11 Member States of the WHO South-East Asia Region committed to eliminating measles and controlling rubella and congenital syndrome (CRS) by 2020.

    The 11 Member States of the WHO South-East Asia Region committed to eliminating measles and controlling rubella and congenital syndrome (CRS) by 2020. The commitment came at the Sixty-sixth Session of the WHO Regional Committee for South-East Asia. The announcement noted that these 11 countries constitute some 45% of global measles deaths and that WHO estimates that US$800 million will be needed to achieve these goals by 2020.  The announcement also reported that “in order to reach the goal of measles elimination and rubella control, governments will need to achieve and maintain 95% population immunity against these diseases within each district through routine immunization and/or supplementary campaigns. Countries will also need to develop and sustain a sensitive and timely case-based measles and rubella/CRS surveillance system. The regional network of accredited measles and rubella laboratories needs to be expanded and strengthened. Strategic plans are being developed by all countries in the Region. These plans will need allocation of adequate funds and human resources.”


IVI announces Yanghyun Foundation gift of 30 million Korean

   IVI announced that the Yanghyun Foundation donated 30 million Korean won to support IVI programs for this year. The announcement came during a ceremony at the Hanjin Shipping Building in Seoul, Korea on September 6. As one of IVI’s long-term donors, the philanthropic foundation has supported IVI since 2008, contributing a cumulative total of 243 million won.
Full announcement: http://www.ivi.org/web/www/07_01?p_p_id=EXT_BBS&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_EXT_BBS_struts_action=%2Fext%2Fbbs%2Fview_message&_EXT_BBS_messageId=551

Bill & Melinda Gates Foundation announces that CEO Jeff Raikes will retire

The Bill & Melinda Gates Foundation announced that CEO Jeff Raikes will retire, remaining in his position until a successor is named. In an email to BMGF employees, Mr. Raikes noted: “…I am proud of the work we’ve all done together in the past five years. We are having an impact on people’s lives every single day, and we are set up to keep on having an even bigger impact in the years to come…Now, I’m looking forward to doing some things I haven’t had time for, including my work at the Raikes Foundation, which is tackling youth and education issues. I have learned so much from Bill, Melinda, our grantees and partners, and all of you about catalytic philanthropy and specific issues like agriculture and education. I have also learned from—and been deeply moved by—the people I’ve met in the field, whether they’re Ethiopian farmers trying to grow enough food to feed their children or a teacher in New Orleans helping students make a better future. These lessons will not only inspire me but also serve me day-to-day, because I will continue to invest my time and energy in these areas…”

Full media release: http://www.gatesfoundation.org/Media-Center/Press-Releases/2013/09/Jeff-Raikes-to-Retire-as-CEO-of-the-Bill-and-Melinda-Gates-Foundation

Aeras names Lewis K. Schrager, M.D., M.A., as Vice President of Scientific Affairs

   Aeras said it appointed Lewis K. Schrager, M.D., M.A., as Vice President of Scientific Affairs.  As a member of the senior leadership team, Dr. Schrager “will oversee and maintain key external relationships focused on research and development and represent Aeras at major scientific meetings and symposiums (as well as) oversee the Regulatory Affairs, Global Affairs, Safety & Pharmacovigilance, Medical Writing and Market Access departments, and function s a member of the Vaccine Advisory Committee and the Aeras Portfolio Review Committee. Dr. Schrager fills the position left by Dr. Ann Ginsberg, who assumed the position of Chief Medical Officer earlier this year.

Full release: http://www.aeras.org/pressreleases/respected-vaccine-expert-lewis-schrager-joins-aeras#.UjT3sD_9qFg

2013 Lasker Award Einners Announced

The Albert and Mary Lasker Foundation announced the winners of the 2013 Lasker Awards –

:: Richard H. Scheller and Thomas C. Sudhof for basic medical research on discoveries concerning neurotransmitters;

:: Graeme M. Clark, Ingeborg Hochmair and Blake S. Wilson for clinical research leading to the development of the modern Cochlear Implant, and

:: Bill Gates and Melinda Gates for public service in improving the lives of the world’s most vulnerable people.”  Alfred Sommer, Chair of the Lasker Foundation’s Board of Directors, commented, “The Lasker Awards showcase the power of biomedical research to advance science, save lives, and avert suffering the world over. This year’s awards celebrate that (68-year old) tradition by honoring fundamental discoveries about brain function, the creation of an innovative technology that confers hearing to profoundly deaf people, and the powerful impact of results-driven philanthropy that has enhanced the quality of life for millions around the globe.”

Full media release: http://www.prnewswire.com/news-releases/2013-lasker-awards-honor-scientists-for-pioneering-medical-research-222955411.html

PhRMA announces recipients of the 2013 Research & Hope Awards

   The Pharmaceutical Research and Manufacturers of America (PhRMA) announced today the recipients of the 2013 Research & Hope Awards, “honoring outstanding achievements in vaccines research and immunization by individuals and research teams in the biopharmaceutical sector, academic/public research and health care provider communities.” Recipients of the PhRMA 2013 Research & Hope Awards are:

   :: The PhRMA Research & Hope Award for Biopharmaceutical Industry Research in Vaccine Development  –  GlaxoSmithKline Malaria Vaccine Team
“The GlaxoSmithKline Malaria Vaccine Team, led by Dr. Sophie Biernaux, is receiving the 2013 PhRMA Research & Hope Award for Biopharmaceutical Industry Research for its ongoing development of a vaccine against malaria targeted to children in Sub-Saharan Africa. For more information on the team’s work, now in the final stages of a large, multi-center Phase III clinical trial, see the video and team bio.”

   :: The PhRMA Research & Hope Award for Academic or Public Research in Vaccine Development – Douglas R. Lowy, MD, National Cancer Institute; John T. Schiller, PhD, National Cancer Institute
“Drs. Lowy and Schiller are receiving the 2013 PhRMA Research & Hope Award for Academic or Public Research for the discovery of the human papilloma virus (HPV) vaccine for the prevention of cervical cancer. For more information on their pivotal work, see the video and bios.”

   :: The PhRMA Research & Hope Award for Patient and Community Health – Linda Yu-Sing Fu, M.D., M.Sc., Children’s National Medical Center (CNMC)
“Dr. Fu, on behalf of her team at CNMC, is receiving the 2013 PhRMA Research & Hope Award for Patient and Community Health for their efforts to increase awareness of the importance of childhood immunization and raise the quality of immunization delivery to an at-risk population in the District of Columbia. For more information, see the video and bio.”

PhRMA noted that recipients of the Biopharmaceutical Industry Research and Academic or Public Research Awards were selected by the Science Advisory Board of the PhRMA Foundation following an open nominations process. The recipient of the Patient and Community Health Award was chosen by an inter-departmental committee of representatives from PhRMA.

Full media release: http://www.businesswire.com/news/home/20130911005390/en/PhRMA-Honors-Vaccines-Pioneers-Research-Hope-Awards

GPEI Update: Polio this week – As of 11 September 2013

Update: Polio this week – As of 11 September 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]
:: Due to the Horn of Africa outbreak, the bulk of polio cases this year (over two-thirds) are in countries which were previously polio-free.
:: Between the endemic countries, cases are down 40% over the same period last year (78 compared to 131); this indicates progress particularly in Afghanistan and Nigeria, which are poised to enter the traditional ‘high season’ for polio transmission in a strong position. The subsequent ‘low season’ will be the most critical in the history of polio eradication.

::One new WPV1 case was reported in the past week (from Taraba), bringing the total number of WPV1 cases for 2013 to 46. It is the most recent WPV case in the country and had onset of paralysis on 17 August…

:: One new WPV1 case was reported in the past week (from Khyber Pakhtunkhwa – KP), bringing the total number of WPV1 cases for 2013 to 28. It is the most recent WPV case in the country and had onset of paralysis on 19 August.
:: FATA remains the major poliovirus reservoir in Pakistan and in Asia, both due to WPV1 and cVDPV2. Efforts are ongoing to curb transmission in this area, including through vaccination at transit points and conducting Short Interval Additional Dose (SIADs) campaigns in areas that have recently become accessible….

Horn of Africa
:: Four new WPV1 cases were reported in the past week, three from Somalia and one from Kenya. The total number of WPV1 cases for 2013 in the Horn of Africa is 179 (163 from Somalia, 14 from Kenya and one from Ethiopia). The most recent WPV1 case in the region had onset of paralysis on 7 August (from Somalia).
:: The Global Polio Eradication Initiative has conducted a three month assessment of the polio outbreaks in Somalia and Kenya. The assessment conclusions are that the response was rapid and aggressive, with strong national leadership and international coordination.
:: In both countries, there is a significant risk that the outbreak will extend beyond six months, due to large numbers of under vaccinated children in Somalia and inconsistent campaign quality in Kenya. Outbreak response planning should therefore continue into 2014…

CDC/MMWR Watch [to 14 September 2013]

CDC/MMWR Watch [to 14 September 2013]
:: National, State, and Local Area Vaccination Coverage Among Children Aged 19–35 Months — United States, 2012
:: Measles — United States, January 1–August 24, 2013
:: Influenza Vaccination Practices of Physicians and Caregivers of Children with Neurologic and Neurodevelopmental Conditions — United States, 2011–12 Influenza Season
:: Notes from the Field: Measles Outbreak Among Members of a Religious Community — Brooklyn, New York, March–June 2013
:: Notes from the Field: Measles Outbreak Associated with a Traveler Returning from India — North Carolina, April–May 2013

   CDC Telebriefing: National Immunization Survey, Vaccine for Children Program, and recent measles outbreaks in the U.S.
Thursday, September 12, 2013 Noon ET
Press Briefing Transcript [Audio recording  [MP3, 5.51 MB]

“….Twenty years ago, the VFC program was developed to fix a national crisis of missed opportunities.  Today we have a strong public private partnership for immunizing children that reflects the success of the VFC program.  But today we also have local measles outbreaks representing a very different dynamic.  Instead of our system missing opportunities to vaccinate young children, in some communities people have been rejecting opportunities to be vaccinated.

