BMJ Head to Head: Should Europe have a universal hepatitis B vaccination programme?

British Medical Journal
03 August 2013 (Vol 347, Issue 7919)
http://www.bmj.com/content/347/7919

Head to Head
Should Europe have a universal hepatitis B vaccination programme?
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4057 (Published 10 July 2013)
Cite this as: BMJ 2013;347:f4057
http://www.bmj.com/content/347/bmj.f4057

Excerpt
WHO recommends that hepatitis B virus should be included in childhood vaccination programmes. Pierre Van Damme and colleagues argue that universal immunisation is essential to stop people becoming carriers but Tuija Leino and colleagues think that a targeted approach is a better use of resources in countries with low endemicity

Yes—Pierre Van Damme, Elke Leuridan, Greet Hendrickx, Alex Vorsters, Heidi Theeten
Hepatitis B occurs worldwide, with more than two billion people having been infected with the virus.1 Of these, about 240 million are living with chronic infection and at risk of cirrhosis and hepatocellular carcinoma, diseases that are estimated to cause 500 000-700 000 deaths a year.2 The risk of developing chronic infection decreases with age, occurring in up to 90% of infants infected during first year of life versus 5% of those infected as adults.1 Globally, newborns and infants are therefore the main target of hepatitis B immunisation programmes. In 1991 the World Health Organization set 1997 as the target for integrating hepatitis B vaccine into national immunisation programmes worldwide,3 and in 2010 the World Health Assembly adopted a resolution calling for a comprehensive prevention and control strategy, including universal hepatitis B vaccination and development of time specific immunisation goals.4 By the end of 2012, 179 countries—93% of WHO member states—had added hepatitis B vaccine to their national newborn, infant, or adolescent immunisation programmes.2 It is time that all European countries followed suit.

Infection in Europe
About 14 million people are chronically infected with hepatitis B virus (HBV) in the WHO European region (53 countries), and 36 000 die each year from HBV related causes.2 Forty seven European countries have a universal HBV immunisation programme as well as strategies for immunising high risk groups. Routine immunisation has created a generation of children and young adults with virtually no markers of HBV infection. Surveillance data from Italy, where universal infant…

Editorial: Universal health coverage and universal access

Bulletin of the World Health Organization
Volume 91, Number 8, August 2013, 545-620
http://www.who.int/bulletin/volumes/91/8/en/index.html

Editorial
Universal health coverage and universal access
David B Evans a, Justine Hsu a & Ties Boerma a
a. World Health Organization, 20 avenue Appia, CH-1211 Geneva 27, Switzerland.
Bulletin of the World Health Organization 2013;91:546-546A. doi: http://dx.doi.org/10.2471/BLT.13.125450 [PDF]

Excerpt
Universal health coverage has been set as a possible umbrella goal for health in the post-2015 development agenda.1 Whether it is a means to an end or an end in itself and whether it is measureable are subjects of heated debate.2 In this issue of the Bulletin, Kutzin argues that universal health coverage not only leads to better health and to financial protection for households, but that it is valuable for its own sake.3 More recently, attention has shifted to just what the goal should be: whether universal coverage or universal access. This editorial focuses on this question.

Universal health coverage is the goal that all people obtain the health services they need without risking financial hardship from unaffordable out-of-pocket payments.4 It involves coverage with good health services – from health promotion to prevention, treatment, rehabilitation and palliation – as well as coverage with a form of financial risk protection. A third feature is universality – coverage should be for everyone. Although many countries are far from attaining universal health coverage, all countries can take steps in this direction.3,4 Improving access is one such step.

Universal health coverage is attained when people actually obtain the health services they need and benefit from financial risk protection. Access, on the other hand, is the opportunity or ability to do both of these things. Hence, universal health coverage is not possible without universal access, but the two are not the same…

Delivery cost of human papillomavirus vaccination of young adolescent girls in Peru, Uganda and Viet Nam

Bulletin of the World Health Organization
Volume 91, Number 8, August 2013, 545-620
http://www.who.int/bulletin/volumes/91/8/en/index.html

Delivery cost of human papillomavirus vaccination of young adolescent girls in Peru, Uganda and Viet Nam
Carol E Levin, Hoang Van Minh, John Odaga, Swampa Sarit Rout, Diep Nguyen Thi Ngoc, Lysander Menezes, Maria Ana Mendoza Araujo & D Scott LaMontagne
http://www.who.int/bulletin/volumes/91/8/12-113837-ab/en/index.html

Abstract
Objective
To estimate the incremental delivery cost of human papillomavirus (HPV) vaccination of young adolescent girls in Peru, Uganda and Viet Nam.

Methods
Data were collected from a sample of facilities that participated in five demonstration projects for HPV vaccine delivery: school-based delivery was used in Peru, Uganda and Viet Nam; health-centre-based delivery was also used in Viet Nam; and integrated delivery, which involved existing health services, was also used in Uganda. Microcosting methods were used to guide data collection on the use of resources (i.e. staff, supplies and equipment) and data were obtained from government, demonstration project and health centre administrative records. Delivery costs were expressed in 2009 United States dollars (US$). Exclusively project-related expenses and the cost of the vaccine were excluded.

Findings
The economic delivery cost per vaccine dose ranged from US$ 1.44 for integrated outreach in Uganda to US$ 3.88 for school-based delivery in Peru. In Viet Nam, the lowest cost per dose was US$ 1.92 for health-centre-based delivery. Cost profiles revealed that, in general, the largest contributing factors were project start-up costs and recurrent personnel costs. The delivery cost of HPV vaccine was higher than published costs for traditional vaccines recommended by the Expanded Programme on Immunization (EPI).

Conclusion
The cost of delivering HPV vaccine to young adolescent girls in Peru, Uganda and Viet Nam was higher than that for vaccines currently in the EPI schedule. The cost per vaccine dose was lower when delivery was integrated into existing health services.

Impact of rotavirus vaccination in Australian children below 5 years of age: A database study

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
August 2013  Volume 9, Issue 8
http://www.landesbioscience.com/journals/vaccines/toc/volume/9/issue/8/

Special Focus: Vaccine Acceptance
Research Paper
Impact of rotavirus vaccination in Australian children below 5 years of age: A database study
Annmarie Pendleton, Maja Galic, Christopher Clarke, Su Peing Ng, Emilio Ledesma, Gunasekaran Ramakrishnan and Yanfang Liu
http://dx.doi.org/10.4161/hv.24831

Abstract
This study was conducted to assess the impact of administration of two-dose rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Vaccines) among children aged less than 5 y in three states/territories of Australia. Aggregated and de-identified data on rotavirus gastroenteritis (RVGE) and all-cause gastroenteritis (AGE) from July 1998–June 2009 were obtained from the Australian Institute of Health and Welfare database. The baseline incidence (July 1998–June 2006) of RVGE hospitalizations before RV vaccine introduction in New South Wales (NSW), the Australian Capital Territory (ACT) and the Northern Territory (NT) were 33.75, 42.93 and 288.67 per 10 000 child-years, respectively among children aged 0–11 mo. Following RV vaccine introduction in NSW, the ACT and the NT, incidence of RVGE hospitalizations reduced to 13.06, 17.35 and 47.52 per 10,000 child-years, respectively, during July 2007–June 2008 and 3.87, 8.40 and 122.79 per 10,000 child-years, respectively, during July 2008–June 2009 among children aged 0–11 mo. Reductions in RVGE and AGE were also observed in all children below 5 y of age in NSW and the ACT. Overall reduction in hospitalizations due to RVGE and AGE was observed following RV vaccine introduction into the NIP in Australia

HPV vaccination coverage among women aged 18–20 years in Germany three years after recommendation of HPV vaccination for adolescent girls: Results from a cross-sectional sur

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
August 2013  Volume 9, Issue 8
http://www.landesbioscience.com/journals/vaccines/toc/volume/9/issue/8/

Short Report
HPV vaccination coverage among women aged 18–20 years in Germany three years after recommendation of HPV vaccination for adolescent girls: Results from a cross-sectional survey
Yvonne Deleré, Merle M. Böhmer, Dietmar Walter and Ole Wichmann
http://dx.doi.org/10.4161/hv.24904

Abstract
Objective:
Routine immunization of adolescent girls aged 12–17 y against human papillomavirus (HPV) was recommended in Germany in March 2007. We aimed to assess HPV-vaccine uptake and knowledge about post-vaccination cervical cancer screening and condom use in women aged 18–20 years, three years after adoption of HPV-vaccination into the routine vaccination schedule.

Results:
Overall 2,001 females participated in our study. Of these, 49% reported receipt of a complete three-dose course of HPV-vaccines; 11% received 1 or 2 doses. Living in East Germany, high educational status, and interest in health-related issues were independently associated with HPV-vaccination. Misconceptions among survey-participants were rare: Only 8% believed that HPV-vaccination would obviate the need for cervical screening and 1% that condom use would be dispensible after vaccination.

Methods:
In 2010, a nationwide cross-sectional telephone-survey was performed among randomly-selected women aged 18–20 years living in Germany. Telephone interviews were conducted by a large professional market research institute as part of a daily omnibus survey.

Conclusion:
HPV-vaccination coverage is low in Germany. The results indicate that there is an urgent need for the implementation of a coordinated adolescent vaccination program to facilitate access to vaccination, including balanced information tailored to this age group. Otherwise, the HPV-vaccination effort will fall short of reaching its maximum public health benefit.

Human Vaccines & Immunotherapeutics: Special Focus Issue – Vaccine Acceptance

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
August 2013  Volume 9, Issue 8
http://www.landesbioscience.com/journals/vaccines/toc/volume/9/issue/8/
Special Focus: Vaccine Acceptance

Special Focus Review
The rise (and fall?) of parental vaccine hesitancy
Charitha Gowda and Amanda F. Dempsey
http://dx.doi.org/10.4161/hv.25085
View Article Abstract

Special Focus Review
Utilizing health information technology to improve vaccine communication and coverage
Melissa S. Stockwell and Alexander G. Fiks
http://dx.doi.org/10.4161/hv.25031
View Article Abstract Keywords

Special Focus Review
Public trust and vaccine acceptance-international perspectives
Sachiko Ozawa and Meghan L. Stack
http://dx.doi.org/10.4161/hv.24961
View Article Abstract

Special Focus Review
Addressing heterogeneous parental concerns about vaccination with a multiple-source model: A parent and educator perspective
Allison Hagood and Stacy Mintzer Herlihy
http://dx.doi.org/10.4161/hv.24888
View Article Abstract

Special Focus Review
Story and science: How providers and parents can utilize storytelling to combat anti-vaccine misinformation
Ashley Shelby and Karen Ernst
View Article Abstract

Special Focus Review
Vaccine hesitancy: An overview
Eve Dubé, Caroline Laberge, Maryse Guay, Paul Bramadat, Réal Roy and Julie A Bettinger
http://dx.doi.org/10.4161/hv.24657
View Article Abstract

Special Focus Review
Professionalism, fidelity and relationship-preservation: Navigating disagreement and frustration in clinical encounters
Christy A. Rentmeester
http://dx.doi.org/10.4161/hv.24432
View Article Abstract

Special Focus Review
How society should respond to the risk of vaccine rejection
David Ropeik
http://dx.doi.org/10.4161/hv.25250
View Article Abstract

Special Focus Research Paper
Provider dismissal policies and clustering of vaccine-hesitant families: An agent-based modeling approach
Alison M. Buttenheim, Sarah T. Cherng and David A. Asch
http://dx.doi.org/10.4161/hv.25635
View Article Abstract

