Vaccines: The Week in Review

25 January 2010
Center for Vaccine Ethics & Policy
http://www.centerforvaccineethicsandpolicy.org/
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. We also invite you to visit
VaccineEthics.org www.vaccineethics.org/ which complements this weekly review
and is edited by Jason Schwartz, MBE, Center for Bioethics.

The WHO continues to issue weekly “updates” and briefing notes on the
H1N1 pandemic at: http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 - update 84
Weekly update
22 January 2010
As of 17 January 2010, worldwide more than 209 countries and overseas
territories or communities have reported laboratory confirmed cases of
pandemic influenza H1N1 2009, including at least 14142 deaths.
WHO is actively monitoring the progress of the pandemic through frequent
consultations with the WHO Regional Offices and member states and through
monitoring of multiple sources of information.
Situation update:
The overall situation in largely unchanged since last week. The most intense
transmission of pandemic influenza virus continues to occur in North Africa,
South Asia, and in limited areas of Eastern Europe. Overall pandemic
influenza activity in the temperate northern hemisphere peaked between late
October and late November 2009 and has continued to decline since…
More at: http://www.who.int/csr/don/2010_01_22/en/index.html

WHO published the report by the Director-General to the

Executive Board at its 126th session in Geneva, Switzerland on 18
January 2010. We excerpt a portion of the speech which addresses
immunization issues and the H1Ni pandemic below. Dr. Chan’s full speech
text is available at the link below and is titled:
Progress in public health during the previous decade and major
challenges ahead
“…We are at the start of the second decade of the 21st century. And we are
just five years away from 2015. A report on progress towards the health-
related Millennium Development Goals is on your agenda.
Several other reports describe activities that are contributing to
achievement of the Goals or point to specific challenges that need to be
addressed. As these reports show, progress in individual countries tends to
be greatest in the better-off populations. We are still not doing enough to
improve life for the most vulnerable and the poorest of the poor.
At the international level, the picture is mixed, and the African region must
continue to be a focus of particular concern. But there are many bright and
motivating examples of success everywhere.
Some of these examples come from big-picture trends. Towards the end of
last year, WHO and other agencies issued substantial reports on trends for
HIV/AIDS, tuberculosis, malaria, vaccines and immunization, and the health of
children.
You will be familiar with the positive trends in all these areas. The progress
is sometimes fragile, threatened by factors ranging from drug resistance to
uncertain funding for the future. But the trends are definitely positive. While
optimism about the malaria situation must be cautious, this is the first time,
in decades, that we are getting some good news. This, too, is progress.
We can all be proud that the drive to reach international health
commitments has never faltered, even at a time of multiple global crises on
multiple fronts.
Apart from these big-picture trends, reports prepared for this session cover
many specific indicators of progress. Vitamin A supplementation has been
implemented as a life-saving measure in 66 of 68 countries with a high
burden of child deaths. Since 2000, measles deaths have dropped by 78%. As
the report on this item concludes, measles eradication is achievable. If we
want to do this, we can.
By 2007, 98% of reported tuberculosis cases were being diagnosed and
treated in DOTS programmes. WHO Child Growth Standards have been
adopted by more than 100 countries. This, in turn, has led to increased
investment in programmes to reduce undernutrition, but also to tackle the
growing problem of childhood obesity. As I have said on many occasions,
what gets measured gets done.
Ten years into this new century, we are seeing signs that aid for health
development can bring solid results. Equally important, in the drive to reach a
limited number of time-bound health goals, fundamental problems are being
uncovered, and solutions are being found that benefit public health across
the board.
We are making progress, as the reports before you show. We need to keep
on setting our sights higher, aiming to do more, for more and more people.
Ladies and gentlemen,
For me, the best health news of the previous decade is the fact that the long
overdue influenza pandemic has been so moderate in its impact. Had the
pandemic taken another course, the agenda for this session would have
looked very different. Had the virus mutated to a more virulent form, we
would not be talking about forging ahead. We would be standing still or
dealing with serious setbacks.
We have been fortunate since the very emergence of the new H1N1 virus,
and have remained fortunate up to now. The virus initially spread in countries
with good surveillance systems. The honesty and speed of early reporting set
the standard for the international response.
The virus did not mutate to a more virulent form. Resistance to oseltamivir
did not become widespread. The vaccine proved safe and a close match with
circulating virus. Things could have gone wrong in any of these areas.
We were fortunate in other ways. This is the first pandemic to occur since
the revolution in communications and information technologies. For the first
time in history, the international community could watch a pandemic unfold,
and chart its evolution, in real time.
The amount of data that have been collected since April of last year, and
the number of research reports and studies that have been published, have
been remarkable. This quick collection of information has allowed WHO to
issue treatment guidelines, track the epidemiology, and keep a close watch
for mutations, including those that confer resistance to antiviral drugs.
When the history of this pandemic is written, I believe that the speed of
actions taken by governments to protect their populations will earn the
highest marks. Though the burden on emergency rooms and intensive care
units has been heavy, nearly all health systems have coped well. Let me pay
tribute to all the health care workers who have worked tirelessly to care for
patients.
The early standard of rapid and transparent reporting was upheld, and the
sharing of information, diagnostic support, test kits, and viruses has been
commendably generous. To date, well over 23,000 viruses and other
specimens have been submitted to WHO network laboratories for analysis.
