Vaccines: The Week in Review

14 June 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
- Childrens 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 Curry, Editor and
Executive Director of the Center, at
david.r.curry@centerforvaccineethicsandpolicy.org.

Editors Note: Vaccines: The Week in Review adds a new feature beginning
this week called Information Resources, intended to highlight important
websites, repositories and sources of information covering global vaccines,
immunization, public health and related ethical and policy issues.
Our first entry is the PATH Vaccine Resource Library which seeks to
gather the world's best immunization resources in a single, easy-to-use
website. The VRL offers high-quality, scientifically accurate documents and
links on specific diseases and topics in immunization. PATH is currently
seeking feedback on this resource, available at
http://www.path.org/vaccineresources/details.php?i=1008

The WHO and the Health Department of South Africa developed a brochure
Health advice for travellers to the FIFA World Cup which includes
information about required immunizations and other health precautions. The
full text section on vaccinations is below:
Vaccinations
Before travelling, you must be up-to-date on your routine travel
vaccinations. These include diphtheria, tetanus, pertussis, polio, measles, and
mumps. Making sure your measles and polio vaccinations are up-to-date is
especially important there have
been recent outbreaks of measles in South Africa, and polio has been
eliminated from South Africa and must not be re-introduced.
 If you are coming from a country where polio cases occurred recently, this
vaccination is crucial (see www.polioeradication.org/casecount.asp ) for
countries where polio cases occurred recently).
As well as the essential vaccines, your doctor might suggest you get others.
What extra vaccines you need depends on where in South Africa youre
going, and what youll be doing when you get there. Other vaccines you
might need include hepatitis A, hepatitis B and typhoid fever.
Yellow fever
If you are arriving in South Africa from an area at risk of yellow fever, you
must have a valid certificate of yellow fever vaccination. This certificate must
show you were vaccinated at least 10 days before travelling, and not more
than 10 years before arriving in South Africa. Find out from your doctor what
areas are at risk of yellow fever transmission: if you need the right papers
and you dont have them, you will be refused entry to South Africa. Please
also note that if you are transiting through a yellow fever area, youll need
the vaccine as well - no matter how short a time you spend in transit.
Flu: Seasonal Influenza and Pandemic A(H1N1) Influenza
Its going to be winter in South Africa during the World Cup, and this means
youll be more at risk from influenza, or flu. Vaccination is the best protection
against flu. If you are coming to South Africa for the World Cup, you should
get vaccinated against seasonal flu and Pandemic A(H1N1) Influenza. In most
countries, routine flu
vaccinations already include protection against Pandemic A(H1N1) Influenza,
but do check this with your doctor.
If you are at high risk of serious disease from flu viruses, its even more
important that you receive the right flu vaccinations. You should make flu
vaccinations a priority if youre pregnant or elderly; if you have a chronic
disease; or if your immune system is already compromised.
http://www.who.int/ith/updates/health_advice_2010_world_cup.pdf

The Bill & Melinda Gates Foundation announced a new initiative

to help advance a comprehensive approach to womens and
childrens health and said it will invest $1.5 billion from 2010 through
2014 to support innovative projects addressing family planning; health care
for pregnant women, newborns, and children; and nutrition. This new pledge
will add to the foundations spending in other areas that affect womens and
childrens health such as developing and delivering childrens vaccines, and
preventing pneumonia, diarrhea, malaria, and HIV/AIDS. Gates said that a
significant portion of the new funding will support programs in India, Ethiopia,
and other countries that have relatively high rates of maternal and child
mortality. http://www.gatesfoundation.org/press-releases/Pages/women-
deliver-2010-100607.aspx

The WHO continues to issue weekly updates on the H1N1 pandemic at

http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 - update 104
Weekly update
11 June 2010
As of 6 June, worldwide more than 214 countries and overseas territories or
communities have reported laboratory confirmed cases of pandemic
influenza H1N1 2009, including over 18156 deaths
Situation update:
Active but declining transmission of pandemic influenza virus persists in
limited areas of the tropics, particularly in Southeast Asia and the Caribbean.
As countries of the temperate southern hemisphere enter winter, only
sporadic influenza activity has been detected so far, except in Chile and
Uruguay, both of which have recently reported small numbers of pandemic
influenza virus detections. Although seasonal influenza B viruses have been
the predominant type of influenza virus circulating worldwide since the end of
February 2010, there have been increasing but low level detections of
seasonal influenza H3N2 viruses, particularly in South America and in East
Africa
More at: http://www.who.int/csr/don/2010_06_11/en/index.html

