Pork-free vaccine wins cheers from some Hajj pilgrims

Pork-free vaccine wins cheers from some Hajj pilgrims
By Omar Sacirbey| Religion News Service, Published: October 18

The nearly 3 million Muslims who will make next week’s annual hajj pilgrimage to the sacred Saudi Arabian city of Mecca are required to be vaccinated against meningitis.

Swiss pharmaceutical giant Novartis claims to have developed, in 2010, the first anti-meningitis vaccine without pork, which Muslims are forbidden to consume under Islamic law. Many religious authorities have already certified the Menveo vaccine as “halal,” or permitted under Islamic law.

Not all Muslims, however, believe the vaccine is truly halal.

Anti-meningitis vaccine was developed in the 1930s, and pork derivatives were and remain an important part of the compound today. But some skeptics say that while Novartis’ final product is pork-free, it still uses pork in the manufacturing process, making it ineligible for halal certification.

Novartis, which made $142 million from Menveo in 2011, did not reply to requests for comment…


Washington Post
Accessed 20 October 2012

Twitter Watch [accessed 20 October 2012 10:43]

Twitter Watch  [accessed 20 October 2012  10:43]
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.

nprGlobalHealth @nprGlobalHealth
Thx everyone for the great chat today on eradicating #polio; ICYMI here’s the highlights http://n.pr/T5RSv3  #ChasingPolio @EndPolioNow
3:28 PM – 19 Oct 12 ·

Seth Berkley @GAVISeth
Great editorial on why science not politics should drive vaccine decisions: NYTimes: An HPV Vaccine Myth Debunked http://nyti.ms/VbaVlh 
5:34 AM – 19 Oct 12

World Bank @WorldBank
New World Bank mobile apps for health, poverty and jobs data: http://cot.ag/OIxMWZ  Free for iOS and Android. #opendata
6:08 PM – 18 Oct 12

Amanda Glassman @glassmanamanda
Can cash transfers help children stay healthy? http://siteresources.worldbank.org/INTHDOFFICE/Resources/Burkina_Faso_E2P.pdf …
10:15 AM – 18 Oct 12

GAVI Alliance @GAVIAlliance
Pakistan is the single largest recipient of GAVI funds worldwide, with more than 36M kids vaccinated. http://ht.ly/evxwV   @Hoybraten
5:50 AM – 18 Oct 12

Cases of #pertussis (whooping cough) increased in many EU countries since 2011. See @ECDC_EU guidance and protocols: http://bit.ly/Tw1HOV 
5:14 AM – 18 Oct 12

PAHO/WHO ‏@pahowho
Important announcement from the One Team against #Cholera in Haiti and Dominican Republic #tt4health http://new.paho.org/colera/ 
12:18 PM – 17 Oct 12

Vaccines: The Week in Review 13 October 2012

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_13 October 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…

Pakistan is first South Asian country to launch vaccine against childhood pneumonia

Pakistan is first South Asian country to launch vaccine against childhood pneumonia
Joint WHO/UNICEF/GAVI Alliance media release

ISLAMABAD, 9 October 2012 – Mir Hazar Khan Bijrani, Minister of Inter-Provincial Coordination announced the introduction of a new vaccine to protect Pakistani children from pneumonia – a disease that takes the lives of approximately 1.3 million children globally before their fifth birthday. With this launch, Pakistan is the first country in South Asia to introduce the pneumococcal vaccine. “As the first country in South Asia to introduce the pneumococcal vaccine, Pakistan’s commitment to immunizing all children against vaccine preventable diseases is to be applauded,” said Dan Rohrmann, UNICEF Pakistan Country Representative. “We are proud to partner with the Government of Pakistan in its efforts to inoculate millions of children against a disease that continues to take too many lives.”

More: http://www.who.int/immunization/newsroom/press/pakistan_first_country_pneumonia/en/index.html

U.S. HHS announces Implementation Plan for the 2010 National Vaccine Plan:

The U.S. HHS announced the Implementation Plan for the 2010 National Vaccine Plan:

Implementation Plan Development and Structure

The National Vaccine Plan Implementation was developed by an interagency working group representing U.S. Department of Health and Human Services (HHS) agencies involved in all aspects of vaccines and immunizations. This working group additionally consulted with partner government agencies outside of HHS, including the U.S. Agency for International Development, the Department of Veterans Affairs (VA), and the Department of Defense (DOD). Individual stakeholder input was obtained through a series of meetings, and is described further below.

The Implementation Plan follows the architecture of the National Vaccine Plan, is organized by the five goals, and focuses on the objectives and strategies related to achieving the 10 priorities described in the Plan (following). These priorities were established with input from the Institute of Medicine, the National Vaccine Advisory Committee, and the interagency working group. They provide strategic action steps to ensure the national has a robust immunization program. The priorities can relate to more than one goal in the National Vaccine Plan, but are presented with the most relevant goal within the Implementation Plan.

The Plan is built around five broad goals:

Goal 1: Develop new and improved vaccines.

Goal 2: Enhance the vaccine safety system.

Goal 3: Support informed vaccine decision-making.

Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the United States.

Goal 5: Increase global prevention of death and disease through safe and effective vaccination.

National Vaccine Plan Priorities for Implementation
A. Develop a catalogue of priority vaccine targets of domestic and global health importance. (Goal 1)

B. Strengthen the science base for the development and licensure of new vaccines. (Goals 1 and 2)

C. Enhance timely detection and verification of vaccine safety signals and develop a vaccine safety scientific agenda. (Goal 2)

D. Increase awareness of vaccines, vaccine-preventable diseases (VPDs), and the benefits/risks of immunization among the public, providers, and other stakeholders. (Goal 3)

E. Use evidence-based science to enhance vaccine-preventable disease surveillance, measurement of vaccine coverage, and measurement of vaccine effectiveness. (Goal 4)

F. Eliminate financial barriers for providers and consumers to facilitate access to routinely recommended vaccines. (Goal 4)

G. Create an adequate and stable supply of routinely recommended vaccines and vaccines for public health preparedness. (Goal 4)

H. Increase and improve the use of interoperable health information technology and electronic health records. (Goal 4)

I. Improve global surveillance for vaccine-preventable diseases and strengthen global health information systems to monitor vaccine coverage, effectiveness, and safety. (Goal 5)

J. Support global introduction and availability of new and under-utilized vaccines to prevent diseases of public health importance. (Goal 5)

The 2010 National Vaccine Plan is a national, not federal, plan that acknowledges the many areas where stakeholder actions are needed to achieve a specific goal. The activities that are described in this Implementation Plan are those that will be undertaken by federal departments and agencies for the years 2010-2015 in line with their respective missions to achieve the specific objectives described for each goal. The scope of work outlined in the Implementation Plan will depend on the availability of future funds and other resources.

Implementation Monitoring and Evaluation
The National Vaccine Program Office (NVPO) will regularly track and annually summarize progress on achieving the goals and priorities in the National Vaccine Plan, identify areas where progress is lagging, and propose corrective action where needed.

Key documents:
2010 National Vaccine Plan [PDF – 356KB]

National Vaccine Plan Implementation [PDF- 822 KB]

Implementation Plan: Summary of Stakeholder Meetings [PDF- 982 KB]


Gates Foundation signed an agreement with Islamic Development Bank

The Bill & Melinda Gates Foundation signed an agreement with the Islamic Development Bank for a program to fight contagious diseases including polio and provide food security in several countries, the Saudi Press Agency reported. The five-year program will cover projects mainly in Pakistan, Afghanistan and Nigeria, and is understood to be valued at about US$277 million.



