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Vaccines_The Week in Review_5 January 2013

Vaccines_The Week in Review_5 January 2013

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Vaccines: The Week in Review 5 January 2013 Center for Vaccine Ethics & Policy (CVEP

This weekly summary targets news, events, announcements, articles and research in the global vaccine ethics and policy space and 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. Vaccines: The Week in Review is also posted in pdf form and as a set of blog posts at http://centerforvaccineethicsandpolicy.wordpress.com/. This blog allows full-text searching of over 3,500 entries. Comments and suggestions should be directed to David R. Curry, MS Editor and Executive Director Center for Vaccine Ethics & Policy david.r.curry@centerforvaccineethicsandpolicy.org

Editor’s Notes: - Vaccines: The Week in Review resumes publication with this edition following a holiday break. - A pdf version of this issue is available on our blog: http://centerforvaccineethicsandpolicy.wordpress.com/

Update: Polio this week - As of 04 January 2013 Global Polio Eradication Initiative http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx [Editor’s Extract and bolded text] - Niger reports polio: In the first outbreak of polio in 2012 outside of an endemic country or a country with re-established poliovirus, Niger has reported a case of wild poliovirus. This is the first case in the country since December 2011 and is related to virus originating in Nigeria. - 2012 ends with fewest wild polio cases ever: The year ended with the fewest children paralyzed by wild polio virus, in the fewest places, in history. Two hundred and eighteen wild polio cases have been reported so far for 2012 – a greater than 60% reduction from 2011. Over the year, through the tireless dedication of the on-the-ground heroes of polio eradication, more than 2 billion doses of vaccine were distributed to 429 million children around the world. Nigeria - One new WPV case was reported in the past week (1 WPV1 from the Federal Capital Territory), bringing the total number of WPV cases for 2012 to 119. This is the most recent in the country and had onset of paralysis on 3 December. The area was covered in Sub-national Immunization Days on 18-21 December.

- No new circulating vaccine-derived poliovirus cases (cVDPV) were reported in the past week. The total number of cVDPV cases for 2012 remains 4, with the most recent having onset of paralysis on 16 August. - Given spread of WPV of Nigerian origin to Niger, targeted Supplementary Immunization Activities will take place in high-risk and under-served districts in Nigeria on 12-15 January, synchronized with Niger. National Immunization Days across Nigeria are planned for 2-5 February and 2-5 March. Pakistan - One new WPV case was reported in the past week, a WPV1 with onset of paralysis on 30 November in Khyber Pakhtunkhwa. The total number of WPV cases for 2012 is 58. - Three new circulating vaccine-derived poliovirus (cVDPV) cases were reported in the past week, two from Balochistan and one from Sindh (Karachi area). The most recently reported case occurred in Sindh on 8 December and is related to the Balochistan outbreak. The total number of cVDPV cases for 2012 is now 15. - Small-scale immunization activities are taking place on an ongoing basis in the polioendemic areas of Pakistan, as the security situation allows. Niger - Niger reports polio: In the first outbreak of polio in 2012 outside of an endemic country or a country with re-established poliovirus, Niger has reported a case of wild poliovirus. This is the first case in the country since December 2011 and is related to virus originating in Nigeria. West Africa - One new WPV case was reported in the past week, a WPV1 from Tahoua province in Niger with onset of paralysis on 15 November. This is the first case in the region in 2012.

[Editor’s Note: Please see an associated editorial in The Lancet “Global polio eradication: not there yet” in Journal Watch below.]

The Decade of Vaccines Collaboration announced that it ended secretariat operations as of 31 December 2012, noting that “the work of the Decade of Vaccines is continuing – carried out by the stakeholders that developed the GVAP. The original plan was for the DoV Collaboration, including the secretariat, to dissolve or “sunset” at the end of 2012 so as not to create an additional structure. The countries, the regions and global health organizations will continue to carry out the vision of the GVAP at the country, regional and global levels.” http://www.dovcollaboration.org/dov-collaboration-updates/december-2012-news-report/ The Weekly Epidemiological Record (WER) for 4 January 2013, vol. 88, 1 (pp 1–16) includes: Meeting of the Strategic Advisory Group of Experts on Immunization, November 2012 – conclusions and recommendations http://www.who.int/entity/wer/2013/wer8801.pdf [Editor’s Note: Below is an excerpt for the WER summary of the meeting’s GVAP agenda item] Decade of Vaccines Global Vaccine Action Plan (GVAP) “The session included an overview of progress in putting the GVAP into operation since the 65th World Health Assembly (WHA) in May 2012. Discussions have begun at the Regional level to update regional immunization plans in alignment with GVAP and to establish processes to monitor and report progress to the respective Regional Committees each year. The WHO and

UNICEF guidance for preparation of national multi-year and annual plans for immunization are being updated to align them with the guiding principles and strategic objectives of GVAP and to foster greater alignment with national health sector plans. ‘The proposed structure and process for monitoring the implementation of the GVAP through a Monitoring & Evaluation /Accountability Framework was described. The framework has 3 elements: (i) monitoring results (based on the indicators for the GVAP Goals and Strategic Objectives); (ii) monitoring commitments and resources; and (iii) an independent review of progress. Progress was described in the efforts to finalize monitoring indicators, establish operational definitions, sources of data, and the reporting process. SAGE was presented with the changes made to the indicators since its April 2012 meeting and the rationale for doing so, and was specifically asked for comments and recommendations. “SAGE discussions mainly focused on: (1) the feasibility and need for surveys to validate district level vaccine coverage measures; (2) adding an indicator of DTP3 coverage ≥80% for ≥3 years; (3) proposed indicators to measure “confidence in immunization”; (4) retention of indicator on district level DTP3 coverage; (5) choice of drop-out rate between the first dose of DTP and first dose of measles containing vaccine (MCV1) (DTP1-MCV1), or between the first and third dose of DTP vaccine (DTP1DTP3); (6) addition of a surveillance indicator; (7) addition of an indicator to measure integration of immunization within health systems; and (8) addition of a vaccine price indicator…” The WHO Executive Board will review an update to the GVAP at its 132nd session [EB132] in Geneva, 21–29 January 2013. The agenda item is listed as: 9. Communicable diseases 9.1 Global vaccine action plan The supporting document - EB132/18 – is not yet posted. http://apps.who.int/gb/ebwha/pdf_files/EB132/B132_1-en.pdf

UNICEF announced tenders for pneumococcal conjugate, rotavirus and HPV vaccines for Middle Income Countries from 2013 to 2015 to assist with affordability, noting that “the disparity between the amounts Low Income and Middle Income Countries pay for the same vaccine can be significant.” Shanelle Hall, Director of UNICEF’s Supply Division, said, “The current market prices of new vaccines put these products out of reach for many countries whose economies have transitioned from ‘Low’ to 'Middle’ Income over the last 20 years. This tender highlights work with the UN World Health Organization, industry, governments and partners to establish affordable, sustainable price levels for countries that are not eligible for international financial support to introduce these new and important life-saving vaccines." UNICEF said that for countries that wish to continue to purchase on their own, this tender “will improve pricing transparency by publishing reference price levels, product profiles and characteristics. This information will serve as the basis for negotiations between interested governments and manufacturers. The final price would be independently contracted.” Ms. Hall added that, “Making sure that children in Middle Income Countries have access to a new generation of life-saving supplies is critical. This tender builds on industry's commitment to improved access and sustainable pricing consistent with the tenets of tiered pricing. Our goal is

