Vaccines: The Week in Review

4 October 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

United States and Norway will co-host a meeting of GAVI Alliance

donors and partners on 6 October 2010. The high-level meeting of GAVI
Alliance donors, potential donors and partners in New York on 6 October “to
build on GAVI's cost-effective success in preventing 5.4 million deaths in its
first 10 years.” GAVI Alliance partners “will agree on action to avert an
estimated 4.2 million future deaths through immunisation. The meeting will
also set the outline for a pledging meeting in 2011. GAVI needs to raise
US$4.3 billion to scale-up immunisation programmes between 2010 and
2015.”
http://www.gavialliance.org/about/resource_event/index.php\

WHO released a revised position paper on Pertussis vaccination in

the Weekly Epidemiological Record, reaffirming “that high coverage of infants
with 3 doses of quality pertussis vaccine remains the most important element
of pertussis vaccination programmes.” WHO recommends a 3-dose primary
series with the first dose administered at 6 weeks of age, and subsequent
doses given 4-8 weeks apart, at 10-14 and 14-18 weeks of age. The last dose
of the recommended primary series should be completed by the age of 6
months, with a booster dose, given at least 6 months after the last primary
dose, recommended for children 1- 6 years of age, preferably during the
second year of life. The position paper includes information on the relative
merits, in terms of efficacy, safety and cost-effectiveness, of the whole-cell
and acellular pertussis vaccines, and detailed information on the
administration and schedules for pertussis vaccines.
http://www.who.int/wer/2010/wer8540.pdf

BARDA (Biomedical Advanced Research and Development

Authority/HHS) said it is providing three sets of grants totaling $10.4
million “to help the World Health Organization (WHO) strengthen the
ability of developing countries to produce flu vaccine, potentially
reducing the global threat from influenza.” The grants will be used to assist
developing countries with pandemic influenza vaccine manufacturing
infrastructure, training on influenza vaccine manufacturing, and development
and distribution of certain technologies for pandemic influenza vaccines.
Robin Robinson, BARDA director, commented, “While we continue to build
vaccine manufacturing capacity in the United States, and develop new, faster
technologies for producing vaccine domestically, we can increase pandemic
preparedness worldwide by helping other countries take advantage of
technology.” Through this WHO initiative over the past five years, $40 million
in U.S. funding has been used to develop vaccine manufacturing
infrastructure in 10 countries: Egypt, India, Indonesia, Vietnam, Brazil,
Mexico, Russia, Romania, Serbia, and Thailand.
“The second set of grants supports training on cutting-edge manufacturing
techniques for WHO grantees. North Carolina State University’s
Biotechnology and Education Center received $861,000, and Utah State’s
Center for Integrated Biosystems received $322,000, to train selected
personnel from manufacturers in developing countries. Trainees will receive
hands-on instruction in the latest U.S. Food and Drug Administration good
manufacturing practices in vaccine production technology. These practices
can be taken back and implemented by manufacturers in their native
countries.
“The third set of grants supports development of adjuvant and the transfer
of technology to produce adjuvant. The use of adjuvants has been shown to
reduce the amount of protein needed for flu vaccine to be effective, so the
adjuvanted vaccine made in these countries could serve a greater number of
people. The Infectious Disease Research Institute in Seattle received
$790,000, and the University of Lausanne in Switzerland received $1.8
million, to develop adjuvants and other technologies that can be transferred
without the restriction of intellectual property rights.”
http://www.businesswire.com/news/home/20100930007040/en/BARDA-
Grants-Build-Global-Flu-Vaccine-Manufacturing

WHO released a transcript of a press briefing by Dr. Harvey

Fineberg, Chair,
International Health Regulations Review Committee, on 29 September
2010 following the third meeting of the IHR Review Committee. Dr, Fienberg
noted that the has a dual charge, “…We’re constituted under the terms of the
International Health Regulations of 2005 which called for a review after five
years of the performance of the International Health Regulations. We’re also
constituted specifically to review the performance and activities in
connection with the H1N1 pandemic. Importantly this pandemic, the H1N1
pandemic was the first incidence under the implemented rules of the IHR of
2005 which went into effect legally in 2007. The first instance where there
was a declared public health emergency of international concern. This is a
special classification under the terms of the International Health Regulations,
and it’s under that authority that the World Health Organization operated to
carry out its programmes and activity under H1N1 and so these two are
closely enough related that it was deemed appropriate to look at both
simultaneously and that in turn affects the approach that the committee is
taking in preparing our report…”
http://www.who.int/entity/mediacentre/multimedia/pc_transcript_30_septemb
er_10_fineberg.pdf

