Vaccines and Global Health: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

World Polio Day – 24 October 2013
“Events worldwide mark World Polio Day, as efforts to eradicate the disease intensify”
http://www.polioeradication.org/tabid/488/iid/327/Default.aspx

Special World Polio Day event:
World Polio Day: Making History, a special Livestream (24 October, 22.30hrs GMT) event presented by Rotary and Northwestern University’s Center for Global Health with speakers including Dr. Bruce Aylward, WHO Assistant Director-General for polio, emergencies and country collaboration, and Dr. Robert Murphy, Director of the Center for Global Health at Northwestern University Feinberg School of Medicine

http://www.polioeradication.org/tabid/488/iid/327/Default.aspx#sthash.TWMBKG6S.dpuf

Update: Polio this week – As of 23 October 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s extract and bolded text]
:: In Syria, reports of suspected polio cases have emerged. A cluster of hot cases is currently being investigated, and has prompted planning for a comprehensive outbreak response across the region. See ‘Syrian Arab Republic’ section below for more.
:: One wild poliovirus type 1 (WPV1) case has been confirmed in Cameroon. This is the first WPV in the country since 2009. WPV1 was isolated from an acute flaccid paralysis (AFP) case from Ouest province, with onset of paralysis on 1 October 2013. Genetic sequencing is on-going to determine origin of the isolated virus. See ‘Chad, Cameroon and Central African Republic’ section for more
Afghanistan
:: One new WPV1 case was reported in the past week. The total number of WPV cases for 2013 is now eight (all WPV1), all of which were reported from Eastern Region, close to the Pakistan border. The most recent WPV1 case had onset of paralysis on 19 September, from Kunar province.
Pakistan
:: Three new WPV1 cases were reported in the past week. All were reported from Federally Administered Tribal Areas (FATA – two from FR Bannu and one from North Waziristan). The total number of WPV1 cases for Pakistan in 2013 is now 46. The most recent WPV1 case had onset of paralysis on 1 October (from FR Bannu). The majority of WPV1 cases in Pakistan this year, 34 (74%), are from FATA, of which 14 from Khyber Agency and 14 from North Waziristan.
:: The situation in North Waziristan is becoming increasingly severe, as it is the area with the largest number of children being paralysed by wild poliovirus (14 cases) and cVDPV2s (22) in all of Asia. It is in an area where immunization activities have been suspended by local leaders since June 2012. It is critical that children in these areas are vaccinated and protected from poliovirus. Immunizations in neighbouring high-risk areas are being intensified, to further boost population immunity levels in those areas and prevent further spread of this outbreak.
Chad, Cameroon and Central African Republic
:: In Cameroon, one WPV1 was reported this week from Ouest province. This is the first WPV in Cameroon since 2009 and had onset of paralysis on 1 October 2013.
:: An outbreak response is now being planned. In 2013, five large-scale supplementary immunization activities (SIAs) have already been conducted in Cameroon (in April, May, August, September and October), as the country was considered at high-risk of re-infection due to its proximity with Nigeria. The latest NIDs were conducted 11-13 October.
Syrian Arab Republic
:: See WHO GAR below

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html
Report of suspected polio cases in the Syrian Arab Republic
26 October 2013 – On 17 October 2013, WHO received reports of a cluster of acute flaccid paralysis (AFP) cases in the Syrian Arab Republic. This cluster of ‘hot’ AFP was detected in early October 2013 in Deir Al Zour province and is currently being investigated. Initial results from the national polio laboratory in Damascus indicate that two of the cases could be positive for polio – final results are awaited from the regional reference laboratory of the Eastern Mediterranean Region of WHO. Wild poliovirus was last reported in Syria in 1999.

The Ministry of Health of the Syrian Arab Republic confirms that it is treating this event as a cluster of ‘hot’ AFP cases, pending final laboratory confirmation, and an urgent response is currently being planned across the country. Syria is considered at high-risk for polio and other vaccine-preventable diseases due to the current situation.

A surveillance alert has been issued for the region to actively search for additional potential cases. Supplementary immunization activities in neighbouring countries are currently being planned.

WHO’s International Travel and Health recommends that all travelers to and from polio-infected areas be fully vaccinated against polio.
http://www.who.int/csr/don/2013_10_19_polio/en/index.html

UNICEF: Millions of children in Syria and region to be vaccinated against polio, measles, mumps and rubella
Major immunisation campaign under way now in Syria
AMMAN, GENEVA, 25 October 2013 – As Syria awaits confirmation of suspected polio cases in the east of the country, UNICEF has joined the World Health Organisation and other partners in mounting a large-scale immunisation effort aimed at protecting as many children as possible both in the country and across the region against polio, as well as other vaccine-preventable diseases.

Inside Syria, a campaign led by the Ministry of Health began on October 24 targeting 2.4 million children with vaccines against polio, measles, mumps and rubella.

Around 500,000 children in Syria have not been vaccinated against polio in the past two years due to insecurity and access constraints. Prior to the conflict, immunisation coverage in Syria was about 95 per cent.

The conflict in Syria has caused immense displacement, with millions of children on the move, either inside the country or across borders into neighbouring countries and beyond. As a result, routine immunisation systems so critical to preventing childhood diseases have been disrupted     or broken down, and children are now at far higher risk of diseases such as polio and measles.

UNICEF is mobilising a huge supply operation to make sure that vaccines are in place across the region, and reaching out to partners across all sectors to help raise community awareness of the importance of vaccinating children.

Multiple, supplemental immunisation campaigns against polio and other vaccine-preventable diseases will take place inside Syria and across the region through the end of the year.

http://www.unicef.org/media/media_70740.html

WHO/Europe: Support for Turkish polio operations from a new field presence in Gaziantep

24 October 2013

Excerpt

As part of the cross-regional response to a suspected poliomyelitis (polio) outbreak in the Syrian Arab Republic, Turkey is scaling up surveillance of suspected cases and vaccination of Syrian citizens under temporary protection in Turkey. A newly established WHO presence in Gaziantep, Turkey, near the border of the Syrian Arab Republic, is serving as an important centre of operations. 24 October is World Polio Day.

Of the 2 million Syrians displaced in neighbouring countries, over 500 000 have found shelter in 21 Turkish camps and private accommodation in 10 provinces. Turkish health authorities plan two rounds of supplementary immunization activities by the end of the year for all children under 5 years of age in selected provinces and for refugee children elsewhere in Turkey. Along with improved surveillance, an active search is being conducted to provide additional doses of vaccine to un- and under immunized resident children nationwide…

http://www.euro.who.int/en/countries/turkey/news/news/2013/10/whoeurope-supports-turkish-polio-operations-from-a-new-field-presence-in-gaziantep

Fear of violence slows polio immunization drive in Kano, Nigeria

IRIN – UN Office for the Coordination of Humanitarian Affairs

Excerpt

KANO, 22 October 2013 (IRIN) – Fear and secrecy have cloaked the roll-out of a polio campaign currently underway in northern Nigeria. Vaccinators are concealing their identities, hiding vaccinations under their veils and visiting some areas only with undercover armed guards, following the February murder by Boko Haram of nine polio workers in the northern city of Kano.
“The [polio] campaign is done under an atmosphere of fear and secrecy, with vaccinators hiding their identity and moving around furtively for fear of being attacked,” a source at the World Health Organization (WHO) office in Kano, who is involved in polio immunization campaigns, told IRIN.
The Ministry of Health temporarily suspended the immunization campaign in March 2013, as vaccinators were too frightened to continue, said Shehu Abdullahi, executive secretary of Kano State’s Primary Healthcare Management Board (PHMB) in charge of polio immunizations. The campaign resumed in April…

…For the current campaign, vaccinator Jamila Ahmad told IRIN: “We conceal the polio kit under our hijab [veil] and move around as if we are going for a wedding or naming ceremony, while the supervisor trails behind us at a safe distance that will not raise any suspicion that he is with us.”
Most door-to-door polio immunizations are performed by women, who can typically access homes unhindered; men would have to seek the consent of male family heads to enter homes – but male supervisors usually form part of the team…

http://www.irinnews.org/report/98977/fear-of-violence-slows-polio-immunization-drive-in-kano

The Global Fund said the Tahir Foundation, based in Indonesia, will invest US$65 million in Global Fund programs. The contribution is being matched by the Bill & Melinda Gates Foundation for a total US$130 million in support. The Tahir Foundation’s contribution is “…by far the largest ever made to the Global Fund by a private foundation in an emerging economy, (and) will support efforts to diagnose, treat, and prevent AIDS, TB and malaria, leading causes of death and disability in Indonesia.

http://www.theglobalfund.org/en/mediacenter/newsreleases/2013-10-21_Tahir_Contributes_USD_65_Million_to_the_Global_Fund/

PATH announced the appointment of Ashley Birkett, PhD as director of its Malaria Vaccine Initiative (MVI), which “drives the development of safe and effective vaccines for the fight against malaria.”  Dr. Birkett is a five-year veteran of MVI, and was most recently the program’s deputy director, serving simultaneously as director of research and development (R&D)—the latter a position he has held since joining PATH in 2008. Dr. David C. Kaslow, vice president of product development at PATH, said, “Since 2008, Ashley has contributed significantly to every major R&D initiative at MVI.  His technical expertise, tireless passion, and indomitable leadership make him the ideal person to lead MVI in the exciting journey that lies ahead for malaria vaccine development. I am also pleased that PATH can attract and grow top talent and is able to promote such talent from within the organization.”

http://www.prnewswire.com/news-releases/path-malaria-vaccine-initiative-names-new-director-228791311.html

The Weekly Epidemiological Record (WER) for 25 October 2013, vol. 88, 43 (pp. 465–476) includes:
:: Progress towards poliomyelitis eradication: Afghanistan, January 2012–August 2013
:: Estimating meningitis hospitalization rates for sentinel hospitals conducting surveillance of invasive bacterial vaccine-preventable diseases

http://www.who.int/entity/wer/2013/wer8813.pdf

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html

:: Human infection with avian influenza A(H7N9) virus – update 24 October 2013
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – update 24 October 2013

:: Cholera in Mexico – 26 October 2013
26 October 2013 – The Ministry of Health in Mexico has reported 171 confirmed cases, including one death, of infection with Vibrio cholerae O1 Ogawa toxigenic between 9 September to 18 October 2013.

In the second week of September 2013, Mexico was affected simultaneously by a hurricane and tropical storm which caused heavy rains, floods, landslides and internal displacement of populations, thus increasing the risk of diarrhoeal diseases.

Of the 171 confirmed cases, two are from the Federal District, 157 cases from the state of Hidalgo, nine from the state of Mexico, one from the state of San Luis Potosi and two from the state of Veracruz.

Eighty-six of the total confirmed cases are women and 85 are men with ages ranging from three months to 88 years old. Of these, thirty-nine cases were hospitalised…

…This is the first local transmission of cholera recorded since the 1991-2001 cholera epidemic in Mexico. The genetic profile of the bacterium obtained from patients in Mexico presents high similarity (95 percent) with the strain that is currently circulating in three Caribbean countries (Haiti, Dominican Republic and Cuba), and is different from the strain that had been circulating in Mexico during 1991-2001 epidemic.

WHO does not recommend that any travel or trade restrictions be applied to Mexico with respect to this event.

WHO: Strategic Advisory Group of Experts (SAGE) on Immunization
The next SAGE meeting will take place n Geneva on 5-7 November 2013.
Draft agenda (as of 17 October 2013)
Selected Agenda Topics (excerpt):
:: Global polio eradication initiative – Session 4
For decision:
–       Optimal schedule for 1 IPV dose
–       Strategic framework for responding to type 2 virus detection post-OPV2 cessation
–       Recommendation for a WHA resolution in 2014 on accelerated IPV introduction, based on the progress toward a global supply and financing strategy

For discussion:
–       Strategy to ensure bOPV access to all OPV-using countries

:: Decade of Vaccines – Global Vaccine Action Plan (GVAP) Monitoring – Session 5
For Decision
SAGE will be expected to produce an independent first report on progress with the Decade of Vaccines Global Vaccine Action Plan.
Specifically, SAGE will be asked to:
– Review the DoV WG “Assessment report on DoV progress” based on:
– the review of the “annual report on the Decade of Vaccines progress” prepared by the DOV secretariat,
– Information provided by other partners’ annual reports on Decade of Vaccines progress.

