leaders to dispel myths about polio vaccination rather than engaging only with regional or provincial religious leaders.

Why We Must Provide Better Support for Pakistan’s Female Frontline Health Workers
Svea Closserl, Rashid Jooma
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001528

Summary Points
:: As the Global Polio Eradication Initiative deploys its endgame strategy, the commitment and effectiveness of field health workers in polio-endemic countries is critical.
:: Ongoing attacks on Lady Health Workers and other frontline health staff in Pakistan appear to be an unintended consequence of the high political profile of polio eradication.
:: Achieving polio eradication and strengthening Pakistan’s health system now depends on a shift in the center of gravity of international engagement, away from high-profile engagement with federal leaders and towards supportive partnerships with Lady Health Workers and other ground-level staff.
:: Nearly all women who work on the health frontline in Pakistan do so because poverty and a lack of other opportunities force them to accept a job with pay of under US$5 per day.
:: Steps to support Lady Health Workers and to engage them as strong partners should include paying a living wage, developing world-class security strategies, and providing opportunities for career development and advancement.