Global Fund: U.K. Multilateral Aid Review & Support; Mali program suspension

The Global Fund noted that it was one of 9 international organizations determined to have an “excellent track record” for delivering results and would receive increased funding in the future, based on the U.K. Multilateral Aid Review (MAR). The review “found that the Global Fund played a critical role in delivering health-related Millennium Development Goals (MDGs) and was likely to remain a key financier of existing and new approaches to tackling AIDS, tuberculosis and malaria.” The purpose of the Multilateral Aid Review, commissioned by the UK’s Department for International Development (DFID), was “to assess whether the UK is getting the best possible value for the money that it contributes to international organizations.” The review also gave the Global Fund “high marks for transparency and accountability, saying that the ‘Fund’s decision to publish/require recipients to publish procurement data has been a major driver for a range of innovations in transparency.’”

http://www.theglobalfund.org/en/pressreleases/?pr=pr_110301

Separately, the Global Fund announced suspension of a US$13.91 million HIV/AIDS grant to Mali “with immediate effect until new arrangements for managing the grant are in place to safeguard Global Fund assets. The current Principal Recipient, Groupe Pivot Santé Population, will be replaced. The decision to suspend the grant comes after evidence was discovered that Global Fund grant money has been misused. It is part of a process of restoring confidence in the ability of Mali’s health sector to manage Global Fund resources appropriately.” In December 2010, the Global Fund suspended funding of two malaria grants in Mali and terminated a third grant for tuberculosis “after evidence of misappropriation and unjustified expenditure was found. The suspended grant provides funding for prevention programs, including condom distribution, voluntary counseling and testing and support for children who have been orphaned or made vulnerable by the AIDS epidemic. The grant suspension does not affect any of the 22,500 patients on antiretroviral treatment in Mali. They are financed by a second grant, managed by the National High Council for HIV/AIDS control of Mali, which is not affected by this decision.”

http://www.theglobalfund.org/en/pressreleases/?pr=pr_110302

HHS: US$125 million to Novavax, VaxInnate for flu vaccine development

The U.S. Department of Health and Human Services (HHS) awarded two contracts “to help make vaccine available more quickly for seasonal flu outbreaks and pandemics.” The contracts involve “advanced development of new types of vaccine and new ways to make flu vaccine known as next-generation recombinant influenza vaccine and total US$215 million.” HHS Secretary Kathleen Sebelius said, “These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months which can save more lives during a pandemic as well as during seasonal flu outbreaks.” HHS awarded one of the contracts to Novavax, Inc.(Rockville, Md) for US$97 million over the first three years, which can be extended for an additional two years, for a total contract value of US$179.1 million. Under its contract, Novavax is “to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate a strong immune response in humans.” HHS awarded a separate contract to VaxInnate, Inc. (Cranbury, N.J.) for US$117.9 million over the first three years, which can be extended for two additional years, for a total contract value of US$196.6 million. VaxInnate is “developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate strong immune response to protect against the flu.”

Through these contracts, both companies will conduct clinical safety and efficacy studies http://www.businesswire.com/news/home/20110228007038/en/HHS-Awards-Contracts-Develop-Flu-Vaccine-Technology

Liquidia Technologies: Gates Foundation PRI: US$10 million

Liquidia Technologies announced the Bill & Melinda Gates Foundation made a US$10 million program-related investment (PRI) to support the company’s “development and commercialization of safer and more effective vaccines and therapeutics. This follows recent announcements of the first Liquidia clinical trial of its lead seasonal flu candidate (LIQ001) and a collaborative agreement with the PATH Malaria Vaccine Initiative (MVI).” Neal Fowler, CEO of Liquidia, said, “We are delighted the Gates Foundation has decided to join an outstanding group of investors that share our confidence in the potential of PRINT technology to improve vaccine delivery and effectiveness. As the field of vaccines continues to grow, success will be defined by our ability to produce and deliver highly efficacious therapies in quantities and costs that will support the global demand.”

http://www.liquidia.com/press/Liquidia_Gates_PR.pdf

THSTI and IAVI announce joint HIV vaccine design program in India

The Translational Health Sciences and Technology Institute (THSTI), an autonomous institute of the Indian government’s Department of Biotechnology, and the International AIDS Vaccine Initiative (IAVI) announced an agreement “to jointly establish, operate and fund an HIV Vaccine Design Program in India. The program will include the establishment of a new laboratory on the campus of THSTI in the National Capital Region of New Delhi…and will primarily focus on one of the greatest scientific challenges of AIDS vaccine design and development: the elicitation of antibodies capable of neutralizing a broad spectrum of circulating HIV variants, a problem that stems in large part from the almost unparalleled mutability of HIV.” M.K. Bhan, Secretary of the Department of Biotechnology, India, said, “With 7,100 people newly infected with HIV every day, effective tools to prevent infection are indispensible to the fight against HIV and AIDS. India alone has 2.7 million HIV-positive people within its borders. A broadly effective AIDS vaccine would be a powerful asset to efforts to arrest the spread of HIV. The Department of Biotechnology believes that it is only through partnerships like the one we have forged, involving international collaborations and the open sharing of scientific knowledge, that we will boost translational research and solve the complex global biomedical problems of our times.”

Seth Berkley, CEO of IAVI, said, “We are very excited about the launch of this collaboration. We are grateful for the unequivocal support this partnership has received from the Indian government and are confident it will contribute to ongoing efforts in India and elsewhere to design a broadly effective AIDS vaccine. India has an exceptional reserve of top-notch researchers, some of whom are already working closely with IAVI.”

http://www.iavi.org/news-center/Pages/PressRelease.aspx?pubID=3194

Twitter Watch: 7 March 2011

Twitter Watch
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and not intended to be exhaustive.

EndPolioNow EndPolioNow
Buy tickets for Itzhak Perlman in Chicago, 7 March, for the Concert to End Polio. http://cot.ag/hl14VS

gatesfoundation Gates Foundation
VOTE: Creative ideas raising awareness on #vaccines and their vital importance for #globalhealth: http://bit.ly/hxuJFl

AIDSvaccine IAVI
@USAID Admin Raj Shah gives #TED talk on #science, #tech & #innovation for #globaldev, #globalhealth: http://bit.ly/fqGWBG

sabinvaccine Sabin Vaccine Inst.
This is a spectacular video @onecampaign – A #Rotavirus Vaccine’s Journey: http://bit.ly/ey8mde

Hepatitis B Virus in the United States

Annals of Internal Medicine
March 1, 2011; 154 (5)
http://www.annals.org/content/current

Original Research
Hepatitis B Virus in the United States: Infection, Exposure, and Immunity Rates in a Nationally Representative Survey
George N. Ioannou
Ann Intern Med March 1, 2011 154:319-328; doi:10.1059/0003-4819-154-5-201103010-00006

Current estimates of the prevalence of hepatitis B virus (HBV) infection, exposure, and immunity are needed to assess the effectiveness of programs to prevent transmission. This study of 39 787 participants in the National Health and Nutrition Examination Survey (1999 to 2008) found that among persons aged 6 years or older, 0.27% (approximately 704 000) had chronic HBV infection and 4.6% (approximately 11 993 000) had been exposed to HBV. Infection and past exposure were uncommon among persons aged 6 to 19 years, and 68.6% of children aged 2 years had immunity. The investigator concludes that vaccination of high-risk adults should continue to be emphasized.