to help catalyse a more efficient and healthy market, which combined with increasing country commitment, will serve children in the decades to come,” she added. The World Bank classifies a Middle Income Country as a country with a per capita Gross National Income between US$1,026 and US$12,475. Today, Middle Income Countries are home to 75 per cent of the world’s poor who live on less than US$2 a day. Middle Income governments that have so far expressed an indicative interest in the outcome of this tender include: Albania, Botswana, Cape Verde, Egypt, Gabon, Jordan, Lebanon, Moldova, Morocco, Namibia, the State of Palestine, the Philippines, Sri Lanka, Swaziland, Syria, Tunisia and Turkmenistan. UNICEF is awaiting manufacturers' responses and expects to begin issuing purchase orders on behalf of subscribing countries as early as June 2013. The Request for Proposal RFP-DAN-2012-501580 for Pneumococcal, Rotavirus and Human Papillomavirus Vaccines is available here: http://www.unicef.org/supply/index_66941.html. UNICEF’s strategy for vaccine procurement in Middle Income Countries is presented here: http://www.unicef.org/supply/index_66348.html http://www.unicef.org/media/media_67112.html UNICEF announced that the Multilateral Organization Performance Assessment Network (MOPAN) – a network of 17 donor countries that rate the effectiveness of multilateral organizations – published its most recent assessment of UNICEF, “finding that UNICEF had shown it was able to strengthen its effectiveness and to coordinate efforts to address key issues.” The latest assessment of UNICEF was led by the governments of Austria and Spain MOPAN assessments “provide an important snapshot of an organization’s management effectiveness from a strategic, operational, relationship and knowledge-based perspective. The assessment relies largely on perception-based surveys of in-country partners, peer organizations and donors. In 2012, country-level surveys were undertaken in Cambodia, the Democratic Republic of the Congo, Ghana, Honduras, Morocco, Niger, Nigeria, Philippines and Zimbabwe, serving as the basis of the 2012 report. UNICEF said it “welcomes the common MOPAN approach and the consultative process and is committed to follow up on the recommendations.” 31 December 2012 http://www.unicef.org/media/media_67100.html Full MOPAN Reports on UNICEF: http://www.mopanonline.org/upload/documents/MOPAN_2012_UNICEF_Final_Vol_1_Issued_D ecember_2012.pdf http://www.mopanonline.org/upload/documents/MOPAN_2012_UNICEF_Final_Vol_2_Issued_D ecember_2012.pdf

The Johns Hopkins Bloomberg School of Public Health won a four-year, $5 million grant from the Bill & Melinda Gates Foundation to promote the effective use of oral cholera vaccine around the world. The Delivering Oral Vaccine Effectively (DOVE) program “will provide relief agencies and governments with technical assistance on how to use oral cholera vaccine, evaluate current vaccine-use practices and develop new field surveillance methods for monitoring and controlling outbreaks of the disease.” David Sack, MD, director of DOVE and professor in the Department of International Health at the Bloomberg School, said, “We believe this grant will greatly facilitate the appropriate use of the new cholera vaccine. In partnership with the World Health Organization, UNICEF and other national and international agencies, we believe the DOVE project will provide the knowledge, technical assistance and

encouragement to bring this life-saving vaccine to those who need it most. In addition to researching and evaluating vaccine-use practices, DOVE “will establish cholera surveillance in the northern region of Cameroon near Lake Chad, which appears to be a cholera hotspot. The site will help researchers develop and study methods for detecting outbreaks in remote areas and potentially for using oral vaccine to contain the disease.” http://www.eurekalert.org/pub_releases/2012-12/jhub-jhr122712.php

WHO - 2012 in review: key health issues December 2012 Key public health milestones were reached in 2012, including the end of polio transmission in India and meeting the Millennium Development Goal target on drinking water ahead of schedule. Governments made important decisions on combating illicit trade in tobacco products, monitoring noncommunicable diseases, and conducting research on H5N1 influenza. WHO supported response to a number of disease outbreaks, including Ebola in Uganda. The Organization encouraged countries to invest in testing, treating and tracking all cases of malaria, and to improve access to contraceptives. It issued guidance on the use of antiretroviral drugs to both prevent HIV transmission and keep people healthy. WHO published new statistics highlighting the growing problem of high blood pressure and diabetes, (and) that 15 million babies are born preterm every year, but that overall progress on child survival is speeding up. Other recommendations showed how to use weather information to protect public health, and how to ensure people with mental health conditions receive good care. World Health Day outlined ways to ensure healthy ageing, and the World Health Assembly adopted decisions on issues including nutrition, adolescent pregnancy, and the reform of WHO. http://www.who.int/features/2012/year_review/en/index.html

Conferences/Reports/Research/Analysis/Book Watch Vaccines: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org
No new content.

Journal Watch Vaccines: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant

to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher. If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org American Journal of Public Health Volume 103, Issue 1 (January 2013) http://ajph.aphapublications.org/toc/ajph/current [Reviewed earlier] Annals of Internal Medicine 1 January 2013, Vol. 158. No. 1 http://www.annals.org/content/current Improved Immunogenicity With High-Dose Seasonal Influenza Vaccine in HIV-Infected Persons: A Single-Center, Parallel, Randomized Trial Noah McKittrick, MD; Ian Frank, MD; Jeffrey M. Jacobson, MD; C. Jo White, MD; Deborah Kim, RPh; Rosemarie Kappes, RN, MPH; Carol DiGiorgio, RN; Thomas Kenney, BS; Jean Boyer, PhD; Pablo Tebas, MD; and for the Center for AIDS Research Abstract Background: HIV-infected persons have less robust antibody responses to influenza vaccines. Objective: To compare the immunogenicity of high-dose influenza vaccine with that of standard dosing in HIV-positive participants. Design: Randomized, double-blind, controlled trial. (ClinicalTrials.gov: NCT01262846) Setting: The MacGregor Clinic of the Hospital of the University of Pennsylvania, Philadelphia, from 27 October 2010 to 27 March 2011. Participants: HIV-infected persons older than 18 years. Intervention: Participants were randomly assigned to receive either a standard dose (15 mcg of antigen per strain) or a high dose (60 mcg/strain) of the influenza trivalent vaccine. Measurements: The primary end point was the rate of seroprotection, defined as antibody titers of 1:40 or greater on the hemagglutination inhibition assay 21 to 28 days after vaccination. The primary safety end point was frequency and intensity of adverse events. Secondary end points were seroconversion rate (defined as a greater than 4-fold increase in antibody titers) and the geometric mean antibody titer. Results: 195 participants enrolled, and 190 completed the study (93 in the standard-dose group and 97 in the high-dose group). The seroprotection rates after vaccination were higher in the high-dose group for the H1N1 (96% vs. 87%; treatment difference, 9 percentage points [95% CI, 1 to 17 percentage points]; P = 0.029), H3N2 (96% vs. 92%; treatment difference, 3 percentage points [CI, −3 to 10 percentage points]; P = 0.32), and influenza B (91% vs. 80%; treatment difference, 11 percentage points [CI, 1 to 21 percentage points]; P = 0.030) strains. Both vaccines were well-tolerated, with myalgia (19%), malaise (14%), and local pain (10%) the most frequent adverse events. Limitations: The effectiveness of the vaccine in preventing clinical influenza was not evaluated. The number of participants with CD4 counts less than 0.200 × 109 cells/L was limited. Conclusion: HIV-infected persons reach higher levels of influenza seroprotection if vaccinated with the high-dose trivalent vaccine than with the standard-dose.