Merck said its ROTATEQ(Rotavirus Vaccine, Live, Oral,

Pentavalent) received the Prix Galien USA 2010 Award for Best
Biotechnology Product. Dr. Peter S. Kim, president of Merck Research
Laboratories, commented, "We are honored that Merck's long-term
commitment to the discovery and development of new, innovative ways to
prevent and treat disease is being acknowledged with this prestigious award.
We congratulate the teams whose hard work and dedication contributed to
ROTATEQ." The Prix Galien recognizes the pharmaceutical industry's
outstanding achievement in the development of new medicines. The award
was presented at a ceremony in New York City on 28 September 2010.
http://www.marketwatch.com/story/rotateqr-rotavirus-vaccine-live-oral-
pentavalent-awarded-prix-galien-usa-2010-top-honor-2010-09-29?
reflink=MW_news_stmp
Prix Galien USA site: http://www.prix-galien-usa.com/

Events/Conference Watch
[Editor’s Note]
Vaccines: The Week in Review is now monitoring key events and conferences
and will include summaries of key announcements and other content. Event
Watch is not intended to be exhaustive, but indicative of themes and
issues the Center is actively tracking. If you would like to suggest events
and conferences for coverage, please write to David Curry at
david.r.curry@centerforvaccineethicsandpolicy.org

The College of Physicians of Philadelphia launched a preview of

The History of Vaccines – www.historyofvaccines.org – described as “a
website that chronicles the history of immunization, from pre-Jennerian
variolation, to the defeat of polio in the Western Hemisphere, to cutting-edge
approaches to novel vaccines. The site highlights the historical contributions
of vaccines to human health and explains the role of immunization in
healthcare through a set of media-rich timelines, activities, and articles.” The
site officially launches on 3 November 2010, when Stanley A. Plotkin, MD,
creator of the rubella vaccine used throughout most of the world, will give the
Samuel X Radbill lecture entitled “Four Centuries of Vaccinology.” Dr. Plotkin
will trace the serendipitous beginnings of vaccinology in the 1700s to its
flowering in the latter half of the 20th century. Dr. Plotkin is Emeritus
Professor of the University of Pennsylvania and The Wistar Institute.
www.historyofvaccines.org.

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 October 2010 Volume 51, Number 8
http://www.journals.uchicago.edu/toc/cid/current
[No relevant content]

Emerging Infectious Diseases

Volume 16, Number 10–October 2010
http://www.cdc.gov/ncidod/EID/index.htm
[Reviewed last week]

Human Vaccines
Volume 6, Issue 10 October 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/9/
Meeting Report
Lessons learned from the H1N1 2009 pandemic
Nikolai Petrovsky
On the 11th June 2010 approximately 80 delegates drawn from government,
industry and academia gathered in Singapore for the 1st World Influenza
Congress Asia held in association with the 4th Annual World Vaccine
Congress Asia 2010. A major focus of the meeting was sharing of experiences
relating to the recent H1N1 2009 pandemic.
Reviews
Haemophilus influenzae type b conjugate vaccines: Considerations
for vaccination schedules and implications for developing countries
Sean P. Fitzwater, James P. Watt, Orin S. Levine and Mathuram Santosham
Prior to widespread vaccination, Haemophilus influenzae type b was a leading
cause of severe childhood bacterial infection, including meningitis, worldwide.
Over the last decade the world has taken great strides towards controlling
Hib disease through routine use of conjugate vaccines in developed and
developing countries. Currently there is no consensus on the appropriate
schedule by which to use Hib vaccine. Vaccination schedules around the
world vary greatly, particularly between high and low income countries.
Questions remain as to the most effective and efficient schedule of primary
doses, the need for a booster dose, and the implications of using combination
vaccines. Here, we present a synthesis of data supporting various Hib vaccine
schedules, with a focus on the implications for developing countries.

JAMA
Vol. 304 No. 12, pp. 1295-1402, September 22/29, 2010
http://jama.ama-assn.org/current.dtl
[Reviewed earlier; No relevant content]

Journal of Infectious Diseases

1 November 2010 Volume 202, Number 9
http://www.journals.uchicago.edu/toc/jid/current
Editorial Commentaries
Hepatitis E Virus Infections among US Military Personnel Deployed to
Afghanistan
Alain B. Labrique and Kenrad E. Nelson

