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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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

World AIDS Day 2013 – 1 December 2013

WHO: New HIV recommendations for adolescents
25 November 2013 — More than 2 million adolescents between the ages of 10 and 19 years are living with HIV, and many do not receive the care and support that they need to stay in good health and prevent transmission. In addition, millions more adolescents are at risk of infection. The failure to support effective and acceptable HIV services for adolescents has resulted in a 50% increase in reported AIDS-related deaths in this group compared with the 30% decline seen in the general population from 2005 to 2012.
New WHO recommendations released in the run-up to World AIDS Day 2013 are the first to address the specific needs of adolescents, both for those living with HIV and those who are at risk of infection.
:: Press release: Adolescents falling through gaps in HIV services
:: Guidance for HIV testing, counselling and care
:: Policy brief

UNICEF: More than 850,000 infants saved from HIV since 2005, but alarming trends seen among adolescents
NEW YORK, 29 November 2013 – A new report released today by UNICEF shows great progress has been made to prevent mother-to-child transmission of HIV, with more than 850,000 new childhood infections averted between 2005 and 2012 in low- and middle-income countries…

NIH Statement on World AIDS Day 2013 — December 1, 2013
Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases; Jack Whitescarver, Ph.D., Director, NIH Office of AIDS Research; Francis S. Collins, M.D., Ph.D., NIH Director
http://www.nih.gov/news/health/nov2013/niaid-27.htm
Excerpt
In the 25 years that have passed since the first annual commemoration of World AIDS Day, extraordinary scientific progress has been made in the fight against HIV/AIDS. That progress has turned an HIV diagnosis from an almost-certain death sentence to what is now for many, a manageable medical condition and nearly normal lifespan. We have come far, yet not far enough.

In 2012, more than 2 million new HIV infections and 1.6 million AIDS-related deaths occurred globally. Although these numbers represent a decline from previous years, they also reflect a grim reality: far too many people become HIV-infected and die from the effects of the disease. On World AIDS Day, the National Institutes of Health (NIH) reaffirms its commitment to finding improved HIV treatments and tools for preventing infection (including a vaccine), addressing the conditions and diseases associated with long-term HIV infection, and, ultimately, finding a cure…

…A cornerstone of our HIV prevention efforts continues to be the search for a safe and effective vaccine. The pathway to an effective HIV vaccine has been challenging and marked by disappointments; however, basic research advances this year are charting the course for a new generation of investigational HIV vaccines. Through the work of NIH scientists and grantees, we have gained insights into how HIV and a strong antibody response to the virus co-evolve in an infected person and improved our understanding of how B-cells create potentially protective immune system responses. Further, NIH-funded researchers have developed a new tool for identifying broadly neutralizing antibodies against HIV that could help speed vaccine research and illuminated in exquisite detail the protein largely responsible for enabling HIV to enter human immune cells and cause infection.

Additionally, ongoing analyses of the landmark RV 144 HIV vaccine trial conducted in Thailand are providing important information about human immune responses and other factors that may explain why the investigational vaccine regimen reduced the risk of HIV acquisition by 31 percent. Large-scale investigational clinical trials to build on the RV 144 results are being planned for South Africa and Thailand….

IAVI: World AIDS Day – December 1, 2013: Honoring Their Memories. Finding a Vaccine.
November 25, 2013
Excerpt
On this World AIDS Day, the International AIDS Vaccine Initiative (IAVI) pays tribute to the tens of millions of people who have lost their lives by reaffirming our commitment to finding a vaccine that will help end the AIDS pandemic.
“There has been tremendous success in treating millions with HIV over the past three decades,” said IAVI President and Chief Executive Officer Margie McGlynn, “but a great deal of continued commitment, innovation and persistence will be needed to realize the vision of a world without AIDS…

http://www.iavi.org/Information-Center/Press-Releases/Pages/World-AIDS-Day-2013-Honoring-Their-Memories-Finding-a-Vaccine.aspx

UNICEF-WHO Joint news note: Children in typhoon-hit Tacloban, Philippines, receive vaccines against measles, polio
Excerpt
TACLOBAN/MANILA, Philippines, 26 November 2013 – Children in Tacloban – the city hit hardest by Typhoon Haiyan – were today vaccinated against measles and polio in the first phase of a mass campaign by the Government of the Philippines with support from UNICEF, the World Health Organization (WHO), and other partners. They also received Vitamin A supplements to help improve their immunity against infections.
Over 30,000 children are expected to be reached by the campaign which is taking place at fixed sites in evacuation centres and in communities using mobile health teams.

The vaccination drive in Tacloban is the first phase of a campaign targeting children under five years old in all the typhoon-affected areas. Fifteen teams (10 foreign and 5 national) including volunteers from the Department of Health, the Philippines Red Cross and other non-governmental organisations, were in locations across Tacloban giving vaccines today. The first to receive them were children in 20 evacuation centres – such as San Jose Elementary School, where more than 300 families currently live in conditions that can heighten the risk of infectious diseases…

…At the government’s request, UNICEF purchased over US$2 million worth of vaccines to replenish in-country stocks now being used for the campaign. In addition, UNICEF and WHO are helping to re-establish the broken cold chain, which is critical in keeping vaccines at the right temperature…
http://www.unicef.org/media/media_71017.html

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 29 November 2013

:: Middle East respiratory syndrome coronavirus (MERS-CoV) – update Arab Republic – update 26 November 2013

:: Cholera in Mexico – update 25 November 2013

:: Polio in the Syrian Arab Republic – update26 November 2013
Excerpt
A total of 17 cases due to wild poliovirus type 1 (WPV1) have been confirmed in the Syrian Arab Republic. In addition to 15 cases confirmed in Deir Al Zour province, two additional cases have been confirmed, one each in rural Damascus and Aleppo, confirming widespread circulation of the virus. The case with most recent onset developed paralysis on 8 October 2013.

A comprehensive outbreak response continues to be implemented across the region. Seven countries and territories are holding mass polio vaccination campaigns targeting 22 million children under the age of five years. In a joint resolution, all countries of the WHO Eastern Mediterranean Region have declared polio eradication to be an emergency, calling for support in negotiating and establishing access to those children who are currently unreached with polio vaccination. WHO and UNICEF are committed to work with all organizations and agencies providing humanitarian assistance to Syrians affected by the conflict to ensure all Syrian children are vaccinated no matter where they live.

It is anticipated that outbreak response will need to continue for at least six to eight months, depending on the area and based on evolving epidemiology…

Update: Polio this week – As of 30 November 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]

:: In Syria, four new wild polio virus type 1 (WPV1) cases were reported in the past week. New cases in Aleppo and Douma (rural Damascus) indicate that polio is spreading within the country and reaffirm the urgent need to vaccinate all children in Syria, regardless of who controls the area where they are.

:: In Kenya, the government declared polio a public health emergency on 22 November and directed the Ministry of Health to fast-track the immunization activities and to ensure the entire country is covered.

Pakistan
:: One new WPV1 case was reported in the past week from FR Bannu, Federally Administered Tribal Areas (FATA). The total number of WPV1 cases for Pakistan in 2013 is now 64. The most recent WPV1 case had onset of paralysis on 4 November (from FATA).
:: Two new cVDPV2 cases were reported in the past week. The total number of cVDPV2 cases for 2013 is now 43. The most recent cVDPV2 case had onset of paralysis 27 October (from North Waziristan, FATA).
:: The situation in North Waziristan is alarming. It is the area with the largest number of children being paralyzed by poliovirus in all of Asia. 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
:: In Cameroon, two new WPV1 cases were reported in the past week, both from Malentouen in Ouest region. The total number of WPV1 cases is now four. The most recent case in Cameroon had onset of paralysis on 30 October 2013 (WPV1 from Ouest).

Middle East
:: In Syria, four new WPV1 cases were reported in the past week, two from previously infected district Mayadeen in Deir-Al-Zour and one from Douma, rural Damascus and Fardous, Aleppo, respectively. The total number of WPV1 cases is now 17. The new cases in Aleppo and rural Damascus signal that polio is spreading in the country, but are also a sign that workers are actively looking for cases of polio. Prior to the outbreak wild poliovirus was last reported in Syria in 1999.
:: In the Middle East, a comprehensive outbreak response continues to be implemented across the region. The large-scale supplementary immunization activity which started in Syria on 24 October to vaccinate 1.6 million children against polio, measles, mumps and rubella, in both government-controlled and contested areas, has been completed.
:: Seven countries and territories are holding mass polio vaccination campaigns repeatedly targeting 22 million children under the age of five years over the next 6-8 months. In a joint resolution, all countries of the WHO Eastern Mediterranean Region have declared polio eradication to be an emergency, calling for support in negotiating and establishing access to those children who are currently unreached with polio vaccination.
:: WHO and UNICEF are committed to working with all organizations and agencies providing humanitarian assistance to Syrians affected by the conflict. This includes vaccinating all Syrian children no matter where they are, whether in government or contested areas, or outside Syria.

The European Medicines Agency (EMA), in collaboration with other organisations involved in assessing the benefits and risks of vaccines, launched the ADVANCE project “to deliver a blueprint for a pan-European framework for monitoring the benefits and risks of vaccines throughout their lifecycle, and for communicating these benefits and risks.” The five-year project, called accelerated development of vaccine benefit-risk collaboration in Europe  (ADVANCE), is supported by the Innovative Medicines Initiative (IMI) and brings together the EMA and the European Centre for Disease Prevention and Control (ECDC), as well as pharmaceutical companies that manufacture vaccines, national public-health and regulatory bodies, academic experts and small and medium-sized enterprises. ADVANCE is coordinated by the Erasmus Medical Center in the Netherlands and the Children’s Hospital Basel , University of Basel, Switzerland. This framework “will further facilitate health professionals, regulatory agencies, public-health institutions and the general public to make prompt, better-informed decisions regarding vaccination strategies.” The role of the EMA in ADVANCE will be to develop and test guidance for the conduct and reporting of studies in this area. This best-practice guidance will include methodological standards, governance rules, a code of conduct and a communication strategy.

26/11/2013: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001976.jsp&mid=WC0b01ac058004d5c1

GAVI Watch: Media Releases/Statements
http://www.gavialliance.org/library/news/statements/

:: Guillaume Grosso appointed head resource mobilisation in European markets -28 November 2013
   Former director of ONE Campaign’s Paris office joins GAVI Alliance.

:: GAVI Alliance to support Nigeria’s first new national yellow fever vaccination campaign in 30 years – 26 November 2013
   Mass preventive campaign will protect close to 60 million children and adults

The Weekly Epidemiological Record (WER) for 29 November 2013, vol. 88, 48 (pp. 509–520) includes:
:: Review of the 2013 influenza season in the southern hemisphere
http://www.who.int/entity/wer/2013/wer8848.pdf

CDC/MMWR Watch [to 30 November 2013]

Princeton University will offer Meningitis B vaccines to recommended groups
Posted November 26, 2013; 03:00 p.m.
Excerpt
The Centers for Disease Control and Prevention (CDC) has now officially recommended that all Princeton University undergraduate students, and also graduate students living in undergraduate dormitories, the Graduate College and annexes, and other members of the University community with certain medical conditions, receive a vaccine that helps protect against meningococcal disease caused by serogroup B bacteria. The vaccine will be provided only to these groups, and it will not be administered anywhere else.

