WHO: Pandemic (H1N1) 2009 briefing note 22: levels of worldwide activity

The WHO continues to issue weekly updates and occasional briefing notes on the H1N1 pandemic at http://www.who.int/csr/disease/swineflu/en/index.html

Monitoring patterns and levels of worldwide activity
Pandemic (H1N1) 2009 briefing note 22
21 JULY 2010

As part of regular monitoring of H1N1 pandemic influenza, the WHO is in close dialogue with public health experts in countries worldwide, specifically to determine whether H1N1 activity has returned to levels and patterns normally seen for seasonal flu.

Worldwide, pandemic influenza activity has remained low over the past few months, and there has been little evidence of outbreaks outside the normal influenza season in most countries since the Northern Hemisphere winter. Temperate regions of the Northern Hemisphere are not presently reporting any outbreaks of influenza following one or two waves of the pandemic, and are adjusting their public health responses accordingly.

The Southern Hemisphere winter, which runs from May to September, is the typical influenza season for this part of the world. In most countries in the temperate zone of the Southern Hemisphere the level of influenza reported at present is low, and countries are reporting a mix of influenza strains comprising pandemic influenza A (H1N1) 2009, H3N2, and influenza B viruses. Where the pandemic H1N1 strain is prevalent, some severe illness and deaths have been reported.

Active transmission of pandemic influenza virus still persists in localized areas of the tropics, particularly in South and Southeast Asia, the Caribbean, Central America and West Africa.

Given the diverse pattern of influenza activity in the tropics and that the influenza season in the Southern Hemisphere is still ongoing, it is too early to determine if these countries have transitioned to levels and patterns expected for seasonal influenza. WHO remains in regular dialogue with countries affected to assess whether the pandemic influenza activity has transitioned to a seasonal pattern.

http://www.who.int/csr/disease/swineflu/notes/briefing_20100721/en/index.html

A(H5N1) epidemic: 6.5 years, 500 notified human cases

The status of A(H5N1) influenza was discussed in Eurosurveillance, Volume 15, Issue 29, 22 July 2010: Rapid communications: The influenza A(H5N1) epidemic at six and a half years: 500 notified human cases and more to come.

Abstract
Since November 2003, the epidemic intelligence team at the French Institut de Veille Sanitaire has been gathering data on influenza A(H5N1) circulation in poultry and on human cases worldwide. As Indonesia notifies the world’s 500th case to the World Health Organization, we discuss the epidemiological situation and trends of A(H5N1) influenza. Although the overall number of cases reported worldwide has decreased, influenza A(H5N1) continues to circulate intensely in some countries and more cases are to be expected, especially in Egypt and Indonesia.

Authors: A Tarantola 1, P Barboza1, V Gauthier1, S Ioos1, N El Omeiri1, M Gastellu-Etchegorry1, for the Epidemic Intelligence team at InVS 1. International and Tropical Department, Institut de Veille Sanitaire, Saint-Maurice, France

http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19619

NIAID/Fauci: CAPRISA 004 Microbicide HIV Prevention Study

Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health on Results from the CAPRISA 004 Microbicide HIV Prevention Study

Today we congratulate the Centre for the AIDS Programme of Research in South Africa (CAPRISA) and the people of South Africa on the positive findings from the CAPRISA 004 microbicide study, which marks a significant milestone both for the microbicide research field and HIV prevention as a whole.

For years, antiretroviral medicines have been effectively used to treat HIV infection. Through the successful conduct of the CAPRISA 004 study, we now have proof that an antiretroviral drug, in this case tenofovir, can be formulated into a vaginal gel that can protect women against HIV infection. Given that women make up the majority of new HIV infections throughout the world, this finding is an important step toward empowering an at-risk population with a safe and effective HIV prevention tool.

The CAPRISA 004 study is an exciting scientific achievement that moves us one step forward to gaining another effective tool to prevent HIV infection. However, because no one approach will be appropriate or acceptable to all, we must continue to pursue a range of HIV prevention modalities, including microbicides, pre-exposure prophylaxis (PrEP), and vaccines, as we simultaneously pursue scientific strategies designed to bring us closer to finding a cure for HIV/AIDS.

The daunting nature of the HIV/AIDS pandemic makes it clear that no single organization can tackle the problem alone. The CAPRISA 004 study is an excellent example of what researchers, governments, countries, industry, communities and individual study volunteers can accomplish when working together to find public health solutions. NIAID is proud to be among the many partner organizations that provided significant support and resources to establish the infrastructure and training necessary to conduct this landmark clinical trial.

Now we must build upon the CAPRISA research and identify a highly effective and acceptable microbicide for women and others at high-risk for HIV infection. The NIAID-sponsored VOICE study which launched last fall and is expected to enroll 5,000 women in four southern African countries, will provide additional safety and effectiveness data for a tenofovir-based vaginal gel as an HIV prevention method. The study also will offer some insight as to the gel’s acceptability as a product used once a day rather than one that is used before and after sexual intercourse. Additionally, the VOICE study is examining oral antiretroviral tablets (tenofovir alone or tenofovir plus emtricitabine) as an HIV prevention method. NIAID and other research organizations are exploring PrEP strategies in studies involving a number of at-risk populations with the first results expected early next year.

http://www.nih.gov/news/health/jul2010/niaid-20.htm

GAVI Alliance and Bloomberg School of Public Health Celebrate Vaccines, Baltimore

The GAVI Alliance and the Johns Hopkins Bloomberg School of Public Health sponsored an event “to review the impact and promise of new vaccines, particularly those that can prevent some of the most common causes of pneumonia and diarrhea in children…the event also celebrated the City of Baltimore’s success with immunizations to improve the health of even its poorest and hard-to-reach children.” Robert Black, MD, Chair, Johns Hopkins Bloomberg School of Public Health’s (JHSPH) Department of International Health, noted, “We now have in hand the latest country-specific estimates of the major causes of child deaths. This should help to focus national programs and donor assistance on the solutions that are most likely to be effective. Achieving the global goal of reducing child mortality by two-thirds is only possible if the high numbers of deaths are addressed by health interventions, including vaccines.”

GAVI noted that Baltimore is one of six US cities to dramatically improve their immunization rates, showing what political will and the courage to take action can accomplish,” said Helen Evans, Deputy CEO of the GAVI Alliance. “With increased leadership and financial support from the US and other donors, we could do globally what Baltimore is doing locally. With an additional $2.6 billion over the next five years, we can prevent about four million deaths by 2015 among the children most at risk, including one million from pneumococcal disease and rotavirus diarrhea.”

http://www.gavialliance.org/media_centre/press_releases/2010_07_22_pr_Baltimore.php

Oxford: multidimensional poverty index (MPI)

The Lancet
Jul 24, 2010  Volume 376  Number 9737  Pages 205 – 302
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Poverty index: who is the poorest of them all?
The Lancet

Preview
In a working paper by the Oxford Poverty and Human Development Initiative, Oxford, UK, this month, Sabine Akire and Maria Emma Santos present a new method for measuring and comparing poverty in 104 developing countries: the multidimensional poverty index (MPI). This index is a composite of three dimensions that are made up of ten indicators—health (child mortality, nutrition), education (years of school education, child enrolment), and living standards (electricity, drinking water, sanitation, flooring, cooking fuel, assets).

Prepublication Data Release, Latency, and Genome Commons

Science
23 July 2010  Vol 329, Issue 5990, Pages 357-480
http://www.sciencemag.org/current.dtl

Policy Forum
Information Access: Prepublication Data Release, Latency, and Genome Commons
Jorge L. Contreras

Preview
Researchers must disclose their data in order to achieve recognition and to enable others to test, validate, and challenge their hypotheses. In doing so, they create bodies of shared knowledge that are analogous to traditional public resources, such as forests and freeways, often referred to as “commons” (1, 2). The rate at which data are added to these information commons, however, varies greatly. The traditional practice has been to contribute experimental and observational data to the commons when, or shortly after, the analysis of that data is published, sometimes years after its initial collection (3, 4). Because of busy schedules, competitive pressures, and other interpersonal vagaries, the sharing of scientific data can be inconsistent even after publication (5, 6). Many traditional data-sharing practices were challenged, with significant and lasting effect, during the race to sequence the human genome.

