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

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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

Editor’s Note:
We provide below the current list of WHO Grade 3 and Grade 2 emergencies. We note that the WHO web pages associated with country links often do not evidence any current information. In a number of cases, the most current information posted is from weeks or months ago.

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WHO Grade 3 and Grade 2 emergencies
[accessed 24 July 2015]

WHO Grade 3 emergencies
Guinea
Iraq
Liberia
Nepal
Philippines
Sierra Leone
South Sudan
The Syrian Arab Republic

WHO Grade 2 emergencies
Central African Republic
Democratic Republic of the Congo
Malawi
Mozambique
Niger
Nigeria
Philippines
Ukraine
Vanuatu
Yemen

Grade definitions
:: Grade 2: a single or multiple country event with moderate public health consequences that requires a moderate WCO response and/or moderate international WHO response. Organizational and/or external support required by the WCO is moderate. An Emergency Support Team, run out of the regional office (the Emergency Support Team is only run out of HQ if multiple regions are affected), coordinates the provision of support to the WCO.

:: Grade 3: a single or multiple country event with substantial public health consequences that requires a substantial WCO response and/or substantial international WHO response. Organizational and/or external support required by the WCO is substantial. An Emergency Support Team, run out of the regional office, coordinates the provision of support to the WCO.

EBOLA/EVD [to 25 July 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Ebola Situation Report – 22 July 2015
[Excerpts]
SUMMARY
:: There were 26 confirmed cases of Ebola virus disease (EVD) reported in the week to 19 July: 22 in Guinea and 4 in Sierra Leone. Liberia reported no new cases. For the second consecutive week more than half of all cases were reported from the capitals of Guinea and Sierra Leone, Conakry and Freetown. By contrast, other recent hotspots of transmission such as Boke in Guinea and Kambia in Sierra Leone have now reported no cases for 18 and 9 days, respectively. There are also indications of a continuation of the improvements in contact tracing and case investigation seen in recent weeks, with all but 2 cases arising among registered contacts of previous cases, including all 13 of the cases reported from the Guinean capital Conakry. This is the highest proportion of cases to arise among contacts since the beginning of the outbreak. However, one of the 2 cases reported from Freetown arose from an unknown source of infection, and is considered to represent a high risk of further transmission. In addition, 2 cases, both from Guinea, were identified as EVD-positive only after post-mortem testing of community deaths….

COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
:: There have been a total of 27 705 reported confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (figure 1, table 1) up to 19 July, with 11 269 reported deaths (this total includes reported deaths among probable and suspected cases, although outcomes for many cases are unknown). A total of 22 new confirmed cases were reported in Guinea and 4 in Sierra Leone in the week to 19 July…

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WHO Stories from Countries
:: Vaccinating and registering the children born during Ebola
23 July 2015
:: Ebola diaries: Helping people to stay safe
21 July 2015

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UNMEER
:: Acting UNMEER SRSG Peter Graaff’s remarks at press conference on Ebola preparedness mission to Guinea-Bissau
25 Jun 2015

POLIO [to 25 July 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 22 July 2015
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: Last week, Forbes.com featured a live discussion on the global polio eradication effort with Dr Hamid Jafari, Director for the Global Polio Eradication Initiative at WHO, and Dr John Sever, Vice Chair of Rotary International’s Polio Plus Program. A podcast of the discussion can be accessed here.
:: 24 July 2015 will mark 12 months since the last reported case due to wild poliovirus in Nigeria had onset of paralysis. See ‘Nigeria’ section for more. As Nigeria approaches a year with no child paralyzed with polio this week, influential figures are calling for continued vigilance and commitment both from the Nigerian government and internationally. Read Nigerian Academy of Science President Oyewale Tomori’s appeal to President Buhari and President Obama here.

Selected excerpts from Country-specific Reports
Nigeria
:: No new wild poliovirus type 1 (WPV1) cases were reported in the past week. No cases have been reported in 2015. Nigeria’s total WPV1 case count for 2014 remains 6. The most recent case had onset of paralysis on 24 July 2014 in Sumaila Local Government Area (LGA), southern Kano state.
:: No new cases of type 2 circulating vaccine-derived poliovirus (cVDPV2) cases were reported in the past week. The most recent case had onset of paralysis in Kwali Local Government Area (LGA), Federal Capital Territory (FCT) Abuja, with onset of paralysis on 16 May; this is the only cVDPV2 case reported in Nigeria in 2015.
:: 24 July 2015 will mark 12 months since the last reported case due to wild poliovirus in Nigeria had onset of paralysis (the full 12-month data is pending final laboratory classification from all environmental samples and acute flaccid paralysis (AFP) cases, collected up until 24 July 2015. Results are expected by September).
:: This progress is thanks to the hard work of the Nigerian government, partners, religious and community leaders, and health workers.
:: While Nigeria is closer than ever to ending polio, the job is not yet finished. At least two more years must pass without a case of wild poliovirus for Nigeria to be certified polio-free along with the rest of the WHO’s African region. To achieve this goal, Nigeria and all countries in the African region must maintain high-quality surveillance for poliovirus and vaccination campaigns, particularly in hard-to-reach and insecure areas, and improve routine immunization.
:: At the same time, efforts are ongoing to rapidly stop a cVDPV2 outbreak affecting the country, with aggressive outbreak response using trivalent OPV being implemented in the affected and high-risk areas.

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Buhari and Obama can end polio in Africa
By Oyewale Tomori, DVM, PhD –
Opinion | Op-Ed
The Hill
07/20/15 01:00 PM EDT
For every one of the almost 70 years I have lived in Nigeria, children – often by the hundreds – have become paralyzed from a virus that I’ve spent my professional life trying to stop. But this year may be different.

Since July 24, 2014, one year ago this week, Nigeria has not recorded a single case of wild poliovirus. This is the first time this has happened in history. If Nigeria is able to stay on track, it can be removed from the short list of countries that have never halted polio transmission.

Also this week, Nigeria’s new president, Muhammadu Buhari, is meeting with President Obama – his first official visit to the White House. I do not expect polio to be top of their agenda. Bringing peace and stability to the northeast and instituting economic and political reforms are clearly key priorities, but it would be a mistake to overlook what could be one of President Buhari’s greatest achievements: the eradication of polio in Nigeria.

Nigeria’s progress to date is encouraging, but the country must go an additional two years without a case to be certified polio-free along with the rest of the WHO African region. We will not make it that far without the steadfast commitment of both leaders. For Buhari, he must appoint a strong health minister and publicly commit to freeing Nigeria from polio by 2017. The U.S. has been a historically strong donor to the Global Polio Eradication Initiative and until Africa is certified polio free and cases have also been stopped in Afghanistan and Pakistan – the only two countries that have had cases of wild polio this year – it is critical that Obama continues to lead the global effort.

Nigeria has shown the world that polio eradication is possible. With the help of seven Emergency Operations Centres throughout the country, the government and partners have been able to respond in real-time to polio outbreaks and coordinate vaccination campaigns. At the local level, health workers, often drawn from the communities they serve, have partnered with polio survivors and religious leaders to help parents understand the importance of the vaccine for their children.

We have also learned from others. Nigeria built on India’s polio eradication success by improving immunization microplans, where local leaders and health workers walk through their communities and map each house so that vaccinators know where to go and no child is missed. In conflict zones, health workers have learned to be nimble and take advantage of short periods of calm to vaccinate children.

But I hope that the most important lesson we’ve learned is not to be complacent. Nigeria is the only country in Africa that has never stopped polio. We have been close before to ridding our country of the deadly virus, but we let our guard down and the disease came roaring back, re-infecting dozens of other African countries.

Yet, despite all the lessons we’ve learned, the end of polio will not come quietly. Insecurity in the northeast part of the country has left many settlements in the area inaccessible to health workers. A recent case of circulating vaccine-derived poliovirus (cVDPV) – a very rare form of the virus mutated from the oral polio vaccine that emerges in under-immunized populations – shows that polio vaccination rates in Nigeria are still not high enough.

Buhari has the historic opportunity to end polio forever on his watch, but only if he dedicates the necessary resources to improve campaign quality, intensify surveillance measures, and reach children in all parts of the country – particularly in insecure areas in the northeast. Until we reach every child, all children remain at risk.

Freeing my country of polio will have benefits beyond just taking Nigeria’s name off that short, inglorious list. The polio program has provided a framework for reaching children all over the country with life-saving vaccines and critical health services. It also taught us how to effectively respond to disease outbreaks, as we did when Ebola came calling.

While it’s critical that we don’t lose focus on eradication, we must also increase investment in our often fragile health system. One in eight Nigerian children still die before reaching their fifth birthday – the vast majority from preventable diseases – making Nigeria one of the most dangerous countries in the world to be a child. A strong and resilient Nigeria rests on building an effective health system that delivers for its citizens, and for its children.

I dream that I will live the last years of my life in Nigeria – in a country where no child becomes paralyzed by polio, or dies from vaccine preventable diseases. So, to Buhari and our friend to the West, let us commit, once again and finally, to rid Nigeria and Africa of polio. Our children, our country and our continent depend on it.
Tomori is president of the Nigerian Academy of Science.

MERS-CoV [to 25 July 2015]

Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: 24 July 2015 – Middle East Respiratory Syndrome coronavirus (MERS-CoV) – Saudi Arabia
Between 1 and 14 July 2015, the National IHR Focal Point for the Kingdom of Saudi Arabia notified WHO of 6 additional cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection…
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:: 21 July 2015 – Middle East respiratory syndrome coronavirus (MERS-CoV) – Republic of Korea
Situation in the Republic of Korea
Between 18 and 21 July 2015, the National IHR Focal Point of the Republic of Korea notified WHO of no additional cases of infection and no new deaths related to Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Additional information on the outbreak in the Republic of Korea
To date, a total of 186 MERS-CoV cases, including 36 deaths, have been reported. One of the 186 cases is the case that was confirmed in China and also notified by the National IHR Focal Point of China…

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MERS-CoV cases 21 July 2015 xlsx, 19kb

European Medicines Agency [to 25 July 2015]
http://www.ema.europa.eu/ema/
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:: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015
24/07/2015
Ten new medicines recommended for authorisation in the EU, and first malaria vaccine receives positive scientific opinion for use outside the EU
At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU).

Mosquirix was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU…

:: First malaria vaccine receives positive scientific opinion from EMA
Mosquirix to be used for vaccination of young children, together with established antimalarial interventions
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), for use outside the European Union (EU).

The malaria vaccine Mosquirix, also known as RTS,S/AS01, was submitted to EMA under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. This means that EMA can help facilitate access to new medicines for people living outside the EU.

Mosquirix is intended for use in areas where malaria is regularly found, for the active immunisation of children aged 6 weeks to 17 months against malaria caused by the Plasmodium falciparum parasite, and against hepatitis B. After decades of research into malaria vaccinations, Mosquirix is the first vaccine for the disease to be assessed by a regulatory agency.

The CHMP highlighted in its opinion that Mosquirix is for use in line with official recommendations that take into account the risk of Plasmodium falciparum malaria in different geographical areas and available malaria control interventions. These recommendations will be defined by the World Health Organization (WHO) and regulatory authorities in the non-EU countries where the vaccine would be used.

As in all Article 58 procedures, the CHMP worked closely with other experts, including from WHO and regulatory authorities from the relevant countries. In its assessment, the CHMP applied the same rigorous standards as for medicines to be marketed within the EU…

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GSK’s malaria candidate vaccine, Mosquirix™ (RTS,S), receives positive opinion from European regulators for the prevention of malaria in young children in sub-Saharan Africa
WHO will now assess how the world’s first malaria candidate vaccine might be used alongside other tools to prevent malaria
GSK Press Release
24 July 2015 Issued: London, UK

GSK announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for its malaria candidate vaccine MosquirixTM, also known as RTS,S, in children aged 6 weeks to 17 months. Following this decision, the World Health Organization (WHO) will now formulate a policy recommendation on use of the vaccine in national immunisation programmes once approved by national regulatory authorities.

RTS,S, which was developed in partnership with the PATH Malaria Vaccine Initiative (MVI), is the first candidate vaccine for the prevention of malaria to reach this milestone. While other vaccines tackle viruses or bacteria, RTS,S has been designed to prevent malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa (SSA). In 2013, there were an estimated 584,000 deaths from malaria with around 90% of these occurring in SSA, and 83% in children under the age of five in SSA.1

The CHMP scientific opinion is a key step in the regulatory process toward making RTS,S available alongside existing tools currently recommended for malaria prevention. The positive opinion for young children was based on the review of data assessing the candidate vaccine’s safety, efficacy and quality. Clinical data submitted for CHMP assessment were mainly from a phase III clinical trial programme involving more than 16,000 young children that was conducted by 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania).

Data from this trial programme demonstrate that over the first 18 months following three doses of RTS,S, malaria cases were reduced by almost half in children aged 5-17 months at the time of first vaccination and by 27% in infants aged 6-12 weeks. At study end, four doses of RTS,S reduced malaria cases by 39% over four years of follow-up in children, and by 27% over three years of follow-up in infants.2 In areas of the highest malaria burden, more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated.2 The efficacy of RTS,S was evaluated in addition to existing malaria control measures, such as insecticide treated bed nets, which were used by approximately 80% of the children and infants in the trial.

