– 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″
.
– 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.
.
– pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_31 August 2013
.
– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
.
– 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.
.
– 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…
.
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

Update: Polio this week – As of 28 August 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]

:: The outbreak of wild poliovirus type 1 (WPV1) in the Horn of Africa, which affects Somalia, Kenya and Ethiopia, has spread into two new states of Somalia.
:: In Israel, the number of sewage samples which have tested positive for WPV1 has reached 85; one sewage sample collected in West Bank and Gaza has tested positive for WPV1.

Pakistan
:: One new case of WPV was reported in the past week, a WPV1 from FR Bannu in the Federally Administered Tribal Areas, with onset of paralysis on 27 July. This is the most recent case in the country and brings the total number of WPV1 cases for 2013 to 25.
:: The total number of cVDPV2 cases for 2013 remains 12.

Chad, Cameroon and Central African Republic
:: In Cameroon, one new cVDPV2 case was reported in the past week, bringing the total number of cVDPV2 cases for 2013 to three. This new case had onset of paralysis on 19 July (from Extreme-Nord).
:: Central African Republic (CAR) continues to be at serious risk of re-infection due to proximity with Chad, ongoing insecurity and humanitarian crises, and destruction of health infrastructure. :: To minimize the risk and consequences of potential re-infection, two subnational immunization campaigns were conducted in June and July. A SNID is planned for September and a NID for October.

Horn of Africa
:: 20 new WPV1 cases were reported in the past week in Somalia and one in Kenya. The total number of WPV1 cases for 2013 is 142 (128 from Somalia, 13 from Kenya, 1 from Ethiopia). The most recent WPV1 case in the region had onset of paralysis on 30 July (from Somalia).
:: The outbreak is spreading geographically in Somalia, with two new states reporting cases: Galgadud and Gedo. Anticipation of this spread has driven intense vaccination activities across the country, in an effort to raise immunity.

Israel and West Bank and Gaza
:: WPV1 has been detected in 85 sewage samples from 27 sampling sites in Israel, collected from 3 February to 18 August 2013. Initially restricted to southern Israel, WPV1 has now also been detected in environmental sampling sites elsewhere in Israel, indicating transmission throughout the country. A sampling site in Tulkarem in the West Bank has also reported a positive sample, collected on 30 June. No case of paralytic polio has been reported in either Israel or the West Bank and Gaza.
:: To interrupt WPV1 transmission, a supplementary immunization activity (SIA) with bivalent oral polio vaccine (OPV) targeting children up to the age of nine years was initiated in the southern district of Israel during the week of 5 August; since August 18, the SIA was expanded to all of Israel. The objective of the SIA with OPV is to boost intestinal immunity in children vaccinated with IPV only in order to rapidly interrupt wild poliovirus transmission.
:: Following the positive sample from Tulkarem, subsequent samples in the West Bank and Gaza have all tested negative. Discussions have begun for a vaccination response to the positive sample in the West Bank.

West Africa
:: One new cVDPV2 was reported in the past week from Niger’s Diffa province, with onset of paralysis on 11 July. Niger has not reported a case of cVDPV since 2011. Genetic sequencing has shown that the virus is related to those seen in Cameroon, Chad and (Borno) Nigeria.

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

Disease outbreak news
Middle East respiratory syndrome coronavirus (MERS-CoV) – update
   30 August 2013 – WHO has been informed of an additional four laboratory-confirmed cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection in Saudi Arabia.

The first patient is a 55-year-old man with an underlying medical condition from Medina who became ill on 17 August 2013 and is currently hospitalised.

The second patient is a 38-year-old man with an underlying medical condition from Hafar al-Batin who became ill on 8 August 2013 and died on 17 August 2013.

The third and the fourth cases are family contacts of the second patient. Both the cases, a 16-year-old boy and a seven year-old girl, tested positive for the MERS-CoV virus. They are both healthy and do not have any symptoms of illness.

Globally, from September 2012 to date, WHO has been informed of a total of 108 laboratory-confirmed cases of infection with MERS-CoV, including 50 deaths.

Based on the current situation and available information, WHO encourages all Member States to continue their surveillance for severe acute respiratory infections (SARI) and to carefully review any unusual patterns.

Health care providers are advised to maintain vigilance. Recent travellers returning from the Middle East who develop SARI should be tested for MERS-CoV as advised in the current surveillance recommendations…

The Weekly Epidemiological Record (WER) for 30 August 2013, vol. 88, 35 (pp. 365–380) includes:
:: Global leprosy: update on the 2012 situation
:: Monthly report on dracunculiasis cases, January–June 2013

http://www.who.int/entity/wer/2013/wer8835.pdf

CDC/MMWR Watch [to 31 August 2013]

August 30, 2013 / Vol. 62 / No. 34
National and State Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2012
Excerpt
At ages 11 through 12 years, the Advisory Committee on Immunization Practices (ACIP) recommends that preteens receive 1 dose of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine, 1 dose of meningococcal conjugate (MenACWY) vaccine,* and 3 doses of human papillomavirus (HPV) vaccine (1–3). ACIP recommends administration of all age-appropriate vaccines during a single visit (4). ACIP also recommends that pre-teens and older adolescents receive an annual influenza vaccine as well as any overdue vaccines (e.g., varicella) (1). To monitor vaccination coverage among persons aged 13–17 years,† CDC analyzed data from the National Immunization Survey–Teen (NIS-Teen). This report highlights findings of that analysis.

From 2011 to 2012, coverage increased for ≥1 Tdap vaccine dose§ (from 78.2% to 84.6%), ≥1 MenACWY vaccine dose (from 70.5% to 74.0%) and, among males, ≥1 HPV vaccine dose (from 8.3% to 20.8%). Among females, vaccination coverage estimates for each HPV vaccine series dose were similar in 2012 compared with 2011. Coverage varied substantially among states.

Regarding Healthy People 2020 targets for adolescents (5), 36 states achieved targets for Tdap, 12 for MenACWY, and nine for varicella vaccine coverage. Large and increasing coverage differences between Tdap and other vaccines recommended for adolescents indicate that substantial missed opportunities remain for vaccinating teens, especially against HPV infection    (6).

Health-care providers should administer recommended HPV and meningococcal vaccinations to boys and girls during the same visits when Tdap vaccine is given. In addition, whether for health problems or well-checks, providers, parents, and adolescents should use every health-care visit as an opportunity to review adolescents’ immunization histories and ensure that every adolescent is fully vaccinated.

Statement from PATH: Cervical cancer demonstration project in India
30 August 2013
Excerpt
Today, the Indian Parliament’s Standing Committee on Health and Family Welfare released a report critical of a cervical cancer vaccine demonstration project conducted in India from 2009 to 2010 through a collaboration among PATH, the Indian Council of Medical Research (ICMR), and the state governments of Andhra Pradesh and Gujarat.

PATH welcomes public discussion about the role of vaccines in preventing life-threatening diseases such as cervical cancer, and we thank the committee members for their time and effort in reviewing this matter. We support the adoption of reasonable measures to further strengthen and clarify protections for individuals participating in research projects. However, we are troubled by the report’s inaccurate characterization of this important work.

…The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against human papillomavirus (HPV), the primary cause of cervical cancer.

…The ICMR, India’s highest medical research authority, reviewed and approved the protocol for this project, including its design and methodology. At the time of its review, the ICMR determined the project was a post-licensure observational study and not a clinical trial. The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had already undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India.

The ICMR’s view was crucial, as it established the approval processes and protocols for the work that followed. PATH designed the project protocols in compliance with the ICMR’s instructions and fully complied with the ICMR’s requirements regarding the necessary approval processes and the requirements of state governments regarding consent processes.

We believe that by following the guidance provided by the ICMR, as well as two state governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women…

–       Full PATH statement: http://www.path.org/news/press-room/642/
–       Standing Committee Report: [no link provided in PATH statement; no web version apparent after google search]

  The Global Fund said it appointed Paul Tuxford as Chief Information Officer and Jason Clark as Head of Controlling and Program Finance. Mr. Tuxford was most recently at  Credit Suisse where he was Director, Chief Operating Officer – Corporate Services Technology. Before joining Credit Suisse, he worked for Quintiles, a pharmaceutical research company, as Director, Global IT Business Solutions. Mr. Clark joins the Global Fund from RWE AG, one of Europe’s largest electricity and gas companies, where he has acted as Director, Finance and Controlling for the last 10 years, leading a team of about 300 people. Both positions will report to Daniel Camus, Chief Financial Officer.

http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-08-29_Global_Fund_Appoints_Paul_Tuxford_as_Chief_Information_Officer/

http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-08-29_Global_Fund_Appoints_Jason_Clark_as_Head_of_Controlling_and_Program_Finance/

American Journal of Infection Control
Vol 41 | No. 9 | September 2013 | Pages 759-852
http://www.ajicjournal.org/current

Prevalence and factors associated with 2009 to 2011 influenza vaccinations at a university medical center
Kathleen A. Crowley, RPA-C, MPH; Ronnie Myers, DDS; Lori A. Magda, MA; Stephen S. Morse, PhD; Paul Brandt-Rauf, MD, DrPH, SciD; Robyn R.M. Gershon, MT, MHS, DrPH

Abstract
Background
Information on the rates and factors associated with influenza vaccinations, although limited, is important because it can inform the development of effective vaccination campaigns in a university medical center setting.

