Twitter Watch
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and by no means intended to be exhaustive.

gatesfoundation Gates Foundation
Blog: A new #vaccine discovered, developed & tested in #India–specifically to help Indian children: http://bit.ly/foqeQ3

VaccinesToday
@VaccinesToday view full profile →
Vaccines Today is an online platform, supported by the European Vaccine Manufacturers (EVM), for discussing vaccines and vaccination. http://www.vaccines-today.org

CDCgov CDC.gov
CDC Observes World TB Day 2011. 1/3 of the world’s population is infected with tuberculosis. Learn more: http://go.usa.gov/2bu

whonews WHO News
#Tuberculosis is curable, yet 4500 people die everyday from it. Watch @CraigDavid #WorldTBDay video http://j.mp/fAhriK @StopTB

PATHtweets PATH
Today is World TB Day. There’s still work to be done before tuberculosis can be stamped out completely. http://ow.ly/4lBFq #WorldTBDay

AIDSvaccine IAVI
IAVI Report Blog on @KeystoneSymp session on search for correlates of protection from RV144 #Thai #HIV #vaccine trial http://bit.ly/fR8dfN

sabinvaccine Sabin Vaccine Inst.
Experts Meet to Develop Plan to Eliminate #Measles and #Rubella in the Americas: http://bit.ly/eXGimw

Clinical Infectious Diseases
Volume 52 Issue 7 April 1, 2011
http://www.journals.uchicago.edu/toc/cid/current

Invited Articles: Vaccines
Paul Fine, Ken Eames, and David L. Heymann
“Herd Immunity”: A Rough Guide
Clin Infect Dis. (2011) 52(7): 911-916 doi:10.1093/cid/cir007

Abstract
The term “herd immunity” is widely used but carries a variety of meanings [1–7]. Some authors use it to describe the proportion immune among individuals in a population. Others use it with reference to a particular threshold proportion of immune individuals that should lead to a decline in incidence of infection. Still others use it to refer to a pattern of immunity that should protect a population from invasion of a new infection. A common implication of the term is that the risk of infection among susceptible individuals in a population is reduced by the presence and proximity of immune individuals (this is sometimes referred to as “indirect protection” or a “herd effect”). We provide brief historical, epidemiologic, theoretical, and pragmatic public health perspectives on this concept.

The Lancet
Mar 26, 2011  Volume 377  Number 9771 Pages 1047 – 1124
a href=”http://www.thelancet.com/journals/lancet/issue/current”>http://www.thelancet.com/journals/lancet/issue/current

Editorial
Health care: an African solution
The Lancet

Preview
In 2006, WHO’s World Health Report detailed the perilous state of health-care provision in sub-Saharan Africa. The statistics are familiar to anyone with an interest in global health. Africa had only 2·3 health-care workers per 1000 population, compared with 18·9 in Europe, and this workforce had to deal with 24% of the global disease burden, with just 1% of the total global funding for health. Since published, these statistics have formed the introduction to many subsequent publications on health in Africa, but so far, practical solutions have been in short supply.

Nature
Volume 471 Number 7339 pp409-542  24 March 2011
http://www.nature.com/nature/current_issue.html

Comment
Africa needs climate data to fight disease
Madeleine C. Thomson and colleagues call on climate and health researchers, policy-makers and practitioners to work together to tackle infectious diseases.

Nature
Volume 471 Number 7339 pp409-542  24 March 2011
http://www.nature.com/nature/current_issue.html

Special Supplement: Cancer
Vaccines: Know your enemy
Michael Eisenstein1
Published online
23 March 2011

Vaccines are arguably our greatest medical achievement. But to what extent can they help prevent cancer?

[Initial article language]
Cancer operates like a well-disguised saboteur. Occasionally it slips up by displaying unusual proteins, tripping immunological surveillance systems that are checking for abnormal growth. For decades now, scientists have tried to exploit this vulnerability with therapeutic vaccines — injections of tumour-associated proteins that essentially hang a ‘Wanted’ poster, helping immune cells recognize and kill cancer cells.

After a string of expensive and dispiriting defeats, therapeutic cancer vaccines recently registered their first big win. In April 2010, the US Food and Drug Administration (FDA) approved Provenge (sipuleucel-T) — a mixture of a patient’s own cells incubated with a protein expressed by 95% of prostate tumours. This was not an unequivocal victory, however. “On average, patients live about four months longer,” says Martin Kast, a cancer vaccine specialist at the Norris Comprehensive Cancer Center at the University of Southern California (USC) in Los Angeles. “It certainly measures up to many chemotherapeutics, but there’s still a long way to go.”

http://www.nature.com/nature/journal/v471/n7339_supp/fig_tab/471S8a_F1.html

PLoS Medicine
(Accessed 27 March 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

The BCG World Atlas: A Database of Global BCG Vaccination Policies and Practices
Alice Zwerling, Marcel A. Behr, Aman Verma, Timothy F. Brewer, Dick Menzies, Madhukar Pai Health in Action, published 22 Mar 2011
doi:10.1371/journal.pmed.1001012

Summary Points
Despite nearly a century of use, the Bacille Calmette-Guérin (BCG) vaccine continues to be controversial, with known variations in BCG substrains and vaccine efficacy.

Because vaccination policies and practices vary across time and countries, we created the first searchable, online, open access database of global BCG vaccination policy and practices, the BCG World Atlas (http://www.bcgatlas.org/), which contains detailed information on current and past BCG policies and practices for over 180 countries.

The Atlas is for clinicians, policymakers, and researchers and provides information that may be helpful for better interpretation of tuberculosis (TB) diagnostics as well as design of new TB vaccines.

