The pdf version of Vaccines: The Week in Review  26 September 2011, comprosing the posts below for this date, is available here: Vaccines_The Week in Review_26 Sep 2011

   WHO confirmed that wild poliovirus type 1 (WPV1), genetically linked to virus currently circulating in Pakistan, has been isolated in China. WHO noted that Pakistan is affected by nationwide transmission of WPV1, and is the location of the only wild poliovirus type 3 (WPV3) case in Asia in 2011 (a strain on the verge of elimination on the continent). As at 13 September 2011, Pakistan had reported 84 cases, compared to 48 cases for the same period in 2010. WHO said that in 2011, supplementary immunization activities (SIAs) in Pakistan have been inadequate in quality in key high-risk areas. In security-compromised parts of the Federally Administered Tribal Areas (FATA), and in particular in Khyber agency, upwards of 200,000 children have been regularly missed during SIAs conducted during the last two years. To urgently address the widespread transmission of wild poliovirus affecting the country, the Government of Pakistan has launched a National Polio Emergency Action Plan, with staggered subnational immunization days “followed by further activities in high-risk union councils in 54 districts of the country.”

http://www.who.int/csr/don/2011_09_20/en/index.html

WHO announced the donation by Sanofi Pasteur to WHO of a vaccine seed-strain used for the production of oral polio vaccine (OPV). The type 3 polio seed-strain is an original viral seed used to produce large quantities of OPV against type 3 poliovirus. With this donation, WHO said it now “owns” all three seed-strain viruses (types 1, 2 and 3) needed for the production of polio vaccines, noting that while Sanofi Pasteur had in the past made available its type 3 seed-strain, in collaboration with WHO, to other manufacturers to help secure a global supply of polio vaccines, this generous donation will further simplify this process. The donation also means that production capacity — including in the developing country setting — can be further scaled-up to help meet the needs of the Global Polio Eradication Initiative (GPEI), and further strengthen public health systems. http://www.who.int/immunization/newsroom/newsstory_donation_vaccine_strain/en/index.html

The United Nations Foundation launched its new Shot@Life campaign, which was featured at the second-annual Social Good Summit focused on “how social media can be used to build and activate a grassroots movement.” Shot@Life “will educate, connect, and empower Americans to champion vaccines as one of the most cost-effective ways to save the lives of children in developing countries.” Peg Willingham, Executive Director, said, “Shot@Life provides easy access for you to learn more and become champions of global vaccines. By joining our online community and signing the Shot@Life pledge online, advocates can voice their support to prevent 1.7 million children from dying of vaccine-preventable diseases.”

Website: http://shotatlife.org
Blog: http://shotatlife.org/blog/

The Wistar Institute broke ground on a US$100 million expansion that “will ensure its future at the forefront of cancer research and vaccine development,” and announced a companion five-year, US$35 million capital campaign: Building Wistar, Changing the World.  Wistar President and CEO Russel E. Kaufman, M.D. commented, “At a time when biomedical research is advancing at a lightning pace, The Wistar Institute finds itself constrained by aging facilities designed for 19th and 20th century science. We designed our new building specifically to foster interactions between researchers in the kinds of multidisciplinary collaborations that spark innovation and drive results.” http://www.businesswire.com/news/home/20110923005054/en/Wistar-Institute-Breaks-Ground-100-Million-Expansion

  WHO announced that World Rabies Day will be observed on 28 September 2011 to “highlight the impact of human and animal rabies and promotes how to prevent and stop the disease by combating it in animals.” The Alliance for Rabies Control and the Centers for Disease Control and Prevention report that 55,00 people die every year from rabies, an average of one death every 10 minutes. WHO noted that there are safe and effective vaccines available for people who have been bitten by an animal that might have the disease, but usage in developing countries is low due to the high cost.

Related links

http://www.worldrabiesday.org/

The MMWR Weekly for September 23, 2011 / Vol. 60 / No. 37 includes:
– FDA Approval of Expanded Age Indication for a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine

– Notes from the Field: Measles Among U.S.-Bound Refugees from Malaysia — California, Maryland, North Carolina, and Wisconsin, August–September 2011

– Announcements: Final State-Level 2010–11 Influenza Vaccination Coverage Estimates Available Online

The Weekly Epidemiological Record (WER) for 23 September 2011, vol. 86, 39 includes: Health conditions for travellers to Saudi Arabia for the pilgrimage to Mecca (Hajj); Mass gatherings: implications and opportunities for global health security

http://www.who.int/entity/wer/2011/wer8639.pdf

Twitter Watch
A selection of items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and by no means intended to be exhaustive.

Ihealthprogress India Health Progress
by GlobalHealth
Panel recommends universal health system for India #IndiaHealth thehindu.com/news/national/…

GAVIAlliance GAVI Alliance
.@GAVIAlliance recognised as a “game changer” in international development aid- http://ht.ly/6Dbt9

pahowho PAHO/WHO
Ministers of Health Meet to Discuss #Health Policies for #Americas #PAHOWHO #cd51 @opsoms 26-30 Sept #WDC http://www.paho.org pic.twitter.com/3W7Xd3JI

PATHtweets PATH
New evidence: a compelling case for #rotavirus #vaccine in #Africa and around the world. http://ow.ly/6D5XR #globalhealth

sabinvaccine Sabin Vaccine Inst.
We need to vaccinate all kids under 5 & women of childbearing age in order to prevent lifelong disability & premature death from #rubella

MalariaVaccine PATH MVI
What is MVI’s role in malaria vaccine development? Watch this video of MVI Director Christian Loucq to find out: bit.ly/npgqGa

PublicHealth APHA
How does U.S. rank vs. other high-income nations on preventable deaths? Dead last, says @commonwealthfnd: goo.gl/J9QMV

unfoundation UN Foundation
Every 20 seconds, a child dies of a disease that could be prevented with #vaccines – help give them a @ShotAtLife! http://ow.ly/6CYSw

unfoundation UN Foundation
Missed anything this week? Catch up on our #SocialGood Summit 2011 @YouTube playlist! http://ow.ly/6CTWO

sabinvaccine Sabin Vaccine Inst.
By 2030, 7 million childhood deaths could be prevented by pneumococcal conjugate #vaccines @ShotAtLife @GAVIalliance

gatesfoundation Gates Foundation
FACT: The Global Fund has improved life for more than 200M people fighting #AIDS, #malaria, & #TB: gates.ly/pMIxfK

CDCgov CDCgov
New study finds that rotavirus vaccine keeps kids healthy and saves on health care costs. go.usa.gov/8ju

HIVEnterprise HIVVaccineEnterprise
by AIDSvaccine
AIDS Vaccine 2011 meeting highlights, including session webcasts and abstracts are now available:… fb.me/17eDZ2NAe

GAVIAlliance GAVI Alliance
Investment in GAVI pays big dividends- more than 288M children immunised and over 5M future deaths averted. http://ht.ly/6BE9p

DFID_UK DFID
by GAVIAlliance
Finally #MDG8: @GAVIAlliance have built a global vaccines partnership to save 4 million kid’s lives http://ht.ly/6Baas #MDGCountdown

PATHtweets PATH
Congrats to Burundi for introducing lifesaving pneumococcal vaccines! http://ow.ly/6B3pl

The Lancet  
Sep 24, 2011  Volume 378  Number 9797  p1117 – 1196
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Malaria: control vs elimination vs eradication
The Lancet

In The Lancet today, we report the presentation of this year’s Lasker-DeBakey Clinical Medical Research Award to Tu Youyou, a Chinese pharmacologist, for discovering the antimalarial drug artemisinin in the 1970s. Breakthroughs in malaria research such as hers, together with increased funding and control efforts during the past decade, have led to impressive reductions in mortality in many developing countries.