Methods
A study was conducted in 2011 to identify individual and organizational level barriers and facilitators to influenza vaccination among clinical and nonclinical personnel (N = 428) from a major university medical center.

Results
Seventy-one percent of clinical personnel (n = 170) reported pandemic H1N1 vaccination compared with 27% of nonclinical personnel (n = 258), even though vaccine was made widely available to all personnel at no cost. Similarly, disparate rates between clinical and nonclinical personnel were noted for the 2009/2010 seasonal influenza vaccine (82% vs 42%, respectively) and 2010/2011 combination (pandemic plus seasonal) influenza vaccine (73% vs 28%, respectively). Factors associated with pandemic vaccination in nonclinical personnel included the following: high level of influenza-related knowledge, concern regarding influenza contagion, history of previous influenza vaccinations or influenza illness, participation in vaccine-related training, and awareness of the institution’s written pandemic plan. For clinicians, past history of seasonal influenza vaccination was associated with pandemic vaccination. For all participants, taking any 1 or more of the 3 influenza vaccines available in 2009 to 2011 was associated with intent to take a hypothetical future novel pandemic vaccine (odds ratio, 6.7; 95% confidence interval: 4.32-10.44; P < .001).

Conclusion
Most of the risk factors associated with lack of vaccination uptake are amenable to organizational strategies

Bulletin of the World Health Organization
Volume 91, Number 9, September 2013, 621-715
http://www.who.int/bulletin/volumes/91/9/en/index.html

Special theme: women’s health beyond reproduction – a new agenda
EDITORIALS
At the crossroads: transforming health systems to address women’s health across the life course
Flavia Bustreo, Oleg Chestnov, Felicia Marie Knaul, Islene Araujo de Carvalho, Mario Merialdi, Marleen Temmerman & John R Beard
doi: 10.2471/BLT.13.128439

Article [HTML]

Cost Effectiveness and Resource Allocation
(Accessed 31 August 2013)
http://www.resource-allocation.com/

Research
A cost-effectiveness analysis of a 10-valent pneumococcal conjugate vaccine in children in six Latin American countries
Martí SG, Colantonio L, Bardach A, Galante J, Lopez A, Caporale J, Knerer G, Gomez JA et al. Cost Effectiveness and Resource Allocation 2013, 11:21 (30 August 2013)

Abstract (provisional)
Background
A recently developed 10-valent pneumococcal non-typeable H influenzae protein D-conjugate vaccine (PHiD-CV) is expected to afford protection against more than two thirds of isolates causing IPD in children in Latin America, and also against acute otitis media caused by both Spn and NTHi. The objective of this study is to assess the cost-effectiveness of PHiD-CV in comparison to non-vaccination in children under 10 years of age in Argentina, Brazil, Chile, Colombia, Mexico and Peru.

Methods
We used a static, deterministic, compartmental simulation model. The dosing regimen considered included three vaccine doses (at 2 months, 4 months and 6 months) and a booster dose (at 13 months) (3 + 1 schedule). Model outcomes included number of cases prevented, deaths averted, quality-adjusted life-years (QALYs) gained and costs. Discount for costs and benefits of long term sequelae was done at 3.5%, and currency reported in 2008-2009 U$S varying between countries.

Results
The largest effect in case prevention was observed in pneumococcal meningitis (from 27% in Peru to 47% in Colombia), neurologic sequelae after meningitis (from 38% in Peru to 65% in Brazil) and bacteremia (from 42% in Argentina to 49% in Colombia). The proportion of predicted deaths averted annually ranged from 18% in Peru to 33% in Brazil. Overall, the health benefits achieved with PHiD-CV vaccination resulted in a lower QALY loss (from 15% lower in Peru to 26% in Brazil). At a cost of USD 20 per vaccine dose, vaccination was cost-effective in all countries, from being cost saving in Chile to a maximum Incremental Cost-effectiveness Ratio of 7,088 US$ Dollars per QALY gained. Results were robust in the sensitivity analysis, and scenarios with indirect costs affected results more than those with herd immunity.

Conclusions
The incorporation of the 10-valent pneumococcal conjugate vaccine into routine infant immunization programs in Latin American countries could be a cost-effective strategy to improve infant population health in the region.

Current Opinion in Infectious Diseases.
October 2013 – Volume 26 – Issue 5  pp: v-vi,399-492
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx

Current issues in dengue vaccination
Thomas, Stephen J.; Endy, Timothy P.

Abstract
Purpose of review: Dengue is a global health problem and of concern to travelers and deploying military personnel, with development and licensure of an effective tetravalent dengue vaccine a public health priority. The recent performance of the lead dengue vaccine in a phase 2b efficacy trial underscores dengue vaccine development challenges. This review focuses on current issues in dengue vaccination.

Recent findings: The dengue viruses (DENVs) are mosquito-borne flaviviruses transmitted by infected Aedes mosquitoes. Illness manifests across a clinical spectrum with severe disease characterized by intravascular volume depletion and hemorrhage. Recent estimates on the burden of DENV infection determined that there are 390 million dengue infections per year, three times the current estimate by the WHO. There are no licensed antivirals or vaccines to treat or prevent dengue though many are in preclinical or clinical development. DENV illness results from a complex interaction of viral properties and host immune responses. Immunologic complexity, lack of an adequate animal model of disease, absence of an immune correlate of protection, and only partially informative immunogenicity assays are challenging dengue vaccine development efforts.

Summary: Dengue vaccine development efforts have numerous complex challenges to overcome before a well-tolerated and effective vaccine is licensed and available. In this review, the authors discuss the current issues in dengue vaccination.

Globalization and Health
[Accessed 31 August 2013]
http://www.globalizationandhealth.com/

Commentary
Open innovation as a new paradigm for global collaborations in health
Patricia Dandonoli
Globalization and Health 2013, 9:41 doi:10.1186/1744-8603-9-41
Published: 30 August 2013  http://www.globalizationandhealth.com/content/9/1/41/abstract

Abstract (provisional)
Open innovation, which refers to combining internal and external ideas and internal and external paths to market in order to achieve advances in processes or technologies, is an attractive paradigm for structuring collaborations between developed and developing country entities and people. Such open innovation collaborations can be designed to foster true co-creation among partners in rich and poor settings, thereby breaking down hierarchies and creating greater impact and value for each partner. Using an example from Concern Worldwide’s Innovations for Maternal, Newborn & Child Health initiative, this commentary describes an early-stage pilot project built around open innovation in a low resource setting, which puts communities at the center of a process involving a wide range of partners and expertise, and considers how it could be adapted and make more impactful and sustainable by extending the collaboration to include developed country partners.

Health Policy and Planning
Volume 28 Issue 6 September 2013
http://heapol.oxfordjournals.org/content/current

Transforming governance or reinforcing hierarchies and competition: examining the public and hidden transcripts of the Global Fund and HIV in India
Anuj Kapilashrami1,* and Barbara McPake2
Author Affiliations
1Global Public Health Unit, University of Edinburgh, Edinburgh EH8 9LD, UK and 2Institute for International Health & Development, Queen Margaret University, Edinburgh EH21 6UU, UK
↵*Corresponding author. Global Public Health Unit, University of Edinburgh, Edinburgh, UK. E-mail: anuj.kapilashrami@gmail.com
Accepted September 10, 2012.
http://heapol.oxfordjournals.org/content/28/6/626.abstract

Abstract
Global health initiatives (GHIs) have gained prominence as innovative and effective policy mechanisms to tackle global health priorities. More recent literature reveals governance-related challenges and their unintended health system effects. Much less attention is received by the relationship between these mechanisms, the ideas that underpin them and the country-level practices they generate. The Global Fund has leveraged significant funding and taken a lead in harmonizing disparate efforts to control HIV/AIDS. Its growing influence in recipient countries makes it a useful case to examine this relationship and evaluate the extent to which the dominant public discourse on Global Fund departs from the hidden resistances and conflicts in its operation. Drawing on insights from ethnographic fieldwork and 70 interviews with multiple stakeholders, this article aims to better understand and reveal the public and the hidden transcript of the Global Fund and its activities in India. We argue that while its public transcript abdicates its role in country-level operations, a critical ethnographic examination of the organization and governance of the Fund in India reveals a contrasting scenario. Its organizing principles prompt diverse actors with conflicting agendas to come together in response to the availability of funds. Multiple and discrete projects emerge, each leveraging control and resources and acting as conduits of power. We examine how management of HIV is punctuated with conflicts of power and interests in a competitive environment set off by the Fund protocol and discuss its system-wide effects. The findings also underscore the need for similar ethnographic research on the financing and policy-making architecture of GHIs.

