Download Vaccines_The Week in Review_27 June 2011

Vaccines: The Week in Review
27 June 2011
Center for Vaccine Ethics & Policy (CVEP)
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 global vaccines ethics and policy
gathered from key governmental, NGO and industry sources, key journals and other
sources. This summary supports 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 pdf form and as a set of blog posts at
http://centerforvaccineethicsandpolicy.wordpress.com/. This blog allows full-texting
searching of some 1,600 items.
Comments and suggestions should be directed to
David R. Curry, MS
Editor and
Executive Director
Center for Vaccine Ethics & Policy
[email protected]
Vaccines from start to finish: harnessing our opportunity
Opening remarks at the Pacific Health Summit:
Dr Margaret Chan, Director-General of the World Health Organization
Seattle, Washington, USA
23 June 2011
[Full text]
“Immunization was on the agenda at the May World Health Assembly, which is
attended by delegations from all 193 WHO member states.
The immunization session covered current progress internationally and within
countries, expectations for the Decade of Vaccines, and plans for WHO to develop a
global vaccine action plan to guide work during the decade.
Well over 50 delegations and representatives of civil society took the floor on this
item. For those of you unfamiliar with the workings of Health Assemblies, this number
represents an extraordinary level of interest and engagement.
I think a brief summary of these interventions is a good way to give you an overview
of what countries themselves see as progress and sources of pride. It also tells you
some of their deep-seated concerns, right now and for the future.
Many developing countries are proud of their ownership of national immunization
programmes, and many have dedicated budget lines as a formal expression of this
commitment.
As we enter this Decade of Vaccines, we heard about great progress and high praise
for support from WHO and UNICEF, but especially for the GAVI Alliance.
GAVI operates according to a fundamental principle that resonates extremely well with
public health thinking in general and the principles that guide the work of WHO: every
child, regardless of where it is born or the wealth of its parents, deserves protection with
the best that science can offer.
This is an expression of fairness, and this is a principle that guides much of my own
personal work.
With GAVI support, vaccines that prevent pneumonia and diarrhoea, the two biggest
childhood killers, are now being rolled out in a number of countries. But these new
vaccines are expensive and sustainability is definitely a problem, as stressed by many
speakers from the developing world.
As reported, many countries have added yellow fever and hepatitis B vaccines to
routine immunization programmes.
We heard first-hand accounts of what the new meningitis vaccine, developed in a
project coordinated by WHO and PATH, with support from the Gates Foundation, means
for Africa and its people.
Launch of the vaccine, which costs less than 50 cents a dose, a price demanded by
African ministers of health, began last December in the three hyper-endemic countries in
Africa’s notorious meningitis belt, namely Burkina Faso, Mali, and Niger. By the end of
that month, 19.5 million people had been vaccinated in the three countries.
WHO and its partners are currently assessing the impact of these initial mass
immunization campaigns, including their safety and efficacy. This is a thorough,
systematic assessment, but early results look extremely promising.
Epidemic meningitis is not the biggest killer in Africa, but it is one of the most greatly
feared of all diseases. My staff in the field tell me that long lines for vaccination form at
the first hint of an epidemic that will leave around 25% of affected children, I mean the
ones that survive, permanently impaired with brain damage or profound hearing loss.
For once, Africa is the first to receive the very best technology that the world, working
together, can offer.
Ladies and gentlemen,
Delegates gave us two extremely clear messages.
First, the achievement of ambitious, yet fully agreed goals, such as expanded
immunization coverage, the introduction of new vaccines, polio eradication, and measles
elimination, is directly tied to funds.
We heard compelling pleas to fully replenish GAVI funds so that recent spectacular
progress, supported by strong country ownership, does not lose its momentum.
Second, expanded vaccination coverage alone will not help countries reach the MDG
for reducing young child mortality. According to the latest UNICEF estimates, some 8.1
million young children died in 2009 from largely preventable causes.