Aeras, GSK to jointly advance the clinical development of investigational tuberculosis (TB) vaccine

Aeras announced an agreement with GSK to jointly advance the clinical development of an investigational tuberculosis (TB) vaccine containing GSK’s proprietary M72 antigen and AS01E adjuvant. The new agreement “comes after promising results from early stage clinical trials showed that the GSK TB vaccine candidate known as M72/AS01E has an acceptable safety and reactogenicity profile and demonstrated an immune response.” Under the new agreement, Aeras and GSK will each provide resources to run a multi-center proof of concept clinical trial to test the vaccine candidate in healthy adults between 18 and 50 years of age.  The Phase IIb trial is scheduled to begin in Kenya , India and South Africa next year pending approvals from authorities. Aeras CEO Jim Connolly said, “When considering the massive public health impact and costs to society of neglected diseases including tuberculosis, global financing for R&D remains critically low in this area. Working in partnership with GSK – sharing resources, capabilities and know-how – affords us the opportunity to conduct this pivotal, multi-country proof of concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world’s deadliest infectious diseases.”

PR Newswire (http://s.tt/1pE0l)

GPEI: Update: Polio this week – As of 10 Oct 2012

Update: Polio this week – As of 10 Oct 2012
Global Polio Eradication Initiative

[Editor’s Extract]
China one year polio-free:  9 October 2012 marked 12 months since China’s last polio case.  In 2011, polio from Pakistan had infected the country, which had eradicated indigenous polio in 1994.  China conducted a model response, and successfully stopped the outbreak in record time – three months from index to last case…

– Two new cases were reported in the past week (WPV1s from Kandahar), bringing the total number of cases for 2012 to 21. One of the newly-reported cases is the most recent in the country, and had onset of paralysis on 20 September…

– Three new cases were reported in the past week (WPV1s from Khyber Pakhtunkhwa – KP, Federally Administered Tribal Areas – FATA, and Sindh), bringing the total number of cases for 2012 to 43. The new case from FATA is the most recent in the country and had onset of paralysis on 25 September.
– Additionally, a positive environmental sample was reported from Peshawar, KP (collected 13 September)…
– In response to recent cases, mop-ups were conducted last week in key areas of KP, Sindh and Punjab, targeting more than a million children under the age of five years.

MMWR Weekly for October 12, 2012

MMWR Early Release October 12, 2012 / Vol. 61 / Early Release
Multistate Outbreak of Fungal Infection Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy — United States, 2012

The MMWR Weekly for October 12, 2012 / Vol. 61 / No. 40 includes:
Evaluation of Vaccination Recall Letter System for Medicaid-Enrolled Children Aged 19–23 Months — Montana, 2011

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Webinar: Understanding the Post-2015 Development Agenda Process Opportunities and Challenges that Lay Ahead

Webinar: Understanding the Post-2015 Development Agenda Process
Opportunities and Challenges that Lay Ahead

18 October 2012 – Time: 11:00 am – 12:30 pm EDT ( Washington, DC USA)
This event is free and open to the public
525 23rd ST NW
Washington DC, 20037 Room 1017

Online: via Blackboard link:
– Spanish room: www.paho.org/virtual/SeminariosSDE 
– English room www.paho.org/virtual/SDESeminars

For those who cannot follow the live seminar, it will be available later at: http://bit.ly/oxoRdS Related readings:
Realizing the Future We Want for All: Report to the Secretary-General

Health in the Post-2015 UN Development Agenda: Thematic Think Piece

More at: http://new.paho.org/equity/index.php?option=com_content&task=view&id=143&Itemid=1926#.UHcyzRo-WIc.twitter

IOM Report: Monitoring HIV Care in the United States: A Strategy for Generating National Estimates of HIV Care and Coverage

IOM Report: Monitoring HIV Care in the United States: A Strategy for Generating National Estimates of HIV Care and Coverage
October 5, 2012
Board on Population Health and Public Health Practice

Approximately 1.2 million people in the United States live with HIV, and the number grows each year. In July 2010, the federal government released the National HIV/AIDS Strategy (NHAS), aimed at reducing HIV transmission, increasing access to care, improving health outcomes, and reducing health disparities for people living with HIV. NHAS is designed to build on Affordable Care Act provisions that will increase access to health insurance for people with HIV.

A critical part of federal efforts will be to accurately monitor the scope of the HIV/AIDS epidemic and the availability and success of treatment and prevention programs. For help in structuring its plans, the White House Office of National AIDS Policy asked the IOM to prepare two reports – the first was released in March 2012 – on monitoring HIV care in the U.S.

Data collected from a nationally representative sample of people with HIV can be used to help monitor the effect of the ACA on health care coverage and utilization. Monitoring will provide an enhanced means of assessing the effect of the NHAS and the ACA on care received by people with HIV – knowledge that can inform future planning and guide potential redistribution of resources to improve the efficiency and quality of care and reduce health disparities.


HHS Conference: 2012 Science of Eliminating Health Disparities Summit

Conference: 2012 Science of Eliminating Health Disparities Summit- Building a Healthier Global Society: Integrating Science, Practice, and Policy
U.S. Department of Health and Human Services (HHS)
October 31 – November 2, 2012
Gaylord National Resort and Convention Center, National Harbor, Maryland

The 2012 Science of Eliminating Health Disparities Summit is the leading scientific gathering on health disparities. Thousands of participants will attend more than 100 sessions to exchange new knowledge, and learn about progress, successes, challenges, and opportunities in implementing innovative research. Sessions will also feature practice and policy interventions to inform health disparities science, and highlight the power and impact of multi-sector partnerships in tackling the social, behavioral, environmental, economic, and biological factors that cause health disparities.

Millions of people globally experience health disparities, and far too many suffer from preventable diseases and health conditions. This is due in part to inadequate attention to their physical or environmental surroundings, and the circumstances into which they are born, grow, live, work, and age. There is increased multi-sector partnership among domestic and international partners to share best practices and enhance approaches to eliminate health disparities, with growing emphasis on the social determinants of health that affect socially disadvantaged and underserved communities.


The Hajj: updated health hazards and current recommendations for 2012

Volume 17, Issue 41, 11 October 2012

Rapid Communications
The Hajj: updated health hazards and current recommendations for 2012
by JA Al-Tawfiq, ZA Memish

This year the Hajj will take place during 24–29 October. Recent outbreaks of Ebola haemorrhagic fever in Uganda and the Democratic Republic of the Congo, cholera in Sierra Leone, and infections associated with a novel coronavirus in Saudi Arabia and Qatar required review of the health recommendations of the 2012 Hajj. Current guidelines foresee mandatory vaccination with quadrivalent meningococcal vaccine for all pilgrims, and yellow fever and poliomyelitis vaccine for pilgrims from high-risk countries. Influenza vaccine is strongly recommended.

From reaching every district to reaching every community…equity in immunization in Cambodia Health Policy Plan

Health Policy and Planning
Volume 27 Issue 7 October 2012

Advance Access: 9 October 2012-10-13
Original Paper:
From reaching every district to reaching every community: analysis and response to the challenge of equity in immunization in Cambodia Health Policy Plan
Sann Chan Soeung, John Grundy, Richard Duncan, Rasoka Thor, and Julian B Bilous
first published online October 9, 2012 doi:10.1093/heapol/czs096

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

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

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

Global reduction in measles mortality

The Lancet  
Oct 13, 2012  Volume 380  Number 9850  p1281 – 1358

Global reduction in measles mortality
Suman Saurabh, Ritesh Kumar
Emily Simons and colleagues’ insightful Article (June 9, p 2173)1 draws highly relevant conclusions for measles control.

Global reduction in measles mortality
David N Durrheim
The recent stalling of measles elimination efforts in Europe and Africa, and downwards revision of estimated measles deaths prevented, has tempered optimism that this killer of children will soon be vanquished.1–3 Progress in the Western Pacific region provides welcome optimism. Measles incidence declined from 27·0 in 2010 to 11·6 per million population in 2011.4

Global reduction in measles mortality
Michael Noll-Hussong
The study by Emily Simons and colleagues1 raises the important issue of measles surveillance and the intensified control measures that are needed to achieve mortality reduction targets. Simons and colleagues focus on the established spectrum of surveillance methods in their modelling approach, but one recently evolving surveillance technique should also be considered: internet search engine analytics.