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 2 Issue 3 September 2013
http://jpids.oxfordjournals.org/content/current

A School-Located Vaccination Adolescent Pilot Initiative in Chicago: Lessons Learned
Rachel N. Caskey1, Everly Macario2, Daniel C. Johnson2, Tamara Hamlish2 and Kenneth A. Alexander2
Author Affiliations
1Department of Pediatrics, University of Illinois at Chicago;
2Department of Pediatrics, University of Chicago
Corresponding Author: Everly Macario, ScD, MS, EdM, Department of Pediatrics, University of Chicago, 5629 S Dorchester Ave, Chicago, IL 60637. E-mail: everly.macario@gmail.com.
Received July 25, 2012.
Accepted November 9, 2012.
http://jpids.oxfordjournals.org/content/2/3/198.abstract

Abstract
Background
Many adolescents underutilize preventive services and are underimmunized.

Methods
To promote medical homes and increase immunization rates, we conceptualized and implemented a 3-year, 8-school pilot school-located vaccination collaborative program. We sought community, parent, and school nurse input the year prior to implementation. We selected schools with predominantly Medicaid-enrolled or Medicaid-eligible students to receive Vaccines For Children stock vaccines. Nurses employed by a mass immunizer delivered these vaccines at participating schools 3 times a year.

Results
Over 3 years, we delivered approximately 1800 vaccines at schools. School administrators, health centers, and neighboring private physicians generally welcomed the program. Parents did not express overt concerns about school-located vaccination. School nurses were not able to participate because of multiple school assignments. Obtaining parental consent via backpack mail was an inefficient process, and classroom incentives did not increase consent form return rate. The influenza vaccine had the most prolific uptake. The optimal time for administering vaccines was during regular school hours.

Conclusions
Although school-located vaccination for adolescents is feasible, this is a paradigm shift for community members and thus accompanies challenges in implementation. High principal or school personnel turnover led to a consequent lack of institutional memory. It was difficult to communicate directly with parents. Because we were uncertain about the proportion of parents who received consent forms, we are exploring Internet-based and back-to-school registration options for making the consent form distribution and return process more rigorous. Securing an immunization champion at each school helped the immunization processes. Identifying a financially sustainable school-located vaccination model is critical for national expansion of school-located vaccination.

The Pediatric Infectious Disease Journal
September 2013 – Volume 32 – Issue 9  pp: A15,931-1044,e348-e382
http://journals.lww.com/pidj/pages/currenttoc.aspx

Changes in Infectious Disease Mortality in Children During the Past Three Decades
Lantto, Marjo; Renko, Marjo; Uhari, Matti

Abstract
Background: Our aim was to evaluate changes in infectious disease mortality in children in Finland from 1969 to 2004. We especially wanted to find out whether infection mortality could be further reduced by means of existing vaccines not included in national vaccination program.

Methods: We analyzed infectious disease mortality in Finland using data obtained from the official Cause of Death statistics for 1969 to 2004. Annual mortality rates were calculated in proportion to those at risk of dying. Infection mortality rates were calculated separately for neonates and children who were 1 month to 15 years.

Results: Childhood mortality due to infectious diseases decreased by 89%, from 0.12% in 1969 to 0.013% in 2004, and neonatal mortality by 69%, from 0.50% to 0.16%. Pneumonia, central nervous system infections and septicemia were the most common fatal infections in childhood. There were slightly more deaths due to all infections and respiratory tract infections in years marked by epidemics of respiratory syncytial virus. We estimated that pneumococcal conjugate vaccines would have prevented 2 deaths annually in our population, rotavirus vaccines 1 to 2 deaths, influenza vaccine 1 death and varicella vaccine 0.7 death.

Conclusions: We found that even though mortality from infectious diseases in childhood decreased markedly during the period concerned, it could have been further reduced by means of existing vaccines. Even though the number of deaths prevented would have been small, the number of years of life saved would have been great because the life expectancy of children is long.

PLoS One
[Accessed 31 August 2013]
http://www.plosone.org/

Research Article
A Qualitative Analysis of Factors Influencing HPV Vaccine Uptake in Soweto, South Africa among Adolescents and Their Caregivers
Ingrid T. Katz mail, Busisiwe Nkala, Janan Dietrich, Melissa Wallace, Linda-Gail Bekker, Kathryn Pollenz, Laura M. Bogart, Alexi A. Wright, Alexander C. Tsai, David R. Bangsberg, Glenda E. Gray
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0072094

Abstract
Background
In South Africa, the prevalence of oncogenic Human Papillomavirus (HPV) may be as high as 64%, and cervical cancer is the leading cause of cancer-related death among women. The development of efficacious prophylactic vaccines has provided an opportunity for primary prevention. Given the importance of psycho-social forces in vaccine uptake, we sought to elucidate factors influencing HPV vaccination among a sample of low-income South African adolescents receiving the vaccine for the first time in Soweto.

Methods
The HPV vaccine was introduced to adolescents in low-income townships throughout South Africa as part of a nationwide trial to understand adolescent involvement in future vaccine research targeting human immunodeficiency virus (HIV). We performed in-depth semi-structured interviews with purposively-sampled adolescents and their care providers to understand what forces shaped HPV vaccine uptake. Interviews were recorded, transcribed, translated, and examined using thematic analysis.

Results
Of 224 adolescents recruited, 201 initiated the vaccine; 192 (95.5%) received a second immunization; and 164 (81.6%) completed three doses. In our qualitative study of 39 adolescent-caregiver dyads, we found that factors driving vaccine uptake reflected a socio-cultural backdrop of high HIV endemnicity, sexual violence, poverty, and an abundance of female-headed households. Adolescents exercised a high level of autonomy and often initiated decision-making. Healthcare providers and peers provided support and guidance that was absent at home. The impact of the HIV epidemic on decision-making was substantial, leading participants to mistakenly conflate HPV and HIV.

Conclusions
In a setting of perceived rampant sexual violence and epidemic levels of HIV, adolescents and caregivers sought to decrease harm by seeking a vaccine targeting a sexually transmitted infection (STI). Despite careful consenting, there was confusion regarding the vaccine’s target. Future interventions promoting STI vaccines will need to provide substantial information for participants, particularly adolescents who may exercise a significant level of autonomy in decision-making.

PLoS One
[Accessed 31 August 2013]
http://www.plosone.org/

Research Article
Timeliness Vaccination of Measles Containing Vaccine and Barriers to Vaccination among Migrant Children in East China
Yu Hu mail, Qian Li, Shuying Luo, Linqiao Lou, Xiaohua Qi, Shuyun Xie
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0073264

Abstract
Background
The reported coverage rates of first and second doses of measles containing vaccine (MCV) are almost 95% in China, while measles cases are constantly being reported. This study evaluated the vaccine coverage, timeliness, and barriers to immunization of MCV1 and MCV2 in children aged from 8–48 months.

Methods
We assessed 718 children aged 8–48 months, of which 499 children aged 18–48 months in September 2011. Face to face interviews were administered with children’s mothers to estimate MCV1 and MCV2 coverage rate, its timeliness and barriers to vaccine uptake.

Results
The coverage rates were 76.9% for MCV1 and 44.7% for MCV2 in average. Only 47.5% of surveyed children received the MCV1 timely, which postpone vaccination by up to one month beyond the stipulated age of 8 months. Even if coverage thus improves with time, postponed vaccination adds to the pool of unprotected children in the population. Being unaware of the necessity for vaccination and its schedule, misunderstanding of side-effect of vaccine, and child being sick during the recommended vaccination period were significant preventive factors for both MCV1 and MCV2 vaccination. Having multiple children, mother’s education level, household income and children with working mothers were significantly associated with delayed or missing MCV1 immunization.

Conclusions
To avoid future outbreaks, it is crucial to attain high coverage levels by timely vaccination, thus, accurate information should be delivered and a systematic approach should be targeted to high-risk groups.

PLoS Neglected Tropical Diseases
August 2013
http://www.plosntds.org/article/browseIssue.action

Policy Platform
Addressing Ethical, Social, and Cultural Issues in Global Health Research
James V. Lavery mail, Shane K. Green, Sunita V. S. Bandewar, Anant Bhan, Abdallah Daar, Claudia I. Emerson, Hassan Masum, Filippo M. Randazzo, Jerome A. Singh, Ross E. G. Upshur, Peter A. Singer
http://www.plosntds.org/article/info%3Adoi%2F10.1371%2Fjournal.pntd.0002227;jsessionid=04509CEF62F57E8BDF1743A89C443DDF

Summary
The purpose of this paper is to encourage reflection among the global health research community and the research ethics community about how a wide range of ethical, social, and cultural (ESC) influences on the conduct, success, and impact of global health research can best be addressed by consultation services in research ethics (CSRE). We draw on lessons we have learned during our experiences with the ESC Program of the Grand Challenges in Global Health initiative to propose key features of CSRE that may prove useful for those designing or implementing similar programs.