Primary Funding Source: National Institute of Allergy and Infectious Diseases and Center for AIDS Research of the University of Pennsylvania. BMC Public Health (Accessed 5 January 2013) http://www.biomedcentral.com/bmcpublichealth/content Addressing inequity to achieve the maternal and child health millennium development goals: looking beyond averages George M Ruhago, Frida N Ngalesoni, Ole F Norheim BMC Public Health 2012, 12:1119 (27 December 2012) Abstract (provisional) Background Inequity in access to and use of child and maternal health interventions is impeding progress towards the maternal and child health Millennium Development Goals. This study explores the potential health gains and equity impact if a set of priority interventions for mothers and under fives were scaled up to reach national universal coverage targets for MDGs in Tanzania. Methods We used the Lives Saved Tool (LiST) to estimate potential reductions in maternal and child mortality and the number of lives saved across wealth quintiles and between rural and urban settings. High impact maternal and child health interventions were modelled for a five-year scale up, by linking intervention coverage, effectiveness and cause of mortality using data from Tanzania. Concentration curves were drawn and the concentration index estimated to measure the equity impact of the scale up. Results In the poorest population quintiles in Tanzania, the lives of more than twice as many mothers and under-fives were likely to be saved, compared to the richest quintile. Scaling up coverage to equal levels across quintiles would reduce inequality in maternal and child mortality from a pro rich concentration index of -0.11 (maternal) and -0.12 (children) to a more equitable concentration index of -0,03 and -0.03 respectively. In rural areas, there would likely be an eight times greater reduction in maternal deaths than in urban areas and a five times greater reduction in child deaths than in urban areas. Conclusions Scaling up priority maternal and child health interventions to equal levels would potentially save far more lives in the poorest populations, and would accelerate equitable progress towards maternal and child health MDGs. The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production. British Medical Bulletin Volume 104 Issue 1 December 2012 http://bmb.oxfordjournals.org/content/current [Reviewed earlier; No relevant content] British Medical Journal 05 January 2013 (Vol 346, Issue 7889)

http://www.bmj.com/content/346/7889 Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study BMJ 2013;345:e7594 (Published 28 December 2012) Abstract – Open Access Article Objective To assess the risk of epileptic seizures in people with and without epilepsy after vaccination with a monovalent AS03 adjuvanted pandemic A/H1N1 influenza vaccine (Pandemrix; Glaxo SmithKline, Sweden). Design Register based self controlled case series. Setting Three Swedish counties (source population 750 000). Participants 373 398 people (age 0-106, median 41.2) who were vaccinated. Vaccinated people with epileptic seizures, diagnosed as inpatients or outpatients, at any time from 90 days before until 90 days after any dose of vaccine. Main outcome measures Endpoints were admission to hospital or outpatient hospital care with epileptic seizures as the main diagnosis. The effect estimate of relative incidence was calculated as the incidence of epileptic seizures in period after exposure relative to the incidence of epileptic seizures in two control periods, one before and one after vaccination. Results 859 people experienced epileptic seizures during the study period. There was no increased risk of seizures in people with previously diagnosed epilepsy (relative incidence 1.01, 95% confidence interval 0.74 to 1.39) and a non-significant decrease in risk for people without epilepsy (0.67, 0.27 to 1.65) during the day 1-7 risk period (where day 1 is the day of vaccination). In a second risk period (day 8-30), there was a non-significant increased risk of seizures in people without epilepsy (1.11, 0.73 to 1.70) but no increase in risk for those with epilepsy (1.00, 0.83 to 1.21). Conclusions This study found no evidence of an increase in risk of presentation to hospital with epileptic seizures after vaccination with a monovalent AS03 adjuvanted pandemic H1N1 influenza vaccine. Bulletin of the World Health Organization Volume 91, Number 1, January 2013, 1-80 http://www.who.int/bulletin/volumes/90/12/en/index.html EDITORIALS Universal health coverage anchored in the right to health Gorik Ooms, Claire Brolan, Natalie Eggermont, Asbjørn Eide, Walter Flores, Lisa Forman, Eric A Friedman, Thomas Gebauer, Lawrence O Gostin, Peter S Hill, Sameera Hussain, Martin McKee, Moses Mulumba, Faraz Siddiqui, Devi Sridhar, Luc Van Leemput, Attiya Waris & Albrecht Jahn doi: 10.2471/BLT.12.115808 Bulletin of the World Health Organization 2013;91:2-2A. doi: 10.2471/BLT.12.115808 European Commissioner for Development Andris Piebalgs recently pointed out the need for “updated and modernised [Millennium Development Goals], providing decent living standards for all – a set of minimum floors below which no one should fall”.1 He added that “these ‘MDGs plus’ would provide the basic rights that every citizen on the planet should expect … with, where necessary, for the poorest countries, the support of the international community through continued overseas development assistance”.1 We concur with Commissioner Piebalgs’ demand for basic rights for all people and feel that the right to health and its imperative of narrowing health inequities should be central to the

post-2015 international health agenda. We take this stand as members of Go4Health, a consortium of academics and members of civil society tasked with advising the European Commission on the international health-related goals to follow the Millennium Development Goals (MDGs). What does this mean, given that the present MDGs on maternal health, child health and infectious disease control will probably be succeeded by the goal of universal health coverage, defined by the World Health Organization (WHO) as universal coverage with needed health services and financial risk protection?2,3 First, we view an aggregate health goal such as universal health coverage as an improvement over the current set of disparate goals. Ensuring the right to health requires a comprehensive approach. Universal health coverage anchored in the right to health, while building on efforts to meet the present health-related MDGs, would raise the bar for improving health care overall. Second, although we support making universal health care one of the post-2015 development goals, we feel that universal health coverage is not enough, as defined by WHO and typically conceived,3 to ensure the right to health. For the right to health to become a reality, policymakers must strive for a healthy physical and social environment (e.g. safe drinking water and good sanitation, adequate nutrition and housing, safe and healthy occupational and environmental conditions and gender equality.)4 These “underlying determinants of health” are partially captured in the present MDGs and their corresponding targets, although under different goals (e.g. nutrition under MDG 1, to eradicate extreme hunger and poverty, and water and sanitation under MDG 7, to promote environmental sustainability). These determinants and many more that are needed for a sustainable healthy environment should figure prominently in the post-2015 health agenda. Third, specifying people’s entitlements is necessary but not enough. One important reason for the failure to attain all MDGs is the ambiguity of the “shared responsibility” mentioned in Article 2 of the Millennium Declaration: “We recognize that, in addition to our separate responsibilities to our individual societies, we have a collective responsibility to uphold the principles of human dignity, equality and equity at the global level.”5 If we want “every citizen on the planet” to claim his or her right to health, the post-2015 health agenda must specify how citizens will participate in the decision-making processes surrounding their health services and their physical and social environment. Furthermore, the agenda should also explicitly describe the accountability mechanisms that will make it possible for people to claim – not beg for – additional national public resources and international assistance, if needed. Finally, we are concerned not just about the substance of the post-2015 health goals, but also about the process of formulating them. We have entered a post-2015 frenzy, as evidenced by the appointment of a high-level panel expected to submit a report to the United Nations Secretary-General in the first half of 2013.6 Go4Health is committed to ensuring that any post2015 health development goals are articulated in collaboration with the communities whose health is at stake. However, truly participatory consultations take time and require a continuing relationship among researchers, governments and those communities. Such an approach should be adopted to prevent goals from being formulated by policy elites after token and superficial consultations, which would be at odds with the rights that must underpin the new goals. References - Piebalgs A. Achieving the MDGs and looking to the future. Luxembourg: European Commission; 2012. Available from: http://europa.eu/rapid/press-release_SPEECH-12707_en.htm [accessed 30 November 2012]. - Evans DB, Marten R, Etienne C. Universal health coverage is a development issue. Lancet 2012; 380: 864-5 doi: 10.1016/S0140-6736(12)61483-4 pmid: 22959373.