Correlation and Causality in the Petaflop Age

Science Translational Medicine
21 July 2010 vol 2, issue 41
http://stm.sciencemag.org/content/current

High-Performance Computing
Closing the Scientific Loop: Bridging Correlation and Causality in the Petaflop Age
Gary An

Abstract
Advances in computing capability offer the biomedical research community the prospect of creating simulations at a previously unimaginable scale. A diagnostic analysis of the underpinnings of the translational dilemma suggests that the current high-throughput, data-rich research environment has led to an imbalance in the relationship between determinations of correlation and the evaluation of causality. Here I describe the use of high-performance computing technologies to facilitate high-throughput hypothesis evaluation combined with an evolutionary paradigm for the advancement of scientific knowledge. This combination provides a roadmap for closing the scientific loop between correlation and causality, a necessary step if translational endeavors are to succeed.

Clostridium difficile vaccine: An economic computer simulation model

Vaccine
http://www.sciencedirect.com/science/journal/0264410X

Volume 28, Issue 32, Pages 5145-5386 (19 July 2010)

The potential value of Clostridium difficile vaccine: An economic computer simulation model
Pages 5245-5253
Bruce Y. Lee, Michael J. Popovich, Ye Tian, Rachel R. Bailey, Paul J. Ufberg, Ann E. Wiringa, Robert R. Muder

Abstract
Efforts are currently underway to develop a vaccine against Clostridium difficile infection (CDI). We developed two decision analytic Monte Carlo computer simulation models: (1) an Initial Prevention Model depicting the decision whether to administer C. difficile vaccine to patients at-risk for CDI and (2) a Recurrence Prevention Model depicting the decision whether to administer C. difficile vaccine to prevent CDI recurrence. Our results suggest that a C. difficile vaccine could be cost-effective over a wide range of C. difficile risk, vaccine costs, and vaccine efficacies especially, when being used post-CDI treatment to prevent recurrent disease.

Duty to treat in influenza pandemic

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 32, Pages 5145-5386 (19 July 2010)

The duty to treat in the context of an influenza pandemic
Pages 5260-5264
C.P. van der Weijden, A.L. Bredenoord, J.J.M. van Delden

Abstract
The recent influenza pandemic proved that an influenza pandemic is no longer a future scenario. It may urge health care workers to undergo certain or even large risks. According to the WHO as well as commentators, a strong case can be made for adopting a duty to treat during a disease outbreak. Many current professional codes of ethics, however, fail to provide explicit guidance sufficient to set policy or assure the public in the event of an infectious disease outbreak. This paper aims to assess whether there is a duty to treat in the case of an influenza pandemic. As we conclude that there are valid reasons that support the duty to treat in this specific context, we will subsequently explore its scope and limits.

HPV vaccine effectiveness: A comparative model-based analysis

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 33, Pages 5387-5512 (26 July 2010)

Understanding differences in predictions of HPV vaccine effectiveness: A comparative model-based analysis
Pages 5473-5484
Nicolas Van de Velde, Marc Brisson, Marie-Claude Boily

Abstract
Mathematical models of HPV vaccine effectiveness and cost-effectiveness have produced conflicting results. The aim of this study was to use mathematical models to compare and isolate the impact of the assumptions most commonly made when modeling the effectiveness of HPV vaccines. Our results clearly show that differences in how we model natural immunity, herd immunity, partnership duration, HPV types, and waning of vaccine protection lead to important differences in the predicted effectiveness of HPV vaccines. These results are important and useful to assist modelers/health economists in choosing the appropriate level of complexity to include in their models, provide epidemiologists with insight on key data necessary to increase the robustness of model predictions, and help decision makers better understand the reasons underlying conflicting results from HPV models.

Communication skills in HPV prevention: Italian HCWs

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 34, Pages 5513-5652 (2 August 2010)

Communication skills in HPV prevention: an audit among Italian healthcare workers
Pages 5609-5613
S. Tafuri, D. Martinelli, M.M. Vece, M. Quarto, C. Germinario, R. Prato

Abstract
This study aims to investigate the knowledge, the attitudes and practices on HPV vaccination of health professionals of Mother and Child Service of Puglia Region (Italy). The study was conducted through a standardized questionnaire. Of 455 respondents, 74.2% judged HPV vaccine very important for immunization calendar. 88.9% did not believe that the administration of HPV vaccine implies consent to the initiation of sexual activity but 34.2% sustained that vaccine can give a false sense of protection against sexually transmitted diseases. 62.2% believed that boys should also be vaccinated. Skills necessary in the implementation of strategies in the promotion of health are partially inadequate and appropriate ongoing education should be carried out for health care workers.

Parental acceptance of a potential cytomegalovirus vaccine

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 35, Pages 5653-5756 (9 August 2010)

Assessment of parental acceptance of a potential cytomegalovirus vaccine for adolescent females
Pages 5686-5690
Tiffany J. Petty, S. Todd Callahan, Qingxia Chen, Kathryn M. Edwards, Amanda F. Dempsey

Abstract
The development of a vaccine against cytomegalovirus (CMV) has been designated as a high priority and adolescent females are a likely target population for CMV vaccination. A self-administered, internet-based survey was developed using constructs from the Health Belief Model to identify factors that may be associated with parental acceptance of a CMV vaccine for their adolescent daughters. Data from 516 parents were analyzed, the majority of whom were female, white, and college educated. Parental acceptance of a CMV vaccine was generally high. Perceived benefits of vaccine were independently associated with vaccine acceptance while history of previous vaccine refusal, concerns about safety and cost of the vaccine were negatively associated. These findings provide initial data on factors that are likely to influence parental acceptance of a CMV vaccine for adolescent girls.

A/H1N1: HCWs refusal of vaccination in Istanbul

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 35, Pages 5653-5756 (9 August 2010)

Vaccination against pandemic influenza A/H1N1 among healthcare workers and reasons for refusing vaccination in Istanbul in last pandemic alert phase
Pages 5703-5710
Sebahat D. Torun, Fuat Torun

Abstract
“Coverage of the HCWs as target population is one of the important determinants for the impact of vaccination. To determine the vaccination against the pandemic influenza A/H1N1 among HCWs, we conducted a cross-sectional questionnaire survey in a public hospital in Istanbul from December 7 to December 22, 2009. Out of total 941 HCWs 718 (76.3%) completed the questionnaires. Nearly one-fourth (23.1%) of the participants were vaccinated against pandemic influenza A/H1N1. Occupation (being a doctor), receiving seasonal influenza vaccine in 2009, agreement with safety of pandemic influenza A/H1N1 vaccine and being comprehend that HCWs have a professional responsibility for getting vaccinated was the strongest independent predictive factor for accepting the pandemic influenza A/H1N1 vaccine (p < .0001). The most frequent reasons for refusing pandemic vaccine were fear of side effects and doubts about vaccine efficacy. Among HCWs 59.6% were recommending pandemic influenza vaccination to a patient even if indicated. In conclusion vaccination against pandemic influenza A/H1N1 is insufficient among HCWs. Misinformed or inadequately informed HCWs are important barrier to pandemic influenza vaccine coverage of the general public also. Educational campaigns concerning HCWs should include evidence based and comprehensible information about possible adverse effects and their incidence besides the advantages of vaccine.”