Science        
30 August 2013 vol 341, issue 6149, pages 929-1032
http://www.sciencemag.org/current.dtl

Research Article
Poverty Impedes Cognitive Function
Anandi Mani1, Sendhil Mullainathan2,*, Eldar Shafir3,*, Jiaying Zhao4
+ Author Affiliations
1Department of Economics, University of Warwick, Coventry CV4 7AL, UK.
2Department of Economics, Harvard University, Cambridge, MA 02138, USA.
3Department of Psychology and Woodrow Wilson School of Public and International Affairs, Princeton University, Princeton, NJ 08540, USA.
4Department of Psychology and Institute for Resources, Environment and Sustainability, University of British Columbia, Vancouver, British Columbia V6T 1Z4, Canada.
↵*Corresponding author. E-mail: mullain@fas.harvard.edu (S.M.); shafir@princeton.edu (E.S.)
http://www.sciencemag.org/content/341/6149/976.abstract

Abstract
The poor often behave in less capable ways, which can further perpetuate poverty. We hypothesize that poverty directly impedes cognitive function and present two studies that test this hypothesis. First, we experimentally induced thoughts about finances and found that this reduces cognitive performance among poor but not in well-off participants. Second, we examined the cognitive function of farmers over the planting cycle. We found that the same farmer shows diminished cognitive performance before harvest, when poor, as compared with after harvest, when rich. This cannot be explained by differences in time available, nutrition, or work effort. Nor can it be explained with stress: Although farmers do show more stress before harvest, that does not account for diminished cognitive performance. Instead, it appears that poverty itself reduces cognitive capacity. We suggest that this is because poverty-related concerns consume mental resources, leaving less for other tasks. These data provide a previously unexamined perspective and help explain a spectrum of behaviors among the poor. We discuss some implications for poverty policy.

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

Further Evidence for Bias in Observational Studies of Influenza Vaccine Effectiveness: The 2009 Influenza A (H1N1) Pandemic
ML Jackson, O Yu, JC Nelson, A Naleway, EA Belongia… – American Journal of …, 2013
Abstract Preinfluenza periods have been used to test for uncontrolled confounding in studies
of influenza vaccine effectiveness, but some authors have claimed that confounding differs
in preinfluenza and influenza periods. We tested this claim by comparing estimates of the …

Risk Factors for Non-Initiation of the Human Papillomavirus (HPV) Vaccine among Adolescent Survivors of Childhood Cancer
J Klosky, K Russell, K Canavera, H Gammel… – Cancer Prevention …, 2013
Abstract Effective vaccination is now available to prevent human papillomavirus (HPV), the
most common sexually transmitted infection and cause of cervical cancer. This study aimed
to estimate the prevalence of HPV vaccination among childhood cancer survivors and …

NOTICE: Vaccines: The Week in Review resumes publication on 24 August 2013 following duty travel by the editor.

– 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″
.
– 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.
.
– pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_24 August 2013
.
– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
.
– 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.
.
– 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…
.
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

Joint GAVI/WHO/UNICEF News Release: “Indonesia introduces five-in-one vaccine for children”
22 August 2013, Jakarta, Indonesia

Excerpt
The pentavalent vaccine is part of “an ambitious plan to reach children across the country’s 6,000 inhabited islands by the end of next year” with GAVI support. The vaccine will be purchased from Bio Farma, an Indonesian vaccine supplier based in Bandung, “meaning that Indonesian children will benefit from Indonesian innovation.”
Full release: http://www.who.int/immunization/newsroom/indonesia_five_in_one_20130822/en/index.html

  The U.K. Department for International Development (DFID) said it is investing £138 million over the next 5 years into 9 public-private partnerships “to support the development of innovative new drugs, vaccines, insecticides, diagnostic tools and microbicides… The partnerships will bring together experts in the field while also sharing the costs and risks across partners.” The nine Product Development Partnerships (PDPs) receiving support include [Editor’s bolded text]:

:: Drugs for Neglected Diseases initiative (DNDi): new drugs for sleeping sickness, skin sores, river blindness and other lymphatic diseases spread by parasites and mosquitoes

:: Medicines for Malaria Venture (MMV): new drugs for malaria, with a focus on treating malaria in pregnancy and the relapsing form of malaria

:: Innovative Vector Control Consortium (IVCC): new insecticides to control insects that carry malaria and some of the neglected tropical diseases

:: Foundation for Innovative New Diagnostics (FIND): new diagnostic tests for TB, malaria and sleeping sickness

:: TB Alliance: new drugs for people with TB and for those also infected with HIV

:: Aeras: development of new vaccines to prevent TB infection

:: New Products for Diarrhoea and Malaria (PATH): developing new drugs, diagnostics and vaccines for diarrhoeal disease and diagnostics for malaria

::: International AIDS Vaccine Initiative (IAVI): support for the development of new AIDS vaccines

::International Partnership for Microbicides (IPM): support for the development of women-controlled HIV prevention technologies.

https://www.gov.uk/government/news/dfid-invests-to-save-millions-from-deadly-diseases

WHO: First medicine for treatment of a neglected tropical disease receives prequalification
20 August 2013
The United Nations Prequalification of Medicines Programme managed by WHO announced the prequalification of a 100 mg tablet of diethylcarbamazine which will be used in large-scale treatment of individuals at risk of lymphatic filariasis. Media release: http://apps.who.int/prequal/info_press/documents/PQ_1st_NTD_medicine.pdf

Update: Polio this week – As of 21 August 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]

:: In Ethiopia, a case of WPV1 has been detected in an 18-month old child from the Somali Region (Warder district.) (see the Horn of Africa section for details)
:: In Israel, WPV1 has been detected in 68 sewage samples collected from 3 February 2013 to 16 August 2013 from 24 sampling sites. (see the Israel section for details)
:: In Somalia, eight new WPV1 cases have been reported this week from previously infected districts.

Pakistan
:: 1 new cVDPV2 case was reported in the past week from a new district, Mohmand, in FATA with the onset of paralysis on 13 July. The total number of cVDPV2 cases for 2013 is 12.
:: FATA remains the major poliovirus reservoir in Pakistan and in Asia, both due to WPV1 and cVDPV2.

Chad, Cameroon and Central African Republic
:: Central African Republic (CAR) continues to be at serious risk of re-infection due to proximity with Chad, ongoing insecurity and humanitarian crises, and destruction of health infrastructure. :: To minimize the risk and consequences of potential re-infection, two subnational immunization campaigns were conducted in June and July. A SNID is planned for September and a NID for October.

Horn of Africa
:: 11 new WPV1 cases were reported in the past week – in previously infected districts in Kenya and Somalia, and in a previously unaffected country, Ethiopia. The total number of WPV1 cases for 2013 is 121 (108 from Somalia,12 from Kenya, 1 from Ethiopia). The most recent WPV1 case in the region had onset of paralysis on 14 July (from Kenya).
:: On 14 August, a case of WPV1 was reported in a child living in Ethiopia with date of onset of paralysis of 10 July 2013. The case is an 18-month old child from the Somali Region (Warder district) of Ethiopia who had never been vaccinated with oral polio vaccine (OPV).
:: Because of the known routes of poliovirus spread in previous outbreaks in the Horn of Africa, the Somali region of Ethiopia had been considered at ‘high risk’, and since June, two large-scale supplementary immunization activities (SIAs) had already been conducted as part of the broader Horn of Africa outbreak response.
:: In Ethiopia, an immediate local immunization campaign is being conducted in the vicinity of the case, with a larger-scale SIA planned targeting 950,000 children under the age of five years. Additional SIAs are planned from September to November. Confirmation of the case in Ethiopia underscores the risk this outbreak continues to pose to countries across the region.
:: Access in some areas of south-central Somalia remains a significant challenge. Analysis shows that as many as 70% of children in inaccessible areas are under-immunized. This compares to 20% in accessible areas of the country. Of the 108 cases reported from Somalia so far, 33 are from inaccessible or only partially-accessible areas; 75 cases are from accessible areas or accessible areas with security challenges.
:: In Kenya, the priority remains on increasing immunity levels in the Dadaab area of North Eastern province. Nearly 50% of children in this area remain under-immunized (compared to less than 5% in Kenya on the whole).

Israel
:: WPV1 has been detected in 67 sewage samples from 24 sampling sites in Israel, collected from 3 February 2013 to 4 August 2013. Initially restricted to southern Israel, WPV1 has now also been detected in environmental sampling sites elsewhere in Israel, indicating widespread transmission throughout the country. No case of paralytic polio has been reported.
:: To interrupt WPV1 transmission, a supplementary immunization activity (SIA) with bivalent oral polio vaccine (OPV) targeting children up to the age of nine years was initiated in the southern district of Israel during the week of 5 August; since August 18, the SIA was expanded to the entire country. The objective of the SIA with OPV is to boost intestinal immunity in children vaccinated with IPV only in order to rapidly interrupt wild poliovirus transmission.

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

Poliovirus detected from environmental samples in Israel – update 15 August 2013
   The World Health Organization (WHO) estimates the risk of further international spread of wild poliovirus type 1 (WPV1) from Israel to remain moderate to high. This risk assessment reflects evidence of increasing geographic extent of circulation over a prolonged period of time.

WPV1 has been detected in 67 sewage samples from 24 sampling sites in Israel, collected from 3 February 2013 to 4 August 2013. Initially restricted to southern Israel, WPV1 has now also been detected in the central district as well. WPV1 has also been isolated in stool samples from 27 healthy children (all under the age of nine years) and one adult, who had been fully immunized for their age as part of ongoing stool sample survey activities. No case of paralytic polio has been reported. In addition to routine acute flaccid paralysis, public health authorities have expanded the surveillance to all age groups and have increased enterovirus surveillance and are screening aseptic meningitis cases for polio.