The International Federation of Pharmaceutical Manufacturers and

Associations (IFPMA) approved a Joint Industry Position on the
Publication of Clinical Trial Results in the Scientific Literature,
previously approved by the European Federation of Pharmaceutical Industries
and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers
Association (JPMA) and the Pharmaceutical Research and Manufacturers of
America (PhRMA). Through the new industry position, the associations and
their member companies and associations commit, as a minimum, to submit
for publication as a manuscript in a peer-reviewed journal, the results of all
their industry-sponsored phase III clinical trials, as well as the results of other
trials of significant medical importance. The new Joint Position requires
submission for publication of the results of all trials within its scope,
regardless of whether the outcome was positive or negative.
Mr. Haruo Naito, President of the IFPMA and President and CEO of Eisai,
said: Our earlier Joint Position on Disclosure of Clinical Trials already requires
members to disclose the trials they are undertaking and to publish summary
results in online registries. This new Joint Position on publication is a logical
extension of that approach, requiring members to seek scientific journal
publication of the results of the specified trials.
The position notes that submission of manuscripts should occur ideally within
12 months and no more than 18 months after approval of the product
concerned or the decision to discontinue the trial. In the case of trials of a
product which is already marketed, submission should ideally be within 12
months of the completion of the trial and not more than 18 months after that
date.
The Position also lays down guidelines which enhance transparency
regarding the authorship of manuscripts. An authorship credit requires a
substantial contribution to the design of the trial, data acquisition or
interpretation, plus drafting or revision of the text, plus final approval. The
roles of medical writers, statisticians and other who contribute to a
manuscript but who do not meet the authorship criteria should be mentioned
appropriately. Company involvement in both the research and publication
should be disclosed, and sponsors should encourage authors to disclose all
relevant interests. The primary publication for a particular trial should provide
an accurate report of its findings, including adverse events, and there should
be a discussion of the strengths and limitations of the study.
http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13801

The MMWR Weekly for June 11, 2010 / Vol. 59 / No. 22 includes:
- Deaths and Hospitalizations Related to 2009 Pandemic Influenza A (H1N1)
--- Greece, May 2009--February 2010
- Addition of Severe Combined Immunodeficiency as a Contraindication for
Administration of Rotavirus Vaccine
http://www.cdc.gov/mmwr/PDF/wk/mm5922.pdf

Journal Watch
[Editors 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

1 July 2010 Volume 51, Number 1
http://www.journals.uchicago.edu/toc/cid/current
[Reviewed last week]

Emerging Infectious Diseases

Volume 16, Number 6June 2010
http://www.cdc.gov/ncidod/EID/index.htm
[Reviewed earlier]

Human Vaccines
Volume 6, Issue 6 June 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/6/
[Reviewed last week]
JAMA
Vol. 303 No. 22, pp. 2219-2312, June 9, 2010
http://jama.ama-assn.org/current.dtl
[No relevant content]

Journal of Infectious Diseases

1 July 2010 Volume 202, Number 1
http://www.journals.uchicago.edu/toc/jid/current
[No relevant content]

The Lancet
Jun 12, 2010 Volume 375 Number 9731 Pages 2051 - 2120
http://www.thelancet.com/journals/lancet/issue/current
Series
New vaccines for tuberculosis
Stefan HE Kaufmann, Gregory Hussey, Paul-Henri Lambert
Summary
New vaccines are urgently needed if we want to reach the goal of
substantially reducing the incidence of tuberculosis by 2050. Despite a
steady increase in funding over the past decade, there is still a striking
financial shortfall for vaccine research and development for tuberculosis. Yet,
around ten vaccine candidates have left the laboratory stage and entered
clinical trials. These vaccines are either aimed at replacing the present
vaccine, BCG, or at enhancing immunity induced by BCG. However, these
pre-exposure candidates are designed for prevention of disease and will
therefore neither eradicate the pathogen, nor prevent stable infection. Long-
term vaccination strategies need to target these more ambitious goals. Even
though vaccine development will have a price, the return of investment will
greatly exceed original costs.