The Lancet  
Sep 24, 2011  Volume 378  Number 9797  p1117 – 1196
http://www.thelancet.com/journals/lancet/issue/current

Articles
Progress towards Millennium Development Goals 4 and 5 on maternal and child mortality: an updated systematic analysis
Rafael Lozano, Haidong Wang, Kyle J Foreman, Julie Knoll Rajaratnam, Mohsen Naghavi, Jake R Marcus, Laura Dwyer-Lindgren, Katherine T Lofgren, David Phillips, Charles Atkinson, Alan D Lopez, Christopher JL Murray

Summary
Background
With 4 years until 2015, it is essential to monitor progress towards Millennium Development Goals (MDGs) 4 and 5. Although estimates of maternal and child mortality were published in 2010, an update of estimates is timely in view of additional data sources that have become available and new methods developed. Our aim was to update previous estimates of maternal and child mortality using better data and more robust methods to provide the best available evidence for tracking progress on MDGs 4 and 5.

Methods
We update the analyses of the progress towards MDGs 4 and 5 from 2010 with additional surveys, censuses, vital registration, and verbal autopsy data. For children, we estimate early neonatal (0—6 days), late neonatal (7—28 days), postneonatal (29—364 days), childhood (ages 1—4 years), and under-5 mortality. We use an improved model for estimating mortality by age under 5 years. For maternal mortality, our updated analysis includes greater than 1000 additional site-years of data. We tested a large set of alternative models for maternal mortality; we used an ensemble model based on the models with the best out-of-sample predictive validity to generate new estimates from 1990 to 2011.

Findings
Under-5 deaths have continued to decline, reaching 7·2 million in 2011 of which 2·2 million were early neonatal, 0·7 million late neonatal, 2·1 million postneonatal, and 2·2 million during childhood (ages 1—4 years). Comparing rates of decline from 1990 to 2000 with 2000 to 2011 shows that 106 countries have accelerated declines in the child mortality rate in the past decade. Maternal mortality has also continued to decline from 409 100 (uncertainty interval 382 900—437 900) in 1990 to 273 500 (256 300—291 700) deaths in 2011. We estimate that 56 100 maternal deaths in 2011 were HIV-related deaths during pregnancy. Based on recent trends in developing countries, 31 countries will achieve MDG 4, 13 countries MDG 5, and nine countries will achieve both.

Interpretation
Even though progress on reducing maternal and child mortality in most countries is accelerating, most developing countries will take many years past 2015 to achieve the targets of the MDGs 4 and 5. Similarly, although there continues to be progress on maternal mortality the pace is slow, without any overall evidence of acceleration. Immediate concerted action is needed for a large number of countries to achieve MDG 4 and MDG 5.

Funding
Bill & Melinda Gates Foundation.

Nature  
Volume 477 Number 7365 pp369-504  22 September 2011
http://www.nature.com/nature/current_issue.html

Editorials
The wrong message on vaccines

Unfounded fears about vaccines are already reaching worrisome proportions. No public figure should stoke them — as US presidential hopeful Michele Bachmann has done

Nature  
Volume 477 Number 7365 pp369-504  22 September 2011
http://www.nature.com/nature/current_issue.html

Letters
Evidence for several waves of global transmission in the seventh cholera pandemic
Ankur Mutreja, Dong Wook Kim, Nicholas R. Thomson, Thomas R. Connor, Je Hee Lee
+ et al

Abstract
Vibrio cholerae is a globally important pathogen that is endemic in many areas of the world and causes 3–5 million reported cases of cholera every year. Historically, there have been seven acknowledged cholera pandemics; recent outbreaks in Zimbabwe and Haiti are included in the seventh and ongoing pandemic1. Only isolates in serogroup O1 (consisting of two biotypes known as ‘classical’ and ‘El Tor’) and the derivative O139 (refs 2, 3) can cause epidemic cholera2. It is believed that the first six cholera pandemics were caused by the classical biotype, but El Tor has subsequently spread globally and replaced the classical biotype in the current pandemic1. Detailed molecular epidemiological mapping of cholera has been compromised by a reliance on sub-genomic regions such as mobile elements to infer relationships, making El Tor isolates associated with the seventh pandemic seem superficially diverse. To understand the underlying phylogeny of the lineage responsible for the current pandemic, we identified high-resolution markers (single nucleotide polymorphisms; SNPs) in 154 whole-genome sequences of globally and temporally representative V. cholerae isolates. Using this phylogeny, we show here that the seventh pandemic has spread from the Bay of Bengal in at least three independent but overlapping waves with a common ancestor in the 1950s, and identify several transcontinental transmission events. Additionally, we show how the acquisition of the SXT family of antibiotic resistance elements has shaped pandemic spread, and show that this family was first acquired at least ten years before its discovery in V. cholerae.

New England Journal of Medicine
September 22, 2011  Vol. 365 No. 12
http://content.nejm.org/current.shtml

Perspective
The Threat of Artemisinin-Resistant Malaria
A.M. Dondorp and Others

[Free Full Text]

New England Journal of Medicine
September 22, 2011  Vol. 365 No. 12
http://content.nejm.org/current.shtml

Original Article
Rotavirus Vaccine and Health Care Utilization for Diarrhea in U.S. Children
Jennifer E. Cortes, M.D., Aaron T. Curns, M.P.H., Jacqueline E. Tate, Ph.D., Margaret M. Cortese, M.D., Manish M. Patel, M.D., Fangjun Zhou, Ph.D., and Umesh D. Parashar, M.B., B.S., M.P.H.
N Engl J Med 2011; 365:1108-1117September 22, 2011

Background
Routine vaccination of U.S. infants with pentavalent rotavirus vaccine (RV5) began in 2006.