A supplementary immunization activity (SIA) with bivalent oral polio vaccine (OPV) started in parts of southern Israel during the week of 5 August 2013, and a nationwide campaign is planned for 18 August 2013 for children up to the age of nine years. The objective of these SIAs with OPV is to boost mucosal immunity levels in cohorts of children naïve to OPV to rapidly interrupt virus circulation.

It is important that all countries, in particular those with frequent travel and contacts with polio affected countries, strengthen surveillance for cases of acute flaccid paralysis (AFP), in order to rapidly detect any new poliovirus importations and facilitate a rapid response. Countries should also analyze routine immunization coverage data to identify any subnational gaps in population immunity to guide catch-up immunization activities and thereby minimize the consequences of any new virus introduction. Priority should be given to areas at high-risk of importations and where OPV3/DPT3 vaccine coverage is less than 80 percent.

WHO’s International Travel and Health recommends that all travellers to and from poliovirus-affected areas be fully vaccinated against polio. Three countries remain endemic for indigenous transmission of WPV: Nigeria, Pakistan and Afghanistan. Additionally, in 2013, the Horn of Africa has been affected by an outbreak of WPV1.

http://www.who.int/csr/don/2013_08_15/en/index.html

The Weekly Epidemiological Record (WER) for 16 August 2013, vol. 88, 33 (pp. 349–356) includes:
:: Poliomyelitis outbreak in Somalia and Kenya, 2013
http://www.who.int/entity/wer/2013/wer8833.pdf

   The WER for 23 August 2013, vol. 88, 34 (pp. 357–364) includes:
:: Japanese encephalitis: status of surveillance and immunization in Asia and the Western Pacific, 2012
http://www.who.int/entity/wer/2013/wer8834.pdf

CDC/MMWR Watch [to 24 August 2013]
MMWR August 23, 2013 / Vol. 62 / No. 33
Polio Field Census and Vaccination of Underserved Populations — Northern Nigeria, 2012–2013
August 23, 2013 / 62(33);663-665

In 2012, the World Health Assembly declared completion of polio eradication a public health emergency (1,2). However, wild poliovirus (WPV) transmission remains endemic in three countries (Afghanistan, Nigeria, and Pakistan) (2–4). In Nigeria, the National Stop Transmission of Polio (N-STOP) program, under the umbrella of the Nigerian Field Epidemiology and Laboratory Training Program (FELTP), has been developed to implement innovative strategies that address the remaining polio eradication challenges in Nigeria. One N-STOP initiative focuses on locating and vaccinating children aged <5 years in remote nomadic, scattered, and border populations in northern Nigeria, where low polio vaccination coverage likely contributes to ongoing WPV transmission. During August 2012–April 2013, N-STOP conducted field outreach activities that enumerated 40,212 remote settlements, including 4,613 (11.5%) settlements never visited by vaccination teams during previous polio supplemental immunization activities (SIAs). Enumeration resulted in documentation of 906,201 children aged <5 years residing in these settlements, including 53,738 (5.9%) who had never received polio vaccination, and in detection of 211 unreported cases of acute flaccid paralysis (AFP) with onset of illness in the 6 months before enumeration. Sustaining access to underserved populations in remote settlements in future SIAs will increase overall population immunity and should decrease WPV transmission. By providing a flexible and capable workforce consisting of Nigerian citizens, N-STOP is able to support evaluation and implementation of innovative polio eradication strategies in Nigeria while building local public health capacity with a potential to address other public health problems following the eradication of polio from Nigeria.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6233a3.htm?s_cid=mm6233a3_w

WHO SAGE: Call for nominations for SAGE Working Group on hepatitis E vaccine
The Working Group will be asked to review the evidence with respect to the following questions/issues and to propose recommendations for review by SAGE. This will lead to the publication of a WHO vaccine position paper on the use of hepatitis E. The target date of the publication of the position paper is early 2015. Details here:
http://www.who.int/immunization/sage/nominations_working_group_hep_E_aug2013/en/index.html

The American Journal of Bioethics
Volume 13, Issue 9, 2013
http://www.tandfonline.com/toc/uajb20/current#.Uhk8Az_hflY

Editorial
Vaccine Mandates Are Justifiable Because We Are All in This Together
John D. Lantos & Mary Anne Jackson
pages 1-2
http://www.tandfonline.com/doi/full/10.1080/15265161.2013.815021#.Uhk8pj_hflY
No abstract

An Ethical Analysis of Mandatory Influenza Vaccination of Health Care Personnel: Implementing Fairly and Balancing Benefits and Burdens
Armand H. Matheny Antommaria
pages 30-37
DOI:10.1080/15265161.2013.814731
Published online: 16 Aug 2013
Abstract
Health care institutions have paid increasing attention to preventing nosocomial transmission of influenza through vaccination of health care personnel. While multifaceted voluntary interventions have increased vaccination rates, proponents of mandatory programs contend the rates remain unacceptably low. Conventional bioethical analyses of mandatory programs are inadequate; they fail to account for the obligations of nonprofessional personnel or to justify the weights assigned to different ethical principles. Using an ethics framework for public health permits a fuller analysis. The framework’s focus on fairness accentuates the potential differences between the risk of transmitting infection and employment status, and the need to equitably evaluate exemptions. The framework’s emphasis on balancing benefits and burdens highlights the need to justify a specific goal and questions the need to exclude all nonmedical exemptions. While mandatory vaccination programs are justifiable, greater attention should be paid to their implementation.

The Case for Mandatory Flu Vaccination of Children
Ben Bambery, Michael Selgelid, Hannah Maslen, Andrew J. Pollard & Julian Savulescu
pages 38-40
DOI:10.1080/15265161.2013.813602
Published online: 16 Aug 2013
No abstract

Guidance From Vaccination Jurisprudence
Michael R. Ulrich
pages 40-42
DOI:10.1080/15265161.2013.813608
Published online: 16 Aug 2013
No abstract

Before the Mandate: Cultivating an Organizational Culture of Trust and Integrity
Joshua E. Perry
pages 42-44
DOI:10.1080/15265161.2013.813600
Published online: 16 Aug 2013
No abstract

Exemptions From Influenza Vaccinations for Health Care Personnel Based on Self or Identity Issues: Are They Justified?
David Trafimow
pages 44-46
DOI:10.1080/15265161.2013.813598
Published online: 16 Aug 2013
No abstract

Evidence and Ethics in Mandatory Vaccination Policies
Jason L. Schwartz
pages 46-48
DOI:10.1080/15265161.2013.815023
Published online: 16 Aug 2013
No abstract

Mandatory Influenza Vaccination: How Far to Go and Whom to Target Without Evidence?
Jean-Christophe Bélisle Pipon & Marjolaine Frenette
pages 48-50
DOI:10.1080/15265161.2013.813607
Published online: 16 Aug 2013
No abstract

Professional Solidarity: The Case of Influenza Immunization
Mariëtte van den Hoven & Marcel Verweij
pages 51-52
DOI:10.1080/15265161.2013.813606
Published online: 16 Aug 2013
No abstract

How the Weight of the Ethical Arguments Depends on the Empirical “Facts”
Georg Marckmann, Anna M. Sanktjohanser & Sabine Wicker
pages 53-55
DOI:10.1080/15265161.2013.813605
Published online: 16 Aug 2013
No abstract

Applying Kass’s Public Health Ethics Framework to Mandatory Health Care Worker Immunization: The Devil is in the Details
Saad B. Omer
pages 55-57
DOI:10.1080/15265161.2013.825122
Published online: 16 Aug 2013
No abstract

Emerging Infectious Diseases
Volume 19, Number 9—September 2013
http://www.cdc.gov/ncidod/EID/index.htm

Dispatch
Middle East Respiratory Syndrome Coronavirus in Bats, Saudi Arabia
Ziad A. Memish, Nischay Mishra, Kevin J. Olival, Shamsudeen F. Fagbo, Vishal Kapoor, Jonathan H. Epstein, Rafat AlHakeem, Abdulkareem Durosinloun, Mushabab Al Asmari, Ariful Islam, Amit Kapoor, Thom
http://wwwnc.cdc.gov/eid/article/19/11/13-1172_article.htm

Abstract
The source of human infection with Middle East respiratory syndrome coronavirus remains unknown. Molecular investigation indicated that bats in Saudi Arabia are infected with several alphacoronaviruses and betacoronaviruses. Virus from 1 bat showed 100% nucleotide identity to virus from the human index case-patient. Bats might play a role in human infection.