The Lancet Infectious Disease

Jun 2010 Volume 10 Number 6 Pages 367 - 440
http://www.thelancet.com/journals/laninf/issue/current
[Reviewed last week]

Nature
Volume 465 Number 7299 pp665-836 10 June 2010
http://www.nature.com/nature/current_issue.html
[No relevant content]

New England Journal of Medicine

Volume 362 June 10, 2010 Number 23
http://content.nejm.org/current.shtml
Original Articles
Comparative Epidemiology of Pandemic and Seasonal Influenza A in
Households
[free full text]
B. J. Cowling and Others
ABSTRACT
Background There are few data on the comparative epidemiology and
virology of the pandemic 2009 influenza A (H1N1) virus and co-circulating
seasonal influenza A viruses in community settings.
Methods We recruited 348 index patients with acute respiratory illness from
14 outpatient clinics in Hong Kong in July and August 2009. We then
prospectively followed household members of 99 patients who tested positive
for influenza A virus on rapid diagnostic testing. We collected nasal and
throat swabs from all household members at three home visits within 7 days
for testing by means of quantitative reverse-transcriptasepolymerase-chain-
reaction (RT-PCR) assay and viral culture. Using hemagglutination-inhibition
and viral-neutralization assays, we tested baseline and convalescent serum
samples from a subgroup of patients for antibody responses to the pandemic
and seasonal influenza A viruses.
Results Secondary attack rates (as confirmed on RT-PCR assay) among
household contacts of index patients were similar for the pandemic influenza
virus (8%; 95% confidence interval [CI], 3 to 14) and seasonal influenza
viruses (9%; 95% CI, 5 to 15). The patterns of viral shedding and the course
of illness among index patients were also similar for the pandemic and
seasonal influenza viruses. In a subgroup of patients for whom baseline and
convalescent serum samples were available, 36% of household contacts who
had serologic evidence of pandemic influenza virus infection did not shed
detectable virus or report illness.
Conclusions Pandemic 2009 H1N1 virus has characteristics that are broadly
similar to those of seasonal influenza A viruses in terms of rates of viral
shedding, clinical illness, and transmissibility in the household setting.

The Pediatric Infectious Disease Journal

June 2010 - Volume 29 - Issue 6
http://journals.lww.com/pidj/pages/currenttoc.aspx
[Reviewed last week]

Pediatrics
June 2010 / VOLUME 125 / ISSUE 6
http://pediatrics.aappublications.org/current.shtml
[No relevant content]

PLoS Medicine
(Accessed 14 June 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
11 June 2010 Vol 328, Issue 5984, Pages 1323-1419
http://www.sciencemag.org/current.dtl
Policy Forum: Public Health
Global HIV/AIDS Policy in Transition
John Bongaarts and Mead Over
Summary
In 2007, the United Nations Joint Programme on HIV/AIDS (UNAIDS) concluded
that "Global HIV incidence likely peaked in the late 1990s" (1), due to
"natural trends in the epidemic as well as the result of prevention
programmes" (1). The slow decline in new infections together with a recent
rise in antiretroviral therapies (ARTs) halted the rise in the estimated number
of AIDS deaths at about 2.2 million per yearequivalent to 4% of all global
deaths (2). Among adults 15 to 49, the proportion currently infected with HIV
(HIV prevalence) plateaued at just under 1% before declining to 0.8%
worldwide (1, 3). These trends raise the question of how global health funding
should be rebalanced between AIDS treatment and HIV prevention, as well as
other health-care investments.

