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 with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before 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.

– pdf version:  A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_24 October 2015

– blog edition: comprised of the approx. 35+ entries posted below on 13 September 2015..

– 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
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

WHO SAGE Meeting/Malaria Vaccine+

WHO – Press Conference on Outcomes of SAGE Immunization Meeting (Geneva, 23 October 2015)
Video
Briefing on outcomes and recommendations of the meeting of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, held this week.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization, which was established to advise WHO on policies and strategies for immunization, met on 20-22 October 20-22 to review the best available scientific evidence on development and use of vaccines including those for use against Ebola virus, poliovirus and malaria. .
Speaker: Professor Jon S. Abramson – Chair of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization

News release
Pilot implementation of first malaria vaccine recommended by WHO advisory groups
Global move to remove type two oral polio vaccine agreed for April
23 October 2015 | GENEVA – The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) jointly recommended pilot projects to understand how to best use a vaccine that protects against malaria in young children.

“This was a historic meeting with two of WHO’s major advisory committees working together to consider current evidence about this vaccine,” said Professor Fred Binka, acting chair of MPAC. “The committees agreed that pilot implementations should be the next step with this vaccine.”

The vaccine, known as RTS,S, is the first vaccine for malaria, but there is one primary question. It requires four doses for a child to be fully protected and therefore requires additional contacts with the health care system. The first three doses are given one month apart followed by an 18-month pause before the fourth dose. Without the fourth dose, children had no overall reduction in severe malaria.

“The question about how the malaria vaccine may best be delivered still need to be answered,” said Professor Jon S. Abramson, chair of SAGE. “After detailed assessment of all the evidence we recommended that this question is best addressed by having 3-5 large pilot implementation projects.”

The malaria vaccine, RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa. It offers no protection against P. vivax malaria, which predominates in many countries outside of Africa. The vaccine is being assessed as a complementary malaria control tool that could potentially be added to—but not replace—the core package of proven malaria preventive, diagnostic and treatment measures.

In other sessions during the SAGE meeting, held from 20-22 October, the group reviewed evidence and offered recommendations on the development and use of vaccines against Ebola virus, poliovirus and measles.

Polio vaccine
Oral polio vaccine (OPV) is the primary tool used to eradicate polio worldwide, thanks to its unique ability to interrupt person-to-person spread of the virus. However, on very rare occasions, the live attenuated vaccine-viruses contained in OPV can be associated with cases of vaccine-associated polio paralysis (VAPP) or circulating vaccine-derived polioviruses (cVDVPs). Withdrawing OPVs is therefore a crucial part of the polio endgame strategy.

The type 2 component of OPV accounts for 40% of VAPP cases, and upwards of 90% of cVDPV cases. By contrast, wild poliovirus type 2 has not been detected anywhere since 1999 and the Global Commission for the Certification of Poliomyelitis Eradication (GCC) declared this strain globally eradicated at its meeting in September 2015. Countries have therefore been preparing to remove the type 2 component from OPV, by switching from trivalent OPV (containing all three serotypes) to bivalent OPV (containing only type 1 and 3 serotypes). All oral polio vaccines will be removed after global eradication of wild poliovirus types 1 and 3 has been certified.

SAGE confirmed that the globally synchronized switch from trivalent oral polio vaccine (tOPV) to bivalent OPV (bOPV) should occur between 17 April and 1 May 2016.

SAGE also concluded that significant progress had been made since its last meeting, in April 2015, with no cases of wild poliovirus in Africa since August and more than a year having passed since the last case was seen in the Middle East, strengthened surveillance and more children being reached with vaccines in key areas of Pakistan and Afghanistan. As a result of these steps, all countries and the partners of the Global Polio Eradication Initiative (GPEI) should intensify their preparations for the global withdrawal of OPV type 2 (OPV2) in April 2016.

SAGE cautioned, however, that more work needs to be done ahead of the switch date. It is critical that countries meet deadlines to protect populations by moving towards destruction of wild poliovirus type 2 stocks or their containment in ‘poliovirus essential’ facilities. Ongoing vaccine-derived type 2 polio outbreaks in Guinea and South Sudan need to be stopped. A global shortage of inactivated polio vaccine needs to be managed ahead of the switch, with available supplies prioritized for the highest-risk areas.

Measles vaccine
Currently 13 percent of measles cases are occurring in children before they reach 9 months – the youngest age at which the first dose is typically given, so SAGE is recommending, in specific circumstances, that a dose may be given earlier to infants as young as 6 months when the risk of contracting measles is high.

Ebola
SAGE also offered provisional recommendations on vaccination in response to an outbreak of Ebola, based on interim trial results suggesting high safety and efficacy. These recommendations are provisional because candidate vaccines are currently being used only in the context of clinical trials, and recommendations for use outside trial settings will depend on the vaccines receiving regulatory approval. The recommendations do not apply to any specific vaccine. Recommendations will be adjusted when more data become available.

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Gavi and Global Fund Statement on Malaria Vaccine Recommendations
23 October 2015
GENEVA – Today’s recommendations by two advisory bodies to the World Health Organization, the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC), for use of the RTS,S malaria vaccine are a step toward making the vaccine available in countries with a heavy malaria burden as well as an opportunity to assess its likely real world impact.

They have called for pilot implementations of the vaccine in three to five settings in sub-Saharan Africa. This follows an earlier four-year trial of the vaccine that found it safe and effective, providing 39 percent efficacy at preventing clinical cases of malaria.

Replicating that success rate in a non-clinical setting poses challenges. The RTS,S vaccine requires four doses and the last dose is critical for sustaining the protective effect of the vaccine. The first three doses of the vaccine will be administered to children between 5 and 9 months of age and the fourth dose is given around the second birthday. This is partially outside the existing immunization schedule in which most vaccines are administered to infants 6 to 14 weeks after birth, potentially posing logistical challenges to health systems in low-income countries. Further assessing the feasibility of providing these vaccinations and the resulting impact is therefore a prudent approach.

While additional studies could demonstrate RTS,S’s utility in the malaria control toolkit, global efforts must continue to expand access to proven methods of malaria control. The RTS,S vaccine could complement – not replace – existing proven and cost-effective methods, such as insecticide-treated mosquito nets and spraying. Tools such as insecticide-treated mosquito nets have significantly reduced the burden of malaria, more than halving the number under-five deaths since 2000. Despite such progress, there are still more than 200 million cases of malaria worldwide each year, resulting in 438,000 deaths, the vast majority of them African children.

It is now for the World Health Organization to confirm its recommendations on the first-ever malaria vaccine based on the recommendations received from SAGE/MPAC. The boards of Gavi and the Global Fund will review the WHO’s recommendation to determine next steps.

Gavi and the Global Fund are continuing to work together to plan for the possible use of a malaria vaccine, if recommended by WHO and if the Gavi and Global Fund boards decide to support the vaccine in conjunction with other proven malaria interventions, as part of an integrated approach towards malaria control. Both organisations are working in close coordination with the Global Malaria Programme at the WHO, other technical and donor partners and implementing countries.

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PATH [to 24 October 2015]
http://www.path.org/news/index.php
GSK and PATH joint statement on WHO advisory group recommendation on use of RTS,S malaria vaccine candidate
October 23, 2015—The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) and Malaria Policy Advisory Committee (MPAC) have today jointly recommended implementation of GlaxoSmithKline’s (GSK) malaria vaccine candidate RTS,S (Mosquirix™) through a number of pilot projects. This is an important step in the process toward making RTS,S available alongside existing tools currently recommended for malaria prevention, diagnosis, treatment, and control. GSK and PATH will now review the SAGE/MPAC advice as we wait for the final policy recommendation from the WHO expected by the end of 2015.

GSK and PATH stand ready to work with the WHO on the pilot implementation of the vaccine, in order to provide the additional information needed about how to best deliver the vaccine in a real-world setting, enabling implementation of a wider scale immunisation programme in children in sub-Saharan Africa (SSA). The results of a large scale phase III efficacy and safety trial of RTS,S, have shown that RTS,S could provide a meaningful public health benefit in reducing the burden of malaria when used alongside currently available interventions such as bed nets and insecticides.

The SAGE/MPAC joint recommendation comes after the vaccine candidate received a positive scientific opinion from the European regulators in July 2015 for the prevention of malaria in young children in SSA.

In 2013, there were an estimated 584,000 deaths from malaria with around 90 percent of these occurring in SSA, and 83 percent in children under the age of five.

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Press release | October 20, 2015
Visualize No Malaria campaign to prove malaria elimination possible in Africa
PATH & Tableau Foundation form unique partnership to aid elimination efforts in Zambia using data visualization.

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Global Fund [to 24 October 2015]
http://www.theglobalfund.org/en/news/

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News
Global Fund Statement on Cambodia’s Programs against Malaria
20 October 2015
Cambodia has made impressive progress against malaria, with a 70 percent decline in the number of cases from 2009 to 2014, and a sharp reduction in deaths in the same period.
However, the situation remains critical, and preliminary data on an increase in malaria cases in parts of Cambodia since mid-2014, as well as resistance to artemisinin-based combination therapies, carries serious implications for the broader Mekong region.

The Global Fund is working with key partners, including the Government of Cambodia and the United Nations Office of Project Services and others, to take all possible measures to reverse the recent increase.

The Global Fund implements a framework of accountability that requires transparent reporting on investments in health, so that a maximum of available resources go toward serving people affected by malaria and other diseases.

The Global Fund has a zero tolerance policy for fraud and corruption, and requires a high degree of transparency and accountability from all partners, even in challenging operating environments where governance and accountability systems do not meet international standards.

In Cambodia, the Global Fund is working with the Ministry of Health to address implementation challenges and to support efforts that maximize results and impact and that further strengthen systems for health to serve the people of Cambodia.

EBOLA/EVD [to 24 October 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Ebola Situation Report – 21 October 2015
[Excerpts]
SUMMARY
:: Three new confirmed cases of Ebola virus disease (EVD) were reported in the week to 18 October, all of which were reported in Guinea. The country had reported zero cases for the previous 2 weeks. Of the 3 new cases, 1 was reported from the capital, Conakry, and 2 were reported from the subprefecture of Kaliah, Forecariah. Of note, 2 cases were not registered contacts, 1 of whom was identified after post-mortem testing of a community death. There are currently 246 contacts under follow-up in Guinea (70 of whom are high risk), and an additional 253 contacts identified during the past 42 days remain untraced. Therefore there remains a near-term risk of further cases among both registered and untraced contacts. Sierra Leone reported zero cases for a fifth consecutive week.

:: Case incidence has remained at 5 confirmed cases or fewer per week for 12 consecutive weeks. Over the same period, transmission of the virus has been geographically confined to several small areas in western Guinea and Sierra Leone, marking a transition to a distinct, third phase of the epidemic. The phase-3 response coordinated by the Interagency Collaboration on Ebola builds on existing measures to drive case incidence to zero, and ensure a sustained end to EVD transmission. Enhanced capacity to rapidly identify a reintroduction (either from an area of active transmission or from an animal reservoir), or re-emergence of virus from a survivor, and capacity for testing and counselling as part of a comprehensive package to safeguard the welfare of survivors are central to the phase-3 response framework…

POLIO [to 24 October 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week as of 21 October 2015
Global Polio Eradication Initiative
Full report link: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
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:: World Polio Day on 24 October is an opportunity to reflect on how far we have come in the last year and to pay tribute to the countless healthcare workers, volunteers, families, traditional and religious leaders, governments, donors, civil society organizations and partners who work tirelessly to protect children against polio. Join Rotary International and UNICEF for a live streamed global update on 23 October and for updates throughout the week from the partners of the Global Polio Eradication Initiative follow @Vaccines on Twitter.
:: The Independent Monitoring Board met in London in October to assess progress towards polio eradication and to make recommendations for the coming months. The report is expected to be published in the next few weeks.
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[Selected Country Update Information]
Afghanistan
:: Three new positive environmental samples were reported in the past week, two in Hilmand district of Hilmand province with collection dates of 19 and 20 September and one in Nangarhar district of Nangarhar province, collected on 21 September.
:: Mop-up campaigns are planned in October in Gulestan district of Farah using the inactivated polio vaccine (IPV) and bivalent OPV with dates to be confirmed. National Immunization Days (NIDs) will take place on 1 – 3 November using trivalent OPV and Subnational Immunisation Days (SNIDs) are planned from 29 November to 1 December in the south and east of the country using bivalent OPV. Further mop up campaigns will take place in Balabuluk and Khak-E-Safed districts of Farah in November.
Pakistan
:: Three new environmental samples positive for WPV1 were reported in the last week. One was collected in Rawalpindi district of Punjab on 10 September, one in Quetta district of Balochistan on 20 September and one in Karachi-Gadap town, Sindh, on 22 September.
Ukraine
:: No new circulating vaccine-derived poliovirus type 1 (cVDPV1) cases have been reported in the past week. The most recent case had onset of paralysis on 7 July in the Zakarpatskaya oblast, in south-western Ukraine, bordering Romania, Hungary, Slovakia and Poland. The number of cVDPV1 cases reported in 2015 remains 2.
:: Ukraine had been at particular risk of emergence of a cVDPV, due to inadequate vaccination coverage.
:: An outbreak response has started in the last week in Ukraine with supplementary immunization activities taking place in every Oblast. The next few weeks will be critical in terms of continued political support and oversight to ensure all children are reached with the vaccines.