Global reduction in measles mortality – Authors’ reply
Emily Simons, Matthew Ferrari, Peter Strebel
In response to Suman Saurabh and Ritesh Kumar, although the rate of infection shares some features of SIR models, our aim was to use a flexible formulation that reproduced the key features of an SIR-type model. Specifically, the infection rate should scale positively with the proportion of the population that is susceptible. As correctly noted, we assume that the force of infection is constant throughout the year, although standard SIR formulations suggest the force of infection should change through time as S/N and I fluctuate.

The Lancet Series – Equity in Child Survival, Health, and Nutrition

The Lancet  
Oct 13, 2012  Volume 380  Number 9850  p1281 – 1358

Equity in Child Survival, Health, and Nutrition
Strategies to improve health coverage and narrow the equity gap in child survival, health, and nutrition
Mickey Chopra, Alyssa Sharkey, Nita Dalmiya, David Anthony, Nancy Binkin, on behalf of the UNICEF Equity in Child Survival, Health and Nutrition Analysis Team

Implementation of innovative strategies to improve coverage of evidence-based interventions, especially in the most marginalised populations, is a key focus of policy makers and planners aiming to improve child survival, health, and nutrition. We present a three-step approach to improvement of the effective coverage of essential interventions. First, we identify four different intervention delivery channels—ie, clinical or curative, outreach, community-based preventive or promotional, and legislative or mass media. Second, we classify which interventions’ deliveries can be improved or changed within their channel or by switching to another channel. Finally, we do a meta-review of both published and unpublished reviews to examine the evidence for a range of strategies designed to overcome supply and demand bottlenecks to effective coverage of interventions that improve child survival, health, and nutrition. Although knowledge gaps exist, several strategies show promise for improving coverage of effective interventions—and, in some cases, health outcomes in children—including expanded roles for lay health workers, task shifting, reduction of financial barriers, increases in human-resource availability and geographical access, and use of the private sector. Policy makers and planners should be informed of this evidence as they choose strategies in which to invest their scarce resources.

Equity in Child Survival, Health, and Nutrition
The comparative cost-effectiveness of an equity-focused approach to child survival, health, and nutrition: a modelling approach
Carlos Carrera, Adeline Azrack, Genevieve Begkoyian, Jerome Pfaffmann, Eric Ribaira, Thomas O’Connell, Patricia Doughty, Kyaw Myint Aung, Lorena Prieto, Kumanan Rasanathan, Alyssa Sharkey, Mickey Chopra, Rudolf Knippenberg, on behalf of the UNICEF Equity in Child Survival, Health and Nutrition Analysis Team

Progress on child mortality and undernutrition has seen widening inequities and a concentration of child deaths and undernutrition in the most deprived communities, threatening the achievement of the Millennium Development Goals. Conversely, a series of recent process and technological innovations have provided effective and efficient options to reach the most deprived populations. These trends raise the possibility that the perceived trade-off between equity and efficiency no longer applies for child health—that prioritising services for the poorest and most marginalised is now more effective and cost effective than mainstream approaches. We tested this hypothesis with a mathematical-modelling approach by comparing the cost-effectiveness in terms of child deaths and stunting events averted between two approaches (from 2011—15 in 14 countries and one province): an equity-focused approach that prioritises the most deprived communities, and a mainstream approach that is representative of current strategies. We combined some existing models, notably the Marginal Budgeting for Bottlenecks Toolkit and the Lives Saved Tool, to do our analysis. We showed that, with the same level of investment, disproportionately higher effects are possible by prioritising the poorest and most marginalised populations, for averting both child mortality and stunting. Our results suggest that an equity-focused approach could result in sharper decreases in child mortality and stunting and higher cost-effectiveness than mainstream approaches, while reducing inequities in effective intervention coverage, health outcomes, and out-of-pocket spending between the most and least deprived groups and geographic areas within countries. Our findings should be interpreted with caution due to uncertainties around some of the model parameters and baseline data. Further research is needed to address some of these gaps in the evidence base. Strategies for improving child nutrition and survival, however, should account for an increasing prioritisation of the most deprived communities and the increased use of community-based interventions.

Attitudes of the General Public and General Practitioners in Five Countries towards Pandemic and Seasonal Influenza Vaccines during Season 2009/2010

PLoS One
[Accessed 13 October 2012]

Attitudes of the General Public and General Practitioners in Five Countries towards Pandemic and Seasonal Influenza Vaccines during Season 2009/2010
Patricia R. Blank, Genevieve Bonnelye, Aurore Ducastel, Thomas D. Szucs
PLoS ONE: Research Article, published 11 Oct 2012 10.1371/journal.pone.0045450

Vaccination coverage rates for seasonal influenza are not meeting national and international targets. Here, we investigated whether the 2009/2010 A/H1N1 pandemic influenza affected the uptake of influenza vaccines.

Methodology/Principal Findings
In December 2009/January 2010 and April 2010, 500 randomly selected members of the general public in Germany, France, the United States, China, and Mexico were surveyed by telephone about vaccination for seasonal and A/H1N1 pandemic influenza. Also, in April 2010, 100 randomly selected general practitioners were surveyed. Adult vaccine coverage in December 2009/January 2010 for A/H1N1 pandemic and seasonal influenza were, respectively, 12% and 29% in France, 11% and 25% in Germany, 41% and 46% in the US, 13% and 30% in Mexico, and 12% and 10% in China. Adult uptake rates in April 2010 were higher in Mexico but similar or slightly lower in the other countries. Coverage rates in children were higher than in adults in the US, Mexico, and China but mostly lower in Germany and France. Germans and French viewed the threat of A/H1N1 pandemic influenza as low to moderate, whereas Mexicans, Americans, and Chinese viewed it as moderate to serious, opinions generally mirrored by general practitioners. The recommendation of a general practitioner was a common reason for receiving the pandemic vaccine, while not feeling at risk and concerns with vaccine safety and efficacy were common reasons for not being vaccinated. Inclusion of the A/H1N1 pandemic strain increased willingness to be vaccinated for seasonal influenza in the United States, Mexico, and China but not in Germany or France.

The 2009/2010 A/H1N1 influenza pandemic increased vaccine uptake rates for seasonal influenza in Mexico but had little effect in other countries. Accurate communication of health information, especially by general practitioners, is needed to improve vaccine coverage rates.

Estimated size of the population at risk of severe adverse events after smallpox vaccination in Israel

Volume 30, Issue 47 pp. 6609-6728 (19 October 2012)

Estimated size of the population at risk of severe adverse events after smallpox vaccination in Israel
Original Research Article
Pages 6632-6635
Yael Levy, Emilia Anis, Ehud Kaliner, Itamar Grotto, Yehuda L. Danon

The population at risk of adverse events after smallpox vaccination has increased in recent years. This has important implications for preparedness strategies against bioterrorism with the variola virus. The aim of the study was to estimate the size of this special population in Israel.

The study was conducted in January 2010. Data on patients with contraindications to smallpox vaccination, as delineated by the Israel Ministry of Health for planning post-event strategies, were retrieved from the computerized records of the Department of AIDS and Tuberculosis and the Transplantation Center of the Israel Ministry of Health. In addition, the database of the main Health Maintenance Organization in Israel which insures 60% of the national population was searched using ICD-9 codes and specific medications issued in the last quarter of 2009.

Of the 7,563,800 persons residing in Israel in January 2010, 326,318 were at risk of an adverse event after smallpox vaccination.

Approximately 4.3% of the Israeli population should not be exposed to the currently used smallpox vaccine. This knowledge is important to ensure the effectiveness of mass vaccination programs in the event of a bioterror attack.