Science Translational Medicine

9 June 2010 vol 2, issue 35
http://stm.sciencemag.org/content/current
[No relevant content]

Vaccine
Volume 28, Issue 29, Pages 4539-4686 (23 June 2010)
http://www.sciencedirect.com/science/journal/0264410X
Meeting Report
Utilization of serologic assays to support efficacy of vaccines in
nonclinical and clinical trials: Meeting at the Crossroads
Dace V. Madore, Bruce D. Meade, Fran Rubin, Carolyn Deal, Freyja Lynn and
the Meeting Contributors
Abstract
In May 2009 the National Institute of Allergy and Infectious Diseases hosted a
workshop on serologic assays that support vaccine efficacy evaluations. The
meeting promoted exchange of ideas among investigators from varying
disciplines who are working on anti-infectious agent vaccines at different
stages of development. The presentations and discussions at the workshop
illustrated the challenges common across various pathogens with recurring
themes: (1) A thorough understanding of the science regarding the pathogen
and the host response to disease and immunization is fundamental to assay
selection. (2) The intended use of the immunoassay data must be clearly
defined to ensure appropriate specificity, accuracy, and precision; a
laboratory must also commit resources to assure data quality and reliability.
(3) During vaccine development, an immunoassay may evolve with respect to
quality, purpose, and degree of standardization, and, in some cases, must be
changed or replaced as data are accumulated. (4) Collaboration on
standardized reagents and methods, harmonization efforts, and
multidisciplinary teams facilitate consistent generation of quality data. This
report provides guidance for effective development and utilization of
immunoassays based on the lessons learned from currently licensed
vaccines. Investigators are encouraged to create additional opportunities for
scientific exchange, noting that the discussed themes are relevant for
immunoassays used for other purposes such as therapeutics and diagnostics.
Regular Papers
Measles in the United Kingdom 19902008 and the effectiveness of
measles vaccines
Hershel Jick, Katrina Wilcox Hagberg
Abstract
We identified all children in the UK General Practice Research Database
diagnosed with measles from 1990 to 2008 and calculated annual incidence
according to age and geographic region by dividing the number of cases per
year by the number of children who were active in the population. We
evaluated the effectiveness of the measles vaccines by comparing the
vaccination histories of children who were diagnosed with measles (cases) to
children who were not (controls). The annual incidence of measles fell after
the introduction of the MMR vaccine in late 1988. However, a modest
outbreak of measles occurred in 1994, leading to large nationwide programs
to immunize children. Since 1996, the incidence of measles has fallen by
more than 80%. Prior measles vaccination is highly effective and has
substantially reduced the risk of measles.
A costeffectiveness analysis of Japanese encephalitis vaccine in
Cambodia
Sok Touch, Chutima Suraratdecha, Chham Samnang, Seng Heng, Lauren
Gazley, Chea Huch, Ly Sovann, Chab Seak Chhay, Sann Chan Soeung
Abstract
This study aimed to evaluate the cost and effectiveness of introducing a live,
attenuated vaccine (SA 14-14-2) against Japanese encephalitis (JE) into the
immunization program. The study demonstrated that SA 14-14-2
immunization is costeffective in controlling JE in Cambodia compared to no
vaccination. Averting one disability-adjusted life year, from a societal
perspective, through the introduction of SA 14-14-2 through routine
immunization, or a combination of routine immunization plus a campaign
targeting children 15 or 110 years of age, costs US$22, US$34 and US$53,
respectively. Sensitivity analyses confirmed that there was a high probability
of SA 14-14-2 immunization being costeffective under conditions of
uncertainty.
Influenza vaccination of future healthcare workers: A cross-sectional
study of uptake, knowledge and attitudes
Debra L. Blank, David M.S. Bodansky, Anna Forbes, Emma Garde, Fleur Story,
Andrea K. Roalfe, Lynda Tait
Abstract
Promotional campaigns recommend immunisation against influenza in
healthcare workers (HCWs) but the uptake in this group remains low. We
conducted a survey study during the 20082009 influenza vaccination period
amongst future HCWs to quantify uptake and identify barriers to
immunisation. Overall uptake was 8.0% (95% CI 5.910.8%), which is lower
than the uptake amongst current HCWs (13.4%) and short of current
government targets (75%). Knowledge about influenza was good but
insufficient to encourage HCWs to get vaccinated. Promotional campaigns are
needed that emphasise the role of vaccination in personal and patient
protection.

Information Resources
Our first entry is the PATH Vaccine Resource Library which seeks to
gather the world's best immunization resources in a single, easy-to-use
website. The VRL offers high-quality, scientifically accurate documents and
links on specific diseases and topics in immunization. PATH is currently
seeking feedback on this resource, available at
http://www.path.org/vaccineresources/details.php?i=1008