Emerging Infectious Diseases
Volume 19, Number 9—September 2013
http://www.cdc.gov/ncidod/EID/index.htm

Research
Protection by Face Masks against Influenza A(H1N1)pdm09 Virus on Trans-Pacific Passenger Aircraft, 2009
Lijie Zhang¹, Zhibin Peng¹, Jianming Ou¹, Guang Zeng¹, Robert E. Fontaine, Mingbin Liu, Fuqiang Cui, Rongtao Hong, Hang Zhou, Yang Huai, Shuk-Kwan Chuang, Yiu-Hong Leung, Yunxia Feng, Yuan Luo, Tao Shen, Bao-Ping Zhu, Marc-Alain Widdowson, and Hongjie Yu
http://wwwnc.cdc.gov/eid/article/19/9/12-1765_article.htm

Abstract
In response to several influenza A(H1N1)pdm09 infections that developed in passengers after they traveled on the same 2 flights from New York, New York, USA, to Hong Kong, China, to Fuzhou, China, we assessed transmission of influenza A(H1N1)pdm09 virus on these flights. We defined a case of infection as onset of fever and respiratory symptoms and detection of virus by PCR in a passenger or crew member of either flight. Illness developed only in passengers who traveled on the New York to Hong Kong flight. We compared exposures of 9 case-passengers with those of 32 asymptomatic control-passengers. None of the 9 case-passengers, compared with 47% (15/32) of control-passengers, wore a face mask for the entire flight (odds ratio 0, 95% CI 0–0.71). The source case-passenger was not identified. Wearing a face mask was a protective factor against influenza infection. We recommend a more comprehensive intervention study to accurately estimate this effect

Eurosurveillance
Volume 18, Issue 34, 22 August 2013
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Rapid communications
Investigation of an imported case of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection in Florence, Italy, May to June 2013
by S Puzelli, A Azzi, MG Santini, A Di Martino, M Facchini, MR Castrucci, M Meola, R Arvia, F Corcioli, F Pierucci, S Baretti, A Bartoloni, D Bartolozzi, M de Martino, L Galli, MG Pompa, G Rezza, E Balocchini, I Donatelli

Globalization and Health
[Accessed 24 August 2013]
http://www.globalizationandhealth.com/

Review
Health technology assessments as a mechanism for increased value for money: recommendations to the global fund
Teerawattananon Y, McQueston K, Glassman A, Yothasamut J and Myint CY Globalization and Health 2013, 9:35 (21 August 2013)

Abstract (provisional)
The Global Fund is experiencing increased pressure to optimize results and improve its impact per dollar spent. It is also in transition from a provider of emergency funding, to a long-term, sustainable financing mechanism. This paper assesses the efficacy of current Global Fund investment and examines how health technology assessments (HTAs) can be used to provide guidance on the relative priority of health interventions currently subsidized by the Global Fund. In addition, this paper identifies areas where the application of HTAs can exert the greatest impact and proposes ways in which this tool could be incorporated, as a routine component, into application, decision, implementation, and monitoring and evaluation processes. Finally, it addresses the challenges facing the Global Fund in realizing the full potential of HTAs.

Health Policy and Planning
Volume 28 Issue 5 August 2013
http://heapol.oxfordjournals.org/content/current

Preparing routine health information systems for immediate health responses to disasters
Eindra Aung1,* and Maxine Whittaker2
Accepted July 7, 2012.
[Free text] http://heapol.oxfordjournals.org/content/28/5/495.abstract

Abstract
During disaster times, we need specific information to rapidly plan a disaster response, especially in sudden-onset disasters. Due to the inadequate capacity of Routine Health Information Systems (RHIS), many developing countries face a lack of quality pre-disaster health-related data and efficient post-disaster data processes in the immediate aftermath of a disaster. Considering the significance of local capacity during the early stages of disaster response, RHIS at local, provincial/state and national levels need to be strengthened so that they provide relief personnel up-to-date information to plan, organize and monitor immediate relief activities. RHIS professionals should be aware of specific information needs in disaster response (according to the Sphere Project’s Humanitarian Minimum Standards) and requirements in data processes to fulfil those information needs. Preparing RHIS for disasters can be guided by key RHIS-strengthening frameworks; and disaster preparedness must be incorporated into countries’ RHIS. Mechanisms must be established in non-disaster times and maintained between RHIS and information systems of non-health sectors for exchanging disaster-related information and sharing technologies and cost.

Health Policy and Planning
Volume 28 Issue 5 August 2013
http://heapol.oxfordjournals.org/content/current

From reaching every district to reaching every community: analysis and response to the challenge of equity in immunization in Cambodia
Sann Chan Soeung¹, John Grundy², Richard Duncan³,*, Rasoka Thor⁴ and Julian B Bilous⁵
Accepted July 11, 2012.

Abstract
Background   An international review of the Cambodian Expanded Programme on Immunization (EPI) in 2010 and other data show that despite immunization coverage increases and vaccine preventable diseases incidence reductions, inequities in access to immunization services exist. Utilizing immunization and health systems literature, analysis of global health databases and the EPI review findings, this paper examines the characteristics of immunization access and outcome inequities, and describes proposed longer-term strategic and operational responses to these problems.

Findings   The national programme has evolved from earlier central and provincial level planning to strengthening routine immunization coverage through the District level ‘Reaching Every District Strategy’. However, despite remarkable improvements, the review found over 20% of children surveyed were not fully immunized, primarily from communities where inequities of both access and impact persist. These inequities relate mainly to socio-economic exposures including wealth and education level, population mobility and ethnicity. To address these problems, a shift in strategic and operational response is proposed that will include (a) a re-focus of planning on facility level to detect disadvantaged communities, (b) establishment of monitoring systems to provide detailed information on community access and utilization, (c) development of communication strategies and health networks that enable providers to adjust service delivery according to the needs of vulnerable populations, and (d) securing financial, management and political commitment for ‘reaching every community’.

Conclusions   For Cambodia to achieve its immunization equity objectives and disease reduction goals, a shift of emphasis to health centre and community is needed. This approach will maximize the benefits of new vaccine introduction in the coming ‘Decade of Vaccines’, plus potentially extend the reach of other life-saving maternal and child health interventions to the socially disadvantaged, both in Cambodia and in other countries with a similar level of development.

International Journal of Infectious Diseases
Vol 17 | No. 9 | September 2013
http://www.ijidonline.com/current

Infectious disease risk from the Syrian conflict
Eskild Petersen, Susan Baekeland, Ziad A. Memish, Hakan Leblebicioglu
Received 3 June 2013; accepted 4 June 2013. published online 15 July 2013.
http://www.ijidonline.com/article/S1201-9712%2813%2900200-2/fulltext

Preview
The breakdown of health care in Syria under the present conflict has been highlighted in ProMED reports on the increasing risk of leishmaniasis and rabies. However, these reports merely reflect the dr…

JAMA   
http://jama.jamanetwork.com/issue.aspx
August 14, 2013, Vol 310, No. 6

Original Investigation | August 14, 2013
The State of US Health, 1990-2010Burden of Diseases, Injuries, and Risk Factors
US Burden of Disease Collaborators; Christopher J. L. Murray, MD, DPhil, et al
http://jama.jamanetwork.com/article.aspx?articleid=1710486

ABSTRACT
Importance   Understanding the major health problems in the United States and how they are changing over time is critical for informing national health policy.

Objectives   To measure the burden of diseases, injuries, and leading risk factors in the United States from 1990 to 2010 and to compare these measurements with those of the 34 countries in the Organisation for Economic Co-operation and Development (OECD) countries.

Design   We used the systematic analysis of descriptive epidemiology of 291 diseases and injuries, 1160 sequelae of these diseases and injuries, and 67 risk factors or clusters of risk factors from 1990 to 2010 for 187 countries developed for the Global Burden of Disease 2010 Study to describe the health status of the United States and to compare US health outcomes with those of 34 OECD countries. Years of life lost due to premature mortality (YLLs) were computed by multiplying the number of deaths at each age by a reference life expectancy at that age. Years lived with disability (YLDs) were calculated by multiplying prevalence (based on systematic reviews) by the disability weight (based on population-based surveys) for each sequela; disability in this study refers to any short- or long-term loss of health. Disability-adjusted life-years (DALYs) were estimated as the sum of YLDs and YLLs. Deaths and DALYs related to risk factors were based on systematic reviews and meta-analyses of exposure data and relative risks for risk-outcome pairs. Healthy life expectancy (HALE) was used to summarize overall population health, accounting for both length of life and levels of ill health experienced at different ages.

Results   US life expectancy for both sexes combined increased from 75.2 years in 1990 to 78.2 years in 2010; during the same period, HALE increased from 65.8 years to 68.1 years. The diseases and injuries with the largest number of YLLs in 2010 were ischemic heart disease, lung cancer, stroke, chronic obstructive pulmonary disease, and road injury. Age-standardized YLL rates increased for Alzheimer disease, drug use disorders, chronic kidney disease, kidney cancer, and falls. The diseases with the largest number of YLDs in 2010 were low back pain, major depressive disorder, other musculoskeletal disorders, neck pain, and anxiety disorders. As the US population has aged, YLDs have comprised a larger share of DALYs than have YLLs. The leading risk factors related to DALYs were dietary risks, tobacco smoking, high body mass index, high blood pressure, high fasting plasma glucose, physical inactivity, and alcohol use. Among 34 OECD countries between 1990 and 2010, the US rank for the age-standardized death rate changed from 18th to 27th, for the age-standardized YLL rate from 23rd to 28th, for the age-standardized YLD rate from 5th to 6th, for life expectancy at birth from 20th to 27th, and for HALE from 14th to 26th.