– Make recommendations on any necessary changes to the formulation of the indicators, operational definitions and/or the processes for data collection.

– Identify successes, challenges and areas where additional efforts or corrective actions by countries, regions, partners, donor agencies or other parties, are needed.

– Provide recommendations and corrective actions for Members States, regions, partners, donor agencies or other parties regarding DoV GVAP implementation in a “SAGE Assessment report on the Decade of Vaccines progress” which will be the basis of the “progress report” for the WHO Board and World Health Assembly.

:: Measles and rubella elimination – Session 7
For discussion:
–       Global status report
–       Report from each Region
–       How to get back on track towards global and Regional targets

For decision:
–        Use of combined measles-rubella vaccine for both routine doses
–        Criteria to guide countries on expansion of the target age range measles and measles-rubella SIAs

For decision:
–        Vaccination of health workers

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:: Smallpox vaccines – Session 8

For decision
:: The last case of Smallpox occurred in 1977. In 1980 the World Health Assembly declared this disease eradicated. A global stockpile of vaccines, held in Switzerland, was created with donations from Member States.

:: In 2004 Previous the Ad-Hoc Orthopoxvirus Committee, recommended that the stockpile should consist 200 million doses. The current physical WHO stockpile is ~ 2.4 million doses, and the virtual stockpile consists of 31 million doses.

:: In order for WHO to make an informed decision (risk-benefit) on which vaccines to stock and to be able to give advice to countries on their stockpile, WHO would like SAGE to answer the following questions:
–  Which vaccine should be recommended to be used during an outbreak of smallpox? (vaccine used during the eradication, vaccine produced in tissue cell, or further attenuated vaccines).
– Composition of stockpile
–Size of stockpile

–       What groups should be prioritized to be vaccinated while faced with limited vaccine supply?
–Age groups, risk factors/safety aspects, vulnerable populations, ethical considerations

–Which vaccine should be given?

–       Which vaccine should be recommended for preventive use?

–       Who should be targeted and with which immunization schedule? (First aid responders, army, police, health workers)

WHO: Global tuberculosis report 2013
http://www.who.int/entity/tb/publications/global_report/en/index.html
–       Gains in tuberculosis control at risk due to 3 million missed patients and drug resistance
–       Progress in TB control can be substantially accelerated by addressing these challenges

Excerpt from media release
…The new data confirm that the world is on track to meet the 2015 UN Millennium Development Goals (MDGs) target of reversing TB incidence, along with the target of a 50% reduction in the mortality rate by 2015 (compared to 1990). A special “Countdown to 2015” supplement to this year’s report provides full information on the progress to the international TB targets. It details if the world and countries with a high burden of TB are “on-track” or “off-track” and what can be done rapidly to accelerate impact as the 2015 deadline approaches.

Key challenges
The report underlines the need for a quantum leap in TB care and control which can only be achieved if two major challenges are addressed.
–       Missing 3 million – around three million people (equal to one in three people falling ill with TB) are currently being ‘missed’ by health systems.
–       Drug-resistant TB crisis – the response to test and treat all those affected by multidrug-resistant TB (MDR-TB) is inadequate.

Insufficient resources for TB are at the heart of both challenges. TB programmes do not have the capacity to find and care for people who are “hard-to-reach”, often outside the formal or state health system. Weak links in the TB chain (a chain that includes detection, treatment and care) lead to such people being missed…

…Five priority actions
The WHO report recommends five priority actions that could make a rapid difference between now and 2015.
–       Reach the 3 million TB cases missed in national notification systems by expanding access to quality testing and care services across all relevant public, private or community based providers, including hospitals and NGOs which serve large proportions of populations at risk.
–       Address with urgency the MDR-TB crisis. Failure to test and treat all those ill with MDR-TB carries public health risks and grave consequences for those affected. High-level political commitment, ownership by all stakeholders, adequate financing and increased cooperation are needed to solve bottlenecks in drug supply and build capacity to deliver quality care.
–       Intensify and build on TB-HIV successes to get as close as possible to full antiretroviral therapy (ART) coverage for people co-infected with TB and HIV.
–       Increase domestic and international financing to close the resource gaps – now estimated at about US$ 2 billion per year – for an effective response to TB in low- and middle-income countries. Full replenishment of the Global Fund is essential, given that most low-income countries rely heavily on international donor funding, with the Global Fund providing around 75% of financial resources in these countries.
–       Accelerate rapid uptake of new tools – through technology transfer and operational research to ensure that countries and communities most at risk benefit from these innovations.

http://www.who.int/mediacentre/news/releases/2013/tuberculosis-report-2013/en/index.html

British Medical Journal
26 October 2013 (Vol 347, Issue 7930)
http://www.bmj.com/content/347/7930

Editorial
Safety of the quadrivalent human papillomavirus vaccine
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5631 (Published 9 October 2013
Now well established
The prophylactic human papillomavirus (HPV) vaccines are remarkable both for their efficacy against HPV infection and related diseases,1 and for their potential to prevent cervical cancer. Cervical cancer, which is caused by persistent infection with oncogenic HPV types, remains a cause of premature death in women around the world, most of whom have no access to secondary prevention through organised cervical screening programmes.2 The linked study by Arnheim-Dahlström and colleagues (doi:10.1136/bmj.f5906) provides a timely and important contribution to the evidence base on the safety of the quadrivalent HPV vaccine,3 which prevents HPV infection and disease due to the oncogenic types HPV-16 and HPV-18 and types HPV-6 and HPV-11, which cause genital warts.

This population based cohort analysis provides strong evidence that autoimmune conditions, neurological diseases, and thromboembolic disease are not triggered by quadrivalent HPV vaccination. Serious sudden onset conditions such as these, which are largely of undetermined cause, are sometimes falsely attributed to vaccination when population based vaccination programmes are implemented.4 It is crucial that surveillance systems can rule out false associations and identify rare but real …
http://www.bmj.com/content/347/bmj.f5631

Research
Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study
Lisen Arnheim-Dahlström, associate professor1, Björn Pasternak, postdoctoral fellow2, Henrik Svanström, statistician2, Pär Sparén, professor1, Anders Hviid, senior investigator2
http://www.bmj.com/content/347/bmj.f5906

Abstract
Objective
To assess the risk of serious adverse events after vaccination of adolescent girls with quadrivalent human papillomavirus (qHPV) vaccine.

Design
Register based cohort study.

Setting
Denmark and Sweden, October 2006 to December 2010.

Participants
997,585 girls aged 10-17, among whom 296,826 received a total of 696,420 qHPV vaccine doses.

Main outcome measures
Incident hospital diagnosed autoimmune, neurological, and venous thromboembolic events (53 different outcomes) up to 180 days after each qHPV vaccine dose. Only events with at least five vaccine exposed cases were considered for further assessment. Rate ratios adjusted for age, country, calendar year, and parental country of birth, education, and socioeconomic status were estimated, comparing vaccinated and unvaccinated person time. For outcomes where the rate ratio was significantly increased, we regarded three criteria as signal strengthening: analysis based on 20 or more vaccine exposed cases (reliability), rate ratio 3.0 or more (strength), and significantly increased rate ratio in country specific analyses (consistency). We additionally assessed clustering of events in time and estimated rate ratios for a risk period that started on day 181.

Results
Among the 53 outcomes, at least five vaccine exposed cases occurred in 29 and these were analysed further. Whereas the rate ratios for 20 of 23 autoimmune events were not significantly increased, exposure to qHPV vaccine was significantly associated with Behcet’s syndrome, Raynaud’s disease, and type 1 diabetes. Each of these three outcomes fulfilled only one of three predefined signal strengthening criteria. Furthermore, the pattern of distribution in time after vaccination was random for all three and the rate ratios for these outcomes in the period from day 181 after vaccination were similar to the rate ratios in the primary risk period. The rate ratios for five neurological events were not significantly increased and there were inverse associations with epilepsy (rate ratio 0.66, 95% confidence interval 0.54 to 0.80) and paralysis (0.56, 0.35 to 0.90). There was no association between exposure to qHPV vaccine and venous thromboembolism (0.86, 0.55 to 1.36).

Conclusions

This large cohort study found no evidence supporting associations between exposure to qHPV vaccine and autoimmune, neurological, and venous thromboembolic adverse events. Although associations for three autoimmune events were initially observed, on further assessment these were weak and not temporally related to vaccine exposure. Furthermore, the findings need to be interpreted considering the multiple outcomes assessments

Developing World Bioethics
August 2013  Volume 13, Issue 2  Pages ii–iii, 57–104
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2013.13.issue-2/issuetoc

Special Issue: Anti-retrovirals for treatment and prevention – new ethical challenges
[Six articles]

ARTICLE
Ethical Tradeoffs in Trial Design: Case Study of an HPV Vaccine Trial in HIV-Infected Adolescent Girls in Lower Income Settings
J.C. Lindsey, S.K. Shah, G.K. Siberry, P. Jean-Philippe, M.J. Levin
http://onlinelibrary.wiley.com/doi/10.1111/dewb.12028/abstract

Abstract
The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria.

Eurosurveillance
Volume 18, Issue 43, 24 October 2013
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

Surveillance and outbreak reports
Study of a measles outbreak in Granada with preventive measures applied by the courts, Spain, 2010 to 2011
by E Navarro, MM Mochón, MD Galicia, I Marín, J Laguna

Abstract
Measles had practically been eliminated in Granada since the systematic vaccination of children with two doses introduced in 1984. However, in 2009 the disease returned in the form of small outbreaks. This study describes the measles outbreak that occurred in Granada from October 2010 to August 2011 and the measures imposed to control it. Information was sourced from the records of the Andalusian epidemiological surveillance system. A total of 308 cases were recorded, representing an incidence rate of 33.6 cases per 100,000 inhabitants. The first wave of the epidemic took place in Granada city, with the majority of cases occurring among families who lived in the Albaycín neighbourhood and were opposed to vaccination for ideological and/or religious reasons. The initial cases were in unvaccinated children  aged 1 to13 years. The outbreak later spread throughout the province. To control the outbreak, the vaccination schedule for the exposed children was brought up to date. The Regional Ministry of Health decided to take legal action in order to ensure vaccination of those in the initial nucleus of the outbreak.

JAMA   
October 23/30, 2013, Vol 310, No. 16
http://jama.jamanetwork.com/issue.aspx

Editorial | October 23/30, 2013
Influenza Vaccination in 2013-2014 – Achieving 100% Participation
Kathleen M. Neuzil, MD, MPH1

Excerpt http://jama.jamanetwork.com/article.aspx?articleid=1758725
Every year, the public and health care system experience clinical and financial consequences of influenza epidemics. Influenza infection leads to hospitalizations, deaths, excess medication usage, and days missed from work and school. Influenza is a preventable disease, and advisory bodies in the United States recommend influenza vaccine for everyone 6 months and older, with particular emphasis on the need to vaccinate young children, older adults, and persons of all ages with high-risk conditions, including cardiovascular disease.1 In 2013, an unprecedented number of influenza vaccines are available in the US market, including quadrivalent vaccines, live, attenuated vaccines, high-dose vaccines, and vaccines manufactured in cell culture.1      Comparative trials in certain pediatric age groups have shown the relative benefits of live, attenuated influenza vaccine and as yet unlicensed adjuvanted vaccines.2,3 Likewise, studies evaluating the comparative benefits of high-dose vs standard-dose influenza vaccines in older adults are nearing completion.4…

JAMA   
October 23/30, 2013, Vol 310, No. 16
http://jama.jamanetwork.com/issue.aspx

Original Investigation | October 23/30, 2013
Association Between Influenza Vaccination and Cardiovascular Outcomes in High-Risk PatientsA Meta-analysis
Jacob A. Udell, MD, MPH, FRCPC1; Rami Zawi, MD2; Deepak L. Bhatt, MD, MPH3,4; Maryam Keshtkar-Jahromi, MD, MPH5,6; Fiona Gaughran, MD7,8; Arintaya Phrommintikul, MD9; Andrzej Ciszewski, MD10; Hossein Vakili, MD11; Elaine B. Hoffman, PhD4; Michael E. Farkouh, MD, MSc, FRCPC12; Christopher P. Cannon, MD4

Abstract http://jama.jamanetwork.com/article.aspx?articleid=1758749
Importance.  Among nontraditional cardiovascular risk factors, recent influenza-like infection is associated with fatal and nonfatal atherothrombotic events.