Let me start with our National Immunization Report Card— National Immunization Survey of Toddlers, age 19 to 35 months, or the NIS. According to the 2012 NIS, the vast majority of parents are vaccinating their children against potentially serious diseases…

The 2012 NIS report shows most that children are complete on the recommended vaccinations.  The U.S. continues to have high rates of immunization coverage at the national level.  Vaccination coverage remains near or above 90 percent for measles, mumps and rubella vaccine or MMR.  For the polio series, for hepatitis B series, and for varicella or chicken pox vaccine.  The percentage of children who received no vaccinations remains low.  Only 0.8 percent or less than one percent of children in this survey had received no vaccines at all.  These are really good results, but there is opportunity for improvement.  Vaccination coverage varies by state.  Both for individual vaccines and for the series measure….

…So, next I want to briefly discuss the national measles situation so far this year.  It is a far cry from that crisis that we had 24 years ago.  But with measles things can change very quickly.  And we need to stay ahead of this virus which means we need to make sure that immunization coverage is high everywhere.  This year, the U.S. is experiencing a higher than usual number of measles cases.  There are three outbreaks that account for most of this year’s measles cases in New York City, North Carolina, and Texas.  From January 1st to August 24th, 159 measles cases have been reported across the United States.  That’s the second largest number of measles cases we have had in this country since measles was eliminated in 2000.       During this period, 16 states reported measles cases and the age of cases ranged widely from birth to 61 years.  Thirty-seven percent of the cases were children under  five.  And 18 or 11 percent of all cases were in babies under 12 months who are too young to be routinely vaccinated.  Seventeen or 11 percent of the cases required hospitalization. Four of the patients had pneumonia.  Fortunately none of the measles cases here in the U.S. this year died.  Most of this year’s cases were unvaccinated. One hundred and thirty-one or 82 percent.  Four had unknown vaccinations status, 16 cases or nine percent. Among the 140 U.S. residents, 117 were unvaccinated.

I want to tell you in particulars about why they were unvaccinated because it’s so different than what we were seeing in back in 1989 to 1991.  Seventy-nine percent of the U.S. residents cases that were unvaccinated had philosophical objections to the vaccine. A smaller numbers, 15 cases or 13 percent, were babies under 12 months that cannot directly be vaccinated but rely on those around them being vaccinated.  Let me say a few words about the outbreaks.  New York City reported 58 cases, making this the largest outbreak reported in the United States since 1996.  None of the patients in that outbreak had documentation of measles vaccination.  North Carolina reported the second largest outbreaks so far with 23 cases.  Cases mainly occurred among people who were unvaccinated due to philosophical objection.  And in the current outbreak in Texas, 20—actually 21 cases, more since we’ve made the report in the MMWR, have — been reported.  The numbers may continue to change as this outbreak may be ongoing.  Seventeen of those cases in Texas were unvaccinated.  As these outbreaks are showing, clusters of people with like-minded beliefs leading them to forego vaccines can be susceptible to outbreaks when measles outbreaks are imported from elsewhere.  Measles, as we know, is highly contagious and can lead to serious complications and even death. We need very high rates of immunization to protect the most vulnerable –children too young to be vaccinated and those who can’t be vaccinated due to health conditions.

Importation of measles in the U.S. continues to occur and it poses a threat to our country.  It poses a particular threat to people who are not vaccinated.  All of the measles cases reported in the U.S. in 2013 were associated with importations from other countries.  There were 42 actual importations from 18 other countries.  You can think of an import associated case as being linked back to a traveler who brought the disease into the U.S. from another country.  Half of the imported measles cases we had in the U.S. originated from Europe.  Not a place that many people think of when they try to update their vaccine records before travel.  Measles is still common in many parts of the world.  And, unfortunately, about 160,000 people around the world die from the disease each year.  Rapid public health response to measles is critical.  Given how very infectious measles is and the fact we still have pockets of unvaccinated people.  We have to rapidly investigate and respond to measles cases.  But thanks to the high vaccination rates and rapid public health response the outbreak in 2013 has been contained and it is – that is at the cost of tremendous effort on the part of public health workers who respond to these outbreaks when they occur….

20 Years of Success: CDC Celebrates 20th Anniversary of Vaccines for Children Program – Digital Press kit

GSK research — incidence of pertussis among U.S. adults 50 and older may be greatly under-reported and under-recognized

GSK research released at the 2013 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) reported that “the incidence of pertussis among U.S. adults 50 and older may be greatly under-reported and under-recognized.”  The research estimated that the actual number of pertussis cases was approximately 520,000 versus the 8,764 medically-attended cases among U.S. adults ages 50 to 64, and approximately 465,000 versus 6,359 medically-attended pertussis cases among adults 65 and older in the same database. That equates to an incidence on average of 202 per 100,000 in adults 50-64, and 257 per 100,000 among adults 65 and older. These estimated incidences were about 42 to 105 times higher than the medically-attended pertussis cases documented in the same database during the years 2006-2010. In 2010, the estimated incidence was 94 and 264 times higher than nationally reported incidences for individuals aged 50-64 and 65 and older, respectively. The GSK researchers who led the study, Cristina Masseria, Ph.D, and Girishanthy Krishnarajah, MPH, MBA/MS, utilized data from the IMS private practice database that included more than 80 million claims per year and analyzed approximately 48 million cases of cough-related illness in the U.S. between 2006 and 2010. The commercial laboratory testing database represents approximately 40 percent of respiratory-laboratory testing that took place in the U.S. during the years looked at in the study.

Leonard Friedland, M.D., Vice President and Director of Scientific Affairs and Public Health for GSK Vaccines, noted, “The CDC, other public health authorities and infectious disease experts have long suspected that pertussis cases in adults go undetected or are misdiagnosed as other respiratory ailments . To our knowledge, this is the first attempt to quantify the incidence of cough illness attributed to B. pertussis via regression modeling among those greater than 50 years old. The authors plan to share their research methods and welcome other researchers to further examine and build upon the findings of this study. These findings suggest a major need for healthcare providers to consider the possibility of pertussis in older patients they see who have respiratory symptoms.”

Full media release: http://www.prnewswire.com/news-releases/gsk-research-estimates-significantly-higher-rates-of-pertussis-among-older-adults-than-now-reported-223473661.html

PhRMA Report: Medicines in Development – Vaccines – A Report on the Prevention and Treatment of Disease Through Vaccines

Report: Medicines in Development – Vaccines – A Report on the Prevention and Treatment of Disease Through Vaccines
The Pharmaceutical Research and Manufacturers of America (PhRMA)
September 2013: 36 pages Link: report

PhRMA released a report which noted that America’s biopharmaceutical companies are currently developing 271 vaccines to prevent – and in some cases treat – a variety of conditions, including infectious diseases, various forms of cancer and neurological disorders. These potential vaccines – all in human clinical trials or under review by the Food and Drug Administration (FDA) – include 137 for infectious diseases, 99 for cancer, 15 for allergies and 10 for neurological disorders. The report also noted that there are 204 active clinical trials for vaccines in the U.S., including 107 that have not yet started recruiting patients or are just now seeking volunteers to participate.

UN Report: Global child deaths down by almost half since 1990

UN Report: Global child deaths down by almost half since 1990
WHO, UNICEF, World Bank Group, UN-DESA Population Division
13 September 2013

:: Download the report.
:: Detailed explanation of the B3 model used in developing the UN IGME child mortality estimates is available here.
:: Under-five mortality estimates: Rates and Deaths
:: Infant mortality estimates: Rates and Deaths
:: Neonatal mortality estimates: Rates and Deaths
:: Sex-specific under-five mortality rate: Estimates
:: Sex-specific infant mortality rate: Estimates
::: Annual rate of reduction of under-five mortality: Estimates and 90% uncertainty intervals
:: Country-specific methodological notes: Summary

The report notes that in 2012, approximately 6.6 million children worldwide – 18 000 children per day – before reaching their fifth birthday, roughly half the number of under-fives who died in 1990, when more than 12 million children died. Anthony Lake, UNICEF Executive Director, commented, “This trend is a positive one. Millions of lives have been saved. And we can do still better. Most of these deaths can be prevented, using simple steps that many countries have already put in place – what we need is a greater sense of urgency.” The leading causes of death among children aged less than five years include pneumonia, prematurity, birth asphyxia, diarrhoea and malaria. Globally, about 45% of under-five deaths are linked to undernutrition.