This is the pdf version of Vaccines: The Week in Review  21 March 2011 compiling all posts below for this date:

Vaccines_The Week in Review_21 March 2011

WHO said that the Tunisian Ministry of Public Health, supported by WHO, UNICEF and other health partners, started a vaccination campaign for an estimated 100 children under 5 years currently residing in Tunisia-Libya border camps. WHO noted that “strong winds and whirling sand are slowing down preparations, but the organizers are aware of the critical importance of vaccination.” Dr. Irshad Shaikh of the World Health Organization said, “As the number of families arriving at the camp incrementally rises, coupled with the fact that the length of stay of some of the families can get longer especially for those from Somalia and Eriteria (countries in conflict themselves), the risk for vaccine preventable illnesses in children inherently goes up.” The vaccination includes 7 antigens – diphtheria, tetanus, poliomyelitis, BCG, measles, whooping cough and hepatitis B. http://www.who.int/hac/crises/lby/releases/15march2011/en/index.html

PAHO/WHO, officials from Haiti’s Ministry of Public, UNICEF and other partners outlined a new plan to improve immunization services in Haiti over the next five years, including the introduction of three new vaccines. Ariel Henry of Haiti’s health ministry said, “We hope to start this multi-year immunization plan as soon as possible in order to save lives and protect Haitians. Diarrhea and pneumonia are the main causes of death in Haitian children, so we also plan to include rotavirus and pneumococcal vaccines in our strategic plan.” Dr. Ciro de Quadros of the Sabin Vaccine Institute, who chaired the meeting, said, “This plan shows the great work being done on immunization and the strong commitment to improve immunization services, and the international community backs the plan in Haiti.”

http://new.paho.org/hq/index.php?option=com_content&task=view&id=5111&Itemid=1

The U.S. Department of Health and Human Services released a report on “critical gaps which exist between older Americans who receive potentially lifesaving preventive services and those who do not.” Clinical prevention services examined in the report include vaccinations that protect against influenza and pneumococcal disease (e.g., bloodstream infections, meningitis, and pneumonia), screenings for the early detection of breast cancer, colorectal cancer, diabetes, lipid disorders, and osteoporosis, and smoking cessation counseling. The report was published by the Centers for Disease Control and Prevention, in partnership with HHS’ Administration on Aging, Agency for Healthcare Research and Quality, and Centers for Medicare and Medicaid Services.

Enhancing Use of Clinical Preventive Services Among Older Adults: Closing the Gap is available at: http://www.cdc.gov/aging/pdf/Clinical_Preventive_Services_Closing_the_Gap_Report.pdf

http://www.cdc.gov/media/releases/2011/p0314_preventiveservices.html

The Global Fund to Fight AIDS, Tuberculosis and Malaria announced that former President of Botswana Festus Mogae and former U.S. Health and Human Services Secretary Michael O. Leavitt “have agreed to lead a high-level panel of experts that will conduct an independent and thorough review of the Global Fund’s financial safeguards.” Michel Kazatchkine, Executive Director of the Global Fund, commented, “The appointment of this panel is part of the Global Fund commitment to ensuring our financial controls are the most robust possible, and that donor investments go directly to fighting AIDS, malaria and tuberculosis. Sound financial controls and anti-corruption protections are essential elements in our continued ability to save millions of lives, and to facilitating social and economic development in the more than 140 countries we support.” The panel “will assess the Global Fund’s current practices in financial oversight and implementation. The panel will also make recommendations where necessary to help strengthen the Global Fund’s fiscal controls and anti-corruption protections. This review is part of a broader set of measures that continue to be implemented to strengthen the Global Fund’s financial safeguards.”

http://www.theglobalfund.org/en/pressreleases/?pr=pr_110316

The Bill & Melinda Gates Foundation announced Round 7 of Grand Challenges Explorations, its US$100 million grant initiative to encourage innovation in global health research. The initiative “offers scientists, inventors and entrepreneurs the opportunity to win $100,000 grants to pursue unconventional ideas that could transform health in developing countries, and focuses on research areas where creative, unorthodox thinking is most urgently needed.: The topics in this round are:

– The Poliovirus Endgame: Create Ways to Accelerate, Sustain and Monitor Eradication

– Create the Next Generation of Sanitation Technologies

– Create Low-Cost Cell Phone-Based Solutions for Improved Uptake and Coverage of Childhood Vaccinations

– Design New Approaches to Cure HIV Infection

– Explore Nutrition for Healthy Growth of Infants and Children

– Apply Synthetic Biology to Global Health Challenges

http://www.gatesfoundation.org/press-releases/Pages/round-7-grand-challenges-explorations-110315.aspx

WHO highlighted deployment of a new “moving warehouse” in Senegal’s Saint Louis district yielding “the prospect of huge efficiencies in the supply of vaccines and medicines to health centres.” WHO said that through the system, insulated trucks deliver vaccines and other health products directly from regional warehouses to health centres, without interim stocking at district level. Products are delivered according to the needs indentified by the health centres, with delivery teams able to provide on-site supportive supervision and maintenance of equipment when deliveries are made. Stock management is computerized, with real-time, web-based information exchange between the moving warehouse, health centres, and regional and national storage facilities.

http://www.who.int/immunization/newsroom/newsstory_Senegal_warehouse_mar2011/en/index.html

The Pharmaceutical Research and Manufacturers of America (PhRMA) and Burrill & Company published a report which notes that “America’s biopharmaceutical research companies invested a record $67.4 billion last year in the research and development of new medicines and vaccines – an increase of $1.5 billion from 2009…PhRMA member companies alone spent an estimated $49.4 billion on biopharmaceutical R&D last year, a 6.5 percent increase over 2009.”.

http://www.phrma.org/media/releases/rd-investment-us-biopharmaceutical-companies-reached-record-levels-2010

