The pdf version of Vaccines: The Week in Review  28 November 2011, comprising the posts for this date below, is available here: Vaccines_The Week in Review_28 November 2011

The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria announced adoption of a new strategy “which commits the institution to work with implementing countries and partner organizations to sustain and accelerate gains in the fight against the pandemics. The Global Fund aspires to contribute substantially to international goals by saving 10 million lives and preventing 140-180 million new infections from AIDS, tuberculosis and malaria from 2012 to 2016.” The Board also approved a Consolidated Transformation Plan for the organization “to improve its risk management, fiduciary controls and governance. The plan will refocus staff and resources on grant management in high-risk countries; reform the way the Global Fund approves grants by moving towards a more interactive process with applicants and partners and strengthen the Board’s governance processes.”

Global Fund Board Chair Simon Bland commented, “The five-year strategy and transformation plan adopted at the meeting together commit the Global Fund to shift to a new funding model that focuses on investing strategically in countries, populations and interventions with high potential for impact and strong value for money. It will provide its funding in a more proactive, flexible and predictable way. It will better manage risk and it will work more actively with countries and partners to facilitate grant implementation success. In doing so, I believe the Global Fund will shift from an institution that has successfully provided emergency funding to allow countries to cope with the runaway pandemics, to become a sustainable, efficient funder of the global efforts to control them and eventually win the battle against AIDS, TB and malaria.”

The Global Fund said it has US$4 billion held at its trustee account to ensure disbursements on all existing grants, and that, based on pledges from donors, the Fund has or expects to receive resources enabling the institution to sign grants for existing approved programs with a value of more than US$10 billion for the period 2011 to 2013.

However, the Global Fund noted that “a revised resource forecast presented to the Board showed that substantial budget challenges in some donor countries, compounded by low interest rates have significantly affected the resources available for new grant funding. As a result, the Global Fund will only be able to finance essential services for on-going programs that come to their conclusion before 2014 by making savings in the existing grant portfolio. The Global Fund Board adopted such measures, including further limiting funding to some middle-income countries.”

The Board “urgently requested donors to consider measures to increase and accelerate funding, and implementing country governments, especially those from middle-income countries, to increase funding for the three diseases and related health investments.” During this period, the Global Fund “will roll out a new way for countries to apply for funding which will reduce the amount of investments a country puts into developing a proposal and engages with partners and implementers.”

Recognizing that the substantial changes that lie ahead will necessitate considerable focus on internal management and administration, the Board decided to appoint a General Manager to work alongside the Executive Director. The General Manager and a potential support team will help to take the organization through its transformation phase over the next twelve months. The strategy, which is the result of more than a year’s discussions and consultations with more than 700 individuals, groups and organizations, will also strengthen the Global Fund’s focus on “most-at-risk” populations and striving to protect human rights through its funding of programs.

http://www.theglobalfund.org/en/mediacenter/pressreleases/2011-11-23_The_Global_Fund_adopts_new_strategy_to_save_10_million_lives_by_2016/

Separately, the Global Fund said it warmly welcomed the announcement by Germany to release EUR 100 million as part of its contribution for 2011. Germany had previously released EUR 100 million in August 2011 and the latest payment fulfils its full pledge of EUR 200 million for the year. Professor Michel Kazatchkine, the Global Fund’s Executive Director, said, “Germany has been a strong supporter of the Global Fund and has taken a lead in the work to strengthen the Global Fund’s oversight of its grants. We appreciate the trust and confidence Germany has shown in our efforts to transform the Global Fund into a highly efficient channel for financing a sustainable, long-term response to the three diseases.” Germany is described as the fourth largest donor to the Global Fund, having pledged over EUR 1.5 billion since 2002. This includes EUR 600 million for the period 2011-13, in yearly installments of EUR 200 million each. Germany has conditioned next year’s contribution of EUR 200 million on the implementation of the Global Fund’s Consolidated Transformation Plan.

http://www.theglobalfund.org/en/mediacenter/pressreleases/2011-11-23_Global_Fund_Welcomes_Germany_Contribution_for_2011/

 GAVI CEO Seth Berkley presented his report on GAVI’s achievements in 2011 and the challenges ahead to the GAVI Board, 16-17 November 2011 in Dhaka, Bangladesh. The slides from the presentation are available here: http://www.gavialliance.org/about/governance/secretariat/seth-berkley/ceo-board-report-presentation-16-nov-2011-bangladesh/

   Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP)
This report updates the previously published summary of recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC) for vaccinating health-care personnel (HCP) in the United States. This report summarizes all current ACIP recommendations for vaccination of HCP and does not contain any new recommendations or policies. The recommendations provided in this report apply, but are not limited, to HCP in acute-care hospitals; long-term–care facilities (e.g., nursing homes and skilled nursing facilities); physician’s offices; rehabilitation centers; urgent care centers, and outpatient clinics as well as to persons who provide home health care and emergency medical services.

November 25, 2011 / Vol. 60 / No. RR–7  – November 2011
http://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf

UNICEF and Save the Children UK issued a report – Progress in Child Well-being: Building On What Works – “showing that children’s well-being has improved dramatically thanks to increased political will globally, supportive policies and well-focused programmes and resources, but that the gains will be sustained only if the most disadvantaged and vulnerable children are reached The report “draws on a more in-depth study commissioned by UNICEF and Save the Children UK, and authored by the Overseas Development Institute.” The report “points to a vastly improved child mortality rate.   Compared to 1990, 12,000 fewer children under five die every day in 2010.  Between 1990 and 2008, stunting due to malnutrition declined in developing countries from 40 per cent to 29 per cent. Impressive gains have also been seen in education. In the decade between 1999 and 2009, the number of children enrolled in pre-primary education jumped almost 40 per cent from 113 million to 157 million; 58 million additional children enrolled in primary school; and the number of primary-aged children out of school decreased by 39 million.”
http://www.unicef.org/media/media_60687.html

The Weekly Epidemiological Record (WER) for 25 November 2011, vol. 86, 48 (pp 541–556) includes: African Programme for Onchocerciasis Control: meeting of national task forces, September 2011; Progress introducing rotavirus vaccine into Latin America and the Caribbean, 2006–2010; Monthly report on dracunculiasis cases, January–September 2011

http://www.who.int/entity/wer/2011/wer8648.pdf

Twitter Watch
A selection of items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and by no means intended to be exhaustive.

GAVIAlliance GAVI Alliance
With #GAVI support, #Tanzania plans to introduce the #rotavirus #vaccine by 2013- ht.ly/7G8ER

Eurovaccine ECDC Eurovaccine
EUROVACCINE 2011: web-based interactive conference on 5 December; register for the webcast j.mp/slcgcv
25 Nov

GAVIAlliance GAVI Alliance
The much awaited pentavalent #vaccine has arrived in India. @GAVIAlliance is supplying the #vaccine to India for free- ht.ly/7E7Zq
24 Nov

globalfundnews The Global Fund
Global Fund Welcomes Germany’s Contribution for 2011 theglobalfund.org/en/mediacenter…
24 Nov

Eurovaccine ECDC Eurovaccine
Over 1000 new measles cases added since the previous reporting; total number of cases in 2011: 30200. #EU, EEA, EFTA bit.ly/u6g5RU
24 Nov

cdchep CDC Hepatitis
Just posted! @CDCMMWR: ACIP recommendations for immunization of healthcare personnel go.usa.gov/IhW CE available! #Hepatitis #HBV
23 Nov

globalfundnews The Global Fund
The Global Fund adopts new strategy to save 10 million lives by 2016 theglobalfund.org/en/mediacenter…
23 Nov

gatesfoundation Gates Foundation
Top 10 Myths About #HIV Vaccine Research: gates.ly/t7rr84 #WorldAIDSDay
21 Nov

British Medical Journal
26 November 2011 (Vol 343, Issue 7833)
http://www.bmj.com/content/current

Views & Reviews
Personal View
Transparent pricing of vaccines would help poor as well as rich countries
BMJ 2011; 343 doi: 10.1136/bmj.d7414 (Published 23 November 2011)
Cite this as: BMJ 2011;343:bmj.d7414
Robert Hecht, managing director, Results for Development Institute, Washington, DC; Miloud Kaddar, group leader, Immunization, Vaccines, and Biologicals Department, World Health Organization, Geneva; Sarah Schmitt, consultant to the World Health Organization on vaccine price and procurement, Geneva

Extract
The BMJ’s editor, Fiona Godlee, recently challenged the UK government to publish the price it pays for vaccines, including the new vaccine Cervarix, which helps prevent cervical cancer (BMJ 2011;343:d6239, doi:10.1136/bmj.d6239). Price transparency is not just a matter for the United Kingdom, however: it is a point of vigorous debate and growing urgency in countries around the world.1

Until recently, only a handful of nations—notably the United States, through its large public sector vaccine programme for children, run by the Centers for Disease Control and Prevention—published the prices that they were paying for vaccines. Yet the questions of how much taxpayers’ money is being spent on vaccines, and which companies are winning the public tenders, is becoming ever more important as science and industry develop a new generation of life saving vaccines.