Europe: The Vaccine Safety, Attitudes, Training and Communication Project (VACSATC)

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 28, Issue 35, Pages 5653-5756 (9 August 2010)

Tracking parental attitudes on vaccination across European countries: The Vaccine Safety, Attitudes, Training and Communication Project (VACSATC)
Pages 5731-5737
Pawel Stefanoff, Svenn-Erik Mamelund, Mary Robinson, Eva Netterlid, Jose Tuells, Marianne A. Riise Bergsaker, Harald Heijbel, Joanne Yarwood and The VACSATC working group on standardization of attitudinal studies in Europe

Abstract
The paper presents the first results from the European project VACSATC which aimed to track parental attitudes on vaccinations across several European countries. We compared five cross-sectional surveys of parents with children less than 3 years of age in England, Norway, Poland, Spain and Sweden carried out during 2008–2009. Data were collected from 6611 respondents. Two countries used face-to face interviews, one used telephone interviews, and two other countries used mail-in questionnaires. In all countries health professionals were indicated as the most important and trusted source of information on vaccination. The study results also show that parental attitudes on vaccinations in the childhood vaccination programs are generally positive. However, there were differences in attitudes on vaccination between the five countries, possibly reflecting different methods of sampling the respondents, context-specific differences (e.g. level of activity of governmental agencies), but also individual-level parental variation in demographic and socioeconomic status variables.

WHO: Chan addresses symposium on creating synergies between intellectual property rights and public health

WHO Director General Dr Margaret Chan delivered opening remarks on “creating synergies between intellectual property rights and public health” at a joint technical symposium by WHO, WIPO and WTO on “Access to Medicines: lessons from procurement practices” held in Geneva, Switzerland, 16 July 2010. The full text is presented below:

Access to medicines: the role of procurement policies

Dr Margaret Chan
Director-General of the World Health Organization

I welcome this opportunity to jointly explore how drug procurement practices, intellectual property policies, competition policies, and ultimately prices can improve access to medicines.

Of all the issues discussed at WHO governing bodies, access to medicines consistently sparks the most heated, sometimes divisive, and potentially explosive debates. This is all the more so since these discussions almost inevitably turn to questions of prices, patents, intellectual property protection, and competition.

The debates are often clouded by suspicions: suspicions that the rules governing international trade in pharmaceutical products are rigged to favour the rich and powerful; that economic interests will trump health concerns; that medicines are being treated just like any other commodity, despite their health-promoting and life-saving roles; and that the social context is forgotten when the rights of patent holders are more important than the right to health.

The debates are further complicated by deep mistrust. Countries unskilled in trade negotiations fear they will be tricked or duped. Countries seeking to use the flexibilities under TRIPS fear they will be punished by trade sanctions imposed in retaliation.     Countries fear that pharmaceutical companies will use unfair tactics, really, every trick in the book, to reduce competition from lower-priced generics.

I understand these suspicions and expressions of mistrust. It is my job to understand them. Taking these concerns on board is part of the quest for consensus on ways to make public health policies, and health outcomes, more equitable.

In a sense, there is nothing new about the main focus of these debates. Improving access to medicines has been a priority for WHO since the Organization began its work in 1948. WHO model lists of essential medicines date back to 1977.

But while the problem of access to medicines is nothing new, the context today is strikingly different than in the past. A quest for greater fairness, in income levels, in opportunities, in access to medicines and health services, has become a strategy for coping with the unique pressures of a globalizing world.

In a world of radically increased interdependence, lives and opportunities, including prospects for better health, are governed by international systems that create benefits, yet have no rules that guarantee fair distribution of these benefits.

The world has changed, and not at all for the better in the roughly one billion people who live on the margins of survival. The gaps in health outcomes are greater today than at any time in recent history. A person in a wealthy country can expect to live more than twice as long as someone from a poor country.

A woman in sub-Saharan Africa faces a risk of dying during pregnancy and childbirth that is more than 100 times greater than a woman living in Europe. These are largely preventable deaths, in which lack of access to essential medicines plays a major role.

This is not a healthy situation, also in terms of social cohesion and stability.

Ladies and gentlemen,

I welcome this opportunity to collaborate with WTO and WIPO as we jointly consider policies for drug procurement, pricing, and intellectual property from a public health perspective. Access to medicines is an appropriate, and a challenging, focus for our joint efforts, which I know will be continuing.

As we seek a common understanding of challenges and potential solutions, let me set out a few big-picture issues and facts. These help explain why access to medicines is such an emotive topic, especially when viewed from the perspective of the developing world.

We face two bottom-line realities. First, the essence of the ethical argument is straightforward. People should not be denied access to life-saving or health-promoting medicines for unfair reasons, including those with economic causes.

Yet the pharmaceutical industry operates in response to economic factors and market forces. This is a profit-driven industry, and not a philanthropist, not a humanitarian enterprise. What incentives does this industry have to fix prices according to their affordability among the poor?

Second, price has a decisive impact on access to medicines. Access is influenced by many other factors, like remoteness, lack of staff, poor procurement practices and delivery systems, and the absence of health insurance schemes. But price can be an absolute barrier to access for the poor. For the poor, access and affordability are usually one and the same.

WHO learned a great deal during the negotiations that eventually led to adoption of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. Some of the tensions between the motives of a profit-driven industry and ethically-driven public health can be circumvented, if not entirely overcome.

Better procurement practices is an area where WHO and UNICEF have extensive experience and some lessons to offer, as you will be hearing later. Government procurement practices have an impact on both the availability and the price of medicines, and are a good entry point for exploring ways to make medicines more accessible.

Let me illustrate the challenge, and the importance of addressing it, with a few facts and figures.

Up to 90% of the population in developing countries purchase medicines through out-of-pocket payments. Medicines account for the second greatest household expenditure, right behind food. As I said, price matters.

The organization of a country’s pharmaceutical sector, its capacity for efficient and impartial procurement, quality control, regulation, and enforcement, affect the availability and price of medicines.

Efficient distribution is also important. When facilities in the public sector experience stock-outs, patients turn to the private sector, where the prices of medicines and the quality of care are often beyond regulatory control.

Surveys conducted in 30 low-income countries found that generic medicines, obtained in the private sector, cost more than 6 times more than their international reference price.

Prices for both originator and generic medicines, in both the public and private sectors, are substantially much lower if procurement and distribution procedures were more efficient, corruption-free and mark-ups were reasonable.

These are some of the problems that can be addressed through more efficient procurement policies. This is a joint opportunity that we are wise to seize.

Thank you.

http://www.who.int/dg/speeches/2010/access_medicines_20100716/en/index.html

WHO: Pandemic (H1N1) 2009 – update 109: 16 July 2010

The WHO continues to issue weekly updates and occasional briefing notes on the H1N1 pandemic at http://www.who.int/csr/disease/swineflu/en/index.html

Pandemic (H1N1) 2009 – update 109
Weekly update
16 July 2010

As of 12 July, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18337deaths…

Situation update:
Worldwide, overall pandemic influenza activity remains low. The most active areas of pandemic influenza virus transmission currently are in parts of South Asia, West Africa, and Central America. In the temperate zone of the southern hemisphere, pandemic and seasonal influenza activity has remained low during the first half of the southern hemisphere winter, except in South Africa, where increased detections of primarily seasonal influenza viruses (type B and H3N2) were reported during late June and early July 2010. Seasonal influenza H3N2 viruses continue to circulate at varying levels across parts of the Americas, Africa, and Southeast Asia. Increased seasonal influenza activity continues to be observed in several countries of Central America…

More at: http://www.who.int/csr/don/2010_07_16/en/index.html

Bavarian Nordic delivers first smallpox vaccine doses for immune-compromised populations

Bavarian Nordic delivered the first 1 million doses of the first smallpox vaccine for certain immune-compromised populations to the Strategic National Stockpile as part of a Project BioShield contract. The Danish company is manufacturing and delivering 20 million doses of its next generation smallpox vaccine known as modified vaccinia Ankara (MVA) or Imvamune. The contract is administered by the Biomedical Advanced Research and Development Authority, BARDA, a part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. HHS said that “in an emergency, such as the virus being obtained from a secure lab and used in an act of terrorism, the vaccine may be authorized for use to protect people who have weakened immune systems, specifically HIV persons who have not progressed to AIDS. Addressing the needs of such special populations is mandated under the Pandemic and All-Hazards Preparedness Act (PAHPA).” HHS noted that Project BioShield gives BARDA the contracting authority to develop and procure medical countermeasures against chemical, biological, nuclear and radiological threat agents. In 2007, Bavarian Nordic was awarded a $505 million contract to develop and deliver the MVA smallpox vaccine to the SNS. http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100714006801&newsLang=en

Vaccine-Induced HIV Seropositivity/Reactivity in Noninfected HIV Vaccine Recipients

JAMA
Vol. 304 No. 3, pp. 239-364, July 21, 2010
http://jama.ama-assn.org/current.dtl

Original Contributions
Vaccine-Induced HIV Seropositivity/Reactivity in Noninfected HIV Vaccine Recipients
Cristine J. Cooper; Barbara Metch; Joan Dragavon; Robert W. Coombs; Lindsey R. Baden; for the NIAID HIV Vaccine Trials Network (HVTN) Vaccine-Induced Seropositivity (VISP) Task Force

Context  Induction of protective anti–human immunodeficiency virus (HIV) immune responses is the goal of an HIV vaccine. However, this may cause a reactive result in routine HIV testing in the absence of HIV infection.