Review
Negotiating vaccine acceptance in an era of reluctance
Heidi J Larson
View Article Abstract

Research Paper
Parental vaccine concerns, information source, and choice of alternative immunization schedules
Marissa Wheeler and Alison M Buttenheim
View Article Abstract

Research gaps for three main tropical diseases in the People’s Republic of China

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 3 August 2013]

Scoping Review
Research gaps for three main tropical diseases in the People’s Republic of China
Qi Zheng, Samantha Vanderslott, Bin Jiang, Li-Li Xu, Cong-Shan Liu, Le-Le Huo, Li-Ping Duan, Ning-Bo Wu, Shi-Zhu Li, Zhi-Gui Xia, Wei-Ping Wu, Wei Hu and Hao-Bing Zhang
Infectious Diseases of Poverty 2013, 2:15 doi:10.1186/2049-9957-2-15
Published: 29 July 2013

Abstract (provisional)
This scoping review analyzes the research gaps of three diseases: schistosomiasis japonica, malaria and echinococcosis. Based on available data in the P.R. China, we highlight the gaps between control capacity and prevalence levels, and between diagnostic/drug development and population need for treatment at different stages of the national control programme. After reviewing the literature from 848 original studies and consultations with experts in the field, the gaps were identified as follows. Firstly, the malaria research gaps include (i) deficiency of active testing in the public community and no appropriate technique to evaluate elimination, (ii) lack of sensitive diagnostic tools for asymptomatic patients, (iii) lack of safe drugs for mass administration. Secondly, gaps in research of schistosomiasis include (i) incongruent policy in the implementation of integrated control strategy for schistosomiasis, (ii) lack of effective tools for Oncomelania sp. snail control, (iii) lack of a more sensitive and cheaper diagnostic test for large population samples, (iv) lack of new drugs in addition to praziquantel. Thirdly, gaps in research of echinococcosis include: (i) low capacity in field epidemiology studies, (ii) lack of sanitation improvement studies in epidemic areas, (iii) lack of a sensitivity test for early diagnosis, (iv) lack of more effective drugs for short-term treatment. We believe these three diseases can eventually be eliminated in mainland China if all the research gaps are abridged in a short period of time.

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

Inequalities in the uptake of Human Papillomavirus Vaccination: a systematic review and meta-analysis

International Journal of Epidemiology
Volume 42 Issue 3 June 2013
http://ije.oxfordjournals.org/content/current

Inequalities in the uptake of Human Papillomavirus Vaccination: a systematic review and meta-analysis
Harriet Fisher*, Caroline L Trotter, Suzanne Audrey, Kyle MacDonald-Wallis and Matthew Hickman
School of Social and Community Medicine, University of Bristol, Bristol, UK
Accepted February 28, 2013.
http://ije.oxfordjournals.org/content/42/3/896.abstract

Abstract
Background The human papillomavirus (HPV) vaccine offers an opportunity to reduce health inequalities associated with cervical cancer provided the vaccine is delivered equitably at population level.

Method We reviewed evidence of inequalities in HPV vaccine uptake in young women after undertaking a comprehensive search of databases from inception to March 2012. Studies that compared HPV vaccination initiation and/or completion by at least one ethnicity or socioeconomic-related variable in adolescent young women were included. There were no language restrictions. Data were extracted by two reviewers and pooled in a meta-analysis using a random-effects model; sub-analyses and meta-regression were undertaken to investigate sources of heterogeneity.

Results In all, 29 publications related to 27 studies were included in the review. Black young women were less likely to initiate HPV vaccination compared with White young women (combined OR: 0.89, 95% CI: 0.82–0.97). In the USA, young women without healthcare insurance were less likely to initiate (combined OR: 0.56, 95% CI: 0.40–0.78). There was no strong evidence that lower family income (combined OR: 1.16, 95% CI: 1.00–1.34) or lower parental education (combined OR 1.06, 95% CI: 0.92–1.22) influenced HPV vaccination initiation.

Conclusions We found strong evidence for differences in HPV vaccination initiation by ethnicity and healthcare coverage, but did not find a strong association with parental education or family income variables. The majority of studies originated from the USA. Population-based studies reporting both initiation and completion of the HPV vaccination programme are required to establish patterns of uptake in different healthcare contexts.

Commentary: The uptake of human papillomavirus vaccination: the power of belief

International Journal of Epidemiology
Volume 42 Issue 3 June 2013
http://ije.oxfordjournals.org/content/current

Commentary: The uptake of human papillomavirus vaccination: the power of belief
Heidi J Larson
Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK. E-mail: Heidi.larson@lshtm.ac.uk
Accepted April 29, 2013.
http://ije.oxfordjournals.org/content/42/3/908.extract

Extract
The systematic review and meta-analysis of ‘Inequalities in the uptake of human papillomavirus vaccination’ in this issue of IJE reveals the complexities of identifying the diverse factors which determine HPV vaccination uptake. The authors note ‘the factors affecting HPV vaccination in Black young women are not yet fully understood’.1

Although the review particularly focuses on socio-economic and ethnic disparities in HPV vaccine uptake among young women in the USA, it acknowledges additional underlying factors—beyond economic and ethnic determinants—which also affect the uptake of HPV vaccines confirmed in studies globally.1–4

The determinants of HPV acceptance are very different from those around childhood vaccines. Firstly, the vaccine prevents a sexually transmitted infection (STI)—evoking the moral judgements and religious and cultural taboos that come with discussing and addressing sexual behaviour. In some settings, the vaccine is being promoted largely as a vaccine for cancer prevention, making it more culturally acceptable than an STI vaccine, particularly for adolescents.1,3 Secondly, and linked to the issue …

No association between the number of vaccine antigens and risk of autism spectrum disorder

Journal of Pediatrics
Vol 163 | No. 2 | August 2013 | Pages 309-612
http://www.jpeds.com/current

No association between the number of vaccine antigens and risk of autism spectrum disorder
Sarah S. Long, MD
http://www.jpeds.com/article/S0022-3476%2813%2900666-5/preview

Abstract
Many well-meaning parents have unfounded fears that their young children are exposed to too much immunologic stimulation through vaccines. Some then take real risks of underimmunizing their children or insisting on schedules that are unstudied for efficacy or safety. In this issue of The Journal, DeStefano et al performed a secondary analysis of the robust database from a case-control study evaluating potential risks of thimerosal exposure from vaccines. They sought to test the hypothesis that increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines was associated with risk of autism spectrum disorder (ASD). They repeatedly found aORs of 0.999 (with narrow CIs) for association of ASD diagnosed by 6-13 years of age with incremental increases in total antigens received, as well as with decreasing ages at receipt. The authors also found no association between the maximum number of antigens that a child was exposed to on a single day and ASD.

The Lancet Editorial – Meningitis B

The Lancet  
Aug 03, 2013  Volume 382  Number 9890  p367 – 478  e2
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Meningitis B
The Lancet
Preview |
Invasive meningococcal disease is a serious global health threat that kills about one in 20 infected individuals. Meningitis B accounts for about 80% of cases of invasive meningococcal disease in high-income countries, 50% of whom are children younger than 2 years; it is the foremost cause of infant bacterial meningitis and severe sepsis in Europe.

Comment
The price of prevention: what now for immunisation against meningococcus B?
Richard Moxon, Matthew D Snape
Preview |
Meningococcal sepsis is one of the most dreaded bacterial infections: the death rate remains at about 5% and the effects for survivors include neurological damage, limb amputation, and widespread skin necrosis.1 There is a compelling case for prevention of meningococcal disease by immunisation. On July 24, 2013, in an interim position statement,2 the UK Joint Committee on Vaccination and Immunisation (JCVI) concluded that it cannot currently recommend a vaccine (4CMenB, licensed as Bexsero, Novartis Vaccines and Diagnostics, Siena, Italy) for use in the UK routine immunisation programme.

Influenza A (H7N9) and the Importance of Digital Epidemiology

New England Journal of Medicine
August 1, 2013  Vol. 369 No. 5
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Influenza A (H7N9) and the Importance of Digital Epidemiology
Marcel Salathé, Ph.D., Clark C. Freifeld, M.S., Sumiko R. Mekaru, D.V.M., Anna F. Tomasulo, M.P.H., and John S. Brownstein, Ph.D.
N Engl J Med 2013; 369:401-404August 1, 2013DOI: 10.1056/NEJMp1307752
http://www.nejm.org/doi/full/10.1056/NEJMp1307752

Excerpt
In recent outbreaks including that of novel H7N9 influenza, digital disease surveillance has supplemented laboratory studies and work by public health officials and epidemiologists, by leveraging widespread use of the Internet, mobile phones, and social media.

Hospital Outbreak of Middle East Respiratory Syndrome Coronavirus

New England Journal of Medicine
August 1, 2013  Vol. 369 No. 5
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Hospital Outbreak of Middle East Respiratory Syndrome Coronavirus
Abdullah Assiri, M.D., Allison McGeer, M.D., Trish M. Perl, M.D., Connie S. Price, M.D., Abdullah A. Al Rabeeah, M.D., Derek A.T. Cummings, Ph.D., Zaki N. Alabdullatif, M.D., Maher Assad, M.D., Abdulmohsen Almulhim, M.D., Hatem Makhdoom, Ph.D., Hossam Madani, Ph.D., Rafat Alhakeem, M.D., Jaffar A. Al-Tawfiq, M.D., Matthew Cotten, Ph.D., Simon J. Watson, Ph.D., Paul Kellam, Ph.D., Alimuddin I. Zumla, M.D., and Ziad A. Memish, M.D. for the KSA MERS-CoV Investigation Team
N Engl J Med 2013; 369:407-416August 1, 2013DOI: 10.1056/NEJMoa1306742
http://www.nejm.org/doi/full/10.1056/NEJMoa1306742

Abstract
Background
In September 2012, the World Health Organization reported the first cases of pneumonia caused by the novel Middle East respiratory syndrome coronavirus (MERS-CoV). We describe a cluster of health care–acquired MERS-CoV infections.
Full Text of Background…

Methods
Medical records were reviewed for clinical and demographic information and determination of potential contacts and exposures. Case patients and contacts were interviewed. The incubation period and serial interval (the time between the successive onset of symptoms in a chain of transmission) were estimated. Viral RNA was sequenced.
Full Text of Methods…

Results
Between April 1 and May 23, 2013, a total of 23 cases of MERS-CoV infection were reported in the eastern province of Saudi Arabia. Symptoms included fever in 20 patients (87%), cough in 20 (87%), shortness of breath in 11 (48%), and gastrointestinal symptoms in 8 (35%); 20 patients (87%) presented with abnormal chest radiographs. As of June 12, a total of 15 patients (65%) had died, 6 (26%) had recovered, and 2 (9%) remained hospitalized. The median incubation period was 5.2 days (95% confidence interval [CI], 1.9 to 14.7), and the serial interval was 7.6 days (95% CI, 2.5 to 23.1). A total of 21 of the 23 cases were acquired by person-to-person transmission in hemodialysis units, intensive care units, or in-patient units in three different health care facilities. Sequencing data from four isolates revealed a single monophyletic clade. Among 217 household contacts and more than 200 health care worker contacts whom we identified, MERS-CoV infection developed in 5 family members (3 with laboratory-confirmed cases) and in 2 health care workers (both with laboratory-confirmed cases).
Full Text of Results…

Conclusions
Person-to-person transmission of MERS-CoV can occur in health care settings and may be associated with considerable morbidity. Surveillance and infection-control measures are critical to a global public health response.