Objectives.  To determine if influenza vaccination is associated with prevention of cardiovascular events.

Data Sources and Study Selection. A systematic review and meta-analysis of MEDLINE (1946-August 2013), EMBASE (1947-August 2013), and the Cochrane Library Central Register of Controlled Trials (inception-August 2013) for randomized clinical trials (RCTs) comparing influenza vaccine vs placebo or control in patients at high risk of cardiovascular disease, reporting cardiovascular outcomes either as efficacy or safety events.

Data Extraction and Synthesis.   Two investigators extracted data independently on trial design, baseline characteristics, outcomes, and safety events from published manuscripts and unpublished supplemental data. High-quality studies were considered those that described an appropriate method of randomization, allocation concealment, blinding, and completeness of follow-up.

Main Outcomes and Measures  Random-effects Mantel-Haenszel risk ratios (RRs) and 95% CIs were derived for composite cardiovascular events, cardiovascular mortality, all-cause mortality, and individual cardiovascular events. Analyses were stratified by subgroups of patients with and without a history of acute coronary syndrome (ACS) within 1 year of randomization.

Results  Five published and 1 unpublished randomized clinical trials of 6735 patients (mean age, 67 years; 51.3% women; 36.2% with a cardiac history; mean follow-up time, 7.9 months) were included. Influenza vaccine was associated with a lower risk of composite cardiovascular events (2.9% vs 4.7%; RR, 0.64 [95% CI, 0.48-0.86], P = .003) in published trials. A treatment interaction was detected between patients with (RR, 0.45 [95% CI, 0.32-0.63]) and without (RR, 0.94 [95% CI, 0.55-1.61]) recent ACS (P for interaction = .02). Results were similar with the addition of unpublished data.

Conclusions and Relevance  In a meta-analysis of RCTs, the use of influenza vaccine was associated with a lower risk of major adverse cardiovascular events. The greatest treatment effect was seen among the highest-risk patients with more active coronary disease. A large, adequately powered, multicenter trial is warranted to address these findings and assess individual cardiovascular end points.

Journal of Pediatrics
Vol 163 | No. 5 | November 2013 | Pages 1235-1536
http://www.jpeds.com/current

Tdap vaccination during pregnancy—no signal of safety concerns for infants
Sarah S. Long, MD
Abstract  http://www.jpeds.com/article/S0022-3476%2813%2901106-2/preview
Taking advantage of a robust electronic medical record system at Intermountain Healthcare facilities in Utah, Shakib et al performed a retrospective cohort study assessing pregnancy, birth, and infancy outcomes for 138 women who were given tetanus and reduced-content diphtheria toxoids and reduced-content acellular pertussis vaccine (Tdap) compared with 552 randomly selected nonvaccinated pregnant women controls. The study, ending in 2009, was performed before routine recommendation for Tdap administration during pregnancy. The most common reason for Tdap was prophylaxis for open wounds or during acute care visits for trauma. Of pregnant women receiving Tdap, 63% received the vaccine during the first trimester.

Tetanus, Diphtheria, Acellular Pertussis Vaccine during Pregnancy: Pregnancy and Infant Health Outcomes
Julie H. Shakib, DO, MS, MPH, Kent Korgenski, MS, MT, Xiaoming Sheng, PhD, Michael W. Varner, MD, Andrew T. Pavia, MD, Carrie L. Byington, MD

Abstract  http://www.jpeds.com/article/S0022-3476%2813%2900734-8/abstract
Objective
To assess pregnancy and birth outcomes in infants born to women who did or did not receive tetanus, diphtheria, acellular pertussis (Tdap) vaccine during pregnancy.

Study design
Retrospective cohort. Pregnant women 12-45 years of age who received Tdap at Intermountain Healthcare facilities and their infants were identified and compared with mother-infant pairs without documented Tdap from May 2005 through August 2009. Primary measures included pregnancy outcomes and infant health outcomes at birth through 12 months.

Results
From 162 448 pregnancies we identified 138 women (0.08%) with documented Tdap administration during pregnancy (cases); 552 pregnant women without documented Tdap were randomly selected as controls. Of 138 immunized women, 63% received Tdap in the first trimester and 37% after. Tdap was given most commonly as wound prophylaxis. The incidence of spontaneous or elective abortion was no greater in Tdap cases than in controls. There were no significant differences in preterm delivery, gestational age, or birth weight between groups. One or more congenital anomaly was identified in 3.7% (95% CI 1.2%-8.5%) of case infants and 4.4% (95% CI 2.7%-6.5%) of control infants (P = .749). In infants born to women receiving Tdap during pregnancy, 3.6% (0.8%-10.2%) had International Classification of Diseases, Ninth Revision, Clinical Modification diagnoses consistent with complex chronic conditions within 12 months compared with 10.4% (95% CI 7.2%-14.4%) of infants of controls (P = .054).

Conclusions
Documented Tdap administration during pregnancy was uncommon and occurred most often in the first trimester as prophylaxis following trauma. No increase in adverse outcomes was identified in infants born to women receiving Tdap compared with infants of controls.

The Lancet  
Oct 26, 2013  Volume 382  Number 9902  p1381 – 1458
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Polio eradication: where are we now?
The Lancet
[Full Text] http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962196-0/fulltext

On Oct 17, WHO received reports of a cluster of acute cases of flaccid paralysis in Syria. Initial results showed two suspected cases of poliomyelitis, indicating the first apparent outbreak of polio in 14 years in the country. Syria is now considered at high risk for polio and other vaccine-preventable diseases, and this suspected outbreak raises the alarm that the country’s health crisis has deepened further. With the appalling conflict in Syria continuing to damage the health system infrastructure needed for polio eradication, as well as other health services, this new suspected outbreak is a reminder that political determinants of health underscore the success or failure of eliminating this disease once and for all.

Beyond Syria, polio campaigns in Pakistan have been damaged by repeated violent attacks and killings of polio workers, lack of public confidence in vaccines because of the false characterisation of vaccination as a plot to sterilise Muslims, and publicly boycotted polio immunisation by the Taliban. Worryingly, the situation in North Waziristan Federally Administered Tribal Areas—where polio vaccines are strictly blocked—is becoming increasingly severe, with the largest number of children being paralysed by poliomyelitis in all of Asia.    Compared with this time last year, Pakistan has made little progress with almost identical numbers of polio cases. Clearly, attacks on health workers are unacceptable, and those who engage in them must face prosecution. Furthermore, the reasons why the general community might be suspicious of vaccination should be addressed. While health education is an important part of promoting vaccine uptake, the mistrust of authority that fuels anti-vaccination conspiracy theories must also be examined. The latest sociological and psychological research as to how and why people come to hold such beliefs, as well as the specific cultural milieu in which vaccination programmes operate, should be taken into consideration.

Poliomyelitis also re-emerged in the Horn of Africa this May, with 174 cases in Somalia, 14 in Kenya, six in Ethiopia, and three in South Sudan according to the most recent reports. In Somalia, many polio cases are in areas south of Mogadishu where Al-Shabaab operates. The group refused to admit supplies of polio vaccine and launched a propaganda campaign in areas it controls, spreading falsehoods about the vaccine to scare off parents. Furthermore, Somalia has been so dangerous for health workers that Médecins Sans Frontières pulled out of the country in August of this year, ending an involvement of 22 years.

Continued virus transmission in endemic countries, and the outbreaks of polio in the Horn of Africa and Syria, are pertinent reminders that the most difficult challenges for global polio eradication are the political determinants of health such as weak health systems, public mistrust, political instability, and conflict—rather than medical barriers.

With regard to the technical dimension of ending polio, global eradication efforts led by WHO, UNICEF, and the Rotary Foundation have made remarkable progress. Poliomyelitis cases have been reduced by more than 99% and there are only three remaining polio-endemic countries—Afghanistan, Nigeria, and Pakistan. In 2013, the number of polio cases from the three endemic countries—99 in total—is 40% lower than in 2012. To further strengthen the efforts, the Global Polio Eradication Initiative (GPEI) launched the new Eradication & Endgame Strategic Plan 2013—18 in May, with a detailed budget and a new deadline for polio eradication set for 2018.      The plan has four simultaneous objectives: detection and interruption of wild poliovirus, strengthening of routine immunisation and withdrawal of the oral polio vaccine (OPV), containment of all virus samples and certification of interruption of transmission, and legacy planning to benefit other health and development initiatives. Notably, the most ambitious vaccine introduction plan in history has been initiated, which aims to introduce inactivated polio vaccines (IPV) by the end of 2015 in 124 countries to replace OPV and eliminate the rare risk of vaccine-derived cases of polio. In June of this year, the GAVI board agreed to provide financial support and play a lead role in introduction of IPV.

Technical improvements are insufficient, however, unless the political context, which has been paid little attention, is tackled more seriously. World Polio Day on Oct 24 is a reminder of the importance of global polio eradication. To end poliomyelitis at this stage, strong political will from international partners and governments to address the political determinants of disease eradication more vigorously and urgently is key.

New England Journal of Medicine
October 24, 2013  Vol. 369 No. 17
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Access to Patient-Level Trial Data — A Boon to Drug Developers
Hans-Georg Eichler, M.D., Frank Pétavy, M.Sc., Francesco Pignatti, M.D., and Guido Rasi, M.D.
N Engl J Med 2013; 369:1577-1579October 24, 2013DOI: 10.1056/NEJMp1310771
http://www.nejm.org/doi/full/10.1056/NEJMp1310771

Excerpt
The provision of access to clinical trial results that include patient-level data is generating much debate. A growing chorus of transparency advocates is pushing for open access to these data, making a case on the basis of respect for patients’ altruism, the need to safeguard public health, and distrust in the integrity and completeness of published trial information.1 We at the European Medicines Agency (EMA) have been actively engaged in this debate, and the EMA has recently published a draft of a policy that would make patient-level data in its possession publicly accessible. The principle of privacy protection will inform the EMA’s policy and activities; robust and proportionate measures will be adopted to safeguard patients’ privacy, in compliance with applicable data-protection legislation.2

Pharmaceutical-industry organizations, however, have expressed concern that “one of the risks to innovation is disclosure to competitors of companies’ trade secrets and proprietary information that could allow others to `free ride’ off of the substantial investments of innovators”; they fear “degradation of incentives for companies to invest in biomedical research.”3

Industry leaders have rightly complained about the unsustainability of the current drug development and business model. The timelines and costs of clinical drug development are increasing relentlessly, and the attrition rate of assets in development remains high. At the same time, growing cost pressures in all health care environments are forcing restrictions on drug use, aiming to limit coverage only to patients who can be expected to benefit from a given intervention and for whom that intervention is clearly cost-effective.

