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_26 May 2012

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

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[Editor’s Note: The 65th World Health Assembly concluded in Geneva earlier today. Full documentation from the WHA continues to be posted here http://www.who.int/mediacentre/events/2012/wha65/en/index.html We highlight just a few items of interest in this issue sourced from the WHA Journal and Daily Notes, and will provide a fuller summary in our next issue]

Sixty-fifth World Health Assembly: daily notes on proceedings
– Notes: Saturday, 26 May 2012

Financing research and development

The Health Assembly unanimously adopted the resolution on the Consultative Expert Working Group on Research and Development: Financing and Coordination in the form presented as draft by the drafting group and circulated yesterday.

Implementation of International Health Regulations (2005)
The annual report on the implementation of the International Health Regulations (2005) was presented in Committee A. Tools are available for State Parties to monitor their national core capacities and to identify areas that require further action. Information collected for 2011 shows State Parties are making fair progress for a number of core capacities, notably surveillance, response, laboratory and zoonotic events. Most regions reported relatively low capacities in human resources and for preparedness to chemical and radiological events.

Many State Parties have requested or will request a two-year extension to the mid-2012 deadline for establishing core capacities under IHR. Delegates made references to the difficulties in implementing measures related to points of entry as well as the need for engaging stakeholders outside the health sector and enhancing regional and trans-regional networks. The draft resolution was approved with a recommendation for developing further progress reports.

Pandemic influenza preparedness
Member States acknowledged that the pandemic influenza preparedness (PIP) framework is a crucial development for global health security, based on the lessons from the 2009 influenza pandemic. Committee A reviewed some of the procedures and processes behind that framework and its future direction. Many delegates highlighted the need for WHO to be flexible. Delegates recognized that industry and other partners play important roles in the development of mass vaccines to counter outbreaks.

Delegates agreed on a 70% and 30% share of resources between preparedness and response respectively, but that this would be regularly reviewed. They welcomed the role of the advisory group which was described as strong and robust, but stressed the need for extra resources – both human and financial – to support WHO capacity and leadership so that the PIP framework can be fully implemented.

Global mass gatherings
Committee A considered and approved the report by the Secretariat on “Global mass gatherings: implications and opportunities for global health security”. The discussions were spearheaded by delegates from countries which hosted mass gatherings in the recent past or host such events on a regular basis. Delegates expressed the need to exchange experiences to ensure lessons learned on adequate preparedness and management. Member States representatives also stressed the need for efficient preventive measures and interventions such as surveillance through mobile teams and laboratories to identify and respond rapidly to outbreaks. They identified mass gatherings as opportunities to reinforce multi-sectoral collaboration and strengthen their health systems.

Progress reports
Committee A welcomed and approved the following progress reports:

– Health system strengthening;

– WHO’s role and responsibilities in health research;

– Global strategy and plan of action on public health, innovation and intellectual property;

– Smallpox eradication: destruction of variola virus stocks;

– Eradication of dracunculiasis;

– Chagas disease: control and elimination;

– Viral hepatitis;

– Prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis;

– Cholera: mechanisms for control and prevention;

– Control of human African trypanosomiasis;

– Global health sector strategy on HIV/AIDS, 2011–2015;

– Prevention and control of sexually transmitted infections: global strategy…

http://www.who.int/mediacentre/events/2012/wha65/journal/en/index.html

Sixty-fifth World Health Assembly: daily notes on proceedings
– Notes: Friday, 25 May 2012

Intensification of the global polio eradication initiative
Committee A today approved a draft resolution (EB130.R10) which declares the completion of poliomyelitis eradication a programmatic emergency for global public health. India was once again congratulated for stopping indigenous wild poliovirus circulation. However, three countries still face endemic transmission of wild polio virus; unless poliovirus transmission is stopped in these countries, there will be a global resurgence of the disease with a real risk of severe outbreaks in areas that have long been polio-free. The approved resolution requires the full implementation of current and new eradication strategies, the institution of strong national oversight and accountability mechanisms for all areas infected with poliovirus, and the application of appropriate vaccination recommendations for all travellers to and from areas infected with poliovirus.

Member States with poliovirus transmission are urged to declare such transmission to be a “national public health emergency”, requiring the development and full implementation of emergency action plans. Pakistan, Nigeria and Afghanistan have already established national emergency plans for polio eradication and shifted their national polio eradication initiatives to an emergency status, with an all-of-government and society approach to ensure all children are reached and vaccinated. During the discussion, partners reiterated their support to the polio eradication initiative and the importance of treating polio eradication as a programmatic emergency, and urged all partners to be fully committed in their action and their financing.

http://www.who.int/mediacentre/events/2012/wha65/journal/en/index1.html

 
SIXTY-FIFTH WORLD HEALTH ASSEMBLY (Draft) A65/55
26 May 2012
Third report of Committee A
(Draft)
Committee A held its eighth, ninth and tenth meetings on 25 May 2012. These meetings were held under the chairmanship of Mr Herbert Barnard (Netherlands) and Dr Zangley Dukpa (Bhutan).

It was decided to recommend to the Sixty-fifth World Health Agenda item 13.10
Poliomyelitis: intensification of the global eradication initiative
The Sixty-fifth World Health Assembly,
– Having considered the report on poliomyelitis: intensification of the global eradication initiative;

– Recalling resolution WHA61.1 on poliomyelitis: mechanism for management of potential risks to eradication, which, inter alia, requested the Director-General to develop a new strategy to reinvigorate the fight to eradicate poliovirus and to develop appropriate strategies for managing the long-term risks of reintroduction of poliovirus and re-emergence of poliomyelitis, including the eventual cessation of use of oral poliovirus vaccine in routine immunization programmes;

– Recognizing the need to make rapidly available the necessary financial resources to eradicate the remaining circulating polioviruses and to minimize the risks of reintroduction of poliovirus and reemergence of poliomyelitis after interruption of wild poliovirus transmission;

– Noting the finding by the Independent Monitoring Board of the Global Polio Eradication Initiative finding in its report of October 2011 that “polio simply will not be eradicated unless it receives a higher priority – in many of the polio-affected countries, and across the world”1 and its recommendation in its April 2011 report that the World Health Assembly “considers a resolution to declare the persistence of polio a global health emergency”;

– Noting the report of the meeting in November 2011 of the Strategic Advisory Group of Experts on immunization at which it stated “unequivocally that the risk of failure to finish global polio eradication constitutes a programmatic emergency of global proportions for public health and is not acceptable under any circumstances”;

– Recognizing the need for Member States to engage all levels of political and civil society so as to ensure that all children are vaccinated in order to eradicate poliomyelitis;

– Having noted the current high cost and limited supplies of inactivated polio vaccine that are hampering the introduction and scaling-up of inactivated polio vaccine, resulting in major programmatic and financial implications to developing countries;

– Noting that the technical feasibility of poliovirus eradication has been proved through the full application of new strategic approaches;

– Noting that continuing poliovirus transmission anywhere will continue to pose a risk to

poliomyelitis-free areas until such time as all poliovirus transmission is interrupted globally;

1. DECLARES the completion of poliovirus eradication a programmatic emergency for global public health, requiring the full implementation of current and new eradication strategies, the institution of strong national oversight and accountability mechanisms for all areas infected with poliovirus, and the application of appropriate vaccination recommendations for all travellers to and from areas infected with poliovirus;1

2. URGES Member States with poliovirus transmission to declare such transmission to be a “national public health emergency” making poliovirus eradication a national priority programme, requiring the development and full implementation of emergency action plans, to be updated every six months, until such time as poliovirus transmission has been interrupted;

3. URGES all Member States:
(1) to eliminate the unimmunized areas and to maintain very high population immunity against polioviruses through routine immunization programmes and, where necessary, supplementary immunization activities;

(2) to maintain vigilance for poliovirus importations, and the emergence of circulating vaccine-derived polioviruses, by achieving and sustaining certification-standard surveillance and regular risk assessment for polioviruses;

(3) to make available urgently the financial resources required for the full and continued implementation, to the end of 2013, of the necessary strategic approaches to interrupt wild poliovirus transmission globally, and to initiate planning for the financing to the end of 2018 of the polio endgame strategy;

(4) to engage in multilateral and bilateral cooperation, including exchanging epidemiologic information, laboratory monitoring data, and carrying out supplementary immunization activities simultaneously as appropriate;

4. REQUESTS the Director-General:
(1) to plan for the renewed implementation through 2013 of the approaches for eradicating wild polioviruses outlined in the Global Polio Eradication Initiative Strategic Plan 2010–2012 and any new tactics that are deemed necessary to complete eradication, including the enhancement of the existing global polio eradication initiative within the Organization;

(2) to strengthen accountability and monitoring mechanisms to ensure optimal

implementation of eradication strategies at all levels;

(3) to undertake the development, scientific vetting, and rapid finalization of a

comprehensive polio eradication and endgame strategy and inform Member States of the potential timing of a switch from trivalent to bivalent oral poliovirus vaccine for all routine immunization programmes; and includes budget scenarios to the end of 2018 that include risk management;

(4) to coordinate with all relevant partners including vaccine manufacturers, to promote the research, production and supply of vaccines, in particular inactivated polio vaccines, to enhance their affordability, effectiveness and accessibility;

(5) to continue mobilizing and deploying the necessary financial and human resources for the strategic approaches required through 2013 for wild poliovirus eradication, and for the eventual implementation of a polio endgame strategy to the end of 2018;

(6) to report to the Sixty-sixth World Health Assembly and the subsequent two Health Assemblies, through the Executive Board, on progress in implementing this resolution.

1 International travel and health. Geneva, World Health Organization, 2012 edition.

  The Global Polio Eradication Initiative (GPEI) announced the Emergency Action Plan (EAP) developed in coordination with new country national emergency plans.  The plan builds on India’s successes and outlines a range of new strategies and initiatives to better support eradication efforts, including:

– Intensified focus on worst-performing areas of Nigeria, Pakistan and Afghanistan to increase vaccination coverage by end of 2012 to levels needed to stop transmission;

– New approaches tailored to each country to tackle persistent challenges and improve polio vaccination campaign performance;

– Heightened accountability, coordination and oversight to ensure success at every level of government and within every partner agency and organization.

– Surge of technical assistance and social mobilization capacity.

GPEI noted that the EAP is currently hindered by a critical funding gap of nearly US$1 billion through 2013, with funding shortages already forcing the GPEI to cancel or scale-back critical vaccination activities in 24 high-risk countries.

Global Emergency Action Plan (EAP) 2012-2013

http://www.prnewswire.com/news-releases/polio-eradication-shifts-into-emergency-mode-153533405.html

65^th World Health Assembly
Journal, Number 6
26 May 2012
pdf, 171kb

Fourth meeting of Committee B
Chairman: Dr Mohammad Hossein Nicknam (Islamic Republic of Iran)
Later: Dr Enrique Tayag (Philippines),Vice-Chairman

Item 13 (continued) Technical and health matters (Subitems transferred from Committee A)
Item 13.12 (continued) – Draft global vaccine action plan
The Chairman reopened the subitem. The Secretariat read the amendments to draft resolution entitled World Immunization Week. The Committee approved the resolution
contained in document EB130.R12 as amended. The Secretariat read the amendments to draft resolution entitled Global vaccine action plan. The Committee approved the resolution contained in document A65/22 as amended.

– World Health Assembly Endorses New Plan to Increase Global Access to Vaccines (Decade of Vaccines Collaboration)

– The Measles & Rubella Initiative Welcomes World Health Assembly Commitment to Measles and Rubella Elimination Goal
http://www.unicef.org/media/media_62517.html

– Statement of Support for New Global Vaccine Action Plan [Sabin Vaccine Institute]

– Statement by Bill Gates on the Occasion of the World Health Assembly Resolutions Declaring Completion of Polio Eradication a Global Emergency and Endorsing the Global Vaccine Action Plan

WHO – Meningococcal disease: situation in the African Meningitis Belt

24 May 2012

From 1 January to 17 April 2012 (epidemiologic week 17), outbreaks of meningococcal disease have been reported in 42 districts in 10 of the 14 countries of the African Meningitis Belt 1. These outbreaks have been detected as part of the enhanced surveillance.

The 10 countries (Benin, Burkina Faso, Chad, Central African Republic, Côte d’Ivoire, Gambia, Ghana, Mali, Nigeria and Sudan) reported a total of 11 647 meningitis cases including 960 deaths resulting in a case fatality ratio of 8.2%. The outbreaks were mainly caused by the W135 serogroup of Neisseria meningitidis (Nm) bacteria.

In response to the outbreaks, the Ministries of Health implemented a series of preventive and control measures which included enhancement of surveillance, case management, sensitization of the population, strengthening of cross border collaboration and provision of vaccines through the International Coordinating Group on Vaccine Provision for Epidemic Meningitis Control (ICG).

The ICG released a total of 11,000 vials of antibiotic (Ceftriaxone) and 1,665,673 doses of vaccines to six countries (see table below 2) most affected by the epidemic, upon requests. The vaccines released include 919,023 doses of polysaccharide ACW/ACYW vaccine, 746,650 doses of meningitis A conjugate vaccine and 81,418 doses of polysaccharide AC vaccine.

The ICG is working with manufacturers and partners to ensure the stockpiles of the appropriate vaccines are maintained in sufficient quantities, for responding effectively to epidemics in the future. ICG partners include WHO, International Federation of Red Cross and Red Crescent Societies (IFRC), United Nations Children Fund (UNICEF), and Médecins Sans Frontières (MSF).

The emergency stockpile was established with the support of Global Alliance for Vaccines and Immunization (GAVI). The vaccination campaigns were conducted with the support of MSF, UNICEF, IFRC, the European Community Humanitarian Aid Office (ECHO), and the United Nations through its Central Emergency Response Fund (CERF).

WHO continues to monitor the epidemiological situation closely, in collaboration with partners and Ministries of Health in the affected countries.