The specified groups were recommended by the CDC to receive the vaccine because young adults and people with certain medical conditions are at increased risk of getting meningitis, especially those who live in close quarters, such as dormitories.

Since March 2013 there have been eight cases of meningococcal disease contracted by Princeton University students and a student visitor, all of which were caused by meningococcal bacteria known as serogroup B, including the latest case reported on Nov. 21….

…The CDC recommends that all members of the University community who have problems with their spleen (including sickle cell disease) or complement pathway disorder (a specific type of immune deficiency) be considered for vaccination. Those who have these conditions would be required to present documentation or a physician’s note to University Health Services before receiving the vaccine.

Princeton University will cover the cost of the vaccine.
http://www.princeton.edu/main/news/archive/S38/54/94A32/index.xml?section=topstories

American Journal of Infection Control
Vol 41 | No. 12 | December 2013 | Pages 1147-1302
http://www.ajicjournal.org/current

B95: A new respirator for health care personnel
Megan E. Gosch, MPH, Ronald E. Shaffer, PhD, Aaron E. Eagan, RN, BSN, Raymond J. Roberge, MD, MPH, Victoria J. Davey, PhD, MPH, RN, Lewis J. Radonovich Jr., MD
published online 31 May 2013.

Abstract
Background
Respiratory protection relies heavily on user compliance to be effective, but compliance among health care personnel is less than ideal.

Methods
In 2008, the Department of Veterans Affairs formed the Project Better Respiratory Equipment using Advanced Technologies for Healthcare Employees (BREATHE) Working Group, composed of a variety of federal stakeholders, to discuss strategies for improving respirator compliance, including the need for more comfortable respirators.

Results
The Working Group developed 28 desirable performance characteristics that can be grouped into 4 key themes: (1) respirators should perform their intended function safely and effectively; (2) respirators should support, not interfere, with occupational activities; (3) respirators should be comfortable and tolerable for the duration of wear; and (4) respiratory protective programs should comply with federal/state standards and guidelines and local policies. As a necessary next step, the Working Group identified the need for a new class of respirators, to be called “B95,” which would better address the unique needs of health care personnel.

Conclusion
This article summarizes the outputs of the Project BREATHE Working Group and provides a national strategy to develop clinically validated respirator test methods, to promulgate B95 respirator standards, and to invent novel design features, which together will lead to commercialized B95 respirators.

British Medical Bulletin
Volume 108 Issue 1 December 2013
http://bmb.oxfordjournals.org/content/current

Social media in public health
Taha A. Kass-Hout* and Hend Alhinnawi
Author Affiliations
Humanitarian Tracker, Washington, DC, USA
Accepted August 27, 2013.
http://bmb.oxfordjournals.org/content/108/1/5.abstract

Abstract
Introduction or background
While social media interactions are currently not fully understood, as individual health behaviors and outcomes are shared online, social media offers an increasingly clear picture of the dynamics of these processes.

Sources of data
Social media is becoming an increasingly common platform among clinicians and public health officials to share information with the public, track or predict diseases.

Areas of agreement
Social media can be used for engaging the public and communicating key public health interventions, while providing an important tool for public health surveillance.

Areas of controversy
Social media has advantages over traditional public health surveillance, as well as limitations, such as poor specificity, that warrant additional study.

Growing points
Social media can provide timely, relevant and transparent information of public health importance; such as tracking or predicting the spread or severity of influenza, west nile virus or meningitis as they propagate in the community, and, in identifying disease outbreaks or clusters of chronic illnesses.

Areas timely for developing research
Further work is needed on social media as a valid data source for detecting or predicting diseases or conditions. Also, whether or not it is an effective tool for communicating key public health messages and engaging both, the general public and policy-makers.

British Medical Journal
30 November 2013 (Vol 347, Issue 7935)
http://www.bmj.com/content/347/7935

Research
Non-publication of large randomized clinical trials: cross sectional analysis
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6104 (Published 29 October 2013)
Cite this as: BMJ 2013;347:f6104
Christopher W Jones, attending physician1, Lara Handler, school of medicine liaison librarian2, Karen E Crowell, clinical information specialist2, Lukas G Keil, research assistant3, Mark A Weaver, assistant professor4, Timothy F Platts-Mills, assistant professor3
http://www.bmj.com/content/347/bmj.f6104

Abstract
Objective  To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public.

Design  Cross sectional analysis

Setting  Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009.

Data sources  PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.

Main outcome measures   The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.

Results  Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.

Conclusions  Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.

Bulletin of the World Health Organization
Volume 91, Number 12, December 2013, 897-972http://www.who.int/bulletin/volumes/91/12/en/index.html

Editorial
Knowledge is power; information is liberation
Rachel Baggaley a, Jesus M Garcia Calleja a, Lawrence Marum b & Elizabeth Marum b
a. Department of HIV/AIDS, World Health Organization, avenue Appia 20, 1211 Geneva 27, Switzerland.
b. US Centers for Disease Control and Prevention, Lusaka, Zambia.
Bulletin of the World Health Organization 2013;91:898-898A. doi: http://dx.doi.org/10.2471/BLT.13.132464
http://www.who.int/bulletin/volumes/91/12/13-132464/en/index.html

Excerpt
In 1597 Francis Bacon stated that “knowledge itself is power”1 and Nelson Mandela, in the same vein, said in 2003 that “education is the most powerful weapon we can use to change the world”.2 In this issue of the Bulletin of the World Health Organization, Dermot Maher discusses the ethics of conducting population-based surveys involving clinical tests for research and surveillance purposes without routinely giving participants their test results, if these are positive, so that they can seek access to lifesaving treatment. Maher argues specifically that because antiretroviral treatment is now widely available, even in low- and middle-income countries, it is no longer ethical to fail to inform research participants when the result of a test for the detection of human immunodeficiency virus (HIV) infection turns out to be positive.3,4

According to the Council for International Organizations of Medical Sciences, “individual subjects will be informed of any finding that relates to their particular health status”.5 In 2004 and 2013, the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) issued ethical guidance for HIV surveillance that included a guiding principle particularly relevant to this discussion: in household or clinical surveys, “participants must be given the opportunity to be informed of their test results”.6 Currently, participants in many population-based surveys in which blood or other samples are collected for research purposes are “given the opportunity” to learn their test results, through testing services provided in the community or referral to local counselling and testing services, but are still allowed to “opt out” of learning their results…

Bulletin of the World Health Organization
Volume 91, Number 12, December 2013, 897-972http://www.who.int/bulletin/volumes/91/12/en/index.html

Editorial
Public health management of mass gatherings: the Saudi Arabian experience with MERS-CoV
Ziad A Memish & Abdullah A Al-Rabeeah
doi: 10.2471/BLT.13.132266
Excerpt
…Building on decades of experience, in October 2010 the Saudi Arabian health ministry established the Global Center for Mass Gathering Medicine, subsequently endorsed by health minis­ters of the League of Arab States. WHO’s Executive Board soon mandated a strat­egy for mass gatherings and established a framework to address the health chal­lenges these entail.

The scientific and practical methods applied in mass gathering medicine, as the field is called, were examined during the Second International Con­ference on Mass Gathering Medicine in Riyadh, Saudi Arabia, in September 2013. The conference highlighted the importance of research and of drawing on the experience of states and regional and international organizations to control accidents and diseases during mass gatherings. The resulting Riyadh declaration calls for cooperation and in­formation exchange between the Global Centre for Mass Gathering Medicine and other WHO collaborating centres and between states, international or­ganizations and scientific centres, with due observance of patient confidentiality and medical ethics. It also states that  global developments in the control of MERS-CoV transmission should be followed to inform arrangements for the hajj and other mass gatherings. Finally, it calls for the coordination of policies and procedures to better define the nature, methods and scope of mass gathering medicine and to launch media and educational campaigns for increas­ing awareness of the field. The confer­ence acknowledged the media’s role in conveying accurate and unbiased health information and underscored the im­portance of relying on reputable sources; ensuring balanced, non-alarmist cover­age based on scientific facts and mindful of public health ethics; and establishing benchmarks for the resources needed during mass gatherings.

The complex public health chal­lenges posed by mass gatherings are best addressed through mutual trust and equitable partnerships and col­laborations. In a globalized world, such collaborations inevitably extend beyond national and regional borders and hence require a fine balance be­tween respect for national sovereignty, public health ethics and global health security priorities.

Bulletin of the World Health Organization
Volume 91, Number 12, December 2013, 897-972http://www.who.int/bulletin/volumes/91/12/en/index.html

Frequent exposure to suboptimal temperatures in vaccine cold-chain system in India: results of temperature monitoring in 10 states
Manoj V Murhekar, Srihari Dutta, Ambujam Nair Kapoor, Sailaja Bitragunta, Raja Dodum, Pramit Ghosh, Karumanagounder Kolanda Swamy, Kalyanranjan Mukhopadhyay, Somorjit Ningombam, Kamlesh Parmar, Devegowda Ravishankar, Balraj Singh, Varsha Singh, Rajesh Sisodiya, Ramaratnam Subramanian & Tana Takum
http://www.who.int/bulletin/volumes/91/12/13-119974-ab/en/index.html
Abstract
Objective
To estimate the proportion of time the vaccines in the cold-chain system in India are exposed to temperatures of < 0 or > 8 °C.

Methods
In each of 10 states, the largest district and the one most distant from the state capital were selected for study. Four boxes, each containing an electronic temperature recorder and two vials of diphtheria, pertussis and tetanus vaccine, were placed in the state or regional vaccine store for each study state. Two of these boxes were then shipped – one per facility – towards the two most peripheral health facilities where vaccine was stored in each study district. The boxes were shipped, handled and stored as if they were routine vaccine supplies.

Findings
In state, regional and district vaccine stores and peripheral health facilities, respectively, the temperatures in the boxes exceeded 8 °C for 14.3%, 13.2%, 8.3% and 14.7% of their combined storage times and fell below 0 °C for 1.5%, 0.2%, 0.6% and 10.5% of these times. The boxes also spent about 18% and 7% of their combined times in transit at < 0 and > 8 °C, respectively. In shake tests conducted at the end of the study, two thirds of the vaccine vials in the boxes showed evidence of freezing.

Conclusion
While exposure to temperatures above 8 °C occurred at every level of vaccine storage, exposure to subzero temperatures was only frequent during vaccine storage at peripheral facilities and vaccine transportation. Systematic efforts are needed to improve temperature monitoring in the cold-chain system in India.

Bulletin of the World Health Organization
Volume 91, Number 12, December 2013, 897-972http://www.who.int/bulletin/volumes/91/12/en/index.html

POLICY & PRACTICE
The ethics of feedback of HIV test results in population-based surveys of HIV infection
Dermot Maher
doi: 10.2471/BLT.13.117309
http://www.who.int/bulletin/volumes/91/12/13-117309-ab/en/index.html

Abstract
Population-based disease prevalence surveys raise ethical questions, including whether participants should be routinely told their test results. Ethical guidelines call for informing survey participants of any clinically relevant finding to enable appropriate management. However, in anonymous surveys of human immunodeficiency virus (HIV) infection, participants can “opt out” of being given their test results or are offered the chance to undergo voluntary HIV testing in local counselling and testing services. This is aimed at minimizing survey participation bias.    Those who opt out of being given their HIV test results and who do not seek their results miss the opportunity to receive life-saving antiretroviral therapy.