During any public health emergency, health officials must make urgent,
often far-reaching decisions in an atmosphere of considerable scientific
uncertainty. Given our duty to safeguard public health, the tendency of
officials facing such a situation is nearly always to err on the side of caution. I
believe we would all rather see a moderate pandemic with ample supplies of
vaccine than a severe pandemic with inadequate supplies of vaccine.
In some countries in the northern hemisphere with good surveillance
systems, the pandemic appears to be easing. The worst may be over. But it
would be unwise for anyone to reach firm conclusions before April, when the
normal influenza season usually ends. There is still quite a lot of winter left.
In addition, we cannot predict what will happen between now and later in
the year, when the southern hemisphere enters its influenza season and the
virus becomes more transmissible.
Data for most parts of Africa are sparse. We are concerned that some
countries in the western part of the continent remain susceptible to intense
waves of transmission. We do not know for sure, but we are keeping a careful
watch.
Population susceptibility to infection by a new virus drives the dynamics of
an influenza pandemic. This is the critical question. Are there enough
susceptible people left to sustain further waves of community-wide
transmission? At present, we simply do not have enough data to answer this
question with certainty. Studies are, however, under way.
We can estimate how much immunity has been conferred through
vaccination. But knowing how much natural immunity has been acquired
through infection is more difficult, especially given the very mild nature of
illness in the vast majority of patients. Some infections produced no
symptoms, and quick surveys of influenza-like illness will not capture these
infections.
In short: I believe that what most countries are doing, that is, urging their
populations to get vaccinated, is the prudent public health approach. Each
country has to assess its own epidemiological situation and the needs and
concerns of its citizens. For developing countries concerned about their lack
of access to pandemic vaccines, WHO is ramping up its donation programme.
This pandemic has also been the first major test of the revised
International Health Regulations. They have given the world an orderly, rules-
based way to respond, and this has been an asset. With few exceptions,
social and economic disruptions have been far less significant than feared.
Another strength of the International Health Regulations is its system of
checks and balances. They ensure that no one, myself included, has
unfettered power.
Although the virus has not yet delivered any devastating surprises, we
have seen some surprises on other fronts. We anticipated problems in
producing enough vaccine fast enough, and this did indeed happen. But we
did not anticipate that people would decide not to be vaccinated.
I mentioned the revolution in communications and information
technologies. In today’s world, people can draw on a vast range of
information sources. People make their own decisions about what information
to trust, and base their actions on those decisions.
The days when health officials could issue advice, based on the very best
medical and scientific data, and expect populations to comply, may be
fading. It may no longer be sufficient to say that a vaccine is safe, or testing
complied with all regulatory standards, or a risk is real.
In my view, this is a new communications challenge that we may need to
address. As the items on your agenda show, persuading people to adopt
healthy behaviours is one of the biggest challenges in public health.
In terms of managing public perceptions, part of the problem arises from
the big difference between what was expected, after watching the highly
lethal H5N1 virus for so long, and what fortunately happened. An event
similar to the 1918 pandemic was feared, when what actually happened is
probably closer to the 1957 or 1968 pandemics.
Let me introduce a word of caution. Reliable estimates of the number of
deaths and the mortality rate during the current pandemic will not be
possible until one to two years after the pandemic has ended.
Let me reassure you on a final point. This has been the most closely
watched and carefully scrutinized pandemic in history. We will have a wealth
of new knowledge as a result. It is natural that every decision or action that
shaped the response will likewise be closely and carefully scrutinized.
WHO can withstand this scrutiny…”
http://www.who.int/dg/speeches/2010/executive_board_126_20100118/en/ind
ex.html
 PATH said it welcomed announcements made by GlaxoSmithKline
(GSK) CEO Andrew Witty concerning sustainable pricing and vaccine
donations for RTS,S malaria vaccine candidate, currently in a large,
late-stage clinical trial that is supported by the PATH Malaria Vaccine
Initiative (MVI). Christian Loucq, director of MVI, said, “The announcements…
are positive steps in the long pathway from discovery to delivery of RTS,S.
These commitments help to illustrate the potential of product development
partnerships—like the one between MVI and GSK Biologicals—for meeting the
health needs of people in developing countries.”
In a speech at the Council on Foreign Relations, Mr. Witty “committed to
setting a price for RTS,S that would cover GSK’s costs and generate a small
return that would be re-invested in research and development for next-
generation malaria vaccines and vaccines against other neglected diseases.
GSK also committed to donating at least 12.5 million doses of RTS,S (if
approved for use) to PATH.”
PATH said that GSK Biologicals, the vaccine division of GSK, and PATH
signed a collaboration agreement in 2001 to pursue the pediatric clinical
development of RTS,S in Africa. To advance the development program,
African research centers in five countries, and collaborating institutions,
joined the partnership. Centers in two additional African countries have joined
for the Phase 3 trial. Together, these partners comprise the Clinical Trials
Partnership Committee and lead the clinical development of RTS,S, PATH
said.
Christopher J. Elias, president and CEO of PATH, commented, “Like other
PATH programs, MVI’s mission goes beyond development of a health
intervention to ensuring that it is available at the lowest price possible and
readily accessible to all who need it. In light of the commitments made today
and as we get closer to the day that the RTS,S vaccine candidate—if all goes
well—could be available for use, we look forward to working with GSK, as well
as other global partners, to ensure that malaria vaccines are available to the
children that need them most.”
20 January 2010. http://www.path.org/news/an100120-MVI.php