High-Value, Cost-Conscious Health Care

Annals of Internal Medicine
March 1, 2011; 154 (5)
http://www.annals.org/content/current

High-Value, Cost-Conscious Health Care: Concepts for Clinicians to Evaluate the Benefits, Harms, and Costs of Medical Interventions
Douglas K. Owens, Amir Qaseem, Roger Chou, Paul Shekelle, and for the Clinical Guidelines Committee of the American College of Physicians
Ann Intern Med February 1, 2011 154:174-180;

Abstract
Health care costs in the United States are increasing unsustainably, and further efforts to control costs are inevitable and essential. Efforts to control expenditures should focus on the value, in addition to the costs, of health care interventions. Whether an intervention provides high value depends on assessing whether its health benefits justify its costs. High-cost interventions may provide good value because they are highly beneficial; conversely, low-cost interventions may have little or no value if they provide little benefit.

Thus, the challenge becomes determining how to slow the rate of increase in costs while preserving high-value, high-quality care. A first step is to decrease or eliminate care that provides no benefit and may even be harmful. A second step is to provide medical interventions that provide good value: medical benefits that are commensurate with their costs.

This article discusses 3 key concepts for understanding how to assess the value of health care interventions. First, assessing the benefits, harms, and costs of an intervention is essential to understand whether it provides good value. Second, assessing the cost of an intervention should include not only the cost of the intervention itself but also any downstream costs that occur because the intervention was performed. Third, the incremental cost-effectiveness ratio estimates the additional cost required to obtain additional health benefits and provides a key measure of the value of a health care intervention.

Rationing healthcare by thresholds of minimum effectiveness

British Medical Journal
5 March 2011 Volume 342, Issue 7796
http://www.bmj.com/content/current

Analysis
Ethics and effectiveness: rationing healthcare by thresholds of minimum effectiveness
Alena M Buyx, Daniel R Friedrich, Bettina Schöne-Seifert

Extract
Alena Buyx, Daniel Friedrich, and Bettina Schöne-Seifert argue that basing rationing decisions on clinical effectiveness rather than cost effectiveness would be fairer and could make it more acceptable

Scarcity of healthcare resources calls for fair, acceptable, and ethically justified ways of allocating and rationing care. Particularly in financially difficult times, this is a formidable challenge. So far, no developed country has managed to introduce criteria for fair rationing that have remained undisputed. This is not surprising. Rationing healthcare by definition goes beyond eliminating waste 1 and thus requires difficult moral choices. 2 Whoever gets afflicted, it almost always hurts, and cuts must therefore have sound ethical justification. Cost effectiveness in particular—one of the main criteria used by the National Institute for Health and Clinical Excellence (NICE) in funding decisions—has long been attacked for ethical reasons. 3

One simple criterion for rationing that has been paid little attention is minimum effectiveness thresholds. Although public debates show increasing reservations about expending enormous effort for very small clinical benefit, 4 medical interventions with only minimal effects seem to be part of today’s regular medical practice. For example, some of the newly approved monoclonal antibody drugs for end stage cancer at best prolong patients’ lives for a few weeks or months without any substantial improvement in their health related quality of life. Reasons for the prevalence of such treatments are manifold: in many Western countries, doctors prescribe the drugs because they are (often wrongly) afraid of legal liability or dread to admit that “there is nothing more we can do”; patients dwell on unrealistic hopes; and relatives have trouble facing their loved one’s end. 5 6

We think it is irrational and wrong to ration clearly effective treatments while offering others that promise very low individual benefits. Before other cuts are considered, …

Pneumococcal Conjugate and Polysaccharide Vaccination in Adults

Clinical Infectious Diseases
Volume 52 Issue 6 March 15, 2011
http://www.journals.uchicago.edu/toc/cid/current
Rajeka Lazarus, Elizabeth Clutterbuck, Ly-Mee Yu, Jaclyn Bowman, Elizabeth A. Bateman, Linda Diggle, Brian Angus, Tim E. Peto, Peter C. Beverley, David Mant,
and Andrew J. Pollard

A Randomized Study Comparing Combined Pneumococcal Conjugate and Polysaccharide Vaccination Schedules in Adults
Clin Infect Dis. (2011) 52(6): 736-742 doi:10.1093/cid/cir003

Combined schedules of pneumococcal conjugate and polysaccharide vaccines do not provide enhanced immunogenicity for the seven serotypes tested in comparison to a single dose of pneumococcal conjugate vaccine in adults.

Bridging Implementation, Knowledge, Ambition Gaps to Eliminate Tuberculosis

Emerging Infectious Diseases
Volume 17, Number 3–March 2011
http://www.cdc.gov/ncidod/EID/index.htm

Perspective
Bridging Implementation, Knowledge, and Ambition Gaps to Eliminate Tuberculosis in the United States and Globally
K.G. Castro and P. Lobue

Abstract
We reflect on remarkable accomplishments in global tuberculosis (TB) control and identify persistent obstacles to the successful elimination of TB from the United States and globally. One hundred and twenty nine years after Koch’s discovery of the etiologic agent of TB, this health scourge continues to account for 9.4 million cases and 1.7 million deaths annually worldwide. Implementation of the Directly Observed Treatment Short-course strategy from 1995 through 2009 has saved 6 million lives. TB control is increasingly being achieved in countries with high-income economies, yet TB continues to plague persons living in countries with low-income and lower-middle–income economies. To accelerate progress against the global effects of disease caused by TB and achieve its elimination, we must bridge 3 key gaps in implementation, knowledge, and ambition.

Civil society in ASEAN

The Lancet
Mar 05, 2011 Volume 377  Number 9768  Pages 783 – 874
http://www.thelancet.com/journals/lancet/issue/current

Comment
Civil society in ASEAN: a healthy development?
Andrew Wells-Dang, Giang Wells-Dang

Preview
Across southeast Asia, local citizens engage in collective action for health, the basis of networks of trust that are often overlooked by state agencies and external observers. Informal groups and Buddhist monks provided first aid and food assistance to survivors after Myanmar’s cyclone Nargis in 2008, in the absence of governmental and external assistance.1,2 In Vietnam, support provided by local Buddhist and Catholic congregations, and organisations such as the Women’s Union, have expanded to fill the increase in demand for local health services as the previously subsidised state monopoly splintered into an uneven mixture of public and private health providers.