The Lancet
Oct 02, 2010 Volume 376 Number 9747 Pages 1117 - 1194
http://www.thelancet.com/journals/lancet/issue/current
Comment
Singapore Statement: a global agreement on responsible research
conduct
Sabine Kleinert
The second World Conference on Research Integrity, held in Singapore on July
22–24, 2010, achieved an important first step and a lasting legacy by
developing and agreeing the Singapore Statement on Research Integrity
(released on Sept 22; panel).1,2 Nick Steneck and Tony Mayer, co-chairs of
the Singapore conference, and Melissa Anderson, the incoming chair for the
next World Conference, drafted the statement, guided discussions and
modifications at the conference, and finalised the statement. It is hoped that
the statement will serve as an international framework for responsible
conduct of research, stimulate further debate, and promote the translation of
core principles into more detailed guidance documents for specific purposes.
The Lancet Infectious Disease
Oct 2010 Volume 10 Number 10 Pages 653 - 736
http://www.thelancet.com/journals/laninf/issue/current
Leading Edge
Mass gatherings medicine
The Lancet Infectious Diseases
A human characteristic is our willingness to travel vast distances to gather
in one place, and for any number of reasons, including warfare, religion,
politics, sport, mourning, and entertainment. Modern transport has allowed
such gathering to increase in their number of participants and in the speed at
which people arrive and disperse to all parts of the globe. Such mass
gatherings bring with them the risk of spread of infectious diseases—both at
the time of the event and when participants return to their homes—and other
health hazards such as stampedes or crush injuries, burns, heat exhaustion,
dehydration, trauma, and the potential for environmental and public health
hazards.
Reflection and Reaction
Reconstructing the past of poliovirus eradication efforts
Carlos Franco-Paredes
The March and June, 2010, issues of The Lancet Infectious Diseases1,2
presented two optimistic views of the polio eradication effort that was led by
the Global Polio Eradication Initiative (GPEI); however, it might be wise to
review the historical record of this initiative and, without losing optimism, be
more cautious in prediction of successes.
Media Watch
The vaccine war
Original Text
Talha Burki
The Vaccine War: Written, directed, and produced by John Palfreman.
FRONTLINE.
To view the film online go to
http://www.pbs.org/wgbh/pages/frontline/vaccines/view/
“For the first time, despite repeated reassurances to the contrary; despite
convincing scientific evidence confirming the safety of the vaccine
programme; despite serious criticisms of the probity of the source of the
[MMR ] rumours; some sections of the public have decided that they know
better, and that they do not need to follow the advice of experts”.

Nature
Volume 467 Number 7315 pp499-622 30 September 2010
http://www.nature.com/nature/current_issue.html
[No relevant content]

Nature Medicine
September 2010, Volume 16 No 9
http://www.nature.com/nm/index.html
[Reviewed last week]
New England Journal of Medicine
September 30, 2010 Vol. 363 No. 14
http://content.nejm.org/current.shtml
[No relevant content]

The Pediatric Infectious Disease Journal

October 2010 - Volume 29 - Issue 10
http://journals.lww.com/pidj/pages/currenttoc.aspx
[Reviewed last week]

Pediatrics
September 2010 / VOLUME 126 / ISSUE 3
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier]

PLoS Medicine
(Accessed 3 October 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
Are Drug Companies Living Up to Their Human Rights
Responsibilities? Moving Toward Assessment
Sofia Gruskin, Zyde Raad
The PLoS Medicine Debate, published 28 Sep 2010
doi:10.1371/journal.pmed.1000310
Abstract
Background to the debate
The human rights responsibilities of drug companies have been considered
for years by nongovernmental organizations, but were most sharply defined
in a report by the UN Special Rapporteur on the right to health, submitted to
the United Nations General Assembly in August 2008. The “Human Rights
Guidelines for Pharmaceutical Companies in relation to Access to Medicines”
include responsibilities for transparency, management, monitoring and
accountability, pricing, and ethical marketing, and against lobbying for more
protection in intellectual property laws, applying for patents for trivial
modifications of existing medicines, inappropriate drug promotion, and
excessive pricing. Two years after the release of the Guidelines, the PLoS
Medicine Debate asks whether drug companies are living up to their human
rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School
of Public Health say more assessment is needed of such responsibilities;
Geralyn Ritter, Vice President of Global Public Policy and Corporate
Responsibility at Merck & Co. argues that multiple stakeholders could do
more to help States deliver the right to health; and Paul Hunt and Rajat
Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to
the highest attainable standard of health, regarding the human rights
responsibilities of pharmaceutical companies and access to medicines.
Are Drug Companies Living Up to Their Human Rights
Responsibilities? The Merck Perspective
Geralyn S. Ritter
The PLoS Medicine Debate, published 28 Sep 2010
doi:10.1371/journal.pmed.1000343
Drug Companies Should Be Held More Accountable for Their Human
Rights Responsibilities
Editorial, published 28 Sep 2010
doi:10.1371/journal.pmed.1000344

Science
1 October 2010 Vol 330, Issue 6000, Pages 1-136
http://www.sciencemag.org/current.dtl
[No relevant content]

Science Translational Medicine

29 September 2010 vol 2, issue 51
http://stm.sciencemag.org/content/current
[No relevant content]

Vaccine
Volume 28, Issue 42 pp. 6809-6942 (4 October 2010)
http://www.sciencedirect.com/science/journal/0264410X
[Reviewed last week]