Objective  To evaluate the frequency of vaccine-induced seropositivity/reactivity (VISP) in HIV vaccine trial participants.

Design, Setting, and Participants  Three common US Food and Drug Administration–approved enzyme immunoassay (EIA) HIV antibody kits were used to determine VISP, and a routine diagnostic HIV algorithm was used to evaluate VISP frequency in healthy, HIV-seronegative adults who completed phase 1 (n = 25) and phase 2a (n = 2) vaccine trials conducted from 2000-2010 in the United States, South America, Thailand, and Africa.

Main Outcome Measure  Vaccine-induced seropositivity/reactivity, defined as reactive on 1 or more EIA tests and either Western blot–negative or Western blot–indeterminate/atypical positive (profile consistent with vaccine product) and HIV-1–negative by nucleic acid testing.

Results  Among 2176 participants free of HIV infection who received a vaccine product, 908 (41.7%; 95% confidence interval [CI], 39.6%-43.8%) had VISP, but the occurrence of VISP varied substantially across different HIV vaccine product types: 399 of 460 (86.7%; 95% CI, 83.3%-89.7%) adenovirus 5 product recipients, 295 of 552 (53.4%; 95% CI, 49.2%-57.7%) recipients of poxvirus alone or as a boost, and 35 of 555 (6.3%; 95% CI, 4.4%-8.7%) of DNA-alone product recipients developed VISP. Overall, the highest proportion of VISP (891/2176 tested [40.9%]) occurred with the HIV 1/2 (rDNA) EIA kit compared with the rLAV EIA (150/700 tested [21.4%]), HIV-1 Plus O Microelisa System (193/1309 tested [14.7%]), and HIV 1/2 Peptide and HIV 1/2 Plus O (189/2150 tested [8.8%]) kits. Only 17 of the 908 participants (1.9%) with VISP tested nonreactive using the HIV 1/2 (rDNA) kit. All recipients of a glycoprotein 140 vaccine (n = 70) had VISP, with 94.3% testing reactive with all 3 EIA kits tested. Among 901 participants with VISP and a Western blot result, 92 (10.2%) had a positive Western blot result (displaying an atypical pattern consistent with vaccine product), and 592 (65.7%) had an indeterminate result. Only 8 participants with VISP received a vaccine not containing an envelope insert.

Conclusions  The induction of VISP in HIV vaccine recipients is common, especially with vaccines containing both the HIV-1 envelope and group-specific core antigen gene proteins. Development and detection of VISP appear to be associated with the immunogenicity of the vaccine and the EIA assay used.

Time for Oncologists to Opt In for Routine Opt-Out HIV Testing?

JAMA
Vol. 304 No. 3, pp. 239-364, July 21, 2010
http://jama.ama-assn.org/current.dtl

Special Communications
Time for Oncologists to Opt In for Routine Opt-Out HIV Testing?
Elizabeth Y. Chiao; Bruce J. Dezube; Susan E. Krown; William Wachsman; Malcolm V. Brock; Thomas P. Giordano; Ronald Mitsuyasu; Liron Pantanowitz

Human immunodeficiency virus (HIV)–infected individuals are at high risk of malignancies. However, it is not currently the standard of care to routinely test cancer patients for HIV. In 2006, the Centers for Disease Control and Prevention recommended HIV testing in all health care settings, calling for standard nontargeted “opt-out” HIV screening. For a variety of reasons, routine opt-out HIV testing is still not widely used in the United States. Although many barriers to routine opt-out HIV testing have been addressed, such opt-out HIV testing continues to be conducted primarily in venues that target specific patient populations such as pregnant women. Although opt-out testing has been piloted in emergency departments, less emphasis has been placed on opt-out HIV testing in other clinical settings. In this article, the background, rationale, and evidence for supporting opt-out HIV testing as routine care for cancer patients are presented. In addition, evidence is discussed for the potential of opt-out HIV testing to improve clinical outcomes by facilitating appropriate HIV management during cancer treatment for individuals who are found to be HIV positive.

Editorial: …Ending the HIV/AIDS Pandemic: A Feasible Goal

JAMA
Vol. 304 No. 3, pp. 239-364, July 21, 2010
http://jama.ama-assn.org/current.dtl

Editorial
Controlling and Ultimately Ending the HIV/AIDS Pandemic: A Feasible Goal
Gregory K. Folkers; Anthony S. Fauci

It has been nearly 3 decades since the recognition of AIDS1-2 and the discovery of its etiologic agent, the human immunodeficiency virus (HIV).3 Despite numerous scientific advances and major successes in the areas of prevention and treatment, HIV/AIDS continues to exact an enormous toll.4 Nonetheless, controlling and ultimately ending the HIV/AIDS pandemic is feasible. Such a goal will require 3 overarching elements: increasing HIV testing and availability of antiretroviral therapy (ART) for HIV-infected individuals; curing a sizeable proportion of HIV infected individuals, such that they no longer require lifelong therapy; and preventing new infections, using both previously proven strategies and a new generation of prevention tools…

The Havasu ‘Baaja tribe and informed consent

The Lancet
Jul 17, 2010  Volume 376  Number 9736  Pages 141 – 204
http://www.thelancet.com/journals/lancet/issue/current
[No relevant content]

Online First, 13 July 2010
Comment
The Havasu ‘Baaja tribe and informed consent
Arthur L Caplan, Jonathan D Moreno

The Havasu ‘Baaja tribe, or as they are more generally referred to, the Havasupai, has about 650 members. This tiny band of Native Americans has won a momentous lawsuit that might demand rethinking about the way biological materials are obtained for use in scientific research.

Nature Special Supplement – Outlook: HIV/AID

Nature
Volume 466 Number 7304 pp295-406
http://www.nature.com/nature/current_issue.html

A special supplement titled Outlook: HIV/AIDS is included in this issue with a number of free access articles. The abstract for the supplement notes:
The miraculous drugs that keep so many HIV-positive individuals alive have blunted the urgency with which people talk about the AIDS epidemic. Even so, there is a renaissance afoot in HIV/AIDS research, with renewed focus on a cure, more powerful drugs and innovative approaches to prevention.

The Havasupai Indian Tribe Case

New England Journal of Medicine
Volume 363 — July 15, 2010 — Number 3
http://content.nejm.org/current.shtml

Perspective
The Havasupai Indian Tribe Case — Lessons for Research Involving Stored Biologic Samples
M. M. Mello and L. E. Wolf

On April 20, 2010, Arizona State University (ASU) agreed to pay $700,000 to 41 members of the Havasupai Indian tribe to settle legal claims that university researchers improperly used tribe members’ blood samples in genetic research.1 The settlement closes a difficult chapter for both parties but leaves open a bedeviling question for genetic research: What constitutes adequate informed consent for biospecimens collected for research to be stored and used in future, possibly unrelated studies? The case illuminates the clashing values that have driven debate in this area and the importance of understanding the study population’s perspectives.