Measles eradication: Heymann et al 2010: correspondence

The Lancet
Mar 05, 2011 Volume 377  Number 9768  Pages 783 – 874
http://www.thelancet.com/journals/lancet/issue/current

Correspondence
Measles eradication
Athalia Christie, Andrea Gay
Preview
The recommendation by David Heymann and colleagues (Nov 20, p 1719)1 that high routine immunisation coverage be a prerequisite for measles campaigns or a measles eradication goal disregards current policy and the progress made in the past decade.

Measles eradication
David N Durrheim, Hyam Bashour
Preview
David Heymann and colleagues1 consider progress towards regional elimination of measles a distraction from polio eradication efforts. However, measles vaccine has proven one of the most cost-effective measures for saving vulnerable children’s lives. Attaining high coverage of measles immunisation worldwide represents one of the most effective propoor strategies available.2

Measles eradication
Jon Kim Andrus, Ciro A de Quadros
Preview
We share David Heymann and colleagues’ concern that “any eventual strategy for measles eradication should truly strengthen routine immunisation and should not become a substitute”.1 Simply put, any measles eradication strategy should strengthen the overall health system’s capacity for improved surveillance and delivery of services, not just immunisation. That was the experience with the eradication of poliomyelitis, measles, and, more recently, rubella and congenital rubella syndrome in the Americas.

Measles eradication – Authors’ reply
David Heymann, Paul E Fine, Ulla K Griffiths, Andew J Hall
Preview
We welcome the comments on a proposed measles eradication strategy, and the further debate on measles eradication that has ensued. That, in fact, was our hope as we wrote the Comment about potential measles eradication strategies. As the correspondents point out, measles elimination—which includes periodic measles vaccination campaigns—is currently underway, and five of the six WHO regions have set elimination targets. Elimination is not eradication, although the terms are often confused.1

Save the Children Report: “No Child Born to Die”

The Lancet Infectious Disease
Mar 2011  Volume 11  Number 3  Pages 153 – 252
http://www.thelancet.com/journals/laninf/issue/current

News Desk
Vaccine progress reveals resource gaps in developing countries
Talha Khan Burki

Preview
In 1990, the baseline year for the Millennium Development Goals, more than 12 million children died before reaching their fifth birthday. By 2009, this number had been reduced to 8 million. Sturdy progress, certainly, but if Millennium Development Goal 4—which aims to reduce child mortality by two-thirds by 2015—is to be achieved the present rate of decline will not suffice. A new report by Save the Children, No Child Born to Die, warns of three resource gaps—immunisation, health workers, and financing—that are impeding progress towards the attainment of Millennium Development Goal 4.

Pdf at: http://www.savethechildren.org.uk/assets/images/No_Child_Born_to_Die_low_res.pdf

Hib Vaccination Coverage During Shortage

Pediatrics
March 2011 / VOLUME 127 / ISSUE 3
http://pediatrics.aappublications.org/current.shtml

Articles
Up-to-Date Haemophilus influenzae Type b Vaccination Coverage During a Vaccine Shortage
Karen E. White, Laura J. Pabst, and Karen A. Cullen
Pediatrics 2011; 127: e707-e712

Abstract
OBJECTIVES We sought to assess Haemophilus influenzae type b (Hib) vaccination coverage in diverse areas of the United States during the 2008–2009 Hib vaccine shortage. Interim recommendations for Hib vaccination during the shortage called for deferral of the booster dose only among children not at high risk for disease; the primary series given during the first year of life continued to be recommended for all children.

METHODS Vaccination data on 123 000 children were collected from 8 Immunization Information System (IIS) sentinel sites. Completion of the primary Hib series (with 2 or 3 doses depending on vaccine type) by 9 months old during the vaccine shortage was compared with coverage of 2 vaccines given at similar ages (7-valent pneumococcal conjugate vaccine and diphtheria, tetanus acellular pertussis vaccine) in children born between November 1, 2007, and March 31, 2008.

RESULTS During the shortage period, Hib vaccination coverage for the primary series was 7.8 to 10.3 percentage points lower than diphtheria, tetanus acellular pertussis vaccine and 7-valent pneumococcal conjugate vaccine coverage for children by the age of 9 months in 7 of 8 sentinel sites.

CONCLUSIONS A significant decrease in Hib vaccination coverage for the primary series was observed and was consistent across several US localities. Close collaboration between the public health community and vaccine providers is essential during vaccine shortages to ensure that interim vaccination recommendations are clear, widely disseminated, and closely followed, and that access to available vaccine supplies is maintained.

Herd immunity post rotavirus vaccination program: Austria

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 15 pp. 2649-2822 (24 March 2011)

Herd immunity after two years of the universal mass vaccination program against rotavirus gastroenteritis in Austria Original Research Article
Pages 2791-2796
Maria Paulke-Korinek, Michael Kundi, Pamela Rendi-Wagner, Alfred de Martin, Gerald Eder, Birgit Schmidle-Loss, Andreas Vecsei, Herwig Kollaritsch

Abstract
Austria was the first country in Europe implementing a universal mass vaccination program against rotavirus gastroenteritis (RV-GE) for all infants nationwide. Epidemiological data from a hospital based surveillance system show that incidence rates of children hospitalized with RV-GE decreased in 2009 compared to 2008 and compared to the prevaccination period 2001–2005. Decreasing hospitalization-rates from RV-GE were observed in children of all age groups, even in those not eligible for vaccination according to their age, suggesting herd immunity induced by universal mass vaccination against RV-GE. In 2009 the disease burden was highest in children below three months of age stressing the importance of the early start of the immunization course.

Text message reminders to promote HPV vaccination

Vaccine
Volume 29, Issue 14 pp. 2509-2648 (21 March 2011)

Text message reminders to promote human papillomavirus vaccination

Original Research Article
Pages 2537-2541
Elyse Olshen Kharbanda, Melissa S. Stockwell, Harrison W. Fox, Raquel Andres, Marcos Lara, Vaughn I. Rickert

Abstract
Objective: To implement and evaluate text message reminders for the second (HPV2) and third (HPV3) vaccine doses.

Design: Site-based intervention.

Setting: Nine pediatric sites (5 academic and 4 private) located in New York City.

Participants: Parents of adolescents 9–20 years who received HPV1 or HPV2 during the intervention period, January–June 2009.

Intervention:Parents who enrolled received up to three weekly text message reminders that their daughter was due for her next vaccine dose.

Outcome measure: On-time receipt of the next vaccine dose, within one month of its due date.

