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Vaccines: The Week in Review

22 June 2009
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, 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 regular updates on both A/(H1N1) and


A/(H5N1) posted on the WHO main page, as well as other advisories linked
from that page. Here are the current updates:
- Influenza A(H1N1) - update 51
19 June 2009 -- As of 07:00 GMT, 12 June 2009, WHO notes 44,287 officially
reported cases of influenza A(H1N1) infection, including 180 deaths.
http://www.who.int/csr/don/2009_06_19/en/index.html
WHO has included an interactive “timeline of all cases” (requires Flash
player) at:
http://gamapserver.who.int/h1n1/atlas.html?select=ZZZ&filter=filter4,confirm
ed
- Cumulative Number of Confirmed Human Cases of Avian Influenza
A/(H5N1) Reported to WHO
2 June 2009 [No update since 2 June 2009]
The published tabular chart reports 433 confirmed cases and 262 deaths.
http://www.who.int/csr/disease/avian_influenza/country/cases_table_2009_06_
02/en/index.html

The Weekly Epidemiological Record (WER) 19 June 2009, vol. 84, 25 (pp
249–260) includes: New influenza A (H1N1) virus: global epidemiological
situation, June 2009; Performance of acute flaccid paralysis (AFP) surveillance
and incidence of poliomyelitis, 2008
http://www.who.int/wer/2009/wer8425.pdf
The MMWR Weekly: June 19, 2009 / 58(23);641-645 includes:
Novel Influenza A (H1N1) Virus Infections Among Health-Care
Personnel --- United States, April--May 2009
“Soon after identification of novel influenza A (H1N1) virus infections in the
United States in mid-April 2009, CDC provided interim recommendations to
reduce the risk for transmission in health-care settings. These included
recommendations on use of personal protective equipment (PPE),
management of health-care personnel (HCP) after unprotected exposures,
and instruction of ill HCP not to report to work (1). To better understand the
risk for acquiring infection with the virus among HCP and the impact of
infection-control recommendations, CDC solicited reports of infected HCP
from state health departments. As of May 13, CDC had received 48 reports of
confirmed or probable infections with novel influenza A (H1N1) virus* (2); of
these, 26 reports included detailed case reports with information regarding
risk factors that might have led to infection. Of the 26 cases, 13 (50%) HCP
were deemed to have acquired infection in a health-care setting, including
one instance of probable HCP to HCP transmission and 12 instances of
probable or possible patient to HCP transmission. Eleven HCP had probable or
possible acquisition in the community, and two had no reported exposures in
either health-care or community settings. Among 11 HCP with probable or
possible patient to HCP acquisition and available information on PPE use, only
three reported always using either a surgical mask or an N95 respirator.
These findings suggest that transmission of novel influenza A (H1N1) virus to
HCP is occurring in both health-care and community settings and that
additional messages aimed at reinforcing current infection-control
recommendations are needed.”
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5823a2.htm

Journal Watch
[Editor’s Note]
Vaccines: The Week in Review continues a new feature, scanning key journals
to identify and cite articles, comment 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. 301 No. 23, pp. 2413-2516, June 17, 2009
http://jama.ama-assn.org/current.dtl
[No relevant content]
Journal of Infectious Diseases
15 July 2009 Volume 200, Number 2
http://www.journals.uchicago.edu/toc/jid/current
Editorial Commentaries
Influenza Vaccines for Elderly Individuals—An Evolving Story
Gregory A. Poland and Mark J. Mulligan
[No abstract published]
MAJOR ARTICLE
Randomized, Double-Blind Controlled Phase 3 Trial Comparing the
Immunogenicity of High-Dose and Standard-Dose Influenza Vaccine
in Adults 65 Years of Age and Older
Ann R. Falsey,1,2; John J. Treanor,2; Nadia Tornieporth,3; Jose Capellan,5 and
Geoffrey J. Gorse4
1Department of Medicine, Rochester General Hospital and 2University of Rochester School of
Medicine, Rochester, New York; 3sanofi pasteur, Swiftwater, Pennsylvania; 4Saint Louis
Department of Veterans Affairs Medical Center and Saint Louis University, Saint Louis, Missouri;
5sanofi pasteur, Toronto, Canada
Background. Influenza‐associated morbidity and mortality has not
decreased in the last decade, despite increased receipt of vaccine. To
improve the immunogenicity of influenza vaccine, a high‐dose (HD) trivalent,
inactivated influenza vaccine was developed.
Methods. A multicenter, randomized, double‐blind controlled study was
conducted to compare HD vaccine (which contains 60 μg of hemagglutinin
per strain) with the licensed standard‐dose (SD) vaccine (which contains 15
μg of hemagglutinin per strain) in adults 65 years of age.
Results. HD vaccine was administered to 2575 subjects, and SD vaccine
was administered to 1262 subjects. There was a statistically significant
increase in the rates of seroconversion and mean hemagglutination inhibition
titers at day 28 after vaccination among those who received HD vaccine,
compared with those who received SD vaccine. Mean postvaccination titers
for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2,
and 69 for B strain; for those who received SD vaccine, mean postvaccination
titers were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine
met superiority criteria for both A strains, and the responses for B strain met
noninferiority criteria. Seroprotection rates were also higher for those who
received HD vaccine than for those who received SD vaccine vaccine, for all
strains. Local reactions were more frequent in individuals who received HD
vaccine, but the reactions were mild to moderate.
Conclusions. There was a statistically significant increase in the level of
antibody response induced by HD influenza vaccine, compared with that
induced by SD vaccine, without an attendant increase in the rate or severity
of clinically relevant adverse reactions. These results suggest that the high‐
dose vaccine may provide improved protective benefits for older adults.
Trial registration. ClinicalTrials.gov identifier: NCT00391053.

