Vaccines: The Week in Review

2 August 2010
Center for Vaccine Ethics & Policy
http://centerforvaccineethicsandpolicy.wordpress.com/
A program of
- Center for Bioethics, University of Pennsylvania
http://www.bioethics.upenn.edu/
- The Wistar Institute Vaccine Center
http://www.wistar.org/vaccinecenter/default.html
- Children’s Hospital of Philadelphia, Vaccine Education Center
http://www.chop.edu/consumer/jsp/microsite/microsite.jsp

This weekly summary targets news and events in the global vaccines field gathered
from key governmental, NGO and company announcements, key journals and
events. This summary provides support for ongoing initiatives of the Center for
Vaccine Ethics & Policy, and is not intended to be exhaustive in its coverage.
Vaccines: The Week in Review is now also posted in a blog format at
http://centerforvaccineethicsandpolicy.wordpress.com/. Each item is treated as an individual
post on the blog, allowing for more effective retrospective searching. Given email
system conventions and formats, you may find this alternative more effective. This
blog also allows for RSS feeds, etc.
Comments and suggestions should be directed to
David R. Curry, MS
Editor and
Executive Director
Center for Vaccine Ethics & Policy
david.r.curry@centerforvaccineethicsandpolicy.org

WHO said Horn of Africa is marking one year of being polio-free,

following an outbreak of polio in Ethiopia, Kenya, Uganda, and Sudan in 2008-
2009. The countries in the region “responded rapidly to the outbreak and
returned to their polio-free status.” They join neighbour Somalia, which has
now been polio-free for three years, WHO said.
The “Global Polio Eradication Initiative: new strategy” is available at:
http://www.polioeradication.org/content/publications/GPEI.StrategicPlan.2010-
2012.ENG.May.2010.pdf

The WHO continues to issue weekly updates and occasional briefing notes
on the H1N1 pandemic at
http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 - update 111
Weekly update
30 July 2010
As of 25 July 2010, worldwide more than 214 countries and overseas
territories or communities have reported laboratory confirmed cases of
pandemic influenza H1N1 2009, including over 18398 deaths….
Situation update:
Summary: Worldwide, overall pandemic and seasonal influenza activity
remains low. In the southern hemisphere (where the winter season is in
progress), current influenza activity remains variable: ranging from low and
stable activity in Chile and Argentina, to low but increasing activity in
Australia and New Zealand, to elevated and recently peaked activity in South
Africa. Significant seasonal and pandemic influenza virus transmission
continues to be detected at variable levels across parts of the tropics,
particularly in several countries of the Americas and South and Southeast
Asia…
More at: http://www.who.int/csr/don/2010_07_30/en/index.html

The MMWR Weekly for July 30, 2010 / Vol. 59 / No. 29 includes:
- Update: Influenza Activity --- United States, 2009--10 Season
- Regional Influenza A (H1N1) 2009 Monovalent Vaccination Campaign ---
Skokie, Illinois, October 16--December 31, 2009

The U.S. Food and Drug Administration announced approval of

vaccines for the 2010-2011 influenza season in the United States.
The FDA noted that each year, “experts from FDA, World Health Organization,
CDC, and other institutions study virus samples and patterns collected
worldwide to identify strains likely to cause the most illness during the
upcoming season. Based on that information and the recommendations of
FDA’s Vaccines and Related Biological Products Advisory Committee,
manufacturers are including the respective three strains in the 2010-2011
vaccines:
- A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
- A/Perth /16/2009 (H3N2)-like virus
- B/Brisbane/60/2008-like virus
The brand names and manufacturers for the upcoming season’s vaccines are:
Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix,
GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist,
MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics
Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220718
.htm

The World Vaccine Congress Asia named Dr. John D. Clemens,

Director-General of the International Vaccine Institute (IVI) as
“Vaccine Executive of the Year” at its Vaccine Industry Excellence (ViE)
Asia 2010 Awards in Singapore. IVI, headquartered in Seoul, Korea, is
described as “the world’s only international organization devoted exclusively
to developing and introducing new and improved vaccines for the world’s
poorest people, especially children.” The award citation stated: “Dr. Clemens
was recognized for exhibiting visionary leadership with an outstanding
degree of commitment to disease prevention and control with vaccine
research and development.” The organization said the finalists included
Weidong Yin, CEO of the Chinese vaccine manufacturer Sinovac Biotech, and
Cyrus Poonawalla, Chairman of the Serum Institute of India, noting that Dr.
Clemens “emerged as the winner in the second round of voting, which
involved 10,000 voters.”
http://www.ivi.org/event_news/news_view.asp?enid=112