About half of under-five deaths occur in only five countries: China, Democratic Republic of the Congo, India, Nigeria, and Pakistan. India (22%) and Nigeria (13%) together account for more than one-third of all deaths of children under the age of five.


Drug versus vaccine investment: a modelled comparison of economic incentives

Cost Effectiveness and Resource Allocation
(Accessed 14 September 2013)

Drug versus vaccine investment: a modelled comparison of economic incentives
Stéphane A Régnier12* and Jasper Huels2
Investment by manufacturers in research and development of vaccines is relatively low compared with that of pharmaceuticals. If current evaluation technologies favour drugs over vaccines, then the vaccines market becomes relatively less attractive to manufacturers.
We developed a mathematical model simulating the decision-making process of regulators and payers, in order to understand manufacturers’ economic incentives to invest in vaccines rather than curative treatments. We analysed the objectives and strategies of manufacturers and payers when considering investment in technologies to combat a disease that affects children, and the interactions between them.
The model confirmed that, for rare diseases, the economically justifiable prices of vaccines could be substantially lower than drug prices, and that, for diseases spread across multiple cohorts, the revenues derived from vaccinating one cohort per year (routine vaccination) could be substantially lower than those generated by treating sick individuals.
Manufacturers may see higher incentives to invest in curative treatments rather than in routine vaccines. To encourage investment in vaccines, health authorities could potentially revise their incentive schemes by: (1) committing to vaccinate all susceptible cohorts in the first year (catch-up campaign); (2) choosing a long-term horizon for health technology evaluation; (3) committing higher budgets for vaccines than for treatments; and (4) taking into account all intangible values derived from vaccines.

Eurosurveillance – Volume 18, Issue 37, 12 September 2013

Volume 18, Issue 37, 12 September 2013

Research articles
The test-negative design: validity, accuracy and precision of vaccine efficacy estimates compared to the gold standard of randomised placebo-controlled clinical trials
by G De Serres, DM Skowronski, XW Wu, CS Ambrose

Laboratory-confirmed invasive meningococcal disease: effect of the Hajj vaccination policy, Saudi Arabia, 1995 to 2011
by Z Memish, R Al Hakeem, O Al Neel, K Danis, A Jasir, D Eibach

Viewpoint: Reconsidering the Politics of Public Health

September 11, 2013, Vol 310, No. 10

Viewpoint | September 11, 2013
Reconsidering the Politics of Public Health
Dave A. Chokshi, MD, MSc1; Nicholas W. Stine, MD2
Initial language
A central dilemma in public health is reconciling the role of the individual with the role of the government in promoting health. On the one hand, governmental policy approaches—taxes, bans, and other regulations—are seen as emblematic of “nanny state” overreach. In this view, public health regulation is part of a slippery slope toward escalating government intrusion on individual liberty. On the other hand, regulatory policy is described as a fundamental instrument for a “savvy state” to combat the conditions underlying an inexorable epidemic of chronic diseases. Proponents of public health regulation cite the association of aggressive tobacco control, physical activity, and nutritional interventions with demonstrable increases in life expectancy…1

Editorial: Closing the killer gap in children’s health inequality

The Lancet  
Sep 14, 2013  Volume 382  Number 9896  p913 – 998

Closing the killer gap in children’s health inequality
The Lancet
Preview |
Globally, the pervasive disparities in the health and wellbeing of children are detrimental not only to the poorest and most vulnerable children and their families and communities, but also to the whole of society. To eliminate such disparities, three major questions need to be answered. How wide is the health gap? What are the underlying and driving factors? What can be done?

Editorial: USA missing opportunities for HPV vaccination

The Lancet Infectious Diseases
Sep 2013  Volume 13  Number 9   p725 – 822

USA missing opportunities for HPV vaccination
The Lancet Infectious Diseases
Since the US Advisory Committee for Immunization Practices (ACIP) recommended vaccination to protect against human papillomavirus (HPV) for girls at age 11–12 years, year-on-year increases in vaccine uptake have been disappointingly small. Data from the National Immunization Survey-Teen (NIS-Teen) show that the proportion of girls age 13–17 years who had received one dose of the vaccine increased from 25·1% in 2007 to just 53·0% in 2011. Despite substantial improvement in coverage in the early years, this slowed, and worryingly new figures released on July 26 indicate that uptake has stalled, with coverage at 53·8% in 2012.

Risk of Guillain-Barré syndrome after seasonal influenza vaccination and influenza health-care encounters: a self-controlled study

The Lancet Infectious Diseases
Sep 2013  Volume 13  Number 9   p725 – 822

Comment –
Association between vaccination and Guillain-Barré syndrome

Lucija Tomljenovic, Yehuda Shoenfeld
Preview |
Guillain-Barré syndrome is a serious neurological autoimmune disorder characterised by inflammatory demyelination of peripheral nerves.1 Up to 25% of patients experience respiratory failure,2 and 4% die within the first year from disease complications.3 The disorder can be triggered by viral infections and bacterial and viral vaccinations.1,4 After the 1976 influenza vaccine campaign in the USA, an increase in the rate of Guillain-Barré syndrome resulted in the suspension of the vaccination programme…

Risk of Guillain-Barré syndrome after seasonal influenza vaccination and influenza health-care encounters: a self-controlled study
Dr Jeffrey C Kwong MD a b c j k, Priya P Vasa MD b l, Michael A Campitelli MPH a, Steven Hawken MSc a, Kumanan Wilson MD a g h, Laura C Rosella PhD a c j, Prof Therese A Stukel PhD a d, Natasha S Crowcroft MD(Cantab) c e j, Prof Allison J McGeer MD c e, Lorne Zinman MD f i, Shelley L Deeks MD c j




The possible risk of Guillain-Barré syndrome from influenza vaccines remains a potential obstacle to achieving high vaccination coverage. However, influenza infection might also be associated with Guillain-Barré syndrome. We aimed to assess the risk of Guillain-Barré syndrome after seasonal influenza vaccination and after influenza-coded health-care encounters.


We used the self-controlled risk interval design and linked universal health-care system databases from Ontario, Canada, with data obtained between 1993 and 2011. We used physician billing claims for influenza vaccination and influenza-coded health-care encounters to ascertain exposures. Using fixed-effects conditional Poisson regression, we estimated the relative incidence of hospitalisation for primary-coded Guillain-Barré syndrome during the risk interval compared with the control interval.


We identified 2831 incident admissions for Guillain-Barré syndrome; 330 received an influenza vaccine and 109 had an influenza-coded health-care encounter within 42 weeks before hospitalisation. The risk of Guillain-Barré syndrome within 6 weeks of vaccination was 52% higher than in the control interval of 9—42 weeks (relative incidence 1·52; 95% CI 1·17—1·99), with the greatest risk during weeks 2—4 after vaccination. The risk of Guillain-Barré syndrome within 6 weeks of an influenza-coded health-care encounter was greater than for vaccination (15·81; 10·28—24·32). The attributable risks were 1·03 Guillain-Barré syndrome admissions per million vaccinations, compared with 17·2 Guillain-Barré syndrome admissions per million influenza-coded health-care encounters.


The relative and attributable risks of Guillain-Barré syndrome after seasonal influenza vaccination are lower than those after influenza illness. Patients considering immunisation should be fully informed of the risks of Guillain-Barré syndrome from both influenza vaccines and influenza illness.


Canadian Institutes of Health Research.

The emergence of influenza A H7N9 in human beings 16 years after influenza A H5N1: a tale of two cities

The Lancet Infectious Diseases
Sep 2013  Volume 13  Number 9   p725 – 822

The emergence of influenza A H7N9 in human beings 16 years after influenza A H5N1: a tale of two cities
Kelvin KW To FRCPath a †, Jasper FW Chan FRCPath a †, Honglin Chen PhD a c, Lanjuan Li MD b c, Dr Kwok-Yung Yuen MD a c
Infection with either influenza A H5N1 virus in 1997 or avian influenza A H7N9 virus in 2013 caused severe pneumonia that did not respond to typical or atypical antimicrobial treatment, and resulted in high mortality. Both viruses are reassortants with internal genes derived from avian influenza A H9N2 viruses that circulate in Asian poultry. Both viruses have genetic markers of mammalian adaptation in their haemagglutinin and polymerase PB2 subunits, which enhanced binding to human-type receptors and improved replication in mammals, respectively. Hong Kong (affected by H5N1 in 1997) and Shanghai (affected by H7N9 in 2013) are two rapidly flourishing cosmopolitan megacities that were increasing in human population and poultry consumption before the outbreaks. Both cities are located along the avian migratory route at the Pearl River delta and Yangtze River delta. Whether the widespread use of the H5N1 vaccine in east Asia—with suboptimum biosecurity measures in live poultry markets and farms—predisposed to the emergence of H7N9 or other virus subtypes needs further investigation. Why H7N9 seems to be more readily transmitted from poultry to people than H5N1 is still unclear.