Beyond the traditional antigens for measles, tetanus, and polio, new vaccines that prevent childhood pneumonia and rotavirus diarrhoea are now in use, as well as cancer blocking vaccines for hepatitis B (liver cancer) and human papillomavirus (cervical cancer). Better vaccines for typhoid are just a few years away. A first vaccine against malaria is in advanced trials and showing promising results.2

These fruits of government and private sector investment will save millions of lives …

The Lancet  
Nov 26, 2011  Volume 378  Number 9806  p1825 – 1894  e9 – 10
http://www.thelancet.com/journals/lancet/issue/current

Review
Making new vaccines affordable: a comparison of financing processes used to develop and deploy new meningococcal and pneumococcal conjugate vaccines
James R Hargreaves, Brian Greenwood, Charles Clift, Akshay Goel, Anne Roemer-Mahler, Richard Smith, David L Heymann

Summary
Mechanisms to increase access to health products are varied and controversial. Two innovative mechanisms have been used to accelerate the development of low-price supply lines for conjugate vaccines. The Meningitis Vaccine Project is a so-called push mechanism that facilitated technology transfer to an Indian company to establish capacity to manufacture a vaccine. The Advanced Market Commitment for pneumococcal vaccines is a so-called pull mechanism that guarantees companies a supplement paid in addition to the purchase price for vaccines for a specific period. We compare these approaches, identifying key dimensions of each and considering their potential for replication. We also discuss issues that the Global Alliance for Vaccines and Immunisation (GAVI) face now that these new vaccines are available. Progress towards GAVI’s strategic aims is needed and funding is crucial. Approaches that decrease the financial pressure on GAVI and greatly increase political and financial engagement by low-income countries should also be considered.

The Lancet Infectious Disease
Dec 2011  Volume 11  Number 12  p887 – 970
http://www.thelancet.com/journals/laninf/issue/current

Editorial
A spotlight on neglect
The Lancet Infectious Diseases

Preview
On Oct 14, 2010, WHO launched the report Working to Overcome the Global Impact of Neglected Tropical Diseases, which was accompanied by pledges from governments of some of the 149 countries affected by neglected tropical diseases and from pharmaceutical companies to commit themselves to prevention and control programmes. To maintain focus, WHO recently marked the first anniversary of the report with an update on the status of these 17 infectious diseases.

Pediatrics
November 2011, VOLUME 128 / ISSUE 5
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier]

Early Releases
Financial Impact to Providers Using Pediatric Combination Vaccines
Angela K. Shen, Elizabeth Sobczyk, Lone Simonsen, Farid Khan, Allahna Esber, and Margie C. Andreae
Pediatrics 2011; peds.2011-0025; Published online November 21, 2011 (10.1542/peds.2011-0025)

Abstract
Objective: To understand the financial impact to providers for using a combination vaccine (Pediarix [GlaxoSmithKline Biologicals, King of Prussia, PA]) versus its equivalent component vaccines for children aged 1 year or younger.

Methods: Using a subscription remittance billing service offered to private-practice office-based physicians, we analyzed charge and payment information submitted by providers to insurance payers from June 2007 through July 2009. We analyzed provider and payer characteristics, payer comments, and the ratio of vaccine product to immunization administration (IA) codes and computed total charges and payments to providers for both arms of the study.

Results: Most providers in our data set were pediatricians (74%), and most payers were commercial (75%), primarily managed care. The ratio of the number of vaccine products to the number of IAs was 1:1 in the majority of the claims. Twenty percent of claims were paid with no adjustment by the payer, whereas 76% of the claims were adjusted for charges that exceeded the contract arrangement or the fee schedule. Providers received $23 less from commercial payers and $13 less from Medicaid for the use of Pediarix compared with the equivalent component vaccines. The mean commercial payment was greater for age-specific Current Procedural Terminology IA codes 90465 and 90466 than for non–age-specific codes 90471 and 90472, whereas the reverse was true for Medicaid.

Conclusions: Providers who administer vaccines to children face a reduction in payment when choosing to provide combination vaccines. The new IA codes should be monitored for correction of financial barriers to the use of combination vaccines.

Vaccine
Volume 29, Issue 51 pp. 9411-9572 (28 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Short Communications
Failure-to-success ratios, transition probabilities and phase lengths for prophylactic vaccines versus other pharmaceuticals in the development pipeline
Pages 9414-9416
Matthew M. Davis, Amy T. Butchart, John R.C. Wheeler, Margaret S. Coleman, Dianne C. Singer, Gary L. Freed

Abstract
Research and development of prophylactic vaccines carries a high risk of failure. In the past, industry experts have asserted that vaccines are riskier to produce than other pharmaceuticals. This assertion has not been critically examined. We assessed outcomes in pharmaceutical research and development from 1995 to 2011, using a global pharmaceutical database to identify prophylactic vaccines versus other pharmaceuticals in preclinical, Phase I, Phase II, or Phase III stages of development. Over 16 years of follow-up for 4367 products (132 prophylactic vaccines; 4235 other pharmaceuticals), we determined the failure-to-success ratios for prophylactic vaccines versus all other products. The overall ratio of failures to successes for prophylactic vaccines for the 1995 cohort over 16 years of follow-up was 8.3 (116/14) versus 7.7 (3650/475) for other pharmaceuticals. The probability of advancing through the development pipeline at each point was not significantly different for prophylactic vaccines than for other pharmaceuticals. Phase length was significantly longer for prophylactic vaccines than other pharmaceuticals for preclinical development (3.70 years vs 2.80 years; p < .0001), but was equivalent for all 3 human clinical trial phases between the two groups. We conclude that failure rates, phase transition probabilities, and most phase lengths for prophylactic vaccines are not significantly different from those of other pharmaceutical products, which may partially explain rapidly growing interest in prophylactic vaccines among major pharmaceutical manufacturers.

Vaccine
Volume 29, Issue 51 pp. 9411-9572 (28 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Review

Preparing for introduction of a dengue vaccine: Recommendations from the 1st Dengue v2V Asia-Pacific Meeting
Pages 9417-9422
Sai Kit Lam, Donald Burke, Maria Rosario Capeding, Chee Keong Chong, Laurent Coudeville, Jeremy Farrar, Duane Gubler, Sri Rezeki Hadinegoro, Jeffrey Hanna, Jean Lang, Han Lim Lee, Yee Sin Leo, Chan Quang Luong, Richard Mahoney, John Mcbride, Jorge Mendez-Galvan, Lee Ching Ng, Suchitra Nimmannitya, Eng Eong Ooi, Donald Shepard, et al.

Abstract
Infection with dengue virus is a major public health problem in the Asia-Pacific region and throughout tropical and sub-tropical regions of the world. Vaccination represents a major opportunity to control dengue and several candidate vaccines are in development. Experts in dengue and in vaccine introduction gathered for a two day meeting during which they examined the challenges inherent to the introduction of a dengue vaccine into the national immunisation programmes of countries of the Asia-Pacific. The aim was to develop a series of recommendations to reduce the delay between vaccine licensure and vaccine introduction. Major recommendations arising from the meeting included: ascertaining and publicising the full burden and cost of dengue; changing the perception of dengue in non-endemic countries to help generate global support for dengue vaccination; ensuring high quality active surveillance systems and diagnostics; and identifying sustainable sources of funding, both to support vaccine introduction and to maintain the vaccination programme. The attendees at the meeting were in agreement that with the introduction of an effective vaccine, dengue is a disease that could be controlled, and that in order to ensure a vaccine is introduced as rapidly as possible, there is a need to start preparing now.

Vaccine
Volume 29, Issue 51 pp. 9411-9572 (28 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers

Seasonal influenza vaccine provision in 157 countries (2004–2009) and the potential influence of national public health policies
Pages 9459-9466
Abraham Palache

Abstract
Seasonal influenza places a major burden on public health. Consequently, the World Health Organization (WHO) and over 40% of national governments recommend vaccination of at-risk groups. However, no systematic global data are available to assess vaccine provision nor the effect of immunization policies. To address this situation, IFPMA IVS surveyed global vaccine supply, covering 157 countries from 2004 to 2009. The study also used UN data and a novel vaccine provision “hurdle” rate (set at 15.9% of the population, based on WHO immunization recommendations for the elderly) to compare vaccine supply with development status. In a sub-group of 26 countries, the level of vaccine provision was also correlated to the presence/absence of specific vaccination policies.