HPV vaccine acceptability among Kenyan women

Vaccine
Volume 28, Issue 31, Pages 4859-5144 (12 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Short Communications
HPV vaccine acceptability among Kenyan women
Sylvia Becker-Dreps, Walter Agingu Otieno, Noel T. Brewer, Kawango Agot, Jennifer S. Smith

Abstract
As human papillomavirus (HPV) vaccines become available in less-developed countries, understanding women’s attitudes towards HPV vaccines can help guide approaches to immunization programs. We assessed knowledge and interest in prophylactic HPV vaccines among Kenyan women seeking women’s health services (N = 147). They knew little about cervical cancer or HPV vaccine. Most women (95%, 95% confidence interval [CI]: 92%, 99%), however, were willing to have their daughters vaccinated with a vaccine that would prevent cervical cancer, with preference for an inexpensive vaccine requiring fewer doses.

Computer simulation of H1N1 vaccine allocation

Vaccine
Volume 28, Issue 31, Pages 4859-5144 (12 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

A computer simulation of vaccine prioritization, allocation, and rationing during the 2009 H1N1 influenza pandemic
Bruce Y. Lee, Shawn T. Brown, George W. Korch, Philip C. Cooley, Richard K. Zimmerman, William D. Wheaton, Shanta M. Zimmer, John J. Grefenstette, Rachel R. Bailey, Tina-Marie Assi, Donald S. Burke

Abstract
In the fall 2009, the University of Pittsburgh Models of Infectious Disease Agent Study (MIDAS) team employed an agent-based computer simulation model (ABM) of the greater Washington, DC, metropolitan region to assist the Office of the Assistant Secretary of Public Preparedness and Response, Department of Health and Human Services, to address several key questions regarding vaccine allocation during the 2009 H1N1 influenza pandemic, including comparing a vaccinating children (i.e., highest transmitters)—first policy versus the Advisory Committee on Immunization Practices (ACIP)—recommended vaccinating at-risk individuals-first policy. Our study supported adherence to the ACIP (instead of a children-first policy) prioritization recommendations for the H1N1 influenza vaccine when vaccine is in limited supply and that within the ACIP groups, children should receive highest priority.

Review: the RTS,S malaria vaccine

Vaccine
Volume 28, Issue 31, Pages 4859-5144 (12 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Reviews
The RTS,S malaria vaccine
Sofia Casares, Teodor-Doru Brumeanu, Thomas L. Richie

Abstract
RTS,S is the most advanced candidate vaccine against human malaria. During its remarkable journey from conception and design in the early 1980s to the multicenter Phase 3 trial currently underway across sub-Saharan Africa, RTS,S has overcome tremendous challenges and disproved established vaccine paradigms. In the last several years, Phase 2 studies conducted in infants and children in endemic areas have established the efficacy of RTS,S for reducing morbidity due to clinical malaria. If the results are realized in the Phase 3 trial, the chances for licensure in the near future appear high. Such progress is all the more remarkable given our lack of clear understanding regarding how the vaccine activates the human immune system, the immune correlates of protection or the mechanism whereby a vaccine targeting sporozoites and liver stage parasites can reduce the clinical disease associated with parasitemia. These unanswered questions pose important challenges to be addressed in the quest to understand the protection afforded by RTS,S and to build a more efficacious second generation vaccine against malaria. This review will focus on current knowledge about the protective efficacy of RTS,S and what we have learned regarding its impact on the human immune system.

Influenza vaccine uptake among Dutch health care workers in nursing homes

Vaccine
Volume 28, Issue 31, Pages 4859-5144 (12 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Effects of a multi-faceted program to increase influenza vaccine uptake among health care workers in nursing homes: A cluster randomised controlled trial
I. Looijmans-van den Akker, J.J.M. van Delden, Th.J.M. Verheij, M.A.B. van der Sande, G.A. van Essen, J. Riphagen-Dalhuisen, M.E. Hulscher, E. Hak

Abstract
Despite the recommendation of the Dutch association of nursing home physicians (NVVA) to be immunized against influenza, vaccine uptake among HCWs in nursing homes remains unacceptably low. Therefore we conducted a cluster randomised controlled trial among 33 Dutch nursing homes to assess the effects of a systematically developed multi-faceted intervention program on influenza vaccine uptake among HCWs. The intervention program resulted in a significantly higher, though moderate, influenza vaccine uptake among HCWs in nursing homes. To take full advantage of this measure, either the program should be adjusted and implemented over a longer time period or mandatory influenza vaccination should be considered.

Rotavirus vaccination: worldwide perspective

Vaccine
Volume 28, Issue 31, Pages 4859-5144 (12 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Recommendations for rotavirus vaccination: A worldwide perspective
Carlos Rodrigo, Nuran Salman, Vladimir Tatochenko, Zsofia Mészner, Carlo Giaquinto

Abstract
Official guidelines are crucial for new vaccines to be accepted by physicians and policy makers, and for reimbursement decisions, particularly for vaccines against diseases with an under-appreciated burden, such as rotavirus gastroenteritis (RVGE). Evidence-based guidelines, which take into account the best available data, ensure that new vaccine introductions achieve the greatest sustainable impact. For rotavirus vaccination, guidelines are specific to the locality for which they are developed, reflecting, for example, potential differences in disease burden, prevalence of co-infections (e.g. human immunodeficiency virus) and existing vaccination schedules. By adapting existing evidence-based guidelines, local strategies can be devised to optimise protection against RVGE in different settings.

NIAID funds 10 International Centers of Excellence for Malaria Research

NIAID (National Institute of Allergy and Infectious Diseases), part of the National Institutes of Health, announced approximately US$14 million in first-year funding to establish 10 International Centers of Excellence for Malaria Research (ICEMRs). NIAID said the seven-year awards will establish the Centers in regions where malaria is endemic, including parts of Africa, Asia, the Pacific Islands and Latin America. Teams of scientists involved in the ICEMR program will be conducting research in more than 20 countries. Lee Hall, M.D., Ph.D., chief of the Parasitology and International Programs Branch in NIAID, commented that sustainable and effective malaria control requires research in multiple settings on the complex interactions among the parasite, the mosquito vector, the local ecology and the human host. Dr. Hall added that “The ICEMR program seeks to address this need by creating a network of multidisciplinary research centers in malaria-endemic settings. The centers aim to generate critical knowledge, tools and evidence-based strategies to support intervention and control programs by government organizations and health care institutions.” Each center will:

– Design and conduct multidisciplinary research on the epidemiology, transmission and pathogenesis of malaria in endemic geographic regions;

– Design and conduct special projects to capitalize on new opportunities and emerging public health needs; and

– Develop and conduct training and career development programs for researchers from malaria-endemic areas.