The justification for HIV surveys without routine feedback of results to participants is based on a public health utility argument: that the benefits of more rigorous survey methods – reduced participation bias – outweigh the benefits to individuals of knowing their HIV status. However, people with HIV infection have a strong immediate interest in knowing their HIV status. In consideration of the ethical value of showing respect for people and thereby alleviating suffering, an argument based on public health utility is not an appropriate justification.

In anonymous HIV surveys as well as other prevalence surveys of treatable conditions in any setting, participation should be on the basis of routine individual feedback of results as an integral part of fully informed participation. Ensuring that surveys are ethically sound may stimulate participation, increase a broader uptake of HIV testing and reduce stigmatization of people who are HIV-positive.

Bulletin of the World Health Organization
Volume 91, Number 12, December 2013, 897-972http://www.who.int/bulletin/volumes/91/12/en/index.html

Rapid monitoring in vaccination campaigns during emergencies: the post-earthquake campaign in Haiti
Jeanette J Rainey, David Sugerman, Muireann Brennan, Jean Ronald Cadet, Jackson Ernsly, François Lacapère, M Carolina Danovaro-Holliday, Jean-Claude Mubalama & Robin Nandy
Problem
The earthquake that struck Haiti in January 2010 caused 1.5 million people to be displaced to temporary camps. The Haitian Ministry of Public Health and Population and global immunization partners developed a plan to deliver vaccines to those residing in these camps. A strategy was needed to determine whether the immunization targets set for the campaign were achieved.

Approach
Following the vaccination campaign, staff from the Ministry of Public Health and Population interviewed convenience samples of households – in specific predetermined locations in each of the camps – regarding receipt of the emergency vaccinations. A camp was targeted for “mop-up vaccination” – i.e. repeat mass vaccination – if more than 25% of the children aged 9 months to 7 years in the sample were found not to have received the emergency vaccinations.

Local setting
Rapid monitoring was implemented in camps located in the Port-au-Prince metropolitan area. Camps that housed more than 5000 people were monitored first.

Relevant changes
By the end of March 2010, 72 (23%) of the 310 vaccinated camps had been monitored. Although 32 (44%) of the monitored camps were targeted for mop-up vaccination, only six of them had received such repeat mass vaccination when checked several weeks after monitoring.

Lessons learnt
Rapid monitoring was only marginally beneficial in achieving immunization targets in the temporary camps in Port-au-Prince. More research is needed to evaluate the utility of conventional rapid monitoring, as well as other strategies, during post-disaster vaccination campaigns that involve mobile populations, particularly when there is little capacity to conduct repeat mass vaccination.
http://www.who.int/bulletin/volumes/91/12/12-117044-ab/en/index.html

The European Journal of Public Health
Volume 23 Issue 6 December 2013
http://eurpub.oxfordjournals.org/content/current

Prevention of sexually transmitted infections among girls and young women in relation to their HPV vaccination status
Delphine Lutringer-Magnin1,2, Julie Kalecinski3, Claire Cropet1, Giovanna Barone1, Vincent Ronin1, Véronique Régnier3, Yann Leocmach4, Anne-Carole Jacquard4, Philippe Vanhems2,5, Franck Chauvin3 and Christine Lasset1,2

Author Affiliations
1 Département de santé publique, Centre Léon Bérard, Lyon, France
2 Laboratoire de biométrie et biologie évolutive, Université Lyon 1, CNRS UMR 5558, Villeurbanne, France
3 Département de santé publique, Institut de Cancérologie Lucien Neuwirth, CIC-EC 3 Inserm, IFR 143, Saint-Etienne, France
4 Sanofi Pasteur MSD, Lyon, France
5 Département d’Hygiène, Epidémiologie et Prévention, Hospices Civils de Lyon, Lyon, France
Correspondence: Christine Lasset, Université Lyon 1, CNRS UMR 5558 Centre Léon Bérard, 28, rue Laennec, 69373 Lyon cedex 08, France, tel: +33 4 78 78 27 52, fax: +33 4 78 78 27 15,

Abstract
Background: Having been vaccinated against the human papilloma virus (HPV) may affect other behaviours related to sexual health. This study assessed knowledge and behaviour relevant to the prevention of sexually transmitted infections (STIs) among girls/women aged 14–23 years in relation to their HPV vaccination status.

Methods: From November 2008 to February 2009, 328 girls/women from the Rhône-Alpes region were recruited by general practitioners and completed a self-administered questionnaire. Results: In all, 316 of the 328 respondents provided information on their HPV vaccination status: 135 (42.7%) had been vaccinated (51.2% of girls aged 14–16 years, 44% of women aged 17–20 years and 18.9% of 21–23-year-olds). Knowledge about HPV and the Pap smear was poor overall but greater in those who had been vaccinated: vaccinated 14–16-year-olds were significantly more likely to know the aim of the Pap smear than those not vaccinated (72.7% vs. 41.3%, P < 0.001), and vaccinated 21–23-year-olds were more likely to know about the need to continue Pap smear screening, despite vaccination (60.0% vs. 25.6%, P = 0.06). Irrespective of vaccination status, >80% cited condoms as a means of STI prevention and >85% of those who were sexually active used them. No difference was observed between vaccinated and non-vaccinated groups regarding requests for HIV serology, history of abortions or emergency hormonal contraception.

Conclusion: Knowledge about cervical cancer prevention was better among those who had been vaccinated against HPV than among those who had not. Knowledge and behaviour relevant to STI prevention seemed appropriate whatever the respondents’ vaccination status.

Global Health: Science and Practice (GHSP)
November 2013 | Volume 1 | Issue 3
http://www.ghspjournal.org/content/current
[“A new no fee, open-access journal, was developed for global health professionals, particularly program implementers, to validate their experiences and program results by peer reviewers and to share them with the greater global health community.”]

COMMENTARIES
Routine immunization: an essential but wobbly platform
Robert Steinglass
Glob Health Sci Pract 2013;1(3):295-301. http://dx.doi.org/10.9745/GHSP-D-13-0012
http://www.ghspjournal.org/content/1/3/295.full

Abstract
Despite their vital role, routine immunization programs are taken for granted. Coverage levels are poor in some countries and have stagnated in others, while addition of new vaccines is an additional stressor. We need to strengthen: (1) policy processes, (2) monitoring and evaluation, (3) human resources, (4) regular delivery and supply systems, (5) local political commitment and ownership, (6) involvement of civil society and communities, and (7) sustainable financing. Rebalancing immunization direction and investment is needed.

Global Health: Science and Practice (GHSP)
November 2013 | Volume 1 | Issue 3
http://www.ghspjournal.org/content/current
[“A new no fee, open-access journal, was developed for global health professionals, particularly program implementers, to validate their experiences and program results by peer reviewers and to share them with the greater global health community.”]

Factors limiting immunization coverage in urban Dili, Timor-Leste
Ruhul Amina⇑, Telma Joana Corte Real De Oliveirab, Mateus Da Cunhab, Tanya Wells Brownc,
a href=”http://www.ghspjournal.org/search?author1=Michael+Favin&sortspec=date&submit=Submit”>Michael Favina, Kelli Cappeliera
Author Affiliations
aMCHIP-Maternal and Child Health Integrated Program, John Snow, Inc., Washington, DC, USA
bThe Ministry of Health, Dili, Timor-Leste
cU.S. Agency for International Development, Dili, Timor-Leste
Correspondence to Ruhul Amin (dr_ruhul@yahoo.com).

Simple access to immunization services does not necessarily translate into uptake of services. In Timor-Leste, key determinants of the success of vaccination efforts are health workers’ attitudes, the manner in which patients are treated, aspects of service organization, adequate supply of vaccines, and caregivers’ basic knowledge about immunization.
http://www.ghspjournal.org/content/1/3/417.abstract

ABSTRACT
Background: Timor-Leste’s immunization coverage is among the poorest in Asia. The 2009/2010 Demographic and Health Survey found that complete vaccination coverage in urban areas, at 47.7%, was lower than in rural areas, at 54.1%. The city of Dili, the capital of Timor-Leste, had even lower coverage (43.4%) than the national urban average.

Objective: To better understand the service- and user-related factors that account for low vaccination coverage in urban Dili, despite high literacy rates and relatively good access to immunization services and communication media.

Methods: A mixed-methods (mainly qualitative) study, conducted in 5 urban sub-districts of Dili, involved in-depth interviews with18 Ministry of Health staff and 6 community leaders, 83 observations of immunization encounters, 37 exit interviews with infants’ caregivers at 11 vaccination sites, and 11 focus group discussions with 70 caregivers of vaccination-eligible children ages 6 to 23 months.

Results: The main reasons for low vaccination rates in urban Dili included caregivers’ knowledge, attitudes, and perceptions as well as barriers at immunization service sites. Other important factors were access to services and information, particularly in the city periphery, health workers’ attitudes and practices, caregivers’ fears of side effects, conflicting priorities, large family size, lack of support from husbands and paternal grandmothers, and seasonal migration.

Conclusion: Good access to health facilities or health services does not necessarily translate into uptake of immunization services. The reasons are complex and multifaceted but in general relate to the health services’ insufficient understanding of and attention to their clients’ needs. Almost all families in Dili would be motivated to have their children immunized if services were convenient, reliable, friendly, and informative.

JAMA   
November 27, 2013, Vol 310, No. 20
http://jama.jamanetwork.com/issue.aspx

Viewpoint | November 27, 2013
The 50th Anniversary of the Declaration of Helsinki- Progress but Many Remaining Challenges
Joseph Millum, PhD1,2; David Wendler, PhD1; Ezekiel J. Emanuel, MD, PhD3,4
[+] Author Affiliations
JAMA. 2013;310(20):2143-2144. doi:10.1001/jama.2013.281632.
Excerpt [Free full text: http://jama.jamanetwork.com/article.aspx?articleid=1760320 ]

Since 1964, through 7 revisions, the World Medical Association’s (WMA’s) Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. The declaration is consulted by ethics review committees, funders, researchers, and research participants; has been incorporated into national legislation; and is routinely invoked to ascertain the ethical appropriateness of clinical trials.

There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. The Working Group extensively consulted stakeholders and justified the proposed revisions. The result is a declaration that is better organized into clear sections, more precise, and likely to be more effective at protecting research participants.

For the first time, the declaration requires compensation and treatment for research-related injuries (paragraph 15), an explicit recognition that research participants should not bear the costs of research gone wrong.1 The revised declaration’s emphasis on the dissemination of research results, including studies with negative results, should increase the value of medical research (paragraphs 23, 35, and 36).