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) published a new paper – Technology Transfer: A Collaborative Approach to Improve Global Health – the R&D Pharmaceutical Industry Experience – which “documents the growing trend of technology transfer in medicines and vaccines. It also identifies the critical enabling conditions which allow technology transfer to contribute successfully to global economic development and health.” IFPMA Director General Eduardo Pisani said, “Through technology transfer, R&D-based pharmaceutical companies are helping partner companies around the world to make advanced medicines and vaccines for their local markets. This is stimulating economic and social development, while also contributing to the health of recipient countries’ populations. With appropriate government encouragement and continued engagement by our members, the benefits of this approach could be extended to more countries. WHO Member States have asked us to share our best practice in this area, and this is what our new paper delivers.”
The IFPMA paper “identifies the risk of a ‘technology transfer gap’: while middle income economies are involved in a growing number of pharmaceutical technology transfer partnerships, low income countries may not be so attractive as partners, as they may lack many of the enabling conditions for successful technology transfer. The paper therefore recommends that low income country governments should help to improve local companies’ attractiveness as technology transfer partners, encourage them to focus initially on more accessible technologies and to create larger, regional markets through mutual recognition of medicine approvals with neighboring countries. High income countries can assist this process by technical means, such as giving low income countries greater access to international standard-setting bodies as a way of strengthening in-country competencies, as well as other forms of development assistance.”

http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13820

Paper available at: http://www.ifpma.org/documents/NR13820/IFPMA_Technology_Transfer_Booklet_2011.pdf

The Weekly Epidemiological Record (WER) for 18 March 2011, vol. 86, 12 (pp 101–112) includes:

– Outbreak news (Meningococcal disease, Chad; Yellow fever, Sierra Leone)
– First meeting of the GPEI Independent Monitoring Board
– Progress in interrupting wild poliovirus circulation in countries with re-established transmission: Africa, 2009–2010

http://www.who.int/entity/wer/2011/wer8612.pdf

The MMWR for March 18, 2011 / Vol. 60 / No. 10  includes:

– Progress Toward Interrupting Wild Poliovirus Circulation in Countries With Reestablished Transmission — Africa, 2009–2010

– Notes from the Field: Poliomyelitis Outbreak — Republic of the Congo, September 2010–February 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.

HarvardHSPH HSPH Communications
RT @FramingTC Julio Frenk: We must decide if there is a universal set of health entitlements. #NCDs, #MDGs are next steps. #bottombillion

CDCgov CDC.gov
CDC Observes National Native HIV/AIDS Awareness Day 2011. http://go.usa.gov/4ha

gatesfoundation Gates Foundation
A report from Afghanistan’s National Immunization Day: Persevering against all obstacles: http://bit.ly/fBSpQT #polio

AIDSvaccine IAVI
Where does IAVI work? Check out our interactive map: http://bit.ly/i3CNld #research #HIV #vaccines #globalhealth #IN #AIDS

ECDC_EU ECDC
by eurovaccine
Vaccination helps to prevent diseases and, above all, saves lives, says #ECDC Director Marc Sprenger http://bit.ly/e61FTQ #vaccine

WHO_Europe WHO/Europe
by eurovaccine
#Measles continues to spread in #Europe & beyond; #polio returns. Coordinated #vaccinations planned in #Russia, #Asia. http://bit.ly/dF2vx3

IHME_UW IHME at UW
TY! RT @cindyrankin: Launch of Global Health Data Exchange #GHDx | HealthData.gov data.gov/communities/no… cc @PeterSpeyer @GHMEcon #ghme2011

GAVIAlliance GAVI Alliance
via @ONE: Sec. Clinton discusses critical importance of GAVI http://ht.ly/4e9G2

Annals of Internal Medicine
March 15, 2011; 154 (6)
http://www.annals.org/content/current

Original Research
Student Vaccination Requirements of U.S. Health Professional Schools: A Survey
Megan C. Lindley, Suchita A. Lorick, Jovonni R. Spinner, Andrea R. Krull, Gina T. Mootrey, Faruque Ahmed, Rosa Myers, Geraldine P. Bednash, Tyler C. Cymet, Rika Maeshiro, C. Fay Raines, Stephen C. Shannon, Henry M. Sondheimer, and Raymond A. Strikas
Ann Intern Med March 15, 2011 154:391-400; doi:10.1059/0003-4819-154-6-201103150-00004

The number of vaccines recommended for health care workers has increased over the past 2 decades, but national data on prematriculation vaccine policies of health professional schools were unavailable. This 2008–2009 survey of deans of 563 U.S. schools of medicine and nursing found that most schools’ policies adhere to the Advisory Committee on Immunization Practices recommendations for health care workers. However, exemption policies, measurement of titers to confirm vaccination, and payment mechanisms varied. In particular, nursing and osteopathic schools were less likely than allopathic medical schools to pay for influenza vaccination.

JAMA
March 16, 2011, Vol 305, No. 11, pp 1061-1154
http://jama.ama-assn.org/current.dtl

Cholera Vaccination
M. J. Friedrich
JAMA. 2011;305(11):1085.doi:10.1001/jama.2011.295

Extract
Oral cholera vaccination can help control cholera spread after an outbreak has begun, 2 new studies report.

Using existing data from a number of recent cholera outbreaks to simulate the number of cholera cases preventable by mass vaccination once an outbreak has occurred, researchers from the International Vaccine Institute (IVI) in Seoul, Korea, and other international institutions found that even a delayed response to vaccinate could be beneficial. (Reyburn R et al. PLoS Negl Trop Dis. 2011;5[1]:e952).

In a separate case-control study, researchers from the IVI and the National Institute of Hygiene and Epidemiology in Hanoi, Vietnam, found that giving 1 to 2 doses of vaccine after a cholera outbreak began in Hanoi in 2007-2008 was 76% protective against cholera in this setting (Anh DD et al. PLoS Negl Trop Dis. 2011;5[1]:e1006).