Contrary to industry fears, we argue that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry. We predict that it will help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors…

Health Law, Ethics, and Human Rights
Preparing for Responsible Sharing of Clinical Trial Data
Michelle M. Mello, J.D., Ph.D., Jeffrey K. Francer, J.D., M.P.P., Marc Wilenzick, J.D., Patricia Teden, M.B.A., Barbara E. Bierer, M.D., and Mark Barnes, J.D., LL.M.
N Engl J Med 2013; 369:1651-1658October 24, 2013DOI: 10.1056/NEJMhle1309073

Excerpt  http://www.nejm.org/doi/full/10.1056/NEJMhle1309073
Data from clinical trials, including participant-level data, are being shared by sponsors and investigators more widely than ever before. Some sponsors have voluntarily offered data to researchers,1,2 some journals now require authors to agree to share the data underlying the studies they publish,3 the Office of Science and Technology Policy has directed federal agencies to expand public access to data from federally funded projects,4 and the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have proposed the expansion of access to data submitted in regulatory applications.5,6 Sharing participant-level data may bring exciting benefits for scientific research and public health but may also have unintended consequences. Thus, expanded data sharing must be pursued thoughtfully.

We provide a suggested framework for broad sharing of participant-level data from clinical trials and related technical documents. After reviewing current data-sharing initiatives, potential benefits and risks, and legal and regulatory implications, we propose potential governing principles and key features for a system of expanded access to participant-level data and evaluate several governance structure…

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X
Progress in the establishment and strengthening of national immunization technical advisory groups: Analysis from the 2013 WHO/UNICEF joint reporting form, data for 2012

Original Research Article
Pages 5314-5320
Philippe Duclos, Laure Dumolard, Nihal Abeysinghe, Alex Adjagba, Cara Bess Janusz, Richard Mihigo, Liudmila Mosina, Yashohiro Takashima, Murat Hakan Öztürk

Abstract
The majority of industrialized and some developing countries have established National Immunization Technical Advisory Groups (NITAGs). To enable systematic global monitoring of the existence and functionality of NITAGs, in 2011, WHO and UNICEF included related questions in the WHO/UNICEF Joint Reporting Form (JRF) that provides an official means to globally collect indicators of immunization program performance. These questions relate to six basic process indicators.

According to the analysis of the 2013 JRF, data for 2012, notable progress was achieved between 2010 and 2012 and by the end of 2012, 99 countries (52%) reported the existence of a NITAG with a formal legislative or administrative basis (with a high of 86% in the Eastern Mediterranean Region – EMR), among the countries that reported data in the NITAG section of the JRF.

There were 63 (33%) countries with a NITAG that met six process indicators (47% increase over the 43 reported in 2010) including a total of 38 developing countries. 11% of low income countries reported a NITAG that meets all six process criteria, versus 29% of middle income countries and 57% of the high income ones. Countries with smaller populations reported the existence of a NITAG that meets all six process criteria less frequently than more populated countries (23% for less populated countries versus 43% for more populated ones).

However, progress needs to be accelerated to reach the Global Vaccine Action Plan (GVAP) target of ensuring all countries have support from a NITAG. The GVAP represents a major opportunity to boost the institutionalization of NITAGs. A special approach needs to be explored to allow small countries to benefit from sub-regional or other countries advisory groups

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Vaccines against diseases transmitted from animals to humans: A one health paradigm
Review Article
Pages 5321-5338
Thomas P. Monath

Abstract
This review focuses on the immunization of animals as a means of preventing human diseases (zoonoses). Three frameworks for the use of vaccines in this context are described, and examples are provided of successes and failures. Framework I vaccines are used for protection of humans and economically valuable animals, where neither plays a role in the transmission cycle. The benefit of collaborations between animal health and human health industries and regulators in developing such products is discussed, and one example (West Nile vaccine) of a single product developed for use in animals and humans is described. Framework II vaccines are indicated for domesticated animals as a means of preventing disease in both animals and humans. The agents of concern are transmitted directly or indirectly (e.g. via arthropod vectors) from animals to humans. A number of examples of the use of Framework II vaccines are provided, e.g. against brucellosis, Escherischia coli O157, rabies, Rift Valley fever, Venezuelan equine encephalitis, and Hendra virus. Framework III vaccines are used to immunize wild animals as a means of preventing transmission of disease agents to humans and domesticated animals. Examples are reservoir-targeted, oral bait rabies, Mycobacterium bovis and Lyme disease vaccines. Given the speed and lost cost of veterinary vaccine development, some interventions based on the immunization of animals could lead to rapid and relatively inexpensive advances in public health. Opportunities for vaccine-based approaches to preventing zoonotic and emerging diseases that integrate veterinary and human medicine (the One Health paradigm) are emphasized.

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Influenza cost and cost-effectiveness studies globally – A review
Review Article
Pages 5339-5348
Samuel K. Peasah, Eduardo Azziz-Baumgartner, Joseph Breese, Martin I. Meltzer, Marc-Alain Widdowson

Abstract
Every year, approximately 10–20% of the world’s population is infected with influenza viruses, resulting in a significant number of outpatient and hospital visits and substantial economic burden both on health care systems and society. With recently updated WHO recommendations on influenza vaccination and broadening vaccine production, policy makers in middle- and low-income countries will need data on the cost of influenza disease and the cost effectiveness of vaccination. We reviewed the published literature to summarize estimates of cost and cost-effectiveness of influenza vaccination. We searched PUBMED (MEDLINE), EMBASE, WEB of KNOWLEDGE, and IGOOGLE using the key words ‘influenza’, ‘economic cost’, ‘cost effectiveness’, and ‘economic burden’. We identified 140 studies which estimated either cost associated with seasonal influenza or cost effectiveness/cost–benefit of influenza vaccination. 118 of these studies were conducted in World Bank-defined high income, 22 in upper-middle income, and no studies in low and lower-middle income countries.

The per capita cost of a case of influenza illness ranged from $30 to $64. 22 studies reported that influenza vaccination was cost-saving; reported cost-effectiveness ratios were $10,000/outcome in 13 studies, $10,000 to $50,000 in 13 studies, and ≥$50,000 in 3 studies. There were no studies from low income countries and few studies among pregnant women. Substantial differences in methodology limited the generalization of results.

Decision makers in lower income countries lack economic data to support influenza vaccine policy decisions, especially of pregnant women. Standardized cost-effectiveness studies of influenza vaccination of WHO-recommended risk groups’ methods are urgently needed.

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Adolescents and vaccines in the western world
Review Article
Pages 5366-5374
Nicola Principi, Susanna Esposito

Abstract
Recent data have shown that the immune protection evoked by vaccines given in the first years of life progressively weakens, and that this is associated with a higher than expected incidence of vaccine-preventable diseases in adolescents and young adults. Furthermore, the greater circulation of pathogens among adolescents and young adults leads to a high risk of infection in unvaccinated or not fully vaccinated younger children. These findings, together with the availability of vaccines specifically developed to prevent infections that typically occur during adolescence, have induced a number of experts to suggest radical changes in the immunisation schedules usually recommended by health authorities. The most important of these relate pertussis, meningococcal and human papillomavirus vaccines but, although they are based on unexceptionable scientific premises, the suggestions have been only slowly and partially received in most countries, even in those in which vaccination programmes are usually adequately implemented and monitored. Adolescence is a particular period of life characterised by changes in intellectual, moral, physical, emotional and psychological development. All of these can have a considerable impact on compliance with immunisation schedules because the approach to any preventive method no longer entirely depends on parents’ and pediatricians’ judgements as in the first years of life but is the consequence of a more complex process involving the adolescents’ thoughts and opinions, their relationships with their parents, friends and physicians, and the information they receive from the mass media. Every effort should be made to overcome the barriers to adolescent immunisation, including those arising from the adolescents themselves.

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

Cost-effectiveness of targeted vaccination to protect new-borns against pertussis: Comparing neonatal, maternal, and cocooning vaccination strategies
Original Research Article
Pages 5392-5397
Anna K. Lugnér, Nicoline van der Maas, Michiel van Boven, Frits R. Mooi, Hester E. de Melker

Abstract
Pertussis (whooping cough) is a severe infectious disease in infants less than 6 months old. Mass vaccination programmes have been unable to halt transmission effectively. Strategies to protect new-borns against infection include vaccination of the neonate or the mother directly after birth (cocooning), or the mother during pregnancy (maternal). Here we investigate the cost-effectiveness of these three strategies in the Netherlands. Costs for health care utilization and productivity losses, as well as impact on quality of life were calculated for a 10-year vaccination programme, assuming that vaccine-induced immunity lasts 5 years. Cocooning was the most attractive option from a cost-effectiveness viewpoint (€89,000/QALY). However, both cocooning and maternal vaccination would reduce the disease burden in infants and mothers vaccinated (about 17–20 QALY/year). Specifically, with a persistent epidemic as seen in 2012, there is need for reconsidering the vaccination schedules against pertussis in order to increase protection of the vulnerable new-borns.

Vaccine
Volume 31, Issue 46, Pages 5297-5494 (4 November 2013)
http://www.sciencedirect.com/science/journal/0264410X

How parents make decisions about their children’s vaccinations
Original Research Article
Pages 5466-5470
Emily K. Brunson

Abstract
Background
Continued parental acceptance of childhood vaccination is essential for the maintenance of herd immunity and disease prevention. As such, understanding parents’ decision-making in relation to their children’s vaccinations is vitally important.

Objective
This qualitative study sought to develop an understanding of the general process parents go through when making decisions about their children’s vaccinations.

Methods
Interviews were conducted with U.S.-born parents living in King County, Washington who had children ≤18 months of age. These interviews were recorded and transcribed verbatim.

Results
Through the application of grounded theory, a general decision-making process was identified. Stages in this process included: awareness, assessing and choosing, followed by either stasis or ongoing assessment. The greatest variation occurred during the assessing stage, which involved parents examining vaccination-related issues to make subsequent decisions. This research suggests that three general assessment groups exist: acceptors, who rely primarily on general social norms to make their vaccination decisions; reliers, who rely primarily on other people for information and advice; and searchers, who seek for information on their own, primarily from published sources.

Conclusions
These results imply that one-size-fits-all approaches to vaccination interventions are inappropriate. Instead, this research suggests that interventions must be targeted to parents based on how they assess vaccination.

Vaccine
Volume 31, Issue 45, Pages 5147-5296 (25 October 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/45

“HPV? Never heard of it!”: A systematic review of girls’ and parents’ information needs, views and preferences about human papillomavirus vaccination
Review Article
Pages 5152-5167
Maggie Hendry, Ruth Lewis, Alison Clements, Sarah Damery, Clare Wilkinso

Abstract
Background and objective
Two human papillomavirus vaccines were licenced in 2006/2007 for cervical cancer prevention. National vaccination programmes for schoolgirls were subsequently introduced in some European countries, North America and Australia. To understand factors influencing vaccine uptake and to inform the development of appropriate UK educational materials, we aimed to synthesise evidence of girls’ and parents’ information needs, views and preferences regarding HPV vaccination.

Design
Systematic review and mixed method synthesis of qualitative and survey data.

Data sources
Twelve electronic databases; bibliographies of included studies 1980 to August 2011.

Review methods
Two reviewers independently screened papers and appraised study quality. Studies were synthesised collaboratively using framework methods for qualitative data, and survey results integrated where they supported, contrasted or added to the themes identified.

Results
Twenty-eight qualitative studies and 44 surveys were included. Where vaccination was offered, uptake was high. Intention to decline was related to a preference for vaccinating later to avoid appearing to condone early sexual activity, concerns about vaccine safety and low perception of risk of HPV infection. Knowledge was poor and there were many misconceptions; participants tried to assess the potential benefits and harms of vaccination but struggled to interpret limited information about HPV in the context of existing knowledge about sexually transmitted infections and cancer.

Conclusion
Many girls and their parents have limited understanding to an extent that impinges on their ability to make informed choices about HPV vaccination and could impact on future uptake of cervical screening. This is a considerable challenge to those who design and provide information, but getting the messages right for this programme could help in developing patient information about other HPV related cancers.