The principal investigators selected to establish the ICEMRs are as follows:

– Malaria Transmission and the Impact of Control Efforts in Southern Africa
Principal Investigator: Peter Agre, M.D.
Lead Institution: Johns Hopkins University, Baltimore

– Center for the Study of Complex Malaria in India
Principal Investigator: Jane Carlton, Ph. D.
Lead Institution: New York University School of Medicine, New York City

– Southeast Asia Malaria Research Center
Principal Investigator: Liwang Cui, Ph.D.
Lead Institution: Pennsylvania State University, University Park

– Program for Resistance, Immunology, Surveillance & Modeling of Malaria in Uganda
Principal Investigator: Matthew Dorsey, M.D.
Lead Institution: University of California, San Francisco

– Latin American Center for Malaria Research and Control
Principal Investigator: Socrates Herrera-Valencia, M.D.
Lead Institution: Caucaseo Scientific Research Center, Cali, Colombia

– Research to Control and Eliminate Malaria in SE Asia and SW Pacific
Principal Investigator: James Kazura, M.D.
Lead Institution: Case Western Reserve University, Cleveland

– Population-based Approach to Malaria Research and Control in West Africa
Principal Investigator: Donald Krogstad, M.D.
Lead Institution: Tulane University, New Orleans

– Malaria Evolution in South Asia
Principal Investigator: Pradipsinh Rathod, Ph. D.
Lead Institution: University of Washington, Seattle

– Determinants of Malaria Disease in Malawi
Principal Investigator: Terrie Taylor, D.O.
Lead Institution: Michigan State University, East Lansing

– Peruvian/Brazilian Amazon Center of Excellence in Malaria
Principal Investigator: Joseph Vinetz, M.D.
Lead Institution: University of California, San Diego

http://www.nih.gov/news/health/jul2010/niaid-08a.htm

WHO: Measles Initiative highlights global goals and strategies

The WHO released this update on the Measles Initiative [full text]:
Measles Initiative highlights the importance of adherence to global goals and strategies

In light of recent reports in the media concerning measles outbreaks, the Measles Initiative clarifies global goals and underlines the importance of full implementation of the recommended control strategies. No target date has been established for achieving the global eradication of measles. Member States attending the World Health Assembly in 2010 endorsed the following global measles control targets for 2015 as milestones towards the eventual eradication of measles:
– to exceed 90% coverage with the first dose of measles-containing vaccine nationally and exceed 80% vaccination coverage in every district or equivalent administrative unit;
– to reduce annual reported measles incidence to less than five cases per million and maintain that level; and
– to reduce measles mortality by 95% or more in comparison with 2000 estimates.

The strategies for achieving these goals are: achieving and maintaining high population immunity through delivery of two doses of measles vaccine to all children; effective laboratory-backed disease surveillance; and effective treatment of measles cases including administration of vitamin A.

Consistent implementation of these strategies has resulted in substantial progress in reducing deaths from measles — by 78%, from an estimated 733 000 deaths in 2000 to an estimated 164 000 deaths in 2008. In 2008, global routine coverage with the first dose of measles-containing vaccine reached 83%, an increase from 72% in 2000. In 2008, more than 110 million children received measles vaccine through mass immunization campaigns in the 47 priority countries identified as having a high measles mortality burden in 2000. The reduction of measles deaths worldwide is advancing progress on Millennium Development Goal 4 — to reduce child mortality.

However, significant challenges to further progress remain. These include: competing public health priorities; weak immunization systems; sustaining high routine vaccination coverage; addressing the funding gap of almost US$ 300 million for the 47 priority countries if the 2015 goals are to be met; vaccinating hard-to-reach populations; and addressing an increasing number of measles outbreaks.

In the past 12 months (from July 2009 to June 2010), measles outbreaks have occurred in over 30 African countries, resulting in more than 89 000 reported measles cases and nearly 1400 reported measles deaths. The majority of measles cases in these outbreaks have occurred among children who have never been vaccinated, indicating that lack of vaccination is the underlying cause. The recent outbreaks serve as a stark reminder of the risks of not achieving very high vaccination coverage (>95%) through routine services and mass immunization campaigns. Commitment by countries with a high burden of measles and all partners working on measles activities to agreed goals and strategies will be the cornerstone of all efforts.

http://measlesinitiative.org/Measles/News%20Releases%20&%20Statements/2010/MI_Statement%20in%20Response%20to%20Guardian%20Article_July%202,%202010.pdf

Related links: Measles Initiative  http://www.measlesinitiative.org/

WHO: Pandemic (H1N1) 2009 – update 108: 9 July 2010

The WHO continues to issue weekly updates and occasional briefing notes on the H1N1 pandemic at http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 – update 108
Weekly update
9 July 2010

As of 4 July, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18311 deaths…

Situation update:
Worldwide, overall pandemic influenza activity remains low. Active circulation of pandemic influenza virus persists in areas of the tropics, particularly in South and Southeast Asia, the Caribbean and West Africa. Overall pandemic and seasonal influenza activity has remained low during the early part of the current winter season in the temperate zone of the southern hemisphere. Low levels of seasonal influenza (H3N2 and type B) viruses were detected during June 2010 in South Africa, while Chile, Australia, and New Zealand, have all recently detected low levels of predominantly pandemic influenza virus. Increasing seasonal influenza activity has also recently been observed in several countries of Central America….

More at:http://www.who.int/csr/don/2010_07_09/en/index.html

Global Health Council elects PATH president and CEO Dr. Christopher Elias to board

The Global Health Council Board of Directors elected PATH president and CEO Dr. Christopher Elias to a three-year term. The Global Health Council describes itself as the world’s largest membership alliance of public health organizations and professionals dedicated to saving lives by improving health throughout the world. Dr. Elias joins new members Elizabeth Furst Frank, senior vice president for Global Program Operations at AmeriCares, and Patricia McGrath, a commercial real estate investor, asset manager, and consultant. Joel Lamstein, co-founder and president of John Snow Inc., was appointed chair of the board, succeeding Susan Dentzer, editor-in-chief of Health Affairs.

http://www.path.org/news/an100707-ghc-board.php

IAVI elects Margaret McGlynn to board

The International AIDS Vaccine Initiative (IAVI) announced the appointment of Margaret McGlynn, former President of Global Vaccines and Anti-infectives at Merck, to its board of directors. IAVI said Ms. McGlynn “joins a highly independent group of 16 advisors from 10 countries who meet three times a year to assess IAVI’s progress and shape its long-term strategy.” IAVI President and CEO Seth Berkley said, “We are delighted to have Margie on the board. We expect that her business acumen, her hands-on experience in the vaccine industry and HIV marketplace, and the depth of her knowledge about health, public policy and development issues will prove invaluable to the board. She also brings considerable insight on building strong relationships between the nonprofit and private sectors in global health initiatives.” http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100706005057&newsLang=en

Lancet Editorial: Muskoka: G8–G20 standing at a crossroads

The Lancet
Jul 10, 2010  Volume 376  Number 9735  Pages 69 – 140
http://www.thelancet.com/journals/lancet/issue/current

Editorial
G8–G20: standing at a crossroads
The Lancet

All eyes were on Canada, as first the G8 summit in Muskoka and then the G20 summit in Toronto delivered their visions for the future. It is the first time that the two groups have met so close in time and space, and provides an opportunity to gauge what we can and should expect in terms of global health governance from two very different groups.

A welcome cornerstone of the G8’s final communiqué was the Muskoka Initiative, which seeks to raise US$30 billion of new funds from G8 members plus a group of non-G8 countries over the next 5 years to meet Millennium Development Goals 4 and 5 on maternal, newborn, and child health. However, with the 2011 G8 hosts, France, yet to commit to keeping maternal, newborn, and child health on next year’s agenda, and with the G8 still licking its wounds after falling $15 billion short of its 2005 Gleneagles commitments, there is ample opportunity for the G20 to seize the initiative on global health.

The G20 were willing to take up the slack from the G8 on that most benighted of issues, financial regulation. On June 23, 2010, we published a Viewpoint by Sudeep Chand and colleagues that posed the question: should health be next? Judging by the final communiqué from Toronto, the G20 does not yet have an answer. The communiqué mentions health only once, in the context of strengthening social safety nets. However, it did commit to forming a Working Group on Development tasked with devising a development agenda to be outlined at the Seoul G20 summit in November. Health has to be central to this agenda.

Brazil, Russia, India, and China signalled their intention to take a more active role in world affairs in June last year, with Russian President Dmitry Medvedev marking the first ever summit between the four countries by saying they wanted to “create the conditions for a fairer world order”. These countries have the political and economic capital to set the G20 agenda on health, so let us hope they recognise that health security is not an optional extra for a stable and prosperous world.

Malaria in Africa: the decade since the Abuja Declaration

The Lancet
Jul 10, 2010  Volume 376  Number 9735  Pages 69 – 140
http://www.thelancet.com/journals/lancet/issue/current

Viewpoint
Malaria in Africa: progress and prospects in the decade since the Abuja Declaration
Robert W Snow, Kevin Marsh

Preview
Malaria is a global health problem but more than 70% of the total morbidity is in Africa.1 10 years ago, heads of state from across Africa signed a declaration in Abuja, Nigeria, to “halve the malaria mortality for Africa’s people by 2010”.2 This Viewpoint discusses how far we have come in this effort, what we can expect for the future, and what our priorities should be.

Science Special Report: HIV/AIDS

Science
9 July 2010  Vol 329, Issue 5988, Pages 109-244
http://www.sciencemag.org/current.dtl

Special Report: HIV/AIDS
HIV/AIDS: Eastern Europe

Editorial:
AIDS Response at a Crossroads

Jessica Justman and Wafaa M. El-Sadr

Policy Forum
Gender Inequities Must Be Addressed in HIV Prevention
Rachel Jewkes

Building gender equity and reducing gender-based violence are vital in the fight against AIDS.
Universal Access in the Fight Against HIV/AIDS
Françoise Girard, Nathan Ford, Julio Montaner, Pedro Cahn, and Elly Katabira.

Cholera vaccines: WHO position paper

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Meeting Reports
Cholera vaccines: WHO position paper—Recommendations
WHO Publication

Abstract
This article presents the WHO recommendations on the use of cholera vaccines excerpted from the recently published Cholera vaccines: WHO position paper. This document replaces the WHO position paper on Cholera vaccines published in the Weekly Epidemiological Record in April 2001. Footnotes to this paper provide a limited number of core references; their abstracts as well as a more comprehensive list of references may be found at http://www.who.int/immunization/documents/positionpapers/en/index.html.

Grading tables which assess the quality of scientific evidence for key conclusions are also available through this link and are referenced in the position paper. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO’s current position on the use of vaccines in the global context. This updated paper reflects the recent recommendations of WHO’s Strategic Advisory Group of Experts on immunization (SAGE).

MALVAC 2009: Whole Organism Malaria Vaccines for Endemic Countries

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

MALVAC 2009: Progress and Challenges in Development of Whole Organism Malaria Vaccines for Endemic Countries, 3–4 June 2009, Dakar, Senegal
M. Pinder, V.S. Moorthy, B.D. Akanmori, B. Genton, G.V. Brown

Abstract
Research and development into whole organism malaria vaccines is progressing rapidly thanks to the major investments over recent years from several funders, and the commitment and interest of many leading researchers. Progress includes the discovery of potential new candidate vaccines and the start of the first phase 1/2a clinical trial of the radiation attenuated sporozoite approach for Plasmodium falciparum, under US Food and Drug Administration regulatory oversight. A group of leading scientists, clinical trialists and stakeholders, together with representatives of regulatory authorities including some from African countries, met recently to document the issues that will require detailed consideration to assess this promising approach. Questions related to scale-up, quality, purity and consistency of a manufacturing process using mosquitoes to generate a commercial product, and demonstration of the stability of attenuated sporozoites will need further work. Should a high level of efficacy be demonstrated in clinical challenge studies, it will become a priority to agree in which populations and age groups questions about strain-transcendence and duration of efficacy should be answered, and how clinical development can progress with an approach based on cryopreservation in liquid nitrogen.

2009–2010 global production of seasonal and pandemic (H1N1) influenza vaccines

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Short Communications
Global production of seasonal and pandemic (H1N1) influenza vaccines in 2009–2010 and comparison with previous estimates and global action plan targets
Jeffrey Partridge, Marie Paule Kieny and the World Health Organization H1N1 influenza vaccine Task Force

Abstract
Immunization against influenza is considered among the most important interventions in reducing the public health impact of seasonal epidemic and pandemic influenza infections. However, there are marked differences across countries with regards to production, supply and access to influenza vaccines. A global action plan (GAP) to increase supply of pandemic influenza vaccine was developed by the World Health Organization in May 2006 to reduce the anticipated gap between potential vaccine demand and supply during an influenza pandemic. To quantify the increase in global influenza vaccine production capacity and actual production in response to the influenza A(H1N1) 2009 pandemic, 3 years after the development of the GAP, the WHO conducted a survey of vaccine producers from December 2009 through February 2010, and compared the results of this survey with results from surveys conducted in 2006–2007 and May 2009.

Post-licensure surveillance initiatives for GARDASIL/SILGARD

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Reviews
A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD
Paolo Bonanni, Catherine Cohet, Susanne K. Kjaer, Nina B. Latham, Paul-Henri Lambert, Keith Reisinger, Richard M. Haupt

Abstract
GARDASIL has been shown to reduce the incidence of pre-cancerous cervical, vulvar, and vaginal lesions, and external genital warts causally related to HPV6/11/16/18. Because of its expected public health benefit on reduction of cervical cancer and other HPV-related diseases, this vaccine has been rapidly implemented in the routine vaccination programs of several countries. It is therefore essential to assess its impact and safety through post-licensure surveillance programs. Here, we present a summary of 16 post-licensure safety and impact studies across 20 countries. These studies address general safety, including autoimmune disorders, long-term effectiveness, and type replacement. A summary of the surveillance efforts of the Unites States Centers for Disease Control and Prevention can be found in the accompanying article by Markowitz et al.

Post-licensure monitoring of HPV vaccine in U.S.

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Post-licensure monitoring of HPV vaccine in the United States
Lauri E. Markowitz, Susan Hariri, Elizabeth R. Unger, Mona Saraiya, S. Deblina Datta, Eileen F. Dunne

Abstract
Post-licensure evaluation of vaccines plays an important role in monitoring the progress of immunization programs, demonstrating population impact of vaccines, and providing data for ongoing policy decisions. Two human papillomovirus (HPV) vaccines are licensed and recommended for use in females in the United States, a quadrivalent human HPV vaccine, licensed in 2006 and a bivalent vaccine HPV vaccine licensed in 2009. HPV vaccination is recommended for females 11 or 12 years of age with catch-up vaccination through age 26 years. Post-licensure monitoring of the HPV vaccine program has included some of the same systems established for other vaccines, such as those for vaccine safety and coverage monitoring. However, monitoring HPV vaccine impact on infection and disease outcomes has required new efforts. While there are well established cancer registries in the United States, it will take decades before the impact of vaccine on cervical cancer is observed. More proximal measures of vaccine impact include outcomes such as prevalence of HPV vaccine types, incidence of cervical precancers and genital warts. We review systems in place or being established for post-licensure monitoring of HPV vaccine in the United States.

Seasonal and H1N1 influenza vaccination coverage and attitudes: HCWs: Spanish University Hospital

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
Seasonal and Pandemic A (H1N1) 2009 influenza vaccination coverage and attitudes among health-care workers in a Spanish University Hospital
Silvia Vírseda, María Alejandra Restrepo, Elena Arranz, Purificación Magán-Tapia, Mario Fernández-Ruiz, Agustín Gómez de la Cámara, José María Aguado, Francisco López-Medrano

Abstract
Influenza vaccination coverage among health-care workers (HCWs) remains the lowest compared with other priority groups for immunization. Little is known about the acceptability and compliance with the pandemic (H1N1) 2009 influenza vaccine among HCWs during the current campaign. Between 23 December 2009 and 13 January 2010, once the workplace vaccination program was over, we conducted a cross-sectional, questionnaire-based survey at the University Hospital 12 de Octubre (Madrid, Spain). Five hundred twenty-seven HCWs were asked about their influenza immunization history during the 2009–2010 season, as well as the reasons for accepting or declining either the seasonal or pandemic vaccines. Multiple logistic-regression analysis was preformed to identify variables associated with immunization acceptance. A total of 262 HCWs (49.7%) reported having received the seasonal vaccine, while only 87 (16.5%) affirmed having received the pandemic influenza (H1N1) 2009 vaccine. “Self-protection” and “protection of the patient” were the most frequently adduced reasons for acceptance of the pandemic vaccination, whereas the existence of “doubts about vaccine efficacy” and “fear of adverse reactions” were the main arguments for refusal. Simultaneous receipt of the seasonal vaccine (odds ratio [OR]: 0.27; 95% confidence interval [95% CI]: 0.14–0.52) and being a staff (OR: 0.08; 95% CI: 0.04–0.19) or a resident physician (OR: 0.16; 95% CI: 0.05–0.50) emerged as independent predictors for pandemic vaccine acceptance, whereas self-reported membership of a priority group was associated with refusal (OR: 5.98; 95% CI: 1.35–26.5). The pandemic (H1N1) 2009 influenza vaccination coverage among the HCWs in our institution was very low (16.5%), suggesting the role of specific attitudinal barriers and misconceptions about immunization in a global pandemic scenario.