Probing the protective effects of a conformationally constrained nicotine vaccine

Volume 30, Issue 47 pp. 6609-6728 (19 October 2012)

Probing the protective effects of a conformationally constrained nicotine vaccine
Original Research Article
Vaccine, Volume 30, Issue 47, Pages 6609-6728 (19 October 2012)
Pages 6665-6670
Amira Y. Moreno, Marc R. Azar, George F. Koob, Kim D. Janda

Despite being consistently ranked as the leading cause of preventable death in the United States, about 20% of the population continues to smoke. Current smoking cessation therapies offer limited success, show high rates of relapse, and have potentially dangerous side effects, consequently emphasizing the need for alternative therapies. Immunopharmacotherapy aims to use highly specific antibodies to sequester nicotine in the bloodstream thus blunting passage into the brain and minimizing positive reinforcing effects. A successful vaccination strategy is dependent upon the appropriate hapten design, carrier protein and adjuvant which affect both the magnitude and affinity of the immune response elicited. Our laboratory previously demonstrated the use of molecular constraint as a means to increase the intrinsic immunogenicity and antigenicity of a nicotine vaccine. The present study expands upon those initial results and explores the protective effects of vaccination with both constrained hapten CNI and its unconstrained counterpart NIC. Our results demonstrate how immunization with CNI-KLH produces large amounts of moderate affinity anti-nicotine antibodies even when formulated with ALUM adjuvant, making it particularly relevant for human use. In contrast, vaccination with NIC-KLH produced moderate amounts of high affinity anti-nicotine antibodies. These differential responses proved critical in offering protecting effects. Vaccination with CNI, but not NIC, resulted in an increase of self-administration responding on a progressive ratio schedule using a high nicotine dose (0.03 mg/kg/infusion; ∼2 cigarettes in human) as compared to KLH-controls. Furthermore, vaccination with CNI was able to antagonize the analgesic effects of a heavy bolus dose of nicotine (0.35 mg/kg). These results support our hypothesis that molecular constraint can be advantageously utilized to increase the immunogenicity of a nicotine vaccine. Furthermore in correlating the behavioral effects with the differential responses elicited, we shed light on the distinct roles of antibody concentration and affinity.

Distinguishing vaccine efficacy and effectiveness

Volume 30, Issue 47 pp. 6609-6728 (19 October 2012)

Distinguishing vaccine efficacy and effectiveness
Original Research Article
Pages 6700-6705
Eunha Shim, Alison P. Galvani

Mathematical models of disease transmission and vaccination typically assume that protective vaccine efficacy (i.e. the relative reduction in the transmission rate among vaccinated individuals) is equivalent to direct effectiveness of vaccine. This assumption has not been evaluated.

We used dynamic epidemiological models of influenza and measles vaccines to evaluate the common measures of vaccine effectiveness in terms of both the protection of individuals and disease control within populations. We determined how vaccine-mediated reductions in attack rates translate into vaccine efficacy as well as into the common population measures of ‘direct’, ‘indirect’, ‘total’, and ‘overall’ effects of vaccination with examples of compartmental models of influenza and measles vaccination.

We found that the typical parameterization of vaccine efficacy using direct effectiveness of vaccine can lead to the underestimation of the impact of vaccine. Such underestimation occurs when the vaccine is assumed to offer partial protection to every vaccinated person, and becomes worse when the level of vaccine coverage is low. Nevertheless, estimates of ‘total’, ‘indirect’ and ‘overall’ effectiveness increase with vaccination coverage in the population. Furthermore, we show how the measures of vaccine efficacy and vaccine effectiveness can be correctly calculated.

Typical parameterization of vaccine efficacy in mathematical models may underestimate the actual protective effect of the vaccine, resulting in discordance between the actual effects of vaccination at the population level and predictions made by models. This work shows how models can be correctly parameterized from clinical trial data.

From Google Scholar: Dissertations, Theses, Selected Journal Articles

From Google Scholar: Dissertations, Theses, Selected Journal Articles

[PDF] Linear Categorical Marginal Modeling of Solicited Symptoms in Vaccine Clinical Trials
WP Bergsma, EMD Aris, FS Tibaldi – Journal of Biopharmaceutical Statistics. …, 2012
Abstract Analysis of the occurrence of adverse events, and in particular of solicited symptoms, following vaccination is often needed for the safety and benefit-risk evaluation of any candidate vaccine, and typically involves taking repeated measurements. In this …

[PDF] Cost-effectiveness analysis of intranasal live attenuated vaccine (LAIV) versus injectable inactivated influenza vaccine (TIV) for Canadian children and adolescents
JE Tarride, N Burke, C Von Keyserlingk, D O’Reilly… – … and Outcomes Research, 2012
Background: Influenza affects all age groups and is common in children. Between 15% and 42% of preschool-and school-aged children experience influenza each season. Recently, intranasal live attenuated influenza vaccine, trivalent (LAIV) has been approved in …

Twitter Watch [accessed 13 October 2012 17:46]

Twitter Watch  [accessed 13 October 2012  17:46]
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.

Know what’s the best way to control pandemics? No, it’s not scientists in white coats. It’s handwashing #iwashmyhands
12:17 PM – 13 Oct 12

World Bank @WorldBank
“It is time to bend the arc of history” – Pres Kim http://bit.ly/RkcBYD 
2:00 AM – 13 Oct 12

World Bank Live @WorldBankLive
New #MDGs should be a ‘catalytic’ force for eliminating poverty. – Kim http://bit.ly/Rn82Nf  #wblive
Retweeted by World Bank
8:10 PM – 12 Oct 12

Peter Speyer @PeterSpeyer
WHO Forum on Health Data Standardization and Interoperability, 12/3-4 in Geneva http://new.paho.org/equity/index.php?option=com_content&task=view&id=144&Itemid=1 … #healthdata
Retweeted by Amanda Glassman
5:23 PM – 12 Oct 12

CDCgov ‏@CDCgov
Join us Oct 16th at 1pm ET for the next #CDCGrandRounds: “Public Health Approaches to Reducing U.S. Infant Mortality” http://is.gd/kdxCbQ 
11:00 AM – 12 Oct 12

Seth Berkley @GAVISeth
Good talk with former Japanese PM Naoto Kan who is part of UNSG’s post 2015 MDGs high level commission on power of vaccines and GAVI’s model
7:53 AM – 12 Oct 12

Seth Berkley ‏@GAVISeth
Great WB&GAVI event on economic benefit of vaccines http://goo.gl/3i7w8  Encouraging finance ministers to prioritise immunisation funding
7:30 AM – 12 Oct 12

PAHO/WHO Equity @eqpaho
Health in the post-2015 UN development agenda Thematic Think Piece UNAIDS UNICEF UNFPA WHO http://www.un.org/millenniumgoals/pdf/Think%20Pieces/8_health.pdf …
Retweeted by PAHO/WHO
2:47 PM – 11 Oct 12

Vaccines: The Week in Review 6 October 2012

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_6 October 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…

Polio Round-up to 6 October 2012

Update: Polio this week – As of 03 Oct 2012
Global Polio Eradication Initiative
[Editor’s Extract]
One new case was reported in the past week (WPV1 from the previously-uninfected province of Ghor), bringing the total number of cases for 2012 to 19. It was the most recent case, with onset of paralysis on 31 August.
Three new cases were reported in the past week (2 WPV1 from Khyber Pakhtunkhwa and 1 from Gilgit Baltistan) bringing the total number of cases for 2012 to 40. The most recent case was a WPV1 from Khyber Pakhtunkhwa with onset of paralysis on 13 September.

   The Weekly Epidemiological Record (WER) for 5 October 2012, vol. 87, 40 (pp. 381–388) includes:
– Progress towards eradicating poliomyelitis: Afghanistan and Pakistan, January 2011–August 2012

The World Bank’s Board of Directors approved a US$24 million second additional financing for the Third Partnership for Polio Eradication Project (TPPEP) “to support the Government of Pakistan’s efforts to immunize 34.8 million children against the crippling effects of polio with the goal of eradicating the disease from the country.” Rachid Benmessaoud, World Bank Country Director for Pakistan, commented, “Although Pakistan has seen great progress in the reduction of polio over the last 20 years, it remains one of the few countries where polio still impacts lives and recent cases are worrying. Pakistan still has a large role to play to aggressively stop transmission of polio virus to help achieve the global public good of polio eradication in the world”. The announcement noted that the recent floods also forced large scale population movements, resulting in large population groups living together in temporary housing with inadequate water and sanitation facilities. This, in turn, has led to exposure of people who had not been previously exposed to the polio virus. In addition, the prevailing security situation affecting the population in areas of Khyber Pakhtunkhwa (KP) and the Federally Administered Tribal Areas (FATA) has seriously affected immunization coverage, with an estimated 90% of children under 5 years no longer receiving adequate immunization.