The Weekly Epidemiological Record (WER) for 30 July 2010, vol. 85,
31 (pp 293-308) includes: Cholera, 2009
http://www.who.int/wer/2010/wer8531.pdf

Journal Watch
[Editor’s Note]
Vaccines: The Week in Review continues its weekly scanning of key journals
to identify and cite articles, commentary and editorials, books reviews and
other content supporting our focus on vaccine ethics and policy. Journal
Watch is not intended to be exhaustive, but indicative of themes and
issues the Center is actively tracking. We selectively provide full text of
some editorial and comment articles that are specifically relevant to our
work. Successful access to some of the links provided may require
subscription or other access arrangement unique to the publisher. Our initial
scan list includes the journals below. If you would like to suggest other titles,
please write to David Curry at
david.r.curry@centerforvaccineethicsandpolicy.org

Clinical Infectious Diseases

15 August 2010 Volume 51, Number 4
http://www.journals.uchicago.edu/toc/cid/current
[Reviewed earlier; No relevant content]

Emerging Infectious Diseases

Volume 16, Number 8–August 2010
http://www.cdc.gov/ncidod/EID/index.htm
Research
Responses to Pandemic (H1N1) 2009, Australia
K. Eastwood et al.
Abstract
In 2007, adults in Australia were interviewed about their willingness to
comply with potential health interventions during a hypothetical influenza
outbreak. After the first wave of pandemic (H1N1) 2009 in Australia, many of
the same respondents were interviewed about behavior and protection
measures they actually adopted. Of the original 1,155 respondents, follow-up
interviews were conducted for 830 (71.9%). Overall, 20.4% of respondents in
2009 had recently experienced influenza-like illness, 77.7% perceived
pandemic (H1N1) 2009 to be mild, and 77.8% reported low anxiety. Only
14.5% could correctly answer 4 questions about influenza virus transmission,
symptoms, and infection control. Some reported increasing handwashing
(46.6%) and covering coughs and sneezes (27.8%) to reduce transmission.
Compared with intentions reported in 2007, stated compliance with
quarantine or isolation measures in 2009 remained high. However, only
respondents who perceived pandemic (H1N1) 2009 as serious or who had
attained higher educational levels expressed intention to comply with social
distancing measures.
Pandemic (H1N1) 2009 Surveillance, New York, New York, April–July
2009
S. Balter et al.
Abstract
On April 23, 2009, the New York City Department of Health and Mental
Hygiene (DOHMH) was notified of a school outbreak of respiratory illness; 2
days later the infection was identified as pandemic (H1N1) 2009. This was the
first major outbreak of the illness in the United States. To guide decisions on
the public health response, the DOHMH used active hospital-based
surveillance and then enhanced passive reporting to collect data on
demographics, risk conditions, and clinical severity. This surveillance
identified 996 hospitalized patients with confirmed or probable pandemic
(H1N1) 2009 virus infection from April 24 to July 7; fifty percent lived in high-
poverty neighborhoods. Nearly half were <18 years of age. Surveillance data
were critical in guiding the DOHMH response. The DOHMH experience during
this outbreak illustrates the need for the capacity to rapidly expand and
modify surveillance to adapt to changing conditions.
Pandemic (H1N1) 2009 Surveillance in Marginalized Populations,
Tijuana, Mexico
T. Rodwell et al.
Quarantine Methods and Prevention of Secondary Outbreak of
Pandemic (H1N1) 2009
C.-Y. Chu et al.
Pandemic (H1N1) 2009 Vaccination and Class Suspensions After
Outbreaks, Taiwan
P.-R. Hsueh et al.
Effects of School Closures during Pandemic (H1N1) 2009,
Pennsylvania
T. Gift et al.
Conference Summary
One Health Approach to Influenza: Assessment of Critical Issues and
Options
T. F. Powdrill et al.
A task force of experts on influenza, public health, and animal health met at
the conference One Health Approach to Influenza: Assessment of Critical
Issues and Options in Washington, DC, on December 1–2, 2009. These
experts discussed the role of the One Health approach in preparing for and
responding to an influenza pandemic or other emerging zoonotic disease by
using pandemic (H1N1) 2009 as a case study. The meeting was convened by
the US Department of Homeland Security National Center for Foreign Animal
and Zoonotic Disease Defense, and the National Institute of Allergy and
Infectious Diseases/National Institutes of Health Western Regional Center of
Excellence for Biodefense and Emerging Infectious Diseases.
The One Health concept is the realization that human, animal, and
environmental health are interrelated. In practice, it is imperative to
implement a One Health approach to high-consequence zoonotic diseases.
Although pandemic (H1N1) 2009 virus has primarily affected humans (with
some documented human-to-animal transmission), the genesis of this
circulating human virus involved reassortment of viral genomic segments
from human, porcine, and avian influenza virus lineages. The task force
focused on 4 topics: 1) epidemiology and surveillance, 2) transmission
dynamics, 3) immunobiology and vaccines, and 4) molecular approaches and
pathobiology.

