Vaccines: The Week in Review

17 May 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 Curry, Editor and
Executive Director of the Center, at
david.r.curry@centerforvaccineethicsandpolicy.org.

“The U.S. Food and Drug Administration today revised its

recommendations for rotavirus vaccines for the prevention of the
disease in infants and has determined that it is appropriate for
clinicians and health care professionals to resume the use of Rotarix
and to continue the use of RotaTeq.
“The agency reached its decision based on a careful evaluation of
information from laboratory results from the manufacturers and the FDA’s
own laboratories, a thorough review of the scientific literature, and input from
scientific and public health experts, including members of the FDA’s Vaccines
and Related Biological Products Advisory Committee that convened on May 7,
2010 to discuss these vaccines.
“The FDA also considered the following in its decision:
- Both vaccines have strong safety records, including clinical trials involving
tens of thousands of patients as well as clinical experience with millions of
vaccine recipients.
- The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans,
and neither is known to cause infection or illness in humans.
- The benefits of the vaccines are substantial, and include prevention of
death in some parts of the world and hospitalization for severe rotavirus
disease in the United States. These benefits outweigh the risk, which is
theoretical.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm212149
.htm
 The WHO continues to issue weekly updates on the H1N1 pandemic updates
at http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 - update 100
Weekly update
14 May 2010
As of 9 May, worldwide more than 214 countries and overseas territories or
communities have reported laboratory confirmed cases of pandemic
influenza H1N1 2009, including over 18036 deaths.
Situation update:
The most active areas of pandemic influenza virus transmission currently are
in parts of the Caribbean and Central America, and to a lesser extent in West
Africa and South and Southeast Asia. In the temperate zone* of the northern
and southern hemisphere, overall pandemic influenza activity remains
sporadic. Seasonal influenza virus type B continues to be detected at low
levels across parts of Asia, Africa, and Europe…
More at: http://www.who.int/csr/don/2010_05_14/en/index.html

The Bill & Melinda Gates Foundation announced 78 grants of

US$100,000 each in the latest round of Grand Challenges
Explorations. Grand Challenges Explorations is a five-year, $100 million
initiative to promote innovation in global health. It is part of the Grand
Challenges in Global Health initiative which is supported by the Gates
Foundation to achieve major breakthroughs in global health.
Gates said that projects winning grants around more effective vaccines
include:
- Sweat-triggered vaccine delivery: Carlos Alberto Guzman of the
Helmholtz Centre for Infection Research in Germany with Claus-Michael Lehr
and Steffi Hansen of the Helmholtz-Institute for Pharmaceutical Research will
develop nanoparticles that penetrate the skin through hair follicles and burst
upon contact with human sweat to release vaccines.
- A “seek-and-destroy” laser vaccine: Owain Millington and Gail
McConnell of University of Strathclyde in the United Kingdom will use existing
imaging systems to identify and destroy Leishmania parasites with a targeted
laser;
- Treating worm infections to improve vaccine effectiveness: Susanne
Nylén Spoormaker of the Karolinska Institute in Sweden will research whether
treating patients for worm infections prior to vaccinations can improve the
ability of the immune system to respond effectively to vaccines.
Applications for the next round of Grand Challenges Explorations are being
accepted through May 19, 2010. Topics for Round 5 are:
- Create Low-Cost Cell Phone-Based Applications for Priority Global Health
Conditions
- Create New Technologies to Improve the Health of Mothers and Newborns
- Create New Ways to Protect Against Infectious Disease
- Create New Technologies for Contraception
- Grant application instructions, including the list of topic areas in which
proposals are currently being accepted, are available at the Grand
Challenges Explorations website: www.grandchallenges.org.
http://www.gatesfoundation.org/press-releases/Pages/grand-challenges-
explorations-round-four-winners-100509.aspx