Nevertheless, the proposed declaration contains persistent flaws. While the document purports to be a statement of enduring ethical principles, the nearly continuous process of revision undermines its authority.2 Moreover, the declaration continues to assert that “consistent with the mandate of the WMA,” its primary audience is physicians (paragraph 2).    This is a mistake. Indeed, the document then offers recommendations for other health professionals (paragraph 9), research ethics committees (paragraph 23), sponsors and governments (paragraph 34), and editors and publishers (paragraph 36). It is time for the WMA to recognize that the Declaration of Helsinki should address physicians as well other health professionals and personnel involved in research. A statement of ethical principles does not require a mandate from the people who ought to follow those principles.2

The revised declaration’s treatment of informed consent remains inadequate. It fails to recognize the possibility of waiving consent for some research involving competent adults, even though such research is common and widely endorsed. Similarly, the declaration avoids providing guidance on when it can be appropriate to ask participants to give broad consent for their biological samples to be used in a wide range of future studies, rather than seeking consent for each specific study. This is a pressing issue on which researchers need clear guidance. In addition, the declaration prohibits individuals who cannot consent from participating in research that does not address the condition that caused their incapacity (paragraph 30), even when the research offers participants the potential for important medical benefit and there are no—or few—potential participants who can consent. This approach transforms a protection into a barrier….

Viewpoint | November 27, 2013
The Declaration of Helsinki, 50 Years Later
Paul Ndebele, PhD1
JAMA. 2013;310(20):2145-2146. doi:10.1001/jama.2013.281316.
Excerpt [Free full-text: http://jama.jamanetwork.com/article.aspx?articleid=1760319 ]

Fifty years and 7 revisions later, the 2013 version of the Declaration of Helsinki includes several important changes. By changing the format and including several subsections, the revised declaration enhances and improves clarity regarding specific issues. By having specific issues covered under these subsections, the declaration is now “ bolder” in the way it addresses specific issues. The new formatting will also be welcomed by readers because the subsections improve the readability of the document. By so doing, the Declaration of Helsinki is a better and more important authority at what it is aimed at achieving—providing guidance on conducting medical research involving humans.

The increase in international studies over the past few decades has contributed to serious debate about the ethics of research conducted in various settings. Most of the debate centered on issues related to limited resources and justice: use of placebo and posttrial access to interventions. Through this and previous revisions, the World Medical Association (WMA) has demonstrated that the declaration is a living document that considers current issues in medical research. Important documents such as the declaration are expected to respond to new areas of need or areas that require revision…

Special Communication | November 27, 2013
World Medical Association: Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
World Medical Association
JAMA. 2013;310(20):2191-2194. doi:10.1001/jama.2013.281053.
Full text of newest  version adopted by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013: http://jama.jamanetwork.com/article.aspx?articleid=1760318

The Lancet  
Nov 30, 2013  Volume 382  Number 9907  p1757 – 1856  e26 – 32
http://www.thelancet.com/journals/lancet/issue/current

Comment
WHO’s 2013 global report on tuberculosis: successes, threats, and opportunities
Alimuddin Zumla, Andrew George, Virendra Sharma, Nick Herbert, Baroness Masham of Ilton

Preview |
Tuberculosis has been a global public health emergency since 1993.1 In 2006 WHO launched the Stop TB strategy, which was linked to the Millennium Development Goal (MDG) 6 target of reversing the spread of tuberculosis by 2015.2 WHO’s Global Tuberculosis Report 2013,3 published on Oct 23, provides a comprehensive assessment of the current tuberculosis pandemic, and assesses progress in implementing tuberculosis services and control measures at country, regional, and global levels.3 The report details some striking successes towards achieving MDG 6 and related 2015 targets for global tuberculosis control.

The Lancet Global Health
Dec 2013  Volume 1  Number 6  e310 – 379
http://www.thelancet.com/journals/langlo/issue/current

Articles
The drug and vaccine landscape for neglected diseases (2000—11): a systematic assessment
Dr Belen Pedrique MD a, Nathalie Strub-Wourgaft MD a, Claudette Some PharmD b, Piero Olliaro MD c d, Patrice Trouiller PharmD e, Nathan Ford PhD f, Bernard Pécoul MD a, Jean-Hervé Bradol MD g
http://www.thelancet.com/journals/langlo/article/PIIS2214-109X%2813%2970078-0/abstract

Summary
Background
In 1975—99, only 1·1% of new therapeutic products had been developed for neglected diseases. Since then, several public and private initiatives have attempted to mitigate this imbalance. We analysed the research and development pipeline of drugs and vaccines for neglected diseases from 2000 to 2011.

Methods
We searched databases of drug regulatory authorities, WHO, and clinical trial registries for entries made between Jan 1, 2000, and Dec 31, 2011. We defined neglected diseases as malaria, tuberculosis, diarrhoeal diseases, neglected tropical diseases (NTDs; WHO definition), and other diseases of poverty according to common definitions.

Findings
Of the 850 new therapeutic products registered in 2000—11, 37 (4%) were indicated for neglected diseases, comprising 25 products with a new indication or formulation and eight vaccines or biological products. Only four new chemical entities were approved for neglected diseases (three for malaria, one for diarrhoeal disease), accounting for 1% of the 336 new chemical entities approved during the study period. Of 148 445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for neglected diseases.

Interpretation
Our findings show a persistent insufficiency in drug and vaccine development for neglected diseases. Nevertheless, these and other data show a slight improvement during the past 12 years in new therapeutics development and registration. However, for many neglected diseases, new therapeutic products urgently need to be developed and delivered to improve control and potentially achieve elimination.

Funding
None.

New England Journal of Medicine
November 28, 2013  Vol. 369 No. 22
http://www.nejm.org/toc/nejm/medical-journal

Perspective
The Quest for an HIV-1 Vaccine — Moving Forward
Dan H. Barouch, M.D., Ph.D.
N Engl J Med 2013; 369:2073-2076November 28, 2013DOI: 10.1056/NEJMp131271

Excerpt
Vaccines have historically been the most effective biomedical interventions for controlling global infectious diseases. The development of a safe and effective vaccine against human immunodeficiency virus type 1 (HIV-1) is therefore a critical research priority. Although other HIV-1 prevention efforts based on behavioral risk reduction, male circumcision, topical microbicides, preexposure prophylaxis, and treatment as prevention have had substantial effects on HIV-1 transmission rates, it is likely that a vaccine will be required to end the global HIV-1 epidemic.

The challenges in the development of a prophylactic HIV-1 vaccine, however, are unprecedented in the history of vaccinology. First, HIV-1 exhibits tremendous global genetic diversity as well as mutational capacity that can evade both humoral and cellular immune responses. The generation of vaccine antigens that will elicit immunologically relevant and broadly cross-reactive immune responses thus represents a major challenge. Second, HIV-1 rapidly integrates into the host genome and establishes a latent reservoir that cannot be eliminated by conventional antiretroviral drugs or virus-specific immune responses. A vaccine will therefore most likely need to induce potent and functional virus-specific antibodies that block establishment of initial infection, in addition to high levels of T lymphocytes for virologic control. Third, there are no known examples of spontaneous immune-mediated clearance of HIV-1 infection indicative of natural immunity, and thus the precise types of immune responses that need to be induced by a vaccine are not well understood. Fourth, although a series of broad and potent neutralizing monoclonal antibodies have recently been discovered, such antibodies are induced only in a subgroup of HIV-1–infected persons after several years of infection and typically exhibit extensive somatic hypermutation. No method currently exists to induce such antibodies by vaccination…

Original Article
Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine
Scott M. Hammer, M.D., Magdalena E. Sobieszczyk, M.D., M.P.H., Holly Janes, Ph.D., Shelly T. Karuna, M.D., Mark J. Mulligan, M.D., Doug Grove, M.S., Beryl A. Koblin, Ph.D., Susan P. Buchbinder, M.D., Michael C. Keefer, M.D., Georgia D. Tomaras, Ph.D., Nicole Frahm, Ph.D., John Hural, Ph.D., Chuka Anude, M.D., Ph.D., Barney S. Graham, M.D., Ph.D., Mary E. Enama, M.A., P.A.-C., Elizabeth Adams, M.D., Edwin DeJesus, M.D., Richard M. Novak, M.D., Ian Frank, M.D., Carter Bentley, Ph.D., Shelly Ramirez, M.A., Rong Fu, M.S., Richard A. Koup, M.D., John R. Mascola, M.D., Gary J. Nabel, M.D., Ph.D., David C. Montefiori, Ph.D., James Kublin, M.D., M.P.H., M. Juliana McElrath, M.D., Ph.D., Lawrence Corey, M.D., and Peter B. Gilbert, Ph.D. for the HVTN 505 Study Team
N Engl J Med 2013; 369:2083-2092November 28, 2013DOI: 10.1056/NEJMoa1310566
http://www.nejm.org/doi/full/10.1056/NEJMoa1310566

Abstract
Background
A safe and effective vaccine for the prevention of human immunodeficiency virus type 1 (HIV-1) infection is a global priority. We tested the efficacy of a DNA prime–recombinant adenovirus type 5 boost (DNA/rAd5) vaccine regimen in persons at increased risk for HIV-1 infection in the United States.

Methods
At 21 sites, we randomly assigned 2504 men or transgender women who have sex with men to receive the DNA/rAd5 vaccine (1253 participants) or placebo (1251 participants). We assessed HIV-1 acquisition from week 28 through month 24 (termed week 28+ infection), viral-load set point (mean plasma HIV-1 RNA level 10 to 20 weeks after diagnosis), and safety. The 6-plasmid DNA vaccine (expressing clade B Gag, Pol, and Nef and Env proteins from clades A, B, and C) was administered at weeks 0, 4, and 8. The rAd5 vector boost (expressing clade B Gag-Pol fusion protein and Env glycoproteins from clades A, B, and C) was administered at week 24.

Results
In April 2013, the data and safety monitoring board recommended halting vaccinations for lack of efficacy. The primary analysis showed that week 28+ infection had been diagnosed in 27 participants in the vaccine group and 21 in the placebo group (vaccine efficacy, −25.0%; 95% confidence interval, −121.2 to 29.3; P=0.44), with mean viral-load set points of 4.46 and 4.47 HIV-1 RNA log10 copies per milliliter, respectively. Analysis of all infections during the study period (41 in the vaccine group and 31 in the placebo group) also showed lack of vaccine efficacy (P=0.28). The vaccine regimen had an acceptable side-effect profile.

Conclusions
The DNA/rAd5 vaccine regimen did not reduce either the rate of HIV-1 acquisition or the viral-load set point in the population studied. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00865566.)

New England Journal of Medicine
November 28, 2013  Vol. 369 No. 22
http://www.nejm.org/toc/nejm/medical-journal

Medicine and Society
Contagious Diseases in the United States from 1888 to the Present
Willem G. van Panhuis, M.D., Ph.D., John Grefenstette, Ph.D., Su Yon Jung, Ph.D., Nian Shong Chok, M.Sc., Anne Cross, M.L.I.S., Heather Eng, B.A., Bruce Y. Lee, M.D., Vladimir Zadorozhny, Ph.D., Shawn Brown, Ph.D., Derek Cummings, Ph.D., M.P.H., and Donald S. Burke, M.D.
N Engl J Med 2013; 369:2152-2158November 28, 2013DOI: 10.1056/NEJMms1215400
http://www.nejm.org/doi/full/10.1056/NEJMms1215400

Summary
Using data from digitized weekly surveillance reports of notifiable diseases for U.S. cities and states for 1888 through 2011, the authors derived a quantitative history of disease reduction in the United States, focusing particularly on the effects of vaccination programs.