IVI announced the licensure of Shanchol, an oral cholera vaccine, in

India in 2009, noting that “efforts to accelerate the global use of new
generation cholera vaccines gained significant momentum with the licensure.
IVI said its scientists developed this vaccine, with funding from the Bill &
Melinda Gates Foundation, “by significantly modifying a vaccine used and
produced only in Vietnam so that it meets international Good Manufacturing
Practice (GMP) standards and WHO production guidelines.”
http://www.ivi.org/popup/files/ocv_article.pdf
 The Weekly Epidemiological Record (WER) for 22 January 2009, vol.
85, 4 (pp 21–28) includes: Preliminary review of D222G amino acid
substitution in the haemagglutinin of pandemic influenza A (H1N1) 2009
viruses; African Programme for Onchocerciasis Control – report of the sixth
meeting of national task forces, October 2009
http://www.who.int/wer/2010/wer8504.pdf

The MMWR Weekly for January 22, 2010 / Vol. 59 / No. 2 includes:
- Prevalence of Abnormal Lipid Levels Among Youths --- United States, 1999--
2006
- Transfusion-Related Transmission of Yellow Fever Vaccine Virus ---
California, 2009
- Update: Influenza Activity --- United States, August 30, 2009--January 9,
2010
- Interim Results: Influenza A (H1N1) 2009 Monovalent Vaccination Coverage
--- United States, October--December 2009
http://www.cdc.gov/mmwr/mmwr_wk.html

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

JAMA
Vol. 303 No. 3, pp. 199-288, January 20, 2010
http://jama.ama-assn.org/current.dtl
Commentary
Public Health Response to Influenza A(H1N1) as an Opportunity to Build
Public Trust
Heidi J. Larson; David L. Heymann
JAMA. 2010;303(3):271-272