More: http://www.worldbank.org/en/news/2012/10/02/world-bank-help-immunize-34-8-million-children-pakistan-polio

WHO: Global Vaccine Safety Initiative website launched

WHO: Global Vaccine Safety Initiative website launched

The GVSI promotes efforts to strengthen “vaccine pharmacovigilance” worldwide. This means identifying any “adverse events” that may occur following immunization and investigating them to see if they are related to the vaccine or the immunization procedure. The Blueprint refers to vaccine pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, prevention and communication of adverse events following immunization, or of any other vaccine- or immunization-related issues”, as defined by CIOMS/WHO (2012). Adverse events are also sometimes referred to as “side-effects”. Vaccine pharmacovigilance is not just a scientific exercise. Its purpose is to ensure that vaccines are safe and to follow up if a case arises where a vaccination may be linked to harm.

This site provides a wide range of information about vaccine safety in general and the GVSI in particular. The site includes:

– information on established untoward effects of vaccines and estimates of their rates of occurrence;

– advice from an Expert Advisory Group on vaccine safety issues of global importance;

– links to tools and methods for enhancing local capacity in vaccine safety;

– up-to-date information on the management of the GVSI.

The GVSI is a global collaborative effort to ensure that everyone everywhere can be protected from serious infectious diseases with minimal untoward effects from the best available vaccines.

Training materials, tools for investigating vaccine safety concerns, and links to the web sites of other organizations are also provided.


Partners of Harmonization for Health in Africa – Tunis Declaration

WHO SEAR: Partners of Harmonization for Health in Africa discuss action plans for high quality, affordable healthcare and implementation of Tunis Declaration

“3 October 2012,  Nairobi, Kenya – Partners in the Harmonization for Health in Africa (HHA) initiative are convening in Nairobi this week as a follow-up to the recent Tunis ministerial conference for African health and finance ministers. Regional Directors, senior representatives and a multidisciplinary group of technical experts from the HHA partner agencies will use this opportunity to discuss how to further strengthen their support to countries in providing quality and affordable healthcare to African populations, particularly the under-served…”



PAHO Pushes Forward Roadmap to Support Parliamentary Activity on Health in the Americas

PAHO: PAHO/WHO Pushes Forward Roadmap to Support Parliamentary Activity on Health in the Americas

“With the aim of supporting parliamentary work on health in the Americas, the Pan American Health Organization/World Health Organization (PAHO/WHO) will present a portal with information on legislative processes in health policy in the region and also convene roundtables where parliamentarians of all countries will be able to exchange experiences on parliamentary procedures for health issues.”


Enhanced Routine Immunization Activity (ERIA) – Ethiopia

WHO: New immunization approach in Ethiopia reaches more children
October 2012

“A new approach to routine immunization in the rural Afar region in north-eastern Ethiopia nearly quadrupled the numbers of children vaccinated against measles, diphtheria, pertussis, tetanus, polio and other diseases in 2010 (from as low as 22% to nearly 80% coverage in the target area). The immunization activity used “community champions” to encourage nomadic, pastoral families to have their children vaccinated and introduced new approaches such as task shifting to improve service delivery to these hard-to-reach populations.

“The Enhanced Routine Immunization Activity (ERIA) had already generated strong results among nomadic, pastoral families on a small scale in the neighbouring Somali region. With support from WHO and partners, health officials replicated the approach on a larger scale in Afar to reach more children.”


GAVI: High mark in 2012 aid transparency index

GAVI said it welcomed the 2012 aid transparency index that acknowledges the global health partnership for its increasing dedication to aid transparency. GAVI said the index gave it high marks for the “publication of high quality, current activity data” and calls on the organisation “to continue to lead on aid transparency”. The index – produced annually by Publish What You Fund – ranks 72 aid organisations across the world, from country donors to private foundations. GAVO CEO Dr Seth Berkley said, “Accountability for results in country is the highest order of what we do; therefore communicating effectively on what is being spent where, by whom, and with what results is the basic foundation of the GAVI model.” GAVI noted that it was a founding signatory to the International Aid Transparency Initiative (IATI) in 2008, and uses this global standard for publishing aid information to make information about aid spending easier to find, use and compare.


Malaria: History, Past Decade’s Achievements, and Future Priorities

Speech/Panel/Webcast: Malaria: History, Past Decade’s Achievements, and Future Priorities
Center for Strategic and International Studies
Wednesday, October 17th  3:00 – 5:00pm (EST)

The first hour, Sir Richard Feachem will speak to the historical patterns of malaria control, the outcomes of accelerated global efforts in the past decade, outstanding challenges, and policy priorities for the next Administration and Congress. The second hour will include a moderated discussion with Sir Richard Feachem and Rear Admiral Tim Ziemer on the U.S. anti-malaria agenda moving forward.

This event will be webcast live at: www.SmartGlobalHealth.org/Live

Global Fund: Final Report of the Independent Evaluation of AMFm Phase 1

Global Fund: Final Report of the Independent Evaluation of AMFm Phase 1
The Global Fund to Fight AIDS, Tuberculosis and Malaria
4 October 2012

The Global Fund made public the final report of an independent evaluation of the pilot phase of the Affordable Medicines Facility–malaria, also known as AMFm. The report was commissioned to provide an independent evaluation to assess the extent to which AMFm has achieved the main objectives laid out for its pilot phase, which ends in December 2012. The independent evaluation was mandated by the Global Fund Board and will inform its decision in November 2012, when the Board is expected to consider the future of AMFm beyond the pilot phase.

The goal of AMFm is 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. It set out to increase availability, particularly through private outlets where most people seek their treatments, and drive down the price of ACTs through a factory-gate global subsidy of ACTs combined with country-level measures to support its implementation.

The AMFm pilot phase currently operates in eight countries: Cambodia, Ghana, Kenya, Madagascar, Niger, Nigeria, Tanzania, and Uganda. The independent evaluation assessed the program in each of the pilot countries that was operational at the time of the endline survey.

Links to Executive Summary and Full Report here: http://www.theglobalfund.org/en/amfm/independentevaluation/

What Primary Care Providers Need to Know About Preexposure Prophylaxis for HIV Prevention: A Narrative Review

Annals of Internal Medicine
2 October 2012, Vol. 157. No. 7

What Primary Care Providers Need to Know About Preexposure Prophylaxis for HIV Prevention: A Narrative Review
Douglas Krakower, MD; and Kenneth H. Mayer, MD

Abstract [Free full-text]
As HIV prevalence climbs globally, including more than 50,000 new infections per year in the United States, we need more effective HIV prevention strategies. The use of antiretrovirals for preexposure prophylaxis (PrEP) among high-risk persons without HIV is emerging as one such strategy. Randomized, controlled trials have demonstrated that once-daily oral PrEP decreased HIV incidence among at-risk men who have sex with men and African heterosexuals, including serodiscordant couples. An additional randomized, controlled trial of a topical pericoital antiretroviral microbicide gel decreased HIV incidence among at-risk heterosexual South African women. Two other studies in African women did not demonstrate the efficacy of oral or topical PrEP, raising concerns about adherence patterns and efficacy in this population.

The U.S. Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee reviewed these studies and additional data in May 2012 and voted to advise the approval of oral tenofovir–emtricitabine for PrEP in high-risk populations. On 16 July 2012, the FDA recommended that this combination medication be approved for use as PrEP in high-risk persons without HIV. Patients may seek PrEP from their primary care providers, and those receiving PrEP require monitoring. Thus, primary care providers should become familiar with PrEP. This review outlines current knowledge about PrEP as it pertains to primary care, including identifying persons likely to benefit from PrEP; counseling to maximize adherence and reduce potential increases in risky behavior; and monitoring for potential drug toxicities, HIV acquisition, and antiretroviral drug resistance. Issues related to cost and insurance coverage are also discussed. Recent data suggest that PrEP, combined with other prevention strategies, holds promise in helping to curtail the HIV epidemic.