Vaccine
Volume 31, Issue 45, Pages 5147-5296 (25 October 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/45

HPV vaccination among French girls and women aged 14–23 years and the relationship with their mothers’ uptake of Pap smear screening: A study in general practice
Original Research Article
Pages 5243-5249
D. Lutringer-Magnin, C. Cropet, G. Barone, G. Canat, J. Kalecinski, Y. Leocmach, P. Vanhems, F. Chauvin, C. Lasset

Abstract
Introduction
HPV vaccination is recommended in France for girls aged 14 and for those aged 15–23 before sexual debut or who have become sexually active within the previous year. The first aim was to describe vaccination practice among 14–23-year-old girls visiting a general practitioner. A second objective was to investigate factors associated with starting vaccination among girls aged 14–18, in particular the regular practice of Pap-smear screening (PSS) by their mothers.

Methods
A cross-sectional study was conducted from June to August 2009. A total of 87 general practitioners from the large Rhône-Alpes region contributed data on 502 girls/women who came for consultation.

Results
231 (46.0%) of these girls/women had begun the process of HPV vaccination (68.2%, 56.9% and 18.7% of the 14–16, 17–20 and 21–23-year-olds respectively) of whom 139 (60.2%) had received all three doses. 92 girls/women (39.8%) had received only one or two doses at the time of study. However, in 71 (77.2%) cases, the gap between the last dose received and the time of study was within the between-dose interval recommended in the vaccination schedule. GPs reported that 16 (11.5%) had mentioned side effects following injections. Having a mother who practised regular PSS (Odds Ratio 6.2 [1.5–25.8]), having never lived with a partner (4.6 [1.6–13.5]) and vaccination against hepatitis B (3.2 [1.6–6.1]) were found to be independently correlated with the initiation of HPV vaccination among girls/women aged 14–18 years.

Conclusion
Two years after the start of the programme, only half of girls/women aged 14–23 years had begun the process of HPV vaccination. HPV vaccination status was correlated with PSS in the mother, family status and hepatitis B vaccination. Such information may help to better target girls who are less likely to be vaccinated.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Human papillomavirus vaccine intentions among males: A test of the Parallel Processing Model
CW Wheldon, ER Buhi, EM Daley, ND Hernandez… – Journal of Health Psychology …, 2013

Abstract
We investigated the cognitive and emotional reactions resulting from a human papillomavirus–related illness threat (i.e. testing positive for human papillomavirus) and the potential behavioral implications resulting from these psychosocial processes among men (N = 536). Structural equation modeling was used to explore a theoretical model explaining human papillomavirus vaccine intentions. The model fit the data well and explained 16 percent of the variance in vaccine intentions. Negative emotional response mediated the path between illness threat and vaccine intentions. Threat of genital warts was a salient concern and was positively associated with negative emotional response and subsequent vaccine intentions. Implications for vaccine promotion are discussed.

Vaccines and Global Health: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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– Email Summary: Vaccines and Global health : The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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– pdf version: A pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_19 Oct 2013
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– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

    IVI (International Vaccine Institute) announced that a new clinical study shows for the first time that an oral cholera vaccine (Shanchol) provides sustained protection against cholera, with protective efficacy of 65% over a five-year period in humans. The study, published in the Lancet Infectious Diseases, was a collaboration between scientists from the International Vaccine Institute (IVI) an international organization based in Seoul, and the National Institute of Cholera and Enteric Diseases, (NICED), an institute under the Indian Council of Medical Research (ICMR) of India’s Ministry of Health and Family Welfare.    A Phase III clinical trial was jointly conducted by IVI and NICED in Kolkata, India in 2006 to assess the efficacy of the vaccine. More than 30,000 volunteers from one year old and up were enrolled in the study. A placebo group with a similar number of volunteers was also included.
Previous results from this study had shown that the vaccine provided 66% protection over a three-year period, and the new result shows that such protection is sustained for two additional years. Since vaccine protection does not wane over time, the study has important practical implications in terms of vaccination cost and vaccination strategies in developing countries.

Dr. Thomas F. Wierzba, Deputy Director General of Vaccine Development & Delivery at IVI and co-author of the study, said, “The study results suggest that this vaccine will protect persons at risk of severe cholera for five years. With protection sustained for five years, we will be able to provide greater benefits to the poor at reduced costs.” Dr. Christian Loucq, IVI’s Director General, commented, “The vaccine is safe, easy to administer, cost effective, and provides protection for up to five years. The use of the vaccine, combined with other control measures, will make it more feasible for developing countries afflicted by cholera to control a disease that plagues millions of people every year.”
http://www.ivi.org/web/www/07_01?p_p_id=EXT_BBS&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_EXT_BBS_struts_action=%2Fext%2Fbbs%2Fview_message&_EXT_BBS_messageId=560

[See also Journal Watch below: The Lancet Infectious Diseases]

The GAVI Alliance released it Mid-Term Review report, described as “a comprehensive and transparent assessment…aimed at examining the progress GAVI has made midway through its current strategic period from 2011 to 2015, and the challenges it faces in meeting its commitments to developing countries and to donors.” GAVI noted that the report is being published two weeks before GAVI partners – including the World Health Organization, UNICEF, the World Bank, the Bill & Melinda Gates Foundation, implementing and donor countries, civil society organisations and vaccine manufacturers – meet in Stockholm for the Alliance’s Mid-Term Review. GAVI said the report highlights that:

:: Since 2011, GAVI has funded a total of 67 new vaccine introductions and campaigns. By 2014 all 73 GAVI-supported countries will have introduced 5-in-1 pentavalent vaccines, including introductions in Haiti, Myanmar, Somalia and South Sudan.

:: Following a slow start, GAVI’s recently revamped health system strengthening programme now ensures that investments are translated more clearly into improved immunisation outcomes. As a result, GAVI is seeing investments and improvements in health system rapidly picking up speed.

:: GAVI is close to achieving its target of timely receipt of 100% of co-financing payments (contributions made by developing countries towards the cost of the vaccines). As of August, 64 of the 67 co-financing countries had fulfilled their commitments for 2012. And from 2011 to 2013 these payments totalled US$ 125 million, representing 8% of GAVI’s total support to these countries. All this is also helping to drive increases in country investment in their own health systems.

:: GAVI has also helped to produce more predictability and competition in the vaccine market, which has helped to bring down the cost of fully vaccinating a child with three priority vaccines – pentavalent, pneumococcal and rotavirus – from US$ 35 in 2010 to US$ 23 in 2012.

GAVI said the report “also highlights the challenges that the Alliance is attempting to address” including “improving the reliability of supply chains and finding ways to improve in-country data collection; adopting tailored approaches to meet the unique and challenging needs of fragile states; and ensuring the sustainability of immunisation programmes in countries whose wealth has increased to the point that they are no longer eligible for GAVI support.”
http://www.prnewswire.com/news-releases/gavi-alliance-on-track-to-immunise-a-quarter-of-a-billion-children-by-2015-and-prevent-nearly-4-million-deaths-227627121.html

*****

GAVI’s Mid-Term Review report http://midtermreview.gavialliance.org/
October 2013
[Editor’s formatting and extracted detail]

:: Introduction – Foreword by Dagfinn Høybråten, Chair of the GAVI Alliance Board

:: Bigger picture – Overview of the health & immunisation landscape & GAVI’s impact since 2000

:: Results- Delivering on the GAVI mission & strategic goals 2011-2015

:: Challenges – New approaches and measures in response to the changing global context

:: Looking ahead – GAVI’s role until 2015 and beyond

:: Key performance indicators
    Updates on the mission & goal-level indicators that monitor GAVI’s progress

GAVI uses 14 key performance indicators to monitor its five-year strategy. Click on each indicator below for a mid-term assessment of the Alliance’s progress against its 2015 targets. 

Mission: To save children’s lives and protect people’s health by increasing access to immunisation in poor countriesGAVI is currently on track to meet 2015 targets for its mission indicators. Key issues affecting progress include the strength of country systems and GAVI’s ability to mobilise timely, effective support in response to country demand. Other key issues to watch include uncertainties in global estimates of disease burden and immunisation coverage, and changes in estimates over time.

:: Timeline of vaccine introductions and campaigns, 2011–2013

:: View all the data graphics in this report

:: The role GAVI’s founding partners play in the Alliance

:: Donors to the GAVI Alliance

[See Lancet editorial in Journal Watch below]

    NIAID named John R. Mascola, M.D. as the new director of the Vaccine Research Center (VRC) where “he will lead a comprehensive research program aimed at the design, development and testing of candidate vaccines against HIV/AIDS, influenza and other globally important infectious diseases.” He will also serve as chief of the VRC virology laboratory. NIAID Director Anthony S. Fauci, M.D. commented, “John Mascola is a visionary leader who brings a wealth of talents as a basic scientist, clinician, clinical trialist and administrator to the helm of the Vaccine Research Center. In particular, his exemplary work on elucidating the protective role of antibodies against HIV has greatly influenced current vaccine design efforts.  I am confident that Dr. Mascola will continue and even accelerate our momentum toward the development of novel, effective vaccines against infectious diseases.”

http://www.nih.gov/news/health/oct2013/niaid-01.htm

Update: Polio this week – As of 16 October 2013
Global Polio Eradication Initiative
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]
:: Eleven new wild poliovirus (WPV) cases were reported in the past week (one from Afghanistan, two from Ethiopia, four from Pakistan and four from Somalia).
:: The total number of WPV cases for 2013 is now 296 (all WPV1), with 99 from endemic countries and 197 from outbreak countries.
:: Although the total WPV count is now higher than the same period 2012, the quantity of cases from the three endemic countries is 60% of the same time period 2012. Afghanistan has one third and Nigeria half the amount of cases when compared to 2012. Pakistan, with the majority of cases from Federally Administered Tribal Areas (FATA), has almost identical numbers to this time 2012. The situation in North Waziristan, FATA, is becoming increasingly severe, as it is the area with the largest number of children being paralyzed by poliovirus in all of Asia; 13 WPV cases and 22 circulating vaccine-derived poliovirus type 2 (cVDPV2). See ‘Pakistan’ section for more.

Afghanistan
:: One new WPV1 case was reported in the past week. The total number of WPV cases for 2013 is now seven (all WPV1), all of which were reported from Eastern Region, close to the Pakistan border. The most recent WPV1 case had onset of paralysis on 15 September, from Kunar province…

Pakistan
:: Four new WPV1 cases were reported in the past week. All were reported from FATA (two from Khyber Agency and two from North Waziristan). The total number of WPV1 cases for Pakistan in 2013 is now 43. The most recent WPV1 case had onset of paralysis on 26 September (from Khyber Agency). The majority of WPV1 cases in Pakistan this year, 31 (72%), are from FATA, of which 14 are from Khyber Agency and 13 from North Waziristan.
:: The situation in North Waziristan is becoming increasingly severe, as it is the area with the largest number of children being paralyzed by wild poliovirus (13 cases) and cVDPV2s (22) in all of Asia. It is in an area where immunization activities have been suspended by local leaders since June 2012. It is critical that children in these areas are vaccinated and protected from poliovirus. Immunizations in neighboring high-risk areas are being intensified, to further boost population immunity levels in those areas and prevent further spread of this outbreak…

Chad, Cameroon and Central African Republic
:: Central African Republic (CAR) continues to be at serious risk of re-infection due to proximity with Chad, ongoing insecurity and humanitarian crises, and destruction of health infrastructure. To minimize the risk and consequences of potential re-infection, SNIDs were conducted on 30 September to 2 October and NIDs are planned for end October…

Horn of Africa
:: Six new WPV1 cases were reported in the past week (four from Somalia and two from Ethiopia). The total number of WPV cases (all WPV1) for 2013 in the Horn of Africa is now 197 (174 from Somalia, 14 from Kenya, six from Ethiopia and three from South Sudan). The most recent WPV1 case in the region had onset of paralysis on 19 September (from Somali region, Ethiopia)…

WHO: Global Alert and Response (GAR) – Disease Outbreak News
http://www.who.int/csr/don/2013_03_12/en/index.html
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – update 18 October 2013
:: Human infection with avian influenza A(H7N9) virus – update 16 October 2013
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – update 14 October 2013

The Weekly Epidemiological Record (WER) for 18 October 2013, vol. 88, 41 (pp. 449–464) includes:
:: Antigenic and genetic characteristics of zoonotic influenza viruses and development of candidate vaccine viruses for pandemic preparedness
:: Monthly report on dracunculiasis cases, January–August 2013
http://www.who.int/entity/wer/2013/wer8842.pdf

Globalization and Health
[Accessed 19 October 2013]
http://www.globalizationandhealth.com/

Debate
Developing global health technology standards: what can other industries teach us?
Hassan Masum, Rebecca Lackman and Karen Bartleson
Globalization and Health 2013, 9:49 doi:10.1186/1744-8603-9-49
Published: 17 October 2013  http://www.globalizationandhealth.com/content/9/1/49/abstract

Abstract (provisional)
Background
There is a lack of effective and affordable technologies to address health needs in the developing world. One way to address problems of innovation and affordability is to design global health technologies to follow agreed-upon standards. This Debate article argues that we can better develop standards for global health technologies if we learn lessons from other industries.