The Lancet
Jun 20, 2009 Volume 373 Number 9681 Pages 2083 - 2170
http://www.thelancet.com/journals/lancet/issue/current
Editorials
Who runs global health?
The Lancet
The past two decades have seen dramatic shifts in power among those who
share responsibility for leading global health. In 1990, development
assistance for health—a crude, but still valid measure of influence—was
dominated by the UN system (WHO, UNICEF, and UNFPA) and bilateral
development agencies in donor countries. Today, while donor nations have
maintained their relative importance, the UN system has been severely
diluted. This marginalisation, combined with serious anxieties about the
unanticipated adverse effects of new entrants into global health, should
signal concern about the current and future stewardship of health policies
and services for the least advantaged peoples of the world.
Access to health care for undocumented migrants in Italy
R Ravinetto, C Lodesani, U D'Alessandro, L De Filippi, A Pontiroli
In Italy, since 1998, undocumented migrants have had the right to receive
health care under national law, without being reported to immigration
authorities. This aspect of the legislation is in line with Article 32 of the Italian
Constitution, which states that health is a fundamental right of the individual
(not only of the citizen) and statutes free health care for the poor.
Financing of global health: tracking development assistance for
health from 1990 to 2007
Nirmala Ravishankar, Paul Gubbins, Rebecca J Cooley, Katherine Leach-
Kemon, Catherine M Michaud, Dean T Jamison, Christopher JL Murray
This study documents the substantial rise of resources for global health in
recent years. Although the rise in DAH has resulted in increased funds for
HIV/AIDS, other areas of global health have also expanded. The influx of
funds has been accompanied by major changes in the institutional landscape
of global health, with global health initiatives such as the Global Fund and
GAVI having a central role in mobilising and channelling global health funds.

The Lancet Infectious Disease


Jul 2009 Volume 9 Number 7 Pages 393 - 454
http://www.thelancet.com/journals/laninf/issue/current
Leading Edge
Compulsory childhood vaccination
The Lancet Infectious Diseases
The UK faces an outbreak of measles virus infection on a scale not seen since
vaccination became available. Figures released in February for England and
Wales show a 36% rise in confirmed cases of measles, from 990 in 2007 to
1348 in 2008, the highest number since monitoring was introduced in 1995. A
further 382 cases were reported in the first 3 months of this year. According
to the Health Protection Agency, most cases are among children who have
not been fully vaccinated with the combined measles, mumps, and rubella
(MMR) vaccine.
Reflection and Reaction
Protecting children with HIV against pneumococcal disease
Andrea Meehan, Grant Mackenzie, Delane Shingadia, Robert Booy
Rwanda has become the first developing nation to introduce pneumococcal
conjugate vaccine. The aim is to vaccinate nearly all Rwandan infants by the
end of 2009. However, equally at risk older children with HIV are
unfortunately not yet on the agenda.1 WHO estimates that disease due to
Streptococcus pneumoniae claims the lives of up to 1 million children every
year.2 These deaths are disproportionately represented in the developing
world, particularly in children infected with HIV3 of whom there are about 2
million in sub-Saharan Africa alone.

Nature
Volume 459 Number 7249 pp889-1026
http://www.nature.com/nature/journal/v459/n7249/
Review
Emergence and pandemic potential of swine-origin H1N1 influenza
virus
Gabriele Neumann1, Takeshi Noda2 & Yoshihiro Kawaoka1,2,3,4
Influenza viruses cause annual epidemics and occasional pandemics that
have claimed the lives of millions. The emergence of new strains will continue
to pose challenges to public health and the scientific communities. A prime
example is the recent emergence of swine-origin H1N1 viruses that have
transmitted to and spread among humans, resulting in outbreaks
internationally. Efforts to control these outbreaks and real-time monitoring of
the evolution of this virus should provide us with invaluable information to
direct infectious disease control programmes and to improve understanding
of the factors that determine viral pathogenicity and/or transmissibility.
Department of Pathobiological Sciences, University of Wisconsin-Madison, Madison, Wisconsin
53711, USA
International Research Center for Infectious Diseases,
Division of Virology, Department of Microbiology and Immunology, Institute of Medical Science,
University of Tokyo, Tokyo 108-8639, Japan
ERATO Infection-Induced Host Responses Project, Japan Science and Technology Agency,
Saitama 332-0012, Japan
Correspondence to: Yoshihiro Kawaoka1,2,3,4 Correspondence should be addressed to Y.K.
(Email: kawaokay@svm.vetmed.wisc.edu).

New England Journal of Medicine


Volume 360 — June 18, 2009 — Number 25
http://content.nejm.org/current.shtml
The Signature Features of Influenza Pandemics — Implications for
Policy
M. A. Miller, C. Viboud, M. Balinska, and L. Simonsen
Vast amounts of time and resources are being invested in planning for the
next influenza pandemic, and one may indeed have already begun. Data from
past pandemics can provide useful insights for current and future planning.
Having conducted archeo-epidemiologic research, we can clarify certain
"signature features" of three previous influenza pandemics — A/H1N1 from
1918 through 1919, A/H2N2 from 1957 through 1963, and A/H3N2 from 1968
through 1970 — that should inform both national plans for pandemic
preparedness and required international collaborations.
Past pandemics were characterized by a shift in the virus subtype, shifts of
the highest death rates to…
Emergence of a Novel Swine-Origin Influenza A (H1N1) Virus in
Humans
Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team
ABSTRACT
Background On April 15 and April 17, 2009, novel swine-origin influenza A
(H1N1) virus (S-OIV) was identified in specimens obtained from two
epidemiologically unlinked patients in the United States. The same strain of
the virus was identified in Mexico, Canada, and elsewhere. We describe 642
confirmed cases of human S-OIV infection identified from the rapidly evolving
U.S. outbreak.
Methods Enhanced surveillance was implemented in the United States for
human infection with influenza A viruses that could not be subtyped.
Specimens were sent to the Centers for Disease Control and Prevention for
real-time reverse-transcriptase–polymerase-chain-reaction confirmatory
testing for S-OIV.
Results From April 15 through May 5, a total of 642 confirmed cases of S-OIV
infection were identified in 41 states. The ages of patients ranged from 3
months to 81 years; 60% of patients were 18 years of age or younger. Of
patients with available data, 18% had recently traveled to Mexico, and 16%
were identified from school outbreaks of S-OIV infection. The most common
presenting symptoms were fever (94% of patients), cough (92%), and sore
throat (66%); 25% of patients had diarrhea, and 25% had vomiting. Of the
399 patients for whom hospitalization status was known, 36 (9%) required
hospitalization. Of 22 hospitalized patients with available data, 12 had
characteristics that conferred an increased risk of severe seasonal influenza,
11 had pneumonia, 8 required admission to an intensive care unit, 4 had
respiratory failure, and 2 died. The S-OIV was determined to have a unique
genome composition that had not been identified previously.
Conclusions A novel swine-origin influenza A virus was identified as the cause
of outbreaks of febrile respiratory infection ranging from self-limited to severe
illness. It is likely that the number of confirmed cases underestimates the
number of cases that have occurred.

Pediatrics
June 2009 / VOLUME 123 / ISSUE 6
http://pediatrics.aappublications.org/current.shtml
[Reviewed last week]

PLoS Medicine
(Accessed 22 June 2009)
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 new relevant content]
Science
19 June 2009 Vol 324, Issue 5934, Pages 1477-1602
http://www.sciencemag.org/current.dtl
Reports
Pandemic Potential of a Strain of Influenza A (H1N1): Early Findings
Christophe Fraser,1,* Christl A. Donnelly,1,* Simon Cauchemez,1 William P.
Hanage,1 Maria D. Van Kerkhove,1 T. Déirdre Hollingsworth,1 Jamie Griffin,1
Rebecca F. Baggaley,1 Helen E. Jenkins,1 Emily J. Lyons,1 Thibaut Jombart,1
Wes R. Hinsley,1 Nicholas C. Grassly,1 Francois Balloux,1 Azra C. Ghani,1 Neil
M. Ferguson,1, Andrew Rambaut,2 Oliver G. Pybus,3 Hugo Lopez-Gatell,4
Celia M. Alpuche-Aranda,5 Ietza Bojorquez Chapela,4 Ethel Palacios Zavala,4
Dulce Ma. Espejo Guevara,6 Francesco Checchi,7 Erika Garcia,7 Stephane
Hugonnet,7 Cathy Roth,7 The WHO Rapid Pandemic Assessment
Collaboration
A novel influenza A (H1N1) virus has spread rapidly across the globe.
Judging its pandemic potential is difficult with limited data, but nevertheless
essential to inform appropriate health responses. By analyzing the outbreak
in Mexico, early data on international spread, and viral genetic diversity, we
make an early assessment of transmissibility and severity. Our estimates
suggest that 23,000 (range 6000 to 32,000) individuals had been infected in
Mexico by late April, giving an estimated case fatality ratio (CFR) of 0.4%
(range: 0.3 to 1.8%) based on confirmed and suspected deaths reported to
that time. In a community outbreak in the small community of La Gloria,
Veracruz, no deaths were attributed to infection, giving an upper 95% bound
on CFR of 0.6%. Thus, although substantial uncertainty remains, clinical
severity appears less than that seen in the 1918 influenza pandemic but
comparable with that seen in the 1957 pandemic. Clinical attack rates in
children in La Gloria were twice that in adults (<15 years of age: 61%; 15
years: 29%). Three different epidemiological analyses gave basic
reproduction number (R0) estimates in the range of 1.4 to 1.6, whereas a
genetic analysis gave a central estimate of 1.2. This range of values is
consistent with 14 to 73 generations of human-to-human transmission having
occurred in Mexico to late April. Transmissibility is therefore substantially
higher than that of seasonal flu, and comparable with lower estimates of R0
obtained from previous influenza pandemics.
1 MRC Centre for Outbreak Analysis and Modelling, Department of Infectious Disease
Epidemiology, Imperial College London, Faculty of Medicine, Norfolk Place, London W2 1PG, UK.
2 Institute of Evolutionary Biology, University of Edinburgh, Ashworth Laboratories, Edinburgh
EH9 3JT, UK.
3 Department of Zoology, University of Oxford, South Parks Road, Oxford OX1 3PS, UK.
4 Directorate General of Epidemiology, FCO. De P. Miranda, 177 5th Floor, Mexico City, 01480,
Mexico.
5 National Institute of Epidemiological Diagnosis and Reference, Prolongación Carpio No. 470
(3° piso), Col Santo Tomás, México City, C.P. 11340, Mexico.
6 Secretaría de Salud - Servicios de Salud de Veracruz Soconusco No. 36, Colonia Aguacatal,
C.P. 910 Xalapa, Veracruz, México State.
7 World Health Organization.
* These authors contributed equally to this work.
All authors are members of this collaboration.
To whom correspondence should be addressed. E-mail: neil.ferguson@imperial.ac.uk
Vaccine
Volume 27, Issue 32, Pages 4247-4380 (9 July 2009)
http://www.sciencedirect.com/science/journal/0264410X
Review
Pneumococcal vaccination in developing countries: Where does
science end and commerce begin?
Pages 4247-4251
Joseph L. Mathew
Abstract
Recently Pneumococcal vaccines have generated considerable interest in
developing countries as an intervention for protecting children from
pneumonia and thereby reducing childhood mortality. Many convincing
scientific arguments have been put forward, although they are often based
either on extension of information from developed countries, or estimation
plus extrapolation of limited local data. In addition, there is also significant
commercial pressure to prescribe/recommend Pneumococcal vaccine(s).
Against such a background, it is important for developing countries to
critically appraise the issues involved in order to make a rational choice. This
brief paper explores these issues, showing that the current Pneumococcal
vaccines have limited effectiveness in developing countries and the hype
surrounding them is more commercial than scientific.
Regular papers
Evaluating the impact of human papillomavirus vaccines
Pages 4355-4362
Yuli Chang, Noel T. Brewer, Allen C. Rinas, Karla Schmitt, Jennifer S. Smith
Abstract
While two prophylactic HPV vaccines have been proven notably efficacious in
clinical trials, the effectiveness of these vaccines at the population level
remains to be evaluated. To lay the foundation for understanding the
strengths and limitations of different endpoints for future effectiveness
research, we present a comprehensive review of HPV-related clinical
outcomes, including: (i) HPV type-specific positivity and persistence, (ii) Pap
diagnoses (ASC-US, LSIL, and HSIL), (iii) histologic cervical cancer precursor
lesions (i.e., CIN1, CIN2, and CIN3), (iv) invasive cervical cancer (ICC), (v)
anogenital warts, (vi) recurrent respiratory papillomatosis (RRP), and (vii)
other HPV-associated cancers (vulvar, vaginal, anal, penile, and
oropharyngeal). While research on the vaccines’ effects on these HPV clinical
outcomes in the general population is presently limited, numerous large trials
will soon be completed, making a priori discussion of these potential
outcomes especially urgent. Furthermore, population level systems to track
HPV-associated clinical outcomes may need to be developed for HPV vaccine
effectiveness evaluation.

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