15 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 Finance Ministers of Italy, Canada and Russia, together with the United
Kingdom, Norway and the Bill & Melinda Gates Foundation, the World Bank
Group, the GAVI Alliance, UNICEF and WHO, “formally activated the
implementation phase of the Advance Market Commitment (AMC)
pilot project to accelerate introduction of vaccines against
pneumococcal diseases in developing countries.” The action represents
a formal step in their $1.5-billion commitment, made in Rome on February 9,
2007, “when they decided to adopt the innovative AMC approach to save
lives in the world’s poorest nations.”
The AMC against pneumococcal disease “will prompt the establishment of
new production plants dedicated to pneumococcal vaccines (and) over the
long term, this will create a self-sustainable market at affordable prices for
recipient countries.” The currently existing pneumococcal vaccine is sold at
over US$70 in industrialized countries. But thanks to the AMC, the long term
price for developing countries will be US$3.50. In June 2008 the GAVI Alliance
Board confirmed its intent to provide US$1.3 billion to support the purchase
of pneumococcal vaccines by poor countries interested in buying them. GAVI
hopes to assist up to 60 of the world’s poorest countries to introduce these
vaccines by 2015. With today’s ceremony, “donors are making the AMC fully
operational, helping create a new market with all parties having signed the
package of legal agreements that outline their respective roles.”
AMC donor contributions (US$)
Italy - $635 million
UK - $485 million
Canada - $200 million
Russia - $80 million
Norway - $50 million
The Bill & Melinda Gates Foundation - $50 million
TOTAL - $ 1.5 Billion
http://www.gatesfoundation.org/press-releases/Pages/advance-market-
commitment-pneumococcal-pilot-090612.aspx
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. 22, pp. 2301-2402, June 10, 2009
http://jama.ama-assn.org/current.dtl
Commentaries
Influenza A(H1N1) and Pandemic Preparedness Under the Rule of
International Law
Lawrence O. Gostin
JAMA. 2009;301(22):2376-2378
Journal of Infectious Diseases
1 July 2009 Volume 200, Number 1
http://www.journals.uchicago.edu/toc/jid/current
[Reviewed last week: No relevant content]
The Lancet
Jun 13, 2009 Volume 373 Number 9680 Pages 1997 - 2082
http://www.thelancet.com/journals/lancet/issue/current
Editorial
Right-to-health responsibilities of pharmaceutical companies
Original Text
The Lancet
Almost 2 billion people worldwide lack access to essential medicines. The
human rights responsibility to improve access lies mainly with the state.
However, non-state actors, such as the pharmaceutical industry, share that
responsibility too. On June 3, a UN independent human rights report on the
practices and policies of GlaxoSmithKline (GSK) in relation to their right-to-
health responsibilities and access to medicines was presented to the UN
Human Rights Council. It is the first time that such a mission on a
pharmaceutical company has ever been done. GSK should be commended for
subjecting themselves to the process.
In 2008, Paul Hunt, UN Special Rapporteur on the right to highest attainable
standard of health (2002—08), prepared human rights guidelines for the
pharmaceutical industry that addressed transparency, management,
monitoring and accountability, pricing, and ethical marketing.
Recommendations from Hunt's recent GSK report in these areas will apply to
other companies and include: greater transparency to ensure access to
reliable information about medicines; greater accountability in relation to
right-to-health standards, such as wider access to medicines especially for
marginalised populations; and finally, as patent holders of life-saving
medicines, to make the medicine as accessible as possible, as soon as
possible, to all those in need within a viable business model. More
specifically, companies should favour using commercial voluntary licences.
GSK was uncomfortable with the recommendations. It insisted that the right
to health is not well-defined for non-state actors, and hence they cannot be
held accountable to this international human right. On the contrary, both UN
reports set out with reasonable precision how the right to health, in the
international code of human rights, applies to the pharmaceutical industry,
and both move from broad statements of principle to much more specific,
operational requirements.
Pharmaceutical companies help deliver the right to health. They save lives.
But with this role comes responsibilities—and companies must be better held
to public account in relation to those responsibilities. The 2008 guidelines and
the GSK report move us closer to that goal.
For GSK response see: http://198.170.85.29/GSK-response-to-Paul-Hunt-
report-June-2009.pdf
The Lancet Infectious Disease
Jun 2009 Volume 9 Number 6 Pages 331 - 392
http://www.thelancet.com/journals/laninf/issue/current
[Reviewed earlier]
Nature
Volume 459 Number 7248 pp751-880
http://www.nature.com/nature/journal/v459/n7248/
[No relevant content]
Pediatrics
June 2009 / VOLUME 123 / ISSUE 6
http://pediatrics.aappublications.org/current.shtml
[Reviewed last week]
PLoS Medicine
(Accessed 8 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
Published 09 Jun 2009
In Global Health Research, Is It Legitimate To Stop Clinical Trials
Early on Account of Their Opportunity Costs?