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Nationwide polio immunization campaign under way in Ukraine
After an outbreak of circulating vaccine derived poliovirus was reported in Ukraine in September, a vaccination campaign using the oral polio vaccine has been launched.
Wednesday, October 21, 2015
A nationwide vaccination campaign with oral polio vaccine was launched today in Ukraine in response to a polio outbreak in the country. WHO applauded the decision taken by the Ministry of Health to begin the campaign, which is mandated by international guidelines as part of a comprehensive outbreak response. “With the campaign now under way, we call on health care providers and parents in Ukraine to exercise their right and responsibility to vaccinate all children in the designated age groups urgently to stop transmission of this dreaded virus,” said Dr Zsuzsanna Jakab, WHO Regional Director for Europe.
The first phase of the campaign will target 2.85 million children under the age of 6. At least two additional rounds, with one targeting 4.75 million children up to 10 years, are expected to follow at 1-month intervals. The vaccine is to be given free to all children in the designated age groups…

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Mass polio immunization campaign aims to reach 3 million children in Syria
UNICEF and WHO appeal for improved access to children
DAMASCUS, Syria, 18 October 2015 — A 5-day nationwide immunization campaign began today in Syria aiming to vaccinate 3 million children against polio.
The current campaign is part of a comprehensive response to the polio outbreak in October 2013. 15 mass vaccination campaigns reaching on average 2.9 million children each round have been carried out since. No new cases have been reported since January 2014.
The campaign is jointly organized by the Ministry of Health, UNICEF, the World Health Organization and local partners, including the Syrian Arab Red Crescent. It aims to reach children under the age of 5 across the country, including those who have been displaced. The vaccination will take place at fixed clinics, and in areas where the conflict is heavy vaccinators will go house to house…

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Rotary gives US$40.4 million to end polio worldwide
Oct 23, 2015
On the heels of historic success against polio in Nigeria and across the continent of Africa, the global effort to end polio is receiving an additional US$40.4 million boost from Rotary to support immunization activities and surveillance spearheaded by the Global Polio Eradication Initiative….
… Following Nigeria’s polio-free milestone, and no cases of wild polio in all of Africa in more than a year, Rotary is contributing $26.8 million to African countries to ensure the disease never returns to the continent: Burkina Faso ($1.6 million), Cameroon ($2.7 million), Chad ($2.6 million), Democratic Republic of Congo ($499,579), Equatorial Guinea ($685,000), Kenya ($750,102), Madagascar ($562,820), Mali ($1.5 million), Niger ($3 million), Nigeria ($6.9 million), Somalia ($4.9 million) and South Sudan ($1.5 million).
Rotary has earmarked $6.7 million to polio-endemic Pakistan, $400,000 to Iraq and $5.3 million to India. The remaining $990,542 will support immunization activities and surveillance…

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WHO: World Polio Day: Thanking the health worker for the progress
24 October 2015 — World Polio Day marks the milestones that have been reached in the past year towards a polio-free world, and most importantly, recognises the incredible contributions made by healthcare workers, volunteers, families, and partners. WHO and partners are marking this day by celebrating progress towards eradication and planning for what still needs to be done to achieve a polio-free world.
Video message from the WHO Director-General

MERS-CoV [to 24 October 2015]
Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 22 October 2015
Between 10 and 13 October 2015, the National IHR Focal Point for the Kingdom of Saudi Arabia notified WHO of 4 additional cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection. The four cases are from the same compound in Riyadh city…

…The National IHR Focal Point for the Kingdom of Saudi Arabia also notified WHO of the death of 3 MERS-CoV cases that were reported in previous DONs on 27 September (case no. 13), on 17 September (case no. 9) and on 2 September (case no. 1).

Globally, since September 2012, WHO has been notified of 1,599 laboratory-confirmed cases of infection with MERS-CoV, including at least 574 related deaths….

WHO & Regionals [to 24 October2015]
Disease Outbreak News (DONs)
:: Zika virus infection – Brazil and Colombia 21 October 2015
:: Cholera – United Republic of Tanzania 21 October 2015
:: Human infection with avian influenza A(H7N9) virus – China 19 October 2015

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Weekly Epidemiological Record (WER) 23 October 2015, vol. 90, 43 (pp. 577–588):
577 Progress towards eliminating onchocerciasis in the WHO Region of the Americas: verification of elimination of transmission in Mexico
581 Progress towards poliomyelitis eradication: Afghanistan, January 2014–August 2015

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:: WHO Regional Offices
WHO African Region AFRO
:: Statement by the WHO Regional Director for Africa on World Polio Day 2015: A tribute to polio successes in Africa
Brazzaville, 24 October 2015 – Today, we celebrate a very special World Polio Day and a historic moment in the WHO African Region, one without a case of wild polio virus in over a year. The day comes just days before the official ceremony with the President of Nigeria to take the country off the polio endemic list. The day is a true testament of what political will, government leadership and the collective efforts of partners can achieve when united behind a global public health good. The successes in Africa demonstrate that strategies for eradication of vaccine preventable diseases work…
:: WHO ramps up response to cholera outbreak in two regions – 22 October 2015
:: WHO scales up efforts to detect and control the spread of influenza viruses in Africa – 19 October 2015

WHO Region of the Americas PAHO
No new digest content identified.

WHO South-East Asia Region SEARO
:: Act tough against tobacco 20 October 2015

WHO European Region EURO
:: Towards domestic funding of HIV and TB response in eastern Europe and central Asia 23-10-2015
:: Day 2 of Life-course Conference: Minsk Declaration signed 23-10-2015
:: World Polio Day highlights progress and concerns in the final stretch to polio eradication 23-10-2015
:: Day 1 of Life-course Conference: synergies between Health 2020 and sustainable development goals 21-10-2015
:: Nationwide polio immunization campaign under way in Ukraine 21-10-2015

WHO Eastern Mediterranean Region EMRO
:: WHO responds to deteriorating health situation in Taiz, Yemen
20 October 2015, Sana’a, Yemen – Ongoing violence and insecurity continue to limit the delivery of aid in Taiz, Yemen, where more than 3.3 million people, including 300,585 internally displaced persons, are in critical need of health assistance. WHO has provided 30 metric tonnes of medicines and medical supplies to Taiz and is distributing almost one million litres of water. It urgently needs US$ 60 million to continue life-saving response operations across the country until the end of 2015.
:: Mass polio immunization campaign aims to reach 3 million children in Syria
18 October 2015

WHO Western Pacific Region
:: World Polio Day: Fewer children than ever with polio

IDRI AND SANOFI PASTEUR TEAM WITH PHILANTHROPY TO DEVELOP NEW MODEL FOR VACCINE DEVELOPMENT
Seattle, WA | October 15, 2015
In an effort to accelerate timelines and decrease development costs of life-saving vaccines, the Infectious Disease Research Institute (IDRI) and Sanofi Pasteur today announced the establishment of the Global Health Vaccine Center of Innovation (GHVCI), to be headquartered at IDRI in Seattle. This project is funded in part by a grant from the Bill & Melinda Gates Foundation. The GHVCI represents an alliance among the three organizations, focused on accelerating the development of vaccines and associated technologies to fight a wide range of global infectious diseases, and ensuring that these critical vaccines are accessible globally, especially to people in need within developing countries.

Each partner will bring its respective world-leading expertise and technologies to the GHVCI and, collectively, the parties will collaborate with a wide range of other vaccine development organizations. Funding for the establishment, operation and growth of the GHVCI will come from Sanofi and the Gates Foundation, and additional funding will be sought to support collaborative research activities with respect to specific vaccines to be developed at the GHVCI.

This distinctive collaboration leverages the potential power of the partners’ collective expertise, combining IDRI’s vaccine design, formulation and production technologies; Sanofi’s position as a leading multi-national vaccine developer, manufacturer and seller; and the Gates Foundation’s knowledge, influence and financial support regarding the discovery and development of global health interventions, including vaccines. A key component is the application of IDRI’s vaccine adjuvant technologies and formulation expertise, which have been developed over the past few years with strong financial support from the Gates Foundation. These adjuvant technologies are uniquely designed to improve immune responses, broaden vaccine protection and significantly save costs by reducing the amount of vaccine needed…

…A Joint Steering Committee, comprised of representatives from each of the three partners, will mutually identify areas of research to discover, evaluate and develop novel human vaccines, as well as adjuvant/formulation platforms for the rapid response to emerging pathogens, that can prevent or treat infectious diseases.

Initial funding will be used to establish and operate the GHVCI, build capacity as the collaboration grows, and provide management and scientific recruitment as well as training…

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Sanofi Pasteur and the Infectious Disease Research Institute Partner on a Global-Health, Open-Innovation, Vaccine Research & Development Center
The GHVCI will address a range of infectious diseases
SWIFTWATER, Pennsylvania, October 15, 2015 /PRNewswire/ —
Sanofi Pasteur, the vaccines division of Sanofi, announced today the creation of a Global Health Vaccine Center of Innovation (GHVCI) with the Infectious Disease Research Institute (IDRI)… This project is also funded in part by a grant from the Bill & Melinda Gates Foundation, as the proposed R&D alliance is related to the Gates Foundation and Sanofi Pasteur’s strategic agreement on a Vaccine Discovery Partnership signed in 2013.

The addition of IDRI will enable vaccine adjuvant/formulation platforms and a pipeline of vaccine candidates to be discovered, evaluated and developed to address a range of infectious diseases under the center of innovation based at IDRI. The GHVCI will be co-funded by the Gates Foundation and Sanofi Pasteur under a tripartite agreement…

…”IDRI is a partner of choice as they are a world-leader in the development and evaluation of adjuvant formulations, using a broad portfolio of adjuvants with different immune-stimulating properties,” commented Jim Tartaglia, PhD, R&D VP for new vaccine projects at Sanofi Pasteur. “The Institute has a world-class staff and capabilities in immunology and GMP production”.

“There are a number of diseases that are of great global-health significance, where Sanofi Pasteur could significantly contribute,” according to John Shiver, PhD, Sr. VP for R&D at Sanofi Pasteur; “however, commercial realities provide a challenge to investment. The establishment of this Global Health Vaccines Center of Innovation represents a new opportunity–operating within the open innovation R&D model–to provide antigens, adjuvanted formulations, funding, and expertise to allow development of needed vaccines.”…

IAVI International AIDS Vaccine Initiative [to 24 October2015]
http://www.iavi.org/press-releases/2015

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Human Vaccines Project Welcomes Janssen as Newest Partner
October 23, 2015
The Human Vaccines Project welcomes Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), as the newest industry partner in its effort to accelerate the research and development of vaccines and immunotherapies for infectious diseases and cancer.

Incubated at the International AIDS Vaccine Initiative (IAVI), the Human Vaccines Project is an ambitious new public-private partnership seeking to transform the future of global disease prevention and treatment by solving the primary scientific obstacles impeding the research and development of new vaccines and immunotherapies. Endorsed by 35 leading vaccine scientists, the Project brings together top academic research centers, and government, non-profit and industry research and development efforts into a global consortium.

“The Human Vaccines Project offers an unprecedented opportunity to merge cutting-edge academic science with industrial product development capabilities to elucidate how the human immune system confers effective immunity, and thus accelerate the development of new interventions for a broad range of critical diseases,” said Johan van Hoof, Global Head, Infectious Diseases and Vaccines, Janssen. “Collaborative partnerships such as this, which bring together key expertise to solve complex scientific problems, are essential to deliver the transformational medical innovations needed to advance human health.”…

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Research and Development of New Biomedical HIV Prevention Tools for Women and Girls: Combating the Global AIDS Epidemic Through a More Empowered Response in Sub-Saharan Africa
IAVI Policy Brief
September 2015 :: 8 pages
High HIV prevalence and incidence puts a disproportionate burden on girls and women in Sub-Saharan Africa and threatens to reverse current success in combating the global AIDS epidemic. Programs to fight HIV/AIDS among women and girls can be bolstered by new biomedical prevention tools including pre-exposure prophylaxis, microbicides and vaccines that enhance women and girls’ ability to protect themselves. Better aligning research and development efforts with the needs of women and girls can accelerate the introduction of a wider, more effective array of HIV prevention tools to enhance the health of girls and women, as well as the global response to HIV/AIDS.

European Medicines Agency [to 24 October2015]
http://www.ema.europa.eu/ema/

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First oncolytic immunotherapy medicine recommended for approval
Advanced therapy medicine Imlygic indicated to treat certain stages of melanoma
23/10/2015
The European Medicines Agency (EMA) has recommended authorising Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma that cannot be removed by surgery and that has spread either to the surrounding area or to other areas of the body (regionally or distantly metastatic) without affecting the bones, brain, lung or other internal organs.
Imlygic is a first-in-class advanced therapy medicinal product (ATMP) derived from a virus, that has been genetically engineered to infect and kill cancer cells. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP) based on an assessment carried out by the Committee for Advanced Therapies (CAT), the Agency’s expert committee for ATMPs…

Gavi [to 24 October2015]

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Lions and Bill Gates commit to vaccinations
21 October 2015
The Lions Clubs International Foundation (LCIF) has committed to raising US$30 million by 2017 to improve access to vaccines through Gavi, The Vaccine Alliance. The funds raised will be matched by the United Kingdom’s Department for International Development and the Bill & Melinda Gates Foundation, bringing the total to US$60 million.