Discussion
The article’s Background section begins by explaining why standards are needed in global health. For example, if global health technologies can be modularized into independent interfacing parts, these parts can then interact via well-defined standards in a “plug and play” fashion. This can avoid development of mutually incompatible solutions by different organizations, speed the pace of innovation, unlock health systems from single providers and approaches, and lower barriers to entry. The Background then gives a brief primer on standards and discusses incentives for health standards. The article’s Discussion section begins with brief relevant cases of standards development from other industries, including electricity, container shipping, CD standards, Universal Serial Bus (USB), and the Internet. It then explores lessons from these and other industries that suggest how to develop standards for global health technologies. The remainder of the Discussion considers intellectual property and regulatory issues and standards-based global health business models, and ends with a checklist of considerations for health standards development leaders. (The associated Additional file discusses observations from standards development for cell phones and semiconductors, as well as challenges in the standards development process itself.) Throughout the article, point-of-care diagnostics are used as an illustrative example. An initiative is already underway to explore standardized diagnostics platforms.

Summary
This Debate article aims to convince the reader that standards can benefit global health technologies if we learn lessons from other industries. The article draws from historical examples and the authors’ experiences to suggest principles, challenges, and opportunities in developing these standards. If implemented well, standardized platforms can lower barriers to entry, improve affordability, and create a vibrant ecosystem of innovative new global health technologies.

International Journal of Infectious Diseases
Vol 17 | No. 11 | November 2013
http://www.ijidonline.com/current

Short Communications
Immune response to hepatitis B vaccine in a group of health care workers in Sri Lanka
L.S. Chathuranga, F. Noordeen, A.M.S.B. Abeykoon
http://www.ijidonline.com/article/S1201-9712%2813%2900177-X/abstract

Summary 
Health care workers (HCWs) are considered at high risk of acquiring the hepatitis B virus (HBV). Seroconversion rates after vaccination against HBV among HCWs have not previously been available in Sri Lanka. In the current study, the response to HBV surface antigen (HBsAg) vaccine was assessed in a selected group of HCWs by testing for antibodies against HBsAg (anti-HBs). This was a retrospective descriptive study to measure the anti-HBs levels, using an ELISA, in an immunized group of HCW referred to Department of Microbiology, Faculty of Medicine, University of Peradeniya, Sri Lanka. Among the 342 participants, 9.9% (n=34) were non-responders. Female participants had a significantly higher immune response (94.7%) than males (p<0.05). The results of the study found no significant decline in the immune response with time (p > 0.05). Post HBsAg vaccination immunity in HCW in Sri Lanka is similar to that of global rates with similar gender variation. Anti-HBs levels should be tested in all HCW following HBsAg vaccination so that necessary precautions can be taken.

Journal of Public Health Policy
Volume 34, Issue 4 (November 2013)
http://www.palgrave-journals.com/jphp/journal/v34/n4/index.html

The Federation’s Pages
Journal of Public Health Policy (2013) 34, 574–579. doi:10.1057/jphp.2013.38
The right to health is coming of age: Evidence of impact and the importance of leadership
Flavia Bustreo a and Paul Hunt b
A Assistant Director-General, Family, Women’s and Children’s Health, World Health Organisation
B UN Special Rapporteur on the right to the highest attainable standard of health (2002–2008)
The content of the Federation’s Page is selected and edited by the WFPHA and not reviewed by JPHP.
 Excerpt http://www.palgrave-journals.com/jphp/journal/v34/n4/full/jphp201338a.html

“At this year’s high-level session of the World Health Assembly, the right to the highest attainable standard of health was mentioned by Ministers of Health more often than at any recent meeting of the Assembly.1 Nepal’s Minister of Health and Population confirmed that his country has adopted a rights-based approach to health. The South African Minister of Health spoke about health care as ‘a birth right’. Colombia’s Assistant Health Minister called for a ‘global effort for the development and effective universalization of the human right to health’.

“Germany’s Minister of Health emphasized that health is ‘a key human right and of vital importance for all human development’. The US Secretary of Health and Human Services quoted the words of President Obama: access to healthcare is ‘not some earned privilege – it is a right’. Speakers observed that the right to the highest attainable standard of health is enshrined in the Constitution of the World Health Organization. Multiple references to the right to the highest attainable standard of health (or ‘right to health’) came from every region of the world.

“Some health policymakers will be quick to dismiss these references as rhetorical. After all, these are high-level speeches, not detailed policy prescriptions. Nonetheless, speeches can tell us something. Sometimes they signal important shifts in opinion and direction.

In our view, the numerous human rights references in Ministers’ speeches reflect profound changes in the relationship between health and human rights – changes beginning to be felt in many countries.

“Today, it is universally accepted that human rights not only include classic civil and political rights, but also economic, social, and cultural rights, including the right to the highest attainable standard of health. This right is to be realized progressively and subject to the availability of resources. It demands accountability that comes in many forms, for example, by way of community groups, parliamentary committees, suitably designed maternal and peri-natal death audits, independent inspectors, national human rights institutions, and UN treaty-bodies…

…So, in conclusion, is it wise to dismiss as rhetorical flourishes the numerous references to human rights in high-level speeches at this year’s World Health Assembly? We do not think so. The speeches reflect growing recognition that the health community has an indispensable role to play in the implementation of the right to the highest attainable standard of health; they acknowledge that this fundamental human right can help health workers achieve their professional objectives; and they reflect profound changes that are taking place in the relationship between health and human rights. Moreover, all of these insights are confirmed by the WHO report: some Ministries of Health are already explicitly and actively using the right to health in their work, with evidence of beneficial impact. In short, the right to health is coming of age.

“If the right to the highest attainable standard of health is to realize its potential to save lives and reduce suffering, much remains to be done by a wide range of stakeholders. We hope that Ministers, Secretaries of Health, and other leaders of the public health community will chart the way forward in future meetings of the World Health Assembly – and beyond.”

The Lancet  
Oct 19, 2013  Volume 382  Number 9901  p1309 – 1380
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Integrity in research collaborations: The Montreal Statement
The Lancet
Preview
Last week, new guidance was issued as an outcome of the 3rd World Conference on Research Integrity, held in May in Montreal, Canada. The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations was developed before, during, and after the conference. Three workshop sessions at the conference were dedicated to in-depth discussions and further comments after the conference were taken into account to arrive at this version. Cross-boundary research includes collaboration between different institutions, disciplines, sectors, and countries.

The Lancet  
Oct 19, 2013  Volume 382  Number 9901  p1309 – 1380
http://www.thelancet.com/journals/lancet/issue/current

Editorial
The GAVI Alliance—successes and ongoing challenges
The Lancet
[Full text] http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962127-3/fulltext

GAVI’s Mid-Term Review, published on Oct 14, examines the organisation’s progress midway through the period 2011—15. It notes that by 2014, 73 countries with GAVI’s support will introduce five-in-one pentavalent vaccines, including fragile states—Haiti, Burma, Somalia, and South Sudan. The costs of new, priority vaccines, such as those targeting pneumococcal and rotaviral infections, are falling owing to GAVI’s efforts. Countries are graduating from GAVI support to self-financing of vaccines, and provision of new vaccines to those most in need is speeding up.

The report is published ahead of a mutual accountability meeting on Oct 30, in Stockholm, Sweden, to take stock of GAVI’s progress in immunisation and resource mobilisation since 2011.    A Lancet Series on the New Decade of Vaccines, in 2011, highlighted some predicaments facing GAVI—eg, a need to scale-up country commitments, high prices for new vaccines that are slowing delivery, and a need for GAVI to evaluate performance more effectively.

GAVI notes, however, that 2 years after its successful pledging conference in London, 243 million children will be reached with GAVI-supported vaccines in developing countries during 2011—15. Still, at least 22 million children worldwide do not have access to the basic package of childhood vaccines each year. Despite this gap, GAVI argues that it is reaching its strategic goals, which include acceleration of the uptake and use of under-used and new vaccines, strengthening of health systems to improve immunisation coverage, and improvement of vaccine market conditions for developing countries.

Despite the achievements documented in the report, challenges remain: looking for better ways to collect country-level data and ensuring supply chains are more reliable; addressing low-income countries’ unique and challenging needs with individualised approaches; and ensuring sustainability of immunisation programmes in countries wealthy enough to no longer be eligible for GAVI support. GAVI should continue to work hard and successfully to address these issues, to ensure that all children are protected against vaccine-preventable diseases, wherever they live.

The Lancet Infectious Diseases
Oct 2013  Volume 13  Number 10  p823 – 906
http://www.thelancet.com/journals/laninf/issue/current

Online First
Comment
A rare success for cholera vaccines
Saranya Sridhar a, Narendra Kumar Arora b
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970296-2/fulltext?_eventId=login

Cholera is a truly neglected infectious disease that is endemic in most parts of Africa and Asia. Despite an estimated annual burden of 2—4 million cases,1 it garners public attention only when outbreaks rampage through disaster-struck populations.2 Control of cholera depends on the long-term strategy of improving water quality and sanitation systems, but an effective vaccine conferring durable protection could offer an additional weapon in the depleted armoury of prevention strategies for this disease.

In 2001, WHO prequalified the licensed oral cholera vaccine Dukoral (SBL Vaccin AB, Sweden) for purchase by UN organisations.3 However, this vaccine is expensive, its efficacy lasts for only 2 years,4 and it is primarily used to protect travellers.3 In a technology transfer that should serve as a model for vaccine development, a modified version of the vaccine (Shanchol, Shantha Biotechnics, India) was manufactured and licensed in India in 2009. Shanchol was prequalified by the WHO in 2011. A field trial5 showed 67% cumulative efficacy in the first 2 years after vaccination. At that time, we sounded a note of cautious optimism and awaited the results of longer follow-up since other promising cholera vaccines with similar efficacy had failed to deliver longlasting protection.6

In The Lancet Infectious Diseases, Sujit Bhattacharya and colleagues7 report on whether Shanchol was protective over 5 years in a follow-up of 66 900 participants in a cluster-randomised placebo-controlled trial in Kolkata, India. The whole-cell vaccine containing killed strains from the O1 and O139 serogroups was given in two doses 2 weeks apart to non-pregnant individuals older than 1 year. The vaccine showed 65% (95% CI lower boundary of 52%) cumulative efficacy in the 5 year period for prevention of cholera episodes severe enough for individuals to seek treatment. This cholera vaccine is the first in the long history of cholera vaccine development to show more than 50% efficacy lasting up to 5 years. However, in children aged 1—5 years, who are at greatest risk of disease, the vaccine conferred only 42% cumulative efficacy (95% CI lower boundary of 5%) and too few cases occurred during the fifth year of follow-up to judge whether protection in these children lasted into the fifth year after vaccination. This lower level of protection is compounded by the difficulty of delivering oral vaccination to young children in poor sanitary and hygiene conditions. Nonetheless, we believe this result of an unprecedented level of long-term efficacy will be a giant leap forward for global control of cholera.