Results: During the intervention period, of 765 eligible HPV vaccine events, 434 enrollment instructions were distributed to parents (56.7% of doses). Parents of 124 adolescent girls (28.6% of those handed instructions) activated text message reminders. Comparing children of parents who enrolled versus those who did not, on-time receipt of next HPV vaccine dose occurred among 51.6% (95% CI 42.8–60.4%) versus 35.0% (95% CI 29.6–40.2%) of adolescents (p = .001). Similarly, among a historical cohort of adolescents, receiving HPV1 or HPV2 in the six months prior to the intervention period, on-time receipt of next vaccine dose was noted for 38.1% (95% CI 35.2–41.0%) (p = .003). Increases in receipt of next vaccine dose among intervention subjects were sustained at 4 months following the vaccine due date. Using a logistic regression model, after controlling for insurance and site of care, intervention subjects were significantly more likely than either control population to receive their next HPV vaccine dose on-time.

Conclusion: Among those choosing to enroll, text message reminders were an effective intervention to increase on-time receipt of HPV2 or HPV3.

Mothers’ support for voluntary HPV vaccination in schools

Vaccine
Volume 29, Issue 14 pp. 2509-2648 (21 March 2011)

Mothers’ support for voluntary provision of HPV vaccine in schools

Original Research Article
Pages 2542-2547
Jessica A. Kadis, Annie-Laurie McRee, Sami L. Gottlieb, Morgan R. Lee, Paul L. Reiter, Patricia J. Dittus, Noel T. Brewer

Abstract
HPV vaccination rates among adolescents in the United States lag behind some other developed countries, many of which routinely offer the vaccine in schools. We sought to assess mothers’ willingness to have their adolescent daughters receive HPV vaccine at school. A national sample of mothers of adolescent females ages 11–14 completed our internet survey (response rate = 66%). The final sample (n = 496) excluded mothers who did not intend to have their daughters receive HPV vaccine in the next year. Overall, 67% of mothers who intended to vaccinate their daughters or had vaccinated their daughters reported being willing to have their daughters receive HPV vaccine at school. Mothers were more willing to allow their daughters to receive HPV vaccine in schools if they had not yet initiated the vaccine series for their daughters or resided in the Midwest or West (all p < .05). The two concerns about voluntary school-based provision of HPV vaccine that mothers most frequently cited were that their daughters’ doctors should keep track of her shots (64%) and that they wished to be present when their daughters were vaccinated (40%). Our study suggests that most mothers who support adolescent vaccination for HPV find school-based HPV vaccination an acceptable option. Ensuring communication of immunization records with doctors and allowing parents to be present during immunization may increase parental support.

Reaching Every District (RED) strategy – Assam, India: 2005–2008

Vaccine
Volume 29, Issue 14 pp. 2509-2648 (21 March 2011)
Implementation and evaluation of the Reaching Every District (RED) strategy in Assam, India, 2005–2008 Original Research Article
Pages 2555-2560
Tove K. Ryman, Ajay Trakroo, Aaron Wallace, Satish Kumar Gupta, Karen Wilkins, Pankaj Mehta, Vance Dietz

Abstract
In 2005, UNICEF and the Centers for Disease Control and Prevention implemented and evaluated the Reaching Every District (RED) approach, an intervention designed to improve key components of immunization services including planning, outreach, community mobilization, supervision, and monitoring, in select districts of Assam, India. Two intervention and 3 comparison districts were selected for a 2-year evaluation trial. In intervention districts, immunization staff received comprehensive training and ongoing supervision by a fulltime consultant, and regular monitoring of progress was conducted. Population-based vaccination coverage surveys were conducted at baseline and 2 years after the start of implementation in the 5 districts. Post-intervention process indicators were systematically collected and focus group discussions were held. At follow-up, children in both the intervention and comparison districts were twice as likely to be fully vaccinated as they were at baseline. However, sites that received intervention training were better performing than those that did not, as measured by process indicators, including a higher number of outreach visits planned and held (p = 0.02), having a monitoring chart (p < 0.01), and correctly calculating dropout (p < 0.01). The number of supervisory visits was significantly and positively associated with other key process indicators. Although coverage did not differ significantly between intervention and comparison districts, among individual districts, process data indicate significant improvements in program quality in the intervention districts. Further studies are needed to determine if the improved process indicators have sustainable impact on maintaining improvements in coverage.

U.S. Supreme Court affirms National Childhood Vaccine Injury Act

The U.S. Supreme Court decided 6-2 to affirm a lower court ruling upholding the National Childhood Vaccine Injury Act. The Act prevents civil suits against manufacturers of FDA-approved childhood vaccines “based on a claim that a particular vaccine should have been designed differently.” The opinion of the Court in the case – Bruesewitz v. Wyeth – stated that “[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”  In an amicus brief, the American Academy of Pediatrics and over 20 other professional and public health organizations argued that a ruling against Wyeth could “precipitate the same crisis that Congress sought to avert in passing the Vaccine Act: ‘the very real possibility of vaccine shortages, and, in turn increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable diseases.’” The court’s opinion is available at: http://www.supremecourt.gov/opinions/10pdf/09-152.pdf.

IVI and Sanofi Pasteur to collaborate on dengue vaccine accessibility

The International Vaccine Institute (IVI) and Sanofi Pasteur announced “their intent to work together towards creating the conditions to make a dengue vaccine widely accessible to countries where this disease is endemic.” Dr. Ragnar Norrby, Chairman of the IVI Board of Trustees, said, “A dengue vaccine represents the most viable prevention tool in our quest to reduce the growing number of dengue infections occurring globally each year. We thank Sanofi Pasteur for their commitment to reducing the considerable burden placed on communities and health systems around the world due to dengue and dengue hemorrhagic fever.“ Earlier this month, the IVI announced the launch of the Dengue Vaccine Initiative, in collaboration with the Sabin Vaccine Institute, the Johns Hopkins University, and the World Health Organization. Through a $6.9 million grant from the Bill & Melinda Gates Foundation, DVI “will accelerate the availability and utilization of safe, affordable and broadly protective vaccines to combat dengue.”

http://www.ivi.org/event_news/news_view.asp?enid=118

WHO: priorities for vaccine prequalification evaluations – 2011-2012

WHO released the priorities for vaccine evaluations for prequalification for 2011-2012. The prioritization list below “is a tool published every two years by the WHO by the prequalification programme to guide decisions as to the vaccines on which to focus resources.” Vaccines are categorized in four groups: high, medium, low and no priority. The priority list was developed by consultation between WHO and the two United Nations purchasing agencies (UNICEF and the Pan American Health Organization Revolving Fund) which use the prequalification service for vaccines. The prioritization exercise takes into account needs from WHO programmes (e.g. polio, measles, rabies) and the International Health Regulations, as well as vaccines defined globally as priority for accelerated introduction.