Sir Andrew Witty, CEO of GSK said: “Today’s scientific opinion represents a further important step towards making available for young children the world’s first malaria vaccine. While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most. The work doesn’t stop here and GSK remains committed to investing in R&D for malaria vaccines and treatments to find more ways to tackle this devastating disease.”

Dr David C. Kaslow, Vice President of Product Development at PATH said: “Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite. PATH will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decision-making on those remaining steps.”

GSK has committed to a not-for-profit price for RTS,S so that, if approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around five per cent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Next steps
Following the CHMP positive scientific opinion, two of the WHO’s independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) will now jointly review the evidence base for RTS,S and make a joint policy recommendation for how it might be used alongside other tools to prevent malaria in the event the vaccine candidate is approved by national regulatory authorities in SSA. The WHO has indicated that such a policy recommendation may be possible by end of this year.

Following the WHO policy recommendation, GSK will also submit an application to the WHO for pre-qualification of RTS,S. WHO pre-qualification involves a scientific assessment of the quality, safety and efficacy of any new vaccine proposed for introduction in WHO Expanded Programme on Immunization. A pre-qualification decision is used by the United Nations agencies and other large scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorisation in countries in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin implementation of RTS,S through their universal immunisation programmes.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS,S into local immunisation programmes supported by UNICEF.

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PATH [to 25 July 2015]
http://www.path.org/news/index.php
Press release | July 13, 2015
:: PATH Malaria Vaccine Initiative welcomes positive opinion by European regulators on GSK’s Mosquirix™ (RTS,S)
Announcement | July 23, 2015
Decision paves the way for World Health Organization to assess how a malaria vaccine might be used in young children in sub-Saharan Africa

WHO & Regionals [to 25 July 2015]
The Weekly Epidemiological Record (WER) 24 July 2015, vol. 90, 30 (pp. 373–380) includes:
:: Genetic diversity of wild-type measles viruses and the global measles nucleotide surveillance database (MeaNS)
http://www.who.int/entity/wer/2015/wer9030.pdf?ua=1

WHO calls for urgent action to curb hepatitis
News release
23 JULY 2015 ¦ GENEVA – On World Hepatitis Day (28 July) WHO highlights the urgent need for countries to enhance action to prevent viral hepatitis infection and to ensure that people who have been infected are diagnosed and offered treatment. This year, the Organization is focusing particularly on hepatitis B and C, which together cause approximately 80% of all liver cancer deaths and kill close to 1.4 million people every year…

The control of neglected zoonotic diseases
July 2015 — A newly published report finds that most neglected zoonotic diseases can be controlled through the use of existing knowledge and tools. WHO estimates that nearly two-thirds of all human pathogens originate from zoonoses.
:: WHO Regional Offices
WHO African Region AFRO
:: High level delegation from the Bill & Melinda Gates Foundation visits World Health Organization Regional Office for Africa
Brazzaville, 21 July 2015 – A high level delegation from the Bill & Melinda Gates Foundation (BMGF) has begun a four-day official visit to the World Health Organization Regional Office for Africa (AFRO) in Brazzaville, Congo from 21-24 July 2015. The aim of the visit is to review ongoing collaboration between the two organizations and explore new ways of working together to improve the health of people in the African Region. An initial team of senior leaders from BMGF including Dr Steve Landry Director, Multilateral Partnerships and Mr Tom Hurley, Deputy Director, Multilateral Partnerships, began discussions with the senior management…

WHO Region of the Americas PAHO
:: WHO validates Cuba’s elimination of mother-to-child transmission of HIV and syphilis (06/30/2015)
:: Women’s health needs still not adequately met, according to new articles in the Pan American Journal of Public Health (06/24/2015)
:: Health Coverage Reaches 46 Million More in Latin America and the Caribbean, says new PAHO/WHO–World Bank report (06/22/2015)

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

WHO European Region EURO
:: WHO delivers emergency health kits to Suruc in Turkey 24-07-2015
:: Georgia sets sights on eliminating hepatitis C 23-07-2015
:: Viral hepatitis – 400 deaths a day in the WHO European Region could be prevented 23-07-2015
:: WHO receives Turkmenistan State award for collaboration in public health 21-07-2015

WHO Eastern Mediterranean Region EMRO
:: World Hepatitis Day in Egypt focuses on hepatitis B and C prevention
23 July, 2015 | Cairo – Preventing hepatitis B and C is the regional theme of this year’s World Hepatitis Day. Viral hepatitis is a global health problem affecting hundreds of millions of people worldwide. The Eastern Mediterranean Region has some of the highest rates of viral hepatitis in the world, with an estimated 4.3 million people becoming infected with hepatitis B and 800 000 with hepatitis C every year. This year, the WHO Regional Office will host an event to observe World Hepatitis Day on 28 July 2015 in Cairo, Egypt.

WHO Western Pacific Region
:: Do your part to prevent hepatitis
MANILA, 24 July 2015 – Nearly 40% of global deaths attributable to viral hepatitis occur in the Western Pacific, more than the combined death toll from HIV/AIDS, tuberculosis and malaria. To mark World Hepatitis Day on 28 July, the World Health Organization (WHO) in the Western Pacific Region urges policy-makers, health workers and the public to take action to stop infection and death from hepatitis B and C.
Read the news release

IVI [to 25 July 2015]
http://www.ivi.org/web/www/home

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:: Dr. In-Kyu Yoon Appointed as Director of the Dengue Vaccine Initiative
WASHINGTON, DC – July 24, 2015 – The Dengue Vaccine Initiative (DVI) a consortium comprised of the International Vaccine Institute, the Johns Hopkins University’s International Vaccine Access Center, Sabin Vaccine Institute and the World Health Organization, is delighted to announce the appointment of Dr. In-Kyu Yoon as its new Director. Dr. Yoon, former Chief of the Department of Virology, Armed Forces Research Institute Medical Sciences in Bangkok, Thailand, will lead DVI starting August, 2015.

“We greatly look forward to Dr. Yoon’s leadership of DVI,” said Dr. Jerome Kim, the International Vaccine Institute’s Director General. “Dr. Yoon’s extensive research experience and knowledge of dengue and vaccine clinical trials will further strengthen DVI’s management and operations. His experience will be welcomed by the International Vaccine Institute as he can also provide additional scientific leadership at the Institute.”

In his previous position, Dr. Yoon investigated arbovirus and respiratory virus infections including clinical trials of candidate vaccines. He has conducted research on the epidemiology, pathophysiology and immunology of dengue and other emerging infectious diseases, was a faculty member of the Uniformed Services University of the Health Sciences in Maryland, United States and authored over 70 publications and provided clinical care in a variety of civilian and military settings internationally…

…“I’m excited to lead the Dengue Vaccine Initiative during this critical period in the development and implementation of dengue vaccines. DVI and PDVI have played a crucial role over the past 12 years in advancing the field of dengue vaccines. As we move forward, DVI will continue to work diligently to promote measures to prevent and control this global problem” commented Dr. Yoon on his new endeavor

Aeras [to 25 July 2015]
http://www.aeras.org/pressreleases

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:: Aeras Welcomes David Blumberg to its Board of Directors
Rockville, MD, July 20, 2015 – David L. Blumberg, M.B.A., an expert in the life sciences industry, recently joined Aeras’s Board of Directors. He has more than 20 years of business and consulting experience across the life sciences continuum, including large global, specialty, and generic pharmaceuticals, biotech, and medical devices and products.

Global Fund [to 25 July 2015]
http://www.theglobalfund.org/en/mediacenter/newsreleases/
:: Global Fund Statement on International Investment in Global Health  24 July 2015
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:: Breakthrough Global Agreement Sharply Lowers Price of Early Infant Diagnosis of HIV  20 July 2015

NIH [to 25 July 2015]
http://www.nih.gov/news/releases.htm
:: Young South African women can adhere to daily PrEP regimen as HIV prevention
July 21, 2015 — NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.

:: Early antiretroviral therapy prevents non-AIDS outcomes in HIV-infected people
July 20, 2015 — NIH-supported findings illustrate manifold benefit of therapy.

:: HIV control through treatment durably prevents heterosexual transmission of virus
July 20, 2015 — NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.

Perspective
Establishing a Global Vaccine-Development Fund
Stanley A. Plotkin, M.D., Adel A.F. Mahmoud, M.D., Ph.D., and Jeremy Farrar, M.D., Ph.D.
N Engl J Med 2015; 373:297-300 July 23, 2015 DOI: 10.1056/NEJMp1506820

As the Ebola epidemic in West Africa continues, albeit at a much lower level than it reached in the spring, we still lack a vaccine that has been shown to be safe and effective. There has been no shortage of basic research: by 2009, at least seven Ebola vaccines had been tested in monkeys, with encouraging results.1 But before the West African epidemic, only one of these vaccine candidates was tested in healthy humans, in phase 1 trials to evaluate its safety, and it was subsequently abandoned.2 No vaccine had reached the later processes that would lead to licensure, and none was available in sufficient supply to be deployed in an emergency. Unfortunately, the same applies to many other infections: vaccines against them are not available because collectively we have not been willing or able to invest in the costly and complex development process that would be required to establish safety and immunogenicity, at a minimum.

Vaccine development is facing a crisis for three reasons: the complexity of the most challenging targets, which necessitates substantial investment of capital and human expertise; the diminishing numbers of vaccine manufacturers able to devote the necessary resources to research, development, and production; and the prevailing business model, which prioritizes the development of vaccines with a large market potential. We consider an international vaccine-development fund to be urgently needed to provide the resources and the momentum to carry vaccines from their conception in academic and government laboratories and small biotechnology firms to development and licensure by industry. Such a fund would enable basic scientists to move candidate vaccines from the laboratory through the so-called valley of death — the critical steps after good preclinical data have been obtained, comprising manufacture to Food and Drug Administration standards, a phase 1 clinical trial, and proof of concept in terms of protective immune responses. This support would permit efficacy assessment to begin — and thereby avert a repetition of the Ebola crisis.

Much attention has appropriately been directed at major disease targets such as human immunodeficiency virus (HIV), tuberculosis, and malaria, for which organizations such as the National Institutes of Health, the Bill and Melinda Gates Foundation, and the Wellcome Trust are providing considerable financial support. Similar attention has been devoted to the provision of currently licensed pediatric vaccines, which is supported by GAVI (formerly the Global Alliance for Vaccines and Immunization). However, there are many infectious disease targets for which vaccines are both badly needed and feasible but which are not being developed owing to either a lack of governmental prioritization or a lack of incentives because the market has been considered too small to justify the capital investment, to allow development costs and to reward the required investment risk. These targets…include Ebola, chikungunya, Middle East respiratory syndrome coronavirus (MERS-CoV), acute respiratory syndrome (SARS) virus (which is not extinct in its animal reservoir), West Nile virus, and Lyme disease, to name a few. They are not attractive to major manufacturers because the anticipated revenues would be small. In the table, we compare the three major global health funds with the vaccine-development fund that we are proposing.

There are now only four major manufacturers that focus on vaccine development: GlaxoSmithKline, Merck, Pfizer, and Sanofi Pasteur. These days, the development of just one new vaccine requires a capital investment ranging from $500 million for the least complex to $1 billion or more for the most complex, including construction of facilities for manufacture.3 Moreover, only about 7% of vaccine development projects that reach the preclinical development phase result in a licensed vaccine.4 With few exceptions, the scores of biotechnology companies and government and university laboratories engaged in vaccine discovery and development lack the necessary resources to carry candidate vaccines through early-stage clinical trials — let alone the costly phase 3 trials required for licensure. They and other groups must convince an increasingly skeptical investor or a major vaccine manufacturer to take up development after the initial stages.

Thus, the pharmaceutical industry’s enthusiasm for vaccine development has dropped well below the levels seen in the 1980s and 1990s. The ClinicalTrials.gov website shows that only a minority of trials of vaccines against new infectious disease targets are sponsored by major vaccine companies and that the total number of trials is not increasing. Although we may hope that manufacturers in developing countries will soon be able to develop needed new vaccines from research to licensure, that is only beginning to be the case.

In addition to producing new vaccines, there is a growing need to improve old vaccines. Pertussis and influenza vaccines, for example, are currently recommended for everyone, but their effectiveness leaves much to be desired. Efforts to improve them are stymied by the need for costly, new — and in many cases impractically large — studies of vaccine safety and efficacy to validate reformulated products. Also weighing against efforts to develop improved vaccines are the low prices of existing vaccines and the lack of economic incentives to improve them. External funding could permit the exploration of ideas for improving partially effective vaccines.

Seed money for the proposed fund could come from governments, foundations, the pharmaceutical industry, and nontraditional sources, perhaps including the insurance and travel industries. At least $2 billion would be needed at the outset. This level of funding should be achievable, even at a time when resources are scarce. Witness the cost of addressing the Ebola emergency, estimated at $8 billion to date, with the final figure likely to be far higher.

The proposed fund would invite competitive proposals from scientists, their institutions, and eligible biotech companies. Requests for support to help carry promising vaccine projects through tests in large animals, manufacturing for human use, phase 1 and 2 clinical trials, including the initial demonstration of efficacy and the production of a small stockpile, would be reviewed by an independent panel of scientists and funders. Grants would be awarded and renewed on the basis of milestones achieved and overall grant performance, which would be closely monitored by independent auditors. Institutional overhead costs would be capped. Costly phase 3 trials would have to be funded and conducted by an interested pharmaceutical partner, most likely with substantial government support or special incentives, as circumstances dictated. With initial support, however, at least a vaccine would be available for emergency use. In some cases, if phase 3 trials were impractical, results from animal or human challenge models might suffice for licensure.