Methods
Using MarketScan databases, we assessed RV5 coverage and diarrhea-associated health care use from July 2007 through June 2009 versus July 2001 through June 2006 in children under 5 years of age. We compared the rates of diarrhea-associated health care use in unvaccinated children in the period from January through June (when rotavirus is most prevalent) in 2008 and 2009 with the prevaccine rates to estimate indirect benefits. We estimated national reductions in the number of hospitalizations for diarrhea, and associated costs, by extrapolation.

Results
By December 31, 2008, at least one dose of RV5 had been administered in 73% of children under 1 year of age, 64% of children 1 year of age, and 8% of children 2 to 4 years of age. Among children under 5 years of age, rates of hospitalization for diarrhea in 2001–2006, 2007–2008, and 2008–2009 were 52, 35, and 39 cases per 10,000 person-years, respectively, for relative reductions from 2001–2006 by 33% (95% confidence interval [CI], 31 to 35) in 2007–2008 and by 25% (95% CI, 23 to 27) in 2008–2009; rates of hospitalization specifically coded for rotavirus infection were 14, 4, and 6 cases per 10,000 person-years, respectively, for relative reductions in the rate from 2001–2006 by 75% (95% CI, 72 to 77) in 2007–2008 and by 60% (95% CI, 58 to 63) in 2008–2009. In the January–June periods of 2008 and 2009, the respective relative rate reductions among vaccinated children as compared with unvaccinated children were as follows: hospitalization for diarrhea, 44% (95% CI, 33 to 53) and 58% (95% CI, 52 to 64); rotavirus-coded hospitalization, 89% (95% CI, 79 to 94) and 89% (95% CI, 84 to 93); emergency department visits for diarrhea, 37% (95% CI, 31 to 43) and 48% (95% CI, 44 to 51); and outpatient visits for diarrhea, 9% (95% CI, 6 to 11) and 12% (95% CI, 10 to 15). Indirect benefits (in unvaccinated children) were seen in 2007–2008 but not in 2008–2009. Nationally, for the 2007–2009 period, there was an estimated reduction of 64,855 hospitalizations, saving approximately $278 million in treatment costs.

Conclusions
Since the introduction of rotavirus vaccine, diarrhea-associated health care utilization and medical expenditures for U.S. children have decreased substantially

New England Journal of Medicine
September 22, 2011  Vol. 365 No. 12
http://content.nejm.org/current.shtml

Sounding Board
Reforming the Regulations Governing Research with Human Subjects
Ezekiel J. Emanuel, M.D., Ph.D., and Jerry Menikoff, M.D., J.D.
N Engl J Med 2011; 365:1145-1150September 22, 2011

[Free full-text] http://www.nejm.org/doi/full/10.1056/NEJMsb1106942

Science                                                        
23 September 2011 vol 333, issue 6050, pages 1669-1784
http://www.sciencemag.org/current.dtl

Editorial
Rethinking Clinical Trials
Andrew Grove

The biomedical industry spends over $50 billion per year on research and development and produces some 20 new drugs. One reason for this disappointing output is the byzantine U.S. clinical trial system that requires large numbers of patients. Half of all trials are delayed, 80 to 90% of them because of a shortage of trial participants. Patient limitations also cause large and unpredicted expenses to pharmaceutical and biotech companies as they are forced to tread water. As the industry moves toward biologics and personalized medicine, this limitation will become even greater. A breakthrough in regulation is needed to create a system that does more with fewer patients.

The pdf version of Vaccines: The Week in Review  19 September 2011, comprising the posts below for this date, is available here: Vaccines_The Week in Review_19 Sep 2011

The Bill & Melinda Gates Foundation announced that Dr. Trevor Mundel has been named president of the foundation’s Global Health Program. Dr. Mundel is currently global head of development for Novartis Pharma AG and is based in Basel, Switzerland. Bill Gates, co-chair of the foundation, said, “We are very pleased that Dr. Mundel has agreed to lead our global health program. He brings tremendous scientific and medical credentials, in the lab and in the clinic.  We look forward to working with him to help improve the health of people in the world’s poorest countries.”  In this role, Dr. Mundel “will lead the foundation’s efforts to develop and deliver drugs, vaccines, and other tools to fight developing-world diseases, such as HIV/AIDS, tuberculosis, and malaria, and take the world closer to the goal of polio eradication. He will oversee the foundation’s global health grant portfolio, which includes more than $14.7 billion in grants to date.”

http://www.prnewswire.com/news-releases/gates-foundation-names-dr-trevor-mundel-to-lead-global-health-program-129717323.html

   The European Commission (EC) announced a commitment of “an additional 20 million Euros” to the GAVI Alliance. GAVI CEO Dr Seth Berkley commented, “We are grateful for the European Commission’s confidence in GAVI. This donation, combined with the evident commitment from developing countries to expand immunisation programmes, will further support our efforts to protect children from death and disability. All children have a right to a healthy start in life and vaccination is critical to this.”

http://www.gavialliance.org/library/news/press-releases/2011/ec-makes-further-commitment-to-saving-lives/

The Global Fund said it welcomed a report by an “independent panel of distinguished individuals” recommending “major changes in the way the Global Fund does its business and manages its grants.” The panel was co-chaired by former U.S. Health and Human Services Secretary Michael O. Leavitt and former President of Botswana Festus Mogae and found that the Global Fund “needs to focus much more on its core business of managing grants to save and protect lives. It recommends improving financial and Board oversight, simplifying grant application processes, and putting in place a robust risk management framework.” Simon Bland, Chair of the Global Fund’s Board, commented, “The panel’s report provides a great opportunity to sharpen the focus of the Global Fund and make it fit for the future. We commissioned the panel to give us an honest, hard look at the institution from the outside and that is exactly what we have got. The panel’s findings will play a central role in accelerating reform. As an organization we are totally committed to making the necessary changes to strengthen oversight, improve impact, value for money and sustainability.” The Global Fund said its Board will hold a special meeting on 26 September in Geneva to “consider the report’s findings and prepare an action plan and will meet again in November for its regular meeting to consider larger changes to the organization’s governance structure, strategy and work processes.”

http://www.theglobalfund.org/en/mediacenter/pressreleases/2011-09-19_Global_Fund_welcomes_call_by_Independent_High_Level_Panel_for_stronger_financial_safeguards/

   WHO released the draft agenda for the Meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) to be held 8 – 10 November 2011, in Geneva

http://www.who.int/entity/immunization/sage/AGENDA_Nov_SAGE_with_timings_13_Sep_2011.pdf

     NIH launched an “initiative that will facilitate the ability of start-up companies to license inventions for groundbreaking medical technologies for drugs, vaccines and therapeutics developed by intramural scientists at NIH.” As part of this program, the NIH “is reducing both the costs and paperwork requirements for start-up companies to obtain an exclusive option agreement to license the extensive patent portfolio developed by intramural research laboratories at both NIH and the U.S. Food and Drug Administration.” The new start-up license agreements have been developed the Office of Technology Transfer (OTT) at NIH: Companies that are less than five years old, have fewer than 50 employees and received investment of less than $5 million are eligible to use the new, short-term exclusive Start-Up Evaluation License Agreement and the new Start-Up Commercial License Agreement. Starting on 1 October 2011, “biomedical entrepreneurs will be able to apply for any of the available patents and patent applications relating to drugs, vaccines or therapeutics in the NIH/FDA portfolio by submitting a business plan for how they propose to use them.”

http://www.nih.gov/news/health/sep2011/od-16a.htm

   Meeting Profile: United Nations high-level meeting on noncommunicable disease prevention and control
Place: New York, USA
Date: 19–20 September 2011

The four main noncommunicable diseases – cardiovascular disease, cancer, chronic lung diseases and diabetes – kill three in five people worldwide, and cause great socioeconomic harm within all countries, particularly developing nations.