James V. Lavery, Peter A. Singer, Renee Ridzon, Jerome A. Singh, Arthur S.
Slutsky, Joseph J. Anisko, David Buchanan
Background to the debate: After the failure of three large clinical trials of
vaginal microbicides, a Nature editorial stated that the microbicide field
“requires a mechanism to help it make rational choices about the best
candidates to move through trials” [1]. In this month's debate, James Lavery
and colleagues propose a new mechanism, based on stopping trials early for
“opportunity costs.” They argue that microbicide trial sites could have been
saturated with trials of scientifically less advanced products, while newer, and
potentially more promising, products were being developed. They propose a
mechanism to reallocate resources invested in existing trials of older
products that might be better invested in more scientifically advanced
products that are awaiting clinical testing. But David Buchanan argues that
the early stopping of trials for such opportunity costs would face
insurmountable practical barriers, and would risk causing harm to the
participants in the trial that was stopped.
Science
12 June 2009 Vol 324, Issue 5933, Pages 1362-1462
http://www.sciencemag.org/current.dtl
[No relevant content]
Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 27, Issue 30, Pages 3927-4078 (19 June 2009)
Influenza vaccination of health care workers in hospitals—A review
of studies on attitudes and predictors
Pages 3935-3944
Helge G. Hollmeyer, Frederick Hayden, Gregory Poland, Udo Buchholz
Abstract
Introduction
Immunization guidelines from many countries recommend influenza
vaccination of health care workers (HCW). However, influenza vaccination
rates among HCW are universally low. To aid in designing effective
immunization programs we reviewed the literature for studies reporting on
(1) self-reported reasons of HCW regarding vaccination against influenza and
(2) predictive factors for influenza vaccination in HCW.
Methods
We searched PUBMED for relevant publications from 1980 to 2008 with
predetermined search strategies and applied pre-defined criteria for inclusion
or exclusion. To be included in the review as a predictor study, a multivariate
analysis must have been conducted.
Results
We included 25 studies relevant to self-reported reasons for rejecting or
accepting vaccination. These studies identified two major reasons for lack of
vaccine uptake by HCW: firstly, a wide range of misconceptions or lack of
knowledge about influenza infection; and secondly, a lack of convenient
access to vaccine. In contrast, among studies reporting on reasons for
vaccination acceptance, all but two found that HCW stated self-protection
was the most important reason. In the area of “predictive factors for influenza
vaccination”, we included 13 studies. At least five of them identified the
following three factors: previous receipt of influenza vaccine, belief in the
vaccine's effectiveness, and older age.
Conclusion
Our findings indicate that if HCW get immunized against influenza, they do so
primarily for their own benefit and not for the benefit to their patients.
Misconceptions about influenza and influenza vaccine could be improved by
education, and organizational barriers could be bridged with sustainable,
structural changes to allow flexible and workplace vaccine delivery.
Acceptance of the HPV vaccine among women, parents, community
leaders, and healthcare providers in Ohio Appalachia
Pages 3945-3952
Mira L. Katz, Paul L. Reiter, Sarah Heaner, Mack T. Ruffin, Douglas M. Post,
Electra D. Paskett
Abstract
To assess HPV vaccine acceptability, focus groups of women (18–26 years),
parents, community leaders, and healthcare providers were conducted
throughout Ohio Appalachia. Themes that emerged among the 23 focus
groups (n = 114) about the HPV vaccine were: barriers (general health and
vaccine specific), lack of knowledge (cervical cancer and HPV), cultural
attitudes, and suggestions for educational materials and programs. Important
Appalachian attitudes included strong family ties, privacy, conservative
views, and lack of trust of outsiders to the region. There are differences in
HPV vaccine acceptability among different types of community members
highlighting the need for a range of HPV vaccine educational
materials/programs to be developed that are inclusive of the Appalachian
culture.
Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 27, Issue 31, Pages 4079-4246 (24 June 2009)
Report of the 5th meeting on the evaluation of pandemic influenza
prototype vaccines in clinical trials: World Health Organization,
Geneva, Switzerland, 12–13 February 2009
Pages 4079-4089
Frederick G. Hayden, Wendy A. Howard, Laszlo Palkonyay, Marie Paule Kieny
Abstract
Influenza vaccines are potentially the most efficacious means of mitigating
the impact of influenza pandemic and might contribute to the rapid
containment of an emerging pandemic virus.