WHO said that in the consultation process for the current list, vaccines were considered if, based on information available to the UN purchasing agencies and WHO, they were already available in the market or were expected to become available during the biennium 2011-2012. The criteria used to assign priorities include:

a) Demand in the respective UN-supplied markets, with consideration given to plans for introduction;
b) WHO programmatic needs;
c) recommendations of WHO’s Strategic Advisory Group of Experts (SAGE) on immunization ; and
d) security of supplies: number, diversity, and production capacity of suppliers in the market.

Vaccines prequalification priority list 2011-12

– High priority vaccines

– Bivalent oral polio (bOPV1+3)

– DTwP based pentavalent combination (fully liquid DTwP-Hep B-Hib)

– Inactivated polio (IPV)

– Meningococcal A-containing conjugate

– Meningoccocal AC-containing polysaccharide

– Meningococcal W-containing polysaccharide

– Meningococcal W-containing conjugate

– Pneumococcal conjugate

– Rotavirus

– Trivalent oral polio (tOPV)

– Yellow fever

Vaccines of high programmatic interest but not available for supply in January 2011 (e.g. dengue; malaria; and new formulations of current vaccine types with enhanced stability outside of the currently accepted storage conditions) may be considered as high priority if they become available before the end of the period for which the list is in force.

http://www.who.int/immunization_standards/vaccine_quality/pq_priorities/en/index.html

Global Immunization News (25 February 2011)

WHO released the newest issue of Global Immunization News (25 February 2011) http://www.who.int/entity/immunization/GIN_February_2011.pdf Included in this issue:

ANNOUNCEMENTS FROM THE SIVAC INITIATIVE

25/02/2011 from Julia Blau, AMP

The briefing described below is available in the Center of Expertise on the NITAG Resource

– The “Introduction to Health Economic Evaluations for NITAG members briefing” is an e-learning tool that provides NITAG members with a basic background on health economic evaluations applied to immunization. It contains 4 modules of 10 to 40 minutes each:

– Module 1: The usefulness of economic evaluations for public health

– Module 2: The different types of economic evaluations

– Module 3: The main methodological issues of an economic evaluation

– Module 4: Interpretation of cost-effectiveness ratios

http://www.nitag-resource.org/en/training/rapid-briefing.php

Twitter Watch: 28 February 2011

Twitter Watch

A selection of items of interest this week from a variety of twitter feeds from NGOs and other sources

SingerPeter Peter Singer
Great photo of polio vaccination @gatesfoundation! Is there an ethical obligation to complete polio eradication? Yes! http://bit.ly/dfbjT2
26 Feb

CDCgov CDC.gov
Protect your child against #rotavirus. #Vaccinate beginning at 2 months of age. http://go.usa.gov/g7A
25 Feb

USAID USAID
Podcast of Deputy Assistant Admin for Global Health Amie Batson on the importance of #vaccines: @GLOBALHEALTHorg http://tinyurl.com/643gtse
24 Feb

MalariaVaccine PATH MVI
RT @PATHtweets: RTS,S is the first malaria vaccine candidate to ever reach large-scale Phase 3 clinical testing. http://ow.ly/3XFed
22 Feb

Health outcomes in economic evaluation: the QALY and utilities

British Medical Bulletin
Volume 96 Issue 1 December 2010
http://bmb.oxfordjournals.org/content/current

Articles
Sarah J. Whitehead and Shehzad Ali

Health outcomes in economic evaluation: the QALY and utilities
Br Med Bull (2010) 96(1): 5-21 first published online October 29, 2010 doi:10.1093/bmb/ldq033

Abstract
The quality-adjusted life year (QALY) is routinely used as a summary measure of health outcome for economic evaluation, which incorporates the impact on both the quantity and quality of life. Key studies relating to the QALY and utility measurement are the sources of data. Areas of agreement include the need for a standard measure of health outcome to enable comparisons across different disease areas and populations, and the methods used for valuing health states in utility measurement. Areas of controversy include the limitation of the QALY approach in terms of the health benefits it can capture, its blindness towards equity concerns, the underlying theoretical assumptions and the most appropriate generic preference-based measure of utility. There is growing debate relating to whether a QALY is the same regardless of who accrues it, and also the issue as to who should value health states. Research is required to further enhance the QALY approach to deal with challenges relating to equity-weighted utility maximization and testing the validity of underlying assumptions. Issues around choosing between condition-specific measures and generic instruments also merit further investigation.

Editorial: Pandemic influenza vaccines

British Medical Journal
26 February 2011 Volume 342, Issue 7795
http://www.bmj.com/content/current

Editorials
Pandemic influenza vaccines
John M Watson, Richard G Pebody
BMJ 342:doi:10.1136/bmj.d545 (Published 8 February 2011

Extract
Are protective, but are limited by delays in availability

Almost as soon as the new influenza A/H1N1 2009 virus was identified in April 2009, its pandemic potential was realised. 1 Immediate steps were taken by vaccine manufacturers, working with the World Health Organization’s network of influenza reference laboratories, and with regulatory and standardisation authorities, to develop a pandemic specific vaccine and manufacture enough to meet global needs. To make best use of the H1N1 antigen, low dose monovalent vaccines were developed with the addition of adjuvant to enhance immunogenicity. These vaccines became available towards the end of 2009. The first of several studies to assess the effectiveness of these pandemic influenza A/H1N1 vaccines, including the linked study (doi: 10.1136/bmj.c7297 ) by Skowronski and colleagues, 2 are now being published.

On the basis of the emerging epidemiological picture, pandemic vaccines were given to subsets of the population at higher risk of infection and severe disease according to national immunisation policies. In the United Kingdom, people with underlying health conditions that place them at increased risk from the complications of influenza, including those aged 65 years and over …

Editorial: Better spending needed for neglected diseases

The Lancet
Feb 26, 2011  Volume 377  Number 9767  Pages 691 – 782
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Better spending needed for neglected diseases
The Lancet

Preview
Over the past decade, there has been a concerted effort, mainly by public and philanthropic organisations, to counter the neglect of developing world diseases by increasing funding for research and development. The Global Funding of Innovation for Neglected Diseases (G-FINDER) survey, now in its third year, does the valuable job of tracking this global investment. The latest survey covers 31 neglected diseases, including HIV, malaria, and tuberculosis as well as conditions such as leprosy and trachoma.

Universal health care in India by 2020

The Lancet
Feb 26, 2011  Volume 377  Number 9767  Pages 691 – 782
http://www.thelancet.com/journals/lancet/issue/current

Series
Towards achievement of universal health care in India by 2020: a call to action
K Srinath Reddy, Vikram Patel, Prabhat Jha, Vinod K Paul, AK Shiva Kumar, Lalit Dandona, for The Lancet

Preview
To sustain the positive economic trajectory that India has had during the past decade, and to honour the fundamental right of all citizens to adequate health care, the health of all Indian people has to be given the highest priority in public policy. We propose the creation of the Integrated National Health System in India through provision of universal health insurance, establishment of autonomous organisations to enable accountable and evidence-based good-quality health-care practices and development of appropriately trained human resources, the restructuring of health governance to make it coordinated and decentralised, and legislation of health entitlement for all Indian people.