Measuring the Global Burden of Disease

New England Journal of Medicine
August 1, 2013  Vol. 369 No. 5
http://www.nejm.org/toc/nejm/medical-journal

Review Article
Global Health
Measuring the Global Burden of Disease
Christopher J.L. Murray, M.D., D.Phil., and Alan D. Lopez, Ph.D.
N Engl J Med 2013; 369:448-457August 1, 2013DOI: 10.1056/NEJMra1201534
http://www.nejm.org/doi/full/10.1056/NEJMra1201534

Excerpt
It is difficult to deliver effective and high-quality care to patients without knowing their diagnoses; likewise, for health systems to be effective, it is necessary to understand the key challenges in efforts to improve population health and how these challenges are changing. Before the early 1990s, there was no comprehensive and internally consistent source of information on the global burden of diseases, injuries, and risk factors. To close this gap, the World Bank and the World Health Organization launched the Global Burden of Disease (GBD) Study in 1991.1 Although assessments of selected diseases, injuries, and risk factors in selected populations are published each year (e.g., the annual assessments of the human immunodeficiency virus [HIV] epidemic2), the only comprehensive assessments of the state of health in the world have been the various revisions of the GBD Study for 1990, 1999–2002, and 2004.1,3-10 The advantage of the GBD approach is that consistent methods are applied to critically appraise available information on each condition, make this information comparable and systematic, estimate results from countries with incomplete data, and report on the burden of disease with the use of standardized metrics.

The most recent assessment of the global burden of disease is the 2010 study (GBD 2010), which provides results for 1990, 2005, and 2010. Several hundred investigators collaborated to report summary results for the world and 21 epidemiologic regions in December 2012.11-18 Regions based on levels of adult mortality, child mortality, and geographic contiguity were defined. GBD 2010 addressed a number of major limitations of previous analyses, including the need to strengthen the statistical methods used for estimation.11 The list of causes of the disease burden was broadened to cover 291 diseases and injuries. Data on 1160 sequelae of these causes (e.g., diabetic retinopathy, diabetic neuropathy, amputations due to diabetes, and chronic kidney disease due to diabetes) have been evaluated separately. The mortality and burden attributable to 67 risk factors or clusters of risk factors were also assessed.

GBD 2010, which provides critical information for guiding prevention efforts, was based on data from 187 countries for the period from 1990 through 2010. It includes a complete reassessment of the burden of disease for 1990 as well as an estimation for 2005 and 2010 based on the same definitions and methods; this facilitated meaningful comparisons of trends. The prevalence of coexisting conditions was also estimated according to the year, age, sex, and country. Detailed results from global and regional data have been published previously.11-18

The internal validity of the results is an important aspect of the GBD approach. For example, demographic data on all-cause mortality according to the year, country, age, and sex were combined with data on cause-specific mortality to ensure that the sum of the number of deaths due to each disease and injury equaled the number of deaths from all causes. Similar internal-validity checks were used for cause-specific estimates related to impairments such as hearing loss and vision loss, anemia, heart failure, intellectual disability, infertility, and epilepsy when there were substantial data on the overall levels of the impairment.

Although GBD 2010 provides the most comprehensive and consistent assessment of global data on descriptive epidemiology, there remain many limitations. There were insufficient data on many diseases, injuries, and risk factors from many countries. Estimates depended on sophisticated statistical modeling to address sparse and often inconsistent data.13,16,19,20 All outcomes were measured with 95% uncertainty intervals, which captured uncertainty from sampling, nonsampling error from the study designs or diagnostic methods, model parameter uncertainty, and uncertainty regarding model specification. This combined assessment of uncertainty was meant to communicate the strength of the evidence available for a particular condition in a particular place…

Editorial and Special Report: Clinical Trial Data and Transparency/GSK data-access plan

New England Journal of Medicine
August 1, 2013  Vol. 369 No. 5
http://www.nejm.org/toc/nejm/medical-journal

Editorial
Participant-Level Data and the New Frontier in Trial Transparency
Deborah A. Zarin, M.D.
N Engl J Med 2013; 369:468-469August 1, 2013DOI: 10.1056/NEJMe1307268
http://www.nejm.org/doi/full/10.1056/NEJMe1307268
Excerpt
Medical progress is possible only because altruistic volunteers put themselves at risk in clinical trials. The results of those trials are then used to inform medical decisions. The traditional system of relying on investigators, sponsors, and journal editors to decide whether, when, and how to report trial results was based on trust. There was no way to know what trials had been conducted, what data were collected, how they were analyzed, and whether the reported data were complete and accurate. Policies mandating the registration of trials and the reporting of summary results were instituted to provide greater transparency. In turn…

Special Report
Access to Patient-Level Data from GlaxoSmithKline Clinical Trials
Perry Nisen, M.D., Ph.D., and Frank Rockhold, Ph.D.
N Engl J Med 2013; 369:475-478August 1, 2013DOI: 10.1056/NEJMsr1302541
http://www.nejm.org/doi/full/10.1056/NEJMsr1302541

GlaxoSmithKline is providing access to patient-level clinical trial data under a new policy. This article reviews the data-access plan

Understanding the Cost-Effectiveness of Influenza Vaccination in Children: Methodological Choices and Seasonal Variability

Pharmacoeconomics
Volume 31, Issue 8, August 2013
http://link.springer.com/journal/40273/31/7/page/1

Understanding the Cost-Effectiveness of Influenza Vaccination in Children: Methodological Choices and Seasonal Variability
Anthony T. Newall, Juan Pablo Dehollain, Prudence Creighton, Philippe Beutels, James G. Wood
http://link.springer.com/article/10.1007/s40273-013-0060-7

Abstract
Background
The universal vaccination of children for influenza has recently been recommended in the UK and is being considered in other developed countries.

Objectives
The aim of this study was to explore the potential costs and benefits of childhood influenza vaccination to gain a better understanding of the key drivers of cost-effectiveness.

Methods
As our case study we examined the cost-effectiveness of vaccination in Australian schoolchildren using an age-stratified Susceptible Exposed Infectious Recovered model.

Results
The results of this study highlight the critical role that methodological choices play in determining the cost-effectiveness of influenza vaccination. These choices include decisions about the structure of the model (including/excluding herd immunity) and what costs and benefits to include in the analysis. In scenarios where herd protection was included we estimated that the program was likely to be cost-effective. The study also illustrates the importance of the inherent seasonal variability of influenza, which can produce counter-intuitive results, with low transmission seasons being easier to control by vaccination but resulting in fewer benefits.

Conclusions
Universal childhood influenza vaccination is likely to be cost-effective if a substantial herd protection effect can be achieved by the program. However, it is important that decision makers understand the role of seasonal variability and the impact of alternative methodological choices in economic evaluations of influenza vaccination.

Risk Map of Cholera Infection for Vaccine Deployment: The Eastern Kolkata Case

PLoS One
[Accessed 3 August 2013]
http://www.plosone.org/

Research Article
Risk Map of Cholera Infection for Vaccine Deployment: The Eastern Kolkata Case
Young Ae You, Mohammad Ali, Suman Kanungo, Binod Sah, Byomkesh Manna, Mahesh Puri, G. Balakrish Nair, Sujit Kumar Bhattacharya, Matteo Convertino, Jacqueline L. Deen, Anna Lena Lopez, Thomas F. Wierzba, John Clemens, Dipika Sur
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0071173

Abstract
Background
Despite advancement of our knowledge, cholera remains a public health concern. During March-April 2010, a large cholera outbreak afflicted the eastern part of Kolkata, India. The quantification of importance of socio-environmental factors in the risk of cholera, and the calculation of the risk is fundamental for deploying vaccination strategies. Here we investigate socio-environmental characteristics between high and low risk areas as well as the potential impact of vaccination on the spatial occurrence of the disease.

Methods and Findings
The study area comprised three wards of Kolkata Municipal Corporation. A mass cholera vaccination campaign was conducted in mid-2006 as the part of a clinical trial. Cholera cases and data of the trial to identify high risk areas for cholera were analyzed. We used a generalized additive model (GAM) to detect risk areas, and to evaluate the importance of socio-environmental characteristics between high and low risk areas. During the one-year pre-vaccination and two-year post-vaccination periods, 95 and 183 cholera cases were detected in 111,882 and 121,827 study participants, respectively. The GAM model predicts that high risk areas in the west part of the study area where the outbreak largely occurred. High risk areas in both periods were characterized by poor people, use of unsafe water, and proximity to canals used as the main drainage for rain and waste water. Cholera vaccine uptake was significantly lower in the high risk areas compared to low risk areas.

Conclusion
The study shows that even a parsimonious model like GAM predicts high risk areas where cholera outbreaks largely occurred. This is useful for indicating where interventions would be effective in controlling the disease risk. Data showed that vaccination decreased the risk of infection. Overall, the GAM-based risk map is useful for policymakers, especially those from countries where cholera remains to be endemic with periodic outbreaks.

Citation: You YA, Ali M, Kanungo S, Sah B, Manna B, et al. (2013) Risk Map of Cholera Infection for Vaccine Deployment: The Eastern Kolkata Case. PLoS ONE 8(8): e71173. doi:10.1371/journal.pone.0071173

Editor: Matteo Convertino, University of Florida, United States of America

Received: April 11, 2013; Accepted: June 25, 2013; Published: August 2, 2013

Funding: This study is supported by the Bill & Melinda Gates Foundation through the Diseases of the Most Impoverished Program and the Cholera Vaccine Initiative. Additional funding is provided by the Swedish International Development Cooperation Agency and the Governments of South Korea, Sweden, and Kuwait. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Physicians Infrequently Adhere to Hepatitis Vaccination Guidelines for Chronic Liver Disease

PLoS One
[Accessed 3 August 2013]
http://www.plosone.org/

Research Article
Physicians Infrequently Adhere to Hepatitis Vaccination Guidelines for Chronic Liver Disease
Kavitha Thudi, Dhiraj Yadav, Kaitlyn Sweeney, Jaideep Behari mail
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0071124

Abstract
Background and Goals
Hepatitis A (HAV) and hepatitis B (HBV) vaccination in patients with chronic liver disease is an accepted standard of care. We determined HAV and HBV vaccination rates in a tertiary care referral hepatology clinic and the impact of electronic health record (EHR)-based reminders on adherence to vaccination guidelines.

Methods
We reviewed the records of 705 patients with chronic liver disease referred to our liver clinic in 2008 with at least two follow-up visits during the subsequent year. Demographics, referral source, etiology, and hepatitis serology were recorded. We determined whether eligible patients were offered vaccination and whether patients received vaccination. Barriers to vaccination were determined by a follow-up telephone interview.

Results
HAV and HBV serologic testing prior to referral and at the liver clinic were performed in 14.5% and 17.7%; and 76.7% and 74% patients, respectively. Hepatologists recommended vaccination for HAV in 63% and for HBV in 59.7% of eligible patients. Patient demographics or disease etiology did not influence recommendation rates. Significant variability was observed in vaccination recommendation amongst individual providers (30–98.6%), which did not correlate with the number of patients seen by each physician. Vaccination recommendation rates were not different for Medicare patients with hepatitis C infection for whom a vaccination reminder was automatically generated by the EHR. Most patients who failed to get vaccination after recommendation offered no specific reason for noncompliance; insurance was a barrier in a minority.