Between 2004 and 2009, global annual vaccine provision increased 72% to 449 million doses. Europe and the Americas accounted for 75% to 80% of the total each year, with several countries in these regions, as well as China, Japan and Thailand, achieving notable increases during the study period. However, despite the global growth, only 20% of countries reached the study’s modest “hurdle” rate. On a per capita basis, dose distribution did not correlate directly with income, and several less developed countries, particularly in Latin America, outperformed more developed nations (notably in Eastern and Southern Europe). In the sub-group analysis, the presence of official public health authority vaccination recommendations did not correlate well with higher vaccine supply (positive:negative correlation = 1.3:1), while reimbursement (4.5:1) and the use of wide-scale communication activities (5.3:1) correlated more strongly than development status (2.7:1).

This study shows that globally vaccination levels remain low, and official vaccination recommendations alone are insufficient to drive higher coverage. Rather, policy measures that directly impact patients (i.e. reimbursement and communication) appear more effective, irrespective of countries’ development status, and therefore may do more to help protect local populations against influenza.

Vaccine
Volume 29, Issue 51 pp. 9411-9572 (28 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers

Economic and clinical evaluation of a catch-up dose of 13-valent pneumococcal conjugate vaccine in children already immunized with three doses of the 7-valent vaccine in Italy
Pages 9521-9528
Sara Boccalini, Chiara Azzari, Massimo Resti, Claudia Valleriani, Martina Cortimiglia, Emilia Tiscione, Angela Bechini, Paolo Bonanni

Abstract
A new 13-valent conjugated polysaccharide vaccine (PCV13) against Streptococcus pneumoniae infections, which replaced the 7-valent vaccine (PCV7) in the regional immunization programmes for newborns and children who started but not completed the 3 doses schedule of PCV7, is available in Italy since 2010. The opportunity of administering a further dose of PCV13 to children under 5 years of age who had already completed their vaccination with PCV7, with the aim of extending the serotype coverage, triggered an animated scientific debate. The purpose of this study was to perform a clinical/economic evaluation of the administration of a dose of PCV13, in a catch-up programme, for children under 5 years of age, who had already received 3 doses of PCV7.

A mathematical model of the clinical/economic impact of the adoption of 4 catch-up strategies with PCV13 (children up to 24, 36, 48 and 60 months old) was set up, with a vaccination coverage of 80%, versus immunization with 3 doses of PCV7 without the catch-up programme. The time span covered by the simulation was 5.5 years. The following clinical outcomes of infection were evaluated: hospitalised meningitis/sepsis, hospitalised bacteraemic pneumonias (complicated and uncomplicated), hospitalised non-bacteraemic pneumonias, and non-hospitalised pneumonias.

The administration of one dose of PCV13 to children up to 60 months of age significantly reduces the number of cases of pneumococcal diseases (especially, non-hospitalised pneumonias, 80% of all events prevented, and hospitalised cases of non-bacteraemic pneumococcal pneumonias, 15% of all events prevented) and, subsequently, the relative cost for medical treatment. This results in savings for medical costs amounting to more than 1,000,000 Euros when vaccinating children under 24 months of age (up to almost 3 million Euros for children up to 60 months). More than half of those savings are attributable to avoided hospitalised cases of non-bacteraemic pneumococcal pneumonias. Increasing the number of cohorts involved in the vaccination programme, the impact of immunization increases. The average cost per event avoided is 1674 Euros vaccinating children up to 24 months, and increases to 2522 Euros by vaccinating up to 60 months of age. The cost per year of life saved for different vaccination strategies is always acceptable (from 12,250 Euros to 22,093 Euros).

The results of this study justify, even from the economic point of view, the recommendation of the Italian Ministry of Health to vaccinate children up to 24 months of life in a catch-up programme, as well as the administration of PCV13 children up to 36 months of age, already used in some Italian regions. Furthermore, a catch-up programme that provides the immunization of children under 60 months of age, is also justified from both the economic and clinical point of view.

Vaccine
Volume 29, Issue 51 pp. 9411-9572 (28 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers

Vaccination policies for health-care workers in acute health-care facilities in Europe
Pages 9557-9562
Helena C. Maltezou, Sabine Wicker, Michael Borg, Ulrich Heininger, Vincenzo Puro, Maria Theodoridou, Gregory A. Poland

Abstract
The aim of this study was to evaluate existing policies regarding recommended and mandatory occupational vaccinations for health-care workers (HCWs) in Europe. A standardized questionnaire was sent to experts in Infection Control or Occupational Health in all 27 European Union Member States, as well as Norway, Russia, and Switzerland. All 30 countries have established policies about HCW vaccination against vaccine-preventable diseases. However significant gaps and considerable country-to-country variation were found, in terms of number of recommended vaccines and target subgroups of HCWs and health-care settings. Vaccination against hepatitis B and annual vaccination against seasonal influenza are almost universally recommended for HCWs in Europe (29 countries each, including eight countries where vaccination against hepatitis B is mandatory or required for employment). Policies regarding HCW vaccination also exist against mumps (12 countries), measles or rubella (15 countries), varicella (17 countries), diphtheria-tetanus (14 countries), pertussis (9 countries), poliomyelitis (11 countries), hepatitis A (11 countries), tuberculosis (BCG vaccine) (9 countries), and against meningococcus group C or meningococci groups A, C, W135, Y (tetravalent vaccine) (in 4 countries each). Re-evaluation of occupational vaccine policies for HCWs in Europe on a consensus basis is imperative in order to promote HCW and patient safety

The pdf version of Vaccines: The Week in Review  21 November 2011, comprising the posts below for this date, is available here: Vaccines_The Week in Review_21 November 2011

The GAVI Board said it “will take the first steps towards the introduction of HPV and rubella vaccines in developing countries.” Regarding HPV vaccine, GAVI said that “if negotiations to secure a sustainable price from manufacturers are successful and countries can demonstrate their ability to deliver the vaccines, up to two million women and girls in nine countries could be protected from cervical cancer by 2015.”  Regarding rubella, GAVI said that “responding to projected demand from 30 countries and World Health Organization (WHO) recommendations, the Board also agreed to open a funding window for vaccines against the rubella virus, which threatens pregnancies and child health. The plan is to reach 588 million children by 2015.” Seth Berkley MD, CEO of GAVI, commented, “These two initiatives have huge potential impact for women and families in the developing world…The HPV vaccine is critical to women and girls in poorer countries because they usually do not have access to screening to prevent cervical cancer and treatment taken for granted in richer nations. Today, we have taken deliberate first steps to correct this inequity.”  GAVI-funded rubella vaccines will be combined for easy delivery with measles vaccines in a single measles-rubella (MR) shot, supporting the global measles immunisation effort. If contracted by pregnant women, rubella can lead to multiple severe birth defects that cause lifelong disabilities. Some 90,000 birth defects occur each year in GAVI-eligible countries, equivalent to 80% of the global burden. It can also lead to miscarriage and stillbirth. The GAVI Board also said it will consider funding a vaccine against Japanese encephalitis once an appropriate vaccine is prequalified by WHO, and that it “looked forward to the development of an appropriate conjugate vaccine against typhoid.”

http://www.gavialliance.org/library/news/press-releases/2011/gavi-takes-first-steps-to-introduce-vaccines-against-cervical-cancer-and-rubella/

   WHO recommended that countries with high or intermediate endemic rates of meningococcal disease and countries with frequent epidemics introduce large scale vaccination programmes, using meningococcal conjugate vaccines. The recommendation was made in a position paper published in the Weekly Epidemiological Record. In countries where meningococcal disease occurs less frequently, vaccination is recommended for defined risk groups such as children and young adults living in closed communities, for instance in boarding schools or military camps. Laboratory workers at risk of exposure to meningococci and travellers to high-endemic areas should also be vaccinated. For all countries, knowledge of meningococcal disease burden is critical in ensuring that available vaccines are appropriately used. Countries considering the use of meningococcal vaccines should develop the surveillance systems to characterize meningococcal disease epidemiology. And continued surveillance should dictate the need and timing of repeat mass vaccination campaigns.