- World Health Organization [Internet]. Positioning health in the post-2015 development agenda. Geneva: WHO; 2012. Available from: http://www.who.int/topics/millennium_development_goals/post2015/en/ [accessed 30 November 2012]. - General Comment No. 14. The right to the highest attainable standard of health. In: Twentysecond session, Committee on Economic, Social and Cultural Rights, Geneva, 25 April–12 May 2000 [Internet]. Geneva: CESCR; 2000 (E/C.12/2000/4). Available from: http://www2.ohchr.org/english/bodies/cescr/ [accessed 30 November 2012]. - Resolution 55/2. United Nations Millennium Declaration. In: Fifty-fifth United Nations General Assembly, New York, 5–8 September 2000 [Internet]. New York: United Nations; 2000 (A/RES/55/2). Available from: https://www.un.org/ga/55/ [accessed 30 November 2012]. - United Nations Secretary-General [Internet]. Secretary-General assembles high-level panel on post-2015 development agenda: appointing 26 members of government, civil society, private sector (press release). New York: Department of Public Information, News and Media Division; 31 July 2012. Available from: http://www.un.org/News/Press/docs/2012/sga1364.doc.htm [accessed 30 November 2012]. PERSPECTIVES Vaccine Presentation and Packaging Advisory Group: a forum for reaching consensus on vaccine product attributes Osman David Mansoor, Debra Kristensen, Andrew Meek, Simona Zipursky, Olga Popovaa, InderJit Sharma, Gisele Miranda, Jules Millogo & Heidi Lasher doi: 10.2471/BLT.12.110700 “…Conclusion The VPPAG is an important forum where stakeholders from the vaccine industry and immunization programmes interact to discuss in depth vaccine product characteristics and their impact on immunization programmes. Already, the VPPAG has brought about meaningful changes in the way vaccines are packaged and presented for developing country programmes. (The group’s 2008 terms of reference,18 current gPPP24 and a profile previously completed for the pneumococcal vaccine19 are available for download on WHO’s web site.) The VPPAG could provide a model for organizations struggling to meet the needs of markets in both high- and low-income countries. Such organizations would benefit from feedback on product characteristics that could improve product applicability in markets with different infrastructures, and consumers in developing countries could benefit from access to a wider array of suitable products without unnecessary delay. Having a forum that allows constructive dialogue between the public and private sector furthers our shared goal of preventing disease, disability and death from vaccine-preventable diseases by designing products that can more easily reach those who will most benefit from immunization.” Cost Effectiveness and Resource Allocation (Accessed 5 January 2013) http://www.resource-allocation.com/ [No new relevant content] Emerging Infectious Diseases Volume 19, Number 1—January 2013 http://www.cdc.gov/ncidod/EID/index.htm

[Reviewed earlier] Eurosurveillance Volume 18, Issue 1, 03 January 2013 http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678 [No relevant content] Global Health Governance Volume VI, Issue 1: Fall 2012 – December 31, 2012 http://blogs.shu.edu/ghg/2012/12/31/volume-vi-issue-1-fall-2012/ Improving United Nations Funding to Strengthen Global Health Governance- Amending the Helms – Biden Agreement Timothy K. Mackey and Thomas E. Novotny Abstract Global health governance is widely considered fragmented after more than a decade of inconsistent support for multi-lateral organizations and faced with the emergence of many new global health donors and non-state enterprises. This paper addresses a series of events marked by enactment of the Helms-Biden agreement in 1999. This legislation ensured that United States funding for the United Nations was to be conditional upon reforms and reductions of U.S. assessments. Although passage of the legislation allowed its largest contributor/debtor to pay back arrears and continue payments going forward, it also represented a growing trend in U.S. unilateralism and disengagement from support for multi-national organizations. In particular, continued arrears and budgetary restrictions have affected specialized U.N. agencies such as the World Health Organization. This agency has experienced a zero nominal growth budget that may have impacted its governance capacity. We review the potential impact of the Helms-Biden legislation on WHO governance, and suggest that the governance of this important global health agency may benefit from its timely repeal. Human Rights and Global Health Funding- What Contribution Can the Right to Health Make to Sustaining and Extending International Assistance for Health Lisa Forman, Donald C. Cole, Gorik Ooms, and Merrick Zwarenstein Abstract Global health funding has experienced dramatic growth over the past decades, rising to unprecedented levels through the 2000s. Since the onset of the 2008 global recession, funding growth has significantly slowed down and in some cases regressed. In this paper we argue that the right to health and a rights-based approach to health may offer important norms, strategies and tools to sustain, supplement, and advance global health funding and to thereby mitigate persisting inter- and intra-country health inequities. This paper interrogates this thesis through the legal framework of the right to health, the theoretical perspective of social constructivism, and practical strategies where human rights have contributed towards progressive health outcomes within countries and in global fora. While many new institutional global health funders are non-state actors and therefore weakly bound under international human rights law, the predominant source of funding still comes from states, which are the primary human rights duty-bearers under international law. Accordingly, we argue that states hold international responsibilities to cooperate and assist in realizing the right to health in low and middle income countries (LMICs) and that this duty extends to providing international assistance for health. We

set out five paths by which use of the human right to health might directly and indirectly advance funding for health and health services at the domestic and global levels: including rights-based litigation, rights-based social advocacy, development of the ethical content of the right to health, use of rights-based approaches to monitor and promote the right to health, and developing a new legal paradigm of funding essential health services globally. We conclude that human rights and the right to health can offer important tools to health policy-makers and civil society actors alike to address inadequate resource allocations to health at various levels.

Globalization and Health [Accessed 5 January 2013] http://www.globalizationandhealth.com/ [No new relevant content] Health Affairs December 2012; Volume 31, Issue 12 http://content.healthaffairs.org/content/current Theme: Topics In Public Health, Medicare Advantage, Health Reform Post Election [No specific relevant content on vaccines/immunization] Health and Human Rights Vol 14, No 2 (2012) http://hhrjournal.org/index.php/hhr [Reviewed earlier] Health Economics, Policy and Law Volume7 / Issue04 / October 2012, pp 383 - 384 http://journals.cambridge.org/action/displayIssue?jid=HEP&tab=currentissue Special Issue: End of Life Care and Evaluation [Reviewed earlier; No specific relevant content on vaccines/immunization] Health Policy and Planning Volume 27 Issue 8 December 2012 http://heapol.oxfordjournals.org/content/current [Reviewed earlier] Human Vaccines & Immunotherapeutics (formerly Human Vaccines) Volume 9, Issue 1 January 2013 http://www.landesbioscience.com/journals/vaccines/toc/volume/9/issue/1/ REVIEWS Nicotine vaccines to treat tobacco dependence Maciej L. Goniewicz and Marcin Delijewski http://dx.doi.org/10.4161/hv.22060

Abstract: Tobacco smoking is globally far more widespread than use of any other substance of abuse. Nicotine is an important tobacco constituent that is responsible for addictive properties of smoking. The currently available medications for the treatment of nicotine addiction have limited efficacy. A challenging novel therapeutic concept is vaccination against nicotine. An efficient vaccine would generate antibodies that sequester nicotine in the blood and prevent its access to the brain. The vaccine would have great potential for treating nicotine addiction and for relapse prevention. We reviewed the current status of vaccines against nicotine addiction that are undergoing clinical trials or are in preclinical development. We discuss problems associated with the development of nicotine vaccines, their efficacy in addiction treatment, challenges and ethical concerns. Existing evidence indicates that nicotine vaccination is well tolerated and capable of inducing an immune response but its effectiveness in increasing smoking abstinence has not been shown so far. Reviews Plant-derived virus-like particles as vaccines Qiang Chen and Huafang Lai http://dx.doi.org/10.4161/hv.22218 Abstract: Virus-like particles (VLPs) are self-assembled structures derived from viral antigens that mimic the native architecture of viruses but lack the viral genome. VLPs have emerged as a premier vaccine platform due to their advantages in safety, immunogenicity, and manufacturing. The particulate nature and high-density presentation of viral structure proteins on their surface also render VLPs as attractive carriers for displaying foreign epitopes. Consequently, several VLPbased vaccines have been licensed for human use and achieved significant clinical and economical success. The major challenge, however, is to develop novel production platforms that can deliver VLP-based vaccines while significantly reducing production times and costs. Therefore, this review focuses on the essential role of plants as a novel, speedy and economical production platform for VLP-based vaccines. The advantages of plant expression systems are discussed in light of their distinctive posttranslational modifications, cost-effectiveness, production speed, and scalability. Recent achievements in the expression and assembly of VLPs and their chimeric derivatives in plant systems as well as their immunogenicity in animal models are presented. Results of human clinical trials demonstrating the safety and efficacy of plantderived VLPs are also detailed. Moreover, the promising implications of the recent creation of “humanized” glycosylation plant lines as well as the very recent approval of the first plant-made biologics by the U. S. Food and Drug Administration (FDA) for plant production and commercialization of VLP-based vaccines are discussed. It is speculated that the combined potential of plant expression systems and VLP technology will lead to the emergence of successful vaccines and novel applications of VLPs in the near future. RESEARCH PAPERS Human papillomavirus vaccine uptake, knowledge and attitude among 10th grade students in Berlin, Germany, 2010 Petra Stöcker, Manuel Dehnert, Melanie Schuster, Ole Wichmann and Yvonne Deleré http://dx.doi.org/10.4161/hv.22192 Abstract Purpose: Since March 2007, the Standing Committee on Vaccination (STIKO) recommends HPV vaccination for all 12–17 y-old females in Germany. In the absence of an immunization register,