Conclusions
Hepatitis vaccination rates were suboptimal even in an academic, sub-speciality setting, with wide-variability in provider adherence to vaccination guidelines.

From Google Scholar & other sources [to 3 August 2013]

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

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… COST-EFFECTIVENESS ANALYSES OF VACCINES: THE EXAMPLE OF A POTENTIAL GROUP B STREPTOCOCCAL (GBS) VACCINE PROGRAM FOR PREGNANT
SY Kim – The 35th Annual Meeting of the Society for Medical …, 2013
Purpose: In low-and middle-income countries, cost-effectiveness analyses of new vaccine
introduction have typically compared vaccine against doing nothing. We illustrate the impact
of competing new vaccines against other realistic prevention alternatives, using maternal …

Carbon nanotubes as vaccine scaffolds
DA Scheinberg, MR McDevitt, T Dao, JJ Mulvey… – Advanced Drug Delivery …, 2013
Abstract Carbon nanotubes display characteristics that are potentially useful in their
development as scaffolds for vaccine compositions. These features include stability in vivo,
lack of intrinsic immunogenicity, low toxicity, and the ability to be appended with multiple …

[PDF] Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial
HC Rümke, JH Richardus, L Rombo, K Pauksens… – BMC Infectious Diseases, 2013
Background Improved influenza vaccines are needed to reduce influenza-associated
complications in older adults. The aim of this study was to identify the optimal formulation of
adjuvanted seasonal influenza vaccine for use in elderly people. Methods This observer- …

[PDF] Factors influencing women’s intentions to obtain the Human Papillomavirus (HPV) vaccine
B Ebertz, M Sjöberg, AT Bengtsson – 2013
Abstract Background: Cervical cancer is second most common cancer in women. The 15%
incidence of cervical cancer in women worldwide can potentially be reduced by the vaccine
against human papillomavirus (HPV). It is therefore important for all healthcare …

The Private Sector in the New Global Development Agenda

Brookings
http://www.brookings.edu/
Accessed 3 August 2013

The Private Sector in the New Global Development Agenda
Kemal Derviş, Strobe Talbott and Richard C. Blum | July 31, 2013 10:33am

This weekend, global leaders, entrepreneurs, practitioners and public intellectuals will come together at the Brookings Blum Roundtable to discuss innovative ideas and advance groundbreaking initiatives to alleviate global poverty. This year marks the roundtable’s 10th anniversary and a time when the prospects for eradicating extreme poverty are arguably the best they have ever been…

http://www.brookings.edu/blogs/up-front/posts/2013/07/31-blum-roundtable-global-poverty-blum-dervis-talbott

Can collaboration resuscitate global health funding?

The Guardian
http://www.guardiannews.com/
Accessed 3 August 2013

Can collaboration resuscitate global health funding?
theguardian.com, 31 Jul 2013
Anurag Mairal

  As support for global health projects declines, governments, NGOs and the private sector will have to be creative and commit to collaboration, argues Anurag Mairal
A golden era of funding for global health has ended. After rising threefold during the first decade of the twenty-first century, development assistance for health has plateaued.

Although funding from international donors has catalysed remarkable improvements in health in many countries, the gap between rich and poor remains wide. To further reduce health inequities, we need new approaches that make the most of available resources and I believe public-private partnerships across international borders are key to providing the highest value for money and achieving sustainable impact.

Others share the same view. In an open letter to G8 leaders who met in Northern Ireland in June, global health groups noted that “public-private partnership models supported by our governments have accelerated progress towards the millennium development goals and will have a critical role in the post-2015 development agenda.”

At Path, the US-based nongovernmental organisation where I work, our mantra is to always begin with the end in mind. In 35 years of developing and delivering high-impact, cost-effective health technologies for developing countries, we have found that both public- and private-sector partners are essential to effectively and efficiently drive lifesaving innovations to scale…

Washington Post Editorial: A setback on polio [Somalia, Kenya]

Washington Post
http://www.washingtonpost.com/
Accessed 3 August 2013

The Post’s View
A setback on polio
By Editorial Board, Published: July 29

ONLY A few months ago, there was great optimism that polio was on the verge of eradication. The world saw only 223 cases in 2012, the lowest level in history, and the Global Polio Eradication Initiative, an umbrella group, unveiled a major strategy to wipe out the disease over the next five years.

Those hopes now seem clouded by a poliovirus outbreak in Somalia and Kenya. This year, there have been 81 cases in these two countries, more than the 59 cases in the three countries where polio remains endemic: Afghanistan, Pakistan and Nigeria. The first case in this outbreak, on April 30, was a 4-month-old girl who developed symptoms of acute paralysis in Dadaab, Kenya — the site of a major refugee camp, with 500,000 people, near the Somali border; within days, a case was confirmed in neighboring Somalia, according to the World Health Organization (WHO).

Polio is a highly contagious disease that affects the nervous system and can lead to paralysis, largely among children age 5 and younger. It spreads rapidly.

The WHO has warned that the “risk to neighboring countries is deemed very high, due to large-scale population movements across the Horn of Africa and persistent immunity gaps in some areas.” The worry about immunity gaps is serious. Vaccination is the most critical tool in the battle against polio, and oral vaccines are much improved, but some 500,000 children in Somalia have not been vaccinated in several years, if at all. These vulnerable children are in areas largely outside the control of Somalia’s weak central government, and the fear is these regions could become a cauldron for poliovirus, fueling the outbreak for a long time. Health workers simply can’t reach them.

In hopes of containing the virus, road posts are being set up along major corridors to vaccinate those going and coming from the remote areas, while fresh vaccination campaigns are targeting Mogadishu, the Somali capital.

The latest outbreak underscores how armed conflicts threaten populations not only with bullets but also with disease. In Pakistan, polio has maintained a stubborn foothold in areas roiled by violence, including the assassination of polio vaccination workers by militants. Fortunately, in Somalia there does not appear to be resistance to vaccination, just an inability to extend it to those in need.

This is not the first outbreak of its kind. When vaccination was suspended in Nigeria in 2003, the virus spread across the continent, including into the Horn of Africa, and eventually into Yemen, resulting in some 700 cases. Lessons learned from that experience are being deployed in battling the current outbreak, and it is not likely to derail the global campaign for eradication. But the virus is demonstrating a dogged resilience, and it will take enormous determination and hard work to extinguish the latest scourge.

Vaccines: The Week in Review 27 July 2013

Vaccines: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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Email Summary: Vaccines: The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_27 July 2013
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Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
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Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

HPV Vaccination Coverage Among Adolescent Girls, 2007–2012; Postlicensure Vaccine Safety Monitoring, 2006–2013 — U.S.

CDC/MMWR Watch [to 27 July 2013]
CDC Telebriefing on human papillomavirus (HPV) vaccination coverage and vaccine safety monitoring
Thursday, July 25, 2013 at Noon ET

Press Briefing Transcript
Excerpt [Editor’s text bolding]
TOM FRIEDEN:
“…Just last month, I had a chance to share with you really good news that HPV vaccination works even better than we anticipated.  The types of HPV, that’s human papillomavirus, that commonly cause cervical cancer in the U.S., had dropped by about half in girls aged 14 to 19 in the seven years since we recommended routinely vaccinating against HPV.  I noted at that time that the results were striking, and would serve – should serve as a wake-up call to increase vaccination rates, because we really can protect the next generation of adolescents against cancers caused by HPV.  Unfortunately, today we have disappointing news.  An article in today’s MMWR shows that HPV vaccination coverage for girls getting the anti-cancer vaccine has not increased at all from one year to the next.  Zero.  We’re dropping the ball.  We’re missing opportunities to give HPV vaccines, and that needs to change to protect girls from cervical cancer.  I’ll provide some more detail and then discuss missed opportunities and information about vaccine safety.

But the article published today has data from what’s called the National Immunization Survey on teen vaccinations.  This is how we measure how we’re doing.  It collects vaccine information for 13 to 17-year-olds using a random digit sample of landlines and, starting in 2011, cellular telephone phones as well.  After a teen’s parental guardian gives permission, we contact the vaccination provider, doctor, nurse practitioner or other provider and mail a questionnaire to get the vaccination history.  The 2012 survey which we’re reporting about today included vaccination records of about 19,000 teens.  And today’s article focuses on HPV vaccination among girls from 2007 to 2012.  Next month we’ll share the data we collected last year on other vaccines recommended specifically for preteens and teens, and that will include vaccination coverage estimates for HPV vaccinations among boys, something that’s only more recently been recommended.

These national data show no progress, zero, with HPV vaccine coverage in 2012.  We’re used to seeing coverage increases of 10 percent per year when a new vaccine hits the market.  Last year we were disappointed at the increase in HPV vaccine was only 4 percentage points.  This year, it’s zero percentage points.  The HPV vaccine coverage hasn’t kept pace with other vaccines recommended for preteens and teens.  One dose does not provide all of the protection that the HPV vaccine series has to offer so we want all girls to get their second and third doses.  By 2011, 34.8 percent of teen girls finished their three-dose series.  2012 data is not different.  It’s 33.4 percent.  Actually, slightly fewer teen girls are given all doses from the previous years.  This is a huge disappointment, but I’m confident that we will turn it around.  And one of the reasons for that is in the next piece of data that we got from this survey.

We assumed that one of the reasons we had such low rates was that adolescents don’t see the doctor regularly so it’s hard to get a three-dose series in.  But actually, we found that – that the data showed that if HPV vaccine were given every single time a young person went to the doctor to get another vaccine, the completion of those series would be at 93 percent.  That’s important, because if we get three-dose series to 80 percent, an estimated 53,000 cases of cervical cancer could be prevented over the lifetimes of girls aged 12 and younger.  Now there are lots of ways we can work together to increase vaccination rates.  A key one is to take advantage of every opportunity to vaccinate against HPV.  The teens are in the doctor’s office, they’re getting another vaccination, but they’re not getting the HPV second and third doses.