Recent outbreaks of the disease suggest that current global action plans against cholera are failing, but …

Journal of Infectious Diseases
Volume 203 Issue 7 April 1, 2011
http://www.journals.uchicago.edu/toc/jid/current

EDITORIAL COMMENTARIES
Neal Nathanson
Eradication of Poliovirus: Fighting Fire With Fire
J Infect Dis. (2011) 203(7): 889-890 doi:10.1093/infdis/jiq148

Extract
Endemic wild polioviruses have been eliminated from most of the world, and the number of human paralytic cases has been reduced by >99%, from an estimated annual incidence of >500,000 cases to <2000 cases [ 1– 3]. Circulating wild polioviruses remain endemic in only 2 major locations, Nigeria and a zone extending from northern India west to Pakistan and Afghanistan [ 1– 3]. Furthermore, wild-type 2 poliovirus has been eliminated altogether, with the last documented case reported in northern India in 1999 [ 4]. These remarkable accomplishments represent a triumph for oral poliovirus vaccine (OPV), composed of attenuated variants of the 3 poliovirus serotypes [ 5]. OPV is administered by mouth, induces mucosal and humoral immunity, and is relatively inexpensive to produce—attributes that have contributed to its widespread use even in regions with rudimentary health systems.

However, OPV has an Achilles heel. The attenuated variants in the vaccine are rapidly replaced by revertant mutants, even on a single passage through the human intestine [ 6]. …

Journal of Infectious Diseases
Volume 203 Issue 7 April 1, 2011
http://www.journals.uchicago.edu/toc/jid/current

MAJOR ARTICLES AND BRIEF REPORTS
VIRUSES
Steven Wassilak, Muhammad Ali Pate, Kathleen Wannemuehler, Julie Jenks, Cara Burns, Paul Chenoweth, Emmanuel Ade Abanida, Festus Adu, Marycelin Baba, Alex Gasasira, Jane Iber, Pascal Mkanda, A. J. Williams, Jing Shaw, Mark Pallansch, and Olen Kew
editor’s choice: Outbreak of Type 2 Vaccine-Derived Poliovirus in Nigeria: Emergence and Widespread Circulation in an Underimmunized Population
J Infect Dis. (2011) 203(7): 898-909 doi:10.1093/infdis/jiq140

Free Full Text (HTML)
Wild poliovirus has remained endemic in northern Nigeria because of low coverage achieved in the routine immunization program and in supplementary immunization activities (SIAs). An outbreak of infection involving 315 cases of type 2 circulating vaccine-derived poliovirus (cVDPV2; >1% divergent from Sabin 2) occurred during July 2005–June 2010, a period when 23 of 34 SIAs used monovalent or bivalent oral poliovirus vaccine (OPV) lacking Sabin 2. In addition, 21 “pre-VDPV2” (0.5%–1.0% divergent) cases occurred during this period. Both cVDPV and pre-VDPV cases were clinically indistinguishable from cases due to wild poliovirus. The monthly incidence of cases increased sharply in early 2009, as more children aged without trivalent OPV SIAs. Cumulative state incidence of pre-VDPV2/cVDPV2 was correlated with low childhood immunization against poliovirus type 2 assessed by various means. Strengthened routine immunization programs in countries with suboptimal coverage and balanced use of OPV formulations in SIAs are necessary to minimize risks of VDPV emergence and circulation.

The Pediatric Infectious Disease Journal
April 2011 – Volume 30 – Issue 4
http://journals.lww.com/pidj/pa     ges/currenttoc.aspx

Brief Reports
Lessons Learned From A Measles Outbreak in Antwerp, Belgium: 2007–2008
Asnong, Carine; Van Herck, Koen; Lernout, Tinne; Theeten, Heidi; Van Damme, Pierre
Pediatric Infectious Disease Journal. 30(4):343-345, April 2011.
doi: 10.1097/INF.0b013e3181fbf5b7

Abstract:
A 2007 to 2008 measles outbreak in Antwerp, Belgium, identified the orthodox Jewish communities as a new risk group. This study analyzes vaccination data of 949 school children of 4 belief systems to assess the completeness and timeliness of their measles-mumps-rubella vaccination. Orthodox Jewish children show a 4-fold lower chance of complete vaccination, a delayed start, and increased temporal spacing of childhood vaccinations. Not only belief issues but difficulties to access the regular vaccination program also seem to be the main reason.

Pharmacoeconomics
April 1, 2011 – Volume 29 – Issue 4  pp: 269-359
http://adisonline.com/pharmacoeconomics/pages/currenttoc.aspx

Review Articles
Sensitivity Analysis in Cost-Effectiveness Studies: From Guidelines to Practice
Jain, Rahul; Grabner, Michael; Onukwugha, Eberechukwu
Pharmacoeconomics. 29(4):297-314, April 1, 2011.
doi: 10.2165/11584630-000000000-00000

Abstract:
Cost-effectiveness analysis (CEA) is one of the main tools of economic evaluation. Every CEA is based on a number of assumptions, some of which may not be accurate, introducing uncertainty. Sensitivity analysis (SA) formalizes ways to measure and evaluate this uncertainty. Specific sources of uncertainty in CEA have been noted by various researchers. In this work, we consolidate across all sources of uncertainty, discuss the imbalanced attention to SA across different sources, and discuss criteria for conducting and reporting SA to help bridge the gap between guidelines and practice.

Guidelines on how to perform SA have been published for many years in response to requests for greater standardization among researchers. Decision makers tasked with reviewing new health technologies also seem to appreciate the additional information conveyed by a robust SA, including the attention to important patient subgroups. Yet, past reviews have shown that there is a substantial gap between the guidelines’ suggestions and the quality of SA in the field. Past reviews have also focused on one or two but not all three sources of uncertainty. The objective of our work is to comprehensively review all different sources of uncertainty and provide a concise set of criteria for conducting and presenting SA, stratified by common modelling approaches, including decision analysis and regression models.

We first provide an overview of the three sources of uncertainty in a CEA (parameter, structural and methodological), including patient heterogeneity. We then present results from a literature review of the conduct and reporting of SA based on 406 CEA articles published between 2000 and mid-2009. We find that a minority of papers addressed at least two of the three sources of uncertainty, with no change over time. On the other hand, the use of some sophisticated techniques, such as probabilistic SA, has surged over the past 10 years. Lastly, we identify criteria for reporting uncertainty-robust SA and also discuss how to conduct SA and how to improve the reporting of SA for decision makers. We recommend that researchers take a more comprehensive view of uncertainty when planning SA for an economic evaluation.

PLoS Medicine
(Accessed 20 March 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

The Challenge of Discharging Research Ethics Duties in Resource-Constrained Settings Jerome Amir Singh Perspective, published 15 Mar 2011
doi:10.1371/journal.pmed.1000421

Linked Research Article
Jones-López EC, Ayakaka I, Levin J, Reilly N, Mumbowa F, et al. (2011)
Effectiveness of the Standard WHO Recommended Retreatment Regimen (Category II) for Tuberculosis in Kampala, Uganda: A Prospective Cohort Study. PLoS Med 8: e427. doi:10.1371/journal.pmed.1000427

Abstract
Prospective evaluation of the effectiveness of the WHO-recommended standardized retreatment regimen for tuberculosis by Edward Jones-López and colleagues reveals an unacceptable proportion of unsuccessful outcomes.

The paper by Jones-López et al. in this week’s PLoS Medicine [1] (hereinafter “the Uganda study”) illustrates the challenge of conducting research in resource-constrained settings. At the time the study was proposed and initiated, the prevalence of multidrug resistant tuberculosis (MDR-TB) in Uganda was unknown. Further, second-line therapy for MDR-TB, available in other settings, was not available in the country. The Uganda study accordingly highlights at least two classic ethical conundrums: (1) should research be conducted in a setting if the existing standard of care for the health issue under investigation is “no treatment,” despite efficacious treatment existing elsewhere? and (2) should investigators introduce

The pdf version f Vaccines: The Week in Review  14 March 2011 is available here and comprises to posts below for this date:

Vaccines_The Week in Review_14 March 2011

The GAVI Alliance Board said it appointed Dr Seth Berkley as GAVI’s new CEO. Dr. Berkley is currently President, CEO and founder of the International AIDS Vaccine Initiative (IAVI). Dagfinn Høybråten, GAVI Alliance Board Chair, commented, “The GAVI Board is delighted to have attracted such a highly qualified and charismatic individual as Dr Berkley. (He) is an experienced leader in global public health with strong advocacy skills and is highly motivated to making vaccines available for all children. I am confident that, with Dr Berkley as the CEO, the Alliance will further increase its crucial role in providing cost effective immunisation for the world’s disadvantaged.”  Dr Berkley is expected to take up his new role in August but will participate in several key GAVI meetings, including the Alliance’s first pledging conference on 13 June, which will be hosted by the UK government.

Dr Berkley commented, “I am very familiar with GAVI’s life-saving work and have great admiration for its successful track record. I am, therefore, honored and extremely excited to have been chosen to lead the Alliance as it works to deliver on an ambitious new strategy to introduce new vaccines including those against pneumococcal and rotavirus diseases, Meningitis A, HPV, rubella and Japanese encephalitis. I also look forward to the day when malaria and HIV will be added to this list.”

http://www.gavialliance.org/media_centre/press_releases/new_gavi_ceo.php

IFFIm’s first issue of “Vaccine Bonds” for 2011 was jointly announced by Daiwa Securities Group, the International Finance Facility for Immunisation Company (“IFFIm”), the GAVI Alliance, and the World Bank. The group said this is the fourth issue of IFFIm’s vaccine bonds arranged by Daiwa, and that, including previous, highly successful issues in March 2008, February 2009 and March 2010, the total amount of IFFIm’s vaccine bonds arranged by Daiwa is now over USD 1 billion equivalent. Alan Gillespie, the Chairman of the IFFIm Board, commented, “This transaction marks another milestone in our successful partnership with Daiwa. Daiwa’s work in placing over USD 1 billion equivalent of IFFIm’s bonds is having a meaningful impact in furthering IFFIm’s life-saving work through the GAVI Alliance.”

http://www.gavialliance.org/media_centre/press_releases/iffim_bonds_2011.php

The WHO Strategic Advisory Group of Experts (SAGE) posted the draft agenda for its meetings scheduled for 5-7 April 2011 at:
http://www.who.int/entity/immunization/sage/DRAFT_AGENDA_Apr_SAGE_with_timings_9_March_2011.pdf

Separately, WHO issued a call for experts to serve on WHO SAGE Working Group on Vaccination in Humanitarian Emergencies. WHO is establishing a new Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on Vaccination in Humanitarian Emergencies, and solicits proposals for experts to serve on this working group for which the terms of reference and needed expertise appear in the attached document. Proposals for nominations should be sent by email to SAGE Executive Secretary at sageexecsec@who.int with curriculum vitae and indication of expertise no later than 23 March 2011.
http://www.who.int/entity/immunization/sage/ToR_SAGE_WorkingGp_Vaccines_Emergencies_March_7.pdf

The MMWR for March 11, 2011 / 60(09);276-278 includes:

Japanese Encephalitis in Two Children — United States, 2010

Japanese encephalitis virus (JEV) is the leading cause of vaccine-preventable encephalitis in Asia and the western Pacific. JEV is maintained in an enzootic cycle involving mosquitoes and amplifying vertebrate hosts, mainly pigs and wading birds. The virus is transmitted to humans primarily by Culex mosquitoes, which breed in flooded rice fields and pools of stagnant water and most often feed outdoors during the evening and night. JEV transmission occurs mainly in rural agricultural areas, but occasional human cases occur in urban areas. Japanese encephalitis (JE) in persons who have traveled or lived overseas is diagnosed infrequently in the United States, with only four cases identified from 1992 (when a JE vaccine was first licensed in the United States) to 2008 (1). This report describes the only cases diagnosed in the United States and reported to CDC since then. The first was a fatal case in a U.S. child who had visited relatives in the Philippines. The other occurred in a refugee who became ill while traveling from Thailand to the United States and whose diagnosis was complicated by concurrent neurocysticercosis. JE should be considered in the differential diagnosis for any patient with an acute neurologic infection who recently has been in a JE-endemic country. Travelers to JE-endemic countries should be advised of the risk for JE and the importance of personal protective measures to prevent mosquito bites (2). JE vaccine should be considered for travelers who might be at greater risk based on the season, location, and duration of their visit and their planned activities….

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6009a3.htm?s_cid=mm6009a3_w

The Weekly Epidemiological Record (WER) for 11 March 2011, vol. 86, 11 (pp 93–100) includes: Antigenic and genetic characteristics of influenza A(H5N1) and influenza A(H9N2) viruses for development of candidate vaccines viruses for pandemic preparedness – February 2011.

http://www.who.int/entity/wer/2011/wer8611.pdf

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.

usaid_info USAID
Saving Lives at Birth: A Grand Challenge for Development: Saving Lives at Birth: A Grand Challenge for Develo… http://1.usa.gov/eMpUO5

USAID USAID
Panel discussion with @gatesfoundation @GChallenges @WorldBank and Prime Minister of Norway. http://www.savinglivesatbirth.net/news

AIDSvaccine IAVI
Seth Berkley @IAVISeth reflects on 15 years heading IAVI & advances in #HIV #vaccine R&D in Q&A w/ @NatureMedicine http://bit.ly/gOKD6E

WHO_Europe WHO/Europe
by eurovaccine
European Member States plan for health in 2020 http://bit.ly/hLSRM6

sabinvaccine Sabin Vaccine Inst.
Three new #vaccines to be added to #Haiti‘s New Immunization Action Plan: http://bit.ly/gFgIsu

eurovaccine ECDC Eurovaccine
New #TB drugs, #vaccines, and diagnostics will help save the lives of millions of women and children http://bit.ly/iaJUDf from TBAlliance

sabinvaccine Sabin Vaccine Inst.
First African Vaccination Week to be observed in April: http://bit.ly/h0IFNd #vaccines #immunization

TheLancet The Lancet
Group B streptococcal vaccine for resource-poor countries http://fb.thelancet.com/eQN

British Medical Bulletin
Volume 97 Issue 1 March 2011
http://bmb.oxfordjournals.org/content/current
Eugena Stamuli

Health outcomes in economic evaluation: who should value health?
Br Med Bull (2011) 97(1): 197-210 first published online January 31, 2011 doi:10.1093/bmb/ldr001

Abstract
The valuation of health states is an integral part of economic evaluation studies. The source of these valuations (general public vs. patients) is surrounded by controversy. Health state values generated by the general public are often different compared with those of patients. General public values may not account for adaptation of the patients; patients’ values potentially incorporate self-interest. Decisions on the appropriate source of health values ultimately depend on the specific decision-making context and objectives of the evaluation. Differences in valuations and implications for decision-making should be explicitly addressed. Further research should systematically identify circumstances in which public and patients’ valuations diverge. There appears ground for development of methods that allow the simultaneous incorporation of patients and public preferences. Existing literature which discusses the issues around the health state valuation is summarized.

Health Economics, Policy and Law
Volume 6 – Issue 01
http://journals.cambridge.org/action/displayJournal?jid=HEP

Articles
Eliminating drug price differentials across government programmes in the USA
Kalipso Chalkidou, Gerard F Anderson and Ruth Faden

Abstract
Federal agencies in the USA pay significantly different prices for the same prescription drugs because each agency uses a different approach to derive the payment rate. Because we do not identify any economic rationale or socially accepted moral reasoning that would justify the current level of price variation, we suggest that the federal government should pay a uniform price for each drug. Laws and regulations that give certain federal agencies the ability to earn rebates, use formularies, or permit other special arrangements would need to be eliminated in order to have a single payment rate. This could make some government agencies worse off than others; however, a uniform payment rate would not need to affect beneficiaries’ current financial contributions, access to drugs, benefits or overall public expenditures. At the same time, having a single rate would permit the government to adopt a more effective approach to purchasing drugs and send a consistent message to pharmaceutical companies concerning which types of drugs the government wants them to develop for government beneficiaries. How this single price would be derived and how it would compare with the lowest or highest prices currently achieved by government agencies would depend on a variety of policy issues including the government’s desire to encourage pharmaceutical research and development and the need to control health care spending.