Dengue Vaccines: Regulatory Pathways

PLoS Medicine
(Accessed 27 February 2011)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results

Dengue Vaccines Regulatory Pathways: A Report on Two Meetings with Regulators of Developing Countries
Richard Mahoney, Liliana Chocarro, James Southern, Donald P. Francis, John Vose, Harold Margolis Policy Forum, published 22 Feb 2011
doi:10.1371/journal.pmed.1000418

Summary Points
– Because a dengue vaccine should be tetravalent in nature and provide protection against all four dengue serotypes, regulatory agencies need to address additional issues associated with multi-valent vaccines such as interference between the vaccine serotypes.

– Safety assessment needs to account for the potential risk of inducing antibody-enhanced diseases (antibody-dependent enhancement).

– Because of the varying epidemiology and disease impact in different countries and regions, dengue vaccines will likely need to be evaluated in diverse populations initially in both the Americas and the Asia Pacific region.

– Several national regulatory authorities (NRAs) in endemic developing countries are likely to be engaged in review of both applications for clinical evaluation and for marketing of vaccines and they should receive support as appropriate.

– Manufacturers can submit a dossier to the European Medicines Agency for the Evaluation of Medicinal Products (EMA) for review (Scientific Opinion). This is possible due to the introduction of Article 58 of EMA’s regulation 726/2004 (within which the example of dengue is specifically mentioned). This Opinion could facilitate the review process by NRAs in developing countries. Manufacturers may also obtain scientific advice and protocol assistance from the EMA, which may facilitate later Article 58 review.

– The Developing Countries’ Vaccine Regulators Network recommends that consideration be given to agreements for joint reviews of clinical trial applications by similarly affected NRAs and also the review of applications for licensure in order to accelerate the launch and introduction of dengue vaccines. The NRAs would need to have access to the necessary expertise to review the quality and safety aspects of the license application.

– It is critical that improved standardized tests be introduced as soon as possible for the diagnosis of early infection and for the measurement of immune protection (requiring identification of a correlate of protection). The World Health Organization (WHO), through its Expert Committee on Biological Standardization, can evaluate and standardize such tests; in addition, WHO and its Collaborating Centers may also help ensure availability of necessary standards and reagents for use in the field.

EDITORIAL: Advancing Regulatory Science

Science
25 February 2011 vol 331, issue 6020, pages 975-1098
http://www.sciencemag.org/current.dtl

EDITORIAL:
Advancing Regulatory Science
Margaret A. Hamburg, Commissioner of the U.S. Food and Drug Administration

Summary
Ensuring the safety and quality of food and medical products has never been more complicated. Societies around the world face increasingly complex challenges that require harnessing the best available science and technology on behalf of patients and consumers. This effort requires a strong field of regulatory science to develop new tools, standards, and approaches that efficiently and consistently assess the safety, efficacy, quality, and performance of products. Yet, despite being a critical component of the scientific enterprise, regulatory science has long been underappreciated and underfunded.

HPV vaccine: adolescent girls in high-risk communities

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 12 pp. 2227-2348 (9 March 2011)

Regular Papers
Human papillomavirus vaccine initiation among adolescent girls in high-risk communities Original Research Article
Pages 2235-2241
Sarah L. Guerry, Christine J. De Rosa, Lauri E. Markowitz, Susan Walker, Nicole Liddon, Peter R. Kerndt, Sami L. Gottlieb

Abstract
Background
We assessed human papillomavirus (HPV) vaccine uptake among adolescent girls, parents’ intentions to vaccinate daughters, and barriers and facilitators of vaccination in a population at elevated risk for cervical cancer.

Methods
Between October 2007 and June 2008, telephone surveys were conducted with randomly selected parents/guardians of 11–18 year old girls attending public middle and high schools serving economically disadvantaged populations in Los Angeles County.

Results
We surveyed 509 predominantly Hispanic (81%) and African American (16%) parents; 71% responded in Spanish. Overall, 23% reported their daughter had received ≥1 dose of HPV vaccine. Although 93% of daughters had seen a doctor in the past year, only 30% reported that a provider recommended HPV vaccine. Characteristics positively associated with odds of having initiated HPV vaccine were having heard of the vaccine (adjusted odds ratio [aOR] 2.6), belief in vaccine effectiveness (aOR 2.9), and doctor recommendation (aOR 48.5). Negative attitudes toward HPV vaccine (aOR 0.2) and needing more information about it (aOR 0.1) were negatively associated with vaccine initiation. Of those with unvaccinated daughters (n = 387), 62% said they “probably/definitely will” vaccinate within the next year and 21% were undecided or didn’t know; only 11% said they definitely won’t.

Conclusions
About one-quarter of adolescent girls in this at-risk community had initiated HPV vaccine by mid-2008. Provider recommendation was the single most important factor associated with vaccination. Because a substantial proportion of parents remain undecided about HPV vaccine, health care providers can play a key role by providing needed information and offering HPV vaccine to all eligible adolescents.

Lessons from smallpox eradication campaign in Bihar State and India

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 11 pp. 2005-2226 (3 March 2011)

Meeting Report
Lessons from smallpox eradication campaign in Bihar State and in India
Pages 2005-2007
Mahendra Dutta, R.N. Basu

Abstract
Following several key breakthroughs during the mid-1960s under the global smallpox eradication programme namely, development of a thermo-stable vaccine, efficient and acceptable technique of it’s delivery by bifurcated needle and evolution of a strategy (in lieu of mass vaccination) of active case search and containment, an intensified campaign of smallpox eradication from India was successfully implemented during 1973–1975. A formidable battle was fought, particularly in Bihar state leading to the occurrence of last indigenous case on 17 May 1975. The rapid achievement of eradication of the scourge from India in a record time was hailed as unprecedented in public health history. The single key factor in the achievement was the sustained efforts of a band of national and international epidemiologists, supported by young medical interns heading mobile containment teams, working under trying field conditions.

Through the campaign several important lessons were learnt and innovations made. Important among these were: (i) need for refinement of tools, techniques, and strategies for attaining the objective; (ii) implementation of a time and target oriented campaign; (iii) support of adequate and dedicated short term personnel to supplement supervision and field activities; (iv) providing of flexible funding and a convenient disbursement procedure; (v) building private-public partnership; (vi) devising of simple innovations, based on feedback from field, to support activities; (vii) development of political commitment; (viii) improved communication from field to higher levels to enable action on recent information; (ix) regular periodic staff meetings at each administrative level to facilitate early recognition and correction of deficiencies; (x) mobilization of support from international community, whenever required.