Human Vaccines
Volume 6, Issue 8 August 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/8/
Reviews
Pricing of new vaccines
Bruce Y. Lee and Sarah M. McGlone
New vaccine pricing is a complicated process that could have substantial
long-standing scientific, medical, and public health ramifications. Pricing can
have a considerable impact on new vaccine adoption and, thereby, either
culminate or thwart years of research and development and public health
efforts. Typically, pricing strategy consists of the following ten components:
1. Conduct a target population analysis; 2. Map potential competitors and
alternatives; 3. Construct a vaccine target product profile (TPP) and compare
it to projected or actual TPPs of competing vaccines; 4. Quantify the
incremental value of the new vaccine's characteristics; 5. Determine vaccine
positioning in the marketplace; 6. Estimate the vaccine price-demand curve;
7. Calculate vaccine costs (including those of manufacturing, distribution, and
research and development); 8. Account for various legal, regulatory, third
party payer, and competitor factors; 9. Consider the overall product portfolio;
10. Set pricing objectives; 11. Select pricing and pricing structure. While the
biomedical literature contains some studies that have addressed these
components, there is still considerable room for more extensive evaluation of
this important area.
Short Report
The Spanish human papillomavirus vaccine consensus group: A
working model
Javier Cortés-Bordoy and Federico Martinon-Torre
Successful implementation of Human Papillomavirus (HPV) vaccine in each
country can only be achieved from a complementary and synergistic
perspective, integrating all the different points of view of the diverse related
professionals. It is this context where the Spanish HPV Vaccine Consensus
Group (Grupo Español de Consenso sobre la Vacuna VPH, GEC-VPH) was
created. GEC-VPH philosophy, objectives and experience are reported in this
article, with particular attention to the management of negative publicity and
anti-vaccine groups. Initiatives as GEC-VPH -adapted to each country’s
particular idiosyncrasies- might help to overcome the existing barriers and to
achieve wide and early implementation of HPV vaccination.

JAMA
Vol. 304 No. 4, pp. 377-486, July 28, 2010
http://jama.ama-assn.org/current.dtl
[No relevant content]

Journal of Infectious Diseases

15 August 2010 Volume 202, Number 4
http://www.journals.uchicago.edu/toc/jid/current
[Reviewed earlier; No relevant content]

The Lancet
Jul 31, 2010 Volume 376 Number 9738 Pages 303 - 388
http://www.thelancet.com/journals/lancet/issue/current
[No relevant content]

The Lancet Infectious Disease

Aug 2010 Volume 10 Number 8 Pages 505 - 576
http://www.thelancet.com/journals/laninf/issue/current
Leading Edge
WHO failing in duty of transparency
The Lancet Infectious Diseases
[This editorial carries The Lancet Infectious Disease’s view of the
management of the H1N1 pandemic with a focus on WHO transparency]
Review
Changes in the burden of malaria in sub-Saharan Africa
Wendy Prudhomme O'Meara, Judith Nekesa Mangeni, Rick Steketee, Brian
Greenwood
Preview
The burden of malaria in countries in sub-Saharan Africa has declined with
scaling up of prevention, diagnosis, and treatment. To assess the contribution
of specific malaria interventions and other general factors in bringing about
these changes, we reviewed studies that have reported recent changes in the
incidence or prevalence of malaria in sub-Saharan Africa. Malaria control in
southern Africa (South Africa, Mozambique, and Swaziland) began in the
1980s and has shown substantial, lasting declines linked to scale-up of
specific interventions.

Nature
Volume 466 Number 7306 pp531-660
http://www.nature.com/nature/current_issue.html
[No relevant content]
Nature Medicine
July 2010, Volume 16 No 7
http://www.nature.com/nm/index.html
[No relevant content]

New England Journal of Medicine

July 29, 2010 Vol. 363 No. 5
http://content.nejm.org/current.shtml
Perspective
The Renaissance in HIV Vaccine Development — Future Directions
W.C. Koff, S.F. Berkley [free full text]