we aimed at assessing HPV-vaccination coverage and knowledge among students in Berlin, the largest city in Germany, to identify factors influencing HPV-vaccine uptake. Methods: Self-administered questionnaires were distributed to 10th grade school students in 14 participating schools in Berlin to assess socio-demographic characteristics, knowledge, and statements on vaccinations. Vaccination records were reviewed. Multivariable statistical methods were applied to identify independent predictors for HPV-vaccine uptake among female participants. Results: Between September and December 2010, 442 students completed the questionnaire (mean age 15.1; range 14–19). In total 281/442 (63.6%) students specified HPV correctly as a sexually transmitted infection. Of 238 participating girls, 161 (67.6%) provided their vaccination records. Among these, 66 (41.0%) had received the recommended three HPV-vaccine doses. Reasons for being HPV-unvaccinated were reported by 65 girls: Dissuasion from parents (40.2%), dissuasion from their physician (18.5%), and concerns about side-effects (30.8%) (multiple choices possible). The odds of being vaccinated increased with age (Odds Ratio (OR) 2.19, 95% Confidence Interval (CI) 1.16, 4.15) and decreased with negative attitude toward vaccinations (OR = 0.33, 95%CI 0.13, 0.84). Conclusions: HPV-vaccine uptake was low among school girls in Berlin. Both, physicians and parents were influential regarding their HPV-vaccination decision even though personal perceptions played an important role as well. School programs could be beneficial to improve knowledge related to HPV. SHORT REPORT Trust and the demand for autonomy may explain the low rates of immunizations among nurses Orna Baron-Epel, Batya Madjar, Rami Gerfat and Shmuel Rishpon http://dx.doi.org/10.4161/hv.22503V and vaccines, and to offer low-barrier access to HPV vaccination. Abstract: Rates of vaccinations of healthcare workers with recommended vaccines are generally low in the developed countries. Our goals were to identify attitudes associated with self-reported vaccinations against pertussis and seasonal influenza among Israeli nurses in Mother and Child Healthcare Centers (MCHC) in the Haifa District. Over 100 nurses answered a self-administered questionnaire. Forty two percent of the nurses reported receiving the pertussis vaccine in the last five years and 44% reported receiving the influenza vaccine during the previous year. Attitudes toward the importance of vaccinating nurses, trust in the public health authorities and demand for autonomy were associated with receiving the pertussis vaccine. Attitudes toward the importance of vaccinating nurses and trust were associated with receiving the influenza vaccine in a bivariant analysis. However, in the logistic regression models only attitudes toward the importance of vaccinating nurses were associated with vaccinations [odds ratio (OR)- 3.66, 95% confidence interval (CI)- 1.4–9.6 for pertussis and OR- 4.53, CI-1.6–13.0 for influenza]. Jewish nurses reported more often receiving the influenza vaccine compared with the Arab nurses, whereas there was no difference between them in receiving the pertussis vaccine. Low levels of positive attitudes toward the importance of vaccinating nurses may inhibit nurses in MCHC from receiving vaccines. The demand for autonomy and low levels of trust may, in part, form these low levels of positive attitudes toward the importance of vaccinating nurses.

Infectious Diseases of Poverty 2012, 1 http://www.idpjournal.com/content [Accessed 5 January 2013] [No new relevant content] International Journal of Infectious Diseases December 2012, Vol. 16, No. 12 http://www.ijidonline.com/ [Reviewed earlier] JAMA http://jama.ama-assn.org/current.dtl January 02, 2013, Vol 309, No. 1 [No relevant content] December 26, 2012, Vol 308, No. 24 [No relevant content] Journal of Health Organization and Management Volume 26 issue 6 - Published: 2012 http://www.emeraldinsight.com/journals.htm?issn=1477-7266&show=latest [Reviewed earlier; No relevant content] Journal of Infectious Diseases Volume 207 Issue 3 February 1, 2013 http://www.journals.uchicago.edu/toc/jid/current [No relevant content] Journal of Global Infectious Diseases (JGID) October-December 2012 Volume 4 | Issue 4 Page Nos. 187-224 http://www.jgid.org/currentissue.asp?sabs=n [Reviewed earlier; No relevant content] Journal of Medical Ethics January 2013, Volume 39, Issue 1 http://jme.bmj.com/content/current [Reviewed earlier]

Journal of Medical Microbiology January 2013; 62 (Pt 1) http://jmm.sgmjournals.org/content/current [Reviewed earlier; No relevant content] Journal of the Pediatric Infectious Diseases Society (JPIDS) Volume 1 Issue 4 December 2012 http://jpids.oxfordjournals.org/content/current [Reviewed earlier] The Lancet Jan 05, 2013 Volume 381 Number 9860 p1 - 88 http://www.thelancet.com/journals/lancet/issue/current Editorial Global polio eradication: not there yet The Lancet On Dec 31, the world missed the deadline for the 24-year-old Global Polio Eradication Initiative to halt all wild poliovirus transmission by the end of 2012. Set in 1988, WHO's original target—global eradication of polio by the year 2000—has been extended several times. With only 215 cases reported worldwide as of Dec 26, 2012—an encouraging contrast to 650 cases in 2011—success seemed close. But recently, the global effort to eradicate polio has suffered devastating setbacks. In midDecember, nine health workers were shot dead while travelling from house to house to administer polio vaccine to children during the national anti-polio campaign in Pakistan. And on Jan 1, six female Pakistani aid workers and a male doctor were shot dead. The brutal attacks took place in several locations, including Khyber Pakhtunkhwa province, which in 2012 accounted for more than 40% of all Pakistan's polio cases and 46% of Pakistan's infected towns and districts; Karachi, the largest city in Pakistan with a population of 18 million; and Sindh province. The killing of the health workers was condemned as “senseless and inexcusable” by UN Secretary-General, Ban Ki-moon. Owing to the safety concerns, the UN was forced to halt its participation in the vaccination campaign, and the campaign itself has been suspended temporarily by the Government of Pakistan and the affected provinces. In this tragedy, women and children are the main victims. Most of the health workers who were killed were women, and the youngest was a schoolgirl aged 17 years. Female health workers are standing fearlessly and selflessly on the frontline of Pakistan's war against polio, because culturally only women are allowed to enter into houses to talk to mothers and vaccinate their children. Last June, in Federally Administered Tribal Areas, the Pakistani Taliban banned polio vaccination in retaliation for the use of unmanned drones by the USA. It is of deep concern that women who stand for something big have become the Pakistani Taliban's target. Female polio health workers are one example; the schoolgirl Malala Yousafzai, whom the Taliban shot in the head in October for campaigning for access to education—another essential ingredient in promoting children's health—is another. More than 3.5 million Pakistani children have missed vaccinations as a result of the campaign's suspension. “Such attacks deprive Pakistan's most vulnerable populations—especially children—of basic life-saving health interventions”, said WHO and UNICEF in a joint statement.