Despite this advance, questions remain. How do we improve vaccine efficacy in young children? The cholera community might learn from influenza vaccination, in which live attenuated vaccines are most efficacious in children and killed vaccines most efficacious in adults. Perhaps more effort needs to be placed on development, improvement, and testing of new and old attenuated cholera vaccines.8 A booster dose 2—3 years after the first vaccination might be necessary. Would the vaccine work equally well in areas that are not cholera endemic?

In endemic cholera areas, such as the Kolkata trial site,7 the vaccine might boost existing naturally acquired immunity. This boosting effect is given more credence by trial results showing an increased efficacy in the fourth and fifth year of the study, especially in adults, after a large cholera outbreak in the third year. Whether the vaccine will be equally efficacious in immunologically naive individuals, especially in the context of cholera outbreaks, is unknown. Individuals with HIV infection and those who are pregnant and elderly are the other high-risk populations in whom this vaccine needs to be assessed.

Vaccine efficacy was shown only against the O1 strain circulating in the study population. Efficacy against the O139 strains and newly emergent O1 strains expressing the classical toxins should be investigated.3 Resolution of whether the vaccine can reduce infection or transmission and not just protect against severe disease would help to further strengthen the case for vaccination.

We are only allowed the luxury of posing such questions because today’s study offers the cholera community an effective vaccine conferring durable protection. Despite all these unresolved issues, the need for an affordable cholera vaccine for international use has now been partly fulfilled. The focus now shifts to global policy makers and individual governments as they determine how to translate these study results into effective public good. While we celebrate a rare success story, perhaps the first in the WHO supported Decade of Vaccines collaboration, we need to seize this opportunity to transform global cholera control before we are once again overwhelmed by the next, inevitable, outbreak.

Articles
5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial
Sujit K Bhattacharya, Dipika Sur, Mohammad Ali, Suman Kanungo, Young Ae You, Byomkesh Manna, Binod Sah, Swapan K Niyogi, Jin Kyung Park, Banwarilal Sarkar, Mahesh K Puri, Deok Ryun Kim, Jacqueline L Deen, Jan Holmgren, Rodney Carbis, Mandeep Singh Dhingra, Allan Donner, G Balakrish Nair, Anna Lena Lopez, Thomas F Wierzba, John D Clemens
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970273-1/abstract

Summary
Background
Efficacy and safety of a two-dose regimen of bivalent killed whole-cell oral cholera vaccine (Shantha Biotechnics, Hyderabad, India) to 3 years is established, but long-term efficacy is not. We aimed to assess protective efficacy up to 5 years in a slum area of Kolkata, India.

Methods
In our double-blind, cluster-randomised, placebo-controlled trial, we assessed incidence of cholera in non-pregnant individuals older than 1 year residing in 3933 dwellings (clusters) in Kolkata, India. We randomly allocated participants, by dwelling, to receive two oral doses of modified killed bivalent whole-cell cholera vaccine or heat-killed Escherichia coli K12 placebo, 14 days apart. Randomisation was done by use of a computer-generated sequence in blocks of four. The primary endpoint was prevention of episodes of culture-confirmed Vibrio cholerae O1 diarrhoea severe enough for patients to seek treatment in a health-care facility. We identified culture-confirmed cholera cases among participants seeking treatment for diarrhoea at a study clinic or government hospital between 14 days and 1825 days after receipt of the second dose. We assessed vaccine protection in a per-protocol population of participants who had completely ingested two doses of assigned study treatment.

Findings
69 of 31 932 recipients of vaccine and 219 of 34 968 recipients of placebo developed cholera during 5 year follow-up (incidence 2·2 per 1000 in the vaccine group and 6·3 per 1000 in the placebo group). Cumulative protective efficacy of the vaccine at 5 years was 65% (95% CI 52—74; p<0·0001), and point estimates by year of follow-up suggested no evidence of decline in protective efficacy.

Interpretation
Sustained protection for 5 years at the level we reported has not been noted previously with other oral cholera vaccines. Established long-term efficacy of this vaccine could assist policy makers formulate rational vaccination strategies to reduce overall cholera burden in endemic settings.

Funding
Bill & Melinda Gates Foundation.

Medical Decision Making (MDM)
November 2013; 33 (8)
http://mdm.sagepub.com/content/current

Vaccination, Herd Behavior, and Herd Immunity
Matan J. Cohen, Mayer Brezis, Colin Block, Adele Diederich, David Chinitz

Abstract http://mdm.sagepub.com/content/33/8/1026.abstract
Background: During the 2009 outbreak of novel influenza AH1N1, insufficient data were available to adequately inform decision makers about benefits and risks of vaccination and disease. We hypothesized that individuals would opt to mimic their peers, having no better decision anchor. We used Game Theory, decision analysis, and transmission models to simulate the impact of subjective risks and preference estimates on vaccination behavior.

Methods: We asked 95 students to provide estimates of risk and health state valuations with regard to AH1N1 infection, complications, and expectations of vaccine benefits and risks. These estimates were included in a sequential chain of models: a dynamic epidemic model, a decision tree, and a population-level model. Additionally, participants’ intentions to vaccinate or not at varying vaccination rates were documented.

Results: The model showed that at low vaccination rates, vaccination dominated. When vaccination rates increased above 78%, nonvaccination was the dominant strategy. We found that vaccination intentions did not correspond to the shift in strategy dominance and segregated to 3 types of intentions: regardless of what others do 29/95 (31%) intended to vaccinate while 27/95 (28%) did not; among 39 of 95 (41%) intention was positively associated with putative vaccination rates.

Conclusions: Some people conform to the majority’s choice, either shifting epidemic dynamics toward herd immunity or, conversely, limiting societal goals. Policy leaders should use models carefully, noting their limitations and theoretical assumptions. Behavior drivers were not explicitly explored in this study, and the discrepant results beg further investigation. Models including real subjective perceptions with empiric or subjective probabilities can provide insight into deviations from expected rational behavior and suggest interventions in order to provide better population outcomes.

Nature   
Volume 502 Number 7471 pp271-402  17 October 2013
http://www.nature.com/nature/current_issue.html

Nature | Editorial
High hopes
Care must be taken not to raise unrealistic expectations for RTS,S malaria vaccine.
16 October 2013
Excerpt  http://www.nature.com/news/high-hopes-1.13953

Vaccines have been an unparalleled public-health success: they have eradicated smallpox and driven polio to near extinction, and routine childhood immunization saves millions of children a year from death from diseases such as measles, diphtheria, tetanus and whooping cough. So it is not surprising that the public tend to view vaccines as synonymous with elimination, or near elimination, of our microbial foes.

This may help to explain last week’s extensive and often upbeat media coverage of the 18-month results of a huge phase III trial of the malaria vaccine candidate RTS,S/AS01 in more than 15,000 children across 7 African countries. In the United Kingdom, for example, the front page of The Guardian stated that the vaccine “could save lives of millions of children”.    Unfortunately, however, it won’t. The 18-month results only confirm the disappointing results seen after 12 months.

The RTS,S vaccine is not what most people would think of as a vaccine. It provides only partial protection and most of those vaccinated, particularly those in areas with moderate to high malaria transmission rates, will eventually contract the disease. There is also confusion over its efficacy. Many media reports concluded that although the vaccine did not give the 90%-plus efficacy levels of most childhood vaccines, it might nonetheless be satisfactory, with a reported 46% reduction in cases in children vaccinated when they were aged 5 to 17 months, and 27% in 6–12-week-old babies.

Not so. The efficacy figures given for RTS,S are not directly comparable with those usually given for vaccines. The conventional measurement of a vaccine’s success is how may people remain protected after a given period, such as 12 months. Because RTS,S is only partially protective, a different measurement of efficacy is used — a complex statistical model that computes hazard ratios on the basis of the first clinical episodes of malaria. As the designers of the method themselves concede, “a shortcoming of the vaccine efficacy calculated from hazard ratios could be that it is not intuitively understood”. Too true. In the hands of experts, and regulatory agencies, this hazards-ratio model offers a valid measurement of the efficacy of a partially protective vaccine, but it can be easily misinterpreted by the media, politicians and policy-makers…

… The work will continue. Data on the effects of a booster dose given after 18 months will not be available until next year, and RTS,S is also due to be tested in combination with a vaccine developed by researchers at the University of Oxford, UK, in an early-stage clinical trial. Meanwhile, the RTS,S trials are to be applauded for having left a lasting legacy in the unprecedented collaboration with African scientists who led the study, and a first-class clinical-trials infrastructure on the continent.

RTS,S has been in the works for almost 30 years. Since 2001, the MVI has put some US$200 million into it, and GSK more than $350 million, with a further $260 million earmarked to complete its development. The huge past impact of vaccines risks fuelling illusions over the impact of having a malaria ‘vaccine’. But the modest efficacy of RTS,S means that it falls squarely in competition with other malaria control measures, many of which might be more cost-effective. Care must be taken not to build excessive expectations that can only lead to disappointment over its potentially limited public-health impact.”

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
September 2013  Vol. 34, No. 3
http://www.paho.org/journal/index.php?option=com_content&view=article&id=132&Itemid=228&lang=en

Trends in mortality from respiratory diseases among the elderly and the influenza vaccine intervention, 1980–2009
[Tendencias de la mortalidad por enfermedades respiratorias en ancianos e influencia de la vacuna antigripal, 1980–2009]
Priscila Maria Stolses Bergamo Francisco, Maria Rita Donalisio, and Leticia Marín-León

PLoS One
[Accessed 19 October 2013]
http://www.plosone.org/
Hepatitis B Screening and Vaccination Strategies for Newly Arrived Adult Canadian Immigrants and Refugees: A Cost-Effectiveness Analysis
Carmine Rossi, Kevin Schwartzman, Olivia Oxlade, Marina B. Klein, Chris Greenaway Research Article | published 18 Oct 2013 | PLOS ONE 10.1371/journal.pone.0078548

Abstract
Background
Immigrants have increased mortality from hepatocellular carcinoma as compared to the host populations, primarily due to undetected chronic hepatitis B virus (HBV) infection. Despite this, there are no systematic programs in most immigrant-receiving countries to screen for chronic HBV infection and immigrants are not routinely offered HBV vaccination outside of the universal childhood vaccination program.

Methods and findings
A cost-effective analysis was performed to compare four HBV screening and vaccination strategies with no intervention in a hypothetical cohort of newly-arriving adult Canadian immigrants. The strategies considered were a) universal vaccination, b) screening for prior immunity and vaccination, c) chronic HBV screening and treatment, and d) combined screening for chronic HBV and prior immunity, treatment and vaccination. The analysis was performed from a societal perspective, using a Markov model. Seroprevalence estimates, annual transition probabilities, health-care costs (in Canadian dollars), and utilities were obtained from the published literature. Acute HBV infection, mortality from chronic HBV, quality-adjusted life years (QALYs), and costs were modeled over the lifetime of the cohort of immigrants. Costs and QALYs were discounted at a rate of 3% per year. Screening for chronic HBV infection, and offering treatment if indicated, was found to be the most cost-effective intervention and was estimated to cost $40,880 per additional QALY gained, relative to no intervention. This strategy was most cost-effective for immigrants < 55 years of age and would cost < $50,000 per additional QALY gained for immigrants from areas where HBV seroprevalence is ≥ 3%. Strategies that included HBV vaccination were either prohibitively expensive or dominated by the chronic HBV screening strategy.