Global Fund [to 24 October2015]
http://www.theglobalfund.org/en/news/
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News
Malawi and Global Fund Deepen Partnership
22 October 2015
LILONGWE, Malawi – Malawi and the Global Fund are strengthening their partnership by signing grants worth more than US$332 million, to expand treatment and prevention for HIV, TB and malaria and build resilient and sustainable systems for health. This brings the total Global Fund commitment to Malawi to US$616 million from 2014-2017.
The financial resources provided through the Global Fund come from many sources and partners, represented at the signing ceremony today by the United States, the European Union, the United Kingdom, Germany, Japan, Ireland and Norway, as well as technical partners such as UNAIDS and WHO…

NIH [to 24 October2015]
http://www.nih.gov/news/releases.htm

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New prize competition seeks innovative ideas to advance open science
Applicants asked to develop new products or services to harness the power of “big data” to improve health

October 20, 2015 — The National Institutes of Health has partnered with London-based Wellcome Trust to launch a global science competition for new products or services to advance “open science,” a movement to make scientific research data broadly accessible to the public. Up to six teams of technology experts and researchers stand to win $80,000 each to develop their ideas into a prototype or to advance an existing early stage prototype. The prototype judged to have the greatest potential to further open science will receive $230,000.

“Research is a global, data-driven enterprise and our ability to improve health increasingly hinges on our ability to manage and make sense of the enormous amounts of data being produced by scientific research,” said NIH Director Francis S. Collins, M.D., Ph.D. “I expect the Open Science Prize to generate innovative ideas to improve data access and establish new international collaborations that will illustrate the transformative power of sharing research data.”…

FAO Food & Agriculture Organization [to 24 October2015]
http://www.fao.org/news/archive/news-by-date/2015/en/
U.S. backs FAO efforts to combat global animal disease threats with $87 million
Ebola, MERS-CoV and H5N1 avian influenza among diseases with human health implications and pandemic potential being targeted in Africa, Middle East and Asia
20 October 2015, Rome – The United States Agency for International Development (USAID) is backing FAO’s efforts to combat pandemic animal disease threats in Asia, Africa and the Middle East with an additional $87 million in funding covering the 2015-19 period.

USAID and FAO have worked in partnership on controlling animal diseases and managing related human health threats for over a decade. USAID financial backing for this work now amounts to $320 million since 2004.

The new funds will support monitoring and surveillance, epidemiological studies, prevention and control activities as well as improving veterinary capacities in Asia, Africa and the Middle East and promoting links between animal health specialists and the public health sector.

FAO Director-General José Graziano da Silva thanked the U.S. for its support and longstanding partnership. “This shows how important transboundary diseases are for FAO and the UN system, and how much more important they will be in in the future if we want to achieve the Sustainable Development Goals,” he said. “Millions of people rely on livestock for survival, income and nutrition, and their livelihoods must be protected,” he said…

The Selection and Use of Essential Medicines
WHO Technical Report Series
Report of the WHO Expert Committee, 2015
(including the 19th WHO Model List of Essential Medicines and the 5th WHO Model List of Essential Medicines for Children)
Executive summary
The 20th meeting of the WHO Expert Committee on the Selection and Use of Essential medicines took place in Geneva, Switzerland, from 20 to 24 April 2015. The goal of the meeting was to review and update the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc).
In accordance with approved procedures,1 the Expert Committee evaluated the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines. Both lists went through major revisions this year, as the Committee considered 77 applications, including 29 treatment regimens for cancer, and innovative hepatitis C and tuberculosis (TB) medicines.
The Expert Committee –
:: recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list); and
:: recommended the addition of 16 new medicines to the EMLc (four to the core list and 12 to the complementary list).

Section 19: Immunologicals [p. 313]
19.3: Vaccines (review) – EML and EMLc
The EML Secretariat, with input from the WHO Immunization, Vaccines and Biologicals Department, proposed a slightly revised approach to the listing of vaccines on the EML and EMLc for consideration by the Expert Committee.

The revised approach involves the full alignment of vaccines on the Model Lists with current WHO immunization policy recommendations as published in vaccine position papers on the basis of recommendations made by the Strategic Advisory Group of Experts on Immunization (SAGE).

SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development to delivery of immunization and its linkages with other health interventions in accordance with its mandate to provide guidance to Member States on health policy matters (http://www.who.int/immunization/policy/sage/en). SAGE consists of 15 internationally renowned independent experts in the field of immunization and is concerned not just with childhood vaccines and immunization but with all vaccine-preventable diseases. SAGE meets twice a year, generally in April and October. Working groups are established for detailed review of specific topics in advance of discussion by SAGE. Members of working groups review the evidence and prepare options for recommendations for discussion by the full SAGE group in an open forum. In developing recommendations, SAGE follows an evidence-based review process and applies GRADE. Processes follow the critical elements required by WHO’s Guideline Review Committee in the development of WHO guidelines.

SAGE may decide to recommend specific vaccines to be used universally or to be used conditionally or to not use specific vaccines at a given point in time. These recommendations translate into WHO policy recommendations. WHO publishes its global vaccine policy recommendations as vaccine position papers within the Weekly Epidemiological Record, available on the WHO website at http://www.who.int/immunization/documents/positionpapers/en/index.html. The position papers summarize essential background information on diseases and vaccines, and conclude with the current WHO position concerning vaccine use in the global context. The papers are designed for use by national public health officials and immunization programme managers. They may also be of interest to international funding agencies, the vaccine manufacturing industry, the medical community, and the scientific media.

WHO position papers undergo a formal review process both internally and externally before publication. Processes for managing potential conflicts of interest and ensuring careful and critical appraisal of the best scientific evidence have become more rigorous in recent years. The need for updating vaccine position papers is reviewed periodically and depends primarily on the availability of new scientific evidence and public health priorities. A brief update concerning a specific recommendation in a paper is released when warranted.

The Expert Committee agreed that the EML and EMLc should include those vaccines for which a WHO position paper exists (as at a specific publication date), with reference to the WHO immunization website for up-to-date recommendations at any point in time. The Committee also agreed that the EML and EMLc should specify whether vaccines are recommended for universal or conditional use (e.g. only in certain regions, populations, or in other specified circumstances), with reference to relevant WHO vaccine position papers for detail.

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 24 October2015)

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Research article
Key factors in children’s competence to consent to clinical research
Irma Hein, Pieter Troost, Robert Lindeboom, Marc Benninga, C. Zwaan, Johannes van Goudoever, Ramón Lindauer
BMC Medical Ethics 2015, 16:74 (24 October 2015)
Abstract
Background
Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children’s consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children’s competence to consent to clinical research and to what extent they explain the variation in competence judgments.
Methods
From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children’s competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child’s or parents decision to participate.
Results
Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P < 0.05). Total explained variance in competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05).
Conclusions
Age is the factor that explaines most of to the variance in children’s competence to consent, followed by intelligence. Experience with disease did not affect competence in this study, nor did other variables.

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 24 October2015)

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Correspondence
Role of healthcare workers in early epidemic spread of Ebola: policy implications of prophylactic compared to reactive vaccination policy in outbreak prevention and control
Cordelia Coltart, Anne Johnson, Christopher Whitty BMC Medicine 2015, 13:271 (19 October 2015)
Abstract
Ebola causes severe illness in humans and has epidemic potential. How to deploy vaccines most effectively is a central policy question since different strategies have implications for ideal vaccine profile. More than one vaccine may be needed. A vaccine optimised for prophylactic vaccination in high-risk areas but when the virus is not actively circulating should be safe, well tolerated, and provide long-lasting protection; a two- or three-dose strategy would be realistic. Conversely, a reactive vaccine deployed in an outbreak context for ring-vaccination strategies should have rapid onset of protection with one dose, but longevity of protection is less important.

In initial cases, before an outbreak is recognised, healthcare workers (HCWs) are at particular risk of acquiring and transmitting infection, thus potentially augmenting early epidemics. We hypothesise that many early outbreak cases could be averted, or epidemics aborted, by prophylactic vaccination of HCWs. This paper explores the potential impact of prophylactic versus reactive vaccination strategies of HCWs in preventing early epidemic transmissions. To do this, we use the limited data available from Ebola epidemics (current and historic) to reconstruct transmission trees and illustrate the theoretical impact of these vaccination strategies. Our data suggest a substantial potential benefit of prophylactic versus reactive vaccination of HCWs in preventing early transmissions. We estimate that prophylactic vaccination with a coverage >99 % and theoretical 100 % efficacy could avert nearly two-thirds of cases studied; 75 % coverage would still confer clear benefit (40 % cases averted), but reactive vaccination would be of less value in the early epidemic.

A prophylactic vaccination campaign for front-line HCWs is not a trivial undertaking; whether to prioritise long-lasting vaccines and provide prophylaxis to HCWs is a live policy question. Prophylactic vaccination is likely to have a greater impact on the mitigation of future epidemics than reactive strategies and, in some cases, might prevent them. However, in a confirmed outbreak, reactive vaccination would be an essential humanitarian priority.

The value of HCW Ebola vaccination is often only seen in terms of personal protection of the HCW workforce. A prophylactic vaccination strategy is likely to bring substantial additional benefit by preventing early transmission and might abort some epidemics. This has implications both for policy and for the optimum product profile for vaccines currently in development.

Clinical Infectious Diseases (CID)
Volume 61 Issue 10 November 15, 2015
http://cid.oxfordjournals.org/content/current

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Association of Influenza Vaccination Coverage in Younger Adults With Influenza-Related Illness in the Elderly
Glen B. Taksler, Michael B. Rothberg, and David M. Cutler
Clin Infect Dis. (2015) 61 (10): 1495-1503 doi:10.1093/cid/civ630
Abstract
Background.
Older adults have the highest influenza-related morbidity and mortality risk, but the influenza vaccine is less effective in the elderly. It is unknown whether influenza vaccination of nonelderly adults confers additional disease protection on the elderly population.
Methods.
We examined the association between county-wide influenza vaccination coverage among 520 229 younger adults (aged 18–64 years) in the Behavioral Risk Factors Surveillance System Survey and illnesses related to influenza in 3 317 709 elderly Medicare beneficiaries aged ≥65 years, between 2002 and 2010 (13 267 786 person-years). Results were stratified by documented receipt of a seasonal influenza vaccine in each Medicare beneficiary.
Results.
Increases in county-wide vaccine coverage among younger adults were associated with lower adjusted odds of illnesses related to influenza in the elderly. Compared with elderly residents of counties with ≤15% of younger adults vaccinated, the adjusted odds ratio for a principal diagnosis of influenza among elderly residents was 0.91 (95% confidence interval, .88–.94) for counties with 16%–20% of younger adults vaccinated, 0.87 (.84–.90) for counties with 21%–25% vaccinated, 0.80 (.77–.83) for counties with 26%–30% vaccinated, and 0.79 (.76–.83) for counties with ≥31% vaccinated (P for trend <.001). Stronger associations were observed among vaccinated elderly adults, in peak months of influenza season, in more severe influenza seasons, in influenza seasons with greater antigenic match to influenza vaccine, and for more specific definitions of influenza-related illness.
Conclusions.
In a large, nationwide sample of Medicare beneficiaries, influenza vaccination among adults aged 18–64 years was inversely associated with illnesses related to influenza in the elderly.

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The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial
Najaaraq Lund, Andreas Andersen, Anna Sofie K. Hansen, Frida S. Jepsen, Amarildo Barbosa,
Sofie Biering-Sørensen, Amabelia Rodrigues, Henrik Ravn, Peter Aaby, and Christine Stabell Benn
Clin Infect Dis. (2015) 61 (10): 1504-1511 doi:10.1093/cid/civ617
Abstract
Background.
Routine vaccines may have nonspecific effects on mortality. An observational study found that OPV given at birth (OPV0) was associated with increased male infant mortality. We investigated the effect of OPV0 on infant mortality in a randomized trial in Guinea-Bissau.
Methods.
A total of 7012 healthy normal-birth-weight neonates were randomized to BCG only (intervention group) or OPV0 with BCG (usual practice). All children were to receive OPV with pentavalent vaccine (diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and hepatitis B) at 6, 10, and 14 weeks of age. Seven national OPV campaigns were also conducted during the trial period. Children were followed to age 12 months. We used Cox regression to calculate hazard ratios (HRs) for mortality.
Results.
The trial contradicted the original hypothesis about OPV0 increasing male infant mortality. Within 12 months, 73 children in the BCG + OPV group and 87 children in the BCG-only group died, all from infectious diseases. Comparing BCG + OPV0 vs BCG only, the HR was 0.83 (95% confidence interval [CI], .61–1.13): 0.72 (95% CI, .47–1.10) in boys and 0.97 (95% CI, .61–1.54) in girls. For children enrolled within the first 2 days of life, the HR for BCG + OPV0 vs BCG only was 0.58 (95% CI, .38–.90). From enrollment until the time of OPV campaigns, the HR was 0.68 (95% CI, .45–1.00), the beneficial effect being separately significant for males (0.55 [95% CI, .32–.95]).
Conclusions.
This is the only randomized trial of the effect of OPV0 on mortality. OPV0 may be associated with nonspecific protection against infectious disease mortality, particularly when given early in life. There are reasons to monitor mortality when OPV is being phased out.