WHO noted that in Africa, major epidemics have been occurring over the past 100 years, most of them attributed to serogroup A and occurring in the African “meningitis belt”, a large area that spans sub-Saharan Africa from Senegal in the west to Ethiopia in the east. In 1996 to 1997, the largest epidemic in history swept across the belt, causing over 250,000 cases, an estimated 25,000 deaths, and disability in 50,000 people. Large epidemics recur in the meningitis belt on a regular basis. In December 2010, the first meningococcal A conjugate vaccine to be developed specifically for countries in the African meningitis belt was introduced in Burkina Faso, Mali and Niger. Three additional countries ― Cameroon, Chad and Nigeria ― are introducing the vaccine in December 2011. Position paper on meningococcal vaccines: http://www.who.int/entity/wer/2011/wer8647.pdf

http://www.who.int/immunization/newsroom/newsstory_countries_menin_high_vacc_programmes/en/index.html

PATH announced that Cameroon, Chad, and Nigeria will MenAfriVac™ meningitis vaccine campaigns in December.  These countries in Africa’s meningitis belt are “poised to vaccinate 22 million people against epidemic meningitis next month” and become the fourth, fifth, and sixth countries to introduce the vaccine. MenAfriVac™ targets the strain of meningitis that has plagued sub-Saharan Africa with deadly and debilitating epidemics for more than a century.

http://www.path.org/news/an111115-meningitis-vaccine.php

PAHO/WHO said it is collecting examples of cell phones and other mobile devices being used to improve vaccine coverage and data collection as part of efforts to promote exchange of information and best practices in ‘mHealth’ among its member countries. Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Guatemala, Honduras, Mexico, Panama, Peru, the United States and Uruguay are among the countries in the Americas that are using devices such as personal digital assistants (PDAs) and mobile phones in their immunization programs. The countries “are at different stages in their use of these technologies, ranging from pilot projects focused on improving management of the vaccine cold chain and supplies, to comprehensive electronic patient records systems.”

http://new.paho.org/hq/index.php?option=com_content&task=view&id=6212&Itemid=1926

  Sweden released its most current assessment of multilateral organisations noting that four organisations have been assessed: The Global Alliance for Vaccines and Immunisation (GAVI), the International Fund for Agricultural Development (IFAD), the UN Office for the Coordination of Humanitarian Affairs (OCHA) and the United Nations Children’s Fund (UNICEF). The assessments are described as “a key tool in strengthening Sweden’s involvement in multilateral organisations. They are also part of the Government’s efforts to more clearly show the results of our international development cooperation.” In 2008, assessments of 23 organisations were conducted, and assessments since have averaged five organisations annually.

The summary document highlights the assessments http://www.sweden.gov.se/sb/d/15331/a/180674

GAVI
GAVI is a partnership and an alliance that brings together governments, multilateral organisations, philanthropists, the private sector, research institutions and civil society. Its overall objective is to save children’s lives and protect people’s health by increasing access to immunisation in the world’s poorest countries.

GAVI is assessed as highly relevant to Swedish development policy. It has an explicit poverty focus and a clear role in contributing to the achievement of the UN’s Millennium Development Goals.

GAVI is assessed as having a very high level of internal effectiveness, due partly to the fact that its structure is well suited to its activities and it has a distinct results culture. It is also considered a swift-footed and responsive organisation with a small and efficient secretariat.

GAVI is assessed as having a very high level of external effectiveness. This may be partly explained by the fact that it has a clearly defined and limited mandate that is relatively easy to measure. GAVI has unquestionably achieved important development results. From its launch in 2000 and up to the end of 2009, the organisation financed the vaccination of 257 million children and helped prevent some 5.4 million future deaths.

UNICEF
UNICEF, the United Nations Children’s Fund, is mandated by the UN General Assembly to promote children’s rights, i.e. the right of the child to survival, development, protection and participation. Its activities encompass both long-term development work and humanitarian action.

UNICEF is assessed as highly relevant to Swedish development goals. The organisation has a unique mandate and contributes significantly to the achievement of the Millennium Development Goals. UNICEF focuses on supporting the poorest and least developed countries and on reaching the most vulnerable and marginalized children.

UNICEF is assessed as having a high level of internal effectiveness. Several aspects of the organisation’s internal effectiveness have been significantly improved. Sweden’s assessment is that the changes already introduced or currently in the pipeline will pave the way for greater accountability, improved risk management and better tools and mechanisms for results-based management, and will also simplify and improve working procedures. It is too soon, however, to assess the extent to which the reforms and systems that UNICEF has recently introduced work in practice. This is one of the reasons why UNICEF cannot be awarded top marks for internal effectiveness.

UNICEF is assessed as having a high level of external effectiveness. The organisation enjoys a good reputation at country level, and this has impacted favourably on its chances of achieving practical results. Swedish embassies emphasise that UNICEF has high credibility and has performed well in the area of capacity-building. The fact that the organisation is not rated as having a ‘very high’ level of external effectiveness is due to the varying quality of its work in different countries and the somewhat scattered nature of its country programmes.

http://www.sweden.gov.se/download/3aa5503d.pdf?major=1&minor=180567&cn=attachmentPublDuplicator_0_attachment

Sanofi Pasteur, announced a new education campaign – ImmYounity(SM) – “designed to help answer parents’ questions about immunization and to offer health-care professionals a reference tool to supplement their discussions about vaccination with patients.” The new campaign “provides consumer-friendly, accurate and science-based information about immunization that can be easily accessed at www.vaccines.com. The site contains useful facts and resources, including visuals that can be easily shared via social media and email, and is supplemented by educational brochures offered for use by health-care providers.” Sanofi noted that “while a majority of parents are committed to childhood vaccination, a rising tide of questions has emerged over the past 20 years regarding the benefit and safety of vaccines. Many parents have questions about vaccines and are looking for credible sources of information that respect their desire to come to a decision on their own terms. While parents continue to look to health-care professionals for information, they also have more access than ever before to many other sources of information that can be confusing, conflicting, and ultimately make it more difficult for parents to come to a well-informed decision about what is best for their children.” Phil Hosbach, vice president, Immunization Policy, Sanofi Pasteur, said, “From listening to parents’ concerns about the current vaccine environment, we began to think about what else we could do to support them.  We concluded that it is critical to enhance our commitment to educate parents about the importance of vaccines.”

http://www.prnewswire.com/news-releases/sanofi-pasteur-launches-nationwide-education-campaign-to-help-parents-make-informed-decisions-about-immunization-134030683.html

BIO Ventures for Global Health (BVGH) announced that Don Joseph, JD, currently Chief Operating Officer, will assume the role of CEO effective 1 February 2012. Prior to joining BVGH, Mr. Joseph served as the Chief Operating Officer at the Institute for OneWorld Health, a non-profit, global health organization engaged in drug development for neglected tropical diseases. Carl Feldbaum, Chair of the Board at BVGH, commented, “We are very pleased to name Don Joseph to this position and are confident that BVGH will continue to benefit from his leadership, in light of his deep ties with the biotech community and experience in global health. This leadership transition will allow the organization to continue the momentum that has built over the past two years under Melinda Moree’s leadership.” Moree will continue her involvement with BVGH in the new role of Executive Chair of the Board of Directors.

http://www.prnewswire.com/news-releases/don-joseph-to-succeed-dr-melinda-moree-as-ceo-of-bio-ventures-for-global-health-moree-to-become-executive-chair-of-the-board-of-directors-134111973.html

The Weekly Epidemiological Record (WER) for 18 November 2011, vol. 86, 47 (pp 521–540) includes: Meningococcal vaccines: WHO position paper, November 2011; Monthly report on dracunculiasis cases, January–August 2011

http://www.who.int/entity/wer/2011/wer8647.pdf

Twitter Watch
A selection of items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and by no means intended to be exhaustive.

GAVIAlliance GAVI Alliance
Have you seen @unfoundation‘s @shot@life campaign? They highlight the #powerofvaccines! ht.ly/7vV0q
6 hours ago

GAVIAlliance GAVI Alliance
GAVI’s support for yellow fever #vaccine has averted 140,000 future deaths- ht.ly/7vZJz
19 Nov

sabinvaccine Sabin Vaccine Inst.
Today on the blog read about innovations in vaccine R&D! bit.ly/ttOLYE
18 Nov

MeaslesInit Measles Initiative
GAVI’s new rubella funding will protect hundreds of millions against measles and rubella wp.me/p1UXPA-1I
17 Nov

WHOnews WHO
MT @GAVIAlliance takes first steps to protect women & children from cervical cancer & rubella bit.ly/uDBKRf #HPV #vaccine
17 Nov

preventdengue DVI
“Dengue anywhere is a threat everywhere.” Govts must lay the groundwork now to implement a future #dengue #vaccine bit.ly/v0ciAQ
16 Nov

unfoundation UN Foundation
#Pneumonia: one disease, two @UNFoundation solutions – @cookstoves & @ShotAtLife. Read more from our CEO, Kathy Calvin: ow.ly/7wKkn
17 Nov

GAVISeth Seth Berkley
Delighted that GAVI board in Dhaka decided to take first steps to introduce vaccines against cervical cancer & rubella bit.ly/rT6bMS
17 Nov

GAVIAlliance GAVI Alliance
News Update: GAVI takes first steps to introduce vaccines against cervical cancer and rubella. ht.ly/7wm4L
17 Nov

GAVIAlliance GAVI Alliance
A step in the eradication of #polio! Millions of children get polio #vaccine in UN-backed campaign in South-Sudan- ht.ly/7vYMk
16 Nov

PATHtweets PATH
Don’t remember diphtheria? Maybe that’s because you got vaccinated against it. See our new video. ow.ly/7odHj #powerofvaccines
16 Nov

The Lancet  
Nov 19, 2011  Volume 378  Number 9805  p1757 – 1824 e8
http://www.thelancet.com/journals/lancet/issue/current

Comment
The Global Fund: getting the reforms right
Richard GA Feachem

Preview
As its Board meets this month in Accra, Ghana, for its 25th meeting, the Global Fund to fight AIDS, Tuberculosis, and Malaria finds itself at a crossroads.1 Major reforms are needed to ensure its survival. The final report of a High-Level Independent Review Panel, which was tasked to examine the Global Fund’s operations in light of allegations of fraud, made six recommendations.2 The Global Fund, it argued, must transition from an emergency to a sustainable response; develop new risk-management approaches; strengthen internal governance; institute a new grant-approval process; strengthen decision making by middle management; and “get serious about results”.