The extraordinary challenges facing vaccine developers are not dissimilar to those of developing new classes of antibiotics. Indeed, the rationale for the proposed $2 billion antibiotic-resistance fund is remarkably similar to our arguments for a vaccine-development fund; the two funds would be complementary. The economic reality today is that strategic support from government and other investors is needed to address the most difficult infectious disease problems.

The fundamental challenges facing the discovery and development of new vaccines are growing in significance and can no longer be ignored. The lack of resources at critical stages of the early development process is the key rate-limiting factor that discourages vaccine discovery and development by impeding scientific advances that could lead to new and improved vaccines. If a global vaccine-development fund had enabled just one candidate Ebola vaccine to be tested for safety and immunogenicity in humans before the 2014 outbreak in West Africa, public health workers could have begun vaccinating people at the start of the epidemic, potentially saving thousands of lives. The lesson we take from the Ebola crisis is that disease prevention should not be held back by lack of money at a critical juncture when a relatively modest, strategic investment could save thousands of lives and billions of dollars further down the line.

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Interview with Dr. Stanley Plotkin on a strategy for stimulating and supporting global vaccine research. (9:21)
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Using Existing Platforms to Integrate and Coordinate Investments for Children—Workshop in Brief
IOM Report
July 21, 2015
Online full report: http://books.nap.edu/openbook.php?record_id=21783
Overview
On March 14–15, 2015, the Forum on Investing in Young Children Globally, in partnership with the Centre for Health Education and Health Promotion and Wu Yee Sun College of the Chinese University of Hong Kong, held a workshop in Hong Kong to examine the science and policy issues involved in coordinating investments in children and their caregivers. Over the course of a day and a half, researchers, policy makers, program practitioners, and other experts on early childhood development from 22 countries discussed how best to coordinate such investments using existing platforms across areas of health, education, nutrition, social protection, and other service domains. This brief summary of the presentations and discussions at the workshop highlights the major issues raised by individual workshop participants, including suggestions for future discussion and action.

Improving Quality of Care in Low- and Middle-Income Countries: Workshop Summary
IOM Report
July 23, 2015
Online full report: http://books.nap.edu/openbook.php?record_id=21736
Overview
Momentum for universal health coverage has underscored the problem of poor quality care in low- and middle-income countries. While concern with access to services sometimes overshadows interest in the standard of the services provided, unsafe care is a leading cause of disability-adjusted life years (DALYs) lost worldwide. As governments and donors spend more on health, they want to ensure that the services they pay for are safe and effective and, therefore, have more reason to invest in quality improvement.
Quality of care is a priority for U.S. Agency for International Development (USAID), but a lack of evidence has constrained the ability of the agency and its partners to make informed choices. With investments in quality continuing to grow, there is demand for more scientific evidence on the best ways to reliably improve quality of care in low- and middle-income countries.

To this end, the Institute of Medicine convened a two-day workshop on January 28–29, 2015, focusing on the six methods that currently make up the majority of USAID’s investment in quality improvement: accreditation, COPE®, improvement collaborative, standards-based management and recognitions (SBM-R), supervision, and clinical in-service training. The workshop considered how the different methods work to improve quality, when and where certain approaches might be most effective, and the best ways to measure success and shortcomings. Participants reflected on the state of the evidence and opportunities for advancing the global quality improvement agenda through policy, practice, and research.

The State of the National Vaccine Plan – 2014 [United States]
U.S. HHS
July 2015 :: 118 pages
The Annual Report of the State of the National Vaccine Plan 2014 highlights the work done by HHS agencies and our partners toward attaining the 5 goals of the 2010 National Vaccine Plan [PDF]. It features accomplishments across the vaccination system in regards to development, safety, communications, access and global vaccination, and reflects new opportunities and challenges presented by the 21st century immunization landscape.

This report includes:
Goal 1: Details about the discovery and creation of new vaccines
Goal 2: Information about advancing vaccine safety
Goal 3: Insight on communications efforts enhancing informed decision-making
Goal 4: Examples of work expanding access to vaccines
Goal 5: Summaries of global immunization activities

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Download the full Annual Report of the State of the National Vaccine Plan 2014 [PDF – 11MB]

Annals of Internal Medicine
21 July 2015, Vol. 163. No. 2
http://annals.org/issue.aspx

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Characteristics and Clinical Management of a Cluster of 3 Patients With Ebola Virus Disease, Including the First Domestically Acquired Cases in the United States FREE
Allison M. Liddell, MD; Richard T. Davey Jr., MD; Aneesh K. Mehta, MD; Jay B. Varkey, MD; Colleen S. Kraft, MD, MSc; Gebre K. Tseggay, MD; Oghenetega Badidi, MD; Andrew C. Faust, PharmD; Katia V. Brown, MD; Anthony F. Suffredini, MD; Kevin Barrett, RN; Mark J. Wolcott, PhD; Vincent C. Marconi, MD; G. Marshall Lyon III, MD, MMSc; Gary L. Weinstein, MD; Kenney Weinmeister, MD; Shelby Sutton, MD; Munir Hazbun, MD; César G. Albariño, PhD; Zachary Reed, MPH; Debi Cannon; Ute Ströher, PhD; Mark Feldman, MD; Bruce S. Ribner, MD, MPH; H. Clifford Lane, MD; Anthony S. Fauci, MD; and Timothy M. Uyeki, MD, MPH, MPP

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Sexual Orientation Identity Disparities in Awareness and Initiation of the Human Papillomavirus Vaccine Among U.S. Women and Girls: A National Survey
Madina Agénor, ScD, MPH; Sarah Peitzmeier, MSPH; Allegra R. Gordon, MPH; Sebastien Haneuse, PhD; Jennifer E. Potter, MD; and S. Bryn Austin, ScD
Abstract
Background: Lesbians and bisexual women are at risk for human papillomavirus (HPV) infection from female and male sexual partners.
Objective: To examine the association between sexual orientation identity and HPV vaccination among U.S. women and girls.
Design: Cross-sectional, using 2006–2010 National Survey of Family Growth data.
Setting: U.S. civilian noninstitutionalized population.
Participants: The 2006–2010 National Survey of Family Growth used stratified cluster sampling to establish a national probability sample of 12 279 U.S. women and girls aged 15 to 44 years. Analyses were restricted to 3253 women and girls aged 15 to 25 years who were asked about HPV vaccination.
Measurements: Multivariable logistic regression was used to obtain prevalence estimates of HPV vaccine awareness and initiation adjusted for sociodemographic and health care factors for each sexual orientation identity group.
Results: Among U.S. women and girls aged 15 to 25 years, 84.4% reported having heard of the HPV vaccine; of these, 28.5% had initiated HPV vaccination. The adjusted prevalence of vaccine awareness was similar among heterosexual, bisexual, and lesbian respondents. After adjustment for covariates, 8.5% (P = 0.007) of lesbians and 33.2% (P = 0.33) of bisexual women and girls who had heard of the vaccine had initiated vaccination compared with 28.4% of their heterosexual counterparts.
Limitation: Self-reported, cross-sectional data, and findings may not be generalizable to periods after 2006 to 2010 or all U.S. lesbians aged 15 to 25 years (because of the small sample size for this group).
Conclusion: Adolescent and young adult lesbians may be less likely to initiate HPV vaccination than their heterosexual counterparts. Programs should facilitate access to HPV vaccination services among young lesbians.
Summaries for Patients
Sexual Orientation Identity and Human Papillomavirus Vaccination

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 25 July 2015)

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Research article
The relationship of women’s status and empowerment with skilled birth attendant use in Senegal and Tanzania
Kyoko Shimamoto* and Jessica D. Gipson
Author Affiliations
BMC Pregnancy & Childbirth 2015, 15:154 doi:10.1186/s12884-015-0591-3
Published: 24 July 2015
Abstract
Background
Maternal mortality remains unacceptably high in sub-Saharan Africa with 179,000 deaths occurring each year, accounting for 2-thirds of maternal deaths worldwide. Progress in reducing maternal deaths and increasing Skilled Birth Attendant (SBA) use at childbirth has stagnated in Africa. Although several studies demonstrate the important influences of women’s status and empowerment on SBA use, this evidence is limited, particularly in Africa. Furthermore, few studies empirically test the operationalization of women’s empowerment and incorporate multidimensional measures to represent the potentially disparate influence of women’s status and empowerment on SBA use across settings.
Methods
This study examined the relationship of women’s status and empowerment with SBA use in two African countries – Senegal and Tanzania – using the 2010 Demographic and Health Surveys (weighted births n = 10,688 in SN; 6748 in TZ). Factor analysis was first conducted to identify the structure and multiple dimensions of empowerment. Then, a multivariate regression analysis was conducted to examine associations between these empowerment dimensions and SBA use.
Results
Overall, women’s status and empowerment were positively related to SBA use. Some sociodemographic characteristics showed similar effects across countries (e.g., age, wealth, residence, marital relationship, parity); however, women’s status and empowerment influence SBA use differently by setting. Namely, women’s education directly and positively influenced SBA use in Tanzania, but not in Senegal. Further, each of the dimensions of empowerment influenced SBA use in disparate ways. In Tanzania women’s higher household decision-making power and employment were related to SBA use, while in Senegal more progressive perceptions of gender norms and older age at first marriage were related to SBA use.
Conclusions
This study provides evidence of the disparate influences of women’s status and empowerment on SBA use across settings. Results indicate that efforts to increase SBA use and to reduce maternal mortality through the improvement of women’s status and empowerment should focus both on improving girls’ education and delaying marriage, as well as transforming gender norms and decision-making power. However, given the multi-dimensional and contextual nature of women’s status and empowerment, it is critical to identify key drivers to increase SBA use in a given setting for contextually tailored policy and programming.

Research article
A cross sectional comparison of postnatal care quality in facilities participating in a maternal health voucher program versus non-voucher facilities in Kenya
Charlotte E Warren, Timothy Abuya, Lucy Kanya, Francis Obare, Rebecca Njuki, Marleen Temmerman, Ben Bellows
BMC Pregnancy & Childbirth 2015, 15:153 (24 July 2015)

BMC Public Health
http://www.biomedcentral.com/bmcpublichealth/content
(Accessed 25 July 2015)

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Research article
Informal employment and health status in Central America
María López-Ruiz, Lucía Artazcoz, José Martínez, Marianela Rojas, Fernando Benavides BMC Public Health 2015, 15:698 (24 July 2015)

Research article
Promotion of influenza vaccination among health care workers: findings from a tertiary care children’s hospital in Italy
Vanessa Cozza, Valeria Alfonsi, Maria Rota, Valerio Paolini, Marta Ciofi degli Atti BMC Public Health 2015, 15:697 (24 July 2015)

British Medical Journal
25 July 2015 (vol 351, issue 8018)
http://www.bmj.com/content/351/8018

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Editorials
Rethinking governance for trade and health
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h3652 (Published 08 July 2015) Cite this as: BMJ 2015;351:h3652
Helen Walls, research fellow,
Richard Smith, professor
Author affiliations
1London School of Hygiene and Tropical Medicine and Leverhulme Centre for Integrative Research on Agriculture and Health, London, UK
The mechanism for dispute settlement in preferential trade agreements risks riding roughshod over health
[Initial text]
Strengthening governance for more “healthy” trade is a recognised public health priority,1 and increasingly so given recent shifts in the international trade regime.2 After the second world war increasing trade liberalisation became a focus of international attention, and the General Agreement on Tariffs and Trade (GATT) was set up to coordinate international trade agreements. This was highly successful, and average world tariff rates fell from about 40% in 1948 to 4% in the early 1990s.3
At this time, GATT was replaced by the World Trade Organization (WTO), which had an increased scope. However, over the past two decades bilateral and regional trade agreements have proliferated. These have generally been negotiated in extreme secrecy, with increasingly “deep” commitments that go beyond those required by the WTO.2 4 These commitments, the specifics of which have been well documented,2 5 6 7 have important implications for public health. One focus of concern is the investor-state dispute settlement (ISDS) mechanism, which allows foreign companies to sue host governments for compensation when policy changes …

Developing World Bioethics
August 2015 Volume 15, Issue 2 Pages ii–iii, 59–114
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2015.15.issue-2/issuetoc

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ARTICLE
Prioritising Healthcare Workers for Ebola Treatment: Treating Those at Greatest Risk to Confer Greatest Benefit
Priya Satalkar*, Bernice E. Elger and David M. Shaw
Article first published online: 6 FEB 2015
DOI: 10.1111/dewb.12079
Abstract
The Ebola epidemic in Western Africa has highlighted issues related to weak health systems, the politics of drug and vaccine development and the need for transparent and ethical criteria for use of scarce local and global resources during public health emergency. In this paper we explore two key themes. First, we argue that independent of any use of experimental drugs or vaccine interventions, simultaneous implementation of proven public health principles, community engagement and culturally sensitive communication are critical as these measures represent the most cost-effective and fair utilization of available resources. Second, we attempt to clarify the ethical issues related to use of scarce experimental drugs or vaccines and explore in detail the most critical ethical question related to Ebola drug or vaccine distribution in the current outbreak: who among those infected or at risk should be prioritized to receive any new experimental drugs or vaccines? We conclude that healthcare workers should be prioritised for these experimental interventions, for a variety of reasons.