Science        
29 November 2013 vol 342, issue 6162, pages 1013-1132
http://www.sciencemag.org/current.dtl

Perspective
Engineering
Devices for Low-Resource Health Care
Rebecca Richards-Kortum, Maria Oden
Bioengineering Department, Rice University, 6100 Main Street, Houston, TX 77005, USA.
http://www.sciencemag.org/content/342/6162/1055.summary

Summary
Most of the world receives health care in low-resource settings (see the figure), yet medical technologies are designed to be used mainly in high-resource settings, where designers take for granted basic infrastructure that supports their safe use and effective distribution. The corridors of many hospitals in low-resource settings are lined with donated medical equipment, but up to three-quarters of these devices do not work, often due to lack of spare parts or consumables (1). As a result, most of the world’s population lacks access to life-saving technologies developed decades ago, including infant incubators, oxygen concentrators, and simple laboratory diagnostics. In this Perspective, we review the challenges of developing and translating medical technologies and highlight promising new technologies to improve health in low-resource settings.

Science Translational Medicine
27 November 2013 vol 5, issue 213
http://stm.sciencemag.org/content/current

TUBERCULOSIS
TB or Not TB: That Is No Longer the Question
Robert L. Modlin and Barry R. Bloom
27 November 2013: 213sr6
http://stm.sciencemag.org/content/5/213/213sr6.abstract

Summary
Tuberculosis (TB) remains a devastating infectious disease and, with the emergence of multidrug-resistant forms, represents a major global threat. Much of our understanding of pathogenic and immunologic mechanisms in TB has derived from studies in experimental animals. However, it is becoming increasingly clear in TB as well as in other inflammatory diseases that there are substantial differences in immunological responses of humans not found or predicted by animal studies. Thus, it is critically important to understand mechanisms of pathogenesis and immunological protection in humans. In this review, we will address the key immunological question: What are the necessary and sufficient immune responses required for protection against TB infection and disease in people—specifically protection against infection, protection against the establishment of latency or persistence, and protection against transitioning from latent infection to active disease.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 52, Pages 6161-6266 (16 December 2013)

Third European Influenza Summit: Organized by the European Scientific Working group on Influenza (ESWI)
Pages 6161-6167
Janet McElhaney, Ab. Osterhaus
Abstract
On 2 May 2013, the European Scientific Working group on Influenza (ESWI) held its third influenza summit at the Institute of European Studies at the Free University of Brussels. ESWI brought together more than 90 representatives of organizations of healthcare providers, senior citizens, at-risk patients and public health authorities for a day of tailored lectures, Q&A sessions and networking. Since recent studies, surveys and reviews have shed new light on some of the most intriguing influenza issues, the Summit faculty translated the newest scientific data into practice. The first part of the Summit programme focused on the current flu status in Europe, paying special attention to the protection of pregnant women and the elderly as well as to the issues of vaccine safety and effectiveness. The programme continued to highlight future challenges and evolutions like novel antiviral drugs against influenza, improved flu vaccines and the prospect of a universal flu vaccine. The annual ESWI flu summits are the pinnacles of ESWI’s efforts to bridge the gap between science and society. ESWI’s members are convinced that the fight against influenza can only be won when all parties are well informed and ready to work together.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 52, Pages 6161-6266 (16 December 2013)

Ethical analyses of institutional measures to increase health care worker influenza vaccination rates
Review Article
Pages 6172-6176
Richard K. Zimmerman

Abstract
Health care worker (HCW) influenza vaccination rates are modest. This paper provides a detailed ethical analysis of the major options to increase HCW vaccination rates, comparing how major ethical theories would address the options. The main categories of interventions to raise rates include education, incentives, easy access, competition with rewards, assessment and feedback, declination, mandates with alternative infection control measures, and mandates with administrative action as consequences.

The aforementioned interventions, except mandates, arouse little ethical controversy. However, these efforts are time and work intensive and rarely achieve vaccination rates higher than about 70%. The primary concerns voiced about mandates are loss of autonomy, injustice, lack of due process, and subsuming the individual for institutional ends. Proponents of mandates argue that they are ethical based on beneficence, non-maleficence, and duty. A number of professional associations support mandates. Arguments by analogy can be made by mandates for HCW vaccination against other diseases.

The ethical systems used in the analyses include evolutionary ethics, utilitarianism, principalism (autonomy, beneficence, non-maleficence, and justice), Kantism, and altruism. Across these systems, the most commonly preferred options are easy access, assessment and feedback, declinations, and mandates with infection control measures as consequences for non-compliance.

Given the ethical imperatives of non-maleficence and beneficence, the limited success of lower intensive interventions, and the need for putting patient safety ahead of HCW convenience, mandates with additional infection control measures as consequences for non-compliance are preferred. For those who opt out of vaccination due to conscience concerns, such mandates provide a means to remain employed but not put patient safety at risk.

Vaccine
Volume 31, Issue 51, Pages 6041-6160 (9 December 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/51

The role of health economic analyses in vaccine decision making
Review Article
Pages 6046-6049
Steven Black
Abstract
Beginning in the 20th century with the consideration of the seven-valent pneumococcal conjugate vaccine in the US, the cost effectiveness became a topic of discussion when this vaccine was being considered for universal use by the US Advisory Committee on Immunization practices (ACIP). In 2008, the ACIP began using formal criteria for the presentation of such data and their inclusion in ACIP discussions. More recently, the US Institute of Medicine has recommended that health economic considerations play a primary role in the prioritization of future vaccine for development. However, such analyses can be biased towards vaccines that provide economic benefit rather than those that reduce severe morbidity and mortality. This is because the economic impact of minor common events that result in medical utilization or time lost from work for parents can outweigh the economic impact of severe morbidity and mortality.    Thus diseases with a low mortality and morbidity but with a common clinical manifestation such as the common cold could be prioritized over vaccines against diseases such as meningococcal sepsis where the morbidity and mortality associated with each case is very high, but there is no associated common clinical syndrome. Thus the use of cost effectiveness analyses as a ‘gating criteria’ to decide which vaccines should be developed or routinely used runs the risk of transforming vaccines into primarily a tool for achieving cost savings within the health care system rather than a public health intervention targeting human suffering, death and disability.    It is the purpose of this article to review the framework under which health economic evaluations can be undertaken, to review the experience with and reliability of such analyses, and to discuss the potential negative implications of the use of health economic analyses as a primary decision making tool.

Vaccine
Volume 31, Issue 51, Pages 6041-6160 (9 December 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/51

Using solar-powered refrigeration for vaccine storage where other sources of reliable electricity are inadequate or costly
Review Article
Pages 6050-6057
Steve McCarney, Joanie Robertson, Juliette Arnaud, Kristina Lorenson, John Lloyd

Abstract
Large areas of many developing countries have no grid electricity. This is a serious challenge that threatens the continuity of the vaccine cold chain. The main alternatives to electrically powered refrigerators available for many years—kerosene- and gas-driven refrigerators—are plagued by problems with gas supply interruptions, low efficiency, poor temperature control, and frequent maintenance needs. There are currently no kerosene- or gas-driven refrigerators that qualify under the minimum standards established by the World Health Organization (WHO) Performance, Quality, and Safety (PQS) system.

Solar refrigeration was a promising development in the early 1980s, providing an alternative to absorption technology to meet cold chain needs in remote areas. Devices generally had strong laboratory performance data; however, experience in the field over the years has been mixed. Traditional solar refrigerators relied on relatively expensive battery systems, which have demonstrated short lives compared to the refrigerator. There are now alternatives to the battery-based systems and a clear understanding that solar refrigerator systems need to be designed, installed, and maintained by technicians with the necessary knowledge and training. Thus, the technology is now poised to be the refrigeration method of choice for the cold chain in areas with no electricity or extremely unreliable electricity (less than 4 h per average day) and sufficient sunlight.

This paper highlights some lessons learned with solar-powered refrigeration, and discusses some critical factors for successful introduction of solar units into immunization programs in the future including:

:: Sustainable financing mechanisms and incentives for health workers and technicians are in place to support long-term maintenance, repair, and replacement parts.

:: System design is carried out by qualified solar refrigerator professionals taking into account the conditions at installation sites.

:: Installation and repair are conducted by well-trained technicians.

:: Temperature performance is continuously monitored and protocols are in place to act on data that indicate problems.

Vaccine
Volume 31, Issue 51, Pages 6041-6160 (9 December 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/51

Coverage and cost of a large oral cholera vaccination program in a high-risk cholera endemic urban population in Dhaka, Bangladesh
Original Research Article
Pages 6058-6064
Iqbal Ansary Khan, Amit Saha, Fahima Chowdhury, Ashraful Islam Khan, Md Jasim Uddin, Yasmin A. Begum, Baizid Khoorshid Riaz, Sanjida Islam, Mohammad Ali, Stephen P. Luby, John D. Clemens, Alejandro Cravioto, Firdausi Qadri
Abstract
A feasibility study of an oral cholera vaccine was carried out to test strategies to reach high-risk populations in urban Mirpur, Dhaka, Bangladesh. The study was cluster randomized, with three arms: vaccine, vaccine plus safe water and hand washing practice, and no intervention. High risk people of age one year and above (except pregnant woman) from the two intervention arms received two doses of the oral cholera vaccine, Shanchol™. Vaccination was conducted between 17th February and 16th April 2011, with a minimum interval of fourteen days between two doses. Interpersonal communication preceded vaccination to raise awareness amongst the target population. The number of vaccine doses used, the population vaccinated, left-out, drop out, vaccine wastage and resources required were documented. Fixed outreach site vaccination strategy was adopted as the mode of vaccine delivery. Additionally, mobile vaccination sites and mop-up activities were carried out to reach the target communities. Of the 172,754 target population, 141,839 (82%) and 123,666 (72%) received complete first and second doses of the vaccine, respectively. Dropout rate from the first to the second dose was 13%. Two complete doses were received by 123,661 participants. Vaccine coverage in children was 81%. Coverage was significantly higher in females than in males (77% vs. 66%, P < 0.001). Vaccine wastage for delivering the complete doses was 1.2%. The government provided cold-chain related support at no cost to the project. Costs for two doses of vaccine per-person were US$3.93, of which US$1.63 was spent on delivery. Cost for delivering a single dose was US$0.76. We observed no serious adverse events. Mass vaccination with oral cholera vaccine is feasible for reaching high risk endemic population through the existing national immunization delivery system employed by the government.

Vaccine
Volume 31, Issue 51, Pages 6041-6160 (9 December 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/51

Cost-effectiveness of a new rotavirus vaccination program in Pakistan: A decision tree model
Original Research Article
Pages 6072-6078
Hiten D. Patel, Eric T. Roberts, Dagna O. Constenla
Abstract
Background
Rotavirus gastroenteritis places a significant health and economic burden on Pakistan. To determine the public health impact of a national rotavirus vaccination program, we performed a cost-effectiveness study from the perspective of the health care system.

Methods
A decision tree model was developed to assess the cost-effectiveness of a national vaccination program in Pakistan. Disease and cost burden with the program were compared to the current state. Disease parameters, vaccine-related costs, and medical treatment costs were based on published epidemiological and economic data, which were specific to Pakistan when possible. An annual birth cohort of children was followed for 5 years to model the public health impact of vaccination on health-related events and costs. The cost-effectiveness was assessed and quantified in cost (2012 US$) per disability-adjusted life-year (DALY) averted and cost per death averted. Sensitivity analyses were performed to assess the robustness of the incremental cost-effectiveness ratios (ICERs).

Results
The base case results showed vaccination prevented 1.2 million cases of rotavirus gastroenteritis, 93,000 outpatient visits, 43,000 hospitalizations, and 6700 deaths by 5 years of age for an annual birth cohort scaled from 6% current coverage to DPT3 levels (85%). The medical cost savings would be US$1.4 million from hospitalizations and US$200,000 from outpatient visit costs. The vaccination program would cost US$35 million at a vaccine price of US$5.00. The ICER was US$149.50 per DALY averted or US$4972 per death averted. Sensitivity analyses showed changes in case–fatality ratio, vaccine efficacy, and vaccine cost exerted the greatest influence on the ICER.

Conclusions
Across a range of sensitivity analyses, a national rotavirus vaccination program was predicted to decrease health and economic burden due to rotavirus gastroenteritis in Pakistan by ∼40%. Vaccination was highly cost-effective in this context. As discussions of implementing the intervention intensify, future studies should address affordability, efficiency, and equity of vaccination introduction.

Vaccine
Volume 31, Issue 51, Pages 6041-6160 (9 December 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/51

Evaluation of several approaches to immunize parents of neonates against B. pertussis
Original Research Article
Pages 6087-6091
Julie Frère, Philippe De Wals, Philippe Ovetchkine, Léna Coïc, François Audibert, Bruce Tapiero
Abstract
Background
Parental immunization (“cocooning”) is a potentially effective strategy to protect neonates against Bordetella pertussis. The objective of this study was to evaluate three approaches to parental immunization: (1) current practice (single dTap dose to adolescents, one additional dose recommended in adults); (2) promotion of vaccination in the maternity ward, with vaccine offered in the community; and (3) promotion and administration of vaccine in the maternity ward.

Methods
We conducted a two-phase study of postpartum women in a tertiary care obstetric–pediatric hospital in Montreal, Canada. In Phase I, mothers completed a standardized questionnaire regarding pertussis knowledge, attitudes and immunization status. Interviews provided information on cocooning and pertussis vaccination, and invited parents to receive the vaccine in the community. In phase II, information was provided (no questionnaire) with vaccination offered in the maternity ward before discharge.

Results
Phase I included 101 participants; Phase II, 244. Baseline knowledge on infant disease severity and adult vaccine recommendations was poor. Only 6% of women were considered protected. In Phase I, 56.3% and 62.5% of eligible mothers and fathers, respectively, were willing to receive the vaccine; only 5.4% and 8.7% were immunized in the community. In Phase II, 53.1% and 62.6% of mothers and fathers, respectively, would accept vaccination; 46.9% of mothers and 60.5% of fathers were immunized onsite (p < 0.01).

Conclusion
Offering dTap vaccine in the maternity ward is an effective approach to promote cocooning and increase vaccine uptake. The generalizability and cost effectiveness of this strategy should be investigated further.

Vaccine
Volume 31, Issue 51, Pages 6041-6160 (9 December 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/51

Long-term clinical studies of varicella vaccine at a regional hospital in Japan and proposal for a varicella vaccination program
Review Article
Pages 6155-6160
Takao Ozaki
Abstract
In 1974, a live varicella vaccine (Oka strain) was developed in Japan for the prevention of varicella. It has been commercially available since 1987 for the voluntary vaccination program, in which children over the age of 1 year with no history of previous varicella infection receive a single dose. From before approval up to the present, we have been carrying out long-term studies in healthy children at a regional hospital to assess the immunogenicity, safety, and efficacy of the varicella vaccine. This vaccine is very safe, and serious adverse reactions have not been observed since the year 2000 when it changed gelatin-free. In the past three studies, seroconversion was detected in around 95% of subjects by the immune adherence hemagglutination (IAHA) test, and this high rate was considered to indicate good immunogenicity. Breakthrough varicella is observed in approximately 20–30% of children who receive a single dose of the vaccine, but most cases are mild.

Although recent vaccination has generally been effective, the IAHA test has shown that immunogenicity is somewhat lower than was previously demonstrated. The sensitivity of the IAHA test has been shown to be adequate when compared with the neutralization test, so the current testing system is sufficient for the maintenance of immunity levels. An additional vaccination increased the IAHA antibody level in subjects who failed to seroconvert after a single dose vaccination. According to another clinical study, additional varicella vaccination at 3–5 years after the initial vaccination achieved stronger immunogenicity.

Because it is administered as part of the voluntary vaccination program, the varicella vaccination coverage rate has remained low in Japan, with no sign of a decrease in the number of varicella patients. We consider that implementation of routine varicella vaccination program based on the Preventive Vaccination Law would be the most effective approach for improvement of the coverage rate. Along with this, introduction of a two-dose schedule would also be desirable. In addition to decreasing the prevalence of characteristic breakthrough varicella infection, the vaccination coverage rate would also be expected to improve with a two-dose schedule due to an increase in opportunities for vaccination.

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

Journal of Adolescent Health
Available online 26 November 2013
What Parents and Adolescent Boys Want in School Vaccination Programs in the United States
PD Shah, AL McRee, PL Reiter, NT Brewer –
http://www.sciencedirect.com/science/article/pii/S1054139X13005211
Abstract
Purpose
Schools are increasingly a part of vaccine provision, because of laws mandating provision of information by schools about vaccination, school entry requirements, and mass vaccination campaigns. We examined preferences for programmatic aspects of voluntary school mass vaccination programs (i.e., “vaccination days”).

Methods
We analyzed data from a national sample of United States parents of adolescent males ages 11–19 years (n=308) and their sons (n=216), who completed an online survey in November 2011.

Results
Sons believed that adolescents should be able to get vaccinated without parental consent at a younger age than parents did (p<.001) and were more willing to participate in vaccination days without a parent present (p=.04). Parents perceived school vaccination days to be a more convenient way to get their sons recommended vaccines if they were younger parents, had older adolescent sons, supported laws letting schools share vaccination records with health care providers, or had sons who were previously immunized at school (all p < .05). Parents of older sons were less likely to want their sons’ vaccination records sent home (odds ratio [OR]=.47; 95% confidence interval [CI], .29-.77) or to their sons’ physicians (OR = .61; 95% CI, .37-.98) compared with parents of younger sons, but more likely to prefer their sons’ records be entered in an immunization registry (OR=1.66; 95% CI, 1.05-2.63).

Conclusions
Sons’ age had an important role in support for vaccination days and preferences for sharing vaccination information with health care professionals. Parents and sons had similar beliefs about vaccination in schools, but the sons’ responses suggested an interest in greater autonomy.

Council on Foreign Relations
http://www.cfr.org/
Accessed 30 November 2013

Wired: The Surge [Polio eradication]
http://www.cfr.org/health/wired-surge/p31963
Matthieu Aikins
November 26, 2013
Excerpt
“Once you have beaten back a disease to just a few hundred cases, they will almost by definition be concentrated in places where there’s some barrier—geographical, cultural, political—to easy vaccination. In general, each marginal case will cost more, and will consume more time and effort and labor, than the one before it…[but] the math of cost-benefit analy­ses runs aground when it comes to eradication campaigns, because the benefits, in theory, are infinite.”

In 1988 there were 350,000 cases of polio worldwide. Last year there were 223. But getting all the way to zero will mean spending billions of dollars, penetrating the most remote regions of the globe, and facing down Taliban militants to get to the last unprotected children on earth.

The border regions between Pakistan and Afghanistan are wracked by violence, and their rural hinterlands are largely under the control of a diverse array of militant groups. The Taliban in Afghanistan have been mostly cooperative with the polio campaign–in the south of the contry, where their writ is strongest, they even help point out areas missed by vaccine teams–but in 2012 Taliban leaders in Pakistan began banning vaccinations in their areas, condemning the campaign as an American plot. They also started targeting campaign workers for assassination: Since the ban started, 22 people have been killed in attacks on vaccine teams…

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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Center for Vaccine Ethics and Policy
a program of the
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Associate Faculty, Division of Medical Ethics, NYU Medical School

News release: WHO and the Philippine Government launch mass vaccination campaign
22 November 2013
Excerpt
MANILA, Philippines – WHO and the Philippine Department of Health have launched a vaccination campaign to prevent outbreaks of measles and polio among survivors of Typhoon Haiyan (Yolanda)…The campaign targets children in areas hardest hit by the disaster – starting with the evacuation centres in the city of Tacloban and at receiving centres in Cebu, where evacuated families are finding temporary shelter. Children under 5 years old are being vaccinated against polio and measles and given Vitamin A drops to boost their immune systems. ..WHO worked with the Department of Health to finalize plans and procure all necessary vaccines and supplies to carry out the campaign and set up immunization stations…WHO is working with partners to arrange for the delivery of vaccines using gas-powered and generator-powered fridges, freezers, vaccine-cases, cold boxes and ice packs for affected areas that have lost power. This “cold chain” is necessary to keep the vaccines from being spoiled. USAID has sent 6 solar-powered refrigerators to Tacloban.
http://www.who.int/mediacentre/news/releases/2013/philippines-vaccination-20131122/en/index.html

WHO – Humanitarian Health Action
http://www.who.int/hac/en/index.html
WHO responding to health needs caused by typhoon Haiyan (Yolanda) 2013 – Health Cluster Bulletin – 20 November 2013

The GAVI Alliance Board, meeting in Phnom Penh, Cambodia, took a number of decisions on additional vaccines for the Alliance’s future portfolio, having received detailed analysis on five disease areas as part of the Vaccine Investment Strategy. The Board:
:: Decided new support would be made available for additional yellow fever campaigns in light of a resurgence of the disease in some parts of Africa.
:: Approved a contribution towards a global cholera vaccine stockpile for the period 2014-2018 to increase access to oral cholera vaccine in outbreak situations and endemic settings.
:: Agreed to continue to consider support for a malaria vaccine if and when one is licensed, prequalified by the WHO and recommended for use by the joint meeting of the WHO Strategic Advisory Group of Experts (SAGE) and the Malaria Programme Advisory Committee (expected in 2015), taking into account updated projections of impact, cost and country demand.
:: Concluded that further evidence is necessary on the impact and operational feasibility of supporting the important rabies vaccine as well as influenza vaccines for pregnant women. The Board agreed that GAVI will fund an observational study to address critical knowledge gaps around access to rabies vaccine and will monitor the evolving evidence base for maternal influenza vaccination in coming years.
Full media Release:  Phnom Penh, 22 November 2013 –   http://www.gavialliance.org/library/news/press-releases/2013/gavi-alliance-to-support-introduction-of-inactivated-polio-vaccine-in-worlds-73-poorest-countries/

    The GAVI Alliance Board approved providing support for the introduction of inactivated poliovirus vaccine (IPV) as part of routine immunisation programmes in the world’s 73 poorest countries.  GAVI noted that in May 2013, the World Health Assembly endorsed the new Polio Eradication & Endgame Strategic Plan 2013-2018, “calling on countries to introduce at least one dose of IPV and begin the phased removal of oral polio vaccines. Removing oral polio vaccines will eliminate the risk of vaccine-associated polio outbreaks.  Introducing IPV is a critical step to manage any risks associated with this phased removal. Adding IPV to routine immunisation programmes will improve immunity and help prevent new vaccine-associated outbreaks from emerging. At the same time, it will hasten eradication of wild polio serotypes in the remaining endemic countries of Afghanistan, Nigeria and Pakistan….”
The GAVI Board “endorsed opening a window of support for IPV for all GAVI-eligible countries and those graduating from GAVI support. Given the global health priority of polio eradication, the Board agreed to a number of policy exceptions for IPV, such as encouraging but not requiring countries to co-finance IPV introduction.”

   The Jeffrey Modell Foundation (JMF) announced “an unprecedented surveillance study…to shed light on important questions about vaccine-derived polioviruses throughout the globe…” This study will include 25 sites across a wide geographical range involving  patient population for this surveillance, including JMF Centers in Argentina, Brazil, Colombia, Mexico, China, Hong Kong, India, Israel, Iran, Kuwait, Russia, Poland, Turkey and Tunisia. JMF “will work alongside the World Health Organization (WHO), The Centers for Disease Control and Prevention (CDC), Task Force for Global Health (TFGH), and the Bill & Melinda Gates Foundation.” The study will ”…focus on patients with Primary Immunodeficiencies (PI) who have either received the Oral Polio Vaccine (OPV), a live-weakened form of the virus, or have been exposed to it. Due to little or no immune system, when a patient with PI receives OPV, he or she is unable to create an immune response and therefore, cannot clear the intestinal vaccine virus infection, which is typically excreted within six to eight weeks by individuals with healthy immune systems. After prolonged periods of time, the virus may no longer be the same as the original vaccine-virus as it can genetically alter. This is called Vaccine Derived Poliovirus (VDPV). Although rare, it is expected that patients with PI are at risk of developing Vaccine Associated Paralytic Poliomyelitis (VAPP) and VDPV excretion, which could lead to possible exposure to the community…Once wild poliovirus is eradicated globally, vaccine-viruses will be the only type of live poliovirus in the community and could potentially lead to an outbreak. In order to prevent this occurrence, the Polio Antivirals Initiative (PAI), an essential part of the TFGH’s Polio Eradication effort, aims to create an efficient and inexpensive antiviral.”
More information about PI: www.info4pi.org
Full media release: NEW YORK, Nov. 18, 2013 /PRNewswire/   http://www.prnewswire.com/news-releases/global-polio-study-begins-232335041.html

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 November 2013
:: Wild poliovirus in Cameroon 21 November 2013
Excerpt
21 November 2013 – Wild poliovirus type 1 (WPV1) has been confirmed in Cameroon, the first wild poliovirus in the country since 2009. Wild poliovirus was isolated from two acute flaccid paralysis (AFP) cases from West Region. The patients developed paralysis on 1 October and 19 October 2013. Genetic sequencing indicates that these viruses are linked to wild poliovirus last detected in Chad in 2011.
An emergency outbreak response plan is being finalized, including at least three national immunization days (NIDs), the first of which was conducted on 25-27 October 2013. Subnational immunization days (SNIDs) will be implemented in December 2013, followed by two subsequent national immunization days in January and February 2014. Routine immunization rates are reported to be approximately 85.3 percent for oral polio vaccine (OPV3).      A response in neighbouring countries is also being planned, notably in Chad and Central African Republic…
…This event confirms the risk of ongoing international spread of a pathogen (wild poliovirus) slated for eradication. Given the history of international spread of polio from northern Nigeria across West and Central Africa and subnational surveillance gaps, WHO assesses the risk of further international spread across the region as high…
http://www.who.int/csr/don/2013_11_21/en/index.html

Update: Polio this week – As of 23 November 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]
:: In the Middle East, a comprehensive outbreak response continues to be implemented across the region. Seven countries and territories are holding mass polio vaccination campaigns targeting 22 million children under the age of five years. In a joint resolution, all countries of the WHO Eastern Mediterranean Region have declared polio eradication to be an emergency, calling for support in negotiating and establishing access to those children who are currently unreached with polio vaccination. WHO and UNICEF are committed to working with all organizations and agencies providing humanitarian assistance to Syrians affected by the conflict. This includes vaccinating all Syrian children no matter where they are, whether in government or contested areas, or outside Syria.
:: In southern Afghanistan, the traditional endemic region in the country, no WPV cases have been reported for one year. All nine cases in the country this year are from Eastern Region, linked to cross-border transmission with Pakistan. For more, please click here.

Pakistan
:: Four new WPV1 cases were reported in the past week. Two of the cases are from Federally Administered Tribal Areas (FATA), one from Punjab and one from Sindh. The total number of WPV1 cases for Pakistan in 2013 is now 63. The most recent WPV1 case had onset of paralysis on 21 October (from Punjab).
:: The situation in North Waziristan is increasingly alarming. It is the area with the largest number of children being paralyzed by poliovirus in all of Asia. 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.

Horn of Africa
:: Three new WPV1 cases were reported in the past week (from Somalia), bringing the total number of WPV1 cases in the Horn of Africa to 203 (183 from Somalia, 14 from Kenya and six from Ethiopia). The most recent WPV1 case in the region had onset of paralysis on 9 October (from Lower Shabelle, Somalia).
:: Outbreak response across the Horn of Africa is continuing. As a result of concerted outbreak response efforts, the impact of the response is beginning to be seen, as the number of newly-reported cases from Banadir, Somalia (the epicentre of the outbreak) has declined. All efforts continue to be made to reach all children everywhere.

Middle East
:: In Syria, no new WPV1 cases were reported in the past week. The total number of WPV1 cases remains 13. Wild poliovirus was last reported in Syria in 1999.
:: A comprehensive outbreak response continues to be implemented across the region. On 24 October, an already-planned large-scale supplementary immunization activity was launched in Syria to vaccinate 1.6 million children against polio, measles, mumps and rubella, in both government-controlled and contested areas.
:: Implementation of a supplementary immunization campaign in Deir Al Zour province commenced promptly when the first ‘hot’ acute flaccid paralysis (AFP) cases were reported .

Editor’s Note: See New England Journal of Medicine below in Journal Watch:
Editorial
No Country Is Safe without Global Eradication of Poliomyelitis
Trevor Mundel, M.D., Ph.D., and Walter A. Orenstein, M.D.
Original Article
Identification and Control of a Poliomyelitis Outbreak in Xinjiang, China
Hui-Ming Luo, M.D et al

The Weekly Epidemiological Record (WER) for 22 November 2013, vol. 88, 47 (pp. 501–508) includes:
:: Progress towards poliomyelitis eradication in Pakistan, January 2012– September 2013
http://www.who.int/entity/wer/2013/wer8847.pdf

CDC/MMWR Watch [to 23 November 2013]
A serogroup B meningococcal vaccine is being considered for use at Princeton University. FDA is allowing the use of the vaccine at Princeton University under an Investigational New Drug application. Get the latest information and additional questions and answers about the outbreak from the University and the New Jersey Department of Health  [9 pages]
   MMWR November 22, 2013 / Vol. 62 / No. 46
:: Progress Toward Poliomyelitis Eradication — Afghanistan, January 2012–September 2013
:: Progress Toward Poliomyelitis Eradication — Pakistan, January 2012–September 2013

    The U.S. Food and Drug Administration approved the first adjuvanted vaccine for the prevention of H5N1 influenza: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus. The H5N1 avian influenza vaccine “is not intended for commercial availability. The U.S. Department of Health and Human Services has purchased the vaccine from the manufacturer, ID Biomedical Corporation of Quebec, Quebec City, Canada (a subsidiary of GlaxoSmithKline Biologicals), for inclusion within the National Stockpile for distribution by public health officials if needed.”
Full FDA NEWS RELEASE, Nov. 22, 2013:

 Nigeria unveiled its National Routine Immunization Strategic Plan (NRISP) 2013-2015, “outlining a comprehensive strategy to increase access to live-saving vaccines through strengthened routine immunization (RI) systems.” The plan was co-launched by the Nigerian Minister of Health, Prof. Onyebuchi Chukwu and Mr. Bill Gates in an event hosted by the National Primary Health Care Development Agency (NPHCDA) and attended by traditional and religious leaders, private sector representatives, and development partners, including Alhaji Aliko Dangote and the Sultan of Sokoto.
http://www.jhsph.edu/research/centers-and-institutes/ivac/about-us/news.html#Nigeria_NRISP_launch_2013

National Routine Immunization Strategic Plan (NRISP) 2013-2015
Executive Summary
This National Routine Immunization Strategic Plan (NRISP) lays out key goals and objectives for Nigeria’s routine immunization (RI) system, and details the strategies that will allow the country to achieve its aims, while recognizing important challenges.

NRISP is not a standalone document, instead it was developed to fit within the National Strategic Health Development Plan 2010-2015 (NSHDP) and expand upon the comprehensive Multi-Year Plan 2011-2015 (cMYP). The NRISP will also operate within and alongside Nigeria’s Saving One Million Lives Initiative (SOML) and other efforts to meet the MDGs. As highlighted in these initiatives, the NRISP is guided by a set of core principles, namely: accountability, efficiency, equity, ownership, integration, sustainability, and transparency.

Within the NRISP, the Strategic Framework enumerates strategies to improve the country’s RI system. Three strategic focal areas have been identified to concentrate efforts to improve the system in practice; these strategies are already in place to varying extents and are recognizable by stakeholders at all levels in Nigeria. They are: Reaching Every Ward (REW), Accountability for RI Framework (AFRIN), and Health System Strengthening.

The Strategic Framework’s strategies are categorized into RI system areas, and outputs, indicators, and responsible parties have been developed for each. A monitoring and evaluation (M&E) process describes a regular reporting structure inclusive of relevant stakeholders, and seeks to ensure that data are available in a timely manner and used in decision making. A system of rewards and sanctions are also suggested to improve accountability.

The NRISP aims to clarify the roles and responsibilities for different levels of government in the execution of the RI system. The National Primary Health Care Development Agency (NPHCDA)and partners are responsible for providing policy direction, mobilizing resources to fill gaps, building capacity, providing supportive supervision, and conducting M&E of the RI program. Implementation of this strategic plan and accountability framework will fall on the shoulders of states and local government areas (LGAs). The expectation is that State Primary Health Care Development Agencies (SPHCDAs) will guide LGAs, and LGAs will in turn support health facilities (HFs).

Consequent upon the above, the total budget to implement this plan for the period July 2013 to December 2015 estimated at USD 642,038,476 has been shared among the three tiers of governments. Therefore, 69% will be the responsibility of the federal, 15% that of the states, and 16% will be borne by the local governments. This averages USD 35.41 per child born in Nigeria over the next two and a half years.

Finally, the NRISP was developed through a consultative process that included stakeholders from all levels of government and various facets of society. Commitments were made on behalf of MoH, NPHCDA, states, and other important institutions to take up and implement these recommendations for the unanimously agreed upon purpose of this strategy: protecting the health of Nigeria’s children through equitable provision of RI.

Media Release: New framework for neglected tropical diseases could unlock potential for world’s poorest people
22 November 2013

Excerpt
A new concept and policy framework published in PLOS NTDs outlines concrete steps for  the global development community as it works to synthesize health goals with economic, environmental and social priorities. The concept, “blue marble health,” emphasizes the role of the Group of 20 (G20) nations in tackling neglected tropical diseases (NTDs) to expedite poverty reduction efforts. Peter Hotez, MD PhD, president of the Sabin Vaccine Institute, director of the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, said “Blue marble health connects countries worldwide by recognizing that extreme poverty is a fundamental underlying factor for neglected tropical diseases (NTDs), regardless of where they occur. G20 countries have an exceptional opportunity to embrace NTD control as a cross-cutting strategy and achieve long-lasting, inclusive prosperity within their societies and lower-income countries.”…
…Existing medicines for the seven most common NTDs are safe, effective, and inexpensive. However, new tools and diagnostics will help us stay ahead of how current treatment needs evolve and enable us to address several NTDs for which there are no current options available. G20 countries have an important role to play in investing in R&D, including building up the local capacity of vaccine manufacturers in disease-endemic countries:
:: Vaccine Diplomacy: Promoting scientific collaboration between institutions from countries regardless of their ideological perspectives can foster essential dialogue on these life-threatening diseases and lead to new, effective interventions.
:: NTD Integration: Strong linkages exist between NTDs and nearly every major development priority. Efforts to control and eliminate should be incorporated into existing programs working to improve maternal and child health; water, sanitation and hygiene; hunger and nutrition; education; and combat HIV/AIDS, tuberculosis and malaria.
:: Health of Girls and Women: This population is especially disproportionately affected – indeed NTDs may be the most common afflictions of girls and women living in poverty.
:: NCDs: NTDs contribute to a hidden but substantial proportion of the world’s non-communicable diseases.
:: Sustainable Development Goals (SDGs): Controlling NTDs will serve as a catalyst for the achievement of the Millennium Development Goals and a broad set of issues likely to be addressed in the new SDGs. It will be essential to incorporate NTDs into this framework…
http://www.sabin.org/updates/pressreleases/new-framework-neglected-tropical-diseases-could-unlock-potential-world%E2%80%99s

The Global Fund “welcomed an announcement by the Republic of Korea to double its contribution to the Global Fund over the next three years by drawing on the proceeds of a levy on airline tickets.” The Korean Ministry of Health will contribute US$6 million to the Global Fund for 2014-16. An additional US $10 million, from a levy on all passengers leaving Korea on international flights, will be paid by the Korean Ministry of Foreign Affairs to the Global Fund in five annual installments of $2 million from 2013-17. The 1,000 won (US $0.95) levy, known as the Global Poverty Eradication Tax, was introduced in 2007, primarily to contribute financial resources to fight poverty and disease in impoverished countries. Korea has contributed US$19 million since it started lending financial support to the Global Fund in 2004, of which US$6 million was pledged for the 2011-13 period.
http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-11-21_Republic_of_Korea_Boosts_Contribution_to_Global_Fund/

   The International Vaccine Institute (IVI) announced that Professor Fred Binka, Dr. Joseph J. Kim, and Dr. George R. Siber will join the IVI Board of Trustees. The three new Board members, who hail from Ghana, the United States, and Canada, respectively, will serve a three-year term to oversee the governance and management of the institute. IVI Director General Dr. Christian Loucq commented, “The new members bring scientific, industrial, and global health expertise that will boost IVI’s ability to make an impact in improving the health of the most impoverished. IVI has undergone several changes to strengthen its governance and management and to increase transparency. We look forward to capitalizing on the experience and knowledge they bring as we continue to evolve as an institute.”

Full media release: SEOUL, South Korea, Nov. 18, 2013 /PRNewswire:   http://www.prnewswire.com/news-releases/international-vaccine-institute-announces-appointments-of-new-members-to-its-board-of-trustees-232427031.html

Aeras announced that Lota S. Zoth, CPA was appointed Chair of its Board of Directors, noting that Ms. Zoth “assumes leadership of Aeras during its 10th year, at a time when the organization is focused on diversifying and advancing a pipeline of next-generation vaccine candidates.” Ms. Zoth joined the board in 2011 and is a strategic finance and operations executive who served as Senior Vice President and Chief Financial Officer of MedImmune, Inc., now part of AstraZeneca. She replaces R. Gordon Douglas, Jr., outgoing Chair of the Board and Emeritus Professor of Medicine at Weill Cornell Medical College. Dr. Douglas served as Board Chair for the past 12 years and “guided the organization through its growth from a small nonprofit research group to an international nonprofit biotech with offices in South Africa and China; six TB vaccine candidates in its clinical portfolio; and global partnerships in Africa, Asia, Australia, Europe, and North America.”
November 21, 2013, ROCKVILLE, MD – http://www.aeras.org/pressreleases/aeras-announces-new-board-leadership#.UpEwd-Ky-F8

    The Gates Foundation announced a new round of winners as part of its Grand Challenges Explorations (GCE) initiative. GCE grants associated with vaccines included those in the category: The ‘One Health’ Concept: Bringing Together Human and Animal Health for New Solutions – “Over the last century, both human and veterinary medicine have made great advancements. In spite of the many overlaps between the two disciplines, they have become distinctly separate, limiting cross-disciplinary sharing of knowledge. These projects are exploring innovative ideas within the concept of ‘One Health’ to address human and livestock diseases, human nutrition, health service delivery, and measurement of impact. Projects include:
:: Milosz Faber of Thomas Jefferson University in the U.S. will develop a rabies vaccine that both protects dogs against rabies and reduces their population levels to control the incidence of human rabies. Human rabies causes 70,000 deaths annually and is mostly spread by dogs.
:: George Warimwe of the Jenner Institute at the University of Oxford in the United Kingdom will develop a vaccine to protect a variety of species, including humans, sheep, and cattle, against Rift Valley fever, which can cause serious illness….”
Full media release: http://www.gatesfoundation.org/Media-Center/Press-Releases/2013/11/Gates-Foundation-Awards-Grants-to-Test-Ideas-2

PATH said it will receive two US$1 million grants from the Bill & Melinda Gates Foundation’s Grand Challenges Explorations initiative “to advance a new category of cold chain equipment and expand access to donated breast milk by simplifying human milk banking.” The two-year, follow-on grants recognize successful projects with additional funding, allowing PATH and collaborators to build on work already under way. The first grant will support PATH work with equipment manufacturers to design novel approaches that catalyze the introduction of low-cost, durable, freeze-safe cold chain solutions into country immunization programs. PATH aims to advance “fail-safe” innovations in cold boxes and vaccine carriers that allow vaccines to remain cold for longer periods of time without damaging freeze-sensitive vaccines. PATH will work with manufacturing partners to overcome technical hurdles through design optimization, laboratory testing, and field evaluations in country immunization supply chains. In addition, PATH will engage with key stakeholders and country decision-makers to raise awareness of the need to prevent vaccine freezing and assess demand for cold chain equipment that meets this need.
Full media release: http://www.path.org/news/press-room/660/

DFID –  GAVI – Summary Assessment 2013
Excerpt
Summary assessment: Continues to deliver results with activity across all reform priorities. Impact of increased focus on market shaping being felt. Key changes have begun to support health system strengthening.

Baseline
The GAVI Alliance is a public-private partnership committed to saving children’s lives and protecting people’s health by increasing access to immunisation in developing countries. The MAR highlighted several strengths:
:: GAVI has made a significant contribution to MDG 4 by increasing finance for vaccinations, including from innovative sources, and has improved coverage of new and underused vaccines.
:: It has a strong partnership with governments, civil society and the private sector.
:: It provides highly cost-effective health interventions with vaccines selected on strict criteria for health impact and cost effectiveness with appropriate administration costs.
:: It has effective financial oversight, with a proactive Audit and Finance Committee, an internal auditor and a robust Transparency and Accountability Policy.

The MAR also highlighted several weaknesses:
:: The need for more focus on market shaping to reduce prices and secure sustainable supply.
:: It has relatively poor performance of cash based programmes, particularly Health Systems Strengthening (HSS) support.
:: The need for a more systematic evidence based approach to working in fragile contexts.
:: There is lack of clarity in roles and responsibilities of key partners, such as WHO and UNICEF, and on the inclusion of civil society.

DFID’s reform priorities for the MAR Update were:
:: Better approach to working in fragile settings through the development of a policy and systematic evidence of performance in fragile contexts – assessed under attention to cross-cutting issues (fragile states).
:: Greater focus on outcomes and performance, specifically in relation to the delivery of its cash based programmes (HSS) – assessed under strategic and performance management and financial resource management.
:: Stronger performance on influencing markets and more strategic approach to procurement for sustainable and affordable vaccine supply – assessed under cost and value consciousness.
:: Further alignment and clarity in roles and responsibilities of partners, including civil society – assessed under partnership behaviour.

Summary of Overall Progress
GAVI continues to be a high performing institution providing a very cost-effective health intervention. From the 2011 MAR high baseline, evidence collected for the 2013 MAR Update demonstrates GAVI’s on-going commitment to improvement across the DFID reform priorities and in all at least some evidence of commitment being translated into implementation exists. However work streams are at different stages and for some, e.g. HSS support, it is too early to judge country level impact.

Full DFID Documentation – Multilateral Aid Review: Global Alliance for Vaccines and Immunisation (GAVI) at: https://www.gov.uk/government/publications/multilateral-aid-review-global-alliance-for-vaccines-and-immunisation-gavi

BMC Public Health
(Accessed 23 November 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article
Comparison of the Use of H1N1 and seasonal influenza vaccinations between veterans and non-veterans in the United States, 2010
Claudia Der-Martirosian, Kevin C Heslin, Michael N Mitchell, Karen Chu, Kim Tran and Aram Dobalian
BMC Public Health 2013, 13:1082  doi:10.1186/1471-2458-13-1082
Published: 20 November 2013

Abstract (provisional)
Background
Veterans of the U.S. armed forces tend to be older and have more chronic health problems than the general adult population, which may place them at greater risk of complications from influenza. Despite Centers for Disease Control and Prevention (CDC) recommendations, seasonal influenza vaccination rates for the general adult population remain well below the national goal of 80%. Achieving this goal would be facilitated by a clearer understanding of which factors influence vaccination.

Methods
Using the 2010 U.S. National Health Interview Survey (NHIS), this study estimates models of two types of vaccinations (H1N1 and seasonal flu), assesses if the correlates differ for these vaccinations, and analyses the distribution of the correlates by veteran status.

Results
Veterans, women, non-Hispanic whites, non-smokers, those at high risk, educated, with health insurance, and who use clinics as a usual source of care were more likely to receive both types of vaccinations. Those who were older, married, and with higher income were more likely to get vaccinated for seasonal flu, but not for H1N1. Age and number of children living in the household were found to have different effects for H1N1 compared to seasonal flu.

Conclusion
Veterans are more likely to get vaccinated for seasonal influenza and H1N1 compared to the general population. This might be due to Veterans having better access to care or Veterans participating in better health care practices. Future studies should examine potential differences in flu vaccination use among Veterans using Veterans Affairs (VA) health care system vs. non-VA users.