National HIV Vaccine Awareness Day, May 18, 2010

Statement of Anthony S. Fauci, M.D., Margaret I. Johnston, Ph.D., and Gary J.
Nabel, M.D., Ph.D., National Institute of Allergy and Infectious Diseases,
National Institutes of Health
“More people today have access to life-saving antiretroviral therapy for
HIV/AIDS than ever before. Yet for every person who begins treatment for HIV
infection, two to three others become newly infected. Treatment alone will
not curtail the HIV/AIDS pandemic. To control and ultimately end this
pandemic, we need a powerful array of proven HIV prevention tools that are
widely accessible to all who would benefit from them.
Vaccines historically have been the most effective means to prevent and
even eradicate infectious diseases. They safely and cost-effectively prevent
illness, disability and death. We at the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health, have
been working for more than two decades with our colleagues worldwide to
develop an HIV vaccine, and this research continues to rank among our top
priorities.
National HIV Vaccine Awareness Day marks an opportunity to reflect on
our progress, renew our commitment to finding an HIV vaccine, and
personally thank the scientists, community educators, health care workers,
and especially the many study volunteers who have dedicated their time and
energy to this important endeavor. Only with the continued commitment of
volunteers may we more effectively confront the global scourge of HIV/AIDS
and pursue the goal of an HIV vaccine.
We have witnessed significant progress in HIV vaccine research during the
past year. Notably, a major clinical trial in Thailand gave us the first
indication that an experimental vaccine can protect some humans against
HIV infection
(http://www.niaid.nih.gov/news/newsreleases/2009/Pages/ThaiVaxStudy.aspx)
. With the participation of more than 16,000 volunteers, investigators found
the vaccine to be 31 percent effective at preventing HIV infection. Although
this level of protection is modest, it gives us hope that a safe and effective
HIV vaccine is possible. The priority now is to try to understand how the
vaccine induced protection against HIV infection in some individuals, and to
build on those results.
The Thai trial demonstrated the power of large-scale clinical trials to
advance HIV vaccine development and to answer fundamental scientific
questions. Such trials are possible only through strategic partnerships among
federal collaborators, nongovernmental organizations and the private sector.
NIAID continues to pursue focused clinical HIV vaccine research through such
partnerships.
 At the same time, we are bolstering our commitment to the basic
laboratory research that provides a foundation for future vaccine
development. In the past year, scientists at NIAID and elsewhere discovered
several new antibodies able to neutralize diverse HIV strains that circulate
worldwide. These antibodies disable HIV by latching onto vulnerable sites on
the virus. Some of these sites previously were unknown, so their discovery
widens the field of targets that a vaccine could exploit. Current and future
studies will determine whether scientists can develop HIV vaccines based on
protein replicas of these targets, and whether the immune response to these
vaccines might protect people from HIV infection. Many other studies also are
under way to explore basic questions about HIV and its interaction with the
immune system.
As we recognize recent progress in HIV vaccine research and hope for
continued advances, we must remember that a vaccine alone will not end the
HIV/AIDS pandemic. If an HIV vaccine is developed, it will need to be used in
concert with multiple other scientifically proven HIV prevention tools. NIAID
continues to support research into an array of investigational HIV prevention
methods, including pre-exposure prophylaxis with antiretroviral drugs,
microbicides, and expanded HIV testing and treatment with linkage to care.
(http://www.niaid.nih.gov/topics/hivaids/research/prevention/Pages/default.as
px).
http://www.nih.gov/news/health/may2010/niaid-11.htm

WHO announced EVIPNet Africa's first series of policy briefs on

malaria treatment, noting that “six countries in sub-Saharan have
developed their own set of policy briefs on how to improve access to malaria
treatment working with EVIPNet (Evidence-informed policy network).”
EVIPNet was set up in response to a 2005 World Health Assembly resolution
calling for WHO to establish or strengthen “mechanisms to transfer
knowledge in support of evidence-based public health and health care
delivery systems and evidence-based related policies” WHO said that
development of the policy briefs are “a significant achievement because it
represents the first time that policy-makers, researchers, and members of
civil society in Burkina Faso, Cameroon, Central African Republic, Ethiopia,
Mozambique and Uganda have collaborated with each other to better use
scientific evidence to produce health policies.” The EVIPNet tools are now
being applied to different problems in Africa, Asia and Latin America and the
Caribbean. These include: maternal and child mortality; the integration of
noncommunicable diseases programmes at community level; effective
financing of primary health care; and outbreak response.
http://www.who.int/rpc/evipnet/policybriefs/en/index.html

The International Federation of Pharmaceutical Manufacturers

and Associations (IFPMA) launched its Ten Principles on Counterfeit
Medicines, “to re-focus attention on this issue and underline the R&D-based
pharmaceutical industry’s stance in the global fight against counterfeit
medicines.” Mr Haruo Naito, President of the IFPMA, and President and CEO of
Eisai, commented: “Counterfeit medicines are a crime, and our industry is
serious about tackling this problem head on. These criminals pose a threat to
global public health: deliberately and deceitfully they attempt to pass off
their dangerous products as legitimate medicines, and risk patients’ lives in
order to make illegal profits. This is not about commercial interest; this is
about protecting patients, and we stand ready to be an active partner in
WHO-led efforts, including IMPACT.”
Speaking in support of the IFPMA Principles, Mr. Thomas T. Kubic, CEO of
PSI, said: “Based on our research, the number of counterfeit medicine
incidents worldwide rose almost seven percent last year, to 1,693. Of
particular concern has been the growth in counterfeit anti-infectives. In 2009,
incidents involving counterfeit anti-infectives increased by almost 50% over
the previous year. Anti-infectives, which include anti-malarials, are the
therapeutic category most affected by counterfeiting incidents in Africa.
Moreover, criminal gangs engaged in the manufacture, distribution and sale
of counterfeit medicines are now copying other life-saving treatments
including cancer therapies and heart disease medicines.” Eduardo Pisani,
Director General of the IFPMA, commented: “We hope that the Ten Principles
will highlight the full scope of the problem and demonstrate that the fight
against counterfeit medicines is simply about protecting patients’ health. The
IFPMA calls on all stakeholders, including governments, health care providers,
patients, the private sector and the WHO, to take collaborative action and
create a global policy environment that recognizes, prioritizes and effectively
addresses this major threat to global health.”
http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13800
Ten Principles (one page summary):
http://www.ifpma.org/documents/NR13800/IFPMA_Ten_Principles_on_Counterf
eit_Medicines_12May2010.pdf