Emerging Infectious Diseases
Volume 21, Number 8—August 2015
http://wwwnc.cdc.gov/eid/

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Response Strategies against Meningitis Epidemics after Elimination of Serogroup A Meningococci, Niger PDF Version [PDF – 1.90 MB – 8 pages]
H. Maïnassara et al.
Summary
Surveillance and epidemic vaccine response would be most effective at the health area level.

Estimates of Outbreak Risk from New Introductions of Ebola with Immediate and Delayed Transmission Control PDF Version [PDF – 812 KB – 7 pages]
D. Toth et al.
Summary
Identifying incoming patients can have a larger risk-reduction effect than efforts to reduce transmissions from identified patients.

Transmission Models of Historical Ebola Outbreaks PDF Version [PDF – 724 KB – 4 pages]
J. M. Drake et al.

The European Journal of Public Health
Volume 25, Issue 4, 1 August 2015
http://eurpub.oxfordjournals.org/content/25/4

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Access to healthcare for undocumented migrants with communicable diseases in Germany: a quantitative study
Maren Mylius, Andreas Frewer
DOI: http://dx.doi.org/10.1093/eurpub/ckv023 582-586 First published online: 15 March 2015
Abstract
Background:
Migrants without residence permits are de facto excluded from access to healthcare in Germany. There is one exception in relevant legislation: in the case of sexually transmitted infections and tuberculosis, the legislator has instructed the local Public Health Authorities to offer free and anonymous counseling, testing and, if necessary, treatment in case of apparent need. Furthermore, recommended vaccinations may be carried out free of charge. This study intends to comprehensively capture the services for undocumented migrants at Public Health Authorities in Germany.
Methods:
An e-mail survey of all Local Public Health Authorities (n = 384) in Germany was carried out between January and March 2011 using a standardized questionnaire.
Results:
One hundred thirty-nine of 384 targeted local Health Authorities completed the questionnaire (36.2%), of which approximately a quarter (n = 34) reported interaction with ‘illegal’ immigrants. Twenty-give authorities (18.4%) gave the indication to carry out treatment. This outpatient treatment option is mostly limited to patients afflicted with sexually transmitted infections with the distinct exception of human immunodeficiency virus/acquired immune deficiency syndrome.
Conclusions:
The study highlights the gap between legislation and the reality of restricted access to medical services for undocumented migrants in Germany. It underlines the need of increased financial and human resources in Public Health Authorities and, overall, the simplification of national legislation to assure the right to healthcare.

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Severe maternal morbidity associated with maternal birthplace in three high-immigration settings
Marcelo L. Urquia, Richard H. Glazier, Laust Mortensen, Anne-Marie Nybo-Andersen, Rhonda Small, Mary-Ann Davey, Mattias Rööst, Birgitta Essén,
DOI: http://dx.doi.org/10.1093/eurpub/cku230 620-625 First published online: 13 January 2015
Abstract
Background:
Maternal mortality and morbidity vary substantially worldwide. It is unknown if these geographic differences translate into disparities in severe maternal morbidity among immigrants from various world regions. We assessed disparities in severe maternal morbidity between immigrant women from various world regions giving birth in three high-immigration countries. Methods:
We used population-based delivery data from Victoria; Australia and Ontario, Canada and national data from Denmark, in the most recent 10-year period ending in 2010 available to each participating centre. Each centre provided aggregate data according to standardized definitions of the outcome, maternal regions of birth and covariates for pooled analyses. We used random effects and stratified logistic regression to obtain odds ratios (ORs) with 95% confidence intervals (95% CIs), adjusted for maternal age, parity and comparability scores.
Results:
We retrieved 2,322,907 deliveries in all three receiving countries, of which 479,986 (21%) were to immigrant women. Compared with non-immigrants, only Sub-Saharan African women were consistently at higher risk of severe maternal morbidity in all three receiving countries (pooled adjusted OR: 1.67; 95% CI: 1.43, 1.95). In contrast, both Western and Eastern European immigrants had lower odds (OR: 0.82; 95% CI: 0.70, 0.96 and OR: 0.64; 95% CI: 0.49, 0.83, respectively). The most common diagnosis was severe pre-eclampsia followed by uterine rupture, which was more common among Sub-Saharan Africans in all three settings.
Conclusions:
Immigrant women from Sub-Saharan Africa have higher rates of severe maternal morbidity. Other immigrant groups had similar or lower rates than the majority locally born populations.

Eurosurveillance
Volume 20, Issue 29, 23 July 2015
http://www.eurosurveillance.org/Public/Articles/Archives.aspx?PublicationId=11678

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Surveillance and outbreak reports
Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012
by JA Bettinger, I Rouleau, MC Gariépy, WR Bowie, L Valiquette, OG Vanderkooi, JD Kellner, BL Coleman, SA McNeil, A McCarthy, G De Serres, On behalf of the Public Health Agency of Canada/Canadian Institutes for Health Research Influenza Research Network

Global Public Health
Volume 10, Issue 7, 2015
http://www.tandfonline.com/toc/rgph20/current

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Policy responses to HIV/AIDS in Central Asia
DOI:10.1080/17441692.2015.1043313
Svetlana Anckera* & Bernd Rechelb
pages 817-833
Published online: 20 Jul 2015
Abstract
The countries of Central Asia (Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan) are confronted with one of the fastest growing HIV/AIDS epidemics worldwide, largely driven through injecting drug use. This article, based on a review of academic and grey literature, explores how they have responded. We find major similarities and differences across the region. At one extreme is Turkmenistan, which denies that there is any problem, does not offer harm reduction services or HIV/AIDS treatment and does not report any meaningful data to the international community. Uzbekistan is also pretty closed to outside influences, has discontinued its opioid substitution project and shares with Turkmenistan the legal prohibition of male-to-male sex. Kyrgyzstan originally led many progressive approaches in the region and, like neighbouring Tajikistan, has received substantial assistance by international agencies, in particular the Global Fund. Kazakhstan, with a much higher gross domestic product per capita, has taken on the financing of harm reduction activities through its national budget and has liberalised its drug policies. Yet, across the region punitive approaches to injecting drug use and people living with HIV/AIDS persist as do stigma and discrimination, while coverage with harm reduction programmes and treatment services is still low although with substantial variation across countries.

The experience of cash transfers in alleviating childhood poverty in South Africa: Mothers’ experiences of the Child Support Grant
Open access
DOI:10.1080/17441692.2015.1007471
Wanga Zembe-Mkabilea*, Rebecca Surrenderb, David Sandersc, Debra Jacksonc & Tanya Dohertyacd
pages 834-851
Published online: 16 Feb 2015
Abstract
Cash transfer (CT) programmes are increasingly being used as policy instruments to address child poverty and child health outcomes in developing countries. As the largest cash-transfer programme in Africa, the South African Child Support Grant (CSG) provides an important opportunity to further understand how a CT of its kind works in a developing country context. We explored the experiences and views of CSG recipients and non-recipients from four diverse settings in South Africa. Four major themes emerged from the data: barriers to accessing the CSG; how the CSG is utilised and the ways in which it makes a difference; the mechanisms for supplementing the CSG; and the impact of not receiving the grant. Findings show that administrative factors continue to be the greatest barrier to CSG receipt, pointing to the need for further improvements in managing queues, waiting times and coordination between departments for applicants trying to submit their applications. Many recipients, especially those where the grant was the only source of income, acknowledged the importance of the CSG, while also emphasising its inadequacy. To maximise their impact, CT programmes such as the CSG need to be fully funded and form part of a broader basket of poverty alleviation strategies.

International Journal of Infectious Diseases
August 2015 Volume 37, p1
http://www.ijidonline.com/current

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Editorial
Middle East Respiratory Syndrome – need for increased vigilance and watchful surveillance for MERS-CoV in sub-Saharan African Africa
Alimuddin Zumla, Roxana Rustomjee, Francine Ntoumi, Peter Mwaba, Matthew Bates, Markus Maeurer, David S. Hui, Eskild Petersen
p77–79
Published online: June 30 2015
Open Access
Abstract
The past two decades have witnessed the emergence of several new and old respiratory tract infectious diseases, which threaten global health security due to their epidemic potential.1,2 These include multi-drug resistant TB, Severe Acute Respiratory Syndrome (SARS), avian and swine influenza and more recently the Middle East Respiratory Syndrome (MERS). MERS is a new zoonotic disease of humans caused by a coronavirus (MERS-CoV) which was first isolated in September, 2012 from a patient who died from a severe respiratory disease in Jeddah Saudi Arabia.

Outbreak of varicella in a highly vaccinated preschool population
Jiye Fu, Juguang Wang, Chu Jiang, Rujing Shi, Tianwei Ma
Beijing Haidian Center for Disease Control and Prevention, NO.5 Xibeiwang 2nd Road, Haidian district, Beijing 100094, People’s Republic of China
Corresponding Editor: Eskild Petersen, Aarhus, Denmark
Open Access
DOI: http://dx.doi.org/10.1016/j.ijid.2015.06.003
Highlights
:: Breakthrough varicella may be as infectious as varicella in unvaccinated persons.
:: The potential for transmission due to breakthrough varicella should be focused on.
:: No increased risk for breakthrough varicella was found in 1-dose vaccine recipients.
:: High 1-dose varicella vaccination coverage is not sufficient to prevent outbreak.
:: To control varicella outbreak, a second dose may deserve additional consideration.
Summary
Background
Varicella vaccine is available for private purchase in Beijing, with single dose recommended for children aged ≥12 months before 2013. Despite the success achieved in reducing varicella incidence, varicella outbreaks continued to occur, including in schools and kindergartens among highly vaccinated children. We investigated a varicella outbreak in a preschool with high varicella vaccination coverage in Haidian district, Beijing.
Methods
Through questionnaires, data including children’s medical and vaccination history were collected from their parents. A case of varicella was defined as an acute, generalized, maculopapulovesicular rash without other apparent cause in a child in the preschool from March 10 through March 29, 2010. Attack rates in vaccinated and unvaccinated children were calculated, and the analyses of vaccine effectiveness (VE) and of risk factors for breakthrough disease (varicella occurring >42 days after vaccination) were conducted.
Results
A total of 12 cases occurred during the outbreak, and ten of them (83.3%) had breakthrough varicella. The index case with mild varicella occurred in a child who had been vaccinated four years previously. Questionnaires were returned for all of 150 children in the preschool. Of all the 150 children, 144 (96.0%) had no prior history of varicella disease. Among these children, 135(93.7%) had received single-dose varicella vaccine before the outbreak. VE was 84.5% [95% confidence interval (CI): 62.8%∼93.5%] in preventing varicella of any severity, and VE was 92.2% (95% CI: 81.4%∼96.8%) against moderate to severe varicella. Age at vaccination (<15 months vs. ≥15 months) and time since vaccination before the outbreak (<3 years vs. ≥3 years) were not associated with the increased risk of breakthrough varicella(P=0.124 and 1, respectively). All the varicella cases with vaccination history verified through immunization records had received varicella vaccine and measles-mumps-rubella vaccine >30 days apart.
Conclusions
Breakthrough infection with fever in vaccinated person may be as infectious as varicella in unvaccinated persons. High single-dose varicella vaccination coverage is effective in reducing varicella incidence, but not sufficient to prevent outbreak. To control varicella outbreak a second dose may deserve additional consideration.

Journal of Immigrant and Minority Health
Volume 17, Issue 4, August 2015
http://link.springer.com/journal/10903/17/4/page/1

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HPV Awareness and Vaccine Willingness Among Dominican Immigrant Parents Attending a Federal Qualified Health Clinic in Puerto Rico
Vivian Colón-López, Valerie Quiñones, Lizbeth M. Del Toro-Mejías, Alexandra Conde-Toro, Michelle J. Serra-Rivera, Tania M. Martínez, Verónica Rodríguez, Luis Berdiel,
Héctor Villanueva
Abstract
The purpose of this study was to describe the socio-demographic characteristics, awareness of human papillomavirus (HPV), and willingness to vaccinate among a convenience sample of 60 immigrant Dominican parents of adolescent sons in a Federal Qualified Health Clinic in Puerto Rico. Participation involved completing a self-administered survey. Even though more than half of the parents had not received proper HPV vaccine orientation from healthcare provider (58.3 %) nor asked provider for vaccination recommendation for their adolescent sons (56.7 %), most parents were aware of HPV (91.7 %) and HPV vaccination among males (55.0 %). Among those with unvaccinated sons, willingness to vaccinate the son within the next year was high (83.8 %). The low vaccination percentage (31.7 %) and information exchange between the parents and the son’s healthcare provider indicates an opportunity for future culturally tailored interventions to target HPV vaccination among healthcare providers and parents of foreign descent in order to increase HPV vaccine uptake among males.