This figure is the lowest recorded in more than six decades. It is a measure of
welcome progress, but the figure is still way too high. Immunization is thought to
prevent 2 to 3 million childhood deaths each year. Vaccines are magic bullets, yes, but
they don’t hit all the enemies that extinguish so many young lives.
Countries reminded us of the critical role of basic primary health care measures, such
as oral rehydration therapy, home-based antibiotic treatment for pneumonia, and things
so straightforward, yet so difficult for the poor, as adequate nutrition and good hygiene.
The issue of sustainable funding came up over and over again. As I have heard on
many occasions, a vaccine that is too expensive for the developing world is worse than
no vaccine at all.
Many asked the international community to seek ways to reduce the costs of vaccines,
especially the newer ones.
Delegates from the developing world referred to the need for technology transfer and
skills training to enable local manufacturing of vaccines, especially in Africa. Some
described WHO’s key role in achieving exactly this objective for the local manufacturing
of pandemic influenza vaccines.
And what has happened since the May Assembly?
On 6 June, leading drug companies announced dramatic slashes in vaccine prices for
the developing world, including a 95% price cut on the new rotavirus vaccine that can
prevent diarrhoeal deaths.
On 13 June, donors pledged more than $4 billion to support the work of GAVI, an
amount that exceeded anyone’s wildest dreams. This money will certainly hasten the
introduction of new vaccines and expand vaccination campaigns in Africa’s meningitis
belt, which has 25 countries.
There are critics, of course. Many cite the lack of basic infrastructure for delivering
vaccines and the crumbling of public health services, after years of neglect, throughout
most of the developing world.
But let me reassure the critics. The strengthening of health systems has moved near
the top of the international health agenda. The May Health Assembly adopted no fewer
than 5 resolutions setting out ways to build stronger health systems that extend
affordable services to the poor.
This is, after all, how health operates in the context of the MDGs, with their
overarching goal of poverty reduction. By improving health, you reduce poverty. But to
do so, you must reach the poor.
Ladies and gentlemen,
This decade of vaccines has a vision, and vision always feeds that perennial optimism
of public health that keeps us going despite the many obstacles and setbacks thrown
our way by policies and events beyond our control.
This decade will help realize the full power of immunization to prevent morbidity and
mortality. And the young lives saved from death or life-long disability will be numbered
in the millions.
Thank you.
http://www.who.int/dg/speeches/2011/vaccines_20110623/en/index.html
Sabin Vaccine Institute announced receipt of a two-year, US$12 million
grant from the Bill & Melinda Gates Foundation “to continue development of a
vaccine to prevent human hookworm infection, a parasitic disease that affects
600 million people worldwide.” Hookworm infection, most commonly found in subSaharan Africa, Southeast Asia and Latin America, is a significant contributor to the
global burden of iron-deficiency anemia that disproportionately affects children and
women of reproductive age. The infection results in approximately 65,000 deaths and
the loss of up to 22 million disability adjusted life years (DALYs) annually. Hookworm is
one of the seven most common neglected tropical diseases (NTDs), which together
carry a greater health burden than malaria and tuberculosis and rival that of HIV/AIDS.
http://sabin.org/news-resources/releases/2011/06/22/major-funding-announcedcontinue-development-vaccine-leading-dise
Sabin also announced that WHO granted prequalification for Typhim Vi, a
typhoid Vi polysaccharide vaccine produced by Sanofi Pasteur. This is the first
typhoid vaccine to be prequalified by the WHO, “allowing UNICEF, other UN agencies
and the Pan American Health Organization Revolving Fund to procure the vaccine. WHO
prequalification is also a prerequisite for GAVI Alliance support.” Sabin noted that with at
least 200,000 deaths occurring worldwide from typhoid fever each year, and a further
16-33 million people falling ill, use of typhoid vaccines can contribute to achieving the
United Nations Millennium Development Goals. Dr. Shyam Raj Upreti, Director of the
Child Health Division of the Department of Health Services, Ministry of Health and
Population of Nepal, said, “WHO prequalification of a typhoid vaccine will accelerate the
availability of this vaccine for children in Nepal and throughout Asia, where the burden
of typhoid fever is highest.” http://sabin.org/newsresources/releases/2011/06/23/coalition-against-typhoid-applauds-world-healthorganization-preq
J.P. Morgan announced that it will donate £1.5 million to the GAVI Alliance.