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Editorial Commentary: Oral Polio Vaccine at Birth
Lawrence D. Frenkel
Clin Infect Dis. (2015) 61 (10): 1512-1513 doi:10.1093/cid/civ619
Extract
The carefully done randomized study by Lund and colleagues, published in this issue of Clinical Infectious Diseases [1], is reassuring, after a previous observational study reported an increase in male infant mortality following oral poliovirus vaccine (OPV) given at birth [2]. That article by Benn and colleagues was disconcerting to vaccine advocates around the world, both for the possible detrimental effect on the control of polio disease in the few remaining endemic countries and because it could give additional fodder to antivaccine groups. The study by Lund et al reports the opposite—namely, a protective effect of OPV given within 2–3 days of birth, and an overall (uncensored) reduction in mortality of 16% by specifically decreasing male infant mortality. The specific causes of mortality are unfortunately not documented in this article, although the statement is made that they were all related to infectious diseases.
It is important to note that none of the studies of nonspecific effects of live viral vaccines given at birth show the same protective or detrimental effects in female infants as is seen in males. It is generally hypothesized that females have an extra …

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Chicago Ebola Response Network (CERN): A Citywide Cross-hospital Collaborative for Infectious Disease Preparedness
Omar Lateef, Bala Hota, Emily Landon, Larry K. Kociolek, Julie Morita, Stephanie Black, Gary Noskin, Michael Kelleher, Krista Curell, Amy Galat, David Ansell, John Segreti, and Stephen G. Weber
Clin Infect Dis. (2015) 61 (10): 1554-1557 doi:10.1093/cid/civ510
Abstract
The Chicago Ebola Response Network, a hospital and public health collaboration, was formed in response to the 2014–2015 Ebola virus epidemic and is a roadmap for how a region can prepare to respond to public health emergencies.

Emerging Infectious Diseases
Volume 21, Number 11—November 2015
http://wwwnc.cdc.gov/eid/

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Perspective
Ebola in West Africa—CDC’s Role in Epidemic Detection, Control, and Prevention
T. R. Frieden and I. K. Damon
Abstract
Since Ebola virus disease was identified in West Africa on March 23, 2014, the Centers for Disease Control and Prevention (CDC) has undertaken the most intensive response in the agency’s history; >3,000 staff have been involved, including >1,200 deployed to West Africa for >50,000 person workdays. Efforts have included supporting incident management systems in affected countries; mobilizing partners; and strengthening laboratory, epidemiology, contact investigation, health care infection control, communication, and border screening in West Africa, Nigeria, Mali, Senegal, and the United States. All efforts were undertaken as part of national and global response activities with many partner organizations. CDC was able to support community, national, and international health and public health staff to prevent an even worse event. The Ebola virus disease epidemic highlights the need to strengthen national and international systems to detect, respond to, and prevent the spread of future health threats.

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Contact Tracing Activities during the Ebola Virus Disease Epidemic in Kindia and Faranah, Guinea, 2014
M. G. Dixon et al.
Summary
Thorough case identification and contact tracing are necessary to end this epidemic.

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 24 October2015]

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Research
SDH-NET: a South–North-South collaboration to build sustainable research capacities on social determinants of health in low- and middle-income countries
Lucinda Cash-Gibson, German Guerra, V Salgado-de-Snyder Health Research Policy and Systems 2015, 13:45 (22 October 2015)
Abstract
Background
It is desirable that health researchers have the ability to conduct research on health equity and contribute to the development of their national health system and policymaking processes. However, in low- and middle-income countries (LMICs), there is a limited capacity to conduct this type of research due to reasons mostly associated with the status of national (health) research systems. Building sustainable research capacity in LMICs through the triangulation of South–North-South (S-N-S) collaborative networks seems to be an effective way to maximize limited national resources to strengthen these capacities. This article describes how a collaborative project (SDH-Net), funded by the European Commission, has successfully designed a study protocol and a S-N-S collaborative network to effectively support research capacity building in LMICs, specifically in the area of social determinants of health (SDH); this project seeks to elaborate on the vital role of global collaborative networks in strengthening this practice.
Methods
The implementation of SDH-Net comprised diverse activities developed in three phases. Phase 1: national level mapping exercises were conducted to assess the needs for SDH capacity building or strengthening in local research systems. Four strategic areas were defined, namely research implementation and system performance, social appropriation of knowledge, institutional and national research infrastructure, and research skills and training/networks. Phase 2: development of tools to address the identified capacity building needs, as well as knowledge management and network strengthening activities. Phase 3: identifying lessons learned in terms of research ethics, and how policies can support the capacity building process in SDH research.
Results
The implementation of the protocol has led the network to design innovative tools for strengthening SDH research capacities, under a successful S-N-S collaboration that included national mapping reports, a global open-access learning platform with tools and resources, ethical guidelines for research, policy recommendations, and academic contributions to the global SDH discourse.
Conclusions
The effective triangulation of S-N-S partnerships can be of high value in building sustainable research capacity in LMICs. If designed appropriately, these multicultural, multi-institutional, and multidisciplinary collaborations can enable southern and northern academics to contextualize global research according to their national realities.

JAMA
October 20, 2015, Vol 314, No. 15
http://jama.jamanetwork.com/issue.aspx

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The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines
Jing Luo, MD; Aaron S. Kesselheim, MD, JD, MPH
[Initial text]
This Viewpoint discusses the importance of patent protection and its role in the Trans-Pacific Partnership (TPP) Agreement.

After a difficult legislative battle, President Obama signed into law Trade Promotion Authority on June 29, 2015. The legislation allows for an up-or-down vote with no amendments in Congress for international trade agreements such as the Trans-Pacific Partnership (TPP) Agreement. The TPP Agreement includes 12 Asia-Pacific countries (United States, Canada, Mexico, Peru, Chile, Japan, Vietnam, Malaysia, Singapore, Brunei, Australia, and New Zealand) with a collective trading power amounting to 40% of the global gross domestic product. The TPP Agreement is still being negotiated; recently, in a meeting of trade ministers in Maui, Hawaii, negotiators failed to finalize the text of the Agreement due in large part to disagreement regarding intellectual property protections for pharmaceutical products.1

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Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations
Lakshmi Sukumaran, MD, MPH; Natalie L. McCarthy, MPH; Elyse O. Kharbanda, MD, MPH; Michael M. McNeil, MD, MPH; Allison L. Naleway, PhD; Nicola P. Klein, MD, PhD; Michael L. Jackson, MPH, PhD; Simon J. Hambidge, MD, PhD; Marlene M. Lugg, DrPH; Rongxia Li, PhD; Eric S. Weintraub, MPH; Robert A. Bednarczyk, PhD; Jennifer P. King, MPH; Frank DeStefano, MD, MPH; Walter A. Orenstein, MD; Saad B. Omer, MBBS, MPH, PhD
Abstract
Importance
The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking.
Objective
To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates.
Design, Setting, and Participants
A retrospective cohort study in 29 155 pregnant women aged 14 through 49 years from January 1, 2007, through November 15, 2013, using data from 7 Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.
Exposures
Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before.
Main Outcomes and Measures
Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls.
Results
There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. For example, local reactions occurred at a rate (per 10 000 women) of 4.2 in those who received Tdap in pregnancy less than 2 years before (adjusted risk ratio [RR], 0.49 [95% CI, 0.11-2.20]; P = .35) and 7.0 two to 5 years before (adjusted RR, 0.77 [95% CI, 0.31-1.95]; P  = .59) a prior tetanus-containing vaccine compared with 11.2 in controls. Preterm delivery occurred in 6.6% of women receiving Tdap in pregnancy less than 2 years before (adjusted RR, 1.15 [95% CI, 0.98-1.34]; P = .08) and 6.4% two to 5 years before (adjusted RR, 1.06 [95% CI, 0.94-1.19]; P  = .33) a prior tetanus-containing vaccine compared with 6.8% of controls. Small for gestational age delivery occurred in 9.0% of women less than 2 years before (adjusted RR, 0.99 [95% CI, 0.87-1.13]; P = .88) and 8.7% of women 2 to 5 years before (adjusted RR, 0.96 [95% CI, 0.87-1.06]; P = .45) a prior tetanus-containing vaccine compared with 9.1% of controls.
Conclusions and Relevance
Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.

Journal of Public Health Policy
Volume 36, Issue 4 (November 2015)
http://www.palgrave-journals.com/jphp/journal/v36/n4/index.html

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Climate change: Assessing effects on health and wealth of populations
Anthony Robbins
Excerpt
Can the health consequences of climate change be at the center of discussions at this year’s climate summit in Paris? Very possibly. Pope Francis’ encyclical letter and The Lancet’s excellent report on the topic give us hope.1, 2 Now the World Federation of Public Health Associations (whose Federation’s Pages we publish in JPHP) is preparing to participate in the twenty-first Conference of the Parties, United Nations Framework Convention on Climate Change. The Federation and its Environmental Health Working Group have developed a strategy to put population health front and center in the Paris discussions. We commend them…

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Viewpoint: Counterfeit medicines and substandard medicines: Different problems requiring different solutions
Ellen ‘t Hoen and Fernando Pascual
J Public Health Pol 36: 384-389; advance online publication, July 16, 2015; doi:10.1057/jphp.2015.22
Ensuring that all effective and necessary medicines are affordable, available, and of assured quality will combat falsified and substandard medicines. The authors explain how and why this will protect consumers.

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Global prevention and control of NCDs: Limitations of the standard approach
Neil Pearce, Shah Ebrahim, Martin McKee, Peter Lamptey, Mauricio L Barreto, Don Matheson, Helen Walls, Sunia Foliaki, J Jaime Miranda, Oyun Chimeddamba, Luis Garcia-Marcos, Andy Haines, and Paolo Vineis
J Public Health Pol 36: 408-425; advance online publication, September 17, 2015; doi:10.1057/jphp.2015.29
The standard approach to prevention and control of non-communicable disease, called ‘25×25’ has the benefit of simplicity, but also has major weaknesses described herein.

The Lancet
Oct 24, 2015 Volume 386 Number 10004 p1599-1706
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Ebola: forgotten but not gone?
The Lancet
On Oct 16, two new Ebola cases were reported in Guinea, indicating the continuing danger of Ebola virus even after progress in bringing the west African Ebola outbreak under control. The outbreak in Guinea, Liberia, and Sierra Leone caught the world badly unprepared during 2013–14, resulting in more than 11 000 deaths. WHO responded slowly to this major challenge in countries with sparse health provision, and disease control measures worked imperfectly. During 2015, lost ground has been made up by provision of care for those infected and at risk of infection, yet recent developments illustrate the continuing health risks for those who have been infected.
Despite previous outbreaks in sub-Saharan Africa, limited understanding of the physiological effects of Ebola virus has compromised preventive and therapeutic efforts. However, a recent study on 100 Ebola survivors in Sierra Leone has shown the importance of continuing research by indicating that viral RNA can be detected in semen up to 9 months after overt recovery from infection. A study in The Lancet Infectious Diseases on 49 survivors of a 2007 Ebola outbreak in Uganda reported ocular deficits and hearing loss, among other health problems, which persisted for 2 years. On Oct 6, Pauline Cafferkey, a Scottish nurse who contracted Ebola early in 2015 and was thought to have made a full recovery after treatment, was rehospitalised with severe health problems. At the time of writing, Ms Cafferkey’s condition was reported to be serious but stable, with disease transmission unlikely. Post-Ebola discharge criteria are discussed by Nazaria Bevilacqua and colleagues in The Lancet Global Health.
Salutary lessons are still being learned from the west African Ebola outbreak—opportunities for and benefits of research will be greatest in the communities most affected. WHO’s Director-General Margaret Chan believes the world is “dangerously ill-prepared” for further infectious disease outbreaks spread through the air or contagious during an incubation period. Strengthening of and investment in health systems in countries most at risk of infectious disease outbreaks are key to prevention, and in the worst case scenarios control, of health emergencies.

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Comment
Essential medicines are still essential
Andy L Gray, Veronika J Wirtz, Ellen F M ‘t Hoen, Michael R Reich, Hans V Hogerzeil
DOI: http://dx.doi.org/10.1016/S0140-6736(15)00514-0
On Oct 21, WHO published the full report of the 20th Expert Committee on the Selection and Use of Essential Medicines,1 with its new WHO Model List of Essential Medicines (EML).2 The new list includes recently developed medicines for drug-resistant tuberculosis (bedaquiline and delamanid), a number of new cancer treatments (such as imatinib, rituximab, and trastuzumab), and, perhaps most controversially, new direct-acting antiviral drugs (DAA) for the treatment of hepatitis C (sofosbuvir, simeprevir, daclatasvir, ledipasvir, and ombitasvir).