Human Vaccines
Volume 7, Issue 2  February 2011
http://www.landesbioscience.com/journals/vaccines/toc/volume/7/issue/2/

NEWS, POLICY AND PROFILES
High time for GAVI to push for lower prices
Daniel Berman and Rohit Malpani

Beyond patents: The GAVI Alliance, AMCs and improving immunization coverage through public sector vaccine production in the global south
Anne-Emanuelle Birn and Joel Lexchin

The pilot AMC: The acceptance of policy evolution
Jim Dobbins, Lord Avebury and Hugh McKinney

Diverse tools needed to ensure affordable vaccines for the poor
Christopher J. Elias

Fixing GAVI’s cash crunch
Andrew Farlow

Getting priorities straight
Richard T. Mahoney

New vaccines for the least developed countries
Mark Kane

The AMC is helping save children’s lives today
Nina Schwalbe

Why the AMC matters
Frederick Were

JAMA
March 9, 2011, Vol 305, No. 10, pp 969-1050
http://jama.ama-assn.org/current.dtl

Research Letter
A Multifaceted Mandatory Patient Safety Program and Seasonal Influenza Vaccination of Health Care Workers in Community Hospitals
Edward J. Septimus, Jonathan B. Perlin, Scott B. Cormier, Julia A. Moody, Jason D. Hickok
JAMA. 2011;305(10):999-1000.doi:10.1001/jama.2011.244

Extract
To the Editor: Seasonal influenza is the leading cause of vaccine-preventable death in the United States. 1 Since health care workers can contribute to the spread of seasonal influenza among vulnerable patients, US national health objectives for 2010 included a target vaccination rate for health care workers of 60%. 2 However, reaching and exceeding this goal has been difficult.

Most health care institutions recognize their ethical and professional responsibility to protect patients from preventable nosocomial infections while accommodating employees’ needs. Accordingly, we developed a multifaceted patient safety program that required seasonal influenza vaccination of health care workers but accommodated declination for any reason. We assessed vaccination rates in a large, diverse health care system primarily comprised of community hospitals after implementing this program.

JAMA
March 9, 2011, Vol 305, No. 10, pp 969-1050
http://jama.ama-assn.org/current.dtl

Book and Media Reviews
Progress in Bioethics: Science, Policy, and Politics
Andrew R. Barnosky
JAMA. 2011;305(10):1036-1037.doi:10.1001/jama.2011.275

Extract
With the increasing politicization of bioethics, the essays in Progress in Bioethics: Science, Policy, and Politics offer a persuasive perspective on the philosophy of the topic, with a respectful comparison with traditional conservative approaches in the ethics debate. The book is a valuable contribution to leading scholarship in the field, and its overarching message is consistent with the Latin phrase with which Howard Shapiro begins the foreword: “ audi alteram partem (hear the other side).”

The book, edited by Jonathan Moreno and Sam Berger, includes contributions from 16 prominent scholars, including Callahan, Caplan, Wolpe, Shapiro, and Lempert; all are civil and refined in their approaches. Whether readers consider themselves on the right or the left regarding ethical and political approaches to issues in the life sciences and medicine, it would be difficult after reading this book to not have an enhanced understanding of the differing philosophical approaches to these topics …

The Lancet
Mar 12, 2011  Volume 377  Number 9769  Pages 875 – 966
http://www.thelancet.com/journals/lancet/issue/current

Incidence and clearance of genital human papillomavirus infection in men (HIM): a cohort study
Anna R Giuliano, Ji-Hyun Lee, William Fulp, Luisa L Villa, Eduardo Lazcano, Mary R Papenfuss, Martha Abrahamsen, Jorge Salmeron, Gabriella M Anic, Dana E Rollison, Danelle Smith

Summary
Background
Human papillomaviruses (HPVs) cause genital warts and cancers in men. The natural history of HPV infection in men is largely unknown, and that information is needed to inform prevention strategies. The goal in this study was to estimate incidence and clearance of type-specific genital HPV infection in men, and to assess the associated factors.

Methods
Men (aged 18—70 years), residing in Brazil, Mexico, and the USA, who were HIV negative and reported no history of cancer were recruited from the general population, universities, and organised health-care systems. They were assessed every 6 months for a median follow-up of 27·5 months (18·0—31·2). Specimens from the coronal sulcus, glans penis, shaft, and scrotum were obtained for the assessment of the status of HPV genotypes.

Findings
In 1159 men, the incidence of a new genital HPV infection was 38·4 per 1000 person months (95% CI 34·3—43·0). Oncogenic HPV infection was significantly associated with having a high number of lifetime female sexual partners (hazard ratio 2·40, 1·38—4·18, for at least 50 partners vs not more than one partner), and number of male anal-sexual partners (2·57, 1·46—4·49, for at least three male partners vs no recent partners). Median duration of HPV infection was 7·52 months (6·80—8·61) for any HPV and 12·19 months (7·16—18·17) for HPV 16. Clearance of oncogenic HPV infection decreased in men with a high number of lifetime female partners (0·49, 0·31—0·76, for at least 50 female partners vs not more than one partner), and in men in Brazil (0·71, 0·56—0·91) and Mexico (0·73, 0·57—0·94) compared with the USA. Clearance of oncogenic HPV was more rapid with increasing age (1·02, 1·01—1·03).

Interpretation
The data from this study are useful for the development of realistic cost-effectiveness models for male HPV vaccination internationally.

Funding
National Cancer Institute.

The Lancet
Mar 12, 2011  Volume 377  Number 9769  Pages 875 – 966
http://www.thelancet.com/journals/lancet/issue/current

World Report
US bioethics commission hears expert testimonies
Nellie Bristol

Preview
The US Presidential bioethics commission, tasked with reviewing ethical guidelines to protect human trial participants, held its first public meeting on the topic last week. Nellie Bristol reports.

Medical Decision Making (MDM)
March/April 2011; 31 (2)
http://mdm.sagepub.com/content/current

Editorial
Jacob A. Udell and Donald A. Redelmeier
Patient Preferences and the Ironic Nature of Randomized Trials
Med Decis Making March/April 2011 31: 226-228, doi:10.1177/0272989X11399125

Randomized trials are an attractive form of medical research that often contains blemishes when examined carefully. One criticism relates to limited generalizability, because such studies typically include only a fraction of the available patients and often exclude the challenging individuals who have complex comorbidities. 1 Randomized trials can also fail because of practical issues such as insufficient recruitment (inadequate power bias), a limited duration of follow-up (brevity bias), or losses to follow-up (attrition bias). 2 Several other opportunities for misinterpretation arise if the study is not adequately blinded so that outcomes and co-interventions are managed in a slanted manner. 3 Furthermore, the large costs of a randomized trial (both financial and operational) create a potential conflict of interest for investigators and a worrisome reality that the research will not be repeated.