The MMWR for May 14, 2010 / Vol. 59 / No. 18 includes:

Progress Toward Interruption of Wild Poliovirus Transmission ---
Worldwide, 2009
In 1988, an estimated 350,000 cases of poliomyelitis were occurring
annually worldwide. By 2005, because of global vaccination efforts,
indigenous transmission of wild poliovirus (WPV) types 1 and 3 (WPV1 and
WPV3) had been eliminated from all but four countries (Afghanistan, India,
Nigeria, and Pakistan). No cases of WPV type 2 have been reported since
1999. This report describes progress toward global WPV eradication during
2009 and updates previous reports (1--6). During 2009 a total of 1,606 cases
of WPV infection were reported, compared with 1,651 in 2008. WPV3
incidence increased 67%, to 1,124 cases, compared with 675 in 2008.
However, WPV1 incidence decreased 51%, to 482 cases in 2009, compared
with 976 cases in 2008. In India, nearly all polio cases in 2009 were reported
in high-risk districts in western Uttar Pradesh and central Bihar. In
Afghanistan and Pakistan, WPV circulation in high-risk districts continued
because of difficulties vaccinating children in conflict-affected areas and
operational limitations in parts of Pakistan (5). In Nigeria, cases decreased by
51%, to 388 cases in 2009, compared with 798 in 2008. During 2009,
outbreaks from importation of WPV affected 19 previously polio-free African
countries (2). Two key steps are needed to make further progress in polio
eradication: 1) addressing local barriers to interrupting transmission, and 2)
using bivalent oral poliovirus vaccine (bOPV) broadly for WPV 1 and 3 in
supplemental immunization activities (SIAs)…
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5918a1.htm

The Weekly Epidemiological Record (WER) for 14 May 2010, vol. 85,
20 (pp 177–184) includes Outbreak news – Rift Valley fever, South Africa;
Progress in interrupting wild poliovirus transmission worldwide, 2009
http://www.who.int/wer/2010/wer8520.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

1 June 2010 Volume 50, Number 11
http://www.journals.uchicago.edu/toc/cid/current
[Reviewed earlier]

Emerging Infectious Diseases

Volume 16, Number 5–May 2010
http://www.cdc.gov/ncidod/EID/index.htm
[Reviewed earlier]

Human Vaccines
Volume 6, Issue 5 May 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/5/
[Reviewed last week]
JAMA
Vol. 303 No. 18, pp. 1783-1876, May 12, 2010
http://jama.ama-assn.org/current.dtl
[No relevant content]

Journal of Infectious Diseases

15 June 2010 Volume 201, Number 12
http://www.journals.uchicago.edu/toc/jid/current
[No relevant content]

The Lancet
May 15, 2010 Volume 375 Number 9727 Pages 1665 - 1752
http://www.thelancet.com/journals/lancet/issue/current
Correspondence
GAVI's funding challenge
Julian Lob-Levyt
Thanks to The Lancet for highlighting the funding challenge that the GAVI
Alliance faces as we embark on our next decade of work (March 6, p 791).1 It
is important to clarify that all of GAVI's currently approved programmes are
funded up to and including 2015. Such funding includes the existing support
for pentavalent vaccine, which has already been introduced in 57 countries.
An important GAVI principle is to add value through long-term funding.
Since the founding of the alliance in 2000, GAVI partners have increased
immunisation rates to nearly 80% in developing countries, averted over 5
million deaths, and built a solid delivery platform that can now be used to
introduce new life-saving vaccines against two of the world's biggest
childhood killers: pneumonia and diarrhoea. Herein lies our funding
challenge. Only with increased donor support will we be able to expand
further the effect on child mortality by immunising every poor child against
these diseases.
Our donors share our ambition, as illustrated by the Gates Foundation's
dedication of US$10 billion to a “decade of vaccines”.2 As Swedish
Development Minister Gunilla Carlsson herself said in a press conference at
the World Economic Forum in Davos, Switzerland, “Sweden has been with
GAVI from the beginning…I hope that other donors also see the good work
that GAVI is doing.”3
1 Usher AD. GAVI enters its second decade with massive funding gap. Lancet 2010; 375: 791. Full Text |
PDF(43KB) | CrossRef | PubMed
2 Bill & Melinda Gates Foundation. Bill and Melinda Gates pledge $10 billion in call for decade of vaccines.
http://www.gatesfoundation.org/press-releases/Pages/decade-of-vaccines-wec-announcement-
100129.aspx. (accessed April 7, 2010).
3 Davos 2010 Press Conference. Bill & Melinda Gates Foundation pledges new commitment to vaccines.
http://www.livestream.com/worldeconomicforum03/video?clipId=pla_0a5ad43d-be31-42e8-b924-
79b5fd46885e. (accessed April 22, 2010).