Effect of Influenza Vaccination on Acute Respiratory Symptoms in Malaysian Hajj Pilgrims
Habsah Hasan, Zakuan Zainy Deris, Siti Amrah Sulaiman, Mohd Suhaimi Abdul Wahab, Nyi Nyi Naing, Zulkefle Ab Rahman, Nor Hayati Othman
Abstract
Respiratory illness were a major problem and caused high hospital admission during hajj seasons. One of the contributing cause to this illness is infection. Various measures had been implemented to reduce respiratory infections. The aim on the study is to determine the effect of influenza vaccination against acute respiratory illness among Malaysian Hajj pilgrims. This is an observational cohort study. Influenza vaccination was given to pilgrims at least 2 weeks prior to departure. The occurrence of symptoms for respiratory illness such as cough, fever, sore throat and runny nose was monitored daily for 6 weeks during pilgrimage using a health diary. A total of 65 vaccinated hajj pilgrims and 41 controls were analyzed. There was no significant difference in pattern of occurrence of symptoms of respiratory illness by duration of pilgrimage as well as the number of symptoms between both groups. Hajj pilgrims have frequent respiratory symptoms. We were unable to document benefit from influenza vaccination, but our study was limited by a small sample size and lack of laboratory testing for influenza.

The Lancet
Jul 25, 2015 Volume 386 Number 9991 p311-402
http://www.thelancet.com/journals/lancet/issue/current

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Editorial
Financing global health: the poverty of nations
The Lancet
DOI: http://dx.doi.org/10.1016/S0140-6736(15)61392-7
Summary
The Addis Ababa Action Agenda (AAAA), the outcome from the first of three meetings in 2015 intended to set the course for the next 15 years of sustainable development, is remarkable only for its alliteration. The third Financing for Development conference (FFD3), which followed meetings in Monterrey, Mexico, in 2002 and Doha, Qatar, in 2008, was an opportunity for the world to restate its vision of a shared, sustainable, prosperous future, and to make plans for achieving it. In this, FFD3 was a resounding disappointment.

Editorial
Ending institutionalisation of children
The Lancet
DOI: http://dx.doi.org/10.1016/S0140-6736(15)61394-0
Summary
Childhood is a time when the seeds of a person’s future health and wellbeing are sown. Ideally, it happens within a family setting that provides individualised care in a loving, safe, enriching, and happy environment. Sadly, more than 8 million vulnerable children worldwide do not have access to such care and grow up in large institutions or orphanages. Such environments share conditions that can be detrimental to children, such as depersonalisation—through lack of personal possessions, care relationships, or symbols of individuality—strict routines, group treatment, and isolation from wider society.

Special Report
The World Bank under Jim Kim
Sam Loewenberg

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 25 July 2015)

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Guidelines and GuidanceIndividual Participant Data (IPD) Meta-analyses of Randomised Controlled Trials: Guidance on Their Use
Jayne F. Tierney, Claire Vale, Richard Riley, Catrin Tudur Smith, Lesley Stewart, Mike Clarke,
Maroeska Rovers
Published: July 21, 2015
DOI: 10.1371/journal.pmed.1001855
Summary Points
:: Systematic reviews are most commonly based on aggregate data extracted from publications or obtained from trial investigators.
:: Systematic reviews involving the central collection and analysis of individual participant data (IPD) usually are larger-scale, international, collaborative projects that can bring about substantial improvements to the quantity and quality of data, give greater scope in the analyses, and provide more detailed and robust results.
:: The process of collecting, checking, and analysing IPD is more complex than for aggregate data, and not all IPD meta-analyses are done to the same standard, making it difficult for researchers, clinicians, patients, policy makers, funders, and publishers to judge their quality.
:: Following our step-by-step guide will help reviewers and users of IPD meta-analyses to understand them better and recognise those that are well designed and conducted and so help ensure that policy, practice, and research are informed by robust evidence about the effects of interventions.

PLoS One
http://www.plosone.org/
[Accessed 25 July 2015]

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Research Article
School-Age Children Are a Reservoir of Malaria Infection in Malawi
Jenny A. Walldorf, Lauren M. Cohee, Jenna E. Coalson, Andy Bauleni, Kondwani Nkanaunena,
Atupele Kapito-Tembo, Karl B. Seydel, Doreen Ali, Don Mathanga, Terrie E. Taylor, Clarissa alim, Miriam K. Laufer
Published: July 24, 2015
DOI: 10.1371/journal.pone.0134061
Abstract
Malaria surveillance and interventions in endemic countries often target young children at highest risk of malaria morbidity and mortality. We aimed to determine whether school-age children and adults not captured in surveillance serve as a reservoir for malaria infection and may contribute to malaria transmission. Cross-sectional surveys were conducted in one rainy and one dry season in southern Malawi. Demographic and health information was collected for all household members. Blood samples were obtained for microscopic and PCR identification of Plasmodium falciparum. Among 5796 individuals aged greater than six months, PCR prevalence of malaria infection was 5%, 10%, and 20% in dry, and 9%, 15%, and 32% in rainy seasons in Blantyre, Thyolo, and Chikhwawa, respectively. Over 88% of those infected were asymptomatic. Participants aged 6–15 years were at higher risk of infection (OR=4.8; 95%CI, 4.0–5.8) and asymptomatic infection (OR=4.2; 95%CI, 2.7–6.6) than younger children in all settings. School-age children used bednets less frequently than other age groups. Compared to young children, school-age children were brought less often for treatment and more often to unreliable treatment sources. Conclusion: School-age children represent an underappreciated reservoir of malaria infection and have less exposure to antimalarial interventions. Malaria control and elimination strategies may need to expand to include this age group.

Investigation of a Measles Outbreak in China to Identify Gaps in Vaccination Coverage, Routes of Transmission, and Interventions
Xiang Zheng, Ningjing Zhang, Xiaoshu Zhang, Lixin Hao, Qiru Su, Haijun Wang, Kongyan Meng, Binglin Zhang, Jianfeng Liu, Huaqing Wang, Huiming Luo, Li Li, Hui Li, Chao Ma
Research Article | published 24 Jul 2015 | PLOS ONE 10.1371/journal.pone.0133983

Effect of Restricting Access to Health Care on Health Expenditures among Asylum-Seekers and Refugees: A Quasi-Experimental Study in Germany, 1994–2013
Kayvan Bozorgmehr, Oliver Razum
Research Article | published 22 Jul 2015 | PLOS ONE 10.1371/journal.pone.0131483

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/
(Accessed 25 July 2015)

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Global trends in infectious diseases at the wildlife–livestock interface
Anke K. Wiethoeltera, Daniel Beltrán-Alcrudob, Richard Kockc, and Siobhan M. Mora,d,1
Author Affiliations
Significance
Infectious diseases at the wildlife–livestock interface threaten the health and well-being of wildlife, livestock, and human populations, and contribute to significant economic losses to each sector. No studies have sought to characterize the diseases and animals involved on a global level. Using a scoping review framework we show that 10 diseases—mostly zoonoses—have accounted for half of the published research in this area over the past century. We show that relatively few interfaces can be considered important from a disease ecology perspective. These findings suggest that surveillance and research strategies that target specific wildlife–livestock interfaces may yield the greatest return in investment.
Abstract
The role and significance of wildlife–livestock interfaces in disease ecology has largely been neglected, despite recent interest in animals as origins of emerging diseases in humans. Scoping review methods were applied to objectively assess the relative interest by the scientific community in infectious diseases at interfaces between wildlife and livestock, to characterize animal species and regions involved, as well as to identify trends over time. An extensive literature search combining wildlife, livestock, disease, and geographical search terms yielded 78,861 publications, of which 15,998 were included in the analysis. Publications dated from 1912 to 2013 and showed a continuous increasing trend, including a shift from parasitic to viral diseases over time. In particular there was a significant increase in publications on the artiodactyls–cattle and bird–poultry interface after 2002 and 2003, respectively. These trends could be traced to key disease events that stimulated public interest and research funding. Among the top 10 diseases identified by this review, the majority were zoonoses. Prominent wildlife–livestock interfaces resulted largely from interaction between phylogenetically closely related and/or sympatric species. The bird–poultry interface was the most frequently cited wildlife–livestock interface worldwide with other interfaces reflecting regional circumstances. This review provides the most comprehensive overview of research on infectious diseases at the wildlife–livestock interface to date.

Preventive Medicine
Volume 77, In Progress (August 2015)
http://www.sciencedirect.com/science/journal/00917435/77/supp/C

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HPV vaccine for teen boys: Dyadic analysis of parents’ and sons’ beliefs and willingness
JL Moss, PL Reiter, NT Brewer – Preventive Medicine, 2015
Abstract
Objective
Parents and adolescents often decide together whether the child should receive human papillomavirus (HPV) vaccine. However, few studies have investigated the dyadic nature of beliefs that affect this process.
Method
Data came from the 2010 HPV Immunization in Sons (HIS) Study, a national sample of 412 parents and their adolescent sons. We conducted dyadic multivariate logistic regression to test the relationships between parents’ and sons’ HPV vaccine beliefs and their willingness to have the son receive the vaccine.
Results
Fewer than half of parents and sons were willing to have the sons receive HPV vaccine (43% and 29%, respectively). Willing parents and sons anticipated greater regret if the son did not receive HPV vaccine but later contracted an HPV infection (parent odds ratio [OR] = 1.72, 95% confidence interval [CI] = 1.24–2.40; son OR = 1.51, 95% CI = 1.04–2.19) (both p < .05). Lower concerns about side effects, such as pain and fainting, were also associated with willingness.
Conclusion
Parents and sons were more willing to have the son receive HPV vaccine if they had higher anticipated regret about potential HPV infection and lower concerns about side effects. Communication campaigns should target these beliefs to increase parents’ and sons’ willingness to seek HPV vaccination.

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
June 2015 Vol. 37, No. 6
http://www.paho.org/journal/

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Estratégias de desenvolvimento, acompanhamento e avaliação do atendimento da gestante no ciclo gravídico-puerperal [Strategies for development, follow-up, and assessment of care provided to women in the pregnancy-postnatal cycle]
Cristyanne Samara Miranda de Holanda, João Carlos Alchieri, Fátima Raquel Rosado Morais e Técia Maria de Oliveira Maranhão

Moving toward universal access to health and universal health coverage: a review of comprehensive primary health care in Suriname [Avanzando hacia el acceso universal a la salud y la cobertura universal de salud: un análisis de la atención primaria de salud integral en Suriname]
Stephanie Laryea, Hedwig Goede, and Francoise Barten

Regulatory transparency: social, technical, and ethical aspects of clinical trial data access [Transparencia reglamentaria: aspectos sociales, técnicos y éticos del acceso a los datos de los ensayos clínicos]
Varley Dias Sousa and Dâmaris Silveira

A comprehensive protocol to evaluate the use of blood and its components in Latin America and the Caribbean [Un protocolo integral para evaluar el uso de la sangre y sus componentes en América Latina y el Caribe]
Ana E. del Pozo, Maria D. Pérez-Rosales, Cesar de Almeida-Neto, Mirta C. Remesar, Armando D. Cortes, Raquel Baumgratz Delgado, Alfredo Mendrone Jr., and Ester Sabino

Science
24 July 2015 vol 349, issue 6246, pages 341-448
http://www.sciencemag.org/current.dtl

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Policy Forum
Public Health
Toward an HIV vaccine: A scientific journey
Anthony S. Fauci1,*, Hilary D. Marston2
Author Affiliations
1Anthony S. Fauci M.D. is the Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, Bethesda, MD 20892, USA.
2Hilary D. Marston M.D., M.P.H. is a Medical Officer and Policy Advisor for Global Health at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, Bethesda, MD 20892, USA.
Summary
In the face of a global pandemic, the search for an effective vaccine against the human immunodeficiency virus (HIV) remains an urgent priority. From the first HIV vaccine trials in the 1980s to the present, a tension has existed between the desire to move quickly to clinical trials to stem the spread of the epidemic and the view that research into HIV pathogenesis and host immunity were necessary predicates to and informative of vaccine design. Those advocating the first strategy—an empirical (or inductive) approach—argued that in vitro and animal studies were poorly predictive of the human response to HIV infection and that the only way to gauge vaccine efficacy was to test candidates in humans. Those advocating the second strategy—a theoretical (or deductive) approach—hoped to establish an understanding of the immune response to natural infection and to find ways to recapitulate and enhance that response through vaccination. Today, these approaches are coalescing into concomitant paths toward a safe and effective HIV vaccine.

Media/Policy Watch
This section is intended to alert readers to substantive news, analysis and opinion from the general media on vaccines, immunization, global; public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

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Center for Global Development
http://www.cgdev.org/
Restructuring US Global Health Programs to Respond to New Challenges and Missed Opportunities
| 20 July 2015
By Amanda Glassman, Rachel Silverman
Policy Recommendations
:: Appoint US global health leadership with the mandate, budget alignment, and political support to enforce interagency collaboration.
:: Harmonize the approach to multilateral organizations to ensure consistency of priorities and objectives.
:: Establish an office of Global Health Trade, Economics, and Knowledge Exchange responsible for sharing US health-care know-how with policymakers and businesses in developing countries.
Introduction
In the absence of effective international institutions, the United States has become the world’s de facto first responder for global health crises such as HIV/AIDS and new threats like Ebola. The US government has the technical know-how, financial and logistical resources, and unparalleled political support to act quickly and save lives. Initiatives such as the President’s Emergency Plan for AIDS Relief (PEPFAR) and the President’s Malaria Initiative are widely considered among the most effective aid programs in the world.
Yet US global health approaches are based on increasingly outdated engagement models, which fail to reflect emerging challenges, threats, and financial constraints. Effective HIV/AIDS control efforts, which already cost US taxpayers many billions of dollars each year, will require more funding as a result of new science and ambitious program coverage goals.[1] At the same time, noncommunicable diseases — such as cancer, diabetes, and cardiovascular disease — have exploded in developing countries. Moreover, the United States and other donor countries historically have spent little on national health systems; in 2011, for example, just 4 percent of development assistance for health went to programs to strengthen health systems.[2] The inability of West African nations to combat the Ebola crisis demonstrates the practical impact of those past spending decisions, with frightening results in the United States and abroad.