New England Journal of Medicine
November 17, 2011  Vol. 365 No. 20
http://content.nejm.org/current.shtml

Perspective
Global Health
Global Health: War, Drought, Malnutrition, Measles — A Report from Somalia
Jean-Clement Cabrol, M.D.
N Engl J Med 2011; 365:1856-1858November 17, 2011

Free Full Text

New England Journal of Medicine
November 17, 2011  Vol. 365 No. 20
http://content.nejm.org/current.shtml

Original Articles
First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children
The RTS,S Clinical Trials Partnership

Background
An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries.
Full Text of Background…

Methods
From March 2009 through January 2011, we enrolled 15,460 children in two age categories — 6 to 12 weeks of age and 5 to 17 months of age — for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories.
Full Text of Methods…

Results
In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64).
Full Text of Results…

Conclusions
The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.)

New England Journal of Medicine
November 17, 2011  Vol. 365 No. 20
http://content.nejm.org/current.shtml

Editorial
A Vaccine for Malaria
Nicholas J. White, F.R.S.
N Engl J Med 2011; 365:1926-1927November 17, 2011

[Free full-text]

It’s been a long time coming, and indeed we are still not there yet, but it is becoming increasingly clear that we really do have the first effective vaccine against a parasitic disease in humans. If there are no unforeseen disasters, the RTS,S/AS01 Plasmodium falciparum malaria vaccine should become available in just over 3 years. The World Health Organization (WHO) has already taken the unusual step of indicating that it could recommend this first malaria vaccine for use in some African countries as early as 2015, depending on the full phase 3 trial results that will become available in 2014.1 The vaccine has been developed by a public–private partnership between GlaxoSmithKline and the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative, supported by the Bill and Melinda Gates Foundation, primarily for use in infants and young children in sub-Saharan Africa. RTS,S/AS01 is a hybrid construct of the hepatitis B surface antigen fused with a recombinant antigen derived from part of the circumsporozoite protein. This is the protein coat of the sporozoite, the parasite stage that is inoculated by the feeding anopheline mosquito, which then invades liver cells and multiplies there before entering the bloodstream. Keys to the success of the vaccine are the immunogenic polymeric nature of RTS,S particles and the proprietary adjuvant AS01. A large number of other potential malaria vaccines are in various stages of development, but the RTS,S/AS01 vaccine is considerably further along the path to registration and potential deployment than the others.

In this issue of the Journal, the RTS,S Clinical Trials Partnership provides an interim report of a large, multicenter phase 3 trial of this vaccine.2 A total of 15,460 children in two age categories — 6 to 12 weeks and 5 to 17 months — were enrolled. The report describes vaccine efficacy against P. falciparum malaria in the first 6000 of 8923 children in the older age category, together with an evaluation of the first 250 cases of severe malaria from the two age groups. It is not usual practice to publish the results of trials in pieces, and there does not seem to be a clear scientific reason why this trial has been reported with less than half the efficacy results available. The target population for this vaccine is young infants who would receive the malaria vaccine together with routine immunizations, but the critical efficacy results in this subgroup will not be reported for another year. Even then, only results on short-term efficacy will be available, findings that will be insufficient to assess the public health role of this vaccine.

The interim results are broadly in line with those reported previously in extended phase 2 studies.3-5 Protective efficacy against P. falciparum malaria (55% protection against all malaria episodes) was at the upper end of expectations from earlier studies, whereas the overall reduction in severe malaria (35% protection) was slightly less than anticipated.

Trials often throw up unexpected findings. In this trial, there were significantly more cases of meningitis among children receiving the RTS,S/AS01 vaccine than among those receiving the comparator vaccines. There seems to be no plausible explanation for this, and it may well turn out to be a chance finding, but it cannot be ignored. On the other hand, the increased risk of febrile reactions or seizures among RTS,S/AS01 recipients may be real, reflecting the reactogenicity of this highly immunogenic vaccine. Such questions highlight the importance of phase 4 studies of both safety and effectiveness with active surveillance if this vaccine is deployed.

What does this vaccine mean for the future of the control and elimination of malaria? The considerable increase in global funding is paying dividends. In places where effective interventions (insecticide-treated bed nets, insecticides, and artemisinin-combination treatments) are being intensively deployed, malaria morbidity and mortality are falling. Several new, simple, affordable interventions, such as seasonal chemoprevention among young children in areas of seasonally high malaria transmission and the use of artesunate in patients with severe malaria, can also provide substantial reductions in mortality. The very low rate of death from malaria in this large trial (only 10 deaths directly attributed to malaria) testifies to the benefits of providing early diagnosis and effective antimalarial treatment. But there are real dangers ahead. How will the necessary funding be sustained in the face of a global economic downturn, along with a reduction in political pressure associated with declining mortality from malaria? In addition, artemisinin resistance in malaria parasites and pyrethroid resistance in anopheline mosquito vectors pose very serious threats.

All the investigators who have labored long and hard in the development and evaluation of this malaria vaccine deserve congratulations. It is a great achievement and an important advance, but they know that this partially protective vaccine is not the sole solution to the control and elimination of malaria. After registration, the definitive WHO guidance, expected in 2015, may recommend that the inclusion of RTS,S/AS01 in the multipronged attack against malaria is justified. The key question of how long the protection against malaria lasts, particularly in the anticipated context of declining malaria transmission, remains open. An assessment of an 18-month booster dose will not be available until 2014. Another key issue is whether efficacy varies according to the intensity of transmission. We also do not know yet how much the vaccine will cost. All these factors are essential components of the objective assessments of cost-effectiveness that should form the basis of future global and national policy decisions

Pharmacoeconomics
December 1, 2011 – Volume 29 – Issue 12  pp: 1011-1014
http://adisonline.com/pharmacoeconomics/pages/currenttoc.aspx

Current Opinion
QALYs and Carers
Al-Janabi, Hareth; Flynn, Terry N.; Coast, Joanna
Pharmacoeconomics. 29(12):1015-1023, December 1, 2011.
doi: 10.2165/11593940-000000000-00000

Abstract:
When going ‘beyond the patient’, to measure QALYs for unpaid carers, a number of additional methodological considerations and value judgements must be made. While there is no theoretical reason to restrict the measurement of QALYs to patients, decisions have to be made about which carers to consider, what instruments to use and how to aggregate and present QALYs for carers and patients. Current, albeit limited, practice in measuring QALY gains to carers in economic evaluation varies, suggesting that there may be inconsistency in judgements about whether interventions are deemed cost effective.

While conventional health-related quality-of-life tools can, in theory, be used to estimate QALYs, there are both theoretical and empirical concerns over the suitability of their use with carers. Measures that take a broader view of health or well-being may be more appropriate. Incorporating QALYs of carers in economic evaluations may have important distributional consequences and, therefore, greater normative discussion over the appropriateness of incorporating these impacts is required. In the longer term, more flexible forms of cost-per-QALY analysis may be required to take account of the broader impacts on carers and the weight these impacts should receive in decision making.

PLoS One
[Accessed 20 November 2011]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Burden of Pneumonia and Meningitis Caused by Streptococcus pneumoniae in China among Children under 5 Years of Age: A Systematic Literature Review
Ying Chen, Wei Deng, Song-Mei Wang, Qi-Mei Mo, Huan Jia, Qun Wang, Song-Guang Li, Xiang Li, Bao-Dong Yao, Cheng-Jun Liu, Yi-Qiang Zhan, Chen Ji, Anna Lena Lopez, Xuan-Yi Wang
PLoS ONE: Research Article, published 16 Nov 2011 10.1371/journal.pone.0027333

Abstract 
Background and Methods
To understand the burden and epidemiology of Streptococcus pneumoniae disease among children between 1 and 59 months of age in China, we conducted a review of literature published between 1980 and 2008 applying standardized algorithms. Because of the absence of population-based surveillance for pneumococcal disease (PD), we identified all-cause pneumonia, bacteremia and meningitis burden, syndromes most commonly associated with S. pneumoniae, and applied the proportion of disease attributable to S. pneumoniae from studies that determined the etiology of these three syndromes to calculate PD burden. Because of the microbiologic difficulties in identifying S. pneumoniae–attributable pneumonia which likely underestimates the pneumonia burden, we also used the proportion obtained from vaccine efficacy trials.