The effect of the killing of polio vaccine workers in Pakistan will have repercussions for its neighbour Afghanistan, which, together with Pakistan itself and Nigeria, is one of the remaining polio-endemic countries. Genetic analysis shows that two of the three chains of polio transmission in Afghanistan are from Pakistan. Other neighbouring countries have also been put at risk. For instance, polio broke out in China in 2011 for the first time since 1999 after being imported from Pakistan; 18 people were paralysed and one died. Heidi Larson, an anthropologist who studies public trust in vaccines and immunisation at the London School of Hygiene and Tropical Medicine, pointed out that the killings of health workers in Pakistan could be a “game changer” in the global efforts to eradicate polio, calling for a rethink of delivery strategies. She compared it with the 2003—04 immunisation boycott in northern Nigeria, led by religious and political leaders, who claimed that the oral polio vaccine could cause sterility. This boycott led to poliovirus not only rebounding in Nigeria, but also spreading to 15 African countries and to Indonesia. The boycott and its effect prompted discussions between WHO, the Organization of Islamic States, and local religious leaders to help address the rumours and contain the further spread of polio. Indeed, the insecurity of and inaccessibility to vaccination have become the major impediments to the final push for polio eradication. Last year, Kathleen O'Reilly and colleagues reported in The Lancet the effect of mass immunisation campaigns and new oral poliovirus vaccines on the incidence of polio in Pakistan and Afghanistan. They reported that decreases in vaccination coverage in parts of Pakistan and southern Afghanistan had severely restricted the effectiveness of bivalent oral poliovirus vaccines. To eradicate polio, the work that the brave polio health workers died for must be continued in 2013. Furthermore, it is imperative not only to ensure immunisation workers' security, but also to address the determinants behind the shooting of polio health workers—ie, to win the hearts of the public, to go beyond the “polio only” agenda, and to enhance polio vaccination's integration into the routine health and immunisation programme. The Lancet Infectious Disease Jan 2013 Volume 13 Number 1 p1 - 96 http://www.thelancet.com/journals/laninf/issue/current [Reviewed earlier] Medical Decision Making (MDM) November–December 2012; 32 (6) http://mdm.sagepub.com/content/current [Reviewed earlier] The Milbank Quarterly A Multidisciplinary Journal of Population Health and Health Policy December 2012 Volume 90, Issue 4 Pages 631–807 http://onlinelibrary.wiley.com/doi/10.1111/milq.2012.90.issue-4/issuetoc [Reviewed earlier] Nature Volume 493 Number 7430 pp5-128 3 January 2013

http://www.nature.com/nature/current_issue.html [No relevant content] Nature Immunology January 2013, Volume 14 No 1 pp1-99 http://www.nature.com/ni/journal/v14/n1/index.html [Reviewed earlier; No relevant content] Nature Medicine December 2012, Volume 18 No 12 pp1717-1857 http://www.nature.com/nm/journal/v18/n12/index.html [Reviewed earlier] Nature Reviews Immunology January 2013 Vol 13 No 1 http://www.nature.com/nri/journal/v13/n1/index.html [No relevant content] New England Journal of Medicine January 3, 2013 Vol. 368 No. 1 http://content.nejm.org/current.shtml Review Article - Global Health Disease Eradication Donald R. Hopkins, M.D., M.P.H. N Engl J Med 2013; 368:54-63 January 3, 2013 DOI: 10.1056/NEJMra1200391 Extract “Since the last case of naturally occurring smallpox, in 1977, there have been three major international conferences devoted to the concept of disease eradication.1-3 Several other diseases have been considered as potential candidates for eradication,4 but the World Health Organization (WHO) has targeted only two other diseases for global eradication after smallpox. In 1986, WHO's policymaking body, the World Health Assembly, adopted the elimination of dracunculiasis (guinea worm disease) as a global goal,5 and it declared the eradication of poliomyelitis a global goal in 1988.6 Although both diseases now appear to be close to eradication, the fact that neither goal has been achieved after more than two decades, and several years beyond the initial target dates for their eradication, underscores the daunting challenge of such efforts, as does the failure of previous attempts to eradicate malaria, hookworm, yaws, and other diseases.1…” Editorial A Global View of Health — An Unfolding Series Harvey V. Fineberg, M.D., Ph.D., and David J. Hunter, M.B., B.S., Sc.D., M.P.H. N Engl J Med 2013; 368:78-79January 3, 2013DOI: 10.1056/NEJMe1208801 Extract “This issue of the Journal includes the first article in a series of review articles on global health.1 In a journal that proudly bears the name of a U.S. domestic region, this series will

show that local health and local health care are linked to sources of ill health elsewhere in the world. Today, not only are health problems global, but lessons, insights, and fresh solutions regarding such problems flow in all directions. The series is built around articles that explain the need for global health, the challenges to achieving it, and the solutions to problems related to it…” OMICS: A Journal of Integrative Biology December 2012, 16(12) http://online.liebertpub.com/toc/omi/16/12 [Reviewed earlier; No relevant content] The Pediatric Infectious Disease Journal January 2013 - Volume 32 - Issue 1 pp: A13-A14,1-98,e1-e44 http://journals.lww.com/pidj/pages/currenttoc.aspx Original Studies Potential Intussusception Risk Versus Benefits of Rotavirus Vaccination in the United States Desai, Rishi; Cortese, Margaret M.; Meltzer, Martin I.; Shankar, Manjunath; Tate, Jacqueline E.; Yen, Catherine; Patel, Manish M.; Parashar, Umesh D. Pediatric Infectious Disease Journal. 32(1):1-7, January 2013. doi: 10.1097/INF.0b013e318270362c Abstract: Background: International data show a low-level increased risk of intussusception associated with rotavirus vaccination. Although US data have not documented a risk, we assumed a risk similar to international settings and compared potential vaccine-associated intussusception cases with benefits of prevention of rotavirus gastroenteritis by a fully implemented US rotavirus vaccine program. Methods: To calculate excess intussusception cases, we used national data on vaccine coverage and baseline intussusception rates, and assumed a vaccine-associated intussusception relative risk of 5.3 (95% confidence interval [CI]: 3.0–9.3) in the first week after the first vaccine dose, the risk seen in international settings. We used postlicensure vaccine effectiveness data to calculate rotavirus disease burden averted. Results: For a US birth cohort of 4.3 million infants, vaccine-associated intussusception could cause an excess 0.2 (range: 0.1–0.3) deaths, 45 (range: 21–86) hospitalizations and 13 (range: 6–25) cases managed in short-stay or emergency department settings. Vaccination would avert 14 (95% CI: 10–19) rotavirus-associated deaths, 53,444 (95% CI: 37,622–72,882) hospitalizations and 169,949 (95% CI: 118,161–238,630) emergency department visits. Summary benefit–risk ratios for death and hospitalization are 71:1 and 1093:1, respectively. Conclusions: The burden of severe rotavirus disease averted due to vaccination compared with the vaccine-associated intussusception events offers a side-by-side analysis of the benefits and potential risks. If an intussusception risk similar to that seen internationally exists in the United States, it is substantially exceeded by the benefits of rotavirus disease burden averted by vaccination. Factors Affecting Human Papillomavirus Vaccine Use Among White, Black and Latino Parents of Sons

Perkins, Rebecca B.; Apte, Gauri; Marquez, Cecilia; Porter, Courtney; Belizaire, Myrdell; Clark, Jack A.; Pierre-Joseph, Natalie Pediatric Infectious Disease Journal. 32(1):e38-e44, January 2013. doi: 10.1097/INF.0b013e31826f53e3 Abstract: Background: Although human papillomavirus (HPV) vaccination has been available for males since 2009, its uptake remains low. In light of new recommendations for universal vaccination of males, understanding parental attitudes toward this vaccine is important. This study aimed to describe HPV-related knowledge and intention to accept HPV vaccination among White, Black and Latino parents of sons and to assess vaccination rates among their sons. Methods: We interviewed parents (68 Black, 28 Latino and 24 White; mean age, 43.5) of sons (mean age, 14) attending an urban academic medical center and a community health center. Eligible parents self-identified as White, Black or Latino and spoke English, Spanish or HaitianCreole. We collected demographic information, knowledge related to HPV vaccination, parents’ intent to vaccinate sons and HPV vaccination rates. Descriptive statistics and multivariable logistic regression were used to describe data. Results: Most parents were mothers, married, expressed a religious affiliation and had completed high school or college. Parents had limited knowledge about HPV; White parents were more knowledgeable than Black parents. Most parents (75%) intended to accept HPV vaccination if recommended by physicians; no racial differences were noted. However, only 30% of sons were vaccinated. Logistic regression indicated that internet use was negatively associated with intention to vaccinate. Intention to vaccinate, clinical site of care and having an older son were associated with vaccine receipt. Conclusions: Although parents in our study had limited understanding of HPV disease in males, most would vaccinate their sons if recommended by their physicians. Pediatrics January 2013, VOLUME 131 / ISSUE 1 http://pediatrics.aappublications.org/current.shtml Monthly Feature Children’s Rights and Community Well-Being William J. Keenan, MD Pediatrics 2013; 131:3-4 [No abstract] Introductory Commentary Why would anyone, anywhere, question the importance of protective rights for children? Why would anyone, anywhere, question the profound effect children’s rights have on community well-being? In this column, Dr Keenan describes the history and current status of children’s rights and challenges us to advocate for fuller implementation of those rights based on wellestablished principles that are based in good public policy and science. Clearly, children do not have the ability to make all the decisions affecting their optimal health and life success. Adults must decide how children are cared for and how we should vest authority and power to ensure that every child’s best possible outcome is achieved. Concerns should exist when policies and governmental structures become repressive and become exploitive. Children everywhere deserve to be treated as valued members in society and, when developmentally possible, participate in making life choices to their own benefit. —Jay E. Berkelhamer, MD, FAAP