The Pediatric Infectious Disease Journal

August 2010 - Volume 29 - Issue 8
http://journals.lww.com/pidj/pages/currenttoc.aspx
Sustained Decline in Cases of Rotavirus Gastroenteritis Presenting
to the Children's Hospital of Philadelphia in the New Rotavirus
Vaccine Era
Clark, H Fred; Lawley, Diane; Matthijnssens, Jelle; DiNubile, Mark J.; Hodinka,
Richard L.
Pediatric Infectious Disease Journal. 29(8):699-702, August 2010.
doi: 10.1097/INF.0b013e3181d73524
Abstract:
Background: A dramatic diminution in the number of rotavirus
gastroenteritis cases during the 2007 to 2008 rotavirus season in the United
States was likely attributable to the availability of an effective rotavirus
vaccine for infants since February 2006. To exclude the possibility that
factors other than vaccination accounted for the declining case frequency, we
examined the 2008 to 2009 experience at the Children's Hospital of
Philadelphia (CHOP).
Methods: Infants with acute gastroenteritis presenting to CHOP have been
monitored for the presence of rotavirus antigen in the stool by enzyme-linked
immunosorbent assay (followed by serotyping if enzyme-linked
immunosorbent assay-positive) since the 1994 to 1995 epidemic season.
Results: The number of community-acquired cases during the last full
rotavirus season before licensure of a vaccine was 271 in 2005 to 2006,
followed by 167 cases in 2006 to 2007 and 36 in 2007 to 2008. Between
2008 and 2009, 73 community-acquired cases were identified. Almost half of
the cases were seen among children older than 2 years. Unlike the late-
appearing 2007 to 2008 season, the 2008 to 2009 season paralleled the
typical time course observed in the prevaccine era. G9P[8] strains caused
64% of the cases.
Conclusion: The sustained decline in the frequency of community-acquired
rotavirus gastroenteritis has likely resulted from the use of the new rotavirus
vaccines. The age distribution of children hospitalized for rotavirus
gastroenteritis has shifted toward older children with the introduction of
effective vaccines. The G9 serotype (not included in either vaccine) emerged
as the most common cause of rotavirus gastroenteritis at CHOP during the
2008 to 2009 season.
Parental Attitudes About Influenza Immunization and School-Based
Immunization for School-Aged Children
Allison, Mandy A.; Reyes, Maria; Young, Paul; Calame, Lynne; Sheng,
Xiaoming; Weng, Hsin-yi Cindy; Byington, Carrie L.
Pediatric Infectious Disease Journal. 29(8):751-755, August 2010.
doi: 10.1097/INF.0b013e3181d8562c
Abstract:
Objectives: Identify parental beliefs and barriers related to influenza
immunization of school-aged children and acceptance of school-based
influenza immunization.
Methods: We conducted a cross-sectional survey of parents of elementary
school-aged children in November 2008. Outcomes were receipt of influenza
vaccine, acceptance of school-based immunization, and barriers to
immunization.
Results: Response rate was 65% (259/397). Parents reported that 26% of
children had received the vaccine and 24% intended receipt. A total of 50%
did not plan to immunize. Factors associated with receipt were belief that
immunization is a social norm (adjusted odds ratios [AOR], 10.8; 95% CI, 2.8-
41.8), belief in benefit (AOR, 7.8; CI, 1.8-33.8), discussion with a doctor (AOR,
7.0; CI, 2.9-16.8), and belief that vaccine is safe (AOR, 4.0; CI, 1.0-15.8). A
total of 75% of parents would immunize their children at school if the vaccine
were free, including 59% (76/129) who did not plan to immunize. Factors
associated with acceptance of school-based immunization were belief in
benefit (AOR, 6.1; 95% CI, 2.7-14.0), endorsement of medical setting barriers
(AOR, 3.7; 95% CI, 1.3-10.3), and beliefs that immunization is a social norm
(AOR, 3.3; 95% CI, 1.4-7.6) and that the child is susceptible to influenza (AOR,
2.6; 95% CI, 1.2-5.7). Medical setting barriers were competing time demands,
inconvenience, and cost; school barriers were parents' desire to be with
children and competence of person delivering the vaccine.
Conclusions: School-based immunization programs can increase
immunization coverage by targeting parents for whom time demands and
inconvenience are barriers, demonstrating that immunization is a social
norm, and addressing concerns about influenza vaccine benefit and safety.

Pediatrics
July 2010 / VOLUME 126 / ISSUE 1
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier: No relevant content]

PLoS Medicine
(Accessed 1 August 2010)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-
1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1
&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1
c2a2501181c#results
[No relevant content]
Science
30 July 2010 Vol 329, Issue 5991, Pages 481-596
http://www.sciencemag.org/current.dtl
[No relevant content]

Science Translational Medicine

28 July 2010 vol 2, issue 42
http://stm.sciencemag.org/content/current
[No relevant content]

Vaccine
http://www.sciencedirect.com/science/journal/0264410X
[Reviewed last week]