Conclusions
Screening for chronic HBV infection from regions where most Canadian immigrants originate, except for Latin America and the Middle East, was found to be reasonably cost-effective and has the potential to reduce HBV-associated morbidity and mortality.

PLoS One
[Accessed 19 October 2013]
http://www.plosone.org/

Impact of Birth Seasonality on Dynamics of Acute Immunizing Infections in Sub-Saharan Africa
Audrey M. Dorélien, Sebastien Ballesteros, Bryan T. Grenfell
Research Article | published 18 Oct 2013 | PLOS ONE 10.1371/journal.pone.0075806

Abstract
We analyze the impact of birth seasonality (seasonal oscillations in the birth rate) on the dynamics of acute, immunizing childhood infectious diseases. Previous research has explored the effect of human birth seasonality on infectious disease dynamics using parameters appropriate for the developed world. We build on this work by including in our analysis an extended range of baseline birth rates and amplitudes, which correspond to developing world settings. Additionally, our analysis accounts for seasonal forcing both in births and contact rates. We focus in particular on the dynamics of measles. In the absence of seasonal transmission rates or stochastic forcing, for typical measles epidemiological parameters, birth seasonality induces either annual or biennial epidemics. Changes in the magnitude of the birth fluctuations (birth amplitude) can induce significant changes in the size of the epidemic peaks, but have little impact on timing of disease epidemics within the year. In contrast, changes to the birth seasonality phase (location of the peak in birth amplitude within the year) significantly influence the timing of the epidemics. In the presence of seasonality in contact rates, at relatively low birth rates (20 per 1000), birth amplitude has little impact on the dynamics but does have an impact on the magnitude and timing of the epidemics. However, as the mean birth rate increases, both birth amplitude and phase play an important role in driving the dynamics of the epidemic. There are stronger effects at higher birth rates.

PLoS One
[Accessed 19 October 2013]
http://www.plosone.org/

The State of Infectious Diseases Clinical Trials: A Systematic Review of ClinicalTrials.gov
Neela D. Goswami, Christopher D. Pfeiffer, John R. Horton, Karen Chiswell, Asba Tasneem, Ephraim L. Tsalik
Research Article | published 16 Oct 2013 | PLOS ONE 10.1371/journal.pone.0077086
Abstract
Background
There is a paucity of clinical trials informing specific questions faced by infectious diseases (ID) specialists. The ClinicalTrials.gov registry offers an opportunity to evaluate the ID clinical trials portfolio.

Methods
We examined 40,970 interventional trials registered with ClinicalTrials.gov from 2007–2010, focusing on study conditions and interventions to identify ID-related trials. Relevance to ID was manually confirmed for each programmatically identified trial, yielding 3570 ID trials and 37,400 non-ID trials for analysis.

Results
The number of ID trials was similar to the number of trials identified as belonging to cardiovascular medicine (n = 3437) or mental health (n = 3695) specialties. Slightly over half of ID trials were treatment-oriented trials (53%, vs. 77% for non-ID trials) followed by prevention (38%, vs. 8% in non-ID trials). ID trials tended to be larger than those of other specialties, with a median enrollment of 125 subjects (interquartile range [IQR], 45–400) vs. 60 (IQR, 30–160) for non-ID trials. Most ID studies are randomized (73%) but nonblinded (56%). Industry was the funding source in 51% of ID trials vs. 10% that were primarily NIH-funded. HIV-AIDS trials constitute the largest subset of ID trials (n = 815 [23%]), followed by influenza vaccine (n = 375 [11%]), and hepatitis C (n = 339 [9%]) trials. Relative to U.S. and global mortality rates, HIV-AIDS and hepatitis C virus trials are over-represented, whereas lower respiratory tract infection trials are under-represented in this large sample of ID clinical trials.

Conclusions
This work is the first to characterize ID clinical trials registered in ClinicalTrials.gov, providing a framework to discuss prioritization, methodology, and policy.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Potential cost‐effectiveness of the nonavalent Human Papillomavirus (HPV) vaccine
M Drolet, JF Laprise, MC Boily, EL Franco, M Brisson – International Journal of Cancer, 2013
ABSTRACT Randomized clinical trials are currently examining the efficacy of a nonavalent human papillomavirus (HPV) vaccine, including HPV-types 6/11/16/18/31/33/45/52/58.
Evidence on the cost-effectiveness of the nonavalent is required for timely policy- …

Development of real-time PCR to detect oral vaccine-like poliovirus and its application to environmental surveillance
M Iwai-Itamochi, H Yoshida, M Obara-Nagoya… – Journal of Virological …, 2013
Abstract In order to perform environmental surveillance to track oral poliovirus vaccine-like poliovirus sensitively and conveniently, real-time PCR was developed and applied to a raw
sewage concentrate. The real-time PCR method detected 0.01 to 0.1 TCID 50 of 3 …

Infectious disease: Conjugate vaccine is effective against serogroup A meningococcal meningitis
E Bible – Nature Reviews Neurology, 2013
A collaboration between the African Meningococcal Carriage Consortium (MenAfriCar), the Meningitis Vaccine Project and researchers from several countries has shown that a
meningococcal conjugate vaccine prevented meningitis during an epidemic of serogroup …

Live-attenuated bacteria as a cancer vaccine vector
B Toussaint, X Chauchet, Y Wang, B Polack… – Expert Review of Vaccines, 2013
In the emerging field of active and specific cancer immunotherapy, strategies using live-attenuated bacterial vectors have matured in terms of academic and industrial development.
Different bacterial species can be genetically engineered to deliver antigen to APCs with …

Modeling the effect of water, sanitation, and hygiene and oral cholera vaccine implementation in Haiti
ICH Fung, DL Fitter, RH Borse, MI Meltzer, JW Tappero – The American journal of …, 2013
Abstract. In 2010, toxigenic Vibrio cholerae was newly introduced to Haiti. Because resources are limited, decision-makers need to understand the effect of different preventive
interventions. We built a static model to estimate the potential number of cholera cases …

Declines in human papillomavirus infection observed in the vaccine era
MK Barton – CA: A Cancer Journal for Clinicians, 2013
Currently, 2 HPV vaccines are available: a quadrivalent vaccine against HPV types 6 (HPV-6),-11,-16, and-18; and a bivalent one against HPV-16 and-18. HPV-16 and-18 cause
approximately 70% of cervical cancers and although HPV-6 and-11 are not oncogenic, ..

Protection against hepatitis E virus infection by naturally acquired and vaccine induced immunity
J Zhang, XF Zhang, C Zhou, ZZ Wang, SJ Huang… – Clinical Microbiology and …, 2013
Abstract Immunity acquired from infection or vaccination protects humans from suffering of symptomatic hepatitis E. However, whether the risk of hepatitis E virus (HEV) infection is
reduced by the immunity remains unknown. To understand this issue, a cohort with 12,409 …

Specialized program newsletters, online publications
Dengue Vaccine Initiative: DVI newsletter
October 2013
http://us2.campaign-archive2.com/?u=3805c2f42ef8400c2e9729b91&id=3f238b7401&e=6898e601e9

Vaccines: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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– Email Summary: Vaccines: The Week in Review is published as a single email summary, scheduled for release each Saturday eveningbefore midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
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– pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_12 Oct 2013
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– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

Letter: Phase III efficacy trial of the RTS,S malaria vaccine candidate
Dear Colleague:
On behalf of the PATH Malaria Vaccine Initiative, GlaxoSmithKline, and 11 African research centers in seven countries, we are writing to inform you that further results from the Phase III efficacy trial of the RTS,S malaria vaccine candidate are to be presented on Tuesday, 8 October, at the 6th Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference in Durban, South Africa. An article with additional findings and data is in preparation for submission to a peer-reviewed journal.

The results presented are the third set from the ongoing Phase III trial. Over 18 months of follow-up, RTS,S was shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination). These results were demonstrated in the context of existing malaria control measures, such as insecticide treated bednets, which were used by 78% of children and 86% of infants in the trial. The presentation abstract concluded by saying that the vaccine “shows potential for a role in malaria control in Africa.”

Over 18 months of follow-up, children aged 5-17 months at first vaccination with RTS,S experienced 46% (95% CI: 42 to 50) fewer cases of clinical malaria, compared to children immunised with a control vaccine; an average of 941 cases of clinical malaria were prevented for every 1,000 children vaccinated. Severe malaria cases were reduced by 36% (95% CI: 15 to 51), malaria hospitalisations by 42% (95% CI: 29 to 52), and all-cause hospitalizations by 19% (95% CI: 9 to 28).

Infants aged 6-12 weeks at first vaccination with RTS,S had 27% (95% CI: 20 to 32) fewer cases of clinical malaria. Over 18 months of follow-up, 444 cases of clinical malaria were prevented for every 1,000 infants vaccinated. The reduction of severe malaria cases and malaria hospitalisations was not statistically significant.

Vaccine efficacy was also assessed separately at each of the trial sites, which represented a wide range of malaria transmission settings; efficacy was found to be statistically significant at all sites in young children and at four sites in infants. At clinical trial sites where there were more cases of malaria, we found greater impact in both age groups.

RTS,S continued to display an acceptable safety and tolerability profile during the 18 month follow-up. Apart from the meningitis signal previously reported, no other safety signal was identified.     The occurrence of meningitis will be followed closely during the remainder of the trial.

Based on these results, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The World Health Organization (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015.

Follow-up in this Phase III trial is ongoing. Further data from 32 months follow-up and the impact of a fourth ‘booster’ dose given 18 months after the initial three doses are expected to become available in 2014.

The RTS,S malaria vaccine candidate is still under development and subject to the evaluation of the benefits and risks by regulatory authorities before being made available.
The abstract for the presentation at MIM is available at:
http://www.malariavaccine.org/rd-rtss.php
A press release on the findings is available at:
http://www.malariavaccine.org/pr2013Oct8-RTSS.php
On behalf of the partners, we are,
Sincerely yours,
David C. Kaslow, MD                                               Sophie Biernaux
Vice President for Product Development            Vice President and Malaria Vaccine Leader
PATH

   PATH and China National Biotec Group Co., Ltd. (CNBG) announced that SA 14-14-2, a live, attenuated Japanese encephalitis (JE) vaccine, won WHO prequalification.  The action also represents the first time a vaccine produced by a Chinese manufacturer has achieved prequalification. The vaccine is manufactured by Chengdu Institute of Biological Products Co., Ltd. (CDIBP), a subsidiary of CNBG. With funding from the Bill & Melinda Gates Foundation, PATH “led a series of pivotal clinical trials to establish the immunogenicity and safety of the vaccine in at-risk children and provided technical and financial support to help CDIBP meet the international manufacturing standards required for WHO prequalification.” Steve Davis, PATH president and CEO, commented, “This milestone brings the world within reach of an audacious goal: the elimination of a devastating disease through expanded access to an affordable and lifesaving vaccine. Our groundbreaking collaboration with leading Chinese partners also helped lay the foundation for reshaping global vaccine supply, pricing, and accessibility through increased competition. This milestone signals China’s rising importance as a global supplier of high-quality vaccines for the most vulnerable children in the world.”

Read more about PATH’s JE Project.

GAVI said it welcomed Canada’s US$20 million pledge to accelerate access to measles vaccines, to be invested in GAVI’s measles programme. The pledge is part of Canada’s commitment to the Muskoka Initiative on Maternal, Newborn and Child Health launched by G8 partners at the Muskoka Summit in 2010. The six countries covered under Canada’s support are Afghanistan, Pakistan, Chad, Democratic Republic of Congo, Nigeria and Ethiopia.

“We are very grateful to Canada for its commitment,” said GAVI CEO Dr Seth Berkley. “As a leader of the Muskoka Initiative for Maternal, Newborn, and Child Health, Canada’s support paves the way for the introduction of the combined measles-rubella vaccine that will significantly improve the health of mothers and children.”

http://www.gavialliance.org/library/news/statements/2013/gavi-welcomes-canada-s-support-for-measles-vaccines/