Vaccine eligibility and acceptance: ambulatory obstetric and gynecologic patients

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 11 pp. 2005-2226 (3 March 2011)

Regular Papers
Vaccine eligibility and acceptance among ambulatory obstetric and gynecologic patients Original Research Article
Pages 2024-2028
Wendy S. Vitek, Aletha Akers, Leslie A. Meyn, Galen E. Switzer, Bruce Y. Lee, Richard H. Beigi

Abstract
Objective
To assess vaccine eligibility and factors associated with vaccine acceptance among ambulatory obstetric and gynecologic patients.

Methods
An anonymous office-based survey was administered to women seeking ambulatory obstetric and gynecologic care at a large women’s hospital from December 2007 to July 2008. Information collected included: demographics, medical and vaccination history, interest in receiving vaccines and attitudes towards vaccine providers. Vaccine eligibility was based on age and/or self-reported risk factors in accord with the 2007–2008 Center for Disease Control and Prevention (CDC) adult immunization schedule. Vaccine eligibility was examined using descriptive statistics, and demographic characteristics were compared using chi-squared analysis. A multivariable logistic regression model was developed to assess factors associated with participants’ willingness to accept vaccines from their obstetrician–gynecologist.

Results
A total of 1441 women completed the survey. The majority of participants (87%) would accept vaccines if recommended by their obstetrician–gynecologist. The primary factors associated with vaccine acceptance were having less than a high school education, being privately insured, currently being pregnant, reporting a history of vaccinations and previously receiving vaccinations from an obstetrician–gynecologist. A significant portion of participants were eligible for the hepatitis B, influenza and HPV vaccines (≥50% for each). The type of vaccine did not influence willingness to accept vaccines from an obstetrician–gynecologist.

Conclusion
A majority of women appear eligible for, and will accept, vaccinations regardless of specific vaccine, if recommended by their obstetrician–gynecologist. These findings justify ongoing efforts to expand immunization services offered by obstetrician–gynecologists.

Economic value of seasonal and H1N1 influenza vaccination

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 11 pp. 2005-2226 (3 March 2011)

From the patient perspective: The economic value of seasonal and H1N1 influenza vaccination Original Research Article
Pages 2149-2158
Bruce Y. Lee, Kristina M. Bacon, Julie M. Donohue, Ann E. Wiringa, Rachel R. Bailey, Richard K. Zimmerman

Abstract
Although studies have suggested that a patient’s perceived cost-benefit of a medical intervention could affect his or her utilization of the intervention, the economic value of influenza vaccine from the patient’s perspective remains unclear. Therefore, we developed a stochastic decision analytic computer model representing an adult’s decision of whether to get vaccinated. Different scenarios explored the impact of the patient being insured versus uninsured, influenza attack rate, vaccine administration costs and vaccination time costs. Results indicated that the cost of avoiding influenza was fairly low (with one driver being required vaccination time). To encourage vaccination, decision makers may want to focus on ways to reduce this time, such as vaccinating at work, churches, or other normally frequented locations.

H1N1 vaccination uptake among HCWs in Qatar

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Issue 11 pp. 2005-2226 (3 March 2011)

Pandemic influenza A/H1N1 vaccination uptake among health care workers in Qatar: Motivators and barriers Original Research Article
Pages 2206-2211
Mohamed Ghaith Alkuwari, Nagah A. Aziz, Zaher A.S. Nazzal, Saad A. Al-Nuaimi

Abstract
Influenza A/H1N1 new vaccine helps control disease spread. Cross-sectional survey was conducted at PHC & Emergency Departments in Qatar to determine influenza A/H1N1 vaccination rate among HCWs and associated factors, 523 HCWs were enrolled. The study showed that 13.4% HCWs received vaccination. Feeling protected strongly influenced vaccination decision (OR = 14.5). Uncertainty about vaccine efficacy and fear of side effects strongly influenced decision to reject the vaccine (OR = 0.3 and 0.2 respectively). Vaccination coverage was very low. The most common barriers were uncertainty about vaccine efficacy and fear of side effects. Health authorities should build message highlighting how the benefit of vaccination outweighs risk.

HHS: National Vaccine Plan (2020)

The U.S. Department of Health and Human Services released a new National Vaccine Plan to “enhance coordination of all aspects of federal vaccine and immunization activities (and) to ensure that all Americans can access the preventive benefits of vaccines.”  HHS described that new plan as “a wide-ranging guide to innovating the nation’s vaccine system. It addresses such issues as research and development, supply, financing, distribution, safety, global cooperation, and informed decision-making among consumers and health care providers.” This is the first update of the National Vaccine Plan since the original version in 1994.

Bruce Gellin, M.D., M.P.H., Director of the National Vaccine Program Office and Deputy Assistant Secretary for Health, said, “This plan is a 10-year vision for the nation to more effectively prevent infectious diseases and reduce adverse reactions to vaccines. The plan is national in scope. Implementation will require a well-organized effort among stakeholders, including federal, state and local policymakers, health care providers, manufacturers, academia, philanthropic organizations, and the public.” HHS said next steps include “a series of regional meetings with stakeholders in the spring and summer of 2011, which will focus on how to implement the strategies laid out in the National Vaccine Plan. The final implementation plan will be completed by the end of 2011.”

Text of the new National Vaccine Plan: http://www.hhs.gov/nvpo/vacc_plan/.

http://www.businesswire.com/news/home/20110216006036/en/HHS-releases-strategic-plan-advance-vaccine-immunization

Gates Fdn announces retirement of Dr. Tachi Yamada

The Bill & Melinda Gates Foundation announced that Dr. Tachi Yamada president of the Foundation’s Global Health Program intends to retire from his position after serving for five years. Bill Gates, co-chair of the Gates Foundation, commented, “Tachi has done a great job of focusing our ability to create and deliver vaccines and other interventions to the people who need them the most. He has put our global health programs on a path to success, and we look forward to building on his work.” Dr. Margaret Chan, Director-General of the World Health Organization, said, “Tachi’s leadership has helped keep the global health community focused on results. He has built a long-lasting partnership with the WHO and we look forward to remaining deeply engaged with the Gates Foundation.” The Foundation said Dr. Yamada will remain in his role until June and that a global search for his successor is underway. Dr. Yamada said, “It has been my greatest privilege to be able to impact the lives of so many people in need. I will always cherish the friendship and collaboration of my outstanding colleagues who have been my partners in this endeavor.”

http://www.gatesfoundation.org/press-releases/Pages/tachi-yamada-to-leave-110214.aspx

NIH: David E. Barmes Global Health Lecture: 15 February 2011

Dr. Rajiv Shah, Administrator of the United States Agency for International Development (USAID) presented the most recent David E. Barmes Global Health Lecture on Tuesday, 15 February 2011 at NIH in Bethesda, Maryland. In his remarks, Dr. Shah noted USAID is:

– Recommitting to the Millennium Development Goals by building sustainable governance and delivery systems to support healthy and productive lives.