New England Journal of Medicine
October 22, 2015 Vol. 373 No. 17
http://www.nejm.org/toc/nejm/medical-journal

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Perspective
Caring for the Wave of Refugees in Munich
Thomas Nicolai, M.D., Oliver Fuchs, M.D., and Erika von Mutius, M.D.
N Engl J Med 2015; 373:1593-1595 October 22, 2015 DOI: 10.1056/NEJMp1512139
[No abstract]

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Editorial
Declining Malaria Transmission and Pregnancy Outcomes in Southern Mozambique
Nicholas J. White, F.R.S.
N Engl J Med 2015; 373:1670-1671 October 22, 2015 DOI: 10.1056/NEJMe1511278
Free Full Text

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Changing Trends in P. falciparum Burden, Immunity, and Disease in Pregnancy
Mayor and Others
N Engl J Med 2015; 373:1607-1617 October 22, 2015 DOI: 10.1056/NEJMoa1406459
Free Full Text

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
(Accessed 24 October2015)

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Validating the Use of Google Trends to Enhance Pertussis Surveillance in California
October 19, 2015 · Research
Introduction and Methods: Pertussis has recently re-emerged in the United States. Timely surveillance is vital to estimate the burden of this disease accurately and to guide public health response. However, the surveillance of pertussis is limited by delays in reporting, consolidation and dissemination of data to relevant stakeholders. We fit and assessed a real-time predictive Google model for pertussis in California using weekly incidence data from 2009-2014.
Results and Discussion: The linear model was moderately accurate (r = 0.88). Our findings cautiously offer a complementary, real-time signal to enhance pertussis surveillance in California and help to further define the limitations and potential of Google-based epidemic prediction in the rapidly evolving field of digital disease detection.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 24 October2015)

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Cholera Transmission in Ouest Department of Haiti: Dynamic Modeling and the Future of the Epidemic
Alexander Kirpich, Thomas A. Weppelmann, Yang Yang, Afsar Ali, J. Glenn Morris, Ira M. Longini
Research Article | published 21 Oct 2015 | PLOS Neglected Tropical Diseases
10.1371/journal.pntd.0004153

PLoS One
http://www.plosone.org/
[Accessed 24 October2015]

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Community Participation in Health Systems Research: A Systematic Review Assessing the State of Research, the Nature of Interventions Involved and the Features of Engagement with Communities
Asha S. George, Vrinda Mehra, Kerry Scott, Veena Sriram
Research Article | published 23 Oct 2015 | PLOS ONE
10.1371/journal.pone.0141091
Abstract
Background
Community participation is a major principle of people centered health systems, with considerable research highlighting its intrinsic value and strategic importance. Existing reviews largely focus on the effectiveness of community participation with less attention to how community participation is supported in health systems intervention research.
Objective
To explore the extent, nature and quality of community participation in health systems intervention research in low- and middle-income countries.
Methodology
We searched for peer-reviewed, English language literature published between January 2000 and May 2012 through four electronic databases. Search terms combined the concepts of community, capability/participation, health systems research and low- and middle-income countries. The initial search yielded 3,092 articles, of which 260 articles with more than nominal community participation were identified and included. We further excluded 104 articles due to lower levels of community participation across the research cycle and poor description of the process of community participation. Out of the remaining 160 articles with rich community participation, we further examined 64 articles focused on service delivery and governance within health systems research.
Results
Most articles were led by authors in high income countries and many did not consistently list critical aspects of study quality. Articles were most likely to describe community participation in health promotion interventions (78%, 202/260), even though they were less participatory than other health systems areas. Community involvement in governance and supply chain management was less common (12%, 30/260 and 9%, 24/260 respectively), but more participatory. Articles cut across all health conditions and varied by scale and duration, with those that were implemented at national scale or over more than five years being mainstreamed by government. Most articles detailed improvements in service availability, accessibility and acceptability, with fewer efforts focused on quality, and few designs able to measure impact on health outcomes. With regards to participation, most articles supported community’s in implementing interventions (95%, n = 247/260), in contrast to involving communities in identifying and defining problems (18%, n = 46/260). Many articles did not discuss who in communities participated, with just over a half of the articles disaggregating any information by sex. Articles were largely under theorized, and only five mentioned power or control. Majority of the articles (57/64) described community participation processes as being collaborative with fewer describing either community mobilization or community empowerment. Intrinsic individual motivations, community-level trust, strong external linkages, and supportive institutional processes facilitated community participation, while lack of training, interest and information, along with weak financial sustainability were challenges. Supportive contextual factors included decentralization reforms and engagement with social movements.
Conclusion
Despite positive examples, community participation in health systems interventions was variable, with few being truly community directed. Future research should more thoroughly engage with community participation theory, recognize the power relations inherent in community participation, and be more realistic as to how much communities can participate and cognizant of who decides that.

A Mumps Outbreak in Vojvodina, Serbia, in 2012 Underlines the Need for Additional Vaccination Opportunities for Young Adults
Jasminka Nedeljković, Vesna Kovačević-Jovanović, Vesna Milošević, Zorica Šeguljev, Vladimir Petrovic, Claude P. Muller, Judith M. Hübschen
Research Article | published 23 Oct 2015 | PLOS ONE
10.1371/journal.pone.0139815

Vaccine
Volume 33, Issue 43, Pages 5729-5888 (26 October 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/43

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Short communication
HPV vaccination series completion and co-vaccination: Pairing vaccines may matter for adolescents
Pages 5729-5732
Jessica Keim-Malpass, Emma McKim Mitchell, Fabian Camacho
Abstract
Very little is known about the effect of concurrent co-vaccination on HPV series completion. This study utilized a retrospective review of a Clinical Data Repository to assess whether concurrent vaccination had an impact on HPV vaccination series completion, and whether there were differences based on age. 3371 patients who received the HPV vaccine at a single academic medical center between the years 2009–2013 were included in this analysis. The adjusted odds ratio (aOR) for effect of concurrent vaccination on series completion for the age group 9–18 was 1.32 (95% CI 1.09, 1.60). Although not statistically significant, the aOR for effect of concurrent vaccination on completion changed direction for the 19–25 age group and was 0.44 (95% CI 0.17, 1.12). This study provides preliminary evidence that pairing the HPV vaccine with one or more co-vaccines may yield a higher HPV vaccination completion rate among adolescents age 9–18.

Vaccine
Volume 33, Issue 43, Pages 5729-5888 (26 October 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/43

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Text message reminders for timely routine MMR vaccination: A randomized controlled trial
Original Research Article
Pages 5741-5746
Annika M. Hofstetter, Nathalie DuRivage, Celibell Y. Vargas, Stewin Camargo, David K. Vawdrey, Allison Fisher, Melissa S. Stockwell
Abstract
Objective
Measles–mumps–rubella (MMR) vaccination is important for preventing disease outbreaks, yet pockets of under-vaccination persist. Text message reminders have been employed successfully for other pediatric vaccines, but studies examining their use for MMR vaccination are limited. This study assessed the impact of text message reminders on timely MMR vaccination.
Study design
Parents (n = 2054) of 9.5–10.5-month-old children from four urban academically-affiliated pediatric clinics were randomized to scheduling plus appointment text message reminders, appointment text message reminder-only, or usual care. The former included up to three text reminders to schedule the one-year preventive care visit. Both text messaging arms included a text reminder sent 2 days before that visit. Outcomes included appointment scheduling, appointment attendance, and MMR vaccination by age 13 months, the standard of care at study sites.
Results
Children of parents in the scheduling plus appointment text message reminders arm were more likely to have a scheduled one-year visit than those in the other arms (71.9% vs. 67.4%, relative risk ratio (RRR) 1.07 [95% CI 1.005–1.13]), particularly if no appointment was scheduled before randomization (i.e., no baseline appointment) (62.1% vs. 54.7%, RRR 1.14 [95% CI 1.04–1.24]). One-year visit attendance and timely MMR vaccination were similar between arms. However, among children without a baseline appointment, those with parents in the scheduling plus appointment text message reminders arm were more likely to undergo timely MMR vaccination (61.1% vs. 55.1%, RRR 1.11 [95% CI 1.01–1.21]).
Conclusion
Text message reminders improved timely MMR vaccination of high-risk children without a baseline one-year visit.

Vaccine
Volume 33, Issue 43, Pages 5729-5888 (26 October 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/43

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Medicaid provider reimbursement policy for adult immunizations
Original Research Article
Pages 5801-5808
Alexandra M. Stewart, Megan C. Lindley, Marisa A. Cox
Abstract
Background
State Medicaid programs establish provider reimbursement policy for adult immunizations based on: costs, private insurance payments, and percentage of Medicare payments for equivalent services. Each program determines provider eligibility, payment amount, and permissible settings for administration. Total reimbursement consists of different combinations of Current Procedural Terminology codes: vaccine, vaccine administration, and visit.
Objective
Determine how Medicaid programs in the 50 states and the District of Columbia approach provider reimbursement for adult immunizations.
Design
Observational analysis using document review and a survey.
Setting and participants
Medicaid administrators in 50 states and the District of Columbia.
Measurements
Whether fee-for-service programs reimburse providers for: vaccines; their administration; and/or office visits when provided to adult enrollees. We assessed whether adult vaccination services are reimbursed when administered by a wide range of providers in a wide range of settings.
Results
Medicaid programs use one of 4 payment methods for adults: (1) a vaccine and an administration code; (2) a vaccine and visit code; (3) a vaccine code; and (4) a vaccine, visit, and administration code.
Limitations
Study results do not reflect any changes related to implementation of national health reform. Nine of fifty one programs did not respond to the survey or declined to participate, limiting the information available to researchers.
Conclusions
Medicaid reimbursement policy for adult vaccines impacts provider participation and enrollee access and uptake. While programs have generally increased reimbursement levels since 2003, each program could assess whether current policies reflect the most effective approach to encourage providers to increase vaccination services.

Vaccine
Volume 33, Issue 43, Pages 5729-5888 (26 October 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/43

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What determines uptake of pertussis vaccine in pregnancy? A cross sectional survey in an ethnically diverse population of pregnant women in London
Original Research Article
Pages 5822-5828
Beverly Donaldson, Prerna Jain, Beth S. Holder, Benjamin Lindsay, Lesley Regan, Beate Kampmann
Abstract
Introduction
Following the major outbreak of pertussis and 14 infant deaths across England in 2012, the Department of Health (DH) introduced the UK’s first maternal pertussis vaccination programme. Data published by Public Health England (PHE) suggest uptake of the vaccine varies considerably across the country. The reasons for this heterogeneity need to be addressed to optimise the impact of the programme.
Objective
To assess uptake of antenatal pertussis and influenza vaccine in a leading NHS Trust in London and to explore awareness and attitudes of pregnant women towards the pertussis vaccination programme.
Design
A cross sectional survey was conducted in an ethnically diverse group of 200 pregnant women accessing antenatal care at Imperial Healthcare NHS Trust. Quantitative data was tabulated and content analysis was carried out on the free text. Qualitative data was divided into themes for accepting or declining the vaccine.
Results
Awareness of the programme was 63% (126/200) with actual uptake of the vaccine only 26.0% (52/200). Women had received information from multiple sources, primarily General Practitioners (GP) and midwives. 34.0% (68/200) of women were offered the vaccine at their GP practice, only 24% reported a meaningful discussion with their GP about it. Uptake differed by up to 15.0% between ethnicities. Qualitative data showed that uptake could be significantly enhanced if vaccination was recommended by a familiar healthcare professional. Feeling uninformed, lack of professional encouragement and uncertainties of risk and benefit of the vaccine were the greatest barriers to uptake.
Conclusion
Vaccine uptake in this cohort of pregnant women was poor. Understanding the target audience and engaging with key groups who influence women’s decision-making is essential. Knowledgeable health care professionals need to recommend the vaccine and provide accurate and timely information to increase success of this important programme.

Vaccine
Volume 33, Issue 43, Pages 5729-5888 (26 October 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/43

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The effect of various types of patients’ reminders on the uptake of pneumococcal vaccine in adults: A randomized controlled trial
Original Research Article
Pages 5868-5872
Alexandra S. Ghadieh, Ghassan N. Hamadeh, Dina M. Mahmassani, Najla A. Lakkis
Abstract
Background
Invasive pneumococcal disease is one of the most important vaccine-preventable diseases threatening the adult community due to missed opportunities for vaccination. This study compares the effect of three different types of patient reminder system on adulthood Streptococcus pneumoniae immunization in a primary care setting.
Methods
The study targeted patients aged 40 and older eligible for pneumococcal vaccine, but did not receive it yet (89.5% of 3072 patients) based on their electronic medical records in a family medicine center in Beirut. The sample population was randomized using an automated computer randomization system into six equal groups, receiving short phone calls, short text messaging system (sms-text) or e-mails each with or without patient education. Each group received three identical reminders spaced by a period of four weeks. Documentation of vaccine administration was then added to the longitudinal electronic patient record. The primary outcome was the vaccine administration rate in the clinics.
Results
Of the eligible patients due for the pneumococcal 23-polyvalent vaccine, 1380 who had mobile phone numbers and e-mails were randomized into six equal intervention groups. The various reminders increased vaccination rate to 14.9%: 16.5% of the short phone calls group, 7.2% of the sms-text group and 5.7% of the e-mail group took the vaccine. The vaccination rate was independent of the age, associated education message and the predisposing condition.
Conclusion
Use of electronic text reminders via e-mails and mobile phones seems to be a feasible and sustainable model to increase pneumococcal vaccination rates in a primary care center.

Vaccine
Volume 33, Issue 43, Pages 5729-5888 (26 October 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/43

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Childhood vaccination requirements: Lessons from history, Mississippi, and a path forward
Original Research Article
Pages 5884-5887
Philip B. Cawkwell, David Oshinsky
Abstract
Mississippi consistently leads the United States in childhood vaccination with a greater than 99% measles–mumps–rubella vaccination rate for children entering kindergarten. The story of how this came to pass in a state that lags behind on nearly every other public health measure is pertinent given the recent outbreaks of measles in the United States, especially in pockets of the country where there is strong resistance to vaccination. The fight against compulsory vaccination law is centuries old and the enduring success of Mississippi at repelling challenges to their vaccination requirements is a testament to the public health infrastructure and legal framework established in the state. Herein we trace the anti-vaccination movement from its origins in England up until the present time in the United States and explore how Mississippi has established a model vaccination system. Seminal court cases and legislation are evaluated for their impact. Finally, contemporary battles over vaccination legislation are examined and the feasibility of national-level change is considered.