Journal of Infectious Diseases

15 February 2010 Volume 201, Number 4
http://www.journals.uchicago.edu/toc/jid/current
Editorial Commentaries
Unmasking the Confusion of Respiratory Protection to Prevent
Influenza-Like Illness in Crowded Community Settings
Titus L. Daniels and Thomas R. Talbot
MAJOR ARTICLE
Mask Use, Hand Hygiene, and Seasonal Influenza-Like Illness among
Young Adults: A Randomized Intervention Trial
Allison E. Aiello,1,2; Genevra F. Murray,3; Vanessa Perez,1,2;
Rebecca M. Coulborn,1,2; Brian M. Davis,1,2; Monica Uddin,1,2;
David K. Shay,4; Stephen H. Waterman,4 and
Arnold S. Monto,1
1Department of Epidemiology and 2Center for Social Epidemiology and Population Health, School of Public
Health, University of Michigan, Ann Arbor, Michigan; 3Department of Sociology, Anthropology, and Social
Work, University of South Alabama; 4Centers for Disease Control and Prevention, Atlanta, Georgia
Background. During the influenza A(H1N1) pandemic, antiviral prescribing
was limited, vaccines were not available early, and the effectiveness of
nonpharmaceutical interventions (NPIs) was uncertain. Our study examined
whether use of face masks and hand hygiene reduced the incidence of
influenza-like illness (ILI).
Methods. A randomized intervention trial involving 1437 young adults living
in university residence halls during the 2006–2007 influenza season was
designed. Residence halls were randomly assigned to 1 of 3 groups—face
mask use, face masks with hand hygiene, or control— for 6 weeks.
Generalized models estimated rate ratios for clinically diagnosed or survey-
reported ILI weekly and cumulatively.
Results. We observed significant reductions in ILI during weeks 4–6 in the
mask and hand hygiene group, compared with the control group, ranging
from 35% (confidence interval [CI], 9%–53%) to 51% (CI, 13%–73%), after
adjusting for vaccination and other covariates. Face mask use alone showed
a similar reduction in ILI compared with the control group, but adjusted
estimates were not statistically significant. Neither face mask use and hand
hygiene nor face mask use alone was associated with a significant reduction
in the rate of ILI cumulatively.
Conclusions. These findings suggest that face masks and hand hygiene may
reduce respiratory illnesses in shared living settings and mitigate the impact
of the influenza A(H1N1) pandemic.
Trial Registration. ClinicalTrials.gov identifier: NCT00490633.

The Lancet
Jan 16, 2010 Volume 375 Number 9710 Pages 171 - 252
http://www.thelancet.com/journals/lancet/issue/current
[No relevant content]

The Lancet Infectious Disease

Jan 2010 Volume 10 Number 1 Pages 1 - 66
http://www.thelancet.com/journals/laninf/issue/current
[Reviewed earlier]

Nature
Volume 463 Number 7279 pp269-392 21 January 2010
http://www.nature.com/nature/journal/v463/n7279/
[No relevant content]

New England Journal of Medicine

Volume 362 — January 21, 2010 — Number 3
http://content.nejm.org/current.shtml
[No relevant content]

Pediatrics
January 2010 / VOLUME 125 / ISSUE 1
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier]

PLoS Medicine
(Accessed 24 January 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
The Global Health System: Linking Knowledge with Action—Learning
from Malaria
Gerald T. Keusch, Wen L. Kilama, Suerie Moon, Nicole A. Szlezák, Catherine
M. Michaud Policy Forum, published 19 Jan 2010
doi:10.1371/journal.pmed.1000179

Science
22 January 2010 Vol 327, Issue 5964, Pages 381-492
http://www.sciencemag.org/current.dtl
[No relevant content]

Vaccine
Volume 28, Issue 5, Pages 1133-1436 (3 February 2010)
http://www.sciencedirect.com/science?
_ob=PublicationURL&_cdi=5188&_pubType=J&_acct=C000050221&_version
=1&_urlVersion=0&_userid=10&md5=06a70dff873c73731f4a31331c8deee2
&jchunk=28#28
[Reviewed last week]