The next US president, working closely with Congress, should modernize how US global health programs are organized, deployed, and overseen. By taking three specific steps, the United States can reduce the need for costly first responses and generate more health and economic impact for every US taxpayer dollar spent…

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Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 25 July 2015
Opinion
Commentary
A Win for Vaccines, but Worries Remain
Doctors who offer easy exemptions could undermine efforts to rein in the antivaccine crowd.
By Nina Shapiro
July 23, 2015 7:01 p.m. ET
In a growing number of states, parents can no longer refuse to immunize their children due to conflicting “personal beliefs”—at least not if they want their children to attend school. California recently joined West Virginia and Mississippi in requiring a medical exemption from a physician to permit a child to enter school without being immunized. Gov. Jerry Brown signed the controversial bill, SB277, last month.

Most of us rejoice, yet there is still reason to worry that exemptions will proliferate along with preventable diseases. Particularly if doctors feed their patients’ fears and offer easy exemptions with few questions asked.

The overall immunization rate in California is high, but many schools have dangerously low immunization rates. A Hollywood Reporter story last year highlighted schools in tony areas like Santa Monica with immunization rates near 25%, lower than those in South Sudan.

Vaccines have been a hot topic since 1855, when Massachusetts began requiring them for schoolchildren. England had more stringent laws: The Compulsory Vaccination Act of 1853 required all infants born in England and Wales to be immunized against smallpox, unless they were considered medically “unfit.” This became the first “medical exemption” for vaccines.

Others objected to the mandate itself—and so began the antivaccination movement, long before actress Jenny McCarthy spewed her views on national television. A clause to the Compulsory Vaccination Act, created in 1898, allowed for “conscience” exemptions, eventually leading to the term “conscientious objector” for those abstaining from military service. In 1898 alone, 200,000 conscience (or, shall we say, personal belief) vaccine exemptions were granted in the United Kingdom.

In California exemptions are now up to the doctors, as parents must get approval from their physician. A legitimate medical exemption might be given for a child who has a weakened immune system, either due to a congenital condition or to chemotherapy or long-term steroid use.

A second reason for an exemption might be that the child had a serious allergic or other adverse reaction to an earlier vaccine. But serious, life-threatening reactions, such as seizures or severe rashes, are extremely rare, about one in every 100,000 doses. (The death rate from measles, by the way, is closer to one in 1,000 cases.)

Pockets of California residents are in an uproar over SB277; a few hundred rallied against the bill in San Diego in April. They would prefer to not immunize their children, or to design custom schedules on the medically dubious theory that the recommended schedule is unsafe. There is no evidence for this.

Unvaccinated children are themselves at risk, but they also put other children at risk, too. The more exemptions are given, the larger the gaps in herd immunity, and the more outbreaks of preventable diseases. Children with cancer who cannot be safely given the recommended course of vaccines, for instance, are among the most vulnerable to others’ so-called personal decisions.

Along with these California residents are California doctors who share in their uproar. Dr. Jay Gordon of Santa Monica, for example, testified against the bill; he has called the bill “disgracefully arrogant” and said parents “must participate in all health-care decisions for their children.” He is not alone, and these doctors will certainly stand by their patients.
Who will monitor the high volume of medical exemptions? Will doctors who opposed SB277 be allowed to dole out faux medical exemptions to their patients? In that sense, the California bill is an improvement, but antivaccination fear-mongers will continue to find a workaround.

Dr. Shapiro, director of pediatric ear, nose and throat at Mattel Children’s Hospital, is a professor of head and neck surgery at UCLA.

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_18 July 2015

– blog edition: comprised of the approx. 35+ entries posted below on this date.

– 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

Updated data on immunization coverage published by WHO and UNICEF
Geneva, 16 July 2015*
The number of countries reaching and sustaining 90% coverage of children with routine life-saving vaccinations has doubled since 2000.

Updated data on the status of immunization worldwide in 2014 reveal that 129 countries, 6 more than in 2013, now immunize at least 90% of their children with the required 3 doses of diphtheria-tetanus-pertussis containing vaccines (DTP3).

In 2012, all 194 WHO Member States endorsed the Global Vaccine Action Plan (GVAP), and committed to ensuring no one misses out on vital immunizations, with a target of 90% DTP3 vaccination coverage in all countries by 2015. Earlier this year WHO warned that 5 of the 6 targets, including the DTP3 coverage target, contained in the GVAP were worryingly off-track, with only one target, for the introduction of under-utilized vaccines, showing sufficient progress.
The new data highlight the fact that 65 countries will require game changing strategies in order to meet the GVAP goal. Among them, 6 countries with less than 50% coverage with DTP3: Central African Republic, Chad, Equatorial Guinea, Somalia, South Sudan and the Syrian Arab Republic.

Worldwide DTP3 immunization coverage stands at 86% for all 3 doses, with 91% of infants receiving at least 1 dose. In 2000, 21 million children did not receive even a first dose of DTP, a figure that has now dropped to 12 million.

Significantly, the updated estimates also show that India, the country with the largest number of unvaccinated children globally, has now achieved over 80% DTP3 coverage, through a revamping of the national immunization programme and effective use of the infrastructure built up to eradicate polio in the country.

The updated estimates show that coverage with some essential vaccines other than DTP, has also improved. The number of children protected from hepatitis B is high worldwide and increasing steadily. While just 30% of children received three doses of vaccine against the viral disease in 2000, this rose to 82% in 2014, although more needs to be done to ensure that infants receive their birth dose within the first 24 hours of life.

Haemophilus influenzae type b (Hib) vaccine is one of the newest recommended vaccines to fight Hib diseases in children globally and has been introduced in all countries except China and Thailand. Coverage, however, is still low at just 56%.

The number of countries using other new vaccines, such as rotavirus and pneumococcal conjugate vaccine, has increased. However, challenges remain. Only 19% of children are protected against rotavirus, despite the fact that some of the countries that have not introduced the vaccine have the largest share of diarrhoeal diseases.
*Data finalized 15 July, published on who.int 16 July
Data on WHO immunization coverage

EBOLA/EVD [to 18 July 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

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Ebola Situation Report – 15 July 2015
[Excerpts]
SUMMARY
:: There were 30 confirmed cases of Ebola virus disease (EVD) reported in the week to 12 July: 13 in Guinea, 3 in Liberia, and 14 in Sierra Leone. Although the total number of confirmed cases is the same as the previous week, there has been a shift in the foci of transmission. For the first time in several months, most cases were reported from Conakry and Freetown, the capitals of Guinea and Sierra Leone, respectively. All 9 of the cases reported from Conakry and all 10 of the cases reported from Freetown were either registered contacts of a previous case or have an established epidemiological link to a known chain of transmission. One of the 30 cases reported in the week to 12 July arose from a yet unknown source of infection. However, a substantial proportion of cases (7 of 30: 23%) continue to be identified as EVD-positive only after post-mortem testing. This suggests that although improvements to case investigation are increasing our understanding of chains of transmission, contact tracing, which aims to minimise transmission by identifying symptoms among contacts at the earliest stage of infection, is still a challenge in several areas…

COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
:: There have been a total of 27,642 reported confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (figure 1, table 1) up to 12 July, with 11,261 reported deaths (this total includes reported deaths among probable and suspected cases, although outcomes for many cases are unknown). A total of 13 new confirmed cases were reported in Guinea, 3 in Liberia, and 14 in Sierra Leone in the week to 12 July…

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WHO Stories from Countries
Ebola diaries: Lessons from previous Ebola outbreaks help with the response in Guinea
15 July 2015
Getting back to work: Training health staff for life and work after Ebola
14 July 2015

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Bavarian Nordic Announces that the Oxford Vaccines Group has Initiated a Phase 2 Study of the Ebola Prime-Boost Vaccine Regimen Combining MVA-BN® Filo and Janssen’s AdVac® Technology
COPENHAGEN, Denmark, July 15, 2015 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the Oxford Vaccines Group has initiated a Phase 2 clinical study of the Ebola prime-boost vaccine regimen that combines Bavarian Nordic’s MVA-BN® Filo vaccine with the Ad26.ZEBOV vaccine from the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The first volunteers have received their initial vaccine dose.

Preliminary data from the first-in-human Phase 1 study, presented by Janssen in May to a U.S. Food & Drug Administration Advisory Committee, indicated that the prime-boost vaccine regimen is immunogenic, regardless of the order of vaccine administration, and only provoked temporary reactions normally expected from vaccination.

The Phase 2 study, to take place in the UK and France, is a randomized, placebo-controlled, multicenter trial evaluating the safety, tolerability and immunogenicity of the heterologous prime-boost regimen (Ad26.ZEBOV and MVA-BN-Filo) sponsored by Crucell Holland B.V., one of the Janssen Pharmaceutical Companies.

The study is part of the EBOVAC2 project, a collaborative program involving The University of Oxford, French Institute of Health and Medical Research (Inserm), London School of Hygiene & Tropical Medicine (LSHTM), La Centre Muraz (CM), Inserm Transfert (IT) and Janssen. The Innovative Medicines Initiative 2 Joint Undertaking is under grant agreement EBOVAC2 (grant no. 115861), part of the Ebola+ program launched in response to the Ebola virus disease outbreak.

The UK study site is led by the Oxford Vaccines Group, part of the University of Oxford, Department of Paediatrics. Additional sites in France will be coordinated by Inserm once all necessary approvals are received. In total, the studies will enroll 612 healthy adult volunteers in United Kingdom and France, who will be randomized into three cohorts, all receiving the Ad26.ZEBOV prime or placebo on day 1 and then the MVA-BN-Filo boost or placebo on days 29, 57 or 85. More information on the trial can be found at http://www.clinicaltrials.gov/ct2/show/NCT02416453.

A second Phase 2 study in 1,200 volunteers is planned to be initiated in Africa during third quarter of 2015.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: “We are pleased to report further progress in the clinical development of the prime-boost Ebola vaccine regimen which is being led by our partner Janssen. Vaccines play an essential role in outbreak situations, and both the clinical and the manufacturing experience we gain through this accelerated development represent an important piece of work in the combined efforts to ensure preparedness against Ebola, now and in the future.”…

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Two new trials of Ebola vaccines begin in Europe and Africa
Reuters, LONDON, July 15 | By Kate Kelland
Two new Ebola vaccine trials began on Wednesday with volunteers in Britain, France and Senegal getting “prime-boost” immunisations developed by Bavarian Nordic, GlaxoSmithKline and Johnson & Johnson.
The mid-stage, or Phase II, trials are designed primarily to test the vaccines’ safety, but will also assess whether they provoke an immune response against the deadly virus…
…”The current Ebola outbreak has reinforced that speed of response is crucial,” said Egeruan Babatunde Imoukhuede, who is coordinating one of the trials in Senegal.
“Outbreak diseases spread quickly, so any vaccination approach must be able to keep up.”….
…The trial of the Bavarian Nordic and J&J prime-boost combination initially aims to recruit more than 600 healthy adult volunteers in Britain and France.
Bavarian said it hoped to launch another later phase of this trial in Africa later this year involving 1,200 volunteers, but other large clinical trials have recently been thwarted by the drop in case numbers.
Previously planned trials of GSK, Merck and J&J shots in West Africa have been struggling to recruit volunteers with enough exposure to Ebola to prove whether their vaccines are doing the job and preventing infection.
The second trial will be conducted in Senegal and uses two vaccines tested first in people at Oxford University’s Jenner Institute and being developed in a partnership with GSK. The first, based on a chimpanzee adenovirus, is designed to stimulate, or prime, an initial immune response, while the second is designed to boost that response…

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Journal of Clinical Investigation
http://www.jci.org/125/7
First published July 13, 2015
Aerosolized Ebola vaccine protects primates and elicits lung-resident T cell responses
Michelle Meyer1,2,3, Tania Garron1,2,3,4, Ndongala M. Lubaki1,2,3, Chad E. Mire2,3,4, Karla A. Fenton2,3,4, Curtis Klages2,3,5, Gene G. Olinger6, Thomas W. Geisbert2,3,4, Peter L. Collins7, and Alexander Bukreyev1,2,3,4,8
1Department of Pathology, 2Galveston National Laboratory, 3The University of Texas Medical Branch, 4Department of Microbiology and Immunology, and 5Animal Resources Center, Galveston, Texas, USA. 6Viral Pathogenesis and Immunology Branch, Virology Division, United States Army Institute for Infectious Diseases, Frederick, Maryland, USA., 7RNA Viruses Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA., 8Sealy Center for Vaccine Development, Galveston, Texas, USA.
Abstract
Direct delivery of aerosolized vaccines to the respiratory mucosa elicits both systemic and mucosal responses. This vaccine strategy has not been tested for Ebola virus (EBOV) or other hemorrhagic fever viruses. Here, we examined the immunogenicity and protective efficacy of an aerosolized human parainfluenza virus type 3–vectored vaccine that expresses the glycoprotein (GP) of EBOV (HPIV3/EboGP) delivered to the respiratory tract. Rhesus macaques were vaccinated with aerosolized HPIV3/EboGP, liquid HPIV3/EboGP, or an unrelated, intramuscular, Venezuelan equine encephalitis replicon vaccine expressing EBOV GP. Serum and mucosal samples from aerosolized HPIV3/EboGP recipients exhibited high EBOV-specific IgG, IgA, and neutralizing antibody titers, which exceeded or equaled titers observed in liquid recipients. The HPIV3/EboGP vaccine induced an EBOV-specific cellular response that was greatest in the lungs and yielded polyfunctional CD8+ T cells, including a subset that expressed CD103 (αE integrin), and CD4+ T helper cells that were predominately type 1. The magnitude of the CD4+ T cell response was greater in aerosol vaccinees. The HPIV3/EboGP vaccine produced a more robust cell-mediated and humoral immune response than the systemic replicon vaccine. Moreover, 1 aerosol HPIV3/EboGP dose conferred 100% protection to macaques exposed to EBOV. Aerosol vaccination represents a useful and feasible vaccination mode that can be implemented with ease in a filovirus disease outbreak situation.