The United Nations General Assembly is convening a high-level meeting on the prevention and control noncommunicable diseases, which presents a unique opportunity for the international community to take action against the epidemic, save millions of lives and enhance development initiatives.

The high-level meeting will address the prevention and control of noncommunicable diseases worldwide, with a particular focus on developmental and other challenges and social and economic impacts, particularly for developing countries.

WHO has facilitated regional consultations of Member States to give governments the opportunity to contribute, particularly by identifying the challenges posed by noncommunicable diseases in their countries and the measures that exist to start reversing the epidemic.

http://www.who.int/mediacentre/events/meetings/2011/ncd_prevention_control/en/index.html

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) made separate announcements coordinated to the United Nations NCD meeting.
PhRMA reported that “America’s biopharmaceutical research companies have 901 biotechnology medicines and vaccines in development to target more than 100 debilitating and life-threatening diseases, such as cancer, arthritis and diabetes, according to a new report. The medicines in development—all in either clinical trials or under Food and Drug Administration review—include 353 for cancer and related conditions,  187 for infectious diseases, 69 for autoimmune diseases and 59 for cardiovascular diseases.”
http://www.phrma.org/media/releases/over-900-biotechnology-medicines-development-targeting-more-100-diseases

IFPMA “outlined the steps it is taking to address the rise of NCDs in the developing world,” noting “top line findings of the research [see Rand Occasional Paper below] show that effective first-line NCD medicines exist and are now available in generic form, but, in many instances, these medicines are still failing to reach many people living in the developing world.” The study identified four priority areas for the research-based pharmaceutical industry to consider:
– innovative ways to improve NCD medicine adherence
– overcoming barriers to availability in poor and remote areas where large mark-ups, tax and duties, along the supply chain, as well as counterfeit products, are an issue
– improving access to primary care
– removing regulatory restrictions that hamper medicine availability in developing countries.

These priority areas provide the basis for the next four studies in the IFPMA NCD research series. The aim is that the studies will help the research-based pharmaceutical industry and its partners develop and carry out the actions that will most effectively improve access to NCD medicines in developing countries. http://www.ifpma.org/fileadmin/content/News/2011/all/IFPMA_News_Release_UN_NCDs_Summit_19Sept2011.pdf

Improving Access to Medicines for Non-Communicable Diseases in the Developing World [Rand Occasional Paper]
by Soeren Mattke, Marla C. Haims, Nono Ayivi-Guedehoussou, Emily M. Gillen, Lauren Hunter, Lisa Klautzer, Tewodaj Mengistu
Abstract [full text]
Non-communicable diseases (NCDs) now account for the majority of global morbidity and mortality and are increasingly affecting developing countries whose under-resourced health care systems also have to handle a high burden of infectious disease. To counter the global devastation caused by NCDs, the United Nations General Assembly decided to “set a new global agenda” and is convening a high-level meeting on NCDs in September 2011. In connection with this meeting, the authors of this paper took a first step toward developing a policy research agenda for improving access to NCD medicines in developing countries, a step that the research-based pharmaceutical industry, in particular, can carry forward as part of broader global efforts to combat NCD. The authors provide a framework for understanding the obstacles to access for NCD medicines, review specific issues to be confronted within each obstacle in the developing world, identify promising ideas for improving access to NCD medicines, and point to several highly promising areas for the research-based pharmaceutical industry to focus on as it develops its NCD policy research program in close collaboration with other key stakeholders.
http://www.rand.org/content/dam/rand/pubs/occasional_papers/2011/RAND_OP349.pdf

The MMWR Weekly for September 16, 2011 / Vol. 60 / No. 36 includes:
– Influenza-Associated Pediatric Deaths — United States, September 2010–August 2011

– Update: Influenza Activity — United States and Worldwide, May 22–September 3, 2011

http://www.cdc.gov/mmwr/pdf/wk/mm6036.pdf

The Weekly Epidemiological Record (WER) for 16 September 2011, vol. 86, 38 (pp 417–424) includes: InterAmerican Conference on Onchocerciasis, 2010: progress towards eliminating river blindness in the WHO Region of the Americas

http://www.who.int/entity/wer/2011/wer8638.pdf

Twitter Watch
A selection of items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and by no means intended to be exhaustive.

GAVIAlliance GAVI Alliance
Wondering why GAVI’s attending @UN #NCD Summit? @GAVISeth shares why preventing #NCDs is directly related to our mission. http://ht.ly/6xZ9S

GAVIAlliance GAVI Alliance
We are in NYC for the kick-off of the Global Strategy for Women and Children’s Health! http://ht.ly/6xJNW

pahowho PAHO/WHO
#NCDs “This is a global epidemic and this is why we need global actions.” Highlighted at Global Atlas on Prevention and Control #NYC

NIHforHealth NIH for Health
News: NIH launches program to facilitate drug, vaccine and therapeutic license agreements for start-up companies 1.usa.gov/mP4onV

TheLancet The Lancet
First global analysis of breast and cervical cancer estimates 2 million new cases worldwide bit.ly/qGiOgx
Eurovaccine ECDC Eurovaccine
ECDC starts coordinating EUVAC.NET, the European surveillance network for vaccine-preventable diseases bit.ly/qTflgJ #vaccine

ArthurCaplan Arthur Caplan
More from me about the challenge on HPV and vaccine safety from Medscape bit.ly/rgBznB

GAVIAlliance GAVI Alliance
T-5: In 10 years, GAVI support has averted more than 5 million future deaths. #socialgood http://ht.ly/6u6EA

gatesfoundation Gates Foundation
by globalfundnews
.@GlobalFundNews has saved 6.5M lives since 2001. Learn more: gates.ly/o7Z6Wj #malaria #AIDS

British Medical Journal
17 September 2011 Volume 343, Issue 7823
http://www.bmj.com/content/current

Editorial
UN meeting for non-communicable diseases
Tracey Pérez Koehlmoos, programme head

[Extract]
Long term commitment within countries is needed, with support from global development partners and strong leadership from the UN

On 19-20 September 2011, the United Nations will host a general assembly high level meeting on the control and prevention of non-communicable disease (NCD). Although the meeting will be held in New York, the eyes of developing country leaders, decision makers, civil society groups, industry, non-governmental organisations, and researchers will be focused on the event and its outcomes. Previous UN summits have provided the catalyst for change. The summit on HIV/AIDS in 2001 resulted in substantial funding and political commitments. 1

The UN meeting is a crucial moment. This is especially true because it developed in the shadow of global efforts to achieve the millennium development goals, which do not include NCD. NCD is by far the largest killer on the planet and has continued to advance in low and middle income countries, so that the cause of 63% of all global deaths receives less than 3% of international development assistance for health. 2 About 80% of deaths caused by NCD occur in developing countries and generally in a younger population than in high income countries. 3 4 Over the next 10 years, the World Health Organization predicts that deaths from NCD will increase by 17% globally, with the greatest increases in the …

Clinical Infectious Diseases
Volume 53 Issue 8 October 15, 2011
http://www.journals.uchicago.edu/toc/cid/current

Correspondence
Human Papillomavirus Vaccination Programs and Human Immunodeficiency Virus Epidemics
Seema Yasmin, David J. Gerberry, and Sally Blower

TO THE EDITOR—In a recent article, Tracy et al [ 1] use mathematical modeling to predict the potential impact of human papillomavirus (HPV) vaccination programs in developing countries; HPV is the primary causative agent for cervical cancer. The analysis is timely, given the recent announcement that Rwanda will soon launch Africa’s first HPV vaccination program [ 2]. Tracy and colleagues focused on challenges associated with HPV vaccination in Mali (eg, female circumcision, marriage at younger ages, polygamy, cultural and economic factors), but they did not assess the potential effect of human immunodeficiency virus (HIV) on HPV vaccination programs.

Rwanda and many other countries in Sub-Saharan Africa have a significant burden of HPV and HIV. HIV infection increases a woman’s susceptibility to HPV infection, boosts the chances that infection is from high-risk subtypes …

Journal of Infectious Diseases
Volume 204 Issue 8 October 15, 2011
http://www.journals.uchicago.edu/toc/jid/current

EDITORIAL COMMENTARIES
Broadening Indications for Maternal Influenza Vaccination
W. Paul Glezen

[Extract: full text here: http://jid.oxfordjournals.org/content/204/8/1151.full ]
The primary indication for influenza vaccination of pregnant women is to decrease the risk of serious complications during pregnancy [ 1]. The case fatality rates for pregnant women during the influenza pandemics of 1918 and 1957 ranged from 20% to 50% in various reports [ 2]. As a consequence, pregnancy—with or without comorbidities—was considered a high-risk condition by the Surgeon General’s Advisory Committee. A large collaborative perinatal project sponsored by the National Institute for Neurological and Communicative Disorders and Stroke from 1959 to 1965 enrolled over 50 000 pregnant women and their offspring who were intensively followed for all events prior to and after delivery found that influenza vaccine administered to 2291 women during pregnancy had no untoward effects [ 3, 4]. From this study, it can be estimated that about 2 million women received influenza vaccine during pregnancy between 1959 and 1965. Despite the evidence of safety, influenza vaccine was no longer recommended for pregnant women without chronic underlying conditions after 1966 because “influenza-associated excess mortality among pregnant women has not been documented except in the pandemics…” [ 5]. Reports of influenza-related deaths continued to occur, and the sensitivity of the data derived from death certificates was questioned [ 6, 7]. In the early 1990s, investigators looked at risk of influenza-associated hospitalizations during pregnancy and found significant excess occurrence of pneumonia that increased as the pregnancy progressed. This led to reconsideration of the indication for …

Medical Decision Making (MDM)
September/October 2011; 31 (5)
http://mdm.sagepub.com/content/current

Editorials
Katrina Brown and Nick Sevdalis
Lay Vaccination Narratives on the Web: Are They Worth Worrying About?
Med Decis Making September/October 2011 31: 707-709, doi:10.1177/0272989X11419664

Extract
The Internet allows us more access than ever before to the unadulterated anecdotes and opinions of our fellow laypeople. Our decisions—about health care or parenting, for example—were once based on advice from experts, plus perhaps testimonies from a small pool of friends and family, or a finite number of narratives filtered through the press or television. Now the proliferation of social networking and user-generated content in the age of Web 2.0 1 puts at our disposal a huge and often unmoderated bank of online material. Google searches in June 2011 for “health discussion forum” and “mothers discussion forum” yielded 310 million and 62 million hits, respectively—and we know that decision makers do access these online resources. 2, 3

What is less clear is whether, why, and exactly how lay narratives from online forums are associated with real-life decisions. In this issue of Medical Decision Making ( MDM), Betsch and colleagues 4 report an investigation of how lay narratives are used in decision making about vaccination. Using a fictional disease and vaccine context, a mock Internet bulletin board setup, and an undergraduate sample, the authors varied the relative frequency, emotionality, richness, and correlation with official risk estimates of narratives reporting vaccine adverse events and assessed perceived adverse event risk and vaccine uptake intention. Betsch and others found that a higher frequency of narratives reporting vaccine adverse events increased perceived vaccine risk and decreased vaccine uptake intention, that narrative frequency affected risk perception and uptake intention to a greater extent than did statistical information, and that emotionality in narratives increased risk perception, whereas richness had no impact.

Cornelia Betsch, Corina Ulshöfer, Frank Renkewitz, and Tilmann Betsch
The Influence of Narrative v. Statistical Information on Perceiving Vaccination Risks
Med Decis Making September/October 2011 31: 742-753, first published on March 29, 2011 doi:10.1177/0272989X11400419

Abstract
Background. Health-related information found on the Internet is increasing and impacts patient decision making, e.g. regarding vaccination decisions. In addition to statistical information (e.g. incidence rates of vaccine adverse events), narrative information is also widely available such as postings on online bulletin boards. Previous research has shown that narrative information can impact treatment decisions, even when statistical information is presented concurrently.

Objectives. As the determinants of this effect are largely unknown, we will vary features of the narratives to identify mechanisms through which narratives impact risk judgments. Methods. An online bulletin board setting provided participants with statistical information and authentic narratives about the occurrence and nonoccurrence of adverse events. Experiment 1 followed a single factorial design with 1, 2, or 4 narratives out of 10 reporting adverse events. Experiment 2 implemented a 2 (statistical risk 20% vs. 40%) × 2 (2/10 vs. 4/10 narratives reporting adverse events) × 2 (high vs. low richness) × 2 (high vs. low emotionality) between-subjects design. Dependent variables were perceived risk of side-effects and vaccination intentions.

Results. Experiment 1 shows an inverse relation between the number of narratives reporting adverse-events and vaccination intentions, which was mediated by the perceived risk of vaccinating. Experiment 2 showed a stronger influence of the number of narratives than of the statistical risk information. High (vs. low) emotional narratives had a greater impact on the perceived risk, while richness had no effect.

Implications. The number of narratives influences risk judgments can potentially override statistical information about risk.

New England Journal of Medicine
September 15, 2011  Vol. 365 No. 11
http://content.nejm.org/current.shtml

Original Articles
A Field Trial to Assess a Blood-Stage Malaria Vaccine
M.A. Thera and Others

Background
Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02A, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children.

Methods
In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain.

Results
The cumulative incidence of the primary end point was 48.4% in the malaria-vaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P=0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P=0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine.

Conclusions
On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00460525.)

New England Journal of Medicine
September 15, 2011  Vol. 365 No. 11
http://content.nejm.org/current.shtml

Review Article
Genomic Medicine: Genomics, Health Care, and Society
K.L. Hudson

[Initial text from free full text here: http://www.nejm.org/doi/full/10.1056/NEJMra1010517
A new generation of genomic technologies permits the increased collection of data on large study populations.1,2 New methods in informatics facilitate the integration of diverse types of information with genomic data in disease research. As a result, researchers are learning more about the genetic bases of disease and response to drugs.3-6 Genetic tests, including many that are offered directly to the consumer, are growing in number and clinical relevance. Genomic knowledge and technologies are also being adopted in areas distant from human health. Here, I describe evolving policies pertinent to genetic and genomic research, the integration of genetics into clinical care, and the broader issues raised by genetic technologies and information….

The Pediatric Infectious Disease Journal
October 2011 – Volume 30 – Issue 10  pp: A7-A8,821-918,e179-e202
http://journals.lww.com/pidj/pages/currenttoc.aspx

History of Medicine
Smallpox Variolation During the Revolutionary War
Cantey, Joseph B.
Pediatric Infectious Disease Journal. 30(10):821, October 2011.
doi: 10.1097/INF.0b013e318227759a
[No abstract]

Pharmacoeconomics
October 1, 2011 – Volume 29 – Issue 10  pp: 823-911
http://adisonline.com/pharmacoeconomics/pages/currenttoc.aspx

Original Research Articles
Does the Market Share of Generic Medicines Influence the Price Level?: A European Analysis
Dylst, Pieter; Simoens, Steven
Pharmacoeconomics. 29(10):875-882, October 1, 2011.
doi: 10.2165/11585970-000000000-00000

Abstract:
Background: After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited.

Objective: This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets.

Methods: Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007.

Results: Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (−26.6%), while the decrease in low generic market share countries was limited (−0.06%). In high generic market share countries, medicine prices dropped by −43.18% versus −21.56% in low market share countries.

Conclusions: The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

PLoS One
[Accessed 19 September 2011]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Maintaining Vaccine Delivery Following the Introduction of the Rotavirus and Pneumococcal Vaccines in Thailand
Bruce Y. Lee, Tina-Marie Assi, Korngamon Rookkapan, Angela R. Wateska, Jayant Rajgopal, Vorasith Sornsrivichai, Sheng-I Chen, Shawn T. Brown, Joel Welling, Bryan A. Norman, Diana L. Connor, Rachel R. Bailey, Anirban Jana, Willem G. Van Panhuis, Donald S. Burke Diseases Computer Science Maintaining Vaccine … Maintaining Vaccine Delivery Following the Introduction of the Rotavirus and Pneumococcal Vaccines in Thailand … and Pneumococcal Vaccines in Thailand Introducing Rotavirus and Pneumococcal Vaccines Bruce Y. Lee 1 * Tina PLoS ONE: Research Article, published 13 Sep 2011 10.1371/journal.pone.0024673

Abstract 
Although the substantial burdens of rotavirus and pneumococcal disease have motivated many countries to consider introducing the rotavirus vaccine (RV) and heptavalent pneumococcal conjugate vaccine (PCV-7) to their National Immunization Programs (EPIs), these new vaccines could affect the countries’ vaccine supply chains (i.e., the series of steps required to get a vaccine from their manufacturers to patients). We developed detailed computational models of the Trang Province, Thailand, vaccine supply chain to simulate introducing various RV and PCV-7 vaccine presentations and their combinations. Our results showed that the volumes of these new vaccines in addition to current routine vaccines could meet and even exceed (1) the refrigerator space at the provincial district and sub-district levels and (2) the transport cold space at district and sub-district levels preventing other vaccines from being available to patients who arrive to be immunized. Besides the smallest RV presentation (17.1 cm3/dose), all other vaccine introduction scenarios required added storage capacity at the provincial level (range: 20 L–1151 L per month) for the three largest formulations, and district level (range: 1 L–124 L per month) across all introduction scenarios. Similarly, with the exception of the two smallest RV presentation (17.1 cm3/dose), added transport capacity was required at both district and sub-district levels. Added transport capacity required across introduction scenarios from the provincial to district levels ranged from 1 L–187 L, and district to sub-district levels ranged from 1 L–13 L per shipment. Finally, only the smallest RV vaccine presentation (17.1 cm3/dose) had no appreciable effect on vaccine availability at sub-districts. All other RV and PCV-7 vaccines were too large for the current supply chain to handle without modifications such as increasing storage or transport capacity. Introducing these new vaccines to Thailand could have dynamic effects on the availability of all vaccines that may not be initially apparent to decision-makers.

PLoS One
[Accessed 19 September 2011]
http://www.plosone.org/article/browse.action;jsessionid=577FD8B9E1F322DAA533C413369CD6F3.ambra01?field=date

Resource Allocation for Epidemic Control in Metapopulations
Martial L. Ndeffo Mbah, Christopher A. Gilligan vaccination to prevent or mitigate the spread of an outbreak … , they show that when vaccine supplies are limited … , it is optimal to target vaccination toward the more PLoS ONE: Research Article, published 13 Sep 2011 10.1371/journal.pone.0024577

Abstract 
Deployment of limited resources is an issue of major importance for decision-making in crisis events. This is especially true for large-scale outbreaks of infectious diseases. Little is known when it comes to identifying the most efficient way of deploying scarce resources for control when disease outbreaks occur in different but interconnected regions. The policy maker is frequently faced with the challenge of optimizing efficiency (e.g. minimizing the burden of infection) while accounting for social equity (e.g. equal opportunity for infected individuals to access treatment). For a large range of diseases described by a simple SIRS model, we consider strategies that should be used to minimize the discounted number of infected individuals during the course of an epidemic. We show that when faced with the dilemma of choosing between socially equitable and purely efficient strategies, the choice of the control strategy should be informed by key measurable epidemiological factors such as the basic reproductive number and the efficiency of the treatment measure. Our model provides new insights for policy makers in the optimal deployment of limited resources for control in the event of epidemic outbreaks at the landscape scale.

PLoS Medicine
(Accessed 19 September 2011)
http://www.plosmedicine.org/article/browse.action?field=date

Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience Mwanamvua Boga, Alun Davies, Dorcas Kamuya, Samson M. Kinyanjui, Ester Kivaya, Francis Kombe, Trudie Lang, Vicki Marsh, Bibi Mbete, Albert Mlamba, Sassy Molyneux, Stephen Mulupi, Salim Mwalukore Health in Action, published 13 Sep 2011
doi:10.1371/journal.pmed.1001089

Summary Points
– Informed consent is fundamental to ethical health research.

– Significant challenges are experienced in obtaining consent for research, particularly in poor settings.

– Consenting processes can be strengthened by taking into account local social, cultural, and economic contexts in the design and administration of consent forms.

– Institutional wide support is important in ensuring consistency in the consenting process for all studies within a given institution.

Science                                                        
16 September 2011 vol 333, issue 6049, pages 1537-1668
http://www.sciencemag.org/current.dtl

Perspectives
AIDS/HIV
Converging on an HIV Vaccine
Bette Korber and S. Gnanakaran
Science 16 September 2011: 1589-1590.

Summary
Three decades after the discovery of AIDS we still do not have a vaccine against the causative agent, the human immunodeficiency virus (HIV). Multidrug therapy can extend life and health for those with HIV, but only holds the virus at bay, making treatment a lifetime proposition. Access to treatment or other promising infection prevention measures such as topical microbicides (1) are an economic and social challenge (2). A vaccine would be a simple and direct strategy for prevention. On pages 1593 and 1633 of this issue, Wu et al. (3) and Scheid et al. (4) detail the trajectory of an immune response to natural HIV infection that may provide a path to a vaccine.

Tropical Medicine & International Health
October 2011  Volume 16, Issue 10  Pages 1191–1352
http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-3156/currentissue
Implementation research

Research capacity for institutional collaboration in implementation research on diseases of poverty (pages 1285–1290)
M. A. González-Block, E. M. Vargas-Riaño, N. Sonela, A. J. Idrovo, O. Ouwe-Missi-Oukem-Boyer and J. J. Monot
Article first published online: 18 JUL 2011 | DOI: 10.1111/j.1365-3156.2011.02834.x

Summary
Objective  To assess the capacity for research collaboration and implementation research in strengthening networks and institutions in developing countries.

Methods  Bibliometric analysis of implementation research on diseases of poverty in developing countries from 2005 to 2010 through systematically searching bibliographic databases. Methods identified publication trends, participating institutions and countries and the cohesion and centrality of networks across diverse thematic clusters.

Results  Implementation research in this field showed a steadily growing trend of networking, although networks are loose and a few institutions show a high degree of centrality. The thematic clusters with greatest cohesion were for tuberculosis and malaria.

Conclusions  The capacity to produce implementation research on diseases of poverty is still low, with the prominence of institutions from developed countries. Wide ranges of collaboration and capacity strengthening strategies have been identified which should be put into effect through increased investments

Tropical Medicine & International Health
October 2011  Volume 16, Issue 10  Pages 1191–1352
http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-3156/currentissue

Child health
Reaching Millennium Development Goal 4 – The Gambia (pages 1314–1325)
Momodou Jasseh, Emily L. Webb, Shabbar Jaffar, Stephen Howie, John Townend, Peter G. Smith, Brian M. Greenwood and Tumani Corrah
Article first published online: 24 JUN 2011 | DOI: 10.1111/j.1365-3156.2011.02809.x

Summary
Objective  To describe how, through a DSS in a rural area of The Gambia, it has been possible to measure substantial reductions in child mortality rates and how we investigated whether the decline paralleled the registered fall in malaria incidence in the country.

Methods  Demographic surveillance data spanning 19.5 years (1 April 1989–30 September 2008) from 42 villages around the town of Farafenni, The Gambia, were used to estimate childhood mortality rates for neonatal, infant, child (1–4 years) and under-5 age groups. Data were presented in five a priori defined time periods, and annual rates per 1000 live births were derived from Kaplan–Meier survival probabilities.

Results  From 1989–1992 to 2004–2008, under-5 mortality declined by 56% (95% CI: 48–63%), from 165 (95% CI: 151–181) per 1000 live births to 74 (95% CI: 65–84) per 1000 live births. In 1- to 4-year-olds, mortality during the period 2004–2008 was 69% (95% CI: 60–76%) less than in 1989–1992. The corresponding mortality decline in infants was 39% (95% CI: 23–52%); in neonates, it was 38% (95% CI: 13–66%). The derived annual under-5 mortality rates declined from 159 per 1000 live births in 1990 to 45 per 1000 live births in 2008, thus implying an attainment of MDG4 seven years in advance of the target year of 2015.

Conclusion  Achieving MDG4 is possible in poor, rural areas of Africa through widespread deployment of relatively simple measures that improve child survival, such as immunisation and effective malaria control.

The pdf version of Vaccines: The Week in Review  12 September 2011, comprising the posts below for this date, is available at: Vaccines_The Week in Review_12 Sep 2011

   The International Vaccine Institute (IVI announced the appointment of Dr. Christian Loucq as the organization’s next Director General. Dr. Loucq will take up his new role in November. Ragnar Norrby, chairman of the IVI’s board of trustees, commented, “Christian Loucq is well-versed in the management and leadership of private- and public-sector organizations in the vaccine arena, and he has extensive experience in working with public-private partnerships and private collaborations. His distinguished track record and background in global public health and business makes him an ideal leader to effectively set the course for the IVI’s continued success and further growth and development as an institute.” Most recently, Dr. Loucq was the Director of the Malaria Vaccine Initiative (MVI), a product development partnership based at PATH in the U.S.

Dr. Loucq commented, “I am honored and very enthusiastic to be joining the IVI team as Director General. From research and development to epidemiology, from local manufacturing to access, the IVI has been a pioneering organization in many aspects of vaccinology when applied to preventing infectious diseases among the worlds poorest children. I look forward to working with the IVI team, its board and advisors, the many generous donors, and the IVI’s collaborators throughout the world to help the IVI have an even greater impact.”

The International Vaccine Institute (IVI) describes itself as “the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established as an initiative of the United Nations Development Programme in 1997, the IVI operates as an independent international organization under a treaty signed by 40 countries and the World Health Organization. The Institute conducts research in 30 countries of Asia, Africa, and Latin America on vaccines against diarrheal infections, bacterial meningitis and pneumonia, as well as Japanese encephalitis and dengue fever, and develops new and improved vaccines, routes of delivery and adjuvants at its headquarters in Seoul, Korea.”

http://www.ivi.org/event_news/news_view.asp?enid=124

    The NIH announced results of a study that found that “two doses of the human papillomavirus (HPV) vaccine Cervarix were as effective as the current standard three-dose regimen after four years of follow-up.” The results of the study, based on data from a community-based clinical trial of Cervarix in Costa Rica, appeared online Sept. 9, 2011, in the Journal of the National Cancer Institute. NIH said the NCI-sponsored Costa Rica Vaccine Trial was designed to assess the efficacy of Cervarix in a community-based setting. Women ages 18 to 25 years were randomly assigned to receive the HPV vaccine or a Hepatitis A vaccine as the control treatment. Although the investigators intended to administer all three doses of the assigned vaccine to all 7,466 women in the study, about 20 percent of the participants received only one or two doses of the HPV or control vaccine. A third of women did not complete the vaccine series because they became pregnant or were found to have possible cervical abnormalities, reasons that would not likely bias the findings.

NIH said that the investigators found that, “after four years of follow up, two doses of the vaccine conferred the same strong protection against persistent infection with HPV 16 and 18 as did the full three-dose regimen. From just a single dose, they also observed a high level of protection, but they are cautious about the long-term efficacy of a single dose because other vaccines of this type usually require a booster dose. Additional studies are needed to evaluate the efficacy of a single dose, as well as the duration of protection for both one and two doses.” Aimée R. Kreimer, Ph.D., lead author and investigator in NCI’s Division of Cancer Epidemiology and Genetics, commented, “Our study provides evidence that an HPV vaccine program using two doses will work. It may be that vaccinating more women, with fewer doses for each, will reduce cervical cancer incidence more than a standard three-dose program that vaccinates fewer women. The main question will be whether the duration of protection from fewer doses is adequate.”

http://www.nih.gov/news/health/sep2011/nci-09.htm

The MMWR Weekly for September 9, 2011 / Vol. 60 / No. 35 includes:
– Maternal and Infant Outcomes Among Severely Ill Pregnant and Postpartum Women with 2009 Pandemic Influenza A (H1N1) — United States, April 2009–August 2010

– Swine-Origin Influenza A (H3N2) Virus Infection in Two Children — Indiana and Pennsylvania, July–August 2011

http://www.cdc.gov/mmwr/pdf/wk/mm6035.pdf

 WHO released a new issue of GIN (Global Immunization News) dated 31 August 2011, available at: http://www.who.int/entity/immunization/GIN_August_2011.pdf

The Weekly Epidemiological Record (WER) for 9 September 2011, vol. 86, 37 (pp 401–416) includes: Revised recommendations for yellow fever vaccination for international travelers; Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2011

http://www.who.int/entity/wer/2011/wer8637.pdf

Twitter Watch
A selection of items of interest from a variety of twitter feeds associated with immunization, vaccines and global public health. This capture is highly selective and by no means intended to be exhaustive.

GAVIAlliance GAVI Alliance
Global rollout of pneumococcal #vaccine is underway across three continents.650,000 future deaths can be averted by 2015! http://ht.ly/6qIwX

PublicHealth APHA
Health impact assessments essential for solving nation’s health problems, says National Research Council report: goo.gl/WCsnI

Eurovaccine ECDC Eurovaccine
RT @hpscireland: Over 86% of measles cases in current outbreak are in Dublin. Ensure kids are vaccinated w/ 2 MMR doses bit.ly/rsFLOl

NIAIDNews NIAID News
A new #malaria #vaccine strategy? Results of a NIAID clinical trial and follow-up animal studies, and what comes next: go.usa.gov/09e

mrcglobal MRC Global Health
Do u have an innovative idea to strengthen #public & #political support for #vaccines in LMICs? http://www.vaccinechallenge.org

HIVEnterprise HIVVaccineEnterprise
by AIDSvaccine
AIDS Vaccine 2011 (#AIDSVax11) opens 12 Sept. in Bangkok – will present the latest advances in vaccine development and testing

British Medical Journal
10 September 2011 Volume 343, Issue 7822
http://www.bmj.com/content/current

Analysis
Evidence of comparative efficacy should have a formal role in European drug approvals
Corinna Sorenson, Huseyin Naci, Jonathan Cylus, Elias Mossialos
BMJ 2011;343:doi:10.1136/bmj.d4849 (Published 6 September 2011)

Extract
Despite methodological concerns, comparative efficacy evidence should be required at the time of drug approval, says Corinna Sorenson and colleagues, to allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives

Manufacturers of new drugs need to demonstrate that their products are efficacious and safe for a defined group of patients to obtain market approval. However, demonstrating these outcomes relative to existing therapies is required by regulators only when use of placebo is deemed unethical. 1 2 Regulators, clinicians, patients, and payers therefore often lack the necessary information to distinguish between available medicines in terms of their comparative therapeutic value and safety.

Comparative efficacy evidence at the time of drug approval is important, and there are methodological tools available to generate such information. When one or more treatment alternatives are available, demonstrating lack of inferiority through comparative assessment should be a formal requirement, and there are ways to support this objective in European drug licensing.

Need for comparative efficacy evidence
When a drug comes to market, evidence on the comparative risks and benefits is needed to help regulatory authorities to safeguard public health from inferior and unsafe treatments, to ensure that health technology assessment agencies and payers make funding decisions based on the best available evidence of different treatments, and to aid clinicians’ and patients’ understanding of what therapies work best and their appropriate position in the treatment pathway. 3 However, comparative assessment (box 1) is often conducted or made available only once a therapy is already on the market. This is partly because pre-marketing comparative efficacy studies entail potential uncertainty and risk for manufacturers, as failure to demonstrate a therapeutic advantage over older, and less costly, alternatives may affect drug sales or result in a drug not being approved. 2 …

Health Economics, Policy and Law 
Volume 6 – Issue 04 – 01 October 2011
http://journals.cambridge.org/action/displayIssue?jid=HEP&tab=currentissue

Articles
Searchers vs surveyors in estimating the monetary value of a QALY: resolving a nasty dilemma for NICE
Rachel Baker, Sue Chilton, Cam Donaldson, Michael Jones-Lee, Emily Lancsar, Helen Mason, Hugh Metcalf, Mark Pennington and John Wildman

Abstract
Recently, for many health economics researchers, empirical estimation of the monetary valuation of a quality-adjusted life year (QALY) has become an important endeavour. Different philosophical and practical approaches to this have emerged. On the one hand, there is a view that, with health-care budgets set centrally, decision-making bodies within the system can iterate, from observation of a series of previous decisions, towards the value of a QALY, thus searching for such a value. Alternatively, and more consistent with the approach taken in other public sectors, individual members of the public are surveyed with the aim of directly eliciting a preference-based – also known as a willingness-to-pay-based (WTP-based) – value of a QALY. While the former is based on supply-side factors and the latter on demand, both in fact suffer from informational deficiencies. Sole reliance on either would necessitate an acceptance or accommodation of chronic inefficiencies in health-care resource allocation. On the basis of this observation, this paper makes the case that in order to approach optimal decision making in health-care provision, a framework incorporating and thus, to a degree, reconciling these two approaches is to be preferred.