Conclusions and Relevance   From 1990 to 2010, the United States made substantial progress in improving health. Life expectancy at birth and HALE increased, all-cause death rates at all ages decreased, and age-specific rates of years lived with disability remained stable. However, morbidity and chronic disability now account for nearly half of the US health burden, and improvements in population health in the United States have not kept pace with advances in population health in other wealthy nations.

The Lancet  
http://www.thelancet.com/journals/lancet/issue/current
Aug 24, 2013  Volume 382  Number 9893  p659 – 742

Comment
Assessing the pandemic potential of MERS-CoV
Chris T Bauch, Tamer Oraby
Preview |
The emergence in 2012 of a new disease-causing coronavirus has generated substantial concern. As of June 26, 2013, Middle East respiratory syndrome coronavirus (MERS-CoV) had caused 77 laboratory-confirmed cases and 40 deaths.1 The virus is related to the severe acute respiratory syndrome coronavirus (SARS-CoV) that emerged in 2002–03. And, as SARS-CoV had during its prepandemic stage, MERS-CoV has probably been transmitted from an unknown animal host to human beings repeatedly in the past year.2,3 Cases of human-to-human transmission have also been documented in several countries.

Interhuman transmissibility of Middle East respiratory syndrome coronavirus: estimation of pandemic risk
Romulus Breban PhD a, Julien Riou a, Prof Arnaud Fontanet PhD a b
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2961492-0/abstract

Summary
Background
The new Middle East respiratory syndrome coronavirus (MERS-CoV) infection shares many clinical, epidemiological, and virological similarities with that of severe acute respiratory syndrome (SARS)-CoV. We aimed to estimate virus transmissibility and the epidemic potential of MERS-CoV, and to compare the results with similar findings obtained for prepandemic SARS.

Methods
We retrieved data for MERS-CoV clusters from the WHO summary and subsequent reports, and published descriptions of cases, and took into account 55 of the 64 laboratory-confirmed cases of MERS-CoV reported as of June 21, 2013, excluding cases notified in the previous 2 weeks. To assess the interhuman transmissibility of MERS-CoV, we used Bayesian analysis to estimate the basic reproduction number (R0) and compared it to that of prepandemic SARS. We considered two scenarios, depending on the interpretation of the MERS-CoV cluster-size data.

Results
With our most pessimistic scenario (scenario 2), we estimated MERS-CoV R0 to be 0·69 (95% CI 0·50—0·92); by contrast, the R0 for prepandemic SARS-CoV was 0·80 (0·54—1·13). Our optimistic scenario (scenario 1) yielded a MERS-CoV R0 of 0·60 (0·42—0·80). Because of recent implementation of effective contact tracing and isolation procedures, further MERS-CoV transmission data might no longer describe an entire cluster, but only secondary infections directly caused by the index patient. Hence, we calculated that, under scenario 2, eight or more secondary infections caused by the next index patient would translate into a 5% or higher chance that the revised MERS-CoV R0 would exceed 1—ie, that MERS-CoV might have pandemic potential.

Interpretation
Our analysis suggests that MERS-CoV does not yet have pandemic potential. We recommend enhanced surveillance, active contact tracing, and vigorous searches for the MERS-CoV animal hosts and transmission routes to human beings.

Funding
Agence Nationale de la Recherche (Labex Integrative Biology of Emerging Infectious Diseases), and the European Community’s Seventh Framework Programme project PREDEMICS.

The Lancet Global Health
Sep 2013  Volume 1  Number 3  e116 – 168
http://www.thelancet.com/journals/langlo/issue/current

Performance-based financing at the Global Fund to Fight AIDS, Tuberculosis and Malaria: an analysis of grant ratings and funding, 2003–12
Victoria Y Fan, Denizhan Duran, Rachel Silverman, Amanda Glassman
http://www.thelancet.com/journals/langlo/article/PIIS2214-109X%2813%2970017-2/abstract

Summary
Background
Performance-based financing can be used by global health funding agencies to improve programme performance and thus value for money. The Global Fund to Fight AIDS, Tuberculosis and Malaria was one of the first global-health funders to deploy a performance-based financing system. However, its complex, multistep system for calculating and paying on grant ratings has several components that are subjective and discretionary. We aimed to test the association between grant ratings and disbursements, an indication of the extent to which incentives for performance are transmitted to grant recipients.

Methods
We obtained publicly available data for 508 Global Fund grants from 2003 to 2012 with performance ratings and corresponding disbursements, merged with other datasets that contained data for relevant country characteristics. We used regression analysis to identify predictors of grant disbursements in phase 2 (typically the latter 3 of 5 years of a grant), using two dependent variables: whether a grant had any phase-2 disbursements, and the phase-2 disbursement amount. In a separate analysis, we also investigated the predictors of grant performance ratings.

Findings
Grant performance rating in phase 1 was positively associated with having any disbursements in phase 2, but no association was seen between phase-1 ratings and phase-2 disbursement amounts. Furthermore, performance ratings are not replicable by external observers, both because subjective and discretionary decisions are made in the generation of performance measures and because the underlying data are not available.

Interpretation
The Global Fund’s present performance-based funding system does not adequately convey incentives for performance to recipients, and the organisation should redesign this system to explicitly link a portion of the funds to a simple performance measure in health coverage or outcomes, measured independently and robustly.

Funding
Bill & Melinda Gates Foundation

The Lancet Infectious Diseases
Sep 2013  Volume 13  Number 9   p725 – 822
http://www.thelancet.com/journals/laninf/issue/current

Risk of Guillain-Barré syndrome after seasonal influenza vaccination and influenza health-care encounters: a self-controlled study
Jeffrey C Kwong, Priya P Vasa, Michael A Campitelli, Steven Hawken, Kumanan Wilson, Laura C Rosella, Therese A Stukel, Natasha S Crowcroft, Allison J McGeer, Lorne Zinman, Shelley L Deeks
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970104-X/abstract

Summary
Background
The possible risk of Guillain-Barré syndrome from influenza vaccines remains a potential obstacle to achieving high vaccination coverage. However, influenza infection might also be associated with Guillain-Barré syndrome. We aimed to assess the risk of Guillain-Barré syndrome after seasonal influenza vaccination and after influenza-coded health-care encounters.

Methods
We used the self-controlled risk interval design and linked universal health-care system databases from Ontario, Canada, with data obtained between 1993 and 2011. We used physician billing claims for influenza vaccination and influenza-coded health-care encounters to ascertain exposures. Using fixed-effects conditional Poisson regression, we estimated the relative incidence of hospitalisation for primary-coded Guillain-Barré syndrome during the risk interval compared with the control interval.

Findings
We identified 2831 incident admissions for Guillain-Barré syndrome; 330 received an influenza vaccine and 109 had an influenza-coded health-care encounter within 42 weeks before hospitalisation. The risk of Guillain-Barré syndrome within 6 weeks of vaccination was 52% higher than in the control interval of 9—42 weeks (relative incidence 1·52; 95% CI 1·17—1·99), with the greatest risk during weeks 2—4 after vaccination. The risk of Guillain-Barré syndrome within 6 weeks of an influenza-coded health-care encounter was greater than for vaccination (15·81; 10·28—24·32). The attributable risks were 1·03 Guillain-Barré syndrome admissions per million vaccinations, compared with 17·2 Guillain-Barré syndrome admissions per million influenza-coded health-care encounters.

Interpretation
The relative and attributable risks of Guillain-Barré syndrome after seasonal influenza vaccination are lower than those after influenza illness. Patients considering immunisation should be fully informed of the risks of Guillain-Barré syndrome from both influenza vaccines and influenza illness.

Funding
Canadian Institutes of Health Research.

Nature | Scientific American

The hidden threat that could prevent Polio’s global eradication
Polio could soon be wiped out—but only if scientists can track down the last carriers
Helen Branswell
14 August 2013
Extract
Global eradication of polio has been the ultimate game of Whack-a-Mole for the past decade; when it seems the virus has been beaten into submission in a final refuge, up it pops in a new region. Now, as vanquishing polio worldwide appears again within reach, another insidious threat may be in store from infection sources hidden in plain view.

Polio’s latest redoubts are “chronic excreters,” people with compromised immune systems who, having swallowed weakened polioviruses in an oral vaccine as children, generate and shed live viruses from their intestines and upper respiratory tracts for years. Healthy children react to the vaccine by developing antibodies that shut down viral replication, thus gaining immunity to infection. But chronic excreters cannot quite complete that process and instead churn out a steady supply of viruses. The oral vaccine’s weakened viruses can mutate and regain wild polio’s hallmark ability to paralyze the people it infects. After coming into wider awareness in the mid-1990s, the condition shocked researchers…

Nature Reviews Immunology
September 2013 Vol 13 No 9
http://www.nature.com/nri/journal/v13/n9/index.html

Broadly neutralizing antibodies and the search for an HIV-1 vaccine: the end of the beginning
Peter D. Kwong, John R. Mascola & Gary J. Nabel
http://www.nature.com/nri/journal/v13/n9/abs/nri3516.html

Abstract
The field of HIV-1 vaccine research has seen a renaissance with the identification of antibodies that neutralize most circulating HIV-1 strains. An understanding of the structural mode of target recognition that these antibodies use and the immune pathways that lead to their development is emerging. This knowledge has provided fundamental insights into the pathways that elicit broadly neutralizing antibodies and provides a foundation for active and passive immunization strategies to prevent HIV-1 infection.