We also asked parents why they haven’t gotten their daughters vaccinated.  And one of the top reasons is that their doctors didn’t recommend it.  This is critical.  Research consistently showed that a provider’s recommendation to vaccinate is the single most influential factor in determining whether a parent gets their kid vaccinated.  So we need to step up our efforts by talking to parents about the importance of this vaccine.  Doctors need to recommend this vaccine just as they recommend others, and ensure that they’re given every opportunity.  Parents have also told us in other research there are concerns about this – this may be in some way a license or permission to have sex.  But multiple studies have found that preteens and teens who receive this vaccine do not have sex any sooner than their peers who have not received the vaccine.  HPV vaccine does not open the door to sex.  HPV vaccine closes the door to cancer.  The vaccine has to be given before onset of sexual activity.  We can’t let this opportunity go to waste.  And I really would make the analogy to many of our other vaccines.  We make sure that people get vaccinations well before they get exposed.  We’re not saying they’re going to be exposed immediately after.  Just that we want to make sure they get vaccinated well before…”
http://www.cdc.gov/media/releases/2013/t0725-Human-papillomavirus.html

Human Papillomavirus Vaccination Coverage Among Adolescent Girls, 2007–2012, and Postlicensure Vaccine Safety Monitoring, 2006–2013 — United States
MMWR Weekly
July 26, 2013 / 62(29);591-595
Excerpt
Since mid-2006, the Advisory Committee on Immunization Practices (ACIP) has recommended routine vaccination of adolescent girls at ages 11 or 12 years with 3 doses of human papillomavirus (HPV) vaccine (1). Two HPV vaccines are currently available in the United States. Both the quadrivalent (HPV4) and bivalent (HPV2) vaccines protect against HPV types 16 and 18, which cause 70% of cervical cancers and the majority of other HPV-associated cancers; HPV4 also protects against HPV types 6 and 11, which cause 90% of genital warts.* This report summarizes national HPV vaccination coverage levels among adolescent girls aged 13–17 years from the 2007–2012 National Immunization Survey-Teen (NIS-Teen) and national postlicensure vaccine safety monitoring. Although vaccination coverage with ≥1 dose of any HPV vaccine increased from 25.1% in 2007 to 53.0% in 2011, coverage in 2012 (53.8%) was similar to 2011. If HPV vaccine had been administered during health-care visits when another vaccine was administered, vaccination coverage for ≥1 dose could have reached 92.6%. Safety monitoring data continue to indicate that HPV4 is safe. Despite availability of safe and effective vaccines and ample opportunities for vaccine delivery in the health-care setting, HPV vaccination coverage among adolescent girls failed to increase from 2011 to 2012…

Saudi Arabia MOH Issues Health Regulations for Hajj-1434H

Kingdom of Saudi Arabia: MOH Issues Health Regulations for Those Flocking to Saudi Arabia to Perform Umrah and Hajj-1434H
12 July 2013
http://www.moh.gov.sa/en/Ministry/MediaCenter/News/Pages/News-2013-07-12-001.aspx

[Full text]
Proceeding from the keenness of the government of the Custodian of the Two Holy Mosques to maintain the public health and ensure a safe and healthy atmosphere for the performers of Pilgrimage “Hajj” and Umrah, Allah Willing; in order to enable them to perform the rituals easily, healthily and conveniently, and within the framework of the precautionary measures against Novel Coronavirus (MERS-COV), the Ministry of Health (MOH) has issued health regulations and requirements that must be met by those coming to the Kingdom for performing Umrah  and Hajj for the year 1434 H.

These regulations included the recommendation of postponing the performance of Umrah and Hajj this year in case of the elderly people and patients suffering from chronic diseases such as heart, kidney, and respiratory diseases, not to forget diabetes, as well as patients with congenital and acquired immune deficiency, in addition to patients suffering from tumors, and pregnant women and children.

Within the same vein, the regulations included some tips and health awareness guidelines for citizens, residents and visitors to perform Umrah or Hajj such as: washing hands well and continually with water and soap, or with other hand disinfectants, especially after coughing, sneezing, using a tissue when coughing or sneezing, then getting rid of it in a waste basket, avoiding touching eyes, nose or mouth directly with hands, limiting direct contact with infectious people and avoiding sharing their personal tools, wearing face-masks in overcrowded places, and maintaining hygiene in general. Furthermore, these regulations included obtaining a valid certificate of vaccination against meningitis at least 10 days before travelling to the Kingdom, and up to 3 years, as well as getting a certificate of vaccination against polio-affected countries, according to specific requirements.

It is worth mentioning that the health regulations have shed light on the importance of vaccination against seasonal influenza vaccine, especially for people with chronic diseases such as heart and kidney diseases, diabetes and respiratory and neurological diseases, as well as people with congenital and acquired immune deficiency diseases, metabolic diseases, pregnant women and children under 5 years, aside from people suffering from obesity and overweight.

To view the Health Regulations for Travellers to Saudi Arabia to Perform Umrah & Hajj-1434H.​

http://www.moh.gov.sa/en/Ministry/MediaCenter/News/Pages/News-2013-07-12-001.aspx

Novartis, Biological E Limited in agreement for two vaccines to protect against typhoid and paratyphoid fevers

Novartis announced a development and licensing agreement with Biological E Limited (BioE, India) ) for two vaccines to protect against typhoid and paratyphoid fevers. Under the license, Novartis Vaccines Institute for Global Health (NVGH) will transfer technology to BioE, which will have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world. The typhoid vaccine (Vi-CRM197) involved has achieved Proof of Concept, had successful Phase 2 results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine will be transferred once Proof of Concept is completed through early, small-scale studies in humans to determine safety and immunogenicity. The Wellcome Trust continues to support the development of the dual-acting vaccine through a Strategic Award that was awarded in 2009. BioE said it is committed to achieving WHO pre-qualification and fulfill specific obligations to meet Novartis standards. The agreement is worldwide except for developed countries, where Novartis will retain rights.

http://www.novartis.com/newsroom/media-releases/1714633.shtml

WHO: World Hepatitis Day 2013

WHO: World Hepatitis Day 2013
News Release
24 July 2013

Excerpt
On World Hepatitis Day (28 July), WHO is urging governments to act against the five hepatitis viruses that can cause severe liver infections and lead to 1.4 million deaths every year. Some of these hepatitis viruses, most notably types B and C, can also lead to chronic and debilitating illnesses such as liver cancer and cirrhosis, and in addition to, loss of income and high medical expenses for hundreds of millions of people worldwide…

…“The fact that many hepatitis B and C infections are silent, causing no symptoms until there is severe damage to the liver, points to the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy,” says Dr Keiji Fukuda, WHO Assistant Director-General for Health Security and the Environment.

“Many of the measures needed to prevent the spread of viral hepatitis disease can be put in place right now, and doing so will offset the heavy economic costs of treating and hospitalizing patients in future.”

This year, in the run up to World Hepatitis Day, the Organization is releasing its first-ever country hepatitis survey, covering 126 countries. The WHO “Global policy report on the prevention and control of viral hepatitis in WHO Member States” identifies successes as well as gaps at country level in the implementation of four priority areas. The priority areas are raising awareness, evidence-based data for action, prevention of transmission, and screening, care and treatment.

The findings show that 37% of the countries have national strategies for viral hepatitis, and more work is needed in treating hepatitis. It also highlights that while most of the countries (82%) have established hepatitis surveillance programmes, only half of them include the monitoring of chronic hepatitis B and C, which are responsible for most severe illnesses and deaths…
http://www.who.int/mediacentre/news/releases/2013/hepatitis_threat_20130724/en/index.html

World Hepatitis Day Statement by HHS Secretary Kathleen Sebelius and HHS Assistant Secretary for Health Dr. Howard Koh
http://www.businesswire.com/news/home/20130726005621/en/World-Hepatitis-Day-Statement

IVI launches new matrix-based organization

IVI said it launched a new matrix-based organization “as part of its efforts to increase efficiency and accountability in management and implementation of its research projects.” The key elements of the new organization, which has been put in place in line with IVI’s new Strategic Plan, are the introduction of formal portfolio and project management, and a greater focus on vaccine pipeline and delivery. IVI now comprises of the following units:
:: Portfolio Management
:: Development and Delivery
:: Laboratory Sciences
:: Finance & Administration
:: Communications & Advocacy
:: Human Resources

The Portfolio Management Unit has three main programs as of now: Cholera, Typhoid and Dengue, and also includes the functions of Portfolio Manager, Grant Manager, and Business Development Manager. The Development and Delivery Unit has four departments: Clinical Development and Regulatory, Epidemiology, Biostatistics and Data Management, and Access. As well, an internal Portfolio Management Committee has been created to overlook IVI’s research and development projects.

IVI noted that these changes have been made “to ensure that IVI will be well-positioned to achieve maximal impact and deliver on its mission – the discovery, development, and delivery of safe, effective and affordable vaccines for developing nations.”

http://www.ivi.org/web/www/07_01?p_p_id=EXT_BBS&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_EXT_BBS_struts_action=%2Fext%2Fbbs%2Fview_message&_EXT_BBS_messageId=540

UN to establish WHO-led Interagency Task Force on the Prevention and Control of Noncommunicable Diseases

United Nations to establish WHO-led Interagency Task Force on the Prevention and Control of Noncommunicable Diseases
Note for media

22 July 2013 | Geneva – The Economic and Social Council (ECOSOC) adopted a resolution requesting the UN Secretary-General to establish a United Nations Interagency Task Force on the Prevention and Control of Noncommunicable Diseases. The Task Force will be convened and led by the WHO and will be created by expanding the mandate of the existing United Nations Ad Hoc Interagency Task Force on Tobacco Control and the work to support the implementation of the WHO Framework Convention on Tobacco Control (WHO FCTC). The resolution was adopted in ECOSOC’s 2013 Substantive Session being held in Geneva, Switzerland.

The Task Force will coordinate the activities of all UN organizations to implement the WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020, adopted by the World Health Assembly in May 2013. This is important because new WHO estimates show that 3 of the 4 leading causes of death worldwide are linked to noncommunicable diseases, specifically cardiovascular diseases and chronic obstructive pulmonary disease.

The Action Plan aims to achieve 9 voluntary global targets, including a 25% reduction in premature mortality from cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases by 2025. The plan provides a road map and a menu of policy options for Member States, WHO, other UN organizations, NGOs and private sector entities to implement collectively.

Heads of State and Government in 2011 recognized the role and responsibility of governments in reducing noncommunicable diseases through the United Nations Political Declaration on the Prevention and Control of NCDs. With this resolution, ECOSOC is following up on those commitments.

WHO will convene a formal meeting with Member States on 13 November 2013 to complete the work on a draft terms of reference for the UN Task Force on NCDs.

http://www.who.int/mediacentre/news/notes/2013/ncds_ecosoc_20130722/en/index.html

EFPIA/PhRMA: Joint Principles for Responsible Clinical Trial Data Sharing

EFPIA/PhRMA: Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients
Media Release: July 24, 2013

Excerpt
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) today strengthened their long-standing commitment to enhancing public health by endorsing joint “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”

“Companies routinely publish their clinical research, collaborate with academic researchers, and share clinical trial information on public websites,” said Christopher Viehbacher, President of EFPIA and CEO of Sanofi. “By endorsing the Principles, biopharmaceutical companies commit to enhance these efforts by making additional information available to the public, patients who participate in clinical trials, and to qualified researchers.

Under the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.

Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be encouraged to publish their findings.

Companies will work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials.

The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration [FDA], European Medicines Agency [EMA], or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.

Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication….

Implementation of the commitments begins on January 1, 2014. The Principles are available at http://transparency.efpia.eu/responsible-data-sharing and http://onphr.ma/18yru3e.

http://phrma.org/press-release/EFPIA-and-phrma-release-joint-principles-for-responsible-clinical-trial-data-sharing-to-benefit-patients

GPEI Update: Polio this week – As of 24 July 2013

Update: Polio this week – As of 24 July 2013
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]
:: In Nigeria, the first circulating vaccine-derived poliovirus type 2 (cVDPV2) case of 2013 was reported, from Borno state. It is linked to cVDPV2 currently circulating in Chad. Previously, no cVDPV2 cases had been reported from Nigeria since November. See ‘Nigeria’ section for more.

Nigeria
:: One new cVDPV2 case was reported in the past week – the first in the country in 2013. Previously, no cVDPV2 cases had been reported since November 2012. This most recent cVDPV2 case had onset of paralysis on 6 June (from Borno).

:: This latest case is linked to cVDPV2 currently circulating in Chad, which have also been detected in Cameroon. In addition to the case in Borno, cVDPV2 linked to this transmission chain had previously been isolated from an environmental sample in Kano in March, indicating circulation in Nigeria.

Horn of Africa
:: Eight new WPV1 cases were reported in the past week (seven from Somalia and one from Kenya), bringing the total number of WPV1 cases in the region to 81 (72 from Somalia and nine from Kenya). The most recent case in the region had onset of paralysis on 3 July (from Kenya).

:: One of the newly-reported cases from Somaliland, in the north, the first in that area associated with this outbreak and close to the border with Ethiopia. Additionally, some of the newly-reported cases are from inaccessible areas of south-central Somalia.

:: In Somalia, NIDs are currently ongoing (21-25 July), targeting children under the age of five years. Specific radio messages had been developed with the involvement of the Ministry of Religious Affairs, as this latest campaign is being implemented during Ramadan.

:: The next SIAs in Kenya are planned for 27-30 July, targeting host communities around the Dadaab camps.

:: Campaigns across the Horn of Africa, including in Ethiopia and Yemen, will continue throughout August.

WHO: Global policy report on the prevention and control of viral hepatitis

Global policy report on the prevention and control of viral hepatitis
World Health Organization
Number of pages: 220
Publication date: July 2013
Languages: English
ISBN: 978 92 4 156463 2

The periodic evaluation of implementation of the WHO strategy requires an initial baseline survey of all Member States. In mid-2012, WHO, in collaboration with the World Hepatitis Alliance, conducted such a survey, asking Member States to provide information relating to the four axes of the WHO strategy. In particular, Member States were asked whether key prevention and control activities are being conducted. This report presents the results.

The first chapter provides an introduction to viral hepatitis and to the global response to this group of diseases. The second chapter provides a global overview of the survey findings. Chapters three through eight present findings from the six WHO regions, including summaries of data from all responding countries. Additional survey data, study methodology information and the survey instrument can be found in Annexes A–E.

pH1N1 – a comparative analysis of public health responses in Ontario to the influenza outbreak, public health and primary care: lessons learned and policy suggestions

BMC Public Health
(Accessed 27 July 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article  
pH1N1 – a comparative analysis of public health responses in Ontario to the influenza outbreak, public health and primary care: lessons learned and policy suggestions
Paul Masotti, Michael E Green, Richard Birtwhistle, Ian Gemmill, Kieran Moore, Kathleen O¿Connor, Adrienne Hansen-Taugher, Ralph Shaw BMC Public Health 2013, 13:687 (27 July 20 Abstract (provisional)

Background
Ontario’s 36 Public Health Units (PHUs) were responsible for implementing the H1N1 Pandemic Influenza Plans (PIPs) to address the first pandemic influenza virus in over 40 years. It was the first under conditions which permitted mass immunization. This is therefore the first opportunity to learn and document what worked well, and did not work well, in Ontario’s response to pH1N1, and to make recommendations based on experience.

Methods
Our objectives were to: describe the PIP models, obtain perceptions on outcomes, lessons learned and to solicit policy suggestions for improvement. We conducted a 3-phase comparative analysis study comprised of semi-structured key informant interviews with local Medical Officers of Health (n = 29 of 36), and Primary Care Physicians (n = 20) and in Phase 3 with provincial Chief-Medical Officers of Health (n = 6) and a provincial Medical Organization. Phase 2 data came from a Pan-Ontario symposium (n = 44) comprised leaders representing: Public Health, Primary Care, Provincial and Federal Government.

Results
PIPs varied resulting in diverse experiences and lessons learned. This was in part due to different PHU characteristics that included: degree of planning, PHU and Primary Care capacity, population, geographic and relationships with Primary Care. Main lessons learned were: 1) Planning should be more comprehensive and operationalized at all levels. 2) Improve national and provincial communication strategies and eliminate contradictory messages from different sources. 3) An integrated community-wide response may be the best approach to decrease the impact of a pandemic. 4) The best Mass Immunization models can be quickly implemented and have high immunization rates. They should be flexible and allow for incremental responses that are based upon: i) pandemic severity, ii) local health system, population and geographic characteristics, iii) immunization objectives, and iv) vaccine supply.

Conclusion
“We were very lucky that pH1N1 was not more severe.” Consensus existed for more detailed planning and the inclusion of multiple health system and community stakeholders. PIPs should be flexible, allow for incremental responses and have important decisions (E.g., under which conditions Public Health, Primary Care, Pharmacists or others act as vaccine delivery agents.) made prior to a crisis.

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

A cross sectional survey of attitudes, awareness and uptake of the parental pertussis booster vaccine as part of a cocooning strategy, Victoria, Australia

BMC Public Health
(Accessed 27 July 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article  
A cross sectional survey of attitudes, awareness and uptake of the parental pertussis booster vaccine as part of a cocooning strategy, Victoria, Australia
Ellen J Donnan, James E Fielding, Stacey L Rowe, Lucinda J Franklin, Hassan Vally BMC Public Health 2013, 13:676 (23 July 2013)

Abstract (provisional)
Background
The Victorian Government Department of Health funded a diphtheria, tetanus and acellular pertussis vaccine for parents of infants from June 2009 to June 2012 as part of a cocooning strategy for the control of pertussis. The aim of this study was to assess parents’ attitudes and awareness of the vaccination program, and to estimate vaccine uptake.

Methods
A cross-sectional survey of 253 families with a child born in the first quarter of 2010 residing within five metropolitan and four rural local government areas in Victoria was conducted. Univariate analyses were performed to describe the relationship between demographic variables, knowledge and awareness of the disease, the vaccine program and vaccine uptake. Multivariate analyses examining predictors for awareness of the vaccine program and for the uptake of vaccination were also conducted.

Results
One hundred and five families were surveyed (response rate 43%). Of these, 93% indicated that they had heard of ‘pertussis’ or ‘whooping cough’ and 75% of mothers and 69% of fathers were aware the pertussis vaccine was available and funded for new parents. Overall, 70% of mothers and 53% of fathers were vaccinated following their child’s birth, with metropolitan fathers less likely to be vaccinated as rural fathers (RR = 0.6, p = 0.002). Being a younger mother (p = 0.02) or father (p = 0.047), and being an Australian-born father (RR = 1.9, p = 0.03) were found to predict uptake of the vaccine in parents.

Conclusion
Parents indicated a reasonable level of knowledge of pertussis and a willingness to be vaccinated to protect their child. However, vaccine uptake estimates indicated further opportunity for program improvement. Future cocooning strategies would benefit from specifically targeting fathers and metropolitan maternity hospitals to increase vaccine uptake. Wider promotion of the availability of vaccine providers may increase uptake to maximise the success of cocooning programs. Further investigation of the effectiveness of the cocooning strategy in decreasing infant morbidity and mortality is required.

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

Determinants of government HIV/AIDS financing: A 10-year trend analysis from 125 low- and middle-income countries

BMC Public Health
(Accessed 27 July 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article  
Determinants of government HIV/AIDS financing: A 10-year trend analysis from 125 low- and middle-income countries
Carlos Ávila, Dejan Loncar, Peter Amico, Paul De Lay BMC Public Health 2013, 13:673 (19 July 2013)

Abstract (provisional)
Background
Trends and predictors of domestic spending from public sources provide national authorities and international donors with a better understanding of the HIV financing architecture, the fulfillment of governments’ commitments and potential for long-term sustainability.

Methods
We analyzed government financing of HIV using evidence from country reports on domestic spending. Panel data from 2000 to 2010 included information from 647 country-years amongst 125 countries. A random-effects model was used to analyze ten year trends and identify independent predictors of public HIV spending.

Results
Low- and middle-income countries spent US$ 2.1 billion from government sources in 2000, growing to US$ 6.6 billion in 2010, a three-fold increase. Per capita spending in 2010 ranged from 5 cents in low-level HIV epidemics in the Middle East to US$ 32 in upper-middle income countries with generalized HIV epidemics in Southern Africa. The analysis found that GDP per capita and HIV prevalence are positively associated with increasing levels of HIV-spending from public sources; a 10 percent increase in HIV prevalence is associated with a 2.5 percent increase in domestic funding for HIV. Additionally, a 10 percent increase in GDP per capita is associated with an 11.49 percent increase in public spending for HIV and these associations were highly significant at the .001 percent level.

Conclusion
Domestic resources in low- and middle-income countries showed a threefold increase between 2000 and 2010 and currently support 50 percent of the global response with 41 percent coming from sub-Saharan Africa. Domestic spending in LMICs was associated with increased economic growth and an increased burden of HIV. Sustained increases in funding for HIV from public sources were observed in all regions and emphasize the increasing importance of government financing.

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

Editorial: The next step in controlling HBV in China

British Medical Journal
27 July 2013 (Vol 347, Issue 7918)
http://www.bmj.com/content/347/7918

Editorial
The next step in controlling HBV in China
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4503 (Published 16 July 2013)
BMJ2013;347:f4503
Yuanyong Xu, associate professor1, Huihui Liu, research assistant2, Yong Wang, associate professor1, Rongzhang Hao, research assistant1, Zhenjun Li, associate professor3, Hongbin Song, professor1
http://www.bmj.com/content/347/bmj.f4503

Focus on preventing perinatal transmission of the virus
Infection with hepatitis B virus (HBV) is one of the most important infectious diseases in China.1 Although highly effective vaccines against HBV have been available since 1982, about 93 million people in China carry the virus, and treatment costs about ¥100bn (£10.6bn; €12.3bn; $16bn) a year.2 As well as being at increased risk of developing cirrhosis and hepatocellular carcinoma,3 carriers often encounter discrimination at school, at work, in relationships, and with families.4

The Chinese government introduced infant vaccination with HPV vaccine in 1992, followed by a national expanded programme for immunisation in 1999, with special efforts to provide a timely dose at birth. Since 2002, the government has paid for the vaccine. Furthermore, from 2009 to 2011, the government provided the vaccine free of charge to all children under 15 who had not been vaccinated.

These measures have helped control the transmission of HBV in China, and the proportion of carriers in the population has dropped from 9.8% to 7.2% between 1992 and 2006. Over the …

Effectiveness of pertussis vaccines for adolescents and adults: case-control study

British Medical Journal
27 July 2013 (Vol 347, Issue 7918)
http://www.bmj.com/content/347/7918

Research
Effectiveness of pertussis vaccines for adolescents and adults: case-control study
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4249 (Published 17 July 2013)
BMJ 2013;347:f4249
Roger Baxter, codirector, Joan Bartlett, analyst/programmer, Ali Rowhani-Rahbar, vaccine safety fellow, Bruce Fireman, statistician, Nicola P Klein, codirector
http://www.bmj.com/content/347/bmj.f4249

Abstract
Objective: To assess the effectiveness of reduced acellular pertussis (Tdap) vaccines in adolescents and adults.

Setting:  Kaiser Permanente Northern California.

Design:  Case-control study.

Participants:  All polymerase chain reaction (PCR) confirmed cases of pertussis in members aged 11 years and older from January 2006 to December 2011. We compared the Tdap vaccination status of PCR positive cases with two control groups: people testing negative for pertussis by PCR and closely matched people from the general Kaiser Permanente Northern California population.

Main outcome measure: PCR confirmed pertussis. The association of Tdap vaccination with the odds of pertussis infection was estimated by conditional logistic regression, with adjustment for calendar time, pertussis vaccine type received in early childhood, age, sex, race or ethnic group, and medical clinic. We calculated Tdap vaccine effectiveness as 1 minus the adjusted odds ratio.

Results:  The study population included 668 PCR positive cases, 10 098 PCR negative controls, and 21 599 Kaiser Permanente Northern California matched controls. Tdap vaccination rates were 24.0% in PCR positive cases and 31.9% in PCR negative controls (P<0.001). The adjusted estimate of effectiveness of Tdap vaccination against pertussis was 53.0% (95% confidence interval 41.9% to 62.0%) in the comparison with PCR controls, and 64.0% (55.5% to 70.9%) in the comparison with Kaiser Permanente Northern California controls.