Human immunodeficiency virus continues to spread, with more than 2 million new infections globally (1) and 50,000 new infections in the United States per year (2). Thus, more effective HIV prevention strategies are urgently needed. Administration of antiretroviral medications to uninfected persons at high risk to protect against HIV acquisition, known as preexposure prophylaxis (PrEP), has recently emerged as a promising prevention strategy.

Over the past 2 years, randomized, controlled trials have demonstrated that PrEP can decrease HIV incidence in high-risk populations (3 – 6). With the FDA’s approval of oral tenofovir–emtricitabine for PrEP in high-risk populations (7), clinicians can now prescribe PrEP to prevent HIV acquisition in their at-risk patients. Thus, it is important that practicing physicians understand this new evidence and its implications.

EDITORIAL – Stockpiling oral cholera vaccine

Bulletin of the World Health Organization
Volume 90, Number 10, October 2012, 713-792

Stockpiling oral cholera vaccine
Stephen Martin a, Alejandro Costa a & William Perea a
a. Control of Epidemic Diseases Unit, Pandemic and Epidemic Diseases Department, World Health Organization, 20 avenue Appia, 1211 Geneva 27, Switzerland.
Bulletin of the World Health Organization 2012;90:714-714. doi: 10.2471/BLT.12.112433

Cholera is re-emerging as a threat on the global public health stage. The number of reported cases worldwide is back at the peak level observed two decades ago,1 new Vibrio cholerae strains have appeared and antimicrobial resistance has increased. Weak surveillance systems and the possibility of travel and trade sanctions contribute to widespread underreporting of cholera cases, which results in great uncertainty surrounding global disease burden estimates. Such estimates suggest that about 1.4 billion people are at risk of cholera and that the risk is highest among children under five years of age. Annually 2.8 million cases and 91 000 deaths from cholera occur in endemic countries; non-endemic countries contribute another 87 000 cases and 2500 deaths.2 Although effective preventive and therapeutic regimens are well established, clearly cholera remains poorly controlled in both outbreak and endemic contexts.

Cholera-related morbidity and mortality are particularly high during humanitarian crises. Large cholera epidemics in Zimbabwe (2008–2009), Haiti (2011) and now Sierra Leone (2012) have made the international community aware of the need to not merely control endemic disease, but also to strengthen epidemic preparedness and response capacity. In 2011, the Sixty-fourth World Health Assembly issued a resolution calling for a reinvigorated focus on cholera and defined a range of actions required of the World Health Organization (WHO) and its Member States towards creating an integrated, comprehensive strategy for cholera prevention and control.3 As part of this strategy, WHO is facilitating a multi-partner initiative aimed at establishing a stockpile of oral cholera vaccine (OCV) for use in outbreak response as an adjunct to established prevention and control measures. This approach was endorsed in September 2011 by global cholera experts, who affirmed that such a stockpile is both necessary and feasible.4 There are currently two stockpile candidate oral cholera vaccines, both prequalified by WHO.

A WHO technical working group convened in April 2012 and defined the required characteristics of a stockpiled vaccine, the epidemiological and operational considerations for deployment, and the mechanisms for stockpile governance, replenishment and appraisal.5 This working group agreed on an initial OCV stockpile of 2 million annual doses to be available for epidemic response in low-income countries. The International Coordinating Group (ICG) has a decade of experience as a decision-making partnership that oversees the meningococcal and yellow fever vaccine stockpiles and their deployment. The ICG is composed of experts from four organizations: Médecins sans Frontières, the International Federation of the Red Cross and Red Crescent Societies, the United Nations Children’s Fund and WHO, which is both a decision-making partner and the ICG’s secretariat. All members of the ICG, including WHO, will oversee the proposed OCV stockpile.

The WHO technical working group emphasized that deployment of the stockpiled vaccine must be guided by epidemiological, technical and operational evidence, some of which remains incomplete and must be consolidated as experience is gained. While acknowledging the difficulties in predicting outbreaks and the need for more detailed empirical data, the working group created an advisory framework for assessing outbreak severity based on three criteria: the biological susceptibility of the population, the social vulnerability of the population and the risk of spatial extension. For each of these criteria, the working group defined epidemiological and demographic indicators, thresholds for deciding when to deploy the vaccine and indicators for determining the anticipated impact of a vaccination campaign. The framework proposed by the working group is intended only to inform decision-making; actual deployment of the OCV from the stockpile would follow not only an analysis of these indicators, but also an assessment of programmatic factors, such as local capacity to organize a mass vaccination campaign and prevailing security conditions.

Progress is being made on the working group’s action plans for 2012. The work streams are focused on advocacy for funding, negotiations with vaccine producers and preparedness planning for countries and regions. A stockpile evaluation group has been established to define and implement the detailed monitoring required. As experience and data accrue, the results of this evaluation should enable continuous improvement in the structure and functioning of the stockpile. Successful assessment of a stockpile vaccination campaign will require reinforcement of surveillance systems in most locations where an epidemic is likely to arise.

Public health interventions, such as case management, enhanced environmental control, improved hygiene and sanitation and social mobilization, should form the backbone of all cholera control programmes. In turn, these interventions depend on effective surveillance and strong health-care systems. This initial, necessarily small, OCV stockpile will not constitute sufficient preparedness for a large or sustained epidemic, its use should complement existing measures as part of a reinvigorated and comprehensive approach to meeting the new challenges involved in global cholera control and prevention.


Cholera annual report 2011. Wkly Epidemiol Rec 2012; 87: 289-304 pmid: 22905370.

Ali M, Lopez AL, You YA, Kim YE, Sah B, Maskery B, et al., et al. The global burden of cholera. Bull World Health Organ 2012; 90: 209-218 doi: 10.2471/BLT.11.093427 pmid: 22461716.

Resolution WHA64.15. Cholera: mechanism for control and prevention. In: Sixty-fourth World Health Assembly, Geneva, 16–24 May 2011. Volume 1. Resolutions, decisions and annexes. Geneva: World Health Organization; 2011 (WHA64/2011/REC/1). Available from: www.who.int/entity/cholera/…/Resolution_CholeraA64_R15-en.pdf [accessed 5 September 2012].

WHO Consultation on oral cholera vaccine (OCV) stockpile strategic framework: potential objectives and possible policy options. Geneva: Department of Immunization, Vaccines and Biologicals, World Health Organization; 2012 (WHO/IVB/12.05). Available from: http://www.who.int/immunization/documents/innovation/WHO_IVB_12.05/en/ [accessed 4 September 2012].

World Health Organization [Internet]. WHO Technical Working Group on creation of an oral cholera vaccine stockpile. Geneva: World Health Organization; 2012 (WHO/HSE/PED/2012.2). Available from: http://www.who.int/cholera/publications/oral_cholera_vaccine/en/index.html [accessed 1 September 2012].

A new entity for the negotiation of public procurement prices for patented medicines in Mexico

Bulletin of the World Health Organization
Volume 90, Number 10, October 2012, 713-792

A new entity for the negotiation of public procurement prices for patented medicines in Mexico
Octavio Gómez-Dantés, Veronika J Wirtz, Michael R Reich, Paulina Terrazas & Maki Ortiz

As countries expand health insurance coverage, their expenditures on medicines increase. To address this problem, WHO has recommended that every country draw up a list of essential medicines. Although most medicines on the list are generics, in many countries patented medicines represent a substantial portion of pharmaceutical expenditure.

To help control expenditure on patented medicines, in 2008 the Mexican Government created the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), whose role, as the name suggests, is to enter into price negotiations with drug manufacturers for patented drugs on Mexico’s list of essential medicines.

Local setting
Mexico’s public expenditure on pharmaceuticals has increased substantially in the past decade owing to government efforts to achieve universal health-care coverage through Seguro Popular, an insurance programme introduced in 2004 that guarantees access to a comprehensive package of health services and medicines.

Relevant changes
Since 2008, the CCPNM has improved procurement practices in Mexico’s public health institutions and has achieved significant price reductions resulting in substantial savings in public pharmaceutical expenditure.

Lessons learnt
The CCPNM has successfully changed the landscape of price negotiation for patented medicines in Mexico. However, it is also facing challenges, including a lack of explicit indicators to assess CCPNM performance; a shortage of permanent staff with sufficient technical expertise; poor coordination among institutions in preparing background materials for the annual negotiation process in a timely manner; insufficient communication among committees and institutions; and a lack of political support to ensure the sustainability of the CCPNM.

Impact of rotavirus vaccination in regions with low and moderate vaccine uptake in Germany

Human Vaccines & Immunotherapeutics(formerly Human Vaccines)
Volume 8, Issue 10  October 2012

SPECIAL FOCUS: Allergy Vaccines and Immunotherapeutics
Research Papers
Impact of rotavirus vaccination in regions with low and moderate vaccine uptake in Germany
Sandra Dudareva-Vizule, Judith Koch, Matthias an der Heiden, Doris Oberle, Brigitte Keller-Stanislawski and Ole Wichmann

In Germany, routine RV-vaccination is not adopted into the national immunization schedule as of 2012. Because RV-vaccines were already on the market since 2006, in 2010 a moderate (58%) and low (22%) vaccine uptake was observed in the 5 eastern federal states (EFS) and the 11 western federal states (WFS), respectively. To assess the impact of RV-vaccination, we compared the incidence rates (IR) of RV-related hospitalizations before (2004‒2006) and in seasons after (2008/09–2010/11) RV-vaccine introduction in Germany by utilizing data from the national mandatory disease reporting system. In the EFS, the IR was significantly reduced in age-groups < 18 mo in 2008/09 and in age-groups < 24 mo in 2009/10–2010/11. In the WFS an IR-reduction was observed only in age-groups < 12 mo in 2008/09 and in age-groups < 18 mo in 2009/10–2010/11. Overall IR-reduction in age-groups < 24 mo comparing 2008–11 with 2004–06 was 36% and 25% in EFS and WFS, respectively. In addition, we computed IR-ratios (IRR) in the seasons after mid-2006 with negative binomial regression. The effect of vaccination was independent from the geographic region. Vaccination was associated with a significant reduction in RV-related hospitalizations in the age-groups 6–23 mo. Most prominently, vaccination of 50% of infants led to an estimated decrease in age group 6–11 mo by 42%. No significant reduction was observed in age-groups ≥ 24 mo. In conclusion, in the German setting with low to moderate vaccine uptake, RV-related hospitalization incidence decreased substantially depending on the achieved vaccination coverage, but only in the first two years of life.

COMMENTARIES: Business models and opportunities for cancer vaccine developers

Human Vaccines & Immunotherapeutics(formerly Human Vaccines)
Volume 8, Issue 10  October 2012

Business models and opportunities for cancer vaccine developers
Alex Kudrin

Despite of growing oncology pipeline, cancer vaccines contribute only to a minor share of total oncology-attributed revenues. This is mainly because of a limited number of approved products and limited sales from products approved under compassionate or via early access entry in smaller and less developed markets. However revenue contribution from these products is extremely limited and it remains to be established whether developers are breaking even or achieving profitability with existing sales. Cancer vaccine field is well recognized for high development costs and risks, low historical rates of investment return and high probability of failures arising in ventures, partnerships and alliances. The cost of reimbursement for new oncology agents is not universally acceptable to payers limiting the potential for a global expansion, market access and reducing probability of commercial success. In addition, the innovation in cancer immunotherapy is currently focused in small and mid-size biotech companies and academic institutions struggling for investment. Existing R&D innovation models are deemed unsustainable in current “value-for-money” oriented healthcare environment. New business models should be much more open to collaborative, networked and federated styles, which could help to outreach global, markets and increase cost-efficiencies across an entire value chain. Lessons learned from some developing countries and especially from South Korea illustrate that further growth of cancer vaccine industry will depends not only on new business models but also will heavily rely on regional support and initiatives from different bodies, such as governments, payers and regulatory bodies.

Tetanus toxoid vaccine: Elimination of neonatal tetanus in selected states of India

Human Vaccines & Immunotherapeutics(formerly Human Vaccines)
Volume 8, Issue 10  October 2012

Tetanus toxoid vaccine: Elimination of neonatal tetanus in selected states of India
Ramesh Verma and Pardeep Khanna

Tetanus is caused by a neurotoxin produced by Clostridium tetani (C. tetani), a spore-forming bacterium. Infection begins when tetanus spores are introduced into damaged tissue. Tetanus is characterized by muscle rigidity and painful muscle spasms caused by tetanus toxin’s blockade of inhibitory neurons that normally oppose and modulate the action of excitatory motor neurons. Maternal and neonatal tetanus (MNT) are caused by unhygienic methods of delivery, abortion, or umbilical-cord care. Maternal and neonatal tetanus are both forms of generalized tetanus and have similar clinical courses. About 90% of neonates with tetanus develop symptoms in the first 3–14 d of life, mostly on days 6–8, distinguishing neonatal tetanus from other causes of neonatal mortality which typically occur during the first two days of life. Overall case fatality rates for patients admitted to the hospital with neonatal tetanus in developing countries are 8–50%, while the fatality rate can be as high as 100% without hospital care. Tetanus toxoid (TT) vaccination of pregnant women to prevent neonatal tetanus was included in WHO’s Expanded Program on Immunization (EPI) a few years after its inception in 1974. In 2000, WHO, UNICEF, and UNFPA formed a partnership to relaunch efforts toward this goal, adding the elimination of maternal tetanus as a program objective, and setting a new target date of 2005. By February 2007, 40 countries had implemented tetanus vaccination campaigns in high-risk areas, targeting more than 94 million women, and protecting more than 70 million subjects with at least two doses of TT. In 2011, 653 NT cases were reported in India compared with 9313 in 1990. As of February 2012, 25 countries and 15 States and Union Territories of India, all of Ethiopia except Somaliland, and almost 29 of 34 provinces in Indonesia have been validated to have eliminated MNT.

CDC Grand Rounds: the TB/HIV Syndemic

October 03, 2012, Vol 308, No. 13

CDC Grand Rounds: the TB/HIV Syndemic
JAMA. 2012;308(13):1311-1317. doi:.

Extract [Free full-text]
Since Robert Koch’s 1882 discovery of Mycobacterium tuberculosis, substantial progress has been made in tuberculosis (TB) control. Nevertheless, in the latter part of the 20th century, a long period of neglect of both quality program implementation and research led to persistently high TB incidence rates and failure to develop new tools to adequately address the problem. Today, most of the world continues to rely on the same diagnostic test invented by Koch approximately 125 years ago and on drugs developed 40 years ago. The world now faces a situation in which approximately 160 persons die of TB each hour (1.45 million died in 2009), in which a quarter of all deaths in persons with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) (PWHA) are caused by TB, and in which the evolution of the bacteria has outpaced the evolution of its treatment to such an extent that some forms of TB are now untreatable.1 More recently, renewed attention has been given to reducing the global burden of TB,2 but much remains to be done…

The quest for universal health coverage: achieving social protection for all in Mexico

The Lancet  
Oct 06, 2012  Volume 380  Number 9849  p1203 – 1280

Health Policy
The quest for universal health coverage: achieving social protection for all in Mexico
Felicia Marie Knaul, Eduardo González-Pier, Octavio Gómez-Dantés, David García-Junco, Héctor Arreola-Ornelas, Mariana Barraza-Lloréns, Rosa Sandoval, Francisco Caballero, Mauricio Hernández-Avila, Mercedes Juan, David Kershenobich, Gustavo Nigenda, Enrique Ruelas, Jaime Sepúlveda, Roberto Tapia, Guillermo Soberón, Salomón Chertorivski, Julio Frenk

Mexico is reaching universal health coverage in 2012. A national health insurance programme called Seguro Popular, introduced in 2003, is providing access to a package of comprehensive health services with financial protection for more than 50 million Mexicans previously excluded from insurance. Universal coverage in Mexico is synonymous with social protection of health. This report analyses the road to universal coverage along three dimensions of protection: against health risks, for patients through quality assurance of health care, and against the financial consequences of disease and injury. We present a conceptual discussion of the transition from labour-based social security to social protection of health, which implies access to effective health care as a universal right based on citizenship, the ethical basis of the Mexican reform. We discuss the conditions that prompted the reform, as well as its design and inception, and we describe the 9-year, evidence-driven implementation process, including updates and improvements to the original programme. The core of the report concentrates on the effects and impacts of the reform, based on analysis of all published and publically available scientific literature and new data. Evidence indicates that Seguro Popular is improving access to health services and reducing the prevalence of catastrophic and impoverishing health expenditures, especially for the poor. Recent studies also show improvement in effective coverage. This research then addresses persistent challenges, including the need to translate financial resources into more effective, equitable and responsive health services. A next generation of reforms will be required and these include systemic measures to complete the reorganisation of the health system by functions. The paper concludes with a discussion of the implications of the Mexican quest to achieve universal health coverage and its relevance for other low-income and middle-income countries

Background Rates of Adverse Pregnancy Outcomes for Assessing the Safety of Maternal Vaccine Trials in Sub-Saharan Africa

PLoS One
[Accessed 6 October 2012]

Background Rates of Adverse Pregnancy Outcomes for Assessing the Safety of Maternal Vaccine Trials in Sub-Saharan Africa
Lauren A. V. Orenstein, Evan W. Orenstein, Ibrahima Teguete, Mamoudou Kodio, Milagritos Tapia, Samba O. Sow, Myron M.
PLoS ONE: Research Article, published 04 Oct 2012 10.1371/journal.pone.0046638

Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa.

We developed a mathematical model that calculates a clinical trial’s expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM), low birth weight (LBW), prematurity, and major congenital malformations (MCM) in Sub-Saharan African countries were also performed.

Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6–73.3) per 1,000 total births, and the most common causes were hemorrhage (34%), dystocia (22%), and severe hypertensive disorders of pregnancy (22%). Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9–16.4) or premature (median 15.4%, IQR: 10.6–19.1) were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5–17.6), with the musculoskeletal system comprising 30%.

Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies that quantify population-based background rates of adverse pregnancy outcomes will improve safety assessment of interventions during pregnancy.

Interplay of Public Intervention and Private Choices in Determining the Outcome of Vaccination Programmes

PLoS One
[Accessed 6 October 2012]

The Interplay of Public Intervention and Private Choices in Determining the Outcome of Vaccination Programmes
Alberto d’Onofrio, Piero Manfredi, Piero Poletti
PLoS ONE: Research Article, published 01 Oct 2012 10.1371/journal.pone.0045653

After a long period of stagnation, traditionally explained by the voluntary nature of the programme, a considerable increase in routine measles vaccine uptake has been recently observed in Italy after a set of public interventions aiming to promote MMR immunization, whilst retaining its voluntary aspect. To account for this take-off in coverage we propose a simple SIR transmission model with vaccination choice, where, unlike similar works, vaccinating behaviour spreads not only through the diffusion of “private” information spontaneously circulating among parents of children to be vaccinated, which we call imitation, but also through public information communicated by the public health authorities. We show that public intervention has a stabilising role which is able to reduce the strength of imitation-induced oscillations, to allow disease elimination, and to even make the disease-free equilibrium where everyone is vaccinated globally attractive. The available Italian data are used to evaluate the main behavioural parameters, showing that the proposed model seems to provide a much more plausible behavioural explanation of the observed take-off of uptake of vaccine against measles than models based on pure imitation alone.

Review: Lipidated promiscuous peptides vaccine for tuberculosis-endemic regions

Trends in Molecular Medicine
Volume 18, Issue 10, Pages 575-626 (October 2012)

Lipidated promiscuous peptides vaccine for tuberculosis-endemic regions
Review Article
Pages 607-614
Uthaman Gowthaman, Pradeep K. Rai, Nargis Khan, David C. Jackson, Javed N. Agrewala

Despite nine decades of Bacillus Calmette–Guérin (BCG) vaccination, tuberculosis continues to be a major global health challenge. Clinical trials worldwide have proved the inadequacy of the BCG vaccine in preventing the manifestation of pulmonary tuberculosis in adults. Ironically, the efficacy of BCG is poorest in tuberculosis endemic areas. Factors such as nontuberculous or environmental mycobacteria and helminth infestation have been suggested to limit the efficacy of BCG. Hence, in high TB-burden countries, radically novel strategies of vaccination are urgently required. Here we showcase the properties of lipidated promiscuous peptide vaccines that target and activate cells of the innate and adaptive immune systems by employing a Toll-like receptor-2 agonist, S-[2,3-bis(palmitoyloxy)propyl]cysteine (Pam2Cys). Such a strategy elicits robust protection and enduring memory responses by type 1 T helper cells (Th1). Consequently, lipidated peptides may yield a better vaccine than BCG.

Malaria in the Post-Genome Era

5 October 2012 vol 338, issue 6103, pages 1-160

Perspective –
Malaria in the Post-Genome Era
Brian Greenwood1,
Seth Owusu-Agyei2

Ten years ago, the genome sequence of the mosquito Anopheles gambiae, the most important vector of malaria in Africa, and the genome sequence of Plasmodium falciparum, the most dangerous human malaria parasite, were published (1, 2). It was anticipated that these remarkable pieces of research heralded a bright future for malaria control. Has this happened? The genome projects have made some contribution to the development of new malaria tools, such as new vaccine candidates, but a decade is probably too short a period for the research to be translated into success in the field. Knowledge gained from the genome projects may contribute more substantially in the coming decade as efforts to control infection increasingly focus on development of new drugs, insecticides, and vaccines.

A tale of two vaccines: Lessons from polio that could inform the development of an HIV vaccine

From Google Scholar: Dissertations, Theses, Selected Journal Articles

A tale of two vaccines: Lessons from polio that could inform the development of an HIV vaccine
J Esparza – AIDS, 2012

Abstract Two vaccine trials that were conducted 50 years apart are reviewed and compared: The 1954 field trial of the Salk inactivated polio vaccine and the RV144 HIV vaccine trial conducted in Thailand between 2003 and 2009. Despite the obvious differences in…

Human Papillomavirus (HPV) Vaccines as an Option for Preventing Cervical Malignancies:(How) Effective and Safe?

From Google Scholar: Dissertations, Theses, Selected Journal Articles

Human Papillomavirus (HPV) Vaccines as an Option for Preventing Cervical Malignancies:(How) Effective and Safe?
L Tomljenovic, CA Shaw, JP Spinosa – Current pharmaceutical design, 2012

… We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We find that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate…

Parents’ Source of Vaccine Information and Impact on Vaccine Attitudes, Beliefs, and Nonmedical Exemptions

From Google Scholar: Dissertations, Theses, Selected Journal Articles

[PDF] Parents’ Source of Vaccine Information and Impact on Vaccine Attitudes, Beliefs, and Nonmedical Exemptions
AM Jones, SB Omer, RA Bednarczyk, NA Halsey… – Advances in Preventive …, 2012
In recent years, use of the Internet to obtain vaccine information has increased. Historical
data are necessary to evaluate current vaccine information seeking trends in context.
Between 2002 and 2003, surveys were mailed to 1,630 parents of fully vaccinated…

Interview – GAVI Alliance CEO: Leadership Is About Vision and Responsibility, Not Power

Accessed 6 October 2012

10/04/2012 @ 1:21PM |
RahimKanani, Contributor

GAVI Alliance CEO: Leadership Is About Vision and Responsibility, Not Power

Recently, I interviewed Seth Berkley, CEO of the GAVI Alliance, a public-private global health partnership committed to saving children’s lives and protecting people’s health by increasing access to immunization in poor countries. We discussed the evolution and impact of the organization, their unique approach to development, their secret to successful collaborations, and much more….