POLIO [to 18 July 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 15 July 2015
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: The National Emergency Action Plan (NEAP) for Pakistan has been officially endorsed by the Prime Minister, outlining the actions that must be taken to stop polio transmission. It is now vital that the commitment and efforts of the government, the partners, and the community as well as funding, be sustained throughout the coming months to keep cases of polio low during the high season for polio transmission.
:: In the first half of 2015 we have seen the lowest number of cases ever during this period, with just 33 cases in 2 countries as opposed to 122 cases in 9 countries at this time in 2014. This progress needs to be maintained through hard work to end transmission in endemic countries and to prevent future outbreaks.

Selected excerpts from Country-specific Reports
Afghanistan
:: One new polio case was reported in the past week in Balabuluk district of Farah province. This most recent case had onset of paralysis on 07 June 2015. The total number of WPV1 cases for 2015 is now five.
:: Intensive and strengthened supplementary immunization activities are planned in the coming months. National Immunization Days (NIDs) are scheduled on 16 to 18 August using bivalent oral polio vaccine (OPV). Subnational Immunization Days (SNIDs) will follow across the south of the country in September, and NIDs using trivalent OPV will take place in October.
Pakistan
:: Two new wild poliovirus type 1 (WPV1) cases were reported in the past week; one with onset of paralysis in Peshawar, Khyber Pakhtunkhwa and the second in a nearby district which is to be confirmed. The most recent case had onset of paralysis on 30 June. The total number of WPV1 cases for 2015 is now 28, compared to 94 at this time last year.

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Sustaining Achievements in Polio Eradication in Ethiopia and Africa
ADDIS ABABA, Ethiopia, July 14, 2015/African Press Organization (APO)/ — Ethiopian Minister of Health Dr Kesetebirhan Admasu, World Health Organization (WHO) Director General Dr Margaret Chan, The Global Alliance for Vaccines and Immunization (GAVI) Chief Executive Officer Dr Seth Berkley and UNICEF Deputy Executive Director Ms Yoka Brandt participated in a high level polio vaccination event at Selam Health Centre in Addis Ababa. Also present at the event were UNAIDS Executive Director Mr Michel Sidibe, US Ambassador Ms Patricia M. Haslach, Brazil Ambassador Mrs Isabel Cristina, President and CEO of PATH Dr Davis Steve, and Rotary National Polio Plus Committee Chairperson PDG Dr Tadesse Alemu as well as national and international EPI partners, health workers and mothers with their children.

“Strong leadership, political will and coordination are key to sustaining the gains made in interrupting polio transmission in Ethiopia and Africa,” said Dr Margaret Chan, commending Ethiopia’s aggressive response to the 2013 outbreak of wild polio virus. “Horn of Africa countries should continue to immunize all at risk age groups until the threat drops to zero and eradication is achieved. And this is possible only through high quality immunization activities for all communities.”

When the wild polio virus outbreak in the Horn of Africa spread to Ethiopia in August 2013, the Government of Ethiopia intensified vigilance, surveillance and mass immunization campaigns, together with partners like WHO, UNICEF, USAID, the US Centers for Disease Control and Prevention (CDC) and Rotary International. Fifteen supplementary immunization campaigns were implemented with a focus on high risk areas. Cross-border coordination was heightened, with Horn of Africa countries coming together to implement synchronized response activities.

It has been 18 months since the last case of wild polio virus was reported in Ethiopia, and 11 months since the last case in Africa.

Dr Kesetebirhan Admasu said, “We will focus on equity and quality for every child and mother in Ethiopia,” adding, “The Government of Ethiopia continues to be committed to eradicating polio from Ethiopia, and Africa.” He further affirmed that “The Government of Ethiopia will continue to engage communities for active participation in routine immunization, and will continue to build strong health partnerships.”…

WHO & Regionals [to 18 July 2015]
The Weekly Epidemiological Record (WER) 17 July 2015, vol. 90, 29 (pp. 365–372) includes:
:: Global Advisory Committee on Vaccine Safety, 10–11 June 2015

WHO’s new guidelines on HIV testing services
17 July 2015 — Globally only 51% of people living with HIV know of their status. The new guidelines provide a recommendation to support HIV testing services by trained lay providers and considers the potential of HIV self-testing to increase access to and coverage of HIV testing. The guidelines also address issues and elements for effective delivery of HIV testing services that are common in a variety of settings, contexts and diverse populations.
Read the new guideline

Deworming campaign improves child health, school attendance in Rwanda
17 July 2015 — Soil-transmitted helminth is one of the most common infections worldwide, with roughly 2 billion people affected, mostly in poor and deprived communities. WHO supported the Ministry of Health in Rwanda to launch a deworming campaign, which has lowered the prominence of Soil-transmitted helminth by nearly 20% in the Musanze region. WHO aims to achieve 75% coverage, of all children, by 2020 against soil-transmitted helminth in the 10 most populous countries…

Global health workforce, finances remain low for mental health
14 July 2015 — Worldwide, nearly 1 in 10 people have a mental health disorder, but only 1% of the global health workforce is working in mental health. This means, for example, that nearly half of the world’s population lives in a country where there is less than one psychiatrist per 100 000 people.
:: WHO Regional Offices
WHO African Region AFRO
:: Delegation from MERCK pays courtesy call to WHO Regional Office for Africa
Brazzaville, 16 July 2015 – A high level delegation from MERCK, a drug pharmaceutical company has paid a courtesy call to the World Health Organization Regional Office in Djoue, Brazzaville where they were received by Dr Matshidiso Moeti, Regional Director for Africa.Dr. Frank Stangenberg-Haverkamp, Chairman of the Board of partners of Merck KG was accompanied by Dr. Karim Bendhaou, President of Merck North West Africa Group, Mr. Frank Gotthardt, Head of public affairs, and the WHO Representative to Congo Dr Fatoumata Diallo. The purpose of the visit was to discuss the ongoing partnership between WHO and Merck, specifically the scaling up of deworming of school age children in the Region, and the control of schistosomiasis in the Republic of Congo…

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

WHO South-East Asia Region SEARO
:: Timor-Leste launches campaign to protect 500 000 children against Measles, Rubella and Polio
13 July 2015
H.E. Prime Minster of Timor-Leste, Dr Rui Maria de Araújo and H.E. Minister of Health, Dr Maria do Céu Sarmento Pina da Costa launched a National Measles, Rubella and Polio Immunization Campaign on July 13th 2015, supported by Measles and Rubella Initiative, WHO, UNICEF and global immunization partners. This campaign targets 500 000 children throughout the country.

WHO European Region EURO
:: Uzbekistan strengthens the safety and resilience of its hospitals 14-07-2015
:: New report: Investing in public health offers large gains in health, the economy and other sectors 14-07-2015
:: Building capacity for laboratory services 14-07-2015

WHO Eastern Mediterranean Region EMRO
:: WHO delivers urgently needed health supplies to Aden as part of United Nations convoy
13 July 2015, Sana’a, Yemen — WHO has delivered 46.4 tonnes of medicines, medical supplies, and water and sanitation supplies to Aden in Yemen. Access to health care in Aden is extremely limited due to fighting and most of the governorate’s 31 health facilities are non-functional due to critical shortages in medical supplies and fuel needed for generators. To date, WHO has distributed more than 175 tonnes of medicines and medical supplies in Yemen, reaching a total of almost 5 million people.
Read more about the shipment

WHO Western Pacific Region
:: The Western Pacific Region scales up response to antimicrobial resistance
MANILA, 14 July 2015 – The World Health Organization (WHO) in the Western Pacific Region continues to scale-up efforts in the fight against antimicrobial resistance (AMR). Left unaddressed, antimicrobial resistance has the potential to increase the cost of health care, hamper the control of infectious diseases and damage trade and economies…

CDC/MMWR/ACIP Watch [to 18 July 2015]
http://www.cdc.gov/media/index.html

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New CDC study highlights burden of pneumonia hospitalizations among US adults
TUESDAY, JULY 14, 2015
When U.S. adults are hospitalized with pneumonia, viruses are more often to blame than bacteria. However, despite current diagnostic tests, neither viruses nor bacteria are detected in the majority…

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MMWR July 17, 2015 / Vol. 64 / No. 27
:: Pertussis and Influenza Vaccination Among Insured Pregnant Women — Wisconsin, 2013–2014

GAVI [to 18 July 2015]
http://www.gavialliance.org/library/news/press-releases/

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:: Global consensus on financing development provides platform for sustainable development goals
Gavi highlighted at Addis Ababa meeting.
Geneva, 17 July 2015 – Gavi, the Vaccine Alliance today welcomed progress towards financing the upcoming Sustainable Development Goals (SDGs) that world leaders are due to adopt in New York in September during the United Nations General Assembly.

The Addis Ababa Action Agenda, endorsed by the world’s governments at the Financing for Development conference yesterday, highlights key areas of development financing with the ultimate goal of ending extreme poverty by 2030. These include increases in domestic resources, urging donors meet their aid commitments and the use of innovative financing mechanisms and multi stakeholder partnerships to maximise impact of development funding.

In September, countries are expected to finalise the SDGs, which will replace the Millennium Development Goals. The agreement in Addis Ababa underpins the crucial need to fund health interventions such as immunisation.

The Action Agenda commits the world’s governments to “support research and development of vaccines and medicines, as well as preventive measures and treatments for the communicable and non-communicable diseases, in particular those that disproportionately impact developing countries”. It adds, “We will support relevant initiatives, such as Gavi, the Vaccine Alliance, which incentivizes innovation while expanding access in developing countries…

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:: Alwaleed Philanthropies to support childhood immunisation with US$ 1 million pledge
Funding will cover the costs of vaccines in six countries
Geneva, 13 July 2015 – Alwaleed Philanthropies today committed to protecting the lives of children through immunisation by signing an agreement worth US$ 1 million with Gavi, the Vaccine Alliance.

The agreement, which was negotiated at the Gavi Pledging Conference in January, marks the first time Alwaleed Philanthropies has provided support to Gavi. The contribution will support all projected vaccine needs in Timor Leste, Kiribati, Armenia, Azerbaijan, Moldova, and Guyana for the 2016-2020 period…

Sabin Vaccine Institute [to 18 July 2015]
http://www.sabin.org/updates/pressreleases

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:: Sabin PDP Advances World’s First Human Hookworm Vaccine
WASHINGTON, D.C. — July 13, 2015 — The Sabin Vaccine Institute (Sabin) today released updates on its product development partnership (Sabin PDP) and five Phase 1 clinical trials for two vaccine candidates for human hookworm, one of the most common neglected tropical diseases (NTDs).

These studies would not have been possible without broad collaboration across organizations and disciplines. Funding was provided by the Bill & Melinda Gates Foundation, the Dutch Ministry of Foreign Affairs and the European Commission FP7 Programme. The Infectious Disease Research Institute (IDRI), based in Seattle, manufactured the GLA-AF and CpG ODN 10104 adjuvants used in the trials. The CpG ODN 10104 adjuvant was originally developed by Pfizer. Aeras, based in Rockville, Md., manufactured the Na-GST-1 hookworm vaccine used in the studies, while Fraunhofer, based in Newark, Del., and the Walter Reed Army Institute of Research, based in Rockville, Md., manufactured the Na-APR-1 (M74) hookworm vaccine antigen…

Aeras Announces New CEO and Leadership Structure
Jacqueline Shea will assume CEO role in August
Rockville, MD., July 15, 2015 – Aeras announced today a new leadership structure for the nonprofit biotech organization with Jacqueline E. Shea, Ph.D., the current Chief Operating Officer (COO), assuming the role of Chief Executive Officer (CEO), effective August 12. Thomas G. Evans, M.D., will step down as CEO to become Acting Chief Scientific Officer (CSO). Ann M. Ginsberg, M.D., Ph.D., will continue as Chief Medical Officer.

Dr. Evans will serve as Acting CSO while Aeras considers how it wishes to fill the position permanently. “I am extremely happy that Dr. Shea will be leading Aeras as we continue our important work of tuberculosis (TB) vaccine development,” said Dr. Evans. “She is an outstanding choice and I am tremendously pleased to know that Aeras leadership will be in her capable hands. This is the right time for me and the organization to make this change, after five years with Aeras first as CSO, then CEO. As Acting CSO, I will be able to focus on the work I most enjoy. There is much unfinished work for me to do in the science arena, and I am looking forward to having the time to concentrate on a number of exciting TB projects.”