Conclusion:  Tdap vaccination was moderately effective at preventing PCR confirmed pertussis among adolescents and adults.

A Novel Method to Value Real Options in Health Care: The Case of a Multicohort Human Papillomavirus Vaccination Strategy

Clinical Therapeutics
Vol 35 | No. 7 | July 2013 | Pages 901-1050
http://www.clinicaltherapeutics.com/current

A Novel Method to Value Real Options in Health Care: The Case of a Multicohort Human Papillomavirus Vaccination Strategy
Giampiero Favato, DBA, Gianluca Baio, PhD, Alessandro Capone, MD, Andrea Marcellusi, MSc,
Francesco Saverio Mennini, MSc
http://www.clinicaltherapeutics.com/article/S0149-2918%2813%2900237-3/abstract

Abstract 
Background
A large number of economic evaluations have already confirmed the cost-effectiveness of different human papillomavirus (HPV) vaccination strategies. Standard analyses might not capture the full economic value of novel vaccination programs because the cost-effectiveness paradigm fails to take into account the value of active management. Management decisions can be seen as real options, a term used to refer to the application of option pricing theory to the valuation of investments in nonfinancial assets in which much of the value is attributable to flexibility and learning over time.

Objective
The aim of this article was to discuss the potential advantages shown by using the payoff method in the valuation of the cost-effectiveness of competing HPV immunization programs.

Methods
This was the first study, to the best of our knowledge, to use the payoff method to determine the real option values of 4 different HPV vaccination strategies targeting female subjects aged 12, 15, 18, and 25 years. The payoff method derives the real option value from the triangular payoff distribution of the project’s net present value, which is treated as a triangular fuzzy number. To inform the real option model, cost-effectiveness data were derived from an empirically calibrated Bayesian model designed to assess the cost-effectiveness of a multicohort HPV vaccination strategy in the context of the current cervical cancer screening program in Italy. A net health benefit approach was used to calculate the expected fuzzy net present value for each of the 4 vaccination strategies evaluated.

Results
Costs per quality-adjusted life-year gained seemed to be related to the number of cohorts targeted: a single cohort of girls aged 12 years (€10,955 [95% CI, –1,021 to 28,212]) revealed the lowest cost among the 4 alternative strategies evaluated. The real option valuation challenged the cost-effectiveness dominance of a single cohort of 12-year-old girls. The simultaneous vaccination of 2 cohorts of girls aged 12 and 15 years yielded a real option value (€17,723) equivalent to that attributed to a single cohort of 12-year-old girls (€17,460).

Conclusions
The payoff method showed distinctive advantages in the valuation of the cost-effectiveness of competing health care interventions, essentially determined by the replacement of the nonfuzzy numbers that are commonly used in cost-effectiveness analysis models, with fuzzy numbers as an input to inform the real option pricing method. The real option approach to value uncertainty makes policy making in health care an evolutionary process and creates a new “space” for decision-making choices.

Perspective: The New Global Health

Emerging Infectious Diseases
Volume 19, Number 8—August 2013
http://www.cdc.gov/ncidod/EID/index.htm

Perspective
The New Global Health
Kevin M. De Cock , Patricia M. Simone, Veronica Davison, and Laurence Slutsker
http://wwwnc.cdc.gov/eid/article/19/8/13-0121_article.htm

Abstract
Global health reflects the realities of globalization, including worldwide dissemination of infectious and noninfectious public health risks. Global health architecture is complex and better coordination is needed between multiple organizations. Three overlapping themes determine global health action and prioritization: development, security, and public health. These themes play out against a background of demographic change, socioeconomic development, and urbanization. Infectious diseases remain critical factors, but are no longer the major cause of global illness and death. Traditional indicators of public health, such as maternal and infant mortality rates no longer describe the health status of whole societies; this change highlights the need for investment in vital registration and disease-specific reporting. Noncommunicable diseases, injuries, and mental health will require greater attention from the world in the future. The new global health requires broader engagement by health organizations and all countries for the objectives of health equity, access, and coverage as priorities beyond the Millennium Development Goals are set.

Perspective: Norovirus Disease in the United State

Emerging Infectious Diseases
Volume 19, Number 8—August 2013
http://www.cdc.gov/ncidod/EID/index.htm

Perspective
Norovirus Disease in the United State
Aron J. Hall , Ben A. Lopman, Daniel C. Payne, Manish M. Patel, Paul A. Gastañaduy, Jan Vinjé, and Umesh D. Parashar
http://wwwnc.cdc.gov/eid/article/19/8/13-0465_article.htm

Abstract
Although recognized as the leading cause of epidemic acute gastroenteritis across all age groups, norovirus has remained poorly characterized with respect to its endemic disease incidence. Use of different methods, including attributable proportion extrapolation, population-based surveillance, and indirect modeling, in several recent studies has considerably improved norovirus disease incidence estimates for the United States. Norovirus causes an average of 570–800 deaths, 56,000–71,000 hospitalizations, 400,000 emergency department visits, 1.7–1.9 million outpatient visits, and 19–21 million total illnesses per year. Persons >65 years of age are at greatest risk for norovirus-associated death, and children <5 years of age have the highest rates of norovirus-associated medical care visits. Endemic norovirus disease occurs year round but exhibits a pronounced winter peak and increases by ≤50% during years in which pandemic strains emerge. These findings support continued development and targeting of appropriate interventions, including vaccines, for norovirus disease.

Swine influenza and vaccines: an alternative approach for decision making about pandemic prevention

The European Journal of Public Health
Volume 23 Issue 4 August 2013
http://eurpub.oxfordjournals.org/content/current

Swine influenza and vaccines: an alternative approach for decision making about pandemic prevention
Marcello Basili1, Silvia Ferrini2 and Emanuele Montomoli3
http://eurpub.oxfordjournals.org/content/23/4/669.abstract

Abstract
Background: During the global pandemic of A/H1N1/California/07/2009 (A/H1N1/Cal) influenza, many governments signed contracts with vaccine producers for a universal influenza immunization program and bought hundreds of millions of vaccines doses. We argue that, as Health Ministers assumed the occurrence of the worst possible scenario (generalized pandemic influenza) and followed the strong version of the Precautionary Principle, they undervalued the possibility of mild or weak pandemic wave.

Methodology: An alternative decision rule, based on the non-extensive entropy principle, is introduced, and a different Precautionary Principle characterization is applied. This approach values extreme negative results (catastrophic events) in a different way and predicts more plausible and mild events. It introduces less pessimistic forecasts in the case of uncertain influenza pandemic outbreaks. A simplified application is presented using seasonal data of morbidity and severity among Italian children influenza-like illness for the period 2003–10.

Principal Findings: Established literature results predict an average attack rate of not less than 15% for the next pandemic influenza [Meltzer M, Cox N, Fukuda K. The economic impact of pandemic influenza in the United States: implications for setting priorities for interventions. Emerg Infect Dis 1999;5:659–71; Meltzer M, Cox N, Fukuda K. Modeling the Economic Impact of Pandemic Influenza in the United States: Implications for Setting Priorities for Intervention. Background paper. Atlanta, GA: CDC, 1999. Available at: http://www.cdc.gov/ncidod/eid/vol5no5/melt_back.htm (7 January 2011, date last accessed))]. The strong version of the Precautionary Principle would suggest using this prediction for vaccination campaigns. On the contrary, the non-extensive maximum entropy principle predicts a lower attack rate, which induces a 20% saving in public funding for vaccines doses.

Conclusions: The need for an effective influenza pandemic prevention program, coupled with an efficient use of public funding, calls for a rethinking of the Precautionary Principle. The non-extensive maximum entropy principle, which incorporates vague and incomplete information available to decision makers, produces a more coherent

Modelling the risk–benefit impact of H1N1 influenza vaccines

The European Journal of Public Health
Volume 23 Issue 4 August 2013
http://eurpub.oxfordjournals.org/content/current

Modelling the risk–benefit impact of H1N1 influenza vaccines
Lawrence D. Phillips1,2, Barbara Fasolo1,2, Nikolaos Zafiropoulous1, Hans-Georg Eichler1, Falk Ehmann1, Veronika Jekerle1, Piotr Kramarz3, Angus Nicoll3 and Thomas Lönngren4
http://eurpub.oxfordjournals.org/content/23/4/674.abstract

Abstract
Background: Shortly after the H1N1 influenza virus reached pandemic status in June 2009, the benefit–risk project team at the European Medicines Agency recognized this presented a research opportunity for testing the usefulness of a decision analysis model in deliberations about approving vaccines soon based on limited data or waiting for more data. Undertaken purely as a research exercise, the model was not connected to the ongoing assessment by the European Medicines Agency, which approved the H1N1 vaccines on 25 September 2009. Methods: A decision tree model constructed initially on 1 September 2009, and slightly revised subsequently as new data were obtained, represented an end-of-September or end-of-October approval of vaccines. The model showed combinations of uncertain events, the severity of the disease and the vaccines’ efficacy and safety, leading to estimates of numbers of deaths and serious disabilities. The group based their probability assessments on available information and background knowledge about vaccines and similar pandemics in the past. Results: Weighting the numbers by their joint probabilities for all paths through the decision tree gave a weighted average for a September decision of 216 500 deaths and serious disabilities, and for a decision delayed to October of 291 547, showing that an early decision was preferable. Conclusions: The process of constructing the model facilitated communications among the group’s members and led to new insights for several participants, while its robustness built confidence in the decision. These findings suggest that models might be helpful to regulators, as they form their preferences during the process of deliberation and debate, and more generally, for public health issues when decision makers face considerable uncertainty.

Safety of Zoster Vaccine in Elderly Adults Following Documented Herpes Zoster

Journal of Infectious Diseases
Volume 208 Issue 4 August 15, 2013
http://jid.oxfordjournals.org/content/current

Safety of Zoster Vaccine in Elderly Adults Following Documented Herpes Zoster
Vicki A. Morrison1, Michael N. Oxman2, Myron J. Levin3, Kenneth E. Schmader4, John C. Guatelli2, Robert F. Betts5, Larry D. Gelb6, Constance T. Pachucki7, Susan K. Keay8, Barbara Menzies9, Marie R. Griffin10, Carol A. Kauffman11, Adriana R. Marques12, John F. Toney13, Michael S. Simberkoff14, Richard Serrao15, Robert D. Arbeit15, John W. Gnann16, Richard N. Greenberg17, Mark Holodniy18, Wendy A. Keitel19, Shingshing S. Yeh20, Larry E. Davis21, George E. Crawford22, Kathy M. Neuzil9, Gary R. Johnson23, Jane H. Zhang23, Rith Harbecke2, Ivan S. F. Chan24, Paul M. Keller24, Heather M. Williams2, Kathy D. Boardman25, Jeffrey L. Silber24, Paula W. Annunziato24, for the Shingles Prevention Study Group
http://jid.oxfordjournals.org/content/208/4/559.abstract

Abstract
Background. After completion of the Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Studies Program Number 403), SPS participants who had initially received placebo were offered investigational zoster vaccine without charge. This provided an opportunity to determine the relative safety of zoster vaccine in older adults following documented herpes zoster (HZ).

Methods. A total of 13 681 SPS placebo recipients who elected to receive zoster vaccine were followed for serious adverse events (SAE) for 28 days after vaccination. In contrast to the SPS, a prior episode of HZ was not a contraindication to receiving zoster vaccine. The SPS placebo recipients who received zoster vaccine included 420 who had developed documented HZ during the SPS.

Results. The mean interval between the onset of HZ and the receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median interval, 3.77 years [range, 3–85 months]); the interval was <5 years for approximately 80% of recipients. The proportion of vaccinated SPS placebo recipients with prior HZ who developed ≥1 SAE (0.95%) was not significantly different from that of vaccinated SPS placebo recipients with no prior history of HZ (0.66%), and the distribution of SAEs in the 2 groups was comparable.

Conclusions. These results demonstrate that the general safety of zoster vaccine in older persons is not altered by a recent history of documented HZ, supporting the safety aspect of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommendation to administer zoster vaccine to all persons ≥60 years of age with no contraindications, regardless of a prior history of HZ.

Vaccine Poliovirus Shedding and Immune Response to Oral Polio Vaccine in HIV-Infected and -Uninfected Zimbabwean Infants

Journal of Infectious Diseases
Volume 208 Issue 4 August 15, 2013
http://jid.oxfordjournals.org/content/current

Vaccine Poliovirus Shedding and Immune Response to Oral Polio Vaccine in HIV-Infected and -Uninfected Zimbabwean Infants
Stephanie B. Troy1, Georgina Musingwini2, Meira S. Halpern4, ChunHong Huang4, Lynda Stranix-Chibanda2,3, Diana Kouiavskaia5, Avinash K. Shetty2,6, Konstantin Chumakov5,
Kusum Nathoo3 and Yvonne A. Maldonado2,4
http://jid.oxfordjournals.org/content/208/4/672.abstract

Abstract
Background. With prolonged replication, attenuated polioviruses used in oral polio vaccine (OPV) can mutate into vaccine-derived poliovirus (VDPV) and cause poliomyelitis outbreaks. Individuals with primary humoral immunodeficiencies can become chronically infected with vaccine poliovirus, allowing it to mutate into immunodeficiency-associated VDPV (iVDPV). It is unclear if children perinatally infected with the human immunodeficiency virus (HIV), who have humoral as well as cellular immunodeficiencies, might be sources of iVDPV.

Methods. We conducted a prospective study collecting stool and blood samples at multiple time points from Zimbabwean infants receiving OPV according to the national schedule. Nucleic acid extracted from stool was analyzed by real-time polymerase chain reaction for OPV serotypes.

Results. We analyzed 825 stool samples: 285 samples from 92 HIV-infected children and 540 from 251 HIV-uninfected children. Poliovirus shedding was similar after 0–2 OPV doses but significantly higher in the HIV-infected versus uninfected children after ≥3 OPV doses, particularly within 42 days of an OPV dose, independent of seroconversion status. HIV infection was not associated with prolonged or persistent poliovirus shedding. HIV infection was associated with significantly lower polio seroconversion rates.

Conclusions. HIV infection is associated with decreased mucosal and humoral immune responses to OPV but not the prolonged viral shedding required to form iVDPV.

Progress towards Demonstrating the Impact of Haemophilus influenzae Type b Conjugate Vaccines Globally

Journal of Pediatrics
http://www.jpeds.com/current

Special Supplement:  Haemophilus influenzae type b (Hib)
July 2013 – 14 articles
http://www.jpeds.com/supplements#

Progress towards Demonstrating the Impact of Haemophilus influenzae Type b Conjugate Vaccines Globally
Rana Hajjeh, MD, Kim Mulholland, MBBS, FRACP, MD, Anne Schuchat, MD, Mathuram Santosham, MD, MPH

Abstract
Prior to the introduction of vaccines, Haemophilus influenzae type b (Hib) was the most common cause of bacterial meningitis and an important cause of severe pneumonia in children <5 years of age. Hib conjugate vaccines were introduced in developed countries during the early 1990s, resulting in a virtual elimination of Hib disease.1 However, the introduction of Hib vaccine in developing countries was delayed significantly due to multiple barriers, with major obstacles being the lack of local data on disease burden and the lack of awareness of the potential impact of the vaccine. In 2002, a group of scientific experts and public health officials gathered in Arizona, US, to discuss the epidemiology and control of Hib disease and recommended a multifaceted approach to overcome barriers for Hib vaccine introduction.2 In 2005, the GAVI Alliance funded the Hib Initiative, a consortium of public and private institutions (Johns Hopkins School of Public Health, the World Health Organization [WHO], the London School for Hygiene and Tropical Medicine, and the US Centers for Diseases Control and Prevention) to assist countries eligible for GAVI funding in making evidence-based decisions regarding the introduction of Hib vaccines into national immunizations programs. The Hib Initiative adopted a strategy based on improved communications, coordination with key partners at country, regional, and global levels, and supporting selected research studies to address gaps in Hib knowledge, particularly studies that could provide evidence and capacity to sustain vaccine programs beyond the period of GAVI support. Fortunately, significant progress in introduction of Hib vaccines has occurred over the last few years with all GAVI countries, having either introduced the vaccine already or are expected to introduce in 2013.3

A database on global health research in Africa

The Lancet Global Health
Aug 2013  Volume 1  Number 2  e55 – 115
http://www.thelancet.com/journals/langlo/issue/current

Editorial
The good, the bad, and the neglected
Zoë Mullan
Preview
There is a lot to celebrate and applaud in this month’s issue of The Lancet Global Health, but also some sobering findings and a clear demonstration of the need for more research. To start with the positive, Osman Sankoh and fellow INDEPTH Network colleagues announce a new freely accessible repository of Health and Demographic Surveillance System data generated by its member centres across Africa, Asia, and the Pacific. This triumph of dedication, which currently holds data on around 800 000 individuals and more than 3·7 million person-years of observation, represents the first harmonised database of longitudinal population-based data from low-income and middle-income countries.

A database on global health research in Africa
Francis Collins, Alain Beaudet, Ruxandra Draghia-Akli, Peter Gruss, John Savill, André Syrota, Alice Dautry, Mats Ulfendahl, Mark Walport, James Onken, Roger I Glass
Preview
Over the past decade, global concern about the disproportionate burden of disease and mortality in low-income countries, especially in sub-Saharan Africa, has led to a substantial influx of funding for research by many donor and research agencies.1 This investment has energised in-country research; advanced the discovery and the use of new treatments for HIV/AIDS, tuberculosis, and malaria; and stimulated new research strategies for the prevention and control of these and other diseases. Questions have been raised about whether these international efforts could be better coordinated to increase efficiency and improve outcomes, while ensuring that research institutions and universities are supported with these funds.

Financing tuberculosis control: promising trends and remaining challenges

The Lancet Global Health
Aug 2013  Volume 1  Number 2  e55 – 115
http://www.thelancet.com/journals/langlo/issue/current

Financing tuberculosis control: promising trends and remaining challenges
Anna Vassall, Michelle Remme
Preview
The financing of essential health services for the world’s poor is changing. Development assistance to health (DAH) seems to be flat-lining, and use of domestic resources and value for money are increasingly emphasised.1,2 Many development agencies are re-examining thematic and geographic priorities and implementing new cofinancing agreements. The Global Fund to Fight AIDS, Tuberculosis and Malaria, for example, now requires 5–60% counterpart financing, depending on a country’s income.3 Ensuring that scarce development funds flow at a sufficient scale to effective interventions that serve people who need them most remains a challenge.

Domestic and donor financing for tuberculosis care and control in low-income and middle-income countries: an analysis of trends, 2002—11, and requirements to meet 2015 targets
Dr Katherine Floyd PhD a , Christopher Fitzpatrick MSc a, Andrea Pantoja MSc a, Mario Raviglione MD a
http://www.thelancet.com/journals/langlo/article/PIIS2214-109X%2813%2970032-9/abstract

Summary
Background
Progress in tuberculosis control worldwide, including achievement of 2015 global targets, requires adequate financing sustained for many years. WHO began yearly monitoring of tuberculosis funding in 2002. We used data reported to WHO to analyse tuberculosis funding from governments and international donors (in real terms, constant 2011 US$) and associated progress in tuberculosis control in low-income and middle-income countries between 2002 and 2011. We then assessed funding needed to 2015 and how this funding could be mobilised.

Methods
We included low-income and middle-income countries that reported data about financing for tuberculosis to WHO and had at least three observations between 2002 and 2011. When data were missing for specific country—year combinations, we imputed the missing data. We aggregated country-specific results for eight country groups defined according to income level, political and economic profile, geography, and tuberculosis burden. We compared absolute changes in total funding with those in the total number of patients successfully treated and did cross-country comparisons of cost per successfully treated patient relative to gross domestic product. We estimated funding needs for tuberculosis care and control for all low-income and middle-income countries to 2015, and compared these needs with domestic funding that could be mobilised.

Findings
Total funding grew from $1.7 billion in 2002 to $4·4 billion in 2011. It was mostly spent on diagnosis and treatment of drug-susceptible tuberculosis. 43 million patients were successfully treated, usually for $100—500 per person in countries with high burdens of tuberculosis. Domestic funding rose from $1.5 billion to $3.9 billion per year, mostly in Brazil, Russia, India, China, and South Africa (BRICS), which collectively account for 45% of global cases, where national contributions accounted for more than 95% of yearly funding. Donor funding increased from $0.2 billion in 2002 to $0.5 billion in 2011, and accounted for a mean of 39% of funding in the 17 countries with the highest burdens (excluding BRICS) and a mean of 67% in low-income countries by 2011. BRICS and upper middle-income countries could mobilise almost all of their funding needs to 2015 from domestic sources. A full response to the tuberculosis epidemic to 2015, including investments to tackle multidrug-resistant tuberculosis, will require international donor funding of $1.6—2.3 billion each year.

Interpretation
Funding for tuberculosis control increased substantially between 2002 and 2011, resulting in impressive and cost-effective gains. The increasing self-sufficiency of many countries, including BRICS, which account for almost half the world’s tuberculosis cases, is a success story for control of tuberculosis. Nonetheless, international donor funding remains crucial in many countries and more is needed to achieve 2015 targets.

Funding
None.

Universal access to care for multidrug-resistant tuberculosis: an analysis of surveillance data

The Lancet Infectious Diseases
Aug 2013  Volume 13  Number 8  p639 – 724
http://www.thelancet.com/journals/laninf/issue/current

Universal access to care for multidrug-resistant tuberculosis: an analysis of surveillance data
Dennis Falzon, Ernesto Jaramillo, Fraser Wares, Matteo Zignol, Katherine Floyd, Mario C Raviglione

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Six countries (Belarus, Brazil, Kazakhstan, Peru, South Africa, and Ukraine) can achieve universal access to MDR-tuberculosis care by 2015 should they sustain their current pace of progress. In other countries a radical scale-up will be needed for them to have an effect on their MDR-tuberculosis burden. Unless barriers to diagnosis and successful treatment are urgently overcome, and new technologies in diagnostics and treatment effectively implemented, the global targets for 2015 are unlikely be achieved.

Biological features of novel avian influenza A (H7N9) virus

Nature   
Volume 499 Number 7459 pp379-514  25 July 2013
http://www.nature.com/nature/current_issue.html

Biological features of novel avian influenza A (H7N9) virus
Jianfang Zhou, Dayan Wang, Rongbao Gao, Baihui Zhao, Jingdong Song+ et al.
An initial characterization of the receptor-binding properties of the novel avian influenza A (H7N9) shows that the virus has acquired the ability to bind human receptors while retaining the ability to bind avian receptors; the virus infects epithelial cells in the human lower respiratory tract and type II pneumocytes in the alveoli, and hypercytokinaemia was seen in infected patients.