Feasibility of Mass Vaccination Campaign with Oral Cholera Vaccines in Response to an Outbreak in Guinea

PLoS Medicine
(Accessed 14 September 2013)

Feasibility of Mass Vaccination Campaign with Oral Cholera Vaccines in Response to an Outbreak in Guinea
Iza Ciglenecki mail, Keita Sakoba, Francisco J. Luquero, Melat Heile, Christian Itama, Martin Mengel, Rebecca F. Grais, Francois Verhoustraeten, Dominique Legros

Summary Points
:: Oral cholera vaccines are safe and effective, and in 2010 were added to WHO recommendations for cholera outbreak control. However, doubts about feasibility, timeliness, and acceptability by the population, and the fear of diverting resources from other preventive interventions, have discouraged their use during epidemics.
:: We report on the first large-scale use of oral cholera vaccine as an outbreak control measure in Africa; this was also the first time Shanchol vaccine was used in Africa.
:: We administered 312,650 doses of vaccine during two vaccination rounds in two coastal districts in Guinea. The feasibility, timeliness of implementation, and delivery cost were similar to those of other mass vaccination campaigns.
:: The campaign was well accepted by the population, and high vaccination coverage was achieved despite the short time available for preparation, the two-dose schedule, the remote rural setting, and the highly mobile population.
:: Oral cholera vaccines are a promising new tool in the arsenal of cholera control measures, alongside efforts to improve provision of safe water and sanitation and access to cholera treatment.


Risk-Based Input-Output Analysis of Influenza Epidemic Consequences on Interdependent Workforce Sectors

Risk Analysis
September 2013  Volume 33, Issue 9  Pages 1565–1757

Risk-Based Input-Output Analysis of Influenza Epidemic Consequences on Interdependent Workforce Sectors (pages 1620–1635)
Joost R. Santos, Larissa May and Amine El Haimar
Article first published online: 24 DEC 2012 | DOI: 10.1111/risa.12002

Outbreaks of contagious diseases underscore the ever-looming threat of new epidemics. Compared to other disasters that inflict physical damage to infrastructure systems, epidemics can have more devastating and prolonged impacts on the population. This article investigates the interdependent economic and productivity risks resulting from epidemic-induced workforce absenteeism. In particular, we develop a dynamic input-output model capable of generating sector-disaggregated economic losses based on different magnitudes of workforce disruptions. An ex post analysis of the 2009 H1N1 pandemic in the national capital region (NCR) reveals the distribution of consequences across different economic sectors. Consequences are categorized into two metrics: (i) economic loss, which measures the magnitude of monetary losses incurred in each sector, and (ii) inoperability, which measures the normalized monetary losses incurred in each sector relative to the total economic output of that sector. For a simulated mild pandemic scenario in NCR, two distinct rankings are generated using the economic loss and inoperability metrics. Results indicate that the majority of the critical sectors ranked according to the economic loss metric comprise of sectors that contribute the most to the NCR’s gross domestic product (e.g., federal government enterprises). In contrast, the majority of the critical sectors generated by the inoperability metric include sectors that are involved with epidemic management (e.g., hospitals). Hence, prioritizing sectors for recovery necessitates consideration of the balance between economic loss, inoperability, and other objectives. Although applied specifically to the NCR, the proposed methodology can be customized for other regions.

EuSANH workshop “Reasons behind the differences in national vaccination schedules for under-five”, European Public Health pre-conference workshop, Malta, 8 November 2012

Volume 31, Issue 42, Pages 4689-4932 (1 October 2013)

EuSANH workshop “Reasons behind the differences in national vaccination schedules for under-five”, European Public Health pre-conference workshop, Malta, 8 November 2012
Meeting Report
Pages 4694-4696
H. Theeten, H. Nohynek, T.M.M. Coenen, European Science Advisory Network for Health (EuSANH)
Vaccination schedules for under-five children in the EU member states differ markedly, mainly as a consequence of differences in programme organization, decision making and history, and to a limited extent by epidemiological differences. There is little willingness towards unification since little evidence exists to prefer one schedule over the others, but the differences might impact on public confidence. Monitoring key determinants influencing individual decision making on immunization (‘soft impacts’) is thus as important as other existing monitoring systems of the ‘hard’ impacts of immunization programmes, and both should focus on the impact of these schedule differences. Harmonization of vaccination schedules is not the main issue, but the reasons behind the differences should be explained in an understandable and coherent way to the public. Scientists and advisory bodies should look over the country borders and communicate any crucial information, in order to improve scientific consensus on immunization schedules and programmes. These were the main conclusions of a members’ experts panel of the European network of independent science advisory bodies on health (EuSANH), at a workshop in November 2012.

Use of alternative childhood immunization schedules in King County, Washington,

Volume 31, Issue 42, Pages 4689-4932 (1 October 2013)

Use of alternative childhood immunization schedules in King County, Washington, USA
Pages 4699-4701
Douglas J. Opel, Ashmita Banerjee, James A. Taylor
To determine the percentage of parents in King County, Washington using an alternative childhood immunization schedule (ACIS) and the type of ACIS used.
Patient and Methods
We distributed self-administered surveys to parents at 5 practices regarding the immunization schedule they planned to use or were using. Parents who selected an ACIS were asked to describe its main characteristics and information source.
We received 517 surveys and included 502 in analysis. The percentage of parents using an ACIS was 9.4% (95% CI: 7%, 12.2%). Only 6% described their ACIS as the Dr. Sears Schedule, although the book in which it is featured was the most frequently cited ACIS information source (29%). There was a significant association between ACIS use and non-Hispanic white parents and parents of children 12–23 months old.
A minority of King County parents use an ACIS. The Dr. Sears Schedule does not predominate.

Is there a lack of information on HPV vaccination given by health professionals to young women?

Volume 31, Issue 42, Pages 4689-4932 (1 October 2013)

Is there a lack of information on HPV vaccination given by health professionals to young women?
Pages 4710-4713
G. La Torre, E. De Vito, M.G. Ficarra, A. Firenze, P. Gregorio, A. Boccia, HPV Collaborative Group
The aim of this survey is to compare the main sources of information about vaccination against Human papillomavirus (HPV) of young women aged over-18 and under-18 years.
A multicenter study was carried out in Italy through the administration of a questionnaire. Univariate analyses were conducted to evaluate possible differences between age groups and different locations (chi-square test and Fisher test where possible).
The sample consisted of 987 young women. The main sources of information about HPV vaccination are represented by magazines/books (23.1%) and TV (20.5%) for the over-18s, while for the under-18s the sources are general practitioners (22.6%) and pediatricians (15.4%). The over-18s with health professionals as parents consult mostly gynecologists (27.7%) and general practitioners (20.5%).
This study highlights lack of information on HPV vaccination given by health professionals to young women and underlines the need to improve education about cervical cancer, prevention and HPV vaccination.

Quantifying the impact of dissimilar HPV vaccination uptake among Manitoban school girls by ethnicity using a transmission dynamic model

Volume 31, Issue 42, Pages 4689-4932 (1 October 2013)

Quantifying the impact of dissimilar HPV vaccination uptake among Manitoban school girls by ethnicity using a transmission dynamic model
Original Research Article
Pages 4848-4855
Leigh Anne Shafer, Ian Jeffrey, Brenda Elias, Brenna Shearer, Karen Canfell, Erich Kliewer
Gardasil, a human papillomavirus (HPV) vaccine, began among grade 6 girls in Manitoba, Canada in 2008. In Manitoba, there is evidence that First Nations, Métis, and Inuit women (FNMI) have higher HPV prevalence, lower invasive cervical cancer (ICC) screening, and higher ICC incidence than all other Manitoban (AOM) women. We developed a mathematical model to assess the plausible impact of unequal vaccination coverage among school girls on future cervical cancer incidence.
We fit model estimated HPV prevalence and ICC incidence to corresponding empirical estimates. We used the fitted model to evaluate the impact of varying levels of vaccination uptake by FNMI status on future ICC incidence, assuming cervical screening uptake among FNMI and AOM women remained unchanged.
Depending on vaccination coverage, estimated ICC incidence by 2059 ranged from 15% to 68% lower than if there were no vaccination. The level of cross-ethnic sexual mixing influenced the impact that vaccination rates among FNMI has on ICC incidence among AOM, and vice versa. The same level of AOM vaccination could result in ICC incidence that differs by up to 10%, depending on the level of FNMI vaccination. Similarly, the same level of FNMI vaccination could result in ICC incidence that differs by almost 40%, depending on the level of AOM vaccination.
If we are unable to equalize vaccination uptake among all school girls, policy makers should prepare for higher levels of cervical cancer than would occur under equal vaccination uptake.

Associations between health communication behaviors, neighborhood social capital, vaccine knowledge, and parents’ H1N1 vaccination of their children

Volume 31, Issue 42, Pages 4689-4932 (1 October 2013)

Associations between health communication behaviors, neighborhood social capital, vaccine knowledge, and parents’ H1N1 vaccination of their children
riginal Research Article
Pages 4860-4866
Minsoo Jung, Leesa Lin, K. Viswanath
During the H1N1 pandemic in 2009–10, the vaccination behavior of parents played a critical role in preventing and containing the spread of the disease and the subsequent health outcomes among children. Several studies have examined the relationship between parents’ health communication behaviors and vaccinations for children in general. Little is known, however, about the link between parents’ health communication behaviors and the vaccination of their children against the H1N1 virus, and their level of vaccine-related knowledge. We drew on a national survey among parents with at least one child less than 18 years of age (n = 639) to investigate Parents’ H1N1-related health communication behaviors including sources of information, media exposure, information-seeking behaviors, H1N1-related knowledge, and neighborhood social capital, as well as the H1N1 vaccination rates of their children. Findings showed that there is a significant association between the degree at which parents obtained H1N1 vaccination for their children and health communication variables: watching the national television news and actively seeking H1N1 information. And this association was moderated by the extent of the parents’ H1N1-related knowledge. In addition, the parents’ degree of neighborhood social capital mediated the association between H1N1 knowledge of the parents and H1N1 vaccination acceptance for their children. We found, compared to those with a low-level of neighborhood social capital, parents who have a high-level of neighborhood social capital are more likely to vaccinate their children. These findings suggest that it is necessary to design a strategic health communication campaign segmented by parent health communication behaviors.