PLoS One
[Accessed 24 August 2013]
http://www.plosone.org/

Knowledge, Attitude, Practice and Barriers on Vaccination against Human Papillomavirus Infection: A Cross-Sectional Study among Primary Care Physicians in Hong Kong
Martin C. S. Wong, Albert Lee, Karry L. K. Ngai, Josette C. Y. Chor, Paul K. S. Chan
Research Article | published 21 Aug 2013 | PLOS ONE 10.1371/journal.pone.0071827

Abstract
This study explored the knowledge, attitude, practice and barriers to prescribe human papillomavirus (HPV) vaccines among private primary care physicians in Hong Kong. A self-administered questionnaire survey was conducted by sending letters to doctors who had joined a vaccination program for school girls. From 720 surveys sent, 444 (61.7%) completed questionnaires were returned and analyzed. For knowledge, few responded to questions accurately on the prevalence of cervical HPV (27.9%) and genital wart infection (13.1%) among sexually active young women in Hong Kong, and only 44.4% correctly answered the percentage of cervical cancers caused by HPV. For attitude, most agreed that HPV vaccination should be fully paid by the Government (68.3%) as an important public health strategy. Vaccination against HPV was perceived as more important than those for genital herpes (52.2%) and Chlamydia (50.1%) for adolescent health, and the majority selected adolescents aged 12–14 years as the ideal group for vaccination. Gardasil® (30.9%) and Cervarix® (28.0%) were almost equally preferred. For practice, the factors influencing the choice of vaccine included strength of vaccine protection (61.1%), long-lasting immunity (56.8%) and good antibody response (55.6%). The most significant barriers to prescribe HPV vaccines consisted of parental refusal due to safety concerns (48.2%), and their practice of advising vaccination was mostly affected by local Governmental recommendations (78.7%). A substantial proportion of physicians had recommended HPV vaccines for their female clients/patients aged 18–26 years for protection of cervical cancer (83.8%) or both cervical cancer and genital warts (85.5%). The knowledge on HPV infection was low among physicians in Hong Kong. Prescription of HPV vaccine was hindered by the perceived parental concerns and was mostly relied on Governmental recommendations. Educational initiatives should be targeted towards both physicians and parents, and the Government should consider full subsidy to enhance vaccine uptake rate.

PLoS One
[Accessed 24 August 2013]
http://www.plosone.org/

The Expected Number of Background Disease Events during Mass Immunization in China
YouXin Wang, LiJuan Wu, XinWei Yu, FeiFei Zhao, Alyce Russell, ManShu Song, Wei Wang
Research Article | published 20 Aug 2013 | PLOS ONE 10.1371/journal.pone.0071818

Abstract
It is critical to distinguish events that are temporarily associated with, but not caused by, vaccination from those caused by vaccination during mass immunization. We performed a literature search in China National Knowledge Infrastructure and Pubmed databases. The number of coincident events was calculated based on its incidence rate and periods after receipt of a dose of hypothesized vaccine. We included background incidences of Guillain-Barré syndrome, anaphylaxis, seizure, sudden adult death syndrome, sudden cardiac death, spontaneous abortion, and preterm labour or delivery. In a cohort of 10 million individuals, 7.71 cases of Guillain-Barré syndrome would be expected to occur within six weeks of vaccination as coincident background cases. Even for rare events, a large number of events can be expected in a short period because of the large population targeted for immunization. These findings may encourage health authorities to screen the safety of vaccines against unpredictable pathogens.

Qualitative Health Research
September 2013; 23 (9)
http://qhr.sagepub.com/content/current

Vaccine Perceptions Among Oregon Health Care Providers
Sandra J. Bean1, Joseph A. Catania1
1Oregon State University, Corvallis, Oregon, USA
Sandra J. Bean, Oregon State University, School of Social and Behavioral Health Sciences, 322 Milam Hall, Corvallis, OR 97333-5102, USA.
http://qhr.sagepub.com/content/23/9/1251.abstract

Abstract
Health care providers exert a significant influence on parental pediatric vaccination decisions. We conducted hour-long interviews with traditional and alternative health care providers in which we explored a range of associations between vaccination perceptions and practice. A key finding was that the Health Belief Model constructs of perceived susceptibility to and severity of either an illness or an adverse vaccine event partially explained health care provider (HCP) beliefs about the risks or benefits of vaccination, especially among alternative care providers. Low or high perceived susceptibility to a vaccine-preventable disease (VPD) or of the severity of a given VPD affects whether an HCP will promote or oppose pediatric vaccination recommendations. Beyond these perceptions, health and vaccination beliefs are affected by the contextual factors of personal experience, group norms, immunology beliefs, and beliefs about industry and government. Building powerful affective heuristics might be critical to balancing the forces that defeat good public health practices.

UN Chronicle
Vol 1, No.2, 2013
http://www.un.org/wcm/content/site/chronicle/home/archive/issues2013/security

National Security and Pandemics
By Sara E. Davies18.07.2013
Pandemics are for the most part disease outbreaks that become widespread as a result of the spread of human-to-human infection. Beyond the debilitating, sometimes fatal, consequences for those directly affected, pandemics have a range of negative social, economic and political consequences

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 40, Pages 4261-4464 (13 September 2013)

Research on vaccines during pregnancy: Reference values for vital signs and laboratory assessments
Original Research Article
Pages 4264-4273
Jeanne S. Sheffield, Flor M. Munoz, Richard H. Beigi, Sonja A. Rasmussen, Kathryn M. Edwards, Jennifer S. Read, R. Phillips Heine, Kevin A. Ault, Geeta K. Swamy, Indira Jevaji, Catherine Y. Spong, Kimberly B. Fortner, Shital M. Patel, Mirjana Nesin

Highlights
:: A toxicity grading scale is defined for adverse event reporting in pregnancy.
:: Vital sign changes in pregnancy are discussed and toxicity grading developed for each trimester.
:: Normal laboratory values are listed and a toxicity grade is assigned based on value and trimester of pregnancy.

Abstract
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, “Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics”, to discuss enrollment and safety assessments of pregnant women in clinical trials of vaccines. Experts in obstetrics, maternal–fetal medicine, infectious diseases, pediatrics, neonatology, genetics, vaccinology and clinical trial design were charged with identifying normal ranges for vital signs and laboratory assessments in pregnancy. A grading system for adverse events was then developed

Research on vaccines during pregnancy: Protocol design and assessment of safety
Original Research Article
Pages 4274-4279
Flor M. Munoz, Jeanne S. Sheffield, Richard H. Beigi, Jennifer S. Read, Geeta K. Swamy, Indira Jevaji, Sonja A. Rasmussen, Kathryn M. Edwards, Kimberly B. Fortner, Shital M. Patel, Catherine Y. Spong, Kevin Ault, R. Philips Heine, Mirjana Nesin

Abstract
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled “Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics”, to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 40, Pages 4261-4464 (13 September 2013)

A systematic review of interventions for reducing parental vaccine refusal and vaccine hesitancy
Review Article
Pages 4293-4304
Alina Sadaf, Jennifer L. Richards, Jason Glanz, Daniel A. Salmon, Saad B. Omer

Abstract
Unvaccinated individuals pose a public health threat to communities. Research has identified many factors associated with parental vaccine refusal and hesitancy toward childhood and adolescent immunizations. However, data on the effectiveness of interventions to address parental refusal are limited. We conducted a systematic review of four online databases to identify interventional studies.

We used criteria recommended by the WHO’s Strategic Advisory Group of Experts on immunization (SAGE) for the quality assessment of studies. Intervention categories and outcomes were evaluated for each body of evidence and confidence in overall estimates of effect was determined. There is limited evidence to guide implementation of effective strategies to deal with the emerging threat of parental vaccine refusal. There is a need for appropriately designed, executed and evaluated intervention studies to address this gap in knowledge.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 31, Issue 40, Pages 4261-4464 (13 September 2013)

International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines
Original Research Article
Pages 4448-4458
Caitlin N. Dodd, Silvana A. Romio, Steven Black, Claudia Vellozzi, Nick Andrews, Miriam Sturkenboom, Patrick Zuber, Wei Hua, Jan Bonhoeffer, Jim Buttery, Nigel Crawford, Genevieve Deceuninck, Corinne de Vries, Philippe De Wals, M. Victoria Gutierrez- Gimeno, Harald Heijbel, Hayley Hughes, Kwan Hur, Anders Hviid, Jeffrey Kelman, et al

Abstract
Background
The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain–Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination.

Methods
The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach.

Results
We found a relative incidence of GBS of 2.42 (95% CI 1.58–3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28–3.42) using the meta-analytic approach.

Conclusions
This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines.