Editor’s Notes:

– Email Summary: Vaccines: The Week in Review is available as a weekly email summary: 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 November 2012

– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.

– 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…

WHO recommends seasonal influenza vaccination to pregnant women as the highest priority
“In an updated position paper, published in the Weekly Epidemiological Record today, WHO recommends that countries considering the initiation or expansion of seasonal influenza vaccination programmes give the highest priority to pregnant women. Additional risk groups to be considered for vaccination, in no particular order of priority, are: children aged 6-59 months; the elderly; individuals with specific chronic medical conditions; and healthcare workers.”

http://www.who.int/immunization/en/
The Weekly Epidemiological Record (WER) for 23 November 2012, vol. 87, 47 (pp. 461–476) includes: Vaccines against influenza – WHO position paper – November 2012
http://www.who.int/entity/wer/2012/wer8747.pdf

   The FDA said it approved Flucelvax, described as the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older. The manufacturing process for Flucelvax is similar to the egg-based production method, but a significant difference is that the virus strains included in the vaccine are grown in animal cells of mammalian origin instead of in eggs. Cell culture technology has already been in use for several decades to produce other U.S. licensed vaccines. Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “Today’s approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process.” Flucelvax is manufactured by Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm328982.htm

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a marketing authorisation for Bexsero, a new Novartis vaccine intended for the immunisation of individuals over two months of age against invasive meningococcal disease caused by Neisseria meningitidis group B. There is currently no authorised vaccine available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B…In Europe, group B is the most prevalent meningococcal serogroup, with 3,406-4,819 cases reported annually between 2003 and 2007, according to a surveillance report published by the European Centre for Disease Prevention and Control….There are currently some geographical regions within the EU with higher incidence rates, mainly in Belgium, Ireland, Spain and the United Kingdom…The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group-B strains in different geographical areas should be considered when vaccinating. Vaccination with Bexsero should be in accordance with official recommendations applicable in the Member States. The CHMP’s opinion on Bexsero will now be sent to the European Commission for the granting of a marketing authorisation.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/11/news_detail_001656.jsp&mid=WC0b01ac058004d5c1

Update: Polio this week – As of 20 Nov 2012
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s Extract]
– This week, immunization campaigns are being implemented in all three remaining endemic countries, Nigeria, Pakistan and Afghanistan. Focus continues to be on urgently boosting immunity levels in known high-risk areas.

Afghanistan
– Three new WPV cases were reported in the past week (one WPV1 from Kandahar and two WPV1s from Hilmand), bringing the total number of WPV cases for 2012 to 30. The WPV1 from Kandahar is the most recent case in the country and had onset of paralysis on 28 October.
– Supplementary immunization activities (SIAs) are taking place this week (19-21 November), with the next activity planned for 01-06 December.
– The current campaign is being conducted in border areas with Pakistan, and uses a combination of trivalent OPV and bivalent OPV (depending on the area, in response either to recent WPV1 cases in the area, or to detection of a circulating vaccine-derived poliovirus type 2 outbreak – cVDPV2 – across the border in Pakistan).
– The Technical Advisory Group (TAG) is meeting next week in Kabul, to review the impact of the national polio emergency action plan and discuss additional tactics to address on-going immunity gaps in known high-risk districts.

Nigeria
– Four new WPV cases were reported in the past week (one WPV1 each from Jigawa, Kaduna, Kano and Katsina), bringing the total number of WPV cases for 2012 to 104. The WPV1 from Kaduna is the most recent case in the country and had onset of paralysis on 30 October.

Horn of Africa
– Efforts are continuing to stop an ongoing cVDPV2 outbreak in Kenya and parts of Somalia (in a Somali refugee camp in Dadaab, Kenya, and Kismayo, south-central Somalia).
– Immunizations of older age groups have taken place in Dadaab. In Somalia, campaigns have been conducted in border areas with Kenya and Ethiopia, and in some areas of central Somalia (access allowing).

WHO:  Global Alert and Response (GAR) – Disease Outbreak News

– Announcement: WHO to change the way it reports H5N1 cases
Henceforward, WHO will publish information on human cases with H5N1 avian influenza infection on a monthly basis on the Influenza webpage:
Influenza at human-animal interface – Monthly Risk Assessment Summary
Cases of human infection with H5N1 will only be reported on Disease Outbreak News for events that are unusual or associated with potential increased risks.
Member States will be continued to require to report information on every sporadic case of H5N1 human infection or novel influenza virus infection to WHO as per Article 6 of the International Health Regulations (2005).

Most recent news items
– Ebola in Uganda  23 November 2012
– Novel coronavirus infection – update  23 November 2012
– Marburg haemorrhagic fever in Uganda – update  23 November 2012
– Yellow fever in Sudan – update  22 November 2012
http://www.who.int/csr/don/en/index.html

British Medical Journal
24 November 2012 (Vol 345, Issue 7884)
http://www.bmj.com/content/345/7884

Time for global action on fake and substandard drugs
BMJ 2012;345:e7917 (Published 21 November 2012)

Excerpt
“In an article this week a self defined “diverse group of authors from the health professions, health charities, legal and medical academia, and former or current government officials in health” present us with a troubling paradox: the world currently has tighter laws to tackle fake tobacco products than it does to tackle fake drugs (doi:10.1136/bmj.e7381). At the moment, as they explain, there are laws that promote an open global medicines trade but no binding international health law on drug safety. The result is that fake and substandard drugs continue to harm and kill people around the world, affecting both proprietary and generic drugs, and haunting rich countries as well as poor. As Andrew Jack explains (doi:10.1136/bmj.e7836), the rapid growth of unregulated internet sales of drugs has raised the stakes even further. In the accompanying podcast, Amir Attiran emphasises the absurd situation by which trading fake medicines is currently legal under international law, and Sania Nishtar highlights worryingly weak pharmacovigilance systems in Pakistan (www.bmj.com/multimedia).

Why the lack of progress on this globally damaging health problem? There’s no simple answer to what is clearly a complex problem, but the authors suggest that the main barriers have been the lack of an internationally agreed terminology and a focus in law on commercial interests rather than public health…”

Faking it
BMJ 2012;345:e7836 (Published 20 November 2012)
Analysis
Podcast

How to achieve international action on falsified and substandard medicines
BMJ 2012;345:e7381 (Published 13 November 2012)
Analysis
Podcast
Feature
Press release

Commentary: Substandard medicines are the priority for neglected tropical diseases
BMJ 2012;345:e7518 (Published 14 November 2012)
Analysis

Health Policy and Planning
Volume 27 Issue 7   October 2012
http://heapol.oxfordjournals.org/content/current

Advance Access
http://heapol.oxfordjournals.org/content/early/2012/11/21/heapol.czs123.abstract
Lessons learned in shaping vaccine markets in low-income countries: a review of the vaccine market segment supported by the GAVI Alliance
Shawn A.N. Gilchrist and Angeline Nanni

Abstract
Objectives  The Global Alliance for Vaccines and Immunization (GAVI) anticipated that growing demand for new vaccines could sufficiently impact the vaccines market to allow low-income countries (LICs) to self-finance new vaccines. But the time required to lower vaccine prices was underestimated and the amount that prices would decline overestimated. To better understand how prices in the LIC vaccine market can be impacted, the vaccine market was retrospectively examined.

Design  GAVI archives and the published literature on the vaccine markets in LICs were reviewed for the purpose of identifying GAVI’s early assumptions for the evolution of vaccine prices, and contrasting these retrospectively with actual outcomes.

Results  The prices in Phases I and II of GAVI-supported vaccines failed to decline to a desirable level within a projected 5-year timeframe. GAVI-eligible countries were unable to sustain newly introduced vaccines without prolonged donor support. Two key lessons can be applied to future vaccine market-shaping strategies: (1) accurate demand forecasting together with committed donor funding can increase supply to the LIC vaccines market, but even greater strides can be made to increase the certainty of purchase; and (2) the expected time to lower prices took much longer than 5 years; market competition is inherently linked to the development time for new vaccines—a minimum of 5–10 or more years. Other factors that can lower vaccine prices include: large-scale production or alternate financing mechanisms that can hasten vaccine price maturation.

Conclusions  The impacts of competition on vaccine prices in the LIC new-vaccines market occurred after almost 10 years. The time for research and development, acquisition of technological know-how and to scale production must be accounted for to more accurately predict significant declines on vaccine prices. Alternate financing mechanisms and the use of purchase agreements should also be considered for lowering prices when planning new vaccine introductions.

The Lancet Infectious Disease
Dec 2012  Volume 12  Number 12   p897 – 984
http://www.thelancet.com/journals/laninf/issue/current

Review
Strategies to increase responsiveness to hepatitis B vaccination in adults with HIV-1
Jennifer A Whitaker, Nadine G Rouphael, Srilatha Edupuganti, Lilin Lai, Mark J Mulligan

Summary
HIV and hepatitis B virus co-infection leads to substantially increased morbidity and mortality compared with either infection alone. Immunisation with hepatitis B virus vaccine is the most effective way to prevent the infection in people with HIV; however, these patients have decreased vaccine responses and a short duration of protection compared with immunocompetent individuals. Control of HIV replication with highly active antiretroviral therapy and increased CD4 cell counts are associated with improved immune responses to hepatitis B vaccination. New vaccination strategies, such as increased vaccine dose, use of the intradermal route, and addition of adjuvants, could improve response rates in adults with HIV.

PLoS One
[Accessed 24 November 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Longitudinal Investigation of Public Trust in Institutions Relative to the 2009 H1N1 Pandemic in Switzerland
Adrian Bangerter, Franciska Krings, Audrey Mouton, Ingrid Gilles, Eva G. T. Green, Alain Clémence
PLoS ONE: Research Article, published 21 Nov 2012 10.1371/journal.pone.0049806

Abstract
Background
The 2009 H1N1 pandemic left a legacy of mistrust in the public relative to how outbreaks of emerging infectious diseases are managed. To prepare for future outbreaks, it is crucial to explore the phenomenon of public trust in the institutions responsible for managing disease outbreaks. We investigated the evolution of public trust in institutions during and after the 2009 pandemic in Switzerland. We also explored respondents’ perceptions of the prevention campaign and the roles of the government and media.

Methodology/Principal Findings
A two-wave longitudinal survey was mailed to 2,400 members of the Swiss public. Wave 1 was in Spring 2009. Wave 2 was in Spring 2010. Six hundred and two participants responded in both waves. Participants indicated moderate to high levels of trust in medical organizations, the WHO, the Swiss government, the pharmaceutical industry, and the EU. On the other hand, trust in the media was low. Moreover, trust in almost all institutions decreased over time. Participants were satisfied with the amount of information received and indicated having followed official recommendations, but widespread concerns about the vaccine were evident. A large majority of participants agreed the vaccine might have unknown or undesirable side effects. Perceptions of the government’s and the media’s role in handling the outbreak were characterized by a substantial degree of skepticism and mistrust.

Conclusions/Significance
Results show clear patterns of skepticism and mistrust on the part of the public relative to various institutions and their actions. Results underscore the importance of systematically investigating trust of the public relative to epidemics. Moreover, studies investigating the evolution of the public’s memories of the pandemic over the coming years may be important to understand reactions to future pandemics. A systematic research program on trust can inform public health communication campaigns, enabling tailored communication initiatives.

PLoS One
[Accessed 24 November 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Economic Burden of Human Papillomavirus-Related Diseases in Italy
Gianluca Baio, Alessandro Capone, Andrea Marcellusi, Francesco Saverio Mennini, Giampiero Favato
PLoS ONE: Research Article, published 21 Nov 2012 10.1371/journal.pone.0049699

Abstract 
Introduction
Human papilloma virus (HPV) genotypes 6, 11, 16, and 18 impose a substantial burden of direct costs on the Italian National Health Service that has never been quantified fully. The main objective of the present study was to address this gap: (1) by estimating the total direct medical costs associated with nine major HPV-related diseases, namely invasive cervical cancer, cervical dysplasia, cancer of the vulva, vagina, anus, penis, and head and neck, anogenital warts, and recurrent respiratory papillomatosis, and (2) by providing an aggregate measure of the total economic burden attributable to HPV 6, 11, 16, and 18 infection.

Methods
For each of the nine conditions, we used available Italian secondary data to estimate the lifetime cost per case, the number of incident cases of each disease, the total economic burden, and the relative prevalence of HPV types 6, 11, 16, and 18, in order to estimate the aggregate fraction of the total economic burden attributable to HPV infection.

Results
The total direct costs (expressed in 2011 Euro) associated with the annual incident cases of the nine HPV-related conditions included in the analysis were estimated to be €528.6 million, with a plausible range of €480.1–686.2 million. The fraction attributable to HPV 6, 11, 16, and 18 was €291.0 (range €274.5–315.7 million), accounting for approximately 55% of the total annual burden of HPV-related disease in Italy.

Conclusions
The results provided a plausible estimate of the significant economic burden imposed by the most prevalent HPV-related diseases on the Italian welfare system. The fraction of the total direct lifetime costs attributable to HPV 6, 11, 16, and 18 infections, and the economic burden of noncervical HPV-related diseases carried by men, were found to be cost drivers relevant to the making of informed decisions about future investments in programmes of HPV prevention.

PLoS Medicine
(Accessed 24 November 2012)
http://www.plosmedicine.org/article/browse.action?field=date

The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials
Charles Weijer, Jeremy M. Grimshaw, Martin P. Eccles, Andrew D. McRae, Angela White, Jamie C. Brehaut, Monica Taljaard, Ottawa Ethics of Cluster Randomized Trials Consensus Group published 20 Nov 2012
doi:10.1371/journal.pmed.1001346

Summary Points
– In cluster randomized trials (CRTs), the units of allocation, intervention, and outcome measurement may differ within a single trial. As a result of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated.

– The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs.

– A five-year mixed methods research project explored the ethical challenges of CRTs. Empirical studies documented the reporting of ethical issues in published CRTs, interviewed experienced trialists, and surveyed trialists and REC chairs. The ethical issues identified were explored in a series of background papers that provided detailed ethical analyses and policy options, and a panel of experts using a systematic process developed a consensus statement.

– The Ottawa Statement sets out 15 recommendations for the ethical design and conduct of CRTs. The recommendations provide guidance on the justification of a cluster randomized design, the need for REC review, the identification of research participants, obtaining informed consent, the role of gatekeepers in protecting group interests, the assessment of benefits and harms, and the protection of vulnerable participants.

PNAS – Proceedings of the National Academy of Sciences of the United States
of America
(Accessed 24 November 2012)
http://www.pnas.org/content/early/recent

Biological Sciences – Population Biology:
Self-boosting vaccines and their implications for herd immunity
Nimalan Arinaminpathy, Jennie S. Lavine, and Bryan T. Grenfell
PNAS 2012 ; published ahead of print November 19, 2012, doi:10.1073/pnas.1209683109

Abstract
Advances in vaccine technology over the past two centuries have facilitated far-reaching impact in the control of many infections, and today’s emerging vaccines could likewise open new opportunities in the control of several diseases. Here we consider the potential, population-level effects of a particular class of emerging vaccines that use specific viral vectors to establish long-term, intermittent antigen presentation within a vaccinated host: in essence, “self-boosting” vaccines. In particular, we use mathematical models to explore the potential role of such vaccines in situations where current immunization raises only relatively short-lived protection. Vaccination programs in such cases are generally limited in their ability to raise lasting herd immunity. Moreover, in certain cases mass vaccination can have the counterproductive effect of allowing an increase in severe disease, through reducing opportunities for immunity to be boosted through natural exposure to infection. Such dynamics have been proposed, for example, in relation to pertussis and varicella-zoster virus. In this context we show how self-boosting vaccines could open qualitatively new opportunities, for example by broadening the effective duration of herd immunity that can be achieved with currently used immunogens. At intermediate rates of self-boosting, these vaccines also alleviate the potential counterproductive effects of mass vaccination, through compensating for losses in natural boosting. Importantly, however, we also show how sufficiently high boosting rates may introduce a new regime of unintended consequences, wherein the unvaccinated bear an increased disease burden. Finally, we discuss important caveats and data needs arising from this work.

Vaccine
Volume 30, Issue 50, Pages 7131-7342 (26 November 2012)
http://www.sciencedirect.com/science/journal/

Meeting Report
Translating vaccine policy into action: A report from the Bill & Melinda Gates Foundation Consultation on the prevention of maternal and early infant influenza in resource-limited settings
Pages 7134-7140
Justin R. Ortiz, Kathleen M. Neuzil, Vincent I. Ahonkhai, Bruce G. Gellin, David M. Salisbury, Jennifer S. Read, Richard A. Adegbola, Jon S. Abramson

Abstract
Immunization of pregnant women against influenza is a promising strategy to protect the mother, fetus, and young infant from influenza-related diseases. The burden of influenza during pregnancy, the vaccine immunogenicity during this period, and the robust influenza vaccine safety database underpin recommendations that all pregnant women receive the vaccine to decrease complications of influenza disease during their pregnancies. Recent data also support maternal immunization for the additional purpose of preventing disease in the infant during the first six months of life.

In April 2012, the WHO Strategic Advisory Group of Experts (SAGE) on Immunization recommended revisions to the WHO position paper on influenza vaccines. For the first time, SAGE recommended pregnant women should be made the highest priority for inactivated seasonal influenza vaccination. However, the variable maternal influenza vaccination coverage in countries with pre-existing maternal influenza vaccine recommendations underscores the need to understand and to address the discrepancy between recommendations and implementation success.

We present the outcome of a multi-stakeholder expert consultation on inactivated influenza vaccination in pregnancy. The creation and implementation of vaccine policies and regulations require substantial resources and capacity. As with all public health interventions, the existence of perceived and real risks of vaccination will necessitate effective and transparent risk communication. Potential risk allocation and sharing mechanisms should be addressed by governments, vaccine manufacturers, and other stakeholders. In resource-limited settings, vaccine-related issues concerning supply, formulation, regulation, evidence evaluation, distribution, cost-utility, and post-marketing safety surveillance need to be addressed. Lessons can be learned from the Maternal and Neonatal Tetanus Elimination Initiative as well as efforts to increase vaccine coverage among pregnant women during the 2009 influenza pandemic. We conclude with an analysis of data gaps and necessary activities to facilitate implementation of maternal influenza immunization programs in resource-limited settings.

Vaccine
Volume 30, Issue 50, Pages 7131-7342 (26 November 2012)
http://www.sciencedirect.com/science/journal/

WHO Article
Monitoring of progress in the establishment and strengthening of national immunization technical advisory groups
Original Research Article
Pages 7147-7152
Philippe Duclos, Stephanie Ortynsky, Nihal Abeysinghe, Niyazi Cakmak, Cara Bess Janusz, Barbara Jauregui, Richard Mihigo, Liudmila Mosina, Nahad Sadr-Azodi, Yashohiro Takashima, Laure Dumolard, Marta Gacic-Dobo

Abstract
The majority of industrialized and some developing countries have established technical advisory bodies to guide and formulate national immunization policies and strategies. These are referred to as National Immunization Technical Advisory Groups (NITAGs), WHO and its partners have placed a high priority on assisting in the establishment or strengthening of functional, sustainable, and independent NITAGs. To enable systematic global monitoring of the existence and functionality of NITAGs, in 2010, WHO and UNICEF included related questions in the WHO–UNICEF Joint Reporting Form (JRF) that provides an official means for WHO and UNICEF to collect indicators of immunization programme performance.

This paper presents the status of NITAGs based on the analysis of the 2010 JRF. Although 115 countries (64% of responders) reported having a NITAG in 2010, only 50% of countries reported the existence of a NITAG with a formal administrative or legislative basis. Despite limitations in the ability to compare 2010 JRF data with that from a 2008 global survey, it appears that substantial progress has been achieved globally over with 43 committees reporting affirmatively about six NITAG process indicators, compared with 23 in the 2008 survey. Impressive progress has been observed in the proportion of countries reporting NITAGs with formal terms of reference (24% increase), a legislative or administrative basis (10% increase), and a requirement for members to disclose their interests (14% increase). Some of the poorest developing countries now enjoy support from a NITAG which meet all six process indicators. These may serve as examples for other countries.

Vaccine
Volume 30, Issue 50, Pages 7131-7342 (26 November 2012)
http://www.sciencedirect.com/science/journal/

The cost-effectiveness of a 13-valent pneumococcal conjugate vaccination for infants in England
Original Research Article
Pages 7205-7213
Albert Jan van Hoek, Yoon Hong Choi, Caroline Trotter, Elizabeth Miller, Mark Jit

Abstract
Background
In the immunisation schedule in England and Wales, the 7-valent pneumococcal conjugate vaccine (PCV-7) was replaced by the 13-valent vaccine (PCV-13) in April 2010 after having been used since September 2006. The introduction of PCV-7 was informed by a cost effectiveness analysis using an infectious disease model which projected herd immunity and serotype replacement effects based on the post-vaccine experience in the United States at that time.

Aim
To investigate the cost effectiveness of the introduction of PCV-13.

Method
Invasive disease incidence following vaccination was projected from a dynamic infectious disease model, and combined with serotype specific disease outcomes obtained from a large hospital dataset linked to laboratory confirmation of invasive pneumococcal disease. The economic impact of replacing PCV-7 with PCV-13 was compared to stopping the use of pneumococcal conjugate vaccination altogether.

Results
Discontinuing PCV-7 would lead to a projected increase in invasive pneumococcal disease, costs and loss of quality of life compared to the introduction of PCV-13. However under base case assumptions (assuming no impact on non-invasive disease, maximal competition between vaccine and non-vaccine types, time horizon of 30 years, vaccine price of £49.60 a dose + £7.50 administration costs and discounting of costs and benefits at 3.5%) the introduction of PCV-13 is only borderline cost effective compared to a scenario of discontinuing of PCV-7. The intervention becomes more cost-effective when projected impact of non-invasive disease is included or the discount factor for benefits is reduced to 1.5%.

Conclusion
To our knowledge this is the first evaluation of a transition from PCV-7 to PCV-13 based on a dynamic model. The cost-effectiveness of such a policy change depends on a number of crucial assumptions for which evidence is limited, particularly the impact of PCV-13 on non-invasive disease.

Vaccine
Volume 30, Issue 50, Pages 7131-7342 (26 November 2012)
http://www.sciencedirect.com/science/journal/

Re-emergence of diphtheria and pertussis: Implications for Nigeria
Original Research Article
Pages 7221-7228
A.E. Sadoh, R.E. Oladokun

Abstract
In the prevaccine era pertussis and diphtheria were responsible for significant morbidity and mortality in children. In the United States of America more than 125,000 cases of diphtheria with 10,000 deaths were reported annually in the 1920s. In the same period about 1.7 million cases of pertussis with 73,000 deaths were also reported. Vaccination against these two diseases has caused remarkable reduction in the morbidity and mortality from these diseases both in developed and developing countries. The initial vaccines were the combined diphtheria toxoid and whole cell pertussis vaccine.

The recent reported increases in the incidence of these two diseases in countries, which maintain high childhood vaccination coverage is a source of concern not only to these countries but also for developing countries with weak immunization programmes. Nigeria for example reported 11,281 cases of pertussis, the second highest number of cases worldwide in 2009.

Waning immunity in adult and adolescent populations has been reported and epidemiologically, more cases are being reported in adults and adolescents. Also a high proportion of pertussis cases are being reported in infants and most of these infant cases are linked to adult/adolescent sources.

Recent approaches to control of these diseases include booster doses of combined diphtheria, tetanus and acellular pertussis vaccine while the cocooning strategy (which is immunizing every person who is likely to have contact with a given infant such as mother, father, grandparents and health care workers) is being used in a number of countries.

For developing countries including Nigeria where the capacity for making the diagnosis of both diseases is limited, strengthening of routine immunization as well as diagnostic capacity is imperative. Research to determine current levels of immunity in children, adolescents and adults is required. This will enable the determination of the need for booster doses and the age at which such boosters should be administered. Improved surveillance will be needed to delineate current epidemiological profiles of both diseases.

Vaccine
Volume 30, Issue 50, Pages 7131-7342 (26 November 2012)
http://www.sciencedirect.com/science/journal/

Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)
Original Research Article
Pages 7253-7259
Anita M. Loughlin, Colin D. Marchant, William Adams, Elizabeth Barnett, Roger Baxter, Steve Black, Christine Casey, Cornelia Dekker, Katherine M. Edwards, Jerold Klein, Nicola P. Klein, Philip LaRussa, Robert Sparks, Kathleen Jakob

Abstract
Adverse events following immunization (AEFI) reported to the national Vaccine Adverse Event Reporting System (VAERS) represent true causally related events, as well as events that are temporally, but not necessarily causally related to vaccine.

Objective
We sought to determine if the causal relationships between the vaccine and the AEFI reported to VAERS could be assessed through expert review.

Design
A stratified random sample of 100 VAERS reports received in 2004 contained 13 fatal cases, 19 cases with non-fatal disabilities, 39 other serious non-fatal cases and 29 non-serious cases. Experts knowledgeable about vaccines and clinical outcomes, reviewed each VAERS report and available medical records.

Main outcome measures
Modified World Health Organization criteria were used to classify the causal relationship between vaccines and AEFI as definite, probable, possible, unlikely or unrelated. Five independent reviewers evaluated each report. If they did not reach a majority agreement on causality after initial review, the report was discussed on a telephone conference to achieve agreement.

Results
108 AEFIs were identified in the selected 100 VAERS reports. After initial review majority agreement was achieved for 83% of the AEFI and 17% required further discussion. In the end, only 3 (3%) of the AEFI were classified as definitely causally related to vaccine received. Of the remaining AEFI 22 (20%) were classified as probably and 22 (20%) were classified as possibly related to vaccine received; a majority (53%) were classified as either unlikely or unrelated to a vaccine received.

Conclusions
Using VAERS reports and additional documentation, causality could be assessed by expert review in the majority of VAERS reports. Assessment of VAERS reports identified that causality was thought to be probable or definite in less than one quarter of reports, and these were dominated by local reactions, allergic reactions, or symptoms known to be associated with the vaccine administered.

Vaccine
Volume 30, Issue 50, Pages 7131-7342 (26 November 2012)
http://www.sciencedirect.com/science/journal/

Cost-effectiveness of pertussis booster vaccination in the Netherlands
Original Research Article
Pages 7327-7331
Mark H. Rozenbaum, Elisabetta De Cao, Maarten J. Postma

Abstract
The aim of the current study is to estimate the epidemiological and economical consequences of several extended pertussis booster vaccination strategies and to explore the impact of parameters surrounded by large uncertainty on the cost-effectiveness.

We developed an age structured transmission dynamic model to evaluate the impact of programs targeting (i) adolescents or adults using a single booster dose, (ii) a combination of adolescent and adult vaccination, and (iii) an every 10 years booster dose.

The base case analysis, that is a single adolescent booster administered at the age of 12 years, resulted in a reduction of pertussis infections. However, due to an increase in the number of symptomatic infections in adults, the benefits in terms of QALYs gained and costs saved in children were partly offset. Despite these negative indirect effects in the adult population, administering an additional booster dose could still be considered cost effective with an ICER of €4200 per QALY gained. Combining an adolescent booster dose at the age of 10 (most cost-effective age for a single adolescent booster dose) with an adult (18–30 years) booster dose always resulted in favorable ICERs (<€10,000/QALY). Finally the every 10 year booster dose resulted in an ICER of €16,900 per QALY. The impact of different assumptions regarding the disease epidemiology, disease-related parameters, and vaccination program-related issues was limited.

To conclude, we show that extended pertussis booster vaccination strategies are likely to be considered as cost-effective.

American Journal of Preventive Medicine
Volume 43, Issue 6, Supplement 5, December 2012, Pages S490–S496

Research Collaboration with 2-1-1 to Eliminate Health Disparities
2-1-1 research and program innovation
Human Papillomavirus Vaccine: 2-1-1 Helplines and Minority Parent Decision-Making
Lara S. Savas, PhD, Maria E. Fernández, PhD, David Jobe, MSW, Chakema C. Carmack, PhD

Abstract
Background
Research is needed to understand parental factors influencing human papillomavirus (HPV) vaccination, particularly in groups with a higher burden of cervical cancer.

Purpose
To determine correlates of HPV vaccination among a sample of low-income parents of age-eligible daughters (aged 9–17 years) who called the 2-1-1 Helpline. Secondary analyses describe potential differences in HPV vaccination correlates by Hispanic and black parent groups, in particular.

Methods
This 2009 cross-sectional feasibility survey of cancer prevention needs was conducted in Houston at the 2-1-1 Texas/United Way Helpline. In 2012, to examine the association between parental psychosocial, cognitive, and decisional factors and HPV vaccination uptake (one or two doses), bivariate and multivariable logistic regression analyses were conducted for minority parents and for Hispanic and black parent groups, separately.

Results
Lower rates of HPV vaccination uptake were reported among minority daughters of 2-1-1 callers (29% overall) compared with national and Texas rates. In final adjusted analysis, factors positively associated with HPV vaccination uptake included being offered the vaccination by a doctor or nurse, belief that the vaccine would prevent cervical cancer, and Hispanic ethnicity. Secondary analyses detected differences in factors associated with vaccination in Hispanic and black groups.

Conclusions
Findings indicate low levels of vaccination among 2-1-1 callers. Increased understanding of determinants of HPV vaccination in low-income minority groups can guide interventions to increase coverage. Because 2-1-1 informational and referral services networks reach populations considered medically underserved, 2-1-1 can serve as a community hub for informing development of and implementing approaches aimed at hard-to-reach groups.

From Google Scholar+: Dissertations, Theses, Selected Journal Articles

Epidemiology of Invasive Pneumococcal Disease among High-Risk Adults since Introduction of Pneumococcal Conjugate Vaccine for Children
RD Muhammad, R Oza-Frank, E Zell, R Link-Gelles… – Clinical Infectious Diseases, 2012
Background. Certain chronic diseases increase risk for invasive pneumococcal disease (IPD) and are indications for receipt of 23-valent pneumococcal polysaccharide vaccine (PPV23). Since the pediatric introduction of 7-valent pneumococcal conjugate vaccine ( …

Accelerating the development of a therapeutic vaccine for human Chagas disease: rationale and prospects
E Dumonteil, ME Bottazzi, B Zhan, MJ Heffernan… – Expert Review of Vaccines, 2012
Chagas disease is a leading cause of heart disease affecting approximately 10 million people in Latin America and elsewhere worldwide. The two major drugs available for the treatment of Chagas disease have limited efficacy in Trypanosoma cruzi-infected adults …

Science denial: a guide for scientists
J Rosenau – Trends in Microbiology, 2012
… You do not expect to see Draco Malfoy carrying a Hermione Granger poster, let alone one in which she touts the whooping cough vaccine. Yet at the … scientific consensus. The vaccine drive at Dragon*Con fits this model beautifully. The …

Interview: Future of immunotherapy for colorectal cancer
J Marshall – Colorectal Cancer, 2012
… maintaining his regular clinical practice. His own research focuses on the development of a novel vaccine for the treatment of advanced colon cancer. Q What led you to focus your research on immunotherapy in colorectal cancer? …

Reuters
http://www.reuters.com/
Accessed 24 November 2012

Nurses can help improve vaccination rates: study
By Genevra Pittman
NEW YORK | Fri Nov 23, 2012 9:58am EST

Excerpt
(Reuters Health) – More elderly and at-risk adults get their flu and pneumonia vaccinations when the shots are coordinated and given by nurses instead of doctors, a new analysis suggests.

Researchers linked the changeover to a 44-percent increase in patients’ chances of getting a flu shot and a more than doubling of their likelihood of getting vaccinated against pneumonia.

Jeffrey Johnson, who worked on the study, said there’s been a recent effort to get public health nurses and pharmacists involved in giving vaccines – although policies vary by state in the U.S.    He said shifting responsibility to non-doctors might be especially helpful for people with chronic diseases.

“The family physician has all of the responsibility to look after the patient, and so somebody with diabetes, for example, comes in and their first concern is their blood sugar and their blood pressure and pretty soon, the time for the visit is up,” Johnson, from the University of Alberta in Edmonton, Canada, told Reuters Health…

http://www.reuters.com/article/2012/11/23/us-nurses-vaccination-idUSBRE8AM0IK20121123

Twitter Watch [accessed 24 November 2012 – 09:14]
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.

GAVI Alliance ‏@GAVIAlliance
T-12: Over 500 global health and government leaders will gather #GAVIpartners Forum in Dar Es SDalam, Tanzania. http://ht.ly/fw9fW 
3:09 AM – 23 Nov 12

Seth Berkley ‏@GAVISeth
Despite good vax for A, C, Y, W135 mening meningitis, type B still cause morb/mort. New Grp B vax received EU approval http://reut.rs/QxfsT2 
1:16 AM – 23 Nov 12

Peter Singer ‏@PeterASinger
Inspired: Canada funds 68 bold, inventive ways to improve health, save lives in developing countries: http://bit.ly/ScDLnp  @globalhealth
Retweeted by Global Health
7:54 AM – 22 Nov 12

The Global Fund ‏@globalfundnews
News Flash Special: Interview with Mark Dybul http://tinyurl.com/d9lv2e3 
3:03 AM – 21 Nov 12

PAHO/WHO ‏@pahowho
Delegates from 76 countries launch Global Mechanism in Buenos Aires to fight Drug Counterfeiting cc: @who http://new.paho.org/hq/index.php?option=com_content&view=article&id=7484%3Adelegados-de-76-paises-ponen-en-marcha-en-buenos-aires-mecanismo-mundial-contra-la-falsificacion-de-medicamentos&catid=740%3Anews-press-releases&Itemid=1926&lang=en&Itemid=1926 …
5:41 PM – 20 Nov 12

Editor’s Notes:

– Email Summary: Vaccines: The Week in Review is available as a weekly email summary: 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_17 November 2012

– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.

– 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…

WHO:  Global Alert and Response (GAR) – Yellow fever in Sudan

13 November 2012 – The Federal Ministry of Health (FMOH) in Sudan has notified WHO of a yellow fever outbreak affecting 23 localities in Greater Darfur. As of 11 November 2012, a total of 329 suspected cases including 97 deaths were reported from this outbreak. Central and South Darfur have reported most of the suspected cases.

Laboratory confirmation was conducted by WHO regional reference laboratory for yellow fever, the Institut Pasteur in Dakar, Senegal, on two samples which tested positive for yellow fever by IgM ELISA test and RT-PCR Differential diagnosis for other flavivirus was negative.

WHO is supporting the FMOH and other partners in the epidemiological investigation and response to the outbreak. Ongoing activities include strengthening of epidemiological surveillance, conducting entomological assessment and standardizing clinical case management. Community leaders are also being mobilized to support with raising awareness on yellow fever in the affected localities.

The government of Sudan has requested the International Coordinating Group on Yellow Fever Vaccine Provision (YF-ICG) to provide support for a reactive mass vaccination campaign. The YF-ICG has approved of 2.4 million doses of vaccine, which is expected to arrive in the country shortly. Sudan, with support from WHO, is expected to start the emergency mass vaccination campaign in the affected areas in order to protect the at-risk populations and stop the spread of the disease.

The YF-ICG consists of representatives from United Nations Children’s Fund (UNICEF), Médecins sans Frontières (MSF) and the International Federation of Red Cross and Red Crescent Societies (IFRC) and WHO, which also serves as its Secretariat.

http://www.who.int/csr/don/2012_11_13/en/index.html

Media Release: Revolutionary meningitis vaccine breaks another barrier; first to gain approval to travel outside cold chain
14 November 2012

The Meningitis Vaccine Project (MVP) –  a partnership between PATH and the WHO to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa – announced at the American Society of Tropical Medicine and Hygiene (ASTMH) conference that regulatory authorities, after conducting a rigorous review of stability data, will for the first time allow a vaccine in Africa to be transported and stored for as long as four days without refrigeration or even an icepack.” The vaccine involved is MenAfriVac, created to meet the needs of Africa’s meningitis belt, and the regulatory action means that the vaccine can now be kept in a controlled temperature chain (CTC) at temperatures of up to 40°C for up to four days, a decision that could help increase campaign efficiency and coverage and save funds normally spent maintaining the challenging cold chain during the “last mile” of vaccine delivery.

The outcome of the review and decisions of the Drugs Controller General of India (DCGI), supported by a Health Canada analysis and confirmed by WHO Vaccines Pre-qualification Programme. Michel Zaffran, director of Optimize, the PATH-WHO collaboration aimed at improving immunization systems and technologies, said, “The potential for some vaccines to remain safely outside the cold chain for short periods of time has been widely known for over 20 years. But this is the first time that a vaccine intended for use in Africa has been tested and submitted to regulatory review and approved for this type of use. And we expect this announcement to build momentum for applying the CTC concept to other vaccines and initiatives, allowing us to save more lives in low-income countries.”

More at: http://www.who.int/immunization/newsroom/menafrivac_20121114/en/index.html

WHO SAGE: Meeting Summary 6-8 November 2012
[Full text]

IPV recommended for countries to mitigate risks and consequences associated with OPV2 withdrawal

In May 2012, the World Health Assembly declared the completion of polio eradication a programmatic emergency for global public health and requested the Director-General to rapidly finalize a comprehensive eradication and endgame strategy for the period 2013-2018. The draft strategic plan and current status of the global polio eradication programme were presented to SAGE. Noting the substantive progress made in implementing polio emergency action plans in the remaining polio infected countries, detailed attention to oral polio vaccine (OPV) campaign planning in the field, and new evidence in improving performance, SAGE was alarmed by the considerable funding shortfalls at a time when eradication is in sight, with OPV campaigns already cancelled or scaled back in over 25 high risk countries in 2012.

SAGE endorsed the four major objectives and milestones in the new strategic plan. SAGE also recommended that all countries should introduce at least one dose of inactivated polio vaccine (IPV) in their routine immunization programmes to mitigate the risks and consequences associated with the eventual withdrawal of the type 2 component of OPV (OPV2). SAGE will review progress on achieving the pre-requisites for OPV2 withdrawal, including the availability of affordable IPV products, every six months to ensure the earliest possible date for OPV2 withdrawal but with sufficient advance notification to ensure programmatic readiness and vaccine availability.

SAGE reviewed and endorsed the monitoring and evaluation/accountability framework for the Decade of Vaccines Global Vaccine Action Plan (GVAP). A SAGE working group is being established to review progress in rolling out the GVAP and will submit annual reports to SAGE. Following SAGE’s input, the report will then be submitted to the WHO Executive Board and the World Health Assembly for discussion.

SAGE commended countries for the progress made in globally reducing measles mortality. While the Region of the Americas has achieved measles and rubella elimination and the Western Pacific region is close to interrupting endemic measles transmission, current data indicate that global and regional elimination targets for 2015 and 2020 will not be achieved on time. SAGE urges the South-East Asia region to establish a measles elimination goal and for the regions of Africa, Eastern Mediterranean, South-East Asia and Western Pacific to work towards establishing regional rubella elimination goals. SAGE also endorsed the Global Measles and Rubella Strategic Plan for 2012-2020 and recommended the full implementation of key strategies in a manner that elicits country ownership, strengthens routine immunization system, promotes equity and reinforces linkages with polio eradication and other health programmes.

SAGE welcomed the framework on Vaccination in Humanitarian Emergencies, which provides an objective approach to decision making and closes an existing gap on the use of vaccination in humanitarian emergencies. SAGE endorsed the framework and proposed some suggestions to be incorporated in the final document including piloting the framework before finalization.

SAGE noted that Middle Income Countries (MIC) representing a population of 5 billion now have the greatest proportion of the world’s poor. In addition, many of these countries are not eligible for GAVI Alliance funding or support and are lagging behind in their ability to sustainably introduce new vaccines. Reasons for this are broader than just prices and procurement of vaccines, and include equity, sustainability, capacity building and partner support. As the approach from all organizations to assist MICs is currently fragmented and incomplete, SAGE requested WHO to establish a task force to coordinate an inclusive stakeholder engagement mechanism to create an enabling environment and assist MICs.

The report of the meeting will be published in the WHO Weekly Epidemiological Record on 4 January 2013. The meeting documents, including presentations and background readings can be found here: SAGE november 2012 meeting documentation

http://www.who.int/immunization/sage/meetings/2012/november/news_sage_ipv_opv_nov2012/en/index.html

Media Release: SK Chemicals and International Vaccine Institute sign MOU on Typhoid Vaccine Development and Supply
Seoul, October 9, 2012

Under the terms of the MOU, SK Chemicals and IVI will exchange their technology for the development of a Typhoid vaccine and will collaborate on future clinical studies and application for the prequalification from the WHO. SK Chemicals will manufacture and supply about 10 million doses of the Typhoid vaccine to developing countries through the United Nations Children’s Fund (UNICEF).

More at: http://www.ivi.org/web/www/07_01?p_p_id=EXT_BBS&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_EXT_BBS_struts_action=%2Fext%2Fbbs%2Fview_message&_EXT_BBS_messageId=465

Update: Polio this week – As of 14 Nov 2012
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s Extract]
– The Strategic Advisory Group of Experts on immunization (SAGE) met last week in Geneva, Switzerland. During this meeting, the draft polio eradication and endgame strategy for 2013-2018 and current status of the global polio eradication programme were presented to SAGE. Substantial progress has been made in implementing polio emergency action plans in the remaining polio-infected countries, detailed attention to oral polio vaccine (OPV) campaign planning in the field, and new evidence in improving performance. SAGE was alarmed, however, by the considerable funding shortfalls at a time when eradication is in sight.

– SAGE endorsed the four major objectives and milestones in the new strategic plan. SAGE also recommended that all countries should introduce at least one dose of inactivated polio vaccine (IPV) in their routine immunization programmes to mitigate the risks and consequences associated with the eventual withdrawal of the type 2 component of OPV (OPV2). SAGE will review progress on achieving the pre-requisites for OPV2 withdrawal, including the availability of affordable IPV products, every six months to ensure the earliest possible date for OPV2 withdrawal but with sufficient advance notification to ensure programmatic readiness and vaccine availability.

Pakistan
– Six new WPV cases were reported in the past week (one WPV1 from Federally Administered Tribal Areas – FATA – and five WPV1s from Khyber Pakhtunkhwa – KP), bringing the total number of cases for 2012 to 54. The most recent case was one of the newly reported WPV1 cases from KP with onset of paralysis on 27 October.

– In addition to transmission of WPV, the country is also responding to a cVDPV2 outbreak (five cases, all from the greater Quetta area of Balochistan). The most recent NIDs held in October had been conducted with trivalent OPV.

– Initial data from the October NIDs indicates overall good progress achieved, including in key reservoir areas. Efforts to engage all levels of civil society are continuing, including through the distribution of 6.5 million SMS messages during the three-day campaign in polio reservoir areas.

Horn of Africa
– Efforts are continuing to stop an ongoing cVDPV2 outbreak in Kenya and parts of Somalia (in a Somali refugee camp in Dadaab, Kenya, and Kismayo, south-central Somalia).

– Immunizations of older age groups have taken place in Dadaab. In Somalia, campaigns have been conducted in border areas with Kenya and Ethiopia, and in some areas of central Somalia (access allowing).

– Across the region, OPV continues to be added to broader humanitarian response activities.

[Editor’s Note: The Global Fund made a series of announcements last week, including the appointment of a new Executive Director. Excerpt’s from the five media releases are presented below]

Global Fund Appoints Mark Dybul as Executive Director
15 November 2012
GENEVA – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria today appointed as its new Executive Director Ambassador Mark R. Dybul, a former United States Global AIDS Coordinator.

Dr. Dybul is widely recognized as a visionary leader on global health for his role in helping create and then lead the President’s Emergency Program for AIDS Relief, known as PEPFAR, which has been highly effective in helping limit and reverse the growth of HIV infection worldwide. Trained as a medical doctor with a specialty in immunology, he became an expert on AIDS as a clinician, a scientist and as a strategically minded administrator.

“Mark Dybul is a true leader, who can take the Global Fund to the next level,” said Simon Bland, Board Chair of the Global Fund. “He has a really impressive vision of how to achieve global health goals. He is passionate, energetic and focused.”

Dr. Dybul currently co-directs the Global Health Law Program at the O’Neill Institute for National and Global Health Law at Georgetown University, where he is also a Distinguished Scholar…

…Dr. Dybul may be best known for playing a key role in creating, and later leading, PEPFAR –
the largest global health initiative ever undertaken to address a single disease, which is widely credited with helping reverse the trend of AIDS, reducing new infection in many countries.

…Dr. Dybul also has deep knowledge of implementation of programs to treat and prevent AIDS, TB and malaria in developing countries, and has experience working with health administrators at many levels, especially in Africa.

In addition, he currently serves as a director on numerous executive and advisory boards of health organizations, including Malaria No More, the Elizabeth Glaser Pediatric AIDS Foundation, the Children’s Investment Fund Foundation and the Global Business Coalition for Health.

In addition to the medical degree he earned from Georgetown University School of Medicine, he has received honorary doctorates from Georgetown and from the University of San Francisco.

http://www.theglobalfund.org/en/mediacenter/newsreleases/2012-11-15_Global_Fund_Appoints_Mark_Dybul_as_Executive_Director/

Global Fund Board Decides on Transition to New Approach for Funding Grants
15 November 2012
GENEVA – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria today voted to start an immediate transition to a new approach to funding grants by investing additional money in health programs that are poised to achieve the quickest impact.

A new funding model is designed to significantly improve the way the Global Fund invests in health programs, with a process that is more predictable and reliable, and also more flexible, so that it can achieve a higher success rate in all grants and more effectively save the lives of people affected by the three diseases.

The framework for the new funding model was adopted by the Board in September. Today, the Board decided on additional aspects, including a transition to the new funding model starting in 2013.

Special consideration will be given to countries applying with programs that are, among other things, underfunded over the 2013-2014 period or at risk of service interruptions, as well as programs in a position to achieve rapid impact…

…The new system will rely on country dialogue to inform a process that leads to submitting a concept note, as well as early feedback from the Global Fund, other donors and technical experts on how the proposal may need adjusting before moving forward. That is expected to reduce waiting times, and to improve the overall success rate of applications.

http://www.theglobalfund.org/en/mediacenter/newsreleases/2012-11-15_Global_Fund_Board_Decides_on_Transition_to_New_Approach_for_Funding_Grants/

Board Approves Integration of AMFm into Core Global Fund Grant Processes
15 November 2012
GENEVA – The Global Fund Board decided to integrate the Affordable Medicines Facility – malaria (AMFm) into core Global Fund grant management and financial processes, following an orderly transition period in 2013. The decision was reached after extensive consultations with implementers, technical partners and donors about lessons learned from a pilot phase of AMFm.

The AMFm was created to improve access to artemisinin-based combination therapies (ACTs), the most effective anti-malaria treatment. The AMFm pilot phase was launched in April 2009 and began operations in July 2010. As demonstrated by an independent evaluation, it increased availability and drove down the price of ACTs through a factory-gate subsidy on behalf of buyers in pilot countries, combined with measures to support the safe and effective scale-up of access to ACTs. The pilot phase ends on 31 December 2012.

During a transition period in 2013, the lessons learned from the operations and resourcing of Phase 1 of the AMFm, such as manufacturer negotiations and the co-payment mechanism, will be integrated into core Global Fund processes. At its September 2012 meeting, the Board extended the Global Fund’s mandate to host the AMFm until 31 December 2013 in order to ensure that access to quality-assured ACTs is not disrupted during the transition phase.

Under the new, integrated model, eligible countries will be able to allocate funding from their core Global Fund grants and determine how the money should be spent. Following an assessment by technical partners, the AMFm model may be further modified to include malaria rapid diagnostic tests (RDTs)…

http://www.theglobalfund.org/en/mediacenter/newsreleases/2012-11-15_Board_Approves_Integration_of_AMFm_into_Core_Global_Fund_Grant_Processes/

Global Fund Terminates the Employment of Inspector General
15 November 2012
GENEVA – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria announced today that it had decided to terminate the employment of its Inspector General, John Parsons.

The Board decision came after a careful review of his performance, which was found to be unsatisfactory.

Mr. Parsons was responsible for overseeing audits and investigations by the Office of the Inspector General, whose mission is to provide the Global Fund with independent and objective assurance over the design and effectiveness of controls in place to manage risks affecting programs supported by the Global Fund…

http://www.theglobalfund.org/en/mediacenter/newsreleases/2012-11-15_Global_Fund_Terminates_the_Employment_of_Inspector_General/

Statement on Investigation in Cambodia
14 November 2012
An investigation by the Global Fund’s Office of the Inspector General into grants in Cambodia uncovered credible and substantive evidence of serious financial wrongdoing, on procurement and other issues. Immediate action has been taken to protect the health of people supported by Global Fund grants in Cambodia, by adopting safeguards in procurement, financing and management. The Global Fund and country stakeholders are also considering potential changes in implementer arrangements.

The evidence of wrongdoing uncovered by the Global Fund does not diminish the striking successes and impact that Global Fund grants have helped achieve through programs implemented by health officials, civil society organizations and partners in Cambodia. Recently-completed program reviews show an 80 percent decline in malaria deaths over the last decade, and a 43 percent fall in TB prevalence over the same period. These impressive gains, reflecting the hard work and dedication of health workers, civil society and partner organizations, are gaining global recognition…

http://www.theglobalfund.org/en/mediacenter/announcements/2012-11-14_Statement_on_Investigation_in_Cambodia/

The Weekly Epidemiological Record (WER) for 16 November 2012, vol. 87, 45 (pp. 449–460) includes:
– Outbreak news: Yellow fever, Sudan
– Validation of elimination: maternal and neonatal tetanus in Burkina Faso, 2012

http://www.who.int/entity/wer/2012/wer8746.pdf

Meeting: Counterfeit and/or Falsely-Labeled Medical Products
WHO and the Ministry of Health of Argentina

This is described as ”the first global meeting of Member States to focus on counterfeit and/or falsely labeled medical products. The encounter will take place in Buenos Aires from 19 to 21 November 2012 with the presence of WHO Director-General Dr. Margaret Chan and experts and staff from more than 70 countries.”

http://new.paho.org/hq/index.php?option=com_content&view=article&id=7467%3Afuncionarios-y-expertos-debaten-en-cumbre-mundial-de-la-oms-sobre-falsificacion-de-medicamentos&catid=740%3Anews-press-releases&Itemid=1926&lang=en

BMC Public Health
(Accessed 17 November2012)
http://www.biomedcentral.com/bmcpublichealth/content

Research article  
The effect of physician’s recommendation on seasonal influenza immunization in children with chronic diseases
Elisabetta Pandolfi, Maria Giulia Marino, Emanuela Carloni, Mariateresa Romano, Francesco Gesualdo, Piero Borgia, Roberto Carloni, Alfredo Guarino, Antonietta Giannattasio, Alberto E Tozzi BMC Public Health 2012, 12:984 (15 November 2012)

Open Access
Abstract (provisional)
Background
Despite recommendations by Health Authorities, influenza immunization coverage remains low in children with chronic diseases. Different medical providers involved in the management of children with chronic conditions may affect the pattern of influenza vaccine recommendations and coverage. The likelihood of vaccination by type of provider in children with chronic conditions is poorly understood. Therefore, the objectives of this study were to analyze the pattern and the effect of recommendations for seasonal influenza immunization provided by different physician profiles to families of children with chronic diseases and to measure the frequency of immunization in the study population

Methods
We recruited children with chronic diseases aged 6 months–18 years who subsequently presented to specialty clinics for routine follow-up visits, during spring 2009, in three Italian Regions Families of children with chronic diseases were interviewed during routine visits at reference centers through a face-to-face interview. We analyzed the following immunization predictors: having received a recommendation toward influenza immunization by a health provider; child’s sex and age; mothers and fathers’ age; parental education and employment; underlying child’s disease; number of contacts with health providers in the previous year. Influenza immunization coverage was calculated as the proportion of children who received at least one dose of seasonal influenza vaccine in the previous season. We calculated prevalence ratios and we used a generalized linear model with Poisson family, log link and robust error variance to assess the effect of socio-demographic variables, underlying diseases, and recommendations provided by physicians on influenza immunization.

Results
We enrolled 275 families of children with chronic diseases. Overall influenza coverage was 57.5%, with a low of 25% in children with neurological diseases and a high of 91.2% in those with cystic fibrosis. While 10.6% of children who did not receive any recommendation toward influenza immunization were immunized, among those who received a recommendation 87.5-94.7% did, depending on the health professional providing the recommendation. Receiving a recommendation by any provider is a strong predictor of immunization (PR = 8.5 95% CI 4.6;15.6) Most children received an immunization recommendation by a specialty (25.8%) or a family pediatrician (23.3%) and were immunized by a family pediatrician (58.7%) or a community vaccinator (55.2%).

Conclusions
Receiving a specific recommendation by a physician is a strong determinant of being immunized against seasonal influenza in children with chronic diseases independently of other factors. Heterogeneity exists among children with different chronic diseases regarding influenza recommendation despite international guidelines. Increasing the frequency of appropriate recommendations toward influenza immunization by physicians is a single powerful intervention that may increase coverage in children with chronic conditions.

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

International Journal of Infectious Diseases
December 2012, Vol. 16, No. 12
http://www.ijidonline.com/

Neonatal tetanus elimination in Pakistan: progress and challenges
December 2012 (Vol. 16 | No. 12 | Pages e833-e842)
Jonathan A. Lambo, Tharsiya Nagulesapillai

Summary 
Pakistan is one of the 34 countries that have not achieved the neonatal tetanus (NT) global elimination target set by the World Health Organization (WHO). NT, caused by Clostridium tetani, is a highly fatal infection of the neonatal period. It is one of the most underreported diseases and remains a major but preventable cause of neonatal and infant mortality in many developing countries. In 1989, the World Health Assembly called for the elimination of NT by 1995, and since then considerable progress has been made using the following strategies: clean delivery practices, routine tetanus toxoid (TT) immunization of pregnant women, and immunization of all women of childbearing age with three doses of TT vaccine in high-risk areas during supplementary immunization campaigns. This review presents the activities, progress, and challenges in achieving NT elimination in Pakistan.

A review of the literature found TT vaccination coverage in Pakistan ranged from 60% to 74% over the last decade. Low vaccination coverage, the main driver for NT in Pakistan, is due to many factors, including demand failure for TT vaccine resulting from inadequate knowledge of TT vaccine among reproductive age females and inadequate information about the benefits of TT provided by health care workers and the media. Other factors linked to low vaccination coverage include residing in rural areas, lack of formal education, poor knowledge about place and time to get vaccinated, and lack of awareness about the importance of vaccination. A disparity exists in TT vaccination coverage and antenatal care between urban and rural areas due to access and utilization of health care services. NT reporting is incomplete, as cases from the private sector and rural areas are underreported. To successfully eliminate NT, women of reproductive age must be made aware of the benefits of TT vaccine, not only to themselves, but also to their families. Effective communication strategies for TT vaccine delivery and health education focusing on increasing awareness of NT are strongly suggested. It is imperative that the private and government sectors work cooperatively to report NT cases and improve routine TT vaccination coverage.

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 1 Issue 4  December 2012
http://jpids.oxfordjournals.org/content/current

ORIGINAL ARTICLES
Laboratory-Confirmed Rotavirus Disease in Utah Children: Clinical and Economic Impact of Rotavirus Vaccination
Angel Herrera Guerra, Chris Stockmann, Andrew T. Pavia, Adam L. Hersh, Emily A. Thorell, Hsin Yi Weng, Kent Korgenski, Carrie L. Byington, and Krow Ampofo
J Ped Infect Dis (2012) 1(4): 268-277 doi:10.1093/jpids/pis058

Abstract
Background. Rotavirus is the most common cause of infectious diarrhea in children worldwide. Recent studies have described changes in the burden of all-cause gastroenteritis; however, there are limited data on the clinical and economic impact of rotavirus vaccine on cases of laboratory-confirmed rotavirus disease.

Methods. We performed a retrospective study of laboratory-confirmed rotavirus disease from July 2003 through June 2010 at a children’s hospital and a community hospital in Utah. Demographics and hospital costs for children <5 years with rotavirus symptoms and a positive rotavirus enzyme immunoassay test on a stool specimen were abstracted from electronic medical records. We compared the prevaccine period (2003–2007) with the postvaccine period (2008–2010).

Results. The overall incidence of rotavirus gastroenteritis declined in the postvaccine period, from 26.6 to 5.2 cases per 10 000 person-years for Salt Lake County residents. The largest decrease in the incidence of rotavirus gastroenteritis was among children <12 months (−87%; 95% confidence interval [CI], 79–93). Older children (12–23 months) also experienced significant decreases (−81%; 95% CI, 72–88), as did those 24–59 months (−61%; 95% CI, 51–71). In 2009, 3 years after rotavirus vaccine introduction, there was a 79% decrease in emergency department visits and a 78% decrease in hospitalizations across both hospitals. The cost of emergency department visits and hospitalizations for rotavirus gastroenteritis decreased by 79% and 72%, respectively, resulting in annual savings of $790 000 at a children’s hospital and $140 000 at a community hospital.

Conclusion. Rotavirus vaccination in infants has dramatically decreased the clinical burden and direct medical costs of rotavirus gastroenteritis in both infants and young children.

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 1 Issue 4  December 2012
http://jpids.oxfordjournals.org/content/current

INVITED REVIEW
Community-Acquired Pneumonia in the Conjugate Vaccine Era
Derek J. Williams and Samir S. Shah
J Ped Infect Dis (2012) 1(4): 314-328 doi:10.1093/jpids/pis101

Abstract
Community-acquired pneumonia (CAP) remains one of the most common serious infections encountered among children worldwide. In this review, we highlight important literature and recent scientific discoveries that have contributed to our current understanding of pediatric CAP. We review the current epidemiology of childhood CAP in the developed world, appraise the state of diagnostic testing for etiology and prognosis, and discuss disease management and areas for future research in the context of recent national guidelines.

Nature Biotechnology
30(10), 2012

Innovative drugs and vaccines in China, India and Brazil.
Rahim Rezaie, Anita M. McGahan, Abdallah S. Daar and Peter A. Singer..

http://www.nature.com/nbt/journal/v30/n10/full/nbt.2380.html

Just how much innovation is going on within private-sector enterprises in emerging markets? What is the nature of these innovations? Who are the companies in China, India and Brazil innovating for? These are some of the questions addressed in this article. The article details 165 innovative vaccines and medicines in the pipeline of 41 domestic companies in the stated countries. It concludes that: a) a growing number of domestic health enterprises in the stated countries are developing innovative medicines and vaccines, and b) as a group they exhibit a predilection for diseases that are most relevant domestically. It foresees that the rising innovation capacity in emerging markets will have a major effect not only on developing world health systems but also health systems in the developed world, especially as the latter struggle with escalating costs.

Health Research Policy and Systems
10:18, 2012.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.
Rahim Rezaie, Anita M. McGahan, Sarah E. Frew, Abdallah S. Daar and Peter A. Singer.
http://www.health-policy-systems.com/content/10/1/18

This paper analyzes factors that influence innovative activity in the indigenous health biotechnology and pharmaceutical sectors of China, India, Brazil, and South Africa. It a) shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b) identifies common challenges that indigenous entrepreneurs face, c) highlights the key role played by the state in advancing innovation, and d) reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration.

Reuters
http://www.reuters.com/
Accessed 17 November 2012

Novartis receives positive CHMP opinion for Bexsero(R), a groundbreaking vaccine to help prevent devastating MenB infections, the leading cause of meningitis in Europe
http://www.reuters.com/article/2012/11/16/idUS113890+16-Nov-2012+HUG20121116

Twitter Watch[accessed 17 November 2012 – 16:14]

International Health ‏@IntlHealthJHSPH
#Pneumonia Progress Report 2012 Released – International Vaccine Access Center (@IVACtweets) http://bit.ly/Wfontu  via @ZeeNews
11:22 AM – 16 Nov 12

Amanda Glassman ‏@glassmanamanda
No Rest for the Weary: Reform 2.0 at the Global Fund | Amanda Glassman | Global Health Policy http://blogs.cgdev.org/globalhealth/2012/11/no-rest-for-the-weary-reform-2-0-at-the-global-fund.php … via @CGDev
10:18 AM – 16 Nov 12

Seth Berkley @GAVISeth
Congrats Mark Dybul on your appointment as Executive Director GFATM. Looking forward 2 working w/you @globalfundnews http://bit.ly/T3E18a 
12:18 PM – 15 Nov 12

The Global Fund ‏@globalfundnews
Meet Mark Dybul, the new Executive Director of the #GlobalFund! http://bit.ly/RF9BYA 
8:52 AM – 15 Nov 12

The Global Fund @globalfundnews
Global Fund Appoints Mark Dybul as Executive Director (15 November 2012) http://tinyurl.com/d3fsl9k 
8:46 AM – 15 Nov 12

The Global Fund @globalfundnews
Board Approves Integration of AMFm into Core Global Fund Grant Processes http://tinyurl.com/cj3hp8p 
6:34 AM – 15 Nov 12

WHO @WHO
#Meningitis A vaccine, MenAfriVac, is now the only vax that can be transported & stored for up to 4 days without refrigeration or an icepack
3:30 AM – 15 Nov 12

Editor’s Notes:

– Email Summary: Vaccines: The Week in Review is available as a weekly email summary: 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_10 November 2012

– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.

– 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…

PATH MVI Announcement: RTS,S malaria candidate vaccine reduces malaria by approximately one-third in African infants
Results from ongoing Phase III clinical trial announced

Results from a pivotal, large-scale Phase III trial, published online today in the New England Journal of Medicine [see Journal Watch below], show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe malaria and had similar reactions to the injection. In this trial, RTS,S demonstrated an acceptable safety and tolerability profile.

Eleven African research centres in seven African countries1 are conducting this trial, together with GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI.

Dr. Salim Abdulla, a principal investigator for the trial from the Ifakara Health Institute, Tanzania, said: “We’ve made significant progress in recent years in our battle against malaria, but the disease still kills 655,000 people a year—mainly children under five in sub-Saharan Africa. An effective malaria vaccine would be a welcome addition to our tool kit, and we’ve been working toward this goal with this RTS,S trial. This study indicates that RTS,S can help to protect young babies against malaria. Importantly, we observed that it provided this protection in addition to the widespread use of bed nets by the trial participants.”

PDF version of press release (139 KB PDF)
http://www.malariavaccine.org/pr2012Nov9-RTSS.php

MVI Director Dr. David Kaslow comments on malaria vaccine results
Posted on November 9, 2012 http://www.path.org/blog/2012/11/malaria-vaccine-comments/

WHO Announcement: New results from RTS,S/AS01 malaria vaccine trial
9 November 2012
WHO notes the completion of the latest stage of the RTS,S/AS01 Phase 3 malaria vaccine trial. As communicated previously, WHO will make evidence-based recommendations in 2015. These recommendations will be based on the full results from the Phase 3 trial that will become available in 2014, including the site-specific efficacy and booster dose data. WHO recommendations are based on the input of its independent advisors. For malaria vaccines, the Joint Technical Expert Group (JTEG) on malaria vaccines will draft candidate policy recommendations for joint review by the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) in 2015.

RTS,S/AS01 may have an important role in some settings in sub-Saharan Africa, depending on the results in 2014. RTS,S/AS01 will be evaluated as a possible addition to, and not a replacement for, existing preventive, diagnostic and treatment measures, depending on the results that become available in 2014.

Related links: Questions and Answers on Malaria Vaccines (November 2012)
pdf, 134kb
http://www.who.int/vaccine_research/diseases/malaria/new_results_malaria_vaccine_trial_rts-s-as01/en/index.html

.
GAVI: Statement on latest interim trial data on malaria vaccine candidate
Latest interim trial data on malaria vaccine candidate RTS,S published by Glaxosmithkline and Path malaria vaccine initiative

In response to the release of the latest interim data on the trial of malaria vaccine candidate RTS,S, Dr Seth Berkley, CEO of the GAVI Alliance, said. “Malaria claims the lives of hundreds of thousands of children every year so evidence that it is scientifically possible to vaccinate children and babies against the disease and provide protection against malaria and severe malarial disease for a period of time is extremely significant. This is the first protozoa disease that we have convincingly been able to prevent in humans through immunisation.

“While the science is encouraging, today’s interim data showing lower efficacy of protection in infants at the age of the regular immunisation schedule as compared to previous results in older children raises questions from a public health perspective as this is the age group it would be most easy to distribute the vaccine to through the routine immunisation system and get maximum protection from the effects of malaria. More data on duration of protection using this and other vaccine schedules will be important to understand what the vaccination strategy can be and how an efficacious vaccine with a good duration of protection can be used in the relevant settings.

“GAVI is committed to making cost-effective investments in vaccines that protect the lives of the most vulnerable. We await the publication of the full trial results to understand the potential role of RTS,S in Malarial control. An efficacious malaria vaccine has the potential to change the lives of millions of people in some of the world’s poorest countries. A licensed vaccine would join bed nets, insecticide spraying and anti-malarial drugs as ways of protecting the most vulnerable from malaria.”

http://www.gavialliance.org/library/news/statements/2012/gavi-statement-on-latest-interim-trial-data-on-malaria-vaccine-candidate/

Update: Polio this week – As of 07 Nov 2012
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s Extract]
– The Strategic Advisory Group of Experts on immunization (SAGE) met this week in Geneva, Switzerland. Among other topics relating to immunization, SAGE reviewed a detailed summary of the current status of the Global Polio Eradication Initiative and impact of the national emergency action plans in the remaining three endemic countries. SAGE also discussed a draft of the polio endgame strategy, including an eventual switch from trivalent oral polio vaccine (OPV) to bivalent OPV, and the role inactivated polio vaccine (IPV) will play to minimise any risks associated with such a switch.

– Also meeting this week in Geneva was the Polio Partners Group (PPG), including senior representatives from donor agencies, foundations and spearheading partners, to review current status of the global eradication effort, and issues relating to financing, including of the polio endgame. Opening the meeting, WHO Director-General Dr Margaret Chan highlighted the epidemiological opportunity of completing the job and its significant economic and humanitarian benefits, but also cautioned of the consequences of failure: “We know what is at stake if we do not get this job done. More than 250,000 people again paralysed by polio every year, including adults. Today, there are less than 200 new polio cases in the entire world. The prospect of not finishing polio eradication is unthinkable. That would be a humanitarian catastrophe that must be averted at all costs.”

Afghanistan
– One new case was reported in the past week, bringing the total number of cases for 2012 to 27. The most recent case had onset of paralysis on 1 October (WPV1 from Paktya province).
– Strategies to safely access all children continue to be implemented. As a result, access continues to improve in the 13 high-risk districts of Southern Region. During the October immunization campaigns, 3.4% of children were inaccessible due to insecurity, compared to 8.5% in June.
– The ‘Ending Polio Is My Responsibility’ social mobilization campaign continues to be expanded. New public service announcements continue to be aired on radio and television, complemented by billboards and other communications tools. The activity is primarily aimed at increasing awareness among caregivers. Depending on the province, messages on measles vaccination are also included in communications.

Nigeria
– Two new WPV cases were reported in the past week (a WPV3 from Kano and a WPV1 from Katsina), bringing the total number of WPV cases for 2012 to 101. The case from Katsina is the most recent in the country (onset of paralysis on 15 October).
– A special nomadic outreach strategy continues to be implemented. In priority Local Government Areas (LGAs) with high nomadic populations, activities are focusing on identifying settlements and population movements and ensure these are accurately reflected in microplans.

Pakistan
– One new WPV case was reported in the past week (WPV1 from Bajour, Federally Administered Tribal Areas – FATA), bringing the total number of WPV cases for 2012 to 48. It is the most recent case in the country (with onset of paralysis on 9 October).
– Additionally, one new case due to a cVDPV2 was confirmed from Balochistan, bringing the total number of cVDPV2 cases to five (all from the greater Quetta area of Balochistan). In response, the most recent National Immunization Days (NIDs – on 15-17 October) had been conducted with trivalent OPV.

*                                                 *                                                     *                                                    *

Speech: WHO Director-General assesses the status of polio eradiation

Opening remarks at the high level meeting of the Global Polio Partners Group

Dr Margaret Chan
Director-General of the World Health Organization
Geneva, Switzerland – 8 November 2012

[Excerpt]

“…A year ago, we were on the verge of polio eradication in India. Today we can celebrate that victory with confidence.

I fully agree with the assessment of the Independent Monitoring Board. This is a “magnificent” achievement. It tells the world that the poliovirus is not permanently entrenched. It can indeed be driven out of existence.

A year ago, the IMB warned that polio eradication would not be achieved on the current trajectory. While praising India’s performance, the IMB highlighted serious challenges in the remaining countries with ongoing transmission.

That was a harsh assessment, but it was also an accurate assessment. To eradicate polio, we had to respond, to do things differently and with greater urgency.

The partnership took a hard look at each point of criticism, and took swift action. The World Health Assembly declared polio a programmatic emergency for global public health.

The polio programme was restructured. The whole effort moved into emergency overdrive. That meant taking direct oversight of the programmes through a new Polio Oversight Board. We activated our emergency operations centers, established new emergency protocols, and strengthened the leadership of country operations.

We recruited thousands and thousands of additional polio workers to support government efforts. Afghanistan, Pakistan, and Nigeria launched national emergency action plans, overseen by the countries’ presidents.

In late September, the UN Secretary-General convened an extraordinary public meeting with the Presidents of Afghanistan, Pakistan, and Nigeria, myself, Mr Bill Gates, and the heads of partner agencies. That event was an unprecedented show of global solidarity.

We have clear evidence that the national emergency plans are having an impact. More children are being reached, for the first time, in high-risk areas. We can say this with confidence, because we have much more rigorous monitoring systems in place, including ways to hold local officials fully accountable for vaccinating their children.

In its most recent full report from June, the IMB commended these improvements, and noted that polio is now at its lowest levels since records began. This assessment, I remind you, came just eight months after the IMB’s report from October 2011.

I believe we are back on track.

Ladies and gentlemen,

We have a very real opportunity for success. We must seize this opportunity with a sense of urgency appropriate for an emergency situation.

We are right to plan now for the endgame and for a post-polio world. You will be looking at the working paper, Polio eradication endgame strategic plan 2013–2018, legacy planning and financial requirements.

This paper was requested by the World Health Assembly in May. It provides a roadmap for completing the eradication of wild polioviruses, stopping use of the oral polio vaccine, and building on the legacy of this huge public-private initiative…

Wide consultations are still ongoing to improve the strategy, and much revision is still needed.

“…As highlighted in the draft strategic plan, very real challenges remain, like persistent gaps in vaccine coverage in some areas of northern Nigeria, weak management and insecurity in parts of Pakistan and Afghanistan, and the ever-present and very real danger of renewed international spread of the virus, particularly into West and Central Africa.

With programmes now on an emergency footing and performance rapidly improving, the financing gap is again emerging as the greatest threat to success. The funding gap is a serious constraint as we plan for the 2013–2018 period. The IMB noted that the lack of consistent financing was “not compatible with the ambitious goal of stopping polio transmission globally.”

We all know what is at stake. Polio eradication will bring enormous humanitarian and economic benefits. Upwards of $50 billion globally will be saved over the coming 25 years, most of it in developing countries. No child will ever again suffer lifelong polio paralysis.

And we know what is at stake if we do not get this job done. More than 250 000 people again being paralysed by polio every year, including adults.

Today, there are less than 200 new polio cases in the entire world. The prospect of not finishing polio eradication is unthinkable. That would be a humanitarian catastrophe that must be averted at all costs.

I am sure you agree. We are here because we share a passionate determination to get this job done. We need to keep the pressure on governments to act in an emergency mode, to deliver at peak performance, and to be held accountable for results.

We need to secure support for this effort from emerging donors and the private sector. And we especially need the G8, G20, and Islamic countries to help us rid the world of polio once and for all…”

http://www.who.int/dg/speeches/2012/polio_eradication_20121108/en/index.html

UNICEF News note: Maternal and neonatal tetanus eliminated in China
Higher hospital delivery rate, improved mother and baby health play a major role
5 November 2012

Following a maternal and neonatal tetanus (MNT) elimination validation exercise carried out last month, the World Health Organization (WHO) formally declared that China has eliminated MNT on 30 October 2012. The validation exercise was carried out by 103 monitoring teams that conducted cluster surveys in Hechi Prefecture of Guangxi Province and Jiangmen Prefecture of Guangdong Province – chosen because of their high proportion of rural poor and migrant worker populations, who have limited access to clean delivery practices. The survey teams visited 45,088 households and investigated 2,306 live births and found zero cases of MNT.

WHO considers elimination of MNT to be achieved when there is less than one case of neonatal tetanus per one thousand live births in every district. If neonatal tetanus is eliminated, maternal tetanus elimination is assumed. Neonatal tetanus can be prevented by hygienic childbirth, careful handling of the umbilical cord during and after childbirth, or maternal vaccination with tetanus toxoid vaccine. The validation was coordinated by the Ministry of Health with support of UNICEF and WHO and now confirms that all prefectures in China have less than one case of the disease per one thousand live births. China now joins the 161 countries that have eliminated neonatal tetanus…
http://www.unicef.org/media/media_66329.html

WHO: Global Monitoring Framework on (NCDs) noncommunicable diseases
Note for the media –  9 November 2012

The first-ever global monitoring framework to combat several of the world’s biggest killers has been agreed this week by WHO Member States. The framework comprises nine voluntary global targets and 25 indicators to prevent and control diseases such as heart disease, diabetes, cancer, chronic lung disease and other noncommunicable diseases. The draft framework aims to focus efforts to address the impact of noncommunicable diseases and assess:
– the progress made in reducing associated illness and death;
– the reduction of exposures to the main risk factors for the diseases, including tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity; and
– the response of national health systems to noncommunicable diseases.

Achievable targets
“The new global monitoring framework will enable us to assess progress across regional and country settings and to monitor trends,” says Dr Bjørn-Inge Larsen, the chairman of the formal WHO meeting. “The agreed voluntary targets are aspirational but achievable and they will drive progress in prevention and control at national, regional and global levels.”

Member States reached consensus on the NCD targets and indicators during a formal three-day meeting that took place in Geneva from 5-7 November. The meeting was attended by 119 WHO Member States, the African Union, the European Union and 17 nongovernmental organizations.

Voluntary targets
“The indicators and voluntary global targets are key building blocks of our fight against NCDs,” says Dr Oleg Chestnov, WHO’s Assistant Director-General for Noncommunicable Diseases and Mental Health. “They will provide the foundation for advocacy, raising awareness, reinforcing political commitment and promoting global action to tackle these deadly diseases.”

The 9 voluntary global targets are aimed at combating premature mortality from NCDs, harmful use of alcohol, tobacco use, physical inactivity, salt/sodium intake, raised blood pressure, diabetes, obesity, promoting drug therapy and counseling, and medicines and technologies for NCDs.

Indicators

The 25 indicators are aimed at measuring premature mortality, cancer incidence, harmful use or alcohol, low fruit and vegetable intake, overweight and obesity, physical inactivity, raised blood glucose, raised blood pressure, raised total cholesterol, salt/sodium intake, tobacco use, fat intake, cervical cancer screening, drug therapy and counseling to prevent heart attacks and strokes, essential NCD medicines and technologies, palliative care, policies to reduce the marketing of foods and non-alcoholic beverages to children, vaccination against hepatitis B, policies to eliminate partially hydrogenated vegetable oils from food supply, and vaccination against human papillomavirus.

The global monitoring framework will now be considered first by the WHO Executive Board during its 132nd session in January 2013 and then be submitted to the World Health Assembly in May 2013 for consideration and adoption.

http://www.who.int/mediacentre/news/notes/2012/ncd_20121109/en/index.html

WHO: GOVERNING BODY DOCUMENTATION – NCDs
Formal meeting of Member States to conclude the work on the comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of noncommunicable diseases

A/NCD/1 Rev.1 – Provisional agenda

A/NCD/1 Add.1 – Draft programme of work

A/NCD/2 (other languages to follow on Monday)
Report of the Formal Meeting of Member States to conclude the work on the comprehensive global monitoring framework, including indicators and a set of voluntary global targets for the prevention and control of noncommunicable diseases
A/NCD/INF./1
A draft comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of noncommunicable diseases

A/NCD/INF./2
A draft comprehensive global monitoring framework: report summarizing the results of the discussions in the regional committees and inputs from stakeholders

A/NCD/DIV/1
Représentants des États Membres – Representatives of Member States
Liste provisoire des participants – Provisional List of Participants

http://apps.who.int/gb/ncds/

World Pneumonia Day – 12 November 2012

– WHO: World Pneumonia Day seeks to raise awareness of pneumonia as a public health issue and help prevent the millions of avoidable child deaths from pneumonia that occur each year. It is organized by the Global Coalition against Child Pneumonia (a network of international, government, non-governmental and community-based organizations, research and academic institutions, foundations, and individuals) to bring much-needed attention to pneumonia among donors, policy makers, health care professionals, and the general public.
Related links
More information on World Pneumonia Day
http://www.who.int/mediacentre/events/annual/world_pneumonia_day/en/index.html

– MMWR Weekly, November 9, 2012 / 61(44);906
Announcements – World Pneumonia Day  November 12, 2012
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6144a6.htm?s_cid=mm6144a6_w

Pneumonia is the leading killer of young children around the world, causing approximately 20% of all child deaths. For countries to reach United Nations Millennium Development Goal 4 of reducing child mortality by two thirds (from 1990 levels) by 2015, interventions to prevent pneumonia deaths need to be implemented (1). Illness and deaths from pneumonia can be reduced with the use of Streptococcus pneumoniae (pneumococcus), Haemophilus influenzae type b (Hib), influenza, and measles vaccines; antimicrobial treatments; and exclusive breast feeding of young infants, among other strategies (2).

New vaccine introduction to prevent pneumonia in developing countries has had unprecedented momentum over the past few years. Hib vaccines have been introduced or are ready to be introduced in all 71 lowest-income countries eligible for GAVI Alliance funding by 2013, and pneumococcal conjugate vaccines are expected to be introduced in 54 of these countries by 2015 (3). In addition, a study to identify the etiology of pneumonia in developing countries is expected to generate data that will better guide prevention and treatment strategies, especially in countries that already are using Hib and pneumococcal vaccines (4).

The fourth annual World Pneumonia Day is being observed November 12, 2012, to raise awareness about pneumonia’s toll and to promote interventions to protect against, treat, and prevent the disease globally. Activities are being promoted by a coalition of more than 140 community-based organizations, academic institutions, government agencies, and foundations. More information is available at http://worldpneumoniaday.org.

References
– United Nations Development Programme. The Millennium Development Goals: eight goals for 2015. New York, NY: United Nations Development Programme; 2012. Available at http://www.undp.org/content/undp/en/home/mdgoverview.html. Accessed September 7, 2012.
– World Health Organization/United Nations Children’s Fund (UNICEF). Global action plan for prevention and control of pneumonia (GAPP). Geneva, Switzerland: World Health Organization/New York, NY: United Nations Children’s Fund (UNICEF); 2009. Available at http://whqlibdoc.who.int/hq/2009/who_fch_cah_nch_09.04_eng.pdf . Accessed October 28, 2010.
– Hajjeh R. Accelerating introduction of new vaccines: barriers to introduction and lessons learned from the recent Haemophilus influenzae type b vaccine experience. Philos Trans R Soc Lond B Biol Sci 2011;366:2827–32.
– Levine O, O’Brien KL, Deloria-Knoll M, et al. The pneumonia etiology research for child health project: a 21st century childhood pneumonia etiology study. Clin Infect Dis 2012;54(Suppl 2):S93–101.

HIH Media Release: HPV vaccine may benefit HIV-infected women

“Women with HIV may benefit from a vaccine for human papillomavirus (HPV), despite having already been exposed to HPV, a study finds. Although many may have been exposed to less serious forms of HPV, more than 45 percent of sexually active young women who have acquired HIV appear never to have been exposed to the most common high-risk forms of HPV, according to the study from a National Institutes of Health research network.

The researchers noted that earlier studies had found many women with HIV were more likely than were women who did not have HIV to have conditions associated with HPV, such as precancerous conditions of the cervix, as well as for cervical cancer.

“Health care providers may hesitate to recommend HPV vaccines after a girl starts having sex,” said study first author Jessica Kahn, M.D., M.P.H. of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati College of Medicine. “However, our results show that for a significant number of young women, HPV vaccine can still offer benefits. This is especially important in light of their HIV status, which can make them even more vulnerable to HPV’s effects.” The findings appear in the Journal of Acquired Immune Deficiency Syndromes.

http://www.nih.gov/news/health/nov2012/nichd-08.htm

The Weekly Epidemiological Record (WER) for 9 November 2012, vol. 87, 45 (pp. 437–448) includes:

– Outbreak news: Marburg haemorrhagic fever, Uganda; Rift Valley fever, Mauritania
– Progress towards poliomyelitis eradication, Nigeria, January 2011–September 2012
– Monthly report on dracunculiasis cases, January–September 2012

http://www.who.int/entity/wer/2012/wer8745.pdf

Research Report: Policies that encourage biopharmaceutical innovation in middle–income countries
Developed by Charles Rivers Associates; Commissioned by IFPMA
October 2012

The study examined growing biopharmaceutical innovation sectors in Brazil, China, Colombia, India, Malaysia, Russia, South Africa and South Korea, and analyzed key national political and economic factors that foster biopharmaceutical innovation. Eduardo Pisani, IFPMA Director General, said, “In recent years, the number of countries where biopharmaceutical innovation takes places has increased, and this trend is expected to continue. Middle-income countries are becoming increasingly important for innovative activities ranging from early stage research to clinical development. We commissioned this report, because it is crucial for governments and industry to have a clearer understanding of what stimulates and drives innovation in these countries.” The report highlighted the primary success factor as consistent long-term policy and legal frameworks. These should be coupled with effective coordination of national industrial and health policies, encouragement of collaborations between stakeholders, and adequate intellectual property protection. The report further suggests that some countries specialize in those stages of the innovation process in which they have a competitive advantage.

http://www.ifpma.org/fileadmin/content/News/2012/IFPMA_News_Release_CRA_Report_31Oct2012.pdf

CRA Full Report: http://www.ifpma.org/fileadmin/content/Publication/2012/CRA_Policies_that_encourage_innovation_in_middle-income_countries_Web.pdf

CRA Key Findings:
http://www.ifpma.org/fileadmin/content/Publication/2012/CRA_Policies_that_encourage_innovation_in_middle-income_countries_Key_Findings_Web.pdf

Annals of Internal Medicine
6 November 2012, Vol. 157. No. 9
http://www.annals.org/content/current

Original Research
Two Rotavirus Outbreaks Caused by Genotype G2P[4] at Large Retirement Communities: Cohort Studies
Cristina V. Cardemil, MD, MPH; Margaret M. Cortese, MD; Andrew Medina-Marino, PhD; Supriya Jasuja, MD, MPH; Rishi Desai, MD, MPH; Jessica Leung, MPH; Cristina Rodriguez-Hart, MPH; Gissela Villarruel, MPH; Julia Howland, MPH; Osbourne Quaye, PhD; Ka Ian Tam, PhD; Michael D. Bowen, PhD; Umesh D. Parashar, MBBS, MPH; Susan I. Gerber, MD; and the Rotavirus Investigation Team

Abstract
Background: Outbreaks of rotavirus gastroenteritis in elderly adults are reported infrequently but are often caused by G2P[4] strains. In 2011, outbreaks were reported in 2 Illinois retirement facilities.

Objective: To implement control measures, determine the extent and severity of illness, and assess risk factors for disease among residents and employees.

Design: Cohort studies using surveys and medical chart abstraction.

Setting: Two large retirement facilities in Cook County, Illinois.

Patients: Residents and employees at both facilities and community residents with rotavirus disease.

Measurements: Attack rates, hospitalization rates, and rotavirus genotype.

Results: At facility A, 84 of 324 residents (26%) were identified with clinical or laboratory-confirmed rotavirus gastroenteritis (median age, 84 years) and 11 (13%) were hospitalized. The outbreak lasted 7 weeks. At facility B, 90 case patients among 855 residents (11%) were identified (median age, 88 years) and 19 (21%) were hospitalized. The facility B outbreak lasted 9.3 weeks. Ill employees were identified at both locations. In each facility, attack rates seemed to differ by residential setting, with the lowest rates among those in more separated settings or with high baseline level of infection control measures. The causative genotype for both outbreaks was G2P[4]. Some individuals shed virus detected by enzyme immunoassay or genotyping reverse transcription polymerase chain reaction for at least 35 days. G2P[4] was also identified in 17 of 19 (89%) samples from the older adult community but only 15 of 40 (38%) pediatric samples.

Limitation: Medical or cognitive impairment among residents limited the success of some interviews.

Conclusion: Rotavirus outbreaks can occur among elderly adults in residential facilities and can result in considerable morbidity. Among older adults, G2P[4] may be of unique importance. Health professionals should consider rotavirus as a cause of acute gastroenteritis in adults.

Primary Funding Source: None.