This issue of the journal describes a further blemish in randomized trials that is subtle, pervasive, and rarely mentioned. Specifically, such trials randomize the assignment of patients to treatments and thereby require each person to disregard his or her inherent preferences. Such a behavior style is remarkably strange for a sentient adult, does not occur in usual clinical settings, and typically must be maintained for an extended interval. 4, 5 Of course, patients sometimes feel conflicted when facing a choice, and such indecision may take time to resolve before a subsequent commitment. By definition, however, a randomized trial requires each patient to follow a treatment that has been randomly assigned with no basis. 6 …

Nature
Volume 471 Number 7337 pp135-260  10 March 2011
http://www.nature.com/nature/current_issue.html

Comment
Vaccinate for the next H2N2 pandemic now
An old influenza strain still circulating in birds and swine could easily jump back to humans now that immunity to it has dropped, warn Gary J. Nabel and his colleagues.

PLoS Medicine
(Accessed 13 March 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

Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty Jonathan Kimmelman, Alex John London Essay, published 08 Mar 2011
doi:10.1371/journal.pmed.1001010

Summary Points
– Ethical judgments about risk, benefit, and patient eligibility in clinical trials hinge on predictions about harm, therapeutic response, and clinical promise.

– Predictions for novel interventions in preclinical stages of development suffer from two problems: insufficient attention to threats to validity in preclinical research and a reliance on an overly narrow base of evidence that includes only animal and clinical studies of the intervention in question (“evidential conservatism”).

– To improve ethical and scientific decision-making in early phase studies, decision-makers should explicitly attend to reporting quality and methodological features in preclinical experiments that address threats to internal, construct, and external validity.

– Decision-makers should also use evidence that sheds light on the reliability of causal claims embedded within a proposed trial. This evidence can be gathered from outcomes of previous trials involving agents targeting related biological pathways (“reference classes”).

This is the pdf version of Vaccines the Week in Review 7 March 2011:

Vaccines_The Week in Review_7 March 2011

A WHO-led team, following “a comprehensive review by experts from six countries,” concluded that the national regulatory authority of China, the State Food and Drug Administration (SFDA) and affiliated institutions, “meet WHO-published indicators for a functional vaccine regulatory system.” WHO said it has established benchmarks that define international expectations for a functional vaccine regulatory system, and that it also conducts “regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way.” In addition to the general framework for the system, the following regulatory functions were evaluated: marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release by the national regulatory authority; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials. WHO said the review’s conclusion “is the culmination of 19 months of intensive effort by the SFDA to implement a roadmap — developed by national experts, with continuous advice from WHO — to strengthen capacity for regulation of vaccines.”

WHO noted that, with a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for WHO prequalification of specific products, and that it is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers “is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.”

http://www.who.int/immunization_standards/vaccine_regulation/nra_china_functional/en/index.html

USAID Administrator Dr. Rajiv Shah, in a major address at the US National Institutes of Health (NIH), noted “the transformative public health impact of vaccines over the past decade and the potential of new immunisations against pneumococcal disease and the rotavirus to save 4 million lives and achieve a new breakthrough in global health and development.”  Dr. Shah described vaccines as “the best public health investment we can make” as he presented the U.S. Agency for International Development’s global health priorities and new initiatives. Shah also praised GAVI “as a proven mechanism and pledged to increase support in response to its financing needs and first ever replenishment.” He noted, “We will focus on one of the best lifesaving investments USAID has ever made: the first public funding of GAVI, the Global Alliance for Vaccines and Immunization. That initial investment has led to the prevention of more than 5 million childhood deaths, a mammoth return on investment by any account. We will expand our support of GAVI and help it address its current funding shortfall.”

http://www.gavialliance.org/media_centre/statements/usaid_rajiv_shah_speech.php

The GAVI Alliance said it welcomed the results of the U.K.’s Multilateral Aid Review (MAR), which said GAVI “played a unique role in increasing finance for immunisation and bringing together all immunisation partners and wider partners in global health.” The review described GAVI as a “strong strategic fit with DFID (Department for International Development) priority objectives given its core focus on health and strong poverty focus.”  Further the report noted that “GAVI plays a critical role in the delivery of MDG 4 – reducing deaths among children under five years old. It contributes directly to MDG 5 and 6 through its support to health systems and impacts on MDG 1. The fact that these are some of the most off-track MDGs increases GAVI’s relevance as part of the international development system. It has significantly increased finance for vaccinations and substantially improved vaccination coverage of new and underused vaccines.”

Helen Evans, interim CEO at the GAVI Alliance, commented, “The GAVI business model is working well and despite some significant success in the area of pricing, we will not be satisfied until we see prices drop further and faster for all the vaccines that we work with. As a constantly learning organisation, we also note that this review has highlighted areas where we could do more to improve our performance.” The GAVI announcement said that, according to the review, “GAVI’s financial management is generally strong and transparent with evidence of recent improvements and safeguards (Transparency and Accountability Policy and strengthened audit capacity), although lessons on financial management and tracking of cash based investments (are) still to be effectively implemented.” Ms. Evans continued, “We are acutely aware that the financial systems in some of the countries we help are not as robust as those found in developed countries – it is a challenge faced by nearly all development organisations. It is our policy and practice to constantly monitor the use of our funds and immediately halt cash-based support wherever misuse is suspected.”

http://www.gavialliance.org/media_centre/press_releases/dfid_mar.php

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

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 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

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