Human papillomavirus vaccine communication: Perspectives of 11–12 year-old girls, mothers, and clinicians

Volume 31, Issue 42, Pages 4689-4932 (1 October 2013)

Human papillomavirus vaccine communication: Perspectives of 11–12 year-old girls, mothers, and clinicians
Original Research Article
Pages 4894-4901
Tanya L. Kowalczyk Mullins, Anne M. Griffioen, Susan Glynn, Gregory D. Zimet, Susan L. Rosenthal, J. Dennis Fortenberry, Jessica A. Kahn
Because little is known about the content of human papillomavirus (HPV) vaccine-related discussions with young adolescent girls in clinical settings, we explored communication between 11- and 12 year-old girls, mothers, and clinicians regarding HPV vaccines and concordance in reports of maternal and clinician communication.
We conducted individual interviews with 33 girls who had received the quadrivalent HPV vaccine in urban and suburban clinical settings, their mothers, and their clinicians. Data were analyzed using qualitative methods.
From the perspectives of both girls and mothers, clinicians and parents were the preferred sources of HPV vaccine information for girls. Vaccine efficacy and risks/benefits of vaccination were the most commonly reported desired and actual topics of discussion by mothers, girls, and clinicians. Clinician recommendation of vaccination was reported by nearly one-fifth of girls and nearly half of mothers. The most common concordant messages were related to efficacy of the vaccine, with concordance in 70% of triads. The most common discordant messages were related to sexual health. Approximately half of clinicians (16) reported discussing sexual health, but only 5 mothers (15%) and 4 girls (12%) reported this. Triads recruited from suburban (vs. urban) practices had higher degrees of concordance in reported vaccination communication.
HPV vaccine efficacy and safety are important topics for clinicians to discuss with both girls and mothers; educating mothers is important because parents are a preferred source of vaccine-related information for girls. Because girls may be missing important vaccine-related messages, they should be encouraged to actively engage in vaccine discussions.

Public finance of rotavirus vaccination in India and Ethiopia: An extended cost-effectiveness analysis

Volume 31, Issue 42, Pages 4689-4932 (1 October 2013)

Public finance of rotavirus vaccination in India and Ethiopia: An extended cost-effectiveness analysis
Original Research Article
Pages 4902-4910
Stéphane Verguet, Shane Murphy, Benjamin Anderson, Kjell Arne Johansson, Roger Glass, Richard Rheing
An estimated 4% of global child deaths (approximately 300,000 deaths) were attributed to rotavirus in 2010. About a third of these deaths occurred in India and Ethiopia. Public finance of rotavirus vaccination in these two countries could substantially decrease child mortality and also reduce rotavirus-related hospitalizations, prevent health-related impoverishment and bring significant cost savings to households.
We use a methodology of ‘extended cost-effectiveness analysis’ (ECEA) to evaluate a hypothetical publicly financed program for rotavirus vaccination in India and Ethiopia. We measure program impact along four dimensions: 1) rotavirus deaths averted; 2) household expenditures averted; 3) financial risk protection afforded; 4) distributional consequences across the wealth strata of the country populations.
In India and Ethiopia, the program would lead to a substantial decrease in rotavirus deaths, mainly among the poorer; it would reduce household expenditures across all income groups and it would effectively provide financial risk protection, mostly concentrated among the poorest. Potential indirect benefits of vaccination (herd immunity) would increase program benefits among all income groups, whereas potentially decreased vaccine efficacy among poorer households would reduce the equity benefits of the program.
Our approach incorporates financial risk protection and distributional consequences into the systematic economic evaluation of vaccine policy, illustrated here with the case study of public finance for rotavirus vaccination. This enables selection of vaccine packages based on the quantitative inclusion of information on equity and on how much financial risk protection is being bought per dollar expenditure on vaccine policy, in addition to how much health is being bought.

From Google Scholar+ [to 14 Sep 2013]

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Academic Pediatrics
Volume 13, Issue 5, September–October 2013,

A Randomized Trial to Increase Acceptance of Childhood Vaccines by Vaccine-Hesitant Parents: A Pilot Study
S. Elizabeth Williams, MDa, Russell L. Rothman, MD, MPPb, Paul A. Offit, MDd, William Schaffner, MDc, Molly Sullivana, Kathryn M. Edwards, MDa
Pages 475–480
A cluster randomized trial was performed to evaluate an educational intervention to improve parental attitudes and vaccine uptake in vaccine-hesitant parents.
Two primary care sites were randomized to provide families with either usual care or an intervention (video and written information) for vaccine-hesitant parents. Eligible parents included those presenting for their child’s 2-week well-child visit with performance on the Parent Attitudes about Childhood Vaccines (PACV) survey suggesting vaccine hesitancy (score ≥25). Enrollees completed PACV surveys at the 2-month well-child visit and vaccination status at 12 weeks of age was assessed. The primary outcome was the difference in PACV scores obtained at enrollment and 2 months between the 2 groups. The proportion of on-time vaccination was also compared at 12 weeks.
A total of 454 parents were approached, and 369 (81.3%) participated; 132 had PACV scores of ≥25 and were enrolled, 67 in the control group (mean PACV score 37) and 55 in the intervention group (mean PACV score 40). Two-month PACV surveys were completed by 108 (∼90%) of enrollees. Parents in the intervention group had a significant decrease in PACV score at 2 months compared to control (median difference 6.7, P = .049); this remained significant after adjustment for baseline PACV score, race/ethnicity, and income (P = .044). There was no difference in the on-time receipt of vaccines between groups at 12 weeks.
A brief educational intervention for vaccine-hesitant parents was associated with a modest but significant increase in measured parental attitudes toward vaccines.

A Mixed Methods Study of Parental Vaccine Decision Making and Parent–Provider Trust
Jason M. Glanz, PhDa, Nicole M. Wagner, MPHa, Komal J. Narwaney, PhDa, Jo Ann Shoup, MS, MSWa, David L. McClure, PhDb, Emily V. McCormick, MPHc, Matthew F. Daley, MDa
a Kaiser Permanente Colorado—Institute for Health Research, Denver, Colo
b Marshfield Clinic Research Foundation, Marshfield, Wis
c Denver Public Health Department, Denver, Colo
Pages 481–48
To describe parental vaccine decision making behaviors and characterize trust in physician advice among parents with varying childhood vaccination behaviors.
Between 2008 and 2011, a mixed methods study was conducted with parents of children aged <4 years who were members of Kaiser Permanente Colorado health plan. Seven focus groups were conducted with vaccine-hesitant parents. On the basis of findings from the focus groups, a survey was developed, pilot tested, and mailed to a stratified sample of 854 parents who accepted (n = 500), delayed (n = 227), or refused (n = 127) vaccinations for one of their children. Survey results were analyzed by chi-square tests and multivariable logistic regression.
Several themes emerged from the focus groups, including: 1) the vaccine decision-making process begins prenatally, 2) vaccine decision making is an evolving process, and 3) there is overall trust in the pediatrician but a lack of trust in the information they provided about vaccines. The survey response rate was 52% (n = 443). Parents who refused or delayed vaccines were 2 times more likely to report that they began thinking about vaccines before their child was born and 8 times more likely to report that they constantly reevaluate their vaccine decisions than parents who accepted all vaccines. Although parents tended to report trusting their pediatrician’s advice on nutrition, behavior, and the physical examination, they did not believe their pediatrician provided “balanced” information on both the benefits and risks of vaccination.
These results have implications for future interventions to address parental vaccination concerns. Such interventions may be more effective if they are applied early (during pregnancy) and often (pregnancy through infancy), and cover both the risks and benefits of vaccination.

Vaccines: The Week in Review 7 Sep 2013

Vaccines: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
Email Summary: Vaccines: The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_7 Sep 2013
Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
Support: If you would like to join the growing list of individuals who support this service and its contribution to their roles in public health, clinical practice, government, IGOs/NGOs, research, industry and academia, please visit this page at The Wistar Institute, our co-founder and fiduciary. Thank you…
David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

Obama and Nordic countries “underline collective commitment to support GAVI Alliance”

    GAVI reported that U.S. President Barack Obama and the prime ministers of the Nordic countries “underlined their collective commitment to supporting vaccination through the GAVI Alliance” in a joint statement issued on Wednesday after a high-level meeting in Stockholm. The jstatement noted: “We agree that vaccination through GAVI represents one of the most cost-effective approaches to save children’s lives. …Together, we envision a unified post-2015 agenda that addresses poverty, inclusive growth, and sustainability in clear, ambitious, and measurable goals.” The statement was agreed to at a joint meeting between the Nordic leaders and President Obama who visited Sweden from 4-5 September en route to the Group of 20 economic summit in Russia.