The Lancet Infectious Disease

May 2010 Volume 10 Number 5 Pages 289 - 366
http://www.thelancet.com/journals/laninf/issue/current
[Reviewed earlier]
Nature
Volume 465 Number 7295 pp135-260 13 May 2010
http://www.nature.com/nature/current_issue.html
Opinion
Vaccinate before the next pandemic?
Klaus Stöhr of Novartis argues that pre-pandemic immunization with a
cocktail of likely strains could be a cheap, practical and equitable way to
protect people against influenza.

New England Journal of Medicine

Volume 362 — May 13, 2010 — Number 19
http://content.nejm.org/current.shtml
[No relevant content]

The Pediatric Infectious Disease Journal

May 2010 - Volume 29 - Issue 5
http://journals.lww.com/pidj/pages/currenttoc.aspx
[Reviewed earlier]

Pediatrics
May 2010 / VOLUME 125 / ISSUE 5
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier]

PLoS Medicine
(Accessed 16 May 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
Can Foreign Policy Make a Difference to Health?
Sigrun Møgedal, Benedikte Louise Alveberg Perspective, published 11 May 2010
New Complexities and Approaches to Global Health Diplomacy: View from the U.S.
Department of State
Kerri-Ann Jones Perspective, published 11 May 2010

Science
14 May 2010 Vol 328, Issue 5980, Pages 777-936
http://www.sciencemag.org/current.dtl
Special Issue: Tuberculosis & Malaria
Landscapes of Infection
Stella Hurtley, Caroline Ash, and Leslie Roberts
Redrawing Africa's Malaria Map
Martin Enserink
Smaller countries on the hardest-hit continent have shown how aggressive
malaria control can slash cases and deaths. Can the big ones follow?
As Challenges Change, So Does Science
Martin Enserink
Although nobody believes that it is possible in the next 10, 20, or even 30
years, the call to eradicate malaria, combined with the plummeting disease
burden, are already reshaping the scientific agenda. |
Malaria's Drug Miracle in Danger
Martin Enserink
Like many others before it, the latest generation of malaria drugs is losing
its punch. This time, can global disaster be averted?
If Artemisinin Drugs Fail, What's Plan B?
Martin Enserink
If the current generation of artemisinin-based combination therapies should
fail, does the world have a solid backup plan? The short answer: No.
The ‘Do Unto Others’ Malaria Vaccine
Gretchen Vogel
Once neglected, research on transmission-blocking vaccines for malaria is
gaining new prominence.
Shrinking the Malaria Map From the Outside In
Leslie Roberts
A debate is brewing over how best to fight malaria: Go for the quick wins, or
the worst places first, or both?
Elimination Meets Reality in Hispaniola
Leslie Roberts
Hispaniola's fledging program to eliminate malaria, now sidetracked by the
earthquake, illustrates the difficulties that arise when ambitious goals collide
with reality.
Reviews
Tuberculosis: What We Don’t Know Can, and Does, Hurt Us
David G. Russell, Clifton E. Barry, 3rd, and JoAnne L. Flynn
The Population Dynamics and Control of Tuberculosis
Christopher Dye and Brian G. Williams
That Was Then But This Is Now: Malaria Research in the Time of an
Eradication Agenda
Stefan H. I. Kappe, Ashley M. Vaughan, Justin A. Boddey, and Alan F. Cowman
Science 14 May 2010: 862-866.
The Selection Landscape of Malaria Parasites
M. J. Mackinnon and K. Marsh

Science Translational Medicine

12 May 2010 vol 2, issue 31
http://stm.sciencemag.org/content/current
[No relevant content]

Vaccine
Volume 28, Issue 21, Pages 3627-3754 (7 May 2010)
http://www.sciencedirect.com/science/journal/0264410X
[No relevant content]