On the 12–13 February 2009, the Initiative For Vaccine Research (IVR) of the
World Health Organisation convened the 5th meeting on the ‘Evaluation of
pandemic influenza prototype vaccines in clinical trials’ in Geneva. This was a
follow-up meeting to the 4th meeting held on 14–15 February 2008 [Girard M,
Palkonyay L, Kieny MP. Report of the 4th meeting on the evaluation of
pandemic influenza prototype vaccines in clinical trials. Vaccine
2008;26:4975–7], and presentations were made by representatives from
industry, academia, and governmental organisations. This year's meeting
aimed to update the progress made during the past year on H5N1 and other
prototype pandemic vaccines that have undergone clinical trials. A number of
vaccine types were covered, including classical egg-derived inactivated
vaccines, cell-derived inactivated vaccines, live-attenuated vaccines (LAIV)
and vaccines developed using new technologies. The effects of different
adjuvants and prime-boosting schedules were important topics, and further
data were presented to show that children mount vigorous antibody
responses to several H5N1 vaccines. Other subjects presented and discussed
were standardisation, and regulatory issues concerning pandemic vaccines.
Scheduling of measles vaccination in low-income countries:
Projections of a dynamic model
Pages 4090-4098
C.T. Bauch, E. Szusz, L.P. Garrison
Abstract
Large-scale vaccination campaigns (SIAs) and improved routine immunization
(RI) have greatly reduced measles incidence in low-income countries.
However, the interval between SIAs required to maintain these gains over the
long term is not clear. We developed a dynamic model of measles
transmission to assess measles vaccination strategies in Cambodia, Ghana,
India, Morocco, Nigeria, and Uganda. We projected measles cases from 2008
to 2050 under (a) holding SIAs every 2, 4, 6, or 8 years, (b) improvements in
first dose routine measles vaccine (MCV1) coverage of 0%, 1%, 3% annually,
and (c) introducing MCV2 once MCV1 coverage reaches 70%, 80%, 90%. If
MCV1 continues improving, then India and Nigeria could hold SIAs every 4
years without significant probability of large outbreaks, and the other
countries every 6–8 years. If RI remains stagnant, India and Nigeria should
hold SIAs every 2 years, and the other countries every 4–6 years.
Knowledge, attitudes and vaccination coverage of healthcare
workers regarding occupational vaccinations
Pages 4240-4243
P. Loulergue, F. Moulin, G. Vidal-Trecan, Z. Absi, C. Demontpion, C. Menager,
M. Gorodetsky, D. Gendrel, L. Guillevin, O. Launay
Abstract
Objectives
Immunization of healthcare workers (HCWs) is a major issue for infection
control in healthcare facilities. The aim of this study was to evaluate
knowledge regarding occupational vaccinations, HBV, varicella and influenza
vaccination rates and attitudes towards influenza vaccine among HCWs.
Design and setting
A cross-sectional survey was conducted in two wards (Medicine and
Paediatrics) of a 1182-bed teaching hospital in Paris, France.
Methods
A standardized, anonymous, self-administered questionnaire was used.
Results
Of 580 HCWs, 395 (68%) completed the questionnaire. Knowledge about the
occupational vaccinations of HCWs was low. HBV (69%), tuberculosis (54%)
and influenza (52%) were the most cited vaccinations. Paediatric staff was
more aware of influenza and pertussis immunizations (p < .05). HBV
vaccination rate was 93%, among whom 65% were aware of their immune
status. Influenza vaccination rate for 2006–2007 was 30% overall, ranging
from 50% among physicians to 20% among paramedical staff (p < .05).
Physicians based their refusal on doubts about vaccine efficacy, although
paramedics feared side effects. Influenza vaccination was associated with
knowledge of vaccine recommendations [OR = 1.75, 95% CI: 1.13–2.57] and
contact with patients [OR = 3.05, 95% CI: 1.50–5.91].
Conclusions
Knowledge of recommended occupational vaccinations is insufficient in
HCWs, except for HBV and influenza. Although the HBV vaccine coverage of
HCWs is satisfactory, a large proportion of them is unaware of immune status.
Influenza vaccine coverage remains low, especially among paramedical staff
because of fear of side effects. As vaccine coverage is associated with
knowledge, educational campaigns should be strengthened to increase the
adhesion of HCWs to vaccinations.