[No link to the full statement was indicated in the GAVI announcement or evident in a web search]

Global Fund wins pledge of US$750 million from Nordic countries,

The Global Fund said it “strongly welcomed a pledge of US$750 million by Nordic countries, a highly significant contribution to defeating these three infectious diseases.” The announcement was made in Stockholm on 4 September in a joint statement by Sweden, Norway, Finland, Denmark, Iceland and the United States. Collectively, the pledge represents over US$150 million in increased funds from the Nordic countries. The statement specified that the contribution would unlock an additional US$375 million from the U.S., signaling the leverage of every pledge. Dr. Nafsiah Mboi, Chair of the Board of the Global Fund, said, “The vision and foresight of our Nordic partners is a critical piece of seizing this historic moment to defeat HIV, tuberculosis and malaria. This is terrific leadership. We hope others will be inspired by and join these efforts.” Nordic countries have been strong supporters of the Global Fund since its inception in 2002.


IAVI announces new commitment from Department for International Development (DFID)/UK

The International AIDS Vaccine Initiative (IAVI) announced the renewed commitment from the UK’s Department for International Development (DFID), which has confirmed a grant to IAVI of US $1.57 million annually for the next five years. Margaret McGlynn, IAVI President and CEO, said, “We are grateful to the U.K. Government for having been a long standing partner and supporter. The government’s continued trust in and financial support for IAVI will help ensure the development of preventive HIV vaccines that are safe, effective and accessible to all. Vaccines remain among our most effective and efficient tools for combating infectious diseases and can bring particular value to vulnerable populations, including women and children.”


PaxVax commences Phase 3 trial if single-dose oral cholera vaccine candidate

PaxVax announced that it has commenced its Phase 3 clinical trial program for its single-dose oral cholera vaccine candidate, PXVX0200 (also known as CVD 103-HgR). Approximately 3,000 participants will be enrolled in this pivotal program, which is comprised of cholera challenge, safety, and immunogenicity studies. PaxVax said that “a cholera vaccine is available in Europe and elsewhere for travelers, but it requires a two-dose regimen, which takes longer to complete. A single-dose, oral vaccine would be more convenient for all travelers to take, particularly for those traveling on short notice.” The pivotal efficacy cholera challenge studies will be randomized, double-blind, placebo-controlled, and conducted at three top vaccine testing centers, including the University of Maryland, the University of Vermont Vaccine Testing Center, and Cincinnati Children’s Hospital Medical Center. Volunteers enrolled in these studies will first be vaccinated and then challenged, or exposed to the cholera-causing agent (Vibrio cholerae bacterium). At 10 days following vaccination, and again at three months post vaccination, participants will be evaluated to determine the protective ability of PXVX0200. All standard clinical trial safety protocols and guidelines will be followed at each clinical research center. Additional trials will also be conducted at sites in Canada, Australia, and the U.S. to confirm vaccine safety in a larger population, measure immunogenicity, and demonstrate lot-to-lot consistency of different vaccine manufacturing batches required by the U.S. Food and Drug Administration (FDA). In recognition of the lack of any available traveler’s vaccine against cholera, and the corresponding unmet medical need, PXVX0200 has been granted Fast Track designation by FDA.


GPEI Update: Polio this week – As of 4 September 2013

Update: Polio this week – As of 4 September 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s extract and bolded text]
:: The Global Polio Eradication Initiative has conducted a three month assessment of the responses to the Somalia and Kenya polio outbreaks, which concluded that the response was rapid and aggressive, with strong national leadership and international coordination.
:: In both countries, there is a significant risk that the outbreak will extend beyond six months. However, there are indications that the response activities to date are having an impact: fewer cases are being reported in the area considered the ‘engine’ of the outbreak – the Banadir region of Somalia, which includes Mogadishu. Concrete recommendations were made to ensure that the outbreak is stopped rapidly.

:: Two new WPV cases were reported in the past week, bringing the total of WPV1 cases for 2013 to 45. The most recent WPV1 case in the country had onset of paralysis on 14 August (from Borno)…

:: Two new cases of WPV were reported in the past week, both WPV1 from North Waziristan in the Federally Administered Tribal Areas (FATA), with the most recent case having onset of paralysis on 11 August. This brings the total number of WPV1 cases for 2013 to 27.
:: North Waziristan is one of the tribal agencies where a ban is in place against polio vaccination. Measures to prevent spread of the virus from this area include vaccination at transit points. FATA remains the major poliovirus reservoir in Pakistan and in Asia, both due to WPV1 and cVDPV2.

Horn of Africa
:: 32 new WPV1 cases were reported in the past week, in Somalia. The total number of WPV1 cases for 2013 in the Horn of Africa is 174 (160 from Somalia, 13 from Kenya, 1 from Ethiopia). The most recent WPV1 case in the region had onset of paralysis on 7 August (from Somalia).

Israel and West Bank and Gaza
:: WPV1 has been detected in 91 sewage samples from 27 sampling sites in Israel, collected from 3 February to 25 August 2013, indicating widespread transmission throughout the country. :: A sampling site in Tulkarem in the West Bank has reported one positive sample, collected on 30 June. No case of paralytic polio has been reported in either Israel or The West Bank and Gaza.
:: To interrupt WPV1 transmission, a supplementary immunization activity (SIA) with bivalent oral polio vaccine (OPV) targeting children up to the age of nine years is taking place. The activity started on 05 August in southern Israel and was expanded to cover the entire country beginning on 18 August. The objective of the SIA with OPV is to boost intestinal immunity in children vaccinated with Inactivated Polio Vaccine (IPV) only in order to rapidly interrupt WPV transmission.
:: Following the positive sample from Tulkarem, West Bank subsequent samples in the West Bank have all tested negative. Discussions continue on a vaccination response to the positive sample in the West Bank, which uses both OPV and IPV in its routine immunization schedule.

Weekly Epidemiological Record (WER) for 7 September 2013

The Weekly Epidemiological Record (WER) for 7 September 2013, vol. 88, 36 (pp. 381–388) includes:
:: Progress towards eliminating onchocerciasis in the WHO Region of the Americas: verification by WHO of elimination of transmission in Colombia
:: Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2013


Report: International migration, health and human rights

Report: International migration, health and human rights
WHO: Office of the High Commissioner for Human Rights and the International Organization for Migration

Today, more than 214 million people are living outside their countries of origin. They have left their homes for a variety of reasons, including conflict, natural disasters or environmental degradation, political persecution, poverty, discrimination and lack of access to basic services and the search for new opportunities, particularly in terms of work or education.

One aspect of migration that is attracting renewed attention is the impact that it has on public health. Migrants may be subjected to multiple discrimination, violence and exploitation, all of which often directly affect their physical and mental health. In addition, migrants may have health problems that are not well known or understood in their new countries of residence.

To compound this problem, legal and socioeconomic barriers impede access to health services in many cases; in cases where migrants do have access to health services, these may not be migrant-sensitive or culturally and linguistically appropriate.

Communities receiving large numbers of migrants face new challenges, such as increased diversity of the population and the consequent change in the cultural profile and health perspectives of its patients. This inevitably impacts the day-to-day work of health professionals. Current approaches to managing the health of migrants need to keep pace with the growing challenges associated with the complexity, volume, speed, diversity and disparity of modern migration flows to ensure that all migrants are able to realize their fundamental right to health.

The right of everyone to the enjoyment of the highest attainable standard of physical and mental health has long been established in international human rights law. So, too, have the principles of equality and non-discrimination. It is therefore critical for national health systems and policies to address migrants’ right to health, regardless of the legal status of the migrant. Doing so requires active collaboration across the different sectors and close cooperation between governments and the many non-state actors involved in the migration process.

In this publication, the World Health Organization, the Office of the High Commissioner for Human Rights and the International Organization for Migration explore the multifaceted health and human rights challenges that migrants face and report on recent developments in this area. Our aim in producing this publication is to provide all stakeholders with a reference on key health and human rights issues in the context of international migration…

We hope that it provides inspiration to policymakers to devise migration policies and programmes that are guided by public health considerations and human rights imperatives, with a view to protecting the human rights and improving the health of both migrants and the communities in which they live.

Immunization to prevent congenital cytomegalovirus infection

British Medical Bulletin
Volume 107 Issue 1 September 2013

Immunization to prevent congenital cytomegalovirus infection
Stuart P. Adler*
+ Author Affiliations
Department of Microbiology, Medical College of Virginia Campus/Virginia Commonwealth University, Richmond, VA, USA
*Correspondence address. Department of Microbiology, Medical College of Virginia Campus/Virginia Commonwealth University, PO Box 163, Richmond, VA 23298, USA. E-mail: sadler@vcu.edu
Accepted July 9, 2013.

Introduction  A primary maternal cytomegalovirus (CMV) during pregnancy causes newborn disease that includes hearing deficit and/or mental retardation.

Sources of data  Relevant published literature.

Areas of agreement  There are no biologic obstacles to immunization against fetal/placental infection with CMV.