Dr. Shea joined Aeras as COO in April 2014, with more than 20 years of experience in the life sciences. “I came to Aeras last year to be part of the global effort to develop critically needed TB vaccines,” said Dr. Shea. “I’ve enjoyed working with Tom and the entire Aeras team and am looking forward to the challenge of this enhanced leadership role, expanding on Tom’s great work.”…

European Medicines Agency [to 18 July 2015]
http://www.ema.europa.eu/ema/

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:: FDA, European Commission and EMA reinforce collaboration to advance medicine development and evaluation
14/07/2015
US and EU regulators aim to enhance trust in quality, safety and efficacy of medicines
Senior leaders from the United States Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMA) reviewed their ongoing cooperative activities and discussed strategic priorities for the next two years at their regular bilateral meeting held on 19 June 2015, at FDA Headquarters in Silver Spring, Maryland, USA.
Over the past years, EMA and FDA have significantly increased their level of collaboration and sharing of information to advance regulatory excellence worldwide. There are now daily interactions, most of them structured around scientific and regulatory working groups or “clusters”. The focus of the cluster reviews during this bilateral was pharmacovigilance, biosimilars, paediatrics and veterinary medicines….

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:: Call for civil society members of EMA Management Board
14/07/2015
Expressions of interest to be submitted to European Commission by 20 September 2015.

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:: How to improve the availability of veterinary vaccines in Europe
13/07/2015
EMA publishes workshop report on requirements for the authorisation of vaccines…

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:: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2015
13/07/2015
EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of HPV vaccines to further clarify aspects of their safety profile. Like all medicines the safety of these vaccines is monitored by the PRAC. The review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome and postural orthostatic tachycardia syndrome. The review does not question that the benefits of HPV vaccines outweigh their risks.
Article-20 procedure: Human papillomavirus (HPV) vaccines

European Vaccine Initiative [to 18 July 2015]
http://www.euvaccine.eu/news-events

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New EDCTP Executive Director from January 2016
16 July 2015
Dr. Michael Makanga will replace Professor Charles Mgone as Eecutive Director of The European & Developing Countries’ Clinical Trials Partnership (EDCTP) in January 2016.
Dr. Makanga comes from a position as Head of EDCTP Africa Office in Cape Town, which he has held since 2008…

PATH [to 18 July 2015]
http://www.path.org/news/index.php

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Press release | July 13, 2015
:: 30 innovations that could transform global health: introducing the Innovation Countdown 2030 report
PATH leads global initiative to crowdsource and assess innovations with the potential to save millions of lives by 2030

Addis Ababa, Ethiopia, July 13, 2015—The PATH-led Innovation Countdown 2030 initiative (IC2030) today launched its inaugural report, Reimagining Global Health, at the Third International Conference on Financing for Development. The report features 30 innovations selected by international experts for their lifesaving potential and can be downloaded at http://www.ic2030.org.

2015 marks a seminal moment in global health as world leaders coalesce around new global goals that will determine the international development agenda and health investments over the next 15 years. Innovative technologies and approaches that make health care more affordable, more effective, and easier to access are key to reaching the new health goals by 2030.

Reimagining Global Health is the result of a yearlong process to identify, evaluate, and showcase some of those high-potential health technologies and ideas, with the goal of catalyzing investment and support.
Two innovations found to have exceptional potential are a simple, low-cost antiseptic to prevent newborn infections and new technologies for small-scale water treatment at the community level. These two innovations alone, with expanded use, could save the lives of 2.5 million newborns and children by 2030.

Tapping innovation around the world
PATH sought ideas from experts, innovators, and technology developers worldwide, crowdsourcing solutions with great promise to accelerate progress toward reaching the 2030 health targets.

People in nearly 50 countries nominated more than 500 innovations for consideration. Dozens of independent health experts then assessed and ranked them, selecting the 30 innovations featured in the report.

“Innovation is the essential ingredient in empowering communities with solutions they can use to transform their own health,” said Steve Davis, PATH President and CEO. “To achieve the 2030 health targets, we must focus our brightest minds, collective resources, and shared aspirations on accelerating innovations with the most potential for impact.”
“World leaders are coming together in 2015 around new global goals that can ensure good health and equal opportunity for all. By prioritizing and coordinating investments in innovations that can deliver the greatest health value for money, we can create financially sustainable solutions that reach the millions of people who have yet to share in the gains of our progress,” said Mr. Borge Brende, Minister of Foreign Affairs, Norway.

The initiative is supported by the Norwegian Agency for Development Cooperation, the Bill & Melinda Gates Foundation, and the US Agency for International Development.

Innovations to tackle the world’s most urgent health issues
The 30 selected innovations cover four health areas:

:: Maternal, newborn, and child health, an area featuring innovations such as a uterine balloon tamponade to manage excessive bleeding after childbirth, the leading cause of maternal death; portable devices that measure oxygen levels in the blood to improve detection of pneumonia, the top killer of young children; and new treatments for severe diarrhea, another major cause of child deaths.

:: Infectious diseases, where key innovations include malaria vaccine candidates, long-acting injectable drugs to treat HIV infection, and a novel multidrug treatment regimen to shorten the treatment for tuberculosis.

:: Reproductive health, where new injectable contraceptives and expanded access to long-acting, reversible contraceptives such as intrauterine devices may have great impact.
:: Noncommunicable diseases, where potentially transformative innovations include the use of a low-cost polypill to prevent cardiovascular disease and the use of mobile devices for chronic disease prevention and management.

“IC2030 identifies health solutions that have the potential to make a catalytic impact in global health over the next 15 years,” said Chris Elias, President of Global Development, Bill & Melinda Gates Foundation. “By finding and amplifying promising ideas and strengthening the capacity of low-resource countries to develop, introduce, and share innovation, we can accelerate progress so that every person has an equal chance for a healthy and productive life.”..

Global Fund [to 18 July 2015]
http://www.theglobalfund.org/en/mediacenter/newsreleases/

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:: Ethiopia Moves Forward with Major New Grants
16 July 2015
ADDIS ABABA, Ethiopia – The Government of Ethiopia and the Global Fund partnership today signed four new grants for US$551.6 million to fight HIV, tuberculosis, and malaria and to build resilient and sustainable systems for health.
The financial resources provided through the Global Fund come from many sources and partners, represented today by the UK Department for International Development, the European Union, the Italian Development Cooperation, the United States, GAVI, the Vaccine Alliance, UNICEF and WHO, among others.
“With a focus on equity and quality, going forward, Global Fund resources will be used, as in the past, to fulfil our vision for healthy, productive and prosperous Ethiopians… a population free of HIV, malaria and tuberculosis,” said Kesetebirhan Admasu, Ethiopia’s Minister of Health…

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:: Linking Health and Education
15 July 2015
ADDIS ABABA, Ethiopia – Global development partners meeting at the Financing for Development conference today called for stronger linkages between investments in health and education in low- and middle-income countries.
In an event, co-hosted by the governments of Ethiopia and the United States together with the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNAIDS and the Global Partnership on Education, participants called for ambitious investments that strive for a world where everyone has access to quality health and education…

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:: Results Show Strong Progress Against HIV, TB and Malaria
15 July 2015
GENEVA – As world leaders met in Addis Ababa to discuss financing for the Sustainable Development Goals, the Global Fund announced mid-year results that demonstrate strong progress against HIV, tuberculosis and malaria.
The results show that 8.1 million people are receiving antiretroviral treatment for HIV through programs supported by Global Fund grants, a 22 percent increase since the same time last year.
For malaria, 548 million mosquito nets have been distributed to protect children and families from the disease, an annual increase of 32 percent. The number of tuberculosis cases detected and treated increased by 11 percent, with 13.2 million people assisted.
The Global Fund partnership values the strong contributions to these results made by governments, civil society, the private sector and people affected by HIV, TB and malaria.
Other key results of Global Fund-supported programs include:
:: A 55 percent increase in the number of people treated for multi-drug resistant tuberculosis, rising to 210,000 treatments.
:: A 20 percent increase in the number of HIV-positive pregnant women receiving medication to prevent transmission to their child, or 3.1 million women.
:: The number of people receiving counselling and testing for HIV increased by 18 percent, to 423 million.
:: The number of tuberculosis cases successfully treated increased 12 percent to 10.7 million, while the number of malaria cases treated was up 19 percent to 515 million…

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:: Accelerating Domestic Investments in Health
13 July 2015
ADDIS ABABA, Ethiopia – Efforts to increase domestic investment in health programs have taken a prominent spot at the Financing for Development conference in Addis Ababa, Ethiopia, this week.
African leaders, including Ethiopian Prime Minister, Hailemariam Desalegn, addressed a session today focused on the need to invest more in health, attended by Dr. Nkosazana Dlamini-Zuma, Chair of the Africa Union Commission, and others.
“African countries must find more ways to invest more into health,” said Prime Minister Hailemariam Desalegn. “This is fundamental. The transformation of our economies and our countries will never be complete without claiming victory over diseases.”…

Industry / DCVMN / PhRMA / EFPIA / IFPMA / BIO Watch [to 18 July 2015]

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:: GSK begins shipping 2015-16 US flu vaccines with focus on customer needs, volume, and speed
Jul 16, 2015, 08:00 ET GSK announced today it has begun shipping FLUARIX® QUADRIVALENT (Influenza Vaccine) doses to US healthcare providers, following licensing and lot-release approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research

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:: Sanofi Pasteur Ships First 2015-2016 Seasonal Influenza Vaccine Doses in United States
Jul 14, 2015, 08:00 ET Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its first doses of Fluzone® (Influenza Vaccine) for the 2015-2016 influenza (“flu”) season have been released by the U.S. Food and Drug Administration (FDA) for shipment.

IVI [to 18 July 2015]
http://www.ivi.org/web/www/home

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:: IVI Leadership Change Announcement
[undated]
Mr. John Morahan is stepping down as IVI’s Chief Operating Officer (COO), effective July 17, 2015. He is resigning for personal reasons.

A recruitment process has been implemented for John’s successor.

John joined IVI in August, 2011 as the Chief Financial Officer and Deputy Director General of Finance & Administration. During his tenure, the Enterprise Resource Planning (ERP) system was launched, and systems, internal control and financial management were strengthened. John served as Acting Director General in 2014 after the departure of Dr. Christian Loucq as IVI’s Director General, and led the Institute during the transition process until a new Director General was appointed. Following the appointment of Dr. Jerome Kim as IVI’s Director General, John became the Chief Operating Officer (COO) in early 2015.

IVI’s leadership and the Board of Trustees recognize that John’s tenure as CFO, COO and Acting Director General, occurring at a difficult and critical time in IVI’s history, has provided leadership, stability and a foundation for future growth. We thank John for his contributions and wish him all the best in his endeavors.

IAVI International AIDS Vaccine Initiative [to 18 July 2015]
http://www.iavi.org/press-releases/2015

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:: AIDS Vaccine R&D Funding – Latest Data Shows Concerning Trends
July 17, 2015
NEW YORK – The latest data from the HIV Vaccines and Microbicides Resource Tracking Working Group highlights concerning trends in funding for vaccine-related research and development. Among the report’s key findings:

:: There’s a flat trend in AIDS vaccine R&D investment.
While funding for crucial HIV treatment and prevention programs in low- and middle-income countries is rising, vaccine R&D funding has essentially stayed flat for the past seven years.

:: The vaccine R&D donor pool is shrinking and needs greater diversity.
The majority of investment is coming from fewer large funders, raising risks to sustainability: 84% of vaccine R&D funding comes from just two sources: the United States government and the Bill & Melinda Gates Foundation.
The number of philanthropic donors who funded overall HIV prevention R&D in 2014 (16) was about half what it was in 2010 (30).
More than 99% of philanthropic funding for AIDS vaccine R&D in particular comes from just three sources: the Bill & Melinda Gates Foundation (87%), the Ragon Foundation (approx. 8%) and Wellcome Trust (approx. 5%).

:: AIDS vaccine R&D has been getting ever more dependent on US government funding.
US government investments account for 70% of all funding for AIDS vaccine R&D.
Only 4.8% of HIV vaccine funding comes from European sources, a drop of 10% in 2014 over 2013 and of more than half from its 2006 height.
BRICS countries (Brazil, Russia, India, China and South Africa) provide 1.3% of funding.
Read the press release and the full report at http://www.hivresourcetracking.org.
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:: Vanderbilt University Medical Center Joins Human Vaccines Project as First Scientific Hub
July 13, 2015
Vanderbilt University Medical Center (VUMC), the Human Vaccines Project and the International AIDS Vaccine Initiative (IAVI) are pleased to announce that VUMC has become the Project’s first scientific hub.

Incubated by IAVI, the Human Vaccines Project is a new public-private partnership that brings together leading academic research centers, industry, governments and nonprofits to accelerate the development of vaccines and immunotherapies against infectious diseases and cancers by decoding the human immune system.

“We are delighted that Vanderbilt University Medical Center will bring its world-class vaccine research and human immunology expertise to the Human Vaccines Project,” said Wayne C. Koff, IAVI Chief Scientific Officer and the Project’s Founder.

Under the collaboration announced today, VUMC has pledged a multi-year commitment toward the Project which will include a large-scale global effort to decipher the “Human Immunome,” the basic components of the human immune system, to enhance design of next-generation vaccines and immunotherapies…