The donation will be matched by the U.K. government’s newly created
matching fund bringing the total to £3 million. GAVI Alliance Board Chair Dagfinn
Hoybraten commented, “We are delighted to welcome J.P. Morgan as a Matching Fund
partner. We recognise J.P. Morgan's strong commitment to social finance. This generous
investment will help us fulfill our mission to save children’s lives and protect people’s
health by increasing access to immunisation in developing countries. On behalf of the
children we will vaccinate with these resources, our thanks go out to the people of J.P.
Morgan.”
http://www.businesswire.com/news/home/20110620006035/en/J.P.-Morgan-Pledges%C2%A31.5-Million-GAVI-Alliance
Sanofi Pasteur Limited (Canada) said it opened a C$101 million dollar
vaccine research and development facility at Sanofi Pasteur's Connaught
Campus in north Toronto. This new facility “establishes the Connaught Campus as
the North American Centre of Excellence in analytical and bioprocessing R&D for Sanofi
Pasteur globally (and) solidifies the Toronto site as a national strategic asset for the
research, development and manufacturing of vaccines that protect public health - in
Canada and around the world.” The province of Ontario contributed C$13.9 million to
the project through the Biopharmaceutical Investment Program, part of the Next
Generation of Jobs Fund. The new R&D facility, known internally as "Building 95", “will
help the company retain over 300 highly-skilled vaccine research positions and bring
many of the company's accomplished scientists and state-of-the-art technologies under
one roof.” Sanofi noted that the site “manufactures many vaccines vital to public health
with 94% of its vaccine production being delivered to over 90 countries around the
world. http://www.prnewswire.com/news-releases/sanofi-pasteur-opens-100m-rdcentre-in-canada-124348274.html
The Weekly Epidemiological Record (WER) for 24 June 2011, vol. 86, 26 (pp
269–276) includes: Index of countries/areas; Index, Volume 86, 2011, Nos. 1–26 –
Subject index; Performance of acute flaccid paralysis (AFP) surveillance and incidence
of poliomyelitis, 2011
http://www.who.int/entity/wer/2011/wer8626.pdf
Twitter Watch
A selection of items of interest this week from a variety of twitter feeds. This capture is
highly selective and by no means intended to be exhaustive.
AIDSvaccine IAVI
Want to know more about @AIDSvaccine is & what we do? Watch our short video:
bit.ly/kWA5AE #HIV #AIDS #vaccine #research #globalhealth
CDCgov CDC.gov
2.5mil deaths prevented in children under 5 due to measles, polio & diphtheria-tetanuspertussis vaccines go.usa.gov/Wtv #PH10
sabinvaccine Sabin Vaccine Inst.
Major Funding Announced to Continue Development of #Vaccine for Human Hookworm
Infection: bit.ly/lpGxF1
GAVIAlliance GAVI Alliance
WATCH: the Center for Strategic & International Studies has posted a video about the
June 13 conference and GAVI's future http://ht.ly/5nOpf
GAVIAlliance GAVI Alliance
The Economist- A shot in the arm: The world’s market for vaccines is being turned
upside down http://ht.ly/5mG64 #4mlives
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. If you
would like to suggest other journal titles to include in this service, please contact David
Curry at: [email protected]
Annals of Internal Medicine
June 21, 2011; 154 (12)
http://www.annals.org/content/current
[No relevant content]
British Medical Bulletin
Volume 98 Issue 1 June 2011
http://bmb.oxfordjournals.org/content/current
[Reviewed earlier; No relevant content]
British Medical Journal
25 June 2011 Volume 342, Issue 7812
http://www.bmj.com/content/current
Editorials
Measles outbreak in Europe
Simon Cottrell,
Richard John Roberts
BMJ 2011;342:doi:10.1136/bmj.d3724 (Published 15 June 2011)
Extract
Despite the current threat in Europe rates of infection are declining globally
Current outbreaks of measles in Europe are a reminder of the important risks of death
and serious morbidity associated with measles. Between 2009 and 2010, cases of
measles increased dramatically in Europe, with notifications increasing from 7175 to
30 367. 1 In 2010 most reported cases were in Bulgaria (22 005), but there were also
5019 in France, 861 in Italy, 787 in Germany, 406 in Ireland, 397 in the United
Kingdom, and 302 in Spain. Of these, 21 877 people were admitted to hospital and 21
died (case fatality 0.69 deaths/1000 reported cases); 71% of people infected were aged
under 20 years and 85% were unvaccinated. The World Health Organization has
reported outbreaks in 24 European countries already this year. 2 There is little sign of a
decrease in cases in 2011, and travel has facilitated transmission between countries.
From January to March 2011, 9349 cases were reported, and 18 of 32 reporting
countries found that the incidence of measles was higher than during the same period in
2010. 3
Currently the French outbreak is the largest in Europe and it has not yet peaked. Since
it began in 2008, France …
Clinical Infectious Diseases
Volume 53 Issue 2 July 15, 2011
http://www.journals.uchicago.edu/toc/cid/current
Major Articles
Shioko Kawai, Seiichiro Nanri, Eiko Ban, Mikako Inokuchi, Tetsuya Tanaka, Mitsuaki
Tokumura, Keiko Kimura, and Norio Sugaya
Influenza Vaccination of Schoolchildren and Influenza Outbreaks in a School
Clin Infect Dis. (2011) 53(2): 130-136 doi:10.1093/cid/cir336
Abstract
Background. The objective of this retrospective descriptive study was to determine
whether the universal influenza vaccination for schoolchildren was effective in controlling
influenza outbreaks in a school. A universal vaccination program for schoolchildren was
started in Japan in the 1960s, but the government abandoned the program in 1994
because of lack of evidence that the program was effective in preventing influenza in
schoolchildren.
Methods. Influenza vaccine coverage rates, total numbers of class cancellation days, and
absentee rates were reviewed in a single elementary school during the 24-year period
during 1984–2007.
Results. The mean number of class cancellation days and the mean absentee rate in the
compulsory vaccination period (1984–1987; mean vaccine coverage rate, 96.5%) were
1.3 days and 2.5%, respectively, and they increased to 8.3 days and 3.2% during the
quasi-compulsory vaccination period (1988–1994; vaccine coverage, 66.4%). In the novaccination period (1995–1999; vaccine coverage, 2.4%), they were 20.5 days and
4.3%, respectively, and in the voluntary vaccination period (2000–2007; vaccine
coverage, 38.9–78.6%), they were 7.0–9.3 days and 3.8%–3.9%. When minor
epidemics were excluded, there was a significant inverse correlation between the
vaccine coverage rates and both the number of class cancellation days and absentee
rates.
Conclusions. The universal influenza vaccination for schoolchildren was effective in
reducing the number of class cancellation days and absenteeism in the school.
Cost Effectiveness and Resource Allocation
(accessed 26 June 2011)
http://www.resource-allocation.com/
[No relevant content]
Emerging Infectious Diseases
Volume 17, Number 6–June 2011
http://www.cdc.gov/ncidod/EID/index.htm
[Reviewed earlier]
Health Affairs
June 2011; Volume 30, Issue 6
Strategies For The ‘Decade Of Vaccines’
http://content.healthaffairs.org/content/current
[Reviewed earlier]
Health Economics, Policy and Law
Volume 6 - Issue 03 - 2011
http://journals.cambridge.org/action/displayIssue?jid=HEP&tab=currentissue
[Reviewed earlier]
Human Vaccines
Volume 7, Issue 6 June 2011
http://www.landesbioscience.com/journals/vaccines/toc/volume/7/issue/6/
[Reviewed earlier]
JAMA
June 22/29, 2011, Vol 305, No. 24, pp 2493-2592
http://jama.ama-assn.org/current.dtl
Commentaries
Health Advocacy Organizations and Evidence-Based Medicine
Sheila M. Rothman
JAMA. 2011;305(24):2569-2570.doi:10.1001/jama.2011.866
[No abstract: first 150 words per JAMA convention]
Strong and independent not-for-profit advocacy organizations are vital to a democratic
society. At their best, they stand apart from the interests of the marketplace and the
government, helping to promote diverse public concerns. The scope of their activities is
extensive. Some not-for-profit advocacy organizations spearhead campaigns to eliminate
discriminatory legislation and improve the life chances of vulnerable groups. Others
challenge economic interests to better protect the environment. Still others work to
advance civil and human rights.
Health advocacy organizations are part of this sector. They speak for targeted
populations affected by a variety of diseases such as epilepsy, breast cancer, mental
illness, and autism. They effectively communicate their priorities to legislators,
regulators, private and public funders, and the media. Their initiatives often highlight
needs that might otherwise be overlooked. However, some health advocacy
organizations, as shall be illustrated, are so committed to securing diagnostic and
treatment interventions for their targeted …
Journal of Infectious Diseases
Volume 204 Issue 2 July 15, 2011
http://www.journals.uchicago.edu/toc/jid/current
[Reviewed earlier]
The Lancet
Jun 25, 2011 Volume 377 Number 9784 Pages 2151 - 2248
http://www.thelancet.com/journals/lancet/issue/current
[No relevant content]
The Lancet Infectious Disease
Jul 2011 Volume 11 Number 7 Pages 489 - 578
http://www.thelancet.com/journals/laninf/issue/current
Editorial
Measles once again
The Lancet Infectious Diseases
An effective vaccine against measles has been available for the past 40 years. Before
its introduction in 1963 there were almost 135 million cases of measles and over 6
million measles-related deaths per year. Globally, thanks to this vaccine the number of
measles deaths worldwide fell by 78% between 2000 and 2008, from an estimated
733 000 to 164 000.
However, despite these efforts, it is hard to believe that in the 21st century measles
remains a leading vaccine-preventable cause of deaths in children younger than 5 years
old. The disease is still endemic in many parts of Europe. In the past 2 years, Austria,
France, Germany, Ireland, Italy, the Netherlands, Spain, and the UK have all seen
outbreaks. In 2010, more than 27 795 cases of measles were reported in Europe, and
21 853 were reported during the 2009—10 outbreak in Bulgaria where 25 people died.
In USA during the 1980s, the number of measles cases was low but a big increase
occurred in 1989 with almost 18 000 cases reported. Lack of a second dose of measles,
mumps, and rubella (MMR) vaccine could have decreased the level of immunity among
the school-age population, among whom most of the cases were reported.
Subsequently, two rounds of vaccination were recommended. At the end of 2000,
thanks to vaccination, the ongoing transmission of endemic measles was declared
eliminated in the USA. However, this year from January 1 to May 20, 118 cases were
reported in the USA. 46% of the cases were imported, most from countries in the WHO
European region.
Before the era of vaccination, immunity against measles was acquired by natural
infection or by protection given by antibodies transmitted from the mother to the fetus
during gestation. Measles transmission requires contact between a susceptible person
and the infectious secretions of a person with measles. The incidence of measles varies
cyclically. Incidence rises as susceptible individuals enter the population. Acquisition of
immunity through exposure to the virus or vaccination decreases the number of
susceptible individual in the population and measles incidence falls. The interval
between epidemic peaks is proportional to the number of susceptible individuals that
accumulate over time. In the presence of vaccination, the interval between peaks of
disease can be 10 years; without vaccination, the interval can be 3—4 years. A decline
in the uptake of immunisation in the past decade has increased the susceptible
population and measles has resurged.
Elimination of measles, defined as the interruption of indigenous transmission, is
difficult because the disease is very contagious and transmissible before an infected
person shows signs of illness. Ideally, two doses of MMR vaccine given to 95% of
children are required to halt the spread of the virus. By 2009 only 60% of countries
worldwide had achieved 90% coverage with at least one vaccine dose. Difficulty
accessing services, religious beliefs, and vaccine scepticism are only part of the reasons
for low coverage. Better organisation of the vaccination systems is required—for
example, 10% of children receive one dose of vaccine but then miss the second shot.
Lack of reminders and difficulty tracking moving families are among the weaknesses of
the vaccine system.
However, elimination is not impossible. Measles was eliminated from the Americas in
2000, but progress towards elimination in the European region has faltered. By 2010, 30
of the 53 European countries had reached the target of a measles incidence of fewer
than one case per million population. The WHO Europe strategic plan for measles
2010—15 sets targets of 90% measles vaccination coverage, and reductions in the
number of cases to fewer than five per million and in mortality by 95% compared with
2000 levels.
Additional effort and resources from European states are needed to reach the above
targets. Vaccine acceptability could be improved through better communication with the
public. Thought needs to be given to targeted messaging campaigns and perhaps the
recruitment of public figures as advocates for vaccination. Catch-up vaccination
campaigns outside the routine system are needed to cover susceptible populations.
Commitment from governments, donors, and parents is needed to make measles a
disease of the past. Despite recent outbreaks, elimination in Europe in the in the next 4
years should be achievable, and would inspire efforts in developing regions, which still
have the highest burden of the disease: global eradication of the disease in this
generation would spare future generations from this preventable disease.
Articles
Safety and efficacy of the HVTN 503/Phambili Study of a clade-B-based HIV-1
vaccine in South Africa: a double-blind, randomised, placebo-controlled testof-concept phase 2b study
Glenda E Gray, Mary Allen, Zoe Moodie, Gavin Churchyard, Linda-Gail Bekker,
Maphoshane Nchabeleng, Koleka Mlisana, Barbara Metch, Guy de Bruyn, Mary H Latka,
Surita Roux, Matsontso Mathebula, Nivashnee Naicker, Constance Ducar, Donald K
Carter, Adrien Puren, Niles Eaton, M Julie McElrath, Michael Robertson, Lawrence Corey,
James G Kublin, on behalf of the HVTN 503/Phambili study team
Preview
The MRKAd5 HIV-1 vaccine did not prevent HIV-1 infection or lower viral-load setpoint;
however, stopping our trial early probably compromised our ability to draw conclusions.
The high incidence rates noted in South Africa highlight the crucial need for intensified
efforts to develop an efficacious vaccine.
Review
Rationale for pertussis booster vaccination throughout life in Europe
Fred Zepp, Ulrich Heininger, Jussi Mertsola, Ewa Bernatowska, Nicole Guiso, John Roord,
Alberto E Tozzi, Pierre Van Damme
Preview
Although the introduction of universal pertussis immunisation in infants has greatly
reduced the number of reported cases in infants and young children, disease incidence
has been increasing in adolescents and adults in recent years. This changing
epidemiological pattern is probably largely attributable to waning immunity after natural
infection or vaccination. Furthermore, improved diagnostic testing, active surveillance,
changes in disease susceptibility, vaccine characteristics, and increased awareness of
the disease might also be contributing factors.
Medical Decision Making (MDM)
May/June 2011; 31 (3)
http://mdm.sagepub.com/content/current
[Reviewed earlier]
Nature
Volume 474 Number 7352 pp419-536 23 June 2011
http://www.nature.com/nature/current_issue.html
News
Vaccine trial's ethics criticized
Collapsed trial fuels unfounded vaccine fears.
Priya Shetty
A clinical trial that came under fire in India threatens to have a dual legacy: inflaming
unfounded fears about a lifesaving vaccine and raising new questions about the
management of medical research in the country. After four teenage girls taking part in a
test of human papillomavirus (HPV) vaccines died last year, the Indian government
faced accusations that its citizens were being used as guinea pigs to test dangerous
vaccines. A scientific investigation has exonerated the vaccines but uncovered a more
familiar problem in India: ethical irregularities.
The study, funded by the Bill & Melinda Gates Foundation and run by the international
health charity PATH and the Indian Council of Medical Research (ICMR), vaccinated
more than 23,000 girls aged 10–14 against HPV, which can cause cervical cancer. The
vaccines — Merck's Gardasil and GlaxoSmithKline's Cervarix — are already in widespread
use in the developed world, and the study was designed to assess the feasibility of
launching an HPV-immunization programme in the Indian health system. The
researchers hoped to gauge public acceptance of the vaccines and assess the costs of
administering it in different parts of the country.
A committee of three scientists from the All India Institute of Medical Sciences (AIIMS)
in New Delhi, commissioned by the government to look into the trial, confirmed that the
deaths were not linked to the vaccines — two of the girls died of poisoning, one of
drowning and the fourth of a fever. But its report, leaked to India's media last month,
said that the study involved several serious ethical violations. According to media
reports, participants were recruited from vulnerable tribal populations, consent was
improperly obtained — headmasters of the girls' schools signed the forms — and
adverse events were poorly recorded…
Nature Medicine
June 2011, Volume 17 No 6
http://www.nature.com/nm/index.html
[Reviewed earlier]
New England Journal of Medicine
June 23, 2011 Vol. 364 No. 25
http://content.nejm.org/current.shtml
[No relevant content]
The Pediatric Infectious Disease Journal
July 2011 - Volume 30 - Issue 7 pp: A9-A10,545-632,e109-e129
http://journals.lww.com/pidj/pages/currenttoc.aspx
[No relevant content]
Pediatrics
June 2011, VOLUME 127 / ISSUE 6
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier]
Pharmacoeconomics
July 1, 2011 - Volume 29 - Issue 7 pp: 549-635
http://adisonline.com/pharmacoeconomics/pages/currenttoc.aspx
[Reviewed earlier]
PLoS Medicine
(Accessed 26 June 2011: database unavailable)
http://www.plosmedicine.org/article/browse.action?field=date
[No relevant content]
Science
24 June 2011 vol 332, issue 6037, pages 1469-1596
http://www.sciencemag.org/current.dtl
[No relevant content]
Science Translational Medicine
22 June 2011 vol 3, issue 88
http://stm.sciencemag.org/content/current
Research Articles
Tuberculosis
Immunogenicity of the Tuberculosis Vaccine MVA85A Is Reduced by
Coadministration with EPI Vaccines in a Randomized Controlled Trial in
Gambian Infants
Martin O. C. Ota, Aderonke A. Odutola, Patrick K. Owiafe, Simon Donkor, Olumuyiwa A.
Owolabi, Nathaniel J. Brittain, Nicola Williams, Sarah Rowland-Jones, Adrian V. S. Hill,
Richard A. Adegbola, and Helen McShane
22 June 2011: 88ra56
Abstract
New tuberculosis vaccines are urgently needed to curtail the current epidemic. MVA85A
is a subunit vaccine that could enhance immunity from BCG vaccination. To determine
MVA85A safety and immunogenicity as well as interactions with other routine vaccines
administered in infancy, we randomized healthy 4-month-old infants who had received
Bacille Calmette-Guérin at birth to receive Expanded Program on Immunization (EPI)
vaccines alone, EPI and MVA85A simultaneously, or MVA85A alone. Adverse events were
monitored throughout. Blood samples obtained before vaccination and at 1, 4, and 20
weeks after vaccination were used to assess safety and immunogenicity. The safety
profile of both low and standard doses was comparable, but the standard dose was
more immunogenic and therefore was selected for the second stage of the study. In
total, 72 (first stage) and 142 (second stage) infants were enrolled. MVA85A was safe
and well tolerated and induced a potent cellular immune response. Coadministration of
MVA85A with EPI vaccines was associated with a significant reduction in MVA85A
immunogenicity, but did not affect humoral responses to the EPI vaccines. These results
provide important information regarding timing of immunizations, which is required for
the design of infant efficacy trials with MVA85A, and suggest that modifications to the
standard EPI schedule may be required to incorporate a new generation of T cell–
inducing vaccines.
Meeting Reports
Therapeutics Development
Leveraging Crowdsourcing to Facilitate the Discovery of New Medicines
Thea C. Norman, Chas Bountra, Aled M. Edwards, Keith R. Yamamoto, and Stephen H.
Friend
22 June 2011: 88mr1
Abstract
Gloomy predictions about the future of pharma have forced the industry to investigate
alternative models of drug discovery. Public-private partnerships (PPPs) have the
potential to revitalize the discovery and development of first-in-class therapeutics. The
new PPP Arch2POCM hopes to foster biomedical innovation through precompetitive
validation of pioneer therapeutic targets for human diseases. In this meeting report, we
capture insights garnered from the April 2011 Arch2POCM conference.
Tropical Medicine & International Health
July 2011 Volume 16, Issue 7 Pages 773–903
http://onlinelibrary.wiley.com/doi/10.1111/tmi.2011.16.issue-6/issuetoc
[Reviewed earlier]
Vaccine
http://www.sciencedirect.com/science/journal/0264410X
Volume 29, Supplement 1, Pages A1-A50 (1 July 2011)
Supplement Theme:
Transfer of Technology for Pandemic Influenza Vaccine Production in
Developing Countries
Edited by Ray Spier
[13 articles covering this theme are presented in this supplement; the first two articles
are included below]
Technology transfer to developing country vaccine manufacturers to improve
global influenza vaccine production: A success story and a window into the
future
Page A1
F Marc LaForce
[No abstract]
WHO initiative to increase global and equitable access to influenza vaccine in
the event of a pandemic: Supporting developing country production capacity
through technology transfer
Pages A2-A7
Martin Friede, Laszlo Palkonyay, Claudia Alfonso, Yuri Pervikov, Guido Torelli, David
Wood, Marie Paule Kieny
Abstract
Should a highly pathogenic avian influenza virus, such as the H5N1 virus type currently
circulating in birds, become transmissible among humans, an effective vaccine, rapidly
available in vast quantities, would be the best tool to prevent high case-fatalities and the
breakdown of health and social services. The number of vaccine doses that could be
produced on demand has risen sharply over the last few years; however, it is still
alarmingly short of the 13 billion doses that would be needed if two doses were required
to protect fully the world's population. Most developing countries would be last in the
queue to benefit from a pandemic vaccine. The World Health Organization, together
with governments, the pharmaceutical industry and other stakeholders, has been
implementing the global pandemic influenza action plan to increase vaccine supply since
2006. Building capacity in developing countries to manufacture influenza vaccine is an
integral part of this plan, as well as research and development into more efficacious
technologies, e.g. those that allow significant dose-sparing. To this end, the influenza
vaccine technology transfer initiative was launched in 2007 and, to date, vaccine
manufacturers in 11 developing countries have received grants to acquire the capacity
to produce inactivated or live attenuated influenza vaccine for their populations. In
addition, a centralized ‘hub’ has been established to facilitate training in the new
technologies for scientists and regulators in the countries. This supplement of Vaccine is
devoted to showcasing the interim results of the WHO initiative and the impressive
progress made by the developing country manufacturers.
Value in Health
June 2011, Vol. 14, No. 4
http://www.valueinhealthjournal.com/home
[Reviewed last week]