Results
Between 1980 and 2008, there were 12,815 cases/100,000/year of all-cause pneumonia among children between 1 month and 59 months, with 526 deaths/100,000 annually. There were 14 meningitis cases/100,000/year. We estimate that as of 2000, there were 260,768 (113,000 to 582,382) and 902 (114–4,463) cases of pneumococcal pneumonia and meningitis, respectively with 10,703 (4,638–23,904) and 75 (9–370) pneumococcal pneumonia and meningitis deaths, respectively. Pneumococcal pneumonia cases and deaths were more than two-fold higher, 695,382 (173,845–1,216,918) and 28,542 (7,136–49,949), respectively, when parameters from efficacy trials were used. Serotypes 19F, 19A and 14 were the most common serotypes obtained from pneumonia/meningitis patients. Currently available vaccines are expected to cover 79.5% to 88.4% of the prevalent serotypes. With high antibiotic resistance, introducing pneumococcal vaccines to the routine immunization program should be considered in China. Population-based studies are warranted.

PLoS One
[Accessed 20 November 2011]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Estimation of the Health Impact and Cost-Effectiveness of Influenza Vaccination with Enhanced Effectiveness in Canada
David N. Fisman, Ashleigh R. Tuite
PLoS ONE: Research Article, published 14 Nov 2011 10.1371/journal.pone.0027420

Abstract 
Introduction
The propensity for influenza viruses to mutate and recombine makes them both a familiar threat and a prototype emerging infectious disease. Emerging evidence suggests that the use of MF59-adjuvanted vaccines in older adults and young children enhances protection against influenza infection and reduces adverse influenza-attributable outcomes compared to unadjuvanted vaccines. The health and economic impact of such vaccines in the Canadian population are uncertain.

Methods
We constructed an age-structured compartmental model simulating the transmission of influenza in the Canadian population over a ten-year period. We compared projected health outcomes (quality-adjusted life years (QALY) lost), costs, and incremental cost-effectiveness ratios (ICERs) for three strategies: (i) current use of unadjuvanted trivalent influenza vaccine; (ii) use of MF59-adjuvanted influenza vaccine adults ≥65 in the Canadian population, and (iii) adjuvanted vaccine used in both older adults and children aged < 6.

Results
In the base case analysis, use of adjuvanted vaccine in older adults was highly cost-effective (ICER = $2111/QALY gained), but such a program was “dominated” by a program that extended the use of adjuvanted vaccine to include young children (ICER = $1612/QALY). Results were similar whether or not a universal influenza immunization program was used in other age groups; projections were robust in the face of wide-ranging sensitivity analyses.

Interpretation
Based on the best available data, it is projected that replacement of traditional trivalent influenza vaccines with MF59-adjuvanted vaccines would confer substantial benefits to vaccinated and unvaccinated individuals, and would be economically attractive relative to other widely-used preventive interventions

Science Translational Medicine
16 November 2011 vol 3, issue 109
http://stm.sciencemag.org/content/current

Vaccine Development
The Skeleton Key for Intracellular Pathogens: Nanoparticles and Pulmonary Vaccination
Melissa Nyendak
16 November 2011: 109ec186

A nanoparticle-linked antigen induces cytotoxic T cell responses and protective immunity against influenza in mice.

The pdf version of Vaccines: The Week in Review  14 November 2011, comprising the posts below for this date, is available here: Vaccines_The Week in Review_14 November 2011

World Pneumonia Day
12 November 2011
WHO noted that “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
– More information on pneumonia
– Fact sheet on pneumonia
http://www.who.int/mediacentre/events/annual/world_pneumonia_day/en/

The Global Coalition Against Child Pneumonia was established in April 2009 to raise awareness about the toll of pneumonia, the world’s leading killer of children, and to advocate for global action to protect against, effectively treat and help prevent this deadly disease. The Coalition is a global network of more than 125 NGOs, community-based organizations, academic institutions, government agencies and foundations who together provide leadership for World Pneumonia Day, marked each year on November 12 to encourage efforts among donors, policy makers, healthcare professionals and the general public to combat the disease.
http://worldpneumoniaday.org/learn/about-the-coalition/

NIH statement on World Pneumonia Day
Alan E. Guttmacher, M.D., Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development

November 12 is World Pneumonia Day, a day set aside to raise public awareness of the millions of childhood deaths that pneumonia causes each year and to encourage efforts to prevent and treat this deadly disease. Pneumonia is an infection occurring in one or both lungs, caused by any number of infectious organisms, such as bacteria, viruses, and fungi. According to the World Health Organization, pneumonia is the leading cause of death in children under the age of 5. Pneumonia kills almost 1.6 million children each year, more than AIDS, tuberculosis, and malaria combined. Childhood pneumonia remains a serious health risk but is less widespread in the United States and other developed countries.

On this World Pneumonia Day, it is important to keep in mind that a major impediment stands in the way of global efforts to prevent childhood pneumonia. In many countries, inefficient, smoky, indoor stoves fueled by wood, charcoal, dung, or coal, are used widely for cooking and heating. The smoke from these indoor fires is a major contributor to childhood pneumonia in much of the world, undermining the vaccination drives and other public health efforts seeking to prevent and treat the disease.

Fortunately, international efforts to replace these inefficient stoves with inexpensive, clean alternatives are now under way. The United Nations Foundation has launched the Global Alliance for Clean Cookstoves, which seeks to create a global market and manufacturing capability for clean and efficient cookstoves and fuels in the developing world…

http://www.nih.gov/news/health/nov2011/nichd-10.htm

IVI announced the WHO prequalification of Shanchol™, described as an innovative cholera vaccine developed through IVI and produced by Shantha Biotechnics – part of the Sanofi group – in India where the vaccine has been licensed and sold since 2009. IVI said Shanchol™ is “ready to use in a single-dose vial and is administered orally, which facilitates its implementation in large-scale immunization programs.” Dr. Christian Loucq, IVI’s new Director General, said, “I am immensely pleased by the news that Shanchol™, a vaccine enabled by IVI, received WHO prequalification. This stamp of approval shows that public-private partnerships – such as those among IVI, Vabiotech, Shantha and Sanofi – are essential for successful vaccine development, particularly in developing vaccines against neglected diseases of the poor like cholera.”

IVI noted that WHO prequalification of Shanchol™ is “the latest achievement in IVI’s mission to develop and introduce innovative, safe, and effective vaccines to protect vulnerable populations in poor countries against deadly diseases including cholera.” IVI said that “with financial support from the Bill & Melinda Gates Foundation and the governments of Korea and Sweden, and technical support from scientists in Sweden, as well as at Vietnam’s National Institute of Hygiene and Epidemiology and production experts at Shantha, IVI enabled technology transfer from Vabiotech, a vaccine manufacturer in Vietnam, to Shantha for the production of cholera vaccine. IVI also established and transferred tests to ensure the vaccine was of the highest quality and enabled improvements in production to keep manufacturing costs as low as possible.”

The prequalification by WHO sets the stage for the next planned phase of the vaccine: “introducing Shanchol™ in settings where cholera remains a major public health problem, such as countries in Africa and South Asia where the disease is endemic. Dr. Loucq continued, “In light of the devastating cholera outbreaks in Haiti, Pakistan, Nepal and in several countries of Africa, there is a clear need for a solution to halt the countless deaths and suffering.”

www.ivi.int

The Weekly Epidemiological Record (WER) for 11 November 2011, vol. 86, 46 (pp 509–520) includes: Global routine vaccination coverage, 2010; Progress towards eradicating poliomyelitis: Afghanistan and Pakistan, January 2010– September 2011

http://www.who.int/entity/wer/2011/wer8646.pdf

The MMWR for November 11, 2011 / Vol. 60 / No. 44 includes:
– Global Routine Vaccination Coverage, 2010

– Progress Toward Poliomyelitis Eradication — Afghanistan and Pakistan, January 2010–September 2011

– Update on Herpes Zoster Vaccine: Licensure for Persons Aged 50 Through 59 Years

Twitter Watch
A selection of items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and by no means intended to be exhaustive.