Market size and public health value of an HIV-1 vaccine

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

The potential global market size and public health value of an HIV-1 vaccine in a complex global market
Carol A. Marzetta, Stephen S. Lee, Sandra J. Wrobel, Kanwarjit J. Singh, Nina Russell, José Esparza

Abstract
An effective HIV vaccine will be essential for the control of the HIV pandemic. This study evaluated the potential global market size and value of a hypothetical HIV vaccine and considered clade diversity, disease burden, partial prevention of acquisition, impact of a reduction in viral load resulting in a decrease in transmission and delay to treatment, health care system differences regarding access, and HIV screening and vaccination, across all public and private markets. Vaccine product profiles varied from a vaccine that would have no effect on preventing infection to a vaccine that would effectively prevent infection and reduce viral load. High disease burden countries (HDBC; HIV prevalence ≥1%) were assumed to routinely vaccinate pre-sexually active adolescents (10 years old), whereas low disease burden countries (LDBC; HIV prevalence rate <1%) were assumed to routinely vaccinate higher risk populations only. At steady state, routine vaccination demand for vaccines that would prevent infection only was 22–61 million annual doses with a potential market value of $210 million to $2.7 billion, depending on the vaccine product profile. If one-time catch-up campaigns were included (11–14 years old for HDBC and higher risk groups for LDBC), the additional cumulative 70–237 million doses were needed over a 10-year period with a potential market value of $695 million to $13.4 billion, depending on the vaccine product profile. Market size and value varied across market segments with the majority of the value in high income countries and the majority of the demand in low income countries. However, the value of the potential market in low income countries is still significant with up to $550 million annually for routine vaccination only and up to $1.7 billion for a one-time only catch-up campaign in 11–14 years old. In the most detail to date, this study evaluated market size and value of a potential multi-clade HIV vaccine, accounting for differences in disease burden, product profile and health care complexities. These findings provide donors and suppliers highly credible new data to consider in their continued efforts to develop an HIV-1 vaccine to address the worldwide disease burden.

IAVI: Japan pledged US$10 million to support AIDS vaccine research

The International AIDS Vaccine Initiative (IAVI) announced that the Government of Japan pledged US$10 million to support AIDS vaccine research and development over the next five years. The grant will be managed through a newly-established World Bank trust fund. Seth Berkley, President and CEO of IAVI, said, “We are extremely grateful to Japan for its generous contribution to AIDS vaccine research and development, and also to the World Bank for its untiring support to IAVI and the fight against HIV/AIDS. Japan has been a leader in the fight against infectious diseases and has the scientific capacity to help advance research for one of the toughest public health challenges we face today, the control and ultimate elimination of HIV/AIDS.”

IAVI said that with funds from Japan, and in collaboration with its Japanese partners, it “will continue to advance an AIDS vaccine candidate that is constructed using a paramyxovirus known as the Sendai virus. Viral vectors based on the Sendai family have the potential to elicit a durable and highly-targeted immune response in mucosal tissues, where HIV often establishes infection before it amplifies and spreads.”

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100628005160&newsLang=en

FT Editorial: Pandemic lessons

[Editor’s Note: We will occasionally including opinion pieces from major media sources relevant of our focus on vaccines ethic and policy]

Pandemic lessons
Financial Times
Published: July 2 2010 22:26

As last year’s fear of a flu pandemic fades, the search for culprits is intensifying. Several post-mortems are under way, but the feverish search for scapegoats for the many billions of dollars spent by governments in preparations is misguided.

The UK’s evaluation, chaired by Dame Deirdre Hine and published last Thursday, offers a balanced judgment. It argues that the British response – which cost more than £1.2bn – was largely “proportionate and effective”.

Given the shortages of supply, the lengthy period required to make and test flu vaccines, and the uncertainties around the dangers of the virus at the time, ministers were understandably tempted to risk over-spending for a mild virus rather than under-spending and causing unnecessary deaths.

That is a better assessment than a recent hysterical report from the Council of Europe, which – relying on hindsight – claims a conspiracy of drug companies and health agencies exaggerated the threat of the pandemic. Its unsubstantiated critique risks undermining health agencies far more than they weakened themselves by what it claims amounted to “crying wolf.”

Seasonal flu kills hundreds of thousands of people each year. The current pandemic has claimed many more lives than the officially confirmed toll, including a disproportionate number of children and adults of working age.

The virus is still circulating and will return to the northern hemisphere this winter to cause more illness and death. It may yet mutate into a more serious form. Investments already made will help mitigate the effect.

Yet there are lessons to be drawn from the international response of the past few months. The World Health Organisation should introduce more subtlety to its flu pandemic assessment, adding a measure of severity to its simple definition of a new and fast-spreading virus.

Individual countries, including the UK, should modify their plans to make them more flexible. Many decisions were based on assumptions of a far more lethal virus than the current H1N1, and not adapted accordingly.

Greater efforts should also be made to include a broader range of experts in early risk assessments, such as carrying out more extensive blood tests across the UK. Such studies last year suggested early on that H1N1 was likely to be milder than initially feared.

Internationally, the slow pace of donations of flu vaccines to poorer countries has also highlighted excessive red tape that caused unnecessary infection and death.

A relatively benign virus more than any human intervention lay behind the current pandemic’s light burden. Next time, the threat may be greater and the response will need to be better.

WHO: Pandemic (H1N1) 2009 – update 107: 2 July 2010

The WHO continues to issue weekly updates and occasional briefing notes on the H1N1 pandemic at http://www.who.int/csr/disease/swineflu/en/index.html

Pandemic (H1N1) 2009 – update 107
Weekly update
2 July 2010
As of 27 June, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18239 deaths…

Situation update:
Summary: Worldwide, overall pandemic and seasonal influenza activity remains low. In the temperate regions of the Southern Hemisphere, Chile, and Argentina report low activity and only sporadic detections of both pandemic and seasonal influenza viruses during the early part of winter. South Africa, New Zealand, and Australia have all recently noted slight increases in the rate of respiratory disease. South Africa recently reported their first case of confirmed H1N1; however, the predominant influenza virus there currently is seasonal influenza A(H3N2). The H3N2 virus detected in South Africa is similar to the Perth-like strain, which is currently a component of the trivalent seasonal influenza vaccine. Active transmission of pandemic influenza virus still persists in localized areas of the tropics, particularly in South and Southeast Asia, the Caribbean and West Africa. During the last 2 to 3 weeks, seasonal influenza H3N2 viruses have also been detected at increasing levels in Nicaragua, and low levels or sporadically in Australia, Central America, South Africa and East Africa. Global circulation of seasonal influenza virus type B viruses persists at low levels in parts of East Asia, Central Africa, and Central America…

More at: http://www.who.int/csr/don/2010_07_02/en/index.html

WHO podcast: Polio – the fight till eradication

The WHO released a new podcast and transcript: “Polio: the fight till eradication.” The announcement noted that “polio eradication is at a critical juncture. While the world is close to stamping out polio, this will require renewed commitment. Specifically it will entail renewed political, financial and scientific commitment.”

Transcript at: http://www.who.int/mediacentre/multimedia/podcasts/2010/polio_20100702/en/index.html

Podcast at: http://terrance.who.int/mediacentre/podcasts/WHO_podcast_099.mp3