1 The 14 countries in the African Meningitis Belt with enhanced surveillance for meningococcal disease include Benin, Burkina Faso, Cameroon, the Central African Republic, Chad, Côte d’Ivoire, the Democratic Republic of the Congo, Ethiopia, Ghana, Mali, Niger, Nigeria, Sudan and Togo.

http://www.who.int/csr/don/2012_05_24/en/index.html

Merck (MSD outside the United States and Canada) said it welcomed the launch in Rwanda of Africa’s first national rotavirus vaccination program with ROTATEQ (rotavirus vaccine, live, oral, pentavalent). Merck noted that the first infants will receive ROTATEQ at a health center in Musanze District, Northern Province, Rwanda. Following the initial launch, ROTATEQ will be routinely administered to all infants in Rwanda as part of its national vaccination program. During 2012, the Government of Rwanda Ministry of Health expects more than 100,000 children will receive the vaccine. Mark Feinberg, M.D., Ph.D., chief public health and science officer, Merck Vaccines, said, “We congratulate the Government of Rwanda for the launch of this important public health initiative and applaud its efforts to help protect Rwanda’s children against rotavirus-associated diarrhea through a comprehensive initiative including vaccination and other public health efforts. Rwanda is committed to the vaccination of their children and their accomplishments to date have been impressive. Given the impact of rotavirus gastroenteritis in children, working to help reduce severe rotavirus disease represents a critically important public health goal and we’re pleased to be able to work with the GAVI Alliance to make ROTATEQ available to Rwanda and other GAVI-eligible countries worldwide.”

http://www.businesswire.com/news/home/20120525005315/en/Government-Rwanda-Introduces-Mercks-ROTATEQ%C2%AE-Rotavirus-Vaccine

The Weekly Epidemiological Record (WER) for 25 May 2012, vol. 87, 21 (pp 201–216) includes: Meeting of the Strategic Advisory Group of Experts on immunization, April 2012 – conclusions and recommendations

http://www.who.int/entity/wer/2012/wer8721.pdf

Opportunity for Public Comment: Study Designs for the Safety Evaluation of Different Childhood Immunization Schedules

The Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule has commissioned a paper from a consultant, Martin Kulldorff, Ph.D. We will be inviting comments and reactions to the paper to inform the committee discussion. The comment period will be open from May 14th until May 31st, 2012, and can be accessed on http://www.iom.edu/HealthOutcomesCommissionedPaper

Please note that any comments that you submit to the committee, including your name and identifying information, will not be kept confidential and will be included in a Public Access File in compliance with Section 15 of the Federal Advisory Committee Act (FACA). The National Academies shall be authorized to use any such comments or submissions in accordance with the National Academies’ Terms of Use Statement.

The responsibility for the content of the paper rests with the author and does not necessarily represent the views of the Institute of Medicine or its committees and convening bodies.

For more information, please visit the Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule’s webpage: http://www.iom.edu/Activities/PublicHealth/ChildhoodImmunization.aspx

British Medical Journal
26 May 2012 (Vol 344, Issue 7858)
http://www.bmj.com/content/344/7858

Editorial
Influenza vaccination in healthcare professionals
BMJ 2012; 344 doi: 10.1136/bmj.e2217 (Published 28 March 2012)
Cite this as: BMJ 2012;344:e2217
Harish Nair, Alison Holmes, Igor Rudan, Josip Car

Extract
Should be mandatory

There is clear evidence that healthcare workers play an important role in transmitting infections to their patients.1 The World Health Organization and national immunisation guidelines in 60% of developed and emerging economies strongly recommend annual vaccination against seasonal influenza for all healthcare workers in acute and long term care facilities.2 However, unlike other prophylactic measures targeted at healthcare workers, such as hepatitis B vaccination, the uptake of flu vaccine has been generally poor. In the United States, two decades of consistent advocacy by the Centers for Disease Control and Prevention achieved a self reported vaccine coverage of only 64% among healthcare workers by 2010-1.3 In the United Kingdom, despite recommendations by the Department of Health, uptake of seasonal flu vaccine was a dismal 35% among frontline healthcare workers in the same year.4

Flu contributes greatly to global mortality and morbidity and has important economic consequences. Each year, seasonal flu affects 5-10% of the world’s population, causing 3-5 million severe infections and resulting in 250 000-500 000 deaths. Young children (especially those under 1 year); pregnant …

JAMA   
May 23, 2012, Vol 307, No. 20
http://jama.ama-assn.org/current.dtl

Viewpoint
Assessing Value in Health Care Programs
Kevin G. Volpp, MD, PhD; George Loewenstein, PhD; David A. Asch, MD, MBA
JAMA. 2012;307(20):2153-2154. doi:10.1001/jama.2012.3619

Many health care services provided in the United States are of low value, meaning that the cost of providing those services is high relative to the health care benefit they confer. In some cases, the care provided may have no value or even, on average, may be harmful. Examples of low- or negative-value services include unnecessary surgery or diagnostic imaging that will not change management. Given estimates that 30% of the $2.5 trillion the United States spends on health care services each year may provide little benefit,1 there is a widespread eagerness to enhance the ratio of benefits to costs.

Because value matters in health care, when new health care programs are proposed it has become common to ask, “What is the return on investment from implementing this new program?” Implicit in this question is that programs should be supported if they save money but not otherwise. Positive return on investment, meaning that more money is saved than is spent, has become the standard by which new initiatives are evaluated.      This standard has been used to evaluate new programs such as the primary care medical home, disease management, and the projects submitted for the new Center for Medicare & Medicaid Services Innovation Challenge.

Although asking about return on investment might seem to make sense given concerns about health care cost and value, asking about return on investment is the wrong question when assessing whether a health care program is successful. What would happen if the rule were applied to every health care decision that is made? Besides childhood vaccination and flu shots for the elderly, few health care services save money.2 The positive return-on-investment criterion is not applied to most health care services because almost nothing satisfies it. Medicare is prohibited by law from considering cost in coverage decisions, and other insurers tend to follow suit, even if the benefits are small and the costs very large. Would anyone ever ask, “What is the return on investment in treatment of this patient’s cancer?” This is not a meaningless question, but almost certainly one that most people would think inappropriate to ask.

Cost is important and should be considered in many more settings for both existing and new services. Clinicians and policy makers should not apply one standard when tacitly continuing the status quo and a different standard when evaluating innovative programs that might be implemented. It certainly does not make sense to use one criterion—Are there clinical benefits?—for coverage decisions for treatments and a different criterion—Are health care savings greater than program costs?—for preventive services or for delivery system innovations designed to improve health. Programs designed to improve health and prevent disease should be evaluated based on whether they improve health at a reasonable price, essentially comparing whether improvements in health are achieved for less resources than through alternatives, eg, expenditures on health care services.

Health care reimbursement tends to be disease fixated and should be evaluated the same way based on the value of expenditures in achieving improvements in health.3 If an employer spends $100 000 treating late-stage emphysema or lung cancer for its employees—an expenditure with a negative return on investment but one that adds value to employees’ lives—should that employer be willing to spend money on smoking cessation programs? The answer is almost undoubtedly yes. However, if health promotion programs or health system delivery innovations are required to save money, they will likely be labeled failures even if they improve health at a lower price than many of the services that we now willingly pay for under Medicare and private insurance. If we continue with the approach of insisting on a positive return on investment to fund such programs, low-value spending will persist at higher rates than would otherwise be the case.

For example, consider a program that would improve medication adherence after acute myocardial infarction (AMI). Adherence rates to β-blockers, statins, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers after an AMI event is poor; a recent large-scale study showed that even when copayments were lowered to $0 among insured patients, average adherence for these medications was only about 45%.4 If a new program could increase adherence to 70%, it is plausible that the program could significantly reduce the rate of hospital admissions for MI, stroke, and revascularization procedures. If the average cost of health events requiring hospitalization in the 12 months following a hospital admission for a new MI is about $20 000 and the new program reduced the rate of events requiring hospitalization by 10%, the new program could cost up to $2000 per year and still save money. Does that mean the program should not be adopted if it costs $3000? At that point, the calculated return on investment for the program is negative because it costs more than it saves.    But wouldn’t this program still be a much better use of money than letting those MIs occur (mortality rates from AMI are typically more than 10% among hospitalized patients in the 30 days after admission, and many patients die before making it to a hospital)? If this is deemed not a good use of resources, then why are so many other services covered that yield lower value?5 Many insurers, including Medicare, are continuing to cover bevacizumab for metastatic breast cancer, despite the unanimous recommendation by a US Food and Drug Administration panel that it not be covered because it is not helping patients to live longer, does not control their tumors, and exposes them to serious adverse effects6 and despite an average annual cost of $99 000.7

There are political, ethical, and emotional challenges to making explicit resource allocation issues in treating diseases and applying the same metrics used to evaluate the effectiveness of programs that prevent diseases in largely unidentified patients. It is always more difficult to shut down existing programs than to say no to new ones, a phenomenon related to inertia, also known as status quo bias.8 It is also more difficult to justify investments in prevention across broad populations than investments in the treatment of identifiable patients, a phenomenon known as the rule of rescue.9 Changing the criteria used to evaluate health system delivery innovations might help overcome these tendencies. Evaluating success using the same criteria—whether a preventive service, delivery system innovation, or treatment—may be the best way to ensure the maximal value in terms of improvements in health for the resources expended on health care services.

A recent conversation with a benefits manager from a medium-sized employer brought this point home. She reported that when asked by the chief financial officer, “What is the return on investment in putting in place this $125 000 wellness program?” she responded, “What is the return on investment on the $28 million we are spending on treating disease through our health benefits?” If cost is not considered when thinking about the value of covered treatments, it does not make sense to use positive return on investment as a criterion for determining whether promising new delivery system innovations should be covered. A better approach would be to adopt similar metrics for treatment and prevention for current and proposed care, for which the goal in all cases is achieving the most improvement possible with the resources available.

Journal of Infectious Diseases
Volume 206 Issue 1 July 1, 2012
http://www.journals.uchicago.edu/toc/jid/current

EDITORIAL COMMENTARIES
Michelle Clarke and H. Marshall
Editor’s choice: Rotavirus Vaccination for Prevention of Serious Acute Gastroenteritis and the Importance of Postlicensure Safety Monitoring
J Infect Dis. (2012) 206(1): 3-5 doi:10.1093/infdis/jis318
(See the major article by Yen et al, on pages 41–8.)

Extract
With the ability to save millions of lives each year in both the developed and developing nations, vaccination against childhood infectious diseases is a priority area for global health. An essential aspect of the success of any vaccination program is the careful monitoring following implementation to ensure that the benefits of the program outweigh any risks to the recipients or the community. Infant rotavirus vaccination programs are an important example of the collaborative expertise required for effective and timely monitoring and reporting of any adverse events following implementation. Rotavirus vaccines have been instrumental in reducing morbidity from rotavirus infection. Prior to the introduction of rotavirus vaccine, it is estimated that >500 000 rotavirus-related child deaths occurred globally each year [1]. Studies assessing the impact of rotavirus vaccine on incidence of rotavirus hospitalizations have occurred in numerous countries, including Australia and the United States, with dramatic reductions in the incidence of rotavirus hospitalizations (up to 80% reduction) shown following implementation of the rotavirus vaccination programs and suggestions of herd immunity benefits for older, unvaccinated populations [2–6]. The development of vaccines to prevent serious infectious diseases has been a global triumph, but large-scale postlicensure studies are essential to ensure that vaccination programs deliver the anticipated benefits.

In response to the overwhelming global burden of rotavirus infections, particularly in children aged <5 years, a live, attenuated tetravalent rotavirus vaccine (RotaShield) was licensed for routine use in infants in 1998, before being withdrawn in 1999 due to concerns about an increased risk of intussusception in vaccine recipients …

Catherine Yen, Jacqueline E. Tate, Claudia A. Steiner, Margaret M. Cortese, Manish M. Patel, and Umesh D. Parashar
Editor’s choice: Trends in Intussusception Hospitalizations Among US Infants Before and After Implementation of the Rotavirus Vaccination Program, 2000–2009
J Infect Dis. (2012) 206(1): 41-48 doi:10.1093/infdis/jis314

Abstract
Background. Although US data have not documented an intussusception risk with current rotavirus vaccines, international data indicate  a possible low risk, primarily after the first dose.

Methods. Among infants in 26 US states comprising 75% of the birth cohort, we examined age-specific trends in population-level intussusception hospitalization rates before (2000–2005) and after (2007–2009) rotavirus vaccine introduction.

Results. Compared with 2000–2005 (35.3 per 100 000), the rate was greater in 2007 (39.0 per 100 000; rate ratio [RR], 1.10; 95% confidence interval [CI], 1.04–1.18), similar in 2008 (33.4 per 100 000; RR, 0.95; 95% CI, .89–1.01), and lower in 2009 (32.9 per 100 000; RR, 0.93; 95% CI, .87–.99). Among infants aged 8–11 weeks, compared with 2000–2005 (6.9 per 100 000), a small, significant increase was observed in each of 2007 (11.4 per 100 000; RR, 1.64; 95% CI, 1.08–2.50), 2008 (12.2 per 100 000; RR, 1.76; 95% CI, 1.17–2.65), and 2009 (11.0 per 100 000; RR, 1.59; 95% CI, 1.04–2.44).

Conclusions. Following rotavirus vaccine introduction, a small increase in intussusception rates was seen among US infants aged 8–11 weeks, to whom most first doses of vaccine are given; no sustained population-level change in overall rates was observed.

The Lancet  
May 26, 2012  Volume 379  Number 9830  p1923 – 2022  e53 – 54
http://www.thelancet.com/journals/lancet/issue/current

Comment
The US Global Health Initiative: where does it stand?
Jennifer Kates, Josh Michaud

Preview
In May, 2009, shortly after taking office, President Barack Obama announced the Global Health Initiative (GHI), which was to be a 6-year (2009–14), US$63 billion effort to refocus US global health activities by developing the first comprehensive US Government global health strategy.1 The GHI was conceived as a “whole of government approach”2 to act as an umbrella over existing US global health programmes—most notably, the President’s Emergency Plan for AIDS Relief. As President Obama said at the time, “We cannot simply confront individual preventable illnesses in isolation.

The Lancet Infectious Disease
Jun 2012  Volume 12  Number 6  p423 – 496
http://www.thelancet.com/journals/laninf/issue/current

Editorial
The rise and fall of bioterrorism research
The Lancet Infectious Diseases

In the months after the September 11, 2001, attacks in New York, USA, the world was on heightened awareness for terrorist attacks of all kind. The anthrax scares in the USA in the final months of that year led to a focus on bioterrorism. A decade ago this threat was viewed as one of the key areas for infectious disease research: the topic dominated the agendas at academic and clinical conferences at the time, and governments devised plans to address the threat of bioterrorism, often involving substantial investments in research. But a decade on, are we any more prepared for bioterrorist attacks, and what have we gained from the huge resources invested in the research?

Bioterrorism is defined by the US Centers for Diseases Control and Prevention as “the deliberate release of viruses, bacteria, toxins or other harmful agents used to cause illness or death in people, animals, or plants”; although this clearly leads to a murky distinction from biological warfare, and research into both goes hand in hand. Attempts in the early 20th century to weaponise biological agents quickly led to the realisation of the potency of such tactics as terrorist devices. And an arms race developed with governments simultaneously aiming to produce weapons with these agents and the countermeasures to use when faced with their deployment.

Despite a long history of research, the use of biological weapons in warfare and terrorism has been uncommon: the major downsides to their use are their lack of specificity and an inability to contain an infection within a target population. An infectious agent used against one group will almost inevitably infect unintended victims, even those who originally deployed the weapon.

However, in the late 20th century the face of terrorism changed, from one of targeted attacks to the use of indiscriminate tactics, in which the collateral damage of deaths on the aggressor’s side was accepted. In the late 1990s, the threat of bioterrorism was generating serious interest. The topic was a key theme at the 1998 International Conference on Emerging Infectious Diseases, at which experts warned that the growing interest in and proliferation of biological weapons was not being matched by investment in research to counter the effects of such attacks. But the watershed moment was the 9/11 attacks on New York.

The following year, the World Health Assembly agreed that a concerted effort to address bioterrorism was needed. One of their acts was to drop the 2002 deadline for the destruction of smallpox virus stocks. The USA established several initiatives to address potential bioterrorist threats. Among them, the National Institutes of Health launched the National Science Advisory Board for Biosecurity (NSABB) to monitor potential dual-use research and the Department of Defense launched the Transformational Medical Technologies Initiative (TMTI), a US$1·5 billion initiative to sequence the genomes of key microorganisms with bioterrorism potential and to develop one-size-fits-all measures against them.

For all the international concern and efforts to prepare, there has been no major bioterrorist attack. The TMTI has introduced no new antibiotics into clinical trials, the three drugs that have entered clinical trials are for single pathogens rather than providing multifaceted solutions, and now many of its projects have been redistributed to other defence departments. The NSABB has assessed just six papers. Furthermore, bioterrorism has dropped off the programmes of scientific conferences.

Nonetheless, the fear is still present, even if the threat has not materialised. In this month’s Newsdesk, Kathryn Senior discusses two recent bioterrorism scares involving Bacillus anthracis spores, and the case of research in which investigators generated strains of H5N1 transmissible between mammals spawned much debate about dual-use research—as well as providing the NSABB with two of the six papers.

Groups that would willingly instigate a major bioterrorism attack undoubtedly exist. The consequences of widespread dissemination of anthrax spores or a haemorrhagic fever virus such as Ebola, or release of an engineered highly infective and highly pathogenic influenza are almost too dire to contemplate. However, bioterrorism research is perhaps a diversion—resources invested in combating bioterrorist threats would be well invested in research into the real and present damage of these pathogens in nature. Such research need not be viewed as a separate effort, but a much needed integrated effort in biodefence, since undoubtedly it would provide vital information, vaccines, and drugs for the fight against bioterrorism as well as combating natural infections.

The Lancet Infectious Disease
Jun 2012  Volume 12  Number 6  p423 – 496
http://www.thelancet.com/journals/laninf/issue/current

Correspondence
Poliovirus eradication
Carlos Franco-Paredes
Preview |
Your Editorial in the October, 2011, issue covers the theme of polio eradication. Everyone that has a scientific or humanitarian interest in achieving the noble task of eliminating poliomyelitis remains confident that it is an attainable public-health goal in the near future. There is also an agreement that eradication should be a global effort that requires increased financial and political support. However, polio eradication efforts may be at risk of losing political and financial momentum in view of the persistent failures of the Global Polio Eradication Initiative (GPEI) and its inability to consistently reach target dates.

Poliovirus eradication
Masahiko Hachiya, Shinsaku Sakurada, Tomomi Mizuno, Yasuo Sugiura
Preview |
The Editorial,1 in the October, 2011, issue of The Lancet Infectious Diseases discusses innovations for polio eradication. We agree that social factors are one of the most important barriers to a polio eradication initiative. The essential problem is that the Global Polio Eradication Initiative (GPEI) is not consistent with current local priorities. Moreover, the Ministry of Health in Pakistan was devolved, and the relevant federal programme disappeared in June, 2011. Therefore, local governments take more responsibility for immunisation programmes than before.

Nature Immunology
June 2012 – Vol 13 No 6
http://www.nature.com/ni/journal/v13/n6/index.html

Commentary
Immune to addiction: the ethical dimensions of vaccines against substance abuse – pp521 – 524
Michael J Young, Dominic A Sisti, Hila Rimon-Greenspan, Jason L Schwartz & Arthur L Caplan
doi:10.1038/ni.2321

Abstract
Promising advances have been made in recent years for a unique class of immunotherapies that use vaccination to combat substance-use disorders. Although such vaccines are potentially useful for addictions, they raise a variety of ethical and social questions.

New England Journal of Medicine
May 24, 2012  Vol. 366 No. 21
http://content.nejm.org/current.shtml

Perspective
From an Ethics of Rationing to an Ethics of Waste Avoidance
H. Brody
Extract [Free full text]
Bioethics has long approached cost containment under the heading of “allocation of scarce resources.” Having thus named the nail, bioethics has whacked away at it with the theoretical hammer of distributive justice. But in the United States, ethical debate is now shifting from rationing to the avoidance of waste. This little-noticed shift has important policy implications…

Beyond the “R Word”? Medicine’s New Frugality
M.G. Bloche
Extract [Free full text]
Quietly, Washington policymakers have begun to concede the need to weigh health care’s benefits against its costs if our country is to avert fiscal ruin. That costs must be counted against benefits is common sense in other domains — and among health policy professionals. But it’s anathema in public discussion of medical care. To silence talk of tradeoffs, politicians invoke the “R word” — rationing…

PLoS One
[Accessed 26 May 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Individual and Contextual Factors Associated with Low Childhood Immunisation Coverage in Sub-Saharan Africa: A Multilevel Analysis
Charles S. Wiysonge, Olalekan A. Uthman, Peter M. Ndumbe, Gregory D. Hussey 5 Gregory D. Hussey 1 2 1 Vaccines for Africa … -pertussis vaccine by one year of age. An evidence-based … to 145 over the same period. Vaccine-preventable PLoS ONE: Research Article, published 25 May 2012 10.1371/journal.pone.0037905

Abstract 
Background
In 2010, more than six million children in sub-Saharan Africa did not receive the full series of three doses of the diphtheria-tetanus-pertussis vaccine by one year of age. An evidence-based approach to addressing this burden of un-immunised children requires accurate knowledge of the underlying factors. We therefore developed and tested a model of childhood immunisation that includes individual, community and country-level characteristics.

Method and Findings
We conducted multilevel logistic regression analysis of Demographic and Health Survey data for 27,094 children aged 12–23 months, nested within 8,546 communities from 24 countries in sub-Saharan Africa. According to the intra-country and intra-community correlation coefficient implied by the estimated intercept component variance, 21% and 32% of the variance in unimmunised children were attributable to country- and community-level factors respectively. Children born to mothers (OR 1.35, 95%CI 1.18 to 1.53) and fathers (OR 1.13, 95%CI 1.12 to 1.40) with no formal education were more likely to be unimmunised than those born to parents with secondary or higher education. Children from the poorest households were 36% more likely to be unimmunised than counterparts from the richest households. Maternal access to media significantly reduced the odds of children being unimmunised (OR 0.94, 95%CI 0.94 to 0.99). Mothers with health seeking behaviours were less likely to have unimmunised children (OR 0.56, 95%CI 0.54 to 0.58). However, children from urban areas (OR 1.12, 95% CI 1.01 to 1.23), communities with high illiteracy rates (OR 1.13, 95% CI 1.05 to 1.23), and countries with high fertility rates (OR 4.43, 95% CI 1.04 to 18.92) were more likely to be unimmunised.

Conclusion
We found that individual and contextual factors were associated with childhood immunisation, suggesting that public health programmes designed to improve coverage of childhood immunisation should address people, and the communities and societies in which they live.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 27 pp. 3983-4122 (8 June 2012)

Review
Nosocomial transmission of measles: An updated review
Review Article
Pages 3996-4001
E. Botelho-Nevers, P. Gautret, R. Biellik, P. Brouqui

Abstract
Despite a decrease in global incidence, measles outbreaks continue to occur in developed countries as a result of suboptimal vaccine coverage. Currently, an important mode of measles transmission appears to be nosocomial, especially in countries where measles is largely under control. We therefore conducted a review of the literature by searching PubMed for the term “measles” plus either “nosocomial” or “hospital acquired” between 1997 (the date of the last review in the field) and 2011. The reports indicate that measles is being transmitted from patients to health care workers (HCWs) and from HCWs to patients and colleagues. Here, we explain how outbreaks of measles occurring in healthcare settings differ in some ways from cases of community transmission. We also highlight the need for all HCWs to be immunized against measles.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 27 pp. 3983-4122 (8 June 2012)

Regular Papers
Correlates of 2009 H1N1 influenza vaccination among day care-aged children, Miami-Dade County
Original Research Article
Pages 4002-4006
Yessica Gomez, Fermin Leguen, Guoyan Zhang, Erin O’Conne

Abstract
Background
The aim of this study was to assess factors influencing 2009 H1N1 influenza vaccination among a demographically diverse group of day care-aged children. Day care children were chosen because they were an initial target group for vaccination and are at higher risk of influenza infection than children cared for at home.

Methods
A cross-sectional study was conducted from March to May 2010 among parents of day care aged children in 13 day care facilities in Miami-Dade County. Data was collected by an anonymous self-administered two-page 20 question survey which consisted of demographic variables and information regarding 2009 H1N1 influenza vaccine knowledge, attitude and acceptance. Data was analyzed using SAS to conduct both bivariate and multivariate analyses.

Results
There were 773 participants in the study. The response rate ranged from 42% to 72.2% among day care centers. A total of 172 parents (22.3%) and 225 (29.1%) children had received the 2009 H1N1 influenza vaccine. Non-Hispanic White and Black parents were more likely to vaccinate their children than Hispanic and Haitian parents. Primary reasons for non-vaccination included vaccine safety (36.7%) and side effects (27.1%). Among parents who spoke with a health care professional, 274 (61.4%) stated the health care professional recommended the vaccine.

Conclusion
Misperceptions about influenza vaccination among parents created a barrier to 2009 H1N1 influenza vaccination. Parents who got the vaccine, who believed the vaccine was safe and whose children had a chronic condition were more likely to immunize their children. Clear, reliable and consistent vaccine information to the public and health care providers and initiatives targeting minority groups may increase vaccination coverage among this population.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 27 pp. 3983-4122 (8 June 2012)

Regular Papers
Influenza vaccination uptake amongst pregnant women and maternal care providers is suboptimal
Original Research Article
Pages 4055-4059
Angela B. Lu, Alia Abd Halim, Claire Dendle, Despina Kotsanas, Michelle L. Giles, Euan M. Wallace, Jim P. Buttery, Rhonda L. Stuart

Abstract
Objective
To assess the uptake of influenza vaccination by pregnant women and maternity care providers and explore their attitudes towards influenza vaccination.

Design, setting and participants
Cross-sectional survey administered in a Victorian tertiary level public hospital to 337 pregnant women and 96 maternity care providers.

Results
31.3% of patients planned to or had received influenza vaccination this year, but only a quarter had received education about influenza. Women were more likely to receive influenza vaccination if they had been vaccinated in the last two years (RR 4.5, 95% CI: 3.1–6.4, p < 0.001), received education about influenza (RR 2.3, 95% CI: 1.6–3.2, p < 0.001) or believed that they were at high risk of influenza-related complications while pregnant (RR 2.0, 95% CI: 1.4–2.7, p < 0.001). While only 56.8% of maternity care providers believed pregnant women were at high risk of influenza-related complications, 72.9% would recommend influenza vaccination to all pregnant women. Of the maternity care providers studied, 69% planned to or had been vaccinated in 2011, with this group more likely to recommend vaccination to their patients (RR 2.0, 95% CI: 1.3–3.0, p < 0.001). Significantly more maternity care providers indicated that they would routinely recommend influenza vaccination than the proportion of patients who reported receiving education.

Conclusions
Influenza vaccination rates in pregnant women are low, reflecting inadequate patient education despite most maternity care providers indicating that they would routinely recommend influenza vaccination. Increasing influenza vaccination uptake by women in pregnancy will require better education of both women and maternity care providers.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 27 pp. 3983-4122 (8 June 2012)

Regular Papers
Cost-effectiveness of routine vaccination of adolescent females against cytomegalovirus
Original Research Article
Pages 4060-4066
Amanda F. Dempsey, Heidi M. Pangborn, Lisa A. Prosser

Abstract
Background
Congenital cytomegalovirus (CMV) infection is associated with significant infant morbidity and mortality. A prophylactic vaccine to prevent congenital CMV infection is expected to be available in the near future, and will likely be targeted to adolescent females.

Methods
Using a decision tree, we compared the costs, potential clinical impacts, and cost-effectiveness of the current strategy of no CMV vaccination versus a strategy where all adolescent females are vaccinated against CMV prior to their first pregnancy. Both maternal outcomes related to vaccination, and infant outcomes related to congenital CMV infection, were considered in the model.

Results
Under base-case conditions, our analysis suggested that vaccinating all adolescent females against cytomegalovirus would be both less costly and with greater clinical benefits than not vaccinating. Among a population of 100,000 adolescent females, the vaccination strategy cost $32.3 million dollars less than not vaccinating, and avoided substantial numbers of infants affected with hearing loss, vision loss, and mental retardation, and 8 infant deaths. Our model was most sensitive to variations in vaccine efficacy. When vaccine efficacy against disease was less than 61%, not vaccinating became the preferred strategy because it was less expensive than vaccinating, without substantial changes in clinical benefits to the population.

Conclusions
Under a wide variety of conditions, universal vaccination of adolescent females to protect their future children against congenital CMV infection was cost effective. However, for this to be preferred over not vaccinating, our results suggest that vaccine efficacy against disease would need to be at least 61%.

Value in Health
Vol 15 | No. 4 | June 2012
http://www.valueinhealthjournal.com/current

New Concepts for Health Care Decision Making
Individual Decisions and Social Value: A Conceptual Framework to Explore Alternative Decision Making Approaches and the Value of Heterogeneity in the Era of Individualized Care
Preview
The value of understanding and incorporating heterogeneity in decisions based on cost-effectiveness has been matter of growing interest in healthcare. Recent contributions have been proposed to charac…
M.A. Espinoza, A. Manca, M.J. Sculpher, K. Claxton

Advancing the Methods of Cost-Effectiveness Analysis: Why It’s Time to Move on from ICERs and Thresholds
Preview
Cost-effectiveness analysis of health technologies typically involves the calculation of incremental cost-effectiveness ratios (ICERs). In some jurisdictions, decision makers compare these ICERs to an…
M. Paulden

Minimizing the Costs of Analyzing the Value of Health Research
Preview
Value-of-information (VOI) analysis can establish the expected benefits from health research. This typically involves the modeling of a disease and its treatment to fully characterize the uncertainty …
T. Hoomans, J. Seidenfeld, D. Meltzer A2

Cost-Effectiveness Analysis – Appropriate for All Situations?
Preview
Cost-effectiveness analysis (CEA) is routinely proposed to inform decision making, where a new intervention is evaluated against standard of care and the incremental investment per effect is compared …
B. Standaert, O. Ethgen, R.A. Emerson

A Framework for Stakeholder Engagement in Comparative Effectiveness Research
Preview
Soliciting stakeholder input is becoming commonplace in comparative effectiveness research (CER), yet methods for stakeholder engagement in CER are evolving. Drawing from CMTP and University of Maryla…
D.M. Lavallee, P.J. Desai, C.D. Mullins, P.A.

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_19 May 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…

Editor’s Note: The World Health Assembly meeting next week includes a number of agenda sessions around immunization and vaccines. These include:
– A65/19  Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits: report of the Advisory Group
– A65/20 Poliomyelitis: intensification of global eradication initiative
– A65/22  Draft global vaccine action plan

65^th World Health Assembly
Geneva: 21–26 May 2012

“At this session, the Health Assembly will discuss a number of public health issues such as universal health coverage, Millennium Development Goals, noncommunicable diseases, mental disorders, nutrition and adolescent pregnancy. The nomination of Dr Margaret Chan to be WHO Director-General for a second term will be submitted for approval. The Health Assembly will also discuss the programme budget, administration and management matters of WHO.”
– Provisional agenda
– Complete documentation

http://www.who.int/mediacentre/events/2012/wha65/en/index.html

   PATH said it launched a project “to facilitate global access to new adjuvants and formulation technologies, aiming to accelerate the development and introduction of critical, lifesaving vaccines.” PATH said that funding is being provided by the Bill & Melinda Gates Foundation and involves collaboration with key technology partners including the Vaccine Formulation Laboratory at the University of Lausanne (UNIL) in Switzerland.” The project will focus on providing “industry-quality adjuvants and developing adjuvant-vaccine formulations that enhance immune response, reduce dose requirements, and decrease vaccine costs.” As part of the project, “PATH and partners will focus on evaluating novel adjuvants for potential use in the development of an effective and affordable adjuvanted formulation of inactivated polio vaccine (IPV). In collaboration with UNIL and other Bill & Melinda Gates Foundation–funded research teams, PATH will also work to develop multiple formulations of IPV with other adjuvants. A later phase of the project may involve the development of adjuvanted formulations for vaccines against malaria, rotavirus, AIDS, or tuberculosis. Throughout, PATH will work to foster synergies and strategic partnerships that facilitate the development and advancement of future formulations through efforts that might involve securing access to advanced industry-quality adjuvants and the transfer of technology, data, and expertise among adjuvant developers, product-development partnerships, vaccine producers, and other stakeholders.”

http://www.path.org/news/pr120514-vaccine-access.php

HIV Vaccine Awareness Day – May 18, 2012

Modeling Potential Impact on HIV Vaccine Awareness Day
by Margaret McGlynn, President and CEO, International AIDS Vaccine Initiative (IAVI) May 18, 2012
USAID Impact Blog [full text]

Throughout my career, I have witnessed the tremendous power of vaccines to prevent sickness and save lives – delivering incredible victories for humanity against diseases such as polio, smallpox and measles. These vaccines would not have been possible without the inspiration, persistence and courage of researchers, volunteers and health workers around the world.

Thanks to a USAID-supported program, Gladys Njeri Macharia is studying how rare individuals might be blocking HIV infection Photo credit: IAVI

And so today, on HIV Vaccine Awareness Day, I join countless others around the world in reflecting on what it would mean to see AIDS consigned to a list of former pandemics. To achieve that goal, it is essential that we enlist the participation of researchers around the world in the design and development of HIV vaccines.

Young researchers such as Gladys Njeri Macharia in Kenya – who has dedicated her career to exploring immune responses to HIV – will play an especially important role in that effort. And one day, critical scientific questions addressed by this research might help lead to an effective vaccine.

New modeling data available today from the International AIDS Vaccine Initiative (IAVI) and the Futures Institute, with support from the U.S. Agency for International Development (USAID), illustrates how a safe, preventive HIV vaccine that is accessible and affordable can help us end the AIDS pandemic. This information is available in a series of publications and an interactive web tool.

The potential impact of a vaccine is striking. Because HIV is so extraordinarily resistant to the immune response, it is highly unlikely that any single vaccine will be able to prevent infection by all variants of the virus. Still, our modeling shows that if an AIDS vaccine that is only 50% effective is introduced in 2020 to 30% of the population in low- and middle-income countries, 5.2 million new HIV infections could be averted over the first decade. Higher efficacy and more coverage would have an even greater impact on the pandemic.

The world must continue to scale up and improve the response to HIV by using powerful prevention tools that are currently at our disposal. These include condoms, treatment and voluntary medical male circumcision. Our new models show that a vaccine can build on these existing tools and take us down the last mile to the end of the AIDS pandemic.

A 50% effective vaccine combined with greater use of current HIV-prevention tools could prevent nearly 20 million new HIV infections by 2030 – 20 million people that would not need to face the physical, emotional and social hardships caused by the disease and could avoid lifelong, daily antiretroviral treatment to stave off AIDS-related illness or death.

This HIV Vaccine Awareness Day, IAVI and our partners remember those we have lost to AIDS, gain inspiration from those living with and combating the disease today, and look forward to building on the incredible momentum of recent discoveries and study results to deliver on the tremendous potential of an AIDS vaccine.
http://blog.usaid.gov/2012/05/modeling-potential-impact-on-hiv-vaccine-awareness-day/

Statement: NIH – HIV Vaccine Awareness Day – May 18, 2012
Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health [full text]

There is a growing consensus that we can significantly curtail the HIV/AIDS pandemic by implementing scientifically proven HIV prevention strategies, such as voluntary medically supervised adult male circumcision, prevention of mother-to-child transmission and treatment as prevention. With 2.7 million new HIV infections in 2010 alone, however, it is likely that controlling and ultimately ending the HIV/AIDS pandemic will require an effective vaccine as well. This past year, there have been a number of encouraging findings on this front.

Last month, a detailed analysis of specimens from the first HIV vaccine clinical trial to show a modest protective effect yielded important clues about how the vaccine might have worked. These clues suggest directions for improving upon the original vaccine regimen to confer a broader, more potent and longer-lasting effect. The original vaccine regimen was tested among 16,000 adult volunteers in Thailand in a trial co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

Meanwhile, several other NIAID-sponsored HIV vaccine clinical trials are under way. The largest of these is examining whether a prime-boost vaccine regimen can prevent HIV infection or reduce the amount of virus in the blood of those participants who become infected despite vaccination. These trials are possible because of the generous contributions of time and effort by thousands of study participants, community educators, health care workers and scientists. All those involved deserve our gratitude.

Preclinical animal model studies of HIV infection recently have uncovered valuable leads toward designing a preventive HIV vaccine. Scientists have demonstrated that a vaccine can prevent a virulent monkey version of HIV infection and have shown a correlation between this protection and the presence of specific antibodies to the virus.

In basic HIV vaccine research, scientists are discovering and studying HIV neutralizing antibodies that shield cells in the lab against infection with a wide array of HIV strains collected from infected people worldwide. Researchers are analyzing the structure and evolution of these antibodies and the manner in which they bind to HIV, and are using this information to design new molecules to elicit the antibodies through vaccination. In related experiments, injecting these antibodies directly into monkeys has been shown to prevent infection from a monkey version of HIV. Based on these findings, studies to test this concept in people are being planned.

All of these advances reinforce our confidence that one day we will succeed at creating a safe, highly effective vaccine to prevent HIV infection. To contain and ultimately halt the HIV/AIDS pandemic, even the most effective vaccine must be part of a combination of medical and behavioral HIV prevention tools. That is why NIAID continues to support research into promising HIV prevention strategies, such as vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP) and expanded HIV testing with linkage to care. That is also why the public health community will continue to refine and implement scientifically proven HIV prevention measures, including condom use, harm-reduction strategies for injection drug users, and, notably, treatment as prevention: giving antiretroviral therapy to HIV-infected individuals to dramatically reduce their infectiousness while protecting their health

Vaccines historically have been the single most important tool for controlling epidemics. With an ongoing commitment to HIV vaccine research, we have the potential to radically change the trajectory of the HIV/AIDS pandemic.
http://www.nih.gov/news/health/may2012/niaid-14.htm

Video: Recap of the 26th Board Meeting by the Board Chair

Global Fund Board Chair Simon Bland recaps the 26th Board Meeting in Geneva by saying “[continued from video]…This is a really exciting moment for the Global Fund. We’ve had six months where we’ve been going through an incredible transformation, reorganizing this Fund to deliver, and now we recognize that we do have resources at our disposal, to really accelerate implementation of an ambitious new strategy. This strategy is going to dictate the way we do business. We’re going to have new models of implementation at the country level, and we have enough funds now to really get cracking with the development of those new models.

“We’re going to bring the Board of the Global Fund together again in September—earlier than we’d imagined— to really accelerate the implementation of this strategy. And millions of people’s lives will be positively affected as a result.

“Board members came to this meeting I think really quite excited. Clearly from the Board conversations and the decisions we’ve taken today, they have the confidence in the management, they have the confidence in the reorganization, they have the confidence in the resources, and they’re not letting off the pressure to move as quickly as we possibly can to implement this incredibly exciting new strategy…”

Video and additional information: http://www.theglobalfund.org/en/blog/29092/

President’s Bioethics Commission takes up request by HHS Secretary Kathleen Sebelius for ethical advice on the development of medical countermeasures for children.

Excerpt from media release

On Jan. 10, 2012, Secretary Sebelius asked the Commission for ethical advice on the development of medical countermeasures for children…The issue garnered substantial public interest last fall when another Federal advisory committee recommended pediatric testing of the anthrax vaccine.

The question that sparked this broad charge from Secretary Sebelius to the Commission is how to treat children who have been exposed to anthrax; it was a question that arose during a Homeland Security exercise. The National Biodefense Science Board (NBSB) recommended testing children before an anthrax event, rather than waiting for a crisis. However, the NBSB also recommended that such testing occur only after the ethical considerations are adequately reviewed and addressed.

“We are carefully and transparently reviewing all of the ethical considerations surrounding the development of medical countermeasures for children,” Gutmann said.   “The safety of our children is paramount.  It is vital for us to thoroughly address any and all ethical considerations that impact how we treat our children in a time of crisis.”

As she introduced the issue to the Commission, Gutmann clearly outlined the task before the panel, “At issue is the lack of development of appropriate pediatric medical countermeasures that would be needed in a crisis   This is not a review of the merits of vaccine research in general.”

Sebelius today told the Commission she trusted the panel to do the job. “The Commission has delivered rational, independent, evidence-based advice on a wide range of complex bioethical issues. And I know I can look forward to receiving the same, when it comes to countermeasures for children.” Secretary Sebelius said as she addressed the Commission…

http://bioethics.gov/cms/node/688

     The SIVAC (Supporting Independent Immunization and Vaccine Advisory Committees) Initiative said it recently supported the establishment of National Immunization Technical Advisory Groups (NITAGs) in Kazakhstan and Kyrgyzstan. SIVAC, established in 2009, is managed by the Agence de Médecine Préventive (AMP) in partnership with the International Vaccine Institute (IVI). The Initiative “aims to support the creation or strengthening of sustainable NITAGs in low- and middle-income countries. The purpose is to enhance the use of evidence-based decision-making processes in the development of national immunization programs and policies.” SIVAC said Kazakhstan is the first middle-income country to create a NITAG with SIVAC support, and that it helped a national team to develop a concept paper detailing NITAG terms of reference based on WHO guidelines. The opening ceremony of the NITAG was held in Almaty on 23 April 23 2012, in the presence of the 13 committee members and chair, Dr. Bekshin (chief sanitary doctor), and Dr. Christian Loucq, director general of IVI. In Kyrgyzstan, with SIVAC support, the honorable Minister of Public Health, Dr. Dinara Saginbayeva, issued a decree establishing a NITAG to ensure that national immunization policies are developed using evidence-based processes. The committee is chaired by Dr. Babadzhanov, pediatrician at the National Center for Maternal and Child Care, and includes 13 additional members. The inauguration ceremony was held in Bishkek on 6 April 2012. IVI Director General Dr. Christian Loucq said, “Such committees represent a great step forward for these countries. Experts in different fields of vaccinology will gather and provide recommendations based on evidence and the local context. These committees will then be very helpful in guiding the Minister of Health to make informed decisions related to immunization programs, especially in the context of the possible introduction of new vaccines.” http://www.prnewswire.com/news-releases/the-sivac-initiative-supports-kazakhstan-and-kyrgyzstan-to-set-up-national-immunization-technical-advisory-groups-nitags-151665625.html

The Weekly Epidemiological Record (WER) for 18 May 2012, vol. 87, 20 (pp 189–200) includes: Eradication of yaws – the Morges Strategy; Progress towards global interruption of wild poliovirus transmission, January 2011– March 2012

http://www.who.int/entity/wer/2012/wer8720.pdf

Twitter Watch [accessed 19 May 2012 – 16:43]
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.

Hashtags of Interest:
#WHA65 – for tweets on the World Health Assembly meeting in the week ahead in Geneva.
#WorldAIDSVaccineDay and #WAVD  – for tweets related to World AIDS Vaccine Day

USAID Global Health ‏@USAIDGH
A 50% effective vaccine combined w greater use of current HIV prev tools could prevent ~20M new HIV infections by 2030 http://ow.ly/b07LS
4:30 PM – 19 May 12

Doctors w/o Borders ‏@MSF_USA
Global vaccine plan draws criticism: http://bit.ly/J6hLUF @NatureNews blog post on our vaccine report: http://bit.ly/LjCKZn

IAVI @AIDSvaccine
@NIAIDNews Tony Fauci’s #WorldAIDSVaccineDay / #HIV #vacccine Awareness Day statement: http://1.usa.gov/MdJlUe #WAVD
2:39 PM – 18 May 12

IAVI @AIDSvaccine
IAVI’s McGlynn in @USAIDGH blog on modeling impact on #WorldAIDSVaccineDay/HIV Vax Awareness Day: http://bit.ly/JSMyq1 #WAVD #HIVvaximpact
10:30 AM – 18 May 12

USAID Global Health @USAIDGH
There are currently 71 ongoing clinical #HIV vaccine trials at different phases of development #WAVD
9:35 AM – 18 May 12

Arthur Caplan @ArthurCaplan
really going to spend time on ethics of testing anthrax vaccine on kids what an utter waste of time http://on.msnbc.com/JA37aW
7:12 PM – 17 May 12

Amanda Glassman ‏@glassmanamanda
Amanda Glassman on the difficult task of setting priorities at the WHO http://blogs.bmj.com/bmj/2012/05/17/amanda-glassman-on-the-difficult-task-of-setting-priorities-at-the-who/
10:20 AM – 17 May 12

Report: Public Engagement on Facilitating Access to Antiviral Medications and Information in an Influenza Pandemic – Workshop Series Summary
Released: May 17, 2012
Type: Workshop Summary
Note: Workshop Summaries contain the opinion of the presenters, but do NOT reflect the conclusions of the IOM.

Overview
Influenza pandemics overwhelm health care systems with thousands or hundreds of thousands of sick patients, as well as those worried they may be sick. In order to ensure a successful response to the patient swell caused by a pandemic, robust planning is essential to prepare for challenges public health officials may face. This includes the need to quickly distribute and dispense antiviral medications that can reduce the severity and duration of disease to large numbers of people.

In response to a request from the CDC, the IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events held a series of workshops that explored the public’s perception of how to facilitate access to antiviral medications and treatment during an influenza pandemic. To help inform potential strategies still in the development stages at the CDC, workshops were held in Fort Benton, Montana; Chattanooga, Tennessee; and Los Angeles, California; during February and March 2012 to consider the usefulness of several alternative strategies of delivering antiviral medication to the public. Participants considered how the normal systems for prescribing and dispensing antiviral medications could be adjusted to ensure that the public has quick, safe, and equitable access to both potentially life-saving drugs and information about the pandemic and treatment options. This document summarizes the workshops.

http://www.iom.edu/Reports/2012/Public-Engagement-on-Facilitating-Access-to-Antiviral-Medications.aspx

Annals of Internal Medicine
May 15, 2012; 156 (10)
http://www.annals.org/content/current

Editorials
Ethical Dilemmas and Malfunctions in Clinical Trials Research
Stuart J. Pocock
Ann Intern Med May 15, 2012 156:746-747;

Excerpt
Two articles in this issue raise ethical concerns about the conduct and monitoring of clinical trials that are worthy of debate and future action.

Fan and colleagues (1) report a trial of a behavioral intervention strategy for patients with chronic obstructive pulmonary disease. The trial was stopped early primarily because of a statistically significant excess of deaths in the intervention group. This reminds us all that trials of behavioral strategies are no different from drug trials in their need for effective data monitoring for potential harm, even though some might argue that behavioral actions cannot conceivably harm patients. Appropriate structures (for example, planned interim analyses and an independent data monitoring committee) are an integral part of any major trial’s ethical armory in guarding against and acting on nasty surprises.

Having said that, just how convincing is the evidence of harm in this case? Twenty-eight deaths (17%) occurred in the comprehensive care management group compared with 10 deaths (7%) in the usual care group (P = 0.003). Trials that stop early because of an apparent treatment difference, whether for superiority or inferiority, are prone to exaggerate the true effect (2, 3). They stop on a “random high,” whereas the observed difference might well have regressed to the truth if they had continued longer. Inevitably, that unobservable truth will remain a mystery, but the idea of potential exaggeration is reinforced by the following 3 issues: The causes of death did not reveal any clear pattern consistent with a plausible reason for harm; the trial’s primary end point (time …

British Medical Journal
19 May 2012 (Vol 344, Issue 7857)
http://www.bmj.com/content/344/7857

Editorial
Immunisation against influenza during pregnancy
BMJ 2012; 344 doi: 10.1136/bmj.e3091 (Published 2 May 2012)
Marian Knight, NIHR (National Institute for Health Research) research professor in public health 1, Boon Lim, consultant obstetrician2

Excerpt
The benefits outweigh the risks
Since the A/H1N1 2009 influenza pandemic, universal immunisation of pregnant women against seasonal flu has been recommended in many areas of the world.1 2 3 Despite experience with immunisation against seasonal flu in pregnancy over many years, uptake of influenza vaccine in pregnancy during the 2009 A/H1N1 2009 pandemic was low and immunisation rates among pregnant women generally remain low.4 5 One commonly cited reason for this is concern among women and clinical staff about the safety of the vaccine during pregnancy.6

In a linked research paper (doi:10.1136/bmj.e2794), Pasternak and colleagues present findings from an important new Danish national cohort study of women vaccinated against influenza A/H1N1 2009.7 The study suggests that women who are immunised in pregnancy have a lower risk of fetal loss than non-immunised women. The study provides reassuring information for people who are worried about the safety of the vaccine and evidence of the benefits of vaccination, which were previously only hypothesised. This is particularly important because the influenza vaccination season has just started in the southern hemisphere, where the A/California/7/2009 strain is included in the current vaccine. After a World …

Research
Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark
BMJ 2012; 344 doi: 10.1136/bmj.e2794 (Published 2 May 2012)
Björn Pasternak, registrar and postdoctoral fellow12, Henrik Svanström, statistician1, Ditte Mølgaard-Nielsen, researcher1, Tyra G Krause, consultant3, Hanne-Dorthe Emborg, epidemiologist3, Mads Melbye, professor1, Anders Hviid, senior investigator1

Abstract  [Open Access]
Objective  To investigate whether an adjuvanted pandemic A/H1N1 2009 influenza vaccine in pregnancy was associated with an increased risk of fetal death.

Design Nationwide register based cohort study.

Setting  Denmark.

Participants All clinically recognised singleton pregnancies that ended between November 2009 and September 2010. Individual level data on exposure to an inactivated AS03 pandemic A/H1N1 2009 influenza vaccine (Pandemrix) and potential confounders were linked to the study cohort using a unique person identifier.

Main outcome measures The primary outcome measure was risk of fetal death (spontaneous abortion and stillbirth combined) in H1N1 vaccinated compared with unvaccinated pregnancies, adjusting for propensity scores. Secondary outcome measures were spontaneous abortion (between seven and 22 weeks’ gestation) and stillbirth (after 22 completed weeks’ gestation).

Results  The cohort comprised 54 585 pregnancies; 7062 (12.9%) women were vaccinated against pandemic A/H1N1 2009 influenza during pregnancy. Overall, 1818 fetal deaths occurred (1678 spontaneous abortions and 140 stillbirths). Exposure to the H1N1 vaccine was not associated with an increased risk of fetal death (adjusted hazard ratio 0.79, 95% confidence interval 0.53 to 1.16), or the secondary outcomes of spontaneous abortion (1.11, 0.71 to 1.73) and stillbirth (0.44, 0.20 to 0.94). Estimates for fetal death were similar in pregnant women with (0.82, 0.44 to 1.53) and without comorbidities (0.77, 0.47 to 1.25).

Conclusion  This large cohort study found no evidence of an increased risk of fetal death associated with exposure to an adjuvanted pandemic A/H1N1 2009 influenza vaccine during pregnancy.

BMJ Press Release Monday, May 14, 2012 – 14:32
Should childhood vaccination be mandatory?
Is it needed to protect vulnerable people or are there more effective ways to ensure uptake?
On bmj.com today, two experts debate whether childhood vaccination should be mandatory in the UK.

Paul Offit, Chief of Infectious diseases at the Children’s Hospital of Philadelphia believes that mandatory vaccination is needed to protect vulnerable people from infection.

He argues that, when parents choose not to vaccinate, not only are they making a choice for their own children, they are also making a choice for those with whom their children come into contact. This includes children who are too young to receive vaccines and those who can’t be vaccinated and depend on those around them to be protected.

Which is paramount: the freedom to make bad health decisions or the right of the community to protect itself from those decisions, he asks?

In the United States, mandatory vaccination clearly increases uptake, he says. For example, unlike the UK and Europe, the US didn’t suffer a measles epidemic after claims of a link between the MMR vaccine and autism. And in 2011, most of the 200 measles cases in the US were linked to European travel.

“Someday we may live in a world that doesn’t scare patients into making bad health decisions,” he concludes. “Until then, vaccine mandates are the best way to ensure protection from illnesses that have caused so much needless suffering and death.”

But David Salisbury, Director of Immunisation at the UK Department of Health, argues that there are more workable ways to ensure high uptake.

He points out that between 1998 and 2010, the peak age for measles cases in England and Wales was less than five years, so if vaccination were made compulsory for school entry, the law would be coming into effect after many infections had occurred.

He believes that vaccination coverage can be raised by improving immunisation services and argues that, even after the MMR scare, compulsory vaccination “was never considered” and “would probably have made matters much worse.”

He also highlights that in the US, exemptions to mandatory vaccination for school entry can be as high as 20% and the rate is increasing.

“When coverage is already high and rising, target diseases are under excellent control (although measles could be better), and parental acceptance for immunisation is high, compulsion seems a heavy hammer,” he writes. “Compulsion would be unenforceable, unnecessary, and its use would probably do more harm than good.”

Head to Head
Should childhood vaccination be mandatory? Yes
BMJ 2012; 344 doi: 10.1136/bmj.e2434 (Published 15 May 2012)
Paul A Offit, chief of infectious diseases

Paul Offit believes that mandatory vaccination is needed to protect vulnerable people from infection, but David Salisbury (doi:10.1136/bmj.e2435) argues that there are more workable ways to ensure high uptake

Excerpt
In a better world, vaccine mandates wouldn’t be necessary. Parents would educate themselves about the diseases that vaccines prevent and learn that measles causes pneumonia and brain damage, mumps causes deafness and sterility, rubella causes severe birth defects, pertussis causes suffocation, and human papillomavirus (HPV) causes cervical, oropharyngeal, and anal cancers. They would learn about the remarkable safety and effectiveness of vaccines. And they would learn that although vaccines are not free of risk, their benefits clearly outweigh their risks. Mostly, they would learn that vaccines stand on a mountain of scientific evidence. Well informed: the choice to vaccinate their children would be an easy one.

Unfortunately, we don’t live in that world. In our world, science based information is often obscured by false and misleading claims readily available in newspaper and magazine articles, on radio and television …
http://www.bmj.com/content/344/bmj.e2434

Head to Head
Should childhood vaccination be mandatory? No
BMJ 2012; 344 doi: 10.1136/bmj.e2435 (Published 15 May 2012)
David M Salisbury, director of immunisation

Paul Offit (doi:10.1136/bmj.e2434) believes that mandatory vaccination is needed to protect vulnerable people from infection, but David Salisbury argues that there are more workable ways to ensure high uptake
Excerpt
Mandatory vaccination in the UK was attempted first in the 19th century.1 The legislation was ineffective, discriminated in favour of those able to use the exemptions, and was divisive; it fostered substantial anti-vaccine sentiment and was counterproductive. Attempts to impose compulsion today would undoubtedly be challenged in terms of autonomy, inappropriate intrusion of the state, availability of choice, and parental rights and responsibilities. Bolstered by access to information, its unacceptability to the public would be likely to have the same consequences.

Two questions need to be answered: do we need mandatory vaccination and are there examples of it being beneficial?

Compulsion is unnecessary
I presume that the purpose of mandatory vaccination is to raise coverage. If coverage is sufficiently high, compulsion is not needed. If coverage were not adequately high, other interventions are more likely to be successful than compulsion. We have reasonable ideas of what “sufficiently high” means: polio outbreaks do not occur when coverage is consistently above 80% in …
http://www.bmj.com/content/344/bmj.e2435

JAMA   
May 16, 2012, Vol 307, No. 19
http://jama.ama-assn.org/current.dtl

The Cover | May 16, 2012
Dimensions of Global Health, 2012
Thomas R. Frieden, MD, MPH; Richard M. Garfield, RN, PhD
JAMA. 2012;307(19):2006-2006. doi:10.1001/jama.2012.2984

Human health has improved more in our lifetimes than it did in the preceding thousand years. Since 1970, the number of infants who die has decreased by more than half worldwide, and maternal mortality has fallen dramatically in virtually every region of the world. Facing today’s enormous global health challenges, we often lose sight of such advances. Health has improved for several reasons. First and foremost, economic growth improves people’s life chances. In 1970, close to half the world’s population lived in extreme poverty; now one in seven people lives in poverty. More people have access to clean water, immunizations, and basic health services because of the work of governments, charitable groups including faith-based organizations, international organizations, the private sector, and public and private development assistance. Wider dissemination of information and increasing citizen participation make it possible for many lower-income people to make better-informed decisions about their health.

This week’s cover of JAMA highlights major layers that determine global health status. Underlying all is a clean and safe environment: uncontaminated food, water, and air. The economy—the generation and distribution of products and services—makes essential goods available. Policies can decrease inequalities in the distribution of these goods and services. Research develops better tools and strategies. Applied research shows how to use advances to improve health. Recent advances in vaccines, malaria, and HIV prevention and treatment have been translated into practice and have saved millions of lives.

The new and crucial frontiers for global health to cross in the coming years are both infectious and noninfectious. Some global health activities, such as international trade and disease reporting agreements and restrictions on marketing of dangerous products such as counterfeit medicines, tobacco, and controlled substances, are in the interest of all countries. Surveillance of diseases with epidemic potential protects rich and poor alike. The eradication of smallpox did—and eradicating polio and guinea worm will—serve all of humanity. When the Global Polio Eradication Initiative was launched by Rotary International, the World Health Organization, UNICEF, and the Centers for Disease Control and Prevention (CDC) in 1988, the virus disabled nearly 1000 children every day. In all of 2011, polio affected fewer than 1000 children worldwide. Yet polio eradication remains elusive, with ongoing, widespread transmission in several countries and continued importations to others. Disease eradication is the ultimate achievement for both sustainability and equity—it is forever and for everyone. Future generations will judge us by whether we carried polio eradication over the finish line—or dropped the ball.

In noninfectious diseases, reducing tobacco use and improving control of high blood pressure will be among the world’s greatest health challenges in the next decade. Most low-income countries have not yet adopted effective programs to stop smoking and to prevent and treat hypertension. Tobacco control is within reach—WHO’s MPOWER package of evidence-based tobacco control policies has reduced tobacco use everywhere it has been implemented, and progress is accelerating—but scaling up to reach most people must happen much more rapidly. Exposure to second-hand smoke in workplaces and other public places remains common, implementation of evidence-based tobacco control policies is increasing only gradually, the tobacco industry is intensifying its already aggressive marketing and lobbying in many countries, government and private funding remains limited, and in many countries there continues to be insufficient political leadership to address the tobacco epidemic, which will kill 1 billion people in this century unless urgent action is taken now.

Between 1990 and 2007, global assistance for health development rose from about $6 billion to nearly $22 billion. Some middle-income countries are starting to become regional donors, and many governments in low-income countries are increasing their budgetary commitments to health. The world has recently made important technological progress, including in the areas of HIV, malaria, vaccinations, and diagnostics, as well as in mobile computing and communications technologies. Many more technological advances are in the pipeline.

The biggest challenge in global health is the growing gap between the effective and cost-effective actions we know work and what we actually do. Unless we close this implementation gap, billions of people will become ill, injured, or disabled or will die of conditions that could be easily and inexpensively prevented. Accurate and timely monitoring systems are crucial to close this gap. The CDC is working with countries and international organizations to strengthen the coverage and quality of disease surveillance and epidemiologic analysis in low- and middle-income countries so that these countries can better design, monitor, defend, and improve programs. These efforts will require additional investments in both human resources and public health institutions. Closing the implementation gap can prevent literally hundreds of millions of premature deaths in the decades ahead.

Viewpoint | May 16, 2012
Primary Health Care in Low-Income Countries – Building on Recent Achievements
Jeffrey D. Sachs, PhD
JAMA. 2012;307(19):2031-2032. doi:10.1001/jama.2012.4438

Excerpt
Small investments in improved health of the poor have a remarkable return in reduced morbidity and mortality. While the developed economies grapple with health systems that cost several thousand dollars per person per year and often spend hundreds of thousands of dollars on a treatment to eke out an additional few months of life, outlays of just a few dozen dollars per person per year in impoverished countries can add several years to life expectancy. In the least developed countries, approximately 112 of every 1000 children die before their fifth birthday, as opposed to 8 per 1000 in the developed countries.1 With a concerted science-based effort, the under-5 mortality rate of the least developed countries could be reduced to less than 30 per 1000 by 2020. Such low under-5 mortality rates have already been achieved, for example, by the Dominican Republic (28 per 1000), Mexico (17 per 1000), and Thailand (13 per 1000)

Viewpoint | May 16, 2012
Policy Making With Health Equity at Its Heart
Michael G. Marmot, FRCP
JAMA. 2012;307(19):2033-2034. doi:10.1001/jama.2012.3534

Excerpt
…Economic and financial issues have been dominating global policy making. Health and inequalities in health should feature more strongly. This should be done not to enable physicians or ministers of health to have greater authority, but because economic and social developments have profound effects on health inequalities. Moreover, so crucial are economic and social policy decisions for health and the fair distribution of health, health equity should be an important measure of the effectiveness of social and economic policy making. Progress toward achievement of health equity is a measure of success.

I use the term health equity to have a specific meaning: systematic inequalities in health between social groups that are deemed to be avoidable by reasonable means.1 Therefore any policies that retard action to reduce these avoidable health inequalities are unfair..

Viewpoint | May 16, 2012
Achieving Equity in Global Health – So Near and Yet So Far
Zulfiqar A. Bhutta, FRCPCH, PhD; K. Srinath Reddy, MD, DM (Card)
JAMA. 2012;307(19):2035-2036. doi:10.1001/jama.2012.4659

Excerpt
Few issues have generated as much passion and imagination over the last few decades as the challenge of global health. From major studies on the global burden of disease1 to the recognition of the global epidemic of human immunodeficiency virus, AIDS, and tuberculosis, health has been center stage of the global development debate. Issues, which once remained within the purview of health advocacy and policy circles, found their way into the center stage of debates in the World Economic Forum and onto agendas for G8 and G20 summit meetings. The groundbreaking reports from the Commission for Macroeconomics in Health and Social Determinants of Health highlighted the importance of appropriate resource allocations for health as well as focusing on issues that determine population health, but are frequently beyond the purview of ministries of health. Even as the world contends with a worldwide recession, there is clear recognition that health of populations everywhere must be protected and promoted, not only as a developmental commitment to equity but also as an imperative for economic growth and security…

Special Communication | May 16, 2012
A Framework Convention on Global Health – Health for All, Justice for All
Lawrence O. Gostin, JD
JAMA. 2012;307(19):2087-2092. doi:10.1001/jama.2012.4395

Excerpt
Health inequalities represent perhaps the most consequential global health challenge and yet they persist despite increased funding and innovative programs. The United Nations is revising the Millennium Development Goals (MDGs) that will shape the world for many years to come. What would a transformative post-MDG framework for global health justice look like? A global coalition of civil society and academics—the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI)—has formed an international campaign to advocate for a Framework Convention on Global Health (FCGH). Recently endorsed by the UN Secretary-General, the FCGH would reimagine global governance for health, offering a new post-MDG vision. This Special Communication describes the key modalities of an FCGH to illustrate how it would improve health and reduce inequalities. The modalities would include defining national responsibilities for the population’s health; defining international responsibilities for reliable, sustainable funding; setting global health priorities; coordinating fragmented activities; reshaping global governance for health; and providing strong global health leadership through the World Health Organization…

Editorial | May 16, 2012
Health, Economics, and the 2012 G8 Summit
Howard Bauchner, MD; Julio Frenk, MD
JAMA. 2012;307(19):2102-2104. doi:10.1001/jama.2012.4874

Excerpt
Health and economics are inextricably linked. Health constitutes a vigorous sector of the economy, with effects on inflation, employment, and competitiveness. The World Health Organization estimates that health systems worldwide absorb approximately 10% of the world economy—about US $6 trillion.1 Differences in health expenditures, however, are huge. For instance, the United States spends more than $7000 per capita on health, whereas Eritrea spends less than US $10. For low- and middle-income countries, committing more financial resources to health is a complicated and difficult decision, because most nations face many competing priorities. Nor will improving the health of the world’s population be possible unless there is global economic recovery. Enlightened ministers of finance realize that better health contributes to sustainable economic growth through its effects on improved productivity.

Indeed, interest in global health has increased significantly over the past 2 decades. Modern travel and the Internet have made the world a far more intimate place, and health risks and benefits more easily travel the world. Examples of the increasing global transfer of health risks are the human immunodeficiency virus (HIV)/AIDS pandemic, the 2002-2003 severe acute respiratory syndrome outbreak, and the recent H1N1 influenza crisis. But opportunities are also spreading. Access to health care as a basic human right has been vigorously endorsed by governments and international agencies, leading to a global movement toward universal health coverage. Substantially more resources from governments and foundations have been committed to the international effort to improve the health of the world’s population.2 Numerous journals have given a powerful voice to the global health movement.3 – 4 As a reflection of this increasing interest, more than 100 partnerships are now active in global health.

This global health theme issue of JAMA, published to coincide with the May 2012 G8 Summit in the United States, provides new information and insights directly relevant to the related issues of health, economics, and global well-being. This issue begins with 4 Viewpoints from individuals with long and rich commitments to global health. Sachs5 provides insights about the role of economics in health care, emphasizing the need to develop primary health care in low-income countries. Marmot6 addresses health disparities and the potential role of economics in alleviating them. Bhutta and Reddy7 focus on issues related to maternal and child health. Marrero and colleagues8 report on the recent high-level meeting of the United Nations that focused on noncommunicable diseases, signaling the global importance of cardiovascular disease, chronic respiratory disease, diabetes, and cancer. In a Special Communication, Gostin9 details the creation of a Framework Convention on Global Health that “would reimagine global governance for health, offering a new post-[Millennium Development Goals] vision.”…

The Lancet  
May 19, 2012  Volume 379  Number 9829  p1851 – 1922  e52
http://www.thelancet.com/journals/lancet/issue/current

Review
Scaling up interventions to achieve global tuberculosis control: progress and new developments
Mario Raviglione, Ben Marais, Katherine Floyd, Knut Lönnroth, Haileyesus Getahun, Giovanni B Migliori, Anthony D Harries, Paul Nunn, Christian Lienhardt, Steve Graham, Jeremiah Chakaya, Karin Weyer, Stewart Cole, Stefan HE Kaufmann, Alimuddin Zumla

Summary
Tuberculosis is still one of the most important causes of death worldwide. The 2010 Lancet tuberculosis series provided a comprehensive overview of global control efforts and challenges. In this update we review recent progress. With improved control efforts, the world and most regions are on track to achieve the Millennium Development Goal of decreasing tuberculosis incidence by 2015, and the Stop TB Partnership target of halving 1990 mortality rates by 2015; the exception is Africa. Despite these advances, full scale-up of tuberculosis and HIV collaborative activities remains challenging and emerging drug-resistant tuberculosis is a major threat. Recognition of the effect that non-communicable diseases—such as smoking-related lung disease, diet-related diabetes mellitus, and alcohol and drug misuse—have on individual vulnerability, as well as the contribution of poor living conditions to community vulnerability, shows the need for multidisciplinary approaches. Several new diagnostic tests are being introduced in endemic countries and for the first time in 40 years a coordinated portfolio of promising new tuberculosis drugs exists. However, none of these advances offer easy solutions. Achievement of international tuberculosis control targets and maintenance of these gains needs optimum national health policies and services, with ongoing investment into new approaches and strategies. Despite growing funding in recent years, a serious shortfall persists. International and national financial uncertainty places gains at serious risk. Perseverance and renewed commitment are needed to achieve global control of tuberculosis, and ultimately, its elimination.

Medical Decision Making (MDM)
May–June 2012; 32 (3)
http://mdm.sagepub.com/content/current

Original Articles
Anthony J. Culyer and Yvonne Bombard
An Equity Framework for Health Technology Assessments
Med Decis Making May–June 2012 32: 428-441, first published on November 7, 2011 doi:10.1177/0272989X11426484

Abstract
Despite the inclusion of equity in the design of many health care systems, pragmatic tools for considering equity systematically, alongside the efficiency categories of cost-effectiveness in health technology assessment (HTA), remain underdeveloped. This article develops a framework to help decision makers supplement the standard efficiency criteria of HTA and avoid building inequities, explicit or implicit, into their methods. The framework is intended as a first step toward creating a checklist for alerting decision makers to a wide range of equity considerations for HTA. This framework is intended be used as part of the process through which advisory bodies receive their terms of reference; scope the agenda prior to the selection of a candidate intervention and its comparators for HTA; prepare background briefing for decision makers; and help to structure the discussion and composition of professional and lay advisory groups during the assessment process. The framework is offered as only a beginning of an ongoing process of deliberation and consultation, through which the matters covered can be expected to become more comprehensive and the record of past decisions and their contexts in any jurisdiction adopting the tool can serve to guide subsequent evidence gathering and decisions. In these ways, it may be hoped that equity will be more systematically and fully considered and implemented in both the procedures and decisions of HTA.

Medical Decision Making (MDM)
May–June 2012; 32 (3)
http://mdm.sagepub.com/content/current

Original Articles
Impact of Program Scale and Indirect Effects on the Cost-Effectiveness of Vaccination Programs
Med Decis Making May–June 2012 32: 442-446, first published on April 3, 2012 doi:10.1177/0272989X12441397

Extract
Vaccination against infectious disease confers both a direct protective effect to the individual receiving the vaccine as well as an indirect “herd protection” effect by reducing the transmission to the rest of the community. In some cases, the indirect population-level benefits may even outweigh the direct individual-level effects of vaccination.1 This article is motivated by the concern that published cost-effectiveness evaluations of vaccination programs are often conducted in comparison to a nonvaccination scenario 2–8 and that failure to account for considerations of scale—notably, the vaccination coverage both prior to and after program implementation—can lead analysts to ignore the nonlinear effects of herd protection and may misrepresent the cost-effectiveness of program expansion.

We used a simple model of influenza transmission to show how coverage rates affect cost-effectiveness in the evaluation of vaccination programs when herd protection effects are considered. Specifically, we show how estimates of costs, health outcomes, and cost-effectiveness of the vaccination program change with different levels of vaccination coverage due to the herd protection effect.

Methods
Disease Transmission Model
A standard susceptible-infectious-recovered (SIR) differential equation model was used to capture influenza transmission dynamics (Figure 1 and Table 1)9 and to estimate the disease incidence at varying levels of vaccination coverage in a population of 100,000 homogeneous, randomly mixing individuals. Vaccination efficacy (ϵ) was assumed to be 70%.10 The basic reproduction number (R 0), the mean number of infectious cases from a single infection in a totally susceptible population, was assumed to be 1.5,11 producing an influenza attack rate of approximately 10% at 35% vaccination coverage, which mirrors the typical influenza season in the US.12 The contact rate was parameterized to generate the R 0 value, based on the relationship between the contact rate and basic reproduction number: R 0 × …

Medical Decision Making (MDM)
May–June 2012; 32 (3)
http://mdm.sagepub.com/content/current

Original Articles
Jeffrey T. Vietri, Meng Li, Alison P. Galvani, and Gretchen B. Chapman
Vaccinating to Help Ourselves and Others
Med Decis Making May–June 2012 32: 447-458, first published on November 29, 2011 doi:10.1177/0272989X11427762

Abstract
Background. Many behaviors affect not only the self but also others. The utility of a vaccination to each individual depends on population immunity, the cumulative result of individual vaccination decisions. However, little is known about how the benefit to others influences vaccination decisions. Methods. In a series of 3 experiments (N = 292, 316, and 299) using hypothetical scenarios and college student respondents, we tested whether the vaccination decisions of individuals were sensitive to the level of immunity in the population when it had implications for either altruistic or free-riding vaccination behavior. Results. Our findings indicate that decisions of individuals were sensitive to opportunities both to free ride by refusing vaccination and to vaccinate altruistically. Although individuals were most willing to get vaccinated when they were at risk themselves, they were also sensitive to the amount of good they could do for others. This altruistic sensitivity was strongest when individuals were not vulnerable to the disease themselves. Conclusions. The most effective vaccination strategies, from a public health perspective, often entail vaccinating the disease transmitters rather than those who are most vulnerable. Consequently, those who bear the burden of vaccination and those who benefit are not the same individuals. Thus, effective vaccination campaigns require that disease transmitters vaccinate even when it is not in their self-interest to do so. Our results suggest that it may be possible to encourage vaccination by appealing to altruistic motives.

Pharmacoeconomics
June 1, 2012 – Volume 30 – Issue 6  pp: 447-535
http://adisonline.com/pharmacoeconomics/pages/currenttoc.aspx

Leading Article
Value of Information and Pricing New Healthcare Interventions
Willan, Andrew R.; Eckermann, Simon
Pharmacoeconomics. 30(6):447-459, June 1, 2012.
doi: 10.2165/11592250-000000000-00000

Abstract
Previous application of value-of-information methods to optimal clinical trial design have predominantly taken a societal decision-making perspective, implicitly assuming that healthcare costs are covered through public expenditure and trial research is funded by government or donation-based philanthropic agencies. In this paper, we consider the interaction between interrelated perspectives of a societal decision maker (e.g. the National Institute for Health and Clinical Excellence [NICE] in the UK) charged with the responsibility for approving new health interventions for reimbursement and the company that holds the patent for a new intervention. We establish optimal decision making from societal and company perspectives, allowing for trade-offs between the value and cost of research and the price of the new intervention.

Given the current level of evidence, there exists a maximum (threshold) price acceptable to the decision maker. Submission for approval with prices above this threshold will be refused. Given the current level of evidence and the decision maker’s threshold price, there exists a minimum (threshold) price acceptable to the company. If the decision maker’s threshold price exceeds the company’s, then current evidence is sufficient since any price between the thresholds is acceptable to both. On the other hand, if the decision maker’s threshold price is lower than the company’s, then no price is acceptable to both and the company’s optimal strategy is to commission additional research. The methods are illustrated using a recent example from the literature.

PLoS One
[Accessed 19 May 2012]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Cervical, Anal and Oral HPV in an Adolescent Inner-City Health Clinic Providing Free Vaccinations
Nicolas F. Schlecht, Robert D. Burk, Anne Nucci-Sack, Viswanathan Shankar, Ken Peake, Elizabeth Lorde-Rollins, Richard Porter, Lourdes Oriana Linares, Mary Rojas, Howard D. Strickler, Angela Diaz
PLoS ONE: Research Article, published 18 May 2012 10.1371/journal.pone.0037419

Abstract 
Objectives
Published human papillomavirus (HPV) vaccine trials indicate efficacy is strongest for those naive to the vaccine-types. However, few high-risk young women have been followed and cervical HPV has been the predominant outcome measure.

Methods
We collected cervical and anal swabs, as well as oral rinse specimens from 645 sexually active inner-city young females attending a large adolescent health-clinic in New York City that offers free care and HPV vaccination. Specimens were tested for HPV-DNA using a MY09/MY11-PCR system. Type-specific prevalence of HPV at each anatomic site was compared for individuals by vaccination dose using generalized estimating equation logistic regression models.

Results
The majority of subjects reported being of non-Caucasian (92%) and/or Hispanic ethnicity (61%). Median age was 18 years (range:14–20). All had practiced vaginal sex, a third (33%) practiced anal sex, and most (77%) had also engaged in oral sex. At enrollment, 21% had not received the vaccine and 51% had received three doses. Prevalent HPV infection at enrollment was detected in 54% of cervical, 42% of anal and 20% of oral specimens, with vaccine types present in 7%, 6% and 1% of specimens, respectively. Comparing prevalence for vaccine types, the detection of HPV in the cervix of vaccinated compared to unvaccinated adolescents was significantly reduced: HPV6/11 (odds ratio [OR] = 0.19, 95%CI:0.06–0.75), HPV16 (OR = 0.31, 95%CI:0.11–0.88) and HPV18 (OR = 0.14, 95%CI:0.03–0.75). For anal HPV, the risk of detecting vaccine types HPV6/11 (OR = 0.27, 95%CI:0.10–0.72) and HPV18(OR = 0.12, 95%CI:0.01–1.16) were significantly reduced for vaccinated adolescents however, the risk for HPV16 was not significantly decreased (OR = 0.63, 95%CI:0.18–2.20).

Conclusion
HPV Prevalence is extremely high in inner-city female adolescents. Administration of the HPV vaccine reduced the risk for cervical HPV; however continued follow-up is required to assess the protection for HPV at all sites in young women with high exposure

PLoS Medicine
(Accessed 19 May 2012)
http://www.plosmedicine.org/article/browse.action?field=date

A New Deal for Global Health R&D? The Recommendations of the Consultative Expert Working Group on Research and Development (CEWG)
John-Arne Røttingen, Claudia Chamas
Perspective, published 15 May 2012
doi:10.1371/journal.pmed.1001219

Excerpt
In May 2012 at the World Health Assembly, member states of the World Health Organization (WHO) have the opportunity to make substantial progress on a major global health challenge: how to catalyse new knowledge for diseases that primarily affect the global poor and for which patents provide insufficient market incentives. The existing system can neither adequately develop nor deliver health technologies addressing health concerns mainly or only constituting a problem in developing countries. Those markets have no ability to pay the high prices needed to recover research and development (R&D) costs, which is the way the current system operates. We need mechanisms that delink the cost of R&D from the price of products.

PLoS Medicine
(Accessed 19 May 2012)
http://www.plosmedicine.org/article/browse.action?field=date

Innovation and Access to Medicines for Neglected Populations: Could a Treaty Address a Broken Pharmaceutical R&D System?
Suerie Moon, Jorge Bermudez, Ellen ‘t Hoen
Essay, published 15 May 2012
doi:10.1371/journal.pmed.1001218

Summary Points
– The current system for the research and development (R&D) of new medicines does not adequately meet the needs of the majority of the world’s population.

– There is a lack of new medicines for the “neglected diseases”—those that primarily affect populations with little purchasing power, and therefore offer an insufficient incentive for industry to invest in R&D. However, with problems extending far beyond the narrow notion of neglected diseases, the issue is better understood as one of “neglected populations.”

– International debate and proposals for reform have ensued, including the recommendation that governments begin negotiations over a binding medical R&D convention to address systematic, long-standing problems with innovation and globally equitable access to medicines. Despite the emergence of many new approaches to generating R&D that meets the needs of poorer populations, efforts remain ad hoc, fragmented, and insufficient.

– We discuss how an R&D treaty could complement and build on existing initiatives by addressing four areas where the system remains particularly weak: affordability, sustainable financing, efficiency in innovation, and equitable health-centered governance.

– We argue that effective tools for global governance are required to generate medical R&D as a global public good, based on the understanding that a politically and financially sustainable system will require both fair contributions from all, and fair benefit-sharing for all.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 26, Pages 3819-3982 (6 June 2012)

Regular Papers
Estimation of immunization providers’ activities cost, medication cost, and immunization dose errors cost in Iraq
Original Research Article
Pages 3862-3866
Omer Qutaiba B. Al-lela, Mohd Baidi Bahari, Mustafa G. Al-abbassi, Muhannad R.M. Salih, Amena Y. Basher

Abstract
The immunization status of children is improved by interventions that increase community demand for compulsory and non-compulsory vaccines, one of the most important interventions related to immunization providers. The aim of this study is to evaluate the activities of immunization providers in terms of activities time and cost, to calculate the immunization doses cost, and to determine the immunization dose errors cost. Time-motion and cost analysis study design was used. Five public health clinics in Mosul-Iraq participated in the study. Fifty (50) vaccine doses were required to estimate activities time and cost. Micro-costing method was used; time and cost data were collected for each immunization-related activity performed by the clinic staff. A stopwatch was used to measure the duration of activity interactions between the parents and clinic staff. The immunization service cost was calculated by multiplying the average salary/min by activity time per minute. 528 immunization cards of Iraqi children were scanned to determine the number and the cost of immunization doses errors (extraimmunization doses and invalid doses). The average time for child registration was 6.7 min per each immunization dose, and the physician spent more than 10 min per dose. Nurses needed more than 5 min to complete child vaccination. The total cost of immunization activities was 1.67 US$ per each immunization dose. Measles vaccine (fifth dose) has a lower price (0.42 US$) than all other immunization doses. The cost of a total of 288 invalid doses was 744.55 US$ and the cost of a total of 195 extra immunization doses was 503.85 US$. The time spent on physicians’ activities was longer than that spent on registrars’ and nurses’ activities. Physician total cost was higher than registrar cost and nurse cost. The total immunization cost will increase by about 13.3% owing to dose errors.

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 30, Issue 26, Pages 3819-3982 (6 June 2012)

Regular Papers
Impact of pneumococcal vaccination in Denmark during the first 3 years after PCV introduction in the childhood immunization programme
Original Research Article
Pages 3944-3950
Helene Ingels, Jeppe Rasmussen, Peter Henrik Andersen, Zitta B. Harboe, Steffen Glismann, Helle Konradsen, Steen Hoffmann, Palle Valentiner-Branth, Lotte Lambertsen, On behalf of Danish Pneumococcal Surveillance Collaboration Group 2009–2010

Abstract
Background and aims
The 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in Denmark in October 2007 in a 2 + 1 schedule with a catch-up programme for children up to 17 months of age. To assess the impact of PCV we evaluated on the whole population: (1) direct and indirect effects on incidence of invasive pneumococcal disease (IPD), (2) changes in pneumococcal serotype distribution and (3) IPD related mortality.

Methods
We compared disease incidence in pre-PCV (years 2000–2007) and PCV periods (years 2008–2010) based on national surveillance data.

Results
In children aged 0–5 years the overall incidence of IPD decreased from 26.7 to 16.3 cases per 100,000 (IRR 0.58; 95% Confidence Interval (CI) [0.48–0.69]) and case fatality declined from 1.8% (12 deaths) in the eight-year pre-PCV period to 0% (no deaths) in the three-year PCV period. In the whole population the overall incidence of IPD and of IPD caused by vaccine serotypes declined significantly from 19.5 to 17.7 and from 7.7 to 3.8 cases per 100,000 persons comparing the two periods. The incidence of IPD due to non-vaccine serotypes (NVT-IPD) increased significantly from 11.8 to 13.9 cases per 100,000 in the whole population (incidence rate ratio 1.18; 95% CI [1.12–1.24]) with predominance of the serotypes 1.7F and 19A.

Conclusions
We report a marked decline in incidence in IPD in both vaccinated and non-vaccinated age groups and a minor but statistically significant increase in incidence of IPD due to NVTs in both vaccinated and non-vaccinated groups with predominance of serotypes covered by higher valence pneumococcal conjugate vaccines.

Vaccine
Volume 30, Issue 25, Pages 3723-3818 (28 May 2012)
http://www.sciencedirect.com/science/journal/0264410X/30/25

Special Issue: The Role of Internet Use in Vaccination Decisions
Edited by Cornelia Betsch and Katharina Sachse

Section 1. Web 2.0 – What it is and how it may affect vaccination decisions
Opportunities and challenges of Web 2.0 for vaccination decisions
Original Research Article
Pages 3727-3733
Cornelia Betsch, Noel T. Brewer, Pauline Brocard, Patrick Davies, Wolfgang Gaissmaier, Niels Haase, Julie Leask, Frank Renkewitz, Britta Renner, Valerie F. Reyna, Constanze Rossmann, Katharina Sachse, Alexander Schachinger, Michael Siegrist, Marybelle Stryk

Abstract
A growing number of people use the Internet to obtain health information, including information about vaccines. Websites that allow and promote interaction among users are an increasingly popular source of health information. Users of such so-called Web 2.0 applications (e.g. social media), while still in the minority, represent a growing proportion of online communicators, including vocal and active anti-vaccination groups as well as public health communicators. In this paper, the authors: define Web 2.0 and examine how it may influence vaccination decisions; discuss how anti-vaccination movements use Web 2.0 as well as the challenges Web 2.0 holds for public health communicators; describe the types of information used in these different settings; introduce the theoretical background that can be used to design effective vaccination communication in a Web 2.0 environment; make recommendations for practice and pose open questions for future research. The authors conclude that, as a result of the Internet and Web 2.0, private and public concerns surrounding vaccinations have the potential to virally spread across the globe in a quick, efficient and vivid manner. Web 2.0 may influence vaccination decisions by delivering information that alters the perceived personal risk of vaccine-preventable diseases or vaccination side-effects. It appears useful for public health officials to put effort into increasing the effectiveness of existing communication by implementing interactive, customized communication. A key step to providing successful public health communication is to identify those who are particularly vulnerable to finding and using unreliable and misleading information. Thus, it appears worthwhile that public health websites strive to be easy to find, easy to use, attractive in its presentation and readily provide the information, support and advice that the searcher is looking for. This holds especially when less knowledgeable individuals are in need of reliable information about vaccination risks and benefits.

The defining characteristics of Web 2.0 and their potential influence in the online vaccination debate
Original Research Article
Pages 3734-3740
Holly O. Witteman, Brian J. Zikmund-Fisher

Abstract
The emergence of Web 2.0 has led to more and more Web-based resources demonstrating three defining characteristics: user participation, openness and network effects. This paper discusses these characteristics in the context of the online vaccination debate, explores how they structurally alter the way people might interact with vaccination information online, and describes ways in which such characteristics support particular tendencies in human decision making processes. Specifically, user participation supports the influence of narratives and personal accounts, openness shapes expectations for greater levels of detail and movement toward models of informed decision making, and network effects demonstrate the social nature of decision making, the influence of like-minded others and thus, the pitfalls of polarization in the online vaccination debate. Web 2.0 means that concerns about vaccination information online must expand beyond simply the possibility that people might access information of varying quality to incorporate a more comprehensive understanding of how people use current Web functionality, how such usage influences expectations about information sources and decision making processes, and the implications for communication strategies about vaccination.

Section 2. Surfing the web – processing the obtained information
Sorting through search results: A content analysis of HPV vaccine information online
Original Research Article
Pages 3741-3746
Kelly Madden, Xiaoli Nan, Rowena Briones, Leah Waks

Abstract
Introduction
Surveys have shown that many people now turn to the Internet for health information when making health-related decisions. This study systematically analyzed the HPV vaccine information returned by online search engines. HPV is the most common sexually transmitted disease and is the leading cause of cervical cancers.

Methods
We conducted a content analysis of 89 top search results from Google, Yahoo, Bing, and Ask.com. The websites were analyzed with respect to source, tone, information related to specific content analyzed through the lens of the Health Belief Model, and in terms of two content themes (i.e., conspiracy theories and civil liberties). The relations among these aspects of the websites were also explored.

Results
Most websites were published by nonprofit or academic sources (34.8%) and governmental agencies (27.4%) and were neutral in tone (57.3%), neither promoting nor opposing the HPV vaccine. Overall, the websites presented suboptimal or inaccurate information related to the five behavioral predictors stipulated in the Health Belief Model. Questions related to civil liberties were present on some websites.

Conclusion
Health professionals designing online communication with the intent of increasing HPV vaccine uptake should take care to include information about the risks of HPV, including susceptibility and severity. Additionally, websites should include information about the benefits of the vaccine (i.e., effective against HPV), low side effects as a barrier that can be overcome, and ways in which to receive the vaccine to raise individual self-efficacy.

Do the media provide transparent health information? A cross-cultural comparison of public information about the HPV vaccine
Original Research Article
Pages 3747-3756
Nicolai Bodemer, Stephanie M. Müller, Yasmina Okan, Rocio Garcia-Retamero, Angela Neumeyer-Gromen

Abstract
The media is a powerful tool for informing the public about health treatments. In particular, the Internet has gained importance as a widely valued source for health information for parents and adolescents. Nonetheless, traditional sources, such as newspapers, continue to report on health innovations. But do websites and newspaper reports provide balanced information? We performed a systematic media analysis to evaluate and compare media coverage of the human papillomavirus (HPV) vaccine on websites and in newspapers in Germany and Spain. We assessed to what extent the media provide complete (pros and cons), transparent (absolute instead of relative numbers), and correct information about the epidemiology and etiology of cervical cancer as well as the effectiveness and costs of the HPV vaccine. As a basis for comparison, a facts box containing current scientific evidence about cervical cancer and the HPV vaccine was developed. The media analysis included 61 websites and 141 newspaper articles in Germany, and 41 websites and 293 newspaper articles in Spain. Results show that 57% of German websites and 43% of German newspaper reports communicated correct estimates of epidemiological data, whereas in Spain 39% of the websites and 20% of the newspaper did so. While two thirds of Spanish websites explicitly mentioned causes of cervical cancer as well as spontaneous recovery, German websites communicated etiological information less frequently. Findings reveal that correct estimates about the vaccine’s effectiveness were mentioned in 10% of German websites and 6% of German newspaper reports; none of the Spanish newspaper reports and 2% of Spanish websites reported effectiveness correctly. Only German websites (13%) explicitly referred to scientific uncertainty regarding the vaccine’s evaluation. We conclude that the media lack balanced reporting on the dimensions completeness, transparency, and correctness. We propose standards for more balanced reporting on websites and in newspapers.

Parents’ Internet use for information about HPV vaccine
Original Research Article
Pages 3757-3762
Annie-Laurie McRee, Paul L. Reiter, Noel T. Brewer

Abstract
Purpose
The Internet is an increasingly common source of health-related information. We sought to examine associations between parents’ Internet information-seeking and their knowledge, attitudes and beliefs about human papillomavirus (HPV) vaccine.

Methods
We interviewed parents within a year after approval of HPV vaccine for females and males. Participants were North Carolina parents with daughters ages 10–18 surveyed by telephone in Fall 2007 (n = 773); and a national sample of parents with sons ages 11–17 surveyed online in Fall 2010 (n = 115). We used multivariate regression to examine associations of past and intended Internet seeking for HPV vaccine information with knowledge and health belief model-related constructs.

Results
Among parents of daughters, having heard of HPV vaccine through the Internet (8%) was associated with higher HPV knowledge, perceived likelihood of HPV, and vaccination willingness, and with receiving a doctor’s recommendation. It was also associated with lower perceived vaccine harms, uncertainty, and anticipated regret. Parents of sons who heard of HPV vaccine through the Internet (10%) perceived greater barriers to vaccination than parents who learned about HPV vaccine for males through other sources. Intended future Internet information-seeking among parents of daughters (69%) was more likely if they perceived a lower likelihood that their daughters would get HPV if they were vaccinated (all p < .05).

Conclusions
Our findings suggest a positive influence of accessing information on the Internet about HPV vaccine. It was associated with higher knowledge and mostly positive parental attitudes and beliefs.

Vaccine-critical videos on YouTube and their impact on medical students’ attitudes about seasonal influenza immunization: A pre and post study
Original Research Article
Pages 3763-3770
Pierre Robichaud, Steven Hawken, Leslie Beard, Dante Morra, George Tomlinson, Kumanan Wilson, Jennifer Keelan

Abstract
YouTube is a video-sharing platform that is increasingly utilized to share and disseminate health-related information about immunization. Using a pre–post survey methodology, we compared the impact of two of the most popular YouTube videos discussing seasonal influenza vaccine, both vaccine-critical, on the attitudes towards immunizing of first year medical students attending a Canadian medical school. Forty-one medical students were randomized to view either a scientifically styled, seemingly “evidence-based”, vaccine-critical video or a video using anecdotal stories of harms and highly sensationalized imagery. In the pre-intervention survey, medical students frequently used YouTube for all-purposes, while 42% used YouTube for health-related purposes and 12% used YouTube to search for health information. While medical students were generally supportive of immunizing, there was suboptimal uptake of annual influenza vaccine reported, and a subset of our study population expressed vaccine-critical attitudes and behaviors with respect to seasonal influenza. Overall there was no significant difference in pre to post attitudes towards influenza immunization nor were there any differences when comparing the two different vaccine-critical videos. The results of our study are reassuring in that they suggest that medical students are relatively resistant to the predominately inaccurate, vaccine-critical messaging on YouTube, even when the message is framed as scientific reasoning. Further empirical work is required to test the popular notion that information disseminated through social media platforms influences health-related attitudes and behaviors. However, our study suggests that there is an opportunity for public health to leverage YouTube to communicate accurate and credible information regarding influenza to medical students and others.

Measuring people’s knowledge about vaccination: Developing a one-dimensional scale
Original Research Article
Pages 3771-3777
Alexandra Zingg, Michael Siegrist

Abstract
We propose a new scale to measure people’s general knowledge about vaccinations. The scale’s psychometric properties and its relationship with people’s willingness to vaccinate were examined in two studies. In Study 1, a representative sample of the German- and French-speaking populations in Switzerland (N = 1123) responded to a mail survey. In Study 2, members of an online panel answered the same questions (N = 233). The results of both studies suggest that people differ considerably in their ability to correctly answer questions related to vaccinations. Mokken scale analyses and a test-retest analysis showed that nine items form a one-dimensional scale with good psychometric properties. In both studies, a substantial correlation between knowledge and willingness to vaccinate was observed. The scale proposed in this study is well suited for research examining group differences. In a time when new media such as the Internet is highly accessible to most people, misconceptions can easily be spread. A good knowledge scale is important for measuring possible knowledge changes.

Section 3. Online communication strategies – advocacy in a minefield
Anti-vaccine activists, Web 2.0, and the postmodern paradigm – An overview of tactics and tropes used online by the anti-vaccination movement
Original Research Article
Pages 3778-3789
Anna Kata

Abstract
Websites opposing vaccination are prevalent on the Internet. Web 2.0, defined by interaction and user-generated content, has become ubiquitous. Furthermore, a new postmodern paradigm of healthcare has emerged, where power has shifted from doctors to patients, the legitimacy of science is questioned, and expertise is redefined. Together this has created an environment where anti-vaccine activists are able to effectively spread their messages. Evidence shows that individuals turn to the Internet for vaccination advice, and suggests such sources can impact vaccination decisions – therefore it is likely that anti-vaccine websites can influence whether people vaccinate themselves or their children. This overview examines the types of rhetoric individuals may encounter online in order to better understand why the anti-vaccination movement can be convincing, despite lacking scientific support for their claims. Tactics and tropes commonly used to argue against vaccination are described. This includes actions such as skewing science, shifting hypotheses, censoring dissent, and attacking critics; also discussed are frequently made claims such as not being “anti-vaccine” but “pro-safe vaccines”, that vaccines are toxic or unnatural, and more. Recognizing disingenuous claims made by the anti-vaccination movement is essential in order to critically evaluate the information and misinformation encountered online.

Risk perception and communication in vaccination decisions: A fuzzy-trace theory approach
Original Research Article
Pages 3790-3797
Valerie F. Reyna

Abstract
The tenets of fuzzy-trace theory, along with prior research on risk perception and risk communication, are used to develop a process model of vaccination decisions in the era of Web 2.0. The theory characterizes these decisions in terms of background knowledge, dual mental representations (verbatim and gist), retrieval of values, and application of values to representations in context. Lack of knowledge interferes with the ability to extract the essential meaning, or gist, of vaccination messages. Prevention decisions have, by definition, a status quo option of “feeling okay.” Psychological evidence from other prevention decisions, such as cancer screening, indicates that many people initially mentally represent their decision options in terms of simple, categorical gist: a choice between (a) a feeling-okay option (e.g., the unvaccinated status quo) versus (b) taking up preventive behavior that can have two potential categorical outcomes: feeling okay or not feeling okay. Hence, applying the same theoretical rules as used to explain framing effects and the Allais paradox, the decision to get a flu shot, for example, boils down to feeling okay (not sick) versus feeling okay (not sick) or not feeling okay (sick, side effects, or death). Because feeling okay is superior to not feeling okay (a retrieved value), this impoverished gist supports choosing not to have the flu vaccine. Anti-vaccination sources provide more coherent accounts of the gist of vaccination than official sources, filling a need to understand rare adverse outcomes.

A public-professional web-bridge for vaccines and vaccination: User concerns about vaccine safety
Original Research Article
Pages 3798-3805
Alberto L. García-Basteiro, María-José Álvarez-Pasquín, Guillermo Mena, Anna Llupià, Marta Aldea, Victor-Guillermo Sequera, Sergi Sanz, Jose Tuells, José-Antonio Navarro-Alonso, Javier de Arísteguí, José-María Bayas

Abstract
Vacunas.org (), a website founded by the Spanish Association of Vaccinology offers a personalized service called Ask the Expert, which answers any questions posed by the public or health professionals about vaccines and vaccination. The aim of this study was to analyze the factors associated with questions on vaccination safety and determine the characteristics of questioners and the type of question asked during the period 2008–2010. A total of 1341 questions were finally included in the analysis. Of those, 30% were related to vaccine safety. Questions about pregnant women had 5.01 higher odds of asking about safety (95% CI 2.82–8.93) than people not belonging to any risk group. Older questioners (>50 years) were less likely to ask about vaccine safety compared to younger questioners (OR: 0.44, 95% CI 0.25–0.76). Questions made after vaccination or related to influenza (including H1N1) or travel vaccines were also associated with a higher likelihood of asking about vaccine safety. These results identify risk groups (pregnant women), population groups (older people) and some vaccines (travel and influenza vaccines, including H1N1) where greater efforts to provide improved, more-tailored vaccine information in general and on the Internet are required.

Lessons from an online debate about measles–mumps–rubella (MMR) immunization
Original Research Article
Pages 3806-3812
Michelle S. Nicholson, Julie Leask

Abstract
Objective
To provide strategies for immunization advocates on how best to participate in online discussion forums about immunization.

Methods
Content and thematic analysis of an online discussion forum held following the national screening of a documentary about the measles-mumps-rubella (MMR) vaccine and autism scare. A subsample of branches containing more than 20 posts was analysed. Each distinct message (a “post”) was coded for the author’s manifest position on immunization, author type, topic, and evidence presented or sought.

Results
From 103 distinct branches there were 1193 posts sent over a 3½ h period. We selected the 13 longest branches containing 466 posts from 166 individuals. One third of these individuals were explicitly critical of MMR immunization and one third sought information. The remainder were ambivalent but seeking no information (5%), supportive (14%), or unstated (15%). Among five author categories, only 4% identified themselves as health professionals. Topics included alleged adverse effects of immunization (35%); autism spectrum disorders treatment and causes (31%); vaccine ingredients (12%); a conspiracy (9%); immunization policies (8%); and measles, mumps or rubella (4%). Scientific concepts of evidence failed to compete with lay concepts and personal anecdotes prevailed.

Conclu
Health professionals and other advocates of immunization should engage in similar types of post-broadcast online discussion forums in a planned and strategic manner that accounts for the decision processes of lay people. This involves expanding and diversifying the support base of people contributing to the forum; setting the agenda; introducing messages known to influence behaviour; not overselling vaccination; and avoiding personal attacks.

Toward interactive, Internet-based decision aid for vaccination decisions: Better information alone is not enough
Original Research Article
Pages 3813-3818
Terry Connolly, Jochen Reb

Abstract
Vaccination decisions, as in choosing whether or not to immunize one’s small child against specific diseases, are both psychologically and computationally complex. The psychological complexities have been extensively studied, often in the context of shaping convincing or persuasive messages that will encourage parents to vaccinate their children. The computational complexity of the decision has been less noted. However, even if the parent has access to neutral, accurate, credible information on vaccination risks and benefits, he or she can easily be overwhelmed by the task of combining this information into a well-reasoned decision. We argue here that the Internet, in addition to its potential as an information source, could provide useful assistance to parents in integrating factual information with their own values and preferences – that is, in providing real decision aid as well as information aid. We sketch one approach for accomplishing this by means of a hierarchy of interactive decision aids ranging from simple advice to full-scale decision analysis.

Vaccine
Volume 30, Issue 24, Pages 3489-3722 (21 May 2012)
http://www.sciencedirect.com/science/journal/0264410X/30/24

Regular Papers
An update on human papillomavirus vaccine uptake among 11–17 year old girls in the United States: National Health Interview Survey, 2010
Original Research Article
Pages 3534-3540
Tabassum H. Laz, Mahbubur Rahman, Abbey B. Berenson

Abstract
Purpose
A 3-dose human papillomavirus (HPV) vaccine is recommended for adolescents to protect against HPV-related cervical and other cancers. The purpose of this study was to provide an update on HPV vaccine uptake among 11–17 year old girls residing in the US.

Methods
Data from the 2010 National Health Interview Survey (NHIS) were obtained to assess HPV vaccination status and its correlates. Multivariate logistic regression analyses were performed to examine HPV vaccine uptake of ≥1 dose and ≥3 doses among all girls, and completion of the 3-dose series among those who initiated (received ≥1 dose) the vaccine.

Results
Overall, 28.9% and 14.2% received ≥1 dose and ≥3 doses of vaccine: 14.5% and 3.0% among 11–12 year old girls, and 34.8% and 18.7% among 13–17 year olds, respectively. Hispanics had higher uptake of ≥1 dose (odds ratio (OR) 1.63, 95% confidence interval (CI) 1.22–2.17) than whites. Having received an influenza shot in the past year and parents’ awareness of the vaccine were significantly associated with receiving ≥1 dose (OR 1.88, 95% CI 1.51–2.33 and OR 16.57, 95% CI 10.95–25.06) and ≥3 doses (OR 1.48, 95% CI 1.13–1.92 and OR 10.60, 95% CI 5.95–18.88). A separate multivariate model based on girls who initiated the vaccine did not identify any significant correlates of 3-dose series completion. Among parents of unvaccinated girls, 60% were not interested in vaccinating their daughters and mentioned three main reasons: “does not need vaccine” (25.5%), “worried about safety” (19.3%) and “does not know enough about vaccine” (16.6%). Of those who were interested, 53.7% would pay $360–$500 for the vaccination, while 41.7% preferred to receive it at a much lower cost or free.

Conclusions
Only 1 out of 3 girls (11–17 years) have received ≥1 dose of HPV vaccine and much less have completed all 3 doses. Strategies should be taken to improve this vaccine uptake among girls, especially those 11–12 year olds, and to educate parents about the importance of vaccination.