– Investing in country-owned models of inclusive growth and development in a focused set of countries that are well-governed, economically stable, globally connected and market-oriented.

– Developing and delivering scientific and technological breakthroughs.

The recorded videocast of Dr. Shah’s lecture is available here: Addressing Grand Challenges: The Role of Science in Global Health Development [VIDEO] The transcript is available here: Remarks by USAID Administrator Dr. Rajiv Shah

http://www.fic.nih.gov/news/events/barmeslecture.htm

APHA Policy: Influenza vaccination of health workers

The American Public Health Association adopted 17 policies at its 138th Annual Meeting 6-10 November 2010 in Denver. The newly adopted policies “address a broad range of public health concerns, from environmental health issues and public health education and workforce challenges to oral health prevention strategies and implications of immigration policy on public health outcomes.” Included was:

201014 Influenza vaccination of health workers — Supports implementation of requirements for all health workers to receive an annual influenza vaccination. Urges providers, employers and other organizations to implement comprehensive infection control programs, including vaccination training and education, housekeeping and standard respiratory precautions in keeping with infection control standards. Emphasizes that vaccination of health workers is important for their own protection, not just patient safety.

The full text of all policies are available at: http://www.apha.org/advocacy/policy/policysearch/

http://www.apha.org/about/news/pressreleases/2011/2010adoptedpolciesrelease.htm

Twitter Watch: 21 February 2011

Twitter Watch
A selection of items of interest this week from a variety of twitter feeds from NGOs and other sources

gatesfoundation Gates Foundation
“We need a higher sense of urgency.” –@BillGates on the fight against #HIV and #AIDS: http://bit.ly/gQvhLj

PATHtweets PATH
“Relenting in the effort to finally defeat #malaria would be an abdication of our responsibility.”~ Dr. Christian Loucq http://ow.ly/3YEjM

CDCgov CDC.gov
Read the vision for vaccine science and policy over the next decade in @HHSgov’s National #VaccinePlan http://bit.ly/wvW0p

PATHtweets PATH
Injections without needles? PATH and partners are bringing “jet injection” to developing-country immunization programs. http://ow.ly/3XGth

EndPolioNow EndPolioNow
A longtime skeptic in the war against polio, Dr. Henderson has changed his mind. #polio http://cot.ag/gIVdm9

TBVI_EU TBVI
by TropMed_IntHlth
How can we eliminate #tuberculosis? Progress in TB vaccine research – New blogs http://tiny.cc/c8ch8

PATHtweets PATH
@MalariaVaccine RTS,S is the first malaria vaccine candidate to ever reach large-scale Phase 3 clinical testing. http://ow.ly/3XFed

WHO_Europe WHO/Europe
by whonews
WHO Epidemiological Brief 12: Importation of Wild Poliovirus and Response Measures in the European Region http://bit.ly/i7m8OY
nytimeshealth NYTimes Health

Vaccines: Global HPV vaccination

British Medical Journal
19 February 2011 Volume 342, Issue 7794
http://www.bmj.com/content/current

Features
Vaccines: Global HPV vaccination
Sophie Arie

[Initial article language]
Most deaths from cervical cancer occur in countries without the resources to screen, treat, or vaccinate against the disease. Sophie Arie explores what’s being done to make HPV vaccination available to low income countries

In roughly five years since they arrived on the market, vaccines against human papillomavirus (HPV), which causes cervical cancer, have been rapidly and widely adopted in countries that can afford to do so.

The United States and much of Europe have introduced vaccines for school age girls in addition to existing well established screening programmes for women. The vaccines—Cervarix, made by GlaxoSmithKline (GSK), and Gardasil, made by Merck—protect against the most common types of virus, which cause around 70% of all cervical cancers, but they are among the most expensive of all vaccines. Both companies say their prices reflect a major investment in research and development and relatively complex manufacturing processes. Pricing varies from country to country but the current price in the US for a three dose course of Cervarix is a little under $300 (£187; €222) for government health service providers and close to $360 for private healthcare providers.

In the developing world, however, the situation is very different. Nearly 530 000 women each year develop cervical cancer and 275 000 die from it. 2 More than 85% of those deaths occur in low and middle income countries, where cervical cancer is the most common type of cancer in women, but screening is usually available only to women who can afford it privately, and where there is little or no capacity to treat the disease, let alone the resources to invest in a vaccine.

More than 60% of women who contract the disease in the developing world die of it because of late detection. According to the World Health Organization, if current trends continue, the …

Public and Private Sector Roles: Pharmaceutical Innovation

Health Affairs
February 2011; Volume 30, Issue 2
http://content.healthaffairs.org/content/30/2.toc

Policy & Pharmaceuticals
What Are The Respective Roles Of The Public And Private Sectors In Pharmaceutical Innovation?
Bhaven N. Sampat and Frank R. Lichtenberg
Health Aff February 2011 30:2332-339; doi:10.1377/hlthaff.2009.0917

Abstract
What are the respective roles of the public and private sectors in drug development? This question is at the heart of some policy proposals, such as those that would give the government a share of profits from drugs at least partly developed with federal research dollars. This paper provides empirical data on these issues, using information included in the patents on drugs approved between 1988 and 2005. Overall, we find that direct government funding is more important in the development of “priority-review” drugs—sometimes described as the most innovative new drugs—than it is for “standard-review” drugs. Government funding has played an indirect role—for example, by funding basic underlying research that is built on in the drug discovery process—in almost half of the drugs approved and in almost two-thirds of priority-review drugs. Our analyses should help inform thinking about the returns on public research funding—a topic of long-standing interest to economists, policy makers, and health advocates.

Clinical Trials Innovation and Leadership

JAMA
February 16, 2011, Vol 305, No. 7, pp 645-732
http://jama.ama-assn.org/current.dtl

Commentaries
A Historical Perspective on Clinical Trials Innovation and Leadership: Where Have the Academics Gone?
David L. DeMets, Robert M. Califf
JAMA. 2011;305(7):713-714.doi:10.1001/jama.2011.175

[No abstract; initial article text per JAMA convention]

The randomized controlled trial (RCT), the gold standard for evaluating the balance of risk and benefit in medical therapies, first emerged as a key clinical research tool in the mid-20th century thanks to visionary leadership of agencies such as the US National Institutes of Health (NIH), the UK Medical Research Council, and academic research institutions. Since then, clinical trials activity has shifted from the NIH and academia into the purviews of the medical products industry and regulatory authorities. Recent emphasis on evidence-based medicine, patient-centered outcomes research, 1 and learning 2 and accountable 3 health care systems underscores the fact that most clinical trials fail to provide the evidence needed to inform medical decision making. However, the serious implications of this deficit are largely absent from public discourse, and a better balance between commercial interests and public health is critically needed….