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Vaccines - The Week in Review - 1 March 2010
Vaccines - The Week in Review - 1 March 2010
1 March 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 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 89
Weekly update
26 February 2010
As of 21 February 2010, worldwide more than 213 countries and overseas
territories or communities have reported laboratory confirmed cases of
pandemic influenza H1N1 2009, including at least 16226 deaths...
Situation update:
In the temperate zone of the northern hemisphere, pandemic influenza
virus continues to be detected across many countries, however, overall
influenza activity continues to wane in most places. The most active areas of
transmission are currently in parts of south and southeast Asia and in limited
areas of east and southeastern Europe.
In Southeast Asia, pandemic influenza virus continued to circulate in areas,
however, the overall intensity of respiratory diseases activity remained low
and unchanged, except in a few countries.
More at: http://www.who.int/csr/don/2010_02_26/en/index.html
JAMA
Vol. 303 No. 8, pp. 693-804, February 24, 2010
http://jama.ama-assn.org/current.dtl
[No relevant content]
The Lancet
Feb 27, 2010 Volume 375 Number 9716 Pages 697 - 776
http://www.thelancet.com/journals/lancet/issue/current
Comment
Time for fair trade in research data
Elizabeth Pisani, James Whitworth, Basia Zaba, Carla Abou-Zahr
Extract
Geneticists, astrophysicists, and molecular biologists routinely share research
data with colleagues and rivals alike. The reason is that scientists and their
funders know we will understand complex issues sooner if people build on
one another's work.1,2 Yet scientists in the complex area of public health
have been left behind in the data-sharing revolution.
Nature
Volume 463 Number 7284 pp999-1112 25 February 2010
http://www.nature.com/nature/journal/v463/n7284/
[No relevant content]
Pediatrics
February 2010 / VOLUME 125 / ISSUE 2
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier]
PLoS Medicine
(Accessed 1 March 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
26 February 2010 Vol 327, Issue 5969, Pages 1043-1162
http://www.sciencemag.org/current.dtl
News of the Week
Drug Safety: New Network to Track Drugs and Vaccines in Pregnancy
Jennifer Couzin-Frankel
Both doctors and patients are jittery about whether to continue or drop
potentially risky treatments during pregnancy. A new effort to bring risks into
focus is being launched this week with $12.5 million from two U.S. agencies.
It will start by examining asthma medications called short-acting beta
agonists, as well as flu vaccines and antivirals for influenza. Called VAMPSS
(the Vaccines and Medications in Pregnancy Surveillance System), the
program will be funded for 5 years by the Agency for Healthcare Research
and Quality and for 2 years by the Biomedical Advanced Research and
Development Authority and coordinated by the American Academy of Allergy,
Asthma, and Immunology. An advisory committee that includes members
from pediatric and obstetric groups, and the Centers for Disease Control and
Prevention, will guide VAMPSS's research.
Policy Forum
Intellectual Property: Fixing the Legal Framework for Pharmaceutical
Research
Sherry M. Knowles
The cost of drug research and development (R&D) has increased from $230
million per drug in the early 1980s to $1.2 billion today, with R&D currently
requiring about 10 to 15 years per drug (1–4). This investment of time and
money cannot be sustained without a legal system that provides sufficient
time to recoup the investment and to secure a reasonable return, as well as
the ability to make important business decisions that remain correct over a
long period of time. Pharmaceutical companies have historically relied on two
kinds of market protection: (i) the exclusive ownership of their own clinical
research and (ii) patents. However, the U.S. Hatch-Waxman Act (5), which is
designed to strike a balance between innovative pharmaceutical research
and access to generic drugs, is flawed. Further, U.S. courts sometimes
retroactively change standards for patent protection long after large R&D
efforts have been initiated, which increases the risk to defend and rely on
patent protection.
Chief Patent Counsel, GlaxoSmithKline, King of Prussia, PA 19406, USA.
Vaccine
Volume 28, Issue 7, Pages 1661-1892 (17 February 2010)
http://www.sciencedirect.com/science/journal/0264410X
Conference Report
The second Geneva Consensus: Recommendations for novel live TB
vaccines
Pages 2259-2270
K.B. Walker, M.J. Brennan, M.M. Ho, J. Eskola, G. Thiry, J. Sadoff, R. Dobbelaer,
L. Grode, M.A. Liu, U. Fruth, P.H. Lambert
Abstract
Infection with Mycobacterium tuberculosis continues to be a major public
health burden in most developing parts of the world and efforts to develop
effective strategies for containing the disease remain a priority. It has long
been evident that effective mass vaccination programmes are a cost
effective and efficient approach to controlling communicable diseases in a
public health setting and tuberculosis (TB) continues to be a major target.