GAVIAlliance GAVI Alliance
New blog by Kate Dodson about her experience at an Ethiopia Pneumo Vaccine rollout- ht.ly/7rTpI @shotatlife

gatesfoundation Gates Foundation
#Vaccines save lives. No child should die of a disease we can prevent: gates.ly/spxvyv #WPD2011

WHOnews WHO
World Pneumonia Day: Pneumonia kills an estimated 1.4 million kids under five years old every year bit.ly/vBApPN #WPD2011
12 Nov

AIDSvaccine IAVI
The #HIV #vaccine funding landscape in 2010 & how it compares to past yrs: bit.ly/sNBGuW #globalhealth #research #socialgood
11 Nov

sabinvaccine Sabin Vaccine Inst.
Guest blog post by @sabinvaccine‘s Sofia Redford: This World Pneumonia Day, learn the facts & spread the word bit.ly/rpTm9e #WPD2011
11 Nov

globalfundnews The Global Fund
Global Fund Board Communities Delegation Call for Membership 2012-2014 shar.es/bMvwI @AmyCSays
11 Nov

GAVISeth Seth Berkley
Delighted to be back in India asking how GAVI partners can be most helpful to accelerate introduction and expansion of life saving vaccines
11 Nov

sabinvaccine Sabin Vaccine Inst.
#Dengue cases in the Philippines nears 100,000 bit.ly/tiGLu8 Support efforts to produce and deliver a dengue #vaccine! @preventdengue
9 Nov

British Medical Journal
12 November 2011 (Vol 343, Issue 7831)
http://www.bmj.com/content/current

Letters
Doctors choosing not to be vaccinated is choosing to do harm
BMJ BMJ 2011;343:bmj.d7198 (Published 8 November 2011)
Amy J Behrman, Arthur L Caplan, Susan E Coffin, Neil Fishman

Doctors accepting flu vaccination is the sensible and responsible choice
BMJ BMJ 2011;343:bmj.d7199 (Published 8 November 2011)

Flu vaccination prevents nosocomial outbreaks
BMJ BMJ 2011;343:bmj.d7203 (Published 8 November 2011)

Health Policy and Planning
Volume 26 Issue 6 November 2011
http://heapol.oxfordjournals.org/content/current

Commentary
Oliver Sabot, Megumi Gordon, Bruno Moonen, Ambrose Talisuna, and George Amofah
A path to an optimal future for the Affordable Medicines Facility – malaria
Health Policy Plan. (2011) 26(6): 441-444 doi:10.1093/heapol/czr067
Free Full Text (HTML)

Extract
In 2004, the Institute of Medicine (IOM) proposed a simple solution to a pressing global problem (Arrow et al. 2004). The price of artemisinin-based combination therapies (ACTs), the most effective malaria treatment in many countries, would be subsidized at the factory-gate to make them as affordable as ubiquitous, sub-optimal monotherapies such as chloroquine. This would, the IOM theorized, lead to widespread crowding out of the less effective drugs through both public and private channels, thereby improving immediate health outcomes and delaying the development of devastating resistance to artemisinin.

The subsequent process to translate that theory into a corresponding global initiative, however, was complex and lengthy, with 3 years of debate. Sceptics of the subsidy argued that it would not have the necessary impact because middlemen would capture excessive profits, poorer patients would not access the drugs through private shops regardless of price, and most ACTs would be purchased by individuals without malaria and would be wasted (Oxfam International 2009; Kamal-Yanni 2010). Proponents countered that market forces would ensure affordable pricing and broad supply, and that the problems of ensuring the equity and targeting of ACTs were not unique to the private sector and had not hampered major investments in distribution of drugs in the public sector (Roll Back Malaria Partnership 2007). After significant negotiation and compromise, the Affordable Medicines Facility-malaria (AMFm), as the subsidy concept is now known, opened its doors in July 2010. One of the most important compromises was that the AMFm would not begin as a global initiative, but would rather be ‘piloted’ at national-scale in selected malaria-endemic countries with an extensive evaluation of that initial phase. The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which hosts the AMFm, eventually set December 2012 as the target date to review the evaluation …

The Lancet Infectious Disease
Nov 2011  Volume 11  Number 11  p801 – 886
http://www.thelancet.com/journals/laninf/issue/current

Latest Podcast
Mike Osterholm discusses the effectiveness of influenza vaccines based on a new meta-analysis of published studies.
(mp3, 22.24 mins, 20.5Mb)

Online First
Articles
Oct 26, 2011
Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis
Michael T Osterholm, Nicholas S Kelley, Alfred Sommer, Edward A Belongia
| Summary |

The Lancet Infectious Disease
Nov 2011  Volume 11  Number 11  p801 – 886
http://www.thelancet.com/journals/laninf/issue/current

Online First
Comment
Nov 08, 2011
Inactivated polio vaccine and global polio eradication
John F Modlin

Articles
Nov 08, 2011
Immunogenicity of supplemental doses of poliovirus vaccine for children aged 6–9 months in Moradabad, India: a community-based, randomised controlled trial
Concepción F Estívariz, Hamid Jafari, Roland W Sutter, T Jacob John, Vibhor Jain, Ashutosh Agarwal, Harish Verma, Mark A Pallansch, Ajit P Singh, Sherine Guirguis, Jitendra Awale, Anthony Burton, Sunil Bahl, Arani Chatterjee, R Bruce Aylward
Preview | Summary |

New England Journal of Medicine
November 10, 2011  Vol. 365 No. 19
http://content.nejm.org/current.shtml

Perspective
The Role of Cost-Effectiveness in U.S. Vaccination Policy
Jane J. Kim, Ph.D.
N Engl J Med 2011; 365:1760-1761 November 10, 2011

[Full text]
Vaccination policy is driven by several factors, including vaccine safety and efficacy, avertable disease burden, acceptability, and societal value. One measure of value is an intervention’s cost-effectiveness, defined as the additional cost required per additional unit of health benefit produced as compared with the next-most-effective alternative. It is important to differentiate cost-effectiveness (value for money) from affordability (financial resources required); indeed, interventions with high value may not always be affordable. Although information on the cost-effectiveness of health interventions is increasingly being used in health policy globally, the extent to which this information influences decisions varies by country. For example, the governments in Britain and Australia explicitly and routinely incorporate findings from cost-effectiveness analyses into coverage and reimbursement decisions; in contrast, in the United States, it has been essentially taboo for anyone in the public sector to refer explicitly to cost as a factor in health decisions.

One exception is the Advisory Committee on Immunization Practices (ACIP), an independent expert advisory board that formally includes cost-effectiveness among the types of evidence it considers when making vaccine-policy recommendations to the Centers for Disease Control and Prevention (CDC). The ACIP strives to be transparent and balanced, inviting perspectives from stakeholders ranging from scientists to patient groups, and tries to harmonize its recommendations with those of professional organizations, such as the American Academy of Family Physicians and the American Academy of Pediatrics.

Historically, ACIP recommendations have influenced coverage decisions by both private and public insurers. Through a separate process, the ACIP also determines what vaccines are to be covered by the federal Vaccines for Children (VFC) program, which covers children who are Medicaid-eligible, uninsured or underinsured, or American Indians or Alaska natives up to the age of 18. With nearly 50% of U.S. children eligible for VFC coverage,1 the ACIP faces dual pressures: it must maximize underserved children’s access to vaccines while selecting vaccines that provide the most bang for the buck. This pressure will increase with the rollout of the Affordable Care Act, which mandates coverage of all ACIP-recommended childhood immunizations.

With low cost and high efficacy, many vaccines are estimated to be cost-saving — the up-front expenditure for vaccination is entirely offset by costs averted through disease prevention. However, newly licensed and expensive vaccines, such as those against human papillomavirus (HPV, the virus causally linked to cervical cancer) and meningococcal disease, are being considered for use in ways that raise questions regarding their overall public health value as estimated in cost-effectiveness analyses.

In late October, the ACIP is expected to vote on routine HPV vaccination in boys and young men and to discuss meningococcal vaccination in infants, including its cost-effectiveness. Since 2007, routine HPV vaccination has been recommended for girls 11 to 12 years of age (and as early as 9 years), with “catch-up” vaccination recommended up to the age of 26, despite evidence of rapidly diminishing marginal returns and decreasing cost-effectiveness after 21 years of age.2

After the Food and Drug Administration (FDA) approved the quadrivalent HPV (HPV4) vaccine for males in 2009, the ACIP voted for “permissive” — but not routine — use of it in boys and men 9 to 26 years of age for prevention of genital warts. Despite this less enthusiastic stance, the ACIP voted in favor of VFC coverage for eligible males 9 to 18 years of age. The committee was persuaded not to recommend routine male HPV vaccination in part by evidence that it may not be cost-effective, especially if vaccine uptake in girls and young women is high, given the sexual transmission of HPV infections and expected herd-immunity benefits through female-only vaccination. Recent data on uptake among adolescent girls, however, show less than 50% completion of the three-dose series, suggesting that HPV vaccination of boys may be cost-effective at this time. Furthermore, since the 2009 guidelines were issued, the indications for HPV4 have expanded to include prevention of anal cancers. Routine male HPV vaccination, especially if targeted at an early age, when the vaccines are expected to have highest benefit, would maximize protection for men who have sex with men, a group at high risk for HPV-related cancers that would receive little herd-immunity protection from female-only vaccination.