Value in Health
November 2015 Volume 18, Issue 7
http://www.valueinhealthjournal.com/current

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Public Health Impact and cost-Effectiveness of Malaria routine Vaccination in Infants
C Sauboin, E Sicuri, L Van Bellinghen, N Van de Velde, I Van Vlaenderen
A338–A339
Abstract
Final phase III trial results of the first malaria vaccine candidate RTS,S have been published. Based on these results, our study aims at estimating the public health impact and cost-effectiveness of RTS,S implementation in infants in 42 sub-Saharan countries

Cost-Effectiveness analysis of Quadrivalent Versus trivalent Influenza Vaccination In Germany — Linking a Dynamic Transmission Model with Health and Economic Outcomes
FC Dolk, M Eichner, R Welte, A Anastassopoulou, L Van Bellinghen, B Poulsen Nautrup, I Van Vlaenderen, R Schmidt-Ott, M Schwehm, M Postma
A339
Abstract
Trivalent influenza vaccine (TIV) contains two Influenza A strains, but only one of the two B-lineages, resulting in frequent mismatches between vaccines and circulating B-lineages during seasonal epidemics. Quadrivalent influenza vaccine (QIV) prevents such mismatches by including both B-lineages. The objective of our study was to estimate the cost-effectiveness (CE) of QIV versus TIV in Germany by coupling influenza incidence generated by a dynamic individual-based simulation to health and economic outcomes.

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 with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before 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.

– pdf version:  A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_17 October 2015

– blog edition: comprised of the approx. 35+ entries posted below on 13 September 2015..

– 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
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical Schoo

EBOLA/EVD [to 17 October 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Ebola Situation Report – 14 October 2015
[Excerpts]
SUMMARY [excerpt]
No confirmed cases of Ebola virus disease (EVD) were reported in the week to 11 October. This is the second consecutive week with zero confirmed cases. However, 150 registered contacts remain under follow-up in Guinea, of which 118 are high risk, and an additional 259 contacts remain untraced. There remains a near-term risk of further cases among both registered and untraced contacts. In Sierra Leone, 2 high-risk contacts associated with the 2 most recently active chains of transmission in the country were lost to follow-up and have not yet been found. In addition, a patient who was reported as a case in the United Kingdom on 29 December 2014, and who later recovered, was hospitalised on 6 October in the United Kingdom after developing late EVD-related complications. As of 13 October, 62 close contacts have been identified in the UK for follow-up…
WHO: Preliminary study finds that Ebola virus fragments can persist in the semen of some survivors for at least nine months
Freetown, 14 October 2015 – Preliminary results of a study into persistence of Ebola virus in body fluids show that some men still produce semen samples that test positive for Ebola virus nine months after onset of symptoms.

The report, published today in the New England Journal of Medicine, provides the first results of a long-term study being jointly conducted by the Sierra Leone Ministry of Health and Sanitation, Sierra Leone Ministry of Defence, the World Health Organization and the U.S. Centers for Disease Control and Prevention.

“Sierra Leone is committed to getting to zero cases and to taking care of our survivors, and part of that effort includes understanding how survivors may be affected after their initial recovery,” said Amara Jambai, M.D., M.Sc., Deputy Chief Medical Officer for the Sierra Leone Ministry of Health and Sanitation. “Survivors are to be commended for contributing to the studies that help us understand how long the virus may persist in semen.”

The first phase of this study has focused on testing for Ebola virus in semen because of past research showing persistence in that body fluid. Better understanding of viral persistence in semen is important for supporting survivors to recover and to move forward with their lives.

“These results come at a critically important time, reminding us that while Ebola case numbers continue to plummet, Ebola survivors and their families continue to struggle with the effects of the disease. This study provides further evidence that survivors need continued, substantial support for the next 6 to 12 months to meet these challenges and to ensure their partners are not exposed to potential virus,” said Bruce Aylward, WHO Director-General’s Special Representative on the Ebola Response…

::::::

Two new Ebola cases in Guinea confound hopes of end to outbreak
Reuters – Friday 16 October 2015
Weeks away from west African country being declared free of disease, two men have contracted virus, one having had no contact with registered victims
Two people have fallen ill with Ebola in Guinea, the World Health Organisation has said, dashing hopes of an imminent end to the worst recorded outbreak of the disease after a two-week spell without any new cases across west Africa.

Guinea was weeks away from joining Liberia in being declared free of the virus that has killed more than 11,000 people in a near two-year rampage. Neighbouring Sierra Leone is also halfway through the 42-day countdown to being Ebola-free…

Authorities in Guinea said on Friday one of the cases in Forécariah, western Guinea, appeared to be linked to a previously known chain of infection, while the other in the capital, Conakry, seemed to be new.

“On the bumpy road we keep talking about – the high risk of recurrence – once again we are navigating a few bumps,” Margaret Harris, a WHO spokeswoman, told a briefing in Geneva. “Of course we didn’t want it, but we did expect it. Guinea hadn’t got to the stage where we were looking at 42 days.”…

POLIO [to 17 October 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week as of 14 October 2015
Global Polio Eradication Initiative
Full report link: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: In Lao People’s Democratic Republic a circulating vaccine-derived poliovirus type 1 (cVDPV1) outbreak has been confirmed, with one case, an eight year old boy who had onset of paralysis on 7 September. Outbreaks of cVDPVs can arise in areas of low population immunity, emphasizing the importance of strong vaccination coverage. Learn more about VDPVs.
:: Thirty five million children were reached with polio vaccines during the September campaigns in Pakistan. Nearly 3 million children who were previously missed were vaccinated during the catch up days following this campaign. ‘Continuous community-protected vaccination’ (community based vaccinators who carry out immunization activities on an ongoing basis) and health camps are helping to reach children in the most difficult to reach areas.
:: Last week, the Independent Monitoring Board met in London to assess progress towards polio eradication and to make recommendations for the coming months. The report is expected to be published in the next few weeks.
[Selected Country Update Information]
Afghanistan
:: One new wild poliovirus type 1 (WPV1) cases was reported in the past week in Batikot district of Nangarhar with onset of paralysis on 4 September. This is the first case in this district in 2015. The most recent case had onset of paralysis on 6 September in Sherzad district of Nangarhar province. The total number of WPV1 cases for 2015 is now 13.
:: No new positive environmental samples were reported in the past week.
:: Mop-up campaigns are planned in Nangarhar on 18 – 20 October using bivalent oral polio vaccine (OPV), and Gulestan district of Farah using the inactivated polio vaccine (IPV) and bivalent OPV with dates to be confirmed. National Immunization Days (NIDs) will take place on 1 – 3 November using trivalent OPV and Subnational Immunisation Days (SNIDs) are planned from 29 November to 1 December in the south and east of the country using bivalent OPV. Further mop up campaigns will take place in Balabuluk and Khak-E-Safed districts of Farah in November.
Pakistan
:: Two new wild poliovirus type 1 (WPV1) cases were confirmed in the past week, one in Chakwal district of Punjab and one in Karachi-Gulberg, Sindh. The most recent case had onset of paralysis on 16 September in Peshawar. The total number of WPV1 cases for 2015 is now 38, compared to 205 at this time last year.
Lao People’s Democratic Republic
:: One new case of circulating vaccine-derived poliovirus type 1 (cVDPV1) was reported in Lao in the past week, in Bolikhanh district of Borikhamxay province, with onset of paralysis on 7 September. Based on epidemiological considerations and indications that the virus has been circulating for a prolonged period of time, this has been classified as circulating despite it being a single case. This case, an eight year old boy who had received zero doses of polio vaccine, is the only one reported in 2015.
:: Outbreaks of cVDPVs can arise in areas of low population immunity, emphasizing the importance of strong vaccination coverage. Learn more about VDPVs.
:: Planning is underway for an emergency outbreak response
Ukraine
:: No new circulating vaccine-derived poliovirus type 1 (cVDPV1) cases have been reported in the past week. The most recent case had onset of paralysis on 7 July in the Zakarpatskaya oblast, in south-western Ukraine, bordering Romania, Hungary, Slovakia and Poland. The number of cVDPV1 cases reported in 2015 remains 2.
:: Ukraine had been at particular risk of emergence of a cVDPV, due to inadequate vaccination coverage. In 2014, only 50% of children were fully immunized against polio and other vaccine-preventable diseases.
:: Discussions are currently ongoing with national health authorities to plan and implement an urgent outbreak response. More.

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UNICEF and WHO ready to support immediate polio vaccination campaign in Ukraine
UN agencies concerned further delay puts 1.8 million children’s lives at risk
Joint press release
KYIV, Ukraine/COPENHAGEN/GENEVA, 9 October 2015 – Six weeks after the polio outbreak in Ukraine, UNICEF and WHO have stepped up calls for an immediate first round of nationwide polio vaccination…UNICEF and WHO are on standby to support the campaign.

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Vaccination teams work to keep Iraq polio free and combat the spread of cholera
Baghdad, 13 October 2015 – A nationwide campaign to vaccinate 5.8 million children in Iraq against polio was concluded on 11 October after a 2-day extension recommended by the Ministry of Health to achieve maximum vaccination coverage. This effort to ensure that Iraq remains polio free also included the dissemination of life-saving information to 1.5 million households across the country on how to detect, prevent and treat cholera.

Led by the Federal Ministry of Health, in coordination with WHO and UNICEF, the 7-day polio vaccination campaign begun on 4 October included nearly 13 000 vaccination teams deployed throughout Iraq. Each team travelled door to door, visiting individual households to vaccinate children against polio. The current campaign is the eleventh such national effort in Iraq since October 2013, when polio was first detected in neighbouring Syria, and the fourth this year alone.

“WHO is supporting the campaign through a provision of technical expertise at national, regional, and subnational levels in high-risk areas,” said Altaf Musani, acting WHO Representative in Iraq. “Our support also includes financial assistance for polio campaign workers and finger-marking, as well as conducting surveillance activities, which is the only scientific tool to prove that polio has been contained in Iraq,” he added.

Based on preliminary field reports from the campaign, immunization activities are being implemented smoothly. However, security constraints in parts of Ninewa, Al Shergat district in Sala El Din, and parts of Kirkuk are compromising access to all children in these areas.

“UNICEF and partners have taken an innovative approach to the double threat of disease facing children and families in Iraq,” said Peter Hawkins, UNICEF’s Representative in Iraq. “In the context of mass displacement and continuing violence, the humanitarian community has succeeded in administering 36 million doses of oral polio vaccine, doubling the country’s cold chain capacity. Converging existing activities can help the very limited resources make a greater impact, and ultimately save more lives.”

MERS-CoV [to 17 October 2015]
Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 12 October 2015
:: Middle East respiratory syndrome coronavirus (MERS-CoV) – Jordan 12 October 2015

WHO & Regionals [to 17 October 2015]

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Cholera – Iraq
Disease Outbreak News
12 October 2015
WHO has received notification from the National IHR Focal Point of Iraq of additional laboratory-confirmed cases of cholera. As of 8 October, a total of 1,263 laboratory-confirmed cases of Vibrio cholerae 01 Inaba were reported….

Public health response
The Cholera task force led by the Ministry of Health (MoH) has established a Cholera Command and Control Centre to enhance multisectoral coordination for effective response to the outbreak. In the affected governorates, active surveillance has been stepped up for case findings in the community and case management has been standardized across all health facilities currently admitting the cholera cases.

In cholera affected areas, and particularly in the camps hosting the internally displaced people and refugees, preparedness activities have been geared up as well…

Furthermore, discussions are ongoing with the International Coordinating Group to release oral cholera vaccine from the global stock. A risk assessment to identify priority groups for vaccination and a vaccination plan is being developed.

WHO has deployed a team of international experts under the Global Outbreak Alert and Response Network (GOARN) to support MoH respond to this outbreak. Additional requests have also been sent out to the technical partners in GOARN in case of request for additional international support for cholera response.

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Vaccinations made friendly
4 October 2015
Globally, 1 in 5 children still do not receive routine life-saving immunizations, and an estimated 1.5 million children die each year of diseases that could be prevented by vaccines that already exist. WHO recommends how to reduce the pain at the time of vaccination across all age groups.