One approach with increasing acceptance is based upon on live
mycobacterial vaccines, either as recombinant BCG or rationally attenuated
M. tuberculosis, thus generating a new live TB vaccine.
The Geneva Consensus published in March 2005 set out the opinion on
priorities and requirements for developing live mycobacterial vaccines for
Phase I trials. In the intervening period much progress has been made in both
preclinical and clinical development of new TB vaccines and has provided the
impetus for organising the second Geneva Consensus (held at WHO
headquarters, April 2009) to discuss issues, including:
i. Explore the regulatory requirements for live TB vaccines to enter Phase I
trials, in particular those based on attenuated M. tuberculosis. Particular
attention was paid to the characterisation and safety package likely to be
required, including issues of attenuation, the presence of antibiotic resistance
markers in live vaccines and the nature of any attenuated vaccine
phenotype.
ii. To identify the general criteria for further clinical development from
Phase I through to Phase III.
iii. Obtain a perspective of the regulatory landscape of developing countries
where Phase II and III trials are to be held.
iv. Review manufacturing considerations for live TB vaccines and relevance
of the WHO and European Pharmacopeia guidelines and requirements for
BCG vaccine.
v. Consider requirements and associated issues related to the use of these
new vaccines within an existing BCG vaccination programme.
Cost-effectiveness of the CRM-based 7-valent pneumococcal
conjugated vaccine (PCV7) in Argentina
Pages 2302-2310
Norberto D. Giglio, Alejandro D. Cane, Paula Micone, Angela Gentile
Abstract
Due to the region's own conditions, universal vaccination with pneumococcal
conjugate heptavalent vaccine (PCV-7) in Latin American countries is still
controversial.
Objective
To compare projected economic costs and health benefits associated with
pneumococcal conjugate heptavalent vaccine as a routine immunization in
healthy children in Argentina.
Design
A decision analytic model of Markov simulated lifetime evolution of a birth
cohort (n 696,451) was developed and compared costs and health benefits of
pneumococcal disease in the presence and absence of vaccination.
Main outcome measures
Cost per life year (LY) gained, reduce in diseases burden and costs of
vaccination.
Results
From the society's perspective, the incremental cost per LY gained was US$
5599.42 and the purchase of the 4 doses of vaccine for the entire cohort with
a cost of US$ 26.5 dose requires an investment of US$ 73,823,806.00.
The model estimated that vaccination reduce the number of death by 159
cases of meningitis, 756 cases of bacteriemias 4594 cases of pneumonias
about 84,769 cases of otitis media and 20 meningitis sequelae.
The value of the cost per LY gained was considerably modified by the
variation in the cost of the vaccine dose, efficacy/effectiveness of the vaccine
for pneumonia the mortality from pneumonia and herd immunity.
Conclusions
Our analysis predicted that routine vaccination of healthy infants <2 years
could prevent an important number of pneumococcal infectious and reduce
related mortality and morbidity. This strategic could be highly cost-effective
in Argentina.
Meningococcal conjugate vaccination among adolescents aged 13–17
years, United States, 2007
Pages 2350-2355
Peng-jun Lu, Nidhi Jain, Amanda C. Cohn
Abstract
Background
An estimated 1000–2000 cases of invasive meningococcal diseases occur
annually in the United States. In 2005, a new quadrivalent meningococcal
conjugate vaccine (MCV4) was approved and, because of supply constraints,
was recommended for routine vaccination of some groups of adolescents. In
August 2007, vaccination recommendations were expanded for all
adolescents 11–18 years.
Methods
We analyzed data from the 2007 National Immunization Survey-Teen (NIS-
Teen), a nationally representative random digit dialed telephone survey.
Estimates of MCV4 coverage were assessed from provider-reported
vaccination histories. A multivariable logistic regression analysis and
predictive marginal model were performed to identify factors independently
associated with MCV4 vaccination.
Results
Provider-reported vaccination histories were available for 2947 adolescents
aged 13–17 years with a response rate of 55.9%. Overall, MCV4 coverage
was 32.4% (95% confidence interval (CI) = 30.2–34.7%) in 2007. Vaccination
coverage was similar among adolescents aged 13–14 years compared to
those aged 15–17 years (32.1% vs. 32.6%, respectively). Coverage was
30.6% for non-Hispanic whites, 35.9% for non-Hispanic blacks, and 36.1% for
Hispanics; however, these variations were not statistically significant.
Characteristics independently associated with a higher likelihood of MCV4
vaccination included having ≥2 physician contacts in the past year, having a
well child visit at age 11–12 years, and ever having a doctor recommendation
for meningitis vaccination of the adolescent.
Conclusions
In 2007, MCV4 coverage among 13–17 years old increased 20.7 percentage
points from 2006. Achieving high vaccination coverage among adolescents
will be challenging. Targeting adolescents with no health insurance and no
recent healthcare provider visits may be important to increase coverage.