With respect to meningococcal vaccination, in October 2010, the ACIP decided in a narrow vote to recommend a single booster dose of the quadrivalent meningococcal conjugate vaccine (MCV4) at the age of 16 despite evidence that routine adolescent MCV4 vaccination does not provide good value for money, largely because of low disease incidence rates and relatively high vaccine cost. Since then, the FDA has approved the licensure of one meningococcal vaccine for use in infants and is reviewing the licensing application for another. In considering expanding use to infants, the ACIP will need to contend with evidence that MCV4 vaccination at such young ages, which requires at least two doses, is even less cost-effective than adolescent vaccination.3

The cost-effectiveness of vaccines is influenced by several factors, including vaccine efficacy and durability, severity of disease burden, vaccine price, and delivery-program costs. The meningococcal and HPV vaccines are among the most expensive vaccines on the market, with costs of $82 and $109 per dose, respectively, in the public sector (private-sector costs are 20 to 30% higher).4 With the relatively high costs of new vaccines, the U.S. immunization program is placing an increasing financial strain on the health system. Today, the schedule of recommended routine child and adolescent vaccines includes more than 30 doses against 16 diseases — more than double the number in 1980. The public-sector cost of fully vaccinating one person as recommended through adulthood (not including annual influenza vaccines) is roughly $1,450 for males and $1,800 for females, of which the HPV and meningococcal vaccinations alone account for more than 25% at current prices.

Cost-effectiveness analysis provides information on whether the health gain associated with each new vaccine is worth the cost, as compared with other options for health spending. For example, the VFC program must weigh the cost of covering expensive vaccines against an alternative use of those dollars, such as outreach to improve uptake of other routine vaccines in the eligible population. Indeed, a recent CDC analysis showed that it would be more cost-effective to spend up to the purchase price of the HPV vaccine on improving vaccine uptake among girls than it would be to extend the program to boys.5

As the use of cost-effectiveness information increases, we should consider some important limitations of current analyses. The tendency to evaluate single diseases or interventions in isolation is restrictive. Individual vaccines may appear cost-effective, but the overall U.S. vaccination program may be unaffordable or provide less value than other bundled preventive health services targeting the same age group. Real-world obstacles should also be integrated into analyses; for example, the lack of organized vaccine-delivery mechanisms for older age groups can affect vaccine-uptake rates among adolescents and adults, and shortages in vaccine supply (as experienced with influenza vaccines) can influence cost-effectiveness results. To make cost-effectiveness analysis a more practical tool, analysts should evaluate investments across multiple diseases and interventions and include the influences of nonmonetary constraints.

As we confront sobering proposals to cut more than $300 billion in federal health spending over the next decade, public health decision makers will increasingly have to make explicit choices among health investments while keeping a vigilant eye on total expenditures. Identification of high-value health interventions through comparative effectiveness analysis has been prioritized by the new Patient-Centered Outcomes Research Institute. Evidence of cost-effectiveness, if provided in a transparent, standardized, and comprehensive manner, can help to highlight important tradeoffs and contribute to policy recommendations for vaccinations and other health interventions.

Editor’s Note: On October 25, the ACIP voted to recommend that boys 11 to 12 years of age be routinely vaccinated against HPV, indicating that the vaccine series can be started as early as age 9 and that men up to age 21 who have not yet received the vaccine should be vaccinated.

Vaccine
Volume 29, Issue 50 pp. 9289-9410 (21 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Letters to the Editor
Limited benefit of HPV vaccination for sexually active women in developing countries
Pages 9290-9291
Vivien Tsu, Marjorie Murray
[No extract]

Response to Letter to the Editor by Tsu et al. “Benefits of vaccinating young adult women with a prophylactic quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine”
Pages 9292-9293
Joseph Monsonego
[No extract]

Vaccine
Volume 29, Issue 50 pp. 9289-9410 (21 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Brief report
Risk factors for incomplete vaccination in children less than 18 months of age attending the nurseries of day-care centres in Sao Paulo, Brazil
Pages 9298-9302
Tulio Konstantyner, José Augusto de Aguiar Carrazedo Taddei, Laura Cunha Rodrigues

Abstract
To estimate the proportion of children in day-care centres with incomplete vaccination and to identify associated risk factors, we conducted a cross-sectional study among 258 children less than 18 months of age attending public and philanthropic day-care centres in the city of Sao Paulo, Brazil. Interviews, blood collection and anthropometry were performed. Unconditional logistic regression was adjusted for incomplete vaccination risk factors. 10.9% of children had incomplete vaccination. Children who were born prematurely (OR = 4.27; p = 0.004), or were malnourished (OR = 4.99; p = 0.049), or lived in inadequate housing (OR = 2.88; p = 0.039), or whose mothers had had poor prenatal care (OR = 4.98; p = 0.040) were more likely to have incomplete vaccination.   Opportunities are being missed to identify children with incomplete vaccination; strategies to enhance vaccination coverage should pay special attention to the needs of families living in inadequate housing; and health promotion actions in primary health facilities and day-care centres should be performed as concomitant activities

Vaccine
Volume 29, Issue 50 pp. 9289-9410 (21 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
Universal screening for hepatitis B among pregnant women led to 96% vaccination coverage among newborns of HBsAg positive mothers in Denmark
Pages 9303-9307
Katja Majlund Harder, Susan Cowan, Mette Brandt Eriksen, Henrik B. Krarup, Peer Brehm Christensen

Abstract
In Denmark selective screening programs of pregnant women for hepatitis B missed 30–50% of high-risk groups and in late 2005 a universal screening of pregnant women for HBsAg was implemented.

During a 2-year period a prospective enhanced surveillance of the universal screening was performed to examine the effectiveness of universal HBV-screening of pregnant women and HBV-immunizations of their newborn, and to provide a prevalence-estimate for HBV in Denmark. On a opt out basis all women in Denmark attending antenatal care were tested for hepatitis B serology. Vaccination data of the newborns and households of HBsAg positive pregnant women were assembled.

Among 140,376 HBsAg tests of pregnant women, 371 (0.26%) were positive. The prevalence among women of Danish origin was 0.012% and 2.74% among foreign born women, highest for women from Southeast Asia (14.5%). Genotype C was the most prevalent (37%) and 13% had a HBVDNA ≥108 IU/ml. The prevalence estimate of chronic hepatitis B in Denmark was 0.2–0.3% in the general population.

Among children born within the project period, 96% received vaccination at birth compared to 50% of siblings born prior to universal screening. During 3 years of passive follow-up two transmissions (0.5%) have been notified. Among children born of the positive mothers prior to the trial-period 7.3% had been notified.

Thus the prevalence of HBV positive mothers has more than doubled in Denmark over the last 40 years, but among women of Danish origin it has decreased 10-fold. By replacing selective screening with universal, identification of newborns in need of HBV-immunization was increased from 50% to almost complete coverage, and also identifies mothers with high viral load for evaluation of pre-term treatment to interrupt in utero transmission

Vaccine
Volume 29, Issue 50 pp. 9289-9410 (21 November 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
Increases in vaccination coverage of healthcare personnel following institutional requirements for influenza vaccination: A national survey of US hospitals
Pages 9398-9403
Brady L. Miller, Faruque Ahmed, Megan C. Lindley, Pascale M. Wortley

Abstract
Background
Institutional requirements for influenza vaccination, ranging from policies that mandate declinations to those terminating unvaccinated healthcare personnel (HCP), are increasingly common in the US. Our objective was to determine HCP vaccine uptake following requirements for influenza vaccination at US hospitals.

Methods
Survey mailed in 2011 to a nationally representative sample of 998 acute care hospitals. An institutional requirement was defined as an institutional policy that requires receipt or declination of influenza vaccination, with or without consequences for vaccine refusal. Respondents reported institutional-level, seasonal influenza vaccination coverage, if known, during two consecutive influenza seasons: the season prior to (i.e., pre-requirement), and the first season of requirement (i.e., post-requirement). Weighted univariate and multivariate analyses accounted for sampling design and non-response.

Results
808 (81.0%) hospitals responded. Of hospitals with institutional requirements for influenza vaccination (n = 440), 228 hospitals met analytic inclusion criteria. Overall, mean reported institutional-level influenza vaccination coverage among HCP rose from 62.0% in the pre-requirement season to 76.6% in the post-requirement season, representing a single-season increase of 14.7 (95% CI: 12.6–16.7) percentage points. After adjusting for potential confounders, single-season increases in influenza vaccination uptake remained greater among hospitals that imposed consequences for vaccine refusal, and among hospitals with lower pre-requirement vaccination coverage. Institutional characteristics were not associated with vaccination increases of differential magnitude.

Conclusion
Hospitals that are unable to improve suboptimal influenza vaccination coverage through multi-faceted, voluntary vaccination campaigns may consider institutional requirements for influenza vaccination. Rapid and measurable increases in vaccination coverage followed institutional requirements at hospitals of varying demographic characteristics.

The pdf version of Vaccines: The Week in Review  7 November 2011, comprisig the posts below for this date, is available here: Vaccines_The Week in Review_7 November 2011