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The Weekly Epidemiological Record (WER) 16 October 2015, vol. 90, 42 (pp. 561–576)
Includes:
561 Antigenic and genetic characteristics of zoonotic influenza viruses and development of candidate vaccine viruses for pandemic preparedness
571 Chikungunya disease: gaps and opportunities in public health and research in the Americas

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:: WHO Regional Offices
WHO African Region AFRO
:: North central states of Nigeria boost population immunity along nomadic routes
Abuja, 16 October 2015 – The World Health Organization (WHO) in collaboration with the government, has recently intensified its efforts to reach the most marginalised, hard-to-reach and nomadic communities of the North Central region of the country.
Following the adoption of a blueprint, states of Nasarawa, Niger and Plateau are working assiduously to provide the required health interventions to pastoral nomadic populations in their respective states with a view to boost population immunity and improve disease surveillance…
:: Liberia Plans to Strengthen Mental Health
Monrovia 15 October – In view of the traumatic effects of the decade long civil war and the recent Ebola outbreak, mental health promotion is now more relevant to Liberia than ever before.
As part of its concerted efforts to build a Resilient Health System in Liberia, the Ministry of Health (MOH) in collaboration with WHO and other major international and national partners is focusing on advocacy and provision of adequate mental and psychosocial support services for persons affected by the epidemic and people with mental disorders in general…
:: Mass Measles campaign launched in Uganda
Kyegegwa 12th October 2015: The Mass Measles Campaign was launched in Kyegegwa district at the Humura Primary School grounds under the theme ‘Uganda united against measles’. The key message to parents was to have their children immunized against the Vaccine Preventable Diseases (‘VPDs’).
Launching the campaign, Honorable Sarah Opendi, the Minister of State for Health in charge of primary health care called on parents to adhere to the immunization schedule provided to them at health centers. She further denounced the myth about vaccine safety, “vaccine development is a long and laborious process, which lasts for several years, it’s tested and once recommended and certified by the World Health Organization (WHO), then you know that it is safe for our population.” Hon Opendi also said that this is the fourth measles follow up campaign which aims at reducing measles morbidity and mortality by 95 percent in 2015. At the same occasion, Hon. Opendi launched the supplementary Oral Polio Vaccine vaccination that targets at least 2.3 million children between 0-59 months in the 23 high risk districts…

WHO Region of the Americas PAHO
:: PAHO urges accelerated shift to community-based mental health services to widen access, protect human rights (10/10/2015)

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
No new digest content identified.

WHO Eastern Mediterranean Region EMRO
:: Vaccination teams work to keep Iraq polio free and combat the spread of cholera
Baghdad, 13 October 2015 – A nationwide campaign to vaccinate 5.8 million children in Iraq against polio ended on 11 October after a 2-day extension recommended by the Ministry of Health of Iraq to achieve maximum vaccination coverage. The campaign aimed to keep Iraq polio free and also included the dissemination of information to 1.5 million households across the country on how to detect, prevent and treat cholera.

WHO Western Pacific Region
:: Sixty-sixth session of the WHO Regional Committee celebrates progress on ageing and health, NCD prevention and control, and regulatory systems strengthening
GUAM, 15 OCTOBER 2015 – The WHO Regional Committee for the Western Pacific—the Organization’s governing body in the Region—noted significant progress on ageing and health, noncommunicable disease (NCD) prevention and control, and regulatory systems strengthening at its sixty-sixth annual meeting Thursday on Guam.
Read the news release
:: WHO tackles violence, injury prevention; and urban health
GUAM, 14 OCTOBER 2015 – The WHO Regional Committee for the Western Pacific—the Organization’s governing body in the Region—today endorsed an action plan that will help Member States reduce violence and injuries, and a framework plan that will assist the Region’s cities in their efforts to effectively meet the health challenges caused by rapid and unplanned urbanization.
:: WHO takes action to stop viral hepatitis and tuberculosis; promotes universal health coverage
GUAM, 13 October 2015 – On Day 2 of its annual meeting, the World Health Organization (WHO) Regional Committee for the Western Pacific—the Organization’s regional governing body—approved action plans and frameworks to strengthen efforts to reduce viral hepatitis and tuberculosis, and attain universal health coverage in the Region.
Read the news release

CDC/MMWR/ACIP Watch [to 17 October 2015]
http://www.cdc.gov/media/index.html

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WEDNESDAY, OCTOBER 14, 2015
Preliminary study finds that Ebola virus fragments can persist in the semen of some survivors for at least nine months
Preliminary results of a study into persistence of Ebola virus in body fluids show that some men still produce semen samples that test positive for Ebola virus nine months after onset of symptoms….

MMWR October 16, 2015 / No. 40/ Vol. 64
:: State and Territorial Ebola Screening, Monitoring, and Movement Policy Statements — United States, August 31, 2015
::Human Papillomavirus Vaccination Coverage Among School Girls in a Demonstration Project — Botswana, 2013

ACIP Meeting – October 21, 2015 [one-day meeting]
October 21, 2015[2 pages] Final, October 8, 2015

Sabin Vaccine Institute [to 17 October 2015]
http://www.sabin.org/updates/pressreleases

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New Partnership with India Aims to Build Vaccine Manufacturing Network for Hookworm, Other Diseases
WASHINGTON, D.C., BANGALORE, AMSTERDAM — October 14, 2015 — The Amsterdam Institute for Global Health and Development (AIGHD) and Sabin Vaccine Institute Product Development Partnership (Sabin PDP) today announced a new research and innovation partnership with the Association of Biotechnology Led Enterprises (ABLE) of India on vaccine development for hookworm and other neglected tropical diseases (NTDs). The European Union, through its EuropeAid program, recently awarded a five-year grant of €333,000 to AIGHD to establish this EU-India partnership.

Industry Watch [to 17 October 2015]
:: Sanofi Pasteur and the Infectious Disease Research Institute Partner on a Global-Health, Open-Innovation, Vaccine Research & Development Center
SWIFTWATER, Pennsylvania, October 15, 2015 /PRNewswire/ —

Sanofi Pasteur, the vaccines division of Sanofi, announced today the creation of a Global Health Vaccine Center of Innovation (GHVCI) with the Infectious Disease Research Institute (IDRI), a Seattle, USA-based global-health, non-profit institute with a focus on developing new products to combat the world’s most devastating infectious diseases. This project is also funded in part by a grant from the Bill & Melinda Gates Foundation, as the proposed R&D alliance is related to the Gates Foundation and Sanofi Pasteur’s strategic agreement on a Vaccine Discovery Partnership signed in 2013.

The addition of IDRI will enable vaccine adjuvant/formulation platforms and a pipeline of vaccine candidates to be discovered, evaluated and developed to address a range of infectious diseases under the center of innovation based at IDRI. The GHVCI will be co-funded by the Gates Foundation and Sanofi Pasteur under a tripartite agreement.

The GHVCI has been established to accelerate the development of vaccines and supporting technologies to address infectious diseases and ensuring that new critical vaccines are available to populations in developing countries. Sanofi Pasteur will leverage the resources and expertise of this external R&D innovation center and obtain access to IDRI’s adjuvants and vaccine antigens.

“IDRI is a partner of choice as they are a world-leader in the development and evaluation of adjuvant formulations, using a broad portfolio of adjuvants with different immune-stimulating properties,” commented Jim Tartaglia, PhD, R&D VP for new vaccine projects at Sanofi Pasteur. “The Institute has a world-class staff and capabilities in immunology and GMP production”.

“There are a number of diseases that are of great global-health significance, where Sanofi Pasteur could significantly contribute,” according to John Shiver, PhD, Sr. VP for R&D at Sanofi Pasteur; “however, commercial realities provide a challenge to investment. The establishment of this Global Health Vaccines Center of Innovation represents a new opportunity–operating within the open innovation R&D model–to provide antigens, adjuvanted formulations, funding, and expertise to allow development of needed vaccines.”

This distinctive collaboration brings together the complementary expertise of Sanofi Pasteur’s position as a leading, multi-national vaccine developer, manufacturer, and seller; IDRI’s antigens, vaccine design, formulation and production expertise; and the Gates Foundation’s knowledge, global influence and financial support. A Joint Steering Committee, comprised of representatives from each of the three partners, will be formed to manage the mission of the GHVCI.

IAVI International AIDS Vaccine Initiative [to 17 October 2015]
http://www.iavi.org/press-releases/2015

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Human Vaccines Project Partners with MedImmune to Help Accelerate Research and Development in Infectious Disease and Oncology
October 13, 2015
MedImmune is the newest member of the Human Vaccines Project, which will help to accelerate the research and development of vaccines and immunotherapies for infectious disease and cancer.

Incubated at the International AIDS Vaccine Initiative (IAVI), the Human Vaccines Project is an ambitious new public-private partnership seeking to transform the future of global disease prevention and treatment by solving the primary scientific obstacles impeding the research and development of new vaccines and immunotherapies. Endorsed by 35 leading vaccine scientists, the Project brings together top academic research centers, and government, non-profit and industry research and development efforts into a global consortium.

MedImmune will help establish the Project’s global consortium, launch its research program and guide its scientific plan and future direction as a participant of the consortium and member of the Industrial Advisory Committee, a panel of leading industry partners that will advise the Project on its scientific plan and future direction…

Global Fund [to 17 October 2015]
http://www.theglobalfund.org/en/news/

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News
Global Fund Hails Swaziland Partnership at Grant Signing
14 October 2015
MBABANE, Swaziland – Swaziland and the Global Fund deepened their partnership with the signing of three grants totaling more than US$66 million, to expand prevention and treatment for HIV and tuberculosis.

The financial resources provided through the Global Fund come from many sources and partners, represented at the signing ceremony today by the United States and the European Union, as well as technical partners from UNAIDS and WHO.

The new grants will go to government and civil society implementers selected through a vibrant country dialogue. The HIV grants will support treatment for people living with HIV as well prevention of new infections among key populations and vulnerable groups, including young women and girls.

The TB grant will accelerate the response toward TB/HIV co-infection and concentrate on treatment and prevention of key populations affected by tuberculosis. Swaziland is a high disease-burden country, with 26 percent HIV prevalence – one of the highest in the world, as well as a high TB burden…

European Medicines Agency [to 17 October 2015]
http://www.ema.europa.eu/ema/

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Collecting high-quality information on medicines through patient registries
12/10/2015
Initiative aims to support use of existing registries to collect information on medicines in clinical use and support benefit-risk evaluation …

UNESCO [to 17 October 2015]
http://en.unesco.org/news

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15.10.2015 – Natural Sciences Sector
A new approach to research for health to combat infectious diseases in Africa
The burden of infectious diseases continues to be disproportionately high in some African countries, particularly in sub-Saharan Africa, with significant impacts on health and socio-economic development. However, the difficulties in applying scientific research to improve health are particularly acute in the region. Creating an enabling political environment and building capacity for life sciences and health research are fundamental to improving people’s wellbeing across the continent. This will be the focus of the Africa Research Summit organized by UNESCO and Merck that will be live-streamed on 19-20 October 2015 from Geneva.

There is currently a lack of international resources dedicated to regional health needs and a shortage of expenditure on health research. The need to support research in order to address the challenges of infectious disease is recognized in the recently adopted 2030 Agenda for Sustainable Development, as Target 3.b: “Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries”. This year’s Nobel prize in Physiology or Medicine, awarded to research on infectious diseases, is another strong message, shining a light on health-related issues that can only be addressed adequately when countries have built a strong scientific research environment to support discoveries, inventions, and innovations.

The Africa Research Summit is part of an effort to build the capacities of African researchers in the life and medical sciences and thus, support the improvement of health systems in Africa. There are two key areas which must be addressed. Firstly, the lack of local capacity in the life sciences to perform high-quality research on neglected health needs. Secondly, the ineffectiveness of current mechanisms for translating research into health solutions, which can be disseminated to those most in need. The 2015 Summit will focus on the role of building capacities in the life sciences to address challenges of infectious diseases, most notably the Ebola crises…

UNICEF [to 17 October 2015]
http://www.unicef.org/media/media_78364.html

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Selected press releases
Lack of access to hygiene could endanger new Development Agenda – UNICEF
NEW YORK, 15 October 2015 – Handwashing with soap is dangerously low in many countries, UNICEF reports, despite its proven benefits to child health.
The eighth Global Handwashing Day comes less than a month after the United Nations adopted the Sustainable Development Goals, including hygiene for the first time in the global agenda. One of the SDG targets is to achieve ‘access to adequate and equitable sanitation and hygiene’ by 2030.

UNICEF says improvements in hygiene must supplement access to water and sanitation, or children will continue to fall victim to easily preventable diseases like diarrhoea.
“Along with drinking water and access to toilets, hygiene – particularly handwashing with soap – is the essential third leg of the stool holding up the Goal on water and sanitation,” said Sanjay Wijesekera, global head of UNICEF’s water, sanitation and hygiene programmes. “From birth – when unwashed hands of birth attendants can transmit dangerous pathogens – right through babyhood, school and beyond, handwashing is crucial for a child’s health. It is one of the cheapest, simplest, most effective health interventions we have.”…

Declaration of the G7 Health Ministers:: 8 – 9 October 2015 in Berlin
G7 Germany
October 2015
1. In continuation of the G7 Summit in Elmau on 7 and 8 June 2015, we, the G7 Health Ministers, discussed the health topics Antimicrobial Resistance (AMR) and Ebola during our G7-Meeting in Berlin on 8 and 9 October 2015.

2. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being. We are therefore strongly committed to continuing our engagement in this field with a specific focus on strengthening health systems through bilateral programmes and multilateral structures.

3. The G7 Health Ministers agreed on the following actions for the implementation of the G7 Leaders’ Declaration as outlined in the “Berlin Declaration on AMR” and “G7 Health Ministers’ Commitment – Lessons learned from Ebola”…

Berlin Declaration on Antimicrobial Resistance –
Global Union for Antibiotics Research and Development (GUARD)
Agreed by G7 Health Ministers in Berlin 2015
[Excerpt from 22 paragraphs]
…17. We will work, in collaboration with WHO, building on existing networks, to promote a global network of researchers; experts from academia, industry, healthcare, veterinary care, regulatory agencies, food safety and agriculture; philanthropic organizations; and international organizations to provide opportunities to exchange information on ongoing research activities, access to expertise for funded projects, and retention of accumulated knowledge. We welcome the initiative by Germany to organise the first expert meeting in 2016/2017.