Pharmacoeconomics December 1, 2012 - Volume 30 - Issue 12 pp: 1097-1214 http://adisonline.com/pharmacoeconomics/pages/currenttoc.aspx [Reviewed earlier; No relevant content] PLoS One [Accessed 5 January 2013] http://www.plosone.org/ Low Rate of Pandemic A/H1N1 2009 Influenza Infection and Lack of Severe Complication of Vaccination in Pregnant Women: A Prospective Cohort Study Odile Launay, Anne Krivine, Caroline Charlier, Van Truster, Vassilis Tsatsaris, Jacques Lepercq, Yves Ville, Carolyn Avenell, Thibaut Andrieu, Flore Rozenberg, Florence Artiguebielle, Jean-Marc Tréluyer, François Goffinet, Inserm COFLUPREG Study Group Research Article | published 27 Dec 2012 | PLOS ONE 10.1371/journal.pone.0052303 Abstract Background In 2009, pregnant women were specifically targeted by a national vaccination campaign against pandemic A/H1N1 influenza virus. The objectives of the COFLUPREG study, initially set up to assess the incidence of serious forms of A/H1N1 influenza, were to assess the consequences of maternal vaccination on pregnancy outcomes and maternal seroprotection at delivery. Methods Pregnant women, between 12 and 35 weeks of gestation, non vaccinated against A/H1N1 2009 influenza were randomly selected to be included in a prospective cohort study conducted in three maternity centers in Paris (France) during pandemic period. Blood samples were planned to assess hemagglutination inhibition (HI) antibody against A/H1N1 2009 influenza at inclusion and at delivery. Results Among the 877 pregnant women included in the study, 678 (77.3%) had serum samples both at inclusion and delivery, and 320 (36.5%) received pandemic A/H1N1 2009 influenza vaccine with a median interval between vaccination and delivery of 92 days (95% CI 48–134). At delivery, the proportion of women with seroprotection (HI antibodies titers against A/H1N1 2009 influenza of 1:40 or greater) was 69.9% in vaccinated women. Of the 422 non-vaccinated women with serological data, 11 (2.6%; 95%CI: 1.3–4.6) had laboratory documented A/H1N1 2009 influenza (1 with positive PCR and 10 with serological seroconversion). None of the 877 study’s women was hospitalized for flu. No difference on pregnancy outcomes was evidenced between vaccinated women, non-vaccinated women without seroconversion and nonvaccinated women with flu. Conclusion Despite low vaccine coverage, incidence of pandemic flu was low in this cohort of pregnant women. No effect on pregnancy and delivery outcomes was evidenced after vaccination. PLoS Medicine (Accessed 5 January 2013) http://www.plosmedicine.org/

[No new relevant content] PLoS Neglected Tropical Diseases December 2012 http://www.plosntds.org/article/browseIssue.action Research Article Effectiveness of the Viet Nam Produced, Mouse Brain-Derived, Inactivated Japanese Encephalitis Vaccine in Northern Viet Nam Florian Marks, Thi Thu Yen Nguyen, Nhu Duong Tran, Minh Hong Nguyen, Hai Ha Vu, Christian G. Meyer, Young Ae You, Frank Konings, Wei Liu, Thomas F. Wierzba, Zhi-Yi Xu Background Japanese encephalitis (JE) is a flaviviral disease of public health concern in many parts of Asia. JE often occurs in large epidemics, has a high case-fatality ratio and, among survivors, frequently causes persistent neurological sequelae and mental disabilities. In 1997, the Vietnamese government initiated immunization campaigns targeting all children aged 1–5 years. Three doses of a locally-produced, mouse brain-derived, inactivated JE vaccine (MBV) were given. This study aims at evaluating the effectiveness of Viet Nam's MBV. Methodology A matched case-control study was conducted in Northern Viet Nam. Cases were identified through an ongoing hospital-based surveillance. Each case was matched to four healthy controls for age, gender, and neighborhood. The vaccination history was ascertained through JE immunization logbooks maintained at local health centers. Principal Findings Thirty cases and 120 controls were enrolled. The effectiveness of the JE vaccine was 92.9% [95% CI: 66.6–98.5]. Confounding effects of other risk variables were not observed. Conclusions Our results strongly suggest that the locally-produced JE-MBV given to 1–5 years old Vietnamese children was efficacious. PNAS - Proceedings of the National Academy of Sciences of the United States of America (Accessed 5 January 2013) http://www.pnas.org/content/early/recent [No new relevant content] Public Health Ethics Volume 5 Issue 3 November 2012 http://phe.oxfordjournals.org/content/current [Reviewed earlier] Trends in Molecular Medicine Volume 19, Issue 1, Pages 1-70 (January 2013) http://www.sciencedirect.com/science/journal/14714914 [No relevant content]

Science 4 January 2013 vol 339, issue 6115, pages 1-112 http://www.sciencemag.org/current.dtl [No relevant content] Science Translational Medicine 2 January 2013 vol 5, issue 166 http://stm.sciencemag.org/content/current [No relevant content] Vaccine Volume 31, Issue 3, Pages 439-566 (7 January 2013) http://www.sciencedirect.com/science/journal/0264410X Immune responses and protection in children in developing countries induced by oral vaccines Review Article Pages 452-460 Firdausi Qadri, Taufiqur Rahman Bhuiyan, David A. Sack, Ann-Mari Svennerholm Abstract Oral mucosal vaccines have great promise for generating protective immunity against intestinal infections for the benefit of large numbers of people especially young children. There however appears to be a caveat since these vaccines have to overcome the inbuilt resistance of mucosal surfaces and secretions to inhibit antigen stimulation and responses. Unfortunately, these vaccines are not equally immunogenic nor protective in different populations. When compared to industrialized countries, children living in developing countries appear to have lower responses, but the reasons for these lowered responses are not clearly defined. The most likely explanations relate to undernutrition, micronutrient deficiencies, microbial overload on mucosal surfaces, alteration of microbiome and microbolom and irreversible changes on the mucosa as well as maternal antibodies in serum or breast milk may alter the mucosal pathology and lower immune responses to interventions using oral vaccines. The detrimental effect of adverse environment and malnutrition may bring about irreversible changes in the mucosa of children especially in the first 1000 days of life from conception to after birth and up to two years of age. This review aims to summarize the information available on lowered immune responses to mucosal vaccines and on interventions that may help address the constraints of these vaccines when they are used for children living under the greatest stress and under harmful adverse circumstances. The potential economic value of a cutaneous leishmaniasis vaccine in seven endemic countries in the Americas Original Research Article Pages 480-486 Kristina M. Bacon, Peter J. Hotez, Stephanie D. Kruchten, Shaden Kamhawi, Maria Elena Bottazzi, Jesus G. Valenzuela, Bruce Y. Lee Abstract

Cutaneous leishmaniasis (CL) and its associated complications, including mucocutaneous leishmaniasis (MCL) and diffuse CL (DCL) have emerged as important neglected tropical diseases in Latin America, especially in areas associated with human migration, conflict, and recent deforestation. Because of the limitations of current chemotherapeutic approaches to CL, MCL, and DCL, several prototype vaccines are in different states of product and clinical development. We constructed and utilized a Markov decision analytic computer model to evaluate the potential economic value of a preventative CL vaccine in seven countries in Latin America: Bolivia, Brazil, Colombia, Ecuador, Mexico, Peru, and Venezuela. The results indicated that even a vaccine with a relatively short duration of protection and modest efficacy could be recommended for use in targeted locations, as it could prevent a substantial number of cases at low-cost and potentially even result in cost savings. If the population in the seven countries were vaccinated using a vaccine that provides at least 10 years of protection, an estimated 41,000–144,784 CL cases could be averted, each at a cost less than the cost of current recommended treatments. Further, even a vaccine providing as little as five years duration of protection with as little as 50% efficacy remains cost-effective compared with chemotherapy; additional scenarios resembling epidemic settings such as the one that occurred in Chaparral, Colombia in 2004 demonstrate important economic benefits. Voluntary reporting of health care personnel seasonal influenza vaccination rates and the impact of universal policies in Illinois hospitals Original Research Article Pages 514-517 Bonnie Paris, Tracey Arahood, Carl Asche, Gail Amundson Abstract Objective In 2009, voluntary public reporting of hospital health care personnel (HCP) vaccination rates began in Illinois. We describe our experience over 3 influenza seasons and examine the impact universal policies have had on performance. Methods A secure website was used to report monthly HCP vaccination rates by each participating hospital. Overall and individual hospital performance was publicly reported each month. Results In the first two seasons, there were 11 hospitals reporting with an average end of season rate of 76% (2009–2010) and 81% (2010–2011). In the 2011–2012 season, there were 22 hospitals reporting, 9 of which had a new universal policy for HCP influenza vaccination. The average 2011–2012 end of season rate was 72% for hospitals with a voluntary program and 95% for hospitals with a universal policy. HCP were also vaccinated earlier in the influenza season when a universal policy was in place, providing greater benefit over time. Influenza vaccination in Turkey: Prevalence of risk groups, current vaccination status, factors influencing vaccine uptake and steps taken to increase vaccination rate Original Research Article Pages 518-523 Meral Akcay Ciblak, Grip Platformu Abstract Influenza infections cause considerable morbidity and mortality not only during the pandemics but also during annual epidemics. Vaccines are the most effective tools for preventing the infection. Although World Health Organization (WHO) and Ministry of Health (MoH) recommends vaccination for people at increased risk, sales data indicate that vaccination rate remains low in Turkey. Vaccine recommended groups are well defined and reimbursed in

Turkey. However, the prevalence of people in risk groups, current vaccination rates and factors influencing vaccine uptake which are essential in order to develop and sustain effective strategies to increase vaccination rate are not documented. A thorough literature review was performed to determine the estimated number of people in risk groups, vaccination rates, factors influencing vaccine uptake in Turkey. Actions taken by the health authorities in order to increase the vaccine uptake among specified risk groups are also summarized. Based on the published prevalence rates, current study calculated that there are approximately 27 to 33 million people in risk groups. In addition, there are 428,000 health care providers serving in the public sector who are at increased risk for influenza infections. The lowest reported vaccination rate (5.9%) was in the elderly ≥65 years of age and the highest (27.3%) in patients with COPD. Finally, survey results indicated that leading factor negatively influencing vaccine uptake was disbelief in the effectiveness of vaccine. In order to increase vaccination coverage, vaccines are provided to health care providers free of charge and reimbursed for those in the risk groups. Realizing the fact that combating flu requires multidisciplinary collaboration, a stakeholder network, Grip Platformu, has been established in 2011 with the endorsement of the MoH to increase influenza awareness and vaccine coverage rates among risk groups in accordance with WHO recommendations. Waning immunity to measles in young adults and booster effects of revaccination in secondary school students Original Research Article Pages 533-537 Hanqing He, En-fu Chen, Qian Li, Zhifang Wang, Rui Yan, Jian Fu, Jinren Pan Abstract The increasing proportions of adult cases were observed in the recent measles outbreaks in Zhejiang Province, China. In order to identify the high-risk age groups of measles for targeted intervention, a seroprevalence survey of measles antibody was conducted among 1961 participants aged 0–60 years randomly selected by age-stratified purpose sampling, and the effect of revaccination program in secondary school was evaluated in Zhejiang Province. The adjusted overall seropositivity rate of measles was 88% (95% confidence interval [CI]: 86– 89%) with geometric mean titers (GMT), 976 ± 86 mIU/ml. The seropositivity rate of measles was significantly lower in subjects aged 15–19 years than aged 5–9 years (90% vs 96%, χ2 = 5.21, p = 0.022). Both seropositivity rate and GMT level of measles were higher in participants aged 10–14 years with ≥2 doses MCV than those with only 1 dose (95% vs 81%, 1276 mIU/ml vs 666 mIU/ml). The seropositivity rate increased from 91% to 100% after revaccination with MCV among 184 secondary school students. The proportions of measles cases aged ≥15 years were reduced gradually (χ2 = 55.47, p = 0.000) from 2009 to 2011 after implementing the revaccination campaign on secondary school students since 2008. Our findings strongly suggested that a revaccination opportunity with MCV for adolescents helps to improve the population immunity, and it can be conducted effectively and practically in secondary school students. Vaccine: Development and Therapy (Accessed 5 January 2013) http://www.dovepress.com/vaccine-development-and-therapy-journal [No new relevant content]

Value in Health Vol 15 | No. 8 | December 2012 | Pages 991-1192 http://www.valueinhealthjournal.com/current [Reviewed earlier]

From Google Scholar+: Dissertations, Theses, Selected Journal Articles
No new content.

Media Watch Beginning in June 2012, Vaccines: The Week in Review expanded to alert readers to substantive news, analysis and opinion from the general media on vaccines, immunization, global; public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology. We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. WE are conservative in our outlook of adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
BBC http://www.bbc.co.uk/ Accessed 5 January 2013 [No new, unique, relevant content] Economist http://www.economist.com/ Accessed 5 January 2013 [No new, unique, relevant content] Financial Times http://www.ft.com Accessed 5 January 2013 [No new unique, relevant content] Forbes http://www.forbes.com/ Accessed 5 January 2013 [No new unique, relevant content] Foreign Affairs http://www.foreignaffairs.com/ November/December 2012 Volume 91, Number 6

Accessed 5 January 2013 [No new unique, relevant content]
Foreign Policy http://www.foreignpolicy.com/ Accessed 5 January 2013] [No new unique, relevant content] The Guardian http://www.guardiannews.com/ Accessed 5 January 2013 [No new unique, relevant content] The Huffington Post http://www.huffingtonpost.com/ Accessed 5 January 2013 [No new, unique, relevant content] New Yorker http://www.newyorker.com/ Accessed 5 January 2013 [No new, unique, relevant content] NPR/National Public Radio [U.S.] Public Health Accessed 5 January 2013 [No new, unique, relevant content] New York Times http://www.nytimes.com/ Accessed 5 January 2013. [No new, unique, relevant content] Reuters http://www.reuters.com/ Accessed 5 January 2013 [No new, unique, relevant content] Wall Street Journal http://online.wsj.com/home-page Accessed 5 January 2013 [No new, unique, relevant content] Washington Post http://www.washingtonpost.com/ Accessed 5 January 2013 [No new, unique, relevant content]

Twitter Watch Items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and is by no means intended to be exhaustive.
Twitter Watch will resume next week. * * * *

Vaccines: The Week in Review is a service of the Center for Vaccines Ethics and Policy (CVEP) which is solely responsible for its content. Support for this service is provided by its governing institutions – Department of Medical Ethics, NYU Medical School; The Wistar Institute Vaccine Center and the Children’s Hospital of Philadelphia Vaccine Education Center. Additional support is provided by PATH Vaccine Development Program and the International Vaccine Institute (IVI), and by vaccine industry leaders including GSK, Merck, Pfizer, and sanofi pasteur (list in formation), as well as the Developing Countries Vaccine Manufacturers Network (DCVMN). Support is also provided by a growing list of individuals who use this service to support their roles in public health, clinical practice, government, NGOs and other international institutions, academia and research organizations, and industry.





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