Areas of uncertainty  CMV vaccine trials may be difficult due to a lack of public awareness of CMV. Vaccine trials that use fetal infection as an endpoint will be prolonged, since vaccination will need to occur preconception.

Areas timely for developing research  Vaccines in preclinical development include antigens of the CMV gB glycoprotein and the gH/gL UL128, 130 and 131 pentameric complex. These antigens induce antibodies that block viral entry into fibroblasts and endothelial/epithelial cells. Vaccines immunogenic in animals include an inactivated virus with a wild-type UL131 gene, a DNA vaccine using a wild-type UL130 gene and peptide vaccines using peptides from UL130 and 131.

Conclusions  In spite of these potential obstacles, successful evaluation of CMV vaccines is possible.

Canada and access to medicines in developing countries: intellectual property rights first

Globalization and Health
[Accessed 7 September 2013]

Canada and access to medicines in developing countries: intellectual property rights first
Lexchin J Globalization and Health 2013, 9:42 (3 September 2013)

Abstract (provisional)
Canadian reports have recommended that health as a human right must be Canada’s overarching global commitment and that the primacy of human rights should be prioritized over other elements of international law including international trade and investment law as it applies to access to pharmaceuticals. This paper uses a series of case reports to examine Canada’s commitment to this goal. Specifically it examines cases where improved access has been in conflict with increased intellectual property rights. The 6 cases are: Canada’s position when 39 pharmaceutical companies took South Africa to court in 1998 over its legislation to allow parallel importation of patented medicines and to regulate the price of medications; the stance that Canada took in the negotiations around the Doha Declaration in 2001; the passage of Canada’s Access to Medicines Regime in 2004 and subsequent attempts to amend the legislation in 2011 and 2012; Canada’s involvement in the final declaration at the United Nations High-Level meeting on non-communicable diseases in 2012; Canada’s views about the terms in the Anti-Counterfeiting Trade Agreement as expressed in 2009; and Canada’s 2013 position on the extension of the exemption for least developed countries from having to comply with the terms of the Trade Related Aspects of Intellectual Property Rights Agreement. In the first case Canada was neutral but in the remaining 5 cases Canada prioritized intellectual property rights over access. This position is consistent with how Canada has acted around domestic issues involving intellectual property rights for pharmaceutical products. Canada has supported strengthened rights despite the fact that their touted benefits have not been realized either domestically or in developing countries. As a result Canada has failed in its humanitarian duty to protect the human right to health in the form of safe and low cost medicines for the people in developing countries.

Commentary – Making vaccines “on demand”: A potential solution for emerging pathogens and biodefense?

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
September 2013  Volume 9, Issue 9

Making vaccines “on demand”: A potential solution for emerging pathogens and biodefense?
Anne S De Groot, Leo Einck, Leonard Moise, Michael Chambers, John Ballantyne, Robert W Malone, Matthew Ardito and William Martin  Pages 1877 – 1884 http://dx.doi.org/10.4161/hv.25611

The integrated US Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has made great strides in strategic preparedness and response capabilities. There have been numerous advances in planning, biothreat countermeasure development, licensure, manufacturing, stockpiling and deployment. Increased biodefense surveillance capability has dramatically improved, while new tools and increased awareness have fostered rapid identification of new potential public health pathogens. Unfortunately, structural delays in vaccine design, development, manufacture, clinical testing and licensure processes remain significant obstacles to an effective national biodefense rapid response capability. This is particularly true for the very real threat of “novel pathogens” such as the avian-origin influenzas H7N9 and H5N1, and new coronaviruses such as hCoV-EMC. Conventional approaches to vaccine development, production, clinical testing and licensure are incompatible with the prompt deployment needed for an effective public health response. An alternative approach, proposed here, is to apply computational vaccine design tools and rapid production technologies that now make it possible to engineer vaccines for novel emerging pathogen and WMD biowarfare agent countermeasures in record time. These new tools have the potential to significantly reduce the time needed to design string-of-epitope vaccines for previously unknown pathogens. The design process—from genome to gene sequence, ready to insert in a DNA plasmid—can now be accomplished in less than 24 h. While these vaccines are by no means “standard,” the need for innovation in the vaccine design and production process is great. Should such vaccines be developed, their 60-d start-to-finish timeline would represent a 2-fold faster response than the current standard.

Hexavalent IPV-based combination vaccines for public-sector markets of low-resource countries

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
September 2013  Volume 9, Issue 9

Product Review
Hexavalent IPV-based combination vaccines for public-sector markets of low-resource countries
Kutub Mahmood, Sonia Pelkowski, Deborah Atherly, Robert Sitrin and John J. Donnelly  Pages 1894 – 1902 http://dx.doi.org/10.4161/hv.25407

In anticipation of the successful eradication of wild polio virus, alternative vaccination strategies for public-sector markets of low-resource countries are extremely important, but are still under development. Following polio eradication, inactivated polio vaccine (IPV) would be the only polio vaccine available, and would be needed for early childhood immunization for several years, as maintenance of herd immunity will be important for sustaining polio eradication. Low-cost combination vaccines containing IPV could provide reliable and continuous immunization in the post-polio eradication period. Combination vaccines can potentially simplify complex pediatric routine immunization schedules, improve compliance, and reduce costs. Hexavalent vaccines containing Diphtheria (D), Tetanus (T), whole cell pertussis (wP), Hepatitis B (HBV), Haemophilus b (Hib) and the three IPV serotype antigens have been considered as the ultimate combination vaccine for routine immunization. This product review evaluates potential hexavalent vaccine candidates by composition, probable time to market, expected cost of goods, presentation, and technical feasibility and offers suggestions for development of low-cost hexavalent combination vaccines. Because there are significant technical challenges facing wP-based hexavalent vaccine development, this review also discusses other alternative approaches to hexavalent that could also ensure a timely and reliable supply of low-cost IPV based combination vaccines.

Knowledge and attitudes of postpartum women toward immunization during pregnancy and the peripartum period

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
September 2013  Volume 9, Issue 9

Research Paper
Knowledge and attitudes of postpartum women toward immunization during pregnancy and the peripartum period
Elizabeth Rossmann Beel, Marcia A. Rench, Diana P. Montesinos, Betsy Mayes and C. Mary Healy  Pages 1926 – 1931 http://dx.doi.org/10.4161/hv.25096

Influenza and pertussis prevention in young infants requires immunizing pregnant women and all caregivers (cocooning). We evaluated the knowledge and attitude of postpartum women about these two recommendations. A survey of predominantly Hispanic, underinsured, medically underserved postpartum women in Houston, Texas was performed during June 2010 through July 2012. 511 postpartum women [mean age 28.8 y (18–45); 94% Hispanic] with a mean of 3 children (1–12) participated. Ninety-one (17.8%) were first-time mothers. Four hundred ninety-six (97.1%) received prenatal care; care was delayed in 24.3%. Only 313 (61.3%) received vaccine education while pregnant, and 291 (57%) were immunized. Four hundred seventy-four women (93%) were willing to be immunized during pregnancy if recommended by their healthcare provider, (the most trusted information source for 62%). Immunization of infants or infant caregivers had been discussed with 41% and 10% of mothers, respectively. 230 women (45%) had received influenza vaccine; most intended to (79%) or had already received (15%) tetanus, diphtheria, and acellular pertussis (Tdap) vaccine. Preferred locations for cocooning were hospital or community clinics (97%). Insufficient knowledge (46.6%), cost (31.4%), lack of transportation (26%), work commitments (13.3%), and fear of needles (13.3%) were perceived barriers to cocooning. Level of formal education received by mothers had no effect on the quantity or quality of immunization education received during PNC or their attitude toward immunization. Immunization during pregnancy and cocooning, if recommended by providers, are acceptable in this high-risk population. Healthcare providers, as reported in infant studies, have the greatest influence on vaccine acceptance by pregnant and postpartum women.

Economic evaluation of Varicella vaccination: results of a systematic review

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
September 2013  Volume 9, Issue 9

Economic evaluation of Varicella vaccination: results of a systematic review
Brigid Unim, Rosella Saulle, Sara Boccalini, Cristina Taddei, Vega Ceccherini, Antonio Boccia, Paolo Bonanni and Giuseppe La Torre  Pages 1932 – 1942 http://dx.doi.org/10.4161/hv.25228

The aim of the present study is to review the economic burden of varicella disease and the benefit of universal varicella vaccination in different settings pending its implementation in all Italian regions.

Materials and Methods
Research was conducted using PubMed, Scopus and ISI databases. Score quality and data extraction were performed for all included studies.

Twenty-three articles met the criteria: 15 cost-effectiveness, 8 cost-benefit and one cost-utility analysis. Varicella vaccination could save the society from €637,762 (infant strategy) to 53 million annually (combined infant and adolescent strategy). The median and the mean quality scores resulted in 91.8% and 85.4% respectively; 11 studies were considered of high quality and 12 of low quality.

The studies are favorable to the introduction of universal varicella vaccination in Italy, being cost saving and having a positive impact on morbidity. The quality score of the studies varied greatly: recent analyses were of comparable quality to older studies.