18. Given the global nature of drug research, development and commercialisation and the global challenge antimicrobial resistance poses, we call for greater interaction and synergies between research initiatives. We see the need for global access to – and availability, affordability and rational use of – safe, effective and quality-assured antimicrobials. We will therefore explore the feasibility and need of setting up a global antibiotic product development partnership for new and urgently needed antibiotics, vaccine development, alternative therapies and rapid point of care diagnostics and seek collaboration with others such as WHO and Drugs for Neglected Disease Initiative (DNDi).

19. We encourage international cooperation on antimicrobial stewardship and regulatory dialogue on the approval and regulation for antibiotics. Convergence and harmonisation on technical requirements including for clinical trials and for the approvals for new antibiotics can help to bring new antibiotics faster to the market. In this perspective, we support the ongoing efforts in the wider context of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and its veterinary equivalent VICH and emphasise to take the special needs for antibiotics into account. We will take into account the recommendations and action areas of antibiotics of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) as it enters the next five year implementation period.

20. We are committed to explore innovative economic incentives to enhance the research and development of new antibiotics, other therapeutic options, and diagnostics. We will investigate various instruments, such as a global antibiotic research fund and a market entry reward mechanism for truly new antibiotics targeting the most important pathogens and most needed for global public health. We recognise and commend the work of various reviews on AMR, such as the OECD, and other independent Reviews on AMR, tackling the lack of new antibiotics internationally and the initial proposals on how governments around the world could act collectively to stimulate innovation from a range of organisations, private or public, big or small.

21. We will continue close collaboration with our science ministers to advance these goals related to research and development, and invite other countries, international and philanthropic organizations to join this initiative.

22. We call for a High Level Meeting on AMR in 2016 at the United Nations General Assembly to promote increased political awareness, engagement and leadership on antimicrobial resistance among Heads of States, Ministers and global leaders.

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G7 Health Ministers’ Commitment – Lessons Learned from Ebola
Agreed by G7 Health Ministers in Berlin 2015
[Excerpt from 20 paragraphs]
…10. We support the ongoing work of the IHR Review Committee and look forward to the Committee’s findings on effectiveness and functioning of the International Health Regulations, as well as its recommendations for improvement, for instance, related to training, for innovative ways forward for standardized, transparent, and reliable instruments for effective monitoring and reporting under IHR. In this regard, we support a clear role for the WHO to assist countries in IHR implementation.

11. In order to prevent future outbreaks from becoming large-scale public health emergencies, the G7 Leaders have agreed to offer to assist at least 60 countries, including the countries of West Africa, over the next five years to implement the IHR, including through the Global Health Security Agenda (GHSA) and its common targets and other multilateral initiatives. By the end of 2015 we will, in collaboration with WHO, announce the countries that the G7 are collectively supporting or have consulted with or agreed plans to support to fulfill the Leaders’ commitment. This work is responding to country needs and entails building on existing in-country expertise and partnerships, programmes and projects. It is an integral part of an overall health systems strengthening agenda, which includes the development of basic health care systems as well as water, sanitation and hygiene programs. The initiative will be conducted in close cooperation and coordination with the WHO. We will continue also to work closely with other relevant institutions including the World Bank, the Global Fund to fight AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance.

12. The serious domestic and international consequences of the Ebola virus disease outbreak have highlighted the need for a more effective global system of disease surveillance, allowing early event detection, in part through the development of rapid diagnostic tests and the
development of better risk modelling, prevention, and surveillance to trigger timely national and global responses. In the future, countries should be encouraged to immediately notify health risks to the WHO in accordance with the IHR, in addition to removing bureaucratic barriers to escalating early notifications at the local, country and global levels. We commend ongoing efforts of the African Union and its regional organizations to build up a surveillance system that will, in cooperation with WHO, be instrumental in the struggle against future disease.

13. In the research and development (R&D) response to the Ebola crisis, we identified a number of gaps and inefficiencies where actions are needed to prevent and manage future outbreaks. We stress that progress should be made as a matter of preparedness on lead candidate products (vaccines, treatments, diagnostics, and personal protective equipment) pre-established protocols, and capacity to ensure the ability to quickly move to advanced phase clinical trials, product development, and scaled-up product manufacturing, which may only be performed when the outbreak occurs. We highlight the need for a more comprehensive applied and translational research in partnership with at-risk countries. We underline the importance of direct collaboration between countries and health research funders, and we call for continued financing, collaboration and coordination on their collective response to emerging epidemics of global concern, including through initiatives such as the proposed WHO blueprint for research and development preparedness and rapid research response during future public health emergencies and the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R).

14. We are convinced that it is essential to ensure that country-owned research is enhanced, including non-medical research such as social, behavioural, medical anthropology, and communication research. We consider that a broad range of capacity-building is needed in developing countries afflicted by or at risk of serious infectious disease outbreaks. It also requires training of research workers and of health staff extending down to the local level. It is important to ensure that epidemiological and, wherever possible, relevant trial information data is shared openly and transparently and shared early in the event of a public health emergency. It is also important to ensure good coordination and prioritisation of timely access to biological materials and clinical samples for research in accordance with national and international legal frameworks.

15. We recognise global gaps in medical facility infection control and related occupational health and safety frameworks designed to protect and train healthcare workers. Healthcare workers are critical national assets at the front line of initial epidemic detection and containment. Enhanced, national occupational health and safety administrations play a key role in the development of resilient, sustainable, and ready health systems.

16. The Ebola crisis has demonstrated a critical lack of safe and effective systems for deployment of medical experts to public health emergencies of this nature, in particular around insurance, medical evacuation and safe return to work post-deployment. It has also highlighted a lack of standard procedures and protocols across deployable teams which limits their inter-operability. Therefore, we will support national and international efforts, including the WHO’s global health emergency workforce, to provide a sustainable multi-disciplinary pool of experts. WHO should play a central role in coordination and facilitating the deployment of these experts. We welcome the process of developing one such initiative within the European Union (EU) (European Medical Corps), which will provide certain capacities to the global health emergency workforce.

17. We recognize the valuable recommendations of the WHO Ebola Interim Assessment Panel and the reform measures adopted by the 68th World Health Assembly in May 2015 – including the establishment of a contingency fund and the decision to establish a global health emergency workforce, making use of existing and strengthened partner mechanisms. We share the assessment that the WHO needs to be strengthened, and we support the reform process to make WHO fit for purpose to effectively fulfil its core functions in health emergencies.

18. We commit ourselves to strengthening WHO in order to better perform its leadership coordination roles on global health issues, and particularly in the face of epidemic threats, global health security, and the necessary support to countries in their efforts to be better prepared for global health crises. We share the view that the WHO must re-establish itself as the authoritative body, providing leadership, and coordinating the international preparedness for and response to health emergencies. This includes informing governments and the public around the world about the extent and severity of an outbreak as rapidly and as comprehensively as possible.

19. It is important that financial resources and mechanisms be strengthened, both within the WHO and elsewhere, to ensure timely, effective and coordinated response to disease outbreaks. Therefore, along with WHO’s Contingency Fund, we support the initiative by the World Bank to develop a Pandemic Emergency Facility…

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 17 October 2015)

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Research article
A survey of Ethiopian physicians’ experiences of bedside rationing: extensive resource scarcity, tough decisions and adverse consequences
Frehiwot Defaye, Dawit Desalegn, Marion Danis, Samia Hurst, Yemane Berhane, Ole Norheim, Ingrid Miljeteig BMC Health Services Research 2015, 15:467 (14 October 2015)
Abstract
Background
Resource scarcity in health care is a universal challenge. In high-income settings, bedside rationing is commonly discussed and debated as a means to addressing scarcity. However, little is known about physicians’ experiences in resource-limited contexts in low- income countries. Here we describe physicians’ experiences regarding scarcity of resources, bedside rationing, use of various strategies to save resources, and perceptions of the consequences of rationing in Ethiopia.
Methods
A national survey was conducted amongst physicians from 49 public hospitals using stratified, multi-stage sampling in six regions. All physicians in the selected hospitals were invited to respond to a self-administered questionnaire. Data were weighted and analyzed using descriptive statistics.
Results
In total, 587 physicians responded (91 % response rate). The majority had experienced system-wide shortages of various types of medical services. The services most frequently reported to be in short supply, either daily or weekly, were access to surgery, specialist and intensive care units, drug prescriptions and admission to hospital (52, 49, 46, 47 and 46 % respectively). The most common rationing strategies used daily or weekly were limiting laboratory tests, hospital drugs, radiological investigations and providing second best treatment (47, 47, 47 and 39 % respectively). Availability of institutional or national guidelines for whom to see and treat first was lacking. Almost all respondents had witnessed different adverse consequences of resource scarcity; 54 % reported seeing patients who, in their estimation, had died due to resource scarcity. Almost 9 out of 10 physicians were so troubled by limited resources that they often regretted their choice of profession.
Conclusion
This study provides the first glimpses of the untold story of resource shortage and bedside rationing in Ethiopia. Physicians encounter numerous dilemmas due to resource scarcity, and they report they lack adequate guidance for how to handle them. The consequences for patients and the professionals are substantial.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 17 October 2015)

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Research article
Frequency and impact of confounding by indication and healthy vaccinee bias in observational studies assessing influenza vaccine effectiveness: a systematic review
Cornelius Remschmidt, Ole Wichmann, Thomas Harder BMC Infectious Diseases 2015, 15:429 (17 October 2015)
Abstract
Background
Evidence on influenza vaccine effectiveness (VE) is commonly derived from observational studies. However, these studies are prone to confounding by indication and healthy vaccinee bias. We aimed to systematically investigate these two forms of confounding/bias.
Methods
Systematic review of observational studies reporting influenza VE and indicators for bias and confounding. We assessed risk of confounding by indication and healthy vaccinee bias for each study and calculated ratios of odds ratios (crude/adjusted) to quantify the effect of confounder adjustment. VE-estimates during and outside influenza seasons were compared to assess residual confounding by healthy vaccinee effects.
Results
We identified 23 studies reporting on 11 outcomes. Of these, 19 (83 %) showed high risk of bias: Fourteen due to confounding by indication, two for healthy vaccinee bias, and three studies showed both forms of confounding/bias. Adjustment for confounders increased VE on average by 12 % (95 % CI: 7–17 %; all-cause mortality), 9 % (95 % CI: 4–14 %; all-cause hospitalization) and 7 % (95 % CI: 4–10 %; influenza-like illness). Despite adjustment, nine studies showed residual confounding as indicated by significant off-season VE-estimates. These were observed for five outcomes, but more frequently for all-cause mortality as compared to other outcomes (p = 0.03) and in studies which indicated healthy vaccinee bias at baseline (p = 0.01).
Conclusions
Both confounding by indication and healthy vaccinee bias are likely to operate simultaneously in observational studies on influenza VE. Although adjustment can correct for confounding by indication to some extent, the resulting estimates are still prone to healthy vaccinee bias, at least as long as unspecific outcomes like all-cause mortality are used. Therefore, cohort studies using administrative data bases with unspecific outcomes should no longer be used to measure the effects of influenza vaccination.

Research article
Immunogenicity and safety of intradermal influenza vaccine in immunocompromized patients: a meta-analysis of randomized controlled trials
Claudia Pileggi, Francesca Lotito, Aida Bianco, Carmelo Nobile, Maria Pavia BMC Infectious Diseases 2015, 15:427 (14 October 2015)

Research article
The epidemiology of all-cause and rotavirus acute gastroenteritis and the characteristics of rotavirus circulating strains before and after rotavirus vaccine introduction in Yemen: analysis of hospital-based surveillance data
Salem Banajeh, Basheer Abu-Asba BMC Infectious Diseases 2015, 15:418 (13 October 2015)

Research article
Epidemiology of Ebola virus disease transmission among health care workers in Sierra Leone, May to December 2014: a retrospective descriptive study
Olushayo Olu, Brima Kargbo, Sarian Kamara, Alie Wurie, Jackson Amone, Louisa Ganda, Bernard Ntsama, Alain Poy, Fredson Kuti-George, Etsub Engedashet, Negusu Worku, Martin Cormican, Charles Okot, Zabulon Yoti, Kande-Bure Kamara, Kennedy Chitala, Alex Chimbaru, Francis Kasolo BMC Infectious Diseases 2015, 15:416 (13 October 2015)

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 17 October 2015)

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Debate
The importance of values in evidence-based medicine
Michael Kelly, Iona Heath, Jeremy Howick, Trisha Greenhalgh BMC Medical Ethics 2015, 16:69 (12 October 2015)
Abstract
Background
Evidence-based medicine (EBM) has always required integration of patient values with ‘best’ clinical evidence. It is widely recognized that scientific practices and discoveries, including those of EBM, are value-laden. But to date, the science of EBM has focused primarily on methods for reducing bias in the evidence, while the role of values in the different aspects of the EBM process has been almost completely ignored.
Discussion
In this paper, we address this gap by demonstrating how a consideration of values can enhance every aspect of EBM, including: prioritizing which tests and treatments to investigate, selecting research designs and methods, assessing effectiveness and efficiency, supporting patient choice and taking account of the limited time and resources available to busy clinicians. Since values are integral to the practice of EBM, it follows that the highest standards of EBM require values to be made explicit, systematically explored, and integrated into decision making.
Summary
Through ‘values based’ approaches, EBM’s connection to the humanitarian principles upon which it was founded will be strengthened.