Viewpoint: Poverty, Health, and Societies of the Future

September 4, 2013, Vol 310, No. 9

Viewpoint | September 4, 2013
Poverty, Health, and Societies of the Future
Jim Yong Kim, MD, PhD1; Margaret Chan, MD2
[+] Author Affiliations
JAMA. 2013;310(9):901-902. doi:10.1001/jama.2013.276910

Initial content per JAMA convention
The relationship between clinician and patient has been the bedrock of the global health equity movement. It was the call for access to basic medical services for patients—and patients demanding empowerment for their community health workers—that drove the Health for All movement in the 1970s. It was the insistence by patients, activists, and clinicians for all people with AIDS to receive treatment that led to the transformation in access starting just 10 years ago in the developing world. That insistence will continue to be the energy and lifeblood of the movement—patients claiming their rights, and physicians supporting their patients—together advocating for a world in which a child born anywhere can have a life of opportunity, dignity, and access to quality health care…

Conflict and Polio – Winning the Polio Wars

September 4, 2013, Vol 310, No. 9

Viewpoint | September 4, 2013
Conflict and Polio – Winning the Polio Wars
Zulfiqar A. Bhutta, MB, BS, FRCP, FRCPCH, PhD1,2
[+] Author Affiliations
JAMA. 2013;310(9):905-906. doi:10.1001/jama.2013.276583.

Initial content per JAMA convention
The global polio eradication initiative is at a critical crossroads. Some 25 years ago, the World Health Organization (WHO), supported by Rotary International, launched a global goal of eradicating polio from the world by 2000.1 Although the eradication target may not have been achieved, there has been remarkable progress. From more than 350 000 cases of poliomyelitis globally spread over 125 countries with endemic disease in 1990, a mere 223 cases were reported in 2012, with the disease largely restricted to a few regions of Nigeria, Pakistan, and Afghanistan. These hotspots of polio, with a total population exceeding 380 million, include geographic diversity, conflict, and population displacement. Although all 3 countries have made tremendous strides in controlling endemic disease affecting thousands of children annually, they face many residual pockets of polio and widespread virus circulation….

Viewpoint | September 4, 2013

Industry-Sponsored Clinical Trials in Emerging MarketsTime to Review the Terms of Engagement

September 4, 2013, Vol 310, No. 9

Viewpoint | September 4, 2013
Industry-Sponsored Clinical Trials in Emerging MarketsTime to Review the Terms of Engagement
Stephen MacMahon, DSc, FMedSci1,2,3; Vlado Perkovic, MBBS, PhD1,3; Anushka Patel, MBBS, PhD1,3
[+] Author Affiliations
JAMA. 2013;310(9):907-908. doi:10.1001/jama.2013.276913.

Initial content per JAMA convention
A decade ago, clinical trial sponsors routinely excluded low- and middle-income countries such as India and China from participation. These regions contribute large numbers of patients to pivotal trials across a range of clinical conditions. For example, in China the number of pharmaceutical company–sponsored trials doubled between 2005 and 2010. Today, more than 3000 trials are under way in China, a large proportion of which are sponsored by global pharmaceutical companies.1 The key drivers for this change include reduced costs due to lower investigator fees and staff salaries and larger patient numbers, given the greater population sizes and disease burdens. Additionally, enhanced access to treatment-naive participants is thought to be an advantage in certain circumstances. Moreover, the belated acceptance that the emerging markets will soon be the largest global market for pharmaceutical sales is also driving the shift in focus. However, the rapid expansion of clinical trial activity in emerging markets has raised concerns, including questions about the quality of data generated and the relevance of the products being tested to local health care priorities…

Optimizing the Use of Pneumococcal Conjugate Vaccine Globally

September 4, 2013, Vol 310, No. 9

Editorial | September 4, 2013
Optimizing the Use of Pneumococcal Conjugate Vaccine Globally
Katherine L. O’Brien, MD, MPH1
[+] Author Affiliations
JAMA. 2013;310(9):911-913. doi:10.1001/jama.2013.228062.

Initial content per JAMA convention
Pneumococcal conjugate vaccine (PCV) was first licensed in 2000 as a 7-valent product and is now available as 10- and 13-valent products (PCV10 and PCV13). As recommended by the World Health Organization,1 PCVs are now in routine use in more than 95 of 194 countries globally, including use in 27 GAVI Alliance–eligible countries and approval for use in an additional 24 such countries.2 Financial investments by individual countries and the international community, through the GAVI Alliance, are ensuring the sustainable availability of PCV in the places where it is most needed—the poorest countries where children have a substantial risk of serious illness and death from pneumococcal disease. In 2008, more than 500 000 children under 5 years died from pneumococcal disease.3 This mortality and the larger burden of serious morbidity, mostly from pneumococcal pneumonia,4 is the focus of PCV programs.

Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine Administered According to 4 Different Primary Immunization Schedules in Infants:

September 4, 2013, Vol 310, No. 9

Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine Administered According to 4 Different Primary Immunization Schedules in Infants: A Randomized Clinical Trial
Judith Spijkerman, MD1,2; Reinier H. Veenhoven, MD, PhD2; Alienke J. Wijmenga-Monsuur, PhD3; Karin E. M. Elberse, PhD3; Pieter G. M. van Gageldonk, BASc3; Mirjam J. Knol, PhD3; Hester E. de Melker, PhD3; Elisabeth A. M. Sanders, MD, PhD1; Leo M. Schouls, PhD3; Guy A. M. Berbers, PhD3
[+] Author Affiliations
JAMA. 2013;310(9):930-937. doi:10.1001/jama.2013.228052.

Importance   Immunization schedules with pneumococcal conjugate vaccine (PCV) differ among countries regarding the number of doses, age at vaccinations, and interval between doses.

Objective   To assess the optimal primary vaccination schedule by comparing immunogenicity of 13-valent PCV (PCV13) in 4 different immunization schedules.

Design, Setting, and Participants   An open-label, parallel-group, randomized clinical trial of healthy term infants in a general community in the Netherlands conducted between June 30, 2010, and January 25, 2011, with 99% follow-up until age 12 months.

Interventions   Infants (N = 400) were randomly assigned (1:1:1:1) to receive PCV13 either at ages 2, 4, and 6 months (2-4-6); at ages 3 and 5 months (3-5); at ages 2, 3, and 4 months (2-3-4); or at ages 2 and 4 months (2-4), with a booster dose at age 11.5 months.

Main Outcomes and Measures   Primary outcome measure was antibody geometric mean concentrations (GMCs) against PCV13-included serotypes 1 month after the booster dose measured by multiplex immunoassay. Secondary outcomes included GMCs measured 1 month after the primary series, at 8 months of age, and before the booster.

Results   The primary outcome, GMCs at 1 month after the booster dose, was not significantly different between schedules for 70 of 78 comparisons. The 2-4-6 schedule was superior to the 2-3-4 schedule for serotypes 18C (10.2 µg/mL [95% CI, 8.2-12.7] vs 6.5 µg/mL [95% CI, 5.4-7.8]) and 23F (10.9 µg/mL [95% CI, 9.0-13.3] vs 7.3 µg/mL [95% CI, 5.8-9.2]) and superior to the 2-4 schedule for serotypes 6B (8.5 µg/mL [95% CI, 7.1-10.2] vs 5.1 µg/mL [95% CI 3.8-6.7]), 18C (6.6 µg/mL [95% CI, 5.7-7.7]), and 23F (7.2 µg/mL [95% CI, 5.9-8.8]). For serotype 1, the 3-5 schedule (11.7 µg/mL [95% CI, 9.6-14.3]) was superior to the other schedules. Geometric mean concentrations for all 13 serotypes ranged between 1.6 and 19.9 µg/mL. Secondary outcomes demonstrated differences 1 month after the primary series. The 2-4-6 schedule was superior compared with the 3-5, 2-3-4, and 2-4 schedules for 3, 9, and 11 serotypes, respectively. Differences between schedules persisted until the booster dose.

Conclusions and Relevance   The use of 4 different PCV13 immunization schedules in healthy term infants resulted in no statistically significant differences in antibody levels after the booster dose for almost all serotypes. The choice of PCV schedule will require a balance between the need for early protection and maintaining protection between the primary series and the booster.

Trial Registration   trialregister.nl Identifier: NTR2316

Thirty-Year Outcomes of the National Hepatitis B Immunization Program in Taiwan

September 4, 2013, Vol 310, No. 9

Research Letter | September 4, 2013
Thirty-Year Outcomes of the National Hepatitis B Immunization Program in Taiwan
Chun-Ju Chiang, PhD1; Ya-Wen Yang, MSc2; San-Lin You, PhD3; Mei-Shu Lai, MD, PhD1; Chien-Jen Chen, ScD3
[+] Author Affiliations
JAMA. 2013;310(9):974-976. doi:10.1001/jama.2013.276701.

Initial content per JAMA convention
Hepatitis B virus (HBV) infection causes infant fulminant hepatitis (IFH), and chronic HBV infection may progress to chronic liver disease (CLD) and hepatocellular carcinoma (HCC). Taiwan launched a nationwide HBV immunization program for newborns in July 1984,1 which has successfully lowered the prevalence of chronic HBV carriers, incidence of HCC, and mortality of IFH in vaccinated birth cohorts.2- 4 The mortality of CLD before and after HBV immunization has never been examined. We assessed the 30-year outcomes of the immunization program…